# US 10,143,533 B2 · Blood vessel sizing device

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- Number: US 10,143,533 B2
- Document ID: US10143533B2
- Status: Granted
- Kind: B2
- Application number: 15/287,337
- Filed: 2016-10-06
- Published: 2018-04-12
- Granted: 2018-12-04
- Earliest claimed: 2016-10-06
- Assignees: Sizer LLC
- Applicants: Sizer LLC
- Inventors: Richard B. Park
- Web page: https://patentgrep.com/patent/US10143533B2

## CPC

- A61B 90/39: {Markers, e.g. radio-opaque or breast lesions markers}
- A61B 5/1072: {measuring distances on the body, e.g. measuring length, height or thickness (A61B5/1076 takes precedence)}
- A61B 5/1075: {for measuring dimensions by non-invasive methods, e.g. for determining thickness of tissue layer (A61B8/0858 takes precedence)}
- A61B 5/1076: {for measuring dimensions inside body cavities, e.g. using catheters (A61B3/1005 takes precedence)}
- A61B 5/1079: {using optical or photographic means}
- A61B 6/12: Arrangements for detecting or locating foreign bodies
- A61B 6/481: {involving the use of contrast agents}
- A61B 6/504: {for diagnosis of blood vessels, e.g. by angiography}
- A61B 6/583: {using calibration phantoms}
- A61B 34/25: {User interfaces for surgical systems}
- G06T 5/50: using two or more images, e.g. averaging or subtraction
- G06T 7/0012: {Biomedical image inspection}
- G06T 7/55: from multiple images
- G06T 7/60: Analysis of geometric attributes
- G06T 7/73: using feature-based methods
- A61B 5/4887: {Locating particular structures in or on the body}
- A61B 6/461: {Displaying means of special interest}
- A61B 90/96: using barcodes
- A61B 2017/00345: {Micromachines, nanomachines, microsystems}
- A61B 2017/00907: {for light}
- A61B 2034/107: {Visualisation of planned trajectories or target regions}
- A61B 2090/061: {for measuring dimensions, e.g. length}
- A61B 2090/067: {for measuring angles}
- A61B 2090/365: {augmented reality, i.e. correlating a live optical image with another image}
- A61B 2090/374: {NMR or MRI}
- A61B 2090/376: {using X-rays, e.g. fluoroscopy}
- A61B 2090/3937: {Visible markers}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61B 2090/3991: {having specific anchoring means to fixate the marker to the tissue, e.g. hooks}
- A61F 2/00: Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents (dental prostheses A61C13/00; artificial kidneys A61M1/14; artificial hearts A61M60/00)
- A61F 2/95: Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F 2250/0096: Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- G01B 15/00: Measuring arrangements characterised by the use of electromagnetic waves or particle radiation, e.g. by the use of microwaves, X-rays, gamma rays or electrons (characterised by the use of optical techniques G01B9/00, G01B11/00)
- G01R 33/5601: {involving use of a contrast agent for contrast manipulation, e.g. a paramagnetic, super-paramagnetic, ferromagnetic or hyperpolarised contrast agent}
- G01R 33/5635: {Angiography, e.g. contrast-enhanced angiography [CE-MRA] or time-of-flight angiography [TOF-MRA]}
- G06T 2207/10081: Computed x-ray tomography [CT]
- G06T 2207/10088: Magnetic resonance imaging [MRI]
- G06T 2207/10104: Positron emission tomography [PET]
- G06T 2207/10116: X-ray image
- G06T 2207/10132: Ultrasound image
- G06T 2207/30101: Blood vessel; Artery; Vein; Vascular
- G06T 2207/30204: Marker
- G06T 2211/404: Angiography
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G06T: IMAGE DATA PROCESSING OR GENERATION, IN GENERAL
- 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)
- G01B: MEASURING LENGTH, THICKNESS OR SIMILAR LINEAR DIMENSIONS; MEASURING ANGLES; MEASURING AREAS; MEASURING IRREGULARITIES OF SURFACES OR CONTOURS
- G01R: MEASURING ELECTRIC VARIABLES; MEASURING MAGNETIC VARIABLES (indicating correct tuning of resonant circuits H03J3/12)

## Abstract

Medical devices and methods that provide for improved accuracy when positioning of a synthetic structure, such as a MEMS device or a stent, within a biological feature of a patient, such as a blood vessel, are disclosed. A blood vessel sizing device is configured for placement on the skin of a patient near a feature of interest (e.g. a blood vessel to be imaged). The device may include one or more radiopaque elements, including a target element, and one or more positioning markers having known sizes. A clinician may use the radiopaque elements to identify a portion of a blood vessel suitable for positioning of the synthetic structure.

## Claims

### Claim 1

A non-transitory computer-readable medium comprising computer-executable instructions, that when executed, cause a processor to:
receive first radiological image data of an area of a body of a patient as a radiopaque contrast agent is present in one or more biological features within the area;
identify, from the received first radiological image data, a radiopaque target element of a sizing device positioned on an area of skin of the patient;
compare the radiopaque target element to the one or more biological features to identify a biological feature, from the one or more biological features, with a dimensional property within an acceptable dimensional range indicated by the radiopaque target element;
determine a target location of the biological feature relative to one or more radiopaque positioning markers of the sizing device;
receive second radiological image data of the area of the body of the patient;
identify, from the second radiological image data, a radiopaque portion of a synthetic structure to be positioned at the biological feature; and
determine a location of the radiopaque portion of the synthetic structure relative to the target location.

### Claim 2 (depends on 1)

The non-transitory computer-readable medium of claim 1, wherein the biological feature is not visible in the second radiological image data.

### Claim 3 (depends on 1)

The non-transitory computer-readable medium of claim 1, wherein the computer-executable instructions, when executed, further cause the processor to:
identify one or more one or more radiopaque symbols corresponding to the one or more radiopaque positioning markers.

### Claim 4 (depends on 1)

The non-transitory computer-readable medium of claim 1, wherein the computer-executable instructions, when executed, further cause the processor to:
generate, based on the identified radiopaque portion of the synthetic structure, an augmented image of the synthetic structure that includes the radiopaque portion and a radiolucent portion of the synthetic structure.

### Claim 5 (depends on 1)

The non-transitory computer-readable medium of claim 1, wherein the synthetic structure comprises a MEMS device.

### Claim 6 (depends on 1)

The non-transitory computer-readable medium of claim 1, wherein the biological feature is a portion of a blood vessel of the patient.

### Claim 7 (depends on 6)

The non-transitory computer-readable medium of claim 6, wherein the dimensional property is a width of the blood vessel.

### Claim 8

A method comprising:
receiving first radiological image data of an area of a body of a patient as a radiopaque contrast agent is present in one or more biological features within the area;
identifying, from the received first radiological image data, a radiopaque target element of a sizing device positioned on an area of skin of the patient;
comparing the radiopaque target element to the one or more biological features to identify a biological feature, from the one or more biological features, with a dimensional property within an acceptable dimensional range indicated by the radiopaque target element;
determining a target location of the biological feature relative to one or more radiopaque positioning markers of the sizing device;
receiving second radiological image data of the area of the body of the patient;
identifying, from the second radiological image data, a radiopaque portion of a synthetic structure to be positioned at the biological feature; and
determining a location of the radiopaque portion of the synthetic structure relative to the target location.

### Claim 9 (depends on 8)

The method of claim 8, wherein the biological feature is not visible in the second radiological image data.

### Claim 10 (depends on 8)

The method of claim 8, further comprising:
identifying one or more radiopaque symbols corresponding to the one or more radiopaque positioning markers.

### Claim 11 (depends on 8)

The method of claim 8, wherein the sizing device further comprises a radiopaque marking indicating a total size of the synthetic structure that includes the radiopaque portion and a radiolucent portion of the synthetic structure.

### Claim 12 (depends on 8)

The method of claim 8, wherein the synthetic structure comprises a MEMS device.

### Claim 13 (depends on 8)

The method of claim 8, wherein the biological feature is a portion of a blood vessel of the patient.

### Claim 14 (depends on 13)

The method of claim 13, wherein the dimensional property is a width of the blood vessel.

### Claim 15 (depends on 8)

The method of claim 8, wherein the radiopaque target element comprises a ring with two diameters indicating a minimum and a maximum acceptable dimension within the acceptable dimensional range.

### Claim 16

A sizing device, comprising:
a planar base structure having a front surface and a back surface, wherein the base structure is:
configured to be placed on a user's skin during radiological imaging of a target area of the user; and
radiolucent to light with a wavelength in the visible spectrum;
a series of radiopaque positioning markers positioned on the base structure and spaced apart along a longitudinal axis of the sizing device;
a radiopaque target element positioned on the front surface of the base structure, wherein the radiopaque target element indicates an acceptable dimensional range of a biological feature for positioning of a synthetic structure therein; and
an adhesive layer on the back surface of the device configured to adhere the device to the user's skin.

### Claim 17 (depends on 16)

The sizing device of claim 16, wherein the radiopaque target element comprises a radiopaque ring.

### Claim 18 (depends on 17)

The sizing device of claim 17, wherein the radiopaque target is centered at a radiopaque positioning marker, between a first positioning marker and a last positioning marker, from the series of radiopaque positioning markers.

### Claim 19 (depends on 18)

The sizing device of claim 18, wherein a distance between a center of the radiopaque target element and the first positioning marker indicates a length of the synthetic structure.

### Claim 20 (depends on 16)

The sizing device of claim 16, wherein the synthetic structure is a MEMS device configured to be positioned within a blood vessel of the user.