# US 11,439,312 B2 · Monitoring treatment of peripheral artery disease (PAD) using diffuse optical imaging > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,439,312 B2 - Document ID: US11439312B2 - Status: Granted - Kind: B2 - Application number: 16/093,775 - Filed: 2017-04-23 - Published: 2019-05-02 - Granted: 2022-09-13 - Earliest claimed: 2016-04-24 - Assignees: The Trustees of Columbia University in the City of New York - Applicants: The Trustees of Columbia University in the City of New York - Inventors: Andreas H. Hielscher; Christopher J. Fong; Jennifer Hoi; Hyun K. Kim; Michael Khalil - Web page: https://patentgrep.com/patent/US11439312B2 ## CPC - A61B 5/0261: {using optical means, e.g. infrared light} - A61B 5/00: Measuring for diagnostic purposes (radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00); Identification of persons - A61B 5/0073: {by tomography, i.e. reconstruction of 3D images from 2D projections (A61B5/0066 takes precedence)} - A61B 5/0075: {by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy (A61B5/0071 takes precedence)} - A61B 5/02: Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow - A61B 5/02007: {Evaluating blood vessel condition, e.g. elasticity, compliance} - A61B 5/021: Measuring pressure in heart or blood vessels - A61B 5/022: by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers - A61B 5/02255: {the pressure being controlled by plethysmographic signals, e.g. derived from optical sensors} - A61B 5/0245: by using sensing means generating electric signals, {i.e. ECG signals} - A61B 5/1455: using optical sensors, e.g. spectral photometrical oximeters - A61B 5/6828: {Leg} - A61B 5/6829: {Foot or ankle} - A61B 5/6831: {Straps, bands or harnesses} - A61B 5/6884: {Clamps or clips} - A61B 5/7425: {Displaying combinations of multiple images regardless of image source, e.g. displaying a reference anatomical image with a live image} - A61B 2560/0437: Trolley or cart-type apparatus - A61B 2562/04: Arrangements of multiple sensors of the same type - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract A plurality of modules are simultaneously positioned at locations that correspond to different angiosomes. Each of these modules has a front surface shaped and dimensioned for contacting a person's skin, a plurality of different-wavelength light sources aimed in a forward direction, and a plurality of light detectors aimed to detect light arriving from in front of the front surface. Each module is supported by a support structure (e.g., a strap or a clip) that is shaped and dimensioned to hold the front surface adjacent to the person's skin at a respective position. Perfusion in each of the angiosomes is monitored using these modules, and the surgeon can rely on this information to guide his or her intervention. ## Claims ### Claim 1 An imaging apparatus comprising: a first module having a first front surface shaped and dimensioned for contacting a person's skin, a first plurality of light sources aimed in a forward direction with respect to the first front surface, each of the first plurality of light sources having a different wavelength, a first plurality of light detectors aimed to detect light arriving from in front of the first front surface, and a first plurality of electrical conductors that (a) convey electrical signals that drive the first plurality of light sources and (b) convey electrical signals representative of the light detected by the first plurality of light detectors; a first support structure shaped and dimensioned to hold the first front surface adjacent to the person's skin at a first position on the person's skin that corresponds to a first angiosome of the person; a second module having a second front surface shaped and dimensioned for contacting the person's skin, a second plurality of light sources aimed in a forward direction with respect to the second front surface, each of the second plurality of light sources having a different wavelength, and a second plurality of light detectors aimed to detect light arriving from in front of the second front surface, and a second plurality of electrical conductors that (a) convey electrical signals that drive the second plurality of light sources and (b) convey electrical signals representative of the light detected by the second plurality of light detectors; a second support structure shaped and dimensioned to hold the second front surface adjacent to the person's skin at a second position on the person's skin that corresponds to a second angiosome of the person while the first front surface is being held adjacent to the person's skin at the first position; and at least one processor configured to: control generation of the electrical signals that drive the first plurality of light sources, accept data representative of the light detected by the first plurality of light detectors, and determine a first level of perfusion in the first angiosome based on the data representative of the light detected by the first plurality of light detectors; and control generation of the electrical signals that drive the second plurality of light sources, accept data representative of the light detected by the second plurality of light detectors, and determine a second level of perfusion in the second angiosome based on the data representative of the light detected by the second plurality of light detectors. ### Claim 2 (depends on 1) The apparatus of claim 1, wherein the first support structure comprises a strap shaped and dimensioned to hold the first front surface adjacent to the person's skin at a calf muscle of the person, and wherein the second support structure comprises a strap shaped and dimensioned to hold the second front surface adjacent to the person's skin on a top portion of a foot of the person. ### Claim 3 (depends on 1) The apparatus of claim 1, further comprising: a third module having a third front surface shaped and dimensioned for contacting the person's skin, a third plurality of light sources aimed in a forward direction with respect to the third front surface, each of the third plurality of light sources having a different wavelength, and a third plurality of light detectors aimed to detect light arriving from in front of the third front surface, and a third plurality of electrical conductors that (a) convey electrical signals that drive the third plurality of light sources and (b) convey electrical signals representative of the light detected by the third plurality of light detectors; and a third support structure shaped and dimensioned to hold the third front surface adjacent to the person's skin at a third position on the person's skin while the first front surface is being held adjacent to the person's skin at the first position and while the second front surface is being held adjacent to the person's skin at the second position, wherein the first position, the second position, and the third position correspond, respectively, to first, second, and third angiosomes of the person. ### Claim 4 (depends on 3) The apparatus of claim 3, wherein the first support structure is shaped and dimensioned to hold the first front surface adjacent to the person's skin at a calf muscle of the person, the second support structure is shaped and dimensioned to hold the second front surface adjacent to the person's skin on a top portion of a foot of the person, and the third support structure is shaped and dimensioned to hold the third front surface adjacent to the person's skin on a bottom portion of the foot of the person. ### Claim 5 (depends on 1) The apparatus of claim 1, wherein the first support structure and the second support structure are integrated into a single support structure shaped and dimensioned to (i) hold the first front surface adjacent to the person's skin at a calf muscle of the person and (ii) hold the second front surface adjacent to the person's skin on a top portion of a foot of the person. ### Claim 6 (depends on 1) The apparatus of claim 1, wherein the at least one processor is configured to control generation of a display that simultaneously depicts the first level of perfusion, and the second level of perfusion. ### Claim 7 (depends on 1) The apparatus of claim 1, wherein the at least one processor is configured to control generation of a display that simultaneously depicts changes in the first level of perfusion over a period of time, and changes in the second level of perfusion over the period of time. ### Claim 8 (depends on 7) The apparatus of claim 7, wherein the at least one processor is configured to control inflation of a pressure cuff during the period of time. ### Claim 9 (depends on 8) The apparatus of claim 8, wherein: the at least one processor is configured, when the first module is affixed to the first position using the first support structure and the second module is affixed to the second position using the second support structure, to: (a) illuminate the first plurality of light sources, accept data representative of the light detected by the first plurality of light detectors, and determine a first level of perfusion in the first angiosome based on the data representative of the light detected by the first plurality of light detectors; and (b) illuminate the second plurality of light sources, accept data representative of the light detected by the second plurality of light detectors, and determine a second level of perfusion in the second angiosome based on the data representative of the light detected by the second plurality of light detectors, wherein steps (a) and (b) are each performed at a first period of time during which the pressure cuff is not inflated, and steps (a) and (b) are each performed at a second period of time during which the pressure cuff is inflated. ### Claim 10 (depends on 9) The apparatus of claim 9, wherein the at least one processor is configured to control generation of a display that simultaneously depicts the first level of perfusion, and the second level of perfusion. ### Claim 11 (depends on 9) The apparatus of claim 9, wherein the at least one processor is configured to control generation of a display that simultaneously depicts changes in the first level of perfusion over the first period of time, and changes in the second level of perfusion over the second period of time. ### Claim 12 A method of monitoring treatment of peripheral artery disease, the method comprising: (a) providing an imaging apparatus comprising: a first module having a first front surface shaped and dimensioned for contacting a person's skin, a first plurality of light sources aimed in a forward direction with respect to the first front surface, each of the first plurality of light sources having a different wavelength, a first plurality of light detectors aimed to detect light arriving from in front of the first front surface, and a first plurality of electrical conductors that (a) convey electrical signals that drive the first plurality of light sources and (b) convey electrical signals representative of the light detected by the first plurality of light detectors; a first support structure shaped and dimensioned to hold the first front surface adjacent to the person's skin at a first position on the person's skin; a second module having a second front surface shaped and dimensioned for contacting the person's skin, a second plurality of light sources aimed in a forward direction with respect to the second front surface, each of the second plurality of light sources having a different wavelength, and a second plurality of light detectors aimed to detect light arriving from in front of the second front surface, and a second plurality of electrical conductors that (a) convey electrical signals that drive the second plurality of light sources and (b) convey electrical signals representative of the light detected by the second plurality of light detectors; and a second support structure shaped and dimensioned to hold the second front surface adjacent to the person's skin at a second position on the person's skin while the first front surface is being held adjacent to the person's skin at the first position, wherein the first position and the second position correspond, respectively, to first and second angiosomes of the person; (b) using the apparatus to determine a first level of perfusion in each of a plurality of angiosomes of the limb; (c) performing a first surgical intervention to increase perfusion in a first one of the plurality of angiosomes; (d) using the apparatus to determine a second level of perfusion in each of the plurality of angiosomes after the first surgical intervention; (e) determining if at least one of the second levels of perfusion is indicative of PAD; (f) if a determination is made that at least one of the second levels of perfusion is indicative of PAD, performing a second surgical intervention to increase perfusion in a second one of the plurality of angiosomes; (g) using the apparatus to determine a third level of perfusion in each of the plurality of angiosomes after the second surgical intervention; and (h) determining if the third level of perfusion in the second one of the plurality of angiosomes is still indicative of PAD, wherein at least steps (c) - (h) are performed during a single surgical session. ### Claim 13 An imaging apparatus comprising: a first module having a first front surface shaped and dimensioned for contacting a person's skin, a first plurality of light sources aimed in a forward direction with respect to the first front surface, each of the first plurality of light sources having a different wavelength, a first plurality of light detectors aimed to detect light arriving from in front of the first front surface, and a first plurality of electrical conductors that (a) convey electrical signals that drive the first plurality of light sources and (b) convey electrical signals representative of the light detected by the first plurality of light detectors; a first support structure shaped and dimensioned to hold the first front surface adjacent to the person's skin at a first position on the person's skin; a second module having a second front surface shaped and dimensioned for contacting the person's skin, a second plurality of light sources aimed in a forward direction with respect to the second front surface, each of the second plurality of light sources having a different wavelength, and a second plurality of light detectors aimed to detect light arriving from in front of the second front surface, and a second plurality of electrical conductors that (a) convey electrical signals that drive the second plurality of light sources and (b) convey electrical signals representative of the light detected by the second plurality of light detectors; and a second support structure shaped and dimensioned to hold the second front surface adjacent to the person's skin at a second position on the person's skin while the first front surface is being held adjacent to the person's skin at the first position, wherein the first position and the second position correspond, respectively, to first and second angiosomes of the person, and wherein: the first module comprises: a first substrate having a first front face; the first plurality of light sources, wherein each of the first plurality of light sources is mounted to the first substrate and wherein at least a portion of each of the first plurality of light sources is disposed in front of the first front face; the first plurality of light detectors, wherein each of the first plurality of light detectors is mounted to the first substrate, and wherein at least a portion of each of the first plurality of light detectors is disposed in front of the first front face; a first polymer pad shaped and dimensioned to sit in front of the first front face, the first polymer pad having a first plurality of light source openings shaped and dimensioned to accommodate at least a portion of each of the first plurality of light sources disposed in front of the first front face and having a first plurality of light detector openings shaped and dimensioned to accommodate at least a portion of each of the first plurality of light detectors disposed in front of the first front face, the first polymer pad having a first front surface shaped and dimensioned for contacting a person's skin; and the first plurality of electrical conductors that (a) convey electrical signals that drive the first plurality of light sources and (b) convey electrical signals representative of the light detected by the first plurality of light detectors, wherein each of the first plurality of light sources is aimed in a forward direction with respect to the first front surface of the first polymer pad, and wherein each of the first plurality of light detectors is aimed to detect light arriving from in front of the first front surface of the first polymer pad; and the second module comprises: a second substrate having a second front face; the second plurality of light sources, wherein each of the second plurality of light sources is mounted to the second substrate and wherein at least a portion of each of the second plurality of light sources is disposed in front of the second front face; the second plurality of light detectors, wherein each of the second plurality of light detectors is mounted to the second substrate, and wherein at least a portion of each of the second plurality of light detectors is disposed in front of the second front face; a second polymer pad shaped and dimensioned to sit in front of the second front face, the second polymer pad having a second plurality of light source openings shaped and dimensioned to accommodate at least a portion of each of the second plurality of light sources disposed in front of the second front face and having a second plurality of light detector openings shaped and dimensioned to accommodate at least a portion of each of the second plurality of light detectors disposed in front of the second front face, the second polymer pad having a second front surface shaped and dimensioned for contacting a person's skin; and the second plurality of electrical conductors that (a) convey electrical signals that drive the second plurality of light sources and (b) convey electrical signals representative of the light detected by the second plurality of light detectors, wherein each of the second plurality of light sources is aimed in a forward direction with respect to the second front surface of the second polymer pad, and wherein each of the second plurality of light detectors is aimed to detect light arriving from in front of the second front surface of the second polymer pad. ### Claim 14 (depends on 13) The apparatus of claim 13, wherein the first polymer pad comprises silicone and the second polymer pad comprises silicone. ### Claim 15 (depends on 14) The apparatus of claim 14, further comprising a first thin transparent polymer sheet disposed on the first front surface of the first polymer pad, and a second thin transparent polymer sheet disposed on the second front surface of the second polymer pad. ### Claim 16 (depends on 15) The apparatus of claim 15, wherein the first thin transparent polymer sheet has an adhesive backing and the second transparent polymer sheet has an adhesive backing. ### Claim 17 (depends on 16) The apparatus of claim 16, wherein the first thin transparent polymer sheet comprises Mylar and the second thin transparent polymer sheet comprises Mylar. ### Claim 18 (depends on 13) The apparatus of claim 13, wherein the first support structure comprises a first strap shaped and dimensioned to hold the first front surface of the first polymer pad adjacent to the person's skin and the second support structure comprises a second strap shaped and dimensioned to hold the second front surface of the second polymer pad adjacent to the person's skin. ### Claim 19 (depends on 18) The apparatus of claim 18, further comprising a first hook-and-loop fastener configured to selectively fasten the first strap and a second hook-and-loop fastener configured to selectively fasten the second strap.