EP-4734840-A2 - SYSTEM FOR MONITORING MICROCIRCULATION OF A PATIENT

Abstract

Microcirculation assessment systems and methods for determining a systemic response of a patient which may be related to sepsis. A microcirculation assessment device coupled with a patient obtains a microcirculation assessment of the patient. System logic applies an algorithm to the microcirculation assessment to indirectly determine the systemic response. Artificial intelligence and/or machine learning logic collects microcirculation assessment data and corresponding actual systemic responses to define the algorithm that correlates microcirculation assessment with systemic response. System logic may recommend a therapy based the systemic response. System logic may also govern the operation of therapy equipment to deliver a therapy. The microcirculation assessment device may utilize any suitable technology to obtain the microcirculation assessment, such as ultrasound, video capillaroscopy, or thermal imaging, for example. The microcirculation assessment device may be a wearable device or incorporated into hospital bed. Therapy may include body temperature modulation, oxygenation, or infusate delivery.

Inventors

• FELLNER, Stefan, Josef
• SOWARDS, Steffan
• SMITH, Amelia, Marie

Assignees

• Bard Access Systems, Inc.

Dates

Publication Date

20260506

Application Date

20240724

Claims (20)

1. 1. A medical system, comprising: a microcirculation assessment (MCA) device configured to generate microcirculation data pertaining to a defined location of a patient; and a system module having a console coupled with the MCA device, the console including a processor and a memory having logic stored thereon that, when executed by the processor performs operations that include: receiving the microcirculation data from the MCA device; determining a microcirculation assessment from the microcirculation data; and determining a systemic response of the patient based on the microcirculation assessment.
2. 2. The medical system according to claim 1, wherein the systemic response is related to a sepsis condition of the patient.
3. 3. The medical system according to either claim 1 or claim 2, wherein the console is wirelessly coupled with the MCA device.
4. 4. The medical system according to any of the preceding claims, wherein the MCA device is configured to generate microcirculation data via skin temperature sensing, infrared or near infrared thermal imaging, transcutaneous oxygen measurement, laser doppler flowmetry, dark field imaging, orthogonal polarization spectral imaging, ultrasound imaging, video capillaroscopy, micro-dialysis, or any combination thereof.
5. 5. The medical system according to any of the preceding claims, wherein the defined location of a patient includes a finger, a nasal tissue, or a sublingual tissue.
6. 6. The medical system according to any of the preceding claims, wherein the MCA device is incorporated into a hospital bed.
7. 7. The medical system according to any of the preceding claims, wherein the MCA device is a wearable device.
8. 8. The medical system according to claim 7, wherein the MCA device is incorporated into an article of clothing.
9. 9. The medical system according to any of the preceding claims, wherein a patient contact surface of the MCA device includes an adhesive configured to secure the patient contact surface to the patient.
10. 10. The medical system according to any of the preceding claims, wherein the operations further include providing a notification when the systemic response exceeds a defined threshold.
11. 11. The medical system according to any of the preceding claims, wherein the operations further include providing a therapy notification based on the systemic response, the therapy notification including a recommended therapy for treating the patient.
12. 12. The medical system according to any of the preceding claims, further including a display coupled with the console, the operations further including exhibiting a microcirculation assessment image on the display.
13. 13. The medical system according to any of the preceding claims, further comprising a therapy delivery system coupled with the console, the operations further including initiating the therapy delivery system when the systemic response exceeds a defined threshold.
14. 14. The medical system according to claim 12, wherein a therapy of the therapy delivery system includes at least one of modulating body temperature, providing oxygen, or delivering an infusate.
15. 15. The medical system according to claim 12, wherein the operations further include adjusting the therapy based on the systemic response.
16. 16. A system method of determining a systemic response of a patient, comprising: obtaining a microcirculation assessment of the patient via a microcirculation assessment (MCA) device of a system that utilizes skin temperature sensing, infrared or near infrared thermal imaging, transcutaneous oxygen measurement, laser doppler flowmetry, dark field imaging, orthogonal polarization spectral imaging, ultrasound imaging, video capillaroscopy, micro-dialysis, or any combination thereof; and determining the systemic response based on the microcirculation assessment.
17. 17. The system method according to claim 16, wherein determining the systemic response based on the microcirculation assessment comprises: collecting a plurality of microcirculation assessment data sets, wherein each data set includes a microcirculation assessment of a representative patient via the MCA device and an actual systemic response of the representative patient acquired independently from the microcirculation assessment, defining an algorithm that correlates the actual systemic response with the microcirculation assessment across the plurality of data sets; and performing the algorithm on the microcirculation assessment of the patient to determine the systemic response.
18. 18. The system method according to claim 17, wherein: each data set further includes patient data for the representative patient that include one or more of weight, sex, age, or race, and defining the algorithm includes corelating the actual systemic response with the microcirculation assessment together with the patient data across the plurality of data sets.
19. 19. The system method according to claim 17, further comprising initiating therapy delivery equipment of the system to provide a therapy to the patient based on the systemic response.
20. 20. The system method according to claim 19, wherein providing the therapy includes: collecting a subset of the plurality of data sets, each data set of the subset including the microcirculation assessment of the representative patient, the actual systemic response of the representative patient, and a therapy delivered to the representative patient; defining the algorithm to include a correlation of the therapy with the microcirculation assessment; and performing the algorithm on the microcirculation assessment to define the therapy.

Description

SYSTEM FOR MONITORING MICROCIRCULATION OF A PATIENT PRIORITY [0001] This application claims priority to U.S. Patent Application No. 18/226,082, filed luly 25, 2023, which is incorporated by reference in its entirety into this application. BACKGROUND [0002] Sepsis is the body’s overwhelming and life-threatening response to infection that can lead to tissue damage, organ failure, and death. Like strokes or heart attacks, sepsis is a medical emergency that requires rapid diagnosis and treatment. Sepsis must be treated quickly and efficiently as soon as healthcare providers suspect it. If it isn’t recognized and treated quickly, sepsis can progress to severe sepsis and then to septic shock. It is reported that the chance of sepsis progressing to severe sepsis and septic shock, causing death, rises by 4% to 9% for every hour treatment is delayed. Septic shock is related to hypotension causing a decrease on blood flow to organs causing them to shut down. [0003] Disclosed herein are systems and methods that monitor systemic responses that are associated with sepsis, thereby providing early detection of sepsis and enabling rapid treatment. SUMMARY [0004] Disclosed herein is a medical system that, according to some embodiments, includes a microcirculation assessment (MCA) device configured to generate microcirculation data pertaining to a defined location of a patient. The medical system further includes a system module having a console coupled with the MCA device, where the console includes a processor and a memory having logic stored thereon that, when executed by the processor performs operations that include (i) receiving the microcirculation data from the MCA device, (ii) determining a microcirculation assessment from the microcirculation data, and (iii) determining a systemic response of the patient based on the microcirculation assessment. [0005] In some embodiments, systemic response is related to a sepsis condition of the patient. [0006] In some embodiments, the console is wirelessly coupled with the MCA device. [0007] In some embodiments, the MCA device is configured to generate microcirculation data via skin temperature sensing, infrared or near infrared thermal imaging, transcutaneous oxygen measurement, laser doppler flowmetry, dark field imaging, orthogonal polarization spectral imaging, ultrasound imaging, video capillaroscopy, micro-dialysis, or any combination thereof. In some embodiments, the defined location of a patient includes a finger, a nasal tissue, or a sublingual tissue. [0008] In some embodiments, the MCA device is incorporated into a hospital bed. In some embodiments, the MCA device is a wearable device, and in some embodiments, the MCA device is incorporated into an article of clothing. [0009] In some embodiments, a patient contact surface of the MCA device includes an adhesive configured to secure the patient contact surface to the patient. [0010] In some embodiments, the operations further include providing a notification when the systemic response exceeds a defined threshold. [0011] In some embodiments, the operations further include providing a therapy notification based on the systemic response, the therapy notification including a recommended therapy for treating the patient. [0012] In some embodiments, the medical system further includes a display coupled with the console, and the operations further include exhibiting a microcirculation assessment image on the display. [0013] In some embodiments, the medical system further includes a therapy delivery system coupled with the console, where the operations further include initiating the therapy delivery system when the systemic response exceeds a defined threshold. In some embodiments, a therapy of the therapy delivery system includes at least one modulating a body temperature, providing oxygen, or delivering an infusate. In some embodiments, the operations further include adjusting the therapy based on the systemic response. [0014] Also disclosed herein is a system method of determining a systemic response of a patient that, according to some embodiments, includes determining a microcirculation assessment of the patient via a microcirculation assessment (MCA) device that utilizes skin temperature sensing, infrared or near infrared thermal imaging, transcutaneous oxygen measurement, laser doppler flowmetry, dark field imaging, orthogonal polarization spectral imaging, ultrasound imaging, ultrasound doppler, video capillaroscopy, micro-dialysis, or any combination thereof. The system method further includes determining the systemic response based on the microcirculation assessment. [0015] In some embodiments of the system method, determining the systemic response based on the microcirculation assessment includes (i) collecting a plurality of systemic response identification data sets, where each data set includes a microcirculation assessment of a representative patient via the MCA device and an actual systemic response of the re