Thrombectomy System User Interface

Abstract

A user interface for a clot removal fluid management system may include a first mode indicator configured to indicate that a first mode of fluid inflow is active, a second mode indicator configured to indicate that a second mode of fluid inflow is active, and a runtime display including an alphanumeric runtime value displayed in a first color. The alphanumeric runtime value is the sum of the first runtime value for the first mode and the second runtime value for the second mode. The system may include an inflow pump configured to provide fluid inflow through the clot removal device, a controller in communication with the inflow pump and the clot removal device, a user-actuated switch configured to activate the inflow pump, and a display including a user interface. The display may include a touchscreen user interface.

Description

[Technical Field]

[0001] The present disclosure relates generally to thrombectomy systems, and more particularly to user interfaces for thrombectomy systems. [Background technology]

[0002] Thrombectomy is a procedure for removing thrombus, plaque, lesions, clots, etc. from a patient's vascular system. Mechanical and hydraulic systems can be used to remove thrombus. In hydraulic systems, a catheter can be used to inject fluid (e.g., saline) into a treatment area of ​​the blood vessel to soften, loosen, and / or detach the thrombus. In some cases, drainage fluid (e.g., fluid and / or blood) containing the detached thrombus can be extracted from the blood vessel via the catheter. Given the known thrombus removal systems and methods, there is a continuing need to provide alternative configurations of thrombus removal catheters and systems, as well as methods of operating such thrombus removal systems. Summary of the Invention

[0003] In one example, a user interface for a clot removal fluid management system may include a first mode indicator configured to indicate that a first mode of fluid inflow is active, a second mode indicator configured to indicate that a second mode of fluid inflow is active, and a runtime display including an alphanumeric runtime value shown in a first color, the alphanumeric runtime value being the sum of the first runtime value for the first mode and the second runtime value for the second mode.

[0004] In addition to or in the alternative to any example disclosed herein, the runtime display shows a first recommended runtime threshold corresponding to a first treatment condition and a second recommended runtime threshold corresponding to a second treatment condition.

[0005] In addition or in the alternative to any example disclosed herein, the alphanumeric runtime value is configured to change from a first color to a second color when the sum reaches at least one of a first and a second recommended runtime threshold.

[0006] In addition or in the alternative to any example disclosed herein, the alphanumeric runtime values ​​are configured to change from a first color to a second color when the sum reaches a first recommended runtime threshold.

[0007] In addition or as an alternative to any example disclosed herein, the alphanumeric runtime values ​​are configured to change from a first color to a second color when the sum reaches a second recommended runtime threshold.

[0008] In addition to or in the alternative to any example disclosed herein, the alphanumeric runtime value is configured to change to a third color when the sum reaches a second recommended runtime threshold.

[0009] In addition to or in the alternative to any example disclosed herein, the first mode indicator may be user-selectable to activate a first mode of fluid inflow. In addition to or as an alternative to any example disclosed herein, the second mode indicator may be user-selectable to activate a second mode of fluid inflow.

[0010] Additionally or alternatively to any example disclosed herein, the alphanumeric runtime value may be expressed in seconds. In addition to or in place of any example disclosed herein, a clot removal fluid management system may include an inflow pump configured to provide fluid inflow via a clot removal device, a controller in communication with the inflow pump and the clot removal device, a user-actuated switch configured to operate the inflow pump, and a display including a user interface. The user interface may include a first mode indicator configured to indicate that a first mode of fluid inflow is active, a second mode indicator configured to indicate that a second mode of fluid inflow is active, and a runtime display including an alphanumeric runtime value displayed in a first color. The alphanumeric runtime value may be the sum of the first runtime value for the first mode and the second runtime value for the second mode.

[0011] In addition to or in the alternative to any example disclosed herein, the runtime display shows a first recommended runtime threshold corresponding to a first treatment condition and a second recommended runtime threshold corresponding to a second treatment condition.

[0012] In addition or in the alternative to any example disclosed herein, the alphanumeric runtime value is configured to change from a first color to a second color when the sum reaches at least one of a first and a second recommended runtime threshold.

[0013] In addition or in the alternative to any example disclosed herein, the alphanumeric runtime values ​​are configured to change from a first color to a second color when the sum reaches a first recommended runtime threshold.

[0014] In addition or as an alternative to any example disclosed herein, the alphanumeric runtime values ​​are configured to change from a first color to a second color when the sum reaches a second recommended runtime threshold.

[0015] In addition to or in the alternative to any example disclosed herein, the controller is configured to issue a first audible notification when the sum reaches a first recommended runtime threshold.

[0016] In addition to or in the alternative to any example disclosed herein, the alphanumeric runtime value is configured to change to a third color when the sum reaches a second recommended runtime threshold.

[0017] Additionally or alternatively to any example disclosed herein, the controller is configured to issue a second audible notification when the sum reaches a second recommended runtime threshold.

[0018] In addition to or in the alternative to any example disclosed herein, after the first recommended runtime threshold is reached, the inflow pump continues to operate as long as the user-activated switch is activated.

[0019] In addition to or in the alternative to any of the examples disclosed herein, after the second recommended runtime threshold is reached, the inflow pump continues to operate as long as the user-activated switch is activated.

[0020] In addition to or in place of any of the examples disclosed herein, a clot removal fluid management system may include an inflow pump configured to provide fluid inflow via a clot removal device, a controller in communication with the inflow pump and the clot removal device, a user-actuated switch configured to operate the inflow pump, and a display including a touchscreen user interface. The touchscreen user interface may include a first mode indicator configured to highlight that a first mode of fluid inflow is active, the first mode indicator being user-selectable on the touchscreen user interface, a second mode indicator configured to highlight that a second mode of fluid inflow is active, the second mode indicator being user-selectable on the touchscreen user interface, and a runtime display including an alphanumeric runtime value shown in a first color when fluid inflow is initiated. The alphanumeric runtime value may be the sum of a first elapsed runtime of the inflow pump when operated in the first mode and a second elapsed runtime of the inflow pump when operated in the second mode.

[0021] In addition to or in the alternative to any example disclosed herein, the runtime display shows a first recommended runtime threshold corresponding to a first treatment condition and a second recommended runtime threshold corresponding to a second treatment condition.

[0022] In addition to or in the alternative to any example disclosed herein, the controller includes a data acquisition device configured to communicate with the thrombus removal device to acquire specification information associated with the thrombus removal device.

[0023] In addition to or in the alternative to any example disclosed herein, the specification information includes a first recommended runtime threshold and a second recommended runtime threshold. In addition to or in the alternative to any example disclosed herein, the touchscreen user interface includes a graphical display adjacent to the alphanumeric runtime values, the graphical display showing the alphanumeric runtime values ​​for the first recommended runtime threshold and the second recommended runtime threshold.

[0024] The above summary of some embodiments, aspects, and / or examples is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The following figures and detailed description more particularly exemplify these embodiments. [Brief explanation of the drawings]

[0025] The present disclosure can be more fully understood in consideration of the following detailed description in conjunction with the accompanying drawings. [Figure 1] FIG. 1 is a perspective view of a thrombus removal system. [Figure 2] FIG. 2 is a partially exploded perspective view of a portion of the system shown in FIG. 1. [Figure 3] 1A-1C illustrate selected aspects of a user interface for a thrombus removal system. [Figure 4] 1A-1C illustrate selected aspects of a user interface for a thrombus removal system. [Figure 5] 1A-1C illustrate selected aspects of a user interface for a thrombus removal system. [Figure 6] 1A-1C illustrate selected aspects of a user interface for a thrombus removal system. [Figure 7] 10A-10C illustrate selected aspects of a user interface and a look-up table of selected specification information associated with various clot removal devices. DETAILED DESCRIPTION OF THE INVENTION

[0026] While aspects of the present disclosure are susceptible to various modifications and alternative forms, specifics thereof are shown by way of example in the drawings and will be described in detail below. It should be understood, however, that the intention is not to limit aspects of the disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.

[0027] The following description should be read with reference to the drawings, which are not necessarily to scale, in which like reference numerals refer to like elements throughout the several views. The detailed description and drawings are intended to illustrate, not limit, the present disclosure. Those skilled in the art will understand that the various elements described and / or illustrated can be arranged in various combinations and configurations without departing from the scope of the present disclosure. The detailed description and drawings illustrate example embodiments of the present disclosure.

[0028] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification. All numerical values ​​herein are assumed to be modified by the term "about," whether explicitly stated or not. The term "about" in the context of numerical values ​​generally refers to a range of numbers that one of ordinary skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many cases, the term "about" may include numbers that are rounded to the nearest significant figure. Other uses of the term "about" (e.g., in contexts other than numerical values) can be assumed to have their ordinary and customary definition as understood from and consistent with the context of this specification, unless otherwise specified.

[0029] The recitation of numerical ranges by endpoints includes all numbers within that range, inclusive of the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). Although certain preferred dimensions, ranges and / or values ​​for various components, features and / or specifications are disclosed, one skilled in the art, inspired by this disclosure, will understand that the desired dimensions, ranges and / or values ​​may deviate from those expressly disclosed.

[0030] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and / or" unless the content clearly dictates otherwise. For ease of understanding, it should be noted that some features of the present disclosure may be described in the singular even though they may be plural or repeat within the disclosed embodiments. Each instance of a feature may include and / or be encompassed by the singular disclosure unless expressly stated otherwise. For example, a reference to a feature may also refer to all instances and quantities of more than one of that feature unless expressly stated otherwise. Thus, it will be understood that the following description may equally apply to any and / or all components of which more than one is present in a device, unless expressly stated otherwise.

[0031] Relative terms such as "proximal," "distal," "advancing," "retracting," and variations thereof may generally be considered with respect to the positioning, orientation, and / or movement of various elements relative to a user / operator / pilot of a device, with "proximal" and "retracting" indicating or referring to being closer to or toward the user and "distal" and "advancing" indicating or referring to being farther from or away from the user. In some cases, the terms "proximal" and "distal" may be assigned arbitrarily to facilitate understanding of the present disclosure, and such instances will be readily apparent to those skilled in the art. Other relative terms, such as "upstream," "downstream," "inflow," and "outflow," refer to the direction of fluid flow within a body lumen, a lumen such as a blood vessel, or within a device. Still other relative terms, such as "axial," "circumferential," "longitudinal," "lateral," "radial," and / or variations thereof, generally refer to directions and / or orientations relative to a central longitudinal axis of the disclosed structures or devices.

[0032] The term "range" can be preceded by "minimum," which can be understood to mean the minimum measurement of the stated or specified dimension, or can be understood to mean the maximum measurement of the stated or specified dimension, unless the range or dimension is specified as a "minimum." For example, an "outer range" can be understood to mean an outer dimension, a "radial range" can be understood to mean a radial dimension, a "longitudinal range" can be understood to mean a longitudinal dimension, etc. A "range" may vary from case to case (e.g., axial, longitudinal, lateral, radial, circumferential, etc.) and will be apparent to one of ordinary skill in the art from the context of a particular use. Generally, a "range" can be considered the maximum possible dimension measured according to the intended use, while a "minimum range" can be considered the smallest possible dimension measured according to the intended use. Generally, a "range" can be considered the maximum possible dimension measured according to the intended use, and a "minimum range" can be considered the smallest possible dimension measured according to the intended use. In some cases, a "range" may generally be measured diagonally within a plane and / or cross-section, but may also be measured differently (including, but not limited to, diagonally, radially, circumferentially (e.g., along an arc), etc.) as is apparent from the particular context.

[0033] The terms "monolithic" and "integral" shall generally refer to an element or elements made from or consisting of a single structure or basic unit / element. Monolithic and / or integral elements shall exclude structures and / or features made by assembling or otherwise joining together multiple separate structures or elements.

[0034] It should be noted that references in the specification to "one embodiment," "some embodiments," "other embodiments," etc., indicate that the described embodiment may include a particular feature, structure, or characteristic, but not all embodiments necessarily include that particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure, or measurement is described in connection with one embodiment, it is within the knowledge of one skilled in the art to implement that particular feature, structure, or characteristic in connection with other embodiments, whether or not explicitly stated otherwise, unless expressly stated otherwise. That is, various individual elements described below, even if not explicitly shown in specific combinations, are contemplated as being combinable or configurable with one another to form other or additional embodiments or to complement and / or expand the described embodiments, as will be understood by those skilled in the art.

[0035] For purposes of clarity, certain distinguishing numerical nomenclature (e.g., first, second, third, fourth, etc.) may be used throughout the specification and claims to name and / or identify various described and / or claimed features. It should be understood that this numerical nomenclature is not intended to be limiting and is merely exemplary. In some embodiments, for brevity and clarity, variations may be made and deviate from previously used numerical nomenclature. That is, a feature identified as a "first" element may later be referred to as a "second," "third," etc., or may be omitted entirely, and / or a different feature may be referred to as the "first" element. The meaning and / or designation in each instance will be apparent to those of ordinary skill in the art.

[0036] Additionally, it should be noted that in any figure, some features may not be shown or may be shown schematically for clarity and / or brevity. Additional details regarding some components and / or method steps may be shown in more detail in other figures. The apparatus and / or methods disclosed herein may provide several desirable features and advantages, as described in more detail below.

[0037] FIG. 1 is a perspective view of an exemplary thrombectomy system 10. The thrombectomy system 10 may include a drive unit 12 and a pump / catheter assembly 14. In some embodiments, the drive unit 12 may include or be referred to as a control console. In some cases, the pump / catheter assembly 14 may be a disposable, single-use device, such that a new pump / catheter assembly 14 may be used by the drive unit 12 for each medical procedure. The drive unit 12 is illustrated with a plurality of removable panels 16a-16n along the periphery and perimeter of the drive unit 12 that enclose the internal structure of the drive unit 12. An exemplary drive unit 12 is described in commonly assigned U.S. Pat. No. 7,935,077, entitled "THROMBECTOMY CATHETER DEPLOYMENT SYSTEM," the disclosure of which is incorporated herein by reference. Centrally located on drive unit 12 and aligned with the lower region of panel 16g may be doors 18 and 20, which open to expose the interior of drive unit 12 and provide access to carriage assembly 22. As described further herein, carriage assembly 22, which may house components of pump / catheter assembly 14, is accessible by opening doors 18 and 20. In some embodiments, doors 18 and 20 may be configured to open automatically. In some embodiments, doors 18 and 20 may be configured to open in response to movement or actuation of carriage assembly 22. In some embodiments, drive unit 12 may include a drain pan for collecting fluid leakage from components of pump / catheter assembly 14. In one non-limiting example, a removable drip tray 24 may be positioned on the front of drive unit 12 so as to extend from below carriage assembly 22 toward panel 16a. Other drain pan configurations are also contemplated. The removable drip tray 24 and the removable container 26 may collectively support and house a fluid collection bag, such as the fluid collection bag 28 of the pump / catheter assembly 14 .In some embodiments, the drive unit 12 may include different structures, such as a hook for hanging the fluid collection bag 28 or a shelf for placing the fluid collection bag 28. In examples in which the carriage assembly 22 is movable, a carriage assembly activation switch 30 may be provided with the drive unit 12, such as on panel 16g, to selectively position the carriage assembly 22 in an inward or outward orientation. Bag hooks 34 and 36 may extend through and / or from panels 16e and 16f to hang saline bags and / or other fluid supply bags. The drive unit 12 may include a handle 42, multiple wheels 52a-52n to assist the medical professional in maneuvering the drive unit 12, and a brake pedal 54 for locking the wheels.

[0038] 1, pump / catheter assembly 14 is shown detached from drive unit 12. Pump / catheter assembly 14 includes an inflow pump 56 and a clot removal device 58. In some embodiments, inflow pump 56 can be configured to provide fluid inflow via clot removal device 58. During use, a portion of pump / catheter assembly 14 can be secured within a portion of drive unit 12. In some embodiments, the pump / catheter assembly 14 may include a bubble trap 60 attached to the inflow pump 56, a connection manifold assembly 62 connected to the bubble trap 60, a fixture 140, a drainage return tube 66 connected between the connection manifold assembly 62 and the clot removal device 58, a high-pressure fluid supply tube 64 positioned coaxially inside the drainage return tube 66 and attached between the output of the inflow pump 56 and the clot removal device 58, a transition fixture 69 between the distal end of the drainage return tube 66 and the proximal end of the clot removal device 58, a drainage waste tube 68 connecting the drainage collection bag 28 to the connection manifold assembly 62, and a fluid supply tube 70 (with a bag spike 71) connecting a fluid supply bag 72 (e.g., a saline bag) to the connection manifold assembly 62. A fluid supply tube 70 may be in fluid communication with the interior of the bubble trap 60 for supplying fluid from a fluid supply bag 72 to the inflow pump 56 and then through the high-pressure fluid supply tube 64 to the thrombus removal device 58 .

[0039] The drive unit 12 may include a reciprocating linear actuator 84 configured to engage a pump piston head 116 (e.g., FIG. 2 ) of the inflow pump 56 when the inflow pump 56 is engaged with the carriage assembly 22. The reciprocating linear actuator 84 may be disposed within the drive unit 12 and may be aligned with the pump piston head 116 (e.g., FIG. 2 ) when the inflow pump 56 is disposed within the drive unit 12. The reciprocating linear actuator 84 may be actuated to drive the inflow pump 56 through reciprocating (e.g., up and down) movement of the reciprocating linear actuator 84 in response to actuation of a user-actuated switch 40. In some embodiments, the user-actuated switch 40 may be a foot switch. In some embodiments, when the user-actuated switch 40 is depressed, the reciprocating linear actuator 84 and / or the inflow pump 56 are activated and / or driven, and when the user-actuated switch 40 is released, the reciprocating linear actuator 84 and / or the inflow pump 56 are stopped and / or cease operation.

[0040] Drive unit 12 may include a display 31 that includes a user interface 32. In some embodiments, user interface 32 may include memory and / or data storage capabilities. In some embodiments, display 31 and / or user interface 32 may be provided in an upper region of drive unit 12 between upper regions of upper panels 16e and 16f. In some embodiments, display 31 and / or user interface 32 may include a touchscreen user interface. Other configurations are contemplated. Further details related to display 31 and / or user interface 32 are provided below.

[0041] The drive unit 12 may include a controller 33 in electronic communication with the display 31, the user interface 32, the reciprocating linear actuator 84, the inflow pump 56, and / or the clot removal device 58. In some embodiments, the drive unit 12 and / or the controller 33 may include a data acquisition device 35. In some embodiments, the data acquisition device 35 may be located internal to the drive unit 12. In some embodiments, the data acquisition device 35 may be configured for wireless communication. Other configurations are also contemplated. In some embodiments, the user-actuated switch 40 may be in electronic communication with the drive unit 12 and / or the controller 33. In some embodiments, the user-actuated switch 40 may be in electronic communication with the drive unit 12 and / or the controller 33 via a wire or cable. In some embodiments, the user-actuated switch 40 may be in wireless electronic communication with the drive unit 12 and / or the controller 33.

[0042] 2 is a partially exploded perspective view of several components of the pump / catheter assembly 14 (e.g., FIG. 1), generally including the inflow pump 56, the bubble trap 60, the connection manifold assembly 62, and the fixture 140. The inflow pump 56 is centrally disposed about a tubular body 112. The components include a base 109 disposed near a lower region of the tubular body 112 and having an upper portion 110 and a lower portion 111, both of which are disposed near the lower region of the tubular body 112. An annular surface 117 is included at the top of the upper portion 110 of the base 109, which makes intimate contact with a capture tab on the carriage assembly 22 (e.g., FIG. 1) to retain and / or engage the inflow pump 56 within the carriage assembly 22. An upper body 114 is disposed near an upper region of the tubular body 112. The base 109 and upper body 114, as well as the connecting panel 115, may be, for example, molded or otherwise suitably constructed to enclose most of the tubular body 112.

[0043] In some embodiments, a data plate 113 may also be included on the pump / catheter assembly 14, such as on the upper body 114, and the data plate 113 may include a bar code, RFID tag, data storage chip, information display, etc., and may be used to store, communicate, and / or otherwise determine specification information and / or operating parameters associated with the pump / catheter assembly 14, the clot removal device 58, the inflow pump 56, etc., and / or components thereof. In at least some embodiments, the data acquisition device 35 (e.g., FIG. 1 ) may be configured to communicate with the data plate 113 (e.g., bar code, RFID tag, data storage chip, etc.), the pump / catheter assembly 14, the clot removal device 58, the inflow pump 56, etc., to acquire specification information and / or operating parameters associated with the pump / catheter assembly 14, the clot removal device 58, the inflow pump 56, etc., and / or components thereof. In some embodiments, data acquisition device 35 (e.g., FIG. 1 ) can be configured to communicate with data plate 113 (e.g., barcode, RFID tag, data storage chip, etc.), pump / catheter assembly 14, clot removal device 58, inflow pump 56, etc. to obtain identification information associated with and related to specification information and / or operating parameters stored in memory of user interface 32 and / or controller 33. The identification information can be used by user interface 32 and / or controller 33 to access specification information and / or operating parameters stored in memory associated with the pump / catheter assembly 14, clot removal device 58, inflow pump 56, etc. in use.

[0044] In some embodiments, the inflow pump 56 may include a hemispherical-shaped pump piston head 116 with a flexible boot 118 connected to the pump piston head 116 and extending between the upper body 114 and the pump piston head 116. In some examples, the lower portion 111 of the base 109 may serve as a mounting for a first end of the bubble trap 60.

[0045] Connection manifold assembly 62 may be secured directly to the second end of bubble trap 60 and, in some cases, may include a bracket 120. Attached to bracket 120 is a vertically oriented tubular manifold 148 having a plurality of ports formed therethrough or attached thereto, including a fluid (e.g., saline) inlet port 122, a drain outlet port 124, a Luer-type drain return port 126, and / or an auxiliary port 128 and a cap 130. Also shown are connectors 132 and 134 that connect and extend between connection manifold assembly 62 and upper portion 110 of base 109.

[0046] The bubble trap 60 can include two mating halves, of which the first bubble trap half 60a is shown. A hydrophobic filter 136 can be provided in an upper, forward region of the first bubble trap half 60a. In some embodiments, a second hydrophobic filter can be provided on the second bubble trap half (not explicitly shown) opposite the hydrophobic filter 136 on the first bubble trap half 60a.

[0047] The fixture 140 and its associated components aid in supporting and connecting the drain return tube 66 to the drain return port 126 via a connector 142 that is continuously integrated with the connecting tube 144, and aid in supporting, passing, and connecting the fluid supply tube 70 to the fluid inlet port 122. The fixture 140 may include outwardly extending, vertically aligned, opposed tabs 141 a and 141 b. The tabs 141 a and 141 b prevent the fixture 140 and the associated drain return tube 66 (including the high-pressure fluid supply tube 64 and the fluid supply tube 70) from contacting a roller pump (not shown) provided with the drive unit 12, such as a roller pump located in or near the carriage assembly 22 (e.g., FIG. 1).

[0048] In some embodiments, the waste tubing 68 may be disposed within and / or through the roller pump, with the waste tubing 68 being connected to the waste collection bag 28 (e.g., FIG. 1). The waste collection bag 28 may be appropriately positioned to collect waste fluid during the procedure. Pump rollers of the roller pump may engage the waste tubing 68 to control the flow of waste fluid through the waste tubing 68 from the waste outlet port 124 to the waste collection bag 28. In some embodiments, other pump types and / or other configurations may be used in place of a roller pump.

[0049] At an appropriate time, the thrombus removal device 58 may be primed to remove air from the thrombus removal device 58. For example, the tip of the thrombus removal device 58 may be placed in a bowl filled with sterile saline or other fluid, and the inflow pump 56 may be driven by operation of the reciprocating linear actuator 84 (e.g., by actuating and / or depressing the user-actuated switch 40) to prime the thrombus removal device 58. A medical professional may then insert the thrombus removal device 58 into the patient's vasculature and initiate operation of the thrombus removal system 10, including the user interface 32 and user-actuated switch 40, as needed. The reciprocating linear actuator 84 is actuated according to operating parameters affecting fluid inflow pressure, pump speed, flow rate, etc., to operate the inflow pump 56 to deliver pressurized fluid to the thrombus removal device 58 via the high-pressure fluid supply tube 64 located within the drainage return tube 66. The supply fluid is pumped through a bubble trap 60, may be pressurized by an inflow pump 56, and supplied through a high-pressure fluid supply tube 64 to the thrombectomy device 58 for use in the thrombectomy procedure or other related procedures. The effluent is returned to the connection manifold assembly 62 through a drain return tube 66 and may be collected in the effluent collection bag 28 (e.g., FIG. 1) through a drain waste tube 68, which may be controlled by a roller pump.

[0050] 3-4, selected aspects of the display 31 and / or user interface 32 are shown. Note that the display 31 may be incorporated as part of the user interface 32 and / or the user interface 32 may be incorporated as part of the display 31. In other examples, the display 31 may be separate from the user interface 32. In some embodiments, the user interface 32 / display 31 may include a first mode indicator 200 configured to indicate that a first mode of fluid inflow is active. In some embodiments, the first mode of fluid inflow may be a "thrombus removal" mode associated with normal use of the thrombus removal device (e.g., to break up an occlusion or clot). For example, in the first mode (e.g., the "thrombus removal" mode), pressurized fluid may be advanced distally through the high-pressure fluid supply tube 64 toward the distal end of the thrombus removal device 56 by activating the inflow pump 56. The pressurized fluid may be used to break up an occlusion or clot. In some embodiments, when a first mode of fluid infusion (e.g., “thrombus removal” mode) is activated, first mode indicator 200 may be color-coded, highlighted, illuminated, flashing, or otherwise distinguished from other features on display 31 and / or user interface 32 to indicate that the first mode is activated, as shown, for example, in FIG. 3 . For illustrative purposes only, the color (or other distinguishing feature) of first mode indicator 200 and / or the color associated with the first mode of fluid infusion is illustrated using a first crosshatch sloping downward from left to right. In some embodiments, the use of color as a distinguishing feature is preferred. In some embodiments, first mode indicator 200 may be user-selectable to activate the first mode of fluid infusion. In some embodiments, first mode indicator 200 may be selectable via direct touch on a touchscreen of user interface 32 / display 31. In some embodiments, first mode indicator 200 may be selectable via a button on user interface 32.In some embodiments, the first mode indicator 200 may be selectable via the user-actuated switch 40. Other configurations are contemplated. In Figure 3, the first crosshatch is shown in solid lines to indicate that the first mode is active.

[0051] The "Thrombectomy" mode may include fluid drainage (e.g., aspiration) from the treatment site to remove a portion of the blockage or clot as it breaks up and / or prevent excessive fluid injection into the patient. In some embodiments, the first mode indicator 200 may include a first mode time display 202 that indicates the amount of time elapsed since the first mode was activated, and / or a first mode fluid volume display 204 that indicates the amount of fluid injected through the thrombus removal system 10 and / or thrombus removal device 58 in the first mode. While the values ​​shown for the first mode time display 202 and the first mode fluid volume display 204 in FIGS. 3-4 are the same (e.g., 50 seconds have elapsed and 50 cc (milliliters) of fluid have been injected) and indicate an injection rate of 1 milliliter per second, these values ​​are exemplary only, and different injection rates may be used depending on the particular device used, the fluid being injected, and / or the patient parameters selected. For example, in some embodiments, the injection rate can be within the range of about 0.35 milliliters / second to about 1.5 milliliters / second.

[0052] In some embodiments, the user interface 32 may include a second mode indicator 210 configured to indicate that a second mode of fluid inflow is active. In some embodiments, the second mode of fluid inflow may be a “Power Pulse™” mode associated with a particular application of the clot removal device. In some embodiments, the “Power Pulse™” mode may be used when the occlusion or clot is calcified, more organized, and / or resistant to conventional clot removal procedures. In some embodiments, when the second mode of fluid inflow (e.g., the “Power Pulse™” mode) is active, the second mode indicator 210 may be color-coded, highlighted, lit, flashing, or otherwise distinguished from other features on the display 31 and / or user interface 32 to indicate that the second mode is active, as shown, for example, in FIG. 4 . For illustrative purposes only, the color (or other distinguishing feature) of second mode indicator 210 and / or the color associated with the second mode of fluid inflow is illustrated using a second crosshatch that slopes upward from left to right. In some embodiments, using color as the distinguishing feature is preferred. In some embodiments, second mode indicator 210 may be user-selectable to activate the second mode of fluid inflow. In some embodiments, second mode indicator 210 may be selectable via direct touch on a touchscreen of user interface 32 / display 31. In some embodiments, second mode indicator 210 may be selectable via a button on user interface 32. In some embodiments, second mode indicator 210 may be selectable via user-actuated switch 40. Other configurations are also contemplated. In FIG. 4, the second crosshatch is shown as a solid line to indicate that the second mode is activated, and the first crosshatch is shown as a dashed line to indicate that the first mode is deactivated.

[0053] In some embodiments, the "Power Pulse™" mode can include the introduction of a thrombolytic drug to the treatment site while limiting or preventing fluid outflow from the treatment site. In some embodiments, the "Power Pulse™" mode can be used to force or "push" the thrombolytic drug into the occlusion or clot to assist in breaking up the occlusion or clot. For example, in the second mode (e.g., the "Power Pulse™" mode), pressurized fluid containing the thrombolytic drug can be advanced distally through the high-pressure fluid supply tube 64 toward the distal end of the thrombus removal device 56 by activating the inflow pump 56. The pressurized fluid containing the thrombolytic drug can contact and / or penetrate into the occlusion or clot. In some procedures, the thrombolytic drug can "dwell" at the treatment site and penetrate into the occlusion or clot, softening and / or further breaking up the occlusion or clot, after which it can be removed (along with a portion of the occlusion or clot) by fluid outflow (e.g., aspiration). For example, after operating the thrombus removal system 10 in the second mode (e.g., "Power Pulse™" mode) (operating the inflow pump 56 without operating the roller pump of the waste fluid tubing 68) for a period of time, the inflow pump 56 may be stopped to allow the thrombolytic drug to "dwell" at the treatment site for a dwell time (e.g., 1 minute or more, 2 minutes or more, 3 minutes or more, 4 minutes or more, 5 minutes or more, etc.), and then the thrombus removal system 10 may be operated in the first mode (e.g., thrombus removal mode) (operating the inflow pump 56 and the roller pump of the waste fluid tubing 68) for an additional period of time to break up the blockage or clot and extract it through the waste fluid tubing 68 into the waste fluid collection bag 28. In some embodiments, the second mode indicator 210 may include a second mode time display 212 that indicates the elapsed time since the second mode was activated, and / or a second mode fluid volume display 214 that indicates the volume of fluid injected through the thrombus removal system 10 and / or thrombus removal device 58 in the second mode.3-4 are the same (e.g., 50 seconds have elapsed, 50 cc (milliliters) of fluid have been injected) and indicate an injection rate of 1 milliliter per second, but these values ​​are exemplary only and different injection rates may be used depending on the particular device being used, the fluid being injected, and / or the patient parameters selected. For example, in some embodiments, the injection rate may be in the range of about 0.35 milliliters / second to about 1.5 milliliters / second.

[0054] In some embodiments, in the second mode, the thrombus removal system 10 can be configured to inject, under operator control (e.g., "on demand"), approximately 0.62 milliliters of fluid per pulse in a single pulse at a time. In some embodiments, in the second mode, the thrombus removal system 10 can be configured to inject, under operator control (e.g., "on demand"), approximately 0.50 milliliters per pulse to approximately 0.75 milliliters per pulse in a single pulse at a time. Other configurations and / or ranges are also contemplated.

[0055] In some embodiments, the user interface 32 / display 31 may include a runtime display 220 that includes an alphanumeric run time value 222 displayed at a first setting. In some embodiments, the alphanumeric run time value 222 may be displayed at the first setting at the start of fluid inflow and / or the start of treatment (e.g., when the alphanumeric run time value 222 equals zero or begins counting up from zero). In some embodiments, the first setting may include a first color. In some embodiments, the first color may be white. In some embodiments, the first setting may include a first size, a first brightness, and / or a first font style. Other configurations are contemplated. The alphanumeric run time value 222 may be the sum (e.g., accumulation) of a first runtime value for a first mode of fluid inflow and a second runtime value for a second mode of fluid inflow. The first runtime value may be and / or correspond to a first elapsed runtime of the thrombus removal system 10 and / or the inflow pump 56 when activated (and / or operating or having been activated) in a first mode. The second runtime value may be and / or correspond to a second elapsed runtime of the thrombus removal system 10 and / or the inflow pump 56 when activated (and / or operating or having been activated) in a second mode. Thus, the alphanumeric runtime value 222 may be and / or correspond to a total elapsed runtime of the thrombus removal system 10 and / or the inflow pump 56 when activated. In at least some embodiments, the alphanumeric runtime value 222 may be displayed in seconds. Other units (e.g., minutes, minutes and seconds, etc.) are also contemplated. Additionally, in some embodiments, the alphanumeric runtime value 222 may be and / or correspond to a total elapsed runtime of the thrombus removal system 10 across multiple thrombus removal devices when multiple thrombus removal devices are used on the same patient and / or within the same procedure.In some embodiments, the alphanumeric runtime value 222 may be the sum of the total elapsed runtimes for all clot removal devices used on the same patient and / or within the same procedure if multiple clot removal devices are used. For example, if three different clot removal devices are used, the alphanumeric runtime value 222 may be the sum of the total elapsed runtimes for each of the three different clot removal devices (e.g., total sum = total elapsed runtime for device 1 + total elapsed runtime for device 2 + total elapsed runtime for device 3).

[0056] In some embodiments, the runtime display 220 may include and / or indicate a first recommended runtime threshold 224 corresponding to a first working condition 225 (e.g., a recommended runtime threshold for treating a partially occluded vessel) and a second recommended runtime threshold 226 corresponding to a second working condition 227 (e.g., a recommended runtime threshold for treating a completely occluded vessel). As described in more detail with respect to FIG. 7 , the first recommended runtime threshold 224 and the second recommended runtime threshold 226 may be device specific. The second recommended runtime threshold 226 is greater than the first recommended runtime threshold 224. In at least some embodiments, specification information and / or operating parameters associated with the pump / catheter assembly 14, the thrombus removal device 58, the inflow pump 56, etc., and / or components thereof may include the first recommended runtime threshold 224 and the second recommended runtime threshold 226.

[0057] In some embodiments, user interface 32, touchscreen user interface, and / or runtime display 220 may include a graphical display 228 (e.g., a bar graph, etc.) adjacent to alphanumeric runtime value 222, where graphical display 228 illustrates alphanumeric runtime value 222 relative to first recommended runtime threshold 224 and second recommended runtime threshold 226. As shown in FIGS. 3-4 , graphical display 228 illustrates alphanumeric runtime value 222 as the sum (e.g., total elapsed runtime) of a first runtime value (e.g., first elapsed runtime), illustratively illustrated using a first crosshatch, and a second runtime value (e.g., second elapsed runtime), illustratively illustrated using a second crosshatch. As described above, the first crosshatch may be and / or represent a color associated with the first mode indicator 200 and / or a first mode of fluid inflow, and the second crosshatch may be and / or represent a color associated with the second mode indicator 210 and / or a second mode of fluid inflow that is different from the color of the first mode indicator 200 and / or the color associated with the first mode of fluid inflow.

[0058] 5 illustrates selected aspects of display 31 and / or user interface 32 after alphanumeric runtime value 222 (e.g., total elapsed runtime) reaches and / or exceeds first recommended runtime threshold 224. In some embodiments, user interface 32 and / or controller 33 may be configured to provide a notification when alphanumeric runtime value 222 (e.g., total elapsed runtime) reaches and / or exceeds first recommended runtime threshold 224. In some embodiments, alphanumeric runtime value 222 may be configured to change from a first setting (e.g., FIGS. 3-4) to a second setting (e.g., FIG. 5) different from the first setting when the sum (e.g., total elapsed runtime) of a first runtime value (e.g., first elapsed runtime) and a second runtime value (e.g., second elapsed runtime) reaches and / or exceeds first recommended runtime threshold 224. In some embodiments, the alphanumeric runtime value 222 may be configured to change from a first color (e.g., FIGS. 3-4) to a second color (e.g., FIG. 5) different from the first color when the sum (e.g., total elapsed runtime) of a first runtime value (e.g., first elapsed runtime) and a second runtime value (e.g., second elapsed runtime) reaches and / or exceeds a first recommended runtime threshold 224. In some embodiments, the second color may be yellow. Other colors and / or visual cues are contemplated.

[0059] In some embodiments, the first recommended runtime threshold 224 may be configured to change to a second color (e.g., FIG. 5 ) when the alphanumeric runtime value 222 (e.g., the sum (e.g., total elapsed runtime) of the first runtime value (e.g., first elapsed runtime) and the second runtime value (e.g., second elapsed runtime)) reaches and / or exceeds the first recommended runtime threshold 224.

[0060] In some embodiments, the user interface 32 and / or the controller 33 may be configured to emit a first audible notification (e.g., a first "chime") when the alphanumeric runtime value 222 (e.g., the total elapsed runtime) reaches and / or exceeds a first recommended runtime threshold 224. In some embodiments, the volume of the first audible notification may be user-selectable and / or user-defined prior to starting the procedure. In some embodiments, the tone, melody, or sound sequence of the first audible notification may be user-selectable and / or user-defined prior to starting the procedure.

[0061] After the alphanumeric runtime value 222 (e.g., the total elapsed runtime) reaches and / or exceeds the first recommended runtime threshold 224, the thrombus removal system 10, the reciprocating linear actuator 84, and / or the inflow pump 56 may continue to operate as long as the user-activated switch 40 is activated. Thus, even if the alphanumeric runtime value 222 (e.g., the total elapsed runtime) reaches or exceeds the first recommended runtime threshold 224, the thrombus removal system 10, the reciprocating linear actuator 84, and / or the inflow pump 56 do not shut off or stop providing fluid inflow and / or fluid outflow as long as the user-activated switch 40 is activated. The first audible notification and / or second color may serve as a first notification and / or reminder for the user to be aware of and / or note the amount of fluid infused into the patient. Because each procedure and / or patient is different, different amounts of fluid may be infused based on various conditions and / or parameters. For example, some factors and / or conditions that may be considered when determining whether and / or for how long to use the thrombectomy system 10 may include the patient's renal condition, the amount of contrast agent used, the patient's size, the patient's hydration status, and / or the technique being used in conjunction with the thrombectomy system 10. This list is not intended to be exhaustive, and other factors and / or conditions may also be relevant to a particular procedure.

[0062] 6 illustrates selected aspects of display 31 and / or user interface 32 after alphanumeric runtime value 222 (e.g., total elapsed runtime) reaches and / or exceeds second recommended runtime threshold 226. In some embodiments, user interface 32 and / or controller 33 may be configured to provide a second notification when alphanumeric runtime value 222 (e.g., total elapsed runtime) reaches and / or exceeds second recommended runtime threshold 226. In some embodiments, alphanumeric runtime value 222 may be configured to change to a third setting (e.g., FIG. 6 ) different from the first and second settings when the sum (e.g., total elapsed runtime) of the first runtime value (e.g., first elapsed runtime) and the second runtime value (e.g., second elapsed runtime) reaches and / or exceeds second recommended runtime threshold 226. In some embodiments, the alphanumeric runtime value 222 may be configured to change to a third color (e.g., FIG. 6 ), different from the first and second colors, when the sum (e.g., total elapsed runtime) of the first runtime value (e.g., first elapsed runtime) and the second runtime value (e.g., second elapsed runtime) reaches and / or exceeds a second recommended runtime threshold 226. In some embodiments, the third color may be orange. Other colors and / or visual cues are also contemplated.

[0063] In some embodiments, the second recommended runtime threshold 226 may be configured to change to a third color (e.g., FIG. 6 ) when the alphanumeric runtime value 222 (e.g., the sum (e.g., total elapsed runtime) of the first runtime value (e.g., first elapsed runtime) and the second runtime value (e.g., second elapsed runtime)) reaches and / or exceeds the second recommended runtime threshold 226.

[0064] In some embodiments, the user interface 32 and / or the controller 33 may be configured to emit a second audible notification (e.g., a second “chime”) when the alphanumeric runtime value 222 (e.g., the total elapsed runtime) reaches and / or exceeds a second recommended runtime threshold 226. In some embodiments, the volume of the second audible notification may be user-selectable and / or user-defined before starting treatment. In some embodiments, the tone, melody, or sound sequence of the second audible notification may be user-selectable and / or user-defined before starting treatment. In some embodiments, the second audible notification (e.g., a second “chime”) may be emitted two times in succession within a short time of the first audible notification (e.g., a first “chime”).

[0065] In some embodiments, after the alphanumeric runtime value 222 (e.g., total elapsed runtime) reaches and / or exceeds the second recommended runtime threshold 226, the graphical display 228 may be configured to change to a third color (e.g., FIG. 6). For illustrative purposes only, the third color (or other distinguishing element) of the graphical display 228 in FIG. 6 is illustrated using a third crosshatch that is denser than the second crosshatch and slopes upward from left to right. In some embodiments, using color as the distinguishing element is preferred.

[0066] It should be noted that in some embodiments, the color of the alphanumeric runtime value 222 may not change when the sum (e.g., total elapsed runtime) of the first runtime value (e.g., first elapsed runtime) and the second runtime value (e.g., second elapsed runtime) reaches and / or exceeds the first recommended runtime threshold 224. Alternatively, for example, only a first audible notification may be emitted and / or a banner or notification may be temporarily displayed on the display 31 and / or user interface 32.

[0067] In some examples, the color of the alphanumeric runtime value 222 may only change when the alphanumeric runtime value 222 (e.g., total elapsed runtime) reaches and / or exceeds a second recommended runtime threshold 226, at which point the graphical display 228 may be configured to change to a second color.

[0068] In such cases, the user interface 32 and / or the controller 33 may be configured to emit a second audible notification (e.g., a second “chime”) when the alphanumeric runtime value 222 (e.g., the total elapsed runtime) reaches and / or exceeds the second recommended runtime threshold 226. In some embodiments, the volume of the second audible notification may be user-selectable and / or user-defined before starting the procedure. In some embodiments, the tone, melody, or sound sequence of the second audible notification may be user-selectable and / or user-defined before starting the procedure. In some embodiments, the second audible notification (e.g., a second “chime”) may be emitted two times in succession within a short time of the first audible notification (e.g., a first “chime”).

[0069] After the alphanumeric runtime value 222 (e.g., the total elapsed runtime) reaches and / or exceeds the second recommended runtime threshold 226, the thrombus removal system 10, the reciprocating linear actuator 84, and / or the inflow pump 56 may continue to operate as long as the user-activated switch 40 is activated. Thus, even if the alphanumeric runtime value 222 (e.g., the total elapsed runtime) reaches or exceeds the second recommended runtime threshold 226, the thrombus removal system 10, the reciprocating linear actuator 84, and / or the inflow pump 56 do not shut off or stop providing fluid inflow and / or fluid outflow as long as the user-activated switch 40 is activated. The second audible notification and / or third color may serve as a second notification and / or reminder to make the user more aware and / or careful about the amount of fluid infused into the patient than the first audible notification and / or second color. Because each procedure and / or patient is different, different amounts of fluid may be infused based on various conditions and / or parameters. As mentioned above, some factors and / or conditions that may be considered when determining whether and / or for how long to use the thrombus removal system 10 may include the patient's renal condition, the amount of contrast agent used, the patient's size, the patient's hydration status, and / or the technique being used in conjunction with the thrombus removal system 10. This list is not intended to be exhaustive, and other factors and / or conditions may also be relevant to a particular procedure.

[0070] In some embodiments, after the alphanumeric runtime value 222 (e.g., the total elapsed runtime) reaches and / or exceeds the second recommended runtime threshold 226, the user interface 32 may include and / or activate a flag timer 230 that counts up to indicate how long the thrombus removal system 10, the reciprocating linear actuator 84, and / or the inflow pump 56 have continuously operated above the second recommended runtime threshold 226 while the user-activated switch 40 is activated. For example, if the second recommended runtime threshold 226 is 480 seconds and the alphanumeric runtime value 222 (e.g., the total elapsed runtime) is 485 seconds, the flag timer 230 may read “+5” (indicating that the total runtime is 5 seconds longer than the second recommended runtime threshold 226), as shown in FIG. 6 . Thus, the user interface 32 / display 31 may display the flag timer 230 as the amount of time the thrombus removal system 10 has been operating above the second recommended runtime threshold 226. This information may provide a user with an additional point of reference when considering how much fluid has been infused into the patient relative to the actual condition and / or patient parameters. In at least some embodiments, the flag timer 230 may be displayed in a third color to indicate that the flag timer 230 is related to and / or associated with reaching and / or exceeding the second recommended runtime threshold 226.

[0071] In some embodiments, no change may occur in the user interface 32 and / or display 31 after the first recommended runtime threshold 224 is reached. Accordingly, in some embodiments, the user interface 32 and / or controller 33 may be configured to provide a notification when the alphanumeric runtime value 222 (e.g., the total elapsed runtime) reaches and / or exceeds the second recommended runtime threshold 226. In some embodiments, the alphanumeric runtime value 222 may be configured to change from a first setting (e.g., FIGS. 3-4) to a second setting (e.g., FIGS. 5-6) different from the first setting when the sum (e.g., the total elapsed runtime) of the first runtime value (e.g., the first elapsed runtime) and the second runtime value (e.g., the second elapsed runtime) reaches and / or exceeds the second recommended runtime threshold 226. In some embodiments, the alphanumeric runtime value 222 may be configured to change from a first color (e.g., FIGS. 3-4) to a second color (e.g., FIGS. 5-6) different from the first color when the sum (e.g., total elapsed runtime) of the first runtime value (e.g., first elapsed runtime) and the second runtime value (e.g., second elapsed runtime) reaches and / or exceeds a second recommended runtime threshold 226. In some embodiments, the second color may be yellow. In some embodiments, the second color may be orange. Other colors and / or visual cues are also contemplated.

[0072] In some embodiments, the second recommended runtime threshold 226 may be configured to change to a second color (e.g., FIGS. 5 and 6) when the alphanumeric runtime value 222 (e.g., the sum (e.g., total elapsed runtime) of the first runtime value (e.g., first elapsed runtime) and the second runtime value (e.g., second elapsed runtime)) reaches and / or exceeds the second recommended runtime threshold 226.

[0073] In some embodiments, the user interface 32 and / or the controller 33 may be configured to emit a first audible notification (e.g., a first “chime”) when the alphanumeric runtime value 222 (e.g., the total elapsed runtime) reaches and / or exceeds the second recommended runtime threshold 226. In some embodiments, the volume of the first audible notification may be user-selectable and / or user-defined prior to starting the procedure. In some embodiments, the tone, melody, or sound sequence of the first audible notification may be user-selectable and / or user-defined prior to starting the procedure.

[0074] In some embodiments, the alphanumeric runtime value 222 (e.g., total elapsed runtime) reaching and / or exceeding the second recommended runtime threshold 226 may be the first instance, time, or opportunity that a color change occurs in the user interface 32 and / or display 31 and / or that an audible notification (e.g., a “chime”) is emitted.

[0075] After the alphanumeric runtime value 222 (e.g., the total elapsed runtime) reaches and / or exceeds the second recommended runtime threshold 226, the thrombus removal system 10, the reciprocating linear actuator 84, and / or the inflow pump 56 may continue to operate as long as the user-activated switch 40 is activated. Thus, even if the alphanumeric runtime value 222 (e.g., the total elapsed runtime) reaches or exceeds the second recommended runtime threshold 226, the thrombus removal system 10, the reciprocating linear actuator 84, and / or the inflow pump 56 do not shut off or stop providing fluid inflow and / or fluid outflow as long as the user-activated switch 40 is activated. The first audible notification and / or the second color may serve as a notification and / or reminder for the user to be aware of and / or note the amount of fluid infused into the patient. Because each procedure and / or patient is different, different amounts of fluid may be infused based on various conditions and / or parameters. For example, some factors and / or conditions that may be considered when determining whether and / or for how long to use the thrombectomy system 10 may include the patient's renal condition, the amount of contrast used, the patient's size, the patient's hydration status, and / or the technique used in conjunction with the thrombectomy system 10. This list is not intended to be exhaustive, and other factors and / or conditions may also be relevant to a particular procedure.

[0076] In some embodiments, after the alphanumeric runtime value 222 (e.g., the total elapsed runtime) reaches and / or exceeds a recommended runtime threshold, such as a second recommended runtime threshold 226, the user interface 32 may include and / or activate a flag timer 230 that counts up to indicate how long the thrombus removal system 10, the reciprocating linear actuator 84, and / or the inflow pump 56 have continuously operated beyond a recommended runtime threshold, such as the second recommended runtime threshold 226, while the user-activated switch 40 is activated. For example, if the second recommended runtime threshold 226 is 480 seconds and the alphanumeric runtime value 222 (e.g., the total elapsed runtime) is 485 seconds, the flag timer 230 may read “+5” (indicating that the total runtime is 5 seconds longer than the second recommended runtime threshold 226), as shown in FIG. 6 . Thus, the user interface 32 / display 31 may display the flag timer 230 as the amount of time the thrombus removal system 10 has been operating above a recommended runtime threshold, such as the second recommended runtime threshold 226. This information may provide the user with an additional reference point when considering how much fluid has been infused into the patient relative to actual conditions and / or patient parameters. In at least some embodiments, the flag timer 230 may be displayed in a second color to indicate that it is related to and / or associated with reaching and / or exceeding a recommended runtime threshold, such as the second recommended runtime threshold 226.

[0077] 7 illustrates selected aspects of display 31 and / or user interface 32, as well as lookup table 300. In some embodiments, lookup table 300 may be included within and / or stored in memory of user interface 32 and / or controller 33 (e.g., FIG. 1). Lookup table 300 may include specification information and / or operating parameters associated with pump / catheter assembly 14, clot removal device 58, inflow pump 56, etc. Specification information and / or operating parameters associated with pump / catheter assembly 14, clot removal device 58, inflow pump 56, etc. may be associated with identification information associated with pump / catheter assembly 14, clot removal device 58, inflow pump 56, etc.

[0078] For example, lookup table 300 may include specification information and / or operating parameters for multiple devices shown in Figure 7 as "Example Catheters" 1, 2, X, etc. The specification information and / or operating parameters may include a first recommended runtime threshold 224 associated with a first treatment condition 225 (shown in lookup table 300 as "Completely Occluded Vessel") and a second recommended runtime threshold 226 associated with a second treatment condition 227 (shown in lookup table 300 as "Completely Occluded Vessel").

[0079] In the illustrated example, Example Catheter 1 has a first recommended runtime threshold 224 associated with a first treatment condition 225 (shown in lookup table 300 as "Partially Occluded Vessel") of 240 seconds and a second recommended runtime threshold 226 associated with a second treatment condition 227 (shown in lookup table 300 as "Completely Occluded Vessel") of 480 seconds. In the illustrated example, Example Catheter 2 has a first recommended runtime threshold 224 associated with a first treatment condition 225 (shown in lookup table 300 as "Partially Occluded Vessel") of 300 seconds and a second recommended runtime threshold 226 associated with a second treatment condition 227 (shown in lookup table 300 as "Completely Occluded Vessel") of 600 seconds.

[0080] Thus, an additional example X may be included in the lookup table 300, where the additional example X has a first recommended runtime threshold 224 associated with a first treatment condition 225 (shown in the lookup table 300 as a "partially occluded vessel") of Y seconds and a second recommended runtime threshold 226 associated with a second treatment condition 227 (shown in the lookup table 300 as a "completely occluded vessel") of Z seconds. Generally, the second recommended runtime threshold 226 may be approximately twice the first recommended runtime threshold 224. However, other values ​​and / or ratios are also contemplated. In one non-limiting example, catheter example X1 may have a second recommended runtime threshold 226 that is approximately 1.5 times the first recommended runtime threshold 224. In another non-limiting example, catheter example X2 may have a second recommended runtime threshold 226 that is approximately 2.5 times the first recommended runtime threshold 224.

[0081] In other cases, a first recommended runtime threshold 224 associated with a first treatment condition 225 (e.g., treating a partially occluded vessel) and a second recommended runtime threshold 226 associated with a second treatment condition 227 (e.g., treating a completely occluded vessel) may be read from an RFID tag provided on a particular catheter selected for a given medical procedure and provided to the controller 33 of the drive unit 12.

[0082] The controller 33 and / or user interface 32 may be configured to provide specification information and / or operating parameters (which may include a first recommended runtime threshold 224 associated with a first treatment condition 225 and a second recommended runtime threshold 226 associated with a second treatment condition 227 associated with the pump / catheter assembly 14, the thrombus removal device 58, the inflow pump 56, etc.) to the runtime display 220 based on, for example, identification information acquired by the data acquisition device 35 (e.g., FIG. 1) from the data plate 113.

[0083] Materials that may be used for the various components of the clot removal system and its various elements disclosed herein may include those generally associated with medical devices. For simplicity, the following description will refer to systems. However, this is not intended to limit the devices, components, and methods described herein, as this description may apply to other elements, members, components, or apparatuses disclosed herein, such as, but not limited to, drive unit 12, pump / catheter assembly 14, inflow pump 56, clot removal device 58, etc., and / or elements or components thereof.

[0084] In some embodiments, the stent system and / or its components may be made from metals, metal alloys, polymers, metal-polymer composites, ceramics, combinations thereof, etc., or other suitable materials.

[0085] Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN®), polyether block esters, polyurethanes, polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., DSM Engineering Plastics (ARNITEL®)), ether or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers such as HYTREL®), polyamides (e.g., DURETHAN® or CRISTAMID®), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA), e.g., PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), maleates, and the like. MARLEX high density polyethylene, MARLEX low density polyethylene, linear low density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO ), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (GRILAMID®), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinyl chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, polyurethane silicone copolymers (e.g.,These may include Elast-Eon® or ChronoSil®, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, and polymer / metal composites thereof. In some embodiments, the system and / or its components may be blended with a liquid crystal polymer (LCP). For example, the blend may contain up to about 6 percent LCP.

[0086] Some examples of suitable metals and alloys include stainless steels such as 304V, 304L, 316LV stainless steel; mild steel; nickel-titanium alloys such as linear elastic and / or superelastic nitinol; nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400), nickel, and the like. Other nickel alloys, such as nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as MP35-N®), nickel-molybdenum alloys (e.g., UNS: N10665, such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as ELGILOY®, PHYNOX®); platinum-rich stainless steel; titanium; platinum; palladium; gold; combinations thereof, etc.; or any other suitable material.

[0087] In at least some embodiments, some or all of the system and / or its components may be doped with, fabricated from, or otherwise include a radiopaque material. A radiopaque material is understood to be a material that can produce a relatively bright image on a fluoroscopic screen or another imaging technique (e.g., ultrasound) during a medical procedure. This relatively bright image aids the user of the system in determining its location. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials filled with radiopaque fillers, and the like. Additionally, other radiopaque marker bands and / or coils may also be incorporated into the system design to achieve the same results.

[0088] It should be understood that this disclosure is, in many respects, merely illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps, without exceeding the scope of the disclosure. This may include, to the extent appropriate, using any of the features of one example embodiment in other embodiments. The scope of the disclosure is, of course, defined in the language in which the appended claims are expressed.

Claims

1. 1. A user interface for a thrombectomy fluid management system, comprising: a first mode indicator configured to indicate that a first mode of fluid inflow is active; and a second mode indicator configured to indicate that a second mode of fluid inflow is active; and a runtime display including an alphanumeric runtime value displayed in a first color; The user interface, wherein the alphanumeric runtime value is the sum of a first runtime value for the first mode and a second runtime value for the second mode.

2. The user interface of claim 1 , wherein the runtime display indicates a first recommended runtime threshold corresponding to a first treatment condition and a second recommended runtime threshold corresponding to a second treatment condition.

3. 3. The user interface of claim 2, wherein the alphanumeric runtime value is configured to change from the first color to a second color when a sum reaches at least one of the first recommended runtime threshold and a recommended runtime threshold.

4. 3. The user interface of claim 2, wherein the alphanumeric runtime value is configured to change from the first color to a second color when a sum reaches the first recommended runtime threshold, and the alphanumeric runtime value is configured to change to a third color when a sum reaches the second recommended runtime threshold.

5. The user interface of claim 1 , wherein the first mode indicator is user selectable to activate the first mode of fluid inflow.

6. The user interface of claim 1 , wherein the second mode indicator is user selectable to activate the second mode of fluid inflow.

7. The user interface of claim 1 , wherein the alphanumeric runtime value is expressed in seconds.

8. 1. A thrombus removal fluid management system, comprising: an inflow pump configured to provide fluid inflow through the clot removal device; a controller in communication with the inflow pump and the clot removal device; a user-activated switch configured to activate the inflow pump; a display including the user interface of claim 1; The runtime display unit indicates a first recommended runtime threshold corresponding to a first treatment condition and a second recommended runtime threshold corresponding to a second treatment condition.

9. the alphanumeric runtime value is configured to change from the first color to a second color when the sum reaches at least one of the first and second recommended runtime thresholds; and / or 9. The clot removal fluid management system of claim 8, wherein the controller is configured to issue a first audible notification when the sum reaches at least one of the first and second recommended runtime thresholds.

10. the alphanumeric runtime value is configured to change to a third color when the sum reaches the second recommended runtime threshold; 10. The clot removal fluid management system of claim 8 or 9, wherein the controller is configured to issue a second audible notification when the sum reaches the second recommended runtime threshold.

11. 11. The clot removal fluid management system of claim 8, wherein after the first recommended runtime threshold is reached, the inflow pump continues to operate as long as the user-activated switch is activated.

12. 12. The clot removal fluid management system of claim 8, wherein after the second recommended runtime threshold is reached, the inflow pump continues to operate as long as the user-activated switch is activated.

13. the display includes a touchscreen user interface; the first mode indicator is configured to highlight when the first mode of fluid inflow is active, the first mode indicator being user-selectable on the touchscreen user interface; the second mode indicator is configured to highlight when the second mode of fluid inflow is active, the second mode indicator being user-selectable on the touchscreen user interface; the alphanumeric runtime value is shown in the first color when fluid flow is initiated; 13. The clot removal fluid management system of claim 8, wherein the alphanumeric runtime value is the sum of a first elapsed runtime of the inflow pump when operated in the first mode and a second elapsed runtime of the inflow pump when operated in the second mode.

14. The clot removal fluid management system of claim 8 , wherein the controller includes a data acquisition device configured to communicate with the clot removal device to acquire specification information related to the clot removal device.

15. 15. The clot removal fluid management system of claim 13 or 14, wherein the touchscreen user interface includes a graphical display adjacent to the alphanumeric runtime values, the graphical display showing the alphanumeric runtime values ​​relative to the first recommended runtime threshold and the second recommended runtime threshold.

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