Improvements relating to a vein visualisation aid device

Abstract

A visualisation system for vein access has a disposable device with a flexible substrate (3) having an opening (4) for needle insertion, and a ring of LEDs (6) mounted to the substrate to provide a field of emission to illuminate blood vessels via said opening. The system also has is a reusable driver for the light sources. An elongate flat lead (30) extends proximally from the substrate and has conductors linked at its distal end with the LEDs (6) and, at its proximal end, has planar terminals (31) for releasable engagement with the driver connector (120). For use, the lead proximal end is pushed into the driver connector socket (122) for electrical contact with spring terminals (125) pressing them against an opposed platform (124). After use, the lead (30) is pulled from the driver connector (120) and the substrate and the lead are disposed of safely, and the driver may be re-used.

Description

[0001] “Improvements Relating to a Vein Visualisation Aid Device”

[0002] Introduction

[0003] The invention relates to a peripheral venous access aid in humans or animals, for therapeutic treatment, diagnostic, or cosmetic purposes.

[0004] It is estimated that over two billion IV cannulations are carried out annually, and that one billion people annually receive a blood test for diagnosis or treatment and / or have an IV inserted. However, a significant number of patients suffer from difficult vein access (DVA). This often leads to significant waste of clinician time and of course discomfort for the patient. Blood draws are often a painful, fearful procedure, and can cause nerve damage and bruising to the patient and needle stick injuries to medical staff.

[0005] IV insertion plays a very important role in all types of treatments especially patients with ongoing treatment. Over time blood vessels weaken and this can pose a challenge to health care staff when dealing with elderly patients, and this cohort of patients may not be able to travel easily to their local healthcare practice as a result regular blood tests or treatment may pose a challenge when a vein cannot be located and unnecessary bruising and damage to the vessels can occur.

[0006] Patients who need immediate treatment pose another challenge as it may be in a remote area or in an emergency. Vein detection devices are not the best option as the emergency crew can only carry a certain amount of equipment in their emergency kit due to its size and sterilisation options.

[0007] It is known to provide aids or devices for improved visualisation. For example, US2016 / 0242649 (Translite LLC) describes a device for illumination of the skin for enhanced visualization of veins with a switch to select a desired wavelength according to the patient skin colour. US2016 / 0287814 (Jennus Innovation Corp) describes an illumination device which adheres to the skin to define an illumination window. US2019 / 0387975 (AccuVein Inc) describes a projection head for improved visualisation. Also, our published International patent specification number WO2022 / 223677 describes such a device.

[0008] The present invention is directed towards providing improvements to a visualisation aid device, particularly to make the device simpler to use and simpler in construction. Summary of the Invention

[0009] We describe a visualisation device system for vein access, the device comprising: a disposable device comprising: a flexible light source substrate having an opening for needle insertion, a plurality of light sources mounted to the substrate to provide a field of emission within said opening, and an elongate flat lead extending proximally from the substrate and having elongate conductors which are linked at the lead distal end with the light sources (6) and at the lead proximal end terminating in planar terminals; and a reusable driver for the light sources, said driver having a socket configured to receive the lead proximal end in a push fit action for electrical engagement of the lead terminals with spring contacts in the driver, whereby the lead may be engaged by pushing into the driver and to be disengaged after use by being pulled out of the driver for disposal of the substrate and the lead and re-use of the driver.

[0010] In some preferred examples, the drive socket comprises at least one spring terminal which is sloped proximally and towards a path aligned with the socket.

[0011] In some preferred examples, the spring terminal forms a convex shape close to a bed, a gap between the spring terminal and the bed being aligned with the socket.

[0012] In some preferred examples, there are two juxtaposed spring terminals, and the lead comprises two planar juxtaposed planar terminals.

[0013] In some preferred examples, the lead comprises a polymer enveloping said conductors. In some preferred examples, the polymer is polyimide.

[0014] In some preferred examples, the substrate and the lead are integral and have the same thickness.

[0015] In some preferred examples, the substrate forms a generally annular shape around the opening and there is a gap to facilitate peeling of the substrate around a needle. In some preferred examples, the driver comprises a connector which couples with the disposable device lead and is adapted to be linked by a cable with a battery pack which provides isolation of high voltage from the lead.

[0016] In some preferred examples, the battery pack has a clip for attachment to a garment.

[0017] In some preferred examples, the lead has a length of at least 5 cm, and optionally at least 8 cm.

[0018] In some preferred examples, the head comprises a layer supporting the LED substrate and having an adhesive for adhering to a patient’s skin.

[0019] In some preferred examples, the device further comprises a transparent membrane extending across the opening, said membrane being configured to be punctured by a needle and to be directly or indirectly adhered to the skin to form a closed environment around a puncture site when a needle is in situ.

[0020] In some preferred examples, the membrane is adhered to a lower support layer which surrounds part of the membrane and adheres to the skin to provide a closed environment formed by the membrane and the lower layer when the light source substrate has been removed.

[0021] In some preferred examples, the system further comprises a removable protective cover without exposed adhesive to allow the device to be moved along user’ s skin with the light sources activated to locate a preferred blood vessel access site.

[0022] In some preferred examples, the protective cover comprises discrete upper and lower outer peel- of layers, or an integral envelope.

[0023] In some preferred examples, the light sources include LEDs which emit at a wavelength in the range of 620 nm to 670 nm.

[0024] We also describe a disposable vein visualisation device comprising: a flexible light source substrate having an opening for needle insertion, a plurality of light sources mounted to the substrate to provide a field of emission within said opening, and an elongate flat lead extending proximally from the substrate and having elongate conductors which are linked at the lead distal end with the light sources (6) and at the lead proximal end terminating in planar terminals configured for push fitting into a socket of a separate driver.

[0025] Further, we describe a method of visualising a blood vessel of a patient, the method being performed using a system of any example described herein, and the method comprising the steps of: pushing the proximal end of the lead into the socket of the driver, activating the driver to provide power to the light sources, moving the head near the skin to determine an optimum access position, and adhering the head to the skin at said optimum position.

[0026] In some preferred examples, said movement is performed with physical contact of the head with the skin, and a protective cover is removed after determination of the location and the head is adhered to the skin at that location.

[0027] The blood vessel which is accessed with the benefit of the light sources may be a veins or an artery, depending on the medical procedure required.

[0028] We also describe a visualisation device for vein access, the device comprising a plurality of light sources arranged in a pattern on a flexible substrate near an edge of the substrate, and a driver for the light sources. The driver and the LED substrate are separate and are temporarily coupled together for a single use of the substrate, whereas the driver can be re-used.

[0029] We also describe a visualisation device for vein access, the device comprising: a flexible substrate having an opening for needle insertion, a plurality of light sources mounted to the substrate to provide a field of emission within said opening, an elongate flat lead extending proximally from the substrate and having elongate conductors which are linked at the lead distal end with the light sources and at the lead proximal end terminating in planar terminals, a driver for the light sources, and said driver being configured to receive the lead proximal end in a push fit action for electrical engagement of the lead terminals with spring contacts in the driver, whereby the lead may be engaged by pushing into the driver and to be disengaged after use by being pulled out of the driver for disposal of the substrate and the lead and re-use of the driver.

[0030] In some preferred examples, the driver comprises a socket and at least one spring terminal which is sloped proximally and towards a path aligned with the socket. In some preferred examples, the spring terminal forms a convex shape close to a bed, a gap between the spring terminal and the bed being aligned with the socket. In some preferred examples, there are two juxtaposed spring terminals (and the lead comprises two planar juxtaposed planar terminals.

[0031] In some preferred examples, the lead comprises a polymer enveloping said conductors. In some preferred examples, the polymer is polyimide. In some preferred examples, the substrate and the lead are integral and have the same thickness.

[0032] In some preferred examples, the substrate forms a generally annular shape around the opening and there is a gap to facilitate peeling of the substrate around a needle.

[0033] In some preferred examples, the driver is adapted to be linked with a battery pack which provides isolation of high voltage from the lead. In some preferred examples, the battery pack has a clip for attachment to a garment.

[0034] In some preferred examples, the lead has a length of at least 5 cm, and preferably at least 8 cm.

[0035] In some preferred examples, the head comprises a layer supporting the substrate and having an adhesive for adhering to a patient’s skin.

[0036] In some preferred examples, the device further comprises a transparent membrane extending across the opening, said membrane being configured to be punctured by a needle and to be directly or indirectly adhered to the skin to form a closed environment around a puncture site when a needle is in situ.

[0037] In some preferred examples, the device comprises a tear-away bridge for retaining opposed sides of the substrate in close proximity at a gap until the tear-away bridge is removed.

[0038] In some preferred examples, the light sources include LEDs which emit at a wavelength in the range of 620 nm to 670 nm. In some preferred examples, the drive is linked by a cable to a coupler for a battery pack (150).

[0039] Detailed Description of the Invention

[0040] 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 drawings in which:

[0041] Figs. 1(a) and 1(b) are perspective views of a vein visualization aid device and part of a driver of a system of the invention, with a lower (skin-facing side) shown facing upwardly in these views,

[0042] Fig. 2 shows the distal and proximal connector and an interconnecting cable of the driver,

[0043] Fig. 3 is a perspective view of the driver battery pack,

[0044] Fig. 4 is an enlarged perspective view showing the reusable electrical driver distal connector and a disposable device lead fitted into it for use,

[0045] Fig. 5 is a cut away perspective view illustrating how the disposable lead is clamped,

[0046] Fig. 6 is a diagrammatic plan view showing internal components of the driver distal connector, and

[0047] Figs. 7 to 12 are a series of views showing the device in use.

[0048] Referring to Figs. 1 to 6 a vein visualization device 1 comprises a visualization head 2 and a flat elongate lead 30. The head 2 and the lead 30 are integral and are disposable. For provision of power to LEDs on the head 30, the lead 30 is push-fitted into a reusable driver comprising a distal connector 120 linked by a cable 123 to a proximal connector 130 which is insertable into a rechargeable battery pack 150. The battery pack 150 comprises a housing 151 which may be easily fitted into a pocket or clipped to a garment, and it has a switch 152, a status LED 153, and a socket 154 for engagement by the coupler 130. The status LED 153 provides a power indicator to indicate when the battery neds to be recharged. In overview, therefore, a system comprises: disposable: the device comprising the head 2 with the flat lead 30, and reusable: the driver comprising the distal connector 121, the electrical cable 123, the proximal connector 130, and the battery pack 150.

[0049] Because the lead 30 is flat it may be manufactured inexpensively of an insulating polymer such as polyimide with embedded Copper leads, and it can be used in a simple manner by simply pushing into the driver connector 120 for use and then being subsequently pulled out for disposal of the combined head 2 and lead 30 (the device) after use. These benefits are achieved irrespective of the configuration of the head. In the illustrated example the head 2 has a flexible substrate 3 of the same material as the lead 30 and being in the form of a ring with LEDs 6 on a lower (skin-facing) side, and handle tabs 8 and 9 on opposed sides. The substrate 3 has a round opening 4 defining an area of a patient’s skin that is illuminated for vein access. There is a gap 7 in the substrate for easy removal of the substrate while leaving a needle in place. However, in other examples the substate may be closed. Fig. 1(a) shows the lead 30 being pushed into the driver connector 120, and Fig. 1(b) shows it in place.

[0050] For clarity, Figs. 1 to 6 do not illustrate the various layers of material around the substrate 3, these being illustrated in Figs. 7 to 12.

[0051] The diametrically opposed tabs 8 and 9 allow ease of handling during use of the device 1 and are simple because they are of the same material as the substrate 3 and the lead 30, all being flat and integral.

[0052] The proximal end (furthest from the head 2) of the lead 30 has a pair of elongate planar rectangular terminals 31 which have exposed electrical contact surfaces. The driver connector 120 comprises a housing 121 having at its proximal end a permanent terminal linked by a cable 123 to the battery pack connector 130. Within the housing 121 a pair of juxtaposed spring terminals 125 are mounted, each aligned with a lead 30 planar terminal 31. Each spring terminal 125 comprises a conductor formed from a planar metal strip which forms a leading tapered conductor 127 which is inclined inwardly and proximally to form an acute angle facing distally towards a socket opening 122 of the driver connector 120. The conductor 125 is bent at a location aligned with the opening 122 and continues radially and distally. Hence, by pushing the proximal end of the planar lead 30 into the socket opening 122 the spring terminals 125 press against the planar lead terminals 31, the pressing action being against a base 124 within the housing 121. This provides a strong and durable electrical contact engagement simply by the user pushing the proximal end of the lead 30 into the connector 120.

[0053] This power to the head 2 is used for vein visualisation. The LEDs 6 provide percutaneous illumination to assist with location of a vein for a procedure. The lead 30 is then simply pulled out of the connector 120, and the combined head 2 and lead 30 are disposed of safely, leaving the driver for further use. The lead 30 has a length of 8 cm in one example, thereby helping to ensure that there is no contamination by the driver of the puncture site with careful use.

[0054] Referring also to Figs. 7 to 12, in this example, as described in more detail below there is a transparent elastomeric film or membrane 19 across the opening to seal around the needle if it needs to stay there for a period such as a few days. This is suited to IV cannulation, and there is a completely closed environment because the membrane has adhered to the skin after swabbing to the skin is carried out.

[0055] This elastomeric film is not present in a version of the device for blood draws as the needle does not need to remain in place.

[0056] In more detail the substrate 3 has a thickness of 0.7 mm. The size of the round opening 4 formed by the substrate 3 is of 35.0 mm diameter, sufficient to allow adequate space for insertion of a needle in a patient’s skin exposed by the opening.

[0057] The head 2 has layers 15 forming packaging, including an upper layer 16 on the side facing away from the skin in use. The substrate 3 / 9 is adhered to a lower layer 18(b) by an adhesive which in one example is an acrylic hypoallergenic adhesive of the type commonly used for medical tape. The layer 18(b) is covered by a peel-off cover layer 18(a) which protects a skin-contacting adhesive. Also, the membrane is indicated by the numeral 19, being mounted between the layer 18(b) and the substrate 3, its main role being to span the opening 4.

[0058] The gap 7 may in some examples be partially covered over and kept closed by a tear-off strip on the proximal side. This is to hold the device in its original shape until it needs to be removed from a patient’s skin, as described in more detail below.

[0059] Use Fig. 7: The proximal end of the lead 30 is pushed into the driver connector 120, which is a distance of 8 cm from the patient vein location site. Then, the head 2 is moved around the site (as indicated by the arrows B) with the LEDs activated to scan for a healthy vein, the percutaneous region being illuminated by the activated LEDs 8. There is a good deal of scope to do this because of the length of the lead 30 and there is no exposed adhesive. The head 2 remains sterile due to the transparent packaging 15.

[0060] Fig. 8: The protective packaging layer 16 on the near side is removed.

[0061] Fig. 9: the protective layer 18(a) on the lower side (skin-facing in use) is then peeled off to expose the skin-adhering adhesive on the lower side of the layer 18(b). Fig. 9 shows the device with the skin side now facing upwardly as it is being handled. This view shows the LEDs 6 partly obscured by that part of the layer 18(a) which has not been removed as the skin side is facing upwardly here.

[0062] In another embodiment the layers 16 and 18(a) are integrated as a pocket or envelope which is all pulled off at once rather than as two separate layers.

[0063] Fig. 10: The head 2 has been turned back around and is then adhered to the preferred location by the adhesive on the layer 18(b) adhering to the skin. This leaves the clinician’s hands free to insert the needle N, and advantageously this can be done accurately even for children or nervous patients. This needle insertion is through the membrane 19, providing a sealed hygienic environment around the puncture site.

[0064] Fig. 11 : The lead 30 is pulled from the driver connector 120, the substrate 3 together with the lead 30 are peeled off the layer 18(b), and is disposed of safely in a suitable container 200.

[0065] Fig. 12: That leaves the needle N in place penetrating through the membrane 19, which is held in place by the layer 18(b).

[0066] It will be appreciated that the system of the invention allows minimal disposable components (only the head 2 and lead 30) and versatility in choice of a reusable driver. The driver may comprise a single component with a power source into which the lead 30 is coupled, or a connector from which a cable extends to a proximal component with a battery pack and circuit. This arrangement allows convenient holding of the driver, for example in the pocket of a medic, the cable 123 allowing positioning of the head 2 where desired. Additional Detail and Alternatives

[0067] The LEDs 5 have a pattern, number, intensity, and wavelength for effective illumination beneath the patient’s skin. The wavelength provides in one example an orange / red colour of wavelength 620 to 670 nm. This makes it easy to visualise the veins, and the clinician inserts the needle accurately.

[0068] The two-part assembly allows for attaching the slim profile of the PCB, without the expense of the battery and drive components in the disposable part. The arrangement of the LEDs 6 around the opening provides an optimal ratio of the power requirement and the driver to ensure excellent brightness whilst minimising heat generation. Because the driver is reusable it is possible to have this linked to a high energy dense lithium-ion battery pack with a USB port for multiple use. This battery pack may have a clip for attachment to a garment for ease of access.

[0069] The package 15 allows the LEDs 6 to be activated for an initial viewing of the veins before the device is removed from its sterile package, the films being transparent. It is only when a desired location is found that the package needs to be opened.

[0070] It will be appreciated that the device 1 achieves very effective illumination through a patient’ s skin in an area with a circular border bounded by the LED ring. The substrate takes up a minimal amount of space of skin contact, and it may be easily removed even if there is a needle left in place, due to the gap 7. By adhering to the skin, the device can be easily used by a single clinician in an accurate manner. There is excellent sterility because the disposable part can be un-sealed immediately before use.

[0071] In this example the adhesive is on all of the distal surface of the membrane, however it may alternatively be in a pattern such as concentric rings.

[0072] It will be appreciated that after insertion of the needle and the substrate is peeled away, the needle is not disturbed, due to the gap 7. The strength of adhesion of the membrane to the skin is greater than the retention strength of the rim of the membrane to the substrate ring, and hence the substrate easily separates and peels away. That leaves the membrane in position both helping to keep the needle in place and providing a hygienic environment around the puncture. The clinician is never in direct contact with the patient’s skin. Additional dressings may then be applied if required, in conventional manner. There is no need for the clinician to re-palpate the vein to make sure it’s the same vein they are targeting. It is envisaged that the transparent elastomeric membrane 19 may be retained on the substrate on either the proximal or the distal side of the substrate, and it may extend laterally to engage the skin around the substrate.

[0073] By providing a membrane as described the device decreases the number of steps required for intravenous insertion and reduces the number of times required for a clinician to visit the injection site. The device may be conveniently used in any type of medical situation, including emergency use.

[0074] The manner of providing power to the LEDs allows excellent versatility in finding a good vein location due to the length of the lead 30, and it also minimises the amount of material which is single-sue.

[0075] It is envisaged that the device can be included in most medical kits where practitioners can quickly make use of the device as a useful aid for emergency cannulation. Although not limited to fast- paced, critical scenarios, the device helps streamline the process by making it usable by a single person.

[0076] The device can be used in any situation where one needs to locate a vein for insertion of a needle into the vein, or indeed to avoid the vein and inject into muscle. Regarding the latter, avoidance of a vein may be important for diabetics and in the beauty industry for fillers where it's important not to inject into a vein to avoid risk of infection.

[0077] A major benefit of the invention is that it addresses the problem of there being a wide range of competency across clinicians in the task of locating a vein, especially for DVA patients.

[0078] The device is suited to easy transportation where a paramedic or clinician can fit a number of the devices in their emergency kit when they need to travel to a remote site. This would allow a number of patients to be assessed for the best possible vein when inserting an IV cannulation.

[0079] The invention is not limited to the embodiments described but may be varied in construction and detail, for example to suit the size of the individual patient or animal. For example, at least some of the LEDs may be recessed in cavities in the substrate. They may be in any desired arrangement for optimum illumination relative to the intensity of each individual LED, for example in an array of two or more rows. Also, there may be a protective cover or film over the LEDs, which may for example be a transparent strip adhered over the LEDs and the downwardly facing housing surface. In some embodiments a protective layer or film will protect the patent’s skin from overheating as LED’s can feel warm on the skin depending on how long they are left on the skin by the Clinician however due to light intensity it allows the Clinician to locate a vein more quickly.

[0080] Also, it is envisaged that there may not be an adhesive layer, merely the flexible LED substrate linked by the lead to the drive, without the head having a membrane.

[0081] In another embodiment, the device is supplied as a kit which has a needle for use, both the device and the needle having a single use together. In this case the needle may have a mark of a colour which is highlighted by ambient light emitted by the LEDs, thereby providing an indicator for the clinician as to the extent of insertion below the skin. The colour of the indicator is matched to the emission wavelength of the LEDs so that it is particularly clear while the LEDs are activated.

Claims

Claims1. A visualisation device system for vein access, the device comprising: a disposable device comprising: a flexible light source substrate (3) having an opening (4) for needle insertion, a plurality of light sources (6) mounted to the substrate to provide a field of emission within said opening, and an elongate flat lead (30) extending proximally from the substrate and having elongate conductors which are linked at the lead distal end with the light sources (6) and at the lead proximal end terminating in planar terminals (31); and a reusable driver (120) for the light sources, said driver having a socket (122) configured to receive the lead proximal end in a push fit action for electrical engagement of the lead terminals (31) with spring contacts (125) in the driver, whereby the lead may be engaged by pushing into the driver and to be disengaged after use by being pulled out of the driver for disposal of the substrate and the lead and re-use of the driver.

2. A system as claimed in claim 1, wherein the drive socket (122) comprises at least one spring terminal (125) which is sloped proximally and towards a path aligned with the socket.

3. A system as claimed in claim 2, wherein the spring terminal forms a convex shape close to a bed (124), a gap between the spring terminal (125) and the bed (124) being aligned with the socket (122).

4. A system as claimed in claim 2 or claim 3, wherein there are two juxtaposed spring terminals (125) and the lead (30) comprises two planar juxtaposed planar terminals (31).

5. A system as claimed in any preceding claim, wherein the lead (30) comprises a polymer enveloping said conductors.

6. A system as claimed in claim 5, wherein the polymer is polyimide.

7. A system as claimed in any preceding claim, wherein the substrate (3) and the lead are integral and have the same thickness.

8. A system as claimed in any preceding claim, wherein the substrate (3) forms a generally annular shape around the opening (4) and there is a gap (7) to facilitate peeling of the substrate around a needle.

9. A system as claimed in any preceding claim, wherein the driver comprises a connector (120) which couples with the disposable device lead and is adapted to be linked by a cable (123) with a battery pack (150) which provides isolation of high voltage from the lead.

10. A system as claimed in claim 9, wherein the battery pack (150) has a clip for attachment to a garment.

11. A system as claimed in any preceding claim, wherein the lead (30) has a length of at least 5 cm, and optionally at least 8 cm.

12. A system as claimed in any preceding claim, wherein the head comprises a layer (18(b)) supporting the LED substrate and having an adhesive for adhering to a patient’s skin.

13. A system as claimed in any preceding claim, wherein the device further comprises a transparent membrane (19) extending across the opening (4), said membrane being configured to be punctured by a needle and to be directly or indirectly adhered to the skin to form a closed environment around a puncture site when a needle is in situ.

14. A system as claimed in claim 13, wherein the membrane is adhered to a lower support layer (18((b)) which surrounds part of the membrane and adheres to the skin to provide a closed environment formed by the membrane (19) and the lower layer (18(b)) when the light source substrate has been removed.

15. A system as claimed in any preceding claim, further comprising a removable protective cover (16, 18(a)) without exposed adhesive to allow the device to be moved along user’s skin with the light sources activated to locate a preferred blood vessel access site.

16. A system as claimed in claim 15, wherein the protective cover comprises discrete upper and lower outer peel-of layers (16, 18(a)), or an integral envelope.

17. A system as claimed in any preceding claim, wherein the light sources include LEDs which emit at a wavelength in the range of 620 nm to 670 nm.

18. A disposable vein visualisation device comprising: a flexible light source substrate (3) having an opening (4) for needle insertion, a plurality of light sources (6) mounted to the substrate to provide a field of emission within said opening, and an elongate flat lead (30) extending proximally from the substrate and having elongate conductors which are linked at the lead distal end with the light sources (6) and at the lead proximal end terminating in planar terminals (31) configured for push fitting into a socket of a separate driver (120, 123, 130, 150).

19. A method of visualising a blood vessel of a patient, the method being performed using a system of any of claims 1 to 17, and the method comprising the steps of: pushing the proximal end of the lead (30) into the socket of the driver, activating the driver to provide power to the light sources, moving the head (2) near the skin to determine an optimum access position, and adhering the head to the skin at said optimum position.

20. A method as claimed in claim 19, wherein the method is performed with a system of any of claims 15 to 17, and said movement is performed with physical contact of the head with the skin, and the protective cover is removed after determination of the location and the head is adhered to the skin at that location.

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