WO2016102571A1

WO2016102571A1 - A wearable venepuncture training device

Info

Publication number: WO2016102571A1
Application number: PCT/EP2015/080984
Authority: WO
Inventors: Simon Dennis SMITH; Patrick HENN; Robert Gaffney
Original assignee: University College Cork - National University Of Ireland, Cork
Priority date: 2014-12-22
Filing date: 2015-12-22
Publication date: 2016-06-30

Abstract

The invention provides a wearable venepuncture training device configured for attachment to a limb of a mammal, for example a human, for example an arm, a leg, foot, or hand of a human. The device is generally provided in the form of a sleeve configured for attachment to the limb, and typically comprises a needle -resistant layer, an outer needle-permeable elastic sleeve, and a vasculature layer having at least one artificial blood vessel sandwiched between the needle resistant layer and outer elastic sleeve. Preferably, the device also includes an inner (generally elastic) sleeve that abuts the skin of the wearer, and which is connected to the needle impermeable layer. The vasculature layer comprises a resiliently deformable layer that in use overlies a part of the limb containing vasculature, and comprises at least one elongated groove and at least one artificial blood vessel disposed within the groove in which the groove and vessel mimic a vascular scenario (for example forearm vasculature of a healthy adult, or forearm vasculature of a child). Variation of vasculature will allow simulation of different age related models. The resiliently deformable nature of the vasculature layer mimics the feel of the skin enabling trainee doctors to feel for veins as they would in a real clinical scenario. The outer elastic sleeve helps keep the wearable device in-situ on a limb and ensures that it conforms closely to the limb, again mimicking a real clinical situation. The inner sleeve also ensures that the wearable device remain in-situ on the limb without movement.

Description

Title

A wearable venepuncture training device

Introduction

The invention relates to a wearable venepuncture training device. The invention also relates to a venepuncture training kit, and the use of the training kit to teach an individual how to correctly perform a venepuncture procedure. As part of a managed learning process and where appropriate, healthcare professionals should learn skills in a simulation environment and using other technologies before undertaking them in supervised clinical practice (DOH 2011, GMC 2011). The challenges currently facing healthcare training lie in bridging the gap between isolated classroom based training and assessment of skills and performance of these skills in a synergistic manner in clinical practice. At present there are significant limitations to demonstrating robust and defensible assessment of medical competencies in scenarios closely resembling routine practice. Stakeholders (patient groups, politicians and the public), require reassurance that in addition to academic medical knowledge, healthcare education develops transparent and metric -based assessment of medical competence. Further to Professor Greenaways' review (2013) of UK medical education & training, (http ://www . shapeoftraining .co .uk/aboutus/ 1727.asp) , legislation will be amended to require that medical students in England & Wales graduate as fully registered doctors. Patient safety concerns across the developed world are now insisting that healthcare education develop transparent assessment of medical competencies along with periodic revalidation (Wilensky and Berwick 2014). At present, medical educators have limited teaching equipment suitable for teaching such scenarios. There is an unmet need for simulation technology which allows assessment of quantified competence in a synergistic manner, in the context of clinical practice.

Venepuncture is one of the most common procedures that patients undergo in either the hospital or General Practice environment. Current teaching of venepuncture to medical students involves a legacy technology of inert and cumbersome bench top demonstrator arms, which will no longer be fit for purpose under the proposed paradigm shift towards high-fidelity simulations (DOH 2011). [for an illustration see: http ://limb sandthin s . com/uk/products/standard- venepuncture- arm ] Development of venepuncture training technology has remained static since its introduction in medical schools over forty years ago. Typically, groups of students practice venepuncture techniques on an inert demonstrator arm without any surrounding clinical context. Some advances in wearable trainers have been made, but these are generally crude and of low build quality and do not allow for a range of different vasculatures to be assessed. After the student has completed basic skills training on the demonstrator arm, current technology cannot not provide an intermediate stage of learning and assessment in a synergistic manner; leaving no option but the 'post graduate apprenticeship of trial and error' on hospital patients. It is an object of the invention to overcome at least one of the above-referenced problems.

Statements of Invention

The invention provides a wearable venepuncture training device configured for attachment to a limb of a mammal, for example a human, for example an arm, a leg, foot, or hand of a human. The device is generally provided in the form of a sleeve configured for attachment to the limb, and typically comprises a needle -resistant layer, an outer needle-permeable elastic sleeve, and a vasculature layer sandwiched between the needle resistant layer and outer elastic sleeve. Preferably, the device also includes an inner (generally elastic) sleeve that abuts the skin of the wearer, and which is connected to the needle impermeable layer. The vasculature layer comprises a resiliently deformable layer that in use overlies a part of the limb containing vasculature, and ideally comprises at least one elongated groove and at least one artificial blood vessel disposed within the groove in which the groove and vessel mimic a vascular scenario (for example forearm vasculature of a healthy adult, or forearm vasculature of a child). Variation of vasculature will allow simulation of different age related models. The resiliently deformable nature of the vasculature layer mimics the feel of the skin enabling trainee doctors to feel for veins as they would in a real clinical scenario. The outer elastic sleeve helps keep the wearable device in-situ on a limb and ensures that it conforms closely to the limb, again mimicking a real clinical situation. The inner sleeve also ensures that the wearable device remain in-situ on the limb without movement.

Broadly, the invention provides a wearable venepuncture training device comprising a layered structure configured for attachment to a limb of a human (or indeed a mammal) and mimics a first vasculature scenario, the device comprising: an inner needle -resistant layer;

a vasculature layer attached to the needle resistant layer comprising a resiliently deformable material and at least one artificial blood vessel disposed on or within the resiliently deformable material that in use mimics the first vasculature scenario; and an outer needle-permeable sleeve configured to embrace the limb of the human covering at least a part of at least one blood vessel.

Preferably, the vasculature layer comprises an outer face comprising at least one groove and the at least one artificial blood vessel is disposed within the at least one groove whereby in use the combination of the at least one groove and at least one blood vessel mimics the first vasculature scenario. In another embodiment, the at least one artificial blood vessel is embedded within the vasculature layer.

Preferably, the vessel supporting layer is configured for "removable attachment" to the inner needle -resistant layer allowing replacement of the vessel supporting layer. This allows the vessel supporting layer that mimics a first clinical scenario (for example a healthy young adults forearm) to be replaced with a vessel supporting layer that mimics a second clinical scenario (for example a forearm of an elderly person). The term "first vasculature scenario" means an arrangement of groove and vessel that mimics a specific region of human (or more generally mammalian) vasculature or a specific region of human (or mammalian) vasculature is a specific clinical state. The vasculature layer can mimic differing vasculature scenario's, for example a normal scenario (i.e. healthy adult forearm vasculature), a clinical scenario (i.e. adult with collapsed veins or a geriatric vasculature), a paediatric scenario (infant vasculature), or other normal, Sub-clinical or clinical scenarios.

The term "removable attachment" means that the vasculature layer is configured to be separated from the needle -resistant layer when desired, i.e. when a different vasculature scenario is required, whereupon the vasculature layer is replaced with a different vasculature layer bearing a different vasculature scenario.

Preferably, the vasculature layer comprises a network of grooves and corresponding artificial blood vessels that mimic human vasculature Typically, the device takes the form of a sleeve configured to form a tight but sliding fit on a target limb.

Preferably, the device additionally includes an inner skin-abutting elastic sleeve, wherein the inner needle resistant layer is non-removably attached to the inner skin-abutting elastic sleeve.

In one embodiment, the device is configured for attachment to an arm of a human, wherein the inner needle resistant layer comprises a first part configured to cover a lower part of the arm and a separate second part configured to cover an upper part of the arm. Preferably, the first and second parts partly overlap. Ideally, one or both of the overlapping parts are upwardly curved.

Preferably, the needle-resistant layer comprises a plate, generally a rectangular plate. Ideally it is formed of a hard plastic material. Typically, the plate is configured to cover one aspect of the limb, for example the ventral surface of the forearm, or of the lower leg. Typically, the vasculature layer substantially overlies the needle -resistant layer.

Typically, the vasculature layer comprises a resiliently deformable foam layer, although other materials may be employed, for example other polymers. Typically, the vasculature layer has a thickness of 0.5 to 3cm, preferably about l-3cm.Typically; the vasculature layer is dimensioned to cover a part of the limb containing the vasculature to be mimicked.

The vasculature layer can mimic differing vasculature scenario's, for example a normal scenario (i.e. healthy adult forearm vasculature), a clinical scenario (i.e. adult with collapsed veins or a geriatric vasculature), a paediatric scenario (infant vasculature), or other normal, Sub-clinical, or clinical scenarios.

Typically, the outer needle -permeable elastic sleeve is elasticated. Ideally, it is skin coloured and/or typically has a texture of human skin. Typically it is water resistant.

In one embodiment, the outer needle permeable elastic sleeve is translucent. This may be used in the initial stages of training to allow a trainee see the vasculature through the translucent sleeve. The artificial blood vessels preferably are self-sealing, i.e. after being pierced with the needle, the hole seals on its own. Examples of suitable vessels will be known to a person skilled in the art. Ideally, the blood vessel(s) is/are provided in a circuit. Typically, the device comprises a reservoir for blood in fluid communication with the blood vessel(s). Preferably, the blood within the circuit is under a positive pressure (similar to a clinical situation). This may be achieved by charging the reservoir with blood so that it is under a positive pressure, providing a pump to pump blood around the circuit under a positive pressure, or both.

The invention also provides a modular venepuncture training kit comprising:

a wearable venepuncture training device according to the invention that in use mimics a first vasculature scenario ; and

at least one replacement vasculature layer comprising a resiliently deformable material and at least one artificial blood vessel disposed on or within the resiliently deformable material that in use mimics a vasculature scenario that is different to the first vasculature scenario

Thus, the kit provides a venepuncture training device that can be easily adapted to mimic a number of different clinical scenarios. Unlike the device of the prior art, which would require a number of different devices to mimic different scenarios, the kit of the invention can do so with a single device having a removable vasculature layer and one or more replacement vasculature layers. Typically, the kit comprises a plurality of replacement resiliently deformable vessel supporting layers, each of which comprises a combination of at least one groove and at least one blood vessel that in use mimics a different vasculature scenario.

Suitably, the wearable venepuncture training device forming part of the kit comprises a reservoir for blood in fluid communication with the at least one artificial blood vessel, wherein the reservoir is typically configured such that the blood within the at least one artificial blood vessel is under a positive pressure. Suitably, the wearable venepuncture training device forming part of the kit comprises a reservoir for blood in fluid communication with the at least one artificial blood vessel, wherein the reservoir is configured such that the blood within the at least one artificial blood vessel is under a positive pressure.

The invention also provides a method of learning how to perform venepuncture on a limb of a mammal using a wearable venepuncture training device of the invention, the method comprising the steps of:

attaching the wearable venepuncture training device to a limb of an individual; and performing a venepuncture procedure.

In a separate embodiment, the invention provides a method of learning how to perform venepuncture on a limb of a mammal using a modular venepuncture training kit according to the invention, the method comprising the steps of:

attaching the wearable venepuncture training device of the invention that in use mimics a first vasculature scenario to a limb of an individual;

performing a venepuncture procedure;

replacing the in-situ resiliently deformable vessel supporting layer with a replacement resiliently deformable vessel supporting layer that in use mimics a second vasculature scenario that is different to the first vasculature scenario; and

performing a further venepuncture procedure.

Brief Description of the Figures

The invention will be more clearly understood from the following description of some embodiments thereof, given by way of example only, with reference to the accompanying figures in which:

Fig. 1 is a perspective view of a wearable venepuncture training device according to one embodiment of the invention; Fig. 2 is a perspective view of the device of Fig. 1 with the outer sleeve removed and showing the vessel supporting layer with grooves and artificial blood vessels disposed within the grooves mimicking vasculature; Figs3A and 3B are a sectional expanded views of the layers of the device of Fig. 1 in which Fig. 3 A shows the outer sleeve, and Fig. 3B shows the inner sleeve with attached needle resistant layer, and vessel supporting layer with embedded vessels;

Fig. 4 is a sectional view of the assembled device;

Fig. 5A shows an arm with blood vessels exposed, and Fig. 5B shows the same arm with a venepuncture training device of the invention in-situ;

Fig. 6 illustrates the mounting of the device of the invention in which: Fig. 6A shows the inner sleeve with needle resistant layer in-situ on the arm; Fig. 6B shows the removable vessel supporting layer attached to the needle resistant layer; and Fig. 6C shows the arm with the outer sleeve in-situ (with the vasculature shown in broken lines); and

Fig. 7 is a sectional, perspective, partially cut-away view of the device of the invention showing the outer sleeve, vessel supporting layer and embedded vasculature, needle resistant layer, Velcro attachment means for removable attachment of the vessel supporting layer to the needle resistant layer, and inner sleeve.

Detailed Description of the Invention

Referring to the drawings, and initially to Figs 1 to 3, there is illustrated a venepuncture training device according to the invention and indicated generally by the reference numeral 1. The device 1 is shown in a fully assembled form in Fig. 1 and Fig. 2 shows the same device with the outer layer removed. The device 1 comprises an outer elastic sleeve 2 made of venepuncture needle permeable material, an inner elastic sleeve 3 configured to be worn on an arm of a user, a needle resistant plate 4 attached to the inner sleeve 3, and a resiliently deformable vessel supporting layer 5 removably attached to the needle resistant plate 4 by means of Velcro attachments (not shown). The vessel supporting layer comprises a network of grooves 6 and a corresponding network of artificial blood vessel 7 disposed within the grooves 6, thereby mimicking a vasculature scenario (in this case the arteries and veins of the inner lower and upper arm of an adult healthy human. The vessels are provided in a circuit and are in fluid communication with a reservoir for blood 8 and a pump (not shown) configured to pump blood around the blood vessel circuit.

In more detail, the inner sleeve 3 is formed of a soft elasticated fabric that is comfortable for the user to wear and conforms snugly to the limb of a user. The needle resistant plate 4 is provided in two separate parts 4 A and 4B, one of which in use covers part of the upper arm and the other of which in use covers part of the lower arm. The parts 4A and 4B overlap and the overlapping parts are curved to allow hinged movement of the forearm (See Fig. 6A). The parts 4A and 4B extend laterally to cover the sides of the limb. The needle resistant plate 4 is fixed to the inner sleeve 3 by means of a suitable adhesive or by means of stitching, and is flexible to conform to the arms surface. The vessel supporting layer 5 comprises a sheet of soft polymer foam that in use gives a smooth profile to the device, and allows the device mimic the profile of the arm. The network of artificial blood vessels 7 comprises self-sealing polymer tubes that mimic real blood vessels and are capable of self-sealing when a needle is removed.

Fig. 7 shows the device of the invention in more detail, and shows the inner sleeve 3 connected to the needle resistant plate 4 and velcro attachment patches 10 provided on an upper surface of the plate 4 configured for removable attachment to corresponding velcro attachment patches 11 provided on an underside of the vessel supporting foam layer 5. This allows the vessel supporting layer 5 and network of artificial blood vessels 7 be replaced with a replacement vessel supporting layer 5 having a different network of artificial blood vessels 7. The vessel supporting layer 5 comprises grooves 6 and artificial blood vessels 7 partially disposed within the grooves with a top of the vessel protruding proud of the groove. Finally, the outer elastic sleeve 2 embraces the inner layers.

Referring to Fig. 5, there is illustrated an arm 12 with vasculature exposed (Fig. 5 A) and the same arm 12 with a device of the invention 1 in- situ, and comprising a network of artificial blood vessels 7 that mimic the underlying vasculature of the wearers arm. Fig. 5B also shows the vessels 7 extending beyond the outer sleeve 2 and connected to the blood reservoir 8.

In use, and referring to Figs. 6, the inner elastic sleeve 3 and attached needle resistant plate 4 is attached to the users arm 12 such that the sleeve conforms snugly with the arm and needle resistant plate covers the inside part of the user upper and lower arm (Fig. 6A). A vessel supporting layer 5 with embedded blood vessels 7 is then chosen to mimic a vasculature scenario, in this case the vasculature of a health adult forearm. The vessel supporting layer 5 is then attached to the needle resistant plate 4 by means of Velcro attachment patches (not shown) (Fig. 6B). The outer elastic sleeve 2 is than mounted over the underlying layers, completing the device (Fig. 6C). The device is then ready to be used for venepuncture training by a trainee doctor. Need to check the following When the training has been completed, the outer sleeve 2 can be removed, and the vessel supporting layer and embedded vessels can be replaced with a vessel supporting layer with embedded vessels that mimic a different vasculature scenario, for example a collapsed forearm vein scenario, and the outer sleeve placed back in position, allow the trainee train with a different vasculature scenario.

The device described with reference to the attached figures comprises a vasculature layer that is removably attached to the rest of the device. However, it will be appreciated that the device can be configured such that the vasculature layer is not removable, i.e. it is permenantly attached to the needle resistant layer.

The device described with reference to the attached figures comprises a vasculature layer having at least one surface groove configured to receive the at least one artificial blood vessel. However, it will be appreciated that the at least one artificial blood vessel may be embedded within the vasculature layer and not exposed on the surface.

The description provided above shows a device configured for attachment to an arm of a human. However, it will be appreciated that the device can be configured for attachment to different body parts, for example a leg (upper or lower) of a human, a wrist of a human, an ankle of a human, or a neck of a human. Further, the device of the invention as described above comprises an inner sleeve, however it will be appreciated that the inner sleeve is optional. For example, a needle resistant layer may be provided in the form of a sleeve of elastic material. Further, the vessel supporting layer as described above is formed of a resiliently deformable material: however, it will be appreciated that the layer may be formed of a non-resiliently deformable layer of material.

The invention is not limited to the embodiments hereinbefore described which may be varied in construction and detail without departing from the spirit of the invention.

Claims

1. A wearable venepuncture training device comprising a layered structure configured for attachment to a limb of a mammal and to mimic a first vasculature scenario, the device comprising:

an inner needle -resistant layer;

a vasculature layer attached to the needle resistant layer comprising a resiliently deformable material and at least one artificial blood vessel disposed on or within the resiliently deformable material that in use mimics the first vasculature scenario; and an outer needle-permeable sleeve configured to embrace the limb of the mammal covering at least a part of at least one blood vessel.

2. A wearable venepuncture training device as claimed in Claim 1 in which the vessel supporting layer is configured for removable attachment to the inner needle-resistant layer allowing replacement of the vessel supporting layer.

3. A wearable venepuncture training device as claimed in Claim 1 or 2 in which vasculature layer comprises an outer face comprising at least one groove in which the at least one artificial blood vessel is disposed within the at least one groove whereby in use the combination of the at least one groove and at least one blood vessel mimics the first vasculature scenario.

4. A wearable venepuncture training device as claimed in any preceding Claim, in which the outer needle permeable sleeve is translucent.

5. A wearable venepuncture training device as claimed in any preceding Claim additionally including an inner skin-abutting elastic sleeve, wherein the inner needle resistant layer is non- removably attached to the inner skin-abutting elastic sleeve.

6. A wearable venepuncture training device as claimed in any preceding Claim and configured for attachment to an arm of a human, wherein the inner needle resistant layer comprises a first part configured to cover the lower part of the arm and a separate second part configured to cover the upper part of the arm.

7. A wearable venepuncture training device as claimed in any preceding Claim in which the first and second parts partly overlap, and wherein overlapping parts are upwardly curved.

8. A wearable venepuncture training device as claimed in any preceding Claim in which the vessel supporting layer comprises resiliently deformable polymeric foam.

9. A wearable venepuncture training device as claimed in any preceding Claim in which the outer needle permeable layer is configured to resemble human skin in terms of its colour, texture, elasticity, and self-sealing and water resistant properties.

10. A wearable venepuncture training device as claimed in any preceding Claim in which the first vasculature scenario is selected from healthy adult human vasculature, healthy human child vasculature, clinical human adult vasculature, clinical human child vasculature, and large animal vasculature.

11. A wearable venepuncture training device as claimed in any preceding Claim and including a reservoir for blood in fluid communication with the at least one artificial blood vessel, wherein the reservoir is configured such that the blood within the at least one artificial blood vessel is under a positive pressure.

12. A wearable venepuncture training device as claimed in any preceding Claim and including a pump configured to pump blood in a circuit between the reservoir and at least one artificial blood vessel.

13. A modular venepuncture training kit comprising:

a wearable venepuncture training device as claimed in any of Claims 2 to 12 that in use mimics a first vasculature scenario ; and

14. A modular venepuncture training device as claimed in Claim 13 including a plurality of replacement resiliently deformable vessel supporting layers, each of which comprises a combination of at least one groove and at least one blood vessel that in use mimics a different vasculature scenario.

15. A modular venepuncture training kit as claimed in Claim 13 or 14 including a reservoir for blood in fluid communication with the at least one artificial blood vessel, wherein the reservoir is configured such that the blood within the at least one artificial blood vessel is under a positive pressure.

16. A method of learning how to perform venepuncture on a limb of a mammal using a wearable venepuncture training device of any of Claims 1 to 12, the method comprising the steps of:

attaching the wearable venepuncture training device to a limb of a mammal; and performing a venepuncture procedure.

17. A method of learning how to perform venepuncture on a limb of a mammal using a modular venepuncture training kit according to any of Claims 13 to 15, the method comprising the steps of:

attaching the wearable venepuncture training device as claimed in any of Claims 2 to 12 that in use mimics a first vasculature scenario to a limb of a mammal;

performing a venepuncture procedure; and

performing a further venepuncture procedure.