# US 11,304,698 B2 · Cardiac shunt device and delivery system

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- Number: US 11,304,698 B2
- Document ID: US11304698B2
- Status: Granted
- Kind: B2
- Application number: 16/737,790
- Filed: 2020-01-08
- Published: 2020-07-09
- Granted: 2022-04-19
- Earliest claimed: 2016-07-25
- Applicants: Virender K. Sharma
- Inventors: Virender K. Sharma
- Web page: https://patentgrep.com/patent/US11304698B2

## CPC

- A61B 17/11: for performing anastomosis; Buttons for anastomosis
- A61B 17/122: Clamps or clips, e.g. for the umbilical cord {(for the vas deferens A61F6/206)}
- A61B 17/1285: {for minimally invasive surgery}
- A61F 2/2463: {Implants forming part of the valve leaflets}
- A61F 2/2466: {Delivery devices therefor}
- A61B 17/1227: {Spring clips}
- A61B 2017/00243: {cardiac}
- 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 2017/0034: {adapted to be inserted through a working channel of an endoscope}
- A61B 2017/00477: {Coupling (A61B2017/0046 takes precedence)}
- A61B 2017/00783: {Valvuloplasty}
- A61B 2017/00867: {shape memory effect}
- A61B 2017/00876: {magnetic}
- A61B 2017/0649: {Coils or spirals}
- A61B 2017/1107: {for blood vessels}
- A61B 2017/1139: {Side-to-side connections, e.g. shunt or X-connections}
- A61B 2017/12054: {Details concerning the detachment of the occluding device from the introduction device}
- A61F 2210/0033: electrically, e.g. heated by resistor
- A61F 2210/009: magnetic
- A61F 2230/005: Rosette-shaped, e.g. star-shaped
- A61F 2230/0091: helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
- 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)

## Abstract

A shunt device for creating a shunt in an atrial septum includes magnets coupled to inner loops of a coil comprising at least two inner loops and two outer loops, with a diameter of each of the inner loops being less than a diameter of the outer loops. The coil is made of a shape memory alloy (SMA) and is adapted to exert a compressive force upon layers of tissue caught between the inner loops of the coil. The magnets are adapted to provide additional compressive force to adjacent inner loops of the coil, thereby further causing the coil to cut through the layers of tissue and create a shunt. The diameter of the resultant shunt is less than the diameter of the outer loops, thereby preventing the outer two loops from passing through the created shunt. At least one end of the coil has a connection means for connecting with a delivery device.

## Claims

### Claim 1

A cardiac shunt device for creating a shunt in a portion of a patient's heart, comprising:
a wire comprised of a shape memory alloy, wherein the wire is adapted to transform from a substantially straight wire to a coil shape upon heating and wherein the wire, upon transforming to the coil shape, comprises at least two inner loops and at least two outer loops, and wherein the wire, when in the coil shape, is adapted to exert a compressive force upon layers of tissue caught between the at least two inner loops; and
a plurality of magnets coupled to portions of the at least two inner loops, wherein the plurality of magnets are adapted to provide a compressive force to adjacent inner loops of the wire in the coil shape, thereby further causing the wire to cut through the layers of tissue and create a shunt.

### Claim 2 (depends on 1)

The cardiac shunt device of claim 1, wherein at least one end of the wire comprises a connection means for connecting with a delivery device.

### Claim 3 (depends on 1)

The cardiac shunt device of claim 1 wherein a diameter of the wire when in a coil shape ranges between 0.1 mm to 10 mm and a length of the wire ranges from 1 cm to 250 cm.

### Claim 4 (depends on 1)

The cardiac shunt device of claim 1 wherein the plurality of magnets are positioned on the at least two inner loops such that repulsive forces between adjacent magnets of the plurality of magnets on a same one of the at least two inner loops cause said adjacent magnets to maintain a predefined distance between them.

### Claim 5 (depends on 4)

The cardiac shunt device of claim 4 wherein at least 50% of the adjacent magnets on each loop are arranged with like poles facing each other.

### Claim 6 (depends on 1)

The cardiac shunt device of claim 1 wherein the plurality of magnets are rare earth magnets covered with at least one of gold, nickel or titanium.

### Claim 7 (depends on 1)

The cardiac shunt device of claim 1 wherein the wire, when in a coiled shape, has a maximum cross sectional diameter ranging from 5 mm to 50 mm.

### Claim 8 (depends on 1)

The cardiac shunt device of claim 1 wherein each of the plurality of magnets have a maximum cross sectional length ranging from 0.2 mm to 7 mm and a pull force ranging from 0.1 lb. to 4 lb.

### Claim 9 (depends on 1)

The cardiac shunt device of claim 1 wherein a pull force between any two consecutively placed magnets of the plurality of magnets is approximately 2.318 N.

### Claim 10 (depends on 1)

The cardiac shunt device of claim 1 wherein a length, an inner diameter and an outer diameter of each of the plurality of magnets is 3 mm, 0.66 mm and 2.5 mm respectively.

### Claim 11 (depends on 1)

The cardiac shunt device of claim 1 wherein a shape of the shunt formed by using the shunt device is determined by a shape of the at least two inner loops.

### Claim 12 (depends on 1)

The cardiac shunt device of claim 1 wherein adjacent magnets on each of the at least two inner loops are separated by a non-ferromagnetic spacer, thereby preventing adjacent magnets from attaching to each other.

### Claim 13 (depends on 1)

The cardiac shunt device of claim 1 wherein each of the at least two outer loops are connected to opposing ends of the at least two inner loops.

### Claim 14 (depends on 1)

The cardiac shunt device of claim 1 wherein two opposing tips of the wire correspond to ends of the at least two outer loops and comprise a crimped probe at one of the two opposing tips and a cautery probe at a second of the two opposing tips.

### Claim 15 (depends on 14)

The cardiac shunt device of claim 14 wherein the crimped probe is attached to a screw as a connection means for connecting the wire with a delivery device.

### Claim 16 (depends on 15)

The cardiac shunt device of claim 15 wherein a magnet of the plurality of magnets at least partially encompasses the screw.

### Claim 17 (depends on 15)

The cardiac shunt device of claim 15 wherein the delivery device comprises a mechanism for heating the shunt device prior to deploying in the body of the patient.

### Claim 18 (depends on 14)

The cardiac shunt device of claim 14 wherein a magnet of the plurality of magnets at least partially encompasses the cautery probe.

### Claim 19 (depends on 1)

The cardiac shunt device of claim 1 wherein each of the at least two outer loops is wave-shaped so that a location of each crest of one of the at least two outer loops is aligned with each trough of a second of the at least two outer loops.

### Claim 20 (depends on 1)

The cardiac shunt device of claim 1 further comprising a heat source adapted to be connected to an end of the wire, wherein the heat source is adapted to deliver energy to heat the wire and cause the wire to transform from the substantially straight wire to the coil shape.

### Claim 21 (depends on 1)

The cardiac shunt device of claim 1, wherein a diameter of the at least two inner loops are each less than a diameter of each of the at least two outer loops.

### Claim 22 (depends on 1)

The cardiac shunt device of claim 1, wherein a diameter of the at least two inner loops are each less than a diameter of each of the at least two outer loops and wherein the shunt has a diameter that is less than the diameter of the outer loops such that the at least two outer loops do not pass through the shunt.