Device for guiding a tubular element in a vicinity of a point of entry into a human or animal body and for disinfecting tissue surrounding the point of entry

Abstract

A device (100) for guiding a tubular element (10) in a vicinity of a point of entry into a human or animal body and for disinfecting tissue surrounding the point of entry by the application of light comprises a base (120) adapted to be attached to the human or animal body in the vicinity of the point of entry and an upper part (140) adapted to be removably attached to the base (120). The base (120) and / or the upper part (140) form a guide for the tubular element (10). The base (120) and / or the upper part (140) guide at least one optical fiber (131.1…4) along the guide for the tubular element (10), the optical fiber (131.1…4) having at least one emission surface for emitting light to illuminate the tissue surrounding the point of entry when the base (120) is attached to the body. The upper part (140) is adapted to be attached to and removed from the base (120) after the tubular element (10) has been introduced into the human or animal body. The device (100) ensures proper guidance of the tubular element (10) and defines a controlled environment for disinfection by light emitted by the optical fiber(s) (131.1…4). This results in reliable disinfection. At the same time, the device (100) enables easy and error-proof handling.

Description

[0001] Device for guiding a tubular element in a vicinity of a point of entry into a human or animal body and for disinfecting tissue surrounding the point of entry

[0002] Technical Field

[0003] The invention relates to a device for guiding a tubular element in a vicinity of a point of entry into a human or animal body and for disinfecting tissue surrounding the point of entry by the application of light.

[0004] Background Art

[0005] Many medical applications involve the introduction of tubular elements into the human or animal body. In some cases, the tubular elements stay within the body for a considerable duration. As an example, intravenous transfusion is a widely popular technique for automated delivery of lifesaving drugs and fluids directly into the patient's body. This procedure involves a catheter constituting such a tubular element, with one of its ends inserted into a vein, located at an appropriate site such as the subclavian vein, jugular vein, femoral vein or peripheral vein, depending on the specific treatment. A prime example of such catheters is the Central Venous Catheter (CVC), which has several sub-types like tunneled CVCs, non-tunneled CVCs, peripherally inserted central catheters (PICC) and the implanted port. The specific choice of a CVC is determined by the physician, depending on the site of implantation and the estimated application period, which can range from a few days to several months.

[0006] However, the use of catheters or other tubular elements, especially during longer time periods, is associated with a range of infections, such as bloodstream infections commonly known as Central Line Associated Bloodstream Infections (CLABSI) and Catheter-related Bloodstream Infections (CRBSI).

[0007] CLABSI are a type of Hospital Acquired Infections (HAI), that can occur both in the Intensive Care Unit (ICU), and in a non-ICU environment. Furthermore, CLABSI also occur in a non- hospital setting wherein a CVC is inserted into a patient for continual treatment such as in the family home or old-age homes. CLABSI typically leads to extended stays in ICUs and associated treatment costs, exceeding on average respectively 10 days and USD 46’000 per patient in the USA. In regard to HAI in general, the US reports 1. 7 million cases and the EU 4.2 million cases per year ["Health care-associated infections fact sheet." World Health Organization 4 (2015)]. Given these circumstances, it is of utmost importance to not only effectively treat such a severe health problem, but also to strive to prevent the onset of such infections.

[0008] Current recommendations by medical experts mandate an exhaustive multimodal approach [Zingg, Walter, et al. "Hospital-wide multidisciplinary, multimodal intervention programme to reduce central venous catheter-associated bloodstream infection." PloS one 9.4 (2014): e93898], consisting of several therapies to ensure a safe intravenous procedure. These therapies include careful skin preparation, catheter stabilization and securement, patient cleansing, and antibiotic treatment. Although the guidelines developed for these collective strategies have shown effectiveness, it causes an immense burden on the healthcare workers to ensure consistency, in addition to the specialized training and education needed.

[0009] Over the past few decades, different technical solutions have also emerged to counter such infections [CDC - Centers for Disease Control and Prevention. "Guidelines for the Prevention of Intravascular Catheter-Related Infections" (2011)]. One significant improvement pertains to the addition of a non-fouling coating on the inner lumen of the tubes. This technique slows down the rate of biofilm formation on the catheter surfaces, thus delaying the dwell time for CEABSI.

[0010] Similar measures may be taken in the context of other applications of tubular elements entering the human or animal body and staying in their place for a longer period of time.

[0011] Another promising solution is offered by light-based therapies, which exploit the germicidal properties of light at certain wavelengths. A suitable candidate is Ultraviolet-C (UVC) radiation, which ranges between 100-280 nm, and it is known to possess a bacteriostatic and bactericidal effect.

[0012] In WO 2022 / 248691 Al of the present applicant, a system for disinfecting skin tissue around catheters using UVC radiation is proposed. 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 publication disclosed several proposals with respect to the mechanical buildup of the adaptor and the supply and distribution of the UVC light.

[0013] The publication provides a very promising approach to counter infections, nevertheless, usability studies have shown that the system may be improved with respect to ease of use and application safety.

[0014] Summary of the invention

[0015] It is the object of the invention to create a device pertaining to the technical field initially mentioned, that allows for reliable disinfection of the tissue surrounding the point of entry of a tubular element to the human or animal body and that is easy and safe to use.

[0016] The solution of the invention is specified by the features of claim 1. According to the invention, the device comprises a) a base adapted to be attached to the human or animal body in the vicinity of the point of entry; and b) an upper part adapted to be removably attached to the base.

[0017] Different techniques are available for the attachment of the base to the human or animal body. They include in particular the use of an adhesive and / or stitching.

[0018] The base and / or the upper part form a guide for the tubular element. Therefore, in a first group of embodiments of the inventive device, the guide for the tubular element may be formed exclusively by the upper part. In a second group of embodiments, the guide for the tubular element may be formed exclusively by the base . In a third group of embodiments, the guide for the tubular element may be formed together by the base and the upper part, wherein both components may be designed to contact the tubular element along the entire extension of the guide along the tubular element or in parts thereof. The base and / or the upper part guide at least one optical fiber along the guide for the tubular element, the optical fiber having at least one emission surface for emitting light to illuminate the tissue surrounding the point of entry when the base is attached to the body. Therefore, in a first group of embodiments, at least one optical fiber is guided in the base. In a second group of embodiments, at least one optical fiber is guided in the upper part. In third group of embodiments, at least one fiber is guided in the base and at least one further fiber is guided in the upper part.

[0019] Further, the upper part is adapted to be attached to and removed from the base after the tubular element has been introduced into the human or animal body. Several ways of applying the inventive device are available, depending on the specific embodiment of the device and possibly on the specific application. In a first way, the tubular element is first introduced into the body and attached to the body by means known as such. After this, the base part and subsequently the upper part are applied. In a second way, the tubular element is first introduced into the body and attached to the body using the base element. After this, the upper part is applied. In a third way, the base part is first attached to the body. In a second step, the tubular element is introduced and then attached to the base. Finally, the upper part is applied.

[0020] Preferably, the at least one optical fiber enters the base and / or upper part from essentially the same direction and / or on the same face as the tubular element. This improves the usability of the device. In particular, the optical fiber runs parallel to the guide for the tubular element, at least in a section of its course through the respective part(s). In preferred embodiments, the at least one optical fiber leaves the base and / or upper part in essentially the same direction and / or on the same face as the tubular element. This allows for an efficient disinfection in the region surrounding the tube element and in particular the point of entry into the body.

[0021] As explained in more detail below, the at least one emission surface may be located on the end face of the optical fiber (end-emitting optical fiber) and / or on the lateral surface of the optical fiber, in particular in a distal region of the optical fiber (side-emitting fiber). If the device includes more than one optical fiber, fibers of a first group may be end-emitting and fibers of a second group may be side-emitting. Furthermore, fibers that emit light through their side surface as well as through the distal end may be used.

[0022] The upper part can be attached to the base in different ways, e. g. by using a click connection, a press fit, a form fit secured with further means (e. g. screws), a detachable adhesive, etc. The inventive device is applicable in various body regions. The tissue surrounding the point of entry may be skin tissue or other tissue, e. g. tissue of the urethra, the trachea, the mouth or nostrils.

[0023] Preferably, the tubular element is one of the following: a) a catheter, in particular a central venous catheter, a catheter for external ventricular drainage, a catheter for extracorporeal membrane oxygenation, a catheter for dialysis (e. g. haemodialysis, peritoneal dialysis) or a catheter for long-term administration of medication; b) a line for the transmission of electrical or optical signals, in particular to and / or from a human or animal brain or to and / or from an implanted medical device; c) a line for supplying electrical energy in particular to an implanted medical device.

[0024] Therefore, the invention is applicable in a large number of different fields, including inter aha: applications of central venous catheters (CVC); extracorporeal membrane oxygenation (ECMO); external ventricular drainage (EVD); heart assist devices such as the left ventricular assist device (LVAD); implantable brain-computer interfaces (BCIs), e. g. the solution developed by Neuralink Corp., Fremont, California and many more.

[0025] The inventive device may be used in particular to illuminate the tissue surrounding the point of entry with ultraviolet light, preferably UVC light, in particular UVC light with a wavelength of 190-235 nm.

[0026] The inventive device ensures proper guidance of the tubular element and defines a controlled environment for disinfection by light emitted by the optical fiber(s). This results in reliable disinfection. At the same time, the inventive device enables easy and error-proof handling. In addition to avoiding infections it also contributes to reduce the risk of antimicrobial resistance (AMR) as it allows for the reduction of the application of antibiotics. Preferably, the guide for the tubular element is arranged in such a way that at least in a section thereof a distance of a center of an accommodation space for the tubular element from an attachment surface of the base for attaching the device to the human or animal body is at least 2 mm, in particular at least 3 mm.

[0027] The center of the accommodation space is defined to be a central point in a cross section running perpendicular to the (local) longitudinal extension of the fiber. In the case of fibers with a circular cross section the center of the accommodation space coincides with the center of the fiber’s cross section. In the case of fibers with a non-circular cross section, the center of the accommodation space is defined as being the centroid of the respective cross section of the fiber.

[0028] Guiding the tubular element in a distance to the body surface in a section proximal of the entry point into the human body facilitates the illumination of the tissue surrounding the point of entry as this ensures that no body surface in this region is covered or shaded by the tubular element.

[0029] In preferred embodiments, the guide for the tubular element comprises a curved section guiding an accommodated tubular element from an initial direction generally parallel to the attachment surface of the base to an inclined direction directed towards the point of entry. The curved section may be defined by a single continuous element or by two or more cooperating elements that locally guide the tubular element and that include an angle, such that the tubular element is assuming a curved shape. It is to be noted that proximal of the initial direction there may be a further section in which the distance of the tubular element to the body surface is smaller than at the location where the tubular element assumes the initial direction, e. g. when the tubular element such as a catheter is attached to the body surface outside of the inventive device and in a distance from the point of entry into the body.

[0030] The curved section ensures proper guidance of the tubular element, avoiding kinks or excessive mechanical stress. It provides a defined geometry of the tubular element proximal to the point of entry, which is beneficial with respect to controlled distribution of light and thus ensures proper disinfection. Furthermore, the tubular element is arranged to assume the desired angle relative to the body surface, at the point of entry, which reduces radial forces exerted by the tubular element to the surrounding body tissue. Suitable angles may be e. g. 30-60°.

[0031] In preferred embodiments, in an attached configuration of the upper part on the base, the curved section of the guide for the tubular element is formed between a lower guide part in the base and an upper guide part in the upper part. This facilitates the accommodation of the tubular element in the inventive device as the element may be introduced into the lower guide part in the base and the upper part is subsequently attached to the base, accommodating the element between the lower guide part and the upper guide part. It is therefore not required to thread the tubular element through an opening and the lower guide part and the upper guide part may in principle be formed from a rigid material.

[0032] In other embodiments, instead of having a separable upper part, the upper part and the base are attached to the other using a mechanism that allows for relative movement, e. g. a hinge.

[0033] In particular, at least one optical fiber is guided in the lower guide part and at least one further optical fiber is guided in the upper guide part. This allows for a homogenous illumination of the region surrounding the tubular element in the vicinity of the point of entry into the body. In particular, fibers running in the upper guide part have a larger cross section than fibers in the lower guide part or the number of fibers running in the upper guide part is bigger than the number of fibers running in the base. This is due to the fact that higher light intensity may be needed at the emitting surface of the upper fibers as the corresponding light typically illuminates a larger surface than the light emitted by the lower fibers and / or as the light emitted by the upper fiber(s) is scattered to obtain homogenous illumination, whereas the light emitted by the lower fiber(s) may be directly illuminating the respective region. Arranging at least one optical fiber in the base and at least one further optical fiber in the upper part is also possible in embodiments where the guide for the tubular element is not curved and / or formed in either the base or the upper part, respectively.

[0034] In preferred embodiments, the at least one emission surface of the at least one optical fiber is at a distal end of the fiber, wherein the distal end is positioned in a region surrounding a distal end of the guide for the tubular element. This allows for a simple design and homogenous illumination of the region surrounding the point of entry. A main direction of illumination may be parallel to the tubular element.

[0035] A region of a component surrounding the distal end of the fiber may be formed as a cavity, which may be formed of or coated by a scattering material. This improves the distribution of the light emitted by the distal end. In preferred embodiments, at least two optical end-emitting fibers end in the region surrounding the distal end of the guide.

[0036] In particular, the distal end of the at least one fiber is essentially at the distal end of the curved section of the guide and in particular in a distance from the body surface. Furthermore, the distal end of the at least one fiber may be essentially at an outer face of the respective part of the device (base and / or upper part), which means that the fiber is mechanically protected by the respective part(s).

[0037] The at least two end-emitting fibers may be supplied as a fiber bundle. The bundle may be split into individual fibers upstream of the device or only within the device.

[0038] The at least two end-emitting fibers may as well be supplied by a single fiber and connected to this single fiber via a splitter arranged upstream or within the device.

[0039] Not all of the at least two optical fibers need to end in the region surrounding the distal end of the guide and / or have a main direction of illumination parallel to the tubular element. Some of them may include a side-emitting surface and / or their main direction of illumination may be directed to a scattering element for distributing the light.

[0040] In preferred embodiments, the device includes a single optical fiber, in particular and end-emitting fiber. Using a single fiber and preferably additional scattering surfaces, undesirable hot spots (illuminated by more than one light source) and poorly illuminated regions may be avoided. Furthermore, fiber coupling efficiency losses that occur when two or more fibers are used may be avoided and the manufacturing complexity is reduced.

[0041] In preferred embodiments, the base and / or the upper part forms a flexible guide channel for guiding the tubular element and the upper part and / or the base (i. e. the other part) comprises a clamping section for selectively compressing the flexible guide channel and the tubular element accommodated within the flexible guide channel in order to lock the tubular element in the flexible guide channel. The flexibility of the guide channel allows for introducing and / or adjusting the tubular element within the guide channel, prior to (radial) compression of the guide channel due to engaging the clamping section, which leads to a friction fit of the tubular element within the guide channel. Preferably, the flexible guide channel features a continuous slit, in particular in a top region, extending along the entire length of the guide channel, which allows for introducing the tubular element without having to thread in the tubular element.

[0042] In a preferred embodiment, the flexible guide channel is formed in the base and the clamping section is formed in the upper part. The upper part is slidably attachable to the base, wherein a sliding direction for attaching the upper part to the base in particular runs parallel to the guide for the tubular element. This allows for an easy handling of the inventive device and avoids potentially harmful mechanical impact on the tubular element.

[0043] First embodiments are possible, where the sliding direction runs from the proximal to the distal region of the guide as well as second embodiments, where the sliding direction runs from the distal to the proximal region of the guide. It is further to be noted that in certain embodiments, the upper part may be slidably inserted into the base, i. e. between a lower portion of the base and an upper portion of the base, which may partially or completely lie above the upper part.

[0044] Alternatively, the clamping section may be applied to the base with the flexible guide channel from above, in a direction which is essentially perpendicular to the guide for the tubular element (and the body surface) or inclined thereto.

[0045] Preferably, the surfaces of the base and / or the upper part illuminated by the light emitted by the optical fiber are made from a biocompatible, UVC resistant material, in particular from a material (or materials) chosen from the following: PTFE (in particular e-PTFE, or Spectralon), aluminium, alumina, magnesium oxide, titanium, titanium oxide, other ceramic materials.

[0046] This avoids degrading of the material. In particular, the material has also desired optical properties, such as a reflectivity of 98% or more . For instance, building the main optically relevant surfaces from a sintered PTFE (e. g. Spectralon) sheet of at least 0.75mm thickness ensures the desired reflectivity, the biocompatibility and the resistance against UVC radiation, in particular against far UVC radiation in the range of 200 - 220 run.

[0047] The coatings may be applied to a substrate in particular made from a plastic material or glass. In preferred embodiments, the inventive device comprises a dome element for distributing light emitted by the at least one optical fiber in order to homogenize illumination of the skin tissue surrounding the point of entry. In particular, the dome element features an inner surface made of, or covered by a scatering material. Preferably, the dome includes a concave section (as seen from the body surface), allowing for collecting and directing illuminating light to the tissue surrounding the point of entry.

[0048] Preferably, the dome element includes a surface made from a light scatering material, wherein light emitted by the at least one optical fiber is at least partially directed to the surface. In particular, at least 50% of the light emited by the fiber reaches the region to be disinfected not directly but after scatering by the surface of the dome element. This ensures homogenization of the illuminating light.

[0049] Such an arrangement is particularly advantageous if a single optical fiber is used as it provides a homogenous illumination without a substantial increase of complexity.

[0050] The scattering surface may be curved, either in two directions (nonzero Gaussian curvature) or in one direction (nonzero curvature, zero Gaussian curvature). This allows for specifically adapting the optical properties of the dome. In other embodiments, the scattering surface is flat. This minimizes the complexity of the product.

[0051] Alternatively or in addition, sections of the guide for the tubular element may feature a scatering material and / or individual scatering elements are arranged on the base and / or upper part.

[0052] In preferred embodiments, the dome element comprises at least one window allowing for inspection of the tissue surrounding the point of entry. This facilitates handling of the device as it is not necessary anymore to remove it or parts thereof to inspect said tissue.

[0053] The window may be an opening, however it is preferred if the at least one window is covered by a transparent material. This protects the underlying tissue from harmful influences, e. g. germs. Preferably, the transparent material filters out potentially harmful components of the light which is used to disinfect the tissue, e. g. UV components. Most preferably, the window is covered by a film made from a transparent material, in particular a breathable transparent material. Such films are available, e. g. from 3M (Tegaderm), Molnlycke (Mepitel) or Covidien (Kendall).

[0054] Instead or in addition to the window, a part or a section of the inventive device may be selectively movable in order to unblock the view onto the point of entry and the surrounding tissue. In a preferred embodiment, the dome element is adapted to be selectively attached to the upper element. In principle, this allows for selectively attaching a dome or do without, depending on the specific application. Furthermore, the dome element may be temporarily removed if the point of entry of the tubular element shall be inspected.

[0055] The dome element may be constituted in such a way that there is a distance between the dome attached to the upper element and the body surface. This avoids a mechanical interaction between the dome (which has a primary function of distributing the light in order to homogenously illuminate the tissue surrounding the point of entry) and the body surface. Furthermore, it improves breathability and avoids the accumulation of liquids within the dome as the distance allows for the liquids flowing out.

[0056] In other embodiments, the dome may be selectively attached to the base or built unitarily with the base or upper element.

[0057] In preferred embodiments, the at least one optical fiber (or at least one fiber of a multitude of fibers) is guided in the dome element. This enables a targeted distribution of the light energy to where it is needed. In a first group of those embodiments, the optical fiber is purely end emitting and the end face is arranged and directed in such a way that the emitted light falls onto the scattering surface of the dome. In a second group of those embodiments, the optical fiber is sideemitting and runs along the inner surface of the dome in a pattern that allows for the emission of light such that it illuminates the desired region of tissue directly and / or through scattering by respective surfaces. Suitable patterns are e. g. winding around the dome surface in a spiral -like manner.

[0058] In other preferred embodiments, the at least one optical fiber is guided in the upper element and / or in the base, whereas no optical fibers are guided in the dome element. This simplifies the construction, especially in cases where the dome element may be modularly and selectively fitted to the upper part. In such embodiments, the at least one optical fiber preferably includes an end emitting fiber, which ends at a surface of the upper element or base which is directed to an inner space defined by the dome element.

[0059] In further embodiments, the individual components (base, upper element and / or dome) comprise optical connectors that allow for the routing of light from one of the components to another. The connectors may comprise mirrors (e. g. made from polished aluminium) and / or other waveguides. Preferably, the respective connections are established as soon as the respective components are mechanically attached to one another.

[0060] In a preferred embodiment, the base has a central opening for surrounding the point of entry and the base has a lateral slit connecting the central opening to a circumference of the base. This allows for sliding the base over the tubular element even after the tubular element has been introduced into the human or animal body.

[0061] The upper part may as well have a lateral slit for sliding the upper part over the tubular element even after the tubular element has been introduced into the human or animal body, wherein the upper part is rotatable with regard to the base after attaching the upper part to the base in order to lock the tubular element in the upper part.

[0062] In this case, the upper part may be shaped in such a way that the tubular element is introduced into the upper part from top, running essentially perpendicular to the body surface, straight to the point of entry. Alternatively, the upper part features an inclined slit for introducing the tubular element. The inclined slit may have a bayonet-like geometry allowing for locking the fiber in an end position.

[0063] In a further preferred embodiment, the dome element is unitary with the base and the upper element is constituted by a window element, the window element including the film made from the transparent material. Accordingly, the upper element is of a very simple construction and may be easily attached to the base / dome, without having to care about guiding or attaching the tubular element or optical fiber(s).

[0064] The window element may include scattering surfaces. They may be arranged to complement the dome geometry of the base. In an embodiment, the scattering surface is basically ring shaped and surrounds the actual window, covered by the film.

[0065] Alternatively or in addition, the material of the transparent film may be chosen such that its inner surface facing the body surface scatters the illuminating light, adding to the distribution within the space defined by the dome and window element.

[0066] In preferred embodiments, the base is made from a first material and the upper part is made from a second material, wherein a Shore A hardness of the first material is lower than that of the second material. In particular, a difference of the Shore A hardnesses is at least 15. Therefore, the multi- part design of the inventive device allows for having a comparatively soft base which easily adapts to the body of the patient and avoids excessive pressure on the patient’s skin as well as irritation due to mechanical interaction. At the same time, the upper part may be mechanically stable and ensure reliable function of the device.

[0067] Furthermore, using components made from different hardness, embodiments mentioned above, where the base features a flexible guide channel and the upper part features a clamping section may be implemented easily.

[0068] As an example, the base may be made from a soft silicone rubber material with a hardness of about 30-40 Shore A, whereas the upper part is made from a harder material than that of the base, e. g. polyethylene (PE), polypropylene (PP) or a harder silicone, with a hardness of about 50-70 Shore A.

[0069] In certain embodiments, the base may be entirely made from a light-scattering material, whereas the upper part is made from a non-light scattering material. A scattering material is a material which has a bidirectional reflectance distribution function (BRDF) having non-zero values in a certain spatial angle about the geometric mirror ray of an incident light ray. In particular, the light scattering surface exhibits quasi -Lambertian reflectance, which maximises homogenization of the incident light.

[0070] In other embodiments, the upper part may be entirely made from a light-scattering material, whereas the base is made from a non-light scattering material.

[0071] In preferred embodiments, the guide for the tubular element is designed in such a way that light emitted by the at least one optical fiber accommodated in the guide disinfects a region of the tubular element in the vicinity of the point of entry together with the tissue surrounding the point of entry. This ensures disinfection not only of the tissue but also of the catheter or other tubular element and thus further reduces the infection risk. Disinfection of the tubular element may be ensured by various measures, such as selecting a location of a light emitting surface of the optical fiber(s), a main direction of the illuminating light, providing scattering and / or reflective surfaces directing the light to the surfaces to be disinfected, etc.

[0072] Other advantageous embodiments and combinations of features come out from the detailed description below and the entirety of the claims. Brief description of the drawings

[0073] The drawings used to explain the embodiments show:

[0074] Fig. 1A-D views of a first embodiment of a device according to the invention;

[0075] Fig. 2A-C views of a second embodiment;

[0076] Fig. 3A-C views of a third embodiment;

[0077] Fig. 4A-D views of a fourth embodiment;

[0078] Fig. 5A, B views of a fifth embodiment;

[0079] Fig. 6A-E views of a sixth embodiment;

[0080] Fig. 7A-C views of a seventh embodiment;

[0081] Fig. 8A-E views of an eighth embodiment;

[0082] Fig. 9A-C views of a ninth embodiment; and

[0083] Fig. 10A-E views of a tenth embodiment.

[0084] In the figures, the same components are given the same reference symbols.

[0085] Preferred embodiments

[0086] The Figures 1A-D are views of a first embodiment of a device according to the invention. Figure 1A shows an isometric view, Figure IB shows a top view, Figure 1C a bottom view and Figure ID a side view.

[0087] The adaptor 100 includes a base 120 and an upper part 140, which is removably attached to the base 120. The base 120 features an application part 121 to be applied to the skin surface 20 of a patient (cf. Fig. ID). The application part 121 has a horseshoe-shaped footprint with two legs 122a, 122b connected by a central part and has a flat lower surface that may be placed on the skin surface 20. The base 120 is made from a soft material, such as silicone, and is thus adaptable to the shape of the skin surface 20. The base 120 further features a guide channel 123 which elevates from the central part of the application part 121 and which includes a central part made up from two lateral elements enclosing the guide channel 123 and being provided at their outer surfaces by flaps 127a, 127b. In the extension of the guide channel 123 the two lateral elements form a bend 125. The guide channel 123 runs parallel to the lower surface of the application part 121, whereas the bend 125 is curved downwards, towards the application part 121.

[0088] A catheter 10 is accommodated in the guide channel 123 and the bend 125. It runs from a proximal side, where it is e. g. attached to the skin surface 20 at a location in a distance from the adaptor 100 through the guide channel 123 and the bend 125. After passing the bend 125, the main extension of the catheter 10 is pointing towards a point of entry in the skin surface 20. In the shown embodiment, the respective angle is about 45°.

[0089] The upper part 140 forms a horseshoe-shaped clamp 141 featuring two legs 142a, 142b. These legs 142a, 142b are accommodated between the flaps 127a, 127b of the guide channel 123 and the application part 121 of the base 120. The lower surface of the upper part 140 rests on the upper surface of the application part 121. The upper part 140 is unitarily made from a harder material than that of the base, e. g. polyethylene (PE), polypropylene (PP) or a harder silicone.

[0090] In the region of the guide channel 123, the base 120 is provided with four channels each accommodating an optical fiber 131.1, 131.2, 131.3, 131.4. They enter on the outer surface of the base 120, in a direction substantially parallel to the guide channel 123, and their locations are distributed around the guide channel 123. The fiber end faces 132.1, 132.2, 132.3, 132.4 are distributed in a manner around the distal end of the bend 125, such that a desired illumination pattern is obtained (cf. Fig. 1C).

[0091] In order to attach the adaptor 100 to the catheter 10, the catheter 10 is first attached to the base

[0092] 120 with the upper part 140 removed. For that purpose, the catheter 10 is introduced into the guide channel 123 from above, through a slit between the two lateral elements. Due to the soft material of the base 120 the two lateral parts will be easily deflected when the catheter 10 is inserted. As soon as the catheter is accommodated in the guide channel 123 and the bend 125, the upper part 140 may be inserted by sliding the two legs 142, 142b between the flaps 127a, 127b and the application part 121 along a sliding direction parallel to the lower surface of the application part

[0093] 121 resting on the skin surface 20 and running towards the proximal region of the catheter 10. The clamp 141 of the upper part 140 secures the catheter 10 in the guide channel 123. Together with the bend 125 movement of the catheter 10 relative to the adaptor is reliably prevented by friction forces. The adaptor 100 will be attached to the skin surface 20. This may be achieved with a suitable adhesive between the lower surface of the application part 121 and the skin surface 20. Alternatively or in addition, other means may be used such as stitching. After attaching the adaptor 100 to the catheter 10 as well as to the skin surface 20, the adaptor 100 will usually be covered by a transparent adhesive fdm made from a breathable material . Such fdms are commonly used in the hospital environment and are commercially available, e. g. from 3M (Tegaderm), Molnlycke (Mepitel) or Covidien (Kendall).

[0094] Light may be coupled into the optical fibers 131.1...4. It will exit the fibers at their distal fiber end faces 132. 1 ...4 and illuminate the skin surface 20 around the point of entry. Due to the even distribution around the catheter 10, shading is avoided and a homogenous illumination is achieved. The point of entry and the surrounding skin surface 20 may be inspected without removing the adaptor 100 thanks to the window which is formed between the legs 122a, 122b of the base 120 and by the central opening of the horseshoe-shaped upper part 140.

[0095] The Figures 2A-C are views of a second embodiment of a device according to the invention. Figure 2A shows an isometric view, Figure 2B shows a front view, as seen from an entry point side of the device, and Figure 2C shows a back view, as seen from a catheter and fiber supply side of the device.

[0096] The adaptor 200 includes a base 220 and an upper part 240, which is removably attached to the base 220. The base 220 features an application part 221 to be applied to the skin surface of a patient. The application part 221 has a rectangular footprint with two lateral protrusions. It has a flat lower surface that may be placed on the skin surface. The base 220 is made from a soft material, such as silicone, and is thus adaptable to the shape of the skin surface. The base 220 further features a guide channel 223 which elevates from the central part of the application part 221 and which includes a central part made up from two lateral elements enclosing the guide channel 223 and being provided at their outer surfaces by flaps 227a, 227b. In the extension of the guide channel 223 the two lateral elements form a bend 225. The guide channel 223 runs parallel to the lower surface of the application part 221, whereas the bend 225 is curved downwards, towards the application part 221.

[0097] A catheter 10 is accommodated in the guide channel 223 and the bend 225. It runs from a proximal side, where it is e. g. attached to the skin surface at a location in a distance from the adaptor 200 through the guide channel 223 and the bend 225. After passing the bend 225, the main extension of the catheter 10 is pointing towards a point of entry in the skin surface. In the shown embodiment, the respective angle is about 45°.

[0098] The upper part 240 has a butterfly-shaped footprint, matching the footprint of the application part 221 of the base 220. It features two lateral sections 243a, 243b. Both the lateral sections 243a, 243b as well as the application part 221 are provided with through holes, the position of the respective through holes matching when the adaptor 200 is in its assembled state. The upper part 240 forms a clamp 241 which may be accommodated between the flaps 227a, 227b of the guide channel 223 and the application part 221 of the base 220. The lower surface of the upper part 240 rests on the upper surface of the application part 221. The upper part 240 is unitarily made from a harder material than that of the base, e. g. polyethylene (PE), polypropylene (PP) or a harder silicone.

[0099] In the region of the guide channel 223, the base 220 is provided with four channels, each accommodating an optical fiber 231.1, 231.2, 231.3, 231.4. They enter on the outer surface of the base 220, in a direction substantially parallel to the guide channel 223, and their locations are distributed in a region below the guide channel 223. The fiber end faces 232.1, 232.2, 232.3, 232.4 are evenly distributed around the distal end of the bend 225 (cf. Fig. 2B).

[0100] In order to attach the adaptor 200 to the catheter 10, the catheter 10 is first attached to the base 220 with the upper part 240 removed. For that purpose, the catheter 10 is introduced into the guide channel 223 from above, through a slit between the two lateral elements. Due to the soft material of the base 220 the two lateral parts will be easily deflected when the catheter 10 is inserted. As soon as the catheter is accommodated in the guide channel 223 and the bend 225, the upper part 240 may be inserted by sliding the clamp 241 between the flaps 227a, 227b and the application part 221 along a sliding direction parallel to the lower surface of the application part 221 resting on the skin surface and running towards the distal region of the catheter 10. The clamp 241 of the upper part 240 secures the catheter 10 in the guide channel 223. Together with the bend 225 movement of the catheter 10 relative to the adaptor is reliably prevented by friction forces.

[0101] The adaptor 200 may be attached to the skin surface in particular by stitching, wherein the yam may ran through the matching through holes in the base 220 and upper part 240. Alternatively or in addition, other means may be used such as a suitable adhesive. After ataching the adaptor 200 to the catheter 10 as well as to the skin surface, the adaptor 200 will usually be covered by a transparent adhesive film made from a breathable material. Such films are commonly used in the hospital environment and are commercially available, e. g. from 3M (Tegaderm), Molnlycke (Mepitel) or Covidien (Kendall).

[0102] Light may be coupled into the optical fibers 231.1...4. It will exit the fibers at their distal fiber end faces 232. 1 ...4 and illuminate the skin surface 20 around the point of entry. Due to the even distribution around the catheter 10, shading is avoided and a homogenous illumination is achieved. The point of entry and the surrounding skin surface may be inspected without removing the adaptor 200 as the point of entry is located outside of the footprint of the adaptor 200.

[0103] The Figures 3A-C are views of a third embodiment of a device according to the invention. Figure 3A shows an isometric view, Figure 3B shows a front view, as seen from an entry point side of the device, and Figure 3C shows a back view, as seen from a catheter and fiber supply side of the device.

[0104] The adaptor 300 includes a base 320 and an upper part 340, which is removably attached to the base 320. The base 320 features an application part 321 to be applied to the skin surface of a patient. The application part 321 has a rectangular footprint with rounded comers. It has a flat lower surface that may be placed on the skin surface. The base 320 is made from a soft material, such as silicone, and is thus adaptable to the shape of the skin surface. The base 320 further features a guide channel 323 which elevates from the central part of the application part 321 and which includes a central part made up from two lateral elements enclosing the guide channel 323 and being provided at their outer surfaces by flaps 327a, 327b. In the extension of the guide channel 323 the two lateral elements form a bend 325. The guide channel 323 runs parallel to the lower surface of the application part 321, whereas the bend 325 is curved downwards, towards the application part 321.

[0105] A catheter 10 is accommodated in the guide channel 323 and the bend 325. It runs from a proximal side, where it is e. g. atached to the skin surface at a location in a distance from the adaptor 300 through the guide channel 323 and the bend 325. After passing the bend 325, the main extension of the catheter 10 is pointing towards a point of entry in the skin surface. In the shown embodiment, the respective angle is about 45°. The upper part 340 has essentially the same footprint as the base 320. It features two lateral sections 343a, 343b linked by an arch 345. Both the lateral sections 343a, 343b as well as the application part 321 are provided with through holes, the position of the respective through holes matching when the adaptor 300 is in its assembled state. The upper part 340 forms two clamp sections 341a, 341b which may be accommodated between the flaps 327a, 327b of the guide channel 323 and the application part 321 of the base 320. The lower surface of the upper part 340 rests on the upper surface of the application part 321. The upper part 340 is unitarily made from a harder material than that of the base, e. g. polyethylene (PE), polypropylene (PP) or a harder silicone.

[0106] In the region of the guide channel 323, the base 320 is provided with four channels each accommodating an optical fiber 331.1, 331.2, 331.3, 331.4. They enter on the outer surface of the base 320, in a direction substantially parallel to the guide channel 323, and their locations are in an upper region neighboring the guide channel 323. Arranging the optical fibers 331.1...4 like this, which is enabled by the arch 345, reduces the risk of bending or damaging them compared to the arrangement according to the second embodiment. The fiber end faces 332.1, 332.2, 332.3, 332.4 are evenly distributed around the distal end of the bend 325 (cf. Fig. 3B).

[0107] In order to attach the adaptor 300 to the catheter 10, the catheter 10 is first attached to the base 320 with the upper part 340 removed. For that purpose, the catheter 10 is introduced into the guide channel 323 from above, through a slit between the two lateral elements. Due to the soft material of the base 320 the two lateral parts will be easily deflected when the catheter 10 is inserted. As soon as the catheter is accommodated in the guide channel 323 and the bend 325, the upper part 340 may be inserted by sliding the clamp 341 between the flaps 327a, 327b and the application part 321 along a sliding direction parallel to the lower surface of the application part 321 resting on the skin surface and running towards the distal region of the catheter 10. The clamp 341 of the upper part 340 secures the catheter 10 in the guide channel 323. Together with the bend 325 movement of the catheter 10 relative to the adaptor is reliably prevented by friction forces.

[0108] The adaptor 300 may be attached to the skin surface in particular by stitching, wherein the yam may ran through the matching through holes in the base 320 and upper part 340. Alternatively or in addition, other means may be used such as a suitable adhesive.

[0109] After attaching the adaptor 300 to the catheter 10 as well as to the skin surface, the adaptor 300 will usually be covered by a transparent adhesive film made from a breathable material. Such films are commonly used in the hospital environment and are commercially available, e. g. from 3M (Tegaderm), Molnlycke (Mepitel) or Covidien (Kendall).

[0110] Light may be coupled into the optical fibers 331.1...4. It will exit the fibers at their distal fiber end faces 332. 1 ...4 and illuminate the skin surface 20 around the point of entry. Due to the even distribution around the catheter 10, shading is avoided and a homogenous illumination is achieved. The point of entry and the surrounding skin surface may be inspected without removing the adaptor 300 as the point of entry is located outside of the footprint of the adaptor 300.

[0111] The Figures 4A-D are views of a fourth embodiment of a device according to the invention. Figure 4A shows an isometric view of the base, Figure 4B shows an isometric view of the base with attached upper part, Figure 4C is an isometric view of the complete device, including the dome, and Figure 4D a side view of the complete device.

[0112] The adaptor 400 includes a base 420 and an upper part 440, which is removably attached to the base 420. The base 420 features an application part 421 to be applied to the skin surface of a patient. The application part 421 features a central rectangular section and two legs 422a, 422b laterally extending from the central section. The application part 421 has a flat lower surface that may be placed on the skin surface. The base 420 is made from a soft material, such as silicone, and is thus adaptable to the shape of the skin surface . The base 420 further features a guide channel 423 which elevates from the central section of the application part 421 and which includes two lateral elements enclosing the guide channel 423. The guide channel 423 runs parallel to the lower surface of the application part 421.

[0113] A catheter 10 is accommodated in the guide channel 423. It runs from a proximal side, where it is e. g. attached to the skin surface at a location in a distance from the adaptor 400 through the guide channel 423 and further in a curved section towards a point of entry in the skin surface.

[0114] The upper part 440 has essentially the same footprint as the base 420. It features a central part which is adapted to be clipped onto the guide channel 423 of the base 420 and two lateral sections 443a, 443b matching the geometry of the legs 422a, 422b of the base 420. Both the lateral sections 443a, 443b as well as the legs 422a, 422b of the base 420 are provided with through holes, the position of the respective through holes matching when the adaptor 400 is in its assembled state. The central part of the upper part 440 features two longitudinal ribs 446a, 446b on both its lateral sides. The lower surface of the upper part 440 rests on the upper surface of the application part 421. The upper part 440 is unitarily made from a harder material than that of the base, e. g. polyethylene (PE), polypropylene (PP) or a harder silicone, which is still sufficiently flexible to allow for the clicking attachment to the base 420.

[0115] The adaptor 400 further comprises a dome element 460 featuring a base body 461 and a dome 463. On its bottom side, the base body 461 features indentations that are adapted to the geometry of the longitudinal ribs 446a, 446b of the upper part 440 and which allow for clipping the dome element 460 onto the upper part 440. The dome 463 defines a dome-shaped inner volume arranged such that it is centered about the point of entry of the catheter 10 into the skin surface. On its inner surface, the dome 463 is provided with a light-scattering material, namely a cover layer of polytetrafluorethylene (PTFE). Furthermore, in a central top region the dome 463 features a substantially circular window 465.

[0116] An optical fiber 431 is accommodated by the base body 461 of the dome element 460. Its distal end leads into the volume defined by the dome 463. Light emitted by the distal end is directed to the light-scattering inner surface of the dome and distributed in the volume, leading to a substantially homogenous illumination of the skin surface surrounding the point of entry. The dome 463 is elevated from the skin surface, thus avoiding mechanical contact. The lower edge of the dome 463 is rounded to avoid irritations or injuries when it temporarily comes into contact with the patient’s skin surface, e. g. due to movements of the patient.

[0117] In order to attach the adaptor 400 to the catheter 10, the catheter 10 is first attached to the base 420 with the upper part 440 and dome element 460 removed. For that purpose, the catheter 10 is introduced into the guide channel 423 from above, through a slit between the two lateral elements. Due to the soft material of the base 420 the two lateral parts will be easily deflected when the catheter 10 is inserted. As soon as the catheter is accommodated in the guide channel 423, the upper part 440 may be clipped onto the base 420 from above. The inner lateral surfaces of the upper part 440 press against the lateral elements of the guide channel 423 and thus secure the catheter 10 in the guide channel 423 with a friction fit. Finally, the dome element 460 is clipped onto the upper part 440.

[0118] The adaptor 400 may be attached to the skin surface in particular by stitching, wherein the yam may ran through the matching through holes in the base 420 and upper part 440. Alternatively or in addition, other means may be used such as a suitable adhesive. After ataching the adaptor 400 to the catheter 10 as well as to the skin surface, the adaptor 400 will usually be covered by a transparent adhesive film made from a breathable material. Such films are commonly used in the hospital environment and are commercially available, e. g. from 3M (Tegaderm), Molnlycke (Mepitel) or Covidien (Kendall).

[0119] Light may be coupled into the optical fiber 431. It will exit the fiber at its distal fiber end face and illuminate the skin surface 20 around the point of entry. Due to the even distribution obtained by the scatering surface inside the dome 463, shading is avoided and a homogenous illumination is achieved. The point of entry and the surrounding skin surface may be inspected without removing the adaptor 400 thanks to the window 465 in the dome 463.

[0120] In a variant of the fourth embodiment, the optical fiber features a side emiting end section which is coiled around the dome, on the dome’s inner surface, allowing for the distributed emission of light inside the dome.

[0121] The Figures 5A-B are views of a fifth embodiment of a device according to the invention. Figure 5 A is an isometric view and Figure 5B is a side view of the device. The fifth embodiment corresponds widely to the fourth embodiment described above, in connection with Figures 4A-D. It includes the same base 420 and upper part 440, cf. the description above related to Figures 4A, 4B. As well, the assembly and function of the device is the same as that of the fourth embodiment.

[0122] The dome element 560 slightly differs from the dome element 460 of the fourth embodiment. The dome element 560 features a base body 561 and a dome 563. On its botom side, the base body 561 features indentations that are adapted to the geometry of the longitudinal ribs 446a, 446b of the upper part 440 (see Fig. 4B) and which allow for clipping the dome element 560 onto the upper part 440. The dome 563 defines a dome-shaped inner volume arranged such that it is centered about the point of entry of the catheter 10 into the skin surface. On its inner surface, the dome 563 is provided with a light-scatering material, namely a cover layer of PTFE. Furthermore, the dome 463 features two kidney-shaped windows 565a, 565b arranged symmetrically about the longitudinal axis of the dome element 560.

[0123] An optical fiber 531 is accommodated by the base body 561 of the dome element 560. Its distal end leads into the volume defined by the dome 563. Light emited by the distal end is directed to the light-scatering inner surface of the dome and distributed in the volume, leading to a substantially homogenous illumination of the skin surface surrounding the point of entry. The dome 563 is elevated from the skin surface, thus avoiding mechanical contact. Again, in a variant of the fifth embodiment, the optical fiber features a side emitting end section which is coiled around the dome, on the dome inner surface, allowing for the distributed emission of light inside the dome.

[0124] The Figures 6A-E are views of a sixth embodiment of a device according to the invention. Figure 6A shows an isometric view of the base, Figure 6B shows an isometric view of the base with attached upper part, Figure 6C shows in isometric view including an attachable dome element, and Figure 6D is a side view of the device with the dome element. Figure 6E shows an isometric view of the adaptor together with the supplying fibers and the catheter.

[0125] The adaptor 600 includes a base 620 and an upper part 640, which is removably attached to the base 620. The base 620 features an application part 621 to be applied to the skin surface of a patient. The base 620 is wing-shaped and features a central elevated part as well as two lateral legs 622a, 622b. The legs 622a, 622b of the base 620 are provided with through holes. The application part 621 is constituted by a flat lower surface that may be placed on the skin surface. The base 620 is made from a soft material, such as silicone, and is thus adaptable to the shape of the skin surface.

[0126] The base 620 further features a guide channel 623 which is formed as an open channel in the central elevated part running parallel to the lower surface of the application part 621. The crosssection of the channel is semi-circular. On both sides of the guide channel 623, a hook 629a, 629b is arranged, extending in a vertical direction and featuring a protrusion facing outward. A bend 625 connects to the distal end of the guide channel 623.

[0127] The upper part 640 has an essentially rectangular footprint. It features a central part which features two openings 644a, 644b which may accommodate the hooks 629a, 629b of the base 620 and thus allow for clipping the upper part 640 onto the base 620. The upper part further features two lateral sections 643a, 643b. By lifting these sections, the clip connection may be easily unlocked, allowing for easy removal of the upper part 640 from the base 620 if needed. Further, the upper part 640 features a bend 647 arranged in the longitudinal extension of the central part. On the inside, the upper part 640 features a guide channel with a semi-circular cross-section. In the assembled state, the course of this guide channel, running in the central part as well as the bend 647, matches the course of the guide channel 623 in the base 620. The upper part 640 is unitarily made from a harder material than that of the base, e. g. polyethylene (PE), polypropylene (PP) or a harder silicone.

[0128] A catheter 10 is accommodated in the guide channel 623 constituted by the base 620 and upper part 640. It runs from a proximal side, where it is e. g. attached to the skin surface at a location in a distance from the adaptor 600 through the guide channel 623 and further through the bend 625 towards a point of entry in the skin surface. After passing the bend 625, the main extension of the catheter 10 is pointing towards a point of entry in the skin surface. In the shown embodiment, the respective angle is about 45°.

[0129] The adaptor 600 further comprises a dome element 660 featuring a dome 663. On its bottom side, the dome element 660 features indentations that are adapted to the geometry of the upper part 640 and which allow for clipping the dome element 660 onto the upper part 640. The dome 663 defines a dome-shaped inner volume arranged such that it is centered about the point of entry of the catheter 10 into the skin surface. On its inner surface, the dome 663 is provided with a lightscattering material, namely a cover layer of PTFE. Furthermore, the dome 663 features two kidney-shaped windows 665a, 665b arranged symmetrically about the longitudinal axis of the dome element 660. The dome 663 is elevated from the skin surface, thus avoiding mechanical contact.

[0130] The adaptor 600 is supplied by a fiber bundle 631, which is connected to a light source using a connector 635 (cf. Fig. 6E). In a proximal portion, the four fibers 631.1...4 of the fiber bundle 631 run parallel. Close to the adaptor 600, the fibers 631.1...4 branch. Downstream of the branching location, two optical fibers 631.2, 631.3 are accommodated by the base 620, and two further optical fibers 631. 1, 631.4 are accommodated by the upper part 640. All the optical fibers 631.1...4 run substantially parallel to the catheter 10. The fiber end faces are evenly distributed around the distal end of the bend 625, 647. The end tips 646a, 646b of the upper two fibers end on the upper surface of the bend 647. Light emitted by the end faces is directed to the surface to be illuminated and / or the light-scattering inner surface of the dome and thus distributed in the volume, leading to a substantially homogenous illumination of the skin surface surrounding the point of entry. In a preferred variant, the two upper optical fibers 631.1, 631.4 have a larger crosssection than the two lower optical fibers 631.2, 631.3. Their ends are directed to the scattering inner surface of the dome 663. In contrast, the ends of the two lower optical fibers 631.2, 631.3 are directed to the skin surface for direct illumination thereof. In order to attach the adaptor 600 to the catheter 10, the catheter 10 is first inserted into the base 620 with the upper part 640 and dome element 660 removed. The catheter may be easily inserted into the semi-circular guide channel 623 from above; no sliding movement in the direction of the catheter is required. As soon as the catheter is accommodated in the guide channel 623, the upper part 640 may be clipped onto the base 620 from above. Thereby, the guide channel is completed and the catheter is held by friction fit, which is increased due to the bend. Finally, the dome element 660 is clipped onto the bend 647 of the upper part 640.

[0131] The adaptor 600 may be attached to the skin surface in particular by stitching, wherein the yam may ran through the through holes in the base 620. Alternatively or in addition, other means may be used such as a suitable adhesive.

[0132] After attaching the adaptor 600 to the catheter 10 as well as to the skin surface, the adaptor 600 will usually be covered by a transparent adhesive film made from a breathable material. Such films are commonly used in the hospital environment and are commercially available, e. g. from 3M (Tegaderm), Molnlycke (Mepitel) or Covidien (Kendall).

[0133] Light may be coupled into the optical fibers 631.1 ...4. It will exit the fiber at its distal fiber end face and illuminate the skin surface 20 around the point of entry. Due to the even distribution obtained by the scattering surface inside the dome 663, shading is avoided and a homogenous illumination is achieved. The point of entry and the surrounding skin surface may be inspected without removing the adaptor 600 thanks to the windows 665a, 665b in the dome 663.

[0134] In a variant of the sixth embodiment, the optical fiber features a side emitting end section which is coiled around the dome, on the dome inner surface, allowing for the distributed emission of light inside the dome.

[0135] In another variant of the sixth embodiment, the dome is not used and the four optical fibers are used for direct illumination. In principle, the dome may be used or non-used on a case-by-case basis as the optical fibers are completely independent from the dome element. Similarly, the dome element may be easily removed for cleaning and replaced by a new one if needed.

[0136] The Figures 7A-C are views of a seventh embodiment of a device according to the invention. Figure 7A shows an isometric view of the device from above, Figure 7B shows a side view and Figure 7C shows an isometric view from below. The adaptor 700 includes a base 720 and an upper part 740, which is removably attached to the base 720. The base 720 is constituted by a ring-shaped application part 721 to be applied to the skin surface of a patient with its lower surface. In an outer ring, the base 720 has a constant first thickness, in an inner ring, surrounding a central circular opening 724, the thickness is reduced on the upper surface, creating an accommodation for the upper part 740. A radial slit 726 runs through the outer ring. The base 720 is made from a soft material, such as silicone, and is thus adaptable to the shape of the skin surface.

[0137] The upper part 740 has the shape of a flared truncated cone. The larger end face is accommodated in the inner ring of the base 720. Furthermore, one the side of the larger end face, a dome-shaped cavity 748 is arranged. The inner surface of the cavity 748 is provided with a light-scattering material, namely a cover layer of PTFE. An axial opening 743 runs through the upper part 740, connecting its smaller end face with the center of the cavity 748. The upper part 740 further comprises a radial slit 749 connecting the outer surface of the upper part 740 with the axial opening 743 and the cavity 748 respectively. The upper part 740 is unitarily made from a harder material than that of the base, e. g. polyethylene (PE), polypropylene (PP) or a harder silicone.

[0138] A catheter 10 is accommodated in the opening 743 of the upper part. It runs from the smaller end face through the opening 743 and the cavity 748 towards a point of entry in the skin surface.

[0139] Four optical fibers 731.1, 731.2, 731.3, 731.4 are accommodated by the upper part 740, running substantially parallel to the catheter 10. The fiber end faces are evenly distributed around the catheter 10, in an upper wall of the cavity 748. Light emitted by the end faces is directed to the surface to be illuminated and / or the light-scattering inner surface of the cavity 748 and thus distributed in the volume, leading to a substantially homogenous illumination of the skin surface surrounding the point of entry.

[0140] In order to attach the adaptor 700 to the catheter 10, the catheter 10 is first inserted into the base 720 using slit 726. Next, the upper part 740 is slid over the catheter 10 using its slit 749. The upper part 740 may be moved along the catheter 10 until the larger end face rests on the base 720. Next, the upper part 740 is rotated about its longitudinal axis in order to separate its slit 749 from the slit 726 in the base 720. This secures the catheter 10 from slipping out.

[0141] The adaptor 700 may be attached to the skin surface in particular by a suitable adhesive between the lower surface of the application part 721 and the skin surface. After attaching the adaptor 700 to the catheter 10 as well as to the skin surface, the adaptor 700 will usually be covered by a transparent adhesive fdm made from a breathable material. Such films are commonly used in the hospital environment and are commercially available, e. g. from 3M (Tegaderm), Molnlycke (Mepitel) or Covidien (Kendall). In particular, the adaptor 700 is sandwiched between two parts of the film.

[0142] Light may be coupled into the optical fibers 731.1 ...4. It will exit the fiber at its distal fiber end face and illuminate the skin surface around the point of entry. Due to the even distribution obtained by the scattering surface inside the cavity 748, shading is avoided and a homogenous illumination is achieved.

[0143] The device according to the seventh embodiment is particularly suitable to be applied on a catheter that is attached to the human body by the so-called “finger trap” technique, where the catheter is attached to the leather skin via a single stitch at the puncture site, and the two ends of the suture are wrapped around the catheter like a finger trap. The ends of the suture are tied together at the segmentation site of the lumens. In these cases, the device is placed around the catheter after catheter insertion and sewing.

[0144] The Figures 8A-E are views of an eighth embodiment of a device according to the invention. Figure 8A shows an isometric view of the device prior to attaching the window element. Figure 8B is an isometric view of the device with attached window element. Figure 8C is a top view, Figure 8D is a front view, as seen from an entry point side of the device, and Figure 8E shows a back view, as seen from a catheter and fiber supply side of the device.

[0145] The adaptor 800 includes a base 820 and an upper part 840, which is removably attached to the base 820. The base 820 is constituted by a ring-shaped application part 821 to be applied to the skin surface of a patient with its lower surface. In an outer ring, the base 820 has a constant first thickness, in an inner ring, surrounding a central circular opening 824, the base 820 forms a dome 828, i. e. an elevated section defining a dome-shaped cavity. The inner surface of the dome 828 is provided with a light-scattering material, namely a cover layer of PTFE. A radial slit 826 runs through the application part 821 as well as the dome 828. The base 820 is made from a soft material, such as silicone, and is thus adaptable to the shape of the skin surface.

[0146] The upper part 840 is essentially disk-like, having a circular footprint and a radial slit 849. The upper part 840 may feature a window covered by a transparent material. An optical fiber 831 leads into the base 820 and branches into four fiber branches 833a, 833b, 833c, 833d. From the channel leading into the dome 828, two of the branches 833a, 833b run to the left, whereas two of the branches 833c, 833d lead to the right. Two branches 833b, 833d, each on one side, end in the vicinity of the channel, whereas two branches 833a, 833d, each on one side, end in regions neighboring the slit 826 in the base 820. Light emitted by the end faces is directed to the surface to be illuminated and / or the light-scattering inner surface of the dome 828 and thus distributed in the volume, leading to a substantially homogenous illumination of the skin surface surrounding the point of entry.

[0147] The upper part 840 may feature further scattering surfaces, improving the distribution of the light within the dome 828

[0148] The adaptor 800 is attached to the catheter after implanting the catheter to the human body, e. g. with the “finger trap” technique mentioned above. The base 820 is slid over the catheter 10 using the slit 826 and attached to the skin, e. g. using a suitable adhesive. Next, the upper part 840 is attached to the base 820. For this purpose, the upper part 840 is provided with a suitable adhesive on its lower surface. The catheter 10 runs through the slit 849 of the upper part 840.

[0149] After attaching the adaptor 800 to the catheter 10 as well as to the skin surface, the adaptor 800 will usually be covered by a transparent adhesive film made from a breathable material. Such films are commonly used in the hospital environment and are commercially available, e. g. from 3M (Tegaderm), Molnlycke (Mepitel) or Covidien (Kendall).

[0150] The Figures 9A-C are views of a ninth embodiment of a device according to the invention. Figure 9A shows an isometric view of the base and the upper part prior to mutual attachment, Figure 9B shows an isometric view of the base with attached upper part, Figure 9C is a front view of the complete device.

[0151] The adaptor 900 includes a base 920 and an upper part 940, which is removably attached to the base 920. The base 920 features an application part 921 to be applied to the skin surface of a patient. The application part 921 has a generally triangular footprint. The application part 921 has a flat lower surface that may be placed on the skin surface. The base 920 is made from a soft material, such as silicone, and is thus adaptable to the shape of the skin surface. Through holes 922a, 922b, 922c are provided in the application part 921 close to the three comers. The base 920 further features an elevated central part 924 with a generally circular shape and a guide channel 923 which runs from the circular part to one of the edges of the base 920, parallel to the lower surface of the application part 921. The sides of the central part 924 running essentially parallel to the guide channel 923 are flattened and constitute a guide for the upper part 940.

[0152] A catheter may be accommodated in the guide channel 923. It runs from a proximal side, where it is e. g. attached to the skin surface at a location in a distance from the adaptor 900 through the guide channel 923 and further in a curved section towards a point of entry in the skin surface.

[0153] The upper part 940 may be attached to the base 920 by a sliding movement parallel to the guide channel 923. The upper part 940 has a smaller footprint than the base 920, such that the through holes 922a... c remain accessible even after attaching the upper part 940 to the base 920. The upper part 940 has a basically rectangular outer shape with several indentations to improve inter aha the gripping of the upper part 940 when handling it. The inner shape is generally circular with straight lateral sections, matching the geometry of the central part 924 of the base 920. The upper surface of the upper part 940 features a circular window 951 matching the size and position of the inner edge of the circular section of the central part 924 in the base 920. The upper part 940 is unitarily made from a harder material than that of the base, e. g. polyethylene (PE), polypropylene (PP) or a harder silicone.

[0154] An optical fiber 931 is accommodated by the upper part 940. Its distal end leads into the volume defined by the circular part of the central part 924 of the base 920 and the upper part 940. Light emitted by the distal end is directed inter alia to light-scattering inner surfaces of the central part 924 of the base 920 and the upper part 940 and distributed in the volume, leading to a substantially homogenous illumination of the skin surface surrounding the point of entry.

[0155] In order to attach the adaptor 900 to the catheter, the guide channel 923 of the base 920 is slid over the catheter from above. Next, the base 920 may be attached to the skin surface, e. g. by stitching, using the through holes 922a. . .c. Alternatively or in addition, other means may be used such as a suitable adhesive.

[0156] Next, the upper part 940 is slid over the central part 924 of the base 920. An inner geometry of the upper part 940 matches the outer geometry of the guide channel 923 and thus secure the catheter in the guide channel 923 with a friction fit when the upper part 940 is attached to the base 920.

[0157] After attaching the adaptor 900 to the catheter as well as to the skin surface, the adaptor 900 will usually be covered by a transparent adhesive film made from a breathable material. Such films are commonly used in the hospital environment and are commercially available, e. g. from 3M (Tegaderm), Molnlycke (Mepitel) or Covidien (Kendall).

[0158] Light may be coupled into the optical fiber 931. It will exit the fiber at its distal fiber end face and illuminate the skin surface around the point of entry. Due to the even distribution obtained by the scattering surface shading is avoided and a homogenous illumination is achieved. The point of entry and the surrounding skin surface may be inspected without removing the adaptor 900 thanks to the window 951 in the upper part 940.

[0159] The Figures 10A-E are views of a tenth embodiment of a device according to the invention. Figure 10A shows an isometric view, Figure 10B shows a back view of the base only, Figure 10C a bottom view and Figure 10D a side view. Figure 10E is an isometric view of the light guides within the adaptor.

[0160] The construction and functionality of the adaptor 1000 is very similar to the adaptor of the first embodiment. The main difference relates to the light distribution. The adaptor 1000 includes a base 1020 and an upper part 1040, which is removably attached to the base 1020. The base 1020 features an application part 1021 to be applied to the skin surface of a patient. The application part 1021 has a horseshoe-shaped footprint with two legs 1022a, 1022b connected by a central part and has a flat lower surface that may be placed on the skin surface. The base 1020 is made from a soft material, such as silicone, and is thus adaptable to the shape of the skin surface. The base 1020 further features a guide channel 1023 which elevates from the central part of the application part 1021 and which includes a central part made up from two lateral elements enclosing the guide channel 1023 and being provided at their outer surfaces by flaps 1027a, 1027b. In the extension of the guide channel 1023 the two lateral elements form a bend 1025. The guide channel 1023 runs parallel to the lower surface of the application part 1021, whereas the bend 1025 is curved downwards, towards the application part 1021.

[0161] A catheter may be accommodated in the guide channel 1023 and the bend 1025. It runs from a proximal side, where it is e. g. attached to the skin surface at a location in a distance from the adaptor 1000 through the guide channel 1023 and the bend 1025. After passing the bend 1025, the main extension of the catheter is pointing towards a point of entry in the skin surface. In the shown embodiment, the respective angle is about 45°.

[0162] The upper part 1040 forms a horse shoe -shaped clamp 1041 featuring two legs 1042a, 1042b. These legs 1042a, 1042b are accommodated between the flaps 1027a, 1027b of the guide channel 1023 and the application part 1021 of the base 1020. The lower surface of the upper part 1040 rests on the upper surface of the application part 1021. The horse shoe -shaped clamp 1041 surrounds a dome-shaped cavity with a roughly hemispherical inner shape. The inner surface of the cavity is coated with a light-scattering material, e. g. PTFE. The cavity further features a window 1051. The upper part 1040 is unitarily made from a harder material than that of the base, e. g. polyethylene (PE), polypropylene (PP) or a harder silicone.

[0163] The light distribution system of the adaptor 1000 is accommodated in the base 1020. It includes a supplying fiber bundle 1031 entering the base 1020, which branches into six individual fibers 1031.1... 6 inside the base. Two top fibers 1031.1, 1031.2 end in a top section of the bend 1025. Their ends are directed upwards, their central illumination axes pointing to the scattering surface inside the cavity. Two middle fibers 1031.3, 1031.4 end in small hemispherical cavities on side surfaces of the bend 1025. Their illumination axes are pointing in a direction which is basically parallel to the lower surface of the application part 1021 and parallel to the middle plane of the adaptor 1000 defined by the path of the catheter. Their light is distributed by the respective cavity, which is again coated with a light-scattering material such as PTFE. The bottom fibers 1031.5, 1031.6 end in a region below the bend 1025, in further cavities, and are pointing slightly upwards. Their light is scattered inside the cavities to illuminate primarily the region below the catheter which may be partly shaded from the light distributed by the scattering surface in the cavity.

[0164] In order to attach the adaptor 1000 to the catheter, the catheter is first attached to the base 1020 with the upper part 1040 removed. For that purpose, the catheter is introduced into the guide channel 1023 from above, through a slit between the two lateral elements. Due to the soft material of the base 1020 the two lateral parts will be easily deflected when the catheter is inserted. As soon as the catheter is accommodated in the guide channel 1023 and the bend 1025, the upper part 1040 may be inserted by sliding the two legs 1042a, 1042b between the flaps 1027a, 1027b and the application part 1021 along a sliding direction parallel to the lower surface of the application part 1021 resting on the skin surface and running towards the proximal region of the catheter. The clamp 1041 of the upper part 1040 secures the catheter in the guide channel 1023. Together with the bend 1025 movement of the catheter relative to the adaptor is reliably prevented by friction forces.

[0165] The adaptor 1000 will be attached to the skin surface. This may be achieved with a suitable adhesive between the lower surface of the application part 1021 and the skin surface. Alternatively or in addition, other means may be used such as stitching. After attaching the adaptor 100 to the catheter as well as to the skin surface, the adaptor 100 will usually be covered by a transparent adhesive film made from a breathable material. Such films are commonly used in the hospital environment and are commercially available, e. g. from 3M (Tegaderm), Molnlycke (Mepitel) or Covidien (Kendall).

[0166] Light is coupled into the optical fibers 1031.1 ... 6 of the fiber bundle 1031. It will exit the fibers at their distal fiber end faces 1032.1 ... 6 and illuminate the entire skin surface around the point of entry. The point of entry and the surrounding skin surface may be inspected without removing the adaptor 1000 thanks to the window 1051 in the upper part. The invention is not restricted to the described embodiments. In particular, elements of one of the embodiments may be combined with those of another of the embodiments. Furthermore, the geometry of the individual elements may be chosen differently. Various other options for guiding the optical fiber or a fiber bundle exist. End-emitting fibers may be combined with side-emitting fibers within the same device. Furthermore, the emission geometry of the individual fibers may be chosen differently, and further optical elements to scatter, reflect or distribute the light after emission from the fiber may be used.

[0167] In summary, it is to be noted that the invention provides a device for guiding a tubular element in a vicinity of a point of entry into a human or animal body and for disinfecting tissue surrounding the point of entry that allows for reliable disinfection of the tissue surrounding the point of entry of a tubular element to the human or animal body and that is easy and safe to use.

Claims

Claims1. A device for guiding a tubular element in a vicinity of a point of entry into a human or animal body and for disinfecting tissue surrounding the point of entry by the application of light, the device comprising: a) a base adapted to be attached to the human or animal body in the vicinity of the point of entry; b) an upper part adapted to be removably attached to the base; wherein c) the base and / or the upper part form a guide for the tubular element; d) the base and / or the upper part guide at least one optical fiber along the guide for the tubular element, the optical fiber having at least one emission surface for emitting light to illuminate the tissue surrounding the point of entry when the base is attached to the body; and e) the upper part is adapted to be attached to and removed from the base after the tubular element has been introduced into the human or animal body.

2. The device as recited in claim 1, characterized in that the guide for the tubular element is arranged in such a way that at least in a section thereof a distance of a center of an accommodation space for the tubular element from an attachment surface of the base for attaching the device to the human or animal body is at least 2 mm, in particular at least 3 mm.

3. The device as recited in claim 2, characterized in that the guide for the tubular element comprises a curved section guiding an accommodated tubular element from an initial direction generally parallel to the attachment surface of the base to an inclined direction directed towards the point of entry.

4. The device as recited in claim 3, characterized in that in an attached configuration of the upper part on the base, the curved section of the guide for the tubular element is formed between a lower guide part in the base and an upper guide part in the upper part, wherein in particular at least one optical fiber is guided in the lower guide part and at least one further optical fiber is guided in the upper guide part.

5. The device as recited in one of claims 1 to 4, characterized in that the at least one emission surface of the at least one optical fiber is at a distal end of the fiber, wherein the distal end is positioned in a region surrounding a distal end of the guide for the tubular element.

6. The device as recited in claim 5, characterized in that at least two optical end-emitting fibers end in the region surrounding the distal end of the guide.

7. The device as recited in claim 5, characterized in that the device includes a single optical fiber, in particular an end-emitting fiber.

8. The device as recited in one of claims 1 to 7, characterized in that the base and / or the upper part forms a flexible guide channel for guiding the tubular element and that the upper part and / or the base comprises a clamping section for selectively compressing the flexible guide channel and the tubular element accommodated in the flexible guide channel in order to lock the tubular element in the flexible guide channel.

9. The device as recited in claim 8, characterized in that the flexible guide channel is formed in the base and that the clamping section is formed in the upper part, wherein the upper part is slidably attachable to the base, wherein a sliding direction for attaching the upper part to the base in particular runs parallel to the guide for the tubular element.

10. The device as recited in one of claims 1 to 9, characterized in that surfaces of the base and / or the upper part illuminated by the light emitted by the optical fiber are made from a biocompatible, UVC resistant material, in particular from a material chosen from the following: PTFE, aluminium, alumina, magnesium oxide, titanium, titanium oxide, other ceramic materials.

11. The device as recited in one of claims 1 to 10, characterized in that a distal end of the fiber is surrounded by a cavity which is formed of or coated by a scattering material.

12. The device as recited in one of claims 1 to 11, characterized by a dome element for distributing light emitted by the at least one optical fiber in order to homogenize illumination of the tissue surrounding the point of entry.

13. The device as recited in claim 12, characterized in that the dome element includes a surface made from a light-scattering material, wherein light emitted by the at least one optical fiber is at least partially directed to the surface.

14. The device as recited in claim 13, characterized in that the surface is curved.

15. The device as recited in claim 13, characterized in that the surface is flat.

16. The device as recited in one of claims 12 to 15, characterized in that the dome element comprises at least one window allowing for inspection of the tissue surrounding the point of entry.

17. The device as recited in claim 16, characterized in that the at least one window is covered by a film made from a transparent material, in particular a breathable transparent material.

18. The device as recited in one of claims 12 to 17, characterized in that the dome element is adapted to be selectively attached to the upper element.

19. The device as recited in claim 18, characterized in that the at least one optical fiber is guided in the dome element.

20. The device as recited in claim 18, characterized in that the at least one optical fiber is guided in the upper element and / or in the base, whereas no optical fibers are guided in the dome element.

21. The device as recited in one of claims 1 to 20, characterized in that the base has a central opening for surrounding the point of entry and that the base has a lateral slit connecting the central opening to a circumference of the base for sliding the base over the tubular element even after the tubular element has been introduced into the human or animal body.

22. The device as recited in claim 21, characterized in that the upper part has a lateral slit for sliding the upper part over the tubular element even after the tubular element has been introduced into the human or animal body, wherein the upper part is rotatable with regard to the base after attaching the upper part to the base in order to lock the tubular element in the upper part.

23. The device as recited in claims 17 and 21, characterized in that the dome element is unitary with the base and in that the upper element is constituted by a window element, the window element including the film made from the transparent material.

24. The device as recited in one of claims 1 to 23, characterized in that the base is made from a first material and that the upper part is made from a second material, wherein a Shore A hardness of the first material is lower than that of the second material, wherein a difference of the Shore A hardnesses is in particular at least 15.

25. The device as recited in one of claims 1 to 24, characterized in that the base is entirely made from a light-scattering material and that the upper part is made from a non-light scattering material.

26. The device as recited in any of claims 1 to 25, characterized in that the guide for the tubular element is designed in such a way that light emitted by the at least one optical fiber accommodated in the guide disinfects a region of the tubular element in the vicinity of the point of entry together with the tissue surrounding the point of entry.

27. The device as recited in one of claims 1 to 26, characterized in that the tubular element is one of the following: a) a catheter, in particular a central venous catheter, a catheter for external ventricular drainage, a catheter for extracorporeal membrane oxygenation, a catheter for dialysis or a catheter for long-term administration of medication; b) a line for the transmission of electrical or optical signals, in particular to and / or from a human or animal brain or to and / or from an implanted medical device; c) a line for supplying electrical energy in particular to an implanted medical device.

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