Catheter disinfection system

Abstract

The utility model relates to a catheter disinfection system. In some embodiments, a catheter disinfection system may include an introducer sheath and a sterilising irradiation device for irradiating a catheter tubing of a catheter with sterilising radiation. The introducer sheath may include a sheath body configured to be percutaneously inserted into an insertion site of a patient. The sterilization illumination device may be configured to illuminate the catheter tubing as it is inserted into the lumen of the introducer sheath to sterilize the catheter tubing immediately before insertion into the insertion site.

Description

[0001] priority

[0002] This application claims the benefit of priority to U.S. patent application No. 18 / 132,261, filed on April 7, 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 a catheter disinfection system. Background Art

[0004] At present, medical devices (such as catheters) are packaged and sterilized in bulk using ethylene oxide or some other common industrial scale sterilization techniques in their packaging before distribution, sale and use by clinicians. Taking the catheter as one of the aforementioned medical devices as an example, clinicians usually remove the catheter from its packaging and manipulate the catheter in various ways according to procedures before the catheter is inserted and placed in the patient. However, such manipulations impair the sterility of the catheter, which may cause the catheter to be contaminated by bacteria causing infection or its endotoxins causing endotoxemia. Therefore, it would be advantageous to sterilize the catheter (and, by extension, any of many other similar medical devices) before being inserted into the insertion site or subsequently placed in the patient.

[0005] Disclosed herein are catheter sterilization systems and methods for sterilizing a medical device, such as a catheter, prior to insertion and placement within a patient. Utility Model Content

[0006] Disclosed herein is a catheter disinfection system, which in some embodiments includes an introducer sheath and a germicidal irradiation device, the germicidal irradiation device being used to irradiate a catheter tube of the catheter with germicidal radiation. The introducer sheath includes a sheath body and a sheath hub. The sheath body is configured to be percutaneously inserted into an insertion site of a patient. The sheath hub is coupled to a proximal portion of the sheath body. The germicidal irradiation device is configured to irradiate the catheter tube when the catheter tube is inserted into the lumen of the introducer sheath, thereby sterilizing the catheter tube immediately before insertion into the insertion site.

[0007] In some embodiments, the germicidal irradiation device includes one or more internal radiation sources incorporated into the introducer sheath. The one or more internal radiation sources are configured to generate germicidal radiation and emit the germicidal radiation into the lumen of the introducer sheath.

[0008] In some embodiments, one or more internal radiation sources are incorporated into the sheath body so as to circumferentially illuminate the lumen of the introducer sheath.

[0009] In some embodiments, one or more internal radiation sources are incorporated into a diffuser disposed in the sheath body so that the lumen of the introducer sheath is circumferentially illuminated from the diffuser of the sheath body.

[0010] In some embodiments, one or more internal radiation sources are incorporated into the sheath body behind the diffuser so as to circumferentially illuminate the lumen of the introducer sheath through the diffuser of the sheath body.

[0011] In some embodiments, the diffuser includes a plurality of dimples configured to scatter germicidal radiation transmitted into the diffuser into the lumen of the introducer sheath.

[0012] In some embodiments, one or more internal radiation sources are incorporated into the sheath hub so as to circumferentially illuminate the lumen of the introducer sheath.

[0013] In some embodiments, one or more internal radiation sources are incorporated into a diffuser disposed in the sheath hub so that the lumen of the introducer sheath is circumferentially illuminated from the diffuser of the sheath hub.

[0014] In some embodiments, one or more internal radiation sources are incorporated into the sheath hub behind the diffuser so as to circumferentially illuminate the lumen of the introducer sheath through the diffuser of the sheath hub.

[0015] In some embodiments, the diffuser includes a plurality of dimples configured to scatter germicidal radiation transmitted into the diffuser into the lumen of the introducer sheath.

[0016] In some embodiments, the catheter disinfection system further comprises a sheath hub attachment configured to be removably coupled to the sheath hub. The germicidal irradiation device comprises one or more internal radiation sources incorporated into the sheath hub attachment. The one or more internal radiation sources are configured to generate germicidal radiation and emit the germicidal radiation into the lumen of the sheath hub attachment.

[0017] In some embodiments, one or more internal radiation sources are incorporated into the sheath hub attachment body to circumferentially illuminate the lumen of the sheath hub attachment. The lumen of the sheath hub attachment is configured to open into the lumen of the introducer sheath when the sheath hub attachment is coupled to the sheath hub.

[0018] In some embodiments, one or more internal radiation sources are incorporated into a diffuser disposed in the boot bushing attachment body so as to circumferentially illuminate the inner cavity of the boot bushing attachment from the diffuser of the boot bushing attachment.

[0019] In some embodiments, one or more internal radiation sources are incorporated into the boot bushing attachment body behind the diffuser so as to circumferentially illuminate the inner lumen of the boot bushing attachment through the diffuser of the boot bushing attachment.

[0020] In some embodiments, the diffuser includes a plurality of dimples configured to scatter germicidal radiation transmitted into the diffuser into the inner cavity of the sheath hub attachment.

[0021] In some embodiments, the catheter disinfection system further comprises a sheath hub attachment configured to be removably coupled to the sheath hub. The germicidal irradiation device comprises one or more external radiation sources operably coupled to the sheath hub attachment via a waveguide. The one or more external radiation sources are configured to generate germicidal radiation. The waveguide is configured to transmit the germicidal radiation. And, the waveguide or a diffuser operably coupled to the waveguide is configured to emit the germicidal radiation into the lumen of the sheath hub attachment.

[0022] In some embodiments, one or more waveguide terminations are incorporated into the sheath hub attachment body so as to circumferentially illuminate the lumen of the sheath hub attachment. The lumen of the sheath hub attachment is configured to open into the lumen of the introducer sheath when the sheath hub attachment is coupled to the sheath hub.

[0023] In some embodiments, one or more waveguide terminations are incorporated into a diffuser disposed in the boot bushing attachment body so that the inner cavity of the boot bushing attachment is circumferentially illuminated from the diffuser of the boot bushing attachment.

[0024] In some embodiments, one or more waveguide terminations are incorporated into the boot bushing attachment body behind the diffuser so that the inner cavity of the boot bushing attachment is circumferentially illuminated by the diffuser of the boot bushing attachment.

[0025] In some embodiments, the diffuser includes a plurality of dimples configured to scatter germicidal radiation transmitted into the diffuser into the inner cavity of the sheath hub attachment.

[0026] In some embodiments, the waveguide comprises one or more optical fibers. The one or more waveguide terminals are one or more terminals of the one or more optical fibers, respectively.

[0027] In some embodiments, the catheter disinfection system further comprises a sheath inserter configured to be removably inserted into the introducer sheath. The germicidal irradiation device comprises one or more external radiation sources operably coupled to the sheath inserter via a waveguide. The one or more external radiation sources are configured to generate germicidal radiation. The waveguide is configured to transmit the germicidal radiation. And, the waveguide or a diffuser operably coupled to the waveguide is configured to emit the germicidal radiation into the lumen of the sheath inserter.

[0028] In some embodiments, one or more waveguide terminations are incorporated into the sheath insert body so as to circumferentially illuminate the lumen of the sheath insert. When the sheath insert is inserted into the introducer sheath, the lumen of the sheath insert is coaxial with the lumen of the introducer sheath.

[0029] In some embodiments, one or more waveguide terminations are incorporated into a diffuser disposed in the body of the sheath insert so that the lumen of the sheath insert is circumferentially illuminated from the diffuser of the sheath insert.

[0030] In some embodiments, one or more waveguide terminations are incorporated into the sheath insert body behind the diffuser so that the interior cavity of the sheath insert is circumferentially illuminated by the diffuser of the sheath insert.

[0031] In some embodiments, the diffuser includes a plurality of dimples configured to scatter germicidal radiation transmitted into the diffuser into the lumen of the sheath insert.

[0032] In some embodiments, the waveguide comprises one or more optical fibers. The one or more waveguide terminals are one or more terminals of the one or more optical fibers, respectively.

[0033] In some embodiments, the germicidal radiation is selected from broad spectrum ultraviolet ("UV")-visible ("vis") light, broad spectrum UV light, UVA light, UVB light, UVC light, blue light, and modulated light thereof. The modulated light is modulated in frequency, power, duration, or a combination thereof.

[0034] In some embodiments, the introducer sheath is splittable to facilitate removal of the introducer sheath from the insertion site without having to remove the catheter from the insertion site.

[0035] Also disclosed herein is a catheter disinfection system, which in some embodiments includes a catheter, an introducer sheath, and an excitation irradiation device, the excitation irradiation device being used to irradiate the catheter tubing of the catheter with excitation radiation. The catheter includes a catheter tubing. The catheter tubing, the distal lumen coating on the catheter tubing, or both the catheter tubing and the distal lumen coating include a photosensitizer, which is configured to produce disinfecting reactive oxygen species ("ROS") when irradiated with excitation radiation. The introducer sheath includes a sheath body and a sheath sleeve. The sheath body is configured to be percutaneously inserted into an insertion site of a patient. The sheath sleeve is connected to the proximal portion of the sheath body. The excitation irradiation device is configured to irradiate the catheter tubing when the catheter tubing is inserted into the lumen of the introducer sheath, thereby generating ROS and disinfecting the catheter tubing just before insertion into the insertion site.

[0036] In some embodiments, the photosensitizer is incorporated into the catheter tubing.

[0037] In some embodiments, the photosensitizer is incorporated into the distal luminal coating on the catheter tubing.

[0038] In some embodiments, the photosensitizer is selected from toluidine blue, methylene blue, rose bengal, and porphyrin-based ROS-generating compounds.

[0039] In some embodiments, the excitation irradiation device includes one or more internal radiation sources incorporated into the introducer sheath. The one or more internal radiation sources are configured to generate excitation radiation and emit the excitation radiation into the lumen of the introducer sheath.

[0040] In some embodiments, the catheter disinfection system further comprises a sheath hub attachment configured to be removably coupled to the sheath hub. The excitation irradiation device comprises one or more internal radiation sources incorporated into the sheath hub attachment. The one or more internal radiation sources are configured to generate excitation radiation and emit the excitation radiation into the inner cavity of the sheath hub attachment.

[0041] In some embodiments, the catheter disinfection system further comprises a sheath hub attachment configured to be removably coupled to the sheath hub. The excitation irradiation device comprises one or more external radiation sources operably coupled to the sheath hub attachment via a waveguide. The one or more external radiation sources are configured to generate excitation radiation. The waveguide is configured to transmit the excitation radiation. And, the waveguide or a diffuser operably coupled to the waveguide is configured to emit the excitation radiation into the lumen of the sheath hub attachment.

[0042] In some embodiments, the catheter disinfection system further comprises a sheath insert configured to be removably inserted into the introducer sheath. The excitation irradiation device comprises one or more external radiation sources operably coupled to the sheath insert via a waveguide. The one or more external radiation sources are configured to generate excitation radiation. The waveguide is configured to transmit the excitation radiation. Furthermore, the waveguide or a diffuser operably coupled to the waveguide is configured to emit the excitation radiation into the lumen of the sheath insert.

[0043] Also disclosed herein is a method of sterilizing a catheter. In some embodiments, the method includes a catheter insertion procedure and a catheter irradiation procedure. The catheter insertion procedure includes inserting a catheter tubing of the catheter into an introducer sheath, which is percutaneously inserted into an insertion site of a patient. The catheter irradiation procedure includes irradiating the catheter tubing with radiation while inserting the catheter tubing through the sheath hub into a sheath body of the introducer sheath. The irradiation of the catheter tubing sterilizes the catheter tubing immediately prior to insertion into the insertion site.

[0044] In some embodiments, the irradiation operation includes irradiating the catheter tubing with germicidal radiation. The germicidal radiation is selected from broad spectrum UV-vis light, broad spectrum UV light, UVA light, UVB light, UVC light, blue light, and modulated light thereof. The modulated light is modulated in frequency, power, duration, or a combination thereof.

[0045] In some embodiments, the irradiating operation includes irradiating the catheter tubing with excitation radiation.The catheter tubing or the distal luminal coating on the catheter includes a photosensitizer configured to generate disinfecting ROS when irradiated with the excitation radiation.

[0046] In some embodiments, the irradiation operation includes irradiating the catheter tube using one or more internal radiation sources incorporated into the introducer sheath. The one or more internal radiation sources are configured to generate radiation and emit the radiation into the lumen of the introducer sheath.

[0047] In some embodiments, the irradiating operation includes irradiating the catheter tubing with one or more internal radiation sources incorporated into a sheath hub attachment configured to be removably coupled to the sheath hub.

[0048] In some embodiments, the irradiation operation includes irradiating the catheter tubing with one or more external radiation sources operably coupled to a sheath hub attachment via a waveguide, the sheath hub attachment being removably coupled to the sheath hub. The one or more external radiation sources are configured to generate radiation. The waveguide is configured to transmit radiation. And, the waveguide or a diffuser operably coupled to the waveguide is configured to emit radiation into a lumen of the sheath hub attachment.

[0049] In some embodiments, the irradiation operation includes irradiating the catheter tubing with one or more external radiation sources operably coupled to a sheath insert through a waveguide, the sheath insert being removably inserted into the introducer sheath. The one or more external radiation sources are configured to generate radiation. The waveguide is configured to transmit radiation. And, the waveguide or a diffuser operably coupled to the waveguide is configured to emit radiation into the lumen of the sheath insert.

[0050] 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

[0051] Figure 1 A catheter disinfection system according to some embodiments is shown.

[0052] Figure 2 An introducer sheath and sheath hub attachment of a catheter disinfection system according to some embodiments are shown.

[0053] Figure 3 An introducer sheath of a catheter disinfection system according to some embodiments is shown without a sheath hub attachment.

[0054] Figure 4 An internal radiation source is shown incorporated into a sheath body of an introducer sheath, a sheath hub attachment body of a sheath hub attachment, or a sheath insert body of a sheath insert according to some embodiments.

[0055] Figure 5A diffuser disposed in an introducer sheath is shown according to some embodiments.

[0056] Figure 6 An internal radiation source is shown incorporated into the sheath body of an introducer sheath, or the sheath hub attachment body of a sheath hub attachment, behind a diffuser, according to some embodiments.

[0057] Figure 7 An internal radiation source is shown incorporated into a diffuser of a boot body or a boot liner attachment body according to some embodiments.

[0058] Figure 8 An internal radiation source incorporated into the sheath hub attachment body of the sheath hub attachment and a diffuser disposed in the sheath body of the introducer sheath are shown according to some embodiments.

[0059] Fig. 9 Further shown are an internal radiation source incorporated into the sheath hub attachment body of the sheath hub attachment and a diffuser disposed in the sheath body of the introducer sheath according to some embodiments.

[0060] Fig.10 A diffuser having a plurality of dimples configured to scatter radiation transmitted into the diffuser is shown according to some embodiments.

[0061] Fig.11 A catheter including catheter tubing with a photosensitizer is shown according to some embodiments.

[0062] Fig.12 The generation of disinfecting ROS upon irradiation of catheter tubing with a photosensitizer is shown according to some embodiments. DETAILED DESCRIPTION

[0063] 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.

[0064] 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.

[0065] "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.

[0066] "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.

[0067] 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.

[0068] Similarly, medical devices (such as catheters) are currently packaged and sterilized in bulk using ethylene oxide or some other common industrial-scale sterilization techniques in their packaging before distribution, sale and use by clinicians. Taking the catheter as one of the aforementioned medical devices as an example, clinicians usually remove the catheter from its packaging and manipulate the catheter in various ways according to procedures before the catheter is inserted and placed in the patient. However, such manipulations impair the sterility of the catheter, which may cause the catheter to be contaminated by bacteria causing infection or its endotoxins causing endotoxemia. Therefore, it would be advantageous to sterilize the catheter (and, by extension, any of many other similar medical devices) before being inserted into the insertion site or subsequently placed in the patient.

[0069] Disclosed herein are catheter sterilization systems and methods for sterilizing a medical device, such as a catheter, prior to insertion and placement within a patient.

[0070] Catheter Disinfection System

[0071] Figure 1 A catheter disinfection system 100 is shown according to some embodiments. Figure 2 An introducer sheath 102 and a sheath hub attachment 104 of a catheter disinfection system 100 are shown according to some embodiments. And, Figure 3 The introducer sheath 102 of the catheter disinfection system 100 is shown without the sheath hub attachment 104 according to some embodiments.

[0072] According to an embodiment, the catheter disinfection system 100 may include one or more components selected from an introducer sheath 102, a sheath insert 103, a sheath hub attachment 104, and an irradiation device for irradiating a catheter tubing 105 of a catheter 107 (eg, a vascular catheter) with radiation. Figure 1 The irradiation device shown corresponds in part to one or more external radiation sources 140 operably coupled to the sheath hub attachment 104 described below via one or more waveguides 106 within suitable wiring, notably with the sheath hub attachment having an optional dilator 108 of the catheter disinfection system 100 that is removably inserted into the lumen 110 of the introducer sheath 102 through the sheath hub attachment 104. However, as further described below, the irradiation device may vary according to various embodiments.

[0073] The introducer sheath 102 may include a sheath body 112, optionally including a diffuser 114 disposed in or incorporated into the sheath body 112 (e.g., as a layer thereof), and a sheath hub 116 coupled to or surrounding a proximal portion of the sheath body 112. The sheath body 112 is configured to be percutaneously inserted into an insertion site of a patient (optionally over a dilator 108), the dilator 108 being configured to dilate a needle tract from the insertion site to a blood vessel to accommodate the sheath body 112. The sheath hub 116 may include a handle 118 having a pair of arms on opposite sides of the sheath hub 116 for manipulating the introducer sheath 102 when inserting the introducer sheath 102 into the insertion site or splitting the introducer sheath 102. In fact, the introducer sheath 102 may be splittable so as to remove the introducer sheath 102 from the insertion site without having to remove the catheter 107 from the insertion site.

[0074] As an alternative to what is stated above and below, Figure 5 A sheath inserter 103 is shown removably inserted into an introducer sheath 102 according to some embodiments. However, it should be understood that the sheath inserter 103 is truncated such that a truncated distal portion of the sheath inserter 103 is shown.

[0075] When present, the sheath insert 103 is configured to be removably inserted into the introducer sheath 102, such as after the dilator 108 is removed, so that when the sheath insert 103 is inserted into the introducer sheath 102, the lumen 120 of the sheath insert 103 is coaxial with the lumen 110 of the introducer sheath 102. The sheath insert 103 can form part of an irradiation device, as described below. Thus, in some embodiments, the sheath insert 103 can include a diffuser 114 disposed in or incorporated into a sheath insert body 122 of the sheath insert 103.

[0076] When present, the sheath bushing attachment 104 is configured to be removably coupled to the sheath bushing 116; however, in some embodiments, the sheath bushing attachment 104 may be non-removable and capable of being split with the remainder of the introducer sheath 102. Likewise, the dilator 108 may be removably inserted into the lumen 110 of the introducer sheath 102 through the sheath bushing attachment 104. In practice, the lumen 124 of the sheath bushing attachment 104 is configured to open into the lumen 110 of the introducer sheath 102 when the sheath bushing attachment 104 is coupled to the sheath bushing 116, thereby accommodating the dilator 108. The sheath bushing attachment 104 may form part of an irradiation device, as described below. Thus, in some embodiments, the sheath bushing attachment 104 may include a diffuser 114 disposed in or incorporated into a sheath bushing attachment body 126 of the sheath bushing attachment 104.

[0077] The irradiation device may include a germicidal irradiation device configured to irradiate the catheter tubing 105 of the catheter 107 with germicidal radiation when the catheter tubing 105 is inserted into the lumen 110 of the introducer sheath 102, thereby sterilizing the catheter tubing 105 immediately before insertion into the insertion site. Such germicidal radiation may include broad spectrum UV-vis light, broad spectrum UV light, UVA light, UVB light, UVC light, broad spectrum visible light, violet light, blue light, green light, yellow light, orange light, red light, or modulated light thereof, wherein the modulated light is modulated in wavelength or frequency, power (including gradient power), duration (including pulse duration when pulse modulated light), or a combination thereof. Moreover, such germicidal radiation may be provided by one or more internal radiation sources 128 or one or more external radiation sources 140 as described below at sufficient wavelength or frequency, power, and duration to achieve sterilization.

[0078] The irradiation device may alternatively include an excitation irradiation device configured to irradiate the catheter tubing 105 of the catheter 107 with excitation radiation when the catheter tubing 105 is inserted into the lumen 110 of the introducer sheath 102, thereby sterilizing the catheter tubing 105 immediately before insertion into the insertion site. Notably, the excitation radiation is paired with the catheter 142 described below, the catheter having a catheter tubing 144 or a distal lumen coating thereon, the catheter tubing or the distal lumen coating having a photosensitizer. The photosensitizer is configured to generate sterilizing ROS for sterilizing the catheter tubing 144 when the catheter tubing 144 or the distal lumen coating thereon is irradiated with the excitation radiation. Such excitation radiation may include broad spectrum UV-vis light, broad spectrum UV light, UVA light, UVB light, UVC light, broad spectrum visible light, violet light, blue light, green light, yellow light, orange light, red light, or modulated light thereof, wherein the modulated light is modulated in wavelength or frequency, power (including gradient power), duration (including pulse duration when pulse modulated light), or a combination thereof. Also, such excitation radiation may be provided by one or more internal radiation sources 128 or one or more external radiation sources 140 as described below at sufficient wavelength or frequency, power, and duration to achieve disinfection.

[0079] One or more internal radiation sources 128 or one or more external radiation sources 140 as described below can be one or more semiconductor light sources independently selected from at least a light emitting diode ("LED"), a laser, or a superluminescent diode ("SLD"), which combines the high power and brightness characteristics of a laser with the low power characteristics of an LED.

[0080] Figure 4 An internal radiation source 128 is shown incorporated into the sheath body 112 of the introducer sheath 102, the sheath hub attachment body 126 of the sheath hub attachment 104, or the sheath insert body 122 of the sheath insert 103, according to some embodiments.

[0081] As shown, the irradiation device may include one or more internal radiation sources 128 incorporated into the introducer sheath 102, wherein the one or more internal radiation sources 128 are configured to generate radiation and emit radiation into the lumen 110 of the introducer sheath 102. Specifically, the one or more internal radiation sources 128 may be incorporated into the sheath body 112 so as to circumferentially irradiate the lumen 110 of the introducer sheath 102. Because the sheath sleeve 116 is coupled to or surrounds the proximal portion of the sheath body 112, the one or more internal radiation sources 128 may also be at least partially incorporated into the sheath sleeve 116 so as to circumferentially irradiate the lumen 110 of the introducer sheath 102.

[0082] As further shown, the irradiation device may include one or more internal radiation sources 128 incorporated into the sheath bushing attachment 104, wherein the one or more internal radiation sources 128 are configured to generate radiation and emit radiation into the inner cavity 124 of the sheath bushing attachment 104. Specifically, the one or more internal radiation sources 128 may be incorporated into the sheath bushing attachment body 126 so as to circumferentially irradiate the inner cavity 124 of the sheath bushing attachment 104.

[0083] As further shown, the irradiation device may include one or more internal radiation sources 128 incorporated into the sheath insert 103, wherein the one or more internal radiation sources 128 are configured to generate radiation and emit radiation into the lumen 120 of the sheath insert 103. Specifically, the one or more internal radiation sources 128 may be incorporated into the sheath insert body 122 so as to circumferentially irradiate the lumen 120 of the sheath insert 103. It is worth noting that, as an alternative to what is described above and below, Figure 7 An internal radiation source 128 incorporated into the sheath insert body 122 of the sheath insert 103 and the sheath insert 103 inserted into the introducer sheath 102 are shown.

[0084] Notably, one or more internal radiation sources 128 incorporated into the sheath body 112 of the introducer sheath 102, the sheath hub attachment body 126 of the sheath hub attachment 104, or the sheath insert body 122 of the sheath insert 103 may be controlled and powered, respectively, by one or more wires 130, which are operably connected to a controller 132 for controlling and powering the one or more internal radiation sources 128 via an external cable 134. (See, e.g., Figure 1 , it is understood that there is no external radiation source in the aforementioned embodiment).

[0085] Figure 5 A diffuser 114 is shown disposed in the introducer sheath 102, according to some embodiments. Of note, the diffuser 114 may also be disposed in the sheath hub attachment 104, according to some embodiments. Figure 6 An internal radiation source 128 is shown incorporated into the sheath body 112 of the introducer sheath 102, the sheath bushing attachment body 126 of the sheath bushing attachment 104, or the sheath insert body 122 of the sheath insert 103 behind the diffuser 114 according to some embodiments.

[0086] As shown, the illumination device may include one or more internal radiation sources 128 incorporated into the sheath body 112 behind the diffuser 114, wherein the one or more internal radiation sources 128 are configured to generate radiation, the diffuser 114 is configured to transmit the radiation therethrough, and the diffuser 114 is configured to emit the radiation into the lumen 110 of the introducer sheath 102 so as to circumferentially illuminate the lumen 110 of the introducer sheath 102 through the diffuser 114 of the sheath body 112. Because the sheath bushing 116 is coupled to or surrounds the proximal portion of the sheath body 112, the one or more internal radiation sources 128 may also be at least partially incorporated into the sheath bushing 116 so as to circumferentially illuminate the lumen 110 of the introducer sheath 102 through the diffuser 114 of the sheath bushing 116.

[0087] As further shown, the irradiation device may include one or more internal radiation sources 128 incorporated into the jacket bushing attachment body 126 behind the diffuser 114, wherein the one or more internal radiation sources 128 are configured to generate radiation, the diffuser 114 is configured to transmit the radiation therethrough, and the diffuser 114 is configured to emit radiation into the inner cavity 124 of the jacket bushing attachment 104 so as to circumferentially illuminate the inner cavity 124 of the jacket bushing attachment 104 through the diffuser 114 of the jacket bushing attachment 104.

[0088] As further shown, the irradiation device may include one or more internal radiation sources 128 incorporated into the sheath insert body 122 behind the diffuser 114, wherein the one or more internal radiation sources 128 are configured to generate radiation, the diffuser 114 is configured to transmit radiation therethrough, and the diffuser 114 is configured to emit radiation into the inner cavity 120 of the sheath insert 103 so as to circumferentially illuminate the inner cavity 120 of the sheath insert 103 through the diffuser 114 of the sheath insert 103.

[0089] Notably, one or more internal radiation sources 128 incorporated into the sheath body 112 of the introducer sheath 102, or the sheath hub attachment body 126 of the sheath hub attachment 104, may be controlled and powered, respectively, by one or more wires 130, which may be operably connected to a controller 132 for controlling and powering the one or more internal radiation sources 128 via an external cable 134. (See, e.g., Figure 1 , it is understood that there is no external radiation source in the aforementioned embodiment).

[0090] Figure 7 An internal radiation source 128 is shown incorporated into the diffuser 114 of the sheath body 112, the sheath liner attachment body 126, or the sheath insert body 122, according to some embodiments.

[0091] As shown, the irradiation device may include one or more internal radiation sources 128 incorporated into a diffuser 114 disposed in the sheath body 112, wherein the one or more internal radiation sources 128 are configured to generate radiation, the diffuser 114 is configured to transmit the radiation therethrough, and the diffuser 114 is configured to emit radiation into the lumen 110 of the introducer sheath 102 so as to circumferentially illuminate the lumen 110 of the introducer sheath 102 from the diffuser 114 of the sheath body 112. Because the sheath bushing 116 is coupled to or surrounds the proximal portion of the sheath body 112, the one or more internal radiation sources 128 may also be at least partially positioned within the sheath bushing 116 so as to circumferentially illuminate the lumen 110 of the introducer sheath 102 from the diffuser 114 of the sheath bushing 116.

[0092] As further shown, the irradiation device may include one or more internal radiation sources 128 incorporated into a diffuser 114 disposed in a jacket bushing attachment body 126, wherein the one or more internal radiation sources 128 are configured to generate radiation, the diffuser 114 is configured to transmit radiation therethrough, and the diffuser 114 is configured to emit radiation into an inner cavity 124 of the jacket bushing attachment 104 so as to circumferentially illuminate the inner cavity 124 of the jacket bushing attachment 104 from the diffuser 114 of the jacket bushing attachment 104.

[0093] As further shown, the irradiation device may include one or more internal radiation sources 128 incorporated into a diffuser 114 disposed in the sheath insert body 122, wherein the one or more internal radiation sources 128 are configured to generate radiation, the diffuser 114 is configured to transmit radiation therethrough, and the diffuser 114 is configured to emit radiation into the inner cavity 120 of the sheath insert 103 so as to circumferentially illuminate the inner cavity 120 of the sheath insert 103 from the diffuser 114 of the sheath insert 103.

[0094] It is noteworthy that the one or more internal radiation sources 128 incorporated into the diffuser 114 can be controlled and powered respectively via one or more wires 130, and the one or more wires 130 can be operably connected to the controller 132 for controlling and powering the one or more internal radiation sources 128 via external cables 134. (See, e.g. Figure 1 , it is understood that there is no external radiation source in the aforementioned embodiment).

[0095] Figure 8 and Fig. 9 An internal radiation source 128 incorporated into the sheath hub attachment body 126 of the sheath hub attachment 104 and a diffuser 114 disposed in the sheath body 112 of the introducer sheath 102 are shown in accordance with some embodiments.

[0096] As further shown, the irradiation device may include one or more internal radiation sources 128 incorporated into a sheath bushing attachment body 126 of the sheath bushing attachment 104, wherein the one or more internal radiation sources 128 are configured to generate radiation and emit the radiation into a diffuser 114 disposed in a sheath body 112 of the introducer sheath 102. Similar to what was set forth above, the diffuser 114 is configured to transmit radiation therethrough, and the diffuser 114 is configured to emit radiation into the lumen 110 of the introducer sheath 102 so as to circumferentially illuminate the lumen 110 of the introducer sheath 102 through the diffuser 114 of the sheath body 112.

[0097] Notably, embodiments of the catheter disinfection system 100 in which the internal radiation source 128 or the external radiation source 140 is at least external to the introducer sheath 102 can be advantageous because the components can be reused as capital equipment. For example, with respect to the aforementioned sheath hub attachment 104, which includes one or more internal radiation sources 128 external to the introducer sheath 102. This can be advantageous because the sheath hub attachment 104 itself can be sterilized and reused as capital equipment, while the introducer sheath 102 is arranged as a single-use, disposable device.

[0098] Fig.10 A diffuser 114 is shown having a plurality of dimples 136 configured to scatter radiation transmitted into the diffuser 114 in accordance with some embodiments.

[0099] As shown, the diffuser 114 disposed in the introducer sheath 102, sheath liner attachment 104, or sheath insert 103 or otherwise incorporated, integrated, etc. into the introducer sheath 102, sheath liner attachment 104, or sheath insert 103 as a layer thereof may include a plurality of dimples 136. The plurality of dimples 136 may be open toward or facing the lumen 110, 120, or 124 of the introducer sheath 102, sheath liner attachment 104, or sheath insert 103, the plurality of dimples 136 thereby being configured to scatter radiation transmitted into the diffuser 114 into the lumen 110, 120, or 124 of the introducer sheath 102, sheath liner attachment 104, or sheath insert 103.

[0100] As an alternative to what is stated above, Figure 4 The invention is shown in accordance with the invention including one or more external radiation sources 140 (such as Figure 1 Some embodiments of the external radiation source shown) are incorporated into the waveguide terminal 138 in the sheath body 112 of the introducer sheath 102, the sheath bushing attachment body 126 of the sheath bushing attachment 104, or the sheath insert body 122 of the sheath insert 103.

[0101] As shown, the irradiation device may include one or more waveguide terminals 138 incorporated into the introducer sheath 102, wherein one or more external radiation sources 140 are configured to generate radiation, one or more waveguides 106 are operably coupled to the one or more external radiation sources 140 and configured to transmit radiation, and the one or more waveguides 106 or their one or more waveguide terminals 138 are configured to emit radiation into the lumen 110 of the introducer sheath 102. Specifically, the one or more waveguide terminals 138 may be incorporated into the sheath body 112 so as to circumferentially irradiate the lumen 110 of the introducer sheath 102. Because the sheath bushing 116 is coupled to or surrounds the proximal portion of the sheath body 112, the one or more waveguides 106 or their one or more waveguide terminals 138 may also be at least partially incorporated into the sheath bushing 116 so as to circumferentially irradiate the lumen 110 of the introducer sheath 102.

[0102] As further shown, the irradiation device may include one or more waveguide terminals 138 incorporated into the jacket bushing attachment 104, wherein the one or more external radiation sources 140 are configured to generate radiation, the one or more waveguides 106 are operably coupled to the one or more external radiation sources 140 and are configured to transmit radiation, and the one or more waveguides 106 or their one or more waveguide terminals 138 are configured to emit radiation into the inner cavity 124 of the jacket bushing attachment 104. Specifically, the one or more waveguide terminals 138 may be incorporated into the jacket bushing attachment body 126 so as to circumferentially irradiate the inner cavity 124 of the jacket bushing attachment 104.

[0103] As further shown, the irradiation device may include one or more waveguide terminals 138 incorporated into the sheath insert 103, wherein the one or more external radiation sources 140 are configured to generate radiation, the one or more waveguides 106 are operably coupled to the one or more external radiation sources 140 and are configured to transmit radiation, and the one or more waveguides 106 or their one or more waveguide terminals 138 are configured to emit radiation into the lumen 120 of the sheath insert 103. Specifically, the one or more waveguide terminals 138 may be incorporated into the sheath insert body 122 so as to circumferentially irradiate the lumen 120 of the sheath insert 103. It is worth noting that, as an alternative to what is set forth above, Figure 7 The waveguide terminal 138 incorporated into the sheath insert body 122 of the sheath insert 103 and the sheath insert 103 inserted into the introducer sheath 102 are shown.

[0104] It is noted that the one or more waveguides 106 may include one or more optical fibers, optionally having a cladding on each of the one or more optical fibers and a polymer coating on the cladding of each of the one or more optical fibers, the one or more optical fibers being appropriately routed (particularly with respect to, for example, Figure 1 In fact, any internal waveguide (such as Figure 4 , Figure 6 and Figure 7 Any internal waveguide shown) can be disposed in the jacket body 112 of the introducer jacket 102, the jacket bushing attachment body 126 of the jacket bushing attachment 104, or the jacket insert body 122 of the jacket insert 103, such as by extrusion or molding thereon. In addition, the one or more waveguide terminations 138 can be one or more fiber terminations of one or more optical fibers, respectively, wherein each of the one or more fiber terminations is optionally disposed in a fiber ferrule.

[0105] same, Figure 5 1 shows a diffuser 114 disposed in the introducer sheath 102 according to some embodiments. It is worth noting that, according to some embodiments, the diffuser 114 can also be disposed in the sheath hub attachment 104. As an alternative to what is set forth above, Figure 6 The invention is shown in accordance with the invention including one or more external radiation sources 140 (such as Figure 1 Some embodiments of the external radiation source shown) include a waveguide terminal 138 incorporated into the sheath body 112 of the introducer sheath 102, the sheath bushing attachment body 126 of the sheath bushing attachment 104, or the sheath insert body 122 of the sheath insert 103 behind the diffuser 114.

[0106] As shown, the illumination device may include one or more waveguide terminals 138 incorporated into the sheath body 112 behind the diffuser 114, wherein the one or more external radiation sources 140 are configured to generate radiation, the one or more waveguides 106 are operably coupled to the one or more external radiation sources 140 and configured to transmit radiation, and the one or more waveguides 106 or their one or more waveguide terminals 138 are configured to emit radiation into the lumen 110 of the introducer sheath 102 so as to circumferentially illuminate the lumen 110 of the introducer sheath 102 through the diffuser 114 of the sheath body 112. Because the sheath bushing 116 is coupled to or surrounds the proximal portion of the sheath body 112, the one or more waveguides 106 or their one or more waveguide terminals 138 may also be at least partially incorporated into the sheath bushing 116 so as to circumferentially illuminate the lumen 110 of the introducer sheath 102 through the diffuser 114 of the sheath bushing 116.

[0107] As further shown, the irradiation device may include one or more waveguide terminals 138 incorporated into the jacket bushing attachment body 126 behind the diffuser 114, wherein one or more external radiation sources 140 are configured to generate radiation, one or more waveguides 106 are operably connected to the one or more external radiation sources 140 and are configured to transmit radiation, and the one or more waveguides 106 or their one or more waveguide terminals 138 are configured to emit radiation into the inner cavity 124 of the jacket bushing attachment 104 so as to circumferentially illuminate the inner cavity 124 of the jacket bushing attachment 104 through the diffuser 114 of the jacket bushing attachment 104.

[0108] As further shown, the irradiation device may include one or more waveguide terminals 138 incorporated into the sheath insert body 122 behind the diffuser 114, wherein one or more external radiation sources 140 are configured to generate radiation, one or more waveguides 106 are operably connected to the one or more external radiation sources 140 and are configured to transmit radiation, and the one or more waveguides 106 or their one or more waveguide terminals 138 are configured to emit radiation into the inner cavity 120 of the sheath insert 103 so as to circumferentially illuminate the inner cavity 120 of the sheath insert 103 through the diffuser 114 of the sheath insert 103.

[0109] It is noted that the one or more waveguides 106 may include one or more optical fibers, optionally having a cladding on each of the one or more optical fibers and a polymer coating on the cladding of each of the one or more optical fibers, the one or more optical fibers being appropriately routed (particularly with respect to, for example, Figure 1 In fact, any internal waveguide (such as Figure 4 , Figure 6 and Figure 7 Any internal waveguide shown) can be disposed in the jacket body 112 of the introducer jacket 102, the jacket bushing attachment body 126 of the jacket bushing attachment 104, or the jacket insert body 122 of the jacket insert 103 behind the diffuser 114, such as by extrusion or molding thereon. In addition, the one or more waveguide terminations 138 can be one or more fiber terminations of one or more optical fibers, respectively, wherein each of the one or more fiber terminations is optionally disposed in a fiber ferrule.

[0110] As an alternative to what is stated above, Figure 7 A waveguide termination 138 is shown incorporated into the diffuser 114 of the boot body 112, the boot liner attachment body 126, or the boot insert body 122, according to some embodiments.

[0111] As shown, the illumination device may include one or more waveguide terminals 138 incorporated into a diffuser 114 disposed in a sheath body 112, wherein one or more external radiation sources 140 are configured to generate radiation, one or more waveguides 106 are operably coupled to the one or more external radiation sources 140 and configured to transmit radiation, and the one or more waveguides 106 or their one or more waveguide terminals 138 are configured to emit radiation into the lumen 110 of the introducer sheath 102 so as to circumferentially illuminate the lumen 110 of the introducer sheath 102 from the diffuser 114 of the sheath body 112. Because the sheath bushing 116 is coupled to or surrounds a proximal portion of the sheath body 112, the one or more waveguide terminals 138 may also be at least partially positioned within the sheath bushing 116 so as to circumferentially illuminate the lumen 110 of the introducer sheath 102 from the diffuser 114 of the sheath bushing 116.

[0112] As further shown, the irradiation device may include one or more waveguide terminals 138 incorporated into a diffuser 114 disposed in a jacket bushing attachment body 126, wherein one or more external radiation sources 140 are configured to generate radiation, one or more waveguides 106 are operably connected to the one or more external radiation sources 140 and are configured to transmit radiation, and the one or more waveguides 106 or their one or more waveguide terminals 138 are configured to emit radiation into the inner cavity 124 of the jacket bushing attachment 104 so as to circumferentially illuminate the inner cavity 124 of the jacket bushing attachment 104 from the diffuser 114 of the jacket bushing attachment 104.

[0113] As further shown, the irradiation device may include one or more waveguide terminals 138 incorporated into a diffuser 114 arranged in the sheath insert body 122, wherein one or more external radiation sources 140 are configured to generate radiation, one or more waveguides 106 are operably connected to the one or more external radiation sources 140 and are configured to transmit radiation, and the one or more waveguides 106 or their one or more waveguide terminals 138 are configured to emit radiation into the inner cavity 120 of the sheath insert 103 so as to circumferentially illuminate the inner cavity 120 of the sheath insert 103 from the diffuser 114 of the sheath insert 103.

[0114] It is noted that the one or more waveguides 106 may include one or more optical fibers, optionally having a cladding on each of the one or more optical fibers and a polymer coating on the cladding of each of the one or more optical fibers, the one or more optical fibers being appropriately routed (particularly with respect to, for example, Figure 1 In fact, any internal waveguide (such as Figure 4 , Figure 6 and Figure 7 Any internal waveguide shown) can be disposed in the diffuser 114, such as by extrusion or molding thereon. In addition, the one or more waveguide terminals 138 can be one or more fiber terminals of one or more optical fibers, respectively, wherein each of the one or more fiber terminals is optionally disposed in a fiber ferrule.

[0115] Finally, any component of the catheter disinfection system 100 selected from the introducer sheath 102, the sheath insert 103, and the sheath hub attachment 104 can include a material, coating, covering, etc. configured to absorb any outgoing radiation as a protective means for protecting the clinician from exposure to the radiation. Thus, whether the radiation is germicidal or excitation radiation, the catheter disinfection system 100 can be configured to limit it to disinfecting the catheter tubing 105 of the catheter 107 immediately prior to insertion into the insertion site.

[0116] catheter

[0117] As described above, the irradiation device may include a germicidal irradiation device or an excitation irradiation device. Although any catheter or catheter tubing thereof may be irradiated with germicidal radiation to sterilize the catheter tubing immediately prior to insertion into an insertion site, the catheter 142 described below, or a catheter including its photosensitizer as such, is used with an excitation irradiation device to sterilize the catheter tubing 144 immediately prior to insertion into an insertion site. Since the catheter 142 is paired with the excitation irradiation, in some embodiments, the catheter 142 may also be part of the catheter disinfection system 100.

[0118] Fig.11 A catheter 142 is shown including a catheter tubing 144 having a photosensitizer, according to some embodiments.

[0119] As shown, the catheter 142 may include a catheter tube 144, a catheter hub 146, and one or more extension legs 148, which are operably connected in the aforementioned order. In practice, the catheter tube 144 may include a proximal portion disposed in the catheter hub 146, and each of the one or more extension legs 148 may include a distal portion disposed in the catheter hub 146.

[0120] The catheter tubing 144, the distal luminal coating on the catheter tubing 144, or both the catheter tubing 144 and the distal luminal coating may include a photosensitizer configured to generate disinfecting ROS when irradiated with excitation radiation. In practice, the photosensitizer may be incorporated into the catheter tubing 144 during extrusion by mixing the photosensitizer with resin beads during extrusion, or the photosensitizer may be incorporated into the catheter tubing 144 during coextrusion by mixing the photosensitizer with a first resin bead and coextruding the first resin bead onto a second resin bead during coextrusion. Additionally or alternatively, the photosensitizer may be incorporated into the distal luminal coating during coating by mixing the photosensitizer into a coating composition and applying the coating composition to the distal luminal surface of the catheter tubing 144. Such photosensitizers may include, but are not limited to, toluidine blue, methylene blue, rose bengal, porphyrin-based ROS generating compounds, or combinations thereof. Even porphyrin-based compounds within bacterial cells can be used to generate ROS, for example using blue light, which allows the use of excitation radiation with catheter 107 in some embodiments.

[0121] Fig.12 The generation of disinfecting ROS upon irradiation of catheter tubing 144 with a photosensitizer is shown according to some embodiments.

[0122] As shown, when the catheter tube 144 is inserted into the lumen 110 of the introducer sheath 102, when the excitation irradiation device irradiates the catheter tube 144, the photosensitizer or a group of photosensitizers enters an excited singlet state. Although the photosensitizer can lose energy through fluorescence, a group of photosensitizers in the excited singlet state instead enters an excited triplet state through intersystem crossing. And, depending on whether the photosensitizer is a Type I photosensitizer or a Type II photosensitizer, the photosensitizer in its excited triplet state reacts with oxygen through electron transfer or energy transfer to produce disinfecting ROS. In fact, the Type I photosensitizer in its excited triplet state reacts with oxygen through electron transfer to produce superoxide ( · O2 - ), hydrogen peroxide (H2O2) is produced by the dismutation of superoxide, and hydroxyl radicals ( · OH). The type II photosensitizer in its excited triplet state reacts with oxygen via energy transfer to produce singlet oxygen ( 1 O2). Sterilization ROS leads to bacterial death and inactivation of bacterial endotoxins through various reaction mechanisms involving ROS.

[0123] method

[0124] Methods include methods of sterilizing a catheter, such as catheter 107 or 142. In some embodiments, such methods include a catheter insertion procedure and a catheter irradiation procedure.

[0125] The catheter insertion procedure may include inserting the catheter tube 105 or 144 of the catheter 107 or 142 into the introducer sheath 102 as the introducer sheath 102 is percutaneously inserted into the patient's insertion site.

[0126] The catheter irradiation operation may include irradiating the catheter tubing 105 or 144 with radiation while the catheter tubing 105 or 144 is inserted into the sheath body 112 of the introducer sheath 102 through the sheath hub 116. As described above, the radiation may be germicidal radiation or excitation radiation, but in some embodiments, both germicidal radiation and excitation radiation may be used in the catheter irradiation operation to sterilize the catheter tubing 144 according to both modalities. When both germicidal radiation and excitation radiation are used, the wavelength ranges of the germicidal radiation and the excitation radiation may be separate and different from each other, partially overlap, or completely overlap, in which case the germicidal radiation and the excitation radiation are the same. It can be seen that when the wavelength ranges of the sterilizing radiation and the excitation radiation are separated from each other and are different or partially overlapped, the internal radiation source 128 or the external radiation source 140 exists as a plurality of radiation sources each of which is independently configured to generate sterilizing radiation or excitation radiation, or the internal radiation source 128 or the external radiation source 140 exists as a single internal radiation source 128 or external radiation source 140 configured to modulate between sterilizing radiation and excitation radiation. That is, the aforementioned combination is also possible. In any case, the irradiation of the catheter tubing 105 or 144 with radiation sterilizes the catheter tubing 105 or 144 immediately before insertion into the insertion site. The catheter irradiation operation not only eliminates any time when additional bacteria or their endotoxins accumulate on the catheter tubing 105 or 144, but also at any time after the catheter tubing 105 or 144 is sterilized, before the catheter tubing 105 or 144 is removed from the patient's body, the catheter tubing cannot be contaminated.

[0127] Example

[0128] Table 1, set forth below, provides some microbial reduction data obtained by testing various substrates under conditions of darkness, ambient light, and UV light exposure. Sample "E UV" represents a conventional polyurethane test specimen as an exemplary portion of a catheter tubing that was irradiated with UV for 15 minutes. As shown, colony forming units ("CFU") were reduced by 93% to 100%, depending on the microorganisms (i.e., Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans). It should be understood that the increase in light intensity enables sterilization to be achieved at a higher level in a shorter, more clinically relevant period of time.

[0129] Table 1. Microbial reduction data.

[0130]

[0131] 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. A catheter disinfection system, characterized in that: include: An introducer sheath, the introducer sheath comprising: a sheath body configured to be percutaneously inserted into an insertion site of a patient; and a sheath hub coupled to a proximal portion of the sheath body; and A sterilizing irradiation device is used to irradiate the catheter tube of the catheter with sterilizing radiation when the catheter tube is inserted into the inner cavity of the introducer sheath, thereby sterilizing the catheter tube just before insertion into the insertion site.

2. The catheter disinfection system according to claim 1, characterized in that: The germicidal irradiation device includes one or more internal radiation sources incorporated into the introducer sheath, the one or more internal radiation sources configured to generate the germicidal radiation and emit the germicidal radiation into the lumen of the introducer sheath.

3. The catheter disinfection system according to claim 2, characterized in that: The one or more internal radiation sources are incorporated into the sheath body so as to circumferentially illuminate the lumen of the introducer sheath.

4. The catheter disinfection system according to claim 3, characterized in that: The one or more internal radiation sources are incorporated into a diffuser disposed in the sheath body so as to circumferentially illuminate the lumen of the introducer sheath from the diffuser of the sheath body.

5. The catheter disinfection system according to claim 3, characterized in that: The one or more internal radiation sources are incorporated into the sheath body behind a diffuser so as to circumferentially illuminate the lumen of the introducer sheath through the diffuser of the sheath body.

6. The catheter disinfection system according to claim 4 or 5, characterized in that: The diffuser includes a plurality of dimples configured to scatter the germicidal radiation transmitted into the diffuser into the lumen of the introducer sheath.

7. The catheter disinfection system according to claim 2, characterized in that: The one or more internal radiation sources are incorporated into the sheath hub so as to circumferentially illuminate the lumen of the introducer sheath.

8. The catheter disinfection system according to claim 7, characterized in that: The one or more internal radiation sources are incorporated into a diffuser disposed in the sheath hub so as to circumferentially illuminate the lumen of the introducer sheath from the diffuser of the sheath hub.

9. The catheter disinfection system according to claim 7, characterized in that: The one or more internal radiation sources are incorporated into the sheath hub behind a diffuser so as to circumferentially illuminate the lumen of the introducer sheath through the diffuser of the sheath hub.

10. The catheter disinfection system according to claim 8 or 9, characterized in that: The diffuser includes a plurality of dimples configured to scatter the germicidal radiation transmitted into the diffuser into the lumen of the introducer sheath.

11. The catheter disinfection system according to claim 1, characterized in that: Also included is a sheath sleeve attachment configured to be removably coupled to the sheath sleeve, the germicidal irradiation device comprising one or more internal radiation sources incorporated into the sheath sleeve attachment, and the one or more internal radiation sources configured to generate the germicidal radiation and emit the germicidal radiation into an inner cavity of the sheath sleeve attachment.

12. The catheter disinfection system according to claim 11, characterized in that: The one or more internal radiation sources are incorporated into a sheath bushing attachment body so as to circumferentially illuminate the inner lumen of the sheath bushing attachment, the inner lumen of the sheath bushing attachment being configured to open into the inner lumen of the introducer sheath when the sheath bushing attachment is coupled to the sheath bushing.

13. The catheter disinfection system according to claim 12, characterized in that: The one or more internal radiation sources are incorporated into a diffuser disposed in the boot bushing attachment body so as to circumferentially illuminate the interior cavity of the boot bushing attachment from the diffuser of the boot bushing attachment.

14. The catheter disinfection system according to claim 12, characterized in that: The one or more internal radiation sources are incorporated into the boot bushing attachment body behind a diffuser so as to circumferentially illuminate the interior cavity of the boot bushing attachment through the diffuser of the boot bushing attachment.

15. The catheter disinfection system according to claim 13 or 14, characterized in that: The diffuser includes a plurality of dimples configured to scatter the germicidal radiation transmitted into the diffuser into the interior cavity of the sheath hub attachment.

16. The catheter disinfection system according to claim 1, characterized in that: Also included is a sheath sleeve attachment configured to be removably coupled to the sheath sleeve, the germicidal irradiation device comprising one or more external radiation sources operably coupled to the sheath sleeve attachment via a waveguide, the one or more external radiation sources being configured to generate the germicidal radiation, the waveguide being configured to transmit the germicidal radiation, and the waveguide or a diffuser operably coupled to the waveguide being configured to emit the germicidal radiation into an inner cavity of the sheath sleeve attachment.

17. The catheter disinfection system according to claim 16, characterized in that: One or more waveguide terminations are incorporated into the sheath bushing attachment body so as to circumferentially illuminate the lumen of the sheath bushing attachment, the lumen of the sheath bushing attachment being configured to open into the lumen of the introducer sheath when the sheath bushing attachment is coupled to the sheath bushing.

18. The catheter disinfection system according to claim 17, characterized in that: The one or more waveguide terminations are incorporated into the diffuser disposed in the boot bushing attachment body so that the interior cavity of the boot bushing attachment is circumferentially illuminated from the diffuser of the boot bushing attachment.

19. The catheter disinfection system according to claim 17, characterized in that: The one or more waveguide terminations are incorporated into the boot bushing attachment body behind the diffuser so as to circumferentially illuminate the interior cavity of the boot bushing attachment through the diffuser of the boot bushing attachment.

20. The catheter disinfection system according to claim 18 or 19, characterized in that: The diffuser includes a plurality of dimples configured to scatter the germicidal radiation transmitted into the diffuser into the interior cavity of the sheath hub attachment.

21. The catheter disinfection system according to claim 17, characterized in that: The waveguide comprises one or more optical fibers, and the one or more waveguide terminals are one or more terminals of the one or more optical fibers, respectively.

22. The catheter disinfection system according to claim 1, characterized in that: It also includes a sheath insert configured to be removably inserted into the introducer sheath, the sterilizing irradiation device includes one or more external radiation sources operably connected to the sheath insert via a waveguide, the one or more external radiation sources are configured to generate the sterilizing radiation, the waveguide is configured to transmit the sterilizing radiation, and the waveguide or a diffuser operably connected to the waveguide is configured to emit the sterilizing radiation into the inner cavity of the sheath insert.

23. The catheter disinfection system according to claim 22, characterized in that: One or more waveguide terminations are incorporated into the sheath insert body so as to circumferentially illuminate the lumen of the sheath insert, the lumen of the sheath insert being coaxial with the lumen of the introducer sheath when the sheath insert is inserted into the introducer sheath.

24. The catheter disinfection system according to claim 23, characterized in that The one or more waveguide terminations are incorporated into the diffuser disposed in the sheath insert body so that the interior cavity of the sheath insert is circumferentially illuminated from the diffuser of the sheath insert.

25. The catheter disinfection system according to claim 23, characterized in that The one or more waveguide terminations are incorporated into the sheath insert body behind the diffuser so as to circumferentially illuminate the interior cavity of the sheath insert through the diffuser of the sheath insert.

26. The catheter disinfection system according to claim 24 or 25, characterized in that: The diffuser includes a plurality of dimples configured to scatter the germicidal radiation transmitted into the diffuser into the lumen of the sheath insert.

27. The catheter disinfection system according to claim 23, characterized in that The waveguide comprises one or more optical fibers, and the one or more waveguide terminals are one or more terminals of the one or more optical fibers, respectively.

28. The catheter disinfection system according to claim 23, characterized in that The germicidal radiation is selected from broad spectrum ultraviolet-visible light, blue light and modulated light thereof, wherein the modulated light is modulated in frequency, power, duration or a combination thereof.

29. The catheter disinfection system according to claim 23, characterized in that The germicidal radiation is selected from broad spectrum ultraviolet light and modulated light thereof, wherein the modulated light is modulated in frequency, power, duration or a combination thereof.

30. The catheter disinfection system according to claim 23, characterized in that The germicidal radiation is selected from UVA light, UVB light, UVC light, and modulated light thereof, wherein the modulated light is modulated in frequency, power, duration, or a combination thereof.

31. The catheter disinfection system according to claim 23, characterized in that The introducer sheath is splittable to facilitate removal of the introducer sheath from the insertion site without removing the catheter from the insertion site.

32. A catheter disinfection system, characterized in that: include: a catheter comprising a catheter tubing, the catheter tubing, a distal lumen coating on the catheter tubing, or both the catheter tubing and the distal lumen coating comprising a photosensitizer configured to produce a sterilizing reactive oxygen species when irradiated with excitation radiation; An introducer sheath, the introducer sheath comprising: a sheath body configured to be percutaneously inserted into an insertion site of a patient; and a sheath hub coupled to a proximal portion of the sheath body; and An excitation irradiation device is used to irradiate the catheter tube of the catheter with the excitation radiation when the catheter tube is inserted into the inner cavity of the introducer sheath, thereby generating the sterilizing reactive oxygen species and sterilizing the catheter tube just before insertion into the insertion site.

33. The catheter disinfection system according to claim 32, characterized in that The photosensitizer is incorporated into the catheter tubing.

34. The catheter disinfection system according to claim 32, characterized in that The photosensitizer is incorporated into the distal luminal coating on the catheter tubing.

35. The catheter disinfection system according to any one of claims 32 to 34, characterized in that: The photosensitizer is selected from the group consisting of toluidine blue, methylene blue, rose bengal, and porphyrin-based reactive oxygen species generating compounds.

36. The catheter disinfection system according to claim 32, characterized in that The excitation illumination device comprises one or more internal radiation sources incorporated into the introducer sheath, the one or more internal radiation sources being configured to generate the excitation radiation and emit the excitation radiation into the lumen of the introducer sheath.

37. The catheter disinfection system according to claim 32, characterized in that Also included is a sheath sleeve attachment configured to be removably connected to the sheath sleeve, the excitation irradiation device includes one or more internal radiation sources incorporated into the sheath sleeve attachment, and the one or more internal radiation sources are configured to generate the excitation radiation and emit the excitation radiation into the inner cavity of the sheath sleeve attachment.

38. The catheter disinfection system according to claim 32, characterized in that It also includes a sheath sleeve attachment configured to be removably connected to the sheath sleeve, the excitation irradiation device includes one or more external radiation sources operably connected to the sheath sleeve attachment via a waveguide, the one or more external radiation sources are configured to generate the excitation radiation, the waveguide is configured to transmit the excitation radiation, and the waveguide or a diffuser operably connected to the waveguide is configured to emit the excitation radiation into an inner cavity of the sheath sleeve attachment.

39. The catheter disinfection system according to claim 32, characterized in that It also includes a sheath insert configured to be removably inserted into the introducer sheath, the excitation irradiation device includes one or more external radiation sources operably connected to the sheath insert via a waveguide, the one or more external radiation sources are configured to generate the excitation radiation, the waveguide is configured to transmit the excitation radiation, and the waveguide or a diffuser operably connected to the waveguide is configured to emit the excitation radiation into the inner cavity of the sheath insert.

Images