Patent Application
20240252789
Ultraviolet (“UV”) light is known to damage bacteria and their endotoxins, and such knowledge has been implemented in various disinfection systems for disinfecting medical devices with UV light including UV disinfection cabinets and handheld UV lamps. While existing disinfection systems might be effective for disinfecting medical devices with UV light before use of the medical devices, such existing disinfection systems are not suitable for real-time disinfection with UV light during a medical procedure. It follows that the existing disinfection systems are also not suitable for real-time, in-line disinfection of supplier- or clinician-prepared infusate with UV light during an infusion, which disinfection is desirable for reducing infusion-related blood infections.
Disclosed herein are infusion systems for in-line disinfection of prepared infusates with UV light and methods thereof.
Disclosed herein is an infusion system for in-line disinfection of a prepared infusate with UV light. The infusion system includes a vascular access device (“VAD”) and a UV light ring. The VAD includes an intracorporeal conduit, one or more extracorporeal conduits fluidly connected to the intracorporeal conduit, a hub between a proximal portion of the intracorporeal conduit and one or more respective distal portions of the one-or-more extracorporeal conduits, and one or more respective connectors of the one-or-more extracorporeal conduits. The intracorporeal conduit is configured to be percutaneously inserted into a patient, and the extracorporeal conduit is configured to remain outside a body of the patient. The UV light ring is configured to encircle a portion of an infusion lumen of the VAD. The UV light ring is also configured to irradiate the prepared infusate within the infusion lumen with the UV light for infusing a disinfected infusate into the patient during an infusion of the patient.
In some embodiments, the UV light ring is removably or fixedly coupled about an abluminal surface of the intracorporeal conduit, an extracorporeal conduit of the one-or-more extracorporeal conduits, a hub conduit of one or more hub conduits respectively fluidly connecting the one-or-more extracorporeal conduits to the intracorporeal conduit, or a connector of the one-or-more connectors.
In some embodiments, the UV light ring is removably coupled about the abluminal surface of the intracorporeal conduit, the extracorporeal conduit, the hub conduit, or the connector. The UV light ring is configured to automatically adjust its size in accordance with a size of the intracorporeal conduit, the extracorporeal conduit, the hub conduit, or the connector.
In some embodiments, the intracorporeal conduit, the extracorporeal conduit, the hub conduit, or the connector about which the UV light ring is fixedly or removably coupled is formed of a material that does not appreciably reflect or absorb the UV light from the UV light ring.
In some embodiments, the UV light ring is integrated into a luminal surface of the intracorporeal conduit, an extracorporeal conduit of the one-or-more extracorporeal conduits, a hub conduit of one or more hub conduits respectively fluidly connecting the one-or-more extracorporeal conduits to the intracorporeal conduit, or a connector of the one-or-more connectors.
In some embodiments, the VAD further comprises a fixed or removable internal power source and electronic circuitry between the internal power source and the UV light ring. The electronic circuitry is configured to supply power to the UV light ring from the internal power source.
In some embodiments, the infusion system further includes an electrical cable and electronic circuitry between the electrical cable and the UV light ring. The electrical cable is configured to connect to an external power source. The electronic circuitry is configured to supply power to the UV light ring.
In some embodiments, the infusion system further comprises an indicator light operably connected to the electronic circuitry. The indicator light is configured to emit visible light when the UV light ring emits the UV light.
In some embodiments, the UV light ring is configured to automatically emit the UV light upon an activation event selected from an assembly step while assembling the VAD, a connecting step while connecting the VAD to an infusion bag containing the prepared infusate, or an initiating step of infusing the prepared infusate into the patient through the infusion lumen.
In some embodiments, the VAD is a catheter. The intracorporeal conduit, the one-or-more extracorporeal conduits, the hub, and the one-or-more connectors corresponds to a catheter tube, one or more extension legs, a catheter hub, and one or more Luer connectors of the catheter, respectively.
In some embodiments, the VAD is a Huber needle set. The intracorporeal conduit, the one-or-more extracorporeal conduits, the hub, and the one-or-more connectors corresponds to a needle, an extension tube, a needle hub, and a Luer connector of the Huber needle set, respectively.
Also disclosed herein is a method of an infusion system for in-line disinfection of a prepared infusate with UV light. The method includes a VAD-obtaining step, a VAD-connecting step, and an infusing step. The VAD-obtaining step includes obtaining a VAD of the infusion system. The VAD includes an intracorporeal conduit, one or more extracorporeal conduits fluidly connected to the intracorporeal conduit, a hub between a proximal portion of the intracorporeal conduit and one or more respective distal portions of the one-or-more extracorporeal conduits, and one or more respective connectors of the one-or-more extracorporeal conduits. The intracorporeal conduit is configured to be percutaneously inserted into a patient, and the extracorporeal conduit is configured to remain outside a body of the patient. The VAD-connecting step includes connecting the VAD to an infusion bag containing a prepared infusate. The infusing step includes infusing the patient with a disinfected infusate. The disinfected infusate results from irradiation of the prepared infusate within an infusion lumen of the VAD by the UV light from a UV light ring encircling a portion of the infusion lumen.
In some embodiments, the UV light ring is removably or fixedly coupled about an abluminal surface of the intracorporeal conduit, an extracorporeal conduit of the one-or-more extracorporeal conduits, a hub conduit of one or more hub conduits respectively fluidly connecting the one-or-more extracorporeal conduits to the intracorporeal conduit, or a connector of the one-or-more connectors.
In some embodiments, the method further includes a light ring-placing step. The light ring-placing step includes placing the UV light ring over the abluminal surface of the intracorporeal conduit, the extracorporeal conduit, the hub conduit, or the connector, thereby removably coupling the UV light ring to the VAD. The UV light ring is configured to automatically adjust its size in accordance with a size of the intracorporeal conduit, the extracorporeal conduit, the hub conduit, or the connector.
In some embodiments, the intracorporeal conduit, the extracorporeal conduit, the hub conduit, or the connector about which the UV light ring is fixedly or removably coupled is formed of a material that does not appreciably reflect or absorb the UV light from the UV light ring.
In some embodiments, the UV light ring is integrated into a luminal surface of the intracorporeal conduit, an extracorporeal conduit of the one-or-more extracorporeal conduits, a hub conduit of one or more hub conduits respectively fluidly connecting the one-or-more extracorporeal conduits to the intracorporeal conduit, or a connector of the one-or-more connectors.
In some embodiments, the VAD further comprises a fixed or removable internal power source and electronic circuitry between the internal power source and the UV light ring. The electronic circuitry is configured to supply power to the UV light ring from the internal power source.
In some embodiments, the method further includes a cable-connecting step. The cable-connecting step includes connecting an electrical cable to an external power source. Electronic circuitry between the electrical cable and the UV light ring is configured to supply power to the UV light ring.
In some embodiments, an indicator light operably connected to the electronic circuitry is configured to emit visible light when the UV light ring emits the UV light.
In some embodiments, the UV light ring is configured to automatically emit the UV light upon an activation event selected from an assembly step while assembling the VAD, the VAD-connecting step while connecting the VAD to the infusion bag, or initiation of the infusing step of infusing the patient with the disinfected infusate.
In some embodiments, the VAD is a catheter. The intracorporeal conduit, the one-or-more extracorporeal conduits, the hub, and the one-or-more connectors corresponds to a catheter tube, one or more extension legs, a catheter hub, and one or more Luer connectors of the catheter, respectively.
In some embodiments, the VAD is a Huber needle set. The intracorporeal conduit, the one-or-more extracorporeal conduits, the hub, and the one-or-more connectors corresponds to a needle, an extension tube, a needle hub, and a Luer connector of the Huber needle set, respectively.
In some embodiments, the VAD is a Huber needle set. The intracorporeal conduit, the one-or-more extracorporeal conduits, the hub, and the one-or-more connectors corresponds to a needle, an extension tube, a needle hub, and a Luer connector of the Huber needle set, respectively.
These and other features of the concepts provided herein will become more apparent to those of skill in the art in view of the accompanying drawings and following description, which describe particular embodiments of such concepts in greater detail.
Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein.
Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the 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 group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. In addition, any of the foregoing features or steps can, in turn, further include one or more features or steps unless indicated otherwise. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.
“Proximal” is used to indicate a portion, section, piece, element, or the like of a medical device intended to be near or relatively nearer to a clinician when the medical device is used on a patient. For example, a “proximal portion” or “proximal section” of the medical device includes a portion or section of the medical device intended to be near the clinician when the medical device is used on the patient. Likewise, a “proximal length” of the medical device includes a length of the medical device intended to be near the clinician when the medical device is used on the patient. A “proximal end” of the medical device is an end of the medical device intended to be near the clinician when the medical device is used on the patient. The proximal portion, the proximal section, or the proximal length of the medical device need not include the proximal end of the medical device. Indeed, the proximal portion, the proximal section, or the proximal length of the medical device can be short of the proximal end of the medical device. However, the proximal portion, the proximal section, or the proximal length of the medical device can include the proximal end of the medical device. Should context not suggest the proximal portion, the proximal section, or the proximal length of the medical device includes the proximal end of the medical device, or if it is deemed expedient in the following description, “proximal portion,” “proximal section,” or “proximal length” can be modified to indicate such a portion, section, or length includes an end portion, an end section, or an end length of the medical device for a “proximal end portion,” a “proximal end section,” or a “proximal end length” of the medical device, respectively.
“Distal” is used to indicate a portion, section, piece, element, or the like of a medical device intended to be near, relatively nearer, or even in a patient when the medical device is used on the patient. For example, a “distal portion” or “distal section” of the medical device includes a portion or section of the medical device intended to be near, relatively nearer, or even in the patient when the medical device is used on the patient. Likewise, a “distal length” of the medical device includes a length of the medical device intended to be near, relatively nearer, or even in the patient when the medical device is used on the patient. A “distal end” of the medical device is an end of the medical device intended to be near, relatively nearer, or even in the patient when the medical device is used on the patient. The distal portion, the distal section, or the distal length of the medical device need not include the distal end of the medical device. Indeed, the distal portion, the distal section, or the distal length of the medical device can be short of the distal end of the medical device. However, the distal portion, the distal section, or the distal length of the medical device can include the distal end of the medical device. Should context not suggest the distal portion, the distal section, or the distal length of the medical device includes the distal end of the medical device, or if it is deemed expedient in the following description, “distal portion,” “distal section,” or “distal length” can be modified to indicate such a portion, section, or length includes an end portion, an end section, or an end length of the medical device for a “distal end portion,” a “distal end section,” or a “distal end length” of the medical device, respectively.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.
Again, UV light is known to damage bacteria and their endotoxins, and such knowledge has been implemented in various disinfection systems for disinfecting medical devices with UV light including UV disinfection cabinets and handheld UV lamps. While existing disinfection systems might be effective for disinfecting medical devices with UV light before use of the medical devices, such existing disinfection systems are not suitable for real-time disinfection with UV light during a medical procedure. It follows that the existing disinfection systems are also not suitable for real-time, in-line disinfection of supplier- or clinician-prepared infusate with UV light during an infusion, which disinfection is desirable for reducing infusion-related blood infections.
Disclosed herein are infusion systems for in-line disinfection of prepared infusates with UV light and methods thereof.
As shown, the infusion system 100 includes the VAD 104 and a UV light ring 106 either integrated with the VAD 104 or separate therefrom but configured to couple to the VAD 104. Notably, several options for placement of the UV light ring 106 about or within the VAD 104 are shown in
The VAD 104 includes an intracorporeal conduit 108, one or more extracorporeal conduits 110 fluidly connected to the intracorporeal conduit 108, a hub 112 between a proximal portion of the intracorporeal conduit 108 and one or more respective distal portions of the one-or-more extracorporeal conduits 110, and one or more respective connectors 114 of the one-or-more extracorporeal conduits 110. At least a portion of the intracorporeal conduit 108 is configured to be percutaneously inserted into the patient P. In contrast, an entirety of the extracorporeal conduit is configured to remain outside a body of the patient P.
Again, the UV light ring 106 is either integrated with the VAD 104 or separate therefrom but configured to couple to the VAD 104. Regardless, the UV light ring 106 is configured to encircle a portion of an infusion lumen 116 of the VAD 104. Further, the UV light ring 106 is configured to irradiate the prepared infusate 102, when present, within the infusion lumen 116 of the VAD 104 with the UV light therefrom, thereby allowing a disinfected infusate to be infused into the patient P during an infusion of the patient P.
Notably, the UV light ring 106 can be configured to emit the UV light in a range from about 100 nm to about 280 nm, which corresponds to the so-called UVC range; however, the UV light ring 106 need not be limited to emission the UVC range. Indeed, the UV light ring 106 can be configured to emit the UV light anywhere in the UV portion of the electromagnetic spectrum. In an example, the UV light ring 106 can be alternatively configured to emit the UV light in a range from about 280 nm to about 315 nm, which corresponds to the so-called UVB range. In another example, the UV light ring 106 can be alternatively configured to emit the UV light in a range from about 315 nm to about 400 nm, which corresponds to the so-called UVA range. In consideration of the UV light ring 106 being configured to emit the UV light in the UVC range, the UV light ring 106 can include one or more light-emitting diodes (“LEDs”) arranged in a sealed annular conduit 118, which LEDs can independently have emission peaks anywhere in the UVC range such as 265 nm, 273 nm, or 280 nm. Such LEDs advantageously allow the UV light emitted from the UV light ring 106 to be selected to provide a broader range (e.g., 265 nm to 280 nm), a narrower range (e.g., 265 nm to 273 nm or 273 nm to 280 nm), or even a gapped range (e.g., 265 nm to 280 nm with a gap around 273 nm), as desired, to accommodate components of the VAD 104 formed of UV light-sensitive materials or even medicaments including UV light-sensitive molecular entities. That said, at least the VAD 104 including the UV light ring 106 integrated therein or fixedly coupled thereto, and, particularly, the component of the VAD 104 including the UV light ring 106, can be formed of one or more materials sufficiently inert to the UV light of the UV light ring 106.
As shown, the UV light ring 106 can be removably or fixedly coupled about the abluminal surface of the intracorporeal conduit 108 but proximal of a portion of the intracorporeal conduit 108 intended to be within the patient P. Alternatively, the UV light ring 106 can be removably or fixedly coupled about an abluminal surface of an extracorporeal conduit of the one-or-more extracorporeal conduits 110, a hub conduit of one or more hub conduits respectively fluidly connecting the one-or-more extracorporeal conduits 110 to the intracorporeal conduit 108, or a connector of the one-or-more connectors 114. In consideration of the UV light ring 106 being removably coupled about the abluminal surface of the intracorporeal conduit 108, the extracorporeal conduit, the hub conduit, or the connector, the UV light ring 106 can be configured to automatically adjust its size in accordance with a size of the intracorporeal conduit 108, the extracorporeal conduit, the hub conduit, or the connector. However, in other embodiments the UV light ring 106 is manufactured in different sizes for coupling the UV light ring 106 about the abluminal surface of the intracorporeal conduit 108, the extracorporeal conduit, the hub conduit, or the connector of larger or smaller VADs. Notably, the intracorporeal conduit 108, the extracorporeal conduit, the hub conduit, or the connector about which the UV light ring 106 is fixedly or removably coupled should be formed of a material that does not appreciably reflect or absorb the UV light from the UV light ring 106.
As shown, the UV light ring 106 can be integrated into the luminal surface of the intracorporeal conduit 108, an extracorporeal conduit of the one-or-more extracorporeal conduits 110, a hub conduit of one or more hub conduits respectively fluidly connecting the one-or-more extracorporeal conduits 110 to the intracorporeal conduit 108, or a connector of the one-or-more connectors 114. When the UV light ring 106 is integrated into the luminal surface of the intracorporeal conduit 108, the extracorporeal conduit, the hub conduit, or the connector, the UV light is advantageously contained, thereby reducing or eliminating clinician or patient exposure.
As shown, the VAD 104 can include a fixed or removable internal power source for the internal power source 120 with the electronic circuitry 122 between the internal power source 120 and the UV light ring 106.
Alternatively, the infusion system 100 or the VAD 104, itself, can include an electrical cable and the electronic circuitry 122 between the electrical cable and the UV light ring 106. The electrical cable is configured with a plug to connect to an external power source. Whether the VAD 104 includes the internal power source 120 or utilizes the electrical cable, the electronic circuitry 122 is configured to supply power to the UV light ring 106 from the power source.
As shown in
Notably, as set forth in the method below, the UV light ring 106 can be configured to automatically emit the UV light upon an activation event selected from an assembly step while assembling the VAD 104 (e.g., coupling the UV light ring 106 to the VAD 104), a connecting step while connecting the VAD 104 to an infusion bag 126 containing the prepared infusate 102, or an initiating step of infusing the prepared infusate 102 into the patient P through the infusion lumen 116.
Methods include is a method of the infusion system 100 such as in-line disinfection of a prepared infusate (e.g., the prepared infusate 102) with UV light in real-time during an infusion of a patient (e.g., the patient P). Such a method can include one or more steps selected from a VAD-obtaining step, a VAD-connecting step, a light ring-placing step, a cable-connecting step, and an infusing step.
The VAD-obtaining step includes obtaining the VAD 104 of the infusion system 100. As set forth above, the VAD 104 includes the intracorporeal conduit 108, the one-or-more extracorporeal conduits 110 fluidly connected to the intracorporeal conduit 108, the hub 112 between the proximal portion of the intracorporeal conduit 108 and the one-or-more respective distal portions of the one-or-more extracorporeal conduits 110, and the one-or-more respective connectors 114 of the one-or-more extracorporeal conduits 110.
If the UV light ring 106 is not integrated with the VAD 104 or fixedly coupled thereto, the method can include the light ring-placing step. The light ring-placing step includes placing the UV light ring 106 over the abluminal surface of the intracorporeal conduit 108, the extracorporeal conduit, the hub conduit, or the connector, thereby removably coupling the UV light ring 106 to the VAD 104. As set forth above, the UV light ring 106 can be configured to automatically adjust its size in accordance with the size of the intracorporeal conduit 108, the extracorporeal conduit, the hub conduit, or the connector.
The VAD-connecting step includes connecting the VAD 104 to the infusion bag 126 containing the prepared infusate 102.
If the VAD 104 does not include the internal power source 120, or, as an alternative thereto, the method can include the cable-connecting step. The cable-connecting step includes connecting the electrical cable, if present, to an external power source. The electronic circuitry 122 between the electrical cable and the UV light ring 106 is configured to supply power to the UV light ring 106.
The infusing step includes infusing the patient P with a disinfected infusate. The disinfected infusate results from irradiation of the prepared infusate 102 within the infusion lumen 116 of the VAD 104 by the UV light from the UV light ring 106 encircling a portion of the infusion lumen 116. (See
Notably, as set forth above, the VAD 104 can include the indicator light 124 operably connected to the electronic circuitry 122 for emitting visible light when the UV light ring 106 emits the UV light. The UV light ring 106 can be further configured to automatically emit the UV light upon an activation event selected from an assembly step while assembling the VAD 104, the VAD-connecting step while connecting the VAD 104 to the infusion bag 126, or initiation of the infusing step of infusing the patient P with the disinfected infusate.
While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.
