A modular phlebotomy training device

Abstract

The present invention relates to a modular phlebotomy training device 99 comprising a substrate 20 representing a body part, a skin covering 3, and a fluid-filled tube 1. The fluid-filled tube is embedded in the substrate and is removable. The substrate may include one or more channels for receiving one or more tubes. The substrate may further comprise a receiving section 21 for receiving a removable insert 4. Multiple removable inserts may have different sized or shaped channels. The skin covering may comprise a closure means and be provided in a plurality of thicknesses and / or skin tones.

Description

Field of the Invention The present invention relates to a modular phlebotomy training device, particularly a device fortraining users in the intra-venous injection technique. Background Intra-venous cannulation and securing a vein is a basic medical technique, and it is a factor that concerns all societies across the world; It relates to phlebotomy, emergency medicine, anaesthetic provision, long-term care for hospitalized patients, paramedic (emergency) treatment and general medical care. Phlebotomists and all medical care workers’ training will usually be entirely “on the job” and include learning to take blood from different patient groups, including children and the elderly. Securing venous access can be challenging and difficult to learn effectively when dealing with real people, as improper techniques may cause pain and discomfort as well as contribute to anxiety. Prior Art US 2023 0 237 931 (BUTTER et al.) discloses a vein simulator can enable a clinician to perform a PIVC workflow. This workflow can include preparation of simulated skin, insertion of a PIVC into a simulated vein, flushing a line of the PIVC and dressing and securing the PIVC to the simulated skin. The vein simulator may be formed of simulated tissue, simulated skin that is integrated into the simulated tissue, and an embedded simulated vein that may be positioned within a protruding vein channel. Because the simulated skin is integrated into the simulated tissue, the vein simulator will provide a more realistic experience while practicing the workflow. A vein simulator may indude one or more sensors to provide real-time feedback to a clinician while practicing the workflow. GB 2020 16 707 (LARGE) discloses a venepuncture simulation kit comprises a limb core, at least one cover, and a fastener for securing the cover around the core. The cover comprises an inner layer and an outer layer, the inner layer being in direct contact with the core and configured to receive simulation veins. The outer layer of the cover comprises first and second portions, each comprising a plurality of openings 30 and configured to receive the fastener. In use, the first and second portions are configured to butt up against one another to enclose the inner layer and the core. A fastener is also disclosed. CN 209 070 828 (CHEN) discloses a simulated transfusion device for teaching is characterized by comprising a simulation arm, a three-way pipe, a transfusion pipe and a drainage bag; the main body of the simulation arm is in a shape of a human arm, a silica gel skin for simulating skin is coated outside the main body, two pipe holes are formed in the silica gel skin, and one pipe hole is formed in the position, close to the elbow, of the inner side of the forearm and serves as a vein intubation inlet; the other pipe hole is arranged at the position of the outer side of the upper arm close to the upper end part of the arm and is used as a liquid discharge outlet; a hollow area is arranged in the middle of the main body of the simulation arm, and two pipe holes in the silica gel skin are communicated with the hollow area; the infusion tube is arranged in the hollow area and is positioned under the surface of the silica gel; one end of the infusion tube extends out of the venous cannula inlet of the silica gel skin and is connected with one tube opening in the three-way tube; the other end of the transfusion tube extends out of a liquid discharge outlet of the silica gel skin and is connected with the drainage bag the other two pipe orifices of the three-way pipe are provided with replaceable sealing rubber plugs which can be used for acupuncture. Summary of the Invention According to the present invention, a modular phlebotomy training device provides a substrate representing a body part, a skin covering, and a pressurized fluid tube. The design of the tube allows it to be embedded in the substrate and easily removed from it. In this way, the device of the present invention may provide a dummy for practicing the insertion of a cannula into a vein. It can be envisaged that embodiments of the device represent a section of a forearm (ACF) and a hand, both of which come in different sizes. We envision that we will make these mannequin bodies from a soft material to mimic human body parts. Additionally, it will include pre-made channels in the device to allow for the insertion of replaceable fluid-filled veins as needed, along with various "skins” that can be pulled over the assembly. Additionally or alternatively, users may replace, revise, or swap parts of the dummy to allow for greater longevity and flexibility of use. In some embodiments of the device, the substrate comprises one or more channels to house the tube. This may enable the tube to be used in more than one location and / or may enable the tube to have more than one branch. In some embodiments of the device, the substrate comprises a displaceable section and a receiving section, to allow for revision of channels, for example allowing a user to practise on different sections with different diameter tubes. In some such embodiments of the device, the receiving section includes a receiving slot, which allows for easy slotting of the displaceable section into place. In some embodiments of the device, the receiving secHon has a narrowed mouth, ensuring that the displaceable section remains secure once located. In some embodiments of the device, the substrate (receiving section) comprises a plurality of different diameter channels, which may be in the displaceable section, or arranged about a monolithic substrate. In some such embodiments of the device, the narrowed mouth of the channels ensures that the tube can be pushed into place and held securely, for example, by utilizing resilient deformation in the tube. In embodiments of the device, the device comprises a resiliently deformable substrate, to better represent a body part. In embodiments of the device, the tube comprises pressurized and coloured fluid to mimic venous pressure in human patients. In some embodiments of the device, the skin covering comprises a closure and covering means allowing the covering of the pressurized tube and body substrate. In some embodiments of the device, the skin covering comprises a plurality of depths of material, to allow for practising on such. The skin covering may include information or data, printed, or embossed, or debossed to show relation to thickness of “skin". We can imagine that the skin covering may allow movement to mimic human skin. We envision having an assortment of “skin” colours to represent different skin tones. We envision medical carers having a variety of skin tones to choose from when using the mannequin. We will now describe a preferred embodiment of the invention by way of example only and with reference to the Figures in which: Brief Description of Figures r Figure 1: shows an isometric view of a first embodiment of a device according to the present invention. Figure 2: shows a reverse isometric view of the embodiment of the device shown In Figure 1. Figure 3: shows an exploded isometric view of the embodiment of the device shown in Figure 1. Figure 4: shows a reverse exploded isometric view of the embodiment of the device shown in Figure 1. Figure 5: shows an isometric view of a second embodiment of a device according to the present invention. Figure 6: shows a reverse isometric view of the embodiment of the device shown in Figure 5. Figure 7: shows an exploded isometric view of the embodiment of the device shown in Figure 5. Figure 8: shows a reverse exploded isometric view of the embodiment of the device shown in Figure 5. Figures 9 show diagrammatic views of the dimensions of embodiments of the device, as shown in Figure 1 and Figure 5, respectively. Figure 10 shows a sectional view of a skin covering for an embodiment of a device according to the present invention. Figures 11 show diagrammatic views of channels for inserts in embodiments of the device according to the present invention. Detailed Description of Figures The figures show two embodiments 99,199 of modular phlebotomy training devices, which comprise a substrate 20,70 that represents a body part, a skin covering 3,6, and a fluid tube 1. The tube is designed to be embedded in the substrate and can be displaced from it. In particular, reference to the embodiment shown in Figure 1, the embodiment 99 comprises a representation of an antecubital fossa (ACF) as known in the art. The substrate 20 comprises a solid resiliently deformable material, such as silicone, to replicate a body part structure, and which has a flat bottom 23, which allows the resting of the embodiment on a surface to be easy and stable. The substrate includes a slot 21 that forms a receiving section for an insert 4 or displaceable section. In use, the insert is inserted into the receiving section to create a continuous substrate. Such insert may be a monolithic part envisaged to be formed in the same material as the receiving section. Further embodiments may comprise monolithic whole substrates. The slot comprises a longitudinally extending indentation into the top face of the receiving section. The indentation narrows at the mouth and widens as the slot deepens, allowing the insert to be held in place within the slot during use. The top face of the insert comprises a single channel 41, which channel divides into two at a midway joint 42. The insert extends from end 22 to the end of the subsfrate and the channel extends from end to the end of the insert, such that the tube 1 may extend therefrom. The channels on the top face have U-shaped indentations. The ends of the channels continue off the insert top face, allow a tube to be fed into the channel from an end. The channels mimic the Medial Cubital vein in the ACF representation (Figure 1 and 3) and the veins of the dorsum of hand (Figure 5 and 7). For the inserts, the depth may be 1.8mm, 2mm, 2.05mm, 2.1mm, 2.15mm and 2.2mm. The diameter of the tube for the channel may be 2.5mm, 2mm or 1.5mm. The insert's top face has a debossed size indicator 43. This way, a user may be able to identify the diameter and depth of the tube being used. The displaceable insert allows for the insert to be swapped according to user requirements; for example, to allow deeper channels, or different diameters. This allows to practise needle insertion from basic to more complex insertions. The embodiment comprises a rubber skin covering 3, which is elastomeric and comprises an open-ended cylinder of silicone material. When the tube is in the channel, the user can pull the embodiment onto and over the substrate. The skin covering has a glossy or low friction inner surface 31 to permit easy placement and displacement over the substrate. The skin will have a varied thickness, from 1,8mm to 0.6mm, allowing the user to practise on different thicknesses. In particular, regarding the second embodiment in 199, as shown in Figure 5, the embodiment comprises a substrate 50 representation of a forearm and part of a hand. The sta'n covering 6 only extends to a specific area of the hand, leaving the distal end 55 of the substrate uncovered and having a flat bottom 52. The insert 7 slots into the hand end 53 of the substrate and provides a single channel 71, wherein the insert 7 will slot into the slot 51 of the main section 5 vertically and horizontally. The tube 1 includes a silicone tube that replicates the pressure in human veins by being pressurized. A flash back chamber housing can confirm evidence of successful intra-venous cannulation in patients on the cannulation device. Tube 1 replicates this mechanism by being filled with water and a small amount of food colouring that is under pressure within the tube. Sealing both ends of Tube 1 helps maintain pressure within. Users must know that the liquid is pressurized and therefore the integrity of the siltcone tube is weakened at one end, creating a bulb. Figures 9 demonstrate that the embodiments come in three differing sizes to represent an infant, child, and adult. The inventor has only described the invention by way of examples, and it is important to appreciate that variations can be made to the above-mentioned embodiments without deviating from the scope of protection defined by the claims.

Claims

1. The modular phlebotomy training device includes a substrate that represents a body part, a skin covering, and a pressurized fluid tube. The tube in the modular phlebotomy training device is designed to be embedded in the substrate and can be displaced from it.

2. A modular phlebotomy training device, according to claim 1, wherein the substrate comprises one or more channel for the tube.

3. A modular phlebotomy training device, according to claim 1 or 2, wherein the substrate comprises a displaceable section and a receiving section.

4. A modular phlebotomy training device, according to claim 3, wherein the receiving section comprises a receiving slot:

5. A modular phlebotomy training device, according to claim 3 or 4, wherein the receiving section has a narrowed mouth.

6. A modular phlebotomy training device, according to any preceding claim, wherein the substrate comprises a plurality of different diameter channels.

7. A modular phlebotomy training device according to claim 6 wherein the channels comprise a narrowed mouth.

8. A modular phlebotomy training device, according to any preceding claim comprising a resiliently deformable substrate.

9. A modular phlebotomy training device, according to any preceding claim, wherein the tube comprises a pressurisation fluid within the tube.

10. A modular phlebotomy training device, according to any preceding claim wherein the skin covering comprises a closure or cover means allowing closure or covering of the substrate.

11. A modular phlebotomy training device, according to any preceding claim, wherein the skin covering comprises a plurality of depths of material.

12. A modular phlebotomy training device, according to the preceding claim, wherein the skin coverings can be adapted to represent different skin tones.5

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