Antimicrobial catheters and methods of making same

Abstract

The invention relates to an antimicrobial catheter and a method of making the same. The antimicrobial catheter may include one or more polymeric inserts made of filled polymer in a catheter tubing, a catheter bushing, one or more extension legs, one or more extension leg fittings, or a combination thereof. Each of the one or more polymeric inserts may provide a portion of a lumenal surface in a catheter component selected from the group consisting of a catheter fitting, a catheter bushing, one or more extension legs, and one or more extension leg fittings. In addition, each of the one or more polymeric inserts may elute one or more antimicrobial metal species from the polymeric insert upon contact with a liquid. Methods of making such antimicrobial catheters may include a polymer insert molding operation of molding a plurality of polymer inserts, and a catheter component molding operation of molding a plurality of at least one catheter component selected from the group consisting of catheter fittings, catheter bushings, extension legs, and extension leg fittings.

Description

[0001] priority

[0002] This application claims the benefit of priority to U.S. patent application No. 18 / 209,379, filed on June 13, 2023, which is incorporated by reference in its entirety into this application. Technical Field

[0003] The present invention relates to the field of medical devices, and more particularly to antimicrobial catheters and methods for making the same. Background Art

[0004] Catheter-related bloodstream infection ("CRBSI") is one of the most common infections acquired in hospitals. The incidence of CRBSI varies greatly depending on the type of catheter, the site of insertion, the clinician's experience in catheter placement, the duration of catheter placement, the frequency of catheter access, etc. Although knowledge about the epidemiology of CRBSI and methods for its diagnosis, management, and prevention has increased significantly, CRBSI still results in significant morbidity and lengthy and costly hospital stays.

[0005] Disclosed herein are antimicrobial catheters and methods that address the aforementioned problems. Summary of the invention

[0006] In some embodiments, disclosed herein is an antimicrobial catheter comprising a catheter tubing, a catheter hub, one or more extension legs, one or more extension leg fittings, and one or more polymer inserts made of a filled polymer. The proximal portion of the catheter tubing is coupled to the catheter hub, the distal portion of each of the one or more extension legs is coupled to the catheter hub, and the proximal portion of each of the one or more extension legs is coupled to an extension leg fitting in one or more extension leg fittings. Each of the one or more polymer inserts provides at least a portion of an inner cavity surface in a catheter component selected from the group consisting of a catheter tubing, a catheter hub, one or more extension legs, and one or more extension leg fittings. In addition, each of the one or more polymer inserts is configured to elute one or more antimicrobial metal substances from the polymer insert when in contact with a liquid.

[0007] In some embodiments, the catheter tubing includes at least one polymeric insert of one or more polymeric inserts.

[0008] In some embodiments, the catheter tubing includes an antimicrobial agent compounded into the catheter tubing, the antimicrobial agent being different from the one or more antimicrobial metallic substances of the one or more polymeric inserts.

[0009] In some embodiments, the catheter hub includes at least one polymeric insert of one or more polymeric inserts.

[0010] In some embodiments, each of the one or more extension legs includes at least one polymer insert of the one or more polymer inserts.

[0011] In some embodiments, each of the one or more extension leg fittings includes at least one polymer insert of the one or more polymer inserts.

[0012] In some embodiments, the fill polymer of the polymeric insert comprises the same base polymer as the catheter component comprising the polymeric insert.

[0013] In some embodiments, the filler polymer of the polymeric insert comprises a different base polymer than the catheter component comprising the polymeric insert.

[0014] In some embodiments, the polymer insert is overmolded into the catheter component.

[0015] In some embodiments, a polymer insert is inserted into the catheter component.

[0016] In some embodiments, the antimicrobial filler of the filled polymer includes a carrier of one or more antimicrobial metal species.

[0017] In some embodiments, the antimicrobial filler is about 8% to 15% by weight of each of the one or more polymeric inserts.

[0018] In some embodiments, the carrier is a zeolite and the one or more antimicrobial metal species include antimicrobial cations selected from the group consisting of silver, copper, and zinc, which are electrostatically held at the ion exchange sites of the zeolite.

[0019] In some embodiments, the liquid includes dissolved cations selected from sodium and potassium for ion exchange with the antimicrobial cations at the ion exchange sites of the zeolite.

[0020] In some embodiments, an antimicrobial catheter is also disclosed herein, comprising one or more polymer inserts made of a filled polymer. Each of the one or more polymer inserts provides at least a portion of an inner cavity surface in a catheter component selected from a catheter tubing, a catheter hub, one or more extension legs, and one or more extension leg accessories. In addition, each of the one or more polymer inserts is configured to elute one or more antimicrobial metal cations from the polymer insert when in contact with a liquid comprising dissolved cations.

[0021] In some embodiments, the polymer insert is overmolded into or inserted into the catheter component.

[0022] In some embodiments, the antimicrobial filler of the filled polymer includes a carrier of one or more antimicrobial metal cations. The carrier is a zeolite, and the one or more antimicrobial cations are selected from silver, copper and zinc, and the one or more antimicrobial cations are electrostatically held at the ion exchange sites of the zeolite for ion exchange with sodium, potassium or a combination thereof as dissolved cations.

[0023] Also disclosed herein is a method for manufacturing an antimicrobial catheter. In some embodiments, the method includes a polymer insert molding operation, a catheter component molding operation, and a catheter assembly operation. The polymer insert molding operation includes molding a plurality of polymer inserts made of a filled polymer. Each of the plurality of polymer inserts is configured to elute one or more antimicrobial metal substances from the polymer insert when in contact with a liquid. The catheter component molding operation includes molding a plurality of at least one catheter component selected from catheter components including catheter tubing, catheter hubs, extension legs, and extension leg accessories. The catheter component includes one or more polymer inserts, and the one or more polymer inserts provide at least a portion of the lumen surface in the catheter component. The catheter assembly operation includes assembling the antimicrobial catheter from the catheter components.

[0024] In some embodiments, the method further comprises a compounding operation. The compounding operation comprises compounding the base polymer with the antimicrobial filler to form a filled polymer. The antimicrobial filler is about 8 wt % to 15 wt % of the filled polymer.

[0025] In some embodiments, the antimicrobial filler comprises a zeolite. Additionally, the one or more antimicrobial metal species comprises antimicrobial cations selected from the group consisting of silver, copper, and zinc, which are electrostatically held at the ion exchange sites of the zeolite.

[0026] In some embodiments, the catheter component molding operation includes overmolding one or more polymer inserts into the catheter component.

[0027] In some embodiments, the method further comprises a polymer insert insertion operation. The polymer insert insertion operation comprises inserting one or more polymer inserts into the catheter component after the catheter component molding operation.

[0028] These and other features of the concepts provided herein will become more readily apparent to those skilled in the art in view of the accompanying drawings and the following description, which describe in more detail specific embodiments of such concepts. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 An antimicrobial catheter according to some embodiments is shown.

[0030] Figure 2 A polymer insert providing at least a portion of an interior cavity surface in an extension leg fitting is shown according to some embodiments.

[0031] Figure 3 Loading a polymer insert onto a core pin prior to molding an extension leg fitting onto the polymer insert is shown according to some embodiments.

[0032] Figure 4 The molding of the extension leg fitting onto the polymer insert is shown according to some embodiments.

[0033] Figure 5 Unloading the extension leg fitting from the core pin after molding the extension leg fitting onto the polymer insert is shown according to some embodiments.

[0034] Figure 6 Elution of one or more antimicrobial metal species from their carrier by exchange with an exchange species in a liquid contacting the carrier is shown according to some embodiments. DETAILED DESCRIPTION

[0035] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that can be easily separated from the specific embodiments, and these features may be optionally combined with or replace the features of any of the many other embodiments disclosed herein.

[0036] About the terms used herein, it should also be understood that these terms are for the purpose of describing some specific embodiments, and these terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a set of features or steps, and do not provide sequence or numerical restrictions. For example, "first", "second" and "third" features or steps do not necessarily appear in this order, and the specific embodiments including such features or steps are not necessarily limited to these three features or steps. In addition, unless otherwise specified, any feature or step in the aforementioned features or steps and then can also include one or more features or steps. For convenience, using labels such as "left", "right", "top", "bottom", "front", "back", etc., these labels are not intended to imply, for example, any specific fixed position, orientation or direction. On the contrary, such labels are used to reflect, for example, relative position, orientation or direction. The singular forms of "a kind of", "one" and "the" include plural references, unless the context clearly specifies otherwise.

[0037] "Proximal" is used to indicate a portion, segment, component, element, etc. of a medical device that is intended to be placed near or relatively close to a clinician when the medical device is used on a patient. For example, a "proximal portion" or "proximal segment" of a medical device includes a portion or segment of a medical device that is intended to be placed near a clinician when the medical device is used on a patient. Similarly, a "proximal length" of a medical device includes a length of a medical device that is intended to be placed near a clinician when the medical device is used on a patient. The "proximal end" of a medical device includes an end of a medical device that is intended to be placed near a clinician when the medical device is used on a patient. The proximal portion, proximal segment, or proximal length of a medical device need not include the proximal end of the medical device. In fact, the proximal portion, proximal segment, or proximal length of a medical device may be shorter than the proximal end of the medical device. However, the proximal portion, proximal segment, or proximal length of a medical device may include the proximal end of the medical device. If the context does not indicate that the proximal portion, proximal segment, or proximal length of a medical device includes the proximal end of the medical device, or if deemed advantageous in the following description, the "proximal portion," "proximal segment," or "proximal length" may be modified to indicate that such portion, segment, or length includes the end portion, end segment, or end length, respectively, of the medical device to refer to the "proximal portion," "proximal segment," or "proximal length" of the medical device.

[0038] "Distal" is used to indicate that the part, segment, component, element, etc. of the medical device is intended to be placed near the patient, relatively close to the patient, or even in the patient's body when the medical device is used for the patient. For example, the "distal part" or "distal segment" of the medical device includes the part or segment of the medical device intended to be placed near the patient, relatively close to the patient, or even in the patient's body when the medical device is used for the patient. Similarly, the "distal length" of the medical device includes the length of the medical device intended to be placed near the patient, relatively close to the patient, or even in the patient's body when the medical device is used for the patient. The "distal end" of the medical device is the end of the medical device intended to be placed near the patient, relatively close to the patient, or even in the patient's body when the medical device is used for the patient. The distal part, distal segment, or distal length of the medical device does not need to include the distal end of the medical device. In fact, the distal part, distal segment, or distal length of the medical device can be shorter than the distal end of the medical device. However, the distal part, distal segment, or distal length of the medical device can include the distal end of the medical device. If the context does not indicate that the distal portion, distal segment, or distal length of a medical device includes the distal end of the medical device, or if deemed advantageous in the following description, the "distal portion," "distal segment," or "distal length" may be modified to indicate that such portion, segment, or length includes the end portion, end segment, or end length, respectively, of the medical device to refer to the "distal portion," "distal segment," or "distal length" of the medical device.

[0039] Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art.

[0040] As described above, CRBSI is one of the most common infections acquired in hospitals. The incidence of CRBSI varies greatly depending on the type of catheter, the site of insertion, the clinician's experience in catheter placement, the duration of catheter placement, the frequency of catheter access, etc. Although knowledge about the epidemiology of CRBSI and methods for diagnosing, managing, and preventing it has increased significantly, CRBSI still results in significant morbidity and lengthy and expensive hospital stays. Described below are antimicrobial catheters and methods that address the foregoing problems.

[0041] Antimicrobial catheters

[0042] Figure 1 An antimicrobial catheter 100 is shown according to some embodiments.

[0043] As shown, the antimicrobial catheter 100 may include one or more catheter components selected from a catheter tube 102, a catheter hub 104, one or more extension legs 106, and one or more extension leg fittings 108 (e.g., connectors such as Luer connectors). When all of the aforementioned catheter components are present in the antimicrobial catheter 100, as shown in FIG. Figure 1 As in the embodiment of the present invention, the proximal portion of catheter tube 102 can be coupled to catheter hub 104, the distal portion of each of one or more extension legs 106 can be coupled to catheter hub 104, and the proximal portion of each of one or more extension legs 106 can be coupled to an extension leg fitting 108 of one or more extension leg fittings 108. Such antimicrobial catheter 100 can be a central venous catheter ("CVC"), a peripherally inserted central catheter ("PICC"), a midline catheter, a peripheral intravenous catheter ("PIVC"), an acute dialysis catheter, etc.; however, antimicrobial catheter 100 is not limited to such catheters.

[0044] Figure 2 A polymer insert 110 is shown providing a portion of a luminal surface 112 according to some embodiments.

[0045] As shown, the antimicrobial catheter 100 may also include one or more polymer inserts 110 made of a filled polymer. Each of the one or more polymer inserts 110 may be overmolded or inserted into a catheter component selected from the catheter tubing 102, the catheter hub 104, any of the one or more extension legs 106, and any of the one or more extension leg fittings 108, such that the polymer insert 110 provides at least a portion of the luminal surface 112 in its corresponding catheter component, such as a portion of the luminal surface 112 that is less than the entire luminal surface 112 in its corresponding catheter component, for example, less than 75%, 50%, 25%, 15%, 10%, or 5% of the entire luminal surface 112 in its corresponding catheter component. However, in some embodiments of the antimicrobial catheter 100, the polymer insert 110 may provide up to the entire luminal surface 112 of its corresponding catheter component (including the entire luminal surface 112 of its corresponding catheter component).

[0046] In an example of an antimicrobial catheter 100, the catheter tubing 102 may include at least one of the one or more polymer inserts 110 overmolded or inserted into the catheter tubing 102. In another example of an antimicrobial catheter 100, the catheter hub 104 may include at least one of the one or more polymer inserts 110 overmolded or inserted into the distal portion of the catheter hub 104; however, in a multi-lumen catheter such as Figure 1In the illustrated triple lumen antimicrobial catheter 100), for each lumen of the multi-lumen catheter, the catheter hub 104 may include at least one of the one or more polymer inserts 110 overmolded or inserted into the proximal portion of the catheter hub 104. In another example of the antimicrobial catheter 100, each of the one or more extension legs 106 may include at least one of the one or more polymer inserts 110 overmolded or inserted into the extension leg 106. In another example of the antimicrobial catheter 100, each of the one or more extension leg fittings 108 may include at least one of the one or more polymer inserts 110 overmolded or inserted into the extension leg fitting 108, as Figure 2 It is worth noting that Figure 2 The polymer insert 110 shown overmolded or inserted into the extension leg fitting 108 abuts the proximal end of the extension leg 106 also overmolded or inserted into the extension leg fitting 108, such that the polymer insert 110 provides a portion of the luminal surface 112 of the extension leg fitting 108 that is less than the entire luminal surface 112 of the extension leg fitting 108, with the remainder of the luminal surface 112 of the extension leg fitting 108 being provided by the extension leg 106. If multiple catheter components of the antimicrobial catheter 100 optionally include multiple polymer inserts 110, respectively, the multiple polymer inserts 110 can be independently overmolded or inserted into their corresponding catheter components.

[0047] The filling polymer of any of the one or more polymer inserts 110 may include a base polymer that is the same as or different from the base polymer of the catheter component that includes the polymer insert 110. In one example, the filling polymer of the one or more polymer inserts 110 may include thermoplastic polyurethane as a base polymer, and the one or more polymer inserts 110 may be overmolded or inserted into one or more extension leg fittings 108 that also have thermoplastic polyurethane as its base polymer, respectively. Whether the base polymer of the filling polymer is the same as or different from the base polymer of any catheter component of the antimicrobial catheter 100, the filling polymer may include: one or more additional polymers (e.g., a hydrophilic polymer to facilitate exchange of the one or more antimicrobial metal substances 116 with the exchange substance 118) in addition to the base polymer to obtain a polymer blend thereof; one or more additives selected from a plasticizer, a lubricant, an impact modifier, an antistatic agent, and a colorant; or a combination thereof.

[0048] It is noteworthy that the filled polymer includes at least an antimicrobial filler as a filler-type additive, the antimicrobial filler includes a carrier 114 of one or more antimicrobial metal substances 116, or in some embodiments, the antimicrobial filler includes one or more antimicrobial metal substances 116, but does not include a carrier 114. The carrier 114 of the one or more antimicrobial metal substances 116 can in turn be a mineral, such as one or more zeolites, bentonites, montmorillonites, vermiculites, illites, hydroxyapatites, or resins, such as ion exchange resins or chelating resins. Such carriers 114 can electrostatically retain the one or more antimicrobial metal substances 116 at the exchange sites of the carrier 114, include the one or more antimicrobial metal substances 116 in the pores of the carrier 114, or a combination thereof. In one example, the zeolite can electrostatically retain the one or more antimicrobial metal substances 116 at the ion exchange sites of the zeolite, or include the one or more antimicrobial metal substances 116 in the pores of the zeolite, and in some embodiments, the one or more antimicrobial metal substances 116 include antimicrobial cations selected from silver, copper, and zinc cations. It is noteworthy that such antimicrobial fillers can be Antimicrobial products, such as those manufactured by Sciessent, LLC (Beverly, Massachusetts) silver, copper, Zinc or 3x, but it should be understood that the antimicrobial filler is not limited to any one or more Antimicrobial Products. In fact, as above, the antimicrobial filler may not even include carrier 114, and in such embodiments, the one or more antimicrobial metal substances 116 may be any one or more of the aforementioned metal cations (e.g., silver cations), one or more metal nanoparticles (e.g., silver nanoparticles), etc.

[0049] The antimicrobial filler of the filled polymer of the one or more polymer inserts 110 can be at least about 1% by weight of the filled polymer, including at least about 10% by weight of the filled polymer, such as at least about 20% by weight of the filled polymer, for example, at least about 30%, 40% by weight, or 50% by weight of the filled polymer, or concentrations therebetween (e.g., at least about 8%, 15%, 22% by weight of the filled polymer), as defined by the least significant figures in the foregoing concentrations. Alternatively, the antimicrobial filler can be no more than about 50% by weight of the filled polymer, including no more than about 40% by weight of the filled polymer, such as no more than about 30% by weight of the filled polymer, for example, no more than about 20%, 10%, or 1% by weight of the filled polymer, or concentrations therebetween (e.g., no more than about 22%, 15%, 8% by weight of the filled polymer), as defined by the least significant figures in the foregoing concentrations. In one example, the antimicrobial filler may be about 8 to 15 weight percent of the filled polymer, such that the antimicrobial filler is correspondingly about 8 to 15 weight percent of each of the one or more polymeric inserts 110 .

[0050] Figure 6 Elution of one or more antimicrobial metal species 116 from a carrier 114 by exchange with an exchange substance 118 in a liquid contacting the carrier 114 is shown according to some embodiments.

[0051] As shown, each of the one or more polymer inserts 110 can be configured to elute one or more antimicrobial metal species 116 from a carrier 114 in a filling polymer of the polymer insert 110 upon contact with a liquid, thereby imparting antimicrobial activity to the antimicrobial catheter 100. In one example, each of the one or more polymer inserts 110 can be configured to elute one or more antimicrobial metal cations (e.g., silver, copper, zinc, or a combination thereof) from a zeolite in a filling polymer of the polymer insert 110 upon contact with a liquid, thereby imparting antimicrobial activity to the antimicrobial catheter 100. Such a liquid can be an aqueous mixture, such as an aqueous suspension (e.g., blood), an aqueous solution (e.g., saline), or simply aqueous moisture, which includes dissolved cations selected from at least sodium and potassium as exchange substances 118 for ion exchange with one or more antimicrobial cations at the ion exchange sites of the zeolite.

[0052] It is noteworthy that the antimicrobial activity of the antimicrobial catheter 100 is not necessarily limited to the antimicrobial activity imparted to the antimicrobial catheter 100 by the one or more polymer inserts 110. In one example, the catheter tubing 102 can include an antimicrobial coating on at least its distal luminal surface 120. In another example, the entire catheter tubing 102, the catheter hub 104, the one or more extension legs 106, the one or more extension leg fittings 108, or the antimicrobial catheter 100 assembled from such catheter components can include another antimicrobial filler (e.g., silver acetate) compounded into its base polymer that is different from the base polymer of the filler polymer of the one or more polymer inserts 110. Specifically, the other antimicrobial filler compounded into the base polymer of the catheter tubing 102, the catheter hub 104, the one or more extension legs 106, the one or more extension leg fittings 108, or the antimicrobial catheter 100 assembled from them should not be any one or more of the above-described Antimicrobial products.

[0053] In fact, it has been found that when the catheter component or antimicrobial catheter assembled therefrom includes about 8 wt % to 15 wt % of an antimicrobial filler (such as When the catheter component or antimicrobial product is used, only about 1% or less of the one or more antimicrobial metal substances 116 are released from such catheter components or antimicrobial catheters (e.g., released from the inner luminal surface 112 of the catheter component or antimicrobial catheter) under typical use conditions. Under such use conditions, the remaining about 99% of the one or more antimicrobial metal substances 116 remain trapped in the body of the aforementioned catheter component or antimicrobial catheter. In addition, it has been found that due to the 8% to 15% by weight concentration of the aforementioned antimicrobial filler, the aforementioned catheter components or antimicrobial catheters assembled therefrom require special manufacturing considerations, such as bulk drying (e.g., multi-day vacuum drying) of the filled polymer. In contrast, one or more polymer inserts 110 that are overmolded or inserted into the catheter tubing 102, the catheter hub 104, one or more extension legs 106, or one or more extension leg fittings 108 provide antimicrobial activity precisely where the antimicrobial activity is needed in the antimicrobial catheter 100, thereby reducing the manufacturing costs associated with unusable or unavailable antimicrobial fillers and eliminating manufacturing considerations, such as bulk drying, and importantly, without sacrificing antimicrobial efficacy.

[0054] Furthermore, upon contact with liquid as described above, the antimicrobial activity imparted to the antimicrobial catheter 100 by the one or more polymer inserts 110 is advantageous in its on-demand nature. Indeed, the on-demand nature of the antimicrobial activity imparted to the antimicrobial catheter 100 by the one or more polymer inserts 110 helps maintain the antimicrobial efficacy of the antimicrobial catheter 100 over an extended period of time, such as from packaging the antimicrobial catheter 100, to storage of the antimicrobial catheter 100 by the supplier and subsequently by the clinical facility, and to use of the antimicrobial catheter 100. While one or more metal inserts (e.g., one or more copper inserts) overmolded or inserted into the catheter tubing 102, the catheter hub 104, the one or more extension legs 106, or the one or more extension leg fittings 108 may alternatively provide a sufficient level of antimicrobial activity, in contrast, the antimicrobial activity of the one or more metal inserts is of a general nature, since the antimicrobial activity is dependent on exposure of the lumen surface of each of the one or more metal inserts. Such lumen surface exposure over time (e.g., from packaging, to storage, and to use of a catheter including one or more metal inserts) due to surface oxidation reduces the antimicrobial efficacy of the one or more metal inserts, which is a distinct disadvantage compared to the one or more on-demand polymer inserts 110. Despite the aforementioned disadvantages, one or more metal inserts (e.g., one or more silver, copper, or zinc inserts) may additionally or alternatively be overmolded or inserted into the catheter tubing 102, catheter hub 104, one or more extension legs 106, or one or more extension leg fittings 108 to meet the specific needs of the antimicrobial catheter 100 to compensate for such disadvantages.

[0055] method

[0056] Methods include methods of making antimicrobial catheters, such as antimicrobial catheter 100 , and methods of using antimicrobial catheter 100 .

[0057] With respect to methods of making an antimicrobial catheter, such methods may include one or more operations selected from the group consisting of a compounding operation, a polymer insert molding operation, a catheter component molding operation, a polymer insert inserting operation, and a catheter assembly operation.

[0058] The compounding operation may include compounding a base polymer for the plurality of polymer inserts 110 with an antimicrobial filler to form a filled polymer for the plurality of polymer inserts 110. Such compounding operations may include heating the base polymer to obtain a softened or molten base polymer; gradually or continuously adding the antimicrobial filler to the softened or molten base polymer; mixing the softened or molten base polymer with the antimicrobial filler in a kneader, mixer, etc. until the antimicrobial filler is homogeneously dispersed throughout the softened or molten base polymer to obtain a softened or molten filled polymer; cooling the softened or molten filled polymer to obtain a solidified filled polymer; and optionally, pelletizing the solidified filled polymer, etc. to facilitate handling of the filled polymer during a polymer insert molding operation. As described above, the antimicrobial filler may include a zeolite, wherein the one or more antimicrobial metal species 116 are antimicrobial cations selected from silver, copper, and zinc, which are electrostatically retained at ion exchange sites of the zeolite, disposed in pores of the zeolite, or a combination thereof. Furthermore, the antimicrobial filler may be about 8 to 15 weight percent of the fill polymer or about 8 to 15 weight percent of each polymer insert 110 in the plurality of polymer inserts 110 after the polymer insert molding operation.

[0059] The polymer insert molding operation may include molding (e.g., blow molding, injection molding, etc.) a plurality of polymer inserts 110 made of a filled polymer. Each polymer insert 110 in the plurality of polymer inserts 110 may be configured to elute one or more antimicrobial metal substances 116 from the polymer insert upon contact with a liquid, as described above.

[0060] The catheter component molding operation may include molding (e.g., injection molding, compression molding, extrusion molding, etc.) a plurality of at least one catheter component selected from the catheter components including the catheter tube 102, the catheter hub 104, the extension legs 106 of the one or more extension legs 106, and the extension leg fittings 108 of the one or more extension leg fittings 108. The catheter component may include one or more polymer inserts 110, the one or more polymer inserts providing a portion of the luminal surface 112 that is less than the entire luminal surface 112 in the catheter component. However, as described above, in some embodiments, the one or more polymer inserts 110 may provide up to the entire luminal surface 112 in the catheter component.

[0061] Figures 3 to 5 A catheter component molding operation for molding (eg, injection molding) a plurality of extension leg fittings 108 onto a corresponding plurality of polymer inserts 110 is shown, according to some embodiments.

[0062] In one example of a catheter component molding operation, the catheter component molding operation may include loading each of the plurality of polymer inserts 110 onto a core pin 122, such as Figure 3 In addition, each of the plurality of core pins 122 including the plurality of polymer inserts 110 may be arranged in the mold 124, and the plurality of extension leg fittings 108 may be injection molded on the plurality of polymer inserts 110, respectively, as shown. Figure 4 Finally, Figure 5 As shown, multiple core pins 122 each including multiple extension leg fittings 108 molded onto multiple polymer inserts 110 can be removed from a mold 124, and each of the multiple extension leg fittings 108 can be unloaded from its corresponding core pin 122 in the multiple core pins 122 for catheter assembly operations.

[0063] If the catheter component molding operation does not include overmolding the one or more polymer inserts 110 into the catheter component, the polymer insert insertion operation may include inserting the one or more polymer inserts 110 into the catheter component after the catheter component molding operation. Although the one or more polymer inserts 110 may be mechanically coupled to the catheter component via one or more interference fits pursuant to inserting the one or more polymer inserts 110 into the catheter component, thermal bonding, solvent bonding, or adhesive bonding may alternatively or additionally be used.

[0064] The catheter assembly operation may include assembling the antimicrobial catheter from catheter components such that, in each antimicrobial catheter 100, the proximal portion of the catheter tubing 102 is coupled to the catheter hub 104, the distal portion of each of the one or more extension legs 106 is coupled to the catheter hub 104, and the proximal portion of each of the one or more extension legs 106 is coupled to an extension leg fitting 108 of one or more extension leg fittings 108. Notably, if such coupling is accomplished during the catheter component molding operation, the catheter assembly operation need not involve inserting the proximal portion of the catheter tubing 102 into the catheter hub 104, inserting the distal portion of each of the one or more extension legs 106 into the catheter hub 104, or inserting the proximal portion of each of the one or more extension legs 106 into the extension leg fitting 108 of one or more extension leg fittings 108. In one example, during the catheter component molding operation, the proximal portion of the catheter tubing 102 is coupled to the catheter hub 104 by overmolding. Figure 4 A proximal end portion of each of the one or more extension legs 106 is shown coupled to an extension leg fitting 108 of the one or more extension leg fittings 108 .

[0065] With respect to methods of using the antimicrobial catheter 100, such methods may include one or more operations selected from a catheter placement operation, a catheter fixation operation, and a catheter admission operation. The catheter placement operation may include placing the antimicrobial catheter 100 in the vasculature of the patient, such as by a Seldinger technique. The catheter fixation operation may include securing the antimicrobial catheter 100 to the patient, such as by a catheter fixation device, a wound dressing, or a combination thereof. The catheter admission operation may include permitting the antimicrobial catheter 100 to elute one or more antimicrobial metal substances 116 therefrom in accordance with its contact with a liquid (e.g., a body fluid (such as blood), saline, an infusate, etc.), as described above.

[0066] Although some specific embodiments have been disclosed herein, and although these specific embodiments have been disclosed in considerable detail, these specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations or modifications may be envisioned by those of ordinary skill in the art, and in broader aspects, these adaptations or modifications are also encompassed. Therefore, changes may be made to the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. An antimicrobial catheter, characterized in that: include: Conduit fittings; a catheter hub to which the proximal portion of the catheter tube is coupled; one or more extension legs, a distal end portion of each of the one or more extension legs coupled to the catheter hub; one or more extension leg fittings, a proximal end portion of each of the one or more extension legs coupled to an extension leg fitting of the one or more extension leg fittings; and One or more polymer inserts made of a filled polymer, each of the one or more polymer inserts providing at least a portion of an inner cavity surface in a catheter component selected from the catheter tubing, the catheter hub, the one or more extension legs and the one or more extension leg accessories, and each of the one or more polymer inserts being configured to elute one or more antimicrobial metal substances from the polymer insert when in contact with a liquid.

2. The antimicrobial catheter according to claim 1, characterized in that The catheter tubing includes at least one polymeric insert of the one or more polymeric inserts.

3. The antimicrobial catheter according to claim 1 or 2, characterized in that: The catheter tubing includes an antimicrobial agent compounded into the catheter tubing, the antimicrobial agent being different from the one or more antimicrobial metallic species of the one or more polymeric inserts.

4. An antimicrobial catheter according to any one of the preceding claims, characterized in that The catheter hub includes at least one polymer insert of the one or more polymer inserts.

5. An antimicrobial catheter according to any one of the preceding claims, characterized in that Each of the one or more extension legs includes at least one polymer insert of the one or more polymer inserts.

6. An antimicrobial catheter according to any one of the preceding claims, characterized in that Each of the one or more extension leg fittings includes at least one polymer insert of the one or more polymer inserts.

7. An antimicrobial catheter according to any one of the preceding claims, characterized in that The filling polymer of a polymeric insert comprises the same base polymer as the catheter component comprising the polymeric insert.

8. An antimicrobial catheter according to any one of the preceding claims, characterized in that The filling polymer of a polymeric insert comprises a different base polymer than the catheter component comprising the polymeric insert.

9. The antimicrobial catheter according to claim 7, characterized in that The polymer insert is overmolded into the catheter component.

10. The antimicrobial catheter according to claim 7, characterized in that The polymer insert is inserted into the catheter component.

11. An antimicrobial catheter according to any one of the preceding claims, characterized in that The filled polymeric antimicrobial filler comprises a carrier for the one or more antimicrobial metal species.

12. The antimicrobial catheter according to claim 11, characterized in that The antimicrobial filler is from 8% to 15% by weight of each of the one or more polymeric inserts.

13. The antimicrobial catheter according to claim 11, characterized in that The carrier is a zeolite and the one or more antimicrobial metal species include antimicrobial cations selected from the group consisting of silver, copper and zinc, the antimicrobial cations being electrostatically held at the ion exchange sites of the zeolite.

14. The antimicrobial catheter according to claim 13, characterized in that The liquid includes dissolved cations selected from sodium and potassium for ion exchange with the antimicrobial cations at the ion exchange sites of the zeolite.

15. An antimicrobial catheter, characterized in that: include: One or more polymeric inserts made of a filled polymer, each of the one or more polymeric inserts providing at least a portion of a lumen surface in a catheter component selected from a catheter tubing, a catheter hub, one or more extension legs, and one or more extension leg fittings, and each of the one or more polymeric inserts being configured to elute one or more antimicrobial metal cations from the polymeric insert when in contact with a liquid comprising dissolved cations.

16. The antimicrobial catheter according to claim 15, characterized in that The polymer insert is overmolded into or inserted into the catheter component.

17. The antimicrobial catheter according to claim 15 or 16, characterized in that The antimicrobial filler of the filled polymer includes a carrier for the one or more antimicrobial metal cations, the carrier being a zeolite, and the one or more antimicrobial cations are selected from the group consisting of silver, copper and zinc, the one or more antimicrobial cations being electrostatically held at the ion exchange sites of the zeolite for ion exchange with sodium, potassium or a combination thereof as the dissolved cations.

18. A method of manufacturing an antimicrobial catheter, characterized in that: include: molding a plurality of polymer inserts made of a filled polymer, each polymer insert of the plurality of polymer inserts being configured to elute one or more antimicrobial metal substances from the polymer insert upon contact with a liquid; molding a plurality of at least one catheter component selected from the group consisting of catheter tubing, catheter hubs, extension legs, and extension leg fittings, the catheter component including one or more polymer inserts providing at least a portion of a luminal surface in the catheter component; and The antimicrobial catheter is assembled from the catheter components.

19. The method according to claim 18, characterized in that Also included is compounding a base polymer with an antimicrobial filler to form the filled polymer, the antimicrobial filler being 8 wt % to 15 wt % of the filled polymer.

20. The method according to claim 19, characterized in that The antimicrobial filler comprises a zeolite and the one or more antimicrobial metal species comprises an antimicrobial cation selected from the group consisting of silver, copper and zinc, the antimicrobial cation being electrostatically retained at the ion exchange sites of the zeolite.

21. The method according to any one of claims 18 to 20, characterized in that Molding a plurality of the at least one catheter component includes overmolding the one or more polymer inserts into the catheter component.

22. The method according to any one of claims 18 to 21, characterized in that Also included is inserting the one or more polymer inserts into the catheter components after molding a plurality of the at least one catheter component.

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