Peripheral aspiration system

Abstract

Peripheral aspiration systems may be provided by system, comprising: a catheter, a vacuum pump assembly having a pump inlet and a pump outlet, wherein the vacuum pump is configured to provide a negative pressure through the catheter, an aspiration module connectively disposed between the catheter and the pump inlet, the aspiration module including a connection to a relief pressure source, wherein the aspiration module is configured to intermittently connect and disconnect the relief pressure source from the catheter, such that the negative pressure through the catheter is interrupted when the catheter is connected to the relief pressure source by the aspiration module.

Description

Atorney Docket No.: 8001535.00144 Client Docket No.: 2023-288-PCTTITLEPERIPHERAL ASPIRATION SYSTEMCROSS-REFERENCES TO RELATED APPLICATIONS

[0001] The present disclosure claims priority to U.S. Provisional Patent Application No.: 63 / 707,449, filed on 2024-10-15, titled “PERIPHERAL ASPIRATION SYSTEM”, which is incorporated herein in its entirety.BACKGROUND

[0002] Aspiration catheters are often employed for performing medical procedures related to peripheral thrombectomy. While aspirating a thrombus, a substantial amount of a patient’s blood may be incidentally aspirated through the catheter. Oftentimes, this aspirated blood is simply discarded, as the aspiration catheter may subject the blood to pressure conditions which render the blood unusable for return to the patient, for example by lysing the red blood cells carried therein. A thrombectomy may result in substantial blood loss to a patient if a transfusion is not provided during or soon after the procedure.SUMMARY

[0003] The present disclosure provides a peripheral aspiration system, including a catheter, a vacuum pump assembly having a pump inlet and a pump outlet, configured to provide a negative pressure through the catheter; an aspiration module connectively disposed between the catheter and the pump inlet, the aspiration module including a connection to a relief pressure source, and wherein the aspiration module is configured to intermitently connect and disconnect the relief pressure source from the catheter, such that the negative pressure through the catheter is interrupted when the catheter is connected to the relief pressure source by the aspiration module.

[0004] Additional features and advantages of the disclosed method and apparatus are described in, and will be apparent from, the following Detailed Description and the Figures. The features and advantages described herein are not all-inclusive and, in particular, many additional features and advantages will be apparent to one of ordinary skill in the art in view of the figures and description. Moreover, it should be noted that the language used in the specification has been principally selected for readability and instructional purposes, and not to limit the scope of the inventive subject mater.1508440223 1Atorney Docket No.: 8001535.00144 Client Docket No.: 2023-288-PCTBRIEF DESCRIPTION OF THE DRAWINGS

[0005] Figures 1A-1D illustrates examples of a peripheral aspiration system, according to embodiments of the present disclosure.

[0006] Figure 2 illustrates an example method of peripheral aspiration, according to embodiments of the present disclosure.

[0007] Figure 3 illustrates a computing device, according to embodiments of the present disclosure.DETAILED DESCRIPTION

[0008] When performing a thrombectomy using an aspiration catheter, various fluids, such as blood, may be collaterally aspirated from a patient over the course of the procedure. Oftentimes, the aspirated blood is simply discarded, as the aspiration process subjects the blood to vacuum conditions which, in some cases, causes water in the blood to vaporize and for the cells to lyse. When too much water evaporates from the blood due to the vacuum pressure, blood cells can be harmed, rendering the blood unfit for return to a patient, thus leading operators to discard the aspirated blood. In some cases, blood loss to a patient can be substantial during a thrombectomy, and a physician may be compelled to provide a blood transfusion to the patient during or after the procedure to reduce net blood loss to the patient.

[0009] The technology of the present disclosure is related to a peripheral aspiration system in which collaterally aspirated blood is safely returnable to a patient during or after a thrombectomy. In a first aspect, the peripheral aspiration system is configured such that aspirated blood is subjected to pressure conditions that result in levels of vaporization of water from the blood that are below a predetermined threshold or prevented entirely. In another aspect, the peripheral aspiration system uses a pump which interacts with blood cells in such a way as to ensure rates of cell damage to blood cells are below a predetermined threshold. In yet another aspect, the peripheral aspiration system filters the blood to remove impurities, or pieces of thrombi collaterally aspirated with the blood. In another aspect, the peripheral aspiration system is modular, single use, and disposable.

[0010] Figures 1A-1D illustrate examples of a peripheral aspiration system (PAS) 100, according to embodiments of the present disclosure. According to several embodiments, the PAS 100 includes a catheter 102, an aspiration module 104, a pump 106 (e.g., a vacuum or negative pressure pump), a reservoir 108, and a filter 110. A fluid path is defined through the PAS 100 and is supported by various lengths of tubing 112A-E. Various elements may be2508440223 1Atorney Docket No.: 8001535.00144 Client Docket No.: 2023-288-PCT referred to as “upstream” or “downstream” relative to another component along the fluid path. Generally speaking, “upstream” refers to a process or component that is comparably closer to the catheter 102 along the fluid path, and “downstream” refers to a process or component that is comparably further from the catheter 102 along the fluid path.

[0011] According to some embodiments, the catheter 102 is an aspiration catheter, which may be a traditional aspiration catheter, as is known in the art. The catheter 102 is configured to be inserted into a blood vessel of a patient and facilitate suction (via the pump 106) at the tip of the catheter 102 via a channel defined along the length of the catheter 102, the channel being in fluid communication with the tubing 112A.

[0012] The tubing 112A-E (generally or collectively, tubing 112), may be any manner of conventional tubing suitable for medical environments, having various gauges and wall thicknesses, and includes various means of connection to the various components of the PAS 100 to which the tubing 112 connects. Although not illustrated, one or ordinary skill in the art will appreciate that various tube joining elements, access ports, and flow control devices may be included along the length or between sections of tubing 112.

[0013] According to some embodiments, the tubing 112A fluidly connects the catheter 102 to the aspiration module 104. The aspiration module 104 is configured to provide a means to regulate the suction action enacted by the pump 106, which is connected to the aspiration module 104 via tubing 112B. The pump 106 is configured to provide negative pressure through the tubing 112A-B and the aspiration module 104 such that a suction force is exerted by the catheter 102 on a thrombus or other obstruction in the patient being aspirated. The aspiration module 104 includes one or more valves 114A-D (generally or collectively, valve 114) which connects the aspiration module 104 to a pressure relief source 124. According to some embodiments, the pressure relief source 124 may be a source of compressed gas, or an outlet to the atmosphere or a controlled environment at or near atmospheric pressure. In some embodiments, a reservoir 108 acts as the pressure relief source 124 or in conjunction with the pressure relief source 124.

[0014] When the PAS 100 is in operation, the pump 106 provides a negative pressure (e.g., vacuum pressure) by which the catheter 102 exerts suction forces. When inserted into a patient’s blood vessel, collaterally aspirated blood is drawn into the catheter 102 as a result of the suction forces driven by the pump 106. The collaterally aspirated blood is subjected to the negative pressure as the blood is drawn along the fluid path by the negative pressure.

[0015] The aspiration module 104 is configured to connect and disconnect the pressure relief source 124 from the catheter 102 via one or more valves 114. In some embodiments,3508440223 1Atorney Docket No.: 8001535.00144 Client Docket No.: 2023-288-PCT when the pressure relief source 124 is connected, the aspiration module 104 relieves the negative pressure in the catheter 102 and the tubing 112A-B, such that the negative pressure forces experienced by the blood therein are limited in terms of duration, and in some examples, limited in terms of magnitude . Stated differently, the aspiration module 104 connects a pressure relief source 124 to the catheter 102 such that the negative pressure applied to the catheter 102 by the pump 106 is temporarily interrupted or reduced in magnitude. Thus, effects on the blood by the negative pressure, such as vaporization of internal water, are temporarily alleviated. In some embodiments, the pressure relief source 124 can provide positive pressure, in addition to or alternatively to negative pressure, so that the liquid within the catheter 102 is moved back and forth according to the applied pressure changes.

[0016] In various embodiments, such as in Figure 1A, the pressure relief source 124 is selectively connected or disconnected from the aspiration module 104 via a single two-way valve 114 A, and the pump 106 remains in constant fluid communication with the catheter 102. Accordingly, the pump 106 may operate at a consistent duty cycle with the negative pressure generated by the pump 106 remaining nominally applied to the catheter 102 at a given pressure at all times during operation. Although an operator can manually change the nominal pressure for the pump 106 to apply by adjusting pump setings, the single two-way valve 114A provides the ability for the system 100 to automatically adjust the actually applied pressure (vs. the nominal generated pressure) by opening the valve 114A and applying a positive pressure or venting some of the negative pressure via the pressure relief source 124.

[0017] In some embodiments, such as in Figure IB, the pressure relief source 124 is selectively connected or disconnected from the aspiration module 104 via a single three-way valve 114B. Similarly to the single two-way valve 114A shown in Figure 1A, the single three- way valve 114B allows the system 100 to selectively control whether the pressure relief source 124 is in fluid communication with the catheter 102, but may also control whether the pump 106 is in fluid communication with the catheter 102. In various embodiments, the single three- way valve 114B may be configured to communicate at a given time: only the pump 106 to the catheter 102, only the pressure relief source 124 to the catheter 102, both the pump 106 and the pressure relief source 124 to the catheter 102, or neither the pump 106 nor the pressure relief source 124 to the catheter 102 (e.g., the pump 106 to the pressure relief source 124).

[0018] In some embodiments, such as in Figure 1C, an upstream valve 114C and a downstream valve 114D are provided relative to the pump 106 to selectively connect or disconnect the pump 106 and various pressure relief sources 124 from the aspiration module 104 and one another. In various embodiments, the upstream valve 114C operates similarly to4508440223 1Atorney Docket No.: 8001535.00144 Client Docket No.: 2023-288-PCT the single three-way valve 114B discussed in relation to Figure IB, and may be configured to communicate at a given time: only the pump 106 to the catheter 102, only the pressure relief source 124 to the catheter 102, both the pump 106 and the pressure relief source 124 to the catheter 102, or neither the pump 106 nor the pressure relief source 124 to the catheter 102. The downstream valve 114D is connected between the outlet 117 (or a positive pressure vent) of the pump 106, the reservoir 108, and the pressure relief source 124. The downstream valve 114D may be configured to communicate at a given time: only the pump 106 to the reservoir 108, only the pump 106 to the pressure relief source 124, only the pressure relief source 124 to the reservoir 108, or the pump 106 to both the pressure relief source 124 and to the reservoir 108. In various embodiments, the pump 106 charges the pressure relief source 124 with a positive pressure, which may be later imparted to the fluid in the catheter 102 by opening the upstream valve 114C.

[0019] In some embodiments, such as in Figure ID, the pressure relief source 124 may consist of piping or tubing routed from a positive pressure end of the pump 106 to the catheter 102 (e.g., omiting a pressure vessel or other storage container). In such embodiments, the upstream valve 114C and the downstream valve 114D may be operated in tandem to selectively connect the positive pressure end of the pump 106 to the catheter 102.

[0020] In various embodiments, the valves 114 may be operated by motors based on electrical signals received from pressure sensors includes in the aspiration module 104 to selectively adjust the pressure applied to the bodily fluid being aspirated, or may be mechanically controlled (e.g., via ball valves or pressure columns) to operate based on the pressure of the fluid passing therethrough without the use of motors or electrical sensors (or with motors and sensors supplementing mechanical control). In various embodiments, the valves 114 may include negative pressure relief valves that open when an exerted negative pressure exceeds a predefined threshold.

[0021] According to some embodiments, the aspiration module 104 may be operated by a user, to selectively relieve the pressure at a chosen moment. In such examples, the valve 114 may be manually operable, and include conventional features by which to grip and operate the valve 114. In some examples, the valve 114 may be actuated or articulated by a motor or driver, and the aspiration module 104 may further include a connection to a device (e.g., a user device) configured to signal the motor or driver to connect and disconnect the pressure relief source. Such a device may include a push-buton, switch, or other means suitable for triggering the valve 114. In some embodiments, the valve 114 is operated based on a pressure differential between the pressure relief source 124 and the fluids carried in the aspiration module 104, and5508440223 1Atorney Docket No.: 8001535.00144 Client Docket No.: 2023-288-PCT may include a ball or plug that is shifted to release pressure when the differential exceeds a predefined amount.

[0022] In some examples, the aspiration module 104 is automated, and operates on closed loop control, and is configured to intermitently connect and disconnect the relief pressure source 124 at predetermined intervals. In such examples, the valve 114 may be actuated or articulated by a motor or driver and regulated by a connected circuit.

[0023] In some examples, the aspiration module 104 is configured to run on open loop control, and includes a connection to one or more sensors, which are configured to measure one or more conditions of the blood at one or more points along the fluid path of the PAS 100. In such examples, the aspiration module 104 may include a connection to a controller (e.g., computer 300), which is configured analyze signals from the one or more sensors, and connect and disconnect the pressure relief source 124 responsive to the sensor measuring a condition which exceeds or fails to meet a predetermined threshold.

[0024] In some examples, the valve(s) 114 of the aspiration module 104 may be configured to open or close responsive to a pressure condition within the aspiration module 104. For example, a given valve 114 may include a gate or plug biased by a biasing element such that the given valve 114 is closed, and when the pressure in the aspiration module 104 drops below a certain threshold, the biasing force against the gate provided by the biasing element is overcome, unblocking the given valve 114 (such that the relief pressure source 124 is connected). In some examples, the valve 114 may be a conventional pressure relief valve. As will be appreciated, as pressure moves in waves, embodiments of the PAS 100 that include multiple valves 114 may have various valves 114 in different configurations at the same time.

[0025] According to some embodiments, the pump 106 is a vacuum pump. The pump 106 may be configured such that the pumping action and the resulting flow of fluid through the pump 106 limits damage done to blood cells passing through the pump 106. In some examples, the pump 106 is a diaphragm pump. In some examples, the pump 106 may be a suitable peristaltic pump.

[0026] In examples where the pump 106 is a diaphragm pump, the pump 106 may be a dual -headed pump or two diaphragm pumps in parallel. In this manner, the dual heads (or the first and second pumps) may be operated in phase, such that negative pressure is continuously exerted through the tubing 112B. Stated differently, the dual heads (or the first and second pumps) may be configured such that the suction pressure at the catheter 102 is substantially uniform when the relief pressure source 124 is disconnected from the catheter 102.6508440223 1Atorney Docket No.: 8001535.00144 Client Docket No.: 2023-288-PCT

[0027] Depending on the gauge of catheter 102 used, as well as other procedural factors, the PAS 100 may have a minimal head requirement for operation, which may further limit suitable pumps to be selected. According to some embodiments, the pump 106 is capable of facilitating suction pressures in the range of 5 kilopascals (kPa) to 95 kPa at the catheter 102.

[0028] One skilled in the art will recognize that many conventional pumps may be suitable for use in the PAS 100 and may select or configure a pump 106 accordingly.

[0029] After aspiration into the catheter 102, aspirated blood may flow along the fluid path, drawn by the negative pressure provided by the pump 106 through the tubing 112A, the aspiration module 104, and the tubing 112B to the pump 106. The pump 106 may include a pump inlet 116 and a pump outlet 117.

[0030] According to some embodiments, after exiting the pump 106 via the pump outlet 117 into tubing 112C, the blood (now under the influence of positive pressure on the outlet side of the pump 106) may be driven downstream along the fluid path to a reservoir 108. The reservoir 108 is configured to store blood under conditions suitable for the blood to be returned to a patient. In some examples, the reservoir 108 may be temperature controlled, pressure controlled, include agitators, or include anticoagulants or an additive solution to prevent spoilage of aspirated blood. According to some embodiments, the reservoir 108 includes a reservoir inlet 118, disposed upstream from a reservoir outlet 119. In some examples, the reservoir outlet 119 is fluidly connected to tubing 112D.

[0031] According to some embodiments, aspirated blood may exit the reservoir 108 via the reservoir outlet 119 after a period of time, or when the reservoir 108 reaches a predetermined capacity. The aspirated blood may then travel through tubing 112D to a filter 110. The filter 110 is configured to remove particulates and other impurities from the aspirated blood, such as portions of thrombi, or other detritus in the aspirated blood. The filter 110 may include a filter inlet 120 and a filter outlet 121. The filter 110 may be a conventional blood filter, as is known in the art.

[0032] Although illustrated as downstream from the reservoir 108 in Figures 1A-1D, according to some embodiments, the filter 110 may additionally or alternatively be disposed upstream of the reservoir 108, such that aspirated blood entering the reservoir 108 is filtered and in suitable condition to be returned to a patient prior to storage in the reservoir 108. Similarly, although one filter 110 is illustrated, the present disclosure contemplates that several filters 110 may be used, which may be deployed in series or in parallel at one location, or at several different locations throughout the system.7508440223 1Atorney Docket No.: 8001535.00144 Client Docket No.: 2023-288-PCT

[0033] The filter outlet 121 is fluidly connected to tubing 112E, which is connectable to a blood return system. In some examples, the blood return system is an intravenous cannula connected to a blood vessel of a patient, and the blood is reintroduced simultaneously with the aspiration procedure. In some examples, the blood return system is a secondary reservoir, such that blood may be returned to the patient following the procedure or intermitently throughout the procedure in distinct batches. In some examples, the reservoir 108 is disconnected at the reservoir inlet 118, to thereby return some or all of the collected blood or bodily fluids in the reservoir 108 once the procedure is complete.

[0034] According to some embodiments, blood may be driven through the filter 110 via positive pressure exerted from the pump 106. In other embodiments, the PAS 100 may be configured such that blood is drawn through the filter 110 under the influence of gravity.

[0035] According to some embodiments, the PAS 100 may be provided to a user in modular form. For example, each component of the PAS 100 (e.g., tubing 112, catheter 102, aspiration module 104, pump 106, reservoir 108, a filter 110) may be provided in an assembled state to an end user. In some examples the PAS 100 may be provided as a kit, and an end user assembles the PAS 100 prior to use. In some examples, the pump 106 may be supplied to an end user primed with sterile fluid, such as saline. In some examples, the reservoir 108 may be supplied to an end user primed with anticoagulants or additive solution.

[0036] Figure 2 illustrates a flowchart for an example method 200 of peripheral aspiration, according to embodiments of the present disclosure.

[0037] At block 210, a negative pressure is applied through a catheter 102 to a biological lumen (e.g., a vein or artery) of a biological subject (e.g., a patient). In various embodiments, the negative pressure may be supplied by a vacuum pump (e.g., pump 106). The source of the negative pressure may be connected to the catheter 102 via a tubing system (e.g., a medical tubing system, tubing 112). The negative pressure may be applied through the catheter 102 such that the suction pressure at a tip of the catheter 102 is in a range of 5 kPa to 95 kPa.

[0038] At block 220, a fluid is aspirated through the catheter 102. In various embodiments, the fluid aspirated through the catheter 102 is blood, aspirated from a blood vessel of a patient. The blood may be collaterally aspirated during a thrombectomy procedure, however, other fluids which are suitable for aspiration through a catheter 102 are also contemplated. For example, the PAS 100 may initially aspirate a saline solution to prime the fluid flow path before insertion into the blood vessel of the patient or to clear clogs in the system (e.g., at higher pressures or duty cycles than applied to a patient).8508440223 1Atorney Docket No.: 8001535.00144 Client Docket No.: 2023-288-PCT

[0039] At block 230, a pressure relief source 124 is temporarily connected to the catheter 102, such that the negative pressure between the negative pressure source and the catheter 102 is relieved or lessened. In various embodiments, the pressure may be relieved by an aspiration module (e.g., aspiration module 104) which is configured to connect the relief pressure source 124 to the catheter 102, via a valve 114 or similar mechanism. In some examples, the pressure relief source 124 is connected to the catheter 102 at predetermined intervals. In some examples, the pressure relief source 124 is connected to the catheter 102 responsive to a pressure condition of the fluid aspirated by the catheter 102 approaching or exceeding a predetermined threshold. As an example, if a vacuum is exerted on the fluid for a duration of a certain time, water contained in the fluid may potentially vaporize - boiling the blood and damaging the cells therein. The pressure relief source 124 may be connected to prevent water contained in the fluid (including in the cells) from vaporizing. In some examples, predetermined threshold corresponds to a boiling point of the fluid, such that connecting the relief pressure source ensures that the fluid remains below the boiling point. One of ordinary skill in the art will be able to determine the boiling point of a fluid of interest at various temperatures and pressures without undue experimentation.

[0040] In various embodiments, connecting the pressure relief source 124 may be performed by a user, such as a physician, or monitored by an automated control system, or performed automatically (e.g., mechanically) based on a pressure differential by the mechanical systems of the valve 114.

[0041] At block 240 the fluid is fdtered. In various embodiments where the fluid is blood collaterally aspirated during a thrombectomy procedure, particulate mater, such as pieces of thrombi, may be aspirated along with the fluid. The fluid is filtered such that unwanted contaminants or detritus are removed from the fluid, and the fluid is in suitable condition to be returned to a patient (e.g., the patient from which the fluid was aspirated).

[0042] At block 250, the fluid may be returned (e.g., to the patient from which the fluid was aspirated). In various embodiments, the fluid may be retuned as part of a continuous process, where fluid is steadily returned as more fluid is aspirated. In such examples, the fluid may be returned to a patient via an intravenous cannula. In other embodiments, the fluid is collected and stored (e.g., in a reservoir such as reservoir 108) for return following the completion of aspiration or in distinct batches during the procedure. In some embodiments, the collected fluid may be saved for use in autologous transfusion during the current medical procedure, but if not needed may be discarded, saved for use in another medical procedure involving the current biological subject, used for diagnostic purposes, or used in a medical9508440223 1Atorney Docket No.: 8001535.00144 Client Docket No.: 2023-288-PCT procedure for a different biological subject. In various embodiments, aspirated fluid that is not returned, provided for analysis or diagnostic purposes, or otherwise stored for later use may be destroyed or otherwise discarded.

[0043] As will be appreciated, method 200 may describe a continuous process, such that after fluid flow is established through the PAS 100, blocks 210-250 are performed substantially simultaneously, and block 230 may be performed at various times (and locations along the fluid path) according to the pressures exerted or manual intervention within the flow path. Similarly, on conclusion of the medical procedure (e.g., on capture of a thrombus being aspirated), the processes described in method 200 may be considered complete when aspiration of the fluid though the catheter (per block 220) is complete or when the aspirated fluid is finally disposed of (e.g., returned, stored, used, or destroyed per block 250).

[0044] Figure 3 illustrates a computing device 300, as may be used for the control of an aspiration system, according to embodiments of the present disclosure. The computing device 300 may include at least one processor 310, a memory 320, and a communication interface 330. In various embodiments, the computing device 300 is includes in the aspiration module 104.

[0045] The processor 310 may be any processing unit capable of performing the operations and procedures described in the present disclosure. In various embodiments, the processor 310 can represent a single processor, multiple processors, a processor with multiple cores, and combinations thereof.

[0046] The memory 320 is an apparatus that may be either volatile or non-volatile memory and may include RAM, flash, cache, disk drives, and other computer readable memory storage devices. Although shown as a single entity, the memory 320 may be divided into different memory storage elements such as RAM and one or more hard disk drives. As used herein, the memory 320 is an example of a device that includes computer-readable storage media, and is not to be interpreted as transmission media or signals per se.

[0047] As shown, the memory 320 includes various instructions that are executable by the processor 310 to provide an operating system 322 to manage various features of the computing device 300 and one or more programs 324 to provide various functionalities to users of the computing device 300, which include one or more of the features and functionalities described in the present disclosure (e.g., some or all of the operations or logic to perform method 200). One of ordinary skill in the relevant art will recognize that different approaches can be taken in selecting or designing a program 324 to perform the operations described herein, including choice of programming language, the operating system 322 used by the computing device 300,10508440223 1Atorney Docket No.: 8001535.00144 Client Docket No.: 2023-288-PCT and the architecture of the processor 310 and memory 320. Accordingly, the person of ordinary skill in the relevant art will be able to select or design an appropriate program 324 based on the details provided in the present disclosure.

[0048] The communication interface 330 facilitates communications between the computing device 300 and other devices, which may also be computing devices as described in relation to Figure 3. In various embodiments, the communication interface 330 includes antennas for wireless communications and various wired communication ports. The computing device 300 may also include or be in communication, via the communication interface 330, one or more input devices (e.g., a keyboard, mouse, pen, touch input device, etc.) and one or more output devices (e.g., a display, speakers, a printer, etc.).

[0049] Although not explicitly shown in Figure 3, it should be recognized that the computing device 300 may be connected to one or more public and / or private networks via appropriate network connections via the communication interface 330. It will also be recognized that software instructions may also be loaded into a non-transitory computer readable medium, such as the memory 320, from an appropriate storage medium or via wired or wireless means.

[0050] Accordingly, the computing device 300 is an example of a system that includes a processor 310 and a memory 320 that includes instructions that (when executed by the processor 310) perform various embodiments of the present disclosure. Similarly, the memory 320 is an apparatus that includes instructions that, when executed by a processor 310, perform various embodiments of the present disclosure.

[0051] In addition to the embodiments described above, many examples of specific combinations are within the scope of the disclosure, some of which are detailed below:

[0052] Clause 1 : A peripheral aspiration system, comprising: a catheter; a pump having a pump inlet and a pump outlet, wherein the pump is configured to provide a negative pressure through the catheter; and an aspiration module connectively disposed between the catheter and the pump inlet, the aspiration module including a connection to a relief pressure source; wherein the aspiration module is configured to intermitently connect and disconnect the relief pressure source from the catheter, such that the negative pressure through the catheter is interrupted when the catheter is connected to the relief pressure source by the aspiration module.

[0053] Clause 2: The peripheral aspiration system of any one of clauses 1-21 further comprising a reservoir including a reservoir inlet and a reservoir outlet, the reservoir inlet11508440223 1Atorney Docket No.: 8001535.00144 Client Docket No.: 2023-288-PCT connected to the pump outlet, the reservoir configured to collect fluid aspirated through the catheter.

[0054] Clause 3: The peripheral aspiration system of any one of clauses 1-21 further comprising a filter connected to the reservoir, configured to filter particulates out of the fluid aspirated by the catheter.

[0055] Clause 4: The peripheral aspiration system of any one of clauses 1-21 wherein the filter is connectively disposed between the reservoir inlet and the pump outlet, such that the fluid is driven through the filter by the pump.

[0056] Clause 5: The peripheral aspiration system of any one of clauses 1-21 wherein the filter is connected to the reservoir outlet.

[0057] Clause 6: The peripheral aspiration system of any one of clauses 1-21 wherein the peripheral aspiration system is configured such that the fluid is drawn through the filter by gravity.

[0058] Clause 7: The peripheral aspiration system of any one of clauses 1-21 wherein the filter is connected to a cannula configured to be inserted into a blood vessel of a patient.

[0059] Clause 8: The peripheral aspiration system of any one of clauses 1-21 wherein a second filter is connected to a second collection reservoir disposed downstream of an outlet of the collection reservoir.

[0060] Clause 9: The peripheral aspiration system of any one of clauses 1-21 further comprising a sensor configured to measure a pressure exerted on a fluid aspirated by the peripheral aspiration system.

[0061] Clause 10: The peripheral aspiration system of any one of clauses 1-21 further comprising a controller connected to the sensor and the aspiration module, the controller configured to control the aspiration module to connect and disconnect the relief pressure source from the catheter responsive to the pressure exerted on the fluid approaching or exceeding a predetermined threshold.

[0062] Clause 11: The peripheral aspiration system of any one of clauses 1-21 wherein the aspiration module includes a valve, the valve having a first configuration and a second configuration, wherein when the valve is in the first configuration, the relief pressure source is disconnected from the catheter, and when the valve is in the second configuration the relief pressure source is connected to the catheter.

[0063] Clause 12: The peripheral aspiration system of any one of clauses 1-21 wherein the pump is a diaphragm pump.12508440223 1Atorney Docket No.: 8001535.00144 Client Docket No.: 2023-288-PCT

[0064] Clause 13: The peripheral aspiration system of any one of clauses 1-21 wherein the pump is a dual -headed pump.

[0065] Clause 14: The peripheral aspiration system of any one of clauses 1-21 wherein the dual-headed pump is connected in parallel and configured to pump in phase, such that a suction pressure at the catheter is substantially uniform when the relief pressure source is disconnected from the catheter.

[0066] Clause 15: The peripheral aspiration system of any one of clauses 1-21 wherein the relief pressure source is an opening to an environment at atmospheric pressure.

[0067] Clause 16: The peripheral aspiration system of any one of clauses 1-21 wherein the relief pressure source is a reservoir of pressurized gas.

[0068] Clause 17: The peripheral aspiration system of any one of clauses 1-21 wherein the relief pressure source is a reservoir configured to accept blood aspirated via the catheter.

[0069] Clause 18: The peripheral aspiration system of any one of clauses 1-21 wherein the aspiration module includes a single valve to selectively communicate the pressure relief source to the catheter, wherein the pump is in constant communication with the catheter.

[0070] Clause 19: The peripheral aspiration system of any one of clauses 1-21 wherein the aspiration module includes a single valve to selectively communicate one or both of the pressure relief source and the pump to the catheter.

[0071] Clause 20: The peripheral aspiration system of any one of clauses 1-21 wherein the aspiration module includes an upstream valve to selectively communicate one or both of the pressure relief source and the pump to the catheter and further comprising a downstream valve connected to selectively communicate the pump outlet to one or both of the pressure relief source or a reservoir for collecting blood aspirated via the catheter.

[0072] Clause 21: The peripheral aspiration system of any one of clauses 1-21, wherein the pressure relief source consists of piping or tubing connected to a positive pressure end of the pump.

[0073] Clause 22: A method of peripheral aspiration, comprising: applying a negative pressure through a catheter; aspirating a fluid through the catheter; temporarily connecting a pressure relief source to the catheter when a pressure condition of the fluid approaches or exceeds a predetermined threshold.

[0074] Clause 23: The method of any one of clauses 22-25, wherein the predetermined threshold corresponds to a boiling point of the fluid, such that the fluid remains below the boiling point.13508440223 1Atorney Docket No.: 8001535.00144 Client Docket No.: 2023-288-PCT

[0075] Clause 24: The method of any one of clauses 22-25, further comprising filtering the fluid.

[0076] Clause 25: The method of any one of clauses 22-25,, further comprising returning the fluid, after filtering, to a source from which the fluid was aspirated.

[0077] Certain terms are used throughout the description and claims to refer to particular features or components. As one skilled in the art will appreciate, different persons may refer to the same feature or component by different names. This document does not intend to distinguish between components or features that differ in name but not function.

[0078] As used herein, “about,” “approximately” and “substantially” are understood to refer to numbers in a range of the referenced number, for example the range of -10% to +10% of the referenced number, preferably -5% to +5% of the referenced number, more preferably - 1% to +1% of the referenced number, most preferably -0.1% to +0.1% of the referenced number.

[0079] Furthermore, all numerical ranges herein should be understood to include all integers, whole numbers, or fractions, within the range. Moreover, these numerical ranges should be construed as providing support for a claim directed to any number or subset of numbers in that range. For example, a disclosure of from 1 to 10 should be construed as supporting a range of from 1 to 8, from 3 to 7, from 1 to 9, from 3.6 to 4.6, from 3.5 to 9.9, and so forth.

[0080] As used herein, the term “patient” may refer to a human or non-human animal subject to a medical procedure.

[0081] As used in the present disclosure, a phrase referring to “at least one of’ a list of items refers to any set of those items, including sets with a single member, and every potential combination thereof. For example, when referencing “at least one of A, B, or C” or “at least one of A, B, and C”, the phrase is intended to cover the sets of: A, B, C, A-B, B-C, A-C, and A-B-C, where the sets may include one or multiple instances of a given member (e.g., A-A, A- A-A, A-A-B, A-A-B-B-C-C-C, etc.) and any ordering thereof. For avoidance of doubt, the phrase “at least one of A, B, and C” shall not be interpreted to mean “at least one of A, at least one of B, and at least one of C”.

[0082] As used in the present disclosure, the term “determining” encompasses a variety of actions that may include calculating, computing, processing, deriving, investigating, looking up (e.g., via a table, database, or other data structure), ascertaining, receiving (e.g., receiving information), accessing (e.g., accessing data in a memory), retrieving, resolving, selecting, choosing, establishing, and the like.14508440223 1Atorney Docket No.: 8001535.00144 Client Docket No.: 2023-288-PCT

[0083] Without further elaboration, it is believed that one skilled in the art can use the preceding description to use the claimed inventions to their fullest extent. The examples and aspects disclosed herein are to be construed as merely illustrative and not a limitation of the scope of the present disclosure in any way. It will be apparent to those having skill in the art that changes may be made to the details of the above-described examples without departing from the underlying principles discussed. In other words, various modifications and improvements of the examples specifically disclosed in the description above are within the scope of the appended claims. For instance, any suitable combination of features of the various examples described is contemplated.

[0084] Within the claims, reference to an element in the singular is not intended to mean “one and only one” unless specifically stated as such, but rather as “one or more” or “at least one”. Unless specifically stated otherwise, the term “some” refers to one or more. No claim element is to be construed under the provision of 35 U.S.C. § 112(f) unless the element is expressly recited using the phrase “means for” or “step for”. All structural and functional equivalents to the elements of the various embodiments described in the present disclosure that are known or come later to be known to those of ordinary skill in the relevant art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed in the present disclosure is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims.15508440223 1

Claims

Atorney Docket No.: 8001535.00144 Client Docket No.: 2023-288-PCTCLAIMSThe invention is claimed as follows:

1. A peripheral aspiration system, comprising: a catheter; a pump having a pump inlet and a pump outlet, wherein the pump is configured to provide a negative pressure through the catheter; and an aspiration module connectively disposed between the catheter and the pump inlet, the aspiration module including a connection to a relief pressure source; wherein the aspiration module is configured to intermitently connect and disconnect the relief pressure source from the catheter, such that the negative pressure through the catheter is interrupted when the catheter is connected to the relief pressure source by the aspiration module.

2. The peripheral aspiration system of claim 1, further comprising a reservoir including a reservoir inlet and a reservoir outlet, the reservoir inlet connected to the pump outlet, the reservoir configured to collect fluid aspirated through the catheter.

3. The peripheral aspiration system of claim 2, further comprising a filter connected to the reservoir, configured to filter particulates out of the fluid aspirated by the catheter.

4. The peripheral aspiration system of claim 3, wherein the filter is connectively disposed between the reservoir inlet and the pump outlet, such that the fluid is driven through the filter by the pump.16508440223 1Atorney Docket No.: 8001535.00144 Client Docket No.: 2023-288-PCT5. The peripheral aspiration system of claim 3, wherein the filter is connected to the reservoir outlet.

6. The peripheral aspiration system of claim 3, wherein the peripheral aspiration system is configured such that the fluid is drawn through the filter by gravity.

7. The peripheral aspiration system of claim 3, wherein the filter is connected to a cannula configured to be inserted into a blood vessel of a patient.

8. The peripheral aspiration system of claim 4, wherein a second filter is connected to a second collection reservoir disposed downstream of an outlet of the collection reservoir.

9. The peripheral aspiration system of claim 1, further comprising a sensor configured to measure a pressure exerted on a fluid aspirated by the peripheral aspiration system.

10. The peripheral aspiration system of claim 9, further comprising a controller connected to the sensor and the aspiration module, the controller configured to control the aspiration module to connect and disconnect the relief pressure source from the catheter responsive to the pressure exerted on the fluid approaching or exceeding a predetermined threshold.

11. The peripheral aspiration system of claim 1, wherein the aspiration module includes a valve, the valve having a first configuration and a second configuration, wherein when the valve is in the first configuration, the relief pressure source is disconnected from the catheter, and when the valve is in the second configuration the relief pressure source is connected to the catheter.17508440223 1Attorney Docket No.: 8001535.00144Client Docket No.: 2023-288-PCT12. The peripheral aspiration system of claim 1, wherein the pump is a diaphragm pump.

13. The peripheral aspiration system of claim 1, wherein the pump is a dual -headed pump.

14. The peripheral aspiration system of claim 13, wherein the dual-headed pump is connected in parallel and configured to pump in phase, such that a suction pressure at the catheter is substantially uniform when the relief pressure source is disconnected from the catheter.

15. The peripheral aspiration system of claim 1, wherein the relief pressure source is an opening to an environment at atmospheric pressure.

16. The peripheral aspiration system of claim 1, wherein the relief pressure source is a reservoir of pressurized gas.

17. The peripheral aspiration system of claim 1, wherein the relief pressure source is a reservoir configured to accept blood aspirated via the catheter.

18. The peripheral aspiration system of claim 1, wherein the aspiration module includes a single valve to selectively communicate the pressure relief source to the catheter, wherein the pump is in constant communication with the catheter.508440223 1Atorney Docket No.: 8001535.00144 Client Docket No.: 2023-288-PCT19. The peripheral aspiration system of claim 1, wherein the aspiration module includes a single valve to selectively communicate one or both of the pressure relief source and the pump to the catheter.

20. The peripheral aspiration system of claim 1, wherein the aspiration module includes an upstream valve to selectively communicate one or both of the pressure relief source and the pump to the catheter and further comprising a downstream valve connected to selectively communicate the pump outlet to one or both of the pressure relief source or a reservoir for collecting blood aspirated via the catheter.

21. The peripheral aspiration system of claim 1, wherein the pressure relief source consists of piping or tubing connected to a positive pressure end of the pump.

22. A method of peripheral aspiration, comprising: applying a negative pressure through a catheter; aspirating a fluid through the catheter; temporarily connecting a pressure relief source to the catheter when a pressure condition of the fluid approaches or exceeds a predetermined threshold.

23. The method of claim 22, wherein the predetermined threshold corresponds to a boiling point of the fluid, such that the fluid remains below the boiling point.

24. The method of claim 22, further comprising filtering the fluid.19508440223 1Attorney Docket No.: 8001535.00144Client Docket No.: 2023-288-PCT25. The method of claim 24, further comprising returning the fluid, after filtering, to a source from which the fluid was aspirated.508440223 1

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