Kit for the rapid bedside sampling of peripheral intravenous catheters for evidence of microbial infection

Abstract

An apparatus and methods for detecting the presence of bacteria in a catheter are provided. According to various embodiments, an apparatus may include a housing having an aperture configured to orient a catheter through the housing and a compliant portion configured to move inwardly, at least one cutting element coupled to the compliant portion and configured to separate at least one catheter segment from the received catheter when the compliant portion is depressed, a media source having media configured to contact the at least one catheter segment after separating from the received catheter, and a detection element configured to indicate microbial growth in response to contact of the at least one catheter segment with the media.

Description

KIT FOR THE RAPID BEDSIDE SAMPLING OF PERIPHERAL INTRAVENOUS CATHETERS FOR EVIDENCE OF MICROBIAL INFECTIONCROSS-REFERENCE

[0001] This PCT application claims priority to U.S. Provisional Application Serial No. 63 / 438,745, which was filed on January 12, 2023, which is incorporated herein by reference in its entirety.BACKGROUND

[0002] Peripheral intravascular catheter-related infections are a major cause of morbidity and mortality in the United States. Coagulase-negative staphylococci, Staphylococcus aureus, aerobic gram-negative bacilli, and Candida albicans most commonly cause catheter-related bloodstream infection. Best practice recommendations for the diagnosis of peripheral intravenous catheter blood stream infection include removal of the catheter at bedside upon suspicion and culture of its tip within a laboratory setting.

[0003] Current laboratory criteria for the diagnosis of intravascular catheter-related infections include a semiquantitative (roll plate) or quantitative (vortex or sonication methods) catheter culture techniques. These techniques are reliable diagnostic methodologies because they have high specificity in the identification of catheter-related infection. A recently inserted catheter (for example, one with a duration of placement of less than one week) is most commonly colonized by a skin microorganism along the external surface of the catheter. Therefore, a roll plate method will be quite sensitive in the identification of such colonization. For longer- dwelling catheters, such as for duration of placement greater than a single week, in which intraluminal microbes may be present, the roll plate method is less sensitive, and methods that obtain samples of both the internal and external surfaces for culture are more reliable.

[0004] The most widely used laboratory technique for the clinical diagnosis of catheter-related infection is the semiquantitative method, in which a catheter segment is rolled across the surface of an agar plate and colony-forming units are counted after overnight incubation. Quantitative culture of the catheter segment requires either (i) flushing the segment with media or (ii) vortexing or sonicating it in media, followed by serial dilutions and surface plating on blood agar. A yield of >15 colony forming units (cfu) from a catheter, by means of semiquantitative culture, or a yield of >102cfu from a catheter, by means of quantitative culture, with accompanying signs of local or systemic infection, is indicative of catheter-related infection.

[0005] The process of effectively obtaining the peripheral intravenous catheter tip sample at bedside and the transfer of the sample to microbiology laboratory for analysis is time consuming and costly and therefore not typically employed. This scenario in turn leads to a sparsity of data regarding the true blood stream infection rate associated with peripheral intravenous catheters. There are therefore needs for improved systems, devices, and methods for diagnosing intravenous catheter blood stream infections faster and earlier to minimize the risk of serious catheter-related infections and therefore improve patient outcomes.

[0006] Background patent publications include US2020 / 0061215; CN 114989952; and CN 112322476.SUMMARY

[0007] Described herein are an apparatus and methods for detecting the presence of bacteria in a catheter. According to various embodiments, an apparatus may include a housing having an aperture configured to orient a catheter through the housing and a compliant portion configured to move inwardly, at least one cutting element coupled to the compliant portion and configured to separate at least one catheter segment from the received catheter when the compliant portion is depressed, a media source having media configured to contact the at least one catheter segment after separating from the received catheter, and a detection element configured to indicate microbial growth in response to contact of the at least one catheter segment with the media. The media source may include at least one of an ampule, container, or vial. The media source may be held under a vacuum and configured to spray over the catheter segments upon release from vacuum. The at least one separated catheter segment may be two or more.

[0008] The aperture may be shaped to orient the catheter transverse relative to at least one cutting element. The aperture may be shaped to orient the catheter perpendicular to at least one cutting element. The aperture may be substantially straight relative to the housing and configured to direct the catheter to have an orthogonal cut. The aperture may be diagonal to the housing or direction of the cutting and configured to direct the catheter to have an angled cut, where the angled cut results in a greater exposure of an interior of the catheter.

[0009] The housing may include a stopper configured to abut a distal end of the catheter and position the distal end of the catheter a predetermined distance from the aperture, where the at least one cutting element may be positioned within the housing to separate the at least one catheter segment from the received catheter such that the at least one catheter segment has a predetermined dimension. An interior portion of the at least one catheter segment may have enhanced exposure to the media.

[0010] The at least one cutting element may include a first cutting element configured to cut the catheter in a first orientation and a second cutting element configured to cut the catheter in a second orientation. The second orientation may be orthogonal to the first orientation.

[0011] The housing may include an actuator configured to advance the at least one cutting element to cut the catheter. The housing may include an actuator configured to advance the at least one cutting element to separate the at least one catheter segment from the received catheter and advance a seal to cover one or more of the aperture or portion of the housing or chamber adjacent the aperture.

[0012] The housing may include an actuator configured to release the media. The actuator may include a tac configured to puncture the media source containing the media. The apparatus may include a vibration element configured to provide vortexing energy, sonicating energy, or both.

[0013] An apparatus may include a seal configured to prevent bio fouling of the chamber when the catheter is absent. An apparatus may include a seal configured to hold the catheter to the housing. An apparatus may include an actuator configured to advance a movable seal to cover the aperture or any exposed portion of the housing adjacent the aperture. An apparatus may include an actuator configured to simultaneously advance the at least one cutting element and advance a movable seal to cover the aperture or any exposed portion of the housing adjacent the aperture.

[0014] The cutting element has a cross-section configured to cut the catheter into two or more portions along a length of the catheter. The cutting element has a cross-section configured to cut the catheter into a catheter segment having an angled opening of a lumen of the catheter. The aperture may be configured to direct the catheter in an orientation relative to the cutting element.

[0015] The catheter may be segmented based on an amount of surface tension required to penetrate a lumen of the catheter. The catheter may be segmented based on a type or catheter gauge and media type. The media may include at least one of a growth media, an agar, and culture media.

[0016] The detection element may include chromatography paper configured to evoke an indicator when a specific bacterium, product of bacterium, or both is present. The detection element may include an antibody-specific detector strips configured to bind a specific pathogen antigen.

[0017] An apparatus may include an oxygen tablet configured to provide optimal oxygenation within the chamber. The oxygen tablet may be introduced into the chamber prior to catheter insertion. The oxygen tablet may be exposed to the chamber by opening of a seal.

[0018] An apparatus may include a housing including an aperture configured to receive a catheter and an actuator, at least one cutting element configured to cut the catheter into at least one catheter segment when the actuator is activated, a media source holding media configured to contact the at least one catheter segment, and a detection element configured to indicate aerobic microbial growth resulting from the contact of the at least one catheter segment with the media.

[0019] An apparatus may include a housing including an aperture configured to receive a catheter, a first cutting element configured to cut the catheter forming a first predetermined shape, a second cutting element configured to cut the catheter forming a second predetermined shape, where the catheter is cut into at least one catheter segment, a media source having media configured to contact the at least one catheter segment, a detection element configured to indicate aerobic microbial growth resulting from the contact of the at least one catheter segment with the media.

[0020] The first cutting element may be configured to allow the catheter to pass through and be cut by the second cutting element. The first cutting element has an aperture along a substantially uniform length, where the aperture is positioned to allow the cut catheter to pass through the first cutting element. The first cutting element has a non-linear or curved shape along its length configured to cut the catheter at the first cutting element’s distal end and allow the cutting element to pass along a different portion of the first cutting element’s length.

[0021] An apparatus may include a housing including an aperture configured to orient a catheter, a first cutting element configured to cut the catheter in a first orientation, a second cutting element configured to cut the catheter in a second orientation, the second orientation being district from the first orientation, where the catheter is cut into at least two catheter segments, a media source having media configured to contact the at least two catheter segments, and a detection element configured to indicate aerobic microbial growth resulting from the contact of the at least two catheter segments with the media.

[0022] An apparatus may include a housing including an aperture to a first chamber configured to receive a catheter and a second chamber having one or more enzymes, at least one cutting element configured to cut the catheter into at least one catheter segment, where the catheter is cut into a catheter segment with at least two cut orientations, where the second chamber may be configured to receive the at least one catheter segment and to store a media source having media configured to contact the at least one catheter segment, and a detection element configured to indicate aerobic microbial growth resulting from the contact of the at least one catheter segment with the media.

[0023] A method for detecting the presence of bacteria in a catheter may include segmenting a catheter into at least one catheter segment within a sterile chamber, exposing the at least one catheter segment to a detection media within the sterile chamber, and detecting microbial growth within the detection media. Segmenting the catheter may include cutting the catheter with a first cutting element, allowing the catheter to pass through and be cut by a second cutting element.

[0024] A method for detecting the presence of bacteria in a catheter may include a method for detecting the presence of bacteria in a catheter, including segmenting a catheter into at least one catheter segment within a sterile chamber, exposing the at least one catheter segment to a detection media within the sterile chamber, transferring the detection media into a second chamber having one or more enzymes, forming a media mixture, exposing the at least one catheter segment to the media mixture, and detecting microbial growth within the media mixture.

[0025] The method may include allowing the media mixture to mix for a predetermined time. The method may include incubating the at least one catheter segment exposed to the media mixture for a predetermined time. The method may include breaking a second media source configured to release the one or more enzymes in conjunction with the transferring of the media into the second chamber. Exposing the catheter segments to the media within a sterile chamber may include vigorously shaking and allowing the media or media mixture to wash over and through the at least one catheter segment. Transferring the media into the second chamber may be performed by an externally activated mechanism. Transferring the media into the second chamber may be performed automatically after a specified amount of time.BRIEF DESCRIPTION OF THE DRAWINGS

[0026] A better understanding of the features and advantages of the present subject matter will be obtained by reference to the following detailed description that sets forth illustrative embodiments and the accompanying drawings of which:

[0027] FIG. 1A illustrates a front cutaway view of a bacterial detection apparatus including a housing having an aperture to a sterile chamber configured to receive a catheter and a compliant portion configured to advance at least one cutting element to cut the catheter according to certain embodiments.

[0028] FIG. IB illustrates a front cutaway view of the bacterial detection apparatus of FIG. 1A having advanced and cut the catheter into multiple segments according to certain embodiments.

[0029] FIG. 1C illustrates a catheter segment defined by a first height, a second height, and a radius according to certain embodiments.

[0030] FIG. ID illustrates a catheter segment defined by an angle from one edge according to certain embodiments.

[0031] FIG. IE schematically illustrate a catheter segment having an orthogonal cut according to certain embodiments.

[0032] FIG. IF schematically illustrate a catheter segment having an angled cut according to certain embodiments.

[0033] FIG. 1G schematically illustrate a catheter segment having an orthogonal cut and an angled cut according to certain embodiments.

[0034] FIG. 2 illustrates a front cutaway view of a bacterial detection apparatus including a housing having an aperture to a sterile chamber configured to receive a catheter and an actuator configured to advance at least one cutting element to cut the catheter according to certain embodiments.

[0035] FIG. 3 illustrates a front cutaway view of a bacterial detection apparatus including a movable seal configured to cover the aperture according to certain embodiments.

[0036] FIG. 4 illustrates a front cutaway view of a bacterial detection apparatus including a first cutting element configured to cut the catheter at a first predetermined length and a second cutting element configured to cut the catheter at a second predetermined length according to certain embodiments.

[0037] FIG. 5 illustrates a front cutaway view of a bacterial detection apparatus including a housing having an aperture to a first sterile chamber configured to receive a catheter and a second sterile chamber configured to expose the catheter segments to a second media according to certain embodiments.

[0038] FIGs. 6A-6B schematically illustrate an aperture configured to direct the catheter in a relative orientation to the cutting element according to certain embodiments.

[0039] FIGs. 7A-7C schematically illustrate different cross-sections of a cutting element according to certain embodiments.

[0040] FIGs. 8-9 illustrate methods for detecting microbial growth according to certain embodiments.DETAILED DESCRIPTION

[0041] Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present subject matter belongs.

[0042] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. Any reference to “or” herein is intended to encompass “and / or” unless otherwise stated.

[0043] Reference throughout this specification to “some embodiments,” “further embodiments,” or “a particular embodiment,” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrase “in some embodiments,” or “in further embodiments,” or “in a particular embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0044] A detection apparatus is provided for rapid microbial testing at a patient’s bedside. According to certain embodiments, detection apparatus is configured to segment an ex-situ catheter and expose it to one or more detection media and detection elements within a sterile chamber or housing. The detectors may be read for early indicators of microbial growth and an indicator may be activated to alert a user of a result from the detectors. In an example, the microbial growth may be direct or indirect aerobic microbial growth. According to certain embodiments, the detectors may be read for detection of one or more chemicals released from bacteria.

[0045] A bacterial detection apparatus is provided for ex-situ analysis of catheter segments. Turning to FIGs. 1 A-1B, a bacterial detection apparatus 100 is shown including a housing 102 having an aperture 110 to a sterile chamber 104 configured to receive a catheter 150 and a compliant portion 106 configured to advance at least one cutting element 120 to cut the catheter according to certain embodiments. In an aspect, the catheter is mechanically separated, either in one segment or multiple catheter segments 152, from its hub using an integrated cutting mechanism such as the at least one cutting element 120 within the sterile chamber or chamber 104 to prevent external bio fouling.

[0046] According to certain embodiments, the apparatus may include a one or more cutting elements configured to cut the catheter into at least one catheter segment have a predetermined shape. In an example, the catheter segment may result in a truncated cylinder or a cylindrical wedge defined by a first height, a second height, and a radius (see FIG. 1C). In an example, the cylindrical wedge defined by an angle from one edge (see FIG. ID).

[0047] According to certain embodiments, the apparatus may include a first cutting element 120 configured to cut the catheter resulting in a first predetermined shape and a second cutting element 122 configured to cut the catheter resulting in a second predetermined shape.According to certain embodiments, the predetermined shape may be a length of a catheter segment and / or an angle of cut that reveals a certain surface area of lumen of the catheter. In an aspect, for a cylindrical catheter, cutting at a greater angle than directly across a catheter’s length will result in an angled opening of the lumen of the catheter. In an aspect, this exposure to the lumen enhances the penetration of the media to an interior of the catheter resulting in several advantages. For example, the time of detection may be increased while reducing false negative detection results resulting from the media not able to penetrate the length of the catheter. According to certain embodiments, a predetermined shape for catheter segment may be based on an amount of time it would take for media to penetrate the lumen. For example, one type of catheter may have a first surface tension relative to a first media type and a second surface tension relative to a second media type. In an example, the second media type may include media, antibodies, and / or enzymes.

[0048] In an aspect, the catheter may be cut to result in varying catheter segments to enable greater or faster penetration of the media into the lumen of the catheter.

[0049] In an example, the first cutting element 120 may be separated by a first predetermined length 126 from the second cutting element 122 which may be separated from a stopper 130 by a second predetermined length 128. In an example, each cutting element 120, 122 may include a cutting edge 124 configured to cut the catheter at an angle. In an aspect, the cutting edge 124 may be shaped to expose a maximal or minimal interior of a lumen of the catheter. In an example, the cutting element may be a sterile plate or blade and the like.

[0050] According to certain embodiments, an aperture may be configured to orient and direct the catheter relative to a cutting element. In an example, the apparatus may include a housing 602 having an aperture 612 that is substantially straight and configured to make an orthogonal cut. (See FIGs. 6A and IE). In this case, the resulting catheter segment results in a relatively minimal amount of interior exposure to detection media. In an example, the apparatus may include a housing 604 having an aperture 614 that is diagonal to the housing or direction of the cutting and configured to make an angled cut. (See FIGs. 6B and IF). In an aspect, the angled cut results in a greater exposure of an interior of the catheter than the orthogonal cut. In an aspect, the angled cut may also result in faster detection of interior bacterial presence than a catheter with the orthogonal cut alone. In an example, the apparatus may include a housing having an aperture and / or cutting element configured to cut the catheter into a catheter segment having and orthogonal cut and an angled cut. (See FIG. 1G).

[0051] According to an embodiment, the chamber 104 contains a surface having a detection media or growth media or agar such as a blood agar, nutrient agar, and culture media. In an example, the media may include a buffer to mitigate increase in acidity due to microbial aerobicor anaerobic metabolism. The at least one catheter segment may be rolled across the surface within the housing or sterile enclosure using a mechanism controlled by the clinician on an external portion of the housing. In an example, any surface within the housing may be used to hold the growth media or agar. In an aspect, the compliant portion 106 or a second compliant portion on another portion of the housing (not pictured) may be used to manipulate the catheter segments on the surface. According to an embodiment, the sample within the housing is allowed to incubate for a specified time. One or more detectors within the housing may be read for early indicators of microbial growth. According to an embodiment, an indicator may be activated to alert a user of a result from the detectors.

[0052] According to an embodiment, the housing may include a seal 112 configured to hold the catheter to the housing and prevent additional external exposure. In an example, the seal may be thin integrated or removable polymer or rubber layer configured to maintain sterility of the chamber. According to an embodiment, the housing may include an actuator configured to advance a movable seal 330 to cover one or more of the aperture 110 and / or any exposed portion of the housing or chamber adjacent the aperture. According to an embodiment, the housing may include an actuator configured to both advance the at least one cutting element and advance a movable seal 330 to cover one or more of the aperture 110 and / or any exposed portion 340 of the housing or chamber adjacent the aperture. In an aspect, the advancement may be simultaneous, timed, or independent of each actuation.

[0053] According to an embodiment, the housing may include an actuator 210 configured to advance at least one cutting element 220 to cut the catheter according to certain embodiments. In an example, the actuator 210 may include a button causing the cutting element 220 to advance to cut the catheter. In an example, the housing may include an actuator 214 may include a unidirectional button configured to be depressed causing a tac or piston 228 to disrupt a media source 230 within the chamber 104 and release the media into the sterile chamber 104. In an example, when the actuator 210 reaches full depression upon movement of about 3-10 mm. In an example, when the actuator 210 reaches full depression, a lock may retain the actuator 210 in its final position. In an aspect, this lock serves as a safety feature as well as confirmation that the cutting element 220 has advanced enough to cut the catheter. In an example, an actuator 310 may advance each cutting element 320 to cut the catheter, to disrupt a media source 230 within the chamber 104, and to advance a movable seal 330 to cover one or more of the aperture 110 and / or any exposed portion of the housing or chamber adjacent the aperture (see FIG. 3).DETECTION OF DIRECT BACTERIA CONTACT

[0054] In an embodiment, the apparatus may be configured for detecting direct bacteria contact. For example, an apparatus may be provided to mechanically separate the catheter from its hub into a single or multiple pieces within a sterile chamber 104 of the apparatus. According to an embodiment, the catheter is mechanically separated from its hub using an integrated cutting mechanism within the chamber. According to an embodiment, the apparatus may include a media source within the chamber 104. When the media source within chamber 104 is broken, media held within is configured to contact the catheter segments. Examples of media include but are not limited to broth, growth media, solvent, and / or other nutrient media. Examples of media also include Gibco LB broth media produced by Thermo Scientific (Waltham, Massachusetts) such as 10 g SELECT Peptone 140, 5 g SELECT Yeast Extract, and 5 g Sodium Chloride as well as Luria-Bertani Broth Media. In an aspect, the media may be chosen based on its shelf-life and a detection element may reveal when there is a non-conformance with the media.

[0055] The media source within the chamber may be broken in several ways as described herein. According to an embodiment, the apparatus may be vigorously shook allowing fluidic agents such as media, antibodies, and / or enzymes to wash over and through the catheter segments.

[0056] According to certain embodiments, the catheter may be configured for traditional central and peripheral lines for patient use. In an example, the catheter is about 3 cm or less and about 18 gauge or less. In an aspect, the catheter is made from flexible material such as silicone or polyurethane.

[0057] According to an embodiment, the apparatus may include a vibration element 170 configured to provide vortexing and / or sonicating energy. In an example, the vibration element may be activated to shake wash the fluidic agents such as media, antibodies, and / or enzymes over and through the catheter segments. After an incubation time, an externally activated mechanism 510 is activated to allow the fluidic agents to contact a detection element that may indicate early indicators of microbial growth. In an example, the externally activated mechanism 510 is activated by the user. According to an embodiment, the externally activated mechanism 510 may include a flexible membrane that may allow transfer of the fluidic agents.

[0058] According to an embodiment, the apparatus may include a locking mechanism 182 configured to engage with a complementary locking mechanism 180 on a cutting element.

[0059] According to an embodiment, the apparatus may include a second media source 230 configured to hold one or more media, antibodies, and / or enzymes configured to be opened within the sterile container. Examples of media source include but are not limited to an ampule,a container, and a vial. In an aspect, the media source may be held under a vacuum. In an example, the media source may include a vacuum configured to spray the media over the catheter segments upon release. In an example, the media source may have a controlled ratio of gases for promoting microbial growth. In an example, the media may be pre-conditioned with gases for promoting microbial growth.

[0060] According to certain embodiments, a bacterial detection apparatus may include at least one cutting element 120, 122, 220, 222, 420, 422 configured to cut the catheter at a predetermined length within the sterile chamber. According to certain embodiments, the cutting element may be advanced by a spring or manually motioned button external to the housing that when fully depressed will mobilize one or more sterile plates or blades located inside the chamber. In an example, each sterile blade has a sharp edge configured to cut a portion of the inserted catheter into one or more segments.

[0061] According to certain embodiments, a bacterial detection apparatus may include a first cutting element 120 configured to cut the catheter at a first predetermined length and a second cutting element 122 configured to cut the catheter at a second predetermined length. In an example, the first cutting element 120 and the second cutting element 122 may be separated by a second predetermined length 128 (see FIGs. 1 A-B). In an example, the first cutting element 120 and the stopper 130 may be separated by a predetermined length 129 (see FIGs. 1 A, 2).

[0062] Turning to FIG. 2, according to certain embodiments, a bacterial detection apparatus 200 may include a first cutting element 220 having an aperture 224 and / or shape configured to allow the catheter to pass through. In an example, the first cutting element 220 may have an aperture 224 along a substantially uniform length, where the aperture 224 is positioned to allow the cut catheter to pass through. In another example, the first cutting element 220 may have a non-linear or curved shape along its length configured to cut the catheter at the first cutting element’s distal end and allow the cutting element to pass along a different portion of the first cutting element’s length.

[0063] In an example, a cutting element may be separated from a stopper 130 by a spacing distance 226 such that when the catheter abuts the stopper 130, the catheter will first be cut by the first cutting element 120. Further advancement by the first cutting element 120 will align the cut catheter with the aperture 224 allowing the cut catheter to pass through. According to certain embodiments, the cut catheter may abut the stopper 130 and the second cutting element 122 may cut the cut catheter to a second predetermined length. The resulting cuts are configured to cut the catheter at the same or different predetermined lengths. According to certain embodiments, as the cutting element is fully activated, the cut catheter segments fallthrough a secondary opening and into a portion of chamber to interact with a second media source.

[0064] Turning to FIG. 4, according to certain embodiments, a bacterial detection apparatus 400 may include an actuator 412 configured to advance at least one movable cutting element 420 to cut the catheter in a first orientation and at least one stationary cutting element 422 configured to cut the catheter in a second orientation. In an aspect, the second orientation may be orthogonal to the first orientation. In an example, a cutting element may be separated from a stopper 410 by a spacing distance 424 such that when the catheter abuts the stopper 410, the catheter will first be cut by a first cutting element 422 and then catheter will be cut by a second cutting element 420. In an example, a user may press the catheter into the stationary cutting element 422 to be cut and then activate the at least one movable cutting element 420 to cut the catheter in another orientation.

[0065] According to certain embodiments, the cutting element may have different crosssections configured to cut a catheter 710 into a different number of segments along a length of the catheter. In an example, a cutting element 702 may have a cross-section configured to split the catheter into two sections (see FIG. 7A). In an example, a cutting element 704 may have a cross-section configured to split the catheter into three sections (see FIG. 7B). In an example, a cutting element 706 may have a cross-section configured to split the catheter into four sections (see FIG. 7C). In an aspect, the cutting element may have a cross-section configured to split the catheter into even or uneven sections. In an aspect, the catheter may be segmented based on an amount of surface tension required to penetrate a catheter lumen for a shape or material type of catheter and a media.

[0066] According to certain embodiments, a bacterial detection apparatus may include one or more detection elements 140 configured to detect and indicate early indicators of microbial growth. In an aspect, the detection element is configured to indicate microbial growth in response to contact of a portion of catheter segment with the media. In an example, the detection element is configured to indicate microbial growth in response to contact of an interior portion of the catheter segment with the media. In some embodiments, the detection element is configured to indicate microbial growth in response to contact of an exterior portion of the catheter segment with the media. In some embodiments, the detection elements are read for early indicators of direct or indirect microbial growth.

[0067] In some embodiments, the detection element may include one or more antibody-specific detector strips configured to bind a specific pathogen antigen. In an aspect, the media may move into the detector strip via capillary action and may be read for early indicators of microbial growth.

[0068] In an embodiment, the detection element may include antibodies for specific antigens located on the bacteria of interest that may be mixed in with the media. For example, the growth media may contain primary antibodies specific for staphylococcus aureus (SA). When there is a presence of SA on the catheter segment, the primary antibody for SA will bind to the SA and cause an SA-primary antibody complex. The complex will evoke an indication change that may be viewed by the user. In an example, visualization of colorimetric assays may be viewed through a viewing port 160 through the wall of the chamber and housing. In an example, the viewing port 160 may be a glass, a magnified lens, a fiber optic cable, or a transparent portion of the housing viewable to a user for viewing an indication of the detection elements. In an aspect, the viewing port 160 also is a sterile barrier between the housing’s internal and external environments.

[0069] In some embodiments, the detection element may include a secondary antibody or enzyme complex specific to a staphylococcus aureus (SA)-primary antibody complex. Once the SA-primary antibody complex binds to the secondary antibody-enzyme complex on the detection element, it will activate the enzyme and cause a colorimetric change.

[0070] In an example, the media mixture contacts one or more detection elements 140 automatically. In an example, the media mixture contacts one or more detection elements 140 via an external mechanism activated by the user. In some embodiments, the detection elements are located on a portion of the chamber viewable to a user for viewing an indication.

[0071] In an embodiment, the detection element may be a colorimetric assay configured to evoke a visual indicator when a specific bacterium or product of bacterium is present. In an example, an enzyme linked assay may be configured to detect a polypeptide of the specific bacterium or product of the bacterium and cause a sequence of reactions resulting in a visual change of the indicator. In an example, the change of the indicator may be a color or symbol that changes from invisible to visible, changes a property to be differently distinguishable such as color, shape, pattern, and intensity. In an example, the colorimetric assays may be visualized through the viewing port that may span the wall of the chamber and housing.

[0072] According to certain embodiments, the apparatus may include sensor or agent for promoting conditions of microbial growth. According to certain embodiments, a bacterial detection apparatus may include one or more sensors configured to monitor conditions within the chamber. In an example, a sensor may include an oxygen sensor configured to monitor an oxygen level. In an aspect, the oxygen sensor may be electronic or chemical. In an example, the oxygen sensor may be configured to monitor direct or indirect aerobic microbial growth. According to certain embodiments, the apparatus may include an oxygen tablet (not pictured) to provide optimal oxygenation prior to the incubation stage. In an example, the oxygen tabletmay be introduced into the chamber prior to catheter insertion. In another example, the oxygen tablet may be revealed by opening of a seal. In an example, the movable seal 330 may reveal the oxygen tablet and provide optimal oxygenation within the chamber for metabolism to occur.

[0073] According to certain embodiments, a method 800 for detecting microbial growth is provided (see FIG. 8). In an embodiment, the method may include a step 802 of separating a catheter from its hub into a one or more catheter segments within a sterile apparatus or chamber. In an example, the separating a catheter from its hub may include using an apparatus having an integrated cutting mechanism within a sterile chamber 104.

[0074] In an embodiment, the method further may include a step 804 of exposing the at least one catheter segment to a media within the sterile chamber. In an example, the step 804 may further include releasing media from a media source within the chamber 104 and allowing the media to contact the at least one catheter segment.

[0075] In an embodiment, the method further may include a step 806 of allowing one of the exposed media or at least one catheter segment to react to the exposure. In an example, the step 804 may further include waiting for a predetermined time to allow the media to enter a lumen of the catheter segment. In an example, the step 804 may further include incubating the chamber contents for a specified time. In an embodiment, the method or step 804 may further include agitating fluidic components to allow fluidic agents such as media, antibodies, and / or enzymes to wash over and through the at least one catheter segment. In an example, agitating the fluidic components may include vigorously shaking the apparatus or activating a vibration element 170.

[0076] In an embodiment, the method further may include a step 808 of detecting a reaction of the exposure of one of the exposed media and the at least one catheter segment. In an example, the step 804 may be performed by one or more detection elements 140 configured to detect and indicate early indicators of microbial growth. In an aspect, the detection element is configured for a particular test or use as described elsewhere herein.

[0077] Turning to FIG. 5, a bacterial detection apparatus 500 is shown according to certain embodiments including a housing 102 having an aperture 110 to a first sterile chamber 504 configured to receive a catheter and a second sterile chamber 506 configured to expose the catheter segments to one or more of media, antibodies, and / or enzymes. In an example, an externally activated mechanism 510 is configured to initiate the transfer of the media into the second chamber 506.

[0078] According to certain embodiments, a method 900 for detecting microbial growth is provided (see FIG. 9). In an embodiment, the method may include a step 902 of separating a catheter from its hub into a one or more catheter segments within a sterile apparatus orchamber. In an example, the separating a catheter from its hub may include using an apparatus having an integrated cutting mechanism within a sterile chamber 504.

[0079] In an example, the method further may include a step 904 of exposing the at least one catheter segment to a media within the sterile chamber. In an example, a media source within chamber 504 is broken allowing the media to contact the catheter segments. In an example, the method further may include promoting contact between the media mixture and one or more detection elements 140. In an example, the housing may be vigorously shook allowing fluidic agents such as media and / or enzymes to wash over and through the catheter segment(s) and allowed to incubate for a specified time.

[0080] In an example, the method further may include a step 906 of incubating the exposed at least one catheter segment for a predetermined time. In an example, incubation time may include standard times for standard conditions or accelerated times for the smaller segments.

[0081] In an example, the method further may include a step 908 of incubating transferring the media into a second chamber 506 having one or more of media, antibodies, and / or enzymes. In an example, the method may include mixing the media with the one or more of media, antibodies, and / or enzymes forming a media mixture including any combination of media, antibodies, and / or enzymes. In an example, the second chamber 506 may include a second media source holding the one or more media, antibodies, and / or enzymes and configured to be opened by an actuator. In an example, an externally activated mechanism 510 is configured to initiate the transfer of the media into the second chamber 506. In an example, the second media source may be opened and its contents may be mixed with the media. In an aspect, the method may include allowing the media mixture to mix for a specified amount of time. In an example, the method further may include a step 910 of exposing the at least one catheter segment to the media mixture. In an example, the method further may include a step 912 of detecting microbial growth within the media mixture. In an example, the detection elements 140 may be read for early indicators of microbial growth.

[0082] In another embodiment, the catheter is mechanically separated from its hub into a single or multiple pieces using an integrated cutting mechanism within a chamber 504 of a housing. A media source within chamber 504 is broken allowing the media to contact the catheter segment(s). The housing is vigorously shook allowing fluidic agents such as media and / or enzymes to wash over and through the catheter segment(s) and allowed to incubate for a specified time. The media is then allowed to transfer into a second chamber 506 containing a second media source with one or more enzymes. In an example, an externally activated mechanism 510 is configured to initiate the transfer of the media into the second chamber 506. The second media source may be opened and its contents may be mixed with the media. Then,the media mixture is allowed mix for a specified amount of time. The media mixture is then allowed to contact one or more detection elements. In an example, the media mixture is transferred by an external mechanism activated by the user. The detection elements are read for early indicators of microbial growth. In an example, the detection elements may be viewed through a viewing port 160 through the wall of the chamber and housing.

[0083] In an embodiment, the apparatus may be configured for performing a liquid chromatography test. According to certain embodiments, a method for performing a liquid chromatography test is provided. In an embodiment, the method may include separating a catheter from its hub into a one or more catheter segments within a sterile apparatus. In an example, the separating a catheter from its hub may include using an apparatus having an integrated cutting mechanism within a sterile chamber 504. In an example, the method further may include releasing media from a media source within the chamber 504 and allowing the media to contact the catheter segments. In an embodiment, the method further may include agitating the fluidic components to allow fluidic agents to wash over and through the catheter segment(s) and allowed to incubate for a specified time. In an example, agitating the fluidic components may include vigorously shaking the apparatus or activating a vibration element 170. In an example, the method further may include transferring the media into a second chamber 506 having one or more pieces of chromatography paper or strips configured to evoke an indicator when a specific bacterium or product of bacterium is present. In an example, the chromatography paper or strips may be like established liquid chromatography protocols and setups. In an example, the method further may include altering a user when the chromatography strips when early indicators of microbial growth are detected. In an example, an externally activated mechanism 510 is configured to initiate the transfer of the media into the second chamber 506.

[0084] In an embodiment, the apparatus may be configured for detecting antigens as a rapid antigen test. According to certain embodiments, a method for performing a rapid antigen test is provided. In an embodiment, the method may include separating a catheter from its hub into a one or more catheter segments within a sterile apparatus. In an example, the separating a catheter from its hub may include using an apparatus having an integrated cutting mechanism within a sterile chamber 504. In an example, the method further may include releasing media from a media source within the chamber 504 and allowing the media to contact the catheter segments. Alternatively, if incubation is not required, a solvent will be used in place of the media. In an embodiment, the method further may include agitating the fluidic components to allow fluidic agents to wash over and through the catheter segment(s) and allowed to incubatefor a specified time. In an example, agitating the fluidic components may include vigorously shaking the apparatus or activating a vibration element 170.

[0085] The media is then allowed to transfer into a second chamber 506 containing antibody detector strips having complementary primary or secondary antibodies configured to bind pathogen antigens when present. In an example, an externally activated mechanism 510 is configured to initiate the transfer of the media into the second chamber 506. Then, the media is allowed move up and contact the strips for a specified amount of time. The detection strips are read for early indicators of aerobic microbial growth.

[0086] While preferred embodiments of the present disclosure have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the scope of the present disclosure. It should be understood that various alternatives to the embodiments of the present disclosure described herein may be employed in practicing the embodiments of the present disclosure. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

CLAIMSWHAT IS CLAIMED IS:

1. An apparatus for detecting the presence of bacteria in a catheter, the apparatus comprising: a housing including an aperture configured to orient a catheter through the housing and a compliant portion configured to move inwardly; at least one cutting element coupled to the compliant portion and configured to separate at least one catheter segment from the received catheter when the compliant portion is depressed; a media source having media configured to contact the at least one catheter segment after separating from the received catheter; and a detection element configured to indicate microbial growth in response to contact of the at least one catheter segment with the media.

2. The apparatus of claim 1, wherein the aperture is shaped to orient the catheter transverse relative to at least one cutting element.

3. The apparatus of claim 1, wherein the aperture is shaped to orient the catheter perpendicular to at least one cutting element.

4. The apparatus of claim 1, wherein the housing further comprises a stopper configured to abut a distal end of the catheter and position the distal end of the catheter a predetermined distance from the aperture, wherein the at least one cutting element is positioned within the housing to separate the at least one catheter segment from the received catheter such that the at least one catheter segment has a predetermined dimension.

5. The apparatus of claim 1, wherein an interior portion of the at least one catheter segment has enhanced exposure to the media.

6. The apparatus of claim 1, wherein the at least one cutting element comprises a first cutting element configured to cut the catheter in a first orientation and a second cutting element configured to cut the catheter in a second orientation.

7. The apparatus of claim 6, wherein the second orientation is orthogonal to the first orientation.

8. The apparatus of claim 1, wherein the media source comprises at least one of an ampule, container, or vial.

9. The apparatus of claim 1, wherein the housing further comprises an actuator configured to advance the at least one cutting element to cut the catheter.

10. The apparatus of claim 1, wherein the housing further comprises an actuator configured to advance the at least one cutting element to separate the at least one catheter segment from the received catheter and advance a seal to cover one or more of the aperture or portion of the housing or chamber adjacent the aperture.

11. The apparatus of claim 1, wherein the housing further comprises an actuator configured to release the media.

12. The apparatus of claim 11, wherein the actuator may include a tac configured to puncture the media source containing the media.

13. The apparatus of claim 1, further comprising a vibration element configured to provide vortexing energy, sonicating energy, or both.

14. The apparatus of claim 1, further comprising a seal configured to prevent biofouling of the chamber when the catheter is absent.

15. The apparatus of claim 1, further comprising a seal configured to hold the catheter to the housing.

16. The apparatus of claim 1, further comprising an actuator configured to advance a movable seal to cover the aperture or any exposed portion of the housing adjacent the aperture.

17. The apparatus of claim 1, further comprising an actuator configured to simultaneously advance the at least one cutting element and advance a movable seal to cover the aperture or any exposed portion of the housing adjacent the aperture.

18. The apparatus of claim 1, wherein the media source is held under a vacuum and configured to spray over the catheter segments upon release from vacuum.

19. The apparatus of claim 1, wherein the at least one separated catheter segment may be two or more.

20. The apparatus of claim 1, wherein the cutting element has a cross-section configured to cut the catheter into two or more portions along a length of the catheter.

21. The apparatus of claim 1, wherein the cutting element has a cross-section configured to cut the catheter into a catheter segment having an angled opening of a lumen of the catheter.

22. The apparatus of claim 1, wherein the aperture is configured to direct the catheter in an orientation relative to the cutting element.

23. The apparatus of claim 1, wherein the aperture is substantially straight relative to the housing and configured to direct the catheter to have an orthogonal cut.

24. The apparatus of claim 1, wherein the aperture is diagonal to the housing or direction of the cutting and configured to direct the catheter to have an angled cut, wherein the angled cut results in a greater exposure of an interior of the catheter.

25. The apparatus of claim 1, wherein the catheter is segmented based on an amount of surface tension required to penetrate a lumen of the catheter.

26. The apparatus of claim 1, wherein the catheter is segmented based on a type or catheter gauge and media type.

27. The apparatus of claim 1, wherein the media may include at least one of a growth media, an agar, and culture media.

28. The apparatus of claim 1, wherein the detection element may include chromatography paper configured to evoke an indicator when a specific bacterium, product of bacterium, or both is present.

29. The apparatus of claim 1, wherein the detection element may include an antibodyspecific detector strips configured to bind a specific pathogen antigen.

30. The apparatus of claim 1, further comprises an oxygen tablet configured to provide optimal oxygenation within the chamber.

31. The apparatus of claim 30, wherein the oxygen tablet is introduced into the chamber prior to catheter insertion.

32. The apparatus of claim 30, wherein the oxygen tablet is exposed to the chamber by opening of a seal.

33. An apparatus for detecting the presence of bacteria in a catheter, the apparatus comprising: a housing including an aperture configured to receive a catheter and an actuator; at least one cutting element configured to cut the catheter into at least one catheter segment when the actuator is activated; a media source holding media configured to contact the at least one catheter segment; a detection element configured to indicate aerobic microbial growth resulting from the contact of the at least one catheter segment with the media.

34. An apparatus for detecting the presence of bacteria in a catheter, the apparatus comprising: a housing including an aperture configured to receive a catheter; a first cutting element configured to cut the catheter forming a first predetermined shape; a second cutting element configured to cut the catheter forming a second predetermined shape;wherein the catheter is cut into at least one catheter segment; a media source having media configured to contact the at least one catheter segment; a detection element configured to indicate aerobic microbial growth resulting from the contact of the at least one catheter segment with the media.

35. The apparatus of claim 34, wherein the first cutting element is configured to allow the catheter to pass through and be cut by the second cutting element.

36. The apparatus of claim 34, wherein the first cutting element has an aperture along a substantially uniform length, wherein the aperture is positioned to allow the cut catheter to pass through the first cutting element.

37. The apparatus of claim 34, wherein the first cutting element has a non-linear or curved shape along its length configured to cut the catheter at the first cutting element’s distal end and allow the cutting element to pass along a different portion of the first cutting element’s length.

38. An apparatus for detecting the presence of bacteria in a catheter, the apparatus comprising: a housing including an aperture configured to orient a catheter; a first cutting element configured to cut the catheter in a first orientation; a second cutting element configured to cut the catheter in a second orientation, the second orientation being district from the first orientation, wherein the catheter is cut into at least two catheter segments; a media source having media configured to contact the at least two catheter segments; and a detection element configured to indicate aerobic microbial growth resulting from the contact of the at least two catheter segments with the media.

39. An apparatus for detecting the presence of bacteria in a catheter, the apparatus comprising:a housing including an aperture to a first chamber configured to receive a catheter and a second chamber having one or more enzymes; at least one cutting element configured to cut the catheter into at least one catheter segment; wherein the catheter is cut into a catheter segment with at least two cut orientations; wherein the second chamber is configured to receive the at least one catheter segment and to store a media source having media configured to contact the at least one catheter segment; and a detection element configured to indicate aerobic microbial growth resulting from the contact of the at least one catheter segment with the media.

40. A method for detecting the presence of bacteria in a catheter, the method comprising: segmenting a catheter into at least one catheter segment within a sterile chamber; exposing the at least one catheter segment to a detection media within the sterile chamber; and detecting microbial growth within the detection media.

41. The method of claim 40, wherein segmenting the catheter comprises cutting the catheter with a first cutting element, allowing the catheter to pass through and be cut by a second cutting element.

42. A method for detecting the presence of bacteria in a catheter, the method comprising: segmenting a catheter into at least one catheter segment within a sterile chamber; exposing the at least one catheter segment to a detection media within the sterile chamber; transferring the detection media into a second chamber having one or more enzymes, forming a media mixture; exposing the at least one catheter segment to the media mixture; anddetecting microbial growth within the media mixture.

43. The method of claim 42, further comprising allowing the media mixture to mix for a predetermined time.

44. The method of claim 42, further comprising incubating the at least one catheter segment exposed to the media mixture for a predetermined time.

45. The method of claim 42, further comprising breaking a second media source configured to release the one or more enzymes in conjunction with the transferring of the media into the second chamber.

46. The method of claim 42, wherein exposing the catheter segments to the media within a sterile chamber may include vigorously shaking and allowing the media or media mixture to wash over and through the at least one catheter segment.

47. The method of claim 42, wherein transferring the media into the second chamber is performed by an externally activated mechanism.

48. The method of claim 42, wherein transferring the media into the second chamber is performed automatically after a specified amount of time.

Images