Adhesive system for handling a buttonhole device

Abstract

The present invention provides an adhesive system for handling a buttonhole device which is either a plug or a guiding device for guiding a needle in the skin of a subject, comprising at least a bottom and a top element and methods to use such an adhesive system in a subject.

Description

[0001] ADHESIVE SYSTEM FOR HANDLING A BUTTONHOLE DEVICE

[0002] Field of the invention

[0003] The invention is broadly in the field of medical systems, more precisely in the field of cannulation techniques. In particular, the invention concerns an adhesive system for handling a buttonhole device for creating tunnel tracks for the buttonhole technique, and methods to use such an adhesive system.

[0004] BACKGROUND OF THE INVENTION

[0005] Patients with renal disease generally require haemodialysis treatments three times a week, involving the insertion of a dialysis or indwelling needle into their blood vessels. This procedure can cause considerable discomfort and pain. Among the various needle placement methods, the buttonhole cannulation technique is a noteworthy approach.

[0006] The buttonhole technique involves creating a collagenous tunnel from the skin to the blood vessel through repeated punctures at the same site. Using the same cannula for each session helps prevent aneurysm formation and offers advantages such as reduced pain during insertion and minimized bleeding during removal. Initially, a sharp-tipped needle creates the tunnel by creating a scar tissue pathway. After the tunnel is created, and during establishment of the tunnel, a buttonhole device can be employed. This device is partially inserted into the tunnel while resting partially on the skin surface, helping to prevent damage to the tunnel. Optionally, this buttonhole device can also serve as a guiding device for the needle.

[0007] However, this technique has several challenges. The buttonhole device, which typically extends partially outside the skin, can potentially dislodge from the tunnel during or after the procedure. This displacement can lead to complications such as bleeding, tunnel necrosis, infections or tunnel loss, compromising the technique's effectiveness and requiring additional interventions. Furthermore, creating a reliable tunnel can be challenging, and any issues during formation can result in complications and ineffective needle placement. Thus, there remains a need for enhanced techniques and solutions to improve the formation of tunnel tracks for the buttonhole technique and overall haemodialysis treatment.

[0008] SUMMARY OF THE INVENTION

[0009] One of the major challenges for the optimal effect of the buttonhole technique is avoiding damage and allowing proper formation of the tunnel during the generation thereof. The present inventors have developed an adhesive system, thereby addressing one or more of the above-mentioned problems in the art.

[0010] Accordingly, the invention relates to an adhesive system for handling a buttonhole device which facilitates the handling thereof. More particularly, the invention relates to an adhesive system for handling a buttonhole device, comprising a top and bottom element, which can be fixed around the butonhole device. The present inventors realized that the adhesive system for handling a butonhole device, as outlined in this invention, yields several advantages. The adhesive system not only secures the butonhole device to the subject's skin but also allows for angle adjustments of the butonhole device after placement of the butonhole device and the adhesive system. Additionally, the adhesive system creates a seal that helps prevent infections, thereby enhancing the safety and effectiveness of the butonhole cannulation technique. Furthermore, employment of this system greatly simplifies the placement and removal of the butonhole device. Overall, this innovative adhesive system emerges as a great tool for advancing the efficacy, safety, and precision of the butonhole cannulation technique.

[0011] More particularly, the invention provides an adhesive system for handling a butonhole device comprising an elongated tube (which can be hollow or solid) extending from a stopper section, whereby the diameter of the stopper section is at least double that of the diameter of the tube, the adhesive system comprising: a first botom element and a first top element each comprising an upper side and a lower side, wherein the size of the first top element is at least 20% larger than that of the first botom element; wherein the first botom element comprises a hole configured for receiving the tube of the butonhole device, wherein the diameter of the hole is smaller than the outer diameter of a stopper section of the device; wherein the first botom element and the first top element are configured to be secured around the stopper section of the butonhole device; and wherein at least the lower side of the first top element is adhesive and is configured for fixing on to the skin of the subject. In particular embodiments also the upper side of the first botom element is adhesive. In particular embodiments, the adhesive system further comprises tape foil comprising at least a first part positioned to cover at least part of the adhesive lower side of the first top element, in such a way that it covers the area of the adhesive lower side of the first top element extending beyond the area corresponding to the first botom element. In particular embodiments, the first part of the tape foil comprises at least one handle that extends outward from the surface of the first top element. In further particular embodiments, the first part of the tape foil comprises two separable sections each section comprising a handle wherein each section can be removed from the adhesive lower side of the top element independently. In particular embodiments, the rim of the first top element comprises one or more recesses; preferably the recesses are located at positions corresponding to those of the one or more handles of the tape foil.

[0012] In particular embodiments, the butonhole device is a guiding device for guiding a needle in the skin, the guiding device comprising a guiding element, wherein the guiding element is characterized in that the tube comprises a channel extending in a longitudinal direction at least from an opening at the top end of the tube to the botom end of the tube (i.e. in this embodiment, the tube is hollow).

[0013] In particular embodiments, the adhesive system of the invention comprises additional elements making it particularly suitable for a butonhole device that also serves as a guiding device and comprises a guiding element that can be sealed by a sealing component comprising a body and a head, the body configured to fit tightly within the channel of the guiding element and the head configured to fit into the stopper section of the guiding element. In these embodiments, the adhesive system further comprises: a second bottom element and a second top element each comprising an upper side and a lower side. The second bottom element and the second top element is configured to be secured around the head of the sealing component. These elements are characterized in that at least the lower side of the second top element is adhesive and in that the second bottom element comprises a hole configured for receiving the body of the sealing component. The diameter of the hole is smaller than the largest outer diameter of the head of the sealing component. While this is not critical, in particular embodiments the size of the second top element can be larger than that of the second bottom element, such as at least 20% larger, preferably at least 50%, at least 100% larger or more. Also, in particular embodiments, the surface of the second top element is smaller than that of the first top element of the adhesive system.

[0014] In particular embodiments of the adhesive systems of the invention, where the buttonhole device is a guiding device, the first top element comprises a hole configured to match the opening in the stopper section of the guiding element. In alternative embodiments, where the buttonhole device merely serves as a plug, the first top element does not comprise a hole.

[0015] In particular embodiments, also the upper side of the first bottom element and / or the upper side of the second bottom element is / are adhesive.

[0016] In particular embodiments of the adhesive system according to the invention, the first bottom element, and / or first top element and / or second bottom element and / or second top element comprise a continuous shape, preferably, wherein the shape is generally circular.

[0017] In particular embodiments of the adhesive system according to the invention the first bottom and top element and where present, the second bottom and top element are transparent.

[0018] The invention further relates to a kit comprising one or more adhesive systems comprising a first bottom and top element as described herein and one or more buttonhole devices, the buttonhole device comprising an elongated tube extending from a stopper section, whereby the diameter of the stopper section is at least double that of the diameter of the tube.

[0019] In particular embodiments, the buttonhole device is a guiding device comprising a guiding element comprising a tube configured to guide the needle, a stopper section, and a channel extending in a longitudinal direction at least from an opening at the top end of the tube to the bottom end of the tube. Optionally the kit also comprises one or more sealing components comprising a body and a head, the body configured to fit tightly within the channel of the guiding element and the head configured to fit into the stopper section of the guiding element and the adhesive system also comprises corresponding second bottom and top elements as described herein. The application also provides guiding assemblies wherein the elements of the kit are assembled. The application also discloses methods of using the adhesive systems and kits described herein.

[0020] The above and further aspects and preferred embodiments of the invention are described in the following sections and in the appended claims. The subject-matter of appended claims is hereby specifically incorporated in this specification.

[0021] DESCRIPTION OF THE DRAWINGS

[0022] In order to better demonstrate the features of the invention, some examples of possible and preferred embodiments of the present invention are described in the accompanying figures without any limiting character. In these figures, like numbers indicate like or similar elements. The numerical references are discussed in more detail in the examples.

[0023] Throughout the description, claims, and figures, the following numbering is used:

[0024] Figure 1A: illustrates an exploded representation of an adhesive system according to an embodiment of the invention the invention. A: buttonhole device; Al: tube; A2: stopper section; 100: first bottom element; 101: upper side of first bottom element; 102: lower side of first bottom element; 103: hole in first bottom element; 200: first top element; 201: upper side of first top element 202: lower side of first top element;, a = adhesive

[0025] Figure IB illustrates a detail of transversal section of an assembly of a buttonhole device (A) and an embodiment of the adhesive system of the invention comprising a top element (200) and a bottom element (100), showing the interface between these elements and the stopper section of a buttonhole device.

[0026] Figure 1C illustrates a transversal section of an assembly of a buttonhole device (A) and the adhesive system of the invention comprising a top element (200) and a bottom element (100). a = adhesive

[0027] Figure 2: illustrates an exploded representation of an adhesive system according to an embodiment of the invention the invention. A: guiding element; Al: tube; A2: stopper section; A4: opening; 100: first bottom element; 101: upper side of first bottom element; 102: lower side of first bottom element; 103: hole in first bottom element; 200: first top element; 201: upper side of first top element 202: lower side of first top element; 204: recess, a = adhesive

[0028] Figure 3: illustrates a more detailed illustration of an embodiment of the adhesive system. A: guiding element; Al: tube; A2: stopper section; A4: opening; 100: first bottom element; 101: upper side of first bottom element; 102: lower side of first bottom element; 103: hole in first bottom element; 200: first top element; 201: upper side of first top element; 202: lower side of first top element; 203: hole; 204: recess; 300: tape foil; 301, 302: handles of the tape foil; 303, 304: section of the tape foil, a = adhesive Figure 4: illustrates a more detailed illustration of an embodiment of the adhesive system. A: guiding element; Al: tube; A2: stopper section; A4: opening; 100: first bottom element; 101: upper side of first bottom element; 102: lower side of first bottom element; 103: hole in first bottom element; 200: first top element; 201: upper side of first top element; 202: lower side of first top element; 203: hole; 204: recess; 300: tape foil; 301, 302: handles of the tape foil; 303, 304: section of the tape foil; B: sealing component; Bl: body; B2: head; B22: top the head; 400: second bottom element; 401: upper side of second bottom element; 402: lower side of second bottom element; 403: hole in second bottom element; 500: second top element; 501: upper side of second top element; 502: lower side of second top element.

[0029] Figure 5: illustrates a more detailed illustration of an embodiment of the adhesive system. A: guiding element; Al: tube; A2: stopper section; A4: opening; 100: first bottom element; 101: upper side of first bottom element; 102: lower side of first bottom element; 103: hole in first bottom element; 200: first top element; 201: upper side of first top element; 202: lower side of first top element; 203: hole; 204: recess; 300: tape foil; 301, 302: handles of the tape foil; 303, 304: section of the tape foil; B: sealing component; Bl: body; B2: head; B22: top the head; 400: second bottom element; 401: upper side of second bottom element; 402: lower side of second bottom element; 403: hole in second bottom element; 500: second top element; 501: upper side of second top element; 502: lower side of second top element;510: border; a = adhesive

[0030] Figure 6: illustrates a use of an embodiment of a device of the present invention in the context of hemodialysis, (a) inserting a (sharp) needle into the skin of a subject to a blood vessel at a desired cannulation position; (b) performing dialysis i.e. removing blood from the subject, filtering of the drawn blood and re-introduction of filtered blood into the subject; (c) removing the needle from said cannulation position; (d) applying pressure to stop the bleeding; (e) inserting a buttonhole device in the opening generated by the needle and fixing the buttonhole device by removing tape foil and applying the first top element to the skin of the patient; and optionally maintaining it for a time period; (f) removing the buttonhole device by removing the first top element from the skin; (g) inserting a sharp needle through the previously formed channel towards the blood vessel; (h) performing dialysis i.e. removing blood, filtering of the drawn blood and re-introduction of filtered blood; (i) removing the needle from the subject; (j) applying pressure on the blood vessel to stop the bleeding.

[0031] Figure 7: illustrates a use of the device of the present invention in the context of hemodialysis, (a) inserting a (sharp) needle into the skin of a subject to a blood vessel at a desired cannulation position; (b) performing dialysis i.e. removing blood from the subject, filtering of the drawn blood and re- introduction of filtered blood into the subject; (c) removing the needle from said cannulation position; (d) applying pressure to stop the bleeding; (e) inserting a guiding element with the sealing component in the opening generated by the needle; (f) fixing the guiding element by applying the first top element to the skin of the patient; (g) maintaining it for a time period; (h) removing the sealing component from the guiding element by removing the second bottom element and the second top element; (i) inserting a sharp needle through the guiding element towards the blood vessel; (j) performing dialysis; (k) performing dialysis i.e. removing blood, filtering of the drawn blood and re-introduction of fdtered blood removing the guiding element from the subject together with the needle by removing the first top element and the first bottom element; (1) applying pressure on the blood vessel to stop the bleeding.

[0032] DETAILED DESCRIPTION OF THE INVENTION

[0033] As used herein, the singular forms “a”, “an”, and “the” include both singular and plural referents unless the context clearly dictates otherwise.

[0034] The terms “comprising”, “comprises” and “comprised of’ as used herein are synonymous with “including”, “includes” or “containing”, “contains”, and are inclusive or open-ended and do not exclude additional, non-recited members, elements, or method steps. The terms also encompass “consisting of’ and “consisting essentially of’, which enjoy well-established meanings in patent terminology.

[0035] The recitation of numerical ranges by endpoints includes all numbers and fractions subsumed within the respective ranges, as well as the recited endpoints. This applies to numerical ranges irrespective of whether they are introduced by the expression “from. . . to. . . ” or the expression “between. . . and. . . ” or another expression.

[0036] The terms “about” or “approximately” as used herein when referring to a measurable value such as a parameter, an amount, a temporal duration, and the like, are meant to encompass variations of and from the specified value, such as variations of + / -10% or less, preferably + / -5% or less, more preferably + / - 1% or less, and still more preferably + / -0.1% or less of and from the specified value, insofar such variations are appropriate to perform in the disclosed invention. It is to be understood that the value to which the modifier “about” or “approximately” refers is itself also specifically, and preferably, disclosed.

[0037] Whereas the terms “one or more” or “at least one”, such as one or more members or at least one member of a group of members, is clear per se, by means of further exemplification, the term encompasses inter alia a reference to any one of said members, or to any two or more of said members, such as, e.g. any >3, >4, >5, >6 or >7 etc. of said members, and up to all said members. In another example, “one or more” or “at least one” may refer to 1, 2, 3, 4, 5, 6, 7 or more.

[0038] The discussion of the background to the invention herein is included to explain the context of the invention. This is not to be taken as an admission that any of the material referred to was published, known, or part of the common general knowledge in any country as of the priority date of any of the claims.

[0039] Throughout this disclosure, various publications, patents, and published patent specifications are referenced by an identifying citation. All documents cited in the present specification are hereby incorporated by reference in their entirety. In particular, the teachings or sections of such documents herein specifically referred to are incorporated by reference.

[0040] Unless otherwise defined, all terms used in disclosing the invention, including technical and scientific terms, have the meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. By means of further guidance, term definitions are included to better appreciate the teaching of the invention. When specific terms are defined in connection with a particular aspect of the invention or a particular embodiment of the invention, such connotation or meaning is meant to apply throughout this specification, i.e. also in the context of other aspects or embodiments of the invention, unless otherwise defined. For example, embodiments directed to products are also applicable to corresponding features of methods and uses.

[0041] In the following passages, different aspects or embodiments of the invention are defined in more detail. Each aspect or embodiment so defined may be combined with any other aspect(s) or embodiment(s) unless clearly indicated to the contrary. In particular, any feature indicated as being preferred or advantageous may be combined with any other feature or features indicated as being preferred or advantageous.

[0042] Reference throughout this specification to “one embodiment”, “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner, as would be apparent to a person skilled in the art from this disclosure, in one or more embodiments. Furthermore, while some embodiments described herein include some but not other features included in other embodiments, combinations of features of different embodiments are meant to be within the scope of the invention, and form different embodiments, as would be understood by those in the art. For example, in the appended claims, alternative combinations of claimed embodiments are encompassed, as would be understood by those in the art.

[0043] Unless indicated otherwise, all methods, steps, techniques, and manipulations that are not specifically described in detail can be performed and have been performed in a manner known per se, as will be clear to the skilled person. Reference is for example again made to standard handbooks as well as to the general background art referred to herein and to the further references cited therein.

[0044] The inventors have developed an adhesive system for handling a buttonhole device for creating, establishing, maintaining or closing of a tunnel track in the skin a subject to a blood-vessel. As demonstrated by the drawings, which illustrate certain representative embodiments of the present invention, the invention provides an adhesive system for handling a buttonhole device which can be a plug or a guiding device for guiding a needle in the skin.

[0045] Indeed, the term “buttonhole device” is used herein to generally refer to any device which is used to help establish and / or maintain or close off a channel or cannula in the skin towards a blood vessel. The actual function is not critical as the invention relates to the handling of a device based on its physical features, i.e. a stopper section and an elongated section extending therefrom.

[0046] Typically, where the buttonhole device is a plug, the buttonhole device comprises an elongated solid tube extending from a stopper section, whereby the diameter of the stopper section is at least double (200%) that of the diameter of the tube of the device. Typically such plugs are polycarbonate pegs which are small, sterile, thumbtack-shaped plugs which can be used to maintain the needle track between cannulations. The plug helps prevent the tunnel from closing, thereby promoting better establishment of the tunnel. It has been established that scar tissue forms around the plug, which facilitates the development of the tunnel for cannulation. Examples of buttonhole devices which work as a plug are known in the art and include the BIOHOLE™ buttonhole device

[0047] In further embodiments, the buttonhole device also serves as a guiding device for a needle. In these embodiments, the buttonhole device also comprises an elongated tube extending from a stopper section, whereby the diameter of the stopper section is at least double that of the diameter of the tube, but further comprises a channel extending in a longitudinal direction at least from an opening the top end of the tube to the bottom end of the tube.

[0048] In both types of buttonhole devices, the stopper section is preferably provided so as to prevent the device from sinking completely into the skin and ensures that the device remains at least partially present on the skin's surface upon insertion of the tube.

[0049] The adhesive system according to the invention comprises at least a bottom and top element which can be secured around the stopper section of the buttonhole device, thereby facilitating handling of the buttonhole device while at the same time allowing fixation thereof to the skin, each element having an upper and lower side. The terms “bottom” and “top” element of the adhesive system refer to their positioning relative to the components ( more particularly the buttonhole device, or, as detailed below, the sealing component) which they are configured to secure, but before securing around these components these essentially represent subsequent layers of the adhesive system. More particularly, this implies a positioning of the components whereby the tube of the buttonhole device extends vertically downward from the stopper section, and the different elements of the adhesive system represent layers extending horizontally relative thereto. It will be understood that these elements can also be referred to as elements (a) and (b). When referring to the opposing surfaces or “sides” of these elements the terms “upper” and “lower” refer to their positioning relative to that of the horizontally positioned element. It will be understood that this could also be referred to as side (i) and side (ii), with these being opposing sides of the element. In particular embodiments, adhesive system comprises: a (first) bottom element and a (first) top element each comprising an upper side and a lower side, wherein the size of the first top element is at least 20% larger than that of the first bottom element; wherein the first bottom element comprises a hole configured for receiving the tube of the buttonhole device, wherein the diameter of the hole is smaller than the diameter of the stopper section of the buttonhole device and wherein at least the lower side of the first top element is adhesive. In a first embodiment, the adhesive system thus comprises a set of two elements.

[0050] It will be understood that reference to the “first” bottom and top elements herein are only relevant if the adhesive system also comprises further bottom and top elements, which are referred to as “second”. However, where the system only comprises the first bottom and top elements, the reference to “first” can be ignored.

[0051] Upon use, the first top element of the adhesive system is placed over the upper surface of the stopper section of the buttonhole device, the adhesive side directed towards the stopper section of the buttonhole device and tube of the buttonhole device is slid through the hole of the first bottom element of the adhesive system up to where the tube extends to the stopper section and the diameter of the stopper section prevents the bottom element from advancing further.

[0052] As indicated above, the size of the first top element is at least 20% larger than that of the first bottom element. The first top element may have a radial extension that is at least 20% larger than the radial extension of the first bottom element. The actual diameter of the first top and bottom element may vary and is at least in part determined by the diameter of the stopper section. The first top element contains at least two sections, the first section extending beyond the surface of the stopper section allowing adherence of the first bottom element thereto and the second section extending 20% beyond that of the first bottom element. Preferably, the size or surface area of the first top element is at least 50% larger, at least 100% larger, at least 200% larger, at least 300% larger, at least 400% larger or at least 500% than that of the first bottom element, as this allows for solid adherence of the first top element to the skin.

[0053] As used herein, the term “size”, “surface” or “surface area” can be used interchangeably. These terms generally refer to the two-dimensional, planar area occupied by an element (first top element, first bottom element, second top element and second bottom element) when projected or measured in the same plane. In other words, the terms “size”, “surface” or “surface area” may refer to the total area enclosed by the outer boundary of the respective elements (first top element, first bottom element, second top element and second bottom element).

[0054] The first section of the fist top element extending beyond the stopper section of the buttonhole device will adhere to the section of the first bottom element extending beyond the stopper section of the butonhole device. The butonhole device is thus fixed between the first top and first botom element of the adhesive system of the invention. As a result of the surface of the stopper section and the first botom element adhering thereto, during use the adhesive system will not be adherent to the skin in this section.

[0055] The second section of the first top element extends beyond the first section and thus also beyond the diameter of the first botom element. The lower part of this section will remain adhesive and is used to ensure fixture of the device on the skin. The combination of the first section and the second section ensure fixture of the device on the skin while providing a non adhesive area to ease reangulation / free movement of the device. Advantageously, where both the first top and first botom element are transparent, the adhesive system creates a transparent non-adhesive area around the stopper section of the device that facilitates easier manipulation of the device, while also enhancing visibility for this manipulation.

[0056] The absolute size of the first top element may vary depending on the diameter of the stopper section of the butonhole device. Preferably, the outer diameter of the first top element is about 3 -7mm larger than the diameter of the stopper section of the butonhole device. In practice the upper part of the stopper section comprises an outer diameter of about 3.0 mm to 15 mm, such as 4.0 mm to 6.0mm. Accordingly, the outer diameter of the first top element is typically between 50 mm to 70mm.

[0057] Typically, both the first top element and the first botom element have a circular form and the hole is located centrally on the first botom element such that, when the adhesive system is placed on the butonhole device, the first top element extends symmetrically around the circumference of the butonhole device.

[0058] The hole of the first botom element of the adhesive system of the invention should be such that it allows passage of the tube of the butonhole device for which it will be used. In practise, the tube comprises an out diameter of 2.0mm to 4.0 mm, most often the outer diameter of the tube is 2.5- 3.5mm. Accordingly, where the outer diameter of the tube is about to 3.5 mm, the hole in the botom element will typically be about the same size or 0.05-2 mm larger. At the same time the diameter of the hole in the botom element of the adhesive system of the invention is configured to be smaller than the outer diameter of the stopper section of the butonhole device, to ensure that the butonhole device is secured between the two elements. For instance, the outer diameter of the stopper section is typically between 1.5 mm to 20 mm, and the hole of the first botom element will typically be between 0.3-0.5mm smaller than the outer diameter of the stopper section. For instance, where the diameter of the tube is 1mm and the outer diameter of the stopper section is about 1.5 mm, the diameter of the hole is preferably about 1, 1mm. Thus, it be understood by the skilled person that the diameter of the hole in the botom element of the adhesive system is determined by the diameter of the tube and that of the stopper section of the butonhole device for which it is designed. However, the hole is preferably configured to (fitingly) match the outer diameter of the tube of the butonhole device.

[0059] Typically, the stopper section of the butonhole device envisaged for use with the adhesive system of the invention is be tapered towards the tube of the guiding element, preferably the outer wall of the stopper section of the butonhole device has a rounded tapered shape. The section surrounding the hole in the first botom element of the adhesive system will cover this tapered / rounded outer wall of the stopper section and will take on its form as a result of the flexibility of the adhesive. The butonhole device can be secured by the fact that the lower side of the first top element is adhesive and adheres to the outer sections of the first botom element.

[0060] In particular embodiments of the adhesive system of the invention, the upper side of the first botom element is also adhesive. This furthers secures the adhesive system to the butonhole device.

[0061] Typically the surface of the upper part of the stopper section of a butonhole device for use in combination with the adhesive system of the invention can be flat, curved or rounded. Preferably, the surface of the upper part of the stopper section is flat. The first top element of the adhesive system of the invention has a size which is considerably larger than the top surface of the stopper section of the butonhole device. Typically, the diameter of the first top element will be between l-800mm, preferably about 550mm, taking into account that it will be at least 20% larger than the diameter of the botom element.

[0062] In particular embodiments, the butonhole device is a plug and the first top element is configured to cover the upper surface of the stopper section of the butonhole device. Accordingly, in particular embodiments, the first top element does not comprise a hole.

[0063] In alternative embodiments, butonhole device is a guiding device comprising a guiding element with a central opening and the first top element can comprise a hole configured to match the opening in the upper surface of the stopper section of the guiding element. Typically, the hole is located centrally in the top element. In embodiments, the hole of the first top element comprises a diameter and / or circumference that is similar or larger than the diameter and / or circumference of the opening of the upper surface the stopper section of the guiding element for which it will be used and has a diameter and / or circumference that is smaller than the largest diameter and / or circumference of the stopper section of the guiding element. The hole of the first top element is preferably configured to match the diameter of the opening in the stopper section of the guiding element. For instance, the diameter of the opening of the upper part in the stopper section is typically at least 3.0 mm, at least 3.5 mm, at least 4.0 mm, or at least 5.0 mm, and the upper part of the stopper section can have a outer diameter of about 3.0 mm to 20 mm, about 3.5 mm to 15 mm, about 4.0 mm to 15 mm, about 4.0 to 10 mm, about 4.5 mm to 10mm, about 5.0 mm to 10 mm. In a preferred embodiment, the upper part of the stopper section comprises an outer diameter of about 4.0 mm to 15 mm. . The diameter of the opening of the upper part in the stopper section is preferably at least 4.0 mm. The diameter of the hole of the first top element is typically at least 3.0 mm, at least 3.5 mm, at least 4 mm, at least 5 mm, or between 3.0 mm to 20 mm, between 3.5 mm to 15 mm, between 4.5 mm to 15 mm, preferably of 4.0 mm to 10 mm, even more preferably of 4 mm to 7 mm.

[0064] The adhesive system of the invention can further comprise a tape foil positioned on part of the adhesive lower side of the first top element. Advantageously, the tape foil prevents premature sticking of the first top element of the adhesive system to the skin and ensures easier handling thereof. At the same time the foil can easily be removed from the first top element to ensure fixation of the top element onto the skin once the buttonhole device is in its correct position. The tape foil thus comprises at least a first part positioned to cover at least part of the adhesive lower side of the first top element, in such a way that it covers the area of the adhesive lower side of the first top element extending beyond the area corresponding to the bottom element. Typically, where the first top element is circular, the section covered by the tape foil is the outer circular rim of the first top element, i.e. the section extending beyond the diameter of the first bottom element. In particular embodiments, the outer diameter of the tape foil corresponds to the outer diameter of the first top element. In further embodiments, the outer diameter of the tape foil extends beyond that of the first top element, either over the entire area of the tape foil, or in limited sections thereof, so as to form extensions which can be used as a handle as detailed below.

[0065] The first part of the tape foil preferably comprises at least one handle (which can be an extension of the tape foil) extending outward from the surface of the first top element when placed thereon. In particular embodiments, the tape foil comprises two handles, each at opposite sides of the tape foil. In particular embodiments, the tape foil is comprised of separable sections which facilitates removal of the tape foil from the first top element after the buttonhole device is positioned in the skin. In particular embodiments, the tape foil can comprise at least two separable sections, each section comprising a handle, wherein each section can be removed from the adhesive lower side of the top element independently. In further embodiments, the foil comprises more than two sections, such as three or four sections. In particular embodiments the different sections are of identical size, but this is not critical. In embodiments, the different sections of the tape foil are symmetrical, but this is not critical. Preferably, the handles are positioned at the edge of each section. In embodiments, the different sections of the tape foil are preferably transparent. Alternatively, the tape-foil is non-transparent.

[0066] In particular embodiments, the rim of the first top element can comprise one or more recesses. These recesses facilitate easier removal of tape foil from the first top element by staff. These recesses may also facilitate removal of the adhesive system comprising the buttonhole device from the skin after use. In embodiments, the adhesive system of the invention is particularly designed for use with a buttonhole device which is a guiding device that comprises both a guiding element and a (removable) sealing component. The sealing component typically comprises a body and a head, the body configured to fit tightly within the channel of the guiding element and the head configured to fit into the stopper section of the guiding element. In these embodiments, the adhesive system may further comprise additional adhesive elements which facilitate handling and positioning of the sealing component. More particularly, in these embodiments, the adhesive system may further comprise a second bottom element and a second top element each comprising an upper side and a lower side wherein the second bottom element comprises a hole configured for receiving the body of the sealing component. Thus, in these embodiments, the adhesive system comprises both a first set of elements configured for securing around the guiding element and a second set of elements configured for securing around the sealing component.

[0067] This second combination of elements is configured to fit around the sealing component. Upon use, the second top element is placed over the head of the sealing component, while the hole in the second bottom element is slid over the body of the sealing component until it reaches the head of the sealing component. In this way the outer circumference of the second bottom element will stick to the adhesive lower side of the second top element.

[0068] In the guiding devices envisaged for use in the context of the present invention, the size and shape of the head of the sealing component is adapted to mirror the corresponding shape and size of the corresponding opening in the stopper section of the guiding element. The head of the sealing component is preferably tapered towards the body of the sealing component. Accordingly, the size of second top and bottom elements of the adhesive system will dependent on the size of the sealing component. Accordingly, in the adhesive system of the invention, the second top and bottom element will be configured to receive the head of the sealing component, while the hole in the second bottom element will be configured to receive the body of the sealing component. The material of the adhesive ensures that, upon use, when the body of the sealing component is pushed through the hole of the second bottom element, the area around the hole in the second bottom element will deform to match to the shape of the tapered section of the head of the sealing component. The dimensions of the hole of the second bottom element may vary but are at least in part defined by the dimensions of the body and head of the sealing component. More particularly, the diameter of the hole of the second bottom element can be determined by the diameter of the body and head of the sealing component. In embodiments, the hole of the second bottom element comprises a diameter and / or circumference that is similar or slightly larger than the outer diameter and / or circumference of the body and the head of the sealing component while at the same time the diameter and / or circumference of the hole should be smaller than the largest diameter and / or circumference of the top of head of the sealing component. For instance, where the outer diameter of the body of the sealing component is typically about 0.5 to 5mm and the outer diameter of the head of the sealing component is typically between 1.0 mm to 20 mm, the hole in the second bottom element can be between 0.5-15mm. However, as the hole of the second bottom element is preferably configured to (fittingly) match the outer diameter of the body of the sealing component, i.e. it has the same outer diameter or a diameter of about 0.05 -2mm more than that of the body of the sealing component. This precise matching ensures a secure fit and tight seal.

[0069] In particular embodiments of the adhesive system of the invention, also the upper side of the second bottom element is adhesive. This ensures a more secure and tighter fit of the adhesive system around the sealing component, as this ensures that also the bottom element adheres to the head of the sealing component.

[0070] Upon use, the second top element is placed over the head of the sealing component of the guiding device . Where the top surface of the head of the sealing component is rounded, part of the second top element may take on the shape of the rounded surface, appearing like a bulge. In particular embodiments, the second top element can be specifically configured to receive the top surface of the head of the sealing component. For instance, the second top element may also comprise a preformed bulge, preferably located centrally on the adhesive, matching the shape of the top surface of the head of the sealing component.

[0071] The relative dimensions of the second top and bottom element may vary. In particular embodiments, the diameter of the second top and bottom element are the same. In embodiments, the second top element comprises a diameter and / or circumference that is at least 10%, at least 15%, at least 20%, at least 25% at least 30% larger than the diameter and / or circumference of the second bottom element.

[0072] The relative dimensions of the first and second top element may also vary. In particular embodiments, the diameter of the first and the second top element are the same. In particular embodiments, the second top element comprises a diameter and / or circumference that is at least 10%, at least 15%, at least 20%, at least 25% at least 30% smaller than the diameter and / or circumference of the first top element. This allows for the easy removal of both the second top element and the second bottom element along with the sealing component, without removing the guiding element and eliminating the need for a handle on the sealing component to remove the sealing component.

[0073] As detailed above, in systems comprising a second top and bottom element, the lower side of the second top element is adhesive, so as to centrally ensure fixation to the sealing component and to allow adhesion to the first top element. In embodiments, the lower side of the second top element is completely adhesive so that it adheres to the upper side of the second bottom element and, in the part of the surface of the second top element that extends beyond the second bottom element, it can be adhesive to the first top element. However, so as to more easily allow removal of the sealing component from the buttonhole device or to facilitate positioning on the first top element, it can be of interest to reduce or be able to manipulate the adhesion, particularly at the periphery of the bottom surface of the second top element. In a preferred embodiment, the adhesive strength of the adhesive present on the bottom surface of the second top element is weaker than that present on the bottom surface of the first top element. In other embodiments, the adhesive system further comprises a less or non-adhesive outer border region. In particular embodiments this is ensured by providing a cover, preferably of silicone, on this border region (i.e. the shape of a ring covering the outer border) so as to reduce the adhesive strength of the outer border. Alternatively, at least the adhesive present in the outer border region of the lower side of the second top element is present only in discrete locations, such as in a pattern (e.g. alternating stripes with and without adhesive), resulting in an overall reduced adhesive strength of the border region.

[0074] As indicated above, the first bottom element and the first top element and, where present, the second bottom element and second top element are preferably transparent. The materials envisaged for the adhesive system of the present invention generally correspond to materials suitable for application to the skin. Suitable, non-limiting examples of materials may include acrylic or silicone such as polydimethylsiloxane (PDMS), or dimethicone. At the same time the tape foil is preferably a transparent plastic, PU material. In particular embodiments, the tape foil is non-transparent.

[0075] In line with the above, in certain embodiments, the first bottom element and first top element, the tape foil and where present, the second bottom element and second top element are generally circular in shape.

[0076] In related aspect, the invention also provides a kit comprising one or more adhesive systems as described herein and one or more buttonhole devices comprising an elongated tube extending from a stopper section, whereby the diameter of the stopper section is at least double that of the diameter of the tube. In particular embodiments, the buttonhole device is a plug. In these embodiments, the kit comprises an adhesive system according to the invention comprising a first top and a first bottom element, the fist element comprising a tape foil adhered thereto and one or more plugs, wherein the first top element does not comprise a hole. In particular embodiments, the buttonhole device comprises a device for guiding a needle in the skin, the guiding device comprising a guiding element comprising a tube configured to guide the needle and a stopper section and a channel extending in a longitudinal direction at least from an opening in the top end of the tube to the bottom end of the tube. In these embodiments, the kit comprises an adhesive system according to the invention comprising a first top and a first bottom element, the fist element comprising a tape foil adhered thereto and one or more guiding elements, wherein the first top element may or may not comprise a hole. In particular embodiments, the buttonhole device is a guiding device and the kit also comprises one or more sealing components comprising a body and a head, the body configured to fit tightly within the channel of the guiding element and the head configured to fit into the stopper section of the guiding element. In these embodiments, the adhesive system according to the invention comprises both a first top and bottom element and a second top and bottom element, and the first top element comprises a hole.

[0077] In particular embodiments, the kit comprises a buttonhole device positioned within a first top and bottom element of the adhesive system. In particular embodiments, the buttonhole device is a guiding device and the kit optionally further comprises a sealing component positioned within a second top and bottom element of the adhesive system, ready for use.

[0078] The invention thus further provides a method for generating an improved buttonhole device, which can comprise a plug or a guiding device, i.e. a buttonhole device assembly, which method comprises positioning an adhesive system according to the invention on a buttonhole device comprising an elongated tube extending from a stopper section, whereby the diameter of the stopper section is at least double that of the diameter of the tube. More particularly, the method comprises placing the first top element of the adhesive system over the upper surface of the stopper section of the buttonhole device, the adhesive side directed towards the stopper section of the buttonhole device. The method further comprising sliding the tube of the buttonhole device through the hole of the first bottom element of the adhesive system up to where the tube extends to the stopper section until the diameter of the stopper section prevents the bottom element from advancing further. At this time, the section of the fist top element extending beyond the stopper section of the buttonhole device can be adhered to the section of the first bottom element extending beyond the stopper section of the buttonhole device. In the method of the invention, the buttonhole device is thus fixed between the first top and first bottom element of the adhesive system of the invention. The assembly of the buttonhole device and the first bottom and top element (including the tape foil) is a first embodiment of the assembly according to the present invention. In particular embodiments, the buttonhole device comprises a guiding element comprising a tube, a stopper section and a channel extending in a longitudinal direction at least from an opening the top end of the tube to the bottom end of the tube, and upon placement of the top element over the stopper section, the hole of the first top element is aligned with the hole in the stopper section of the guiding element.

[0079] In particular embodiments, where the buttonhole device is a guiding device comprising a sealing component, the method may also involve providing adhesive elements to a sealing component designed to fit on the guiding element, the sealing component comprising a body and a head, the body configured to fit tightly within the channel of the guiding element and the head configured to fit into the stopper section of the guiding element. In these embodiments, the method may further comprise placing a second top element is over the head of the sealing component, and sliding the hole in a second bottom element over the body of the sealing component until it reaches the head of the sealing component. At this time, the section of the second top element extending beyond the head of the sealing component can be adhered to the section of the second bottom element extending beyond the head of the sealing component. In the method of the invention, the sealing component is thus fixed between the second top and second bottom element of the adhesive system of the invention. The assembly of the guiding element and the first bottom and top element (including the tape foil) and the sealing component with the second bottom and top element is a further embodiment of the assembly according to the present invention.

[0080] In further related aspect, the invention provides a method for facilitating the handling of a buttonhole device comprising an elongated tube extending from a stopper section, whereby the diameter of the stopper section is at least double that of the diameter of the tube, the method comprising, prior to introducing said buttonhole device into the skin, positioning the adhesive system as described herein on the buttonhole device, such that the stopper section of the buttonhole device is placed between the first bottom element and first top element and said upper side of said first bottom element adheres to the lower side of said first top element.

[0081] In another related aspect, the invention provides methods of using the adhesive system and guiding device or the buttonhole device assembly as described herein. In particular embodiments, the invention provides a method for the cannulation of the skin in a subject, said method comprising: providing a buttonhole device assembly as described herein inserting a needle in the skin of a subject, wherein the needle reaches at least until blood vessel, creating a hole from the skin’s surface until the blood vessel; removing the needle from the skin; inserting the buttonhole device assembly, as described herein, fixing the buttonhole device to the skin of the subject by, where present removing the tape foil and, applying the lower side of the first top element on to the skin of the subject. Retaining the buttonhole device in a fixed position in the skin, will further tunnel formation in the skin.

[0082] In particular embodiments, the buttonhole device is a plug and the method comprises, providing a buttonhole device assembly comprising the buttonhole and a first top and bottom element according to the invention, inserting a needle into the skin of a subject to a blood vessel at a desired cannulation position; and optionally removing blood or introducing blood into the blood vessel removing the needle from said cannulation position and inserting the buttonhole device comprising the adhesive system of the invention comprising the first bottom and top element in the opening generated by the needle; and, fixing the buttonhole device assembly to the skin by applying the lower side of the first top element on to the skin of the subject, optionally by removing the foil tape from said top element, covering said guiding element and after a given time period, removing the buttonhole device assembly from the subject by removing the first top element from the skin; and optionally inserting a needle into the skin of a subject to a blood vessel in the formed tunnel and optionally removing blood or introducing blood into the blood vessel .

[0083] In particular embodiments, the buttonhole device is a guiding device comprising a guiding element and the method comprises, providing a buttonhole device assembly comprising a guiding element and a first top and bottom element according to the invention, inserting a needle into the skin of a subject to a blood vessel at a desired cannulation position; and optionally removing blood or introducing blood into the blood vessel removing the needle from said cannulation position and inserting the buttonhole device assembly which is a guiding element comprising the adhesive system of the invention comprising the first bottom and top element in the opening in the skin generated by the needle; and, fixing the guiding element to the skin by, where present removing the tape foil and, applying the lower side of the first top element on to the skin of the subject, optionally by removing the foil tape from said top element, covering said guiding element and after a given time period, inserting a needle through the hole in the first top element of the adhesive system and the opening in stopper section of the guiding element towards the blood vessel; and optionally removing blood or introducing blood into the blood vessel; and thereafter removing the guiding element from the subject together with / by removing the first top element and the first bottom element.

[0084] In particular embodiments, buttonhole device is a guiding device comprising a guiding element and a sealing component and the method comprises, providing a buttonhole device assembly according to the invention comprising a guiding element with a first bottom and top element of the adhesive system and further comprising a sealing component with a second bottom and top element of the adhesive system of the invention, inserting a needle into the skin of a subject to a blood vessel at a desired cannulation position; and optionally removing blood or introducing blood into the blood vessel removing the needle from said cannulation position and inserting the buttonhole device assembly comprising the the guiding element and the sealing component and comprising the adhesive system of the invention comprising the first bottom and top element and the second bottom and top element in the opening generated by the needle in the skin in the appropriate position; fixing the assembly to the skin by, where present removing the tape foil and, applying the lower side of the first top element at least partially on to the skin of the subject, optionally by removing the foil tape from the fist top element, whereby the sealing component is fixed to the guiding element by way of at least the second top element of the adhesive system fixed to the first top element. after a given time period, removing the sealing component from the guiding device by removing the second top element from the first top element and inserting a needle through the guiding element towards the blood vessel; and optionally removing blood or introducing blood into the blood vessel; and thereafter removing the guiding element from the subject by removing the first top element of the adhesive system (and the first bottom element adhered thereto) from the skin.

[0085] The invention also provides a method for guiding a needle to a blood vessel in a subject, wherein the method involves the use of the adhesive system in combination with a guiding device as described herein.

[0086] In particular embodiments, said method comprises: introducing the buttonhole device assembly of the invention comprising the guiding element and the sealing component and the adhesive system of the invention, wherein the sealing component is present in the guiding element, into the skin; fixing the guiding element to the skin by, where present removing the tape foil and, applying the lower side of the first top element at least partially on to the skin of the subject, after a given time period removing the sealing component from the guiding element present in the skin of the subject by removing the second top element and the second bottom element, and inserting the needle in the channel of the guiding element into the blood vessel;

[0087] In the methods of the invention, after inserting the needle into the blood vessel, blood can be drawn from the blood vessel or entered into the blood vessel. In particular embodiments, a hemodialysis treatment can be performed.

[0088] In particular embodiments, the methods described herein are a method for hemodialysis using an assembly comprising a buttonhole device which is a plug and an adhesive system according to the invention, the method comprising: (a) inserting a needle into the skin of a subject to a blood vessel at a desired cannulation position to create a tunnel;

[0089] (b) performing dialysis i.e. removing blood, fdtering of the drawn blood and re-introduction of fdtered blood;

[0090] (c) removing the needle from said cannulation position;

[0091] (d) applying pressure on the blood vessel to stop the bleeding;

[0092] (e) inserting a buttonhole device, which is a plug comprising an elongated tube extending from a stopper section, whereby the diameter of the stopper section is at least double that of the diameter of the tube in the opening generated by the needle; and fixing the buttonhole device onto the arm of the patient by, where present removing the tape foil and, applying the lower side of the first top element at least partially on to the skin of the subject, and, after a given time period of rest ,

[0093] (f) removing the buttonhole device by removing the first top element attached to the first bottom element;

[0094] (g) inserting a needle through the formed tunnel towards the blood vessel;

[0095] (h) performing dialysis i.e. removing blood, filtering of the drawn blood and re-introduction of filtered blood;

[0096] (i) removing the needle from the formed tunnel; and thereafter

[0097] (j) applying pressure on the blood vessel to stop the bleeding;

[0098] Thereafter, steps (e) to (k) can be repeated several times.

[0099] In further embodiments, the buttonhole device is a guiding device comprising a guiding element and a sealing component, the method comprising the steps of:

[0100] (a) inserting a needle into the skin of a subject to a blood vessel at a desired cannulation position to create a tunnel;

[0101] (b) performing dialysis i.e. removing blood, filtering of the drawn blood and re-introduction of filtered blood;

[0102] (c) removing the needle from said cannulation position;

[0103] (d) applying pressure on the blood vessel to stop the bleeding;

[0104] (e) inserting a device according to the invention comprising a guiding element and a sealing component and the adhesive system of the invention in the opening generated by the needle;

[0105] (f) fixing the guiding device onto the arm of the patient by applying the lower side of the first top element at least partially on to the skin of the subject,

[0106] (g) and, after a given time period of rest (g),

[0107] (h) removing the sealing component from the guiding device by removing the second top element and the second bottom element; (i) inserting a needle through the guiding element towards the blood vessel;

[0108] (j) performing dialysis i.e. removing blood, filtering of the drawn blood and re-introduction of fdtered blood; and thereafter

[0109] (k) removing the guiding element from the subject by removing the first top element and the first bottom element; and, where necessary,

[0110] (l) applying pressure on the blood vessel to stop the bleeding;

[0111] Thereafter, steps (e) to (1) can be repeated several times. Preferably, steps (e) to (1) are repeated whereby a dialysis is performed using a device of the invention every 2 days for 3 to 6 weeks. In certain embodiments, steps (e) to (1) are repeated 5 to 20 times, preferably 9 to 18 times to establish a cannulation tunnel comprising scar tissue. It will be understood by the skilled person that while a new device is preferably used every time, the adhesive system and guiding device will preferably have the same characteristics and dimensions every time, to ensure that it promotes the formation of the exact same channel.

[0112] Accordingly in particular embodiments, the use of the methods according to the invention comprises repeated steps of:

[0113] (e) inserting a guiding assembly comprising a guiding element, and optionally a sealing component as described above, into a preformed tunnel; and

[0114] (f) fixing the guiding device onto the arm of the patient by applying the lower side of the first top element on to the skin of the subject,; and, after a given time period of rest (g),

[0115] (h) removing the sealing component from the guiding device by removing the second top element and the second bottom element;

[0116] (i) inserting a (sharp) needle through the guiding element towards the blood vessel;

[0117] (j) performing dialysis i.e. removing blood, filtering of the drawn blood and re-introduction of filtered blood; and thereafter

[0118] (k) removing the guiding element from the subject by removing the first top element together with the first bottom element; and, where necessary,

[0119] (l) applying pressure on the blood vessel to stop the bleeding;

[0120] When the channel has formed, the second phase of dialysis can start whereby blunt-tipped needles can be introduced directly into the channel for subsequent dialysis sessions. The blunt needles avoid damaging the wall of the (established) channel. As used herein, the terms “subject” or “patient” are generally used interchangeably and refer to animals, preferably warm-blooded animals, more preferably vertebrates, even more preferably mammals, still more preferably primates, and specifically includes human patients and non-human mammals and primates. Preferred subjects or patients are human subjects.

[0121] As detailed above, in particular embodiments, an adhesive system according to the invention is used in different steps of the channel formation, while the adhesive system and guiding device are preferably a single-use adhesive system and a single-use device. Accordingly, in particular embodiments, the invention provides a kit comprising more than one adhesive system and more than one guiding device. More particularly, the kit may comprise at least 2, 3, 4, 5, 6, 7, 8, 9, 10 or more adhesive system and at least 2, 3, 4, 5, 6, 7, 8, 9, 10 or more guiding devices, preferably each of these having the same characteristics and dimensions. The invention also envisages kits comprising adhesive systems and guiding devices of the present invention having varying dimensions to allow selection of the adhesive system and guiding device with the dimension most suitable for the envisaged use.

[0122] EXAMPLES

[0123] In order to better show the features of the invention, some preferred embodiments are described below, by way of example without any limiting character, with reference to the appended figures. The embodiments illustrated in the figures are preferred embodiments of the present invention and should not be construed as limiting in any way.

[0124] To further explain the adhesive system and its use, reference is made to figures 1 to 4. These figures show a preferred embodiment of the adhesive systems, assemblies and methods according to the present invention from different views.

[0125] The following numbering is used:

[0126] Figure 1A illustrates a representation of an embodiment of an adhesive system for handling a buttonhole device A which in this embodiment is a plug comprising an elongated tube extending from a stopper section, whereby the diameter of the stopper section is at least double that of the diameter of the tube.

[0127] The adhesive system comprises a first bottom element 100 and a first top element 200 each comprising an upper side 101, 201 and a lower side 102, 202. The first top element 200 is larger than the first bottom element 100. The first bottom element 100 comprises a hole 103 configured for receiving the tube Al of the buttonhole device. The first bottom element 100 comprises a continuous shape surrounding the hole 103, wherein, in this embodiment, the shape of the first bottom element 100 is circular. At least the lower side 202 of the first top element 200 is adhesive.

[0128] Figure IB illustrates the detail of an assembly of a buttonhole device (A) and an embodiment of the adhesive system of the invention comprising a first top element (200) and a first bottom element (100), showing how these elements are configured to be securted around the head of the buttonhole device. The buttonhole device can be a plug or a guiding element of a guiding device, which are all referred to herein as “A” as the features of A apply thereto, but could also be considered as embodiments A’ and A” respectively.

[0129] Figure 1C illustrates an assembly of a buttonhole device A and an alternative embodiment of an adhesive system of the invention comprising a first top element 200 and a first bottom element 100 showing how these elements are configured to be securted around the head of the buttonhole device. In this embodiment, the surface of the first top element 200 extends beyond the surface of the first bottom element 100. The lower side (202) of the first top element 200 is adhesive, such that the part that extends beyond the surface of the first bottom element 100 can adhere to the skin of the subject when applied thereto.

[0130] Figure 2 illustrates a representation of a preferred embodiment of an adhesive system for handling a guiding device comprising a guiding element A for guiding a needle in the skin, the guiding element A comprising a tube Al configured to guide the needle and a stopper section A2 and a channel A3 extending in a longitudinal direction at least from an opening A4 at the top end of the tube to the bottom end of the tube. The adhesive system comprises a first bottom element 100 and a first top element 200 each comprising an upper side 101, 201 and a lower side 102, 202. The first top element 200 is larger than the first bottom element 100. The first bottom element 100 comprises a hole 103 configured for receiving the tube Al of the guiding element A. The first bottom element 100 comprises a continuous shape surrounding the hole 103, wherein, in this embodiment, the shape of the first bottom element 100 is circular. The lower side 202 of the first top element 200 is adhesive and the upper side 101 of the first bottom element 100 is adhesive. In the embodiment illustrated in this figure, the first top element 200 further comprises two recesses 204 at its rim.

[0131] Figure 3 provides more detail of an embodiment of the adhesive system for handling a guiding device comprising a guiding element A according to the invention, with the elements as defined for Figure 1 and 2. In the embodiment illustrated in this figure, the adhesive system further comprises a tape foil 300 comprising at least a first part positioned to cover at least part of the adhesive lower side 202 of the first top element 200 in such a way that it covers the area of the adhesive lower side 202 of the first top element 200 extending beyond the area corresponding to the bottom element 100. In the embodiment, the first part of the tape foil 300 comprises two handles 301 that extend outward from the surface of the first top element 200. The first part of the tape foil 300 comprises two separable sections 303, 304, each section comprises a handle 301, 302, such that each section can be removed from the adhesive lower side 202 of the top element 200 independently. In the embodiment, the rim of the first top element 200 comprises two recesses 204 at positions corresponding to those of the handles 301, 302 of the tape foil 300. Figure 4 provides more detail of an embodiment of the adhesive system for handling a guiding device comprising a A and a sealing component B, with its compoentes as described for Figure 3. The guiding element A can be sealed by a sealing component B comprising a body Bl and a head B2, the body Bl configured to fit tightly within the channel of the guiding element A and the head B2 configured to fit into the stopper section A2 of the guiding element A. In the embodiment illustrated in this figure, the adhesive system further comprises a second bottom element 400 and a second top element 500, each comprising an upper side 401, 501 and a lower side 402, 502. Preferably, the upper side 401 of the second bottom element 400 is adhesive. The second bottom element 400 comprises a hole 403 configured for receiving the body Bl of the sealing component B. The second top element 500 is larger than the second bottom element 400, and the surface of the second top element 500 is smaller than that of the first top element 200 of the adhesive system. The head B2 of the sealing component B is tapered towards the body Bl of the sealing component B, and the second bottom element 400 is configured to receive the tapered head B2 of the sealing component B. The second bottom element 400 comprises an adhesive upper side 401 to attach the second bottom element 400 to the tapered head B2 of the sealing component B and the bottom side of the head B2. The head B2 of the sealing component B preferably comprises a rounded top B22, and the second top element 500 is configured to match the shape of the top B22 of the head B2 of the sealing component B. The second top element 500 preferably comprises an adhesive lower side 502 to adhere to the top B22 of the head B2 of the sealing component B.

[0132] Figure 5 illustrates a representation of an embodiment of an adhesive system for handling a guiding device, with its components as described for figure 3 and 4. In the embodiment illustrated in this figure, the second top element 500 extends beyond the second bottom element 400. The second top element 500 may comprise an adhesive on its lower side 502. The lower side 502 of the second top element 500 can be adhesive to the upper side 401 of the second bottom element 400 and the surface of the second top element 500 that extends beyond the second bottom element 400 can be adhesive to the first top element.

[0133] In particular embodiments the (e.g. acrylic) adhesive on the lower side (502) of the second top element has an adhesive strength that is lower than the (e.g. acrylic) adhesive strength of the adhesive of the lower side 202 of the first top element 200. In particular embodiments, the lower side ( 02) of the second top element can comprise a cover on the outer border (510), preferably of silicone, of which the adhesive strength is less than that of the center part of the lower side of the second top element.

[0134] Figure 6 illustrates the use of the adhesive system of the present invention in the context of the embodiment of performing hemodialysis on a subject. The buttonhole device is used to help ensure tunnel formation. There are two phases within the tunnel formation period: the first phase is during the first dialysis session. The second phase is repeated at subsequent dialysis sessions. The first phase is as illustrated from a to e which comprise: inserting a (sharp) needle into the skin of a subject to a blood vessel at a desired cannulation position (a); performing dialysis i.e. removing blood from the subject, filtering of the drawn blood and re-introduction of filtered blood into the subject (b); removing the needle from said cannulation position (c); applying pressure to stop the bleeding (d) inserting a buttonhole device which is a plug in the opening generated by the needle and fixing the buttonhole device by applying the first top element onto the skin of the arm of the patient(e) and after several days, removing the buttonhole device by removing the adhesive system (f) and again inserting a (sharp) needle into the skin of a subject to a blood vessel at a desired cannulation position (g). performing dialysis i.e. removing blood from the subject, filtering of the drawn blood and re- introduction of filtered blood into the subject (h), removing the needle from said cannulation position (i); applying pressure to stop the bleeding (j); and optionally repeating steps e-j with each dialysis session.

[0135] The second phase is used for all other dialysis sessions and includes steps (e) to (j). Indeed, after a given time period, typically every two days during which the element should be kept in place, before the next dialysis session, the steps comprise removing the buttonhole device by removing the first top element of the adhesive system (f) and thereby also removing the first bottom element; inserting a (sharp) needle into the (established) tunnel at the created cannulation position into a blood vessel (g); performing dialysis i.e. removing blood, filtering of the drawn blood and re-introduction of filtered blood (h); and thereafter, removing the needle from said cannulation position (i); applying pressure on the blood vessel to stop the bleeding (j). Thereafter, steps (e) to (j) can be repeated several times, i.e. a new adhesive system and buttonhole device (or assembly) according to the invention is inserted into the tunnel and is fixed onto skin of the arm of the patient by applying the lower side of the first top element to the skin of the patient.

[0136] Figure 7 illustrates another use of the adhesive system of the present invention in the context of the embodiment of performing hemodialysis on a subject. The guiding device is used to help ensure tunnel formation and the adhesive system is used to keep the guiding device in place. There are two phases within the tunnel formation period: the first phase is during the first dialysis session. The second phase is repeated at all subsequent dialysis sessions.

[0137] The first phase is as illustrated from a to g which comprise: inserting a (sharp) needle into the skin of a subject to a blood vessel at a desired cannulation position (a); performing dialysis i.e. removing blood from the subject, filtering of the drawn blood and re-introduction of filtered blood into the subject (b); removing the needle from said cannulation position (c); applying pressure to stop the bleeding (d); inserting a guiding element A with the sealing component present in the guiding element in the opening generated by the needle (e); and fixing the guiding element by applying the first top element to the opening of the guiding element and the skin of the patient (f); and maintaining the guiding element therein for several days (g) until the next dialysis session.

[0138] The second phase is used for all other dialysis sessions and includes steps (h) to (1). Indeed, after a given time period, typically every two days during which the device should be kept in place, before the next dialysis session, the steps comprise removing the sealing component from the guiding element by removing the second bottom element and the second top element (h); inserting a sharp needle through the guiding element towards the blood vessel (i); performing dialysis i.e. removing blood, filtering of the drawn blood and re-introduction of filtered blood (j); and thereafter, removing the guiding element from the subject together with the needle (k) by removing the first top element and the first bottom element; applying; pressure on the blood vessel to stop the bleeding (1);

[0139] Thereafter, steps (e) to (1) can be repeated several times, i.e. a new adhesive system and guiding device with sealing component (also referred to as guiding assembly) is inserted into the tunnel and are fixed onto skin of the arm of the patient by applying the first bottom element and first top element onto the skin of the arm of the patient. When the tunnel is formed stably, the further dialysis sessions can be performed using a blunt needle which is introduced into the tunnel without an adhesive system and guiding device according to the invention.

Claims

CLAIMS1. An adhesive system (1) for handling a buttonhole device (A) for creating a tunnel track in the skin a subject, the buttonhole device (A) being a plug or a guiding element of a guiding device, comprising a tube (Al) and a stopper section (A2), the diameter of the stopper section (A2) being at least twice the size of the diameter of the tube, the adhesive system comprising: a first bottom element (100) and a first top element (200) each comprising an upper side (101, 201) and a lower side (102, 202); wherein the surface of the first top element (200) is at least 20% larger than that of the first bottom element (100); wherein the first bottom element (100) comprises a hole (103) configured for receiving the tube (Al) of the buttonhole device (A), wherein the diameter of the hole (103) is smaller than the outer diameter of the stopper section (A2) of the buttonhole device (A); wherein the first bottom element (100) and the first top element (200) are configured to be secured around the stopper section (A2); and wherein at least the lower side (202) of the first top element (200) is configured for fixing on to the skin of the subject and is adhesive.

2. Adhesive system according to claim 1, wherein also the upper side (101) of the first bottom element (100) is adhesive.

3. Adhesive system according claim 1 or 2 wherein, the buttonhole device (A) is a guiding element of a guiding device for guiding a needle in the skin, wherein the tube comprises a stopper section (A2) with an opening (A4) toward a channel extending in a longitudinal direction from the top end of the tube (Al) to the bottom end of the tube (Al), and wherein the first top element (200) of the adhesive system comprises a hole (203) configured to match the opening (A4) in the stopper section (A2) of the guiding element.

4. Adhesive system according to any of the previous claims, further comprising tape foil (300) positioned to cover at least part of the adhesive lower side (202) of the first top element (200), in such a way that it covers the area of the adhesive lower side (202) of the first top element (200) extending beyond the area corresponding to the bottom element (100).

5. The adhesive system according to claim 4, wherein the tape foil (300) comprises at least one handle (301) extending outward from the surface of the first top element(200).

6. The adhesive system according to claims 4 or 5, wherein the first part of the tape foil (300) comprises two separable sections (303, 304), each section comprising a handle (301, 302), wherein each section can be removed from the adhesive lower side (202) of the top element (200) independently.

7. Adhesive system according to any of the previous claims, wherein the first bottom element (100) comprises a continuous shape surrounding the hole (103), preferably, wherein the shape is circular.

8. The adhesive system according to any of the previous claims, wherein the rim of the first top element (200) comprises one or more recesses (204).

9. The adhesive system according to claim 8, wherein the recesses (204) are located at positions corresponding to those of the one or more handles (301, 302) of the tape foil.

10. Adhesive system according to any of the previous claims, wherein the buttonhole device is the guiding element (A) of a guiding device, wherein the guiding element (A) can be sealed by a sealing component (B) comprising a body (Bl) and a head (B2), the body (Bl) configured to fit tightly within the channel (A3) of the guiding element (A) and the head (B2) configured to fit into the stopper section (A2) of the guiding element (A), whereby the adhesive system further comprises: a second bottom element (400) and a second top element (500) each comprising an upper side (401,501) and a lower side (402,502); wherein the second bottom element (400) and the second top element (500) are configured to be secured around the head (B2) of the sealing component (B); wherein at least the lower side (502) of the second top element (500) is configured for attaching to the upper side (201) of the first top element (200) and is adhesive; wherein the second bottom element (400) comprises a hole (403) configured for receiving the body (Bl) of the sealing component (B), wherein the diameter of the hole (403) is smaller than the largest outer diameter of the head (B22) of the sealing component (B), and wherein the surface of the second top element (500) is smaller than that of the first top element (200) of the adhesive system.

11. Adhesive system according to claim 10, wherein the upper side (401) of the second bottom element (400) is adhesive.

12. Adhesive system according to any one of claims 1 to 11, wherein the first bottom and top element and, where present, the second bottom and top element are transparent.

13. Adhesive system according to any one of claims 1 to 12, wherein the first bottom and top element, the tape foil and where present, the second bottom and top element are generally circular in shape.

14. A kit or assembly comprising one or more guiding adhesive systems according to any one of claims 1 to 13 and one or more buttonhole devices (A), comprising a tube (Al) and a stopper section (A2), thediameter of the stopper section (A2) being at least twice the size of the diameter of the tube, the kit characterized in that it comprises:- a buttonhole device which is a plug (A) and a first top (200) and bottom (100) element of the adhesive system of the preceding claims; or- a guiding device comprising a guiding element (A) for guiding a needle in the skin, the guiding element (A) comprising a tube (Al) configured to guide the needle and a stopper section (A2) and a channel (A3) extending in a longitudinal direction at least from an opening (A4) the top end of the tube to the bottom end of the tube (Al) and a first top (200) and bottom (100) element of the adhesive system of the preceding claims; or- a guiding device comprising a guiding element (A) for guiding a needle in the skin, the guiding element (A) comprising a tube (Al) configured to guide the needle and a stopper section (A2) and a channel (A3) extending in a longitudinal direction at least from an opening (A4) the top end of the tube to the bottom end of the tube (Al) and one or more a sealing components (B) comprising a body (Bl) and a head (B2), the body (Bl) configured to fit tightly within the channel (A3) of the guiding device (A) and the head (B2) configured to fit into the stopper section (A2) of the guiding device (A) and a first and second top (200, 400) and bottom (100, 200) element of the adhesive system of the preceding claims.

15. A method for facilitating the handling of a buttonhole device for creating a tunnel track in the skin a subject, the buttonhole device (A) comprising a tube (Al) and a stopper section (A2), the diameter of the stopper section (A2) being at least twice the size of the diameter of the tube, the method comprising, prior to introducing said buttonhole device (A) into the skin, positioning the adhesive system according to claim 1 to 13 on the buttonhole device (A), such that the stopper section (A2) of the buttonhole device (A) is placed between the first bottom element (100) and first top element (200) and said upper side of said first bottom (102) element adheres to the lower side of said first top element (201).

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