DRESSING SYSTEM

Abstract

An intelligent laminate dressing system (1) for monitoring and treating a wound made up an absorbent pad (2), a sensor (16) for detecting wound data and an electronic module (17) communicable with the sensor (16), the sensor (16) and the electronic module (17) being positionally offset with respect to the centre of the absorbent pad (2).

Claims

1. A dressing system for a wound comprising: an absorbent pad; at least one sensor for detecting wound data, and an electronic module communicable with the sensor, wherein the sensor comprises a moisture sensor array radially offset with respect to the centre of the absorbent pad for mapping exudate progress across the dressing.

2. A dressing system as claimed in claim 1 wherein the moisture sensor array comprises a plurality of moisture sensors.

3. A dressing system as claimed in claim 1 wherein the moisture sensor array is located on the absorbent pad.

4. A dressing system as claimed in claim 1 wherein the moisture sensor array is located in the absorbent pad.

5. A dressing system as claimed in claim 1 wherein the sensor comprises a peripheral sensor located towards a periphery of the absorbent pad.

6. A dressing system as claimed in claim 5 wherein the peripheral sensor is located beyond the periphery of the absorbent pad.

7. A dressing system as claimed in claim 1 wherein the dressing system further comprises a diffusion barrier to delay diffusion of wound exudate towards the sensor.

8. A dressing system as claimed in claim 7 wherein the diffusion barrier comprises a delay channel defined in the absorbent pad.

9. A dressing system as claimed in claim 7 wherein the absorbent pad comprises a first superabsorbent layer and the diffusion barrier comprises a second superabsorbent layer between the sensor and the first superabsorbent layer.

10. A dressing system as claimed in claim 9 wherein the first and second superabsorbent layers comprise superabsorbent fibre layers.

11. A dressing system as claimed in claim 1 wherein the moisture sensors of the moisture sensor array are offset with respect to the centre of the absorbent pad so that activation of the moisture sensors is delayed until after about 50% of the dressing system capacity is reached.

12. A dressing system as claimed in claim 1 wherein the sensor further comprises a pH sensor.

13. A dressing system as claimed in claim 1 wherein the sensor further comprises a pressure sensor.

14. A dressing system as claimed in claim 1 wherein the sensor further comprises a bacterial sensor.

15. A dressing system as claimed in claim 1 wherein the sensor further comprises a temperature sensor.

16. A dressing system as claimed in claim 1 wherein the sensor further comprises an inertial sensor.

17. A dressing system as claimed in claim 1 wherein the electronic module is offset with respect to the absorbent pad.

18. A dressing system as claimed in claim 17 wherein the electronic module is located towards a periphery of the absorbent pad.

19. A dressing system as claimed in claim 18 wherein the electronic module is located beyond the periphery of the absorbent pad.

20. A dressing system as claimed in claim 19 wherein the electronic module is located beyond the periphery of the absorbent pad on a substrate.

21. A dressing system as claimed in claim 1 wherein the electronic module comprises a communications module for communicating the wound data from the electronic module to a clinician.

22. A dressing system as claimed in claim 21 wherein the communications module comprises a wireless communications module.

23. A dressing system as claimed in claim 1 wherein the electronic module further comprises a power source for powering the electronic module.

24. A dressing system as claimed in claim 23 wherein the power source comprises a battery.

25. A dressing system as claimed in claim 1 wherein the dressing system further comprises a backing film on the absorbent pad.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0036] The invention will now be described, by way of example only, with reference to the accompanying drawings in which:

[0037] FIG. 1 is a top plan view of a typical multi-layered intelligent wound dressing system for monitoring and treating a wound made up of an absorbent foam pad with a super-absorbent fibre (SAF) layer and a backing layer, and a moisture sensor centrally located in the dressing on top of the absorbent foam pad and under the backing film at the SAF layer;

[0038] FIG. 2 is a cross-sectional view through the intelligent wound dressing of FIG. 1 on a wound with the vertical and lateral direction of diffusion of wound exudate through the dressing indicated by the arrows;

[0039] FIG. 3 is a top plan view of a first embodiment of a multi-layered intelligent wound dressing system of the invention for monitoring and treating a wound similar to the dressing system of FIG. 1 in which an array of four integral moisture sensors on the absorbent pad in the dressing are radially offset from the centre of the absorbent pad and are located towards the periphery of the dressing at the corners of the absorbent pad;

[0040] FIG. 4 is a top plan view of a second embodiment of a multi-layered intelligent wound dressing system of the invention for monitoring and treating a wound similar to the dressing system of FIG. 3 in which a single moisture sensor is offset from the centre of the absorbent pad and is located towards the periphery of the dressing at a corner of the absorbent pad and a wicking/diffusion barrier in the form of a delay channel is provided in the dressing adjacent the moisture sensor to delay activation of the sensor;

[0041] FIG. 5 is a cross-sectional view through a third embodiment of a multi- layered intelligent wound dressing system of the invention for monitoring and treating a wound similar to the dressing system of FIG. 4 in which the moisture sensors are offset from the absorbent pad on a wicking/diffusion barrier in the form of a secondary super-absorbent fibre layer and the direction of diffusion of exudate is indicated by the arrows;

[0042] FIG. 6 is a top plan view of a variant of the intelligent wound dressing system of FIG. 3 with a radial spacing of moisture sensors and the electronic module is located beyond a periphery of the absorbent pad on a substrate;

[0043] FIG. 7 is a graph of sensor performance of the moisture sensors in the intelligent dressings of FIGS. 1 to 5 showing the improved performance of the offset moisture sensors, and

[0044] FIG. 8 is a graph of exudate threshold volume in the intelligent dressing system of FIG. 6 according to sensor spacing in the dressing system.

DETAILED DESCRIPTION OF THE INVENTION

[0045] FIGS. 1 and 2 show a typical multi-layered intelligent wound dressing system for monitoring and treating a wound generally indicated by the reference numeral 1 and made up of a wicking absorbent foam pad 2 for absorbing wound exudate 3 having an intermediate non-absorbent layer 4 thereon and also an upper super-absorbent fibre (SAF) layer 5. The dressing system 1 also has an adhesive backing film 6 attached to the SAF layer 5 defining a peripheral adhesive side border 7 for adhering the dressing 1 to a patient. The absorbent pad 2 is provided with a silicon adhesive 8 for assisting in adhesion and a removable release film 9 on the absorbent pad 2 and the backing film 6 for protecting the dressing 1 prior to use.

[0046] The absorbent pad 2 is substantially square in shape and is made up of a substantially square lower wound face 10 for contacting a wound having four side walls 11,12,13,14 upstanding therefrom and an upper face 15 disposed towards the non-absorbent layer 4 and the SAF layer 5.

[0047] The dressing system 1 has a (moisture) sensor 16 centrally positioned with respect to the sidewalls 11,12,13,14 on top of the absorbent foam pad 2 and under the backing film 6 at the SAF layer 5. Accordingly, in practice, the centrally positioned moisture sensor 16 of the dressing system 1 is located directly above the exudate 3 source i.e. the wound. The dressing system 1 can also have additional moisture sensors 16 as required.

[0048] The dressing system 1 of FIGS. 1 and 2 is further provided with an electronic module 17 for harvesting and communicating data from the moisture sensor 10.

[0049] As shown in FIG. 2, in use, diffusion of wound exudate 3 takes place initially by vertical diffusion from a wound, through the absorbent foam pad 2, the non-absorbent layer 4 and the SAF layer 5. At the SAF layer 5, fast lateral diffusion then takes place so that the surface of the SAF layer 5, which is in direct contact with the moisture sensor 16 becomes rapidly wet.

[0050] The fast lateral diffusion wicks moisture across the dressing system 1 very rapidly, and into contact with the moisture sensors which 16 which are then activated (i.e. show a sudden and significant drop in resistance where resistance moisture sensors 16 are employed) and saturate earlier than desired i.e. well before about 50% of the dressing capacity is reached. Alternatively any other type of sensor can be used that shows a change in measurand upon contact with or proximity to exudate.

[0051] FIG. 3 shows a top plan view of a first embodiment of a multi-layered intelligent wound dressing system 1 of the invention for monitoring and treating a wound similar to the dressing system 1 of FIG. 1 and like numerals indicate like parts. However, the intelligent wound dressing system 1 of the invention is provided with an array of moisture sensors in the form of a plurality of moisture sensors 16 namely four integral moisture sensors 16 formed as part of the dressing system 1 positionally offset on and with respect to the centre of the absorbent pad 2 so that activation of the sensors 16 via the vertical and lateral diffusion of exudate 3 is delayed until after about 50% of the dressing capacity is reached—i.e. radial positional offsetting of the moisture sensors 16 causes a delay in diffusion of exudate 3 to the moisture sensors 16 so that travel of wound exudate 3 can be mapped and/or measured. More particularly, in the present embodiment, the four moisture sensors 16 are located towards the periphery of the intelligent dressing 1 e.g. towards the sidewalls 11,12,13,14 of the absorbent pad 2. More particularly, in the present embodiment, the four peripheral sensors 16 of the array are located in the four corners of the square absorbent pad 2.

[0052] FIG. 4 shows a top plan view of a second embodiment of a multi-layered intelligent wound dressing system 1 of the invention similar to the dressing system of FIG. 3 in which a single moisture sensor 16 is offset with respect to the centre of the absorbent pad 2 towards the periphery of the dressing 1. Like numerals indicate like parts.

[0053] More particularly, in the present embodiment, the moisture sensor 16 is located at the corner of the absorbent pad 2 defined between the sidewalls 12,13. However, the dressing system 1 is further provided with a diffusion/wicking barrier 18 to delay diffusion of exudate 3 towards the moisture sensor 16 to in turn to delay activation of the moisture sensor 16. In the present embodiment, the diffusion barrier 18 is a delay line or channel 19 defined in and across the absorbent foam pad 2 including the non-absorbent layer 4 and the SAF layer 5 adjacent the moisture sensor 16. The delay channel 19 is cut into absorbent foam pad 2, the non-absorbent layer 4 and the SAF layer 5 to partially diffusively isolate the moisture sensor 16 from the absorbent pad 2 (and hence the exudate 3) so that diffusion of exudate 3 to the moisture sensor 16 is delayed until after about 50% of the dressing capacity is reached. As the moisture sensor 16 is only partially diffusively isolated by the delay channel 19, the delay channel 19 extends only partially across the absorbent pad 2, the non-absorbent layer 4 and the SAF layer 5 so that the moisture sensor 16 remains diffusively communicable with exudate 3 in use.

[0054] FIG. 5 shows a cross-sectional view through a third embodiment of a multi-layered intelligent wound dressing system 1 of the invention similar to the dressing system 1 of FIG. 4 but in which two moisture sensors 16 are offset with respect to the absorbent pad 2 on a diffusion barrier 18 in the form of a secondary superabsorbent (SAF) layer 20 i.e. a second superabsorbent layer 20 between the moisture sensors 16 and the first SAF layer 5. More particularly, the two moisture sensors 16 are offset with respect to the centre of the absorbent pad 2 towards the periphery of the dressing 1 on the secondary SAF layer 20 which is located between the (primary) SAF layer 5 and the backing film 6. The secondary SAF layer 20 is sized and dimensioned to delay exudate 3 diffusion so that sensor 16 activation is delayed until after about 50% of the dressing capacity is reached.

[0055] FIG. 6 shows a top plan view of a variant of the intelligent wound dressing system 1 of FIG. 3 with a radial spacing of moisture sensors 16 and like numerals indicate like parts. However, in the present embodiment, the electronic module 17 is also offset with respect to the centre of the absorbent pad 2 on a laminar substrate 22 to preserve and enhance the performance of the intelligent dressing 1. More particularly, in the present embodiment, the electronic module 17 is located to the left of the side wall 11 of the absorbent pad 2 on the substrate 22. The electronic module substrate 22 is accommodated in the multi-layer dressing system 1 and supports the electronic module 17 in the dressing system 1 fully offset from absorbent pad 2 so that the electronic module 17 does not overlie or overlay the absorbent pad 2. Accordingly, the electronic module 17 in the dressing system 1 does not impact, negatively or otherwise, on exudate 3 diffusion in the dressing system

[0056] As shown in the drawing, in the present embodiment, the dressing system 1 is provided with radially offset peripheral moisture sensors 16 as previously described disposed towards the periphery of the dressing system 1. The offset moisture sensors 16 are positioned adjacent the corners of the side walls 11,12,13,14 of the absorbent pad 2 on peripheral tabs 26 connected to the absorbent pad 2. However, additionally, the dressing system 1 is provided with a further array 27 of moisture sensors 16. The moisture sensors 16 of the array 27 are radially offset from and/or spaced apart across the centre of the absorbent pad 2 between the side walls 11,12 towards the periphery of the dressing system 1 so that exudate 3 diffusion rates across the dressing system 1 can be measured by the array 27 of sensors 16.

[0057] The electronic module 17 on the substrate 22 can include a processor for processing data from the sensors 16, memory for storing data and programmes, a communications module 24 (e.g. a BLE, NFC, WiFi (Trade Mark) or narrowband IoT based communications module) for communicating the sensor data to a base station attended by a clinician, batteries 25 and an actuator for controlling actuation of the dressing system 1. The module can be made up of several sections electrically linked as appropriate. Other components can use an inertial sensor for patient activity monitoring, voltage regulators, switches, LED indicators etc. As shown in the drawing, all the aforementioned components can be accommodated on the electronic module substrate 22 in a fully offset position without overlying the absorbent pad 2.

[0058] FIG. 7 shows a graph of sensor performance of the moisture sensors in the intelligent dressings of FIGS. 1 to 5 showing the improved performance of the offset moisture sensors of the intelligent dressing systems 1 of FIGS. 3 to 5 when compared with that of the non-offset moisture sensor of the dressing system of FIG. 1. The dressing systems 1 shown in FIG. 8 were sized so that the dressing capacity was about 26 mL i.e. the moisture sensors 16 were activated at about 13 mL (50% of the dressing capacity). As shown in the graph, a progressive shift in sensor activation (a drop in resistance) occurred for the intelligent dressing systems 1 of FIGS. 3 to 5. Accordingly, by offsetting the moisture sensors away from the centre of the absorbent pad 2, both with and without the diffusion barrier 18 and the secondary SAF layer 20 the desired dressing saturation target was achieved.

[0059] FIG. 8 shows a graph of exudate threshold volume in the intelligent dressing system 1 of FIG. 6 according to the radial moisture sensor 16 spacing in the dressing system 1. More particularly, the graph illustrates the threshold volume (i.e. the amount of exudate required to activate the moisture sensors 16) as a function of sensor 16 distance from the centre of the dressing system 1. As shown in the graph, sensors 16 placed at or near the dressing centre activated early while those towards the periphery of the dressing system remained inactive until more exudate 3 was absorbed by the dressing system 1. Accordingly, wound exudation rates could be assessed, the diffusion of exudate across the dressing measured, and predictions made regarding the time at which the dressing would become fully saturated and require changing.

[0060] The absorbent pad 2 is formed from a die-cut adhesive bandage material which allows for sufficient transfer of oxygen to a wound site while effectively preventing passage of microbes to the wound. The backing film 6 can be formed from a polymer such as acrylic or polyurethane while the release film 9 can be formed from polyethylene terephthalate (PET).

[0061] The electronic module 17 of the dressing system of the invention includes a communications module such as a wireless communications module for communicating wound data from the electronic module to a clinician and a power source such as a battery for powering the electronic module.

[0062] The dressing system 1 can be manufactured in any suitable size as required in accordance with wound sizes. Typical dressing sizes are 10 cm×10 cm, 7.5 cm ×7.5 cm, 20 cm×10 cm and 20 cm×20 cm.

[0063] The dressing system 1 is sterilised to kill microorganisms transferred during the manufacturing process. A suitable sterilization method is an ethylene oxide (EtO) sterilisation method which protects the sensors 16 and electronic module 17 from damage. This method of sterilisation is also preferred due to its handling ease, versatility and suitability for use with delicate medical dressings which could be damaged by other sterilisation methods such as heat sterilisation.

[0064] In use, data from the sensors 16 is harvested and processed for optimal wound monitoring and healing. Other sensor types can be employed in the dressing system 1 in addition to the moisture sensors 16 as required e.g. pressure sensors, bacterial sensors, temperature sensors and pH sensors. The sensors 16 can be offset from the centre of the absorbent pad 16 as hereinbefore described and can also be included in the offset electronic module 17 if desired. Various data processing methods can be employed as necessary.

[0065] The invention is not limited to the embodiments herein described which may be varied in construction and detail without departing from the scope of the invention.