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WO2025046091A1 - Dispositif de guidage d'une aiguille - Google Patents

Dispositif de guidage d'une aiguille Download PDF

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Publication number
WO2025046091A1
WO2025046091A1 PCT/EP2024/074323 EP2024074323W WO2025046091A1 WO 2025046091 A1 WO2025046091 A1 WO 2025046091A1 EP 2024074323 W EP2024074323 W EP 2024074323W WO 2025046091 A1 WO2025046091 A1 WO 2025046091A1
Authority
WO
WIPO (PCT)
Prior art keywords
sealing component
guiding element
tube
needle
channel
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/EP2024/074323
Other languages
English (en)
Inventor
Lukas VAN CAMPENHOUT
Florentijn VANDECASTEELE
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Universiteit Antwerpen
Original Assignee
Universiteit Antwerpen
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Universiteit Antwerpen filed Critical Universiteit Antwerpen
Publication of WO2025046091A1 publication Critical patent/WO2025046091A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3287—Accessories for bringing the needle into the body; Automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/42—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
    • A61M5/425—Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1585—Needle inserters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0258—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body for vascular access, e.g. blood stream access
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0276—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body for introducing or removing fluids into or out of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0288—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body protectors, caps or covers therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0294—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body having a specific shape matching the shape of a tool to be inserted therein, e.g. for easy introduction, for sealing purposes, guide

Definitions

  • the invention is broadly in the field of medical devices, more precisely in the field of cannulation techniques.
  • the invention concerns a device to guide a needle, and methods to use such a device in a subject.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • given its shape it gives the user the possibility of free angulation (without the risk of damaging).
  • 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.
  • this innovative device emerges as a great tool for advancing the efficacy, safety, and precision of the buttonhole cannulation technique.
  • 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.
  • the outer wall of the stopper section is rounded.
  • the tube has a length of 2 to 25 mm.
  • the channel of the tube has an inner diameter of 0.5 to 2.5 mm.
  • the sealing component is configured to fit at least partially in the channel of the tube of the guiding element.
  • the sealing component is a Plug.
  • 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.
  • 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.
  • the head of the sealing component comprises a handle, allowing removal of the sealing component from the guiding element.
  • 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.
  • the stopper section of the head of the sealing component has a frustoconical shape.
  • 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.
  • the body of the sealing component extends beyond the length of the channel of the tube.
  • the body of the sealing component is at least 5 percent longer than the channel of tube.
  • the body of the sealing component comprises, at the end opposing the head, a tip that is frustoconical.
  • 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).
  • plastic such as polycarbonate (PC), polyethylene (PE), polypropylene (PP), polymethyl methacrylate (PMMA), polyethylene terephthalate (PET), polyvinyl chloride (PVC).
  • the invention further relates to methods of generating a channel for cannulating a subject comprising the steps of
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Figure 5 illustrates a three-dimensional representation of a device according to an embodiment of the invention.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • “one or more” or “at least one” may refer to 1, 2, 3, 4, 5, 6, 7 or more.
  • 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.
  • the sealing component extends through the guiding component and can be removed to allow passage of the needle.
  • 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.
  • 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
  • the frustoconical or rounded outer wall 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • the inner wall of the stopper section is rounded.
  • 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.
  • 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.
  • 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.
  • the inner diameter is about 1.95-2mm.
  • 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.
  • 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.
  • the channel can have a conically narrowing shape from the top end to the bottom end of the tube.
  • 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.
  • 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.
  • 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.
  • 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.
  • the sealing component is a plug.
  • the term "plug” generally refers to a component configured to close, seal, or block the channel of the guiding element.
  • 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 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the length of the body of the sealing component is determined by the length of the tube and channel of the guiding element.
  • 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.
  • 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.
  • 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.
  • the body of the sealing component comprises a similar or the same length as the length of the channel/tube.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the shape of at least part of the head of the sealing component 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.
  • the shape of the opening of the stopper section is frustoconical.
  • the stopper member of the head of the sealing component contains a frustoconical shape.
  • the stopper member can have a rounded, square, or rectangular shape.
  • 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.
  • the device when present in the skin will provide a smooth surface, which facilitates attachment e.g. with an adhesive.
  • the features of the sealing component as described herein are adapted for use in combination with specific features of the guiding element.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the handle comprises a protrusion connected to the head of the sealing component.
  • 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.
  • the handle is flat, which facilitates gripping with tool.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • the device only comprises a guiding element and a sealing component as described herein.
  • 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.
  • 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.
  • the holder can latch onto the device when the sealing component is placed therein.
  • 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.
  • the invention provides a kit comprising the device as described herein and one or more adhesives.
  • the kit comprises an adhesive suitable for application over the guiding element when placed in the body.
  • 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).
  • the kit comprises both the device according to the invention, the holder and one or more adhesives as described herein.
  • the invention provides methods of using the device as described herein.
  • 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.
  • the blood vessel is an arteriovenous fistula (AVF), such as radiocephalica AVF, brachiocephalica AVF, and brachiobasilica AVF.
  • AVF arteriovenous fistula
  • 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.
  • 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.
  • 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.
  • 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;
  • blood can be drawn from the blood vessel or entered into the blood vessel.
  • a hemodialysis treatment can be performed.
  • 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;
  • steps (e) to (m) can be repeated several times.
  • 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.
  • 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.
  • the method comprises in step (e), inserting a device according to the invention using a holder and , thereafter, removing the holder.
  • the use of the methods according to the invention comprises repeated steps of:
  • 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.
  • 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.
  • a device according to the invention is used in different steps of the channel formation, while the device is preferably a single-use device.
  • 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.
  • the device of the invention can be placed with standard tweezers or other existing gripping tools.
  • the device of the invention can be placed using a dedicated placement device.
  • 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.
  • a dedicated placement device i.e. a device which facilitates the placement of the device into the skin.
  • 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.
  • 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.
  • the kit comprises one or more devices according to the invention each of which is fixed onto a placement device, ready for use.
  • 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.
  • the right panel presents a front view
  • the left panel presents a view on section A.
  • 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.
  • 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.
  • 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.
  • FIG. 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.
  • FIG. 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.
  • 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).
  • the guiding element tube 101 (with top end 102 and distal end 103), channel 104 and stopper section 105.
  • opening 106 With opening 106) and sealing component 200 (body 201 (top end 203 and lower/distal end 204), head 201, tip 206, and handle 207).
  • Figure 5 illustrates a three-dimensional representation of the device according to an embodiment of the invention.
  • 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.
  • 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 .
  • 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.
  • Figure 8 illustrates the use of the device according to the invention.
  • 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.
  • the sealing component 200 is removed from the guiding element 100.
  • a sharp needle is inserted through the guiding component 100 and into the blood vessel.
  • the needle and guiding element 100 are removed from the skin.
  • 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.
  • the second phase is repeated at all subsequent dialysis sessions.
  • 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.
  • the second phase is used for all other dialysis sessions and includes steps (h) to (I).
  • steps (h) to (I) 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.
  • 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.
  • the further dialysis sessions are performed using a blunt needle which is introduced into the tunnel without a device according to the invention.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Veterinary Medicine (AREA)
  • Hematology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Dermatology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention concerne des dispositifs médicaux, plus précisément des dispositifs médicaux dans le domaine des techniques de canulation. En particulier, l'invention concerne un dispositif pour guider une aiguille et pour permettre la formation d'un tunnel dans la peau d'un sujet, et des procédés d'utilisation d'un tel dispositif chez un sujet.
PCT/EP2024/074323 2023-09-01 2024-08-30 Dispositif de guidage d'une aiguille Pending WO2025046091A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP23194785.4 2023-09-01
EP23194785 2023-09-01

Publications (1)

Publication Number Publication Date
WO2025046091A1 true WO2025046091A1 (fr) 2025-03-06

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2024/074323 Pending WO2025046091A1 (fr) 2023-09-01 2024-08-30 Dispositif de guidage d'une aiguille

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WO (1) WO2025046091A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4318401A (en) * 1980-04-24 1982-03-09 President And Fellows Of Harvard College Percutaneous vascular access portal and catheter
US20030023208A1 (en) * 2001-07-24 2003-01-30 Osypka Thomas P. Apparatus for vascular access
US20190046233A1 (en) * 2016-03-29 2019-02-14 Medtronic, Inc. Skin surface indwelling device for guiding punctures

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4318401A (en) * 1980-04-24 1982-03-09 President And Fellows Of Harvard College Percutaneous vascular access portal and catheter
US20030023208A1 (en) * 2001-07-24 2003-01-30 Osypka Thomas P. Apparatus for vascular access
US20190046233A1 (en) * 2016-03-29 2019-02-14 Medtronic, Inc. Skin surface indwelling device for guiding punctures

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