# US 11,026,776 B1 · Optimal sizing of iliac vein stents and method of using

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- Number: US 11,026,776 B1
- Document ID: US11026776B1
- Status: Granted
- Kind: B1
- Application number: 16/438,068
- Filed: 2019-06-11
- Granted: 2021-06-08
- Earliest claimed: 2015-03-23
- Applicants: Seshadri Raju
- Inventors: Seshadri Raju
- Web page: https://patentgrep.com/patent/US11026776B1

## CPC

- A61F 2/06: Blood vessels
- A61B 8/06: Measuring blood flow
- A61B 8/0891: {for diagnosis of blood vessels}
- A61B 5/107: Measuring physical dimensions, e.g. size of the entire body or parts thereof
- A61B 8/12: in body cavities or body tracts, e.g. by using catheters
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Whether a vein has a stenosis may be determined using duplex ultrasound (DUS). A method of diagnosing stenosis includes: identifying a patient exhibiting at least one of a group of symptoms in at least one limb consisting of: pain, discomfort, swelling and venous stasis skin changes including ulceration; using duplex ultrasound to measure a cross-sectional area of a vein; and, if the cross-sectional area is less than or equal to 50% of a predetermined anatomical minimum for the vein, diagnosing the vein as stenotic. A device for diagnosing stenosis may include: a duplex ultrasound; a display; and a processor configured to show on the display a cross-sectional area measurement of a vein. Stenosis may be treated by inserting a stent in the vein. The predetermined anatomical minimum for the vein is a predetermined calculated valve based on physical principles. It is not a measured value from the patient, or any patient, or a population of patients.

## Claims

### Claim 1

A method of diagnosing and treating diffuse stenosis, comprising:
a. Using a duplex ultrasound (DUS) to measure a cross-sectional area of a vein portion of a patient; and
b. making a determination that the cross-sectional area is less than or equal to 90% of a calculated predetermined mean cross-sectional area fora vein segment in which the vein portion is located, where the calculated predetermined cross-sectional area is not measured from or determined from any said vein portion of said patient, or measured or determined cross sectional area of any non-stenotic vein portion in any other patient, examining the vein portion with intravascular ultrasound (IVUS) to determine an IVUS cross-sectional area of the vein portion; and
c. making a determination that the measured IVUS cross-sectional area is less than 50% of the predetermined mean cross-sectional area for the vein segment in which the vein portion is located, treat the vein portion by stenting.

### Claim 2 (depends on 1)

The method of claim 1, wherein local velocity changes as measured by DUS in the vein portion are not used to determine stenosis.

### Claim 3 (depends on 1)

The method of claim 1, wherein step (c) further comprises:
using duplex ultrasound to identify a narrowest point in the vein portion and wherein the cross-sectional area is measured at the narrowest point of the vein portion.

### Claim 4 (depends on 3)

The method of claim 3, wherein a focal stenosis in the vein portion is not visually identified with DUS.

### Claim 5 (depends on 3)

The method of claim 3, wherein the vein segment is chosen from a group consisting of: common iliac, external iliac, and common femoral veins.

### Claim 6 (depends on 3)

The method of claim 3, wherein if the vein portion does not have a focal stenosis and the DUS measured cross-sectional area is less than or equal to 70% of the pre-determined mean cross section area of the vein segment in which the vein portion is located, then diagnose the vein portion stenotic.