SYSTEM FOR DELIVERING A VARIABLE PRESSURE FOR AN ENCLOSURE FOR TREATMENT OF A WOUND

Abstract

A system (5) for generating a gaseous mixture for an enclosure (7) for treatment of a wound (3), comprising a generator (11) for generating the gaseous mixture and for delivering said gaseous mixture to the treatment enclosure (7) at a defined flow rate, the generator (11) of the gaseous mixture being designed to vary a molar fraction of dioxygen of said delivered gaseous mixture and to vary a molar fraction of water vapour of said delivered gaseous mixture, a control unit (39) which serves for controlling the delivered gaseous mixture and is provided with a processor (41) for receiving information relating to a pressure (P) inside the treatment enclosure (7) and/or designed to determine a flow rate of said gaseous mixture to be delivered in the treatment enclosure (7) in order to obtain an internal target pressure, the target pressure being defined by a time variation function of the pressure between a minimum pressure, corresponding to an ambient pressure outside the treatment enclosure (7), and a maximum pressure.

Claims

1. A system for generating a gaseous mixture for an enclosure for treatment of a wound comprising; a gaseous mixture generator for delivering said gaseous mixture to the treatment enclosure at a defined flow rate, the gaseous mixture generator being designed to vary a molar fraction of dioxygen (O2) of said delivered gaseous mixture and to vary a molar fraction of water vapor (H2O) of said delivered gaseous mixture, a control unit for controlling the delivered gaseous mixture provided with a processor for receiving data relating to a pressure (P) inside the treatment enclosure and/or designed to determine a flow rate of said gaseous mixture to be delivered inside the treatment enclosure in order to obtain an internal target pressure (P), the target pressure (P) being defined by a time variation function of the pressure (TVFP) between a minimum pressure, corresponding to an ambient pressure outside the treatment enclosure, and a maximum pressure, the processor also being designed to determine a time variation function of the molar fraction of dioxygen (TVFO2) of the gaseous mixture to be delivered and a time variation function of the molar fraction of water vapor (TVFH2O) of the gaseous mixture to be delivered.

2. (canceled)

3. The system of claim 1, wherein the gaseous mixture generator is for delivering said gaseous mixture to the treatment enclosure at a defined temperature (T).

4. The system of claim 1, wherein the time variation function of the pressure (TVFP), the molar fraction of dioxygen (TVFO2), the molar fraction of water vapor (TVFH2O), or temperature (T) inside the treatment enclosure is a periodic function.

5. The system of claim 4, wherein the periodic function is sinusoidal, triangular, or step.

6. The system of claim 1, wherein the gaseous mixture also comprises a molar fraction of dinitrogen (N2) and/or a molar fraction of carbon dioxide (CO2) and/or another suitable gas.

7. The system of claim 1, wherein the control unit comprises sensors for determining an internal pressure (P), an internal relative humidity (RHH2O), molar fraction of dioxygen TVFO2, or a temperature (T) inside the treatment enclosure.

8. The system of claim 7, comprising a measurement system configured to carry out transcutaneous oximetry of the wound and configured to transmit the measurement values to the processor.

9. The system of claim 7, wherein the measurement system also comprises a capillaroscopy device and/or a wound temperature sensor.

10. The system of claim 1, wherein the processor is configured to receive data relating to a dimension (a1, a2, a3) and/or to a development phase (a, b, c) of at least a part of a wound.

11. The system of claim 10, wherein the control unit comprises a sensor for determining said data relating to the dimension (a1, a2, a3) and/or the development phase (a, b, c) of at least a part of the wound.

12. The system of claim 10, wherein the processor comprises a treatment module designed to determine a development phase (a, b, c) of all or part of the wound, the determination being carried out based on the data relating to a dimension (a1, a2, a3) and/or a development phase (a, b, c) of at least a part of a wound.

13. The system of claim 12, wherein the treatment module is designed to determine a contour of all or part of the wound and to assign, to an area delimited by said contour, a development phase (a, b, c), the assignment being carried out based on the data relating to a dimension (a1, a2, a3) and/or a development phase (a, b, c) of at least a part of a wound.

14. (canceled)

15. The system of claim 12, wherein the treatment module is configured to compare the data relating to a dimension (a1, a2, a3) and/or a development phase (a, b, c) of at least a part of a wound with a plurality of data on definitions of development phases for determining the development phase (a, b, c) of all or part of the wound.

16. The system of claim 12, wherein the treatment module is designed to determine a control set point defining the time variation function of the pressure (TVFP) and/or the time variation function of the molar fraction of dioxygen (TVFO2), and/or a relative humidity, a temperature T, a molar fraction of water vapor H2O, a molar fraction of dinitrogen N2, a molar fraction of carbon dioxide CO2, and/or a fraction of additional gas or aerosol.

17. A treatment device comprising a generating system of claim 1 and a treatment enclosure configured to be disposed on and/or around a body part of a user so as to produce a treatment area.

18. A method of treating a wound, comprising arranging a treatment chamber to a portion of a human's body comprising a wound; delivering a gas mixture at a given flow rate into the treatment chamber; and modulating target pressure (P) and composition of the gas mixture.

19. The method of claim 18, further comprising defining said target pressure (P) by a time variation function of the pressure (TVFP) between a minimum pressure, corresponding to an ambient pressure outside the treatment enclosure, and a maximum pressure.

20. The method of claim 18, further comprising determining the time variation function of the pressure (TVFP), the molar fraction of dioxygen (TVFO2), the molar fraction of water vapor (TVFH2O), or temperature (T).

21. The method of claim 18, further comprising delivering the gaseous mixture to the treatment chamber at a defined temperature (T).

22. The method of claim 18, wherein the time variation function of the pressure (TVFP), the molar fraction of dioxygen (TVFO2), the molar fraction of water vapor (TVFH2O), or the temperature (T) is a periodic function.

23. The method of claim 22, wherein the periodic function is sinusoidal, triangular, or step.

24. The method of claim 18, further comprising determining the target internal pressure (P), an internal relative humidity (RHH.sub.2O), or a temperature (T) inside the treatment chamber by sensors comprised by a control unit.

25. The method of claim 18, wherein the gaseous mixture also comprises a molar fraction of dinitrogen (N2) and/or a molar fraction of carbon dioxide (CO2) and/or another suitable gas.

26. The method of claim 18, further comprising measuring transcutaneous oximetry of the wound and transmitting the measurement values to a processor.

27. The method of claim 18, further comprising measuring capillarity and/or wound temperature, said measuring made by a sensor.

28. The method of claim 18, further comprising determining data relating to a dimension (a1, a2, a3) and/or the development phase (a, b, c) of at least a part of the wound using a sensor comprised by a control unit.

29. The method of claim 24, further comprising sending data relating to the dimension (a1, a2, a3) and/or to the development phase (a, b, c) of at least a part of a wound to a configured processor.

30. The method of claim 24, further comprising determining a development phase (a, b, c) of all or part of the wound, the determining being carried out based on the data relating to a dimension (a1, a2, a3) and/or a development phase (a, b, c) of at least a part of a wound.

31. The method of claim 18, further comprising determining a contour of all or part of the wound and assigning an area delimited by said contour, the assigning being carried out based on the data relating to a dimension (a1, a2, a3) and/or a development phase (a, b, c) of at least a part of a wound.

32. The method of claim 18, further comprising comparing data relating to a dimension (a1, a2, a3) and/or a development phase (a, b, c) of at least a part of a wound with a plurality of data on definitions of development phases for determining the development phase (a, b, c) of all or part of the wound.

33. The method of claim 18, further comprising determining a control set point defining the time variation function of the pressure (TVFP) and/or the time variation function of the molar fraction of dioxygen (TVFO2) and/or), and/or a relative humidity, a temperature T, a molar fraction of water vapor H.sub.2O, a molar fraction of dinitrogen N.sub.2, a molar fraction of carbon dioxide CO.sub.2, and/or a fraction of additional gas or aerosol.

34. The method of claim 18, wherein the treatment chamber is configured to be disposed on and/or around a body part of a user so as to produce a treatment area.

Description

[0145] In any event, the invention will be clearly understood by means of the following description with reference to the attached schematic drawings, which show, as a non-limiting example, an embodiment of this system for generating a gaseous mixture.

[0146] FIG. 1 is a perspective view of a treatment device for a wound and a user.

[0147] FIGS. 2 to 8 are perspective views of a treatment enclosure of the treatment device.

[0148] FIG. 9 is a diagram showing development phases of the wound.

[0149] FIG. 10 is a graphical representation of the development phases of the wound over time.

[0150] As shown in FIG. 1, a treatment device 1 of a wound 3 comprises a system 5 for generating a gaseous mixture and a treatment enclosure 7.

[0151] The generating system 5 is configured to be attached to an infusion stand 9. In addition, the generating system 5 is configured to be attached to a bedhead unit. The treatment device 1 can therefore be mobile or stationary according to the constraints of use.

[0152] The generating system 5 comprises a gaseous mixture generator 11 for delivering the gaseous mixture inside the treatment enclosure 7 at a defined flow rate.

[0153] For this purpose, and as shown in FIGS. 2 to 8, the treatment enclosure 7 is provided with an inlet 13 for the gaseous mixture originating from the gaseous mixture generator 11.

[0154] The treatment enclosure 7 also comprises an outlet 15. The delivered gaseous mixture therefore circulates inside the treatment enclosure 7.

[0155] The generating system 5 comprises an inlet line 17 connecting the gaseous mixture generator 11 to the inlet 13 of the treatment enclosure 7 and a return line 19 towards a recirculating device 21 of the generating system 5.

[0156] The recirculating device 21 is configured to receive at least a part of the gaseous mixture that has passed through the treatment enclosure 7 and to incorporate it into the delivered gaseous mixture.

[0157] It is thus possible not to recirculate the gaseous mixture, for example if it is necessary to change the composition of the gaseous mixture or to recirculate part or all of the gaseous mixture in order to economize on the components of the gaseous mixture.

[0158] The recirculating device 21 also comprises a filter 23 capable of removing from the gaseous mixture waste materials originating from the wound 3 and a humidifier 25 for adjusting a relative humidity inside the treatment enclosure.

[0159] The treatment enclosure 7 comprises an external envelope 27 capable of assuming a defined shape when the generating system 5 delivers the gaseous mixture.

[0160] The defined shape is obtained by deployment of the external envelope 27, because a pressure P inside the treatment enclosure 7 is greater than an ambient pressure outside the treatment enclosure 7 under the conditions of use.

[0161] In the present text, therefore, when reference is made to a pressure P inside the treatment enclosure 7 under functioning conditions, this pressure P is expressed as a relative pressure with respect to the external ambient pressure.

[0162] The external envelope 27 is also capable of being deformed in response to a constraint placed on it and of reassuming the defined form when said constraint is removed.

[0163] This arrangement makes it possible to indirectly massage the wound 3 by pressing on the outer envelope. In fact, this pressure locally modifies the pressure P inside the treatment enclosure 7 without requiring that the wound 3 or the skin around the wound 3 be touched.

[0164] The treatment enclosure 7 is configured to be disposed on and/or around a body part of a user so as to create a treatment area 29 in which the gaseous mixture circulates.

[0165] The treatment enclosure 7 comprises a contact surface 31 capable of conforming to the skin of the user, the contact surface 31 being capable of fluidically isolating the treatment area 29 of the treatment enclosure 7 from the exterior.

[0166] The contact surface 31 can be arranged in a silicone seal 33 of the treatment enclosure, as shown in FIGS. 2, 3, 5, 6 and 8. The treatment enclosure 7 also comprises, either instead of or in addition to the silicone seal 33, an adhesive product 35 disposed on said contact surface 31. This is shown by way of example in FIGS. 4, 6 and 7.

[0167] Optionally, the silicone seal 31 can comprise an internal chamber having openings communicating with the treatment area and the outlet of the treatment area as shown in FIGS. 5 and 6.

[0168] The fact that the internal pressure P is greater than the ambient pressure therefore does not mean that the gaseous mixture will leak toward the exterior.

[0169] In FIG. 8, the generating system 5 also comprises straps 37 for maintaining the treatment enclosure 7 in position.

[0170] The generating system 5 comprises a control unit 39 provided with a processor 41 designed to control the gaseous mixture generator 11 and define a flow rate, a temperature, and a composition of the gaseous mixture to be delivered.

[0171] In addition, the gaseous mixture generator 11 comprises a tank for each component of the gaseous mixture or is configured to be attached to one or a plurality of external bottles.

[0172] The gaseous mixture comprises a molar fraction of dioxygen O.sub.2 and a molar fraction of water vapor H.sub.2O. The gaseous mixture can also comprise a molar fraction of dinitrogen N.sub.2, a molar fraction of carbon dioxide CO.sub.2, and/or a molar fraction of components of the air other than those mentioned above.

[0173] The processor is designed to determine a time variation function of the molar fraction of dinitrogen TVFN.sub.2 and/or a time variation function of carbon dioxide TVFCO.sub.2 of said gaseous mixture to be delivered inside the treatment enclosure.

[0174] The control unit 39 can comprise sensors 43 for determining an internal pressure P, an internal relative humidity RHH.sub.2O, or a temperature T inside the treatment enclosure 7.

[0175] These sensors 43 make it possible to respectively transmit to the processor 41, according to a wire communication protocol or by radio waves, a piece of data relating to the current internal pressure P, the current relative humidity RHH.sub.2O, and the current internal temperature.

[0176] One of the sensors 43 can also be a video camera 65 for transmitting a piece of data relating to a dimension a1, a2, a3 and to a development phase a, b, c of the wound or at least a part of the wound.

[0177] A dimension a1, a2, a3 is understood to refer to an area and a development phase a, b, c to refer to one of the three following phases; inflammatory a, proliferative b, or epithelialization c.

[0178] It is also understood that a wound can be defined by a piece of data relating to several parts of a wound, with each of the parts being defined by a dimension a1, a2, a3 and a development phase a, b, c. In a way, the wound is modelled in several parts, each being defined by an area having its own development phase, as shown in FIG. 9.

[0179] All of these data are input data for the processor 41, which can define the composition, the flow rate, and the temperature of the gaseous mixture to be delivered so that a treatment program is applied to the wound 3.

[0180] The processor 41 is configured to define a target temperature T, a target relative humidity RHH.sub.2O, and a target pressure P inside the treatment enclosure 7 and to modify accordingly the composition of the gaseous mixture delivered inside the enclosure, its temperature, and its flow rate.

[0181] These target values can be constant, but may also vary based on time, for example in the form of periodic functions of the sinusoidal, triangular, or step type.

[0182] The processor 41 is thus configured to define a time variation function of the pressure inside the enclosure TVFP, with the pressure P always being greater than the ambient pressure outside the treatment enclosure.

[0183] The function of variation of the pressure TVFP makes it possible to improve the blood circulation and depends on the type of wound 3.

[0184] The processor 41 is also configured to define a time variation function of the molar fraction of dioxygen TVFO.sub.2 of the delivered gaseous mixture, a time variation function of the molar fraction of water vapor TVFH.sub.2O of the delivered gaseous mixture, and a time variation function of the temperature TVFT inside the treatment enclosure 7. FIG. 10 shows the course of development of a wound according to the phases a, b, and c defined in FIG. 9 over six days, D1 to D6. The letters A, B and C are the modes of functioning applied successively to the wound according to phases a, b, and c.

[0185] When the wound comprises several parts of different phases, for example a and b, a treatment program comprises a first part according to one mode then a second part according to another mode, for example A and B. The duration of each part can also be modulated.

[0186] The generating system 5 also comprises an addition device 49 for adding to the mixture an additional gas and/or an aerosol 51 in nebulized, vaporized, or sublimated form.

[0187] The additional gas and/or the aerosol 51 can comprise an active ingredient for the treatment of the wound 3 or any type of product having a positive effect on the healing of the wound 3. For example, this can be an aqueous solution comprising active ingredients for treatment of the wound.

[0188] The processor 41 is also configured to vary the quantity of additional gas and/or aerosol 51 in the gaseous mixture.

[0189] The generating system 5 also comprises a user interface 53 provided with a user control 55 configured to allow the user either to select a treatment program or to manually modify a time variation function TVF.

[0190] Each modification is made possible by entering a key of the access code type in order to override a default locking of the user control 53. Depending on the key used, the user will have access to a greater or lesser number of options.

[0191] One key can thus be defined for a physician, another for a nurse with fewer possible settings, and another for a user provided only with limited access to the settings.

[0192] The user interface 51 can also be used to define the data relating to the dimension a1, a2, a3 and the development phase a, b, c of parts of the wound 3, for example if the generating system does not comprise a video camera 65.

[0193] The user interface 53 also comprises a feedback device 57 provided with a screen and/or an indicator light to allow the user to consult the settings of the time variation functions TVF of pressure and the data readings from the sensors 43.

[0194] The user interface 53 also comprises a data transfer plug 59, for example a USB plug, for transferring data concerning the settings or a history of measurements of the sensors 43 and data concerning the treatment programs previously applied by the user. The transferred data can be in the form of a table of values.

[0195] Alternatively, the plug can be replaced by a transmitter for transmitting data according to a known protocol, for example a wire protocol or by radio waves,

[0196] The treatment device 1 described has the advantage of being portable; the user can therefore move around with it; it can be used for extremely long periods, such as several days or weeks, without hindering the user's life.

[0197] This treatment device 1 also makes it possible to permanently adapt the desired treatment to the type of wound and course of development thereof.

[0198] As shown in FIGS. 1 and 3, the processor 41 comprises a treatment module 61 designed to determine at least one contour 63 of all or part of the wound 3.

[0199] The treatment module 61 is thus configured to utilize the image provided by the video camera 65 as shown in FIG. 7 for determining one or more contours 63 of the wound 3 based on the number of distinct parts of the wound 3.

[0200] The treatment module 61 is also configured to allocate a development phase a, b, c to the area or each area delimited by a contour 63. This determination can be carried out by a segmentation method of the watershed or regional growth type.

[0201] Alternatively, a method of local binary patterns can be used by the treatment module 61.

[0202] When the area(s) has/have been determined, the treatment module 61 allocates to each of the area(s) an individual development phase a, b, c. A development phase a, b, c is defined by a plurality of descriptive elements such as a color and/or a texture.

[0203] The development phase a, b, c is determined by a kernel partial least squares regression or KPLS method, the result being a probability of belonging to a development phase a, b, c.

[0204] Alternatively, a classification method of the software method machine or deep learning type can be used by the treatment module.

[0205] The treatment module 61 is also configured to implement an initial phase, i.e. prior to functioning, during which a plurality of data relating to development phases is transmitted to the determination module, with there being a correspondence with a given development phase a, b, c for each piece of data.

[0206] In addition, and as shown in FIG. 7, the system 5 for generating a gaseous mixture comprises a measurement system 67 configured to carry out transcutaneous oximetry of the wound 3 and configured to transmit the measurement values to the processor 41.

[0207] The purpose is to inform the processor 41 of the status of the wound 3 by determining the real oxygenation status of the tissues of the wound 3. Transcutaneous oximetry is also referred to by the abbreviation TcPO.sub.2.

[0208] According to the variant embodiments, the measurement system 67 can also comprise a capillaroscopy device and/or a wound temperature sensor.

[0209] The treatment module 61 is thus configured to centralize the measurement data in order to utilize them. The treatment module 61 is also designed to determine a treatment set point based on all of these data.

[0210] The control set point defines the time variation function of the pressure TVFP and/or the time variation function of the molar fraction of dioxygen TVFO.sub.2.

[0211] The treatment module 61 thus makes it possible, after the measured values have been analyzed, to determine by calculation the control set point best adapted to the status of the wound 3.

[0212] The control set point defines for the gaseous mixture a relative humidity, a temperature T, a molar fraction of water vapor H.sub.2O, a molar fraction of dinitrogen N.sub.2, a molar fraction of carbon dioxide CO.sub.2, and/or a fraction of additional gas or aerosol 51.

[0213] The user interface 53 is configured to allow the user to validate the control set point determined by the treatment module 61.

[0214] The control set point is thus to be considered a proposal made to the treating physician, who can then, if necessary, modify the control set point if his/her analysis of the status of the wound 3 is different.

[0215] It can therefore be seen that the treatment module 61 considers the real status of the wound and its course of development in order to determine the most suitable treatment. The fact that the interface 53 is configured to propose a treatment allows the physician to gain time if he/she realizes that his/her analysis is identical.

[0216] In such a case, the physician only needs to validate the proposal of the treatment module 61.

[0217] It is obvious that the invention is not limited only to the embodiment of this system for generating a gaseous mixture, which is described above by way of example, but includes all variant embodiments.