Aspirating filter syringe

Abstract

An aspirating filter syringe is provided with an outer barrel having a first lumen of a first diameter and a return port in the first lumen; an inner barrel having a second lumen of a second diameter, less than the first diameter, secured within the first lumen, having a plurality of through-holes allowing fluid communication between the inner barrel and the outer barrel and an intake port in the second lumen; a filter disposed between the first lumen and the second lumen over the plurality of through-holes; and a plunger disposed in the second lumen.

Description

ASPIRATING FILTER SYRINGECROSS-REFERENCES TO RELATED APPLICATIONS

[0001] The present disclosure claims the benefit of U.S. Provisional Patent Application No.: 63 / 530,398 entitled “ASPIRATING FILTER SYRINGE” and filed on 2023-08-02, which is incorporated herein by reference in its entirety.BACKGROUND

[0002] When aspirating body fluids and any solids carried therewith (e.g., embolisms in blood), an aspiration catheter is used that can draw significant quantities of collateral bodily fluid in addition to the solids. Significant loss of certain bodily fluids (e.g., blood) can have serious negative effects on a biological subject, so returning as much fluid as is practical to the biological subject after solids have been removed is desirable.SUMMARY

[0003] The present disclosure is generally related to an aspirating filter syringe that allows a user to return bodily fluid to a biological subject after solids have been aspirated with those fluids from a biological subject. The syringe includes several features to allow quick repeatability within a procedure without replacement of the device or excessive loss of bodily fluids. The syringe also maintains compatibility with current devices and accessories (e.g., catheters, stopcocks, pumps, etc.), and helps operators reduce the duration of clinical procedures.

[0004] One embodiment of the present disclosure is a device, comprising: an outer barrel having a first lumen of a first diameter and a return port in the first lumen; an inner barrel having a second lumen of a second diameter, less than the first diameter, secured within the first lumen, having a plurality of through-holes allowing fluid communication between the inner barrel and the outer barrel and an intake port in the second lumen; a filter disposed between the first lumen and the second lumen over the plurality of through-holes; and a plunger disposed in the second lumen.

[0005] One embodiment of the present disclosure is a device, comprising: an outer barrel having a first lumen of a first diameter and including a return port defined in a first wall of the first lumen; an inner barrel having a second lumen of a second diameter, less than the first diameter, secured within the first lumen, and including a filtering means defined in a second wall of the second lumen; and a plunger disposed in the second lumen.

[0006] One embodiment of the present disclosure is a device, comprising: an outer barrel having a first lumen of a first diameter and including: a first opening on a first end of the first lumen; a second opening on a second side of the first lumen; and a return port defined in a first wall of the first lumen between the first opening and the second opening; and an inner barrel having a second lumen of a second diameter, less than the first diameter, secured within the first lumen, and including: a first port extending through the first opening; a second port extending through the second opening; and a porous filter defined in a second wall of the secondlumen between the first port and the second port; and a pressure imparting means connected to the second port.

[0007] One embodiment of the present disclosure is a method, comprising: opening fluid communication between a biological subject and an intake port and a return port of a filtering aspiration device; applying negative pressure to a first lumen of the filtering aspiration device in fluid communication to a second lumen via a filter to draw a bodily fluid from the biological subject through the intake port; collecting the bodily fluid in the first lumen, wherein the bodily fluid contains an obstruction aspirated from the biological subject; separating the obstruction from the bodily fluid via the filter, to hold the obstruction in the first lumen and pass the bodily fluid into a second lumen in which the first lumen is included; and returning the bodily fluid passed to the second lumen to the biological subject via the return port.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] 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.

[0009] 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 severalFigures.

[0010] 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 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.

[0011] Figure 1A provides a view of an assembled device, according to embodiments of the present disclosure.

[0012] Figure 1 B provides an exploded parts view of a device, according to embodiments of the present disclosure

[0013] Figures 2A-2C provide views of a filter, according to embodiments of the present disclosure.

[0014] Figures 3A and 3B provide views of example plungers, according to embodiments of the present disclosure.

[0015] Figures 4A-4C provide views of an outer barrel, according to embodiments of the present disclosure.

[0016] Figures 5A-5D provide views of an inner barrel, according to embodiments of the present disclosure.

[0017] Figure 6 provides an illustration of the movement of bodily fluids through the device, according to embodiments of the present disclosure.

[0018] Figure 7 is a flowchart describing the user operation of the device, according to embodiments of the present disclosure.DETAILED DESCRIPTION

[0019] The present disclosure is generally related to an improved filtering aspiration device that allows bodily fluid drawn from a biological subject to be returned to the subject’s body after the drawn bodily fluid (e.g., blood, lymph, cerebral-spinal fluid) has been filtered to remove any aspirated solids. The aspiration device described herein allows for avoiding excessive blood loss during aspiration, avoiding the need for blood transfusions following or during aspiration, and allowing for more of the bodily fluid to be filtered on account of that the biological subject does not lose the bodily fluid, among other benefits.

[0020] The described system includes a syringe with an inner barrel, an outer barrel, a filtering means (see Figures 2A-2C), a pressure imparting means (e.g., a pump or a plunger, see Figures 3A and 3B) an intake port, and a return port. Through-holes in the wall of the inner barrel allow bodily fluids drawn through the intake port to pass through the filter, which is located between the inner and outer barrels. Clots, stones, plaques, and other solids are retained by this filter while the bodily fluid passes through. In this way, the solids are separated from the bodily fluid. Once the bodily fluid has passed through the filter, the bodily fluids may bereturned to the biological subject through the return port located on the wall of the outer barrel.

[0021] Figures 1A and 1 B provide a view of the device 100, in an assembled state and an exploded state, respectively, according to embodiments of the present disclosure.

[0022] Figure 1A provides a view of the assembled device 100, according to embodiments of the present disclosure. In Figure 1A, an inner barrel 150 is secured inside a lumen of an outer barrel 1 0. In various embodiments, a filter 120 is placed in contact with an outer wall of the inner barrel 150 to form a filtration section within the lumen of the outer barrel 140, and may be held in place via friction, tabs, adhesives, compression between the two lumens, or the like. In some embodiments, the filter 120 is placed in contact with an inner wall of the inner barrel 150 to form a filtration section, and may be held in place via friction, tabs, adhesives, or the like. In this embodiment, the gasket 160 (one or more of gaskets 160a and 160b) may drag along the filter 120 or filtration section generally when in use, depending on the dimensions and materials used, possibly causing the filter 120 and gasket 160 to snag or catch on one another. To reduce the likelihood or degree of unwanted dragging / catching, the filter 120 may comprise a cartridge filter (not shown). Laterally defined through-holes in the outer wall of the inner barrel 150 and pores in the filter 120 provide a filtration means to permit bodily fluids to flow from the lumen of the inner barrel 150 outward to the lumen of the outer barrel 140, while capturing various solids too large to pass through thefiltrations means within the inner barrel 150. In various embodiments, depending on the size of the solids to be captured relative to the through-holes defined in the inner barrel 150, the filter 120 may be omitted from the filtration means, and the filtration section may therefore be defined by at least the through-holes, and optionally by the presence of a filter 120 disposed in the flowpath between the respective lumens of the inner barrel 150 and the outer barrel 140 (e.g., over or under the though-holes). In another embodiment, the through-holes on the inner barrel 150 may comprise “micro pores” that act as the filter section, obviating the need for a separate filter 120 element. In this embodiment, the inner barrel 150 may be removable and / or replaceable in the event that one or more through-holes of the inner barrel 150 become clogged during use.

[0023] A plunger 130 is located within the lumen of the inner barrel 150 for use as a negative pressure source, although in some embodiments the plunger 130 may be omitted and substituted with another negative pressure source (e.g., a pump). A stopper 110 is secured through the wall of the inner barrel 150, which prevents the plunger 130 from being drawn fully out of the lumen of the inner barrel 150 by making physical contact with the plunger 130 when the plunger 130 is drawn out to the fullest intended extent.

[0024] During use, the device 100 pulls bodily fluids through the intake port 152 into the lumen of the inner barrel 150 by means of the user drawing the plunger 130 outward from the inner lumen (or applying another negative pressure source). The bodily fluids then move into through-holes in the wall of the inner barrel 150and into the filter 120. The filter 120 captures any clots, stones, plaques, and other solids while permitting liquids and smaller solids (e.g., blood cells) to pass through. The filtered bodily fluid can then be returned to the biological subject via the return port 142. More detailed views of embodiments of the filter 120 can be found in Figures 2A-2C. Embodiments of the plunger 130 are presented in greater detail in Figures 3A and 3B. Figures 4A-4C provide more detailed views of embodiments of the outer barrel 140. Greater detail regarding embodiments of the inner barrel 150 can be found in Figures 5A-5D.

[0025] In Figure 1 B the device 100 is shown in an exploded view, according to embodiments of the present disclosure. The device 100 includes a first gasket 160a (generally or collectively, gasket 160) disposed circumferentially to the intake port 152 at an end-face of the inner barrel 150 on a first side of interlocking threads located on the outside of the inner barrel 150 and the inside of the outer barrel 140, when assembled. The first gasket 160a prevents bodily fluids that are passing through the intake port 152 from entering the interlocking threads and helps form a seal for negative pressure to be applied to the biological subject via the device 100 when assembled.

[0026] A second gasket 160b is disposed circumferentially to the inner barrel 150. The second gasket 160b is in contact with an inner wall of the outer barrel 140 and the outer wall of the inner barrel 150 on a first side of filter 120 when the device 100 is assembled. In some embodiments, the second gasket 160b is also in contact with the side of the interlocking threads longitudinally opposite to the firstgasket 160a. The second gasket 160b prevents bodily fluid that has passed through the wall of the inner barrel 150 from entering the interlocking threads and helps form a seal for negative pressure to be applied to the biological subject via the device 100 when assembled.

[0027] A third gasket 160c is disposed circumferentially to the inner barrel 150. When the device is assembled, the third gasket 160c is in contact with an inner wall of the outer barrel 140 and the outer wall of the inner barrel 150 on a second side of the filter 120, longitudinally opposite to the side of the filter 120 that, in some embodiments, is in contact with the second gasket 160b. The third gasket 160c prevents bodily fluid that has passed through the wall of the inner barrel 150 from exiting the device through the interface between the inner barrel 150 and the outer barrel 140 that is longitudinally opposite to the interlocking threads and helps form a seal for negative pressure to be applied to the biological subject via the device 100 when assembled.

[0028] A fourth gasket 160d is disposed circumferentially to the plunger 130 and is in contact with an inner wall of the inner barrel 150 and the outer surface of the plunger 130 when the device 100 is assembled. The fourth gasket 160d is a head gasket that serves as a seal between the plunger 130 and the inner barrel 150, preventing inflow of air from a plunger port (580, see Figure 5A) and allowing the plunger 130 to be used to apply fluid pressure within the lumen inside the inner barrel 150.

[0029] In various embodiments, the gaskets 160 are configured to maintain an airtight seal or joint at imparted pressures of ±20 pounds per square inch (psi), ±40 psi, or the like. In some embodiments, the interlocking threads and the second gasket 160b are located longitudinally opposite to the intake port 152. In some embodiments, one or more of the interlocking threads and the gaskets 160a-c may be omitted based on differing arrangements of the components or using a permanent seal between the inner barrel 150 and the outer barrel 140.

[0030] Figures 2A-2C provide views of the filter 120, according to embodiments of the present disclosure.

[0031] Figure 2A is a view of an example filter 120 with an arc distance of 360 degrees, according to embodiments of the present disclosure. As illustrated, the filter 120 is a cylinder of a filtration material 210 with an inner wall 220 and an outer wall 230. Although illustrated with regular circular edges on the end-faces of the cylinder, in some embodiments cut-outs or other irregularities on the end-faces may be included to define negative spaces that interact with protrusions from the outer wall of the inner barrel 150 to act as a go / no-go element to ensure a desired orientation for the filter 120 in the installed state. In some embodiments, the length of the filter 120 is two thirds or less than the length of the lumen of the inner barrel 150, and is sized according to a porous portion of the inner barrel 150.

[0032] Figure 2B is a view of the filter 120 with an arc distance of between 180 and 360 degrees, according to embodiments of the present disclosure. As illustrated, the filter 120 is a partial cylinder of a filtration material 210 with an innerwall 220, an outer wall 230, and a gap or slot 240 that runs the length of the cylinder. In some embodiments, the gap or slot 240 is positioned within the device 100 to align with a region (512) of the inner barrel 150 that lacks through-holes, as is discussed in greater detail in regard to Figure 5D. Although illustrated with a gap or slot 240 covering approximately 60 degrees of arc distance that includes a rectangular edge profile, in some embodiments the gap or slot 240 covers an arc distance greater or lesser than 60 degrees or includes a differently shaped edge profile to act as a go / no-go element to ensure a desired orientation for the filter 120 in the installed state.

[0033] Figure 2C is a view of the filter 120 with an arc distance of less than 180 degrees, according to embodiments of the present disclosure. As illustrated, the filter 120 is a curved sheet of filtration material 210 with an inner wall 220 and an outer wall 230. Although illustrated as a curved sheet of filtration material 210 that covers an arc distance of approximately 120 degrees that has a rectangular edge profile, in some embodiments the filtration material 210 covers an arc distance greater or lesser than 120 degrees or includes a differently shaped edge profile to act as a go / no-go element to ensure a desired orientation for the filter 120 in the installed state.

[0034] In the various embodiments of the filter 120, bodily fluids enter the filtration material 210 through the inner wall 220 and exit through the outer wall 230. In some embodiments, the filtration material 210 is positioned within the device 100 to align with a portion of the inner barrel 150 that has through-holes.Large solids suspended in bodily fluids are captured by the curved sheet of filtration material 210, which in some embodiments has pores that are sized to be non-lysing (e.g., allowing red blood cells to pass through unbroken). For example, the pores may have an area of 40-160 square micrometers (pm2), which allows red blood cells to pass through the pores without being broken (e.g., lysed). Accordingly, a non-lysing filter 120 can return a bodily fluid with intact (e.g., usable by the biological subject) red blood cells to the biological subject, with larger solids (e.g., thromboses, plaques, foreign bodies, necrotic tissue, etc.) removed from the bodily fluid. The device 100 is designed such that the filter 120 can be quickly and easily removed and replaced or cleaned during operation of the device 100, such as when a clog occurs.

[0035] The thickness of the filter 120 can vary in different embodiments, and may be based, in part, of the gap distance between an outer diameter of the inner barrel 150 and an inner diameter of the outer barrel 140. In various embodiments, a difference between the outer diameter and the inner diameter is at between 2-4 mm (approximately, 0.08-0.15 inches), which defines a fluid-return gap between the first lumen and the second lumen that the filter 120 at least partially occupies (see, Figure 6 for greater detail). A filter 120 having a thickness of approximately 1.4 mm, or between 35-70% of the example fluid-return gap of 2-4 mm in this example, would reduce the free space in the fluid-return gap to approximately between 0.6-2.6 mm, although various thicknesses are contemplated for the filter

[0036] Figures 3A and 3B provide views of example plungers 130, according to embodiments of the present disclosure.

[0037] Figure 3A is a view of an example plunger 130, according to embodiments of the present disclosure. The plunger 130 includes a head 310 for drawing pressure when sealed against the inner wall of the inner barrel 150, a handle 330 for an operator to interact with when drawing or pushing the plunger 130, and a body 320 that connects the head 310 to the handle 330. The handle 330, when drawn outward from the assembled device 100 by an operator, draws the rest of the plunger 130 outward and causes the head 310 to change the volume of a sealed portion of the lumen of the inner barrel 150, which in turn applies a negative pressure to the intake port 152.

[0038] Figure 3B is a view of an example plunger 130, according to embodiments of the present disclosure. The plunger 130 consists of a first head 310 for drawing pressure when sealed against the inner wall of the inner barrel 150, a second head 340 for drawing pressure when sealed against the inner wall of the inner barrel 150, a handle 330 for an operator to interact with when drawing or pushing the plunger 130, and a body 320 that connects the first head 310 and the second head 340 to the handle 330. The handle 330, when drawn outward from the assembled device 100 by an operator, draws the rest of the plunger 130 outward and causes the head 310 to change the volume of a sealed portion of the lumen of the inner barrel 150 and in turn apply a fluid pressure to the intake port152. Additionally, because the presence of through-holes in the inner barrel 150introduces the possibility of a loss of fluid pressure when drawing the plunger 130, the second head 340 maintains fluid pressure by sealing against a different portion of the inner wall of the inner barrel 150 that lacks through-holes once when the first head 310 reaches the filtration portion 510 (see e.g., Figures 5A-5D).

[0039] Figures 4A-4C provide views of example outer barrels 140, according to embodiments of the present disclosure.

[0040] Figure 4A is a view of an example outer barrel 140 with threads at the intake port 152 end, according to embodiments of the present disclosure. As illustrated, the outer barrel 140 includes a body 460 shaped substantially as a cylinder, and is made of a rigid material such as nylon, plastic, metal, or glass. The body 460 includes a return port 142 defined on a side wall, a first opening 410 defined at one end of the body 460, a second opening 420 defined at an end of the body 460 longitudinally opposite to the first opening 410, and a threaded portion 450 defined on an inner wall of the body proximal to the first opening 410, relative to the second opening 420. The first opening 410 allows the intake port 152 to project outward from the inner barrel 150 when the device 100 is assembled, the second opening 420 allows the insertion of the inner barrel 150 into the outer barrel 140, and the return port 142 permits filtered fluid to exit the lumen of the outer barrel 140 while the device 100 is in operation. In some embodiments, the return port 142 includes adapters for connecting the return port 142 to tubing and tubing accessories that connect to the biological subject and control the flow of bodily fluids. In various embodiments, the threaded portion 450 secures the outerbarrel 140 to the inner barrel 150 via a corresponding threaded portion 550 in the inner barrel 150 (see Figure 5A); however, other designs may include different securing means.

[0041] For example, Figure 4B is a view of an example outer barrel 140 with threads at the end opposite the intake port 152, according to embodiments of the present disclosure. When the threaded portion 450 of the outer barrel 140 is positioned proximal to the second opening 420 relative to the first opening 410, the corresponding threaded portion 550 in the inner barrel 150 are similarly located (see Figure 5B).

[0042] In another example, Figure 4C is a view of an outer barrel 140 without threads, according to embodiments of the present disclosure. When no threads are included on the body 460, the outer barrel 140 may be secured to the inner barrel 150 using, in various embodiments, thermal welds, epoxy, adhesives, or other attachment means. In some embodiments, the outer barrel 140 and inner barrel 150 are constructed as a single component, such as via an additive manufacturing process.

[0043] Although not illustrated in Figures 4A-4C, various gaskets 160 may be included or attached to the body 460 to help maintain seals when the device 100 is in use. In some embodiments, the first gasket 160a is attached to the outer barrel 140 on an inner surface surrounding the first opening 410 (see Figures 4A-4C). In some embodiments, the second gasket 160b is attached to an inner surface of the body 460 proximal to the threaded portion 450 relative to the second opening 420(see Figure 4A). In some embodiments, the third gasket 160c is attached to the inner surface of the body 460 proximal to the second opening 420 relative to the threaded portion 450 (see Figure 4A) or proximal to the threaded portion 450 relative to the first opening 410 (see Figure 4B). These gasket attachment points may be made in addition to, in combination with, or instead of using attachment points on the outer surface of the inner barrel 150.

[0044] Figures 5A-5D provide views of example inner barrels 150, according to embodiments of the present disclosure.

[0045] Figure 5A is a view of an example inner barrel 150 with a threaded portion 550 at the intake port 152 end, according to embodiments of the present disclosure. The inner barrel 150 includes a porous filtration portion 510 with a plurality of through-holes 570 defined through the wall of the filtration portion 510. The plurality of through-holes 570 allows fluid communication between the lumen of the inner barrel 150 and a fluid return gap defined by a portion of the lumen of the outer barrel 140 that is not occupied by the inner barrel 150 or the filter 120. The fluid communication allowed by the through-holes includes passing the bodily fluids through the filter 120, which is in contact with the filtration portion 510.

[0046] At one end of the filtration portion 510 of the inner barrel 150 is a first nonporous portion 520, and at the other end is a second nonporous portion 530, which include various seatings 560a-c (generally or collectively, seating 560) for gaskets 160 to secure to the inner barrel 150. In Figure 5A, the first nonporous portion 520 includes a threaded portion 550 and a second seating 560b. Thethreaded portion 550 secures the inner barrel 150 to the outer barrel 140 via a corresponding threaded portion 450 in the outer barrel 140 when the device 100 is assembled (see Figure 4A). The second seating 560b holds the second gasket 160b in place when the device 100 is assembled (see Figure 1 B).

[0047] The second nonporous portion 530 of the inner barrel 150 is attached to the filtration portion 510 on an end longitudinally opposite to the first nonporous portion 520 of the cylinder. The second nonporous portion 530 includes a third seating 560c and a mounting point 532. The third seating 560c holds the third gasket 160c in place and the mounting point 532 secures the stopper 110 in place when the device 100 is assembled. A plunger port 580 is located at the end of the second nonporous portion 530 longitudinally opposite to the first nonporous portion 520. The plunger port 580 permits the movement of the plunger 130 into and out of the lumen of the inner barrel 150, to a draw distance controlled by the stopper 110 (see Figure 1 B).

[0048] In various embodiments, the nonporous sections each occupy at least fifteen percent of the length of the inner barrel 150 on longitudinally opposing sides of the filtration portion 510, with the remainder of the length being occupied by the filtration portion 510. In various embodiments, the lengths of the nonporous sections permit the plunger 130 to form a stronger seal than the filtration portion 510 (e.g., due to the present of through-holes and pores through which bodily fluids are designed to pass). Accordingly, the distance between the nonporous sections and the distance between a first head and a second head of a two-headed plunger130 (see e.g., Figure 2B) are configured such that at least one plunger head maintains a seal against a nonporous section at any given time when the device 100 is assembled and in use.

[0049] An end wall 540 encloses the end of the first nonporous portion 520 longitudinally opposite to the plunger port 580. The intake port 152 is included at the end wall 540, and permits fluid to flow into the lumen of the inner barrel 150 through an opening 542. A first seating 560a located around the intake port 152 and proximal to the end wall 540 holds the first gasket 160a in place when the device 100 is assembled (see Figure 1 B). In some embodiments, the intake port 152 includes adapters for connecting the intake port 152 to tubing and tubing accessories that connect to the biological subject and control the flow of bodily fluids.

[0050] The inner barrel 150, at least for the filtration portion 510, has an outer diameter smaller than that the inner diameter of the filter 120 (in some embodiments the diameter of the inner curve of the sheet of filtration material 210). The outer diameter of the inner barrel 150 and the outer diameter of the filter 120 (or the outer curve of the filtration material 210) are, in turn, smaller than the inner diameter of the outer barrel 140. In some embodiments, the relative diameters of the inner barrel 150, the filter 120, and the outer barrel 140 are chosen such that an empty portion of the lumen of the outer barrel 140 exists outside of the filter 120. In some embodiments, the filter 120 is sized such that an inner surface of the filter 120 is in contact with an outer surface of the inner barrel 150.

[0051] Figure 5B is a view of an example inner barrel 150 with a threaded portion 550 at the end opposite the intake port 152, according to embodiments of the present disclosure. Similarly to the inner barrel 150 shown in Figure 5A, the inner barrel 150 shown in Figure 5B includes a filtration portion 510 with a plurality of through-holes 570, a first nonporous portion 520, a second nonporous portion 530 with a mounting point 532 and a third seating 560c, an end wall 540, an intake port 152 with an opening 542 and a first seating 560a, and a plunger port 580. In the illustrated embodiment, the threaded portion 550 is included on the second nonporous portion 530. The threaded portion 550 secures the inner barrel 150 to the outer barrel 140 via a corresponding threaded portion 450 in the outer barrel 140 when the device 100 is assembled (see Figure 4B). Embodiments that place the threaded portion 550 at the second nonporous portion 530 may omit the second seating 560b because the threaded portion 550 may now be sealed from the lumen within the outer barrel 140 by the third gasket 160c.

[0052] Figure 5C is a view of an example inner barrel 150 without threads, according to embodiments of the present disclosure. Similarly to the inner barrel 150 shown in Figure 5A, the inner barrel 150 shown in Figure 5C includes a filtration portion 510 with a plurality of through-holes 570, a first nonporous portion 520, a second nonporous portion 530 with a mounting point 532, an end wall 540, an intake port 152 with an opening 542, and a plunger port 580. In the illustrated embodiment, the threaded portion 550 is omitted, and the inner barrel 150 may be secured to the outer barrel 140 using various permanent means of attachment(e.g., a thermal weld, epoxy, adhesive, etc ). When permanently attached, the outer barrel 140 may omit the seatings 560 and the device 100 may omit the gaskets 160 because the permanent attachment creates sealed joints or eliminates interfaces between components that the gaskets 160 help seal.

[0053] Figure 5D is a view of an example inner barrel 150 that includes a region lacking through-holes, according to embodiments of the present disclosure.

[0054] Similarly to the inner barrel 150 shown in Figure 5A, the inner barrel 150 shown in Figure 5D includes a filtration portion 510 with a plurality of through-holes 570, a first nonporous portion 520 with a threaded portion 550 and a second seating 560b, a second nonporous portion 530 with a mounting point 532 and a third seating 560c, an end wall 540, an intake port 152 with an opening 542 and a first seating 560a, and a plunger port 580. In the illustrated embodiment, a region 512 lacking through-holes exists in a wall of the filtration portion 510. In various embodiments, the region 512 corresponds with the gap or slot 240 in the filter 120 and protrudes from the outer surface of the inner barrel 150 to prevent the filter 120 from rotating within the lumen of the outer barrel 140 when the device 100 is assembled.

[0055] Figure 6 illustrates movement of bodily fluids through the device 100 for the capture of solids 630, according to embodiments of the present disclosure. When the plunger 130 is drawn outward, or negative pressure is otherwise exerted via the device 100 on a biological subject, bodily fluid enters a first lumen 610 of the inner barrel 150. These bodily fluids may contain solids 630 being aspiratedfrom the biological subject. The bodily fluid flows from the first lumen 610 into through-holes in the wall of the inner barrel 150 and pores in the filter 120, and then into a second lumen 620 of the outer barrel 140. The bodily fluid flows from the second lumen 620 to the return port 142 where the bodily fluid leaves out of an opening 430 in the return port 142, to potentially be returned to the biological subject.

[0056] Figure 7 is a flowchart of an example method 700, according to embodiments of the present disclosure.

[0057] At block 710, an operator opens fluid communication to a biological subject. In various embodiments, the operator opens fluid communication between the biological subject and the intake port 152 and between the return port 142 and the biological subject. Accordingly, the device 100 can draw bodily fluid into the lumens, capturing any solids in the inner lumen 610, and allow the now solids-free bodily fluid in the outer lumen 620 to be returned to the biological subject. In various embodiments, one or more valves or stopcocks are disposed between the device 100 and the biological subject, which are connected via various tubing, catheters, or ports / punctures in the biological subject to allow the operator to selectively open and close fluid communication between the biological subject and the device 100.

[0058] At block 720, the operator applies negative pressure to the bodily fluid. The application of negative pressure may be accomplished by drawing the plunger 130 outward from the assembled device 100, by engaging a pump, or by another means. The negative pressure causes bodily fluid to enter the device 100 via theintake port 152. Additionally, the operator may apply negative pressure to the return port 142 to encourage the bodily fluid collected in the outer lumen 620 to be extracted from the device 100. In various embodiments, the operator may apply the negative pressures at the same time or at different times.

[0059] At block 730, the device 100 collects bodily fluid that may contain solids 630 in the lumen of the inner barrel 150. The collected fluid passes into the through-holes 570 in the wall of the filtration portion 510 of the inner barrel 150 (see Figures 5A-5D and 6).

[0060] At block 740, the device 100 separates the solids 630 from the bodily fluid. The bodily fluid passes from the through-holes 570 in the wall of the inner barrel 150 into the pores of the filter 120. The filter 120 captures the larger solids 630, or otherwise prevents the larger solids 630 from leaving the inner lumen, while allowing the bodily fluid and smaller solids (e.g., blood cells) to pass into the outer lumen 620 of the outer barrel 140 (see Figures 5A-5D and 6).

[0061] At block 750, the device 100 returns the bodily fluid to the biological subject. In some embodiments, the bodily fluid leaves the device 100 through the return port 142 and is sent directly back to the biological subject. In various embodiments, the operator may apply positive pressure to the bodily fluid collected in the inner lumen 610 (e.g. , by pushing the plunger 130 inward, reversing a pump) to push the bodily fluid outward from the inner lumen 610 to the outer lumen 620 and through the return port 142. In embodiments where the operator applies positive pressure, the operator may close fluid communication between the intakeport 152 and the biological subject prior to applying positive pressure. Additionally or alternatively, the operator may apply negative pressure to the return port 142 to pull the bodily fluid from the inner lumen 610 to the outer lumen 620 and out of the device 100 into a collection container to then return (indirectly) to the biological subject.

[0062] At block 760, the operator determines whether a clog has occurred or the plunger 130 has reached an end of travel (e.g., the stopper 110 prevents further drawing out of the plunger 130). When neither of these events has occurred, and the operator wishes to continue aspiration, the method 700 returns to block 720 to continue the application of negative pressure to draw in more bodily fluids to aspirate more solids 630. When either a clog is detected or the plunger 130 has reached the end of travel, the method 700 proceeds to block 770.

[0063] At block 770, the operator closes fluid communication with the biological subject, which prevents additional biological fluid from entering the device 100 through the intake port 152 or leaving the device 100 through the return port 142. In some embodiments, the method 700 proceeds to block 780, block 790, or may terminate at block 770 when the user determines that a threshold amount of bodily fluid has been collected, a blockage has been sufficiently aspirated, or the like. In some embodiments, the method 700 may proceed directly to block 790.

[0064] At block 780, the operator removes and replaces the filter 120 to clear a clog in the filter 120. In some embodiments, the operator cleans the filter 120 to remove clogs or collect the material captured by the filter 120, and places the filter120 back into the device 100, while in some embodiments, the user discards the filter 120, and replaces the original filter 120 with a new filter 120 before proceeding to block 790 or returning to block 710.

[0065] At block 790, the operator resets the plunger 130 to an initial draw position within the device 100. In various embodiments, the operator resets the plunger 130 by pushing the plunger 130 inward into the assembled device 100. In some embodiments (e.g., when using a pump to apply negative pressure), block 790 may be omitted.

[0066] After removing the clog (per block 780) or resetting the plunger 130 (per block 790), the method 700 returns to block 710, where the operator re-opens fluid communication between the biological subject and the device 100 to resume aspiration.

[0067] 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 claimedsubject 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 selectively 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.

[0068] 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.

[0069] 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, 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.

[0070] 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.

[0071] 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.

[0072] 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 integeramount (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).

[0073] 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.

Claims

WE CLAIM:1 . A device (100), comprising: an outer barrel (140) having a first lumen (610) of a first diameter and a return port (142) in the first lumen; an inner barrel (150) having a second lumen (620) of a second diameter, less than the first diameter, secured within the first lumen, having a plurality of through-holes (570) allowing fluid communication between the inner barrel and the outer barrel and an intake port (152) in the second lumen; a filtration section defined by the plurality of through-holes; and a plunger (130 disposed in the second lumen.

2. The device of claim 1 , wherein the inner barrel is secured to the outer barrel via threads on the inner barrel and the outer barrel, further comprising a plurality of gaskets (160) disposed between the inner barrel and the outer barrel to maintain a seal.

3. The device of claim 2, wherein the plurality of gaskets include: a first gasket (160a) disposed circumferentially to the intake port at an end-face of the inner barrel on a first side of the threads; a second gasket (160b) disposed circumferentially to the inner barrel and in contact with the first lumen on a first side of the filtration section and a second side of the threads, longitudinally opposite to the first side of the threads; and a third gasket (160c) disposed circumferentially to the inner barrel and in contact with the first lumen on a second side of the filtration section, longitudinally opposite to the first side of the filtration section.

4. The device of claim 2, wherein the plurality of gaskets include: a first gasket (160a) disposed circumferentially to the intake port at an end-face of the inner barrel on a first side of the filtration section; anda second gasket (160c) disposed circumferentially to the inner barrel and in contact with the first lumen on a second side of the filtration section, longitudinally opposite to the first side of the filtration section and longitudinally between the filtration section and the threads.

5. The device of claim 1 , wherein the inner barrel is secured to the outer barrel by at least one of: welding the inner barrel to the outer barrel; forming sealed joints via an adhesive between the inner barrel and the outer barrel; and forming the outer barrel and the inner barrel as a single piece via additive manufacturing.

6. The device of claim 1 , wherein the filtration section is provided around a circumference of the second lumen for a given arc distance less than 360 degrees.

7. The device of claim 1 , wherein the filtration section includes a plurality of pores wherein each pore of the plurality of pores defines an area of between 40- 160 square micrometers (pm2).

8. The device of claim 1 , wherein the plunger includes a head gasket ( 160d) having a third diameter at least as large as the second diameter, and is configured to draw negative pressure on the intake port defined in an end-face of the inner barrel and prevent inflow of air from a plunger port (580) defined on a longitudinally opposite end of the inner barrel to the intake port.

9. The device of claim 1 , wherein a difference between the first diameter and the second diameter is at between 2 millimeters (mm) and 4 mm to define a fluidreturn gap between the first lumen and the second lumen.

10. The device of claim 1 , wherein the second lumen includes a first nonporous portion longitudinally disposed between an end-face of the inner barrel and the filtration section and a second nonporous portion longitudinally disposed between a plunger port, defined on a longitudinally opposite end of the inner barrel to the end-face, wherein the first nonporous portion occupies at least fifteen percent of a length of the inner barrel and the second nonporous portion occupies at least fifteen percent of the length of the inner barrel.11 . The device of claim 1 , wherein the filtration section further includes a filter (120) disposed in a flowpath between the first lumen and the second lumen across the plurality of through-holes.

12. A device (100), comprising: an outer barrel (140) having a first lumen of a first diameter and including a return port (142) defined in a first wall of the first lumen; an inner barrel (150) having a second lumen of a second diameter, less than the first diameter, secured within the first lumen, and including a filtering means defined in a second wall of the second lumen; and a plunger (130) disposed in the second lumen.

13. The device of claim 12, wherein the filtering means is included around a circumference of the second lumen for a given arc distance less than 360 degrees.

14. The device of claim 12, wherein the filtering means is included along a length of the second lumen less than two thirds of percent of the length.

15. The device of claim 12, wherein the plunger includes a head gasket (160d) having a third diameter at least as large as the second diameter, and isconfigured to draw negative pressure on an intake port (152) defined in an endface of the inner barrel and prevent inflow of air from a plunger port (580) defined on a longitudinally opposite end of the inner barrel to the intake port.

16. A device (100), comprising: an outer barrel (140) having a first lumen of a first diameter and including: a first opening (410) on a first end of the first lumen; a second opening (420) on a second side of the first lumen; and a return port (142) defined in a first wall of the first lumen between the first opening and the second opening; and an inner barrel (150) having a second lumen of a second diameter, less than the first diameter, secured within the first lumen, and including: a first port (152) extending through the first opening; a second port (580) extending through the second opening; and a porous filter (510) defined in a second wall of the second lumen between the first port and the second port; and a pressure imparting means connected to the second port.

17. The device of claim 16, wherein the pressure imparting means includes at least one of: a pump; a negative pressure source; and a plunger (130), disposed with the second lumen, including a head gasket (160d) that forms an airtight seal against the second wall.

18. The device of claim 16, wherein the porous filter is a non-lysing filter having pores with an area of approximately 40-160 square micrometers (pm2).

19. The device of claim 16, wherein the inner barrel is secured to the outer barrel via threads defined on the inner barrel and the outer barrel, furthercomprising a plurality of gaskets disposed between the inner barrel and the outer barrel to maintain an airtight seal.

20. The device of claim 16, wherein the inner barrel is secured to the outer barrel by at least one of: welding the inner barrel to the outer barrel; forming airtight joints via an adhesive between the inner barrel and the outer barrel; and forming the outer barrel and the inner barrel as a single piece via additive manufacturing.21 . The device of claim 16, wherein the first port and the return port include adapters for connection to tubing and tubing accessories.

22. A method (700), comprising: opening (710) fluid communication between a biological subject and an intake port (152) and a return port (142) of a filtering aspiration device (100); applying (720) negative pressure to a first lumen (610) of the filtering aspiration device in fluid communication to a second lumen (620) via a filter (510, 120) to draw a bodily fluid from the biological subject through the intake port; collecting (730) the bodily fluid in the first lumen, wherein the bodily fluid contains an obstruction aspirated from the biological subject; separating (740) the obstruction from the bodily fluid via the filter, to hold the obstruction in the first lumen and pass the bodily fluid into a second lumen in which the first lumen is included; and returning (750) the bodily fluid passed to the second lumen to the biological subject via the return port.

23. The method of claim 22, wherein the bodily fluid comprises blood, and the obstruction is at least one of:a thrombosis; a plaque; necrotic tissue; and a foreign body.

24. The method of claim 22, wherein the negative pressure is applied via a plunger (130) disposed in the first lumen being drawn outward from the filtering aspiration device, further comprising, in response to the plunger reaching (760) a draw stop: closing (770) fluid communication between the biological subject and the intake port and the return port of the filtering aspiration device; resetting (790) the plunger to an initial draw position in the first lumen; re-opening (710) fluid communication between the biological subject and the intake port and the return port of the filtering aspiration device; and re-applying (720) the negative pressure to the first lumen of the filtering aspiration device to resume drawing the bodily fluid from the biological subject through the intake port.

25. The method of claim 22, further comprising, in response to identifying (760) a clog in the filter of filtering aspiration device: closing (770) fluid communication between the biological subject and the intake port and the return port of the filtering aspiration device; removing (780) the first lumen from the second lumen; removing (780) and replacing the filter from the first lumen; re-attaching (780) the first lumen into the second lumen; resetting (790) a plunger to an initial draw position in the first lumen; re-opening (710) fluid communication between the biological subject and the intake port and the return port of the filtering aspiration device; andre-applying (720) the negative pressure to the first lumen of the filtering aspiration device to resume drawing the bodily fluid from the biological subject through the intake port.

26. The method of claim 25, wherein removing and replacing the filter from the first lumen includes: detaching the filter from the first lumen; and one of: clearing the clog from the filter and re-attaching the filter to the first lumen; or attaching a new filter for use as the filter to the first lumen.

27. A device (100), comprising: an outer barrel (140) having a first lumen of a first diameter and a return port (142) in the first lumen; an inner barrel (150) having an intake port (152) and a second lumen of a second diameter, less than the first diameter, secured within the first lumen; and a plunger (130) disposed in the second lumen, wherein the first lumen of the outer barrel is in fluid communication with the second lumen of the inner barrel at a filtration portion (510).

28. The device of claim 27, wherein the filtration portion comprises a plurality of through-holes (570) between the first lumen and the second lumen.

29. The device of claim 28, wherein the filtration portion further comprises a filter (120) at the plurality of through-holes.

30. The device of claim 29, wherein the filter is disposed between the first lumen and the second lumen over or under the plurality of through-holes.31 . The device of claim 28, wherein the plurality of through-holes are micropores.

32. The device of claim 31 , wherein the micro-pores are located on the inner barrel.

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