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WO2025153871A1 - Système de communication dynamique pour thérapie de plaie par pression négative - Google Patents

Système de communication dynamique pour thérapie de plaie par pression négative

Info

Publication number
WO2025153871A1
WO2025153871A1 PCT/IB2024/062456 IB2024062456W WO2025153871A1 WO 2025153871 A1 WO2025153871 A1 WO 2025153871A1 IB 2024062456 W IB2024062456 W IB 2024062456W WO 2025153871 A1 WO2025153871 A1 WO 2025153871A1
Authority
WO
WIPO (PCT)
Prior art keywords
wound
rate
pressure
value
sampling rate
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/IB2024/062456
Other languages
English (en)
Inventor
Benjamin A. Pratt
Dominic Nolan
Robert Howard
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Solventum Intellectual Properties Co
Original Assignee
Solventum Intellectual Properties Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Solventum Intellectual Properties Co filed Critical Solventum Intellectual Properties Co
Publication of WO2025153871A1 publication Critical patent/WO2025153871A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/44—Detecting, measuring or recording for evaluating the integumentary system, e.g. skin, hair or nails
    • A61B5/441—Skin evaluation, e.g. for skin disorder diagnosis
    • A61B5/445—Evaluating skin irritation or skin trauma, e.g. rash, eczema, wound, bed sore
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/96—Suction control thereof
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/30—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02—Operational features
    • A61B2560/0266—Operational features for monitoring or limiting apparatus function
    • A61B2560/0271—Operational features for monitoring or limiting apparatus function using a remote monitoring unit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/01—Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0531—Measuring skin impedance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0537—Measuring body composition by impedance, e.g. tissue hydration or fat content
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14507—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue specially adapted for measuring characteristics of body fluids other than blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14539—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring pH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3324—PH measuring means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3327—Measuring
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3368—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers

Definitions

  • negative wound therapy In addition to stimulating cellular activity at the wound site, negative wound pressure therapy provides a number of benefits, including migration of epithelial and subcutaneous tissues, improved blood flow, removal of wound exudate or other material that may infect the wound site, and micro -deformation of tissue. Cumulatively, these benefits result in increased development of granulation tissue and faster healing times.
  • Devices or systems for performing the negative pressure wound therapy may include various components, such as the dressing which may be coupled to a fluid canister, and a pressure device which is to apply the reduced or negative pressure. Owing to the negative pressure formed at the wound site, the wound extmdate or other fluids are collected and deposited into the fluid cannister. The operation of the system may be controlled by a wound therapy module provided at the wound site, which may monitor wound parameters at the wound site. The wound therapy module may communicate with a wound therapy unit which in turn may control the operation of the pressure device to ensure that an optimal pressure level is maintained at the wound site.
  • FIG. 1 illustrates a system for monitoring and transmission of wound parameters corresponding to the wound site, as per an example
  • FIG. 2 illustrates an example negative pressure wound therapy system for monitoring and transmission of wound parameters, as per an example
  • FIG. 5 illustrates a graph depicting variations of negative wound pressure as monitored by a therapy system, as per another example
  • FIGS. 6A-6B illustrates another graph depicting variations of negative wound pressure and negative pressure in a therapy system, as per an example
  • FIG. 10 illustrates a system environment implementing a non-transitory computer readable medium for monitoring and transmission of wound parameters corresponding to the wound site, as per an example
  • FIG. 11 illustrates a computing environment for monitoring and transmission of wound parameters corresponding to the wound site, as per an example.
  • the negative pressure wound therapy system may include a number of components, such as a wound therapy module.
  • the wound therapy module may be provided near the wound site and may be coupled to a fluid canister and a pressure device through fluid conduits.
  • the pressure device applies the reduced or negative pressure which results in a negative wound pressure at the wound site.
  • the wound therapy module may further include a plurality of sensors which, when operating, may monitor a variety of wound parameters.
  • the wound parameters may be collected by the wound therapy module and may be transmitted to a wound therapy unit. Examples of such wound parameters include, but are not limited to, wound pressure being applied to the wound, humidity at a wound site, temperature at the wound site, pH value at the wound site, electrical impedance at the wound site, fluid composition, or gas composition.
  • the wound therapy module may obtain one or more wound parameters through its the sensors. Based on the wound parameters, the wound therapy unit may accordingly generate control instructions for controlling the pressure device. The pressure device in response to the control instructions may generate the appropriate pressure which is applied to the wound site.
  • the wound therapy unit may either be a different standalone device unit or may include the pressure device as an integrated component.
  • the wound therapy module and the wound therapy unit may be powered through a separate and independent power source.
  • Performant monitoring of wound parameters, and controlling the pressure applied to the wound site ensures that the wound healing is optimum.
  • the sensors provided in the wound therapy module may be activated and the value of the wound parameter may be determined. Thereafter, the sensors may transmit the value of the wound parameters to the wound therapy unit.
  • the wound therapy unit based on the monitored value of the wound parameters, may accordingly determine the manner in which the pressure device is to be controlled in order to manage the pressure at the wound site.
  • Monitoring of the wound parameters by the wound therapy module utilizes power from the power source. Furthermore, such functions would also entail the wound therapy module to be provided with circuity and components that for transmitting the wound parameters. These, in turn, would also draw power from the power source during the course of their operations. Such power usage may further increase in instances where the wound parameters is to be transmitted over a wireless interface. Such challenges may be overcome by increasing the size and/or capacity of the power source. However, such solutions may impact the overall portability of the therapy systems and may not enhance the lifespan or the period of use of the therapy system.
  • the present approaches may be implemented by a wound therapy module of a negative wound pressure therapy system.
  • the wound therapy module is to control the rate at which the wound parameters are sampled or monitored.
  • the wound therapy module may either include one or more sensors or may be coupled to the sensors, which may be employed for sampling the wound parameters.
  • the wound therapy module may determine a rate of change in the value of any one of the wound parameters.
  • the wound parameters are obtained through a sensor which may sample such wound parameters at a current sampling rate. Thereafter, a rate of change of the values of the wound parameters is determined. Once the rate of change is determined, the same may be compared with a predefined threshold.
  • the wound therapy module may vary the sampling rate of the sensors. For example, the sampling rate of the sensors may be changed from the current sampling to a first sampling rate, wherein the first sampling rate is less than the current sampling rate. If, on the other hand, the wound therapy module determines that the rate of change is greater than the predefined threshold, the wound therapy module may allow the sensor to monitor the wound parameters at the current sampling rate.
  • the wound therapy module may also vary a transmission rate at which the wound parameters may be transmitted to a wound therapy unit.
  • the wound therapy unit may be any device which is to receive and process the wound parameters, and/or perform other operational functions of the therapy system.
  • the wound parameters may be shared in chunks or as a data packet comprising values that may have been collected over a certain time period.
  • the wound therapy module and the wound therapy unit may be in communication, wherein which the wound therapy unit is to receive the wound parameters from the wound therapy module and, based on the wound parameters, the wound therapy unit may generate and transmit control instructions for the wound therapy module.
  • a loss of communication may occur between the wound therapy module and the wound therapy unit. In such a case, it would not be possible for the wound therapy unit to determine the wound pressure at the wound site. As a result, the wound therapy unit would not be able to determine whether any changes in the negative pressure (applied by the pressure device) are to be made.
  • the wound therapy module may obtain correlation data which correlates values of the pressure being applied by the pressure device and the resulting wound pressure.
  • a value of a target pressure may be obtained.
  • the value of the target pressure may be such pressure that is desired to be applied to the wound site.
  • an estimated negative pressure may be determined based on the correlation data.
  • the wound therapy module may generate control instmctions for the pressure device so as to result in a target pressure being applied at the wound site.
  • the processor 104 may be implemented as a dedicated processor, a shared processor, or a plurality of individual processors, some of which may be shared.
  • the machine-readable storage medium 106 may be communicatively connected to the processor 104.
  • the processor 104 may fetch and execute computer-readable instructions, including instructions 108, stored in the machine-readable storage medium 106.
  • the machine-readable storage medium 106 may include non-transitory computer-readable medium including, for example, volatile memory such as RAM (Random Access Memory), or non-volatile memory such as EPROM (Erasable Programmable Read Only Memory), flash memory, and the like.
  • the determined rate of change of the wound parameter may be compared with a predefined value. Thereafter, as a result of the instruction 114, based on the comparison, the system 102 may cause the sensors to vary the sampling rate, at which the wound parameters are sampled, to a first sampling rate of the sensor. Thereafter, any subsequent values of the wound parameters are sampled or obtained based on the first sampling rate.
  • the sampling rate may be varied if a current sampling rate (at which the sensors were previously sampling the wound parameters) is less than the predefined value.
  • the current sampling rate may be maintained if the rate of change in the value of the wound parameter is greater than the predefined value.
  • FIG. 2 illustrates a negative pressure wound therapy system 200 to provide a negative pressure to a wound site of a patient, as per one example.
  • the negative pressure wound therapy system 200 (referred to as therapy system 200 or a system 200) comprises a wound therapy module 202, which may be positioned in proximity to the wound site 204.
  • the wound therapy module 202 may be securely held in position relative to the wound site 204, using a draping 206 positioned on the skin surface 208.
  • the draping 206 while retaining to the wound therapy module 202, may also provide an optimal healing environment for the wound therapy module 202 and function as a barrier to external contaminants.
  • the draping 206 may be of non-permeable or semi-permeable material and is to maintain the negative pressure applied to the wound site 204.
  • the wound therapy module 202 may further include one or more sensors (not visible in FIG. 2) for monitoring one or more wound parameters at the wound site 204.
  • the system 200 may further include a distribution manifold 210 positioned onto the wound site 204.
  • the distribution manifold 210 may be porous and manufactured from polyurethane or polyvinyl alcohol foam. It may be noted that the material of the distribution manifold 210 is only indicative and is not to construed as a limitation.
  • the distribution manifold 210 may be shaped so as to be accommodated within the wound site 204.
  • the distribution manifold 210 may be replaced during the course of the treatment, and as tissue regeneration occurs at the wound site 204.
  • the distribution manifold 210 may be coupled to a fluid conduit 212.
  • the fluid conduit 212 enables a fluid communication between the distribution manifold 210 and a fluid cannister 214.
  • the fluid cannister 214 in turn may be coupled to a pressure device 216 which is to apply a negative pressure onto the wound site 204.
  • the distribution manifold 210 when the pressure device 216 is operational, is to distribute the negative pressure thus developed by the pressure device 216.
  • the distribution manifold 210 also enables channeling exudates and other fluids away from the wound site 204.
  • the pressure device 216 may be coupled with a wound therapy unit 218. It may be noted that although depicted as being external to the wound therapy unit 218, the pressure device 216 may be implemented as part of the wound therapy unit 218, without deviating from the scope of the present subject matter. Continuing further, the wound therapy unit 218 may further include a control unit 220. The wound therapy unit 218 may, during the course of its operation (and as will be explained in detail), also store wound parameters as wound parameters 222. The wound parameters 222 may include a variety of parameters or values corresponding to the conditions that may be present at the wound site 204.
  • wound parameters 222 include, but are not limited, pressure applied to the wound, humidity at a wound site, temperature at the wound site, pH value at the wound site, electrical impedance at the wound site, fluid composition, and gas composition.
  • the wound parameters 222 may be monitored and determined through sensors present in the wound therapy module 202.
  • the wound therapy unit 218 may be any processor-based electronic device which may be capable of receiving and transmitting data and information to the wound therapy module 202.
  • the wound therapy module 202 may be specifically configured device which is to be operated along with the wound therapy module 202.
  • the wound therapy unit 218 may be any handheld computing device, such as a mobile phone, or a tablet computer.
  • the control unit 220 may be implemented by a processor, which is similar to the processor of the wound therapy module 202.
  • the wound therapy unit 218 may be communicatively coupled with the wound therapy module 202.
  • the communication between the wound therapy module 202 and the wound therapy unit 218 may be either through a wired communication channel or a wireless communication channel.
  • wired communication may include electrical cables made of electrically conducting material that may allow communication of information or data between the wound therapy module 202 and the wound therapy unit 218.
  • the communication channel may be implemented through a wireless protocol, examples of which include Bluetooth® or Wi-Fi. The present examples are only indicative and other forms of communication modes (wired or wireless) would also be within the scope of the present subject matter.
  • FIG. 3 depicts various functional blocks of the wound therapy module 202, as an example.
  • the wound therapy module 202 includes a processor 302, interface(s) 304, memory(s) 306 and sensor(s) 308.
  • the processor 302 may be implemented as microprocessors, microcomputers, microcontrollers, digital signal processors, central processing units, state machines, logic circuitries, and/or other devices that manipulate signals based on operational instructions.
  • the interface(s) 304 may allow the connection or coupling of the wound therapy module 202 with one or more other devices (such as the wound therapy unit 218), through a wired (e.g., Local Area Network, i.e., LAN) connection or through a wireless connection (e.g., Bluetooth®, Wi-Fi).
  • the interface(s) 304 may also enable intercommunication between different logical as well as hardware components of the wound therapy module 202, such as the pressure device 216.
  • the memory(s) 306 may be a computer-readable medium, examples of which include volatile memory (e.g., RAM), and/or non-volatile memory (e.g., Erasable Programmable read-only memory, i.e., EPROM, flash memory, etc.).
  • volatile memory e.g., RAM
  • non-volatile memory e.g., Erasable Programmable read-only memory, i.e., EPROM, flash memory, etc.
  • the memory(s) 306 may be an external memory, or internal memory, such as a flash drive, a compact disk drive, an external hard disk drive, or the like.
  • the memory(s) 306 may further include data which either may be utilized or generated during the operation of the wound therapy module 202.
  • the sensor(s) 308 may refer to a single sensor or a plurality of sensors for monitoring wound conditions at the wound site 204. Based on the monitoring by the sensor(s) 308, a value representing the same may be stored as wound parameters 222. Examples of wound parameters the sensor(s) 308 may monitor include, but are not limited, pressure applied to the wound, humidity at a wound site, temperature at the wound site, pH value at the wound site, electrical impedance at the wound site, fluid composition, and gas composition. During the course of operation, the sensor(s) 308 may be monitoring the wound site 204 at a current sampling rate. The current sampling rate may be common for one or more wound parameters. In another example, the current sampling rate for monitoring different wound parameters may be different. For example, the wound pressure may be sampled at the rate of 5 Hz but the wound temperature may be monitored at a lower rate of 0.1 Hz. The sampled values may be stored as wound parameters 222 in the wound therapy module 202.
  • the wound therapy module 202 may further include engine(s) 310 and data 312.
  • the engine(s) 310 may be implemented as a combination of hardware and programming, for example, programmable instructions to implement a variety of functionalities of the engine(s) 310.
  • the programming for the engine(s) 310 may be executable instructions.
  • Such instructions may be stored on a non-transitory machine-readable storage medium which may be coupled either directly with the wound therapy module 202 or indirectly (for example, through networked means).
  • the engine(s) 310 may include a processing resource, for example, either a single processor or a combination of multiple processors, to execute such instructions.
  • the non-transitory machine-readable storage medium may store instructions that, when executed by the processing resource, implement engine(s) 310.
  • the engine(s) 310 may be implemented as electronic circuitry.
  • the engine(s) 310 includes a processing engine 314 and other engine(s) 316.
  • the other engine(s) 316 may implement functionalities that supplement functions performed by the wound therapy module 202 or any of the engine(s) 310.
  • the data 312, on the other hand, includes data that is either stored or generated as a result of functions implemented by any of the engine(s) 310 or the wound therapy module 202. It may further be noted that information stored and available in data 312 may be utilized by the engine(s) 310 for performing various functions by the wound therapy module 202. In an example, data 312 may include current sampling rate 318, rate of change 320, predefined value 322, first sampling rate 324, subsequent sampling rate 326, transmission rate 328 and other data 330. It may be noted that such examples are only indicative. Other types of data may also be stored or available within the wound therapy module 202. Such examples would also fall within the scope of the present subject matter.
  • the wound therapy module 202 is to also communicate the sampled wound parameters 222 to the wound therapy unit 218.
  • the wound therapy module 202 comprises a transceiver(s) 334 for communicating the collected and sampled wound parameters 222 to the wound therapy unit 218.
  • the wound therapy module 202 may transmit the wound parameters 222 either continuously (i.e., as it samples the wound parameters 222) or may transmit the wound parameters 222 intermittently after a certain time period has elapsed.
  • the wound therapy module 202 may transmit the wound parameters 222 to the wound therapy unit 218 after every 5 minutes.
  • the wound therapy module 202 may transmit the wound parameters 222 over a wired or a wireless communication channel.
  • the wound therapy module 202 may establish a communication channel as per the applicable communications protocol with the wound therapy unit 218, and thereafter transmit the wound parameters 222 using the transceiver(s) 334.
  • the transceiver(s) 334 may transmit the wound parameters 222 through the interface(s) 304 of the wound therapy module 202.
  • the wound therapy module 202 may manage and control the rate of sampling of the parameters of the wound site 204.
  • the sensor(s) 308 within the wound therapy module 202 may be set to monitor the wound site 204 at the current sampling rate 318.
  • the wound parameters 222 thus collected may then be subsequently transmitted to the wound therapy unit 218.
  • the wound therapy unit 218 may control the pressure device 216. For example, if any one of the wound parameters 222, such as wound pressure, is to change beyond a certain limit, the wound therapy unit 218 may activate the pressure device 216 to bring the wound pressure within permissible limits.
  • other wound parameters 222 may be considered and processed by the wound therapy unit 218 to determine if any action is to be taken.
  • the processing engine 314 may determine whether the rate of change 320 of the wound pressure has exceeded 5 mm of Hg in 60 seconds (as specified in the predefined value 322). If the rate of change 320 for the wound pressure is determined to be greater than the above-mentioned example predefined value (i.e., 5 mm of Hg in 60 seconds), the processing engine 314 may allow the sensor(s) 308 to sample the wound pressure at the corresponding current sampling rate 318. In an example, the processing engine 314 may also generate control instructions that may vary certain operational characteristics of the system 200 to ensure that the healing of the wound site 204 is not impacted.
  • the processing engine 314 may thereafter cause the sensor(s) 308 to sample the wound parameters 222 (e.g., wound pressure) at a different rate.
  • the processing engine 314 may change the configuration or corresponding settings for the sensor(s) 308 such that they may subsequently sample the wound pressure at the first sampling rate 324 (as opposed to the current sampling rate 318).
  • the first sampling rate 324 is less than the current sampling rate 318.
  • consistent values (or values with minor variations) of the wound parameters 222 represent that the conditions at the wound site 204 are not varying. Hence, such wound parameters 222 may be sampled at lower frequency which in turn will conserve power and prolong the life of the wound therapy module 202, without impacting the healing at the wound site 204.
  • the processing engine 314 may set the sampling rate back to the initial current sampling rate 318, i.e., 10 Hz. However, if processing engine 314 determines that the rate of change 320 is less than the example predefined value 322, i.e., 5 mm of Hg in 60 seconds, the processing engine 314 may cause to change the sampling to a subsequent sampling rate 326, say 0.5 Hz.
  • the processing engine 314 may then continue to monitor the wound parameters 222 with respect to subsequent predefined value 322 to ascertain whether the conditions at the wound site 204 have changed rapidly. It may be noted that such changes in the wound parameters 222 may occur due to numerous factors. Pressure leakages due to displacement or dislodging of the draping 206 may cause sudden changes to the wound pressure. Furthermore, a blockage (either temporary or permanent) in the fluid conduit 212 may cause fluid buildup at the wound site 204, which in term may result in changes in the temperature, wound pH, impedance measured, fluid constituents, etc. It may be noted that the present examples are only indicative and in no manner limit the scope of the present subject matter.
  • the processing engine 314 may revert the sampling rate to the previous current sampling rate 318, i.e., 10 Hz.
  • the sampling rate may also be set to a previously set sampling rate value, say the first sampling rate 324.
  • the sampling rate may be progressively increased to ascertain the conditions of the wound site 204 and accordingly determine if any corrective intervention is required by medical personnel.
  • the processing engine 314 may, further decrease the sampling rate to a yet lower subsequent sampling rate 326. Thereafter, the processing engine 314, while monitoring the wound parameters 222 at the set lower predefined value 322, may compare the values of the wound parameters 222 (sampled at the lower subsequent sampling rate 326) to defined threshold range. On determining the sampled wound parameters 222 to be within the threshold range (say within 10% of acceptable limits for the pertinent wound parameter), the processing engine 314 may have the sensor(s) 308 continue to sample the wound parameters 222 at the lower subsequent sampling rate 326.
  • the processing engine 314 may vary the sampling rate to a previously set sampling rate. For example, the processing engine 314 may set the sampling rate to the first sampling rate 324 from the subsequent sampling rate 326. It may be noted that different combinations of options involving the varying of the sampling rate are possible. Such implementations, although differing from the examples described above, would still fall within the scope of the present subject matter. It may be further noted that although some of the examples have been described in the context of wound pressure, such similar approaches would also be applicable for other types of wound parameters without deviating from the scope of the present subject matter.
  • the processing engine 314 may also vary the transmission rate of the wound therapy module 202.
  • the wound parameters 222 would utilize power for transmitting the wound parameters 222 that may have been sampled through the sensor(s) 308.
  • varying the transmission rate of the wound therapy module 202 may also consequently reduce the power consumption of the power source 332.
  • the processing engine 314 may initially control the transceiver(s) 334 to transmit the wound parameters 222 sampled over a certain time period at a first transmission rate. Thereafter, the processing engine 314 may determine the rate of change 320 of the wound parameters 222 to determine whether the first transmission rate is to be changed.
  • the processing engine 314 may vary the transmission rate of the transceiver(s) 334 from the first transmission rate to a second transmission rate (wherein which the second transmission rate is less than the first transmission rate). If it is greater, it may accordingly revert to the transmission rate to the first transmission rate. In another example, the processing engine 314 may compare the transmission rate of the transceiver(s) 334 with a predefined value or a condition. Based on the variance of the transmission rate from such predefined value, the processing engine 314 may vary the transmission rate accordingly. In an example, the different values of the transmission rates for the transceiver(s) 334 may be stored in the transmission rate 328.
  • FIG. 4 depicts the varying of the sampling rate and the transmission rate as described in conjunction with FIGS. 2-3.
  • FIG. 4 illustrates a graph 400 which indicates the variation of wound pressure that may be applied to a wound site, such as the wound site 204. Corresponding variations in the other types of wound parameters may be depicted in a similar manner.
  • the horizontal axis 402 of the graph 400 represents the time over which the negative wound pressure (represented by the vertical axis 404).
  • the negative wound pressure is shown to vary between a lower value 406 and an upper value 408 for the negative wound pressure.
  • the negative wound pressure may be determined through any one of the sensor(s) 308 in the wound therapy module 202.
  • the draping 206 although capable of maintaining the negative wound pressure to a certain extent, cannot maintain the same over a period of time. Therefore, the negative wound pressure varies with time.
  • the processing engine 314 may communicate to the wound therapy unit 218 which in turn may activate the pressure device 216 which increases the negative wound pressure at the wound site 204 from the value 406 to the value 408, as depicted by the leading edge 410.
  • the negative wound pressure may undergo a gradual decrease over a period of time, as depicted by the trailing edge 412.
  • the slope of the leading edge 410 is greater than the slope of the trailing edge 412 depicting that rate at which the negative wound pressure increases at the wound site 204 (owing to the activation of the pressure device 216) is greater than the rate at which the negative wound pressure decreases.
  • the present depiction is exemplary and is not to be construed as a limitation.
  • the rate of change 320 may be compared with the predefined value 322 (as discussed in conjunction with FIGS. 2-3). On determining that the rate of change 320 of the negative wound pressure is less than the predefined value 322 (e.g., 5 mm of Hg in 60 seconds), the processing engine 314 may change the sampling rate of the sensor(s) 308 to the first sampling rate 324.
  • the time interval when the sensor(s) 308 commence sampling the negative wound pressure at the wound site 204 at the first sampling rate 324 is depicted in the time interval T2. When sampled at the first sampling rate 324, the sampling is done less frequently as depicted by the sample points 416.
  • the negative wound pressure is being sampled one when the negative wound pressure at the wound site 204 is increasing and sampled once when the negative wound pressure at the wound site 204 is decreasing.
  • the example as depicted in graph 400 is for instances wherein a stable leak (i.e., uniform decrease in negative wound pressure) occurs at the wound site 204.
  • FIG. 5 provides a graph 500 which depicts the variations in the negative wound pressure at the wound site 204. Similar to FIG. 4, in FIG. 5, the horizontal axis 502 of the graph 500 represents the time over which the negative wound pressure (represented by the vertical axis 504). As depicted in the graph 500, the negative wound pressure is shown to vary between a lower value 506 and an upper value 508 for the negative wound pressure. The negative wound pressure may be determined through any one of the sensor(s) 308 in the wound therapy module 202.
  • the negative wound pressure at the wound site 204 undergoes an increase as depicted by the leading edge 510 (which corresponds to the activation of the pressure device 216) and the decrease in the negative wound pressure is depicted by the trailing edge 512.
  • Whether the wound therapy unit 218 and the wound therapy module 202 are in communication may be determined based on a variety of techniques. For example, the wound therapy unit 218 may periodically monitor for a status signal being provided by the wound therapy module 202. In case the wound therapy unit does not receive the status signal 218 for a threshold time period, the wound therapy unit 218 may accordingly consider that the wound therapy module 202 is no longer ‘online’. It may be noted that any other approach for determining the communication status may be implemented without limiting the scope of the pending subject matter in any way.
  • a pressure differential may be present between a negative pressure applied by a pressure device and the wound pressure measured at the wound site.
  • the pressure differential arises since the entire therapy system 200, i.e., the pressure device 216 applying the negative pressure and the draping 206, is not perfectly sealed.
  • presence of certain leakages may inadvertently lead to pressure differences or offsets between the negative pressure applied by the pressure device 216 and the negative pressure that may be measured at the wound site 204. The same may vary based on the stage or type of treatment being performed by the negative pressure wound therapy unit 218.
  • a graph depicting negative pressure 602 and the wound pressure 604 is illustrated in FIGS.
  • the value of the negative pressure 702 as depicted in FIG. 7A may be compared with an upper threshold value.
  • the upper threshold value may be specified considering an upper limit beyond which the wound pressure 704 at the wound site 204, is not to exceed.
  • the above example is only indicative - the selection of the example upper threshold value may differ based on stage of treatment, nature of wound, size of wound, or other such factors.
  • control unit 220 may control the pressure device 216 in the event that the connection between the wound therapy unit 218 and the wound therapy module 202 is lost.
  • the control unit 220 may reduce the negative pressure 702 by a certain amount.
  • control unit 220 may control the pressure device 216 to reduce the negative pressure 702 to be lower than the upper threshold of 165 mm of Hg.
  • the changed negative pressure is denoted as 706.
  • the negative pressure 702 may be reduced to last known value of the wound pressure 704 that was sampled and communicated to the wound therapy unit 218. It may be noted that the above implementations described are only some of the examples. Other examples are also possible which too would fall within the scope of the present subject matter.
  • FIG. 8 illustrates a method 800 for monitoring and transmission of wound parameters corresponding to the wound site, as per another example.
  • the order in which the above-mentioned method is described is not intended to be construed as a limitation, and some of the described method blocks may be combined in a different order to implement the method, or an alternative method.
  • the above-mentioned method may be implemented in a suitable hardware, computer-readable instructions, or combination thereof. The steps of such method may be performed by either a system under the instruction of machine executable instructions stored on a non-transitory computer readable medium or by dedicated hardware circuits, microcontrollers, or logic circuits.
  • the method may be performed by a negative wound pressure therapy system, such as the therapy system 200.
  • some examples are also intended to cover non-transitory computer readable medium, for example, digital data storage media, which are computer readable and encode computerexecutable instructions, where said instructions perform some or all the steps of the above-mentioned methods.
  • the method 800 may be implemented within the wound therapy module 202, as per an example.
  • the wound therapy module 202 may further comprise a sensor module, such as the sensor(s) 308.
  • the sensor module may obtain a plurality of values of a wound parameter corresponding to a wound.
  • the sensor(s) 308 when controlled by the processing engine 314 may obtain a plurality of values corresponding to the wound parameters 222.
  • the wound parameters 222 are obtained over a certain time interval.
  • the wound parameters 222 are collected by the sensor(s) 308 from the wound site 204 which may be subjected to a negative pressure applied by a negative pressure device, such as the pressure device 216.
  • a rate of change in value of the wound parameter may be determined.
  • the processing engine 314 of the sensor module i.e., the wound therapy module 202 may determine a rate of change in the value of the wound parameters 222.
  • the processing engine 314 may retrieve a value of the wound pressure that may have been sampled or measured a first time instant.
  • the processing engine 314 may further retrieve another measured value of the wound parameter that may have been sampled a later second time instant.
  • the processing engine 314 may retrieve the values of the wound parameters from the wound parameters 222. Based on the retrieved values, the processing engine 314 may determine a rate of change in the value of the wound pressure.
  • one of a current sampling rate and a transmission rate may be varied.
  • the varying of the current sampling rate and the transmission rate is pursuant to comparing the rate of change in the value of a wound parameter with a predefined value.
  • the processing engine 314 may compare the rate of change of the wound parameters 222, i.e., the rate of change 320 with the predefined value 322.
  • the processing engine 314 may vary the sampling rate of the sensor(s) 308 from the current sampling rate 318 to the first sampling rate 324.
  • the processing engine 314 may also change the transmission rate 328 of the transceiver(s) 334 such that the wound therapy module 202 is to transmit the collected wound parameters 222 from a first transmission rate to a second transmission rate, with the second transmission rate being less than the first transmission rate.
  • the processing engine 314 may determine the time instants at which a minimum value and a maximum value of the wound parameter is to occur based on a determined pattern. For example, the processing engine 314 may determine the time instant when the upper value 408) of the wound parameters 222 is sampled. In a similar manner, the processing engine 314 may determine the time instant when the lower value 406 of the wound parameters 222 is sampled. Accordingly, the processing engine 314 may control the transceiver(s) 334 to transmit the wound parameters 222 to the wound therapy unit 218 at the upper value 408 and the lower value 406 at indicated by the transmission points 420.
  • FIG. 9 illustrates a method 900 for monitoring of wound parameters corresponding to the wound site, as per another example.
  • one or more wound parameters may be obtained by a wound therapy module at a current sampling rate.
  • the sensor(s) 308 within the wound therapy module 202 may be set to monitor the wound site 204 at a current sampling rate 318.
  • a rate of change of the wound parameters may be determined.
  • the processing engine 314 of the wound therapy module 202 may determine the rate at which the value of any one or more of the wound parameters 222 changes over a period of time. To this end, the processing engine 314 may accordingly obtain any two values of wound parameters 222, spaced by a certain time period and accordingly determine a rate at which the value of the given wound parameters 222 may have changed.
  • the processing engine 314 may retrieve a value of the wound parameters 222 that may have been sampled or measured a first time instant. In a similar manner, the processing engine 314 may further retrieve another measured value of the wound parameters 222 that may have been sampled a later second time instant. Based on the retrieved values, the processing engine 314 may determine a rate of change in the value of the wound parameters 222.
  • the rate of change of the wound parameter may be compared with a predefined value.
  • the processing engine 314 on determining the rate of change 320 may then proceed and compare the rate of change 320 with a predefined value 322 stored or provided in the wound therapy module 202.
  • the predefined value 322 may prescribe various threshold values for different categories of wound parameters 222.
  • the processing engine 314 may compare it with another predefined threshold prescribed in the predefined value 322. If based on the comparison it is determined that the subsequent rate of change 320 is less than the other predefined value (i.e., ‘No’ path from block 914), the processing engine 314 may vary the sampling rate of the sensor(s) 308 to the subsequent sampling rate 326 (block 916). In an example, the subsequent sampling rate 326 is less than the first sampling rate 324. As may be noted, a further reduction in the sampling rate may further reduce the power consumption of the power source 332 of the wound therapy module 202.
  • FIG. 10 illustrates a method 1000 for managing operation of a wound therapy module, as per another example.
  • a method may be implemented in cases where the wound therapy module, such as the wound therapy module 202, loses communication with a wound therapy unit, such as the wound therapy unit 218, to which the wound therapy module 202 may be coupled with.
  • the wound therapy module 202 may measure the negative wound pressure which may be transmitted to the wound therapy unit 218.
  • the wound therapy unit 218 on the other hand may, depending on the communicated wound parameters 222, control the pressure device 216.
  • the pressure device 216 generates a negative pressure which in turn results in the negative wound pressure at the wound site 204.
  • the measured negative wound pressure and the negative pressure may be correlated.
  • the control unit 220 may correlate the values of the negative wound pressure measured at the wound site 204 (say by the sensor(s) 308) with the applicable negative pressure that may have been applied by the pressure device 216.
  • Such a correlation is obtained by a variety of statistical approaches.
  • the correlation between the negative wound pressure and the negative pressure is implemented in the form of a mapping which maps certain values (or ranges) of the negative wound pressure with corresponding values of the negative pressure that may have been applied by the pressure device 216.
  • the correlation or the mapping may then be stored as correlation data 224.
  • the control unit 220 may determine the value of the negative pressure being applied by the pressure device 216 (at block 1008).
  • the value of the negative pressure being applied may be obtained by a pressure sensor implemented at the pressure device 216.
  • a target wound pressure that is to be applied to the wound site may be obtained.
  • the target negative wound pressure that is to be applied to the wound site 204 may be obtained based on either user input or may be preconfigured based on certain conditions, such as on occurrence of a loss of communication between the wound therapy module 202 and the wound therapy unit 218.
  • an estimated negative pressure may be determined based on the correlation data.
  • the control unit 220 based on the target negative wound pressure may determine an estimated negative pressure that is to be applied by the pressure device 216 using the correlation data 224.
  • the correlation data 224 may be in the form of a mapping which correlates values of negative wound pressure and corresponding negative pressure.
  • the pressure device may be controlled based on the estimated negative pressure.
  • the control unit 220 may generate control instructions to control the pressure device 216 such that the pressure device 216 is able to generate the negative wound pressure at the wound site 204.
  • FIG. 11 illustrates a computing environment 1100 implementing a non-transitory computer readable medium for monitoring and transmission of wound parameters corresponding to the wound site.
  • the computing environment 1100 includes processor(s) 1102 communicatively coupled to a non-transitory computer readable medium 1104 through a communication link 1106.
  • the computing environment 1100 may be a negative pressure wound therapy system, such as the therapy system 200.
  • the processor(s) 1102 may have one or more processing resources for fetching and executing computer readable instructions from the non-transitory computer readable medium 1104.
  • the processor(s) 1102 and the non-transitory computer readable medium 1104 may be implemented, for example, in the wound therapy module 202 of the therapy system 200 (as has been described in conjunction with the preceding figures).
  • the non-transitory computer readable medium 1104 may be, for example, an internal memory device or an external memory device.
  • the communication link 1106 may be a network communication link.
  • the processor(s) 1102 and the non-transitory computer readable medium 1104 may also be communicatively coupled to a computing device 1108 over the network.
  • a target pressure may be obtained.
  • the target negative wound pressure that is to be applied to the wound site 204 may be obtained based on either user input or may be preconfigured based on certain conditions, such as on occurrence of a loss of communication between the wound therapy module 202 and the wound therapy unit 218.
  • the instructions 1110 may estimate a negative pressure to be applied by the pressure device 216 onto the wound site 204.
  • the negative pressure to be applied to the wound site 204 may be estimated based on a mapping correlating historical values of negative pressure applied by the pressure device and historical values of wound pressure. In an example, the mapping may be stored as correlation data 224 in the wound therapy unit 218.
  • the instructions 1110 may cause the generation of one or more control instructions for the pressure device 216.
  • the control instructions are to control the operation of the pressure device 216 to result in a wound pressure corresponding to the target pressure at the wound site. In this manner, despite loss of communication between the wound therapy unit 218 and the wound therapy module 202, the pressure device 216 may be controlled to manage the wound pressure at the wound site 204.

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Abstract

Sont décrits des exemples de surveillance et de transmission de paramètres de plaie d'un site de plaie par un système de traitement de plaie par pression négative. Dans un exemple, un système peut déterminer un taux de changement de valeur d'un paramètre de plaie de la plaie soumis à une pression négative appliquée par un dispositif à pression négative. Ensuite, le taux de changement peut être comparé à une valeur prédéfinie. Ensuite, un taux d'échantillonnage de capteurs peut être modifié d'un taux d'échantillonnage actuel à un premier taux d'échantillonnage, le taux d'échantillonnage étant modifié en réponse à la comparaison du taux de changement de la valeur du paramètre de plaie avec 0 comme valeur prédéfinie.
PCT/IB2024/062456 2024-01-19 2024-12-10 Système de communication dynamique pour thérapie de plaie par pression négative Pending WO2025153871A1 (fr)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1110736C (zh) * 1997-05-22 2003-06-04 艾利森公司 触摸屏输入的自适应抽样
CN108604307A (zh) * 2016-02-12 2018-09-28 开利公司 冷链配送系统的自适应传感器采样
US10137305B2 (en) * 2015-08-28 2018-11-27 Cardiac Pacemakers, Inc. Systems and methods for behaviorally responsive signal detection and therapy delivery
US20200368407A1 (en) * 2014-12-22 2020-11-26 Smith & Nephew Plc. Status indication for negative pressure wound therapy
GB2586557A (en) * 2016-08-12 2021-02-24 Smith & Nephew Inc Systems and methods for applying reduced pressure therapy
WO2021069377A1 (fr) * 2019-10-07 2021-04-15 T.J.Smith And Nephew,Limited Systèmes et procédés de thérapie de plaies par pression négative à multiples sources de pression négative

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1110736C (zh) * 1997-05-22 2003-06-04 艾利森公司 触摸屏输入的自适应抽样
US20200368407A1 (en) * 2014-12-22 2020-11-26 Smith & Nephew Plc. Status indication for negative pressure wound therapy
US10137305B2 (en) * 2015-08-28 2018-11-27 Cardiac Pacemakers, Inc. Systems and methods for behaviorally responsive signal detection and therapy delivery
CN108604307A (zh) * 2016-02-12 2018-09-28 开利公司 冷链配送系统的自适应传感器采样
GB2586557A (en) * 2016-08-12 2021-02-24 Smith & Nephew Inc Systems and methods for applying reduced pressure therapy
WO2021069377A1 (fr) * 2019-10-07 2021-04-15 T.J.Smith And Nephew,Limited Systèmes et procédés de thérapie de plaies par pression négative à multiples sources de pression négative

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