System for monitoring microcirculation of patient

Abstract

Microcirculation assessment systems and methods for determining a systemic response of a patient that may be associated with sepsis are disclosed herein. A microcirculation assessment device coupled to the patient obtains a microcirculation assessment of the patient. The system logic applies an algorithm to the microcirculation assessment to indirectly determine a systemic response. Artificial intelligence and / or machine learning logic collects microcirculation assessment data and corresponding actual systemic reactions to define algorithms that correlate microcirculation assessments with systemic reactions. The system logic may recommend treatments based on systemic reactions. The system logic may also manage operation of the therapeutic equipment to deliver therapy. The microcirculation assessment device may obtain microcirculation assessments, such as ultrasound, video capillary microscopy, or thermal imaging, for example using any suitable technique. The microcirculation evaluation device can be a wearable device or be combined with a sickbed. The treatment may include body temperature regulation, oxygenation, or infusion delivery.

Description

[0001] priority

[0002] This application claims priority to U.S. patent application No. 18 / 226,082 filed on July 25, 2023, which is incorporated by reference in its entirety into this application. Technical Field

[0003] The present invention relates to the field of medical devices, and more particularly to a system for monitoring the microcirculation of a patient. Background Art

[0004] Sepsis is the body’s overwhelming, life-threatening response to infection that can lead to tissue damage, organ failure, and death. Similar to a stroke or heart attack, sepsis is a medical emergency that requires rapid diagnosis and management. Once a healthcare provider suspects sepsis, it must be managed quickly and efficiently. If not recognized and managed quickly, sepsis can progress to severe sepsis and then to septic shock. It has been reported that for every hour of delay in management, the chance of sepsis progressing to severe sepsis and septic shock, leading to death, increases by 4% to 9%. Septic shock is associated with low blood pressure, which results in reduced blood flow to organs, causing them to shut down.

[0005] Disclosed herein are systems and methods for monitoring systemic responses associated with sepsis to provide early detection of sepsis and enable rapid management. Summary of the invention

[0006] According to some embodiments, a medical system is disclosed herein, comprising a microcirculation assessment (MCA) device, the MCA device being configured to generate microcirculation data associated with a defined location of a patient. The medical system also comprises a system module having a console coupled to the MCA device, wherein the console comprises a processor and a memory having logic stored thereon, the logic performing operations when executed by the processor, the operations comprising: (i) receiving 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.

[0007] In some embodiments, the systemic reaction is associated with a septic condition in the patient.

[0008] In some embodiments, the console is wirelessly coupled to the MCA device.

[0009] In some embodiments, the MCA device is configured to generate microcirculatory data via skin temperature sensing, infrared or near infrared thermal imaging, transcutaneous oxygen measurement, laser doppler flowmetry, dark field imaging, orthogonal polarization spectralimaging, ultrasound imaging, video capillaroscopy, microdialysis, or any combination thereof. In some embodiments, the patient's defined location includes a finger, nasal tissue, or sublingual tissue.

[0010] 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.

[0011] In some embodiments, the patient contacting surface of the MCA device includes an adhesive configured to secure the patient contacting surface to the patient.

[0012] In some embodiments, the operations further include providing a notification when the systemic response exceeds a defined threshold.

[0013] In some embodiments, the operations further include providing a treatment notification based on the systemic response, the treatment notification including a recommended treatment for treating the patient.

[0014] In some embodiments, the medical system further includes a display coupled to the console, and the operations further include presenting the microcirculation assessment image on the display.

[0015] In some embodiments, the medical system further comprises a treatment delivery system coupled to the console, wherein the operation further comprises activating the treatment delivery system when the systemic response exceeds a defined threshold. In some embodiments, the treatment of the treatment delivery system comprises at least one of regulating body temperature, supplying oxygen, or delivering an infusion. In some embodiments, the operation further comprises adjusting the treatment based on the systemic response.

[0016] According to some embodiments, a system method for determining a patient's systemic response is also disclosed herein, comprising determining a microcirculatory assessment of the patient via a microcirculatory assessment (MCA) device, the MCA device utilizing skin temperature sensing, infrared or near-infrared thermal imaging, transcutaneous oxygen measurement, laser Doppler flow measurement, dark field imaging, orthogonal polarization spectral imaging, ultrasound imaging, ultrasound Doppler, video capillary microscopy, microdialysis, or any combination thereof. The system method also includes determining a systemic response based on the microcirculatory assessment.

[0017] In some embodiments of the system method, determining a systemic response based on a microcirculation assessment includes: (i) collecting multiple systemic response identification data sets, wherein each data set includes a microcirculation assessment representative of a patient via an MCA device and an actual systemic response representative of the patient collected independently of the microcirculation assessment; (ii) defining an algorithm that correlates the actual systemic response to the microcirculation assessment across multiple data sets; and (iii) executing the algorithm on the patient's microcirculation assessment to identify the systemic response.

[0018] In some embodiments of the system method, each data set also includes patient data representative of the patient, the patient data including one or more of weight, age, gender, or race, and defining the algorithm includes correlating actual systemic response with microcirculatory assessment along with the patient data across multiple data sets.

[0019] In some embodiments, the system method further includes activating a therapeutic device of the system to provide therapy to the patient based on the microcirculation assessment.

[0020] In some embodiments, providing treatment includes: (i) collecting a subset of a plurality of data sets, wherein each data set in the subset includes a microcirculatory assessment on behalf of a patient, an actual systemic response on behalf of a patient, and a treatment delivered to the representative patient; and (ii) defining an algorithm to include a correlation of the treatment with the microcirculatory assessment. In such embodiments, the system method further includes executing the algorithm on the microcirculatory assessment to define the treatment.

[0021] These and other features of the concepts provided herein will become more readily apparent to those skilled in the art in view of the accompanying drawings and the following description, which describe in more detail specific embodiments of such concepts. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 A medical system configured to determine a systemic response of a patient is shown according to some embodiments.

[0023] Figure 2 According to some embodiments, Figure 1 An exemplary data table is utilized by the artificial intelligence logic of the system to define an algorithm that relates microcirculatory assessments to actual systemic responses.

[0024] Figure 3 A block diagram of a systemic method for determining systemic response according to some embodiments is shown.

[0025] Figure 4 According to some embodiments, Figure 1 A second embodiment of a microcirculation assessment device of the system.

[0026] Figure 5 According to some embodiments, Figure 1 A third embodiment of a system for evaluating microcirculation. DETAILED DESCRIPTION

[0027] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that can be easily separated from the specific embodiments, and these features may be optionally combined with or replace the features of any of the many other embodiments disclosed herein.

[0028] About the terms used herein, it should also be understood that these terms are for the purpose of describing some specific embodiments, and these terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a set of features or steps, and do not provide sequence or numerical restrictions. For example, "first", "second" and "third" features or steps do not necessarily appear in this order, and the specific embodiments including such features or steps are not necessarily limited to these three features or steps. For convenience, labels such as "left", "right", "top", "bottom", "front", "back" etc. are used, and these labels are not intended to imply, for example, any specific fixed position, orientation or direction. On the contrary, such labels are used to reflect, for example, relative position, orientation or direction. "A kind of", "one" and "the" in the singular form include plural references, unless the context clearly stipulates otherwise. For example, "systemic reaction" as used herein can include a combination of systemic reactions of a type or multiple types of systemic reactions.

[0029] The phrases "connected to," "coupled to," and "in communication with" refer to any form of interaction between two or more entities, including but not limited to physical, mechanical, electrical, magnetic, electromagnetic, fluid, wireless, and thermal interactions. Two components may be coupled to each other even if they are not in direct contact or communication with each other. For example, two components may be coupled to each other through an intermediate component.

[0030] The term "logic" may refer to hardware, firmware, or software configured to perform one or more functions. As hardware, the term "logic" may refer to or include circuits having data processing and / or storage functions. Examples of such circuits may include, but are not limited to or constrained to, hardware processors (e.g., microprocessors, one or more processor cores, digital signal processors, programmable gate arrays, microcontrollers, application specific integrated circuits "ASICs", etc.), semiconductor memories, or combinational components.

[0031] Additionally or alternatively, the term "logic" may refer to or include software, such as one or more processes, one or more instances, an application programming interface (API), a subroutine, a function, an applet, a servlet, a routine, a source code, an object code, a shared library / dynamic link library (dll), or even one or more instructions. The software may be stored in any type of suitable non-transitory storage medium or transient storage medium (e.g., an electrical, optical, acoustic, or other form of propagating signal, such as a carrier wave, an infrared signal, or a digital signal). Examples of non-transitory storage media may include, but are not limited to or limited to: programmable circuits; non-persistent storage devices, such as volatile memory (e.g., any type of random access memory "RAM"); or persistent memory, such as non-volatile memory (e.g., read-only memory "ROM", power-powered RAM, flash memory, phase change memory, etc.), a solid-state drive, a hard drive, an optical drive, or a portable memory device. As firmware, the logic may be stored in a persistent storage device.

[0032] Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art.

[0033] Any method disclosed herein includes one or more steps or actions for performing the described method. These method steps and / or actions can be interchangeable with each other. In other words, unless the proper operation of the embodiment requires a specific order of steps or actions, the order and / or use of specific steps and / or actions can be modified. In addition, a subroutine or only a portion of the method described herein can be a separate method within the scope of the disclosed text. In other words, some methods can include only a portion of the steps described in the more detailed method. In addition, all embodiments disclosed herein are combinable and / or interchangeable, unless otherwise stated, or such combination or interchange will be contrary to the operability of any embodiment.

[0034] Figure 1 A medical system 100 is shown that is configured to obtain a microcirculatory assessment of a patient and determine a systemic response of the patient from the microcirculatory assessment according to some embodiments. In some embodiments or in some use cases, the medical system 100 can determine the systemic response of a patient experiencing sepsis. Therefore, the medical system 100 can be configured to indirectly monitor the sepsis condition of the patient. As can be appreciated by one of ordinary skill in the art, a sepsis event is merely a patient condition that can result in a systemic response that is suitable for determination via a microcirculatory assessment. Therefore, the medical system 100 can be configured to monitor any patient condition (currently known or unknown) that results in a systemic response that is suitable for determination via a microcirculatory assessment.

[0035] The medical system 100 typically includes a plurality of microcirculation assessment (MCA) systems 110. In some embodiments, each MCA system in the MCA system 110 is communicatively connected (e.g., wirelessly connected) to an external computing device 60. The external computing device 60 can be, for example, any suitable computing device, such as a network server. In some embodiments, the external computing device 60 can be connected to an electronic medical record (EMR) system 160. Artificial intelligence (AI) logic 109 and a database 107 are stored in a memory (e.g., a non-transitory computer-readable medium) of the external computing device 60. The AI ​​logic 109 performs AI and / or machine learning operations on the data stored in the database 107, as further described below. In some embodiments, the MCA system 110 and the external computing device 60 can be communicatively connected to an electronic medical record (EMR) system 160.

[0036] The MCA system 110A represents any one of the MCA systems 110. The MCA system 110A includes an MCA device 150. The MCA device 150 is generally configured to obtain a microcirculatory assessment of the patient 50. The microcirculatory assessment includes MCA data related to any one of a blood flow rate calculation, a perfused vessel calculation, a vascular density, a microvasculature flow index, a vascular diameter, or any combination thereof. The microcirculatory assessment may indicate, for example, a systemic response caused by a septic event, such as changes in blood flow, perfusion, or central venous pressure. In some embodiments, the MCA system 110A may be configured to obtain other vital data from the patient in addition to the microcirculatory assessment, such as blood pressure, temperature, pulse rate, etc.

[0037] MCA device 150 can be configured to obtain microcirculatory assessment via skin temperature sensing, infrared or near-infrared thermal imaging, transcutaneous oxygen measurement, laser Doppler flowmetry, dark field imaging, orthogonal polarization spectroscopy imaging, ultrasound imaging, ultrasound Doppler, video capillary microscopy, microdialysis, or any combination thereof. MCA device 150 can be configured to obtain microcirculatory assessment at a defined location of patient 50 (such as the neck, for example, Figure 1 In other embodiments, the MCA device 150 may be configured to obtain microcirculation assessments at other defined patient locations.

[0038] The MCA device 150 can be configured to obtain a microcirculation assessment, for example, automatically or in response to an action (such as pressing a button) of a user (e.g., a clinician or a patient). In some embodiments, the user can position the MCA device 150 at a defined location on the patient to obtain a single microcirculation assessment. Similarly, the user can repeatedly position the MCA device 150 at a defined location on the patient to repeatedly obtain a single microcirculation assessment as needed. In some embodiments, the user can repeatedly position the MCA device 150 at a defined location on the patient to repeatedly obtain a microcirculation assessment according to a defined schedule in order to obtain a trend in the microcirculation assessment. In other embodiments, the MCA device 150 can be configured to be fixed to the patient so that the MCA device 150 can automatically obtain a microcirculation assessment continuously or repeatedly (such as according to a defined schedule). In some embodiments or deployments, the MCA device 150 can be fixed to the patient, for example, over an extended period of time (such as several days).

[0039] according to Figure 1 In one embodiment shown, the MCA device 150 can include a patch 152. In some embodiments, the patch 152 can include an adhesive 153 disposed across the underside (ie, the patient contacting surface) of the patch 152. The patch 152 can also be secured to the patient via a strap or band.

[0040] According to one embodiment, the patch 152 can be incorporated into a patient's bed. For example, the patch 152 can be placed on the mattress so that the patient contact surface faces upward. In such embodiments, the patch 152 can be sandwiched between the mattress and the patient so that the patch 152 is fixed in operative contact with the patient. According to another embodiment, the patch 152 can be incorporated into an article of clothing, such as a sock, a sleeve, an underwear, a glove, or a watch, for example. According to another embodiment, the MCA device 150 can be incorporated into a medical device configured to be inserted into a patient, such as a probe, a stylet, or a catheter, for example.

[0041] The MCA system 110A includes a system module 111 having a console 115, and the MCA device 150 is communicatively connected to the console 115, such as via a wireless connection (as shown) or a wired connection. In the illustrated embodiment, the console 115 includes a processor (or multiple processors) 116 that executes logic (such as imaging logic 118, MCA logic 119, and systemic response logic 120) stored in a memory 117 (e.g., a non-transitory computer-readable medium). The power supply 114 of the console 115 may, for example, include an external power supply (i.e., a facility power supply) or a battery, such as a rechargeable battery. Therefore, the MCA system 110A can be used, for example, within a medical care facility or away from a medical care facility, such as at home or in an office. The console 115 may include a wireless module 113 to facilitate wireless communication between the MCA device 150 and the system module 111 and / or between the system module 110A and an external computing device 60 or an EMR system 160. In some embodiments, the system module 111 and the MCA device 150 can be combined to form a single unit.

[0042] In some embodiments, the MCA system 110A may include (or be coupled to) a display 112 (e.g., a graphical user interface) configured to display notification information and / or receive input from a user. In some embodiments, the imaging logic 118 may create an MCA image 125 and display it on the display 112. The MCA image 125 may, for example, enable a user (e.g., a trained clinician) to visually detect anomalies or changes in microcirculatory assessment, such as changes in vessel diameter or shape. In some embodiments, the MCA image 125 may be configured to indicate a condition or measurement of a microcirculatory assessment. For example, the MCA image 125 may include colors to indicate a condition of a specific aspect of a microcirculatory assessment. As a specific example, a vessel may: (i) be displayed as red when blood flow through the vessel is in a normal range, and (ii) be displayed as black when blood flow through the vessel is in a reduced range. As another specific example, the background of the MCA image 125 may: (i) be displayed as green when the microcirculatory assessment is in a normal range, and (ii) be displayed as yellow when the microcirculatory assessment is in an abnormal range.

[0043] The MCA logic 119 generally manages the operation of the MCA device 150 to obtain one or more microcirculation assessments, as described above. In some embodiments, the MCA logic 119 can be configured to provide notifications to the user. For example, the MCA logic 119 can generate an alert, for example, when the MCA device cannot obtain a microcirculation assessment (such as when the MCA device 150 is disconnected from the patient 50). The MCA logic 119 can be configured to receive raw data from the MCA device 150 and convert the raw data to MCA data (as described above). In some embodiments, the MCA logic 119 can be configured to compare the instant microcirculation assessment with a known or previously obtained microcirculation assessment.

[0044] The imaging logic 118 may receive the MCA data from the MCA logic 119 for depiction on the display 112. The systemic response logic 120 is configured to receive the MCA data from the MCA logic 119 and determine or identify systemic responses based on the MCA data (as described above). In some embodiments, the systemic response logic 120 may be configured to determine trends or changes in systemic responses over time.

[0045] The systemic response logic 120 may be configured to provide notifications to the user based on the systemic response. As one example, the notification may include an alert (visible and / or audible) when the systemic response exceeds one or more defined thresholds (such as central venous pressure falling below a defined limit). As another example, the notification may include an alert when a trend or change in the systemic response exceeds a threshold (such as a change (e.g., decrease) in central venous pressure exceeding a defined limit).

[0046] The systemic response logic 120 can be configured to suggest or recommend a treatment therapy for the patient 50 based on the systemic response by way of a notification. It has been shown that patients experiencing a sepsis event benefit from treatments including, for example, thermoregulation, oxygenation, and / or medications (e.g., IV infusions). The medications can include, for example, antibiotics and / or vasodilators. Therefore, the systemic response logic 120 can recommend a treatment therapy for the patient 50 based on the systemic response, including thermoregulation, oxygenation, medications, or any combination thereof.

[0047] In some embodiments, the MCA system 110A may include or be coupled to a medical device 170 configured to provide treatment to the patient 50. The medical device 170 may be any device suitable for treating the patient 50. For example, in the event that the patient experiences a sepsis event, the medical device 170 may include a temperature management system, an oxygen source, an infusion pump, or any combination thereof. The medical device 170 is effectively coupled to the patient 50 to provide treatment. The MCA system 110A may be coupled to the medical device 170 so that the MCA system 110A may manage the operation of the medical device 170 in accordance with providing treatment. In some embodiments, the MCA system 110A may initiate treatment only upon receipt of an approval input from a user. Thus, the MCA system 110A, when coupled to the medical device 170, may be configured to treat the sepsis condition of the patient 50.

[0048] According to one embodiment, the body temperature management system may include a targeted temperature management system that utilizes one or more heat pads applied to the patient's skin surface to warm or cool the patient. In such embodiments, the patch 152 or MCA device 150 may generally be attached to or incorporated into the heat pad.

[0049] The MCA system 110A may be configured to utilize machine learning and / or artificial intelligence techniques to determine systemic responses from microcirculatory assessments. As described above, the MCA system 110A may interface with an external computing device 60 having a database 107 and running AI logic 109 .

[0050] The AI ​​logic 109 is generally configured to define a relationship or correlation between the microcirculation assessment and the actual systemic response. The AI ​​logic 109 utilizes AI and / or machine learning techniques to define the correlation based on a series of data sets stored in the database 107. In some embodiments, the AI ​​and / or machine learning techniques may, for example, include statistical operations, such as linear regression. The AI ​​logic 109 may then define an algorithm based on the correlation, wherein the algorithm is configured to determine the systemic response of the instant patient based on the microcirculation assessment of the instant patient. The systemic response logic 120 is configured to collect the microcirculation assessment of the instant patient and apply the algorithm to the microcirculation assessment to determine the systemic response of the instant patient.

[0051] Figure 2An exemplary table 200 of a database 107 according to some embodiments is shown. Table 200 includes multiple (e.g., 10, 100, 1000 or more) data sets (or records) 210 collected from multiple MCA systems 110, wherein each data set 210 may include data related to a microcirculation assessment event of a patient. Data table 200 includes MCA data 220 obtained by MCA device 150 and actual systemic response data 230 obtained independently of microcirculation assessment. In some cases of microcirculation assessment events (such as sepsis events), actual systemic response data may be collected directly from the patient using appropriate methods and techniques for this. For example, central venous pressure may be measured directly via a central catheter. Similarly, sepsis data may be obtained via blood tests. It should be noted that each data set 210 may not include all of the MCA data 220 and / or actual systemic response data 230 shown in table 200. In other words, the data set 210 may include only a subset of the MCA data 220 and / or the actual systemic response data 230 indicated in the table 200 .

[0052] In some embodiments, the actual systemic response data 230 may be input into the MCA system 110 by a clinician via the display 112. In such embodiments, the MCA system 110 may transmit the MCA data 220 and the actual systemic response data 230 as a data set to the external computing device 60 for processing by the AI ​​logic 109. In other embodiments, the actual systemic response data 230 may be included in the patient's electronic medical record (EMR), and in such embodiments, the external computing device 60 may collect the systemic response data 230 from the EMR system 160.

[0053] In some embodiments, although not required, the table 200 may include patient data 240. The patient data 240 may, for example, include data such as weight, gender, age, or race. Of course, the patient data 240 may not be limited to the patient data shown. For example, additional patient data (not shown) may include blood pressure, medication, disease, or any other medical condition of the patient. In some embodiments, the patient data 240 may include only a subset of the patient data shown. In some embodiments, the patient data 240 may be recorded in the patient's EMR, and therefore, the external computing device 60 may collect the patient data 240 from the EMR system 160. In such embodiments, the AI ​​logic 109 defines the relationship or correlation between the microcirculation assessment data 220 together with the patient data 240 and the actual systemic response data 230, and the AI ​​logic 109 defines the algorithm accordingly.

[0054] The AI ​​logic 109 may continue to collect or receive additional data sets from multiple MCA systems 110 and / or EMR systems 160 to refine the algorithm, e.g., to increase the accuracy or statistical confidence of the algorithm. In some embodiments, the AI ​​logic 109 may periodically (e.g., continuously) receive additional data sets.

[0055] In the presence of an algorithm defined by the AI ​​logic 109, the systemic response logic 120 may utilize the algorithm to determine the systemic response from the microcirculatory assessment. In other words, the systemic response logic 120 may apply the algorithm to the MCA data collected by the MCA device 150 for the patient 50 to determine the systemic response of the patient 50. Since the MCA system 110A is communicatively coupled to the external computing device 60, the MCA system 110A may collect the algorithm from the external computing device 60.

[0056] In some embodiments, the AI ​​logic 109 can be configured to define a relationship or correlation between the actual systemic response and the delivered treatment. In some cases of a microcirculation assessment event, a clinician may deliver a treatment to a patient to treat a patient condition, such as sepsis. In such cases, the clinician may record the delivered treatment and the patient's response to the treatment, such as the effectiveness of the treatment in alleviating the patient's condition, in an EMR, for example. Thus, the table 200 may include treatment data 250. The AI ​​logic 109 may then further define an algorithm to include a correlation between the actual systemic response and the delivered treatment, such that the systemic response logic 120 is configured to determine a recommended treatment for the patient based on the microcirculation assessment via the application of the algorithm.

[0057] As an example, the systemic response logic 120 may determine that the systemic response indicates severe sepsis based on the microcirculation assessment. In such cases, infusion therapy may be a typical treatment for treating severe sepsis. The clinician may deliver the infusion therapy and record that the infusion therapy is effective in treating sepsis. The external computing device 60 may collect the microcirculation assessment from the MCA system 110A. The external computing device 60 may also collect actual systemic response and treatment information / data from the EMR system 160. As a result of the example, the table 200 may include a data set 210, which includes MCA data 220, corresponding actual systemic response data 230, and treatment data 250 (i.e., infusion therapy data, which includes the effectiveness of the infusion therapy in treating sepsis).

[0058] Figure 3300 is a block diagram of a system method 300 for determining a patient's systemic response as performed by a medical system 100 according to some embodiments, the system method including all or any subset of the following steps, actions or processes. The system method 300 includes obtaining a microcirculatory assessment of the patient (block 310). Obtaining the microcirculatory assessment is performed by a microcirculatory assessment (MCA) device, which utilizes skin temperature sensing, infrared or near-infrared thermal imaging, transcutaneous oxygen measurement, laser Doppler flow measurement, dark field imaging, orthogonal polarization spectral imaging, ultrasound imaging, ultrasound Doppler, video capillary microscopy, microdialysis, or any combination thereof. The system method 300 also includes determining a patient's systemic response based on the microcirculatory assessment (block 320). The systemic response may include all or any subset of blood flow rate, perfusion, or central venous pressure (including changes therein).

[0059] The system method 300 may also include collecting a plurality of systemic response identification data sets (block 321), wherein each data set includes an evaluation of microcirculation on behalf of the patient via the MCA device and an actual systemic response on behalf of the patient collected independently of the evaluation of microcirculation. The system method 300 may also include defining an algorithm that correlates the actual systemic response to the evaluation of microcirculation across the plurality of data sets (block 322) and executing the algorithm on the evaluation of microcirculation to identify the systemic response (block 323).

[0060] In some embodiments of the system method 300, each data set also includes patient data representative of the patient, such as weight, age, gender, and / or race. Thus, the system method 300 may also include defining an algorithm to correlate actual systemic response with microcirculatory assessments along with patient data across multiple data sets.

[0061] The system method 300 may also include activating a treatment device of the system based on the microcirculation assessment to provide treatment to the patient (box 330). In some embodiments, the system method 300 may also include collecting a subset of the multiple data sets that also includes the delivered treatment (box 331), that is, each data set in the subset includes a microcirculation assessment on behalf of the patient, an actual systemic response on behalf of the patient, and the treatment delivered to the representative patient. The system method 300 may also include defining an algorithm to include a correlation of the treatment with the microcirculation assessment (box 332). In such embodiments, the system method 300 may also include executing an algorithm on the microcirculation assessment to define the treatment (box 333).

[0062] Figure 4 Another embodiment of an MCA system 410 is shown, which may be similar in some respects to the MCA system in conjunction with Figure 1 10A. It should be understood that all of the illustrated embodiments may have similar features. Therefore, similar features are represented by similar reference numerals, with the leading numeral incremented to "4". For example, the MCA device in Figure 1 is designated as "150" in the Figure 4 Therefore, the above disclosures regarding features with similar identifiers may not be repeated in the following. Figure 1 Certain features of the MCA system 410 and related components shown in the drawings may not be shown in the drawings or identified by reference numerals, or may not be specifically discussed in the subsequent written description. However, such features may be the same or substantially the same as features depicted in other embodiments and / or described with respect to such embodiments. Therefore, the relevant description of such features also applies to Figure 4 Features of the MCA system 410. Figure 1 Any suitable combination of features and variations thereof of the MCA system 110A and component descriptions shown in Figure 4 The MCA system 410 and components can be used together, and vice versa. This mode of disclosure is also applicable to other embodiments depicted in subsequent figures and described below.

[0063] The MCA system 410 generally includes an MCA device 450 and a system module 411. The system module 411 includes a display 412 for presenting an MCA image 425. The size and shape of the system module 411 can be designed to enable the system module 411 to be handheld. Buttons 413 provide input and control to the MCA system 410. A console 415 of the MCA system 410 may include a light source 416 and / or a photodetector 417. A connecting member 451 couples the MCA device 450 to the system module 411. In some embodiments, the connecting member 451 may include a plurality of (e.g., 1, 2, 3, or more) optical fibers 452 extending therefrom. The connecting member 451 may include a sufficient length (e.g., 2 feet to 4 feet) to enable the system module 411 to be placed in a clothing pocket or purse, for example, during use.

[0064] The MCA system 410 is configured to obtain a microcirculatory assessment of a finger pad portion or other portion of a patient's finger 56. The MCA device 450 can be configured to obtain a microcirculatory assessment via blood flow velocity calculation, vascular identification, percutaneous oxygen measurement, microvascular flow index, total vascular density, a portion of a perfused vessel, laser Doppler flow measurement, dark field imaging, orthogonal polarization spectral imaging, ultrasound imaging, ultrasound Doppler, video capillaris microscopy, or any combination thereof. The MCA device 450 may include, for example, an attachment device 460 configured to secure the MCA device 450 to the finger 456, such as a clamp, a clip, or a cuff.

[0065] In some embodiments, one or more of the optical fibers 452 can be configured to transmit light 455 from the light source 417 to the MCA device 450, where the light 455 illuminates the finger 56 to enable imaging of the microvasculature of the finger 56. Similarly, image light 456 emitted from the finger 56 in response to the light 455 passes through the lens 457 when entering one or more other optical fibers 452 configured to transmit the image light 456 from the MCA device 450 to the photodetector 417.

[0066] Figure 5 Another embodiment of an MCA system 510 is shown, which generally includes an MCA device 550 and a system module 511 combined into a single unit. The system module 511 includes a display 512 for presenting an MCA image 525. The size and shape of the system module 511 can be designed to enable hand-held system module 511. The MCA system 510 can include buttons 513 to enable input and control of the MCA system 510. A console 515 of the MCA system 510 can include a light source 516 (e.g., an LED) and / or a photodetector 517.

[0067] According to one embodiment, the MCA system 510 is configured to obtain a microcirculatory assessment of the patient's sublingual tissue 58. Alternatively or additionally, according to another embodiment, the MCA system 510 can be configured to obtain a microcirculatory assessment of nasal tissue (not shown). The MCA device 550 can be configured to obtain a microcirculatory assessment via blood flow velocity calculation, vascular identification, transcutaneous oxygen measurement, microvascular flow index, total vascular density, a portion of perfused vessels, laser Doppler flow measurement, dark field imaging, orthogonal polarization spectral imaging, ultrasound, video capillary microscopy, or any combination thereof.

[0068] In some embodiments, the extension member 551 can be configured to transmit light 555 from the light source 517 to the distal end 551A, wherein the light 555 illuminates the sublingual tissue 58 to enable imaging of the microvasculature of the sublingual tissue 58. Similarly, the extension member 551 can be configured to transmit image light 556 emitted from the sublingual tissue 58 from the distal end 551A to the photodetector 517. In some embodiments, the extension member 551 can include a lens 557. In some embodiments, the extension member 551 can include a plurality of (e.g., 1, 2, 3, or more) optical fibers 552 extending along it between the system module 511 and the distal end 551A to facilitate transmission of light 555 or image light 556 along the extension member 551.

[0069] Although the MCA system 510 is configured to obtain microcirculation assessments from sublingual tissue 58 and / or nasal tissue, one of ordinary skill in the art will appreciate that the MCA system 510 may be configured to interface with and obtain microcirculation assessments from any other suitable body tissue without departing from the foregoing disclosure.

[0070] The MCA systems 110, 410, and 510 are each configured for deployment with the medical system 100. The medical system 100 may include multiple MCA systems, including any number of the MCA systems 110, 410, and / or 510.

[0071] Although some specific embodiments have been disclosed herein, and although these specific embodiments have been disclosed in considerable detail, these specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may be envisioned by those of ordinary skill in the art, and in broader aspects, these adaptations and / or modifications are also encompassed. Therefore, changes may be made to the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A medical system comprising: a microcirculation assessment device configured to generate microcirculation data associated with a defined location of a patient; and A system module having a console coupled to the microcirculation assessment device, the console comprising a processor and a memory having logic stored thereon, the logic performing operations when executed by the processor, the operations comprising: receiving the microcirculation data from the microcirculation assessment device; determining a microcirculatory assessment from the microcirculatory data; and Based on the microcirculatory assessment, the patient's systemic response is determined.

2. The medical system of claim 1, wherein the systemic response is associated with a septic condition in the patient.

3. The medical system according to claim 1 or 2, wherein the console is wirelessly connected to the microcirculation assessment device.

4. A medical system according to any of the preceding claims, wherein the microcirculation assessment 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 capillary microscopy, microdialysis, or any combination thereof.

5. A medical system according to any of the preceding claims, wherein the defined location of the patient comprises a finger, nasal tissue, or sublingual tissue.

6. The medical system according to any of the preceding claims, wherein the microcirculation assessment device is integrated into a patient bed.

7. The medical system according to any one of the preceding claims, wherein the microcirculation assessment device is a wearable device.

8. The medical system of claim 7, wherein the microcirculation assessment device is incorporated into an article of clothing.

9. The medical system of any one of the preceding claims, wherein the patient contacting surface of the microcirculation assessment device comprises an adhesive configured to secure the patient contacting surface to the patient.

10. The medical system of any of the preceding claims, wherein the operations further comprise providing a notification when the systemic response exceeds a defined threshold.

11. The medical system of any of the preceding claims, wherein the operations further comprise providing a treatment notification based on the systemic response, the treatment notification comprising a recommended treatment for treating the patient.

12. The medical system of any of the preceding claims, further comprising a display coupled to the console, the operations further comprising presenting a microcirculation assessment image on the display.

13. The medical system of any of the preceding claims, further comprising a therapy delivery system coupled to the console, the operation further comprising activating the therapy delivery system when the systemic response exceeds a defined threshold.

14. The medical system of claim 12, wherein the therapy of the therapy delivery system comprises at least one of regulating body temperature, providing oxygen, or delivering an infusion.

15. The medical system of claim 12, wherein the operations further comprise adjusting the therapy based on the systemic response.

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