# US 6,346,074 B1 · Devices for less invasive intracardiac interventions

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- Number: US 6,346,074 B1
- Document ID: US6346074B1
- Status: Granted
- Kind: B1
- Application number: 08/662,119
- Filed: 1996-06-12
- Granted: 2002-02-12
- Earliest claimed: 1993-02-22
- Assignees: Heartport, Inc.
- Inventors: Alex T. Roth
- Web page: https://patentgrep.com/patent/US6346074B1

## CPC

- A61B 17/0469: {Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery}
- A61B 17/00234: {for minimally invasive surgery (A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence)}
- 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)}
- A61B 17/0218: {for minimally invasive surgery (A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence)}
- 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)}
- A61B 17/320016: {Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes (A61B10/0233, A61B17/29, A61B17/3207 take precedence)}
- A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61B 18/1482: {having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 90/50: Supports for surgical instruments, e.g. articulated arms
- A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation}
- A61M 25/1011: {Multiple balloon catheters}
- A61M 39/0247: {Transcutaneous or percutaneous access sites to the inside of the body}
- A61B 17/0467: {Instruments for cutting sutures (surgical cutting instruments A61B17/32)}
- A61B 17/2909: {Handles}
- A61B 17/3211: Surgical scalpels, knives; Accessories therefor
- 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)}
- A61B 18/1442: {Probes having pivoting end effectors, e.g. forceps}
- A61B 90/37: {Surgical systems with images on a monitor during operation}
- A61B 2017/00053: {Mapping}
- A61B 2017/00243: {cardiac}
- A61B 2017/00247: {Making holes in the wall of the heart, e.g. laser Myocardial revascularization}
- A61B 2017/00349: {Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue (A61B17/06066 takes precedence)}
- A61B 2017/00575: {for closure at remote site, e.g. closing atrial septum defects}
- A61B 2017/00579: {Barbed implements}
- A61B 2017/00592: {Elastic or resilient implements}
- A61B 2017/00597: {Implements comprising a membrane}
- A61B 2017/00606: {Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening}
- A61B 2017/00619: {Locking means for locking the implement in expanded state}
- A61B 2017/00623: {Introducing or retrieving devices therefor}
- A61B 2017/00867: {shape memory effect}
- A61B 2017/00907: {for light}
- A61B 2017/0243: {for immobilizing local areas of the heart, e.g. while it beats}
- 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}
- A61B 2017/0472: {Multiple-needled, e.g. double-needled, instruments}
- A61B 2017/0474: {Knot pushers}
- A61B 2017/0475: {using sutures having a slip knot}
- A61B 2017/2943: {Toothed members, e.g. rack and pinion}
- A61B 2017/2946: {Locking means}
- A61B 2017/306: {holding by means of suction}
- A61B 2017/3405: {using mechanical guide means}
- A61B 2017/3486: {Balloon}
- A61B 2017/3492: {against the outside of the body}
- A61B 2018/00214: {Expandable means emitting energy, e.g. by elements carried thereon}
- A61B 2018/00232: {having an irregular shape}
- A61B 2018/00261: {arranged in a line}
- A61B 2018/00291: {using suction}
- A61B 2018/00363: {Epicardium}
- A61B 2018/00392: {Transmyocardial revascularisation}
- A61B 2018/00577: {Ablation}
- A61B 2018/00898: {Alarms or notifications created in response to an abnormal condition}
- A61B 2018/00982: {combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes}
- A61B 2018/1465: {Deformable electrodes}
- A61M 2025/028: {having a mainly rigid support structure}
- A61M 2039/0273: {for introducing catheters into the body}
- A61M 2039/0279: {for introducing medical instruments into the body, e.g. endoscope, surgical tools}
- A61M 2039/0297: {at least part of it being inflatable, e.g. for anchoring, sealing or removing}
- A61M 2205/3344: Measuring or controlling pressure at the body treatment site
- A61M 2205/3355: Controlling downstream pump pressure
- A61M 2205/366: by liquid heat exchangers
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

Devices, systems, and methods are provided for accessing the interior of the heart and performing procedures therein while the heart is beating. In one embodiment, a tubular access device having an inner lumen is provided for positioning through a penetration in a muscular wall of the heart, the access device having a means for sealing within the penetration to inhibit leakage of blood through the penetration. The sealing means may comprise a balloon or flange on the access device, or a suture placed in the heart wall to gather the heart tissue against the access device. An obturator is removably positionable in the inner lumen of the access device, the obturator having a cutting means at its distal end for penetrating the muscular wall of the heart. The access device is preferably positioned through an intercostal space and through the muscular wall of the heart. Elongated instruments may be introduced through the tubular access device into an interior chamber of the heart to perform procedures such as septal defect repair and electrophysiological mapping and ablation. A method of septal defect repair includes positioning a tubular access device percutaneously through an intercostal space and through a penetration in a muscular wall of the heart, passing one or more instruments through an inner lumen of the tubular access device into an interior chamber of the heart, and using the instruments to close the septal defect. Devices and methods for closing the septal defect with either sutures or with patch-type devices are disclosed.

## Claims

### Claim 1

An assembly for visualization and access within a body cavity comprising:
a sleeve having a distal end, a proximal end, and a lumen therebetween, the sleeve also having a rigid, transparent bulb disposed at the distal end of the sleeve, the transparent bulb having a convex surface;
a scope having a shaft with a distal end and a proximal end, the shaft being slidably positionable in the lumen, a channel extending longitudinally through the shaft, and a lens in the channel near the distal end, the shaft being disposed in the lumen so that the lens is optically aligned with the rigid, transparent bulb; and
a guide sleeve having a lumen, the sleeve being slidably positionable in the lumen to a predetermined position in which the convex surface protrudes from a distal end of the guide sleeve.

### Claim 2 (depends on 1)

The assembly of claim 1 wherein the transparent bulb is made of a material selected from glass, acrylic, polystyrene, and polycarbonate.

### Claim 3 (depends on 1)

The assembly of claim 1 wherein the transparent bulb has a transverse cross-sectional area larger than the transverse cross-sectional area of the shaft.

### Claim 4 (depends on 1)

The assembly of claim 1 wherein the transparent bulb has a distal surface, the distal surface being convex.

### Claim 5 (depends on 1)

The assembly of claim 1 wherein sleeve has a length sufficient to reach an interior of a patient's heart from outside the patient's chest.

### Claim 6 (depends on 5)

The assembly of claim 5 wherein the sleeve has a length of at least about 15 cm.

### Claim 7

A repair system for repairing a septal defect in a patient's heart, the repair system comprising:
a sleeve having a distal end, a proximal end, and a lumen therebetween, the sleeve having a rigid, transparent bulb at the distal end;
a scope having a shaft with a distal end and a proximal end, the shaft being slidably positionable in the lumen, a channel extending longitudinally through the shaft, and a lens in the channel near the distal end, the lens being optically aligned with the transparent bulb when the shaft is positioned in the lumen;
a guide sleeve having a lumen, the sleeve being slidably positionable in the lumen to a predetermined position in which the convex surface protrudes from a distal end of the guide sleeve; and
a septal defect closure device positionable through the lumen of the sleeve.

### Claim 8 (depends on 7)

The repair system of claim 7 wherein the septal defect closure device comprises a delivery shaft having a distal end, a proximal end, and a patch releasably held at the distal end, the patch having a deployed configuration for positioning across a septal defect and a collapsed configuration for positioning through the lumen in the sleeve.

### Claim 9 (depends on 7)

The repair system of claim 7 wherein the septal defect closure device is configured to apply a suture to the cardiac septum.

### Claim 10 (depends on 7)

The repair system of claim 7 wherein the transparent bulb has a transverse cross-sectional area larger than the transverse cross-sectional area of the shaft.

### Claim 11 (depends on 7)

The repair system of claim 7 wherein the transparent bulb has a distal surface, the distal surface being convex.

### Claim 12 (depends on 7)

The repair system of claim 7 wherein sleeve has a length sufficient to reach an interior of a patient's heart from outside the patient's chest.

### Claim 13 (depends on 12)

The repair system of claim 12 wherein the sleeve has a length of at least about 15 cm.

### Claim 14 (depends on 7)

The repair system of claim 7 wherein the sleeve has an outer diameter of less than about 12 mm.

### Claim 15 (depends on 7)

The repair system of claim 7 wherein the sleeve is substantially rigid.

### Claim 16 (depends on 7)

The repair system of claim 7 further comprising an access cannula having a distal end positionable through a wall of the heart, a proximal end, and an access channel therebetween, the sleeve being slidably positionable through the access channel into the heart.

### Claim 17 (depends on 16)

The repair system of claim 16 wherein the access cannula has a flange on a distal end thereof for engaging an interior wall of the heart.

### Claim 18 (depends on 16)

The repairs system of claim 16 further comprising an obturator removably positionable in the access channel.

### Claim 19 (depends on 18)

The repair system of claim 18 wherein the obturator has a distal end configured to penetrate the wall of the heart.