Pressure spike mitigation in biological fluid aspiration systems

Abstract

A device for mitigating sudden changes in pressure in biological fluid filtration systems is provided with a first chamber, a second chamber, a filter defining fluid communication between the first chamber and the second chamber and blocking particles of a predefined size from transferring between the first chamber and the second chamber, and a pressure spike suppression means disposed between the first chamber and an ambient environment, configured to distend outwardly when a pressure in the first chamber increases.

Description

Atty Docket: 1956788.00445Client No.: 2023-217-PCTPRESSURE SPIKE MITIGATION IN BIOLOGICAL FLUID ASPIRATION SYSTEMSCROSS-REFERENCES TO RELATED DISCLOSURES

[0001] The present disclosure claims priority to U.S. Provisional Patent Application 63 / 725,235, filed on 2024-11-26, titled “PRESSURE SPIKE MITIGATION IN BIOLOGICAL FLUID ASPIRATION SYSTEMS”, which is incorporated herein in its entirety to the extent permitted by law.BACKGROUND

[0002] When aspirating biological fluids and any solids carried therewith (e.g. embolisms in blood), a negative pressure is held on a fluid target (e.g., a vein) to draw the fluids and solids out. A higher-pressure relief cycle may be periodically interspersed with the negative pressure. The biological fluids may pass through one or more filters which may retain solids larger than a given size.SUMMARY

[0003] The present disclosure provides a device for mitigating sudden changes in pressure in biological fluid filtration systems. When relieving pressure in such a system, a sudden spike in pressure can dislodge filtered solids, posing a risk of reintroduction of those solids to a biological subject. In some examples, when a clot is engaged at the tip of the catheter, the sudden spike in pressure can cause the clot to dislodge from the tip of the catheter, thereby causing the clot to travel11604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT distally, which can increase the occurrence of a stroke. Devices and methods disclosed herein provide a pressure spike suppression means in the form of a flexible balloon or diaphragm. When an increase in a system’s pressure occurs, the pressure spike suppression means may distend outwardly, thereby decreasing an intensity of the pressure wave and decreasing a likelihood that filtered solids will become dislodged.

[0004] One embodiment of the present disclosure is a device comprising a first chamber, a second chamber, a filter defining fluid communication between the first chamber and the second chamber and blocking particles of a predefined size from transferring between the first chamber and the second chamber, and a pressure spike suppression means disposed between the first chamber and an ambient environment, configured to distend outwardly when a pressure in the first chamber exceeds an ambient pressure in the ambient environment.

[0005] One embodiment of the present disclosure is a device comprising an upper housing configured to define a first chamber, a lower housing configured to define a second chamber, a filter, disposed between the upper housing and the lower housing and configured to allow fluid passage between the first chamber and the second chamber, and a diaphragm affixed to a surface of the lower housing, wherein an interior surface of the diaphragm is in fluid communication with the second chamber, an exterior surface of the diaphragm is in fluid communication with an ambient environment, and wherein the diaphragm is configured to distend21604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT outwardly from the second chamber into the ambient environment when a pressure in the second chamber rises.

[0006] One embodiment of the present disclosure is a device comprising a tube, in which a plurality of holes are defined in a wall of a section of the tube, and a diaphragm disposed circumferentially around an exterior of the section of the tube and sealed to an exterior surface of the wall on a first end of the section and a second end of the section opposite to the first end, in fluid communication with an interior chamber of the tube via the plurality of holes and configured to distend outwards responsive to a rise in fluid pressure within the interior chamber.BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The accompanying figures depict various elements of the one or more embodiments of the present disclosure and are not considered limiting of the scope of the present disclosure.

[0008] In the Figures, some elements may be shown not to scale with other elements so as to more clearly show the details. Additionally, like reference numbers are used, where possible, to indicate like elements throughout the several Figures.

[0009] It is contemplated that elements and features of one embodiment may be beneficially incorporated in the other embodiments without further recitation or illustration. For example, as the Figures may show alternative views and time periods, various elements shown in a first Figure may be omitted from the 31604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT illustration shown in a second Figure without disclaiming the inclusion of those elements in the embodiments illustrated or discussed in relation to the second Figure.

[0010] Figures 1A and 1 B illustrate an example exploded side-on view of a biological fluid aspiration device with distended and undistended pressure spike suppression means, according to embodiments of the present disclosure.

[0011] Figures 2A-2C illustrate example side-on views of biological fluid aspiration devices with alternative element placements to the examples shown in Figures 1A-1 B, according to embodiments of the present disclosure.

[0012] Figures 3A and 3B illustrate example side-on views of an inline fluid aspiration system with relatively distended and undistended pressure spike suppression means, respectively, according to embodiments of the present disclosure.

[0013] Figure 4 illustrates an example exploded side-on view of an inline spike suppressor, according to embodiments of the present disclosure.

[0014] Figures 5A and 5B illustrate example isometric transparent assembled views of orthogonal and diagonal filter assemblies, respectively, according to embodiments of the present disclosure.

[0015] Figure 6 illustrates an example isometric transparent assembled view of an inline spike suppressor, according to embodiments of the present disclosure.41604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT

[0016] Figure 7 is a flowchart of an example method of the operation of a biological fluid aspiration device with pressure spike suppression means, according to embodiments of the present disclosure.DETAILED DESCRIPTION

[0017] The present disclosure provides a device for mitigating sudden changes in pressure in biological fluid filtration systems. When relieving pressure in such a system, a sudden spike in pressure can dislodge filtered solids, posing a risk of reintroduction of those solids to a biological subject. In some examples, when a clot is engaged at the tip of the catheter, the sudden spike in pressure can cause the clot to dislodge from the tip of the catheter, thereby causing the clot to travel distally, which can increase the occurrence of a stroke. Devices and methods disclosed herein provide a pressure spike suppression means in the form of a flexible balloon or diaphragm. When an increase in a system’s pressure occurs, the pressure spike suppression means may distend outwardly, thereby decreasing an intensity of the pressure wave and decreasing a likelihood that filtered solids will become dislodged.

[0018] Figures 1 A and 1 B illustrate an example exploded side-on view of a filter assembly 100 with distended and undistended pressure spike suppression means, according to embodiments of the present disclosure.

[0019] In the example depicted in Figure 1A, an ingress housing 110, defining an ingress chamber 114, is joined with an egress housing 130 defining an egress 51604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT chamber 134. As used herein, “upper” and “lower” refer to the relative placements of the components in the preferred orientation for operations so that fluids and other matter feed from the upper component to the lower component under the influence of gravity. Accordingly, one of ordinary skill in the art will readily understand which element is the “upper” or “lower” element regardless of the current orientation - the ingress housing 110 may therefore also be referred to as an ’’upper” housing, while the egress housing 130 may similarly be referred to as a “lower” housing.

[0020] A filter 120 is disposed between the ingress chamber 114 and the egress chamber 134 such that fluid passing between the ingress chamber 114 and the egress chamber 134 passes through the filter 120 so that solids may be removed therefrom. For example, the filter 120 defined may be a non-lysing filter, which avoids damaging the cells included in the fluid aspirated from a biological lumen so that the fluid and included cells may be returned to the biological subject after being filtered (e.g., to remove clots from a blood vessel and return the blood to a patient with intact / viable blood cells). Accordingly, the filter 120 is located between the chambers of the filter assembly 100 and restricts fluid communication therebetween to block particles of a predefined size from transferring between the chambers.

[0021] A first port 112 of the ingress housing 110 permits fluid communication between the ingress chamber 114 and a biological subject, while a second port 132 of the egress housing 130 permits fluid communication between the egress 61604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT chamber 134 and a pressure source (e.g. a pump). A flexible diaphragm 140 is disposed across a surface of the egress housing 130, and the flexible diaphragm 140 is contained within an expansion chamber 154 defined by an expansion housing 150. One side of the flexible diaphragm 140 is in fluid communication with the egress chamber 134, while an opposite side of the flexible diaphragm 140 is at least partially exposed to an ambient environment.

[0022] In various embodiments, one or both of the ingress housing 110 and the egress housing 130 (or portions thereof) is made of visually transparent material to allow an operator to view the contents off the ingress chamber 114 or the egress chamber 134.

[0023] The communication to the ambient environment may be achieved via one or more perforations or holes 152 in the expansion housing 150, allowing air (or any other ambient fluid, including gases) to enter and leave the expansion housing 150 as needed. The flexible diaphragm 140 may be made of any flexible and biocompatible material, including but not limited to rubber, silicone, elastomers, latex, polyurethane, thermoplastic, paper, and composites thereof. A thickness of the flexible diaphragm 140 may be chosen based upon a desired flexibility of the flexible diaphragm 140 in conjunction with chosen materials’ characteristics.

[0024] In Figure 1 B, the flexible diaphragm 140 is distended outwardly compared to the state of the flexible diaphragm 140 illustrated in Figure 1A.71604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCTAccordingly, Figure 1A may be understood as showing the diaphragm 140 in a resting state or undistended state, while Figure 1 B may be understood as showing the diaphragm 140 in a suppressing state or distended state.

[0025] The flexible diaphragm 140 may be configured to distend outwardly from the lower housing 130 in response to a rise in a fluid pressure within the egress chamber 134 relative to an ambient pressure. In doing so, the flexible diaphragm 140 may partially or wholly fill the expansion chamber 154. It will be appreciated that the expansion housing 150 may constrain a size of pressure spike which the flexible diaphragm 140 is able to compensate for. Thus, the expansion housing 150 may be sized to accommodate a flexion of the flexible diaphragm 140 corresponding to a greatest expected pressure difference between the egress chamber 134 and the ambient environment with an additional margin for any anticipated variances.

[0026] Of note is that while pressure within the egress chamber 134 may rise relative to an ambient pressure, the pressure within the egress chamber 134 relative to the ambient environment may still be negative. That is to say, even though a pressure surge or spike occurs, a vacuum may be maintained for a duration of the pressure spike, with varying intensity of vacuum being applied to a biological subject via tubing connected to the first port 112.

[0027] When a change occurs to a negative pressure which is being applied to the egress chamber 134 via the second port 132, the flexible diaphragm 140 may81604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT distend outwardly from the egress chamber 134 to maintain a pressure within the egress chamber 134. The diaphragm 140 may quickly return to a position relatively close to that which the diaphragm 140 was in before the change in pressure occurred, or the diaphragm 140 may continue to occupy the distended position for some time. Eventually, the original negative pressure may be reapplied and the diaphragm 140 may return to the undistended position (e.g., as shown in Figure 1A).

[0028] Although the filter assembly 100 is contemplated herein with a substantially circular cross section, it will be appreciated that the filter assembly 100 may assume any overall shape and cross section. Cross sections employed may include but are not limited to rectangular (including square), elliptical, triangular, rhomboid, hexagonal, or octagonal.

[0029] Figures 2A-2C illustrate example side-on views of biological fluid aspiration devices with alternative element placements to the examples shown in Figures 1A-1 B, according to embodiments of the present disclosure.

[0030] In Figure 2A, the illustrated example filter assembly 100 includes an ingress housing 110 defining an upper chamber 114 in fluid communication with a biological subject via a first port 112. Similarly, an egress housing 130 defines an egress chamber 234 in fluid communication with a pressure source (e.g. a pump) via a second port 132. In contrast to Figures 1A-1 B, a filter 120 is diagonally91604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT disposed between the ingress chamber 114 and the egress chamber 134 in Figures 2A-2B.

[0031] In Figure 2A, a flexible diaphragm 140 is disposed across a side of the egress chamber 134 such that one side of the flexible diaphragm 140 is in fluid communication with the egress chamber 134 and an opposite side of the flexible diaphragm 140 is at least partially exposed to an ambient pressure. In Figure 2B, the flexible diaphragm 140 is disposed across a side of the ingress chamber 114 such that one side of the flexible diaphragm 140 is in fluid communication with the ingress chamber 114 and an opposite side of the flexible diaphragm 140 is at least partially exposed to an ambient pressure. The flexible diaphragm 140 may be contained within an expansion chamber 154 defined by an expansion housing 150 (see, Figure 1A) attached to either the upper or lower housing, respectively. It will be appreciated that though the terms “upper chamber” and “lower chamber” are used throughout this disclosure, these terms are used only with reference to how the Figures are illustrated and have no bearing on any directional orientation of devices of the present disclosure while in use.

[0032] Figure 2B depicts a filter assembly 100 similar to the example shown in Figure 2A, but with the flexible diaphragm 140 placed on top with the filter 120 between the negative pressure source and the flexible diaphragm 140. It will be appreciated that while the configuration of Figure 2B may mitigate pressure waves traveling towards the biological lumen (e.g., from the second port 132 to the first port 112), pressure waves will travel through the filter 120 at a full magnitude (e.g., 101604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT from the first port 112 to the second port 132). Therefore, the configuration of Figure 2B may be desirable primarily in situations where concern exists for pressure waves reaching the biological lumen at full strength, but where mitigating pressure waves through the filter 120 is less of a concern.

[0033] In various embodiments, The filter 120 may be disposed between the ingress chamber 114 and the egress chamber 134 diagonally in order to increase a surface area of the filter 120 relative to the volumes of the upper and lower chambers. It will be appreciated that increasing the available surface area of the filter 120 may result in increased fluid flow through the filter 120, and that a larger filter 120 may be capable of longer periods of use between changes of the filter 120. It will also be appreciated that a larger filter 120 may be more vulnerable to sharp increases in pressure dislodging solid objects caught in the filter 120. Thus, the flexible diaphragm 140 is of particular utility when a diagonal filter 120 is in use because the ability to mitigate pressure spikes reduces a risk of reintroducing solids to the biological subject. Although illustrated in a diagonal orientation, the present disclosure contemplates that various other orientations of the filter 120 may be used, and that more than one filter 120 (with the same or different orientations) may be used in place of a single filter 120.

[0034] Figure 2C illustrates a filter assembly 100 with the flexible diaphragm 140 placed on a sidewall of the egress housing 130. The flexible diaphragm 140 may be disposed across an outer surface of the egress housing 130, so that fluid communication between an interior surface of the flexible diaphragm 140 and the 111604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT egress chamber 134 is permitted via perforations in a side wall of the egress housing 130. An expansion chamber 154 defined by an expansion housing 150 may be partially or wholly circumferentially disposed around an outer surface of the lower housing 130 to contain the flexible diaphragm 140. The flexible diaphragm 140 may be positioned on a same plane as the second port 132, or may be offset along a vertical axis of the filter assembly 100 such that the flexible diaphragm 140 may be fully circumferentially disposed around the lower housing 130.

[0035] Figures 3A and 3B illustrate example side-on views of an inline fluid aspiration device 300 with relatively distended and undistended pressure spike suppression means, respectively, according to embodiments of the present disclosure.

[0036] In Figure 3A, an example tubular component 310 (e.g., catheter) includes several holes 312. A suppressor balloon 320, as an example spike suppressor or spike suppression means, is circumferentially disposed around a section of the tubular component 310 such that the several holes 312 permit fluid communication between an interior lumen of the tubular component 310 and an envelope 314 defined by the suppressor balloon 320 and an exterior surface of the tubular component 310. The suppressor balloon 320 is sealed to the exterior surface of the tubular component 310 on either end with seals 322 that prevent fluid communication between the envelope 314 and an ambient environment. Although illustrated with one suppressor balloon 320 along the length of the tubular 121604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT component 310, the present disclosure contemplates that the tubular component 310 may include several suppressor balloons 320 located at different positions along the length of the tubular component 310.

[0037] In various embodiments, the tubular component 310 may be a length of flexible surgical tubing, or may be a rigid component to which lengths of surgical tubing are attached on opposing sides. Additionally, in some embodiments, the tubular component 310 may be connected to the first port 112 or the second port 132 of a filter assembly 100.

[0038] The holes 312 defined about the circumference of the tubular component 310 may be of various patterns and sizes (including even or uneven sizes among the holes 312) and be present along various lengths of the tubular component 310 to permit fluid access between the lumen of the tubular component 310 and the interior envelope of the spike suppressor balloon 320. Accordingly, when fluid passes through the tubular component 310, the fluid seeks to exit the lumen via the holes 312, while the elasticity of the spike suppressor balloon 320 seeks to prevent the fluid from expanding the envelope defined by the spike suppressor balloon 320. When different pressures are exerted on the fluid, the fluid may expand the spike suppressor balloon 320 to different extents (e.g., the distended state shown in Figure 3B), which dissipates the pressure wave in the fluid via the temporary expansion of the spike suppressor balloon 320. After the pressure wave has passed, the spike suppressor balloon 320 returns to a131604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT undistended state (e.g., as shown in Figure 3A) via the natural elasticity of the spike suppressor balloon 320, to be ready to dissipate the next pressure wave.

[0039] The tubular component 310 may be installed along a tube between a filtration device (e.g., the device of Figures 1 A-2C) and a negative pressure source. When a transition occurs between an operational negative pressure from the negative pressure source and a relief pressure, the spike suppressor balloon 320 may distend outwardly, as is shown in Figure 3B relative to Figure 3A, thereby increasing a volume of the envelope 314 (e.g., inflating the balloon) and absorbing the increase in pressure. In some embodiments, a rigid sleeve 330 may be included to guard the flexible material of the suppressor balloon 320 against unwanted interactions with the ambient environment. In such embodiments, one or more holes in the rigid sleeve 330 may also be provided to permit fluid (air) communication between the ambient environment and an outer surface of the spike suppressor balloon 320.

[0040] In various embodiments, the spike suppressor balloon 320 is made of any flexible and biocompatible material, including but not limited to rubber, silicone, elastomers, latex, polyurethane, thermoplastic, paper, and composites thereof. A thickness of the spike suppressor balloon 320 may be chosen based upon a desired flexibility of the spike suppressor balloon 320 in conjunction with chosen materials’ characteristics.141604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT

[0041] Figure 3B depicts the inline fluid aspiration device 300 during a pressure spike event in which the spike suppressor balloon 320 distends outwardly relative to the state depicted in Figure 3A. When negative pressure is reapplied, the spike suppressor balloon 320 returns to the relatively undistended state depicted in Figure 3A. It will be appreciated that particular proportions, especially a degree to which the spike suppressor balloon 320 distends, are depicted herein for example purposes only, and that actual embodiments of the present disclosure may possess different proportions, dimensions, and degrees of flexibility. Additionally, the presence of a rigid sleeve 330 may constrain the amount (and relative location) that the spike suppressor balloon 320 is permitted to distend.

[0042] Figure 4 illustrates an example exploded side-on view of a tubular component 310 of an inline fluid aspiration device 300, according to example embodiments of the present disclosure. As shown in Figure 4, the tubular component 310 may be manufactured separately from the spike suppressor balloon 320, which may be slid into place over the holes 312 of the tubular component 310 to form the inline fluid aspiration device 300. For example, the spike suppressor balloon 320 may be as a balloon or tube with two openings positioned longitudinally opposite end to one another and is assembled to be circumferentially disposed around the tubular component 310 and sealed on either end to an exterior surface of the tubular component 310. Sealing may be achieved via a press fit, a chemical bond, a mechanical bond, a locking ring, any other sealing means, or combinations thereof.151604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT

[0043] Similarly, to installation of the spike suppressor balloon 320, in some embodiments, if a rigid sleeve 330 is included, the rigid sleeve 330 may be manufactured separately from the spike suppressor balloon 320, and may be slid into place over the suppressor balloon 320 and the tubular component 310 to form the inline fluid aspiration device 300. In various embodiments, the rigid sleeve 330 may be held in place by clamping, sealing, or applying an adhesive to hold the rigid sleeve 330 to one or both of the spike suppressor balloon 320 and the tubular component 310.

[0044] Figures 5A and 5B illustrate example isometric transparent assembled views of orthogonal and diagonal filter assemblies, respectively, according to example embodiments of the present disclosure.

[0045] Figure 5A depicts an example isometric transparent assembled view of a filter assembly 500 in which a filter 120 is installed orthogonally to a general direction of fluid motion within the filter assembly 500. In this example, an ingress housing 110 defines an ingress chamber 114 and an egress housing 130 defines an egress chamber 134. Similarly to the examples in Figures 1A and 1 B, a first port 112 of the filter assembly 500 allows fluid communication between the ingress chamber 114 and a biological subject, while a second port 132 allows fluid communication between the egress chamber 134 and a negative pressure source. The filter 120 is disposed across a plane between the ingress chamber 114 and the egress chamber 134.161604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT

[0046] A bottom wall 530 of the egress chamber 134 includes several holes 520. These holes 520 allow fluid communication between the egress chamber 134 and an interior surface of a flexible diaphragm 140. The bottom wall 530 may be included to prevent a possibility of the flexible diaphragm 140 distending inwards to the egress chamber 134 and obstructing fluid communication via the second port 132. Some embodiments may omit the bottom wall 530. An expansion housing 150 defines an expansion chamber 154 which may protect the flexible diaphragm 140 from forces in the ambient environment (e.g., being bumped by a user). The expansion housing 150 may include a plurality of holes 152 which permit fluid (e.g., air) communication between an ambient environment and the expansion chamber 154.

[0047] Figure 5B is configured similarly to Figure 5A, but with the filter 120 being disposed on a plane diagonally positioned relative to a flow of fluid within the filter assembly 500 (see e.g., Figures 2A-2B). The fluid flowing through the filter assembly 500 may be any fluid found in or around biological subjects, including but not limited to blood, urine, water, saline solution, liquid medication, combinations thereof which may carry various solids that may be blocked or permitted to pass through the filter 120 based on the size and shape of the through- holes defined in the filter 120.

[0048] Figure 6 illustrates an example isometric transparent assembled view of a tubular component 310 of a biological fluid aspiration device 600, according to embodiments of the present disclosure. As in Figures 3A and 3B, the biological 171604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT fluid aspiration device 600 includes a tubular component 310 which in turn includes a plurality of holes 312. A spike suppressor balloon 320 made of a flexible material is circumferentially disposed around the tubular component 310 and sealed at each end to an exterior surface of the tubular component 310 with a seal 322. An envelope 314 is defined by an interior surface of the spike suppressor balloon 320 and an exterior surface of the tubular component 310.

[0049] The holes 312 in the tubular component 310 define a filter, which allows fluid communication between an interior lumen 610 of the tubular component 310 and the envelope 314. When a pressure spike event occurs (e.g., because a relief pressure cycle is initiated), the spike suppressor balloon 320 may distend outwardly as depicted in Figure 3B. In various embodiments, the number and diameters of the holes 312 may be configured to permit or deny the ability of various particles to pass from the lumen 610 of the tubular component 310 into the envelope 314 or vice versa. For example, the filter defined by the holes 312 may be a non-lysing filter, which avoids damaging the cells included in the fluid aspirated from a biological lumen so that the fluid and included cells may be returned to the biological subject after being filtered (e.g., to remove clots from a blood vessel and return the blood to a patient with intact / viable blood cells).

[0050] Figure 7 is an example flowchart of a method 700 of operation of a biological fluid aspiration device with pressure spike suppression means, according to example embodiments of the present disclosure.181604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT

[0051] At block 710, a pressure spike suppressor (e.g., flexible diaphragm 140) is placed in fluid communication between a negative pressure source and a biological lumen of a biological subject. In some embodiments, a suppressor balloon located in-line with tubing may be used as the pressure spike suppressor. In various use cases, the biological lumen includes an obstruction that will be aspirated via the application of negative pressure exerted by the negative pressure source. In some embodiments, a flexible diaphragm included in a filter assembly may be used as the pressure spike suppressor, where the filter assembly is configured to collect obstructions (e.g., clots) removed from the biological lumen along with the biological fluid (e.g., blood), which is allowed to pass through the filter. The filter may capture any solids larger than a pore size of the filter, and the biological fluid may be returned to the biological subject.

[0052] At block 720, a negative pressure source applies negative pressure to the biological lumen to aspirate the fluid (and any solids or obstructions include therewith) from the biological lumen towards the negative pressure source. For example, the vacuum pump may apply a negative pressure to a port of a filter assembly, which is communicated to the blood vessel (the biological lumen) via another port so as to draw the bodily fluid through a filter disposed between the ports. The negative pressure source (e.g., the vacuum pump) may be employed to draw biological fluid from the biological lumen and through the filter. A relief pressure may periodically be applied, wherein the relief pressure is higher than the negative pressure.191604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT

[0053] At block 730, a higher pressure is applied to the flow path between the negative pressure source and the biological lumen, resulting in a spike in pressure (higher than the negative pressure applied for aspiration) traveling as a pressure wave towards the biological lumen. In some examples, the vacuum pump may deactivate periodically to prevent an overpressure scenario wherein too low of a negative pressure is applied to the biological lumen for too long a time. In some examples, a positive pressure source may be applied to the flow path. Such a transition causes a wave of heightened pressure (relative to the negative pressure) to propagate from the negative pressure source along a system and towards the biological lumen. Block 720 and block 730 may be performed several times throughout an operation.

[0054] At block 740, the pressure spike suppressor engages to distend outwardly into an ambient environment in response to the pressure wave reaching the pressure spike suppressor, thereby reducing a magnitude of the pressure wave. For example, a flexible diaphragm may distend outwardly when the pressure wave reaches the filter assembly or a balloon suppressor may distend outwardly when the pressure wave passes the holes in the tubular component. The outward movement of the spike suppressor increases an effective fluid volume of the fluid pathway between the vacuum pump (the negative pressure source) and the spike suppressor. In doing so, much of the energy of the pressure wave may be absorbed in filling the increased volume with fluid, reducing a magnitude of the pressure wave as the pressure wave continues through the system towards the201604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT biological subject. This reduction in magnitude may correspond to a rigidity of the material used in the spike suppressor, and thus the spike suppressor may be configured (e.g., via materials, dimensions, etc.) to produce a desired reduction in pressure wave magnitude. Additionally, several spike suppressors may be incorporated at different positions along the system, and block 740 may be performed several times - distending the several spike suppressors to gradually reduce the magnitude of the pressure wave.

[0055] At block 750, the reduced-magnitude pressure wave is applied to the biological lumen. The reduced magnitude of the pressure wave may reduce a likelihood that captured obstructions are dislodged from a filter, pushed further into a biological lumen, or broken up during an aspiration operation. Reducing the magnitude of the pressure wave may also reduce pressure-induced movement of biological subject-facing portions of an aspiration system and thereby reduce a risk of a catheter or cannula becoming dislodged from the biological lumen.

[0056] At block 760, the pressure spike suppressor returns to a relaxed state once the pressure wave has passed. In various embodiments, the elasticity of the material used in the pressure spike suppressor allows the pressure spike suppressor to naturally return to the relaxed state from a distended state, although an operator may aid the return to the relaxed state (e.g., pushing the pressure spike suppressor inwardly). Block 760 may be performed multiple times when multiple pressure spike suppressors are included in the flow path of the system.211604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT

[0057] At block 770, an operator optionally returns any collected fluid to the biological subject from which the fluid was collected. For example, by maintaining the pressure in the bodily fluid collected by the system below the boiling point thereof, and by using non-lysing filters, the bodily fluid may retain viable cells therein and be filtered out of any aspirated obstructions (e.g., preserving viable blood that is free of clots).

[0058] The present disclosure may also be understood with reference to the following numbered clauses.

[0059] Clause 1 : A device, comprising: a first chamber; a second chamber; a filter defined between the first chamber and the second chamber and restricting fluid communication therebetween to block particles of a predefined size from transferring between the first chamber and the second chamber; and a pressure spike suppression means disposed between the first chamber and an ambient environment, configured to distend outwardly from the first chamber into the ambient environment when a pressure in the first chamber increases.

[0060] Clause 2: The device of any of clauses 1 -11 , wherein the pressure spike suppression means is a suppressor balloon, an interior envelope of the suppressor balloon defining the first chamber, wherein the second chamber is a lumen of a tube, and wherein the filter is a section of the tube in which a plurality of through-holes are defined between the lumen and the interior envelope.221604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT

[0061] Clause 3: The device of any of clauses 1-11 , wherein a housing defines the first chamber and the second chamber, wherein the pressure spike suppression means is a diaphragm, having a first side in communication with the first chamber and a second side, opposite to the first side, in communication with the ambient environment, and wherein the filter is held within the housing between the first chamber and the second chamber.

[0062] Clause 4: The device of any of clauses 1 -11 , wherein the first chamber is positioned vertically below the second chamber to permit fluid collected in the second chamber to feed, via gravity, through the filter into the first chamber.

[0063] Clause 5: The device of any of clauses 1 -11 , wherein the first chamber is positioned vertically above the second chamber to permit fluid collected in the first chamber to feed, via gravity, through the filter into the second chamber.

[0064] Clause 6: The device of any of clauses 1 -11 , wherein the pressure spike suppression means is contained within a third chamber, and wherein the third chamber is configured to maintain fluid communication with the first chamber on a first side of the pressure spike suppression means and to maintain fluid communication with an ambient environment on a second side of the pressure spike suppression means, opposite to the first side.

[0065] Clause 7: The device of any of clauses 1 -11 , wherein the pressure spike suppression means includes a biocompatible material selected of a silicone, a latex, a thermoplastic polyurethane, a rubber, or an elastomer.231604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT

[0066] Clause 8: The device of any of clauses 1-11 , wherein a fluid transferring between the first chamber and the second chamber is blood and the filter is non-lysing.

[0067] Clause 9: The device of any of clauses 1 -11 , wherein fluid communication between the pressure spike suppression means and the first chamber is maintained through a plurality of holes in a rigid wall disposed between the first chamber and the pressure spike suppression means.

[0068] Clause 10: The device of any of clauses 1 -11 , wherein fluid communication between the pressure spike suppression means and the ambient environment is maintained through a plurality of holes in a rigid wall disposed between the ambient environment and the pressure spike suppression means.

[0069] Clause 11 : The device of any of clauses 1 -11 , wherein the pressure spike suppression means is configured to return to an undistended state when the pressure in the first chamber returns to a previous state.

[0070] Clause 12: A device, comprising: an ingress housing configured to define a first chamber; an egress housing configured to define a second chamber; a filter, disposed between the ingress housing and the egress housing and configured to allow fluid passage between the first chamber and the second chamber; and a diaphragm affixed to a surface of the egress housing, wherein an interior surface of the diaphragm is in fluid communication with the second chamber, an exterior surface of the diaphragm is in fluid communication with an241604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT ambient environment, and wherein the diaphragm is configured to distend outwardly from the second chamber into the ambient environment when a pressure in the second chamber increases.

[0071] Clause 13: The device of any of clauses 12-15, wherein the ingress housing and the egress housing are visually transparent.

[0072] Clause 14: The device of any of clauses 12-15, wherein fluid communication between the diaphragm and the second chamber is maintained through a plurality of holes in a rigid wall disposed between the second chamber and the diaphragm.

[0073] Clause 15: The device of any of clauses 12-15, wherein fluid communication between the diaphragm and the ambient environment is maintained through a plurality of holes in a rigid wall disposed between the ambient environment and the diaphragm.

[0074] Clause 16: A device, comprising: a tube, in which a plurality of holes are defined in a wall of a section of the tube; and a balloon member disposed circumferentially around an exterior of the section of the tube and sealed to an exterior surface of the wall on a first end of the section and a second end of the section opposite to the first end, in fluid communication with an interior lumen of the tube via the plurality of holes and configured to distend outwardly from the wall in response to a rise in fluid pressure within the interior lumen.251604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT

[0075] Clause 17: The device of clause 16, wherein the interior lumen is in fluid communication with a negative pressure source on a first side of the tube and with a biological subject on a second side of the tube, opposite to the first side.

[0076] Clause 18: A method, comprising: placing a pressure spike suppressor in fluid communication between a negative pressure source and a biological lumen of a biological subject; applying a negative pressure, via the negative pressure source, to the biological lumen; applying a higher pressure than the negative pressure to a flow path between the negative pressure source and the biological lumen, thereby resulting in a pressure wave of the higher pressure traveling towards the biological lumen; distending the pressure spike suppressor from a resting state to a distended state that distends outwardly into an ambient environment in response to the pressure wave reaching the pressure spike suppressor, thereby reducing a magnitude of the pressure wave; and applying the pressure wave at the magnitude reduced by the pressure spike suppressor to the biological lumen.

[0077] Clause 19: The method of any of clauses 18-22, further comprising: reapplying negative pressure, via the negative pressure source; and returning the pressure spike suppressor from the distended state to the resting state.

[0078] Clause 20: The method of any of clauses 18-22, wherein the pressure spike suppressor is a balloon suppressor disposed circumferentially261604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT about a tube though which fluid communication is established between the negative pressure source and the biological lumen.

[0079] Clause 21 : The method of any of clauses 18-22, wherein the pressure spike suppressor is a diaphragm disposed in a housing in which a filter is disposed between the negative pressure source and the biological lumen.

[0080] Clause 22: The method of any of clauses 18-22, further comprising: returning a bodily fluid aspirated from the biological lumen via the negative pressure source to the biological subject.

[0081] The descriptions and illustrations of one or more embodiments provided in this disclosure are intended to provide a thorough and complete disclosure the full scope of the subject matter to those of ordinary skill in the relevant art and are not intended to limit or restrict the scope of the subject matter as claimed in any way. The aspects, examples, and details provided in this disclosure are considered sufficient to convey possession and enable those of ordinary skill in the relevant art to practice the best mode of the claimed subject matter. Descriptions of structures, resources, operations, and acts considered well-known to those of ordinary skill in the relevant art may be brief or omitted to avoid obscuring lesser known or unique aspects of the subject matter of this disclosure. The claimed subject matter should not be construed as being limited to any embodiment, aspect, example, or detail provided in this disclosure unless expressly stated herein. Regardless of whether shown or described collectively or separately, the various features (both structural and methodological) are intended to be selectively271604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT included or omitted to produce an embodiment with a particular set of features. Further, any or all of the functions and acts shown or described may be performed in any order or concurrently.

[0082] Having been provided with the description and illustration of the present disclosure, one of ordinary skill in the relevant art may envision variations, modifications, and alternate embodiments falling within the spirit of the broader aspects of the general inventive concept provided in this disclosure that do not depart from the broader scope of the present disclosure.

[0083] 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.

[0084] 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.281604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT

[0085] As used in the present disclosure, the terms “substantially”, “approximately”, “about”, and other relative terms encompass values within ± 5% of a stated quantity, percentage, or range unless a different approximation is explicitly recited in relation to the state quantity, percentage, or range or if the context of the value indicates that a different approximation would be more appropriate. For example, a value identified as about X% may be understood to include values between 0.95*X% and 1 ,05*X% or between X-0.05X and X+0.05X percent, but may stop at zero or one hundred percent in various contexts. In another example, a feature described as being substantially parallel or perpendicular to another feature shall be understood to be within ± 9 degrees of parallel or perpendicular. Any value stated in relative terms shall be understood to include the stated value and any range or subrange between the indicated or implicit extremes.

[0086] As used in the present disclosure, all numbers given in the examples (whether indicated as approximate or otherwise) inherently include values within the range of precision and rounding error for that number. For example, the number 4.5 shall be understood to include values from 4.45 to 4.54, while the number 4.50 shall be understood to include values from 4.495 to 4.504. Additionally, any number or range that explicitly or by context refers to an integer amount (e.g., approximately X users, between about Y and Z states), shall be understood to round downward or upward to the next integer value (e.g., X±1 users, Y-1 and Z+1 states).291604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT

[0087] The following claims are not intended to be limited to the embodiments shown herein, but are to be accorded the full scope consistent with the language of the claims. 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 aspects 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.301604260211.1

Claims

Atty Docket: 1956788.00445Client No.: 2023-217-PCTCLAIMS:What is claimed is:

1. A device, comprising: a first chamber; a second chamber; a filter defined between the first chamber and the second chamber and restricting fluid communication therebetween to block particles of a predefined size from transferring between the first chamber and the second chamber; and a pressure spike suppression means disposed between the first chamber and an ambient environment, configured to distend outwardly from the first chamber into the ambient environment when a pressure in the first chamber increases.

2. The device of claim 1 , wherein the pressure spike suppression means is a suppressor balloon, an interior envelope of the suppressor balloon defining the first chamber, wherein the second chamber is a lumen of a tube, and wherein the filter is a section of the tube in which a plurality of through- holes are defined between the lumen and the interior envelope.

3. The device of claim 1 , wherein a housing defines the first chamber and the second chamber,311604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT wherein the pressure spike suppression means is a diaphragm, having a first side in communication with the first chamber and a second side, opposite to the first side, in communication with the ambient environment, and wherein the filter is held within the housing between the first chamber and the second chamber.

4. The device of claim 3, wherein the first chamber is positioned vertically below the second chamber to permit fluid collected in the second chamber to feed, via gravity, through the filter into the first chamber.

5. The device of claim 3, wherein the first chamber is positioned vertically above the second chamber to permit fluid collected in the first chamber to feed, via gravity, through the filter into the second chamber.

6. The device of claim 1 , wherein the pressure spike suppression means is contained within a third chamber, and wherein the third chamber is configured to maintain fluid communication with the first chamber on a first side of the pressure spike suppression means and to maintain fluid communication with an ambient environment on a second side of the pressure spike suppression means, opposite to the first side.321604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT7. The device of claim 1 , wherein the pressure spike suppression means includes a biocompatible material selected of a silicone, a latex, a thermoplastic polyurethane, a rubber, or an elastomer.

8. The device of claim 1 , wherein a fluid transferring between the first chamber and the second chamber is blood and the filter is non-lysing.

9. The device of claim 1 , wherein fluid communication between the pressure spike suppression means and the first chamber is maintained through a plurality of holes in a rigid wall disposed between the first chamber and the pressure spike suppression means.

10. The device of claim 1 , wherein fluid communication between the pressure spike suppression means and the ambient environment is maintained through a plurality of holes in a rigid wall disposed between the ambient environment and the pressure spike suppression means.11 . The device of claim 1 , wherein the pressure spike suppression means is configured to return to an undistended state when the pressure in the first chamber returns to a previous state.

12. A device, comprising:331604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT an ingress housing configured to define a first chamber; an egress housing configured to define a second chamber; a filter, disposed between the ingress housing and the egress housing and configured to allow fluid passage between the first chamber and the second chamber; and a diaphragm affixed to a surface of the egress housing, wherein an interior surface of the diaphragm is in fluid communication with the second chamber, an exterior surface of the diaphragm is in fluid communication with an ambient environment, and wherein the diaphragm is configured to distend outwardly from the second chamber into the ambient environment when a pressure in the second chamber increases.

13. The device of claim 12, wherein the ingress housing and the egress housing are visually transparent.

14. The device of claim 12, wherein fluid communication between the diaphragm and the second chamber is maintained through a plurality of holes in a rigid wall disposed between the second chamber and the diaphragm.

15. The device of claim 12, wherein fluid communication between the diaphragm and the ambient environment is maintained through a plurality of341604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT holes in a rigid wall disposed between the ambient environment and the diaphragm.

16. A device, comprising: a tube, in which a plurality of holes are defined in a wall of a section of the tube; and a balloon member disposed circumferentially around an exterior of the section of the tube and sealed to an exterior surface of the wall on a first end of the section and a second end of the section opposite to the first end, in fluid communication with an interior lumen of the tube via the plurality of holes and configured to distend outwardly from the wall in response to a rise in fluid pressure within the interior lumen.

17. The device of claim 16, wherein the interior lumen is in fluid communication with a negative pressure source on a first side of the tube and with a biological subject on a second side of the tube, opposite to the first side.

18. A method, comprising: placing a pressure spike suppressor in fluid communication between a negative pressure source and a biological lumen of a biological subject; applying a negative pressure, via the negative pressure source, to the biological lumen;351604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT applying a higher pressure than the negative pressure to a flow path between the negative pressure source and the biological lumen, thereby resulting in a pressure wave of the higher pressure traveling towards the biological lumen; distending the pressure spike suppressor from a resting state to a distended state that distends outwardly into an ambient environment in response to the pressure wave reaching the pressure spike suppressor, thereby reducing a magnitude of the pressure wave; and applying the pressure wave at the magnitude reduced by the pressure spike suppressor to the biological lumen.

19. The method of claim 18, further comprising: reapplying negative pressure, via the negative pressure source; and returning the pressure spike suppressor from the distended state to the resting state.

20. The method of claim 18, wherein the pressure spike suppressor is a balloon suppressor disposed circumferentially about a tube though which fluid communication is established between the negative pressure source and the biological lumen.361604260211.1Atty Docket: 1956788.00445Client No.: 2023-217-PCT21 . The method of claim 18, wherein the pressure spike suppressor is a diaphragm disposed in a housing in which a filter is disposed between the negative pressure source and the biological lumen.

22. The method of claim 18, further comprising: returning a bodily fluid aspirated from the biological lumen via the negative pressure source to the biological subject.371604260211.1

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