WIRELESS PRESSURE ULCER ALERT DRESSING SYSTEM

• US 20170281073A1
• Filed: 03/29/2016
• Published: 10/05/2017
• Est. Priority Date: 03/29/2016
• Status: Active Grant

• Current Assignee: Walgreen Health Solutions, LLC
• Original Assignee: Dm Systems, Inc.
• Inventors: Drennan, Denis Burke, Trapani, Matthew Frank
• Granted Patent: US 11,311,231 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2562/0233 Special features of optical sensors or probes classified in A61B5/00
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 2562/0271 Thermal or temperature sensors
• CPC Class Codes: A61B 2562/04 Arrangements of multiple sensors of the same type
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• CPC Class Codes: A61B 2562/187 Strain relief means
• CPC Class Codes: A61B 2562/247 Hygienic covers, i.e. for covering the sensor or apparatus during use
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0051 by applying vibrations
• CPC Class Codes: A61B 5/0053 by applying pressure, e.g. compression, indentation, palpation, grasping, gauging
• CPC Class Codes: A61B 5/0082 adapted for particular medical purposes
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0531 Measuring skin impedance
• CPC Class Codes: A61B 5/442 Evaluating skin mechanical properties, e.g. elasticity, hardness, texture, wrinkle assessment
• CPC Class Codes: A61B 5/445 Evaluating skin irritation or skin trauma, e.g. rash, eczema, wound, bed sore
• CPC Class Codes: A61B 5/447 specially adapted for aiding the prevention of ulcer or pressure sore development, i.e. before the ulcer or sore has developed
• CPC Class Codes: A61B 5/6829 : Foot or ankle
• CPC Class Codes: A61B 5/6832 : using adhesives A61B5/259 takes precedence
• CPC Class Codes: A61B 5/6892 : Mats
• CPC Class Codes: A61B 5/7405 : using sound
• CPC Class Codes: A61B 5/742 : using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7455 : characterised by tactile indication, e.g. vibration or electrical stimulation
• CPC Class Codes: A61B 5/746 : Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61F 13/00051 : Accessories for dressings
• CPC Class Codes: A61F 13/02 : Adhesive bandages or dressings
• CPC Class Codes: A61F 13/0243 : characterised by the properties of the skin contacting layer, e.g. air-vapor permeability
• CPC Class Codes: A61F 13/0253 : characterized by the adhesive material
• CPC Class Codes: A61F 13/0256 : characterized by the parametric properties of the adhesive
• CPC Class Codes: A61F 15/008 : Appliances for wound protecting, e.g. avoiding contact between wound and bandage corn plasters A61F13/063
• CPC Class Codes: G16H 40/67 : for remote operation

Abstract

A wireless pressure ulcer alert dressing system for warning a patient or caregiver that soft tissue pressure or health condition has exceeded some predetermined level that over time would necessitate moving the patient to prevent or at least reduce a risk of soft tissue damage. The dressing assembly is adapted to be applied to or near a surface of the patient'"'"'s body and generate electrical outputs corresponding to soft tissue pressure and other health characteristics sensed at the surface. The dressing assembly generates output signals based on the electrical outputs and corresponding to whether or not the soft tissue pressure has exceeded a predetermined pressure level during the preselected time period. The dressing assembly includes a pocket formed therein for removable, secured and protected insertion of a variety of different sensors such as multiple pressure sensors.

Claims

1. A pressure monitoring system for providing a warning to a patient or caregiver that the patient should be moved to at least reduce a risk of soft tissue damage to the patient, the system comprising:

a pressure-sensitive dressing assembly adapted to be applied on or near a surface of the patient'"'"'s body that is susceptible to damage from soft tissue pressure, the pressure-sensitive dressing assembly generating electrical outputs corresponding to soft tissue pressure sensed by the pressure-sensitive dressing assembly at the surface of the patient'"'"'s body;

means for wirelessly monitoring a plurality of the electrical outputs generated by the pressure-sensitive dressing assembly; and

means for generating an alarm when the outputs from the dressing assembly exceed a predetermined pressure level.

2. The pressure monitoring system according to claim 1, wherein the pressure-sensitive dressing assembly is adapted to generate the electrical outputs only if the soft tissue pressure exceeds the predetermined pressure level.

3. The pressure monitoring system according to claim 1, wherein the pressure-sensitive dressing assembly generates the electrical outputs at an identical output level regardless of how much the soft tissue pressure exceeds the predetermined pressure level.

4. The pressure monitoring system according to claim 1, wherein the means for wirelessly monitoring the plurality of the electrical outputs generated by the pressure-sensitive pad assembly comprises the pressure-sensitive dressing assembly wirelessly transmitting the electrical outputs from a sensor to a tablet, a smartphone, a computer, a server or a wireless converter box that is physically separate from the pressure-sensitive dressing assembly.

5. The pressure monitoring system according to claim 1, wherein the pressure-sensitive dressing assembly comprises at least one electrically-conductive dome sensor comprising conductive circuitry that are electrically shorted by the dome sensor if the predetermined pressure level is exceeded.

6. The pressure monitoring system according to claim 5, wherein the at least one dome sensor is adapted to collapse and electrically short the conductive circuitry if subjected to a collapsing force of at least forty grams.

8. The dressing assembly according to claim 1, wherein the at least one sensor is a wireless sensor.

7. A dressing assembly for providing a warning to a patient or caregiver that the patient needs attention, the dressing assembly comprising:

a patient facing layer with a first adhesive on a first side thereof that attaches the dressing assembly to the skin of a patient or to another dressing;

a foam layer configured to receive at least one sensor in a sensor pocket, wherein the foam layer distributes the pressure of the sensor on the patient and further comprises a second adhesive to permanently adhere the foam layer to the patient facing layer;

a pocket cover layer covering the sensor pocket in the foam layer; and

a top layer providing a low coefficient of friction when contacting other surfaces wherein the top layer includes an opening to access the at least one sensor in the sensor pocket in the foam layer.

9. The dressing assembly according to claim 7, wherein the adhesive on the patient facing layer is reusable.

10. The dressing assembly according to claim 7, wherein the pocket cover layer is lifted to access the sensor pocket to insert and remove the at least one sensor contained therein.

11. The dressing assembly according to claim 7, wherein the at least one sensor is a pressure or other measurement characteristic sensor that broadcasts a plurality of messages either automatically or based on a particular event.

12. The dressing assembly according to claim 7, wherein the pocket cover layer is comprised of a soft silicone or hydrogel adhesive or another re-applicable and skin friendly adhesive.

13. The dressing assembly according to claim 7, wherein the patient facing layer is impermeable to liquid, water and bacteria.

14. The dressing assembly according to claim 13, wherein the patient facing layer is permeable to moisture vapor and atmospheric gasses.

15. The dressing assembly according to claim 7, wherein the foam layer is a flexible plastic polymer.

17. The dressing assembly according to claim 7, wherein the pocket cover layer is disposed between the foam layer and the top layer and the pocket layer further comprises a tab secured thereupon for opening and closing the pocket cover layer.

18. A method of monitoring a plurality of sensed output signals and providing a warning to a patient or caregiver that the patient needs attention, the method comprising:

applying a dressing assembly to a surface of the patient'"'"'s body, the dressing assembly generating the plurality of sensed output signals corresponding to at least one sensor embedded in the dressing assembly, wherein the dressing assembly comprises a patient facing layer, a foam layer configured to receive the at least one sensor in a sensor pocket formed therein, a pocket cover layer covering the sensor pocket, and a top layer with an opening to access the at least one sensor;

monitoring the plurality of sensed output signals generated by the dressing assembly; and

generating an alert if the plurality of sensed output signals exceeds a threshold level.

19. The method according to claim 18, wherein the patient facing layer includes a first adhesive on a first side thereof that attaches the dressing assembly to the surface of the patient'"'"'s body or to another dressing, the foam layer distributes the pressure of the sensor on the patient and further comprises a second adhesive to permanently adhere the foam layer to the patient facing layer, and the top layer has a low coefficient of friction when contacting other surfaces.

20. The method according to claim 18, wherein the at least one sensor is a wireless sensor.

21. The method according to claim 18, wherein the pocket cover layer is lifted to access the sensor pocket to insert and remove the at least one sensor contained therein.

22. The method according to claim 18, wherein the at least one sensor is a pressure or other measurement characteristic sensor that broadcasts a plurality of messages either automatically or based on a particular event.

23. The method according to claim 18, wherein the pocket cover layer is comprised of a soft silicone or hydrogel adhesive or another re-applicable and skin friendly adhesive.

24. A method of monitoring a plurality of sensed output signals and providing a warning to a patient or caregiver that the patient needs attention, the method comprising:

applying a dressing assembly to a surface of the patient'"'"'s body, the dressing assembly generating the plurality of sensed output signals corresponding to at least one sensor embedded in the dressing assembly, wherein the dressing assembly comprises a patient facing layer, a foam layer configured to receive the at least one sensor in a sensor pocket formed therein, and a top layer opposite the patient facing layer;

monitoring the plurality of sensed output signals generated by the dressing assembly; and

generating an alert if the plurality of sensed output signals exceeds a threshold level.

25. The method according to claim 24, wherein the patient facing layer includes a first adhesive on a first side thereof that attaches the dressing assembly to the surface of the patient'"'"'s body or to another dressing, and the foam layer distributes the pressure of the sensor on the patient and further comprises a second adhesive to permanently adhere the foam layer to the patient facing layer.

26. The method according to claim 24, wherein the at least one sensor is a wireless sensor.

27. The method according to claim 24, wherein the dressing assembly further comprises a first flap opposite a second flap with a middle portion therebetween, wherein the middle portion is placed onto a heel of a patient and the first flap wraps around and adheres to a first portion of an ankle of the patient and the second flap wraps around and adheres to a second portion of the ankle of the patient, thereby securing the dressing assembly onto the heel of the patient.

28. The method according to claim 24, wherein the dressing assembly further comprises a first flap opposite a second flap with a middle portion therebetween, wherein the middle portion is placed onto a heel of a patient and the first flap wraps around an ankle of the patient and the second flap overlaps and adheres to the first flap, thereby securing the dressing assembly onto the heel of the patient.