Antimicrobial catheter

Abstract

The utility model relates to an antimicrobial catheter. 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.

Description

[0001] Priority

[0002] This application claims the priority benefit of U.S. Patent Application No. 18 / 209,379, filed on June 13, 2023, the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] This application relates to the field of medical devices, and more particularly to antimicrobial catheters. Background Art

[0004] Catheter-related bloodstream infections ("CRBSIs") are among the most common infections acquired in hospitals. The incidence of CRBSIs varies widely depending on the type of catheter, the insertion site, the clinician's experience in catheter placement, the duration of catheter placement, the frequency of catheter access, etc. Although there has been a significant increase in the epidemiological knowledge of CRBSIs and the methods for diagnosing, managing, and preventing them, CRBSIs still result in significant morbidity as well as long and costly hospital stays.

[0005] Disclosed herein are antimicrobial catheters and methods for solving the foregoing problems. Summary of the Utility Model

[0006] In some embodiments, disclosed herein is an antimicrobial catheter that includes a catheter body, 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 body 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 among the one or more extension leg fittings. Each of the one or more polymer inserts provides at least a portion of the lumen surface of a catheter component selected from the catheter body, the catheter hub, the one or more extension legs, and the one or more extension leg fittings. Additionally, 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 body includes at least one of the one or more polymer inserts.

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

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

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

[0012] In some embodiments, the filling polymer of the polymer insert comprises the same base polymer as the catheter component including the polymer insert.

[0013] In some embodiments, the filling polymer of the polymer insert comprises a different base polymer from the catheter component including the polymer insert.

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

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

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

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

[0018] In some embodiments, the carrier is zeolite, and the one or more antimicrobial metal substances include antimicrobial cations selected from 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 that includes one or more polymer inserts made of a filled polymer. Each polymer insert of the one or more polymer inserts provides at least a portion of the inner lumen surface in a catheter component selected from a catheter fitting, a catheter bushing, one or more extension legs, and one or more extension leg fittings. Additionally, each polymer insert 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 that includes dissolved cations.

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

[0022] In some embodiments, the antimicrobial filler of the filled polymer includes a carrier for one or more antimicrobial metal cations. The carrier is 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] A method of manufacturing an antimicrobial catheter is also disclosed herein. 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 polymer insert 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 at least one catheter component selected from a group of catheter components including a catheter fitting, a catheter bushing, an extension leg, and an extension leg fitting. The catheter component includes one or more polymer inserts, and the one or more polymer inserts provide at least a portion of the inner 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 includes a compounding operation. The compounding operation includes compounding a base polymer with an 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 includes zeolite. Additionally, the one or more antimicrobial metal substances include antimicrobial cations selected from silver, copper, and zinc, and these antimicrobial cations 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 in the catheter component.

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

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

[0029] Figure 1 An antimicrobial catheter is shown in accordance with some embodiments.

[0030] Figure 2 A polymer insert is shown that provides at least a portion of the lumen surface in an extension leg fitting in accordance with some embodiments.

[0031] Figure 3 A polymer insert is shown loaded onto a core pin prior to molding an extension leg fitting over the polymer insert in accordance with some embodiments.

[0032] Figure 4 An extension leg fitting is shown molded over a polymer insert in accordance with some embodiments.

[0033] Figure 5 An extension leg fitting is shown unloaded from the core pin after molding the extension leg fitting over the polymer insert in accordance with some embodiments.

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

[0035] Before more particularly disclosing some specific embodiments, it is to be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It is also to be understood that the specific embodiments disclosed herein can have features that can be readily separated from the specific embodiments and that such features can optionally be combined with or replace features of any of the many other embodiments disclosed herein.

[0036] Regarding the terms used herein, it should also be understood that these terms are for the purpose of describing certain specific embodiments and 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 group of features or steps and do not provide a sequence or numerical limitation. For example, the "first," "second," and "third" features or steps do not necessarily occur in that order, and a particular embodiment including such features or steps is not necessarily limited to these three features or steps. Additionally, any of the foregoing features or steps may further include one or more features or steps unless otherwise specified. For convenience, labels such as "left," "right," "top," "bottom," "front," "rear," etc. are used, and these labels are not intended to imply, for example, any particular fixed position, orientation, or direction. Instead, such labels are used to reflect, for example, relative position, orientation, or direction. The singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise.

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

[0039] Unless otherwise defined, all technical and scientific terms used herein have the same meaning 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, insertion site, clinician experience in catheter placement, duration of catheter placement, frequency of catheter access, etc. Although there has been a significant increase in the epidemiological knowledge of CRBSI and methods for its diagnosis, management, and prevention, CRBSI still results in significant morbidity as well as long and costly hospital stays. Antimicrobial catheters and methods for addressing the foregoing problems are described below.

[0041] Antimicrobial Catheter

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

[0043] As shown, the antimicrobial catheter 100 can include one or more catheter components selected from catheter fittings 102, catheter sleeves 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 foregoing catheter components are present in the antimicrobial catheter 100, asFigure 1 As in [the previous example], the proximal portion of the catheter fitting 102 can be coupled to the catheter bushing 104, the distal portion of each of the one or more extension legs 106 can be coupled to the catheter bushing 104, and the proximal portion of each of the one or more extension legs 106 can be coupled to the extension leg fitting 108 among the one or more extension leg fittings 108. Such an 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, the antimicrobial catheter 100 is not limited to such catheters.

[0044] Figure 2 A polymer insert 110 providing a portion of the lumen surface 112 is shown in accordance with some embodiments.

[0045] As shown, the antimicrobial catheter 100 can also include one or more polymer inserts 110 made of a filled polymer. Each of the one or more polymer inserts 110 can be overmolded or inserted into a catheter component selected from the catheter fitting 102, the catheter bushing 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 lumen surface 112 in its corresponding catheter component, such as a portion of the lumen surface 112 that is less than the entire lumen surface 112 in its corresponding catheter component, e.g., less than 75%, 50%, 25%, 15%, 10%, or 5% of the entire lumen surface 112 in its corresponding catheter component. However, in some embodiments of the antimicrobial catheter 100, the polymer insert 110 can provide up to the entire lumen surface 112 (including the entire lumen surface 112) of its corresponding catheter component.

[0046] In an example of the antimicrobial catheter 100, the catheter fitting 102 can include at least one of the one or more polymer inserts 110 that is overmolded or inserted into the catheter fitting 102. In another example of the antimicrobial catheter 100, the catheter bushing 104 can include at least one of the one or more polymer inserts 110 that is overmolded or inserted into the distal portion of the catheter bushing 104; however, in a multi-lumen catheter (such as Figure 1In the three-lumen antimicrobial catheter 100 shown, for each lumen of the multi-lumen catheter, the catheter bushing 104 may include one or more polymer inserts 110, at least one of which is overmolded or inserted into the proximal portion of the catheter bushing 104. In another example of the antimicrobial catheter 100, each of the one or more extension legs 106 may include one or more polymer inserts 110, at least one of which is 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 one or more polymer inserts 110, at least one of which is overmolded or inserted into the extension leg fitting 108, as Figure 2 shown. It is noted that, as Figure 2 shown, the polymer insert 110 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 inner lumen surface 112 of the extension leg fitting 108 that is less than the entire inner lumen surface 112 of the extension leg fitting 108, and the remaining portion of the inner lumen surface 112 of the extension leg fitting 108 is provided by the extension leg 106. If the multiple catheter components of the antimicrobial catheter 100 optionally each include multiple polymer inserts 110, the multiple polymer inserts 110 may be overmolded or inserted independently into their corresponding catheter components.

[0047] The filled 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 including the polymer insert 110. In one example, the filled polymer of the one or more polymer inserts 110 may include thermoplastic polyurethane as the base polymer, and the one or more polymer inserts 110 may be overmolded or inserted respectively into one or more extension leg fittings 108 that also have thermoplastic polyurethane as their base polymer. Whether the base polymer of the filled polymer is the same as or different from the base polymer of any catheter component of the antimicrobial catheter 100, the filled polymer may include: one or more additional polymers (e.g., hydrophilic polymers to facilitate the exchange of one or more antimicrobial metal species 116 with the exchange material 118) in addition to the base polymer to obtain its polymer blend; one or more additives selected from plasticizers, lubricants, impact modifiers, antistatic agents, and colorants; or combinations thereof.

[0048] It should be noted 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 the carrier 114. The carrier 114 of one or more antimicrobial metal substances 116 can in turn be a mineral, such as one or more zeolites, bentonite, montmorillonite, vermiculite, illite, hydroxyapatite, or a resin, such as an ion exchange resin or a chelating resin. Such a carrier 114 can electrostatically hold one or more antimicrobial metal substances 116 at the exchange sites of the carrier 114, include one or more antimicrobial metal substances 116 in the pores of the carrier 114, or a combination thereof. In one example, a zeolite can electrostatically hold one or more antimicrobial metal substances 116 at the ion exchange sites of the zeolite or include one or more antimicrobial metal substances 116 in the pores of the zeolite. In some embodiments, one or more antimicrobial metal substances 116 include antimicrobial cations selected from silver, copper, and zinc cations. It should be noted that such antimicrobial fillers can be antimicrobial products, such as those produced by Sciessent, LLC (Beverly, Massachusetts) silver, Lg, 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 noted above, the antimicrobial filler can even not include the carrier 114, and in such embodiments, one or more antimicrobial metal substances 116 can 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 one or more polymer inserts 110 can be at least about 1 wt% of the filled polymer, including at least about 10 wt% of the filled polymer, such as at least about 20 wt% of the filled polymer, for example, at least about 30 wt%, 40 wt% or 50 wt% of the filled polymer, or a concentration in between (e.g., at least about 8 wt%, 15 wt%, 22 wt% of the filled polymer), as defined by the least significant digit in the aforementioned concentrations. Alternatively, the antimicrobial filler can be no greater than about 50 wt% of the filled polymer, including no greater than about 40 wt% of the filled polymer, such as no greater than about 30 wt% of the filled polymer, for example, no greater than about 20 wt%, 10 wt% or 1 wt% of the filled polymer, or a concentration in between (e.g., no greater than about 22 wt%, 15 wt%, 8 wt% of the filled polymer), as defined by the least significant digit in the aforementioned concentrations. In one example, the antimicrobial filler can be about 8 wt% to 15 wt% of the filled polymer, such that the antimicrobial filler is correspondingly about 8 wt% to 15 wt% of each polymer insert 110 in the one or more polymer inserts 110.

[0050] Figure 6 Shown is the elution of one or more antimicrobial metal species 116 from the carrier 114 by exchange with an exchange species 118 in a liquid in contact with the carrier 114, according to some embodiments.

[0051] As shown, each polymer insert 110 of the one or more polymer inserts 110 can be configured to elute one or more antimicrobial metal species 116 from the carrier 114 in the filled polymer of the polymer insert 110 upon contact with a liquid, thereby imparting antimicrobial activity to the antimicrobial catheter 100. In one example, each polymer insert 110 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 combinations thereof) from a zeolite in the filled 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 merely aqueous moisture, which includes dissolved cations as the exchange species 118 selected from at least sodium and potassium for ion exchange with one or more antimicrobial cations at the ion exchange sites of the zeolite.

[0052] Notably, the antimicrobial activity of the antimicrobial catheter 100 need not be limited to the antimicrobial activity imparted to the antimicrobial catheter 100 by one or more polymer inserts 110. In one example, the catheter fitting 102 may include an antimicrobial coating on at least its distal lumen surface 120. In another example, the entire catheter fitting 102, catheter sleeve 104, one or more extension legs 106, one or more extension leg fittings 108, or the antimicrobial catheter 100 assembled from such catheter components may include another antimicrobial filler (e.g., silver acetate) incorporated into the base polymer thereof that is different from the filler polymer of the one or more polymer inserts 110. Specifically, another antimicrobial filler incorporated into the base polymer of the catheter fitting 102, catheter sleeve 104, one or more extension legs 106, one or more extension leg fittings 108, or the antimicrobial catheter 100 assembled therefrom should not be any one or more of those described above antimicrobial products.

[0053] In fact, it has been found that when the catheter component or the antimicrobial catheter assembled therefrom includes about 8 wt% to 15 wt% of an antimicrobial filler (such as antimicrobial products) incorporated into its base polymer, under typical use conditions, only about 1% or less of one or more antimicrobial metal species 116 are released from such catheter component or antimicrobial catheter (e.g., released from the lumen surface 112 of the catheter component or antimicrobial catheter). Under such use conditions, the remaining approximately 99% of the one or more antimicrobial metal species 116 remain trapped within the body of the aforementioned catheter component or antimicrobial catheter. Additionally, it has been found that due to the aforementioned antimicrobial filler at a concentration of 8 wt% to 15 wt%, the aforementioned catheter component or the antimicrobial catheter assembled therefrom requires special manufacturing considerations, such as extensive drying of its filler polymer (e.g., multi-day vacuum drying). In contrast, one or more polymer inserts 110 that are overmolded or inserted into the catheter fitting 102, catheter sleeve 104, one or more extension legs 106, or one or more extension leg fittings 108 provide antimicrobial activity precisely where 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 extensive drying, importantly without sacrificing antimicrobial efficacy.

[0054] In addition, when in contact with a liquid as described above, the antimicrobial activity imparted to the antimicrobial catheter 100 by one or more polymer inserts 110 is advantageous in its on-demand nature. In fact, the on-demand nature of the antimicrobial activity imparted to the antimicrobial catheter 100 by one or more polymer inserts 110 helps to 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 a supplier and subsequently by a clinical facility and to use of the antimicrobial catheter 100). While one or more metal inserts (e.g., one or more copper inserts) encapsulated molded or inserted into the catheter fitting 102, catheter bushing 104, one or more extension legs 106 or one or more extension leg fittings 108 may alternatively provide a sufficient level of antimicrobial activity, in contrast, the antimicrobial activity of one or more metal inserts has a constant-on nature, since the antimicrobial activity depends on the exposure of the lumen surface of each of the one or more metal inserts. Due to surface oxidation, such lumen surface exposure reduces the antimicrobial efficacy of the one or more metal inserts over time (e.g., from packaging, to storage and to use of a catheter including one or more metal inserts), which is clearly a disadvantage compared to one or more on-demand polymer inserts 110. Despite the foregoing disadvantages, one or more metal inserts (e.g., one or more silver, copper or zinc inserts) may additionally or alternatively be encapsulated molded or inserted into the catheter fitting 102, catheter bushing 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] The method includes a method of manufacturing an antimicrobial catheter such as the antimicrobial catheter 100 and a method of using the antimicrobial catheter 100.

[0057] Regarding the method of manufacturing an antimicrobial catheter, such method may include one or more operations selected from a compounding operation, a polymer insert molding operation, a catheter component molding operation, a polymer insert insertion operation, and a catheter assembly operation.

[0058] The compounding operation can include compounding a base polymer for a plurality of polymer inserts 110 with an antimicrobial filler to form a filled polymer for the plurality of polymer inserts 110. Such compounding operations can 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 the polymer insert molding operation. As described above, the antimicrobial filler can include zeolite, wherein one or more antimicrobial metal substances 116 are antimicrobial cations selected from silver, copper, and zinc, and these antimicrobial cations are electrostatically held at the ion exchange sites of the zeolite, disposed in the pores of the zeolite, or a combination thereof. Additionally, after the polymer insert molding operation, the antimicrobial filler can be about 8 wt% to 15 wt% of the filled polymer or about 8 wt% to 15 wt% of each polymer insert 110 in the plurality of polymer inserts 110.

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

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

[0061] Figures 3 to 5 A catheter component molding operation for molding (e.g., injection molding) a plurality of extension leg fittings 108 onto corresponding ones of a 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 can include loading each of a plurality of polymer inserts 110 onto a core pin 122, as Figure 3 shown. Additionally, each of a plurality of core pins 122, each including a plurality of polymer inserts 110, can be disposed in a mold 124, and a plurality of extension leg fittings 108 can be injection molded onto the plurality of polymer inserts 110, respectively, as Figure 4 shown. Finally, as Figure 5 shown, the plurality of core pins 122, each including a plurality of extension leg fittings 108 molded onto the plurality of polymer inserts 110, can be removed from the mold 124, and each of the plurality of extension leg fittings 108 can be unloaded from its corresponding core pin 122 of the plurality of core pins 122 for catheter assembly operations.

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

[0064] The catheter assembly operation can include assembling an antimicrobial catheter from the catheter components such that, in each antimicrobial catheter 100, a proximal portion of a catheter tube 102 is coupled to a catheter bushing 104, a distal portion of each of one or more extension legs 106 is coupled to the catheter bushing 104, and a proximal portion of each of 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 couplings are achieved during the catheter component molding operation, the catheter assembly operation does not need to involve inserting the proximal portion of the catheter tube 102 into the catheter bushing 104, inserting the distal portion of each of one or more extension legs 106 into the catheter bushing 104, or inserting the proximal portion of each of 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, by overmolding, Figure 4 the proximal portion of each of one or more extension legs 106 shown is coupled to an extension leg fitting 108 of one or more extension leg fittings 108.

[0065] A method of using an antimicrobial catheter 100, such methods can include one or more operations selected from catheter placement operations, catheter fixation operations, and catheter permission operations. The catheter placement operation can include placing the antimicrobial catheter 100 in the patient's vasculature, such as by the Seldinger technique. The catheter fixation operation can include fixing the antimicrobial catheter 100 to the patient, such as by a catheter fixation device, a wound dressing, or a combination thereof. The catheter permission operation can include permitting the antimicrobial catheter 100 to elute one or more antimicrobial metal substances 116 therefrom according to its contact with a liquid (e.g., a body fluid (such as blood), saline, an infusion, 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 can be envisioned by those of ordinary skill in the art and, in a broader sense, these adaptations or modifications are also encompassed. Accordingly, changes can 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, Comprising: A catheter fitting; A catheter bushing, with the proximal portion of the catheter fitting being coupled to the catheter bushing; One or more extension legs, with the distal portion of each of the one or more extension legs being coupled to the catheter bushing; One or more extension leg fittings, with the proximal portion of each of the one or more extension legs being coupled to the extension leg fitting among the one or more extension leg fittings; And One or more polymer inserts made of a filled polymer, with each of the one or more polymer inserts providing at least a portion of the inner cavity surface of the catheter components selected from the catheter fitting, the catheter bushing, the one or more extension legs, and the one or more extension leg fittings, and each of the one or more polymer inserts being configured to elute one or more antimicrobial metal substances from the polymer insert upon contact with a liquid.

2. The antimicrobial catheter according to claim 1, wherein The catheter fitting includes at least one of the one or more polymer inserts.

3. The antimicrobial catheter according to claim 1 or 2, characterized in that, The catheter fitting includes an antimicrobial agent incorporated into the catheter fitting, the antimicrobial agent being different from the one or more antimicrobial metal substances of the one or more polymer inserts.

4. The antimicrobial catheter according to claim 1, wherein, The catheter bushing includes at least one of the one or more polymer inserts.

5. The antimicrobial catheter according to claim 1, characterized in that, Each of the one or more extension legs includes at least one of the one or more polymer inserts.

6. The antimicrobial catheter according to claim 1, wherein Each of the one or more extension leg fittings includes at least one of the one or more polymer inserts.

7. The antimicrobial catheter according to claim 1, characterized in that, The filled polymer of the polymer insert contains the same base polymer as the catheter component including the polymer insert.

8. The antimicrobial catheter according to claim 1, wherein The filled polymer of the polymer insert contains a different base polymer from the catheter component including the polymer insert.

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

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

11. The antimicrobial catheter according to claim 1, wherein The antimicrobial filler of the filled polymer includes a carrier for the one or more antimicrobial metal substances.

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

13. The antimicrobial catheter according to claim 11, wherein, The carrier is zeolite, and the one or more antimicrobial metal substances include antimicrobial cations selected from silver, copper, and zinc, with the antimicrobial cations being electrostatically held at the ion exchange sites of the zeolite.

14. The antimicrobial catheter according to claim 13, wherein, 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, Comprising: One or more polymer inserts made of a filled polymer, each of the one or more polymer inserts providing at least a portion of the lumen surface in a conduit component selected from conduit fittings, conduit bushings, one or more extension legs, and one or more extension leg fittings, and each of the one or more polymer inserts being configured to elute one or more antimicrobial metal cations from the polymer insert when in contact with a liquid comprising dissolved cations.

16. The antimicrobial catheter according to claim 15, wherein The polymer insert is overmolded in the conduit component or inserted into the conduit 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 zeolite, and the one or more antimicrobial cations being selected from 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.

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