Method and system for assessing severity and stage of peripheral arterial disease and lower extremity wounds using angiosome mapping

• US 9,254,220 B1
• Filed: 10/18/2012
• Issued: 02/09/2016
• Est. Priority Date: 08/29/2006
• Status: Active Grant

• Current Assignee: Vasamed, Inc.
• Original Assignee: Vasamed, Inc.
• Inventors: Bartnik, Daniel J., Griffith, Rose A., LaPlante, Paulita M.
• Primary Examiner(s): Matthews, Christine H
• Assistant Examiner(s): Reddy, Sunita
• Application Number:
  US13/573,989
• Time in Patent Office: 1,209 Days
• Field of Search: 600/306, 600/363, 600/345, 600/504, 128897-899
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/022 by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
• CPC Class Codes: A61B 5/02233 Occluders specially adapted therefor tourniquets A61B17/132
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/0295 using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/4866 Evaluating metabolism A61B5/083 takes precedence
• CPC Class Codes: A61B 5/6828 Leg
• CPC Class Codes: A61B 5/6829 Foot or ankle
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: A61F 5/566 Intra-oral devices

Abstract

The present invention provides a system for assessing the severity and stage of PAD including at least one sensor that measures skin perfusion pressure; a knowledge base that provides data on lower extremity angiosomes; and a processing device in operable communication with the sensor and the knowledge base, the processing device that outputs a visual representation of at least one of the lower extremity angiosomes that guides the sensor in the mapping of a testing site relative to a target vessel where the skin perfusion pressure measurement will be taken.

Claims

1. A system for assessing severity and stage of lower extremity disease comprising:

at least one sensor that measures peripheral vascular conditions of a patient;

a knowledge base that provides data on a plurality of lower extremity angiosomes;

a processing device in operable communication with said at least one sensor and said knowledge base, said processing device configured to (a) output a visual representation of at least one of said plurality of lower extremity angiosomes, said visual representation to guide the placement of said sensor in angiosome mapping of a testing site relative to a target vessel in an angiosome;

(b) receive a peripheral vascular measurement based on said angiosome mapping; and

(c) cross reference said peripheral vascular measurement with said knowledge base to generate a cross referenced data result indicative of a severity and stage of lower extremity disease,

wherein said processing device outputs data that is indicative of said severity and stage of lower extremity disease based on said angiosome mapping based on said cross referenced data result.

2. The system of claim 1 further comprising a knowledge base of disease scoring and/or classification systems and a knowledge base of peripheral arterial disease and lower extremity wounds, wherein said processing device is further configured to cross reference said peripheral vascular measurement with said knowledge base of disease scoring and/or classification systems and said knowledge base of peripheral arterial disease and lower extremity wounds to generate a combined cross referenced data result indicative of the severity and stage of lower extremity disease and further wherein said processing device outputs data that indicative of the severity and stage of lower extremity disease based on said combined cross referenced data result.

3. The system of claim 1 further comprising at least one metabolic sensor for measuring at least one metabolic condition of the patient, wherein said processing device is arranged to receive inputs from said at least one metabolic sensor.

4. The system of claim 1 further comprising at least one skin perfusion sensor for measuring skin perfusion.

5. The system of claim 4 further comprising at least one metabolic sensor for measuring at least one metabolic condition of the patient, wherein said processing device is arranged to receive inputs from said at least one metabolic sensor.

6. The system of claim 4 further comprising a knowledge base of disease scoring and/or classification systems and a knowledge base of peripheral arterial disease and lower extremity wounds, wherein said processing device is further configured to cross reference a skin perfusion pressure value with said knowledge base of disease scoring and/or classification systems and said knowledge base of peripheral arterial disease and lower extremity wounds to generate a combined cross referenced data result indicative of the severity and stage of lower extremity disease and further wherein said processing device outputs data that is indicative of the severity and stage of peripheral arterial disease and wound healing potential based on said combined cross referenced data result.

7. The system of claim 1 wherein said peripheral vascular measurements is selected from skin perfusion pressure, pulse volume recordings, transcutaneous oxygen monitoring, ankle brachial index, tissue CO2, temperature, spectral imaging and hyperspectral imaging.

8. The system of claim 1 further comprising:

an inflatable cuff, wherein said at least one sensor is a skin perfusion measurement sensor in communication with the cuff;

a pressure sensor in communication with the cuff for reading pressure levels in the cuff;

a pressure instrument in fluid communication with the cuff for inflation and deflation thereof, the pressure instrument comprising;

a source of pressurized air; and

a conduit connected to the source of pressurized air and the cuff, thereby placing the source of pressurized air in fluid communication with the cuff, wherein said processing device is operably coupled to said pressure instrument and capable of controlling pressurized airflow to and from the cuff, and further wherein said processing device is arranged to receive inputs from said skin perfusion measurement sensor and said pressure sensor;

a computer program executable by the processing device such that when executed, the computer program causes the processing device to;

initiate an automatic inflation sequence resulting in a no flow condition;

initiate an automatic deflation sequence;

automatically qualify a perfusion measurement as a skin perfusion pressure value upon all conditions of a set of predetermined conditions being met during the deflation sequence,

wherein said processing device receives said skin perfusion pressure value based on said angiosome mapping, and cross references said skin perfusion pressure value with said knowledge base to generate a cross referenced data result indicative of said severity and stage of lower extremity disease.

9. A system for assessing severity and stage of lower extremity disease comprising:

at least one blood flow sensor that measures skin perfusion pressure;

a knowledge base that provides data on a plurality of lower extremity angiosomes;

a processing device in operable communication with said at least one blood flow sensor and said knowledge base, said processing device configured to output a visual representation of at least one of said plurality of lower extremity angiosomes to guide said at least one blood flow sensor in mapping of a testing site relative to a target vessel;

an inflatable cuff, wherein said at least one blood flow sensor is in communication with the cuff for measuring blood flow in a patient;

a pressure sensor in communication with the cuff for reading pressure levels in the cuff;

a pressure instrument in fluid communication with the cuff for inflation and deflation thereof, the pressure instrument comprising;

a source of pressurized air; and

a conduit connected to the source of pressurized air and the cuff, thereby placing the source of pressurized air in fluid communication with the cuff, wherein said processing device is operably coupled to said pressure instrument and capable of controlling pressurized airflow to and from the cuff, and further wherein said processing device is arranged to receive inputs from said at least one blood flow sensor and said pressure sensor;

a computer program executable by the processing device such that when executed, the computer program causes the processing device to;

initiate an automatic inflation sequence resulting in a no flow condition;

initiate an automatic deflation sequence;

automatically qualify a perfusion measurement as a skin perfusion pressure value upon all conditions of a set of predetermined conditions being met during the deflation sequence,

wherein said processing device receives said skin perfusion pressure value based on angiosome mapping, and cross references said skin perfusion pressure value with said knowledge base to generate a cross referenced data result indicative of a severity and stage of peripheral arterial disease and wound healing potential.