Blood vessel sizing device

• US 10,143,533 B2
• Filed: 10/06/2016
• Issued: 12/04/2018
• Est. Priority Date: 10/06/2016
• Status: Active Grant

• Current Assignee: Sizer LLC
• Original Assignee: Sizer LLC
• Inventors: Park, Richard B.
• Primary Examiner(s): Baker, Charlotte M
• Application Number:
  US15/287,337
• Publication Number:
  US 20180098820A1
• Time in Patent Office: 789 Days
• Field of Search: 382130, 604518, 604151, 604500, 604 9301, 128898, 600407, 600481, 378162, 378165
• CPC Class Codes: A61B 2017/00345 Micromachines, nanomachines, microsystems
• CPC Class Codes: A61B 2017/00907 for light
• CPC Class Codes: A61B 2034/107 Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2090/061 for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/067 for measuring angles
• CPC Class Codes: A61B 2090/365 augmented reality, i.e. correlating a live optical image with another image
• CPC Class Codes: A61B 2090/374 NMR or MRI
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 2090/3937 Visible markers
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 2090/3991 having specific anchoring means to fixate the marker to the tissue, e.g. hooks
• CPC Class Codes: A61B 34/25 User interfaces for surgical systems
• CPC Class Codes: A61B 5/055 involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 5/1072 measuring distances on the body, e.g. measuring length, height or thickness A61B5/1076 takes precedence
• CPC Class Codes: A61B 5/1075 for measuring dimensions by non-invasive methods, e.g. for determining thickness of tissue layer A61B8/0858 takes precedence
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/1079 using optical or photographic means
• CPC Class Codes: A61B 5/4887 Locating particular structures in or on the body
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/461 Displaying means of special interest
• CPC Class Codes: A61B 6/481 : involving the use of contrast agents
• CPC Class Codes: A61B 6/504 : for diagnosis of blood vessels, e.g. by angiography
• CPC Class Codes: A61B 6/583 : using calibration phantoms
• CPC Class Codes: A61B 90/39 : Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61B 90/96 : using barcodes
• CPC Class Codes: 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 as cosmetic articles, see the relevant subclasses, e.g. wigs, hair pieces, A41G3/00, A41G5/00; artificial nails A45D31/00; dental prostheses A61C13/00; materials for prostheses A61L27/00; artificial hearts A61M60/00; artificial kidneys A61M1/14
• CPC Class Codes: A61F 2/95 : Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2250/0096 : Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
• CPC Class Codes: 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
• CPC Class Codes: G01R 33/5601 : involving use of a contrast agent for contrast manipulation, e.g. a paramagnetic, super-paramagnetic, ferromagnetic or hyperpolarised contrast agent
• CPC Class Codes: G01R 33/5635 : Angiography, e.g. contrast-enhanced angiography [CE-MRA] or time-of-flight angiography [TOF-MRA]
• CPC Class Codes: G06T 2207/10081 : Computed x-ray tomography [CT]
• CPC Class Codes: G06T 2207/10088 : Magnetic resonance imaging [MRI]
• CPC Class Codes: G06T 2207/10104 : Positron emission tomography [PET]
• CPC Class Codes: G06T 2207/10116 : X-ray image
• CPC Class Codes: G06T 2207/10132 : Ultrasound image
• CPC Class Codes: G06T 2207/30101 : Blood vessel; Artery; Vein; Vascular
• CPC Class Codes: G06T 2207/30204 : Marker
• CPC Class Codes: G06T 2211/404 : Angiography
• CPC Class Codes: G06T 5/50 : using two or more images, e.g. averaging or subtraction
• CPC Class Codes: G06T 7/0012 : Biomedical image inspection
• CPC Class Codes: G06T 7/55 : from multiple images
• CPC Class Codes: G06T 7/60 : Analysis of geometric attributes
• CPC Class Codes: G06T 7/73 : using feature-based methods

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

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.

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

3. 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.

4. 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.

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

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

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

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.

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

10. The method of claim 8, further comprising:

identifying one or more radiopaque symbols corresponding to the one or more radiopaque positioning markers.

11. 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.

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

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

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

15. 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.

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.

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

18. 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.

19. 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.

20. 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.