# US 12,089,870 B2 · Devices and methods for accessing the left atrium for cardiac procedures

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- Number: US 12,089,870 B2
- Document ID: US12089870B2
- Status: Granted
- Kind: B2
- Application number: 18/189,811
- Filed: 2023-03-24
- Published: 2023-07-27
- Granted: 2024-09-17
- Earliest claimed: 2017-07-13
- Assignees: MITRx, Inc.
- Applicants: MITRx, Inc.
- Inventors: Murali Dharan; Albert K. Chin; Jeffry J. Grainger
- Web page: https://patentgrep.com/patent/US12089870B2

## CPC

- 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 17/3415: {for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters (A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06)}
- A61B 1/3137: {for examination of the interior of blood vessels}
- A61B 17/0469: {Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery}
- A61B 17/3431: {being collapsible, e.g. made of thin flexible material (A61B17/3423 takes precedence)}
- A61F 2/2436: {Deployment by retracting a sheath}
- A61F 2/2445: {Annuloplasty rings in direct contact with the valve annulus}
- A61F 2/2466: {Delivery devices therefor}
- A61N 1/0587: {Epicardial electrode systems; Endocardial electrodes piercing the pericardium}
- A61B 17/0293: {with ring member to support retractor elements}
- A61B 17/0466: {Suture bridges}
- A61B 2017/00039: {Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect}
- A61B 2017/00243: {cardiac}
- A61B 2017/00247: {Making holes in the wall of the heart, e.g. laser Myocardial revascularization}
- A61B 2017/003: {Steerable}
- A61B 2017/00575: {for closure at remote site, e.g. closing atrial septum defects}
- A61B 2017/0061: {Implements located only on one side of the opening}
- A61B 2017/00663: {the implement being a suture}
- A61B 2017/00672: {Locating means therefor, e.g. bleed back lumen}
- A61B 2017/00783: {Valvuloplasty}
- A61B 2017/00884: {enhancing wound closure}
- A61B 2017/00942: {hydrophilic}
- 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 2017/0475: {using sutures having a slip knot}
- A61B 2017/3425: {for internal organs, e.g. heart ports}
- A61B 2017/3427: {for intercostal space}
- A61B 2017/3445: {used as instrument channel for multiple instruments}
- A61B 2017/3484: {Anchoring means, e.g. spreading-out umbrella-like structure}
- A61B 2017/3486: {Balloon}
- A61B 2017/3488: {Fixation to inner organ or inner body tissue}
- 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)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

Systems, devices, and methods for providing access to the heart. The system includes an intracardiac access device comprising an elongate member having a channel extending between a distal end and a proximal end thereof. The intracardiac access device is configured to be advanced through an extrapericardial penetration in the left atrial wall without penetrating the pericardium of the heart. An optional procedural device is configured to be advanced through the channel of the intracardiac access device into an internal chamber of the heart and configured to perform a surgical procedure in the internal chamber of the heart. A working channel of an optional suprasternal access device is configured to facilitate access of the intracardiac access device into the body of the patient by providing a path from a suprasternal opening to a position adjacent the roof of the left atrium.

## Claims

### Claim 1

A method, comprising:
inserting a distal portion of a surgical instrument into a body of a patient through an opening in a suprasternal notch of the patient;
advancing the distal portion of the surgical instrument anteriorly along the trachea of the patient toward a left atrium of a heart of the patient;
making an extrapericardial penetration through a cardiac wall at a first location on a dome of the left atrium of the patient, wherein the first location is a devoid of pericardium of the heart;
advancing the distal portion of the surgical instrument through the extrapericardial penetration in the dome of the left atrium to access an internal chamber of the heart, while a proximal portion of the surgical instrument remains outside the body of the patient;
inserting a procedural instrument through a channel in the surgical instrument into the internal chamber of the heart; and
performing a surgical procedure in the internal chamber of the heart with the procedural instrument.

### Claim 2 (depends on 1)

The method of claim 1, further comprising making an incision adjacent the suprasternal notch of the patient to form the opening in the suprasternal notch of the patient.

### Claim 3 (depends on 2)

The method of claim 2, wherein the incision is made without cutting any portion of a sternum or any ribs of the patient.

### Claim 4 (depends on 1)

The method of claim 1, wherein advancing the distal portion of the surgical instrument toward the heart comprises advancing the distal portion of the surgical instrument through a mediastinal space of the body.

### Claim 5 (depends on 1)

The method of claim 1, wherein advancing the distal portion of the surgical instrument toward the heart comprises advancing the distal portion of the surgical instrument along a path anterior to the trachea.

### Claim 6 (depends on 5)

The method of claim 5, wherein the path extends through a space between the trachea and an ascending aorta, or a space between the trachea and an arch of the aorta or the space between the innominate artery and the trachea.

### Claim 7 (depends on 5)

The method of claim 5, wherein the path extends through a space between the trachea and a right branch of a pulmonary artery, a space between the trachea and a left branch of a pulmonary artery, or a space between the trachea and a bifurcation of a main pulmonary artery.

### Claim 8 (depends on 5)

The method of claim 5, wherein the path is substantially parallel to a plane containing a longitudinal axis of the trachea.

### Claim 9 (depends on 5)

The method of claim 5, wherein the path is substantially parallel to a plane defined by a primary bronchus.

### Claim 10 (depends on 1)

The method of claim 1, wherein advancing the distal portion toward the heart comprises steering the distal portion of the surgical instrument to avoid internal structures of the patient.

### Claim 11 (depends on 10)

The method of claim 10, wherein the internal structures of the patient comprise a pulmonary artery or a primary bronchus of the patient.

### Claim 12 (depends on 1)

The method of claim 1, wherein inserting the distal portion of the surgical instrument through the opening comprises inserting the distal portion of the surgical instrument into a working channel of a mediastinoscope placed in the opening, and wherein advancing the distal portion comprises advancing the distal portion of the surgical instrument through the working channel.

### Claim 13 (depends on 1)

The method of claim 1, wherein the surgical instrument comprises a cannula having a channel and a trocar disposed in the channel, wherein making the extrapericardial penetration comprises making an extrapericardial penetration with the trocar, and further comprising removing the trocar from the channel after advancing the distal portion of the surgical instrument through the extrapericardial penetration.

### Claim 14 (depends on 1)

The method of claim 1, the incision through the cardiac wall at the first location is made without penetrating the pericardium of the heart.

### Claim 15 (depends on 1)

The method of claim 1, further comprising contacting the left atrium of the heart with the distal portion of the surgical instrument prior to making the pericardial penetration.

### Claim 16 (depends on 1)

The method of claim 1, further comprising sealing the cardiac wall of the extrapericardial penetration and the distal portion of the surgical instrument.

### Claim 17 (depends on 16)

The method of claim 16, wherein sealing comprises tightening a pursestring suture in the cardiac wall around the extrapericardial penetration around the distal portion of the surgical instrument.

### Claim 18 (depends on 16)

The method of claim 16, wherein sealing comprises expanding a sealing element coupled to a distal end of the surgical instrument.

### Claim 19 (depends on 18)

The method of claim 18, wherein the sealing element comprises a compression flange or a balloon.

### Claim 20 (depends on 1)

The method of claim 1, further comprising preventing inadvertent removal of the surgical instrument through the extrapericardial penetration.