Devices, systems, and methods for autonomously controlling balloon catheters

Abstract

A method for automatically controlling an expandable member in a blood vessel of a subject may include: acquiring, using a controller, proximal sensor data from a proximal pressure sensor and acquiring distal sensor data from a distal pressure sensor; comparing the acquired proximal sensor data to a proximal pressure threshold; in response to determining that the proximal sensor data is equal to or greater than the proximal pressure threshold, adjusting, using the controller, a volume of the expandable member based on the distal sensor data; and in response to determining that the proximal sensor data is below the proximal pressure threshold, adjusting, using the controller, a volume of the expandable member based on the proximal sensor data.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Patent Application No. 63 / 400,324, filed August 23, 2022, the entire contents of which are incorporated herein by reference.

[0002] (Government support) This invention was made with government support under grants FA8650-20-2-6116 and W81XWH-21-C-0058 awarded by the United States Air Force / Air Force Materiel Command. The government has certain rights in this invention.

[0003] FIELD OF THE INVENTION The present invention relates generally to the field of catheters for monitoring physiological conditions, and more particularly to the field of autonomous control of balloon catheters during medical procedures. [Background technology]

[0004] Over the years, there have been significant advances in technology for performing intravascular procedures. For example, intravascular catheters, such as balloon catheters, are designed to be strategically placed within a patient's blood vessels to partially and / or completely occlude a portion of the blood vessel. Balloon inflation can increase blood pressure and blood flow to branching vessels upstream of the balloon (e.g., central blood pressure), while decreasing blood pressure and blood flow downstream of the balloon (peripheral blood pressure).

[0005] Recent advances have led to the automatic control of balloon catheters when they are placed within a patient's blood vessel. However, existing automated technologies do not adequately ensure patient safety. For example, during intravascular procedures, a patient's condition may become unstable due to blood loss caused by trauma (e.g., vascular trauma). The patient's blood pressure (e.g., upper pressure) proximal to the balloon and closest to the heart may drop to a dangerous level, thereby affecting one or more organs, such as the patient's brain, lungs, or heart. By adjusting the balloon volume, it may be possible to avoid or minimize adverse effects on the patient. In addition, the patient may require blood products (e.g., blood transfusions), intravenous medications, intravenous fluid infusions, etc. to stabilize their condition. Existing technologies are not equipped to track a patient's hemodynamic status and make real-time automatic adjustments to the balloon catheter or device to provide blood products or medications.

[0006] Therefore, there is a need for additional devices, systems, and methods for autonomously controlling balloon catheters and medication, intravenous fluid, and blood delivery while ensuring patient safety. Summary of the Invention

[0007] In some variations, a method for automatically controlling an expandable member in a blood vessel of a subject may include: acquiring, using a controller, proximal sensor data from a proximal pressure sensor and acquiring distal sensor data from a distal pressure sensor; comparing the acquired proximal sensor data to a proximal pressure threshold; in response to determining that the proximal sensor data is equal to or greater than the proximal pressure threshold, adjusting, using the controller, a volume of the expandable member based on the distal sensor data; and in response to determining that the proximal sensor data is below the proximal pressure threshold, adjusting, using the controller, a volume of the expandable member based on the proximal sensor data.

[0008] In some variations, the proximal pressure threshold may be a lower limit of a proximal pressure guard range, and adjusting the volume of the expandable member based on the distal sensor data may further include, in response to determining that the proximal sensor data exceeds an upper limit of the proximal pressure guard range, using the controller to adjust the volume of the expandable member so that the distal sensor data approaches an interim set point and incrementing the interim set point multiple times. The interim set point may be less than or equal to the target distal pressure value.

[0009] In some variations, incrementing the interim set point for a subset of the plurality of times may include incrementing the interim set point by a predetermined value after a set period of time for each of the subset of times. The predetermined value may be between 1 mmHg and 5 mmHg. The set period of time may be between 1 minute and 5 minutes.

[0010] In some variations, incrementing the interim set point may include, each time among the plurality of times, using the controller to compare a difference between the distal sensor data and the interim set point with a delay range, and incrementing the set point by a predetermined value after a set period of time in response to determining that the difference is within the delay range. The method may further include maintaining the interim set point constant in response to determining that the difference is below the delay range. The delay range may be between 20 mmHg and 5 mmHg.

[0011] In some variations, the proximal pressure threshold may be a lower limit of a proximal pressure guard range, and adjusting the volume of the expandable member based on the distal sensor data may further include, in response to determining that the proximal sensor data is within the proximal pressure guard range, using the controller to hold constant an interim set point for the distal sensor data and adjust the volume of the expandable member such that the distal sensor data approaches the interim set point. The interim set point may be less than or equal to the target distal pressure value.

[0012] In some variations, the proximal pressure threshold may be a lower limit of a proximal pressure guard range. Adjusting the volume of the expandable member based on the proximal sensor data may further include adjusting the volume of the expandable member based on the proximal sensor data until the proximal sensor data is above the lower limit of the proximal guard range. In some variations, adjusting the volume of the expandable member based on the distal sensor data may further include adjusting the volume of the expandable member so that the distal blood pressure obtained from the distal sensor data reaches the target distal pressure. In some variations, the method may further include indicating whether the distal sensor data is progressing toward the target distal pressure value. In some variations, the indicating may further include providing a first indicator if the interim set point is progressing toward the target distal pressure value within a predetermined first period of time and providing a second, different indicator if the interim set point remains constant or moves away from the target distal pressure value within the predetermined first period of time. In some variations, providing the first indicator may include using the controller to determine whether the interim set point during the previous time window equaled the target distal pressure value and whether a difference between the current interim set point and the target distal pressure value is greater than or equal to an indicator value, and providing the second indicator includes determining whether the interim set point during the previous time window equaled the target distal pressure value and whether a difference between the current interim set point and the target distal pressure value is less than the indicator value. In some variations, the previous time window may be one or more of the previous 1, 2, 3, 4, or 5 minutes. In some variations, the indicator value may be −1 mmHg. In some variations, providing the first indicator may include displaying a shape including a first color on the display, and providing the second indicator may include displaying a shape including a second color on the display. In some variations, the method may further include providing a third indicator providing progress of the distal sensor data toward the target pressure value during the previous time window. In some variations, providing the third indicator may include displaying a border around the shape. In some variations, the previous time window may be within the previous five minutes.In some variations, the method may further include providing a third indicator indicating that the distal sensor data is at a minimum distal value and a fourth indicator indicating that progress of the distal sensor data toward the target distal pressure value cannot be determined by the controller. The minimum distal value may correspond to distal sensor data when the blood vessel is completely occluded.

[0013] In some variations, the method may further include adjusting the volume of the expandable member in response to a user input that fully contracts the expandable member such that the proximal sensor data remains above the proximal pressure threshold and the expandable membrane sensor reaches a target expandable member pressure. The target expandable member pressure may be a negative pressure. The method may further include maintaining a minimum proximal pressure. The minimum proximal pressure may be configured to support one or more of the subject's brain, lungs, or heart.

[0014] In some variations, a method for automatically controlling an expandable member in a blood vessel of a subject may include using a controller to acquire proximal sensor data from a proximal pressure sensor and acquire distal sensor data from a distal pressure sensor, compare the acquired proximal sensor data with a proximal pressure guard range, and transition the controller to an adjustment state in response to determining that the proximal sensor data exceeds an upper limit of the pressure guard range. The controller may be configured in the adjustment state to adjust a volume of the expandable member to move the distal sensor data toward a distal target value. The method may also include transitioning the controller to a hold state in response to determining that the proximal sensor data is within the proximal pressure guard range. The controller may be configured in the hold state to not adjust the volume of the expandable member to maintain the distal sensor data. The method may also include transitioning the controller to a proximal pressure control state in response to determining that the proximal sensor data is below a lower limit of the pressure guard range.

[0015] In some variations, in the adjustment state, the method may include using the controller to adjust the volume of the expandable member based on the variable distal interim set point. In some variations, in the adjustment state, the method may further include using the controller to adjust the volume of the expandable member so that the distal sensor data reaches the variable distal interim set point. In some variations, in the adjustment state, the variable distal interim set point may be increased by a predetermined value multiple times.

[0016] In some variations, the method may further include detecting a complete occlusion of the blood vessel and, after a first of the plurality of occlusions, increasing the variable interim set point by a first predetermined value in the adjustment state. In some variations, the first predetermined value may be 5 mmHg above the current distal blood pressure obtained at the time of the occlusion. In some variations, the method may further include, after a set period of time a second of the plurality of times, increasing the variable interim set point by a second, different predetermined value in the adjustment state. In some variations, the second predetermined value may be 1 mmHg. In some variations, in the hold state, the volume of the expandable member may be adjusted based on the constant distal interim set point using the controller.

[0017] In some variations, in the proximal pressure control state, the volume of the expandable member is adjusted to move the proximal sensor data above the lower limit of the pressure guard range. In some variations, in the proximal pressure control state, the target value of the distal sensor data is set to the current value of the distal sensor data. In some variations, in response to a user input that fully deflates the expandable member, the controller transitions to a wean to off state. The controller may be configured to fully deflate the expandable member in the wean to off state. In some variations, in the wean to off state, the volume of the expandable member may be adjusted so that the proximal sensor data remains above the lower limit of the pressure guard range.

[0018] In some variations, a system for controller blood flow may include an elongate body including an expandable member, a proximal pressure sensor, and a distal pressure sensor, a pump in fluid communication with the expandable member, and a controller communicatively coupled to the proximal pressure sensor, the distal pressure sensor, and the pump. The controller may be configured to acquire proximal sensor data from the proximal pressure sensor, acquire distal sensor data from the distal pressure sensor, compare the acquired proximal sensor data to a proximal pressure threshold, adjust a volume of the expandable member based on the distal sensor data in response to determining that the proximal sensor data exceeds the proximal pressure threshold, and adjust a volume of the expandable member based on the proximal sensor data in response to determining that the proximal sensor data is below the proximal pressure threshold.

[0019] In some variations, a system for controlling blood flow may include an elongate body including an expandable member, a proximal pressure sensor, and a distal pressure sensor; a pump in fluid communication with the expandable member; and a controller communicatively coupled to the proximal pressure sensor, the distal pressure sensor, and the pump. The controller may be configured to acquire proximal sensor data from the proximal pressure sensor, acquire distal sensor data from the distal pressure sensor, compare the acquired proximal sensor data with a proximal pressure guard range, and transition the controller to an adjustment state in response to determining that the proximal sensor data exceeds an upper limit of the pressure guard range. The controller may be configured to adjust a volume of the expandable member in the adjustment state to move the distal sensor data toward a distal target value. The controller may also be configured to transition the controller to a hold state in response to determining that the proximal sensor data is within the proximal pressure guard range. The controller may be configured to maintain the distal sensor data in the hold state. The controller may also be configured to transition the controller to a proximal pressure control state in response to determining that the proximal sensor data is below a lower limit of the proximal pressure guard range.

[0020] In some variations, the devices, systems, and methods described herein may include a pump and one or more controllers configured to perform the infusion and deliver blood products to the patient to assist in stabilizing the patient's condition. Exemplary blood products include, but are not limited to, red blood cells, plasma, platelets, and cryoprecipitate. Other fluids, such as saline, lactated Ringer's solution, D5W, or medications, may also be infused to assist in achieving or maintaining hemodynamic stability. [Brief explanation of the drawings]

[0021] The patent or application file contains at least one drawing executed in color. Copies of this patent and patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee. [Figure 1A] FIG. 1 is a block diagram illustrating an exemplary variation of a system for measuring a physiological condition. [Figure 1B] 1 illustrates an exemplary variation of a system for measuring a physiological condition. [Figure 1C] 1 illustrates an exemplary variation of a system for measuring a physiological condition. [Figure 2A] 10 illustrates an exemplary variation of a user interface of a system for measuring a physiological condition. [Figure 2B] 10 illustrates an exemplary variation of a user interface of a system for measuring a physiological condition. [Figure 3] 10 illustrates another exemplary variation of a user interface of a system for measuring a physiological condition. [Figure 4] 10 is a flowchart illustrating an exemplary variation of a method for autonomously controlling an expandable member. [Figure 5] 10 provides exemplary sensor data and illustrates autonomous control of an expandable member based on the sensor data. [Figure 6] 10 provides exemplary sensor data and illustrates autonomous control of an expandable member based on the sensor data. [Figure 7] 10 provides exemplary sensor data and illustrates autonomous control of an expandable member based on the sensor data. [Figure 8] 10 provides exemplary sensor data and illustrates autonomous control of an expandable member based on the sensor data. [Figure 9] 10 provides exemplary sensor data and illustrates autonomous control of an expandable member based on the sensor data. [Figure 10] 10 provides exemplary sensor data and illustrates autonomous control of an expandable member based on the sensor data. [Figure 11] 1 illustrates an exemplary approach for estimating the amount of blood product delivered to a patient while also controlling bleeding. [Figure 12] This shows the infusion of blood products at a fixed rate. DETAILED DESCRIPTION OF THE INVENTION

[0022] Non-limiting examples of various aspects and variations of the present invention are described herein and illustrated in the accompanying drawings.

[0023] Described herein are systems, devices, and methods for autonomously or automatically controlling an expandable member (e.g., a balloon) within a subject's blood vessel. More particularly, described herein are systems, devices, and methods for autonomously controlling an expandable member during an intravascular procedure while ensuring the safety of the subject.

[0024] The terms "proximal" and "distal" as used herein with respect to sensors and / or particular local blood pressure readings refer to the patient's physiology and / or the direction of blood flow from the heart. For example, when discussing a patient's physiology, proximal blood pressure (e.g., cephalad) refers to the blood pressure closest to the heart, and distal blood pressure (e.g., rostral) refers to the blood pressure furthest from the heart. As described further herein, a sensor configured to receive proximal blood pressure data is referred to as a "proximal sensor," and a sensor configured to receive distal blood pressure data is referred to as a "distal sensor." For example, when an elongate body comprising an elongate member with a first sensor positioned at the tip of the elongate body (and on a first side of the expandable member) and a second sensor positioned at the base of the elongate body (and on a second, opposite side of the expandable member) is inserted retrograde into the aorta from the common femoral artery, the sensor at the tip of the elongate body and closer to the heart may be referred to as the proximal sensor, and the sensor at the base of the elongate body and farthest from the heart may be referred to as the distal sensor. Similarly, when the elongate body is inserted from the brachial or axillary artery and protrudes antegrade into the aorta, the sensor at the tip of the elongate body and further from the heart may be referred to as the distal sensor, and the sensor at the base of the elongate body and closer to the heart may be referred to as the proximal sensor.

[0025] During an intravascular procedure, a blood flow control device including an expandable member can be advanced into a blood vessel, e.g., the aorta, to affect blood flow within the vessel and thereby affect the patient's blood pressure. Specifically, the volume of the expandable member can be adjusted to control blood flow within the vessel and thereby control the patient's blood pressure. To partially and / or completely occlude the vessel, the volume of the expandable member can be increased such that the expandable member expands or otherwise increases in size. This prevents blood flow through the expandable member, increasing the patient's proximal blood pressure (blood pressure closest to the heart) while decreasing the patient's distal blood pressure (blood pressure farthest from the heart). In some variations, after an initial period of complete occlusion to allow stabilization of the patient's proximal blood pressure, the volume within the expandable member can be adjusted to a target distal blood pressure. This can allow blood to flow past the expandable member to perfuse one or more lower organs, such as the liver, kidneys, or intestines, while continuing to support blood pressure above the balloon to perfuse the brain, heart, and lungs. Once the subject's physiological condition has fully stabilized, the expandable member can be removed from the blood vessel.

[0026] There are several complications that can arise when an expandable member is used during an intravascular procedure. For example, in some cases, the expandable member may over-inflate. For example, the expandable member and / or the blood vessel may rupture, thereby adversely affecting the subject. Furthermore, prolonged occlusion may result in ischemia. Furthermore, in some cases, contraction of the expandable member may cause sudden physiological disturbances. For example, contraction of the expandable member may cause a dangerous drop in the patient's proximal blood pressure, thereby adversely affecting upper organs such as the brain, heart, and lungs. In such situations, the expandable member may need to be re-inflated to stabilize the subject's physiological condition.

[0027] The systems, devices, and methods described herein provide autonomous or automatic control of the expandable member based on information about the patient's physiological state, thus helping to prevent or minimize complications that may arise during expandable member-based endovascular procedures and increasing patient safety. The systems, devices, and methods described herein may also improve the safety of expandable member-based endovascular procedures, such as those in which the expandable member is positioned within the aorta, by helping to maintain sufficient cranial blood pressure to support the brain, lungs, heart, etc., while still allowing blood flow to the extremities, when safely possible. Additionally, the devices, systems, and methods described herein allow for slow deflation of the expandable member, which may help avoid sudden physiological disturbances. For example, slow deflation may allow time for the introduction of blood products, intravenous medications, intravenous fluids, etc. to stabilize the subject's physiological state. Furthermore, the devices, systems, and methods described herein provide feedback to the user (e.g., surgeon, operator, physician, etc.). For example, the user may track the progress of the patient's blood pressure toward a desired blood pressure value. For example, the devices, systems, and methods described herein may allow a user to track the progress of a patient's distal blood pressure toward its target value. This allows a user to closely track a subject's physiological condition to determine underlying issues that may be causing physiological disturbances. This may also allow a user to make therapeutic decisions, such as when to deliver blood products, medications, and / or fluids and the amount of blood products, medications, and / or fluids that may be needed. This may also allow a user to determine whether the patient's physiology allows the device / system to track toward the target blood pressure or whether other interventions and / or changes to the target blood pressure are necessary.

[0028] The systems and devices described herein may include an elongate body comprising an expandable member. One or more pressure sensors may be positioned on the elongate body. For example, a first sensor may be positioned proximal to the expandable member and closer to the base of the elongate body, and a second sensor may be positioned distal to the expandable member and closer to the tip of the elongate body. As described above, when the elongate body is advanced retrograde from the femoral artery into the aorta, the sensor closer to the tip of the elongate body may measure the patient's proximal blood pressure and may be referred to as the proximal sensor. In such a scenario, the sensor closer to the base of the elongate body may measure the patient's distal blood pressure and may be referred to as the distal sensor. Similarly, when the elongate body is advanced antegrade into the aorta, such as through the brachial artery, the sensor closer to the tip of the elongate body may measure the patient's distal blood pressure and may be referred to as the distal sensor. In such a scenario, the sensor closer to the base of the elongate body may measure the patient's proximal blood pressure and may be referred to as the proximal sensor.

[0029] The pump can be in fluid communication with the expandable member. A controller can be communicatively coupled to the proximal pressure sensor, the distal pressure sensor, and the pump. The controller can automatically adjust the volume of the expandable member based on data from the proximal and distal pressure sensors. For example, to automatically adjust the volume of the expandable member, the controller can transition between a proximal pressure control state (e.g., a state capable of controlling the patient's proximal pressure) and a distal pressure control state (e.g., a state capable of controlling the patient's distal blood pressure). In the proximal pressure control state, the controller can adjust the volume of the expandable member based on data from the proximal pressure sensor, and in the distal pressure control state, the controller can adjust the volume of the expandable member based on data from the distal pressure sensor.

[0030] The transition between the proximal pressure control state and the distal pressure control state may be based on a comparison of the proximal sensor data with a proximal threshold. In some variations, the proximal pressure threshold may be a minimum pressure value to which the proximal blood pressure can drop without adversely affecting or risking adverse effects on the subject. For example, if the proximal sensor data is equal to or greater than the proximal threshold, the volume of the expandable member may be adjusted based on the distal sensor data. The controller may transition to the distal pressure control state when the proximal sensor data is equal to or greater than the proximal threshold. Similarly, if the proximal sensor data is below the proximal threshold, the volume of the expandable member may be adjusted based on the proximal sensor data. The controller may transition to the proximal pressure control state when the proximal sensor data is below the proximal threshold.

[0031] As described above, the controller may transition to the proximal pressure control state at or after the subject may be adversely affected or at risk of being adversely affected if the proximal sensor data falls below a minimum pressure value. The controller may enter the distal pressure control state before the proximal pressure drops to a minimum pressure value (e.g., the proximal threshold). In the distal pressure control state, when the proximal sensor data is within a buffer amount from the proximal threshold (i.e., above the proximal threshold by the buffer amount), the controller may adjust the volume of the expandable member based on the distal pressure data so that the proximal sensor data may be prevented from falling below the proximal threshold. This is referred to as the hold state. However, when the proximal sensor data exceeds the buffer amount from the proximal threshold, the controller may adjust the volume of the expandable member based on the distal pressure data so that the distal pressure data approaches a desired distal pressure value (e.g., a target distal value). This is referred to as the “adjust state.”

[0032] Thus, in some variations, the proximal sensor data may be compared to a proximal guard range. The proximal threshold may be the lower limit of the proximal guard range. The upper limit of the proximal guard range may be the proximal threshold plus a buffer amount. If the proximal sensor data exceeds the upper limit of the proximal guard range, the volume of the expandable member may be adjusted so that the distal sensor data approaches a variable interim set point. As described above, the controller may transition to an adjust state if the proximal sensor data exceeds the upper limit of the proximal guard range. If the proximal sensor data is within the proximal guard range (i.e., below the upper limit of the proximal guard range and equal to or greater than the proximal threshold), the volume of the expandable member may be adjusted so that the distal sensor data approaches a certain interim set point. In other words, the interim set point may be held constant, and the volume of the expandable member may be adjusted so that the distal sensor data approaches a certain interim set point to stabilize the proximal pressure data and prevent the proximal pressure from dropping below the proximal threshold. As described above, the controller may transition to a hold state if the proximal sensor data is within the proximal guard range.

[0033] Adjusting the volume of the expandable member based on the distal sensor data when the proximal sensor data is above a proximal threshold (e.g., a distal pressure control state) allows blood flow through the expandable member to perfuse the underlying organs. Adjusting the volume of the expandable member based on the proximal sensor data when the proximal sensor data is below a proximal threshold (e.g., a proximal pressure control state) ensures that proximal blood pressure does not drop to dangerous levels, thereby ensuring cardiac and cerebral perfusion and the safety of the subject.

[0034] system FIG. 1A is a block diagram illustrating an exemplary variation of a system 100 for autonomously controlling an expandable member. FIGS. 1B and 1C show exemplary variations of the system 100. The system 100 may include an elongate body 102 with an expandable member 110. In some variations, an expandable member sensor 115 configured to measure one or more properties of the expandable member 110 (e.g., its internal pressure) may optionally be located within the controller 104. For example, the expandable member sensor 115 may be included within, attached to, integrated with, or otherwise coupled to the controller 104. The expandable member 110 may be fluidly coupled to the expandable member sensor 115 via one or more fluid columns. One or more sensors 111 may be coupled to the elongate body 102. For example, the one or more sensors 111 may be attached to, integrated with, and / or otherwise attached to the elongate body 102. For example, the elongate body 102 may include a first sensor 111b near the base of the elongate body 102 and a second sensor 111a near the tip of the elongate body 102. As described above, the first sensor 111b and the second sensor 111a may be configured to receive local blood pressure, such as proximal and distal blood pressure. The terms “proximal” and “distal” as used herein with respect to sensors and / or particular local blood pressure readings refer to the direction of blood flow from the heart. That is, “proximal” is closer to the heart, while “distal” is farther from the heart. This means that when described in terms of a medical device such as a catheter, the “distal end” of the medical device will generally be understood as the end at the expandable element 110 farthest from the controller 104, and the “proximal end” will be understood as the end closer to the operator, so as not to be confused with the reverse usage of the terms. For purposes of explanation, elongate body 102 in Figures 1A-1C is considered to be advanced retrograde within the aorta (i.e., inserted from the common femoral artery). Accordingly, sensor 111b will be referred to as "distal sensor 111b" and sensor 111a will be referred to as "proximal sensor 111a." It should be readily understood that if the elongate body were advanced antegrade into the thoracic aorta from the brachial or axillary arteries, sensor 111b would be referred to as the "proximal sensor" and sensor 111a would be referred to as the "distal sensor."

[0035] 1C , the system 100 can include a second controller 106 that can be operably coupled to the first controller 104. The controllers 104 and / or 106 can be communicatively coupled to the sensors 111 and / or the expandable member sensors 115 to receive and analyze sensor readings from the sensors 111 and / or the expandable member sensors 115. The pump 108 (e.g., a syringe pump) can be fluidly coupled to the expandable member 110 to adjust the volume of the expandable member 110. For example, the pump can be fluidly coupled to the expandable member 110 via one or more fluid paths (e.g., tubing, valves, lumens within the elongate body) to infuse and / or remove fluid from the expandable member 110.

[0036] Long, slender body The devices described herein may include an elongate body 102 with one or more sensors (e.g., one, two, three, four, five, or more); specifically, the sensors may be incorporated into the elongate body 102. The elongate body 102 may include a shaft sized and shaped for placement within a patient's body (e.g., at an intervention point, such as within a blood vessel). In some variations, the elongate body 102 may be steerable. For example, in some variations, the elongate body 102 may be mechanically coupled to a knob, lever, pull wire, or the like, which may be used to steer or otherwise deflect the distal end of the shaft of the elongate body 102. In some variations, the elongate body 102 may include one or more lumens extending therethrough. The lumens may be partial lumens (e.g., open at one end) and may be disposed or located within a movable shaft. The one or more lumens (e.g., two, three, four, or more) may serve any desired purpose. For example, in some variations, the lumens may be used to transmit fluids to and from the patient's body and / or other components coupled to the elongate body, to advance and / or steer a guidewire to a desired location, to accommodate other components (e.g., sensor wires, pressure-sensing columns, imaging devices such as endoscopes), etc. In some variations, the lumens may include intake and exhaust lumens for delivering fluids and / or compressed gases throughout the elongate body. In some variations, the elongate body 102 may include a lumen for fluidly coupling the expandable member 110 to the pump 108. The lumen fluidly coupling the expandable member 110 to the pump 108 may also serve as a fluid column fluidly coupling the expandable member 110 to the expandable member sensor 115. Additionally or alternatively, the elongate body may include another fluid column for fluidly coupling the expandable member 110 to the expandable member sensor 115. Pressure within the expandable member 110 may be transduced to the expandable member sensor 115 via the fluid column.

[0037] As described above, the elongate body 102 can be sized and shaped to be advanced to and at least partially positioned at a target location in a patient's body. The elongate body 102 can be of any diameter and length suitable for advancement to a target location. For example, the elongate body 102 can have a diameter of about 2 mm to about 36 mm. In some variations, the diameter can be, for example, about 3 mm to about 25 mm, about 4 mm to about 20 mm, or about 5 mm to about 15 mm (including all values ​​and subranges therein). In some variations, the diameter can be, for example, about 6 mm to about 10 mm. The elongate body 102 can have a length of about 1 cm to about 110 cm. In some variations, the length can be, for example, about 10 cm to about 105 cm, about 20 cm to about 100 cm, about 30 cm to about 90 cm, about 40 cm to about 80 cm, or about 50 cm to 70 cm (including all values ​​and subranges therein).

[0038] In some variations, the elongate body 102 may include multiple layers. For example, one or more portions of the elongate body 102 may include multiple layers (e.g., two, three, four or more layers), all portions of the elongate body may include the same layer, or the layers may vary among different portions of the elongate body 102. In other variations, the elongate body 102 may include a single layer, which may include one or more lumens extending therethrough. The elongate body 102, and / or any layers of the elongate body, may be formed of any suitable biocompatible material, such as, for example, polytetrafluoroethylene (PTFE), polyimide, and Pebax®, or combinations thereof.

[0039] Two or more sensors 111 (e.g., blood pressure sensors) may be incorporated into the elongate body 102. One or more sensor wires associated with the sensors 111 may pass through the elongate body 102. In some variations, the elongate body 102 may include an opening and / or window for receiving the sensor 111 through a sensor housing. The window and / or opening may receive the sensor 111 as an inset through the sensor housing. In some variations, the window and / or opening may be a cavity formed with the outer layer of the elongate body 102 that may receive the sensor 111 and / or sensor housing. In some variations, the sensor 111 may be positioned on or otherwise contact the outer surface of the elongate body 102. In some variations, the sensor 111 may be incorporated into the elongate body 102 in a manner similar to the sensors described in International Patent Application No. US2022 / 049335, the contents of which are incorporated herein by reference in their entirety.

[0040] Sensor As mentioned above, elongate body 102 may include two or more sensors. In some variations, one or more sensors on elongate body 102 may be sensor 111. Sensor 111 may be attached to, integrated with, and / or otherwise mounted to elongate body 102 in any suitable manner. As mentioned above, sensor 111 may be incorporated into elongate body 102 similar to the incorporation described in International Patent Application No. US2022 / 049335, the contents of which are incorporated herein by reference in their entirety.

[0041] The sensor 111 may be a pressure sensor configured to measure changes in blood pressure. In some variations, the sensor 111 may include sensors configured to measure other physiological conditions, such as heart rate, respiratory rate, intracranial pressure, cerebral oxygenation, cerebral blood flow, electroencephalography, etc., in addition to a pressure sensor. In some variations, the sensor 111 may include any sensor useful during a medical procedure, such as, for example, a temperature sensor, an electrochemical sensor, an impedance sensor, a microelectrochemical system (MEMS) sensor, a piezoelectric sensor, etc. Any suitable number of sensors (e.g., one, two, three, four or more) may be incorporated within the elongate body to measure physiological conditions.

[0042] In some embodiments, the device may include two sensors, a first distal sensor 111b and a second proximal sensor 111a, integrated into or otherwise coupled to the elongate body 102 (e.g., when the elongate body 102 is advanced retrogradely through the aorta (i.e., inserted through the common femoral artery)). In some variations, the distal sensor 111b and / or the proximal sensor 111a may be positioned at a distance of about 30 mm to about 10 mm, about 25 mm to about 15 mm, or about 22 mm to about 18 mm from the expandable member 110. For example, the distal sensor 111b and / or the proximal sensor 111a may be positioned approximately 20 mm away from the expandable member 110. In some variations, the sensors 111 on the elongate body 102 may be positioned at specific distances from the ends of the expandable member 110 to obtain physiological data upstream and downstream of the expandable member 110.

[0043] Each of the distal sensor 111b and the proximal sensor 111a can measure physiological information of the patient at the point of intervention to determine the patient's underlying physiology and provide that information to a user. For example, in variations where the distal sensor 111b and the proximal sensor 111a can be blood pressure sensors, the distal sensor 111b and the proximal sensor 111a can measure the patient's local blood pressure at or near the location of the respective sensors. Data from the distal sensor 111b can be used to measure the patient's distal systolic and diastolic pressures. For example, the distal systolic and diastolic pressures can be derived from a blood pressure waveform. The distal systolic pressure can be measured by analyzing the peaks of the waveform for a given duration. The distal diastolic pressure can be measured by analyzing the troughs of the waveform for a given duration. In some variations, the data from the distal sensor 111b can be used to measure the current distal proximal mean arterial pressure (DMAP). In some variations, the DMAP may be the arithmetic mean of pressure samples received from the distal sensor 111b over a time window. Similarly, data from the proximal sensor 111a may be used to measure the patient's proximal systolic and diastolic pressures. For example, the proximal systolic and diastolic pressures may be derived from a blood pressure waveform. The proximal systolic pressure may be measured by analyzing the peaks of the waveform for a given duration. The proximal diastolic pressure may be measured by analyzing the troughs of the waveform for a given duration. In some variations, the data from the proximal sensor 111a may be used to measure the current proximal mean arterial pressure (PMAP). In some variations, the PMAP may be the arithmetic mean of pressure samples received from the proximal sensor 111a over a time window.

[0044] Data from the sensors may be collected continuously or intermittently and may be collected over a defined period of time. In some variations, data from the sensors may be collected continuously, for example, every 3, 4, 5, 6, 7, 8, 9, or 10 seconds (e.g., from about 3 to about 6 seconds, from about 4 to about 6 seconds, or from about 5 to about 6 seconds, including all values ​​and subranges therein). In some variations, data from the proximal sensor 118 may be collected every 5 seconds at 200 Hz.

[0045] Expandable Member The expandable member 110 may be disposed on, coupled to, integrated with, attached to, and / or fixed to the shaft of the elongate body 102, and the size (e.g., volume) of the expandable member may be controllable by the controller 104 or a user. For example, the expandable member may be configured to expand and contract and / or inflate and contract so that the size (e.g., volume) of the expandable member may change during use of the blood flow control system. In some variations, the expandable member may be an inflatable / deflatable balloon, while in other variations, the expandable member may be made of a shape-memory material. In still other variations, the expandable member may be connected to a mechanical linkage (e.g., wire, etc.) to change the size of the expandable member. The expandable member 110 may be made of any suitable elastomeric material (e.g., polyurethane, silicone, etc.). Additionally or alternatively, the expandable member 110 may be made of polyester, nylon, etc.

[0046] Blood flow at a target location (e.g., a target blood vessel) within a patient's body can be adjusted or otherwise controlled by changing the size of the expandable member 110. Fluid and / or compressed gas can be delivered through one or more lumens within the elongate body 102 to control and / or adjust the size (e.g., volume) of the expandable member 110. In some variations, the expandable member 110 can be strategically positioned within the patient's aorta, and the size of the expandable member 110 can control blood flow through the patient's aorta such that blood flow proximal to the expandable member 110 can be obstructed to increase blood pressure distal to the expandable member 110. The outer surface of the expandable member 110 can be configured to contact or otherwise interface with the wall of the patient's blood vessel (e.g., during a total occlusion). The expandable member 110 can have any suitable shape when inflated. In some variations, the expandable member 110 can have an elliptical cross-sectional shape along the longitudinal axis when inflated. In other variations, the expandable member 110 can have a spherical shape when expanded (eg, can have a circular cross-sectional shape).

[0047] 1A illustrates the system 100 with a single expandable member 110, it should be readily understood that the elongate body 102 can include any number of suitable expandable members 110. For example, the system 100 can include two, three, four, or more expandable members 110 arranged in series, coupled, integrated, attached, and / or fixed to the elongate body 102. In variations with three or more expandable members, the distance between the expandable members can be the same or different. In some variations, the expandable members 110 can be balloons that can be positioned in series along the length of the elongate body 102 or disposed within one another. In variations with multiple balloons, the balloons can be expanded and deflated individually, or they can be expanded and deflated together.

[0048] The expandable member 110 may be fluidly coupled to an expandable member sensor 115, which may be configured to detect pressure inside the expandable member 110. For example, the expandable member 110 may be fluidly coupled to the expandable member sensor 110 via one or more fluid columns within the elongate body 102. The pressure inside the expandable member 110 may be converted to the expandable member sensor 115 via the fluid columns. In some variations, the controller 104 may include the expandable member sensor 115 and be configured to analyze the pressure inside the expandable member 110 via sensor readings from the expandable member sensor 115.

[0049] pump The system 100 may include a pump 108, such as a syringe pump, that may be operably (e.g., fluidly) coupled to the expandable member 110 to facilitate adjustment of its size. In some variations, the pump 108 may be included within or otherwise carried by or coupled to the controller 104. Additionally or alternatively, the pump 108 may be communicatively coupled to the controller 104. In some variations, the pump 108 may be operated manually (e.g., manually actuated by a user without using the controller 104) or by using the controller 104 (e.g., manually and / or automatically). In some variations, the pump 108 may be operated automatically or autonomously using the controller 104. Additionally or alternatively, the pump 108 may be operated via a user interface (e.g., buttons) on the controller 104. In some variations, the pump 108 may be detached or otherwise separate from the controller 104 and manually operated to establish the position and initial level or volume of the expandable member 110.

[0050] The pump 108 may include or be otherwise coupled to an expandable member 110 that includes a lumen (e.g., tubing), which may in turn be coupled to a lumen of the elongate body 102 of the system 100. In this manner, the pump 108 may be in fluid communication with the expandable member 110.

[0051] In some variations, a set of one or more valves may be utilized to control the flow of fluid, such as saline, and / or compressed gas, such as carbon dioxide. In some variations, the pump 108 may be fluidly coupled to a valve (e.g., a stopcock valve) that can regulate the flow of fluid and / or compressed gas to the expandable member 110.

[0052] The size (e.g., volume) of the expandable member 110 can be adjusted using the controller 104 and the pump 108. For example, the controller 104 can determine the amount of fluid and / or compressed gas to infuse or remove from the expandable member 110 to adjust the size of the expandable member 110 and thereby affect blood flow. The controller 104 can control (e.g., move, modify, or control the position of) an actuator that can be releasably coupled to the pump 108 (e.g., an actuation element on the pump). The actuator can engage and move the actuation element, thereby moving a portion of the pump 108 such that the pump 108 can infuse or remove fluid and / or compressed gas from the expandable member 110 based on commands from the controller 104. In some variations, the removal of fluid and / or compressed gas can be actuated via a screw actuation. In some variations, the pump can be coupled to a position sensor that can provide information regarding the position of a portion of the pump 108 and, therefore, information regarding the amount of fluid delivered to the expandable member 110.

[0053] The pump 108 may be any suitable pump operatively and / or communicatively coupled to an actuator to inject and / or remove fluid and / or compressed gas from the expandable member 110. For example, the pump 108 may be a syringe pump, a diaphragm pump, a peristaltic pump, or other suitable pump.

[0054] In some cases, the syringe pump 108 may include one or more sensors configured to detect the position and / or movement of a component other than the plunger, and may use that position and / or movement as a natural consequence of the plunger's position and / or movement or otherwise to inform a determination of the plunger's position and / or movement, the amount of fluid transferred (delivered or received), and / or the size of the expandable member 110. For example, in some variations, the pump 108 may include a sensor configured to detect the position and / or movement of an actuation mechanism, such as the pump's 108's motor. For example, the pump 108 may include an optical sensor, such as an optical encoder, and / or a magnetic sensor, such as a magnetic encoder, configured to detect the position and / or operation of the motor, which can then be used to determine the plunger's movement and / or position. In some variations, the sensor may be configured to detect the position and / or track the movement of one or more other components of the pump 108 (e.g., a gearbox, a gear within the gearbox, an actuating element (e.g., a linear gear), an actuator (e.g., a circular gear, etc.)).

[0055] Expandable Member Sensor The expandable member sensor 115 can be disposed on, affixed to, attached to, mounted to, coupled to, and / or otherwise included within the controller 104. The expandable member sensor 115 can be configured to detect a property of the expandable member 110, such as, for example, the pressure of a fluid and / or compressed gas within the expandable member 110. For example, the expandable member sensor 115 can be fluidly coupled to the expandable member 110 via one or more fluid columns (e.g., lumens, tubing within the elongate body), such as, for example, through the elongate body 102. The pressure within the expandable member 110 can be translated via a fluid path to the expandable member sensor 115 positioned and / or included within the controller 104. In some variations, the expandable member sensor 115 can measure the expandable member pressure. The expandable member pressure can indicate the pressure outside and surrounding the expandable member 110 when the expandable member 110 is uninflated. When the expandable member is expanded, the expandable member pressure can indicate the amount of expansion of the expandable member 110. The expandable member pressure can indicate the amount of expansion and contraction of the expandable member 110.

[0056] In some variations, data may be collected continuously from the expandable member sensor 115, for example, every 3 milliseconds, 4 milliseconds, 5 milliseconds, 6 milliseconds, 7 milliseconds, 8 milliseconds, 9 milliseconds, or 10 milliseconds (e.g., from about 3 milliseconds to about 6 milliseconds, from about 4 milliseconds to about 6 milliseconds, or from about 5 milliseconds to about 6 milliseconds, including all values ​​and subranges therein).

[0057] controller The devices and / or systems described herein may include one or more controllers (e.g., controller 104 and controller 106). For example, system 100 may include a first controller 104, which may be coupled to a base of elongate body 102. First controller 104 may be communicatively and / or operably coupled to sensor 111 and / or expandable member sensor 115. In some variations, second controller 106 may be releasably coupled to first controller 104, as shown in FIG. 1C . In such variations, second controller 106 may be coupled to elongate body 102 via first controller 104. In some variations, system 100 may not include first controller 104, and second controller 106 may be directly coupled to elongate body 102. In some variations, first controller 104 may be used primarily as a user interface (e.g., may not provide control capabilities to the system). In particular, the user interface of the first controller 104 may display physiological data related to the patient, data related to the control status of the system, feedback provided to the operator, etc. The controller 104 may include a processor and / or perform some functions that enable control of the system, but the controller 104 itself may not control the system. In some variations, the controller 104 and / or the controller 106 may be communicatively coupled to a separate controller included in a separate device (e.g., a separate computing device such as a smartphone, tablet, computer, etc.). In some variations, the separate device may be a handheld device. In variations in which a controller is utilized within a separate device, the separate device may execute software applications that may be used to control or otherwise assist in controlling the system components as described herein.

[0058] A controller (e.g., controller 104 and / or controller 106) may be communicatively coupled to and receive data from sensors, such as sensors integrated into the elongate body. The controller may include a processor (e.g., a CPU) that can process data and / or other signals to control one or more components of the system. The processor may be configured to receive, process, compile, calculate, store, access, read, write, and / or transmit data and / or other signals. In some variations, the processor may be configured to access or receive data and / or other signals from one or more of the sensors and a storage medium (e.g., memory, flash drive, memory card). The processor may be configured to operate and / or execute application processes and / or other modules, processes and / or functions associated with the device.

[0059] In some variations, data from the sensor may be analyzed in the controller over discrete time periods, such as every 3 milliseconds, 4 milliseconds, 5 milliseconds, 6 milliseconds, 7 milliseconds, 8 milliseconds, 9 milliseconds, or 10 milliseconds (e.g., from about 3 milliseconds to about 6 milliseconds, from about 4 milliseconds to about 6 milliseconds, or from about 5 milliseconds to about 6 milliseconds, including all values ​​and subranges therein).

[0060] In some variations, the controller may be communicatively coupled to a user interface. For example, the user interface may be a display on the controller. In some variations, the user interface may be a display on any suitable computing device (e.g., a computer, smartphone, tablet, etc.) communicatively coupled to the controller, for example, via a communication device or module described herein. The user interface may include an input device (e.g., a touchscreen) and an output device (e.g., a display device) and may be configured to receive data from the sensors. For example, the user interface may be configured to receive data from the sensors via a secure communication protocol. In some variations where the user interface is part of the computing device, the communication protocol may include entering a device-specific number and / or scanning a machine-readable code (e.g., a barcode, QR code, etc.) contained on or in any component of the system (e.g., the controller, the elongated body, the pump) to or with an application included in or accessed from the system. In some variations, the input device may include a touch surface for an operator to provide input (e.g., a finger touch on the touch surface) corresponding to a control signal. In some variations, a haptic device may be incorporated into one or more of the input and output devices to provide additional sensory output (eg, force feedback) to the operator.

[0061] The system 100 described herein can be operated in three ways: 1) the system 100 can be operated manually (e.g., by hand), 2) the system 100 can be operated by a controller (e.g., controller 104, controller 106, and / or a separate controller) in an automatic operating mode, or the system 100 can be operated by controller 104 and / or controller 106 in a manual operating mode.

[0062] To operate system 100 manually (e.g., by hand), a user (e.g., a surgeon, doctor, operator, etc.) can manually operate pump 108 (e.g., by moving a part of the pump, such as a plunger of a syringe pump) to adjust the volume of expandable member 110. When operating system 100 manually, pump 108 can be disconnected from controller 104 and / or controller 106.

[0063] Additionally, controller 104 and / or controller 106 may be used to operate system 100. Controller 104 and / or controller 106 may operate in two modes of operation: an automatic mode and a manual mode. In both of these modes, pump 108 may be coupled to controller 104 and / or controller 106.

[0064] In an automatic mode of operation, controller 104 and / or controller 106 may receive one or more inputs from a user (e.g., before and / or during an endovascular procedure) indicating a target physiological state of interest. Controller 104 and / or controller 106 may receive sensor data from one or more sensors (e.g., proximal pressure sensor 111 a and distal pressure sensor 111 b). Controller 104 and / or controller 106 can automatically or autonomously (e.g., by automatically controlling the operation of pump 108) adjust the volume of expandable member 110 based on the sensor data and the target physiological state, as described further herein.

[0065] In the manual mode of operation, a user can utilize a user interface of the controller 104 and / or the controller 106 to adjust the volume of the expandable member 110. For example, the user can press a button included on the housing of the controller 104 and / or the controller 106. Pressing the button can activate the pump 108, thereby changing the volume of the expandable member 110. For example, the user can press a first button to inject fluid from the pump 108 and a second button to draw fluid into the pump 108.

[0066] A user may switch between different methods of operation as desired. For example, during an intravascular procedure, a user may manually (e.g., by hand) operate the pump 108 while initially inserting the elongate body 102 into a blood vessel and manually inflate the expandable member 110 (e.g., to occlusion). The user may then couple the pump 108 to the controller 104 and / or the controller 106 and switch between a manual mode of operation using the controller 104 and / or the controller 106 and an automatic mode of operation using the controller 104 and / or the controller 106. For example, a user may choose to operate the system 100 in an automatic mode of operation with the controller 104 and / or the controller 106, as described further herein. However, because the controller 104 and / or the controller 106 automatically adjusts the volume of the expandable member, a user may decide to switch from the automatic mode of operation to the manual mode of operation using the controller 104 and / or the controller 106.

[0067] In some variations, controller 104 and / or controller 106 may only momentarily switch from the automatic operating mode to the manual operating mode upon receiving user input via a user interface, and then immediately automatically return to the automatic operating mode after adjusting the volume of the expandable member as indicated by the user. In this manner, a user can momentarily "override" the automatic operating mode of the controller by providing instructions to the controller via a user interface to adjust the size of the expandable member (e.g., increase or decrease the volume), and the controller may then remain in the automatic operating mode without additional user action or instruction to re-enter the automatic mode.

[0068] In an automatic mode of operation, the controller 104 and / or the controller 106 can be configured to automatically or autonomously control the expandable member, as described further herein. For example, before or during an intravascular procedure, the controller 104 and / or the controller 106 can be configured to receive one or more inputs from a user indicating a target blood pressure value. The controller 104 and / or the controller 106 can be configured to obtain sensor data from sensors (e.g., the proximal pressure sensor 111 a and the distal pressure sensor 111 b) and automatically adjust the volume of the expandable member 110 so that the sensor data (e.g., the proximal pressure data or the distal pressure data) approaches and / or reaches the target blood pressure value. For example, the target blood pressure value can be a target distal pressure value, and the controller 104 and / or the controller 106 can be configured to automatically adjust the volume of the expandable member 110 so that a distal blood pressure (e.g., DMAP) based on distal sensor data obtained from the distal pressure sensor 111 b approaches and / or reaches the target distal pressure value. However, as the distal blood pressure approaches the target distal pressure value, blood may flow past the expandable member 110 to perfuse the lower organs, and in some cases, the proximal blood pressure (e.g., PMAP) based on proximal sensor data obtained from the proximal pressure sensor 111 a may begin to drop or may drop to an undesirable (e.g., unsafe) level. This may adversely affect, or risk adversely affect, upper organs such as the brain, lungs, or heart. Therefore, in addition to being configured to adjust the volume of the expandable member 110 so that the distal blood pressure approaches the target distal pressure value, the controller 104 and / or the controller 106 may be further configured to maintain the proximal blood pressure (e.g., PMAP) obtained from the proximal pressure sensor 111 a above a threshold level so that the patient's proximal blood pressure does not drop to an undesirable level. It should be readily understood that the distal blood pressure may be determined from or otherwise based on distal sensor data obtained from the distal pressure sensor 111 b. Similarly, the proximal blood pressure may be determined from or otherwise based on proximal sensor data obtained from the proximal pressure sensor 111a.

[0069] The controller 104 and / or the controller 106 can be configured to transition between a proximal pressure control state and a distal pressure control state to adjust the volume of the expandable member so that the distal blood pressure reaches a target distal value while maintaining the patient's proximal blood pressure at or above a desired level. In the proximal pressure control state, the controller can be configured to adjust the volume of the expandable member based on proximal sensor data, and in the distal pressure control state, the controller can be configured to adjust the volume of the expandable member based on distal sensor data. For example, the controller can be configured to compare the proximal sensor data to a proximal pressure threshold. The controller 104 and / or the controller 106 can be configured to transition to different states (e.g., a proximal pressure control state and a distal pressure control state) based on this comparison.

[0070] In some variations, the proximal pressure threshold may be the minimum pressure value to which proximal blood pressure can drop without adversely affecting or risking adverse effects on the subject. In some variations, the proximal pressure threshold may be predetermined. For example, a user may determine the subject's proximal pressure threshold based on the subject's physiological condition. Controller 104 and / or controller 106 may be configured to receive the proximal pressure threshold from a user, e.g., via a user interface, before and / or during the endovascular procedure. In some variations, the proximal pressure threshold may change over the course of the endovascular procedure, and the controller may be configured to receive multiple proximal pressure thresholds (e.g., a first value before the procedure, a second value during the procedure) and vary the proximal pressure threshold based on, e.g., user input. Additionally or alternatively, the proximal pressure threshold may be determined by controller 104 and / or controller 106 based on the subject's physiological condition. In some variations, the proximal pressure threshold may be a universal value that may be the same for all subjects, while in other variations, the proximal threshold may be individualized for each subject.

[0071] Distal pressure control state As described above, the controller 104 and / or the controller 106 can be configured to adjust the volume of the expandable member based on data from a distal pressure sensor when the controller transitions to the distal pressure control state. The transition to the distal pressure control state can be based on a comparison of the proximal sensor data with a proximal pressure threshold. For example, if a proximal blood pressure (e.g., PMAP) determined from the proximal sensor data is equal to or greater than the proximal pressure threshold, the controller 104 and / or the controller 106 can be configured to transition from the proximal pressure control state to the distal pressure control state. Remaining the proximal blood pressure equal to or greater than the proximal pressure threshold can indicate that blood flow to the subject's brain, lungs, heart, etc. is sufficient to allow increased blood flow to organs distal to the expandable member. Thus, in the distal pressure control state, the controller 104 and / or the controller 106 can be configured to adjust the volume of the expandable member based on distal sensor data (e.g., distal blood pressure, such as DMAP). In some variations, in the distal pressure control state, the controller 104 and / or the controller 106 may adjust the volume of the expandable member such that the distal sensor data may progress toward the target distal pressure value. For example, in some variations, the controller 104 and / or the controller 106 may transition to a first state, referred to as an adjustment state, in the distal control state. In the adjustment state, the controller may be configured to adjust the volume of the expandable member such that the distal sensor data may progress toward the target distal pressure value.

[0072] As discussed herein, it may be advantageous to stabilize a subject's physiological condition before the proximal blood pressure drops to an undesirable level, and therefore, it may be advantageous to stabilize a subject's physiological condition before the proximal blood pressure drops below a proximal pressure threshold. Thus, in some variations, in the distal control state, the controller 104 and / or the controller 106 may adjust the volume of the expandable member based on the distal sensor data so that the proximal blood pressure obtained from the proximal sensor data may stabilize. For example, in some variations, the controller 104 and / or the controller 106 may transition to a second state referred to as a hold state in the distal control state. In the hold state, the controller 104 and / or the controller 106 may be configured to adjust the volume of the expandable member so that the subject's physiological condition (e.g., proximal blood pressure) may stabilize before the proximal blood pressure drops to an undesirable level.

[0073] Controller 104 and / or controller 106 may transition to a hold state and / or an adjust state based on a comparison of the proximal blood pressure to a proximal pressure guard range. When the proximal blood pressure exceeds the proximal pressure guard range, controller 104 and / or controller 106 may be configured to transition to the adjust state. When the proximal blood pressure is within the proximal pressure guard range, controller 104 and / or controller 106 may be configured to transition to the hold state.

[0074] The proximal pressure guard range can have an upper and lower limit, thus forming a guard range therebetween. The lower limit of the proximal pressure guard range can be the proximal pressure threshold, described in more detail above. As discussed above, the upper limit of the proximal pressure guard range can be a value above the proximal pressure threshold. For example, the upper limit of the proximal pressure guard range can be a pressure value above the proximal pressure threshold by a predetermined amount. In other words, the upper limit of the proximal pressure guard range can be the proximal pressure threshold plus a buffer volume. The buffer volume can be between about 1 mmHg and about 25 mmHg, between about 5 mmHg and about 50 mmHg, or between about 5 mmHg and about 15 mmHg, including all values ​​and subranges therein. In some variations, the buffer volume can be about 5 mmHg.

[0075] As described above, in the adjustment state, the controller 104 and / or the controller 106 can be configured to adjust the volume of the expandable member 110 so that the distal blood pressure approaches and / or reaches a target distal pressure value. In the hold state, the controller 104 and / or the controller 106 can adjust the volume of the expandable member 110 to stabilize the physiological condition of the subject, as described further herein.

[0076] Adjustment status In the adjust state, the controller 104 and / or the controller 106 may be configured to advance the distal blood pressure toward a target distal pressure value. The controller 104 and / or the controller 106 may be configured to transition to the adjust state when the proximal blood pressure is stable. For example, the controller 104 and / or the controller 106 may be configured to transition to the adjust state (e.g., from the hold state and / or from the proximal pressure control state) when the proximal blood pressure exceeds the upper limit of the proximal pressure guard range (i.e., the proximal pressure threshold plus the buffer amount described above).

[0077] To advance the distal blood pressure toward the target distal pressure value, the controller 104 and / or the controller 106 may set and / or determine an interim set point. The interim set point may be a blood pressure value that may be less than or equal to the target distal pressure value. The controller 104 and / or the controller 106 may adjust the volume of the expandable member so that the distal blood pressure may approach the interim set point. In other words, the interim set point may be an interim target toward which the distal blood pressure may advance so that the distal blood pressure may ultimately approach the target distal pressure value. The interim set point may be varied or changed (e.g., incremented) through an adjustment state to advance the distal blood pressure toward the target distal pressure value.

[0078] As described above, the controller 104 and / or the controller 106 can be configured to transition from the holding state and / or the proximal control state to the adjusting state. However, in some variations, the controller 104 and / or the controller 106 can be configured to transition to the adjusting state immediately after an initial occlusion. In other words, the controller 104 and / or the controller 106 can be configured to transition to the adjusting state after the expandable member first reaches occlusion. In such a scenario, the interim set point immediately after initial occlusion can be a predetermined value. For example, the interim set point immediately after initial occlusion can be 5 mmHg higher than the current occlusion distal blood pressure.

[0079] In some variations, when the controller 104 and / or the controller 106 transitions to the adjustment state, the controller 104 and / or the controller 106 may be configured to first compare an initial distal blood pressure (e.g., the current distal blood pressure at the transition point to the adjustment state) with a target distal pressure value. If the initial distal blood pressure is equal to or greater than the target distal pressure value, the controller 104 and / or the controller 106 may be configured to set an interim set point to the target distal pressure value. In such a scenario, the interim set point may not be changed. The controller 104 and / or the controller 106 may then be configured to adjust the volume of the expandable member so that the distal blood pressure may approach the interim set point. For example, the volume of the expandable member 110 may be adjusted in a manner intended to bring the distal blood pressure closer to the interim set point. For example, the volume of the expandable member 110 may be adjusted quickly so that the distal pressure reaches the interim set point. The volume of the expandable member may be adjusted every 4 seconds, every 5 seconds, every 6 seconds, every 7 seconds, every 8 seconds, every 9 seconds, and / or every 10 seconds until the distal pressure reaches the interim target.

[0080] However, if the initial distal blood pressure is less than the target distal pressure value, the controller 104 and / or the controller 106 may be configured to vary the interim set point. For example, the controller 104 and / or the controller 106 may be configured to increment the interim set point multiple times during the adjustment state. More specifically, the controller 104 and / or the controller 106 may be configured to increase the interim set point multiple times during the adjustment state. For example, in some variations, the controller 104 and / or the controller 106 may be configured to increment the interim set point after a set period of time. Specifically, in some variations, each increment may occur after a set period of time.

[0081] However, in other variations, the increment may not occur after a set period in the adjustment state. For example, in some cases, in the adjustment state, controller 104 and / or controller 106 may be configured to maintain the interim set point without incrementing it after a set period. This may allow the distal blood pressure to move closer to the interim set point if it is lagging behind. This is described in more detail below.

[0082] As described above, the interim set point may be a pressure value that may be less than or equal to the target distal pressure value. The interim set point may be a step function. More specifically, the controller 104 and / or the controller 106 may increment the interim set point by a predetermined value after a set period of time. For example, the controller 106 may increment the interim set point by 1 mmHg every minute. In some variations, the predetermined value may be a percentage of the difference between the target distal pressure value and the current distal blood pressure. For example, if the current distal blood pressure is 10 mmHg and the target distal pressure value is 20 mmHg, the predetermined value may be a percentage of the difference between the target distal pressure value and the current distal pressure value (10 mmHg in this example). For example, the predetermined value may be less than or equal to about 25% of the difference, less than or equal to about 20% of the difference, less than or equal to about 15% of the difference, less than or equal to about 10% of the difference, less than or equal to about 5% of the difference, or less than or equal to about 1% of the difference (including all values ​​and subranges therein). In some variations, the predetermined value can be about 1 mmHg to about 5 mmHg, about 2 mmHg to about 4 mmHg, or about 2.5 mmHg to about 3.5 mmHg (including all values ​​and subranges therein). In some variations, the set period can be about 5 seconds to about 5 minutes, about 30 seconds to about 4 minutes, or about 1 minute to about 3 minutes (including all values ​​and subranges therein). Thus, in the adjustment state, the interim set point can be increased multiple times, and the volume of the expandable member can be adjusted so that the distal blood pressure approaches the interim set point each time. For example, the volume of the expandable member can be adjusted every few seconds until the distal blood pressure (e.g., the current distal blood pressure) reaches the interim set point (e.g., the current interim set point). Thus, in the adjustment state, controller 104 and / or controller 106 can be configured to gradually move the subject's distal blood pressure toward the target distal pressure value.

[0083] In addition to gradually moving the distal blood pressure toward the target distal pressure value in the regulation state, the controller 104 and / or controller 106 may monitor the progress of the distal blood pressure toward the interim setpoint. If the distal blood pressure is lagging behind the interim setpoint, the controller 104 and / or controller 106 may be configured to maintain the interim setpoint (i.e., keep the interim setpoint constant) (referred to as "catch-up operation") until the distal blood pressure approaches the interim setpoint. However, if the distal blood pressure is not lagging behind the interim setpoint, the controller 104 and / or controller 106 may be configured to increment the interim setpoint as described above. To determine whether the distal blood pressure is lagging behind the interim setpoint, the controller 104 and / or controller 106 may be configured to compare the difference between the distal blood pressure (e.g., currently) and the interim setpoint (e.g., currently) to a lag range. The lag range may be a range of pressure values ​​that determines whether the distal blood pressure is lagging behind the interim setpoint. That is, if the difference between the distal blood pressure and the interim set point is within the delay range, the controller 104 and / or the controller 106 may identify that the distal blood pressure is not lagging behind the interim set point. However, if the difference between the distal blood pressure and the interim set point is below the delay range, the controller 104 and / or the controller 106 may identify that the distal blood pressure is lagging behind the interim set point. If the difference between the distal blood pressure and the interim set point at that time is within the delay range, the controller 104 and / or the controller 106 may be configured to continue to change (e.g., increase) the interim set point by a predetermined value after a set period of time (e.g., increment the interim set point by 1 mmHg after 1 minute), as described above. However, if the difference between the distal blood pressure and the interim set point at a particular time is outside (e.g., below) the delay range, the controller 104 and / or the controller 106 may be configured to hold the interim set point constant. In some variations, the delay range can be about 5 mmHg to about 20 mmHg, about 8 mmHg to about 18 mmHg, about 10 mmHg to about 15 mmHg, or about 12 mmHg to about 14 mmHg (including all values ​​and subranges therein). In some variations, the delay range can be about 5 mmHg.

[0084] Holding state When the proximal blood pressure is within the proximal pressure guard range, the controller 104 and / or the controller 106 may be configured to transition to a hold state. More specifically, when the proximal blood pressure drops below the upper limit of the proximal guard range but remains above a proximal pressure threshold (e.g., the lower limit of the proximal guard range), the controller 104 and / or the controller 106 may be configured to transition to a hold state. In some cases, when the proximal blood pressure drops below the upper limit of the proximal guard range, this may indicate that the subject's physiological condition is not stable. For example, the proximal blood pressure may subsequently drop further below the lower limit of the proximal guard range (e.g., the proximal pressure threshold), thereby potentially adversely affecting the subject. Therefore, it may be advantageous to stabilize the subject's proximal and distal blood pressures before continuing to adjust the volume of the expandable mode to drive the distal blood pressure toward a target distal pressure value.

[0085] Thus, in the hold state, the controller 104 and / or the controller 106 may be configured to adjust the volume of the expandable member so that the distal blood pressure may approach the interim set point, but may be configured to hold the interim set point constant. Holding the interim set point constant but continuing to drive the distal blood pressure toward the interim target may allow the distal blood pressure to stabilize. Thus, stabilizing the distal blood pressure may allow the proximal blood pressure to remain above an undesirable level.

[0086] Proximal pressure control state The controller 104 and / or the controller 106 may be configured to adjust the volume of the expandable member based on data from the proximal pressure sensor when the controller transitions to the proximal pressure control state. The transition to the proximal pressure control state may be based on a comparison of the proximal sensor data with a proximal pressure threshold. The controller 104 and / or the controller 106 may be configured to transition to the proximal pressure control state when the proximal blood pressure determined from the proximal sensor data (e.g., PMAP) drops below the proximal pressure threshold. As discussed above, in some cases, a drop in proximal blood pressure below the proximal pressure threshold may adversely affect or risk adversely affect a subject (e.g., brain, lungs, heart, etc.). Thus, in the proximal pressure control state, the controller 104 and / or the controller 106 may be configured to adjust the volume of the expandable member 110 so that the proximal blood pressure rises above the proximal threshold, thereby providing a sufficient and / or desired amount of blood flow to the subject's brain, heart, and / or lungs.

[0087] As described above, in the proximal pressure control state, the controller 104 and / or the controller 106 may be configured to adjust the volume of the expandable member (e.g., to maintain blood flow to the subject's brain, heart, and / or lungs) based (e.g., solely) on the proximal blood pressure. Accordingly, the controller 104 and / or the controller 106 may be configured to set a target distal pressure value to be the current value of the distal sensor data (e.g., the current distal blood pressure). This target distal pressure value may be continually reset as the volume of the expandable member is adjusted to reach the proximal pressure value. Because the volume of the expandable member is adjusted based solely on the proximal sensor data, the target distal pressure value may be any suitable value, such as the current value of the distal sensor data. Accordingly, the controller 104 and / or the controller 106 may repeatedly set an interim setpoint for the distal sensor data to be the current value of the distal sensor data as the current distal pressure value changes. The volume of the expandable member may be adjusted every few seconds so that the proximal blood pressure approaches the proximal pressure threshold.

[0088] Detachment control state During and / or toward the end of the endovascular procedure (e.g., before removing the expandable member 110 from the subject's blood vessel), the user may elect to fully retract the expandable member 110. For example, the user may indicate to the controller 104 and / or the controller 106 that they wish to fully retract the expandable member 110. In response to a user instruction to fully retract the expandable member 110, the controller 104 and / or the controller 106 may be configured to transition to a disengagement state.

[0089] In the weaning control state, controller 104 and / or controller 106 can be configured to adjust the volume of the expandable member such that the distal blood pressure determined from distal sensor data (e.g., DMAP) can progress toward a target distal pressure. The target distal pressure value in the weaning control state can be the pressure inside the expandable member 110 when the expandable member 110 is fully contracted. For example, in some variations, the target expandable membrane pressure value can be a negative pressure.

[0090] In some variations, the target distal pressure value may be determined by controller 104 and / or controller 106 (e.g., based on the subject's physiological condition). In some variations, a user may provide the subject's target distal pressure value as input via a user interface (e.g., before the start of the endovascular procedure and / or during the endovascular procedure). Controller 104 and / or controller 106 may adjust the volume of expandable member 110 such that distal sensor data may progress toward the target distal blood pressure. Unlike the distal pressure control state, in the disengagement control state, controller 104 and / or controller 106 may be configured not to set any interim set points. Instead, the volume of expandable member 110 may be adjusted such that distal blood pressure progresses toward the target distal blood pressure without any interim set points. Additionally or alternatively, controller 104 and / or controller 106 may adjust the volume of expandable member 110 such that distal sensor data may progress toward the interim set points but no distal target set point is set. In this case, the interim distal set point may be advanced until the expandable member pressure sensor obtains a negative number.

[0091] In some variations, the volume of the expandable member 110 may be adjusted more quickly in the disengagement control state than in the distal pressure control state. As an example, instead of adjusting the volume of the expandable member 110 to increment the distal blood pressure by a predetermined value every minute (e.g., in the distal pressure control state), the volume of the expandable member 110 may be adjusted to increment the distal pressure more quickly, e.g., the volume of the expandable member 110 may be adjusted to increment the distal pressure by a predetermined value every 15 seconds. For example, if the volume of the expandable member 110 may be adjusted to increment the distal blood pressure by 1 mmHg every minute in the distal pressure control state, the volume of the expandable member 110 may be adjusted to increment the distal blood pressure by 1 mmHg every 15 seconds in the disengagement control state.

[0092] In some variations, in the disengagement control state, the volume of the expandable member 110 may be adjusted more quickly when the proximal blood pressure is further from the target proximal pressure value. However, as the proximal blood pressure progresses toward the proximal target pressure value, the volume of the expandable member 110 may be adjusted so that the distal pressure progresses toward the target distal pressure value at a slower pace. That is, the volume of the expandable member 110 may be adjusted every few seconds when the proximal blood pressure is further from the target proximal value. As the proximal blood pressure approaches a range in which it can be closer to the target proximal value, the volume of the expandable member may be adjusted at a slower pace. This adjustment may be slower as the proximal blood pressure approaches a range in which it can be even closer to the target proximal value.

[0093] For example, the volume of the expandable member 110 may be adjusted so that the distal blood pressure is incremented by a predetermined value every 15 seconds when the proximal blood pressure is more than 20 mmHg away from the proximal target pressure. However, the volume of the expandable member 110 may be adjusted so that the distal blood pressure is incremented by a predetermined value every 30 seconds when the proximal blood pressure is approximately 20 mmHg to 10 mmHg away from the proximal target pressure. The volume of the expandable member 110 may also be adjusted so that the distal blood pressure is incremented by a predetermined value every minute when the proximal blood pressure is approximately 10 mmHg to 5 mmHg away from the proximal target pressure. When the proximal blood pressure is within 5 mmHg of the proximal target pressure, the volume of the expandable member 110 may be adjusted to maintain the current interim distal pressure target without incrementing toward a higher distal pressure. The controller 104 and / or 106 may also transition from the weaning mode to a proximal pressure control state when the proximal blood pressure is at or below the proximal target pressure. It should be readily understood that the examples described herein are for illustrative purposes only, and the pace at which the distal and / or proximal blood pressure is adjusted can be any suitable pace based on the degree to which the proximal blood pressure deviates from the proximal target pressure.

[0094] In some variations, in the weaning control state, if the proximal blood pressure approaches a proximal pressure threshold, the controller 104 and / or the controller 106 may transition from the weaning control state to the proximal pressure control state.

[0095] In this manner, in the disengagement control state, if the proximal blood pressure drops below the limit of the proximal guard range, the volume of the expandable member 110 can be adjusted based on the proximal blood pressure. In this scenario, the controller 104 and / or the controller 106 can be configured to transition from the disengagement state to the proximal pressure control state. In this mode, the proximal pressure can serve as an input to the expandable member titration. When the proximal blood pressure drops below the proximal pressure threshold, the controller 104 and / or the controller 106 can be configured to increase the volume of the expandable member in order to increase the proximal blood pressure to a pressure within the proximal guard range (i.e., above the proximal pressure threshold).

[0096] Blood product delivery In addition to controlling bleeding, some variations of the devices and / or systems described herein can be configured to deliver blood products (e.g., red blood cells, plasma, platelets) to a patient to stabilize the patient's condition. The blood product can be delivered using a blood product pump, which can be the same pump as the pump used to adjust the size of the expandable member or a different pump than the pump used to adjust the size of the expandable member. If the blood product pump is different from the pump used to adjust the size of the expandable member, the blood product pump and the expandable member pump can be disposed within the same housing (i.e., integrated into a single housing). In some variations, the blood product pump can be a syringe pump, peristaltic pump, differential pressure pump, or other pump designed to provide blood products. The blood product pump can be communicatively coupled to one or more controllers (e.g., controller 104, controller 106, or a different controller). One or more blood products can be delivered based on the patient's hemodynamic or other physiological condition.

[0097] Delivery of the blood product can occur via a manual or automatic mode of operation. When in the manual mode of operation, a user can utilize a user interface on a controller (e.g., controller 104, controller 106, or a different controller) to stop and / or start the infusion of the blood product. For example, a user can press one or more buttons included on the housing of the controller. Pressing the button can activate the blood product pump, thereby causing the blood product to flow out of the pump.

[0098] When in the automatic operating mode, the controller (e.g., controller 104, controller 106, or a different controller) may receive one or more inputs from a user (e.g., before and / or during an endovascular procedure) indicating a target physiological state for the patient. The controller may receive sensor data from one or more sensors (e.g., proximal pressure sensor 111a and distal pressure sensor 111b). The controller may be configured to automatically or autonomously start and stop infusion of a blood product based on the sensor data, the target physiological state, and / or one or more infusion protocols, as described further below. The infusion may be triggered by various conditions, such as blood pressure parameters (e.g., proximal blood pressure, distal blood pressure) not being met during use of the expandable members of the devices described herein to control bleeding, and the infusion of blood products may be used to help maintain hemodynamic stability and perfusion of organs proximal and distal to the expandable member. The controller may also be configured to select an infusion protocol based on whether various blood pressure parameters are met, as described further below. For example, the controller may select an infusion protocol based on whether the distal blood pressure meets an interim setpoint within a predetermined period of time on the way to a target distal blood pressure value, and the proximal or distal blood pressure value is dropping while the volume of the expandable member remains constant for a predetermined period of time. In other examples, the controller may be configured to select an infusion protocol based on whether the frequency of inflating the expandable member to maintain the proximal blood pressure within a proximal pressure guard range exceeds a threshold, or when the proximal blood pressure continues to drop despite an increase in the expandable member volume by automatic or manual inflation.

[0099] Automatic blood transfusion: Fixed rate, fixed volume, FRFV In some variations, the controller may utilize pressure data (e.g., proximal blood pressure, distal blood pressure, and / or expandable member pressure measurements) captured from a proximal sensor (e.g., a proximal blood pressure sensor), a distal sensor (e.g., a distal blood pressure sensor), and / or an expandable member sensor (e.g., a balloon pressure sensor) to trigger metered and / or constant rate delivery of blood product based on whether the distal blood pressure is progressing sufficiently toward an interim set point or target distal blood pressure value.

[0100] For example, when the controller is in a distal pressure control state, as described above, the expandable member volume (e.g., balloon volume) may be slowly decreased to increase the distal blood pressure to an interim set point. If the distal blood pressure does not reach the interim set point within a predetermined time, or if the proximal blood pressure drops below a proximal pressure guard range (which may cause the interim set point to move away from the target distal blood pressure target), the controller may determine that the distal sensor data is not progressing toward the target distal blood pressure value. This lack of progress may indicate continued overall low blood volume in the patient's body, i.e., the patient is losing blood. In some variations, the controller may determine that the distal sensor data is not progressing toward the target distal blood pressure value when the controller also determines that the expandable member was inflated to an occlusion after it was last deflated (e.g., to increase the distal pressure to the target distal pressure value). In these examples, the controller may initiate delivery of one or more constant (i.e., predetermined) amounts of blood products to the patient at constant (i.e., predetermined) rates to restore sufficient blood volume and / or provide additional hemodynamic support to the patient (e.g., to maintain sufficient perfusion and oxygenation of tissues).

[0101] These blood product infusions may be delivered in volumes ranging from about 5.0 mL to about 5,000 mL, including all values ​​and subranges therein. For example, the blood product may be delivered in a volume of about 5.0 mL, about 10 mL, about 20 mL, about 30 mL, about 40 mL, about 50 mL, about 60 mL, about 70 mL, about 80 mL, about 90 mL, about 100 mL, 150 mL, about 200 mL, about 250 mL, about 300 mL, about 350 mL, about 400 mL, about 450 mL, about 500 mL, about 550 mL, about 600 mL, about 650 mL, about 700 mL, about 750 mL, about 800 mL, about 850 mL, about 900 mL, about 950 mL, about 1,000 mL, about 1,500 mL, about 2,000 mL, about 2,500 mL, about 3,000 mL, about 3,500 mL, about 4,000 mL, about 4,500 mL, or about 5,000 mL.

[0102] In some examples, blood product infusions can be delivered in volumes ranging from about 100 mL to about 500 mL, including all values ​​and subranges therein. For example, blood products can be delivered in volumes of about 100 mL, about 110 mL, about 120 mL, about 130 mL, about 140 mL, about 150 mL, about 160 mL, about 170 mL, about 180 mL, about 190 mL, about 200 mL, about 210 mL, about 220 mL, about 230 mL, about 240 mL, about 250 mL, about 260 mL, about 270 mL, about 280 mL, about 290 mL, about 300 mL, about 310 mL, about 320 mL, about 330 mL, about 340 mL, about 350 mL, about 360 mL, about 370 mL, about 380 mL, about 390 mL, about 400 mL, about 410 mL, about 420 mL, about 430 mL, about 440 mL, about 450 mL, about 460 mL, about 470 mL, about 480 mL, about 490 mL, about 500 mL, about 510 mL, about 520 mL, about 530 mL, about 540 mL, about 550 mL, about 560 mL, about 570 mL, about 580 mL, about 590 mL, about 600 mL, about 610 mL, about 620 mL, about 630 mL, about 640 mL, about 650 mL, about 660 mL, about 670 mL, about 680 mL, about 690 mL, about 700 mL, about 710 mL, about 720 mL, about 730 mL, about 740 mL, about 750 mL, about 310 mL, about 320 mL, about 330 mL, about 340 mL, about 350 mL, about 360 mL, about 370 mL, about 380 mL, about 390 mL, about 400 mL, about 410 mL, about 420 mL, about 430 mL, about 440 mL, about 450 mL, about 460 mL, about 470 mL, about 480 mL, about 490 mL, or about 500 mL.

[0103] In other examples, blood product infusions can be delivered in volumes ranging from about 200 mL to about 400 mL, including all values ​​and subranges therein. For example, blood products can be delivered in volumes ranging from about 200 mL, about 205 mL, about 210 mL, about 215 mL, about 220 mL, about 225 mL, about 230 mL, about 235 mL, about 240 mL, about 245 mL, about 250 mL, about 255 mL, about 260 mL, about 265 mL, about 270 mL, about 275 mL, about 280 mL, about 285 mL, about 290 mL, about 300 mL, about 305 mL, about 310 mL, about 315 mL, about 320 mL, about 325 mL, about 330 mL, about 335 mL, about 340 mL, about 345 mL, about 350 mL, about 355 mL, about 360 mL, about 365 mL, about 370 mL, about 375 mL, about 380 mL, about 385 mL, about 390 mL, about 400 mL, about 410 mL, about 420 mL, about 430 mL, about 440 mL, about 450 mL, about 460 mL, about 475 mL, about 480 mL, about 490 mL, about 500 mL, about 510 mL, about 520 mL, about 530 mL, about 540 mL, about 555 mL, about 560 mL, about 570 mL, about 580 mL, about 590 mL, about 600 mL, about 610 mL, about 620 mL, about 630 mL, about 640 mL, about 650 mL, about 660 mL, about 67 It can be delivered in an amount of 5 mL, about 300 mL, about 305 mL, about 310 mL, about 315 mL, about 320 mL, about 325 mL, about 330 mL, about 335 mL, about 340 mL, about 345 mL, about 350 mL, about 355 mL, about 360 mL, about 365 mL, about 370 mL, about 375 mL, about 380 mL, about 385 mL, about 390 mL, about 395 mL, or about 400 mL.

[0104] With respect to the rate of blood product infusion, the blood product can be delivered at a rate ranging from about 1.0 mL / min to about 2,500 mL / min, including all values ​​and subranges therein. For example, the blood product can be delivered at a rate of about 1.0 mL / min, about 2.0 mL / min, about 3.0 mL / min, 4.0 mL / min, about 5.0 mL / min, about 6.0 mL / min, about 7.0 mL / min, about 8.0 mL / min, about 9.0 mL / min, about 10 mL / min, about 11 mL / min, about 12 mL / min, about 13 mL / min, about 14 mL / min, about 15 mL / min, about 16 mL / min, about 17 mL / min, about 18 mL / min, about 19 mL / min, about 20 mL / min, about 25 mL / min, about 30 mL / min, about 35 mL / min, and the like. 40mL / min, 45mL / min, 50mL / min, 55mL / min, 60mL / min, 65mL / min, 70mL / min, 75mL / min, 80mL / min, 85mL / min, 90mL / min, 100mL / min, approx. 150mL / min, approx. 200mL / min, approx. 250mL / min, approx. 300mL / min, approx. 350mL / min, approx. 400mL / min, approx. 450mL / min, approx. 500mL / min, approx. 550mL / min, approx. 600mL / min, approx. 650mL / min, approx. 0mL / min, approx. 750mL / min, approx. 800mL / min, approx. 850mL / min, approx. 900mL / min, approx. 950mL / min, approx. 1,000mL / min, approx. 1,050mL / min, approx. 1,100mL / min, approx. 1,150mL / min, approx. 1,20 0mL / min, approx. 1,250mL / min, approx. 1,300mL / min, approx. 1,350mL / min, approx. 1,400mL / min, approx. 1,450mL / min, approx. 1,500mL / min, approx. 1,550mL / min, approx. 1,600mL / min, approx. 1,650m The compositions may be delivered at a rate of about 1,700 mL / min, about 1,750 mL / min, about 1,800 mL / min, about 1,850 mL / min, about 1,900 mL / min, about 1,950 mL / min, about 2,000 mL / min, about 2,050 mL / min, about 2,100 mL / min, about 2,150 mL / min, about 2,200 mL / min, about 2,250 mL / min, about 2,300 mL / min, about 2,350 mL / min, about 2,400 mL / min, about 2,450 mL / min, and about 2,500 mL / min.

[0105] The blood product may be delivered until the proximal blood pressure rises to a level sufficiently above the proximal pressure guard value (e.g., approximately 5.0 mmHg above), which may provide time for the distal blood pressure to progress sufficiently toward the interim target and target distal blood pressure values. One or more blood product quantities may be delivered to the patient. When multiple blood product quantities (e.g., one, two, three, four, etc.) are delivered, the quantities may be infused sequentially (e.g., one quantity followed by another) or repeatedly (e.g., separated by a predetermined time). In some variations, the controller may continue to deliver several blood product quantities sequentially or repeatedly until the controller determines that one or more threshold blood pressure values ​​(e.g., proximal blood pressure value, distal blood pressure value) have been met. This metered-dose nature of blood product delivery may be useful for preventing the waste of valuable blood product resources while still restoring any blood loss in the patient.

[0106] Automated transfusion: Variable Rate, Variable Volume (VRVV) In some variations, automatic delivery of blood products may be triggered by the same pressure data (e.g., proximal blood pressure, distal blood pressure, and / or expandable member pressure measurements) described above for constant rate and / or fixed rate delivery, but blood products may be delivered at variable rates and / or volumes. The controller's decision whether to initiate variable rate and / or volume delivery may be based on factors such as the rate of distal blood pressure drop and / or the frequency of expandable member inflation. The rate of distal blood pressure drop that may trigger automatic delivery of blood products according to a variable rate and / or volume protocol may range from about 1.0 mmHg / min to about 60 mmHg / min, including all values ​​and subranges therein. For example, the rate of drop in distal blood pressure can be about 1.0 mmHg / min, about 5.0 mmHg / min, about 10 mmHg / min, about 15 mmHg / min, about 20 mmHg / min, about 25 mmHg / min, about 30 mmHg / min, about 35 mmHg / min, about 40 mmHg / min, about 45 mmHg / min, about 50 mmHg / min, about 55 mmHg / min, or about 60 mmHg / min. The inflation volume over 6 seconds can be used with respect to the inflation frequency of the expandable member to determine whether to trigger automatic delivery of a blood product according to a variable rate and / or variable protocol. In some variations, the inflation volume can range from about 20 μL in 6 seconds to about 5,000 μL in 6 seconds, including all values ​​and subranges therein.For example, the inflation volume of the expandable member over a 6 second period, which may trigger automatic delivery of blood products according to a variable speed and / or variable volume protocol, may be about 20 μL, about 50 μL, about 100 μL, about 150 μL, about 200 μL, about 250 μL, about 300 μL, about 350 μL, about 400 μL, about 450 μL, about 500 μL, about 550 μL, about 600 μL, about 700 μL, about 800 μL, about 900 μL, about 1000 μL, about 1100 μL, about 1200 μL, about 1300 μL, about 1400 μL, about 1500 μL, about 1600 μL, about 1700 μL, about 1800 μL, about 1900 μL μL, approximately 650 μL, approximately 700 μL, approximately 750 μL, approximately 800 μL, approximately 850 μL, approximately 900 μL, approximately 950 μL, approximately 1,000 μL, approximately 1,100 μL, approximately 1,200μL, approximately 1,300μL, approximately 1,400μL, approximately 1,500μL, approximately 1,600μL, approximately 1,700μL, approximately 1,800μL, approximately 1,900μL, Approximately 2,000μL, approximately 2,100μL, approximately 2,200μL, approximately 2,300μL, approximately 2,400μL, approximately 2,500μL, approximately 2,600μL, approximately 2,700μL , approx. 2,800 μL, approx. 2,99 μL, approx. 3,000 μL, approx. 3,100 μL, approx. 3,200 μL, approx. 3,300 μL, approx. 3,400 μL, approx. 3,500 μL , about 3,600 μL, about 3,700 μL, about 3,800 μL, about 3,900 μL, about 4,000 μL, about 4,100 μL, about 4,200 μL, about 4,300 μL, about 4,400 μL, about 4,500 μL, about 4,600 μL, about 4,700 μL, about 4,800 μL, about 4,900 μL, or about 5,000 μL. Generally, when it is desired to provide a volume of blood product to a patient quickly, a variable rate and / or variable volume protocol may be employed.

[0107] In one variation, the controller may determine the rate and amount of variable-rate and / or variable-volume blood delivery based on (e.g., by monitoring) distal blood pressure values. For example, because the magnitude of the distal blood pressure drop over a period of time may be proportional to blood loss (and thus the patient's blood volume needs), and the slope of the distal blood pressure drop in the absence of expandable member (e.g., balloon) adjustment may be proportional to the rate at which blood loss or overall patient decompensation occurs, the controller may use the magnitude of the distal blood pressure drop over a period of time and / or the rate of change of the distal blood pressure drop in the absence of expandable member adjustment (e.g., over a period of about 2.0 seconds, about 3.0 seconds, about 4.0 seconds, about 5.0 seconds, or about 6.0 seconds), respectively, to determine the amount of blood product to be delivered and / or the rate of delivery of the blood product. As a more specific example, a 10 mmHg drop in distal blood pressure over one minute may correspond to blood loss of about 250 mL to about 500 mL. In this case, the controller may determine that blood loss is occurring at a rate of about 250 mL / min to about 500 mL / min (i.e., about 4.17 mL / sec to about 8.33 mL / sec) (Johnson MA, Davidson AJ, Russo RM, Ferencz SA, Gotlib O, Rasmussen TE, Neff LP, Williams TK. Small Changes, Big Effects: The Hemodynamics of Partial and Complete Aortic Occlusion to Inform Next Generation Resuscitation Techniques and Technologies. Journal of Trauma and Acute Care Surgery. 2017;82(6):1106-1111, the contents of which are incorporated herein by reference in their entirety). Thus, taking a conservative approach, if the controller determines that the total drop in distal blood pressure from about two minutes ago is about 15 mmHg and the current drop is 10 mmHg / min, the controller may determine that a transfusion volume of 750 mL be given at a rate of 8.33 mL / sec or greater to replace the blood loss.

[0108] After each blood product infusion, the controller may determine whether the delivery rate and / or amount of the blood product should be adjusted based, for example, on distal blood pressure measurements. For example, after each blood product infusion, the controller may determine the rate of decline in distal blood pressure and compare this rate to the pre-infusion rate (e.g., the rate of decline in distal blood pressure immediately prior to the delivery of the previous blood product). If the controller determines that the rate of decline in distal blood pressure remains constant or is increasing, the controller may increase the rate and / or amount of the blood product being delivered. If the controller determines that the rate of decline in distal blood pressure is decreasing, the controller may decrease the rate and / or amount of the blood product being delivered.

[0109] Additionally or alternatively, the controller may evaluate the patient's response to the blood product infusion to predict a desired delivery amount and / or delivery rate of the blood product to reach one or more target blood pressure values, and may subsequently determine the delivery rate and amount of the delivered blood product based on the prediction. For example, the controller may use predictive analysis (e.g., regression analysis) to determine a predicted amount and / or rate that will meet a desired hemodynamic target (e.g., target proximal blood pressure, target distal blood pressure), and then deliver the predicted amount and / or rate of the blood product. This may be particularly useful in variations where the rate of distal blood pressure has recovered but has not yet recovered sufficiently to reach the hemodynamic target (e.g., proximal blood pressure, distal blood pressure). In this manner, the controller may utilize an adaptive approach when determining the delivery amount and / or rate of the blood product.

[0110] In a further variation, the controller may utilize the distal blood pressure curve to estimate blood loss and determine the amount of blood product to be delivered based on this estimate. For example, referring to FIG. 11 , the controller may estimate blood loss based on the area (1100) above the distal blood pressure curve (1101) from the last time point (T1) at which the distal blood pressure did not decrease (e.g., remained constant), with the upper limit bounding the area (1100) being the last pressure at which the distal blood pressure did not decrease (e.g., remained constant) to its current value (T2). In some instances, the controller may calculate the area (1100) above the curve (1101) by calculating the difference between the area of ​​the theoretical box (1102) between T1 and T2 and the area (1104) of the distal blood pressure below the curve (1101), with the upper limit bounding the theoretical box (1102) being the last pressure at which the distal blood pressure did not decrease (e.g., remained constant). In other cases, the controller may determine a proportionality factor based on a correlation between the area (1100) above the distal blood pressure curve (1101) and the amount of blood loss, and determine the amount of blood product to be delivered based on the proportionality factor. The proportionality factor may range from about 10 mL / mmHg per second to about 1,000 mL / mmHg per second, including all values ​​and subranges therein. For example, the proportionality coefficient is about 10 mL / mmHg per second, about 20 mL / mmHg per second, about 30 mL / mmHg per second, about 40 mL / mmHg per second, about 50 mL / mmHg per second, about 60 mL / mmHg per second, about 70 mL / mmHg per second, about 80 mL / mmHg per second, about 90 mL / mmHg per second, about 100 mL / mmHg per second, about 150 mL / mmHg per second, about 200 mL / mmHg per second, about 300 mL / mmHg per second, and about 350 mL / mmHg per second. The proportionality coefficient can be about 400 mL / mmHg per second, about 450 mL / mmHg per second, about 500 mL / mmHg per second, about 550 mL / mmHg per second, about 600 mL / mmHg per second, about 650 mL / mmHg per second, about 700 mL / mmHg per second, about 750 mL / mmHg per second, about 800 mL / mmHg per second, about 850 mL / mmHg per second, about 900 mL / mmHg per second, about 950 mL / mmHg per second, or about 1,000 mL / mmHg per second. Analysis of data obtained from animal studies can be used to determine the proportionality coefficient.For example, animal studies can be performed in which parameters such as blood pressure and blood loss are measured during controlled bleeding, and the data used to determine the correlation between them to obtain a ratio coefficient. The area of ​​the distal blood pressure curve where the expandable member expands in volume can be ignored to reduce overestimation of blood loss (as this drop in distal blood pressure may not be due to blood loss).

[0111] Additionally or alternatively, the controller may determine the delivery rate and / or amount of blood product based on the volume and / or frequency of inflation of the expandable member (e.g., balloon) (e.g., to maintain a proximal blood pressure above a given proximal blood pressure guard value). This is because the volume and / or frequency of inflation of the expandable member may be proportional to the amount and / or rate of blood loss from the patient. For example, a larger inflation volume of the expandable member (e.g., 1.0 mL compared to 50 μL) may indicate a larger amount and / or a faster rate of blood loss. A more frequent inflation (e.g., more than one inflation per 6 seconds) may also indicate a larger amount and / or a faster rate of blood loss. In addition, the total increase in the volume of the expandable member may be proportional to the total amount of pressure support provided and, therefore, the amount of blood product to be delivered. For example, a total increase in the volume of the expandable member of about 1.0 mL over 15 seconds may indicate that a larger amount of blood product may need to be delivered.

[0112] If inflation of the expandable member results in an occlusion, rapid infusion of blood product may be necessary to support the patient's survival. In these situations, the controller can be configured to deliver a predetermined amount of blood product at a predetermined rate. For example, in this situation, rather than attempting to determine the rate and volume to deliver, the controller can be configured to deliver a relatively large amount of blood product, e.g., about 100 mL to about 7,000 mL (including all values ​​and subranges therein), at a relatively fast rate, e.g., about 100 mL / min to about 250 mL / min (including all values ​​and subranges therein), from a clinical perspective and taking into account the size of the subject. During an occlusion, the expandable member may be unable to provide additional proximal pressure support (e.g., maintain a target proximal pressure value that maintains perfusion of organs proximal to the expandable member, such as the heart and brain) without potentially damaging the patient's blood vessels (e.g., the aortic vessels), in which case it may be beneficial for the controller to utilize blood product infusion to hemodynamically support the patient.

[0113] User Interface In some variations, the user interface may be communicatively coupled to controller 104 and / or controller 106. In some variations, the user interface may be a display on controller 104 and communicatively coupled to controller 106. Additionally or alternatively, the user interface may be a display on controller 106 and communicatively coupled to controller 104. Additionally or alternatively, the user interface may be a display on any suitable computing device (e.g., a computer, smartphone, tablet, etc.) communicatively coupled to controller 104 and / or controller 106, for example.

[0114] In some variations, the user interface may include an input device (e.g., a touchscreen) and an output device (e.g., a display device) and may be configured to receive input data from one or more of a user, controller 104 and / or controller 106, pump 108, and sensor 111. For example, user control of an input device (e.g., a keyboard, button, touchscreen) may be received by the user interface and then processed by controller 104 and / or controller 106 for the user interface to output a control signal to controller 104 and / or controller 106 and / or pump 108. Some variations of the input device may include at least one switch configured to generate a control signal. For example, the input device may include a touch surface or a user to provide an input (e.g., a finger touch on the touch surface) corresponding to the control signal. Input devices with a touch surface may be configured to detect contact and movement on the touch surface using any of a number of touch sensitivity technologies, including capacitive, resistive, infrared, optical imaging, dispersive signal, acoustic pulse recognition, and surface acoustic wave technologies. In variations of input devices that include at least one switch, the switch may include, for example, at least one of a button (e.g., hard key, soft key), a touch surface, a keyboard, an analog stick (e.g., a joystick), a directional pad, a mouse, a trackball, a jog dial, a step switch, a rocker switch, a pointer device (e.g., a stylus), a motion sensor, an image sensor, and a microphone. The motion sensor can receive user movement data from an optical sensor and classify the user's gestures as control signals. The microphone can receive acoustic data and recognize the user's voice as a control signal.

[0115] A haptic device can be incorporated into one or more of the input and output devices to provide additional sensory output (e.g., force feedback) to the user. For example, the haptic device may generate a haptic response (e.g., vibration) to cause the input device (e.g., touch surface) to confirm the user input. As another example, the haptic feedback may indicate that the user input is overridden by a pulsed electric field device.

[0116] In some variations, a user may input, via the user interface, a proximal pressure threshold, a target distal pressure value, a proximal pressure guard range, a predetermined value for incrementing the interim set point, a set period for incrementing the interim set point, a delay range, etc. In some variations, a user may input, via the user interface, an instruction to transition controller 104 and / or controller 106 into a weaning mode.

[0117] 2A and 2B show exemplary variations of a user interface for inputting a proximal pressure threshold and a target distal pressure value. As seen in FIGS. 2A and 2B, the user interface may display an operating mode of the controller 104 and / or the controller 106. In FIGS. 2A and 2B, the operating mode may be a "manual" mode 251a. In addition, the user interface may display a systolic proximal pressure 253, a diastolic proximal pressure 255, a PMAP 257, a systolic distal pressure 259, a diastolic distal pressure 261, and a DMAP 263. In FIG. 2A, the user interface may allow a user to input a proximal pressure threshold (e.g., 267). As an example, a user may select 60 mmHg as the target proximal pressure threshold 267. In FIG. 2B, the user interface may allow a user to input a target distal pressure value (e.g., 269). As an example, a user may select a value (e.g., 50 mmHg) from a list of preloaded values ​​as the target distal pressure value for the subject. In other variations, other input methods may be used, such as simply typing or otherwise providing the desired value, for example, using a keypad, voice command, a separate mobile device in communication with the devices described herein, etc.

[0118] In some variations, the user interface may indicate whether distal sensor data may be progressing toward a target distal pressure value. For example, throughout an intravascular procedure, the user interface may indicate whether distal blood pressure may be progressing toward a target distal pressure value. The display may be updated throughout the intravascular procedure. This may enable a user to determine a subject's condition and / or make treatment decisions.

[0119] The user interface may provide progress toward the current target distal pressure. For example, for every time point, the controller 104 and / or the controller 106 may be configured to determine the progress of the distal blood pressure toward the target distal pressure value. If the distal blood pressure is progressing toward the target distal pressure value, the user interface may display a first indicator. If the distal blood pressure remains constant and / or moves away from the target distal pressure value, the user interface may display a second indicator. If the distal blood pressure is at a minimum value (e.g., a distal blood pressure value corresponding to the distal blood pressure when the blood vessel is completely occluded), the user interface may display a third indicator. If the controller 104 and / or the controller 106 does not have enough data to determine the progress of the distal blood pressure toward the target distal pressure value, the user interface may display a fourth indicator. In some variations, the current progress may be displayed as a shape including a color. The shape may be any suitable shape, such as a circle, a triangle, a square, a rectangle, an oval, etc. As a non-limiting example, a first indicator may be displayed as a rectangle comprising a first color (e.g., green), a second indicator may be displayed as a rectangle comprising a second color (e.g., yellow), a third indicator may be displayed as a rectangle comprising a third color (e.g., red), and a fourth indicator may be displayed as a rectangle comprising a fourth color (e.g., black). Although each indicator is described above as being displayed as the same shape (a rectangle), it should be understood that any shape and / or symbol may be used for each indicator, and the shape and / or symbol may, but need not be, the same shape and / or symbol across the indicators.

[0120] In addition to displaying current progress, the user interface may also display a status of progress toward the target distal pressure at a previous time point. For example, to determine whether the distal blood pressure is progressing toward the target blood pressure value, controller 104 and / or controller 106 may be configured to determine whether the interim set point is progressing toward the target distal pressure value from a previous time point. More specifically, an interim set point progressing toward the target distal pressure value from a previous time point may indicate that the distal blood pressure is progressing toward the target distal pressure value. This is because, as described above, controller 104 and / or controller 106 may be configured to adjust the volume of expandable member 110 so that the distal blood pressure may progress toward the interim set point.

[0121] Movement of the interim setpoint relative to the target distal pressure may assist the device and / or user in understanding the patient's stability. For example, continued progression of the interim setpoint toward the target distal pressure may be reassuring regarding the patient's stability. In contrast, failure to increment the interim setpoint toward the target distal pressure due to proximal pressure near or below the proximal pressure threshold may indicate patient instability and an inability to tolerate deflation / contraction of the expandable member. As described above, the user interface may display progress toward the target distal pressure at a previous time point. For example, the user interface may display distal blood pressure progress from 10 minutes ago, 9 minutes ago, 8 minutes ago, 7 minutes ago, 6 minutes ago, 5 minutes ago, 4 minutes ago, 3 minutes ago, 2 minutes ago, etc. In some variations, the user interface may display distal blood pressure progress from 5 minutes ago. Progress at a previous time point may be displayed as a border around a shape. For example, if the current progress is displayed as a shape (e.g., a rectangle) that includes a color, the progress at a previous time point may be displayed as a border around this shape that also includes a color. As described above, the color may indicate whether the distal blood pressure is progressing toward a target distal pressure value (e.g., green), remaining constant and / or moving away from the target distal pressure value (e.g., yellow), whether the distal blood pressure is at a minimum value (e.g., red), or whether there is insufficient data to make a determination (e.g., black).

[0122] To determine whether the interim setpoint is progressing, remaining constant, or moving away from the target distal pressure, the controller 104 and / or the controller 106 may be configured to compare the current interim setpoint with the interim setpoint at a previous time point. If the difference between the current interim setpoint and the interim setpoint at the previous time point is equal to or greater than the progress value, the user interface may display a first indicator (e.g., a green rectangle). In some variations, the previous time point may be 3, 4, or 5 minutes before the current time point. In variations where the previous time point is 5 minutes before, the progress value may be 2 mmHg, meaning that the distal blood pressure has incremented two out of five times over the period (e.g., a 5-minute time interval / window) between the current and previous time points. Thus, if the difference between the current interim setpoint and the interim setpoint at the previous time point is equal to or greater than 2 mmHg, the distal blood pressure may be progressing toward the target distal pressure value. In some variations, the progress value may be between about 1 mmHg and about 5 mmHg, including all values ​​and subranges therein. Thus, if the difference between the current interim set point and the interim set point, for example, five minutes ago, is 2 mmHg or more, the distal blood pressure may be progressing towards the target distal pressure value.

[0123] In some variations, evaluation of forward progress (i.e., increasing the interim setpoint) may utilize a different time interval (the difference between the current and previous time) than evaluation of backward progress (i.e., decreasing the interim setpoint). For example, in some variations, evaluation of forward progress may utilize a 3-5 minute time interval, and evaluation of backward progress may utilize a 1 minute time interval. In other words, in some variations, over a 5 minute period, the difference between the current interim distal setpoint and the previous interim distal setpoint may be 5 or less, but may be a strongly negative number. A value of 0 may indicate no progress, while a negative number may indicate negative progress, or stated another way, a decrement of the interim target. This may occur quickly within a 1 minute time interval. Thus, the determination of stability versus instability may be asymmetric with respect to time. Thus, in some variations, the controller may utilize a minimum sampling window of 3-5 minutes to determine stability, but may determine stability within 1 minute.

[0124] Additionally or alternatively, if the current interim set point is equal to the target distal pressure value, the user interface may display a first indicator (eg, green).

[0125] If the interim set point during the previous window equaled the target distal pressure and the difference between the current interim set point and the target distal pressure value is less than the indicator value, the user interface may display a second indicator (e.g., yellow). As noted above, in some variations, the indicator value may be -1 mmHg. That is, if the interim set point over the last 1 minute, last 2 minutes, last 3 minutes, last 4 minutes, and / or last 5 minutes equaled the target distal pressure value and the current interim set point is more than 1 mmHg away from the target distal pressure value, the distal blood pressure may be stable or may be moving away from the target distal pressure value.

[0126] Furthermore, if the difference between the current interim setpoint and the interim setpoint at the previous time point is less than the progress value, the user interface may display a second indicator (e.g., yellow). In some variations, the previous time point may be five minutes prior to the current time point, as described above. In some variations, the progress value may be 2 mmHg, as described above. Thus, in these variations, if the difference between the current interim setpoint and the interim setpoint five minutes prior is less than 2 mmHg, the distal blood pressure may be stable and / or moving away from the target distal pressure value. As described above, in some variations, the progress value for displaying the first indicator may be any value above a particular setpoint within the range of 1 mmHg to 5 mmHg, while displaying the second indicator may occur at any progress value below the particular setpoint.

[0127] If the distal blood pressure value is at a minimum, the user interface may display a third indicator (e.g., red). In some variations, expansion of the expandable member 110 may impede blood flow beyond the expandable member. Thus, the distal blood pressure may drop to a minimum (e.g., a minimum when the blood vessel is completely occluded). Thus, the third indicator may indicate that blood flow proximal to the expandable member 110 may be impeded, thereby indicating that the expandable member may be occluded or close to occlusion.

[0128] If controller 104 and / or controller 160 does not have enough information to determine the progress of the distal blood pressure toward the distal target pressure value, the user interface may display a fourth indicator. As an example, if a user switches from an automatic to a manual operating mode or vice versa, controller 104 and / or controller 106 may not have enough data to determine the progress of the distal blood pressure. In such a scenario, the user interface may display a fourth indicator (e.g., black, gray).

[0129] FIG. 3 shows an exemplary variation of a user interface displaying distal blood pressure progress at a current time and a previous time. In FIG. 3, controller 104 and / or controller 106 may be in a weaned control state. Although not shown in FIG. 3, it should be readily understood that the user interface may similarly display distal blood pressure progress when controller 104 and / or controller 106 are in a distal pressure control state. The current progress may be displayed as a rectangular box containing a color. The previous progress may be displayed as a border around the rectangular box. The user interface may display green if the interim set point is progressing toward the target distal pressure value, yellow if the interim set point is constant and / or moving away from the target distal pressure value, and red if the distal pressure value is at the minimum possible value.

[0130] In FIG. 3 , rectangular box 371 may indicate that the interim set point is progressing toward the target distal pressure value at the current time and at a previous time (e.g., 5 minutes ago). However, rectangular box 372 may indicate that the interim set point is progressing toward the target distal pressure value at the current time, but that the interim set point was constant or moving away from the target distal pressure value at a previous time (e.g., 5 minutes ago). Rectangular box 373 may indicate that the interim set point may be progressing toward the target distal pressure value at the current time, but that the distal pressure value was at a minimum value at the previous time. Similarly, rectangular box 381 may indicate that the interim set point is constant and / or moving away from the target distal pressure value at the current time, while the interim set point was progressing toward the target distal pressure value at a previous time (e.g., 5 minutes ago). Rectangular box 382 may indicate that the interim set point is constant and / or moving away from the target distal pressure value at the current time and at a previous time. Rectangular box 383 may indicate that the interim set point is currently constant and / or moving away from the target distal pressure value, which was at a minimum value at a previous time point. In this context, if the previous time point indicated a minimum value (third indicator value) but the current interim set point is moving away from the target distal pressure value, this may indicate that the distal pressure trigger for the third indicator value (indicating occlusion or near occlusion) has decreased, thereby allowing further inflation / expansion of the expandable member and a corresponding decrease in the interim set point.

[0131] Similarly, rectangular box 391 may indicate that the distal pressure value is currently at a minimum, but the interim set point was progressing toward the target distal pressure value at a previous time point. Rectangular box 392 may indicate that the distal pressure value is currently at a minimum, but the interim set point was constant and / or moving away from the target distal pressure value at a previous time point. Rectangular box 393 may indicate that the distal pressure value is currently and previously at a minimum.

[0132] Method for automatically controlling an expandable member - Patent Application 20070122997 Generally, a method for automatically controlling an expandable member may include acquiring proximal sensor data from a proximal pressure sensor and acquiring distal sensor data from a distal pressure sensor; comparing the acquired proximal sensor data to a proximal pressure threshold; adjusting a volume of the expandable member based on the distal sensor data in response to determining that the proximal sensor data is equal to or greater than the proximal pressure threshold; and adjusting a volume of the expandable member based on the proximal sensor data in response to determining that the proximal sensor data is below the proximal pressure threshold.

[0133] 4 is a flowchart illustrating an exemplary variation of a method 400 for automatically controlling an expandable member. In some variations, the method 400 may include advancing an expandable member into and within a blood vessel of a subject. A proximal pressure sensor may be positioned distal to the expandable member, and a distal pressure sensor may be positioned proximal to the expandable member. A controller may be operatively and / or communicatively coupled to the expandable member. A user may select to operate the controller in an automatic operating mode. In the automatic operating mode, the controller may autonomously adjust the volume of the expandable member.

[0134] For example, at 402, method 400 may include acquiring proximal sensor data from a proximal pressure sensor and acquiring distal sensor data from a distal pressure sensor. The proximal sensor data may include proximal blood pressures such as systolic proximal blood pressure, diastolic proximal blood pressure, PMAP, combinations thereof, etc. The distal sensor data may include distal blood pressures such as systolic distal blood pressure, diastolic distal blood pressure, DMAP, combinations thereof, etc.

[0135] At 404, the method may include comparing the proximal sensor data to a proximal pressure threshold. For example, method 400 may include comparing a proximal blood pressure (e.g., PMAP) to a proximal pressure threshold. In some variations, method 400 may include receiving the proximal pressure threshold from a user via a user interface. In some variations, method 400 may include automatically determining the subject's proximal pressure threshold using a controller. For example, the method may include determining the subject's proximal pressure threshold based on the subject's physiological condition.

[0136] If the proximal sensor data exceeds the proximal pressure threshold, the method 400 may include transitioning the controller to a distal pressure control state. At 406, the method 400 may include comparing the proximal sensor data to a proximal pressure guard range. A lower limit of the proximal pressure guard range may be the proximal pressure threshold. An upper limit of the proximal pressure guard range may be a predetermined amount of pressure above the proximal pressure threshold. Thus, the upper limit of the proximal pressure guard range may be the proximal pressure threshold plus a predetermined amount. In some variations, the predetermined amount may be 5 mmHg.

[0137] If the proximal sensor data exceeds an upper proximal pressure threshold, the method 400 may include transitioning the controller to an adjustment state. In the adjustment state, the method 400 may include comparing the distal sensor data to a target distal pressure value, at 408. For example, the method may include comparing a DMAP to the target distal pressure value. In some variations, the target distal pressure value may be received from a user via a user interface before or during the endovascular procedure.

[0138] If the distal sensor data is less than the target distal pressure value, then at 410, the method 400 may include setting an interim set point. If the controller transitions to the adjustment state immediately after an initial occlusion (e.g., immediately after the expandable member first reaches occlusion), then the method 400 may include setting the interim set point to a predetermined interim value immediately after the occlusion. The predetermined interim value may be 5 mmHg. At 412, the method may include adjusting the volume of the expandable member so that the distal sensor data approaches the interim set point. After adjusting the volume of the expandable member, then at 414, the method may include incrementing the interim set point. As described above, the interim set point may be incremented multiple times. For example, the interim set point may be a step function. In some variations, 400 may include incrementing the interim set point by a predetermined value after a set period of time. For example, the method may include incrementing the interim set point by 1 mmHg per minute. After incrementing the interim set point, the method 400 may include adjusting the volume of the expandable member so that the distal sensor data approaches the interim set point each time the interim set point is updated (e.g., incremented). For example, the volume of the expandable member 110 may be adjusted every few seconds (e.g., every 6 seconds) so that the distal blood pressure approaches the interim set point.

[0139] In some variations, method 400 may further include monitoring the progress of the distal sensor data toward the interim set point. For example, method 400 may include comparing the difference between the distal sensor data and the interim set point to a delay range. If the difference is within the delay range, the method may include incrementing the interim set point by a predetermined value after a set period of time (e.g., as described at 414). However, if the difference is outside (e.g., below) the delay range, method 400 may include holding the interim set point constant until the distal sensor data approaches the interim set point.

[0140] If the distal sensor data exceeds the target distal pressure value, the method 400 may include setting an interim set point to the target distal pressure value at 416. At 418, the method may include adjusting the volume of the expandable member to advance the distal sensor data toward the interim set point.

[0141] However, if the proximal sensor data is within the proximal pressure guard range at 406, the method 400 may include transitioning the controller to a hold state. In the hold state, the method 400 may include holding the interim set point constant at 420. At 422, the method 400 may include adjusting the volume of the expandable member to advance the distal sensor data toward the (constant) interim set point.

[0142] The above steps described when the proximal sensor data exceeds a threshold (e.g., at 404). However, if the proximal sensor data falls below the proximal threshold at 404, method 400 may include transitioning the controller to a proximal pressure control state. At 424, the method may include setting an interim set point to the current distal pressure value. At 426, method 400 may include adjusting the volume of the expandable member to advance the proximal blood pressure above the proximal pressure threshold. Thus, during an intravascular procedure, method 400 may include continuously monitoring the proximal blood pressure up to the proximal pressure threshold. Method 400 may include transitioning to a distal pressure control state or a proximal pressure control state based on this comparison. In this manner, method 400 can continuously and automatically control the volume of the expandable member.

[0143] In some variations, toward the end of the endovascular procedure (e.g., before removing the expandable member from the target vessel), method 400 may include receiving an indication from a user (e.g., via a user interface) that the user desires to fully deflate the expandable member. In response to the instruction from the user to fully deflate the expandable member, method 400 may include transitioning to a disengagement control state. In the disengagement control state, the method may include setting a target expandable member pressure value to a minimum expandable member pressure value (e.g., at full deflation of the expandable member). In some variations, the expandable member pressure value may be a negative pressure value. Method 400 may include adjusting the volume of the expandable member so that the distal blood pressure progresses rapidly toward the target distal pressure value and / or so that the proximal pressure progresses toward the target distal pressure value at a rate determined by how close the proximal pressure target is. In some variations, progress toward the distal target value and / or interim distal value may be predicted based on maintaining at least a minimum proximal pressure value as set by the user and / or as determined by the device. In some variations, the method may include switching from a weaning mode to a proximal pressure target mode when the proximal pressure drops below a proximal target pressure.

[0144] In addition to automatically controlling the expandable member, the method may include delivering one or more blood products to the patient to help stabilize the patient's condition. Exemplary blood products include, but are not limited to, red blood cells, plasma, platelets, and cryoprecipitate. Other fluids, such as saline, lactated Ringer's solution, D5W, or medications, may also be infused to help achieve or maintain hemodynamic stability.

[0145] Delivery of blood products by the devices and / or systems described herein can be manual or automatic. When delivered manually, a user can press one or more areas or buttons on a user interface of a controller (e.g., controller 104, controller 106, or a different controller) to stop or start the infusion of the blood product. When delivered automatically, a patient's target physiological state can be input by a user into a controller (e.g., controller 104, controller 106, or a different controller) (e.g., before and / or during the intravascular procedure). Upon receiving sensor data from one or more sensors (e.g., proximal pressure sensor 111a and distal pressure sensor 111b), the controller can automatically or autonomously start and stop the infusion of the blood product based on the sensor data, the target physiological state, and one or more infusion algorithms.

[0146] In some variations, the method may include determining, by a controller, to deliver a blood product based on one or more blood pressure parameters (e.g., proximal blood pressure, distal blood pressure) while using the expandable member of a device described herein to control bleeding, where the infusion of blood product can help maintain hemodynamic stability and perfusion of organs proximal and distal to the expandable member. The controller's selection of an infusion protocol may be based, for example, on whether the distal blood pressure meets an interim setpoint within a predetermined period en route to a target distal blood pressure value, where the proximal or distal blood pressure value is dropping but the volume of the expandable member remains constant for a predetermined period. In other examples, the controller's selection of an infusion protocol may be based on whether the frequency of inflation of the expandable member to maintain the proximal blood pressure within a proximal pressure guard range exceeds a threshold, or when the proximal blood pressure continues to drop despite an increase in the volume of the expandable member due to automatic or manual inflation. In some variations, the blood product may be delivered at one or more fixed amounts, at a constant rate, or at one or more fixed amounts and constant rates. In other variations, blood product may be delivered in one or more variable amounts, at variable rates, or at one or more variable amounts and variable rates. When multiple blood product amounts (e.g., one, two, three, four, etc.) are delivered, the amounts may be infused sequentially (e.g., one amount followed by another) or repeatedly (e.g., separated by a predetermined time). The sequential or repeated delivery of blood amounts may occur until a determination by the controller that one or more threshold blood pressure values ​​(e.g., proximal blood pressure value, distal blood pressure value) have been met.

[0147] In some variations, a method for automatically delivering a blood product to a subject may include using a controller to acquire sensor data from at least one of a proximal pressure sensor, a distal pressure sensor, and an expandable member sensor; comparing the acquired sensor data to target values ​​of at least one of a proximal blood pressure, a distal blood pressure, an expandable member pressure, and an interim set point; and delivering one or more amounts of blood product to the subject in response to determining that the acquired sensor data does not meet the target value.

[0148] In some variations, the method may also include using the controller to determine the amount of blood product to include in one or more volumes to deliver to the subject. When multiple volumes are delivered, the amount and / or rate of each volume may remain the same (e.g., as described above for fixed-rate and / or constant-rate infusion). In other variations, when multiple volumes are delivered, the delivered amounts and / or delivery rates of some of the volumes may vary (e.g., as described above for variable-rate and / or variable-rate delivery).

[0149] Examples of autonomous control FIG. 5 illustrates an exemplary variation for autonomously controlling an expandable member using the systems, devices, and methods described herein. More specifically, FIG. 5 is a pressure versus time plot showing how exemplary sensor data may change over time using the techniques described herein. For example, 502a shows the change in proximal sensor data (e.g., PMAP) over time, and 502b shows the change in distal sensor data (e.g., DMAP) over time. The proximal pressure threshold is shown as PMAP guard 506. Value 504 may be the proximal pressure threshold 506 plus a buffer amount (e.g., 5 mmHg in FIG. 5). In other words, proximal pressure threshold 506 and value 504 may represent the lower and upper limits of a pressure range, such as the proximal pressure guard range 509 described above. As described above, proximal pressure threshold 506 is the lower limit of proximal pressure guard range 509. The upper limit of proximal pressure guard range 509 is shown as 504. Thus, the proximal pressure guard range is between 504 and 506. As described above, the controller may transition to a state (e.g., a distal pressure control state, such as an adjust state or a hold state, and a proximal pressure control state) based on a comparison of the proximal sensor data to the proximal pressure guard range 509 or the proximal pressure threshold 506. These states are shown in FIG. 5 as 505 (e.g., adjust state 505a, hold state 505b, proximal pressure control state 505c, hold state 505d, and adjust state 505e). In FIG. 5, the target distal pressure value (DMAP target) is represented as 508, and the change in the interim set point over time is shown as 510 (interim target).

[0150] In variations in which the expandable member volume is adjusted until occlusion, at time 512, just after occlusion, the target distal pressure value is set or is set to a value above the distal blood pressure. Further, at time 512, the controller may be in a distal pressure state. This is because the proximal blood pressure at time 512 is greater than the proximal pressure threshold 506. Further, at time 512, the proximal blood pressure is greater than the proximal pressure guard range 509. Therefore, the controller may be in an adjusting state (e.g., adjusting state 505a). Figure 5 also includes an automated status indicator bar 524 that displays the progress of the distal blood pressure at the current and previous time points.

[0151] The controller can set an interim set point. Because time 512 is immediately after occlusion, the interim set point can be set to a larger predetermined value (e.g., 5 mmHg). The controller can then adjust the volume of the expandable member to advance the distal blood pressure toward the interim set point.

[0152] In FIG. 5, the change in the interim set point over time is shown as 510. As described above, in the adjustment state 505a, the controller can compare the progress of the distal blood pressure against the changing interim set point. For example, the controller can determine the difference between the interim set point and the distal blood pressure. If the difference is within the lag range (i.e., the distal blood pressure does not lag behind the interim set point by more than a predetermined lag value), the interim set point can be incremented, for example, by 1 mmHg per minute as shown. If the difference is outside the lag range, the interim set point can remain constant until the distal blood pressure no longer lags behind the interim set point (e.g., the catch-up operation described above). For example, in FIG. 5, 522a, 522b, and 522c indicate the period during which the interim set point is held constant in the adjustment state. As seen in this example, the interim set point can be held constant in the adjustment state until the distal blood pressure approaches the interim set point.

[0153] At 514, the proximal blood pressure drops below the upper limit of the proximal pressure guard range but remains above the lower limit of the proximal pressure guard range until time 516. Thus, between times 514 and 516, the proximal blood pressure is within the proximal pressure guard range, and therefore the controller transitions to a hold state. As seen in FIG. 5 , after time 514, the interim set point is held constant. The volume of the expandable member may be adjusted so that the distal blood pressure approaches the interim set point. The controller continues in the hold state until 516, when the proximal blood pressure drops below the proximal pressure threshold and is therefore outside the proximal pressure guard range and below the proximal pressure guard range. Because the proximal pressure has fallen below the proximal pressure threshold, the controller transitions to a proximal pressure control state. The interim set point at time 516 is set to be the distal blood pressure at time 516, and the volume of the expandable member may be adjusted based on the proximal sensor data. Specifically, the volume of the expandable member can be adjusted as the proximal blood pressure rises above the proximal pressure threshold, thus re-entering the proximal pressure guard range. After the proximal blood pressure rises above the proximal pressure threshold (e.g., at time 518), the controller transitions to a distal pressure control state, specifically a hold state of the distal pressure control state (e.g., because the proximal blood pressure is within the proximal pressure guard range). At time 520, the proximal blood pressure rises above the upper limit of the proximal pressure guard range, thus the controller transitions to an adjust state. In this manner, the volume of the expandable member can be adjusted until the distal blood pressure reaches the target distal pressure value.

[0154] Referring now to the automated status indicator portion of FIG. 5 , the status indicator bar 524, in some variations, indicates the progress of the distal blood pressure toward the target distal pressure value at the current and previous time points, as may be shown on a user interface. For example, progress at the current time point may be displayed as a rectangular box containing a color within the status indicator bar 524. Progress at the previous time point may be displayed as a border around the rectangular box within the status indicator bar 524. The status indicator bar 524 may display green if the interim set point is progressing toward the target distal pressure value, yellow if the interim set point is constant or moving away from the target distal pressure value, and red if the distal pressure value is at the minimum possible value. In some variations, the status indicator bar 524 may display black or gray (or the like) if there is insufficient data to determine progress. For example, during the first two minutes immediately following an occlusion, the controller may not have enough data to determine distal blood pressure progress. In some variations, the status indicator bar 524 may display black or gray when the controller is unable to determine distal blood pressure progress. Thus, the user interface may display a first status indicator, shown in FIG. 5 as a black rectangle. In addition, the user interface may also display a border around the black rectangle because the controller does not have enough data regarding the progress of the distal blood pressure relative to the target distal pressure value at a previous time (e.g., five minutes ago). After the first two minutes, the controller may begin determining the progress of the interim set point toward the target distal pressure value. If the interim set point is progressing toward the target distal pressure value, the user interface may display a second, different indicator, shown here as a green rectangle. The border around the rectangle may indicate the progress of the interim set point at a previous time, e.g., five minutes ago here. However, if the interim set point remains constant or is moving away from the target distal pressure value, the user interface may display a third user interface, shown here as a yellow rectangle.

[0155] 6-10 illustrate further exemplary variations for autonomously controlling the expandable member based on sensor data. Similar to FIG. 5, FIG. 6 is a pressure versus time plot illustrating how exemplary sensor data may change over time using the techniques described herein. Unlike FIG. 5, FIG. 6 illustrates exemplary sensor data as the distal blood pressure drops to a minimum pressure value (e.g., the distal blood pressure at occlusion). The status bar indicator 624 in FIG. 6 indicates the status at the minimum distal pressure value, as described further below. For example, in FIG. 6, at time 602, the proximal blood pressure may drop below the proximal pressure threshold, and the interim set point may remain constant or may move away from the target distal pressure value. Therefore, the user interface may display a yellow rectangle. The controller may transition to a proximal pressure control state. However, at 604, the distal blood pressure drops to the occlusion pressure. At this point, the vessel may be completely occluded. Therefore, the user interface may display a red rectangle. The border around the red rectangle may be displayed in yellow, thereby indicating that the interim set point five minutes ago may remain constant or may be moving away from the target distal pressure value. Additionally, in FIG. 6 , the distal blood pressure progress may switch rapidly between time point 606 (e.g., from red to yellow at time point 606) and time point 608 (e.g., from yellow to green at time point 608). Therefore, displaying the distal blood pressure progress at a previous time point (e.g., five minutes ago) may be advantageous because even if the user misses the status at one time point (e.g., due to distraction, a requirement to complete another task), the user may still be able to identify the transition point because the progress at the previous time point is displayed.

[0156] Similar to FIG. 5 , FIG. 7 is a pressure versus time plot illustrating how exemplary sensor data may change over time using the techniques described herein. Unlike FIG. 5 , FIG. 7 illustrates exemplary sensor data as the proximal blood pressure drops below the upper limit of the proximal pressure guard range and then stabilizes before adjusting the volume of the expandable member to continue the distal blood pressure progression toward the target distal pressure value. In FIG. 7 , the distal blood pressure may be progressing toward the target distal pressure value, such as from time points 702 to 704. During this period, the controller may be in the Adjust state. However, the proximal blood pressure may drop below the upper limit of the proximal pressure guard range (e.g., at time point 704). In such a situation, as seen in FIG. 7 , the controller may transition from the Adjust state to the Hold state to stabilize the proximal blood pressure. Once the proximal blood pressure stabilizes, the controller may transition back to the Adjust state (e.g., at time point 706) to continue advancing the distal blood pressure toward the target distal pressure value. In some scenarios, after transitioning to the hold state (e.g., at time 708), the proximal blood pressure may continue to drop and fall below the proximal pressure threshold (e.g., at time 710). In such a scenario, the controller may transition from the distal pressure control state (e.g., the hold state) to the proximal pressure control state (e.g., at time 710). A status indicator bar 724, as may be shown on a user interface in some variations, indicates the progress of the distal blood pressure toward the target distal pressure value at the current and previous time points.

[0157] Similar to FIG. 5, FIG. 8 is a pressure versus time plot illustrating how exemplary sensor data may change over time using the techniques described herein. Unlike FIG. 5, FIG. 8 illustrates exemplary sensor data when the proximal blood pressure drops below a proximal pressure threshold. In FIG. 8, the distal blood pressure may initially be closer to the target distal pressure value 808. That is, the distal blood pressure may be closer to and / or at the target distal pressure value 808. However, the proximal blood pressure may drop below the upper limit of the proximal pressure guard range (e.g., at 802). The controller may transition from the adjust state of the distal pressure control state to a hold state. In the hold state, the interim set point may be held constant. At time 804, the proximal blood pressure may drop below the lower limit of the proximal pressure guard range, and the controller may transition to the proximal pressure control state. Thus, the controller may reset the interim set point to the distal blood pressure value and utilize the proximal sensor data to adjust the volume of the expandable member. The proximal blood pressure may rise above the proximal pressure threshold at 806. Accordingly, the controller may transition from the proximal pressure control state to the distal pressure control state at 806. The controller may continue to vary the interim set point such that the volume of the expandable member is adjusted to progress the distal blood pressure toward the target distal pressure value.

[0158] Similar to FIG. 5, FIG. 9 is a pressure versus time plot illustrating how exemplary sensor data may change over time using the techniques described herein. Unlike FIG. 5, FIG. 9 illustrates exemplary sensor data when the distal blood pressure exceeds a target distal blood pressure value. In FIG. 9, the distal blood pressure may exceed the target distal blood pressure value. The controller may be in a distal pressure control state. In such a scenario, when the distal blood pressure exceeds the target distal blood pressure value, an interim set point may be set to the target distal blood pressure value, and the volume of the expandable member may be adjusted to move the distal blood pressure toward the target distal pressure value. After the target distal pressure value is reached, the user may set a new target distal pressure value (e.g., at time point 902). If, at time point 902, the new target distal pressure value exceeds the distal pressure value, the controller may transition back to the adjustment state to continue advancing the distal blood pressure toward the new target distal pressure value.

[0159] Similar to FIG. 5, FIG. 10 is a pressure versus time plot illustrating how exemplary sensor data may change over time using the techniques described herein. Unlike FIG. 5, FIG. 10 illustrates exemplary sensor data as the controller transitions to a weaning control state. In FIG. 10, the controller may transition to the weaning control state (e.g., by user selection). As discussed above, in the weaning control state, the interim set point may be incremented at a faster rate than in the distal pressure control state. For example, the interim set point may be incremented by 1 mmHg every 15 seconds until the proximal blood pressure is 10 mmHg away from the proximal pressure threshold. At this point, the interim set point may be incremented in a slower manner (e.g., by 1 mmHg / min).

[0160] The devices, systems, and methods described herein can be used to control blood flow at various locations within the body. For example, although described above with reference to use in the aorta, it should be readily understood that the devices, systems, and methods described herein can be used in various vascular procedures, such as interventions on arteries, such as coronary or cerebral arteries (e.g., thrombectomy procedures for stroke patients).

[0161] Further Examples The following examples are illustrative only and should not be construed as limiting the present disclosure in any way.

[0162] Fixed-rate infusion of blood products The automated delivery of blood products by the system and device described herein via constant-rate, fixed-rate infusion was evaluated in a porcine model. A catheter equipped with an expandable balloon, a proximal blood pressure sensor, and a distal blood pressure sensor was first advanced through the left femoral artery and positioned within the aorta, as described herein. The liver was then lacerated to induce controlled bleeding, and blood pressures proximal and distal to the balloon were measured. The balloon automatically inflated and deflated according to the above-described adjustments to maintain a target distal blood pressure of 35 mmHg and a proximal pressure of 60 mmHg. Whenever the proximal blood pressure (red line, 1202) fell below the proximal pressure value of 60 mmHg for approximately 2 minutes or the interim set point for the target distal pressure did not increase by at least 2.0 mmHg for 5 minutes, as shown in Figure 12, the pig was automatically transfused with 3.0 mL / kg of blood at a rate of 3.0 mL / kg for 5 minutes until the proximal blood pressure (red line, 1202) reached at least 60 mmHg. After four blood product transfusions (1200), the proximal blood pressure (red line, 1202) was maintained above 60 mmHg and the distal blood pressure (blue line, 1204) was maintained near the target of 35 mmHg, demonstrating that constant-rate and constant-volume delivery of blood products can help establish hemodynamic stability.

[0163] The foregoing description, for purposes of explanation, used specific nomenclature to provide a thorough understanding of the invention. However, it will be apparent to those skilled in the art that specific details are not required to practice the present invention. Thus, the foregoing descriptions of specific embodiments of the present invention have been presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise forms disclosed. Obviously, many modifications and variations are possible in light of the above teachings. The embodiments were chosen and described in order to explain the principles of the invention and its practical application, thereby enabling those skilled in the art to utilize the present invention and various embodiments with various modifications as suited to the particular use contemplated. It is intended that the following claims and their equivalents define the scope of the invention.

Claims

1. 1. A method for automatically controlling an expandable member within a blood vessel of a subject, the method comprising: acquiring, using a controller, proximal sensor data from the proximal pressure sensor and distal sensor data from the distal pressure sensor; comparing the acquired proximal sensor data to a proximal pressure threshold; responsive to determining that the proximal sensor data is greater than or equal to the proximal pressure threshold, adjusting a volume of the expandable member based on the distal sensor data using the controller; and in response to determining that the proximal sensor data is below the proximal pressure threshold, using the controller to adjust the volume of the expandable member based on the proximal sensor data.

2. the proximal pressure threshold is a lower limit of a proximal pressure guard range, and adjusting the volume of the expandable member based on the distal sensor data comprises: in response to determining that the proximal sensor data exceeds an upper limit of the proximal pressure guard range; adjusting the volume of the expandable member so that the distal sensor data approaches an interim set point, the interim set point being less than or equal to a target distal pressure value; The method of claim 1 , further comprising: incrementing the interim setpoint multiple times using the controller.

3. 3. The method of claim 2, wherein incrementing the interim set point for a subset of the plurality of times comprises incrementing the interim set point by a predetermined value after a set period of time for each of the subset of times.

4. The method of claim 3, wherein the predetermined value is between 1 mmHg and 5 mmHg.

5. The method of claim 3, wherein the set period is between 1 minute and 5 minutes.

6. Incrementing the interim set point comprises: For each of the plurality of times, using the controller to compare the difference between the distal sensor data and the interim set point to a delay range; 3. The method of claim 2, further comprising: incrementing the set point by a predetermined value after a set period of time in response to determining that the difference is within the delay range.

7. The method of claim 6 , further comprising, in response to determining that the difference is below the delay range, maintaining the interim set point constant.

8. The method of claim 6, wherein the delay range is from 20 mmHg to 5 mmHg.

9. the proximal pressure threshold is a lower limit of a proximal pressure guard range, and adjusting the volume of the expandable member based on the distal sensor data comprises: in response to determining that the proximal sensor data is within the proximal pressure guard range; using the controller to hold constant an interim set point of the distal sensor data, the interim set point being less than or equal to a target distal pressure value; The method of claim 1 , further comprising adjusting the volume of the expandable member so that the distal sensor data approaches the interim set point.

10. 2. The method of claim 1, wherein the proximal pressure threshold is a lower limit of a proximal pressure guard range, and adjusting the volume of the expandable member based on the proximal sensor data further comprises adjusting the volume of the expandable member based on the proximal sensor data until the proximal sensor data is above a lower limit of the proximal guard range.

11. 10. The method of claim 1, wherein adjusting the volume of the expandable member based on the distal sensor data further comprises adjusting the volume of the expandable member so that the distal blood pressure obtained from distal sensor data reaches a target distal pressure.

12. The method of claim 11 , further comprising indicating whether the distal sensor data is progressing toward the target distal pressure value.

13. To show that providing a first indicator if the interim set point is progressing toward the target distal pressure value within a predetermined first period of time; 13. The method of claim 12, further comprising: providing a second, different indicator if the interim set point remains constant or moves away from the target distal pressure value within the first predetermined period of time.

14. providing the first indicator includes determining, using the controller, whether an interim set point during a previous time window was equal to the target distal pressure value and whether a difference between a current interim set point and the target distal pressure value is greater than or equal to an indicator value; 14. The method of claim 13, wherein providing the second indicator comprises determining whether the interim set point during the previous time window was equal to the target distal pressure value and whether the difference between the current interim set point and the target distal pressure value is less than the indicator value.

15. The method of claim 14 , wherein the previous time window is one or more of the previous 1 minute, 2 minutes, 3 minutes, 4 minutes, or 5 minutes.

16. 15. The method of claim 14, wherein the indicator value is −1 mmHg.

17. 14. The method of claim 13, wherein providing the first indicator comprises displaying a shape comprising a first color on a display, and providing the second indicator comprises displaying the shape comprising a second color on the display.

18. 18. The method of claim 17, further comprising providing a third indicator providing progress of the distal sensor data toward the target pressure value during a previous time window.

19. The method of claim 18 , wherein providing the third indicator comprises displaying a boundary around the shape.

20. 20. The method of claim 18, wherein the previous time window is within the previous five minutes.

21. providing a third indicator indicating that the distal sensor data is a minimum distal value, the minimum distal value corresponding to the distal sensor data when the blood vessel is completely occluded; and 14. The method of claim 13, further comprising: providing a fourth indicator that indicates progress of the distal sensor data toward the target distal pressure value cannot be determined by the controller.

22. 10. The method of claim 1, further comprising adjusting the volume of the expandable member in response to a user input that fully contracts the expandable member such that the proximal sensor data remains above the proximal pressure threshold and the expandable membrane sensor reaches a target expandable member pressure, wherein the target expandable member pressure is a negative pressure.

23. The method of claim 1 , further comprising maintaining a minimum proximal pressure.

24. 24. The method of claim 23, wherein the minimum proximal pressure is configured to support one or more of a subject's brain, lungs, or heart.

25. 10. The method of claim 1, further comprising automatically delivering a blood product to the subject.

26. 26. The method of claim 25, wherein the blood product is one or more of red blood cells, plasma, platelets, and cryoprecipitate.

27. 26. The method of claim 25, wherein the blood product is delivered in one or more predetermined amounts, at predetermined rates, or both.

28. 26. The method of claim 25, wherein the blood product is delivered in one or more variably determined amounts, at variably determined rates, or both.

29. 1. A method for automatically controlling an expandable member within a blood vessel of a subject, the method comprising: acquiring, using a controller, proximal sensor data from the proximal pressure sensor and distal sensor data from the distal pressure sensor; comparing the acquired proximal sensor data with a proximal pressure guard range; in response to determining that the proximal sensor data exceeds an upper limit of the pressure guard range, transitioning the controller to an adjustment state, wherein the controller is configured to adjust a volume of the expandable member to move the distal sensor data toward a distal target value; in response to determining the proximal sensor data is within the proximal pressure guard range, transitioning the controller to a hold state, wherein in the hold state the controller is configured not to adjust the volume of the expandable member to maintain the distal sensor data; transitioning the controller to a proximal pressure control state in response to determining that the proximal sensor data is below a lower limit of the pressure guard range.

30. 30. The method of claim 29, wherein in the adjusting state, the method includes using the controller to adjust a volume of the expandable member based on a variable distal interim set point.

31. 31. The method of claim 30, wherein in the adjusting state, the method further comprises using the controller to adjust the volume of the expandable member such that the distal sensor data reaches the variable distal interim set point.

32. 31. The method of claim 30, wherein in the adjustment state, the variable distal interim set point is increased by a predetermined value multiple times.

33. detecting that the blood vessel is completely occluded; 33. The method of claim 32, further comprising: after the occlusion at a first of the plurality of times, in the adjusting state, increasing the variable interim set point by a first predetermined value.

34. 34. The method of claim 33, wherein the first predetermined value is 5 mmHg above the current distal blood pressure obtained during an occlusion.

35. 34. The method of claim 33, further comprising increasing the variable interim set point by a second, different predetermined value in the adjustment state after a set period of time in a second of the plurality of times.

36. 36. The method of claim 35, wherein the second predetermined value is 1 mmHg.

37. 30. The method of claim 29, wherein in the holding state, the volume of the expandable member is adjusted using the controller based on a constant distal interim set point.

38. 30. The method of claim 29, wherein in the proximal pressure control state, the volume of the expandable member is adjusted to move the proximal sensor data above the lower limit of the pressure guard range.

39. 39. The method of claim 38, wherein in the proximal pressure control state, the target value of the distal sensor data is set to the current value of the distal sensor data.

40. 30. The method of claim 29, wherein the controller transitions to a disengaged state in response to a user input that fully contracts the expandable member, and the controller is configured to fully contract the expandable member in the disengaged state.

41. 41. The method of claim 40, wherein in the disengaged state, the volume of the expandable member is adjusted such that the proximal sensor data remains above the lower limit of the pressure guard range.

42. 30. The method of claim 29, further comprising automatically delivering a blood product to the subject.

43. 43. The method of claim 42, wherein the blood product is one or more of red blood cells, plasma, platelets, and cryoprecipitate.

44. 30. The method of claim 29, wherein the blood product is delivered in one or more predetermined amounts, at predetermined rates, or both.

45. 30. The method of claim 29, wherein the blood product is delivered in one or more variably determined amounts, at variably determined rates, or both.

46. 1. A system for controlling blood flow, comprising: an elongate body comprising an expandable member, a proximal pressure sensor, and a distal pressure sensor; a pump in fluid communication with the expandable member; a controller communicatively coupled to the proximal pressure sensor, the distal pressure sensor, and the pump, the controller comprising: acquiring proximal sensor data from the proximal pressure sensor and distal sensor data from the distal pressure sensor; comparing the acquired proximal sensor data to a proximal pressure threshold; adjusting a volume of the expandable member based on the distal sensor data in response to determining that the proximal sensor data exceeds the proximal pressure threshold; a controller configured to adjust the volume of the expandable member based on the proximal sensor data in response to determining that the proximal sensor data falls below the proximal pressure threshold.

47. 47. The system of claim 46, wherein the controller is further configured to determine whether the blood product should be delivered in one or more predetermined amounts, at a predetermined rate, or both.

48. 47. The system of claim 46, wherein the controller is configured to determine whether blood products should be delivered in one or more variably determined amounts, at variably determined rates, or both.

49. 1. A system for controlling blood flow, comprising: an elongate body comprising an expandable member, a proximal pressure sensor, and a distal pressure sensor; a pump in fluid communication with the expandable member; a controller communicatively coupled to the proximal pressure sensor, the distal pressure sensor, and the pump, the controller comprising: acquiring proximal sensor data from the proximal pressure sensor and distal sensor data from the distal pressure sensor; comparing the acquired proximal sensor data with a proximal pressure guard range; transitioning the controller to an adjustment state in response to determining that the proximal sensor data exceeds an upper limit of the proximal pressure guard range, wherein the controller is configured to adjust a volume of the expandable member to move the distal sensor data toward a distal target value; transitioning the controller to a hold state in response to determining the proximal sensor data is within the proximal pressure guard range, wherein in the hold state, the controller is configured to maintain the distal sensor data; a controller configured to transition the controller to a proximal pressure control state in response to determining that the proximal sensor data is below a lower limit of the proximal pressure guard range.

50. 50. The system of claim 49, wherein the controller is further configured to determine whether the blood product is to be delivered in one or more predetermined amounts and at predetermined rates.

51. 50. The system of claim 49, wherein the controller is configured to determine whether blood products should be delivered in one or more variably determined amounts and at variably determined rates.

52. 1. A method for automatically delivering a blood product to a subject, the method comprising: acquiring sensor data from at least one of a proximal pressure sensor, a distal pressure sensor, and an expandable member sensor using a controller; comparing the acquired sensor data to at least one target value of a proximal blood pressure, a distal blood pressure, an expandable member pressure, and an interim set point; and delivering one or more amounts of the blood product to the subject in response to determining that the acquired sensor data does not meet the target value.

53. 53. The method of claim 52, further comprising using the controller to determine the amount of the blood product to include in the one or more amounts for delivery to the subject.

54. 54. The method of claim 53, wherein when multiple doses are delivered, the amount of each dose remains the same.

55. 54. The method of claim 53, wherein when multiple amounts are delivered, some of the amounts are different.

56. 53. The method of claim 52, further comprising using the controller to determine a delivery rate of the blood product to the subject.

57. 57. The method of claim 56, wherein when multiple doses are delivered, the delivery rate of each dose is constant.

58. 57. The method of claim 56, wherein when multiple amounts are delivered, the delivery rates of some of the amounts are variable.

59. 53. The method of claim 52, wherein the blood product comprises red blood cells, plasma, platelets, or cryoprecipitate.

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