Abstract
The present disclosure relates to a system for disinfecting skin tissue around catheters. The system comprises an adaptor, wherein the adaptor defines a catheter entry opening for entry of a catheter into the adaptor and a catheter exit opening for exit of the catheter from the adaptor. The adaptor comprises an outer surface and an inner surface which defines an inner cavity for receiving at least a section of the catheter, wherein the inner cavity extends from the catheter entry opening to the catheter exit opening. The system further comprises at least one light source for emitting UVC light, wherein the light source is arranged such that the UVC light is emitted away from the adaptor. The disclosure further relates to a method of disinfecting skin tissue around a catheter inserted into the skin of a patient. The disclosure further relates to the use of a catheter in a system disclosed herein.
Claims
1-16. (canceled)
17. A system for disinfecting skin tissue around catheters, the system comprising an adaptor, wherein the adaptor defines a catheter entry opening for entry of a catheter into the adaptor and a catheter exit opening for exit of the catheter from the adaptor, wherein the adaptor comprises an outer surface and an inner surface which defines an inner cavity for receiving at least a section of the catheter, wherein the inner cavity extends from the catheter entry opening to the catheter exit opening; wherein the system further comprises at least one light source for emitting UVC light, wherein the light source is arranged such that the UVC light is emitted away from and optionally within the adaptor; wherein the system further comprises a light guide, which is configured for guiding UVC light from a light receiving opening of the light guide to at least one light emitting opening of the light guide, wherein the at least one light source includes a light emitting opening of the light guide; wherein the system comprises at least one emission chamber, comprising at least one of the light sources; wherein the at least one emission chamber forms part of the outer surface of the adaptor and is arranged around the catheter exit opening; wherein the emission chamber comprises the light emitting opening of the at least one light guide as the at least one light source.
18. The system according to claim 17, wherein the outer surface of the adaptor defines a recess located around the catheter exit opening, and the emission chamber is arranged in the recess.
19. The system according to claim 17, wherein the adaptor comprises a light guide entry opening for entry of the light guide into the adaptor, the light guide entry opening being arranged in a side outer surface of the adaptor.
20. The system according to claim 17, wherein the light guide is an optical fiber.
21. The system according to claim 17, wherein the at least one light source is configured to emit UVC light at a wavelength in the range from 200 nm to 230 nm.
22. The system according to claim 17, wherein the system further comprises a filter, wherein the filter is arranged such that the UVC light emitted from the light source passes through the filter.
23. The system according to claim 22, wherein the system comprises a diffuser which is ring-shaped and surrounds the catheter exit opening.
24. The system according to claim 17, wherein a front exterior surface of the emission chamber has an area from 1 mm.sup.2 to 4 cm.sup.2.
25. The system according to claim 17, wherein the emission chamber has a thickness from 1 mm to 30 mm.
26. The system according to claim 17, wherein the at least one light source is arranged within a ring surrounding the catheter exit opening.
27. The system according to claim 17, wherein the at least one emission chamber has an inner surface which is at least partially covered with a scattering layer configured to scatter and reflect UVC light.
28. The system according to claim 17, wherein the outer surface of the adaptor comprises a front outer surface surrounding the catheter exit opening, a rear outer surface opposite the front outer surface and a side outer surface arranged between the front outer surface and the rear outer surface, wherein the light source is configured such that light is emitted away from the front outer surface.
29. The system according to claim 28, wherein the front outer surface is covered with a coating.
30. The system according to claim 17, wherein the adaptor comprises a coupling mechanism for closing the adaptor around the catheter.
31. The system according to claim 17, wherein the adaptor comprises a first adaptor portion and a second adaptor portion which are releasably connectable to each other.
32. The system according to claim 17, further comprising a guide element for securing and guiding the catheter, wherein the guide element comprises an essentially planar resting surface for resting the guide element on a skin, and a ring-shaped jacket for securing the catheter, wherein the ring-shaped jacket is openable.
33. The system according to claim 17, comprising multiple adaptors for different catheters, the adaptors being applied simultaneously to a same UVC light source.
34. A catheter assembly comprising a catheter and the system according to claim 17, wherein the catheter is inserted into the adaptor such that the catheter extends through the emission chamber.
35. A method of disinfecting skin tissue around a catheter inserted into the skin of a patient, the method comprising mounting the system according to claim 17 to the catheter; subsequently, positioning the system such that the outer surface of the adaptor is within 2 cm of the skin tissue around the catheter; and subsequently, irradiating the skin tissue around the catheter with UVC light emitted from the at least one light source.
36. Use of a catheter in the system according to claim 17.
37. The system according to claim 20, wherein the light guide is a side-emitting optical fiber.
38. The system according to claim 21, wherein the at least one light source is configured to emit UVC light at a radiant flux of at least 100 W.
39. The system according to claim 38, wherein the at least one light source is configured to emit UVC light at a radiant flux from 400 W to 25000 W.
40. The system according to claim 17, wherein the system further comprises a diffuser, wherein the diffuser is arranged such that the UVC light emitted from the light source passes through the diffuser.
41. The system according to claim 24, wherein the front exterior surface of the emission chamber has an area from 3 mm.sup.2 to 2 cm.sup.2.
42. The system according to claim 25, wherein the emission chamber has a thickness from 5 mm to 15 mm.
43. The system according to claim 26, wherein the catheter exit opening is circular and wherein a center point of the catheter exit opening is identical with a center point of the ring surrounding the catheter exit opening.
44. The system according to claim 27, wherein the scattering layer comprises one of the following materials; a) polytetrafluoroethylene; b) aluminium; c) UV phosphor.
45. The system according to claim 29, wherein the coating is comprised by an adhesive patch.
46. The system according to claim 45, wherein the adhesive patch has a shape that is identical to a shape of the front outer surface.
47. The system according to claim 31, wherein the first adaptor portion and the second adaptor portion are connectable to each other in a form-fit fashion.
48. The system according to claim 31, wherein the first adaptor portion and the second adaptor portion each have a connecting surface that intersects the cavity of the adaptor, such that the first adaptor portion comprises a first section of the inner surface of the adaptor and the second adaptor portion comprises a second section of the inner surface of the adaptor.
49. The method according to claim 35, wherein the system is positioned such that the front outer surface of the adaptor is in contact with the skin tissue around the catheter.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0101] The invention described herein will be more fully understood from the detailed description given herein below and the accompanying drawings which should not be considered limiting to the invention described in the appended claims. The drawings show:
[0102] FIG. 1 shows embodiments (FIG. 1a-1f) of the system disclosed herein featuring light guides;
[0103] FIG. 2 shows different embodiments of the system disclosed herein featuring a diffuser (FIG. 2a-2e) and an emission chamber (FIG. 2f-2h);
[0104] FIG. 3 shows embodiments (FIG. 3a-3c) of the system disclosed herein featuring a filter and an antimicrobial coating;
[0105] FIG. 4 shows embodiments (FIG. 4a-4c) of the system disclosed herein featuring LEDs;
[0106] FIG. 5 shows, for example relating to the fifth aspect of the disclosure, a front (FIG. 5a) and side perspective view (FIG. 5b) of an exemplary embodiment of an adaptor with in-built optical fibers;
[0107] FIG. 6 shows, for example relating to the fifth aspect of the disclosure, a side perspective view of an exemplary embodiment of an adaptor with a first version of in-built optical fibers;
[0108] FIG. 7 shows, for example relating to the fifth aspect of the disclosure, a side perspective view of an exemplary embodiment of an adaptor with a second version of in-built optical fibers;
[0109] FIG. 8 shows, for example relating to the fifth aspect of the disclosure, a side perspective view of an exemplary embodiment of an adaptor with a third version of coiled in-built optical fibers;
[0110] FIG. 9 shows, for example relating to the fifth aspect of the disclosure, a side perspective view of an exemplary embodiment of an adaptor that shows a coupling mechanism;
[0111] FIG. 10 shows, for example relating to the fifth aspect of the disclosure, a front, side perspective view of an exemplary embodiment of a second version adaptor with in-built optical fibers in short distance to the skin;
[0112] FIG. 11 shows, for example relating to the fifth aspect of the disclosure, a front view of an exemplary embodiment of a second version adaptor with in-built optical fibers in short distance to the skin;
[0113] FIG. 12 shows, for example relating to the fifth aspect of the disclosure, a front, side perspective view of an exemplary embodiment of an insertion unit in the insertion hole with in-built optical fibers;
[0114] FIG. 13 shows, for example relating to the fifth aspect of the disclosure, a front perspective view of an exemplary embodiment of an adaptor with in-built optical fibers for a chest drainage tube;
[0115] FIG. 14 shows, for example relating to the fifth aspect of the disclosure, a front perspective view of an exemplary embodiment of an adaptor for an external ventricular drainage tube which is inserted into the skull of a patient.
DESCRIPTION OF THE EMBODIMENTS
[0116] Reference will now be made in detail to certain embodiments, examples of which are illustrated in the accompanying drawings, in which some, but not all features are shown. Indeed, embodiments disclosed herein may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. Whenever possible, like reference numbers will be used to refer to like components or parts.
[0117] FIGS. 1a-1e show an embodiment of the system 3 disclosed herein. The system 3 comprises an adaptor 4 that is placed around a catheter 2, which is inserted in the skin 1 of a human patient. The adaptor 4 rests on the skin 1. The adaptor 4 comprises a catheter entry opening 5 and a catheter exit opening 6 through which the catheter 2 enters and exits the adaptor 4, respectively. The system 3 further comprises a light guide 8, which enters the adaptor 4 through a light guide entry opening 7. The adaptor 4 illustrated in FIG. 1a comprises an inner surface, which is not visible in FIG. 1a, and an outer surface. The outer surface comprises a front outer surface 10, a rear outer surface 11 opposite the front outer surface 10 and a side outer surface 12 between the front outer surface 10 and the rear outer surface 11.
[0118] FIGS. 1b, 1c and 1d show the same embodiment shown in FIG. 1a but from a different perspective. In particular, FIG. 1b illustrates the rear outer surface 11 which surrounds the catheter entry opening 5 and FIGS. 1c and 1d illustrate the front outer surface 10 which surrounds the catheter exit opening 6. FIGS. 1c and 1d also show that the illustrated embodiment of the system 3 further includes a light guide 8 which includes a number of light emitting openings. The light emitting openings act as light sources 9 for emitting UVC light. In the illustrated embodiment, the light emitting elements all form part of the front outer surface 10, such that the UVC light is emitted from the light sources 9 directly to the skin 1 around the catheter 2. In the illustrated embodiment, the catheter exit opening 6 has a diameter of 5 mm and the front outer surface 10 is elliptical with a height of 2 cm and a width of 1.5 cm. In other embodiments, the front outer surface may be almost entirely capable of emitting UVC light.
[0119] FIG. 1e shows the embodiment from the same perspective as FIG. 1a but does not show the catheter nor the skin 1. Instead, FIG. 1d illustrates the side outer surface 12 and the cavity 14, which would normally be hidden behind the side outer surface 12 from this perspective. In the illustrated embodiment, the cavity 14 defined by the inner surface of the adaptor has a tubular shape and extends from the catheter entry opening 5 to the catheter exit opening 6. Further, the inner cavity is arranged at an angle of 30 relative to the front outer surface 10.
[0120] FIG. 1f shows a similar embodiment of the system 3 to the one shown in FIG. 1d. In the embodiment illustrated in FIG. 1f, the light guide 8 comprises a number of discrete light emitting openings that act as light sources 9.
[0121] FIGS. 2a-2d show an embodiment of the system 3 disclosed herein which is similar to the embodiments shown in FIG. 1a-1f. The system 3 illustrated in FIG. 2a-2d also comprises an adaptor 4 having a front outer surface 10, a rear outer surface 11 and a side outer surface 12. Once again, the catheter 2 enters into the adaptor 4 through a catheter entry opening 5 and exits the adapter through a catheter exit opening 6. The catheter 2 is shown in a continuous fashion for illustration purposes even though, from the perspective shown in FIG. 2a, the section of the catheter 2 around which the adaptor 4 is placed cannot normally be seen from this perspective.
[0122] The illustrated system 3 further comprises a diffuser 15, which is ring-shaped and surrounds the catheter exit opening 6, as shown in FIG. 2b. The diffuser 15 is comprised in a lens 16. The illustrated embodiment also comprises light sources 9. The light sources 9 are realized by light emitting ends of light guides 8, as illustrated in FIGS. 2c and 2d. The lens 16 forms part of the outer surface of the adaptor 4, specifically of its front outer surface 10. The diffuser 15 is arranged between the light sources 9 and the skin (not shown), such that the UVC light emitted from the light source 9 passes through the diffuser 15.
[0123] FIG. 2e shows an embodiment of the system 3 disclosed herein which is similar to the embodiments shown in FIG. 1a-1f. The system 3 shown in FIG. 2e comprises five rectangular diffuser rods 15.
[0124] FIGS. 2f, 2g and 2h show an embodiment of the system 3 disclosed herein which is similar to the embodiments shown in FIG. 1a-1f. The illustrated embodiments include six emission chambers 27. As illustrated in the cross section view in FIG. 2f, the emission chambers 27 of the illustrated embodiment have a hyperbolic cross section. The emission chambers 27 may further comprise a scattering layer and a filter. As illustrated in the front view illustrated in FIG. 2g, the emission chambers 27 are arranged symmetrically around the catheter exit opening 6. Each emission chamber 27 comprises one light emitting opening of a light guide 8, such as an optical fiber. FIGS. 2f, 2g and 2h also illustrate that the system 3 may comprise none, one or more diffusers 15. As an example, as shown in FIG. 2g, the system 3 may comprise a diffuser 15.
[0125] FIGS. 3a-3b illustrate embodiments of the system 3 disclosed herein featuring a filter 17. The filter 17 is comprised in an emission chamber. Besides the filter 17, the emission chamber further comprises light sources 9 and a diffuser 15. The embodiment further comprises a lens 16. The emission chamber forms part of the outer surface of the adaptor 4, specifically of its front outer surface 10. The filter 17 and the diffuser 15 are arranged between the light sources 9 and the skin (not shown), such that the UVC light emitted from the light source 9 passes through the diffuser 15.
[0126] FIG. 3c illustrates a similar embodiment of the system 3 as the one illustrated in FIG. 3a-3b, but further comprises an antimicrobial coating 18. The antimicrobial coating is realized by way of an antimicrobial patch, which is releasably attached to the front outer surface 10 of the adaptor 4.
[0127] FIGS. 4a-4c illustrate an embodiment of the system 3 disclosed herein comprising LEDs as light sources 9. The illustrated embodiment comprises three LEDs, each having a diameter of 35 mm. The LEDs are arranged uniformly around the catheter exit opening. The LEDs are comprised in an emission chamber, which also includes a lens 16. The emission chamber forms part of the front outer surface 10 of the adaptor 4. The illustrated embodiment further comprises a power cable 29 for supplying the LEDs with electrical power. The power cable 29 is connected directly to the LEDs or to the PCB 28. The illustrated embodiment further comprises a lens 16. Further illustrated is the catheter entry opening 5. The embodiment further comprises a printed circuit board 28.
[0128] FIGS. 5-14 relate primarily to embodiments of the system according to the fifth aspect of the invention. The adaptor of the system according to the fifth aspect is constructed for medical catheters and tubes that are inserted into the patient for different purposes such as intravenous delivery of drugs, chest drainage, dialysis and air ventilation among others. Within the adaptor, light guides such as optical fibers are placed that target directly the infection-prone sites. This refers to the skin around and within the insertion hole and the tube by shining in situ Far-UVC light (200 nm-230 nm) for disinfection. Those optical fibers can deliver light by end-point-emitting or side-emitting designs.
[0129] The adaptor itself is placed around the catheter before, during or after the insertion process. A coupling mechanism closes the adaptor around the catheter. Eventually, it will be fixed and placed close to or directly at the human skin.
[0130] The UVC light source, such as a laser or excimer among others, is fixed at a bed or other infrastructure and emits light in specific intervals through light guides to the adaptor.
[0131] The intensity level, the duration and the time interval of the application can vary with the different catherization processes and the state of the patient. Once it is coupled and the light guides in the adaptor are connected to the UVC source, the disinfection is performed automatically or manually. Moreover, multiple adaptors of different catheters or tubes can be applied simultaneously with the same UVC source.
[0132] This invention primarily concerns intravenous catheters including peripherally inserted central catheters (PICC), but it can also be implemented for other medical devices such as chest drainage tubes, indwelling pleural catheters (IPCs), urinary tract catheter, long-term and short-term hemodialysis catheter, peritoneal dialysis, external ventricular drainage (EVD) tube, endotracheal tubes, diabetes procedures and artificial stoma procedures, among others.
[0133] The Far-UVC disinfection targets different types of bacteria present in the environment such as Methicilin-resistant Staphylococcus aureus (MRSA), Escherichia coli, Staphylococcus aureus, Staphylococcus epidermis, Salmonella enteritidis, Enterococcus, Bacillus subtilis, Pseudomonas aeruginosa and fungal pneumonia among others.
[0134] FIG. 5 is an embodiment of an adaptor 4, which is attached onto the patient's skin 1, through which a catheter 2 is inserted into the body. The optical fibers as light guides 8 deliver UVC into the adaptor, whereas the end-tips of the in-built optical fibers 8 illuminate the human skin uniformly around the insertion point. The opposite ends of the light guides are then connected to a UVC light source such as a laser or excimer. This UVC light source is capable of generating UVC of a desired wavelength. The UVC light source can be switched on and off at regular intervals of time, depending on the disinfection therapy requirements. A micro-controller for instance can be used to automate this process.
[0135] FIG. 6/FIG. 7/FIG. 8 depict different concepts of arrangements of optical fibers 8 in the adaptor 4, which can be end-point-emitting, side-emitting and can be coiled (or a combination thereof) within the adaptor around the catheter 2.
[0136] FIG. 9 depicts one concept of a coupling mechanism for the adaptor 4. The physician would then be able to decide when to close the adaptor (before, during or after the insertion of the catheter) with a locking mechanism 19.
[0137] FIG. 10 depicts a second version of an adaptor 4 attached to the outer surface of a catheter 2 near the insertion hole of the skin 1, through which the catheter is inserted into the patient's body. The adaptor has a flat-bottom surface that can be affixed to the patient's body 1 via an adhesive material or a strap-on belt to stabilise the catheter. The adaptor 4 is fed with optical fibers 8, preferably solari-zation resistant optical fibers with increased durability against UVC radiation. Multiple optical fibers are grouped together into a fiber bundle, and are mechanically coupled to an UVC light source, such as a laser or an excimer, among others.
[0138] FIG. 11 shows a cross-sectional view of the second version adaptor and the catheter assembly, where multiple end-tips of optical fibers 8 are distributed evenly in this adaptor 4. The adaptor is composed of two symmetric units, which can be clipped together at the coupling points 20 and 21. This allows easy plug-and-play incorporation with any catheter or tube. The end-tips of the fibers disperse UVC radiation such that the area of the patient's skin around the insertion hole, along with the outer surface of the catheter 2, is illuminated. This way, the UVC radiation is able to disinfect all the critical regions near the insertion hole.
[0139] FIG. 12 describes an add-on insertion unit 22 of the adaptor 4 that goes into the body, which is involved in the internal disinfection of the epidermis tissues surrounding the catheter. This insertion unit 22 contains in-built optical fibers 8 that are side-emitting 23, whereby the UVC is dispersed radially. In this manner, the UVC radiation is able to illuminate the internal human tissues around the catheter, thereby restricting the further entry of pathogens into the patient's body.
[0140] FIG. 13 illustrates an adaptor 4 for a chest drainage tube 24 connected to a drainage system 25, which is attached onto the patient's skin. The optical fibers 8 deliver UVC into the adaptor, whereas the end-tips of these in-built optical fibers 8 illuminate the human skin uniformly around the insertion point. The opposite ends of the light guides are then connected to a UVC light source 9 such as a laser or excimer.
[0141] The words used in the specification are words of description rather than limitation. It is understood that various changes may be made without departing from the spirit and scope of the invention.
[0142] FIG. 14 illustrates an adaptor 4 for an external ventricular drainage tube 26, which is inserted into the skull of a patient.
LIST OF DESIGNATIONS
[0143] 1 skin [0144] 2 catheter [0145] 3 system [0146] 4 adaptor [0147] 5 catheter entry opening [0148] 6 catheter exit opening [0149] 7 light guide entry opening [0150] 8 light guide [0151] 9 light source [0152] 10 front outer surface [0153] 11 rear outer surface [0154] 12 side outer surface [0155] 13 inner surface [0156] 14 inner cavity [0157] 15 diffuser [0158] 16 lens [0159] 17 filter [0160] 18 antimicrobial coating [0161] 19 locking mechanism [0162] first coupling point [0163] 21 second coupling point [0164] 22 insertion unit [0165] 23 side emission [0166] 24 chest drainage tube [0167] 25 drainage system [0168] 26 external ventricular drainage tube [0169] 27 emission chamber [0170] 28 printed circuit board (PCB) [0171] 29 power cable
