Endoscopic fluid aspiration device

The aspiration catheter with a self-closing aperture mechanism addresses contamination and manufacturing issues, ensuring reliable and sterile sample collection for accurate microbiological analysis.

WO2026072706A1PCT designated stage Publication Date: 2026-04-02HOBBS MEDICAL INC
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Patent Information

Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Filing Date
2025-09-24
Publication Date
2026-04-02

AI Technical Summary

Technical Problem

Current endoscopic aspiration devices face challenges in maintaining sample sterility due to contamination from microflora, leading to flawed microbiological analysis and manufacturing inconsistencies, and are cumbersome to use.

Method used

An aspiration catheter with an outer sheath and inner sheath, featuring a self-closing aperture at the distal end, allows selective exposure of radial ports to collect samples while maintaining sterility by transitioning between closed and open configurations based on axial movement.

Benefits of technology

The device ensures reliable, sterile collection of small fluid volumes by preventing contamination and reducing manufacturing defects, enhancing the accuracy of microbiological analysis.

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Abstract

An aspiration catheter may include inner sheath configured to receive fluid proximate to a distal end of the inner sheath and provide a conduit for movement of the fluid to a proximal end of the inner sheath tube; an outer sheath enclosing a portion of the tube; a closure located about the distal end of the outer sheath; a self-closing aperture passing through a closure of the outer sheath and configured to selectively open and close a path from an exterior space to the interior of the outer sheath; and one or more radial ports located about the distal end of the inner sheath configured to receive fluid.
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Description

[0001] Atty. Docket No.

[0002] 561240-23

[0003] ENDOSCOPIC FLUID ASPIRATION DEVICE

[0004] Cross-Reference To Related Applications

[0005] This Application claims priority to U.S. Provisional Patent Application No. 63 / 698,982, filed on September 25, 2024, the entire contents of which are expressly incorporated by reference herein.

[0006] Technical Field

[0007] The present disclosure relates generally to a device for aspiration including but not limited to an aspiration catheter used during an endoscopic intervention. More specifically, the present disclosure relates to a novel catheter that can aspirate small volumes of liquid in an uncontaminated fashion.

[0008] Background Of The Disclosure Current methods for collecting aspirate involve positioning an endoscope in a hollow organ such as the small bowel. A sterile catheter is then advanced through the working channel of the endoscope, and suction is applied to the catheter to collect a sample (e. , approximately 2 mL of fluid). The aspirate is then transferred to aerobic and / or anaerobic sterile tubes for microbiologic analysis. However, contamination poses a significant challenge when collecting aspirate. For example, the catheter is exposed to the microflora in the body as the catheter is maneuvered to the collection site. The microflora may be transferred onto the catheter and may contaminate the aspirate collected from the collection site.

[0009] The contamination from microflora in other parts of the body may result in a flawed microbiological analysis. More specifically, contamination of the sample may

[0010] 1

[0011] HB: 4919-4226-5708 1 Atty. Docket No.

[0012] 561240-23 result in an (1) inability to confidently identify the pathogens (as opposed to contaminant bacteria, fungus, and viruses); (2) inability to accurately identify anaerobic pathogens due to exposure to open air; (3) inability to accurately develop microbiome banks; and (4) inability to confirm the eradication of infection. Avoiding contamination of the catheter can be particularly challenging in the case of gastrointestinal aspiration. By the time a gastroscope reaches the duodenum, the endoscope may be contaminated by the oral, nasopharyngeal, esophageal, and / or gastric microflora. Furthermore, even relatively low levels of contamination from oral, nasopharyngeal, esophageal, and / or gastric microflora can substantially impact the microbiologic analysis. As an example, bacterial counts in the oral cavity are approximately 10A9 CFU / ml, and bacterial counts in intestinal aspirates are typically less than 10A3 CFU / ml. Therefore, a contamination rate of just 0.001% can result in a misdiagnosis of small intestinal bacterial or fungal overgrowth. Accordingly, obtaining a sterile sample via endoscopic intervention is necessary, but also extremely difficult.

[0013] In addition to the issue of contamination of withdrawn samples, current devices are prone to manufacturing inconsistencies and defects. As a result, a relatively large force may be required to pivot the cap outward in some cases. In such cases, the aspiration catheter may be cumbersome to use during a procedure. In other cases, the cap may be fixed and unmovable due to manufacturing defects, and as a result, the aspiration catheter may be entirely non-functional. In yet other cases, the cap may entirely decouple from the aspiration catheter during the procedure, and the cap may need to be retrieved from within the patient's body. Thus, current solutions for collecting fluid aspirate in vivo are cumbersome and unreliable.

[0014] 2

[0015] HB: 4919-4226-5708 1 Atty. Docket No.

[0016] 561240-23

[0017] Therefore, there is a need for a device for efficient collection of aspirate in vivo in a sterile manner. Preferably, the device should be reliable and easy to use.

[0018] Summary The following embodiments and aspects thereof are described and illustrated in conjunction with systems, compositions and methods that are meant to be exemplary and illustrative, not limiting in scope.

[0019] According to an aspect of the present disclosure, an aspiration catheter may be provided that includes an outer sheath and an inner sheath both having proximal end and a distal end. The inner sheath having at least one radial port extending through a wall of the inner sheath adjacent the distal end of the inner sheath, and the outer sheath enclosing a portion of the inner sheath.

[0020] The aspiration catheter further comprising a closure adj acent the distal end of the outer sheath and a self-closing aperture positioned within the closure and configured to provide selective passage of the inner sheath through the closure and exposure of the at least one radial port to an exterior of the outer sheath.

[0021] In a further aspect, the self-closing aperture is configured to open in response to a force applied to the self-closing aperture upon contact by the distal end of the inner sheath with the self-closing aperture while maintaining contact with at least a portion of an exterior surface of the inner sheath as the distal end of the inner sheath passes through the self-closing aperture. The aspiration catheter may comprise of at least a second radial port extending through the wall of the inner sheath adjacent the distal end of the inner sheath and wherein the radial ports are configured around a circumference of the inner sheath or are positioned in the wall of the inner sheath in a linear, axially aligned configuration. Further, the closure with a self-closing aperture

[0022] 3

[0023] HB: 4919-4226-5708 1 Atty. Docket No.

[0024] 561240-23 is positioned at the distal end of the outer sheath with at least one of an adhesive, friction fitting, interference fitting, and sonic welding.

[0025] According to another aspect of the present disclosure, there may be provided an aspiration catheter for collecting a sample, the aspiration catheter having a first configuration, a second configuration, and an inner sheath. The inner sheath extending from a distal end to a proximal end comprising at least one radial port extending through a wall of the inner sheath adjacent the distal end of the inner sheath. Wherein the inner sheath is configured to collect the sample proximate to the distal end through the at least one radial port and provide a conduit for movement of the sample to the proximal end of the inner sheath. Further, a closure located at the distal end of the outer sheath comprising a self-closing aperture; wherein when the aspiration catheter is in the first configuration, the self-closing aperture is closed and the distal end of the inner sheath with the at least one radial port is positioned and located within the outer sheath; and wherein when the aspiration catheter is in the second configuration, the distal end the inner sheath extends through the self-closing aperture such that at least a portion of the distal end of the inner sheath with the at least one radial port is positioned and located outside of the outer sheath. In another aspect, the aspiration catheter transitions from the first configuration to the second configuration in response to the inner sheath being moved in a first axial direction relative to the outer sheath.

[0026] Yet another aspect of the present disclosure is to provide an endoscopic catheter comprising an inner sheath comprising at least one radial port extending through a wall of the inner sheath adjacent a distal end of the inner sheath. The inner sheath configured to collect a sample through the at least one radial port and provide a conduit for movement of the fluid to a proximal end of the inner sheath. The

[0027] 4

[0028] HB: 4919-4226-5708 1 Atty. Docket No.

[0029] 561240-23 aspiration catheter further including an outer sheath configured to circumscribe at least a portion of the inner sheath and a closure comprising a self-closing aperture at the distal end of the outer sheath. The self-closing aperture configured to have an open configuration and a closed configuration; wherein the self-closing aperture is configured to transition from the closed configuration to the open configuration in reaction to a force applied to the self-closing aperture upon contact by the distal end of the inner sheath with the self-closing aperture while maintaining contact with at least a portion of an exterior surface of the inner sheath as the distal end of the inner sheath passes through the self-closing aperture. Wherein the self-closing aperture transitions from the open configuration to the closed configuration as the distal end of the inner sheath is withdrawn from the opening into the outer sheath.

[0030] In yet another aspect, the endoscopic catheter wherein when the self-closing aperture is in the closed configuration, the self-closing aperture is configured to prevent fluids from passing through the self-closing aperture into an interior space of the outer sheath. At least a portion of the closure having the self-closing aperture is made of a resilient material and wherein the resilient material biases the self-closing aperture to the closed configuration such that the self-closing aperture closes in response to the distal end of the inner sheath being withdrawn from the closure into the outer sheath. In another aspect, the endoscopic catheter is configured to be extendable toward and through a working port of an endoscope.

[0031] These aspects are merely illustrative of the innumerable aspects associated with the present disclosure and should not be deemed as limiting in any manner. These and other aspects, features and advantages of the present disclosure will become apparent from the following detailed description when taken in conjunction with the referenced drawings.

[0032] 5

[0033] HB: 4919-4226-5708 1 Atty. Docket No.

[0034] 561240-23

[0035] Brief Description Of The Drawings

[0036] Reference is now made more particularly to the drawings, which illustrate the best presently known mode of carrying out the present disclosure and wherein similar reference characters indicate the same parts throughout the view s.

[0037] FIG. 1A illustrates a side view of an aspiration catheter within an endoscope according to an embodiment of the present disclosure, the aspiration catheter in a first configuration.

[0038] FIG. IB illustrates a side view of an aspiration catheter within an endoscope according to another embodiment of the present disclosure, the aspiration catheter in a first configuration.

[0039] FIG. 2 illustrates a side view of an aspiration catheter within an endoscope according to an embodiment of the present disclosure, the aspiration catheter in a second configuration. FIG. 3 illustrates a side view' with hidden lines of an aspiration catheter within an endoscope according to an embodiment of the present disclosure, the aspiration catheter in a first configuration.

[0040] FIG. 4 illustrates a side view with hidden lines of an aspiration catheter within an endoscope according to an embodiment of the present disclosure, the aspiration catheter in a second configuration.

[0041] FIG. 5 illustrates a partial side view of the aspiration catheter of FIG. 1A in the second configuration.

[0042] FIG. 6 illustrates a partial side view with hidden lines of the aspiration catheter of FIG. 1A in the first configuration.

[0043] 6

[0044] HB: 4919-4226-5708 1 Atty. Docket No.

[0045] 561240-23

[0046] FIG. 7 illustrates a partial perspective view with hidden lines of the aspiration catheter of FIG. 1A in the second configuration.

[0047] DETAILED DESCRIPTION OF THE DISCLOSURE The following description of technology' is merely exemplary' in nature of the subject matter, manufacture, and use of one or more inventions, and is not intended to limit the scope, application, or uses of any specific invention claimed in this application or in such other applications as may be filed claiming priority to this application, or patents issuing therefrom. The following definitions and non-limiting guidelines must be considered in reviewing the description of the technology' set forth herein.

[0048] The headings (such as ’‘Introduction” and “Summary”) and sub-headings used herein are intended only7for general organization of topics within the present disclosure and are not intended to limit the disclosure of the technology or any aspect thereof. In particular, subject matter disclosed in the “Introduction” may include novel technology and may not constitute a recitation of prior art. Subject matter disclosed in the “Summary” is not an exhaustive or complete disclosure of the entire scope of the technology or any embodiments thereof. Classification or discussion of a material within a section of this specification as having a particular utility is made for convenience, and no inference should be drawn that the material must necessarily or solely7function in accordance with its classification herein when it is used in any given composition.

[0049] The citation of references herein does not constitute an admission that those references are prior art or have any relevance to the patentability of the technology

[0050] 7

[0051] HB: 4919-4226-5708 1 Atty. Docket No.

[0052] 561240-23 disclosed herein. All references cited in the “Description"’ section of this specification are hereby incorporated by reference in their entirety.

[0053] The description and specific examples, while indicating embodiments of the technology, are intended for purposes of illustration only and are not intended to limit the scope of the technology . Moreover, recitation of multiple embodiments having stated features is not intended to exclude other embodiments having additional features, or other embodiments incorporating different combinations of the stated features. Specific examples are provided for illustrative purposes of how to make and use the apparatus and systems of this technology and, unless explicitly stated otherwise, are not intended to be a representation that given embodiments of this technology^ have, or have not, been made or tested.

[0054] “A” and “an” as used herein indicate “at least one” of the item is present; a plurality of such items may be present, when possible. “About” when applied to values indicates that the calculation or the measurement allows some slight imprecision in the value (with some approach to exactness in the value; approximately or reasonably close to the value; nearly). If, for some reason, the imprecision provided by "‘about” is not otherwise understood in the art with this ordinary meaning, then "‘about” as used herein indicates at least variations that may arise from ordinary methods of measuring or using such parameters. In addition, disclosure of ranges includes disclosure of all distinct values and further divided ranges within the entire range.

[0055] FIGS. 1A, IB, 3. and 6 illustrate an aspiration catheter 10 according to embodiments of the present disclosure in a first configuration. As will be described herein, the aspiration catheter 10 may be used to collect a fluid sample in vivo. The aspiration catheter 10 may be generally cylindrical and may extend from a proximal

[0056] 8

[0057] HB: 4919-4226-5708 1 Atty. Docket No.

[0058] 561240-23 end (partially illustrated) to a distal end 12. To collect a sample from a patient, the distal end 12 of the aspiration catheter 10 may be inserted within a patient and navigated to a collection site (e.g., the distal part of the duodenum, proximal portion of the jejunum, or the like). Then, a sample collection system (e.g., a syringe, or a canister coupled to a vacuum regulator) may be placed in fluid communication with the proximal end to draw fluid through the aspiration catheter 10.

[0059] The aspiration catheter 10 may be used in conjunction with an endoscope port 30 (partially illustrated). Preferably, when the aspiration catheter 10 is inserted through an endoscope 30 and advanced through a working port of the endoscope 30, the distal end 12 of the aspiration catheter 10 may be advanced to a distal tip of the endoscope 30. Thus, the distal end 12 of the aspiration catheter 10 may be positioned within the patient by advancing the endoscope 30 into the patient. Furthermore, the distal tip of the endoscope 30 may include a lens positioned and located proximate to the distal end 12 of the aspiration catheter 10. Thus, a medical provider may view the distal end 12 of the aspiration catheter 10 as the aspiration catheter 10 collects a sample.

[0060] Illustrated in the first configuration of FIGS. 1A, IB, 3, and 6, the aspiration catheter 10 outer sheath 18 is shown. The outer sheath 18 comprises distal end 12 and an outer wall 20 wherein the outer wall 20 is positioned about the internal endoscope port 30. The outer sheath 18 may have any suitable cross-sectional shape, for example, cylindrical. In preferred embodiments, the cross-sectional shape of the outer sheath 18 may be cylindrical. Further, the aspiration catheter 10 as shown in FIGS. 2 and 4, 5, and 7 includes a hollow inner sheath suction tube 14 with a distal end 16 for conveying fluid from to the proximal end. The inner sheath suction tube 14 is located within the outer sheath 18 outer wall 20. The inner sheath suction tube 14 is sized and

[0061] 9

[0062] HB: 4919-4226-5708 1 Atty. Docket No.

[0063] 561240-23 shaped to be surrounded by the outer sheath 18 outer wall 20 circumference with tolerance for the inner sheath suction tube 14 to extend or rotate. For example, the inner sheath suction tube 14 may be an elongated hollow body that extends from a proximal end (partially illustrated) to a distal end 16. The distal end of the inner sheath may be closed or open. The inner sheath suction tube 14 may have any suitable cross-sectional shape, for example, cylindrical. In preferred embodiments, the cross- sectional shape of the inner sheath suction tube 14 may be cylindrical. As illustrated in FIG. 7, the inner sheath suction tube 14 with a distal end 16 may further comprise one or more radial ports 22 located in the lateral wall of the inner sheath suction tube 14. In the illustrated and preferred embodiments, the radial ports 22 are aligned in a row parallel to the axis of the inner sheath suction tube 14. Alternately, the radial ports may be configured about the outer circumference of the inner sheath suction tube 14. When a suction force is applied at the proximal end, the inner sheath suction tube 14 may collect fluid through the one or more radial ports 22 and convey the collected fluid to the proximal end. In embodiments in which the distal end of the inner sheath suction tube 14 is open, fluid may also be collected through the open distal end.

[0064] To help mitigate contamination of the inner sheath suction tube 14, the inner sheath suction tube 14 may be enclosed by the outer sheath 18 when the aspiration catheter 10 is in a first configuration as illustrated in FIGS. 1A, IB. 3, and 6. The outer sheath 18 may also be an elongated hollow body having any suitable cross- sectional shape, for example cylindrical, extending from the proximal end of the aspiration catheter 10 to the distal end 12 and having an interior area defined by the outer wall 20 of the outer sheath 18. In preferred embodiments, the outer sheath 18 and inner sheath suction tube 14 may have complementary cross-sectional shapes, but

[0065] 10

[0066] HB: 4919-4226-5708 1 Atty. Docket No.

[0067] 561240-23 implementation of embodiments with an outer sheath 18 and inner sheath suction tube 14 having dissimilar cross-sectional shapes are also contemplated. In all embodiments, the respective size and shape of the exterior of the inner sheath suction tube 14 and that of the interior of the outer wall 20 of the outer sheath 18 allow for axial movement of the inner sheath suction tube 14 within the outer sheath 18.

[0068] A closure 24 may be positioned and located at and enclosing the distal end 12 of the outer sheath 18 . The closure 22 may be a solid-body member with a crosssection that is sized and shaped similarly to the cross-section of the outer sheath 18. In preferred embodiments, the closure 22 comprises an insert that fits within the inner circumference of the distal end 12 of the outer sheath 18. In alternate embodiments, the closure 22 may take the form of a cap-like structure that fits over the distal end 12 of the outer sheath 18. In some embodiments, the closure 24 may be alternatively or additionally retained to the outer sheath 18 by an adhesive, a fastener, sonic welding, or other suitable manufacturing methods. In other embodiments, the closure 24 may be molded with the outer sheath 18 such that the closure 24 is integral with the outer sheath 18.

[0069] The closure 24 further comprises a self-closing aperture 26. The self-closing aperture 26 may comprise an incision in the closure 24 sized and shaped to allow the distal end 16 of the inner sheath suction tube 14 to pass through the closure 24. The incision may take the form of a linear slit, cross- or star-shaped incision, flap or similar disruption in the surface of the closure 24 that allows a portion of the closure to be opened to allow the inner sheath suction tube 14 to pass through the self-closing aperture 26. The closure 24 or at least a portion of the closure 24 in which the selfclosing aperture 26 is located may be made of a resilient material, for example, an elastomeric material, wherein the material of the closure 24 is biased to return to a

[0070] 11

[0071] HB: 4919-4226-5708 1 Atty. Docket No.

[0072] 561240-23 position in which the self-closing aperture 26 is closed unless a force is exerted on the closure 24, for example, a portion of the closure 24 at the self-closing aperture 26, to push edges of the self-closing aperture 26, for example, edges of an incision as described herein, apart. As a result, the closure 24 may selectively close the distal end 12 of the outer sheath 18 to prevent exterior substances, for example, fluids and microflora, from entering the interior space of the outer sheath 18. Thus, the outer sheath 18 and the closure 24 preferably maintain a sterile environment for the inner sheath suction tube 14.

[0073] The first configuration of the aspiration catheter 10 is illustrated in an FIGS. 1A, IB, 3, and 6. This first configuration illustrates the aspiration catheter 10 in a non-depl oyed state. The second configuration of the aspiration catheter 10 is illustrated in FIGS. 2 and 4, 5, and 7. This second configuration illustrates the aspiration catheter 10 in a deployed position. In the illustrated embodiment, the closure 24 comprising a self-closing aperture 26 may position the self-closing aperture 26 having opposing sides that are naturally biased toward one another, for example, by the natural resiliency of the material from which the closure 24 is made, such that the self-closing aperture 26 remains closed in its normal state unless a force acts on the self-closing aperture to push the opposing sides apart. When the selfclosing aperture 26 is in its closed state, as shown in the first configuration, the path from the interior of the outer sheath 18 to the exterior through the self-closing aperture 26 is blocked, thereby closing the wall of the outer sheath 18 to prevent intrusion of exterior substances, including, for example, fluids, microflora, and other contaminants, into the interior of the outer sheath 18.

[0074] Once the distal end of the endoscope 30 is maneuvered to a collection site within the patient's body, the distal end 12 of the aspiration catheter 10 may be axially

[0075] 12

[0076] HB: 4919-4226-5708 1 Atty. Docket No.

[0077] 561240-23 extended out of the distal end of the endoscope 30, for example through a working port or other opening in the endoscope 30 provided for that purpose, to expose the distal end 12 of the aspiration catheter 10 to the exterior space around the endoscope. At that point, the inner sheath suction tube 14 distal end 16 may be advanced axially though the self-closing aperture 26 of the closure 24 toward the exterior of the aspiration catheter 10, by automated or manual actuation.

[0078] As the distal end 16 of the inner sheath suction tube 14 moves toward the distal end 12 of the outer sheath 18, the distal end 16 of the inner sheath suction tube 14 preferably encounters closure 24 wherein the self-closing aperture 26 is in its first position as shown in FIG. 1A, IB, 3, and 6. Advantageously, the self-closing aperture 26 of the closure 24 may be shaped to direct the distal end 16 of the inner sheath suction tube 14 toward the exterior of the outer sheath 18. For example, the selfclosing aperture 26 may be formed to directly extend the inner sheath suction tube 14 to the exterior of the aspiration catheter 10 in a concentric manner. This can be viewed w hen the aspiration catheter 10 is viewed from the side of the outer sheath 18.

[0079] Referring to the transition from the first configuration to the second configuration of the aspiration catheter 10, as the inner sheath suction tube 14 continues to move within the outer sheath 18, the closure 24 and the distal end 12 of the outer sheath 18 may continue to direct the distal end 16 of the inner sheath suction tube 14 into contact with the closure 24 proximately to the self-closing aperture 26. Contact of the distal end 16 of the inner sheath suction tube 14 exerts a sufficient force on the portion of the closure 24 where the self-closing aperture 26 is located to push the opposing sides of the self-closing aperture 26 apart and open the self-closing aperture 26. Thus, in the second configuration, the distal end 16 of the inner sheath

[0080] 13

[0081] HB: 4919-4226-5708 1 Atty. Docket No.

[0082] 561240-23 suction tube 14 moves the self-closing aperture 26 into its open position to draw fluid through the inner sheath suction tube 14.

[0083] When the aspiration catheter 10 is in the second configuration as illustrated in the second configuration, a vacuum or suction force may be applied to the proximal end of the inner sheath suction tube 14 to collect a sample through the radial ports 22, and in some embodiments the open distal end 16 of the inner sheath suction tube 14. Then, once the aspirate has been collected, the inner sheath suction tube 14 may be retracted or w ithdrawn through the self-closing aperture 26 of the closure 24 and back into the outer sheath 18. As the inner sheath suction tube 14 is retracted or withdrawn through the self-closing aperture 26 and into the outer sheath 18, the self-closing aperture 26 may transition from the open configuration to the closed configuration as result of removal of the force previously applied to the self-closing aperture 26 by the inner sheath end port 28 of the inner sheath suction tube 14. More particularly, in other embodiments using the self-closing aperture 26, withdrawal of the inner sheath end port 28 of the inner sheath suction tube 14 back through the self-closing aperture 26 allows the natural resiliency of the closure 24 allows the opposing sides of the selfclosing aperture 26 to return to their original position, again sealing the distal end 12 of the outer sheath 18. Thus, the self-closing aperture 26 may be self-closing.

[0084] The resiliency of the matenal of the closure 24 at least in the portion thereof where the self-closing aperture 26 is located allows the opposing sides of the selfclosing aperture 26 to deform sufficiently to generally conform to and maintain contact w ith the exterior of inner sheath suction tube 14 as it passes through the selfclosing aperture 26. Contact of the opposing sides of the self-closing aperture 26 with the exterior of the inner sheath suction tube 14 may maintain at least a partial seal or

[0085] 14

[0086] HB: 4919-4226-5708 1 Atty. Docket No.

[0087] 561240-23 barrier to entry of contaminants from the collection site into the interior space of the outer sheath 18.

[0088] The preferred embodiments of the disclosure have been described above to explain the principles of the invention and its practical application to thereby enable others skilled in the art to utilize the invention. However, as various modifications could be made in the constructions and methods herein described and illustrated without departing from the scope of the invention, it is intended that all matter contained in the foregoing description or shown in the accompanying drawings, including all materials expressly incorporated by reference herein, shall be interpreted as illustrative rather than limiting. Thus, the breadth and scope of the present invention should not be limited by the above-described exemplary embodiment but should be defined only in accordance with the following claims appended hereto and their equivalents.

[0089] 15

[0090] HB: 4919-4226-5708 1

Claims

Atty. Docket No.561240-23Claims1. An aspiration catheter for use in a patient's body, comprising: an inner sheath having proximal end and a distal end and having at least one radial port extending through a wall of the inner sheath adjacent the distal end of the inner sheath; an outer sheath enclosing a portion of the inner sheath having a proximal end and a distal end; a closure adjacent the distal end of the outer sheath; and a self-closing aperture positioned within the closure and configured to provide selective passage of the inner sheath through the closure and exposure of the at least one radial port to an exterior of the outer sheath.

2. The aspiration catheter of claim 1, wherein the self-closing aperture is configured to open in response to a force applied to the self-closing aperture upon contact by the distal end of the inner sheath with the self-closing aperture while maintaining contact with at least a portion of an exterior surface of the inner sheath as the distal end of the inner sheath passes through the selfclosing aperture.

3. The aspiration catheter of claim 1, wherein the self-closing aperture comprises an incision in the closure.

4. The aspiration catheter of claim 1, wherein the further comprising at least a second radial port extending through the wall of the inner sheath adjacent the16HB: 4919-4226-5708 1Atty. Docket No. 561240-23 distal end of the inner sheath and wherein the radial ports are configured around a circumference of the inner sheath.

5. The aspiration catheter of claim 1, wherein the further comprising at least a second radial port extending through the wall of the inner sheath adjacent the distal end of the inner sheath and wherein the radial ports are positioned in the wall of the inner sheath in a linear, axially aligned configuration.

6. The aspiration catheter of claim 1, wherein the closure is secured at the distal end of the outer sheath with at least one of an adhesive, friction fitting, interference fitting, and sonic welding.

7. An aspiration catheter for collecting a sample, the aspiration catheter comprising: a first configuration and a second configuration; an inner sheath extending from a distal end to a proximal end and comprising at least one radial port extending through a wall of the inner sheath adjacent the distal end of the inner sheath, the inner sheath configured to collect the sample proximate to the distal end through the at least one radial port and provide a conduit for movement of the sample to the proximal end of the inner sheath; a closure at the distal end of the outer sheath comprising a self-closing aperture;17HB: 4919-4226-5708 1Atty. Docket No.561240-23 wherein w en the aspiration catheter is in the first configuration, the self-closing aperture is closed and the distal end of the inner sheath with the at least one radial port is positioned and located within the outer sheath; and wherein when the aspiration catheter is in the second configuration, the distal end the inner sheath extends through the self-closing aperture such that at least a portion of the distal end of the inner sheath with the at least one radial port is positioned and located outside of the outer sheath.

8. The aspiration catheter of claim 7, wherein the self-closing aperture comprises an incision in the closure.

9. The aspiration catheter of claim 7, wherein the aspiration catheter transitions from the first configuration to the second configuration in response to the inner sheath being moved in a first axial direction relative to the outer sheath.

10. An endoscopic catheter comprising: an inner sheath comprising at least one radial port extending through a wall of the inner sheath adjacent a distal end of the inner sheath and configured to collect a sample through the at least one radial port and provide a conduit for movement of the fluid to a proximal end of the inner sheath; an outer sheath configured to circumscribe at least a portion of the inner sheath; a closure comprising a self-closing aperture at the distal end of the outer sheath, the self-closing aperture configured to have an open configuration and a closed configuration;18HB: 4919-4226-5708 1Atty. Docket No.561240-23 wherein the self-closing aperture is configured to transition from the closed configuration to the open configuration in reaction to a force applied to the self-closing aperture upon contact by the distal end of the inner sheath with the self-closing aperture while maintaining contact with at least a portion of an exterior surface of the inner sheath as the distal end of the inner sheath passes through the self-closing aperture; and wherein the self-closing aperture transitions from the open configuration to the closed configuration as the distal end of the inner sheath is withdrawn from the opening into the outer sheath.

11. The endoscopic catheter of claim 10, wherein the self-closing aperture comprises an incision in the closure.

12. The endoscopic catheter of claim 10, wherein when the self-closing aperture is in the closed configuration, the self-closing aperture is configured to prevent fluids from passing through the self-closing aperture into an interior space of the outer sheath.

13. The endoscopic catheter of claim 10, wherein at least a portion of the closure having the self-closing aperture is made of a resilient material and wherein the resilient material biases the self-closing aperture to the closed configuration such that the self-closing aperture closes in response to the distal end of the inner sheath being withdrawn from the closure into the outer sheath.19HB: 4919-4226-5708 1Atty. Docket No.561240-2314. The endoscopic catheter of claim 10, wherein the endoscopic catheter is configured to be extendable toward and through a working port of an endoscope.20HB: 4919-4226-5708 1

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