Antibacterial Skin Isolator for Catheters

Abstract

The antimicrobial medical device (100) is used during placement of a catheter (50). The antimicrobial medical device (100) includes a tubular body (120) configured to receive a catheter (50) through a lumen of the tubular body (120) during an intravascular procedure. The wall of the tubular body (120) forms a liner between the catheter (50) and the patient's skin (10). The device (100) further includes an antimicrobial material associated with the tubular body (120), such that, in use, the antimicrobial material inhibits microbial growth at the insertion site (12).

Description

[Background technology]

[0001] Intravascular procedures provide a variety of therapeutic options to patients. Access to internal organs or parts of the body via vascular pathways has significant advantages over access via surgery. Despite the advantages, vascular access poses risks to patients, such as exposure to microbial contamination that can lead to infection and disease transmission. Microbial intrusion via vascular access pathways is a constant concern for medical personnel due to the large number of endovascular procedures, and microbial intrusion can result in increased patient hospital stays and medical costs for necessary corrective measures. Prolonged catheterization increases the incidence and risks associated with microbial intrusion. Thus, systems and methods for reducing the incidence and severity of microbial intrusion, as described herein, can provide significant benefits to patients and health care providers while reducing the cost of performing endovascular procedures.

[0002] Disclosed herein are systems and methods for providing a barrier against microbial intrusion during intravascular procedures. Summary of the Invention

[0003] Disclosed herein is an antimicrobial medical device for use during placement of a catheter. According to some embodiments, the antimicrobial medical device includes a tubular body defining a lumen extending between a proximal end and a distal end of the tubular body. The lumen is configured to receive a catheter therethrough during an intravascular procedure. The device further includes an antimicrobial material associated with the tubular body. The antimicrobial material is a coating on the tubular body and / or is impregnated into the material of the tube body. The tubular body is configured for insertion into a vascular access pathway extending through a skin layer of a patient, such that, in use, the walls of the tubular body define a microbial barrier between the skin layer and the catheter.

[0004] The device may include a flange projecting radially outward from the tubular body. The flange is configured to extend along a skin surface when the tubular body is inserted into a vascular access pathway. The flange may also be configured to attach to a skin surface. In some embodiments, the flange includes an adhesive applied to an underside of the flange. In some embodiments, the flange is oriented at an angle relative to a longitudinal axis of the tubular body.

[0005] The tubular body may be configured to form a seal with the catheter to prevent the escape of bodily fluids between the tubular body and the catheter. In some embodiments, the tubular body includes an inwardly directed annular protrusion configured to form a seal. In some embodiments, the tubular body is sized such that a distal end of the tubular body is placed within a blood vessel during use.

[0006] Also disclosed herein is an intravascular catheter assembly including a catheter and an antimicrobial medical device of any embodiment described above. The antimicrobial medical device is coupled to the catheter such that the antimicrobial medical device annularly covers at least a portion of the catheter. In some embodiments, the antimicrobial medical device covers a distal tip of the catheter.

[0007] Further disclosed herein is a catheter introducer assembly including a catheter introducer and an antimicrobial medical device of any embodiment described above. The antimicrobial medical device is coupled to the catheter introducer such that the antimicrobial medical device annularly covers at least a portion of the catheter introducer. In some embodiments, the antimicrobial medical device covers a distal tip of the catheter introducer.

[0008] Also disclosed herein is a method of placing a catheter within a patient. According to some embodiments, the method includes providing an isolator including a tubular body defining a lumen extending between a proximal end and a distal end. The lumen is configured to receive a catheter. The isolator further includes an antimicrobial material coupled to the tubular body. The method further includes (i) inserting the isolator into a vascular access pathway of the patient, (ii) inserting a catheter through the lumen of the isolator, and (iii) advancing the catheter along a blood vessel of the patient.

[0009] In some embodiments, insertion of a catheter through a lumen of the isolator creates a fluid seal between the catheter and the isolator, hi further embodiments, the isolator defines a microbial barrier between the patient's skin layer and the catheter.

[0010] In some embodiments, the method further includes inserting the isolator into the vascular access pathway such that a distal end of the tubular body is disposed within the blood vessel. In some embodiments, the method further comprises inserting a catheter through a lumen of the isolator after inserting the isolator into the vascular access pathway.

[0011] In some embodiments, the method further includes inserting an isolator into the vascular access pathway such that a flange of the isolator is disposed adjacent to a skin surface of the patient and / or attaching a flange of the isolator to the skin surface. The method may also include attaching the isolator to a catheter.

[0012] In some embodiments, the method further includes inserting a catheter into the lumen of the isolator such that a distal end of the catheter is disposed proximal to the distal end of the tubular body prior to inserting the isolator into the vascular access pathway. The method may further include manually applying a distally directed force to the catheter, the distally directed force being transmitted to the isolator through the catheter.

[0013] In some embodiments, the method further includes inserting a catheter introducer into the isolator. The method may further include inserting the catheter introducer into the vascular access pathway after inserting the catheter introducer into the isolator. These and other features of the concepts provided herein will become more apparent to those of ordinary skill in the art upon consideration of the accompanying drawings and the following description, which describe in more detail certain embodiments of such concepts. [Brief description of the drawings]

[0014] [Figure 1A] 1 illustrates an antimicrobial medical device for use with a catheter, according to some embodiments. [Figure 1B] 1B shows a side cross-sectional view of the antimicrobial medical device of FIG. 1A, according to some embodiments. [Figure 2A] 1A and 1B show a catheter assembly including the antimicrobial medical device of FIG. 1A and FIG. 1B, according to some embodiments. [Figure 2B] FIG. 2B is a detailed view of the distal tip of the catheter assembly of FIG. 2A, according to some embodiments. [Figure 3A] 1A and 1B show a catheter introducer assembly including the antimicrobial medical device of FIG. 1A according to some embodiments. [Figure 3B] FIG. 3B is a detailed view of the distal tip of the catheter introducer assembly of FIG. 3A, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein are not intended to limit the scope of the concepts provided herein. It should also be understood that a specific embodiment disclosed herein may have features that are easily separable from the specific embodiment and that may be combined or substituted in any way with features of any of the numerous other embodiments disclosed herein.

[0016] With regard to the terms used herein, it should also be understood that these terms are intended to describe certain embodiments and are not intended to 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 within a group of features or steps and do not provide sequential or numerical limitations. For example, the "first", "second", and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. In addition, in a similar manner, any of the aforementioned features or steps may further include one or more features or steps unless otherwise specified. Designations such as "left", "right", "upper", "lower", "front", "rear", etc. are used for convenience and do not imply, for example, a specific fixed position, orientation, or direction. Instead, such designations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0017] The phrases "connected to," "coupled to," and "in communication with" refer to any form of interaction between two or more elements, including, but not limited to, mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interactions. Two components may be connected to one another even if they are not in direct contact with one another. For example, two components may be coupled to one another through an intermediate component. Additionally, two components may be coupled to one another when one component is integrated into the other.

[0018] With respect to "proximal," for example, a "proximal portion" or "proximal section" of an isolator disclosed herein includes a portion of a catheter that is intended to be near or pointing toward a clinician (e.g., away from a patient) when in use on a patient. For example, a "proximal end" of an isolator includes an end of the isolator that is intended to extend away from the skin surface when the isolator is in use on a patient. A proximal portion, section, or length of an isolator may include the proximal end of the isolator. However, a proximal portion, section, or length of an isolator need not include the proximal end of the isolator. That is, unless the context suggests otherwise, a proximal portion, section, or length of an isolator is not a terminal portion or length of an isolator.

[0019] With respect to "distal," for example, a "distal portion" or "distal section" of an isolator includes a portion of the isolator that is intended to be within a patient's body when the isolator is used with a patient. Similarly, for example, a "distal length" of an isolator includes a length of the isolator that is intended to extend within a patient's body when the isolator is used with a patient. For example, a "distal end" of an isolator includes an end of the isolator that is intended to be within a patient's body when the isolator is used with a patient. A distal portion, section, or length of an isolator may include the distal end of the isolator. However, a distal portion, section, or length of an isolator need not include the distal end of the isolator. That is, unless the context suggests otherwise, a distal portion, section, or length of an isolator is not a terminal portion or length of an isolator.

[0020] 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. Any method disclosed herein includes one or more steps or actions for carrying out the method described. The steps and / or actions of the method may be interchanged with one another. In other words, the order and / or use of specific steps and / or actions may be modified, unless a specific order of steps or actions is required to properly implement an embodiment.

[0021] Throughout this specification, similar references are made, such as by use of the term "substantially." To each such reference, it is to be understood that in some embodiments, the value, feature, or characteristic may be specified without the similar. For example, when modifiers such as "about" and "substantially" are used, these terms include within their scope the modified word in the absence of the modifier. For example, when the term "substantially linear" is described with respect to a feature, it is to be understood that in further embodiments, the feature may be in a strictly linear configuration.

[0022] 1A and 1B show an embodiment of an antimicrobial medical device in the form of an isolator for use with a catheter. The isolator 100 is generally configured to prevent microbial intrusion into a patient's body during an intravascular procedure. More specifically, the isolator 100 defines a microbial barrier that extends along at least a portion of a vascular access pathway 12, such as through a skin layer 11 of the patient 10. By preventing infection of the patient from microbial intrusion at the vascular access site during an intravascular procedure, significant patient risks, patient lengthy hospital stays, and medical costs are avoided. The skin layer 11 of the patient 10 generally forms a microbial barrier for the patient 10. Thus, openings through the skin layer 11, such as pathway 12, provide a pathway for microbial intrusion into the patient 10. The isolator 100, having antimicrobial properties, is configured to prevent microbial intrusion during an intravascular procedure.

[0023] 1A, a catheter 50 is shown inserted into a passageway 12 and further into a blood vessel 15. In the example shown in FIG. 1A, an isolator 100 is shown extending through the skin layer 11 (i.e., along only a portion of the passageway 12). However, in other examples, the isolator 100 may extend along the entire passageway 12 from the skin surface 11A to the blood vessel 15. The isolator 100 thus provides a tubular liner for the catheter 50 that extends along at least the skin layer portion of the passageway 12. The catheter 50 is thus physically separated from the patient 10 along at least the skin layer portion of the passageway 12 by the tubular wall 120 of the isolator 100. The isolator 100 includes antimicrobial properties to kill or inhibit the growth of microorganisms adjacent to the isolator 100, as described further below.

[0024] In some embodiments, the catheter 50 may be a central line catheter, such as a central venous catheter (CVC) or a peripherally inserted central catheter (PICC). In other embodiments, the catheter 50 may be an intravascular device, such as a stylet, guidewire, introducer, dilator, or any other device configured for insertion into or advancement along the vascular system of the patient 10.

[0025] In use, the isolator 100 may be inserted along the pathway 12 prior to inserting the catheter 50. As shown, the catheter 50 is inserted through a lumen of the isolator 100. In some cases, the catheter 50 may remain inserted within the patient 10 for an extended period of time, such as several days or more. Thus, the isolator 100 may remain in place within the pathway 12 for the duration of the endovascular procedure. In some cases, the isolator 100 may be removed from the patient 10 at the same time that the catheter 50 is removed. In other instances, the isolator 100 may remain in place for use with a subsequent catheter or other endovascular device.

[0026] The isolator 100 may be configured to form a fluid seal with the catheter 50 to prevent bodily fluids (e.g., blood) from migrating along the annular space between the isolator wall 120 and the catheter 50. This seal may also prevent microorganisms from passing longitudinally along the annular space.

[0027] In some embodiments, the isolator 100 may be configured to be attached to the patient 10. For example, the isolator 100 may include a flange 140 extending radially outward from the tubular wall 120. The flange 140 defines a structure of the isolator 100 suitable for attachment to the patient 10. For example, a clinician may tape the isolator 100 to the patient 10 via the flange 140.

[0028] 1B is a cross-sectional front view of an isolator 100. As shown, the isolator 100 is generally tubular in shape having a lumen 11 defined by a tubular wall 120 extending between a proximal end 101 and a distal end 102. An opening 110 at the proximal end 101 of the isolator 100 is configured to receive a catheter 50 therethrough. Although not required, the opening 110 may include an internal taper 121 to help guide or facilitate insertion of the catheter 50 through the lumen 111. An external taper 122 at the distal end 102 may facilitate insertion of the isolator 100 along the pathway 12 while also providing a tip structure that inhibits abrasion, puncture, or other trauma to the vessel wall.

[0029] The tubular wall 120 can be substantially thin and sufficiently flexible to conform to the shape (e.g., curvature) of the catheter 50. In some embodiments, the tubular wall 120 can be sufficiently flexible to allow body tissue, such as the skin layer 11, internal body tissue, or blood vessel walls, to flatten the lumen 111 when the catheter 50 is not disposed within the isolator 100. Flattening the lumen 111 can reduce the escape of bodily fluids, such as bleeding, through the lumen 111.

[0030] In some embodiments, the isolator 100 may be stretchable. More specifically, the tubular wall 120 may be laterally stretchable such that the diameter of the isolator 100 expands to define or facilitate an interference fit with the catheter 50. In some embodiments, the isolator 100 may define an interference fit with the catheter 50. The interference fit may create frictional forces between the tubular wall 120 and the catheter 50 to resist longitudinal displacement of the catheter 50 relative to the isolator 100. The isolator 100 may be formed from any suitable medical grade material, including silicone, polyethylene, polypropylene, polytetrafluoroethylene, and the like.

[0031] The length 127 of the isolator 100 may be sized to extend at least through the skin layer 11 and / or in some embodiments to extend between the skin surface 11 and a blood vessel 15. Thus, the length 127 may be about 0.2 cm to 1.0 cm, about 0.3 cm to 0.7 cm, or about 0.5 cm.

[0032] As discussed above, the isolator 100 includes antimicrobial properties. For example, in the illustrated embodiment, the isolator 100 may include an antimicrobial coating 130 disposed on any or all surfaces of the isolator 100, including the interior luminal surface. The antimicrobial coating 130 may include chlorhexidine, rifampin, silver sulfadiazine, or any other suitable antimicrobial substance. Instead of or in addition to a surface coating, the antimicrobial coating 130 may be impregnated or otherwise incorporated into the isolator material.

[0033] As discussed above, the isolator 100 may be configured to form a seal with the catheter 50. In some embodiments, the isolator 100 may be sized to define an interference fit with the catheter along at least a portion of the length of the isolator 100. In some embodiments, although not required, the isolator 100 may include a seal member 123 to define a seal. For example, the seal member 123 may be an inwardly directed annular protrusion disposed on the inner surface of the tubular wall 120. For example, the seal member 123 may take any form, such as a simple protruding rib as shown, or other forms, such as a deflectable lip.

[0034] The flange 140, as described above, can facilitate attachment of the isolator 100 to the patient 10, and more particularly, to the skin layer 11. The flange 140 can also ensure that the proximal end 101 of the isolator 100 remains outside the patient 10. In some embodiments, the flange 140 can be formed from an annular ring extending around the circumference of the isolator 100. The flange 140 can also be a plurality of protrusions extending radially outwardly of the tubular wall 120.

[0035] In some embodiments, the flange 140 may define a plane 140A. The flange 140 (i.e., the plane 140A) may be oriented at an angle 126 relative to the tubular wall 120 as shown, or relative to a longitudinal axis (not shown) of the isolator 100. In the embodiment shown in FIG. 1B, the angle 126 is 90 degrees. In other embodiments, the angle 126 may be an angle other than 90 degrees to accommodate the orientation of the isolator 100 relative to the skin surface 11A. In other words, as shown in FIG. 1A, the angle 126 may be defined with consideration of the insertion angle of the isolator 100 relative to the skin layer 11. In some embodiments, the flange 140 may be deflectable with respect to the tubular wall 120 with consideration of the insertion angle. In some embodiments, the flange 140 may include an adhesive 141 disposed on an underside of the flange 140 to facilitate attachment of the isolator 100 to the skin surface 11A.

[0036] In some embodiments, although not required, the isolator 100 may be configured to mate with the catheter 50 to prevent longitudinal displacement of the catheter 50 relative to the isolator 100. In some embodiments, an interference fit (as described above) can prevent longitudinal and / or rotational displacement of the catheter 50 relative to the isolator 100. In other embodiments, the isolator 100 may optionally include one or more attachment mechanisms 145 for attaching the isolator 100 to the catheter 50. The attachment mechanisms 145 may be disposed adjacent the proximal end 101 to engage with corresponding attachment mechanisms (not shown) of the catheter 50. As can be appreciated by one of ordinary skill in the art, the attachment mechanisms 145 may take any form suitable for preventing longitudinal and / or rotational displacement of the catheter 50 relative to the isolator 100.

[0037] A method of using the isolator may generally include inserting the isolator through a skin layer and into a defined pathway such that a proximal end of the isolator is disposed outside the patient's body. In some embodiments, inserting the isolator into the defined pathway may include placing a distal end of the isolator within a blood vessel. The method also generally includes inserting a catheter through the isolator. In some embodiments, the isolator is inserted into the patient's body prior to inserting the catheter through the isolator. In some embodiments, the catheter is inserted into the isolator prior to inserting the isolator into the patient's body. The method may further include manually applying a distally directed force to the catheter while inserting the isolator into the patient's body, the catheter transmitting the distally directed force to the isolator. The method may further include inserting the catheter into the isolator such that a distal end of the catheter is proximal to a distal end of the isolator while the isolator is positioned external to the patient, and then further inserting the catheter into the isolator such that a distal end of the catheter is distal to the distal end of the isolator after the isolator is inserted into the patient. In some embodiments, the method may include attaching the isolator to the catheter to prevent movement of the catheter relative to the isolator. The method may also include attaching the isolator to the patient to prevent movement of the isolator during the medical procedure.

[0038] In some embodiments, the method includes inserting a catheter introducer (or dilator) into the isolator. The method may further include manually applying a distally directed force to the catheter introducer while inserting the isolator into the patient, the catheter introducer transmitting the distally directed force to the isolator. The method may also include removing the introducer from the isolator. In some embodiments, the method may include threading the isolator onto a guidewire (not shown).

[0039] 2A and 2B show an embodiment of a catheter assembly 210 including a catheter 250 and an isolator 200. The isolator 200 may be similar in some respects to the components of the isolator 100 described in connection with FIGS. 1A and 1B. It should be understood that all of the illustrated embodiments may have similar features. Accordingly, similar features are labeled with similar reference numbers, with the leading digit incremented to "2." For example, the flange is labeled "140" in FIGS. 1A and 1B, and the similar flange is labeled "240" in FIGS. 2A and 2B. Thus, the relevant disclosure set forth above with respect to similarly identified features may not be repeated hereafter. Additionally, certain features of the isolator 100 and related components shown in FIGS. 1A and 1B may not be indicated or identified by reference numbers in the drawings or described in detail in the following description. However, such features may obviously be the same or substantially the same as features shown in and / or described with respect to other embodiments. Thus, the relevant discussion of such features applies equally to the features of the isolator of Figures 2A and 2B. Any suitable combinations of features, and variations thereof, described with respect to the isolator 100 and components shown in Figures 1A and 1B may be used with the isolator and components of Figures 2A and 2B, and vice versa. This pattern of disclosure applies equally to further embodiments shown in subsequent figures and described below.

[0040] 2A, according to one embodiment, the isolator 200 is coupled to the catheter 250 at the distal end 251 of the catheter 250. In other embodiments, the isolator 200 may be coupled to the catheter 250 at a location other than the distal end 251, such as between the distal end 152 and the hub 252.

[0041] 2B is a detailed view of the distal portion of the catheter assembly 210. As shown, the distal tip 252 of the catheter 250 is disposed within the isolator 200 such that the isolator 200 covers the distal tip 252. By covering the distal tip 252, the isolator 200 prevents the distal tip 252 from contacting objects outside the body, including the skin surface 11A, prior to insertion, thereby preventing contamination of the distal tip 252.

[0042] In some embodiments, the isolator 200 may include a tapered portion 223 that extends over a distal-most portion of the distal tip 252. The tapered portion 223 may also assist in guiding the isolator 200 along the pathway 12.

[0043] In some embodiments, the isolator 200 may be coupled to the catheter 250 during manufacturing of the catheter 250. Thus, the method of manufacturing the catheter assembly 210 may include coupling the isolator 200 to the catheter 250 and sterilizing the isolator 200 and catheter 250 after assembly. In other embodiments, a clinician may couple the isolator 200 to the catheter 250 prior to use.

[0044] 3A and 3B show one embodiment of an introducer assembly 310 including an introducer 360 and an isolator 300. As shown in FIG 3A, according to one embodiment, the isolator 300 is coupled to the introducer 360 at a distal end 361 of the introducer 360. In other embodiments, the isolator 300 may be coupled to the introducer 360 at a location other than the distal end 361, such as between the distal end 361 and a hub 362.

[0045] 3B is a detailed view of the distal portion of introducer assembly 310. As shown, the distal tip 362 of introducer 360 is disposed within isolator 300 such that isolator 300 covers distal tip 362. By covering distal tip 362, isolator 300 prevents distal tip 362 from contacting objects outside the body, including skin surface 11A, prior to insertion, thereby preventing contamination of distal tip 362.

[0046] In some embodiments, the isolator 300 may include a tapered portion 323 that extends over a distal-most portion of the distal tip 362. The tapered portion 323 may also assist in guiding the isolator 300 along the pathway 12.

[0047] In some embodiments, the isolator 300 may be coupled to the introducer 360 during manufacture of the introducer 360. Thus, a method of manufacturing the introducer assembly 310 may include coupling the isolator 300 to the introducer 360 and sterilizing the isolator 300 along with the introducer 360 after assembly. In other embodiments, a clinician may couple the isolator 300 to the introducer 360 prior to use.

[0048] Some specific embodiments are disclosed herein, and although the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concept provided herein. Additional adaptations and / or modifications may be apparent to those skilled in the art, and the broader aspects also encompass these adaptations and / or modifications. Thus, one may deviate from the specific embodiments disclosed herein without departing from the scope of the concept provided herein.

Claims

1. a tubular body defining a lumen extending between a proximal end and a distal end, the lumen configured to receive a catheter therethrough during an intravascular procedure; an antimicrobial material coupled to the tubular body, the tubular body configured for insertion into a vascular access pathway extending through a patient's skin layer, whereby, in use, a wall of the tubular body defines a microbial barrier between the skin layer and the catheter.

2. The antimicrobial medical device of claim 1 , wherein the antimicrobial material is a coating applied to the tubular body.

3. The antimicrobial medical device of claim 1 , wherein the antimicrobial material is impregnated into the body material of the tubular body.

4. 10. The antimicrobial medical device of claim 1, wherein the tubular body includes a flange projecting radially outward from the tubular body, the flange configured to extend along a skin surface.

5. The antimicrobial medical device of claim 4 , wherein the flange is configured to be attached to the skin surface.

6. The antimicrobial medical device of claim 4 , wherein the flange includes an adhesive applied to an underside thereof.

7. 5. The antimicrobial medical device of claim 4, wherein the flange is oriented at an angle relative to the longitudinal axis of the tubular body.

8. 10. The antimicrobial medical device of claim 1, wherein the tubular body is configured to form a seal with the catheter to prevent the escape of bodily fluids between the tubular body and the catheter.

9. 9. The antimicrobial medical device of claim 8, wherein the tubular body includes an inwardly directed annular projection configured to form the seal.

10. 10. The antibacterial medical device of claim 1, wherein the tubular body is sized such that, in use, the distal end of the tubular body is placed within a blood vessel.

11. The antimicrobial medical device of claim 1 , wherein the catheter is a central line catheter.

12. 2. The antibacterial medical device of claim 1, wherein the wall of the tubular body is sufficiently flexible to allow body tissue or blood vessel walls to flatten the lumen when the catheter is not placed within the lumen of the tubular body.

13. The antimicrobial medical device of claim 1 , wherein the diameter of the tubular body is configured to expand to form an interference fit with the catheter.

14. A catheter, An intravascular catheter assembly comprising: an antibacterial medical device according to any one of claims 1 to 13, which is coupled to the catheter so as to annularly cover at least a portion of the catheter.

15. The intravascular catheter assembly of claim 14 , wherein the antimicrobial medical device covers the distal tip of the catheter.

16. a catheter introducer; A catheter introducer assembly comprising: an antibacterial medical device according to any one of claims 1 to 13 coupled to the catheter introducer so as to annularly cover at least a portion of the catheter introducer.

17. 17. The catheter introducer assembly of claim 16, wherein the antimicrobial medical device covers a distal tip of the catheter introducer.

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