# US 2014/0194971 A1 · Devices and methods for coronary sinus pressure relief

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- Number: US 2014/0194971 A1
- Document ID: US20140194971A1
- Status: Published application
- Kind: A1
- Application number: 14/152,094
- Filed: 2014-01-10
- Published: 2014-07-10
- Earliest claimed: 2006-11-07
- Assignees: Corvia Medical, Inc.
- Applicants: DC Devices, Inc.
- Inventors: Edward McNamara
- Web page: https://patentgrep.com/patent/US20140194971A1

## CPC

- 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)}
- A61F 2/2493: {Transmyocardial revascularisation [TMR] devices}
- A61F 2/844: folded prior to deployment
- A61F 2/90: characterised by a net-like or mesh-like structure
- A61B 17/221: Gripping devices in the form of loops or baskets {for gripping calculi or similar types of obstructions (surgical snare instruments A61B17/32056)}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 2017/00247: {Making holes in the wall of the heart, e.g. laser Myocardial revascularization}
- A61B 2017/00252: {for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel}
- A61B 2017/00575: {for closure at remote site, e.g. closing atrial septum defects}
- 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 2017/00623: {Introducing or retrieving devices therefor}
- A61B 2017/22035: {for retrieving or repositioning foreign objects}
- A61B 2017/2215: {having an open distal end}
- A61B 2018/00023: {closed, i.e. without wound contact by the fluid}
- A61B 2018/00351: {Heart}
- A61B 2018/144: {Wire}
- A61F 2/2403: {with pivoting rigid closure members (check valves with hinged closure members in general F16K15/03)}
- A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves}
- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61F 2/2451: {Inserts in the coronary sinus for correcting the valve shape}
- A61F 2/2478: {Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands}
- A61F 2/82: Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents (stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07)
- A61F 2/91: made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
- A61F 2/954: for placing stents or stent-grafts in a bifurcation
- A61F 2002/061: {provided with means for allowing access to secondary lumens}
- A61F 2002/821: {Ostial stents}
- A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol
- A61F 2220/0008: Fixation appliances for connecting prostheses to the body
- A61F 2220/0041: using additional screws, bolts, dowels or rivets, e.g. connecting screws
- A61F 2220/005: using adhesives
- A61F 2220/0058: soldered or brazed or welded
- A61F 2230/0017: Angular shapes
- A61F 2230/005: Rosette-shaped, e.g. star-shaped
- A61F 2230/0054: V-shaped
- A61F 2230/0067: conical
- A61F 2250/0067: Means for introducing or releasing pharmaceutical products into the body
- A61F 2250/0069: Sealing means
- A61F 2250/0098: radio-opaque, e.g. radio-opaque markers
- A61L 31/022: {Metals or alloys}
- A61M 1/3613: {Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion}
- A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)}
- 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)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- 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

A method and devices for relieving pressure in the left atrium of a patient's heart is disclosed. The method includes using an ablative catheter in a minimally invasive procedure to prepare an opening from the coronary sinus into a left atrium of the patient's heart. Once the opening is prepared, the opening may be enlarged by a technique such as expanding a balloon within the opening. A stent is then placed within the coronary sinus of the patient, with a transverse portion expanding within the opening, allowing blood to flow from the left atrium to the coronary sinus and then to the right atrium. Pressure within the left atrium is thus relieved.

## Claims

### Claim 1

A stent for use in a patient, comprising:
a plurality of struts; and
a plurality of intersections joining the struts to form a stent having a longer cylindrical portion and a shorter cylindrical portion adjacent the longer cylindrical portion and extending beyond the longer cylindrical portion in a direction perpendicular to an axis of the longer cylindrical portion,
wherein the longer cylindrical portion is adapted to fit into and bear against a coronary sinus and wherein the shorter portion is adapted to form an opening from the coronary sinus to a left atrium of the patient.

### Claim 2 (depends on 1)

The stent according to claim 1, wherein the struts are made from a metal selected from the group consisting of shape memory alloys, nitinol, stainless steel and MP35.

### Claim 3 (depends on 1)

The stent according to claim 1, wherein the stent further comprises at least two features with properties selected from the group consisting of radiographic properties and echogenic properties.

### Claim 4 (depends on 1)

The stent according to claim 1, further comprising at least one flap attached to the shorter portion, the flap attached and oriented to allow blood to flow only one way, from the left atrium into the coronary sinus.

### Claim 5 (depends on 1)

The stent according to claim 1, further comprising at least one flap made from mammalian pericardium attached to the shorter portion, the flap attached and oriented to allow blood to flow only one way, from the left atrium into the coronary sinus.

### Claim 6 (depends on 1)

The stent according to claim 1, further comprising a flange on the shorter portion for engaging an atrial wall of the patient.

### Claim 7 (depends on 1)

The stent according to claim 1, further comprising a segmented flange on the shorter portion for engaging an atrial wall of the patient.

### Claim 8

A stent for use in a patient, comprising:
a longer, radially-expanding portion adapted for placement in a coronary sinus of the patient; and
a shorter portion adjacent and joined to the longer, radially-expanding portion, the shorter portion extending beyond the longer, radially-expanding portion in a direction perpendicular to an axis of the longer radially-expanding portion, the shorter portion adapted for placement within a left atrium of the patient,
wherein the longer, radially-expanding portion is adapted to bear against a wall of the coronary sinus and wherein the shorter portion is adapted to form an opening between the left atrium and the coronary sinus of the patient.

### Claim 9 (depends on 8)

The stent of claim 8, wherein the longer or shorter portion comprises radiopaque or echogenic features.

### Claim 10 (depends on 8)

The stent of claim 8, wherein the shorter portion is formed from a plurality of struts and intersections joining the struts, and further comprising at least one flap attached to the shorter portion, the flap attached and oriented to allow blood to flow only one way, from the left atrium into the coronary sinus.

### Claim 11 (depends on 10)

The stent of claim 10, wherein the at least one flap is attached and oriented so that blood flows from the left atrium into the coronary sinus when a pressure difference across the at least one flap reaches at least 1-10 mm Hg.

### Claim 12 (depends on 8)

The stent of claim 8, wherein the shorter portion is more flexible than the longer portion.

### Claim 13

A method for relieving intracardial pressure, the method comprising:
providing an opening between a left atrium of a heart and a coronary sinus; and
allowing blood to flow from the left atrium into the coronary sinus, thus relieving pressure.

### Claim 14 (depends on 13)

The method of claim 13, further comprising providing a stent and implanting the stent in the opening between the left atrium and the coronary sinus.

### Claim 15

A method for relieving intracardial pressure, the method comprising:
furnishing a stent suitable for implantation into a coronary sinus of a patient, the stent suitable for extending from the coronary sinus to within a left atrium of the patient and for maintaining communication between the left atrium and the coronary sinus;
preparing an opening into the left atrium using at least one instrument in the coronary sinus;
maneuvering the stent into the coronary sinus to a position near the opening; and
deploying a portion of the stent into the opening, wherein the stent maintains communication between the left atrium and the coronary sinus to relieve pressure within the left atrium.

### Claim 16 (depends on 15)

The method according to claim 15, wherein the step of preparing the opening further comprises:
guiding a first catheter into the coronary sinus of the patient, the first catheter including a side port and also including a cutting or ablating instrument for creating the opening into the left atrium.

### Claim 17 (depends on 15)

The method according to claim 15, further comprising expanding the opening using a balloon catheter.

### Claim 18 (depends on 15)

The method according to claim 15, wherein the step of maneuvering the stent comprises:
guiding the stent into the coronary sinus with a catheter; and
placing the stent into the opening by withdrawing an outer sheath from around the stent.

### Claim 19

A method for relieving intracardial pressure, the method comprising:
furnishing a stent suitable for implantation into coronary sinus of a patient, the stent suitable for extending from the coronary sinus to within a left atrium of the patient and for maintaining communication between the left atrium and the coronary sinus;
preparing an opening in a wall between the left atrium and the coronary sinus;
maneuvering the stent to a position near the opening; and
deploying the stent into the opening, wherein the stent maintains communication between the left atrium and the coronary sinus.

### Claim 20 (depends on 19)

The method of claim 19, wherein the opening in the wall is prepared using an ablative catheter in the coronary sinus to create the opening and a balloon catheter in the coronary sinus to expand the opening to a desired dimension.

### Claim 21 (depends on 19)

The method of claim 19, further comprising engaging a wall of the atrium with a flange of the stent.

### Claim 22 (depends on 19)

The method of claim 19, further comprising engaging an inner surface of the coronary sinus using a close fit between the stent and the coronary sinus.
