DYNAMIC NEGATIVE PRESSURE WOUND THERAPY SYSTEM

Abstract

Systems and methods for negative pressure wound therapy which provides efficient treatment and a faster healing process. Negative pressure is applied selectively to a part of the wound surface that is most important and/or needs to be treated first. The therapy also enables removing viral components from the wound's surface and preventing cross-contamination through the application of pressure to the wound area by supplying therapeutic fluids in the form of high-pressure micro-jets.

Claims

1-13. (canceled)

14. A method for treatment of a wound comprising: applying negative pressure (TNP) to the wound; supplying healing fluids to the wound; and removing foreign particles, contaminated liquids, and wound secretions from a treatment area, wherein the treatment area surface is smaller than the wound surface.

15. The method of claim 1 further comprising regulating strength of the negative pressure applied to the wound.

16. The method of claim 1 wherein therapeutic fluids are supplied to the wound under increased pressure.

17. The method of claim 3 further comprising regulating strength of the increased pressure at which therapeutic fluids are supplied.

18. The method of claim 3 wherein the steps of supplying healing fluids to the wound and removing foreign particles are performed concurrently.

19. The method of claim 1 further comprising adjusting the treatment area within the surface of the wound.

20. The method of claim 6 further comprising adjusting the treatment area within periwound skin surrounding the wound.

21. A method for wound treatment through a mobile negative pressure wound therapy, the method comprising: drawing a fluid from a reservoir; creating a high-pressure fluid for supplying 406 the fluid to a negative pressure applicator, wherein the negative pressure applicator is in fluid communication with a proximal end of an operating handle for healing a wound surface; applying a controlled amount of the fluid on the wound surface through a negative pressure by the negative pressure applicator; varying a magnitude and direction of the negative pressure; and draining the fluid contaminated with wound particles.

22. The method according to claim 21, wherein the process of applying the fluid on the wound and peri-wound skin surface is done using a plurality of micronozzles connected to the negative pressure applicator, wherein the applicator with the plurality of micronozzles has a size smaller than that of a wound surface area under treatment.

23. The method according to claim 22, wherein the micro nozzles are configured to create an angle of 90 degrees with respect to a surface forming an inner conical part of the negative pressure applicator such that the fluid stream emanating from the plurality of micronozzles of the negative pressure applicator is perpendicular to the surface of the wound.

24. The method according to claim 21, wherein the process of drawing the fluid from the reservoir is performed by an infusion pump.

25. The method according to claim 21, wherein varying the magnitude and direction of the negative pressure is done to control the speed and volume of aspiration.

26. The method according to claim 21, wherein applying the controlled amount of the fluid on the wound surface comprises providing a controlled amount of liquid/medication and vacuum to the wound surface under pressure in a vacuum atmosphere.

27. The method according to claim 26, wherein the magnitude of the applied vacuum is significantly lower than 125 mm at an exposure time of a contact area of 1-2 seconds, without developing cellular stress and cell apoptosis.

28. The method according to claim 26, wherein the application of vacuum and pressurized fluid by the negative pressure applicator to the wound surface is carried out by moving the operating handle along the surface by changing the speed and the direction of movement.

29. A system for wound treatment through a mobile negative pressure wound therapy, the system comprising: a control unit comprising two peristaltic pumps, said control unit configured to regulate operation of the pumps and wherein one of the peristaltic pumps is configured for creating high fluid pressure for supplying a fluid to a wound surface and the other pump is configured to apply negative pressure on the wound; an elongated operating handle configured to be in fluid communication with the peristaltic pumps, wherein the handle comprising a central aspiration channel and a side infusion channel defining two ports through which a vacuum occlusion tube and an occlusion infusion tube connect said handle with said peristaltic pumps of the control unit; a disposable transparent applicator configured to be in fluid communication with said two ports, said applicator installed in a receiving channel of the operating handle and held in place by the friction forces of an applicator sealing elements and due to difference of negative pressures in the aspiration channel, wherein the applicator comprises: a cylindrical hollow body formed by an inner part and an outer part glued at their ends, said inner part defining an axial cylindrical channel with a conical surface at a distal end thereof forming an inner conical part of the applicator hermetically contacting a part of the wound surface; and a plurality of micronozzles disposed around wide portion of the conical surface which contacts the wound surface and configured to supply pressurized therapeutic fluid micro-jets delivered via said hollow body in fluid communication with the infusion channel to remove contaminations from the wound and peri-wound skin, wherein the axial channel of the cylindrical hollow body is disposed in direct communication with the central aspiration channel of the handle to apply negative pressure on the wound causing the treated area to be deformed and retracted into said conical part, thereby obtaining the therapeutic level of negative pressure above the wound and to aspirate the contaminated fluid containing therefrom.

30. The system according to claim 29, wherein one of the peristaltic pumps comprises of an infusion pump configured to draw the fluid from a reservoir and create pressurized fluid for wound treatment.

31. The system according to claim 29, wherein the rotation speed of each of the peristaltic pumps is variable to control the speed and volume of aspiration.

32. The system according to claim 29, wherein the micro nozzles have a diameter in the range of 40 and 60 microns.

33. The system according to claim 29, wherein an axis of the micronozzles creates an angle of 90 degrees with respect to a surface forming the inner conical part of the applicator such that the micro-jets emanating from the nozzles of the applicator are perpendicular to the surface of the wound.

34. The system according to claim 29, wherein the application of vacuum and pressurized fluid by the negative pressure applicator to the wound surface is carried out by moving the operating handle along the wound surface by changing the speed and the direction of movement.

35. The system according to claim 29, wherein the fluid comprises one or more therapeutic fluids.

36. The system according to claim 29, wherein the applicator may be of cylindrical shape with a diameter of contact sport of 5 mm.

37. The system according to claim 29, wherein the occlusion tubes may be elastic tubes.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0041] For a better understanding of the embodiments and to show how it may be carried into effect, reference will now be made, purely by way of example, to the accompanying drawings.

[0042] With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of selected embodiments only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects. In this regard, no attempt is made to show structural details in more detail than is necessary for a fundamental understanding; the description is taken with the drawings making apparent to those skilled in the art how the several selected embodiments may be put into practice.

[0043] As used in this specification, the singular indefinite articles a, an, and the definite article the should be considered to include or otherwise cover both single and plural referents unless the content clearly dictates otherwise. In other words, these articles apply to one or more referents. As used in this specification, the term or is generally employed to include or otherwise cover and/or unless the content clearly dictates otherwise.

[0044] In the accompanying drawings:

[0045] FIG. 1 illustrates a schematic representation of a system including a negative pressure applicator, following an illustrative embodiment of a present invention;

[0046] FIG. 2 illustrates a partial sectional view of an operating handle with the negative pressure applicator equipped with micro nozzles for use in the device, following an illustrative embodiment of the present invention;

[0047] FIG. 3 is an enlarged schematic representation of the negative pressure applicator equipped with micro nozzles, following an illustrative embodiment of the present invention; and

[0048] FIG. 4 presents a series of images of a wound treated with DYNAMIC NPWT.

DESCRIPTION OF THE SELECTED EMBODIMENTS

[0049] Aspects of the present disclosure relate to systems and methods for a DYNAMIC negative pressure wound therapy which provides efficient treatment and a faster healing process. In particular, the therapy involves applying the negative pressure selectively to a part of the wound surface that is most important and/or needs to be treated first. The therapy also enables removing viral components from the wound's surface and preventing cross-contamination through the application of pressure to the wound area by supplying therapeutic fluids in the form of high-pressure micro-jets.

[0050] The application of negative pressure to the specific part of the wound and/or periwound skin allows moving of a treatment zone sequentially along the surface of the wound using a required speed of motion, change directions and repeat treatments for each area.

[0051] The therapy system of the disclosure allows changing the magnitude of the applied negative pressure and high pressure of micro-jets with medicinal fluids while simultaneously removing viral components from the wound's surface and preventing cross-contamination.

[0052] In the therapy system of the present disclosure pure antiseptic liquids when applied to the area of negative pressure inside the applicator do not mix with the viral medium outside of the applicator. Instead, they are removed into the aspiration line immediately after interacting with the wound's surface. The therapy allows an NPWT to be performed in full visibility and accessibility to all wounds and surrounding fragments. It allows to make changes to a required number of passes in selected areas, area's size, and speed enhancing the procedure's efficacy. Further, changing the movement direction when treating the wound surface and the periwound skin allows for an assessment of the condition of the underlying tissues and a degree of homogeneity of their parameters at the edge between the wound and skin. The applicator sizes are chosen with consideration of the characteristic scale of heterogeneity of a wound to allow the processing of a wound and periwound skin with no additional damages. These applicator dimensions allow treating wounds with flat and rugged surfaces which is not always available for existing devices. The therapy also allows the application of a much deeper negative pressure while moving along the wound surface. The small dimensions of the applicator orifice and its motion features expose the wound surface to strong negative pressure for a short period reducing the chances of cell stress. The setting of stronger negative pressure inside the applicator and making its motion faster allows to expedite the treatment, reduce healing time making the procedure more comfortable for patients.

[0053] The DYNAMIC NPWT improves vascular function and blood circulation by applying dynamic negative pressure along the main blood vessels located in vulnerable skin areas that are distant from the wound. The therapy system stimulates the work of blood vessels and prevents the emergence of new wounds which often occur in various chronic conditions.

[0054] Reference is made to FIG. 1 which illustrates a schematic representation of a system including a negative pressure applicator following an illustrative embodiment of a present invention. FIG. 1 illustrates system 10 which includes a control console 12, two peristaltic pumps including an aspiration pump 16 and an infusion pump 14, an operating handle 30 with a negative pressure applicator 40. System 10 further includes an infusion occlusion tube 18, and a vacuum occlusion tube 22 of the piping system. Both tubes 18, and 22 are introduced into the operating handle 30, located at the distal end of system 10. The operating handle 30 has two ports through each of which the tubes 18, and 22 are connected, respectively. Tube 22 is connected through port 31 of the operating handle 30 while tube 18 is connected through port 32 of the operating handle 30.

[0055] The control console 12 is configured to regulate the infusion pump 14 and the aspiration pump 16 to establish the vacuum level in tube 22 connected to port 31. The control console 12 is also configured to regulate the pressure of the liquid in tube 18. The negative pressure applicator 40 is inserted into the operation handle 30 and configured to apply negative pressure on the wound.

[0056] During the operation, tube 18 draws the fluid from reservoir 20 and feeds it to the inlet of the infusion pump 14 for supplying pressurized fluid which is further supplied through tube 18 (which is an infusion channel) to port 31. The pressurized fluid is then supplied to the operating handle 30 for wound treatment.

[0057] As applicator 40 is introduced to the wound site 50, the pressurized fluid removes the affected particles of the wound material therefrom. Such fluid with wound particles migrates into tube 22 which is connected to outlet port 31 of the operating handle 30. Tube 22 serves as an occlusion element in the peristaltic aspiration pump 16. The aspiration pump 16 communicates with a vessel 24 for storage of hazardous waste after the procedure of NPWT is performed.

[0058] The peristaltic pumps 14 and 16 configured to rotate, having variable rotating speed. Such variable rotating speed is configured to control the speed and volume of the aspiration. Since, after exiting the peristaltic pump, the exudate is under atmospheric pressure, it is possible to use a simplified prefabricated tank at atmospheric pressure instead of a pumped-out prefabricated tank. For example, the vessel/collecting bag 24 can be connected to an outlet drain pipe that previously stored a liquid for the treatment.

[0059] A vacuum tube can be installed in the vacuum pump and bag 24 for collecting aspirate installed next to the control console 12 before the beginning of the treatment with the negative pressure applicator 40. The infusion peristaltic pump 14 is configured to adjust rotational speeds and control the change of the volume and pressure of the infusion. A simple package or another infusion tank, such as those used for intravenous infusions can be used to deliver the liquid. The infusion tube 18 is provided as a part of a sterile disposable operating handle 30, and a distal end of the infusion tube 18 is mounted on the infusion tank 20, (for example a saline bag). Tube 22 is connected by the end to the operating handle 30 and is connected with a standard connector to the opposite endthe vessel 24 with the contaminated liquid.

[0060] The console unit 12 may also be equipped with control switches for switching the infusion pump system 14 and the aspiration pump 16 on and off. Such control functions can be performed in the form of simple on/off switches. Alternatively, systems providing different aspiration and infusion rates can be manually selected by the operator. Such regulation is essential due to differences in the conditions or conditions of the treated wound of specific wound fragments.

[0061] The control unit 12, together with the aspiration pump 16, the infusion pump 14, and the corresponding controls, are provided as a separate, reusable unit, for example as a standard control unit. In the illustrated system, control unit 12 is not contaminated because it has no contact with the aspirate during the operation, and the procedure control systems are durable and can be used repeatedly. Control unit 12 can be designed for installation on a portable structure and/or a post for I/O or other structures. According to an aspect of the invention, an NPWT system comprising the operating handle 30, with the negative pressure applicator 40 equipped with micronozzles, tube 22 for aspiration, and tube 18 for infusion can be provided in the form of a sterile single-stranded system.

[0062] FIG. 3 illustrates a partial sectional view of the operating handle 30 with the negative pressure applicator 40 equipped with micro nozzles 43 for use in the device.

[0063] The applicator 40 is installed in the operating handle 30 and can be easily replaced with another one in the event of a blockage of the nozzles. The operating handle 30 is made of two parts, 33 and 34, connecting between themselves after fixing aspiration tube 22 and infusion tube 18. The applicator 40 is installed in the receiving channel of the operating handle 30 and held by the friction forces of the applicator's sealing elements after the start of treatment. The applicator 40 is also held in the operation handpiece due to the difference of negative pressures in the aspiration channel 22.

[0064] The aspiration tube 22 is connected by the end to the operating handle 30 and is connected with a standard connector to the opposite enda vessel 24 with the contaminated liquid.

[0065] For vacuum creation in the NPWT system, tube 22 is passed through the peristaltic pump 16 as an occlusion element and then to the handle 30.

[0066] A liquid supply tube passes through port 32 and is glued to the side port of part 31 of the receiving channel which is located between the applicator's sealing rings. The medical fluid flows are moving so that their mixing with waste liquid occurs only after high-pressure jets collide with the wound's surface and remove the infected debris and bioburden from its contact area. Mixing a stream of sterile fluid and aspirate inside the operating handle is technically impossible. Solutions supply to the applicator 40 is carried out under pressure. The infusion tube 18 is connected to the operating handle 30 at one end and container 20 with the infusion on the other end and passes through the peristaltic pump 14, as shown in FIG. 1.

[0067] FIG. 3 is a schematic representation of a negative pressure applicator 40 equipped with DYNAMIC NPWT micro-nozzles 43. The applicator consists of two partsthe inner 42 and the outer 41 which are glued at the ends forming applicator 40.

[0068] The micronozzles 43 may have a diameter of 40-60 u. The micro-nozzles 43 are placed to be at the closest distance from the wound site 50 with the inner side of the applicator 42 in a plane passing through the axis thereof. Under the action of negative pressure, the treated area will be deformed and retracted into a conical part 42 of the applicator 40.

[0069] The axis of the micronozzles 43 creates a 90? angle to the surface forming the inner portion of the conical part 41 of the applicator 40 such that the stream emanating from the applicator 40 is perpendicular to the surface of the wound drawn into the applicator 40 under the action of the vacuum.

[0070] The infusion tube 18 supplying the liquid, passes through port 32. Tube 18 is glued to the side part 33 of the receiving channel which is located between sealing rings of the applicator 40. The fluid flows are moving in such a way that their mixing occurs only on the surface of the wound. Mixing a stream of sterile fluid and aspirate inside the operating handle is technically impossible. Solutions supply to the applicator 40 can be carried out under pressure.

[0071] FIG. 3 is a schematic representation of a negative pressure applicator equipped with micro-nozzles. The applicator consists of two partsthe inner 42 and the outer 41. Parts 42 and 41 are glued at the ends forming applicator 40, which has a hollow wall and has 1 or more inlets 45 and 1 or more micro-nozzles with a diameter of more than 40 microns. The micro-nozzles outlets are the closest distance from the wound on the applicator's inner conical surface in a plane passing through its axis. Under negative pressure, the treated area will be deformed and retracted into the conical part of the applicator. It covers the micro nozzles' outlets, as shown in FIG. 2. The axis of the micro-nozzle is directed at a 90? angle to the surface, forming the inner conical part of the applicator. The jets emanating from the applicator's nozzles are perpendicular to the wound surface till the applicator touch the wound surface and the vacuum inside the applicator occurs. After attaching the applicator, the wound tissue will be pressed by vacuum and will block nozzles outlets. The solution pump starts to increase the pressure to overcome force blocking the liquid streaming, and the solution under the pressure will release from nozzles. As the result of the clashing of two forcesvacuum and liquid pressurespace will be created between the wound and applicator, filled with solution. Due to the obstacle of the wound pressed down to the applicator's inner surface and hindering to medical high-pressure liquid injected from nozzles will change the perpendicular direction of its streaming onto parallel inside the gap between the applicator and wound surface obtaining maximum efficacy for cleaning wounds surface from the most difficult for the removal bioburden pluck. To evaluate invention feasibility and compare its efficacy to SMWT and NPWT, the conceptual prototype builts to treat neuro-ischemic foot ulcers with the anamnesis below.

TABLE-US-00001 Determinants and estimation of healing times in neuro-ischemic foot ulcers Parameter SMWT and NPWT DYNAMIC NPWT Initial wound area 26.6 mm 45 mm Wound area after 6.25 mm 5.8 mm 10 weeks Radius of wound 0.019 mm/day 0.034 mm/day reduction rate Days for wound 123.4 days 94 days closing Number of 123.4 days 10 treatments Average treatment 20 minutes 20 minutes duration The total duration 2468 minutes 200 minutes of all treatments Treatments Everyday Three treatments per month in frequency dressing change two first months then two per month in the next two month

[0072] FIG. 4 presents a series of images of a wound treated with DYNAMIC NPWT in 10 treatments over a 94 day period. It is noted that NPWT has significant advantages over all other chronic wound treatments, healing and closing wound 12 times faster and saving 38 hours of operation time by spending only 3 hours for the neuro-ischemic wound treatment.

[0073] The DYNAMIC NPWT results recorded in FIG. 4 and the above table achieved in 10 visits compared with 123 visits, which much more beneficial for patients and physicians.