# US 9,750,921 B2 · Valve plane locator method and device

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- Number: US 9,750,921 B2
- Document ID: US9750921B2
- Status: Granted
- Kind: B2
- Application number: 14/260,167
- Filed: 2014-04-23
- Published: 2014-11-27
- Granted: 2017-09-05
- Earliest claimed: 2013-04-23
- Applicants: Subbarao V. Myla
- Inventors: Subbarao V. Myla
- Web page: https://patentgrep.com/patent/US9750921B2

## CPC

- A61M 25/0108: {using radio-opaque or ultrasound markers}
- A61M 25/04: in the body, e.g. expansible {(A61M25/10, A61M16/0488 take precedence)}
- A61B 6/487: {involving fluoroscopy}
- A61F 2/2496: {Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers}
- A61M 2025/0096: {being laterally outward extensions or tools, e.g. hooks or fibres}
- A61M 2025/0175: {having telescopic features, interengaging nestable members movable in relations to one another}
- A61M 2025/0681: {Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube}
- 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)}
- 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 catheter system is disclosed, having a plurality of expandable arms with radiopaque markers at their ends. Once deployed at a patient's valve, a user can obtain a correct 3D localization image for placement of the replacement valve by aligning the radiopaque markers to be substantially equidistant from each other and substantially located in the same plane, relative to the sensor of an X-Ray machine.

## Claims

### Claim 1

A catheter system for placement in a body organ, obtaining an X-Ray image of said body organ, and illustrating a valve plane in said body organ, said catheter system comprising:
an outer catheter sheath for insertion into the vasculature of a patient;
an inner catheter positioned in said outer catheter; said inner catheter having a distal stylet forming a distally pointed cone-shape centered relative to said inner catheter and that is sized to center said inner catheter in the center of a valve where three aortic valve cusps meet; and,
three expandable extensions disposed at and non-removably fixed to a distal region of said inner catheter; said expandable extensions each being discrete loops in radially equidistant positions from each other and each having a distal tip; each of said distal tips radially expanding away from said inner catheter relative to a proximal portion of said discrete loops when said outer catheter sheath is proximately withdrawn, such that a distal tip of each of said expandable extensions locate on one of said three aortic valve cusps;
wherein said distal tip of each of said plurality of expandable extensions are radiopaque,
wherein imaging said three expandable extensions within said body organ with an X-Ray machine, such that said three expandable extensions are viewed as equidistant and in the same plane, results in said three expandable extensions illustrating said valve plane.

### Claim 2 (depends on 1)

The catheter system of claim 1, wherein said wire loops are diamond shaped.

### Claim 3 (depends on 1)

The catheter system of claim 1, wherein said wire loops are teardrop-shaped.

### Claim 4 (depends on 1)

The catheter system of claim 1, wherein said wire loops are located at the distal end of an elongated wire.

### Claim 5 (depends on 1)

The catheter system of claim 1, wherein said plurality of expandable extensions further comprise three radially equidistant rectangular members.

### Claim 6

A catheter system for placement in a body organ, obtaining an X-Ray image of said body organ, and illustrating a valve plane in said body organ, said catheter system comprising:
an outer sheath;
a catheter having a guidewire passage opening at a distal and proximal end of said catheter for passing a guidewire therethrough;
a stylet forming a distally pointed cone-shape at a center and distal end of said catheter and shaped to center said catheter in a center of a valve where aortic valve cusps meet; and,
three expandable extensions disposed at and non-removably fixed to a distal region of said catheter; said plurality of expandable extensions each being discrete loops in radially equidistant positions from each other and each having a distal tip; each of said distal tips sized and positioned to radially expand away from said catheter relative to a proximal portion of said discrete loops and rest on said aortic valve cusps when said outer sheath is withdrawn;
wherein each of said plurality of expandable extensions have a radiopaque material on each of said distal ends;
wherein imaging said three expandable extensions within said body organ with an X-Ray machine, such that said three expandable extensions are viewed as equidistant and in the same plane, results in said three expandable extensions illustrating said valve plane.

### Claim 7 (depends on 6)

The catheter system of claim 6, wherein said plurality of expandable extensions are composed of a shape-memory material and biased to radially expand from said catheter when unconstrained.

### Claim 8 (depends on 6)

The catheter system of claim 6, wherein said expandable extensions have a shape of a loop, spiral, or diamond.

### Claim 9 (depends on 8)

The catheter system of claim 8, wherein said catheter has a guidewire passage with a distal and proximal opening.

### Claim 10 (depends on 8)

The catheter system of claim 8, further comprising an outer sheath located over said catheter.

### Claim 11 (depends on 6)

The catheter system of claim 6, wherein said catheter is configured for over-the-wire, monorail use.

### Claim 12

A method of using a catheter system for placement in a body organ, obtaining an X-Ray image of said body organ, and illustrating a valve plane in said body organ, said method of using a catheter system comprising advancing a catheter system to a valve, said catheter system comprising:
an outer catheter sheath for insertion into the vasculature of a patient;
an inner catheter positioned in said outer catheter; said inner catheter having a distal stylet forming a distally pointed cone-shape centered relative to said inner catheter and that is sized to center said inner catheter in the center of a valve where three aortic valve cusps meet; and,
three expandable extensions disposed at and non-removably fixed to a distal region of said inner catheter; said expandable extensions each being discrete loops in radially equidistant positions from each other and each having a distal tip; each of said distal tips radially expanding away from said inner catheter relative to a proximal portion of said discrete loops when said outer catheter sheath is proximately withdrawn, such that a distal tip of each of said expandable extensions locate on one of said three aortic valve cusps;
wherein said distal tip of each of said plurality of expandable extensions are radiopaque;
imaging said three expandable extensions within said body organ with an X-Ray machine, such that said three expandable extensions are viewed as equidistant and in the same plane, results in said three expandable extensions illustrating said valve plane.
