Device for guiding a needle

Abstract

The present invention relates to medical devices, more precisely medical devices in the field of cannulation techniques. In particular, the invention concerns a device to guide a needle and to support the formation of a tunnel in a subject's skin, and methods to use such a device in a subject.

Description

[0001] DEVICE FOR GUIDING A NEEDLE

[0002] Field of the invention

[0003] The invention is broadly in the field of medical devices, more precisely in the field of cannulation techniques. In particular, the invention concerns a device to guide a needle, and methods to use such a device in a subject.

[0004] BACKGROUND OF THE INVENTION

[0005] Patients suffering from renal disease require haemodialysis treatment at a frequency of 3 sessions per week. This procedure involves the insertion of a dialysis needle or indwelling needle into the patient's body. The needle is inserted through the skin and into the blood vessels, causing considerable pain to the individuals undergoing haemodialysis. Currently, there are several methods used for placing the dialysis needle or indwelling needle, one of which is the buttonhole cannulation technique.

[0006] The buttonhole cannulation technique involves creating a collagenous tunnel from the surface of the skin to the blood vessel by repeated puncturing at the same location. Accordingly, the exact same cannula is used for every dialysis session. This prevents aneurysms forming and offers other benefits such as reduced pain when needles go in and reduced bleeding times when the needles are removed.

[0007] During a first phase, a needle with a sharp tip is used for the cannulations, which is introduced at the same location and with the same angle. A tract or tunnel is formed from the skin to the blood vessel by the formation of scar tissue. It is important that during tract development, the insertion of the sharp needle is performed by the same person, or a limited number of persons. Once the tunnel has formed, in the second phase, blunt-tipped needles can be used for subsequent dialysis sessions, to avoid damaging the wall of the tract. These needles are inserted into the previously established tunnel or tract formed by the sharp needle.

[0008] The buttonhole cannulation technique is aimed at streamlining the process and improving patient comfort. While the buttonhole cannulation technique is a step forward, there are significant drawbacks. Creating a consistent tunnel through the skin and to the blood vessel is challenging, leading to difficulties in establishing a reliable path for subsequent needle insertions. The sharp needle can damage the developing tunnel, thereby causing bleeding and complication such as prolonging the formation time of the tunnel. In some cases, the tunnel might not form properly, making the buttonhole technique less effective.

[0009] In view thereof, there remains a need in the art for further and / or improved means and techniques for placement of indwelling needles and the concomitant haemodialysis treatment. SUMMARY OF THE INVENTION

[0010] One of the major challenges for the optimal effect of the buttonhole technique is avoiding damage to the channel during the generation thereof. The present inventors have developed a device to guide a needle during this phase of channel generation, thereby addressing one or more of the above- mentioned problems in the art.

[0011] Accordingly, a first aspect of the invention relates to a device for guiding a needle in the skin, the device comprising a guiding element and a sealing component which together facilitate the needle-insertion process. More particularly, the invention relates to a device for guiding a needle in the skin comprising: a guiding element, comprising a tube configured to guide a needle, the tube comprising a top end, a bottom end and a channel extending in a longitudinal direction in the tube from the top end to the bottom end of the tube; a sealing component configured to close at least the top end of the tube.

[0012] The present inventors realized that the device designed to guide a needle, as outlined in this invention, yields several advantages. The device does not only serve its primary purpose, guiding a needle, it also provides protection to the incipient puncture tunnel during its formative stages. This dual functionality simplifies the application of the buttonhole cannulation technique. Moreover, given its shape, it gives the user the possibility of free angulation (without the risk of damaging). Furthermore, employment of this device greatly reduces the dependency on the precision of needle insertion at a singular point and the accurate angle of insertion, especially during the formative stages of the puncture tunnel. Overall, this innovative device emerges as a great tool for advancing the efficacy, safety, and precision of the buttonhole cannulation technique.

[0013] In particular embodiments, the guiding element further comprises a stopper section connected to the top end of the tube, with an opening in direct connection with the channel, wherein the diameter and / or circumference of the stopper section is at least 50% larger than that of the tube. In particular embodiments, the outer wall of the stopper section is rounded. In certain embodiments, the tube has a length of 2 to 25 mm. In particular embodiments, the channel of the tube has an inner diameter of 0.5 to 2.5 mm. In particular embodiments, the sealing component is configured to fit at least partially in the channel of the tube of the guiding element. In certain embodiments, the sealing component is a Plug.

[0014] In certain embodiments of the device as provided herein, the sealing component comprises a head and a body extending from the head, wherein at least the body of the sealing component is configured to fit closely in the channel of the tube. In particular embodiments, the head comprises at least a stopper section with a diameter which is larger than the diameter of the body of the sealing component and is larger than the diameter of the channel. In particular embodiments, the head of the sealing component comprises a handle, allowing removal of the sealing component from the guiding element.

[0015] In certain embodiments, at least part of the opening of the stopper section of the guiding element is configured to correspond to the shape of the stopper section of sealing component.

[0016] In certain embodiments, the stopper section of the head of the sealing component has a frustoconical shape.

[0017] In particular embodiments of the invention the head of the sealing component comprises a distinct section, referred to herein as a topper element, which is connected to the stopper member, and has a rounded top side and a flat bottom side which extends over the stopper member. In particular embodiments, the body of the sealing component extends beyond the length of the channel of the tube. In particular embodiments, the body of the sealing component is at least 5 percent longer than the channel of tube. In certain embodiments, the body of the sealing component comprises, at the end opposing the head, a tip that is frustoconical.

[0018] In particular embodiments, the tube and / or the sealing component are manufactured of plastic such as polycarbonate (PC), polyethylene (PE), polypropylene (PP), polymethyl methacrylate (PMMA), polyethylene terephthalate (PET), polyvinyl chloride (PVC).

[0019] The invention further relates to methods of generating a channel for cannulating a subject comprising the steps of

[0020] (a) inserting a needle into the skin to blood vein at a desired cannulation position;

[0021] (b) removing the needle from said cannulation position and inserting the device according to the invention comprising the guiding element and the sealing component in the opening generated by the needle;

[0022] (c) removing the sealing component from the guiding element and inserting a needle through the guiding component towards the blood vein; and

[0023] (d) removing the guiding element together with the needle.

[0024] 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.

[0025] DESCRIPTION OF THE DRAWINGS 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.

[0026] Throughout the description, claims, and figures, the following numbering is used:

[0027] Figure 1A: illustrates an exploded representation of a device (1) according to an embodiment of the invention the invention. 100: guiding element; 101: tube; 102: top end; 103: bottom end; 104: channel; 105: stopper section; 106: opening; 200: sealing component ; 201: body; 202: head.

[0028] Figure IB: illustrates an assembled representation of a device (1) according to an embodiment of the invention. 100: guiding element; 105: stopper section; 106: opening; 201: body; 202: head.

[0029] Figure 2: illustrates a more detailed illustration of an embodiment of the guiding element (100). 101: tube; 102: top end; 103: bottom end; 104: channel; 105: stopper section; 106: opening; 107: outer wall of the tube; 108: outer wall of the stopper section.

[0030] Figure 3: illustrates a more detailed illustration of an embodiment of the sealing component (200). 201: body; 202: head; 203: top end of the tube; 204: bottom / distal end of the tube; 205: stopper member; 206: tip: 207: handle.

[0031] Figure 4: illustrates the assembled device according to an embodiment of the invention. 100: guiding element; 101: tube; 102: top end; 103: bottom end; 104: channel; 105: stopper section; 106: opening; 200: sealing component ; 201: body; 202: head; 206: tip: 207: handle.

[0032] Figure 5: illustrates a three-dimensional representation of a device according to an embodiment of the invention.

[0033] Figure 6: provides a more detailed illustration of another embodiment of the sealing component. 200: sealing component; 202 head; 205 stopper member 208: topper element; 209: bottom side; 210: top side.

[0034] Figure 7 provides another embodiment of an assembled device (1) according to the invention. 100: guiding element; 105: stopper section; 108: outer wall of the stopper section; 109: bottom part of the stopper section; 110: upper part of the stopper section; 200 sealing component; 205 stopper member; 208: topper element; 209: bottom side; 210: top side.

[0035] Figure 8: illustrates a use of the device according to an embodiment of the invention. 100: guiding element; 200: sealing component; (a) introduction of the device comprising guiding element and sealing component into the skin; (b) removal of sealing component; (d) introduction of sharp needle through the guiding element; (d) removal of the guiding element together with the sharp needle.

[0036] Figure 9: 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 device according to the invention comprising the guiding element and the sealing component in the opening generated by the needle; (f) fixing the device onto the arm of the patient with a tape; (g) the device is maintained in the same position during a time period; (h) removing the fixing aid; (i) removing the sealing component from the guiding element of the device; (j) inserting a sharp needle through the guiding element towards the blood vessel; (k) performing dialysis i.e. removing blood, filtering of the drawn blood and re-introduction of filtered blood; (I) removing the guiding element from the subject together with the needle; (m) applying pressure on the blood vessel to stop the bleeding; (n) inserting a device comprising a guiding element and the sealing component is into the tunnel; (o) fixing it onto the arm of the patient with a tape.

[0037] Figure 10: illustrates several steps of a use of the device according to an embodiment of the invention after it has been inserted into the skin and sealed off with an adhesive, (a) removing a fixing aid or adhesive; (b) removing the sealing component from the guiding element of the device; (c) inserting a sharp needle through the guiding element towards the blood vessel; (d) performing dialysis i.e. removing blood, filtering of the drawn blood and re-introduction of filtered blood; and thereafter, (e) removing the guiding element from the subject together with the needle; (f) applying pressure on the blood vessel to stop the bleeding; (g) inserting a device according to the invention comprising the guiding element and the sealing component in the opening generated by the needle (optionally by way of a holder which allows manipulation of the device by way of the stopper section of the guiding element and / or head of the sealing component without touching the skin); (h) fixing the device onto the arm of the patient with a tape or adhesive and (i) maintaining for a certain period until the next dialysis session.

[0038] DETAILED DESCRIPTION OF THE INVENTION

[0039] As used herein, the singular forms "a", "an", and "the" include both singular and plural referents unless the context clearly dictates otherwise.

[0040] 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.

[0041] 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.

[0042] 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 + / - % 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.

[0043] 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.

[0044] 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.

[0045] 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.

[0046] 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.

[0047] 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.

[0048] 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.

[0049] 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.

[0050] The inventors have developed a device for guiding a needle through the skin of a subject to a bloodvessel, the device comprising a guiding element and a sealing component. Particularly, the sealing component extends through the guiding component and can be removed to allow passage of the needle. As demonstrated by the drawings, which illustrate certain representative embodiments of the present invention, the invention provides a device for guiding a needle in the skin, the device comprising: a guiding element, comprising a tube configured to guide a needle, the tube comprising a top end, a bottom end and a channel extending in a longitudinal direction in the tube from the top end to the bottom end of the tube; the stopper section being connected to the top end of the tube, and comprising an opening (106) in direct connection with the channel , wherein the diameter and / or circumference of the stopper section is at least 50% larger than that of the tube and the stopper section having an outer wall wherein at least a bottom part of said outer wall connected to the outer wall of the tube is rounded or frustoconical; a sealing component configured to be removably positioned within at least the top end of the tube, thereby closing off the opening.

[0051] An advantage of the frustoconical or rounded outer wall is that it gives medical staff greater flexibility in all directions ( around the x , y and z axis) to manoeuvre the device, in particular the tube of the guiding element, while inserting the tube into the (developing) puncture tunnel and while inserting the needle into the guiding element toward the blood vessel. The rounded or frustoconical outer wall allows the tube's axis to adjust in relation to the (developing) puncture tunnel by rolling the guiding element over the stopper section's rounded outer wall. The outer wall of the stopper section of the guiding element is configured to rest on the skin's surface and preferably has a smooth surface so as not to damage the skin. This provides more comfort to the patient after insertion of the device. The outer diameter of the stopper section is typically about 1.5 mm to 20 mm, more particularly 4-6mm.

[0052] The guiding element is preferably provided so as to ensure positioning in the skin of the subject but not entering completely therein. The tube can be cylindrical, with an equal diameter at the top end of the tube of the bottom end of the.

[0053] In alternative embodiments, the tube can have a conically narrowing shape from the top end to the bottom end. The diameter of the tube is typically about 1 to 2.5 mm. Accordingly, in particular embodiments, the guiding element further comprises a stopper section connected to the top end of the tube, with an opening in direct connection with the channel. The device's stopper section prevents 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. The outer diameter and / or circumference of the stopper section is not critical but is preferably at least 50% larger than (the outer diameter of) the tube. For instance, the diameter of the tube is typically about 1 to 2.5 mm, and the stopper section can have a diameter of 1.5 mm to 20 mm, preferably of 2.5 mm to 15 mm, even more preferably of 3 mm to 10 mm, such as 4-6mm. Accordingly, in particular embodiments, the diameter of the stopper section is 4- 6mm and the outer diameter of the tube is about 2.5-3.5mm. Expressed in a different way, the circumference of the stopper section is greater than the circumference of the outer wall of the tube of the guiding element, preferably at least 1, 2, 3, 4, 5, 6, 7, 8 or 9 mm greater than the circumference of the outer wall of the tube of the guiding element. In particular embodiments, the upper part of the stopper section which contains the opening of the stopper section, has a flat surface. In alternative embodiments, the surface of the upper part of the stopper section has a three-dimensional pattern (see below).

[0054] The stopper section of the guiding element comprises an opening in direct connection with the channel of the guiding element. This opening is formed by the inner wall of the stopper section. In particular embodiments, the inner wall of the stopper section comprises a frustoconical shape. This shape can help guide the needle towards the channel of the guiding element. Indeed, in particular embodiments, the frustoconical shape of the opening of the stopper section corresponds to a large extent to the shape of the head of the needle used for the cannulation. In embodiments, the inner wall of the stopper section is rounded.

[0055] In the guiding element of the device of the invention, the length of the tube can vary and will depend on a number of variables, the location of the blood vessel to be reached (the distance from the skin surface to the blood vessel), the age of the patient etc. The length A of the tube can range for instance from 2 mm to 25 mm, preferably 3 mm to 23 mm, even more preferably from 3 mm to 10 mm.

[0056] The tube of the guiding element is hollow in that it contains a channel which runs from one end of the tube to the other. The length of the tube's channel is determined by the length of the tube. The diameter of the channel may vary depending on the diameter of the indwelling needle envisaged for use with the device. Exemplary needles used for haemodialysis are G17-G14, which have a diameter of 1.473 mm-2.108 mm. Accordingly, in particular embodiments, the channel comprises an inner diameter of 0.5 to 4mm, preferably 0.7 mm to 3.5 mm, preferably 1 mm to 3 mm, more preferably 1.1 to 2.8 mm, even more preferably 1.3 to 2.5 mm. In an exemplary embodiment, the inner diameter is about 1.95-2mm. In a particular embodiment, the diameter of the channel of the tube is only slightly greater than the outer diameter of the indwelling needle envisaged for use with the device, preferably about 0.3 mm greater than the outer diameter of the indwelling needle, more preferably at least 0.2 mm greater than the outer diameter of the indwelling needle, even more preferably at least 0.1 mm greater than the outer diameter of the indwelling needle.

[0057] In particular embodiments, the channel is cylindrical, with an equal diameter at the top end of the tube of the bottom end of the tube of the guiding element. In alternative embodiments, the channel can have a conically narrowing shape from the top end to the bottom end of the tube.

[0058] The channel's inner wall is preferably smooth. However, in alternative embodiments it can be textured, threaded, or a combination of smooth, textured and / or threaded. The device of the invention further contains a sealing component comprising at least a body which fits onto the guiding element and closes at least the top end thereof. More particularly, where the guiding element comprises a stopper section at the top end of the tube, the sealing component closes at least part of the opening of the stopper section. In particular embodiments, the body of the sealing component is configured to fit at least partially into the channel of the tube of the guiding element. Nevertheless, in particular embodiments, the sealing component contains one or more parts that extend beyond or protrude from the channel of the tube of the guiding element.

[0059] The dimensions of the sealing component may vary but are at least in part defined by the dimensions of the channel of the tube of the guiding element. More particularly, the diameter of the body of the sealing component is determined by the diameter of the channel of the guiding element. In particular embodiments, the diameter of the body of the sealing component is slightly smaller than the inner diameter of the channel, preferably at most 0.5 mm smaller than the inner diameter of the channel, more preferably at most 0.4 mm smaller than the inner diameter of the channel, even more preferably at most 0.3 mm smaller than the inner diameter of the channel. In particular embodiments, the body of the sealing component comprises an outer diameter of 0.5 to 4mm, preferably 0.7 mm to 3.5 mm, preferably 1 mm to 3 mm, more preferably 1.1 to 2.8 mm, even more preferably 1.3 to 2.5 mm, such as about 1.5-2mm, depending on the diameter of the tube of the guiding element. The shape of the body of the sealing component is preferably cylindrical with an identical diameter over its entire length. However, as the shape of the body of the sealing component is preferably complementary to the shape of the channel of the tube of the sealing component it can also be conical.

[0060] In certain embodiments, the sealing component is a plug.

[0061] As used herein, the term "plug" generally refers to a component configured to close, seal, or block the channel of the guiding element. In a particular embodiment, the sealing component serves the purpose of a barrier, preventing intrusion fluids, micro-organisms, or other substances from entering the channel of the guiding element, and thereby reducing the risk of infections and potential harm to the blood vessel and scar tissue formation inside the channel. The sealing however does not need to be airtight. Accordingly, the characteristics of the sealing component, including dimensions, shape, and composition, are adjusted to suit the features of the tube and channel of the guiding element.

[0062] In particular embodiments, the sealing component comprises a head and a body extending from the head, wherein at least part of the body of the sealing component is configured to fit closely in the channel of the tube of the guiding element. The body's shape and size is adapted to mirror the corresponding shape and size of the corresponding channel of the tube of the guiding element. The term "fit closely" in this context implies matching of dimensions between the body of the sealing component and the channel of the tube of the guiding element, while still allowing the body of the sealing component to move smoothly within the channel of the guiding element.

[0063] In a particular embodiment, the diameter of the body of the sealing component is slightly smaller than the inner diameter of the channel of the guiding element, preferably 0.5 mm or less smaller than the inner diameter of the channel, more preferably 0.4 mm or less smaller than the inner diameter of the channel, even more preferably 0.3 mm or less smaller than the inner diameter of the channel.

[0064] In particular embodiments, the body of the sealing component comprises an outer diameter of 0.5 to 4mm, preferably 0.7 mm to 3.5 mm, preferably 1 mm to 3 mm, more preferably 1.1 to 2.8 mm, even more preferably 1.3 to 2.5 mm.

[0065] The length of the body of the sealing component is determined by the length of the tube and channel of the guiding element. In particular embodiments, the length of the body of the sealing component extends beyond the length of the channel of the tube of the guiding element, such that, when the body of the sealing component is introduced into the channel of the guiding element, part of the body of the sealing component extends beyond the bottom part of the tube. In certain embodiments, the body of the sealing component is at least 5 percent longer than the tube, preferably at least 10% longer or even up to 15-20% longer than the channel / tube of the guiding element. This provides the advantage that the sealing component can be used to touch the blood vessel, preferably at the juncture where the needle punctured the blood vessel and where a clot is naturally formed. Effectively, the application of pressure by the sealing component promotes the stabilization of the clot and prevents bleeding and blood from entering the tunnel in the skin and the channel of the guiding element of the device. In alternative embodiments, the body of the sealing component comprises a similar or the same length as the length of the channel / tube.

[0066] As detailed above, the term 'bottom end" of the channel or tube generally refers to the end of the channel / tube that is inserted into the patient, typically also known as the distal end. Where the guiding element has a stopper section, this is at the end opposite to the bottom end of the tube of the guiding element. The corresponding end of the sealing component when introduced into the guiding element is also referred to herein as the bottom or distal end of the sealing component.

[0067] In particular embodiments, the body of the sealing component extends into a conical tip at the bottom or distal end (i.e., the end opposing the head). The tip can be formed as an extension of the body of the sealing component. Typically, at least this tip extends beyond the bottom end of the channel / tube of the guiding element, preferably both part of the body and the tip extend beyond the bottom end of the channel / tube of the guiding element when inserted completely therein.

[0068] In particular embodiments, the shape of the tip is blunt, frustoconical or rounded, so as to enable a smooth insertion of the device and avoid damage of the skin (including the tunnel and blood vessels therein) upon contact therewith. The tip of the body or the part of the body extending beyond the bottom end of the channel / tube of the guiding element may touch the blood vessel during use of the device of the invention.

[0069] In embodiments, the sealing component further comprises a protrusion extending from the top of the body, referred to herein as the head of the sealing component. The head of the sealing component comprises one or more features which prevents the body of the sealing component from sliding completely through the channel of the guiding element. In particular embodiments this feature corresponds to a widening of the body of the sealing component. In alternative embodiments, the head can comprise one or more protrusions, such that the total diameter of the sealing component taking into account the one or more protrusions extends beyond that of the channel of the guiding element. In particular embodiments, where the guiding element comprises a stopper section, the head of the sealing component comprises a stopper member that is configured to fit at least partly, closely in the stopper section of the guiding element. In particular embodiments, the head of the sealing component comprises a stopper member with a diameter which is larger than the diameter of the body of the sealing component and is larger than the diameter of the channel of the guiding element. The head of the sealing component, while preferably fitting closely into the opening of the stopping section, particularly at the top end of the tube, can be the same size, or smaller or larger than the opening of the stopping section of the guiding element. In particular embodiments, the head of the sealing component is smaller than that of the opening of the stopper section, so as to facilitate removal of the sealing component during use of the device.

[0070] The shape of at least part of the head of the sealing component (stopper member) preferably corresponds to the shape of the opening of the stopper section of the guiding element, particularly the section of the opening adjacent to the channel of the tube, so as to allow a close fit between the head of the sealing component (stopper member) and the opening of the stopper section. As detailed above, in particular embodiments, the shape of the opening of the stopper section is frustoconical. Accordingly, in particular embodiments, the stopper member of the head of the sealing component contains a frustoconical shape. Alternatively, the stopper member can have a rounded, square, or rectangular shape. In particular embodiments, the sealing component further comprises a topper element connected to the stopper member of the sealing component and extending therefrom that is configured to fit at least partly on the upper part of the stopper section of the guiding element. More particularly the topper element provides a rounded top surface of the sealing component extending over the at least part of, preferably all of the upper part of the stopper section of the guiding element. In this embodiment, the device when present in the skin will provide a smooth surface, which facilitates attachment e.g. with an adhesive.

[0071] Preferably, the features of the sealing component as described herein are adapted for use in combination with specific features of the guiding element. In particular embodiments, where the guiding element comprises a stopper section with an upper part that is flat, the head of the sealing component comprises a topper element that extends over the stopper member of the sealing component and also extends over the opening of the guiding element such that, when the sealing component is introduced into the guiding element, it is configured to fit onto at least part of the flat upper part of the stopper section of the guiding element. In particular embodiments, where the guiding element comprises a stopper section with a specified upper part, the topper element of the corresponding sealing component comprises a part extending over the of the sealing component with a bottom side configured to fit on the upper part of the stopper section. In particular embodiments both the upper part of the stopper section of the guiding element and the bottom side of the part of the topper element extending over the stopper member of the sealing component are flat. In further embodiments, both surfaces of the upper part of the stopper section and of the bottom side of the part of the topper element extending over the stopper member have a three-dimensional pattern such that there is a perfect fit. The outer most diameter of the topper element of the sealing component, while preferably fitting on the upper part of the stopper section of the guiding element, is preferably the same size, but can also be somewhat smaller than the outer most diameter of the stopper section of the guiding element.

[0072] In particular embodiments, the head of the sealing component further comprises a handle, facilitating removal of the sealing component from the guiding element, either manually or using a gripping tool, such as a tweezer. The handle can be executed in different manners. In particular embodiments, the handle comprises a protrusion connected to the head of the sealing component. In certain embodiments, the handle extends beyond the upper plane of the stopper section of the guiding element when the sealing component is positioned in the guiding element. The handle may have a variety of shapes, including square, rectangular, and cylindrical forms. In particular embodiments, the handle is flat, which facilitates gripping with tool. In particular embodiments, the handle has a circular shape. The handle can be adapted to specific preferences and / or requirements to allow easy manipulation. The handle can be provided with a grip or a textured surface to facilitate a more secure grasp of the handle, especially when using tweezers or forceps. In alternative embodiments, the handle corresponds to one or more recesses in the head of the sealing component. The recess may encompass a variety of shapes, including cross, square, rectangular and / or cylindrical forms. The recesses can be adapted to specific preferences and / or requirements to facilitate the removal of the sealing component.

[0073] In line with the above, in certain embodiments, at least part of the opening of the stopper section of the guiding element is configured to correspond to the shape of the stopper member of the sealing component.

[0074] The surface of the head and / or body of the sealing component of the device of the invention is preferably smooth. In particular embodiments however, it can be envisaged that at least part of the surface can be textured or threaded or a combination thereof.

[0075] The materials envisaged for the device of the present invention generally correspond to materials used in the production of medical devices of this type. Suitable, non-limiting examples of materials include plastic such as polycarbonate (PC), polyethylene (PE), polypropylene (PP), polymethyl methacrylate (PM MA), polyethylene terephthalate (PET), polyvinyl chloride (PVC).

[0076] In particular embodiments, at least part of the device according to the invention, and more particularly the bottom part of the guiding element (and optionally the sealing component) is covered with a composition which is bactericidal or has an antiseptic or bacterial coating to prevent the formation of biofilms. Suitable examples of such coatings include but are not limited to coatings with hydrophilic polymers such as hyaluronic acid, hydrogel coatings and heparin coatings, nanoplasma trimethyl silane coatings and covalently coupled quaternary ammonium silane coatings.

[0077] Although different elements such as the tube and the stopper section of the guiding element or the different parts of the sealing component can generally be moulded integrally by injection moulding, they may also be moulded separately and then combined together. The material utilised to create the different elements are preferably identical but may also be different.

[0078] As detailed herein, the device of the present invention is configured for direct application to the skin. The device thus does not require or comprise a support element that contacts the skin of a subject to support and fixate the tube of the guiding element. In particular embodiments, the device only comprises a guiding element and a sealing component as described herein. In another related aspect, the invention provides a kit comprising the device as described herein and the kit further comprising a holder adapted to releasably fit onto the guiding element, more particularly the stopper section of the guiding element and / or the head of the sealing component. Preferably the holder has an elongated shape (allowing easy manual manipulation thereof, or fitting onto a robotic arm) with one end configured to fit onto and / or lock onto the shape of the guiding element and / or head of the sealing component only (i.e. it does not contact the tube of the guiding element or the body of the sealing component), such that when fitted on the device it allows manipulation thereof without the holder coming in contact with the skin. More particularly, the holder can latch onto the device when the sealing component is placed therein. In particular embodiments, the guiding element and / or sealing component and optionally the holder comprise features which facilitate locking of the holder onto the guiding element and / or sealing component, such as protrusions, hooks etc. The locking of the holder onto the guiding element and / or sealing component may also be based on magnetic interaction. The size and shape of the remainder of the holder can vary as long as it does not prevent easy access to the guiding element and / or sealing component(s) for placement into (and optionally also removal from) the skin.

[0079] In further embodiments, the invention provides a kit comprising the device as described herein and one or more adhesives. In particular embodiments, the kit comprises an adhesive suitable for application over the guiding element when placed in the body. In particular embodiments, the kit comprises an adhesive suitable for application over the guiding element when assembled with the sealing component. An adhesive suitable for application over the guiding element extends over the top surface of the stopper section of the guiding element and comprises a hole which allows insertion of the sealing component or a needle therein. An adhesive suitable for application over the guiding element assembled with the sealing component extends over the top of the top surface of the head (topper element) of the sealing component (and the top surface of the guiding element if they are not of the same size).

[0080] In particular embodiments, the kit comprises both the device according to the invention, the holder and one or more adhesives as described herein.

[0081] In another related aspect, the invention provides methods of using the device as described herein. In particular embodiments, the invention provides a method for the cannulation of the skin in a subject, said method comprising: 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 device as described herein to allow tunnel formation from the skin's surface until the blood vessel.

[0082] In particular embodiments the blood vessel is an arteriovenous fistula (AVF), such as radiocephalica AVF, brachiocephalica AVF, and brachiobasilica AVF.

[0083] In particular embodiments, the method comprises, 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 device according to the invention comprising the guiding element and the sealing component in the opening generated by the needle; and, after a given time period, removing the sealing component from the guiding element of the device and inserting a needle through the guiding component 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 the needle.

[0084] In particular embodiments the method further comprises, after introducing the device of the invention into the body, the step of fixing the device into position with a fixing aid such as tape.

[0085] In yet another aspect, the invention provides a method for guiding a needle to a blood vessel in a subject, wherein the method involves the use of the device described herein.

[0086] In particular embodiments, said method comprises: introducing the device as described herein comprising the guiding element and the sealing component, wherein the sealing component is present in the guiding element, into the skin; removing the sealing component from the guiding element present in the skin of the subject; inserting the needle in the channel of the guiding element into the blood vessel;

[0087] 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 invention provides methods for hemodialysis, 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, filtering of the drawn blood and re-introduction of filtered 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 device according to the invention comprising a guiding element and a sealing component in the opening generated by the needle;

[0093] (f) fixing the device onto the arm of the patient with a fixing aid; and, after a given time period of rest (g),

[0094] (h) removing the fixing aid;

[0095] (i) removing the sealing component from the guiding element of the device;

[0096] (j) inserting a needle through the guiding element towards the blood vessel;

[0097] (k) performing dialysis i.e. removing blood, filtering of the drawn blood and re-introduction of filtered blood; and thereafter

[0098] (l) removing the guiding element from the subject together with the needle; and, where necessary,

[0099] (m) applying pressure on the blood vessel to stop the bleeding;

[0100] Thereafter, steps (e) to (m) can be repeated several times. Preferably, steps (e) to (m) 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 (m) 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 device will preferably have the same characteristics and dimensions every time, to ensure that it promotes the formation of the exact same channel.

[0101] In particular embodiments, where a holder is used, the method comprises in step (e), inserting a device according to the invention using a holder and , thereafter, removing the holder.

[0102] Accordingly in particular embodiments, the use of the methods according to the invention comprises repeated steps of:

[0103] (i) inserting a device according to the invention comprising a guiding element and a sealing component into the tunnel; and

[0104] (ii) fixing the device onto the arm of the patient with a fixing aid; and, after a given time period of rest (p),

[0105] (iii) removing the fixing aid;

[0106] (iv) removing the sealing component from the guiding element of the device;

[0107] (v) inserting a (sharp) needle through the guiding element towards the blood vessel;

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

[0109] (vii) removing the guiding element from the subject together with the needle; and, where necessary,

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

[0111] 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 tract.

[0112] 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.

[0113] As detailed above, in particular embodiments, a device according to the invention is used in different steps of the channel formation, while the device is preferably a single-use device. Accordingly, in particular embodiments, the invention provides a kit comprising more than one device according to the invention. More particularly, the kit may comprise at least 2, 3, 4, 5, 6, 7, 8, 9, 10 or more devices according to the invention, preferably each of these having the same characteristics and dimensions. The invention also envisages kits comprising devices of the present invention having varying dimensions to allow selection of the device with the dimension most suitable for the envisaged use.

[0114] The device of the invention can be placed with standard tweezers or other existing gripping tools. In particular embodiments, the device of the invention can be placed using a dedicated placement device. Accordingly, in particular embodiments, the kit may comprise, in addition to one or more devices of the invention, a dedicated placement device, i.e. a device which facilitates the placement of the device into the skin. In particular embodiments, such a placement device comprises an elongated section and a fitting section, whereby the fitting section fits onto the stopper section of the guiding element and / or the sealing component of the device. In particular embodiments, the placement device may further contain a fixing / releasing mechanism with a latch which can be easily operated with one hand to release the device according to the invention from the placement device after the device has been introduced into the subject's skin. In particular embodiments, the kit comprises one or more devices according to the invention each of which is fixed onto a placement device, ready for use.

[0115] EXAMPLES

[0116] 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.

[0117] To further explain the device and its use, reference is made to figures 1 to 7. These figures show a preferred embodiment of a device according to the present invention from different views.

[0118] The following numbering is used:

[0119] Figure 1A illustrates a representation of a preferred embodiment of device 1 comprising a guiding element 100 and a sealing component 200 according to the invention. In the example shown in figure 1A, the right panel presents a front view, while the left panel presents a view on section A. As illustrated in the left panel, the guiding element 100 contains a tube 101 comprising a top end 102, a bottom end 103 and a channel 104 extending in a longitudinal direction in the tube 101 from the top end 102 to the bottom end 103 of the tube 101. In the embodiment illustrated in this figure, the guiding element 100 further comprises a stopper section 105 connected to the top end 102 of the tube 101, with an opening 106 in direct connection with the channel 104. The sealing component 200 contains a body 201 and a head 202.

[0120] Figure IB illustrates a cross-section of the device 1 according to an embodiment of the invention when the sealing component is introduced into the guiding component, which demonstrates how the shape of the body 201 and head 202 of the sealing component 200 correspond to the opening 106 of the stopper section of the guiding element 100.

[0121] Figure 2 provides more detail of an embodiment of the guiding element 100 of the device 1 according to the invention. The tube 101 has a length A and a diameter B. The length A of the tube 101 determines the length C of the channel 104. The diameter D of the channel 104 can vary and depends on the size of the needle used. The stopper section 105 of the guiding element has a length E and a diameter F. The diameter F of the stopper section 105 of the guiding element 100 at it widest point in this embodiment is more than 50% larger than the diameter B of the tube 101. The outer wall 107 of the tube 101 is smooth. The bottom part 109 of the outer wall 108 of the stopper section is rounded.

[0122] Figure 3 provides more detail of an embodiment of the sealing component 200 of the device 1 according to the invention. The body 201 has a length G between the top end 203 and the lower / distal end 204 and has a diameter H. The head 202 has a length I and a diameter J. The head 202 comprises a stopper member 205 with a length K and a widest diameter L, wherein, in this embodiment, the diameter L is larger than the diameter H of the body 201 of the sealing component 200. The stopper member 205, in this case, is executed to have a frustoconical shape. The body 201 of the sealing component 200 comprises a cylindrical shape with the same diameter from the top end 203 of the body 201 until the lower / distal end 204 of body 201. At the lower / distal end 204, the body 201 extends into a tip 206, and is in this embodiment executed in a frustoconical shape. Additionally, the head 202 of the sealing component 200 comprises a handle 207, which is connected to the head 202 of the sealing component 200. In this embodiment the length G of the body 201 is longer than the length A of the tube 101 of the guiding element 100, such that when assembled, at least the tip 206 of the body 201 extends through the tube 101.

[0123] Figure 4 provides schematical representation of an embodiment of the device 1 as assembled with the different components of the guiding element (tube 101 (with top end 102 and distal end 103), channel 104 and stopper section 105. With opening 106) and sealing component 200 (body 201 (top end 203 and lower / distal end 204), head 201, tip 206, and handle 207).

[0124] Figure 5 illustrates a three-dimensional representation of the device according to an embodiment of the invention.

[0125] Figure 6 provides a front view of an embodiment of the sealing component 200 of the device 1 according to the invention. The head 202 of the sealing component 200 further comprises a topper element 208 which is connected to the stopper member 205 of the sealing component 200. The topper element 208 comprises a part extending over the stopper member 205 which comprises a bottom side 209 that is connected to the stopper member 205. The bottom side 209, in this embodiment, is executed to be flat. The topper element 208 further comprises a top side 210. The top side 210, in the exemplary figure has a rounded shape. This is advantageous for the application of an adhesive over the sealing component when present in the guiding element.

[0126] Figure 7 provides schematical representation of a transversal section of an embodiment of the device 1 wherein the guiding element 100 and the sealing component 200 are assembled. The upper part of the stopper section 110 of the guiding element 100 is flat and the sealing component 200 comprises a topper element 208 with a part which has a flat bottom side 209 extending over the stopper member 205 . In this embodiment the topper element 208 of the sealing component 200 aligns with the upper side of the stopper section 105 of the guiding element. The widest diameter M of the topper element 208 of the sealing component 200 is the same as the widest diameter F of the stopper section 105 of the guiding element 100.

[0127] Figure 8 illustrates the use of the device according to the invention. In a first step (a) the device 1 comprising the guiding element 100 and sealing component 200 is introduced into the skin in a cannulation hole made by a sharp needle. In a next step (b) the sealing component 200 is removed from the guiding element 100. In a next step (c) a sharp needle is inserted through the guiding component 100 and into the blood vessel. In the last step (d) the needle and guiding element 100 are removed from the skin.

[0128] Figure 9 illustrates the use of the device of the present invention in the context of the embodiment of performing hemodialysis on a subject. The 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 all subsequent dialysis sessions.

[0129] 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 device according to the invention comprising the guiding element and the sealing component in the opening generated by the needle (optionally by way of a holder fitting onto the device) (e); fixing the device onto the arm of the patient with a tape or adhesive (f) and maintaining for several days (g) until the next dialysis session.

[0130] The second phase is used for all other dialysis sessions and includes steps (h) to (I). 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 fixing aid or adhesive (h); removing the sealing component from the guiding element of the device (i); inserting a sharp needle through the guiding element towards the blood vessel (j); performing dialysis i.e. removing blood, filtering of the drawn blood and re-introduction of filtered blood (k); and thereafter, removing the guiding element from the subject together with the needle (I); applying pressure on the blood vessel to stop the bleeding (m); Thereafter, steps (e) to (m) are repeated several times, i.e. a new device according to the invention comprising the guiding element and the sealing component is inserted into the tunnel (n) (or (e)) and this is fixed onto the arm of the patient with a tape (f) (or (o)) etc.

[0131] Figure 10 illustrates the use of the device according to an embodiment of the present invention. The device is used to help ensure tunnel formation. This figure demonstrates the use of the device in the context of blood withdrawal and describes the steps once the device has been inserted into the skin and sealed off with an adhesive. The steps illustrated are the removing of the fixing aid or adhesive (a); removing the sealing component from the guiding element of the device (b); inserting a sharp needle through the guiding element towards the blood vessel (c); performing dialysis i.e. removing blood, filtering of the drawn blood and re-introduction of filtered blood (d); and thereafter, removing the guiding element from the subject together with the needle (e); applying pressure on the blood vessel to stop the bleeding (f); inserting a device according to the invention comprising the guiding element and the sealing component in the opening generated by the needle (optionally by way of a holder fitting onto the device) (g); fixing the device onto the arm of the patient with a tape or adhesive (h) and maintaining for a certain period (i) until the next dialysis session.

[0132] When the tunnel is formed stably, the further dialysis sessions are performed using a blunt needle which is introduced into the tunnel without a device according to the invention.

Claims

CLAIMS1. A device (1) for guiding a needle in the skin, the device (1) comprising:■ a guiding element (100), comprising a tube (101) configured to guide the needle and a stopper section (105), the tube (101) comprising a top end (102), a bottom end (103) and a channel (104) extending in a longitudinal direction in the tube (101) from the top end (102) to the bottom end (103) of the tube (101); the stopper section (105) being connected to the top end (102) of the tube (101), and comprising an opening (106) in direct connection with the channel (104), wherein the diameter and / or circumference of the stopper section (105) is at least 50% larger than that of the tube(103) and the stopper section having an outer wall (108) wherein at least a bottom part of said outer wall connected to the outer wall of the tube (107) is rounded or frustoconical;■ a sealing component (200) configured to be removable positioned within at least the top end (102) of the tube (101), thereby closing off the opening (106).

2. The device according to claim 1, wherein the stopper section (105) comprises an upper part with a flat surface, which contains the opening (106) of the stopper section (105).

3. The device according to any of the claims 1 to 2, wherein the sealing component (200) is configured to fit at least partially in the channel (104) of the tube (101) of the guiding element (100).

4. The device according to any of the claims 1 to 3, wherein sealing component (200) is a plug.

5. The device according to any of the claims 1 to 4, wherein the sealing component (200) comprises a body (201) and a head (202), the body (201) extending from the head (202), wherein at least the body (201) of the sealing component (200) is configured to fit closely in the channel (104) of the tube (101).

6. The device according to claim 5, wherein the head (202) of the sealing component (200) comprises at least a stopper member (205) with a diameter which is larger than the diameter of the body (201) of the sealing component (200) and is larger than the diameter of the channel(104) of the guiding element (100).

7. The device according to claim 5 or 6, wherein the head (202) of the sealing component (200) comprises a handle (207), allowing removal of the sealing component (200) from the guiding element 100).

8. The device according to any one of claims 5 to 7, wherein at least part of the opening (106) of the stopper section (105) of the guiding element (101) is configured to correspond to the shape of the stopper member (205) of sealing component (200).

9. The device according to claim 8, wherein the stopper member (205) of the head (202) of the sealing component (200) has a frustoconical shape.

10. The device according to any one of claims 1 to 9, wherein the head (202) of the sealing component comprises a topper element (208) connected to the stopper member (205), which has a rounded top side (210) and extends over the stopper member (205) with a flat bottom side (209).

11. The device according to any of the claims 5 to 10, wherein the body (201) of the sealing component (200) extends beyond the length of the channel (104) of the tube (101).

12. The device according to claim 11, wherein the body (201) of the sealing component (200) is at least 5 percent longer than the channel (104) of tube (101).

13. The device according to any of the claims 5 to 12, wherein the body (201) of the sealing component (200) comprises, at the distal end (204) opposing the head (202), a tip (206) that is frustoconical.

14. The device according to any of the claims 1 to 13, wherein the guiding element (100) and / or the sealing component (200) are manufactured at least in part of plastic such as polycarbonate (PC), polyethylene (PE), polypropylene (PP), polystyrene, polymethyl methacrylate (PMMA), polyethylene terephthalate (PET), polyvinyl chloride (PVC).

15. A kit comprising the device according to any one of claims 1 to 14, further comprising one or more of:- a holder adapted to releasably fit onto the guiding element and / or the sealing component;- one or more adhesives fitting onto the guiding element and / or the sealing component.

16. A method for generating a tunnel for cannulating a subject comprising the steps of:(a) inserting a needle into the skin to a blood vessel at a desired cannulation position, said method comprising:(b) removing the needle from said cannulation position and inserting the device according to any one of claims 1 to 14 comprising the guiding element (100) and the sealing component (200) in the opening created by the needle;(c) removing the sealing component (200) from the guiding element (100) and inserting the needle through the guiding component towards the blood vessel; and(d) removing the sealing component (200) from the subject together with the needle.

Images