CN110944608B - Control devices for wound therapy delivery and related methods of use - Google Patents

Abstract

In various aspects of the invention, the wound treatment apparatus disclosed herein includes a wound interface that forms a fluid-tight enclosed space over a wound bed when the wound interface is secured to a skin surface surrounding the wound bed. In various aspects of the invention, a wound treatment apparatus includes a control group that cooperates with a wound interface to regulate the input of fluid into an enclosed space and the output of fluid from the enclosed space to be at substantially a minimum pressure p _min To a maximum pressure p _max Change the actual pressure p in the enclosed space _a Minimum pressure p _min Less than ambient pressure p _amb Wherein the input fluid contains O ₂ A gas having a concentration greater than atmospheric air. The introduction of the fluid and the discharge of the fluid may be performed sequentially. Related methods of using wound therapy devices are disclosed herein.

Description

Control devices for wound therapy delivery and related methods of use

Cross Reference to Related Applications

This application claims priority from the following patent applications: us patent application No. 15/663,708 filed on 29.7.2017, us patent application No. 15/663,709 filed on 29.7.7.2017, us patent application No. 15/663,710 filed on 29.7.7.7, us patent application No. 15/663,713 filed on 29.7.7.7, us patent application No. 15/663,714 filed on 29.7.7.2017. All priority-claims patent applications are hereby incorporated by reference in their entirety as if fully set forth herein.

Background

Technical Field

The present disclosure relates to medical devices, and more particularly, to apparatus for wound therapy and related methods.

Background

The wound bed, as referred to herein, comprises a localized area of tissue that has lost its cortex affected by adverse factors, resulting in, for example, cellular abnormalities such as swelling, inflammation, degeneration, infection or cell death. The wound bed may contain varying degrees of exposed underlying tissue and structures, with possible infection and tissue changes. The wound bed represents an unhealed wound. By contrast, a healing wound is meant the surface of the skin, previously wounded, but now the major gap has been completely closed and covered by a varying amount of epidermis and scar tissue. The wound bed may be located within a wound boundary that extends along the affected area at the skin surface of the skin. The wound bed may continue deep into the dermis and the wound bed may extend deeper, for example, deep into the subcutaneous fat, muscle, or deeper. Thus, the wound bed may include damaged flaps, sinuses, tracts and fistulas, as well as surrounding affected tissue. Fig. 1 illustrates a wound bed including some of the anatomical structures involved therein. Wound boundary, as referred to herein, refers to the perimeter of the wound bed at the skin surface of the skin.

A variety of Negative Pressure Wound Therapy (NPWT) devices are currently used to treat wound beds, including dressings, films, and drainage tubes. To use the current NPWT device, the wound is filled with dressing and the drainage tube is placedOn the dressing. The film is then placed over the wound bed and adhered to the skin surface around the wound bed to seal the wound bed, dressing, and drainage tube in place. Finally, air in the region between the membrane and the wound bed is removed through a drainage tube in fluid communication with the dressing to create a sub-ambient pressure p in the enclosed space between the membrane and the wound bed _amb Negative pressure p _s . When negative pressure p _s Reduced to below ambient pressure p _amb In time, the wound bed and surrounding skin are compressed. Exudate from the wound bed may be transported through the dressing and then discharged through the drainage tube. A suction pressure p applied to the wound bed which may be static _s Between about-80 mmHg to about-175 mm Hg, sub-ambient pressure p _amb 。

The negative pressure p being applied during periods other than dressing changes _s Can be statically maintained continuously for weeks or even months until the treatment is finished. Since the capillary vessels are extremely thin-walled, minute blood vessels, the capillary vessels are easily collapsed by suction pressure. Studies have shown that at distances of 2.5cm from the wound edge, the increase in blood flow is associated with a negative pressure p _s Proportionally, blood flow is deleteriously reduced at 0.5cm from the wound edge, and closer to the wound bed, where increased blood flow is most needed.

It has therefore been recognized that the negative pressure p is relieved from time to time _s To allow for re-filling of the capillaries adjacent the wound bed, may be advantageous. However, the negative pressure p _s The mitigation of (b) is achieved in current NPWT apparatus by introducing atmospheric air into the enclosed space between the membrane and the wound bed, if provided at all. Negative pressure p _s Can be mitigated, for example, to p _amb -25mm Hg instead of p _amb To keep the membrane sealingly secured to the wound bed. In some arrangements, the negative pressure p _s The release in this manner of (a) may occur only intermittently, or not at all.

NWPT lasts on average about 6 months, demonstrating that it is challenging to get sufficient blood flow and oxygen to the wound bed to enable healing. NWPT requires intensive care and supervision by physicians, and NWPT may need to be performed in a hospital or other similar facility. NWPT often fails due to wound-related complications, resulting in thousands of deaths, with 8 million amputation surgeries in the united states each year, each amputation potentially representing months, or even years, failure of expensive treatment. Around the world, approximately 100 million amputation surgeries will be performed every month. NPWT can be difficult to apply, dressing changes are often very painful, since granulation tissue destruction will occur with each dressing change, which typically occurs every other day. This damage to the granulation tissue may impede the healing process. About 66% of the wound beds require 15 weeks of NWPT, while another 10% require 33 weeks or more for NWPT to heal.

Furthermore, due to protein exudates, the drainage tube may become clogged, which may lead to an interruption of the NWPT. When there is practically little or no negative pressure in the enclosed space above the wound bed, the negative pressure p _s The negative pressure p may be inaccurately sensed and indicated _s At the desired value. Because of the cumbersome application of the dressing, and the pain associated with removal, repeated removal of the dressing to attach devices for delivery of other therapies is considered impractical.

NPWT has been combined with antibiotic infusion to treat particularly difficult wound beds. The system inserts one or more liquid treatments several times a day, with the solution introduced into the wound bed and allowed to "dwell" for a period of time, then removed. Such "NPWT with perfusion" requires a prior measurement of the wound bed volume, input to an infusion pump, so that no excess perfusion occurs, which could compromise the sealing integrity of the cover around the wound bed. Additional time, equipment and great attention need to be provided to manage the NPWT in conjunction with perfusion.

Another common wound treatment is systemic hyperbaric oxygen (HBO). The patient is placed in a hyperbaric chamber and is exposed to medically pure oxygen, typically at 2.5ATA (absolute atmospheric pressure), for 90 minutes. Possibly due to peroxides, H ₂ O ₂ Or other oxidative free radical formation, exposure for 120 minutes increases the risk of oxygen poisoning, possiblySeizures and other serious consequences can result. Such a 90 minute treatment period corresponds to only 6% of the day providing oxygen enrichment to the wound bed. The U.S. branch of medical insurance typically approves 30-40 HBO treatments per treatment session, which costs hundreds to $ 1000 per treatment session. This underscores not only the high cost of chronic wound care and the low ability to affect healing through only a few courses of HBO, but also the general lack of a more effective treatment modality. Other alternatives, such as wrapping a plastic bag around a wound bed and inflating it with pure oxygen under high pressure for 90 minutes, are less costly but suffer from similar drawbacks, since static compression of the wound bed during treatment generates a counter-force pressure that largely counteracts the low arterial perfusion.

Thus, for at least these reasons, it is apparent that there is a strong and unmet need to improve wound treatment devices and related wound treatment methods and related combinations of modalities.

Disclosure of Invention

These and other needs and disadvantages are met and overcome by the wound treatment devices and associated methods of use disclosed herein. Additional modifications and advantages may be recognized by those skilled in the art upon studying the disclosure.

Sometimes, the wound treatment apparatus disclosed herein includes a wound interface that forms an enclosed space above a wound bed, the wound interface being fluid-tight when secured to a skin surface surrounding the wound bed. At times, the wound treatment apparatus includes a control group that cooperates with the wound interface to regulate the introduction of an input fluid, including O, into the enclosed space ₂ A gas of greater concentration than atmospheric air, and a regulated output fluid is directed from the enclosed space to be at substantially the minimum pressure p _min To a maximum pressure p _max In the closed space, the actual pressure p in the closed space is changed _a Minimum pressure p _min Less than ambient pressure p _amb . At some time, O ₂ The input of a gas having a concentration greater than atmospheric air, and O ₂ The removal of gases with a concentration greater than atmospheric air is carried out sequentially.

Sometimes, the wound treatment devices disclosed herein include a source of liquid, O ₂ A source of gas at a concentration greater than atmospheric air, and a wound interface coupled to the skin surface surrounding the wound bed to form an enclosed space surrounding the wound bed, the enclosed space being fluid-tight. At times, the wound treatment apparatus includes a control group operatively connected to the liquid source, the gas source and the enclosed space to selectively input the liquid and gas into the enclosed space and to regulate the output fluid to be directed out of the enclosed space.

A related method of use of the wound treatment devices disclosed herein may include the steps of: connecting the wound interface to the skin surface surrounding the wound bed, thereby forming an enclosed space, and the steps of: at times, using the control group, the introduction of the regulated input fluid into the enclosed space and the discharge of the regulated output fluid from the enclosed space are sequenced, so as to be in accordance with the target pressure p ₀ Periodically changing the actual pressure p in the enclosed space _a . At some time, the pressure cycle has a minimum pressure p _min And a maximum pressure p _max The input fluid comprising O ₂ A gas having a concentration greater than atmospheric air.

This summary presented provides a basic understanding of some aspects of the devices and methods disclosed herein, as a prelude to the detailed description that follows. Accordingly, this summary is not intended to identify key elements or to delineate the scope of the apparatus and methods disclosed herein.

Drawings

Fig. 1 depicts a cross-sectional view of an exemplary wound bed with erosion, wound tunnels and fistulas;

FIG. 2 illustrates, by way of a schematic diagram, one exemplary implementation of a wound treatment apparatus;

FIG. 3A illustrates, by way of a schematic diagram, a first operative configuration of a second exemplary implementation of a wound treatment apparatus;

FIG. 3B illustrates schematically a second operational configuration of an exemplary implementation of the wound treatment apparatus of FIG. 3A;

FIG. 4A illustrates a schematic cross-sectional view of a portion of the exemplary wound treatment apparatus of FIG. 3A in a first operative configuration;

FIG. 4B illustrates a schematic cross-sectional view of a portion of the exemplary wound treatment apparatus of FIG. 3A in a second operational configuration;

FIG. 5 illustrates schematically the operational state of the exemplary wound treatment apparatus of FIG. 3A;

fig. 6A illustrates a cross-sectional elevation view of a third exemplary implementation of a wound treatment apparatus at a first stage of operation.

Fig. 6B illustrates a cross-sectional elevation view of a portion of the wound treatment apparatus of fig. 6A in a second stage of operation.

FIG. 7 illustrates, in a cut-away perspective view, a fourth exemplary embodiment of a wound treatment apparatus

FIG. 8 illustrates, by a cross-sectional elevation view, a fifth exemplary embodiment of a wound treatment apparatus

Fig. 9A illustrates, by cartesian diagram, an exemplary pressure cycle delivered to a wound bed by a wound treatment apparatus (e.g., the exemplary wound treatment apparatus of fig. 2, 3A, 6A, 7, and 8);

fig. 9B illustrates, by cartesian plot, a second exemplary pressure cycle delivered to a wound bed by a wound treatment apparatus (e.g., the exemplary wound treatment apparatuses of fig. 2, 3A, 6A, 7, and 8);

fig. 9C illustrates, by cartesian diagram, a third exemplary pressure cycle delivered to a wound bed by a wound treatment device (e.g., the exemplary wound treatment devices of fig. 2, 3A, 6A, 7, and 8);

fig. 9D illustrates, by cartesian plot, a fourth exemplary pressure cycle delivered to a wound bed by a wound treatment apparatus (e.g., the exemplary wound treatment apparatuses of fig. 2, 3A, 6A, 7, and 8);

fig. 9E illustrates, by cartesian plot, a fifth exemplary pressure cycle delivered to a wound bed by a wound treatment apparatus (e.g., the exemplary wound treatment apparatuses of fig. 2, 3A, 6A, 7, and 8);

fig. 9F illustrates, by cartesian plot, a sixth exemplary pressure cycle delivered to a wound bed by a wound treatment apparatus (e.g., the exemplary wound treatment apparatuses of fig. 2, 3A, 6A, 7, and 8);

fig. 9G illustrates, by cartesian diagram, a seventh exemplary pressure cycle delivered to a wound bed by a wound treatment device (e.g., the exemplary wound treatment devices of fig. 2, 3A, 6A, 7, and 8);

fig. 9H illustrates, by cartesian plot, an eighth exemplary pressure cycle delivered to a wound bed by a wound treatment device (e.g., the exemplary wound treatment devices of fig. 2, 3A, 6A, 7, and 8);

fig. 9I illustrates, by cartesian plot, a ninth exemplary pressure cycle delivered to a wound bed by a wound treatment apparatus (e.g., the exemplary wound treatment apparatuses of fig. 2, 3A, 6A, 7, and 8);

fig. 9J illustrates, by cartesian plot, a tenth exemplary pressure cycle delivered to a wound bed by a wound treatment apparatus (e.g., the exemplary wound treatment apparatuses of fig. 2, 3A, 6A, 7, and 8); and

FIG. 10 illustrates, via a flow diagram, a wound treatment apparatus (e.g., the exemplary wound treatment apparatus of FIGS. 2, 3A, 6A, 7, and 8)

Exemplary methods of use of (a);

the illustrations are exemplary only, with the illustrated embodiments selected herein for convenience of explanation. The elements shown in the figures, such as numbers, positions, relationships, and dimensions, constitute various implementations described herein, and likewise, dimensions and proportions may correspond to particular force, weight, strength, flow, and the like requirements explained herein, or will be readily understood by those of ordinary skill in the art in view of this disclosure. Wherever possible, the same reference numbers are used in different drawings to refer to the same or like elements. Furthermore, when the terms "top," "bottom," "right," "left," "front," "rear," "first," "second," "inner," "outer," and similar terms are used, they should be understood with reference to the orientation of the embodiments as shown in the drawings and utilized to facilitate the description thereof. Relative terms used herein, such as substantially, approximately, substantially, may refer to engineering, manufacturing, or scientific tolerances, such as ± 0.1%, ± 1%, ± 2.5%, ± 5%, or other such tolerances, as would be readily understood by one of ordinary skill in the art studying this disclosure.

Detailed Description

Wound treatment devices and related methods of wound treatment are disclosed herein. In some instances, the wound treatment apparatus includes a wound interface secured to a skin surface surrounding a wound bed to form an enclosed space over the wound bed, the enclosed space being fluid-tight. At times, the control group, in cooperation with the wound interface, regulates the introduction of input fluid into the enclosed space and regulates the discharge of output fluid from the enclosed space to be at approximately the minimum pressure p _min And a maximum pressure p _max In the closed space, the actual pressure p in the closed space is changed _a . At all times, the minimum pressure p _min Less than ambient pressure p _amb ，O ₂ The input and output of the gas with the concentration higher than the atmosphere are carried out in sequence. The control group can be at a minimum pressure p _min And a maximum pressure p _max Periodically changing the actual pressure p in the enclosed space during the pressure cycle in between _a . The gas may have a greater than atmospheric O ₂ Concentration (about 20.95 vol% or about 0.2095 moles of O per mole of dry air ₂ )。

Fluids, including, liquids, gases, and combinations thereof, are described herein. Liquids, such as saline solutions, daptomine solutions, proteolytic enzyme solutions, biofilm degradation solutions, cytokines, antibiotic lavage fluids, amniotic fluid, platelet rich plasma, antibiotics, analgesics, anesthetics, and combinations thereof. The liquid may comprise saline or a water-based solution, for example, to irrigate the wound bed, remove initial contaminating bacteria, or wet the wound bed.

The gas may include, for example, air, oxygen, nitric oxide, nitrogen or suitable therapeutic or inert gases, and combinations thereof. The gas, for example, may be nitric oxide, which is a nitrogen diluent from about 200ppm to about 800 ppm. At some time, the actual pressure p in the enclosed space is input into the enclosed space _a From the minimum pressure p _min Increase to maximum pressureForce p _max Of gas of (a) ₂ The concentration is greater than atmospheric air (about 21.95% by volume). At times, the gas may be medical grade oxygen. Medical grade oxygen may meet certain standards, for example, the U.S. food and drug administration standards, or other appropriate regulatory standards. Sometimes, the medical grade oxygen may be U.S. medical grade oxygen. At times, the input fluid 16 provided to the wound interface 115 may be a liquid with certain therapeutic benefits.

The sequential exit of the output fluid from the enclosed space and the introduction of the input fluid into the enclosed space means that the exit of the output fluid and the introduction of the input fluid do not occur simultaneously. The input fluid may be introduced into the enclosed space or the output fluid may be withdrawn from the enclosed space, but the introduction of the input fluid and the withdrawal of the output fluid do not occur simultaneously. One exception is when the input fluid is a liquid and the liquid is both input and output, for example, during a wound bed irrigation procedure. The wound bed can be irrigated or irrigated by pumping or rinsing it with an amount of input liquid several times the volume of the enclosed space to clean the wound bed, e.g. from bacteria, cell debris and biofilms.

Using the "down time" of the relaxation phase of NPWT, programmed to deliver oxygen or other therapeutic fluids (including gases and liquids) into an enclosed space, a large number of new beneficial treatments can be effectively produced in the 24 hour range, which has not even existed before with negative pressure therapy. The net result is that many new uniform, periodic, additional hours of beneficial therapy are interspersed between negative pressure therapies, which may accelerate healing by synergistic effects. Since chronic wounds heal very long, lasting on average 23 weeks, the ability to increase daily the important required treatments without reducing the duration of the basic negative pressure therapy can produce other synergistic effects as accelerated healing. For example, assume a pressure cycle of 6 minutes duration, where the pressure p ₀ At p is _min For 4 minutes, and pressure p ₀ Is released to p _max Lasting 2 minutes (i.e., 1/3 for the negative pressure cycle was pressure released). In this example, p _max May be an environmentPressure p _amb Or larger. In this example, O is used ₂ A fluid at a concentration higher than atmospheric air, resulting in a local oxygen therapy at about ambient pressure or higher for 2 minutes. This topical oxygen therapy was performed 10 times an hour for 2 minutes, increasing up to 240 cycles per day, corresponding to 8 hours per day topical oxygen therapy, without reducing the total amount of negative pressure therapy delivered. This may provide additional therapy without replacing or shortening the underlying preferential negative pressure therapy. It is noted that p is _min ，p _max And p _amb Are approximate and relative and may vary from pressure cycle to pressure cycle depending on the equipment and environmental factors, including altitude. But the therapeutic result can be substantially achieved regardless of whether the target pressure is accurately or approximately achieved.

As a second example, a pressure cycle has a duration of 6 minutes, where the pressure p ₀ At p is _min For 3 minutes, the pressure is released to p _max For 3 minutes (1/2 for the duration of the pressure cycle), this resulted in delivery of topical oxygen therapy to the wound bed at approximately ambient or above ambient pressure for a total of 12 hours per day. Thus, in the healing phase towards the later stage, when edema and exudation are greatly reduced, less negative pressure p is required _min The duration of local oxygen may be correspondingly increased to accelerate the next stage of healing.

At times, each release of the nth pressure cycle (where n is any suitable number such as 2 to 60 or even 120 or more) is performed with a liquid.

A method of wound treatment includes, at times, providing a treatment regimen to a wound bed in an enclosed space, the treatment regimen comprising continuously delivering an actual pressure p in the enclosed space _a Each pressure cycle typically includes a pressure range p _min ≤p _a ≤p _max Wherein p is _min ≤p _amb ，p _amb ≤p _max ，p _min ＜p _max ，p _amb Is ambient pressure, when each pressure cycle is from p _min To p _max When the temperature of the water is higher than the set temperature,an input fluid comprising a gas and a liquid is introduced into the enclosed space. Pressure p _min ，p _max And the duration of the pressure cycle, as well as the fluid introduced into the enclosed space, may vary within each pressure cycle, depending on the desired therapeutic goal.

At times, the method of wound treatment may include the steps of: the wound interface is connected to the skin surface surrounding the wound bed, thereby forming an enclosed space. At times, the method of wound treatment may include the steps of: using the control group, the introduction of the regulated input fluid into the enclosed space and the discharge of the regulated output fluid from the enclosed space are sequenced, thereby periodically varying the actual pressure p within the enclosed space _a Substantially according to the target pressure p ₀ Pressure cycle of (2), the pressure cycle having a minimum pressure p _min And maximum pressure p _max The input fluid containing O ₂ A gas having a concentration greater than atmospheric air. At times, the method of wound treatment may include the steps of: exudate is removed from the enclosed space by flowing the output fluid to the container. The input fluid may be a liquid at times, in which case the introduction of the input liquid and the withdrawal of the output liquid may occur sequentially or simultaneously, depending on the goal of the treatment. At times, the method of wound treatment may include the steps of: receiving data from a user side through an I/O interface; and communicating data from the user I/O to the controller to thereby change the target of the pressure cycle. At times, the method of wound treatment may include the steps of: delivering a treatment regime to the wound bed, the treatment regime comprising an actual pressure p within the enclosed space _a A series of pressure cycles.

At some point, during the partial pressure cycle, by adding O ₂ At a concentration greater than O found in the atmosphere ₂ The gas with the concentration is input into the closed space, and the generated rich O ₂ Can resuscitate hypoxic wound cells, resuscitate cells that can support cell division and collagen synthesis, inhibit the growth of anaerobic bacteria, enhance the efficacy of antibiotics, and can increase the survival of stem cells and tissue grafts, and enhance other biological processesTherapeutic benefits of the materials of course. In addition, the wound bed is provided with so abundant O ₂ May be beneficial because of the abundance of O ₂ [1]Under favorable concentration gradient; [2]Under favorable pressure gradients that do not interfere with baseline arterial perfusion (e.g., 20-60mm Hg, but may be higher for short durations), and [3]During relatively reflective hyperemia of a tissue region, where capillaries may have previously collapsed under negative pressure. The result is that maximum absorption and uptake of oxygen is achieved with increased flow. In addition, O provides high pressure conditions in a fluid tight enclosure ₂ The amplitude and period of delivery may additionally be used and programmed to provide external pulsed pressurization O ₂ In a form in which beneficial circulatory effects are in some ways similar to providing external CPR to a wound bed.

At times, the method of wound treatment may include the steps of: introducing a liquid into the enclosed space, and comprising the steps of: the liquid is conducted away from the enclosed space. Methods of wound therapy may include irrigating a wound bed using sequential fluid input and output to and from an enclosed space. A method of wound treatment may include providing treatment to a wound bed by delivering a liquid of therapeutic properties into an enclosed space. Therapeutic attributes may include, for example, proteolytic, analgesic, antimicrobial, or healing attributes. Similarly, at times, if the goal is to achieve a fast flow flush, the liquid input and output relative to the enclosed space may occur simultaneously rather than sequentially.

Reference herein to ambient pressure p _amb By pressure in the area surrounding the wound treatment device is meant. Ambient pressure p _amb For example, atmospheric pressure, hull pressure within an aircraft in which the wound therapy device is used, or pressure generally maintained within a building or other structure in which the wound therapy device is used may be referred to. Ambient pressure p _amb May change due to, for example, altitude or weather conditions. At some time, the pressure p _min Refers to the minimum pressure reached within the enclosed space of the wound treatment device, the pressure p varying periodically ₀ Pressure variations, varying pressures and the likeThe term refers to a time-varying pressure p in an enclosed space ₀ A change in the position of the mobile terminal. Pressure p _max Refers to the maximum pressure reached within the enclosed space of the wound treatment device. Exudate as referred to herein includes, for example, proteinaceous liquids exuded from the wound bed, along with various plasma and blood components. The exudate may also include waste liquids, such as irrigation fluids.

The term "fluid-tight" or related terms, as used herein, refers at times to having sufficient leak resistance to permit the creation of a pressure p, which may be above or below ambient pressure, within the enclosed space of the wound interface, by insufflation or vacuum suction _amb Actual pressure p of ₀ . Or to substantially maintain fluid within the enclosed space, including gases and liquids, except through one or more lumens in fluid communication with the enclosed space. The term "fluid-tight" or related terms, as used herein, sometimes refers to a fluid-tight seal that has sufficient leak resistance to allow insufflation or vacuum suction to maintain the actual pressure p within the enclosed space of the wound interface ₀ Above or below ambient pressure p _amb 。

The terms "distal" and "proximal", as used herein, are defined from the perspective of a user using the wound treatment apparatus to treat a patient, such as a doctor, nurse, or medical care provider. The distal portion of the wound therapy device faces the patient and the proximal portion of the wound therapy device faces the healthcare provider. When the distal portion of the device is near the patient, the proximal portion of the device is near the user treating the patient.

At some point, the wound interface described herein resists deformation to resist collapse and substantially retains its shape, including forming an enclosed space within which to apply the actual pressure p _a ≤p _amb When it is sufficient to direct a portion of the wound bed toward or into the enclosed space, including the enclosed space occupied by the wound bed. At least a portion of the wound interface forming the enclosed space may, at times, be substantially rigid. At times, the wound interface, with sufficient deformability to remain sealingly fixed to the skin surface, is maintained over the entire pressure range p _min ≤p _a ≤p _max The inner part is not sealed by fluid.

The apparatus, associated methods of use, and associated compositions disclosed herein may be implemented, at least in part, by software in the form of readable instructions that are operably received by one or more computers to cause, at least in part, one or more computers to operate as an apparatus, or to perform steps of a method of use. At times, the methods of use disclosed herein may be embodied as a combination of hardware and operatively received software. The compositions disclosed herein include a non-transitory computer-readable medium that is operatively received by one or more computers to cause, at least in part, one or more computers to function as a device, or to perform steps of a method of use.

The computer referred to herein comprises computer readable instructions operable to be received by a processor for execution. The computer may be, for example, a single processor computer, a multi-core computer, a minicomputer, a mainframe computer, a supercomputer, a distributed computer, a personal computer, a handheld computing device, a tablet, a smartphone, and a virtual machine, and the computer may include multiple processors in networked communication with one another. At times, the computer may include memory, screens, keyboards, mice, storage devices, I/O devices, etc., which are operatively coupled to the network. The computer may execute a variety of Operating Systems (OSs), such as Microsoft Windows, Linux, UNIX, MAC OS X, real-time operating system (RTOS), VxWorks, INTEGRITY, Android, iOS, or a single software or firmware implementation without a traditional operating system.

The networks referred to herein may include the internet cloud, and other local to global networks. The network may include, for example, data storage devices, input/output devices, routers, databases, computers containing servers,

mobile devices, wireless communication devices, cellular networks, optical devices, cables and other hardware and operational software will be readily recognized by those of ordinary skill in the art upon studying this disclosure. The network may be wired (e.g., optical, electromagnetic), wireless (e.g., Infrared (IR), electromagnetic), or a combination of wired and wireless, and the network may conform, at least in part, to a variety of standards (e.g., Bluetooth FDDI, ARCNET IEEE 802.11, IEEE 802.20, IEEE 802.3, IEEE 1394-1995, USB).

Fig. 2 illustrates an exemplary wound treatment apparatus 10, as shown in fig. 2, a wound interface 15 is secured to a skin surface 11 to form a fluid-tight enclosure 17 over a wound bed (e.g., wound beds 213, 313, 413). In this embodiment, the wound treatment apparatus 10 includes a gas source 82 and a liquid source 84 in fluid communication with the enclosed space 17 of the wound interface 15. As shown in FIG. 2, wound treatment apparatus 10 comprises an administration set 30, with administration set 30 including controller 87, user I/O86, valve 88, pump 89, and pressure sensor 91. As shown, the control group 30 regulates gas 22 from a gas source 82, liquid 24 from a liquid source 84, or a combination of gas 22 and liquid 24, as the input fluid 16, into the enclosed space 17. As shown, the control group 30 regulates the output fluid 18 to be directed from the enclosed space 17. the output fluid 18 may include, for example, input fluid 16, exudate 19, and air, which are directed from the enclosed space 17 after the wound interface 15 is secured to the skin surface 11. It should be appreciated that in this embodiment, the controller 87, user I/O86, valve 88, pump 89 and pressure sensor 91 are combined into the control group 30, merely for purposes of explanation, the controller 87, which has no space or other physical structure or proximity, the user I/O86, valve 88, pump 89 and pressure sensor 91 are hidden with respect to one another or with respect to the gas source 82, the liquid source 84 or wound interface 15 by being combined into the control group 30.

Controller 87 is operatively connected to user I/O86, and user I/O86 for communicating data 74 via communications path 64. Controller 87 is in operative communication with valves 88, pump 89 and pressure sensor 91 via communication paths 61, 62, 66 to control operation of valves 88, pump 89 and pressure sensor 91, respectively, to vary the enclosure by regulating the introduction of input fluid 16 into enclosed space 17 and the discharge of output fluid 18 from enclosed space 17 at least partially in response to data 74 from user I/O86 received by controller 87Pressure p in the enclosed space 17 ₀ For example, according to exemplary pressure cycles 500, 550, 600, 650, 700, 750, 800, 850, 900, 950 (see fig. 9A, 9B, 9C, 9D, 9E, 9F, 9G, 9H, 9I, 9J, respectively). The controller 87 can control the operation of the valves 88, pumps 89, and pressure sensors 91 to respond, at least in part, to the data 74 from the user I/O86, for example, to deliver therapy protocols 1, 2, 3, or 4 to a wound bed surrounded by the wound interface 15 (see example 1). Using the user I/O86, the user may select a pressure cycle, such as pressure cycles 500, 550, 600, 650, 700, 750, 800, 850, 900, 950, and the user may select a treatment protocol, such as treatment protocol 1, 2, 3, or 4.

The controller 87 controls operation of the wound treatment apparatus 10 based, at least in part, on the data 74 transmitted to the controller 87 from the user I/O86. The controller 87 can control operation of the wound treatment apparatus 10 based, at least in part, on the data 71, 72, 73, which is communicated between the controller 87 and the valve 88, the pump 89, and the pressure sensor 91, respectively. In this embodiment, for illustrative purposes, the valve 88 and the pressure sensor 91 are illustrated as a single valve and a single pressure sensor. It should be appreciated that the valve 88 may include one or more valves disposed at various locations of the wound treatment apparatus 10 and the pressure sensor 91 may include one or more pressure sensors disposed at various locations of the wound treatment apparatus 10, as will be readily appreciated by those of ordinary skill in the art having reviewed the present disclosure. The controller 87 may include, for example, a processor, memory, software, operative to communicate with a microprocessor, A/D converter, D/A converter, clock, I/O connector, etc., and the controller 87 may be configured, for example, as a single chip or as a combination of chips disposed on a circuit board, as will be readily recognized by those of ordinary skill in the art having the benefit of this disclosure. In certain embodiments, the controller 87 may be configured as software, operatively received by a computer, the location of which may be at least partially remote from, for example, the valve 88, the pump 89, and the pressure sensor 91.

The user I/O86 may include a variety of switches, buttons, dials, sliders, graphics, and the like, whether virtualEither quasi-or physical, to obtain data 74 from the user, which is then communicated to the controller 87 to allow the user to direct the operation of the wound treatment apparatus 10, including the pressure p within the enclosed space 17 ₀ Pressure cycling and the provision of multiple treatment protocols. In some embodiments, the user I/O is formed as software that is operably received by the computer. The controller 87 may communicate the data 74 with a user I/O to direct the operation of the wound treatment apparatus 10, which the user I/O86 may display to the user.

As shown in fig. 2, a gas source 82 is in fluid communication with gas 22 in the enclosed space 17 of the wound interface 15, a liquid source 84 is in fluid communication with liquid 24 in the enclosed space 17 of the wound interface 15, and input fluid 16 is controlled by a controller 87 using a valve 88. For example, when controlled by the controller 87, the valve 88 can select gas 22 from the gas source 82, liquid 24 from the liquid source 84, or a combination of gas 22 from the gas source 82 and liquid 24 from the liquid source 84 as the input fluid 16 into the enclosed space 17. The valve 88 can regulate, at least in part, the entry of the input fluid 16 into the enclosed space 17 of the wound interface 15. The gas source 82 may be, for example, a cylinder containing oxygen, an oxygen bag, an oxygen generator, or a mains gas containing mains oxygen. The liquid source 84 may be, for example, a container of liquid 24, or a mains supply of liquid 24.

As shown in fig. 2, the output fluid 18 directed from the enclosed space 17 passes through the container 81, and the container 81 captures exudate 19 or liquid, such as liquid 24, from the output fluid 18 in the chamber 99 of the container 81. The gaseous portion of output fluid 18, or gas that is expelled from chamber 99 of container 81 by capturing liquid 24 or exudate 19, may then be discharged from pump 89 to the atmosphere. The valve 88, pump 89, or combination of valve 88 and pump 89, can regulate the output fluid 18 to be directed out of the enclosed space 17 of the wound interface under the control of the controller 87. Container 81 may be omitted when the amount of exudate 19 is minimal or no liquid, such as liquid 24, is present in output fluid 18.

By the pressure p in the chamber 99 of the container 81 _r When the pressure in the chamber p _r Less than ambient pressure p _amb At least a portion of the liquid 24 may be dispensed from the sealAnd exits the closed space 17. Chamber 99, which may be disposable and replaceable, provides a reservoir for liquid 24 flowing through enclosed space 17 such that a volume of liquid 24 approximately equal to the volume of chamber 99 may flow through enclosed space 17 and collect in chamber 99. When the pump 89 is in the closed position and the pressure p in the chamber _r Less than ambient pressure p _amb When the liquid 24 conducted from the closed space 17 collects in the chamber 99, the pressure p in the chamber _r Towards ambient pressure p _amb And (4) reducing. For example, when the pressure p in the chamber _r To a sub-ambient pressure p _amb At some set point, e.g., -10mm Hg, or when liquid 24 fills a particular portion of cavity 99, to prevent excessive pressure p within enclosed space 17 ₀ The introduction of liquid into the enclosed space 17 may be stopped, possibly breaking the seal of the wound interface 15 to the skin surface 11.

As illustrated in the schematic of fig. 2, valve 88 is in operative communication with gas 22, liquid 24, input fluid 16, and output fluid 18. Thus, in the illustrated embodiment, the valve 8 may comprise one or more valves configured on the wound treatment apparatus to select whether the input fluid 16 is a gas 22, a liquid 24, or a combination of gas 22 and liquid 24 to at least partially regulate the introduction of the input fluid 16 into the enclosed space 17 of the wound interface 15 and to at least partially regulate the exit of the output fluid 18 from the enclosed space 17 of the wound interface 15. Data 71 may control the operation of valve 88, and data 71 may indicate the operation of valve 88. For example, the data 71 may position the valve 88 from an open position to a closed position, or the data 71 may indicate that the valve 88 is in an open position or in a closed position.

As shown in the schematic diagram of fig. 2, pressure sensor 91 is in operative communication with gas 22, liquid 24, input fluid 16, and output fluid 18, and enclosed space 17. Pressure sensor 91 may include one or more pressure sensors operable, for example, to detect the pressure of gas 22, liquid 24, input fluid 16, output fluid 18, gas source 82, liquid source 24, or enclosed space 17 of wound interface 15 at various locations. The pressure sensors 91 may communicate data 73 to the controller 87 indicating the location of the gas 22, liquid 24, input fluid 16, output fluid 18,the gas source 82, the liquid source 84 or the pressure in the enclosed space 17, and the controller 87 can vary the operation of the valve 88 or the pump 89 in response to the data 73 from the pressure sensor 91. Specifically, the controller may control the valve 88 or the pump 89 to maintain the actual pressure p in the enclosed space 17 _a Is maintained approximately at a minimum pressure p _min And maximum pressure p _max And the actual pressure p in the enclosed space 17 may be varied in accordance with a pressure cycle, such as the pressure cycles 500, 550, 600, 650, 700, 750, 800, 850, 900, 950 described in relation to fig. 9A, 9B, 9C, 9D, 9E, 9F, 9G, 9H, 9I, 9J, for example _a . When p is in the enclosed space 17 _a Exceeding the maximum pressure p _max In operation, the output fluid 18 can be directed out of the enclosed space 17 through the control stack 30, and the gaseous portion of the output fluid can be vented to atmosphere. As another example, if liquid 24 is introduced as input fluid 16, the actual pressure p in the enclosed space is increased _a Exceeding the minimum pressure p _min Once the actual pressure p _a Upon reaching a preset value (e.g., -20mmHg), the control group can stop the delivery of liquid 24 to prevent fluid from escaping from the enclosed space, which could potentially disrupt the connection of the wound interface 15 to the skin surface 11. As another example, when liquid 24 is input as input fluid 16 while output fluid 18 is being directed from the enclosed space, the control group may adjust the input of liquid 24 to maintain the actual pressure p of liquid 24 in enclosed space 17 _a Equal to the target pressure p ₀ (e.g., -20mmHg or ambient pressure p _amb ) To prevent fluid spillage from the enclosed space which could break the link of the wound interface 15 with the skin surface 11.

Data 73 may be communicated between controller 87 and pressure sensor 91 to control the sensing of pressure, e.g., the frequency of pressure sensing, by pressure sensor 91. Data 73 may be indicative of the pressure sensed by pressure sensor 91.

The input fluid 16 may be delivered under pressure from a gas source 82 (e.g., a compressed gas tank), a liquid source 84 (e.g., a pressure tap at a liquid source), suction from a pump 89, and combinations thereof. Pump 89 may direct output fluid 18 from enclosed space 17. In certain embodiments, the pump 89 may be, for example, a centrifugal pump, a positive displacement pump, or a peristaltic pump. Data 72, for example, may be communicated from the controller 87 to the pump 89 to control the speed of the pump 89, or data 72 may be communicated from the pump 89 to the controller 87 to indicate the actual speed of the pump 89.

The wound treatment apparatus 10 may include a variety of fluid delivery devices, such as hoses, tubes, valves, conduits, connectors, pressure regulators, plenums, and a variety of other fittings to convey gas 22 and liquid 24 from the gas source 82 and liquid source 84, respectively, as input fluid 16 and to conduct output fluid 18 from the enclosed space 17 of the wound interface 15. In certain embodiments, the communication paths 61, 62, 63, 64 may be, for example, wired, wireless, optical (e.g., fiber optic, infrared), networked (e.g., the internet), or various combinations thereof. The valve 88, pump 89 and pressure sensor 91 may include, for example, an a/D converter, D/a converter, actuator, solenoid valve, stepper motor, microprocessor to direct the operation of the valve 88, pump 89 and pressure sensor 91 by using the data 71, 72, 73 to control the operation of the valve 88, pump 89 and pressure sensor 91, respectively, or to communicate the data 71, 72, 73 to the controller 87, as will be readily recognized by one of ordinary skill in the art in studying this disclosure. In certain embodiments, the data 71, 72, 73, 74 may be digital, analog, or a combination thereof.

One or more power sources may be disposed on the wound treatment apparatus 10 in electrical communication with the controller 87, valve 88, pump 89 and pressure sensor 91. The power source may be, for example, mains electricity, a battery, or a combination of mains electricity and a battery, and the power source may include, for example, a transformer, an inverter, a rectifier, a filter, and a surge protector, as would be readily recognized by one of ordinary skill in the art studying this disclosure.

Fig. 3A, 4A and fig. 3B, 4B illustrate the operating configurations 111, 113, respectively, of an exemplary wound treatment apparatus 100. In the operative configuration 111, as shown in FIG. 3A, the control group 130, including the reservoir housing 120, and the control package 160, are releasably secured to one another. As shown in FIG. 3B, the receptacle housing 120 has been removed from releasable securement to the control pack 160 such that, in the operating configuration 113, the control group 130 includes only the control pack 160. Thus, in the exemplary wound treatment apparatus 100, the control group 130 may be operably configured to be releasably secured to the receptacle housing 120 of the control package 160 in the operational configuration 111, or to a separate control package 160 in the operational configuration 113.

As shown in fig. 3A and 3B, wound treatment apparatus 100 includes a gas source 112, a moisture source 114, a wound interface 115 defining an enclosed space 117, and an administration set 130. As shown in fig. 3A, 3B, the control package 160 of the control group 130 selects whether the input fluid 116 is gas 125 from the gas source 112 plus moisture 129 from the moisture source 114, or air 128 from the atmosphere 127. Control package 160 controls the introduction of input fluid 116 into enclosed space 117 of wound interface 115, controls the exit of output fluid 118 from enclosed space 117 of wound interface 115, and vents at least a portion of output fluid 118 to the atmosphere. The wound treatment apparatus 100 includes a variety of fluid transport means, such as hoses, tubes, valves, conduits, connectors, plenums, containers and various other fittings to convey gas 125 from the gas source 112 and air 128 from the atmosphere 127 as input fluid 116 into the enclosed space 117 and to transport the output fluid 118 between the wound interface 115 and the control group 130. In the event of a power outage in the wound treatment apparatus 100, air 128 from, for example, the atmosphere 127 may be introduced into the enclosed space 117 as the input fluid 116 to establish the actual pressure p within the enclosed space 117 _a Set to ambient pressure p _amb 。

As shown in fig. 3A, the reservoir housing 120 includes a reservoir 150, and the output fluid 118 directed from the enclosed space 117 flows through the reservoir 150. Container 150 captures exudate 152 (including other liquids) from output fluid 118 in chamber 155 of container 150, as shown in the implementation of fig. 3A. As shown, the gaseous portion of output fluid 118, or gas expelled by capturing exudate 152 through cavity 155 of container 150, may then be expelled into atmosphere 127 by pump 189. The container 150 may be, for example, a tank, a shipping container, or a space within the container housing 120 that generally includes the interior of the container housing 120. In certain embodiments, the reservoir 150 and the reservoir housing 120 may be formed as a unitary structure. In certain embodiments, the container 150 may be removable and replaceable. In certain embodiments, the container 150 may be openable to allow the container 150 to be emptied and reused. In certain embodiments, the container 150 is sealed and non-reusable. In such embodiments, the reservoir housing 120 may be functionally a reservoir and may be entirely replaceable. Thus, the receptacle 150, with or without the receptacle housing 120 of the receptacle 150, may be configured to be disposable. The cavity 155 of the container 150 may contain a cushion or super absorbent polymer bag to gelatinize the exudate 152. An odor neutralizer can also optionally be included in the reservoir housing 120, within the chamber 155.

As shown in FIG. 3B, in the operating configuration 113, the container housing 120 has been removed from releasable securement to the control pack 160, and the control group 130 includes only the control pack 160. In the operating configuration 113, input fluid 116 is introduced to the wound interface 115 and output fluid 118 flows from the wound interface 118 toward the control package 160 without flowing through the containment housing 120, as shown in fig. 3B, under the control of the control package 160. In the operational configuration 113, the containment housing 120 may be disengaged from the control package 160 in which the control group 130 is placed, due to, for example, when exudate 152 is low to nonexistent from the wound bed, or when the wound interface 115 holds exudate 152 within the wound interface 115, or when the patient desires to be unimpeded by the containment housing 120. The control group 130 may identify the change in configuration and deliver the therapy appropriate for the corresponding configuration applicable.

As shown in fig. 4A, the control package 160, including the power source 162, the power source 162 may be different, such as a battery, a mains power supply, or a combination of a mains power supply and a battery, to provide backup power. In certain embodiments, power supply 162, which may include, for example, a transformer, an inverter, and a conditioning circuit, will be readily understood by one of ordinary skill in the art studying this disclosure. If power source 162 includes a battery, the battery may be, for example, a nickel-cadmium, nickel-metal hydride, or lithium ion based battery.

In this embodiment, the power source 162 is electrically connected to the various components of the control package 160, including the controller 165, the pump 168, the valves 172, 173, 174, the pressure sensor 176, the pressure sensor 178, and the user I/O145, to flow power to the above components. Various power paths may be provided around the control group 130 to transmit power from the power source 162 to the controller 165, pump 168, valves 172, 173, 174, pressure sensors 176, 178 and user I/O145. In certain embodiments, the pump 168 may be, for example, a rotary pump or a positive displacement pump. The valves 172, 173, 174 may be driven electromechanically by, for example, an electromagnetic motor or a stepper motor. In certain embodiments, one or more of the valves 172, 173, 174 may be configured as a three-way valve, or as a combination of valves. Although this embodiment includes pressure sensors 176, 178, other embodiments may include a combination of pressure sensors 176, 178 or a single pressure sensor that senses pressure at different locations. Other embodiments of the control group 130 may include a different number of valves, such as valves 172, 173, 174, operatively associated with a different number of pressure sensors, such as pressure sensors 176, 178, to measure and regulate pressure from, in, or downstream of the housing. Such multipoint sensing can enable more intelligent differential monitoring and diagnosis of system or fault conditions, and can indicate the location and nature of the condition to assist in troubleshooting, adjusting or correcting the action.

In this embodiment, controller 165 controls, at least in part, the operation of wound therapy device 10, including control group 130. The controller 165 may include, for example, a microprocessor, memory, a/D converter, D/a converter, clock, I/O connector, etc., as will be readily recognized by those of ordinary skill in the art studying this disclosure. The controller 165 may be connected to the power source 162 to monitor the power source 162, to receive power from the power source 162, or to regulate current flow from the power source to the pump 168, valves 172, 173, 174, pressure sensors 176, 178, and user I/O145. The controller 165 may be in operative communication with the pump 168, valves 172, 173, 174, and pressure sensors 176, 178 to regulate operation thereof. The controller 165 may be in operative communication with the pump 168, the valve 172, the valve 174, and the pressure sensors 176, 178 to receive information from the pump 168, the valves 172, 173, 174, and the pressure sensors 176, 178 indicative of operation thereof or of operation of the wound treatment apparatus 100.

User I/O145, which may be located outside of control group 130 or remote from control group 130, may include a display for displaying the operational status of wound treatment apparatus 100 to the user. User I/O145 may include a variety of switches, buttons, dials, and the like, whether virtual or physical, for obtaining user input to allow a user to adjust the operation of wound treatment apparatus 100, including control group 130. User I/O145 and controller 165 may communicate with each other to transmit user input from user I/O145 to controller 165 to adjust operation of wound treatment apparatus 100, including control group 130, and to communicate information from controller 165 to user I/O145 indicating operation of wound treatment apparatus 100.

Various communication paths, such as wired, optical (e.g., LASER, IR) and network, may be included in wound treatment apparatus 100 including control group 130 for communication between controller 165 and pump 168, valve 172, valve 173, valve 174, pressure sensors 176, 178 and user I/O145. For example, in some embodiments, at least some of user I/O145 may be located remotely from the rest of control group 130, such as on a smart phone application, through various networks that may be wireless, and user I/O145 may communicate, at least in part, with controller 165. The user I/O145 may interface with a network, communicate over a network, communicate data, indicate operation of the wound treatment apparatus 100, or receive input to adjust operation of the wound treatment apparatus 100, either through a wired or wireless connection.

As shown in FIG. 3B, the control group 130 includes a control package 160, the control package 160 including a power source 162, a controller 165, a pump 168, valves 172, 173, 174, pressure sensors 176, 178, and a user I/O145. In the operating configuration 113, the receptacle housing 120 has been removed from connection with the control package 160 such that the control group 130 includes the control package 160 and does not include the receptacle housing 120, as shown in FIG. 3B.

As shown in fig. 3A, the wound treatment apparatus 100 may be placed in an operating configuration 111. As shown in fig. 3A, wound interface 115 is secured to skin surface 111 to enclose a wound bed, such as wound beds 113, 213, 313, within fluid-tight enclosed space 117. As shown in FIG. 3A, the wound interface 115, control group 130 including the container housing 120 and control package 160, the moisture source 114, and the gas source 112 are then placed in fluid communication with each other. When the wound bed is exuding exudate 152, for example, during an early stage of wound treatment, the wound treatment apparatus may be in the operating configuration 111 because the operating configuration 111 (as shown in fig. 3A, 4A) includes a container 150 for collecting exudate 152.

As shown in fig. 4A and 4B, gas 125 from gas source 112 is combined with moisture 129 from moisture source 114 and communicated to valve 174 through connector 182 of control group 130 and air 128 from atmosphere 127 is communicated to valve 173 through connector 183 of control package 160. It should be noted that in fig. 4A and 4B, the path of the input fluid 116 is indicated by the arrows with white inside, and the path of the output fluid 118 is indicated by the solid arrows with black inside. The input fluid 116 may be selected from air 128 or gas 125 including moisture 129 by operation of valves 173, 174. The controller 165 may operate the valve 174 to select the gas 125 with the added moisture 129 as the input fluid 116, or the controller 165 may operate the valve 173 to select the air 128 as the input fluid. The input fluid 116 then flows from the valve 173 or valve 174, through the connector 184 of the control group 130, and into the enclosed space 117 of the wound interface 115.

It should be noted that in some embodiments, the moisture source 114 may be omitted, for example, when the flow rate of the input fluid 116 is low, the oxygen flow is very low, and no humidification is required, as the moisture in the wound bed is already sufficient. Moreover, it should be appreciated that the gas source 112 may include a variety of gas sources, providing a variety of gas and gas combinations as the gas 125, and that the composition of the gas 125 may vary during the course of wound treatment. The composition of gas 125 may be variously selected for use by the user at various stages of wound treatment.

As shown in FIG. 4A, in this embodiment, the pressure sensor 176 is operable with the enclosed space 117 containing the input fluid 116 (when the input fluid 116 is input into the enclosed space 117)Is communicated to detect the actual pressure p in the enclosed space 117 _a . The actual pressure p in the enclosed space 117, detected by the pressure sensor 176 _a From the pressure sensor 176 to the controller 165, the controller 165 can position the valve 173 or the valve 174 to regulate the flow of the input fluid 116 into the enclosed space 117 to produce the actual pressure p _a Close to the target pressure p in the enclosed space 117 ₀ (i.e., such that p is _a ≈p ₀ )。

In this embodiment, the pressure sensor 178 is in operable communication with the enclosed space 117 including the output fluid 118 (when the output fluid 118 is directed out of the enclosed space 117) to detect the actual pressure p within the enclosed space 117 _a . The actual pressure p in the enclosed space detected by the pressure sensor 178 _a May be communicated from the pressure sensor 178 to the controller 165, and the controller 165 may position the valve 172, regulate the pump 168, or both the valve 172 and the pump 168 to regulate the output fluid 118 directed from the enclosed space and thereby generate the actual pressure p _a Close to the target pressure p in the enclosed space 117 ₀ (i.e., so that p is _a ≈p ₀ )。

As shown in FIG. 4A, output fluid 118 is directed at least partially out of the enclosed volume of wound interface 115 by pump 168 under the control of valve 172, through connector 186 of control set 130, through reservoir 150, to filter 124, to connector 188 between reservoir housing 120 and control package 160, and to pump 168. Exudate 152, including other liquids, remaining in chamber 155 flows through chamber 155 of container 150 as output fluid 118, and exudate 152, including other liquids, as output fluid is captured by filter 124 as output fluid 118 passes through filter 124, as shown. The remaining gas portion of the output fluid 118 is then vented to atmosphere on the exhaust side of the pump 168.

Filter 124 prevents exudate 152, which includes other liquids in output fluid 118, from reaching control package 160, which includes pump 168, thereby serving a protective function. For example, in certain embodiments, the filter 124 can comprise hydrophobic ultra high molecular weight polyethylene (UHMW-PE), which can optionally be impregnated with carboxymethyl cellulose. The filter 124 may comprise a hydrophobic filter material, which may comprise sintered PTFE, optionally with the addition of a super absorbent polymer, such as sodium polyacrylate or sodium carboxymethyl cellulose. When exudate 152 reaches filter 124, filter 124 suddenly clogs and expands, for example, increasing the pressure detected by pressure sensor 178, which, in turn, may trigger a protective shut-off for pump 168 by controller 165. In certain embodiments, the filter 124 may alternatively be placed in the reservoir housing 120, or the filter 124 may be omitted.

It should be noted that a variety of numbers and combinations of valves, such as valves 172, 173, 174, and pressure sensors, such as pressure sensors 176, 178, may be used in conjunction with controller 165 to regulate the flow of input fluid 116 into enclosed space 117 or to regulate the flow of output fluid 118 out of enclosed space 117 to produce actual pressure p _a Approaching a target pressure p in an enclosed space ₀ . For example, the valves 173, 174 may be replaced with a three-way valve that can select between no flow, air 128, or gas 125 that includes moisture 129.

Alternatively, in operation, the wound treatment apparatus 100 may be in the operating configuration 113, as shown in fig. 3B, 4B. As shown, wound interface 115 is secured to skin surface 111 to enclose a wound bed (e.g., wound beds 213, 313, 413) within fluid-tight enclosure 117. When the wound bed is no longer draining exudate 152, for example, during a later stage of wound bed healing, the wound treatment apparatus 100 may be in the operating configuration 113, as shown in fig. 3B, 4B. In this embodiment, the operative configuration 113 excludes the receptacle 150 including the receptacle housing 120 from the control group 130, as the receptacle 150 containing the receptacle housing 120 may not be needed. In certain embodiments, in the operating configuration 113, a filter 124 may be included in the controller bank 130 to capture stray liquids.

As shown in fig. 4B, output fluid 118, at least partially drawn by pump 168, flows out of enclosed space 117 of wound interface 115, through connector 188 of control pack 160 of control group 130, through valve 172, and through pump 168. In this embodiment, the output fluid 118 is then discharged to the exhaust side of the pump 168In the middle of qi. As shown in fig. 3A, 4A, described with respect to the operating configuration 111, in the operating configuration 113, the input fluid 116 may flow from the gas source 112 or the atmosphere 127 into the enclosed space of the wound interface 115. In the operating configuration 113, the controller 165 interacts with the valves 172, 173, 174, pressure sensors 176, 178 and the pump 168 to control the flow of the input fluid 116 and the output fluid 118, e.g., to generate the actual pressure p _a Approaching a target pressure p in an enclosed space ₀ Or to deliver air 128 to the wound bed.

Connector 188 forms a connection point between reservoir housing 120 and control pack 160 such that in operating configuration 111 reservoir housing 120 and control pack 160 are removably secured to one another at least at connector 188. In the operational configuration 111, when the reservoir housing 120 and the control pod 160 are removably secured to one another, the connector 188 forms a fluid pathway for the flow of the output fluid 118 from the reservoir housing 120 to the control pod 160. In the operational configuration 113, the reservoir housing 120 is not present in the control pack 130, and in the operational configuration 113, the connector 188 provides a fluid-transmitting connection point between the wound interface 115 and the control pack 160 for transmitting the output fluid 118. In this embodiment, connectors 182, 184, 186 provide connection points for the delivery of multiple fluids to the administration set 130, allowing the delivery of both the input fluid 116 and the output fluid 118 via the connection points.

In this embodiment, the receptacle housing 120 may be removed from securement with the control package 160 by at least breaking the connection at the connector 188, and a new receptacle housing 120 may be removably secured to the control package 160 by at least securing to the connector 188. Alternatively, in this embodiment, the receptacle housing 120 may be removed from securement with the control package 160 by at least disconnecting the connector 188, and the fluid transfer between the wound interface 115 and the control package 160 may be secured to the connector 188, whereby the wound treatment apparatus 100 may be moved from the operating configuration 111 to the operating configuration 113.

As shown in FIG. 5, the controller 165 is in operative communication with the valves 172, 174, the pressure sensors 176, 178 and the pump 168 to substantially within the pressure range p _min ≤p _a ≤p _max Internal, change closureThe actual pressure p in the space 117 _a To correspond to the pressure range p possible _min ≤p ₀ ≤p _max Target pressure p varying periodically ₀ Wherein p is _min Is a target pressure p ₀ Minimum value of p _max Is the target pressure p ₀ Of (c) is calculated.

In certain embodiments, p _min ≤p _amb Wherein p is _amb Is the ambient pressure of the atmosphere 127 adjacent the wound treatment apparatus 100. In certain embodiments, p _max ≥p _amb . In certain embodiments, p _max ≤p _amb . The minimum pressure may be, for example, p _min ≈p _amb 130mm Hg. The minimum pressure may be, for example, p _min ≈p _amb -90mm Hg. Minimum pressure p _min May be, for example, in the pressure range (p) _amb -130mm Hg)≤p _min ＜(p _amb -90mm Hg). Minimum pressure p _min Can be approximately in the pressure range (p) _amb -90mm Hg)≤p _min ＜p _amb . In certain embodiments, the target pressure p ₀ May vary substantially over a pressure range p _min ≤p ₀ ≤p _max In which p is _max ＞p _amb . For example, p _max ≈(p _amb +40mm Hg). In certain embodiments, the maximum pressure p _max May be slightly less than ambient pressure p _amb E.g. approximately at p _amb -5mm Hg to p _amb -20mm Hg.

Fig. 5 illustrates exemplary operating states 132, 134, 136, target pressure p of wound treatment apparatus 100 ₀ In a pressure range p _min ≤p ₀ ≤p _max Periodically, the wound treatment apparatus 100 may be varied between operating states 132, 134, 136 to generate the actual pressure p _a To correspond to the target pressure p ₀ . The operational states 132, 134, 136 are exemplary, and not limiting, such that the wound treatment apparatus 100 may be in an operational state other than the operational states 132, 134, 136. It should be noted that the wound treatment apparatus is sequentially changed between the operational states 132, 134, 136Such that, for example, the operating states 132, 136 cannot exist simultaneously. For clarity of illustration, fig. 5 does not include the moisture source 114 and the container 150, and thus fig. 5 illustrates operation of the wound treatment apparatus 100 in two operating configurations 111, 113. The valve 173, which is also omitted from fig. 5 for clarity of explanation, is in the closed position in the exemplary operating state 132, 134, 136 shown in fig. 5 for the valve 173.

In an exemplary operating state 132, as shown in FIG. 5 (shown in phantom in FIG. 5), the output fluid 118 is directed from the enclosed space 117 of the wound interface 115 to vary the actual pressure p _a Pressure p corresponding to the target ₀ Towards a minimum pressure p _min To reach p _a ≈p ₀ ＝p _min Or to remove exudate 152 from enclosed space 117. In the operating state 132, the pump 168 may be in an ON state. As shown, output fluid 118 is drawn from the enclosed space of wound interface 115 through valve 172, which is in an open position, and pump 168 by suction of pump 168, venting the gaseous portion of output fluid 118 to atmosphere 127. As shown, the valve 174 is in a closed position such that in the operating state 132, no input fluid 116 is introduced into the enclosed space of the wound interface 115. In this embodiment, pressure sensor 178 is in operative communication with the enclosed space of wound interface 115 to detect an actual pressure p within enclosed space 117 comprising output fluid 118 _a . When the target pressure p ₀ Towards p _min At decreasing time, the actual pressure p detected by the pressure sensor 178 _a Can be communicated from the pressure sensor 178 to the controller 165, and the controller 165 can position the valve 172 between the OPEN position and the CLOSED position, including positions intermediate the OPEN position and the CLOSED position, to achieve p _a ≈p ₀ . The controller 165 may regulate operation of the pump 168, including, for example, the speed of the pump 168 to achieve p _a ≈p ₀ And to realize p _a ≈p ₀ ≈p _min. 。

In the exemplary operating condition 134, as shown in fig. 5 (by solid lines in fig. 5), both valves 172, 174 are in the CLOSED position, such that substantially no input fluid 116 is introduced into the enclosed space 117,or output fluid 118, is directed out of enclosed space 117. For example, in operational stage 134, in enclosed space 117 of wound interface 115, p _a ≈p ₀ ≈p _min Or p _a ≈p ₀ ≈p _max 。

At operational stage 134, although substantially no input fluid 116 is directed into enclosed space 117 of wound interface 115 and no output fluid 118 is directed out of enclosed space 117, it should be appreciated that there may be some leakage into or out of enclosed space 117 of wound interface 115. Thus, in the operating state 134, the pressure sensor 176, the pressure sensor 178, or both the pressure sensors 176 and 178, may detect the actual pressure p within the enclosed space of the wound interface 115 _a Actual pressure p detected by pressure sensors 176, 178 _a May be communicated from the pressure sensors 176, 178 to the controller 165. In the exemplary operational phase 134, the controller 165 may position the valves 172, 174, change the pump 168 between an OFF closed state and an ON open state, or intermittently adjust the operation of the pump 168 or the valves 172, 174, for example, to maintain p _a ≈p ₀ ≈p _min To hold p _a ≈p ₀ ≈p _max Or exudate 152 may be drawn from the enclosed space 117 of the wound interface 115 as desired.

In an exemplary operating state 136, as shown in fig. 7 (represented by dashed lines), the input fluid 116 is introduced into the enclosed space 117 of the wound interface 115 to change the actual pressure p _a So as to correspond to the target pressure p ₀ Towards the maximum pressure p _max To reach p _a ≈p ₀ ≈p _max . In this embodiment, the input fluid 116 is introduced into the enclosed space 117 of the wound interface 115 through the valve 174 in the OPEN position, and the input fluid 116 is introduced into the enclosed space 117 by the pressure p of the gas source 112 _s And (3) driving. Valve 172 is in the CLOSED position such that in operating state 136, when input fluid 116 is introduced into enclosed space 117, no output fluid 118 is directed out of enclosed space 117 of wound interface 115. In this embodiment, in the operating state 136, the pressure sensor 176 is operable to contain the input fluid116, and detecting an actual pressure p within the enclosed space 117 of the wound interface 115 _a . The actual pressure p detected by the pressure sensor 176 _a Can be communicated from the pressure sensor 176 to the controller 165, and the controller 165 can position the valve 174 between the OPEN and CLOSED positions, including positions intermediate the OPEN and CLOSED positions, to achieve p _a ≈p ₀ Target pressure p ₀ Towards p _max And (4) increasing. In the operating state 136, the pump 168 may be in an OFF state.

Thus, as shown in FIG. 5, the valves 172, 174 are positioned between the open and closed positions to sequentially introduce the input fluid 116 into the enclosed space 117 and to direct the output fluid 118 from the enclosed space 117, meaning that the directing of the output fluid 118 and the directing of the input fluid 116 do not occur simultaneously. In the illustrated embodiment, the input fluid 116 may be introduced into the enclosed space or the output fluid 118 may be withdrawn from the enclosed space, but the introduction of the input fluid 116 and the withdrawal of the output fluid 118 cannot occur simultaneously. Thus, in the illustrated embodiment, valve 172 may be in the OPEN position while valve 174 is in the CLOSED position, valve 172 may be in the CLOSED position while valve 174 is in the OPEN position, or valve 172 may be in the CLOSED position while valve 174 is in the CLOSED position, and valves 172, 174 may not be in the OPEN position at the same time.

A pressure sensor 176 or other pressure sensor, disposed about control group 130, may, for example, sense pressure p of gas source 112 _s Below a certain minimum value, this indicates that the gas source 112 is being depleted. As another example, the control group 130 may be disconnected from the gas source 112. Valve 174 may then be in the CLOSED position, and valve 173 may be changed between the CLOSED position and the OPEN position, in place of valve 174, to change the wound treatment apparatus between operating states 132, 134, 136. Air 128 from the atmosphere 127 is regulated by a valve 173 and then fed into the enclosed space 117, for example to change the actual pressure p _a So as to correspond to the target pressure p ₀ Towards maximum pressureForce p _max 。

Fig. 6A and 6B illustrate the wound treatment apparatus 200 in an exemplary first operational stage 236 and a second stage of exemplary operation 238, respectively. As shown in fig. 6A, 6B, wound treatment apparatus 200 includes a deformation-resistant wound interface 215 that, when wound interface 215 is coupled to skin surface 211, forms a fluid-tight enclosure 217 for enclosing wound bed 213 on skin surface 211. As shown, wound interface 215 includes a cover 240, and cover 240 is slidably, sealingly, frictionally, removably coupled to base 220. The cover 240 may include at least partial transparency to allow visual inspection of the wound bed 213 through the cover 240. The base 220 may include a flange 209 along the outer perimeter of the base 220 that may be used to provide a structural support or sealing surface when mated with the cover 240. .

In some embodiments, the cover 240 and the base 220 may be formed as a unitary structure, or the cover 240 may be hinged or otherwise connected to the base 220. Although the illustrated wound interface 215 is cylindrical, enclosing a circular area of the skin surface 211, it should be understood that in some embodiments, structures such as the wound interface 215 may take on other geometries to enclose other geometrically shaped areas of the skin 211, such as rectangular, polygonal, or oval, to enclose wounds of various shapes, and may include other modifications, such as by modification of the base 220 to accommodate the skin surface 211 in various areas of the body. In certain embodiments, one or more additional ports in communication with the enclosed space 217 may be located on the wound interface 215 for monitoring parameters within the enclosed space 217, communication of fluid within the enclosed space 217, or other therapeutic intervention of the enclosed space 217.

In this embodiment, the base 220 includes a flange 229 along the entire perimeter of the outer side 223 of the base 220, generally at the distal end of the base 220. The flange 229 is secured to the skin surface 211 by an adhesive 290, as shown in fig. 6A and 6B, around the entire perimeter of the base 220 to form a fluid-tight enclosure 217 with the wound boundary 212 enclosed within the enclosure 217. Can be made flexible by designing the thickness of the flange 229 and/or the polymer materialConformable, in a fluid-tight manner, to maintain wound interface 215 sealed against wound 213, while simultaneously resulting in an actual pressure p from within enclosed space 217 _a From the wound interface 215 onto the skin surface 211.

Adhesive 290 may optionally extend over portions of skin surface 211 to include all skin surfaces below and near distal end 222 of flange 229. The adhesive is a member of the class of medically suitable cyanoacrylates, such as N-butyl-2-cyanoacrylate (Histoacryl Blue), or octyl 2-cyanoacrylate (dermobond), and the water-resistant adhesive coating around the wound skin surface provides the additional function of protecting normal skin from prolonged exposure to other fluids such as exudates, proteolytic enzyme soak or saline lavage, etc., causing secondary maceration. Other medical adhesives, such as acrylic, silicone, and hydrocolloid may secure the flange 229 of the wound interface 215 to the skin surface 211. In some embodiments, other securing means, such as velcro or adhesive bandages, may also be employed to secure, at least in part, the wound interface 215 to the skin surface 211. The base 220 of the wound interface may be formed from any of a variety of medical-grade polymers, including, for example, polycarbonate, polystyrene, polypropylene, or ABS; additional sealing structures may further be associated, such as an inflatable adjustable circumferential cushion between the base and the adhesive layer along the perimeter of the wound bed.

In this embodiment, port 242, located on wound interface 215, is in fluid communication with enclosed space 217 via inner lumen 245. In this embodiment, the lumen 245 of the port 242 may be in fluid communication with an administration set, such as administration sets 30, 130 of the wound treatment apparatus 10, 100, respectively, which may direct the input fluid 216 into the enclosed space 217 or the output fluid 218 out of the enclosed space 217 through the lumen 245.

The input fluid 216 may be input into the enclosed space 217 via the inner cavity 245 of the port 242, as shown by the arrows in fig. 6A, 6B, for example, to at least partially regulate the actual pressure p within the enclosed space 217 _a To control the composition of the gaseous fluid in the enclosed space 217, orFor a variety of therapeutic purposes. The input fluid 216, for example, may be directed into the enclosed space 217 to increase the actual pressure p within the enclosed space 217 _a To the target pressure p ₀ And (5) the consistency is achieved. The input fluid 216 may include a gas, such as gas 22, 125, plus the gas 22, 125 of moisture 129 from a moisture source, such as moisture source 114. The input fluid may include a liquid, such as liquid 24.

The output fluid 218 may include the input fluid 216 and the output fluid 218 may include the exudate 252, such that the output fluid 218 may include liquid, gas, and combinations of liquid and gas from within the enclosed space 217. The input fluid 216 or the output fluid 218 may include a liquid, such as liquid 24, which may have a variety of therapeutic purposes. As shown, the output fluid 218 is directed from the enclosed space 217 through an inner cavity 245 of the port 242, for example, to reduce the actual pressure p within the enclosed space 217 _a To conform to the target pressure p to remove exudate 252 from the enclosed space 217 or to remove a liquid, such as liquid 24, from the enclosed space 217.

A pad 250 may be disposed within the enclosed space 217 to absorb and transfer exudate 252 from the wound bed 213, the pad 250 may be in fluid communication with the port 242 to allow exudate 252 to pass from the wound bed 213 through the pad 250 and then out through the port 242. The pad 250 may be formed of a material having absorbent and fluid transfer properties to absorb exudates. These materials include, for example, open-cell foams composed of polyvinyl alcohol (PVA), polyurethane or other polymers. The pad 250 can be formed from a variety of woven or non-woven fibers, such as sodium carboxymethylcellulose water soluble fiber (Aquacel), or knitted fibers having primarily hydrophobic polyester fibers on the outer surface and primarily hydrophilic nylon fibers on the inner side to act as a conduit for fluid transfer. The hydrophobic polyester fibers may be kept away from the liquid, preventing moisture accumulation, thereby causing secondary maceration of the tissue in continuous contact with the pad 250. Depending on the specific fluid management objective, whether the exudate is primarily transported to another location or primarily absorbs and immobilizes the topical exudate, an amount of superabsorbent polymer (SAP), such as sodium polyacrylate, may optionally be included in the pad 250. The addition of an amount of SAP to a closed cell polyurethane may allow the passage of liquid through the matrix, thereby enhancing the absorption and fluid transfer properties of the matrix.

The wound treatment apparatus 200 may be periodically changed between the first stage of operation 236 and the second stage of operation 238 by continuously directing output fluid 218 out of the enclosed space 217 and input fluid into the enclosed space 217 via the lumen 245 of the port 242. In a first stage 236 of exemplary operation, as shown in FIG. 6A, a target pressure p ₀ Equal to the maximum pressure p _max (i.e., p) ₀ ＝p _max ) The maximum pressure may be substantially equal to the ambient pressure p _amb (i.e. p) _max ≈p _amb ) Actual pressure p _a Is substantially equal to the target pressure p in the enclosed space 217 ₀ (i.e., p) _a ≈p ₀ )). The wound bed 213 is in a baseline state 293 in spatial relationship to the pad 250 such that there is reduced or no contact between the pad 250 and the wound bed 213. The gap, if any, between the pad 250 and the wound bed may vary depending on the shape, configuration, and materials used to make the pad 250. As shown in fig. 6A, the wound interface 215 forms an inlet 226 into the enclosed space 217, and in the baseline state 293, the portion of the wound bed 213 enclosed by the enclosed space 217 is generally outside of the inlet 226. As shown in fig. 6A, in the first state of operation 236, the capillary 296 adjacent to the wound bed 213, in an unexpanded baseline state 297, delivers a baseline amount of blood to the wound bed 213.

In the second stage 238 of the exemplary operation of the apparatus 200, as shown in FIG. 6B, the enclosed space 217 is evacuated, or partially evacuated, by conducting the output fluid 218 from the enclosed space 217 through the lumen 245 of the port 242, thereby causing the target pressure p ₀ ＝p _min Actual pressure p _a Is substantially equal to the target pressure p in the enclosed space 217 ₀ . In the expanded state 294, the pressure p _min Less than ambient pressure p _amb (i.e. p) _min ＜p _amb ) By a sufficient amount to expand at least a portion of the wound bed 213 through the inlet 226 into the enclosed space 217. As shown in FIG. 6B, in a second stage of operation 238, at least a portion of the wound bedOr more heavily towards the pad 250 than the wound bed 213 of the first stage 236 of operation. During the second stage of operation 238, the pad 250 may thus effectively absorb and transfer exudate from the wound bed 213 as at least a portion of the output fluid 218 through the inner chamber 245. The pad 250 is in fluid communication with the inner lumen 245 of the port 242 such that exudate may be conducted from the pad 250 through the inner lumen 245 as at least a portion of the output fluid 218 via external negative pressure applied to the port 242. As shown in fig. 6B, in the second stage of operation 238, when the wound bed 213 is in the expanded state 294, capillaries adjacent the wound bed, such as capillary 296, may be in the expanded state 298.

One problem, for example, when the output tubing is clogged with exudate, results in the control package maintaining a false reassuring target negative pressure indication, while there is a much lower actual negative pressure at the wound site. By adding additional ports that are also in independent communication with enclosed space 217, different pressure readings from the same enclosed space can be obtained from the front and back ends of the pressure piping system, more accurate diagnostics can be achieved, problem situations can be localized, allowing more targeted solutions or precautions. The additional port may be located at a distance from the first port, both ports being in fluid communication with the wound. In addition, when a bolus of fluid is introduced through the second port to suddenly relieve negative pressure within the enclosed space, this sudden unidirectional pressure relief can be used to clear exudate from the negative pressure port spraying out, dredging the conduit from one end of the wound bed toward the other, keeping the conduit unobstructed, helping to maintain effective therapy. The use of lavage fluid as the bolus of liquid provides the further benefit of rinsing out any clotted exudate, cell debris and maintaining the circuit open. When used with dressing systems where the port for delivery of the negative pressure is near one end of the absorbent pad and the negative pressure port is near the other end, intermittent application of irrigation solution to relieve the negative pressure can extend the clinical life of such dressing systems, unlike self-cleaning diapers where exudate and cellular debris are washed away and the dressing is "refreshed". In addition to the savings in replacement costs, other benefits may include a lower incidence of tape allergy, which is typically due to the accumulation of repeated loss of the epidermal layer with each dressing change; the epidermis layer may isolate the subcutaneous tissue of the dermis layer from exposure to the adhesive.

Fig. 7 illustrates a wound treatment apparatus 300 including a wound interface 315. The device 300 comprises a member 315, the member 315 comprising a cover 320, the member 315 being attached to the skin surface 311 by an adhesive 390 to close the wound bed 313 of the skin surface 311, the entire wound boundary 312 being covered by the cover 320. The distal side 322 of the cover 320 faces the wound bed 313, and the cover 320 is secured to the skin surface 311 by an adhesive 390 on at least a portion of the distal side 322 of the cover 320, thereby forming a portion of the enclosed space 317. As shown, the enclosed space 317 includes at least a portion of the wound bed 313. As shown, the dressing 350 is placed against the wound bed 313 and sealingly covered by the cover 320 such that the dressing 350 is located within the enclosed space 317.

As shown in fig. 7, the ports 342, 344 are in fluid communication with the enclosed space 317 between the distal side 322 of the cover 320 and the proximal side 324 of the cover 320 through lumens 347, 345, respectively.

In this embodiment, the lumens 345, 347 are in fluid communication with a control group, e.g., control groups 30, 130 of the wound treatment devices 10, 100, respectively, which may regulate the introduction of the input fluid 316 into the enclosed space 317 through the lumen 347 and regulate the exit of the output fluid 318 from the enclosed space 317 through the lumen 345. In this embodiment, exudate 352 moves from the wound bed 313 into the dressing 350, and the exudate 352 may be directed out of the dressing 350 as part of the output fluid 318.

For example, when the actual pressure p in the enclosed space 317 is _a Variation from target pressure p ₀ In concert, input fluid 316 may be introduced into enclosed space 317 via lumen 347 of port 342, and output fluid 318 may be directed out of the enclosed space via lumen 345 of port 344. For example, the target pressure p ₀ Can be in the pressure range p _min ≤p ₀ ≤p _max Periodically change in which p _min Is the minimum target pressure, p, over the pressure cycle _amx Is the maximum target pressure, the actual pressure p, over the pressure cycle _a To a target pressureForce p ₀ And (5) the consistency is achieved.

Fig. 8 illustrates an exemplary wound treatment apparatus 400. As shown in fig. 8, wound treatment apparatus 400 includes a wound interface 415, wound interface 415 including a member 420, and an adhesive 490 coated on at least a portion of a distal surface 422 of member 420 for securing member 420 to skin surface 411. When secured to the skin surface 411, the distal surface 422 of the member 420 encloses the wound bed 413 on the skin surface 411 within the enclosed space 417. The member 420 may be formed from a variety of polymers, for example, polyurethane. Member 420 may be fluid tight and member 420 may be deformation resistant.

As shown in fig. 8, flange 414 of port 442 secures port 442 to member 420 for fluid communication with enclosed space 417 through lumen 445. The flange may be adhesively secured to the underside of the member 420 through the apertures of the member 420 as shown, or it may be adhesively secured to the upper and outer surfaces of the member 420, via apertures or connecting channels, in fluid communication with the enclosed space 437 within the wound interface.

Input fluid 416 may be input into enclosed space 417 via lumen 445 of port 442 and output fluid 418 may be output from enclosed space 417 via lumen 445 of port 442. Lumen 445 may be in fluid communication with a control group, such as control groups 30, 130 of wound treatment apparatus 10, 100, respectively. In this embodiment, for example, in order to make the actual pressure p _a With a target pressure p ₀ When the target pressure p in the enclosed space 417 is consistent ₀ E.g. according to a pressure substantially in the pressure range p _min ≤p ₀ ≤p _max Is cyclically changed, where p is _min Is the minimum target pressure, p, of the entire pressure cycle _max Which is the maximum target pressure for the entire pressure cycle, the control group can regulate the introduction of input fluid 416 into enclosed space 417 through lumen 445 and regulate the removal of output fluid 418 from enclosed space 417 through lumen 445.

As shown in fig. 5, the device 400 includes layers 460, 470, and 480 within the enclosed space 417. As shown, a portion of the layer 480 is secured to the distal side 422 of the member 420, and a portion of the distal side 482 of the layer 480 is proximate the skin surface 411 and the wound bed 413. The layer 470 is positioned between the layer 480 and the layer 460, with the distal side 472 of the layer 470 being biased toward the proximal side 484 of the layer 480 and the proximal side 474 of the layer 470 being biased toward the distal side 462 of the layer 460. The layer 460 is disposed between the layer 470 and the spacer 430 with the proximal side 474 of the layer 470 biased toward the distal side 432 of the spacer 430. In some embodiments, various numbers of layers, such as layers 460, 470, 480 may be included in apparatus 400, arranged in various ways depending on the application, or certain layers may be omitted. The different layers may have particular characteristics and functions, such as liquid absorption, fluid transport, and release of therapeutic substances.

In this embodiment, the proximal side 434 of the spacer 430 is secured to the distal side 422 of the member 420 within the enclosed space 417. The spacer 430 forms a space 437 within the spacer 430, the spacer 430 maintaining the layers 460, 470, 480 biased toward one another as shown. The space 430 may be generally a double layer polymeric bag, with or without additional shunts, which may be formed by partial bonding or welding 464. It may optionally be welded at a plurality of points 464 in the double layer volume to limit expansion of volume 437 under pressure. The purpose of the spacer 430 is to distribute the input fluid 416 across the wound surface. The spacer 430 may have a variety of sizes and shapes, such as circular, rectangular, oval, or starburst, with a perimeter that substantially approximates the perimeter of the proximal side 464 of the layer 460.

Lumen 445 passes through port 442 and proximal side 434 of spacer 430 into volume 437, input fluid 416 may be conveyed into volume 437 via lumen 445, or output fluid 418 may be directed out of volume 437 through lumen 445.

For example, input fluid 416 may be delivered into volume 437 via lumen 445, and input fluid 416 may then be dispersed within volume 437 such that substantially the same actual pressure p exists throughout volume 437 _a . The input fluid 416 may then flow from the volume 437 through spacer channels, such as spacer channels 435, on the distal side 432 of the spacer 430 into the layer 460. The spacer channels are evenly dispersed on the distal side 432 of the spacer 430 so that the input fluid 416 from the space 437 is evenly dispersed on the proximal side of the layer 460. The input fluid 416 may then flow through layer 460, through layer 470, and through layer 480, such as layer channel 485, to contact the wound bed 413 and the skin surface 411. The channels on the proximal side 484 through layer 480 and evenly distributed on the distal side 482 of layer 480 allow the input fluid 416 to be evenly distributed across the skin surface 411 and wound bed 413. Thus, for example, the input fluid 416 may, for example, provide enhanced O ₂ Antibiotics, or cytokines in the form of amniotic fluid to the wound bed 413 and skin surface 411. Actual pressure p _a Present throughout the enclosed space 417, the enclosed space 417 including the wound bed 413 and the skin surface 411, the input fluid 416 and the output fluid 418 may flow through the entire enclosed space 417, including the layers 460, 470, 480, and through the spacer 430. The spacer 430 may optionally be configured farther to be near or even adjacent to the wound surface, in which case spacer channels 435 may be present in both the distal and proximal sides of the spacer 430.

Exudate 452 may flow from wound bed 413, through layer channels, such as layer channel 485 in layer 480, into layer 470, from layer 470 into layer 460, and from layer 460 through spacer channels, such as spacer channel 435, into space 437. In this embodiment, output fluid 418, including exudate 452, may flow out of layers 480, 470, 460, through spacer channel 435 into volume 437, through lumen 445 of port 442, and output fluid 418 may be directed out of volume 437.

In this embodiment, layer 480 is formed of silicone, including similar materials with scar regulating properties, and wound bed 413 is in the form of an incision with sutures 499. The silicone, as referred to herein, including silicones, polysiloxanes, silicone-like materials, and combinations thereof, can be generally solid. The silicone resin may have the formula [ R2SiO ] n, where R is an organic radical. The silicone may include, for example, silicone polymers having an average molecular weight in excess of 100,000 (e.g., between about 100,000 and about 10,000,000). Examples include, but are not limited to, cross-linked silicones (e.g., cross-linked polydimethylsiloxanes or polydimethyl siloxane derivatives), copolymers such as stearyl methyl-dimethylsiloxane copolymer, polysiloxane-11 (a cross-linked silicone rubber resulting from the reaction of a vinyl-terminated silicone and a (dimethylhydro) silicone in the presence of cyclomethicone), cetearyl dimethicone/vinyl dimethicone crosspolymer (copolymer of cetearyl dimethicone cross-linked with vinyl dimethicone), dimethicone/phenyl vinyl dimethicone crosspolymer (copolymer of dimethicone cross-linked with phenyl vinyl dimethicone)/vinyl dimethicone crosspolymer (copolymer of dimethicone cross-linked with vinyl dimethicone).

In certain embodiments, wound bed 413 may be any type of wound bed and layer 480 may be formed from other silicone or similar materials. Layer channel 485 may take a variety of forms ranging from small holes, crosses, to fine slits, allowing fluid exchange between wound bed 413 and skin surface 411 through layer 480 to prevent maceration of skin 411.

Layer 470 may comprise a layer of material that delivers the therapeutic agent in a slow release manner. These therapeutic agents may include antibacterial agents such as antibiotics or silver preparations, local anesthetics for pain relief, amnion or placenta derived cytokines and growth factors such as BMP, hemostatic and clotting agents for hemostasis, oxygen generating and releasing compounds, exothermic or endothermic agents, and the like.

The layer 460 may be made of a variety of materials, including cotton gauze, polyester or polyamide fibers, or polyurethane open cell foam, or polyvinyl alcohol open cell foam. The material of these layers 460 may help transfer exudate 452 from wound bed 413 to space 437 for egress through lumen 445. The layer 460 may optionally include a superabsorbent polymer such as sodium polyacrylate, particularly when the objective is to lock the exudate 452 within the layer 460.

In operation of a wound treatment apparatus (e.g., wound treatment apparatus 10, 100, 200, 300, 400), a control input fluid (e.g., input fluid 16, 116, 216, 316, 416) is introduced into the enclosed space of the wound interface and an output fluid (e.g., output fluid 18, 118, 218, 318, 418) is withdrawn from the enclosed space of the wound interface using a control group, e.g., control group 30, 130. Wound interface (e.g., wound interface 1)5,115, 215, 315, 415) (e.g., enclosed space 17, 117, 217, 317, 417) ₀ The actual pressure p within the enclosed space of the wound interface may vary with respect to time t according to a pressure cycle (e.g., exemplary pressure cycles 500, 550, 600, 650, 700, 750, 800, 850, 900, 950 (see fig. 9A, 9B, 9C, 9D, 9E, 9F, 9G, 9H, 9I, 9J, respectively), with respect to time t _a Can be matched with the target pressure p ₀ Agree so as to reach p _a ≈p ₀ . In certain embodiments, the input fluid may be a gas, such as gas 22, 125, or a liquid, such as liquid 24. The output fluid may include exudates, such as exudates 19, 152, 252, 352, 452, and any residual gas or liquid from previous pressure cycles, or any combination thereof.

Fig. 9A, 9B, 9C, 9D, 9E, 9F, 9G, 9H, 9I, 9J illustrate exemplary pressure cycles 500, 550, 600, 650, 700, 750, 800, 850, 900, 950, respectively, wherein a target pressure p within the enclosed space of the wound interface ₀ Plotted as a function of time t. Although according to the target pressure p ₀ Pressure cycle 500, 550, 600, 650, 700, 750, 800, 850, 900, 950 is described, but the actual pressure p _a Substantially corresponding to a target pressure p in the enclosed space ₀ Such that the pressure cycle 500, 550, 600, 650, 700, 750, 800, 850, 900, 950 can be described as the actual pressure p in the enclosed space _a The reaction of (3). In some embodiments, the input fluid has a higher O than atmospheric air ₂ Concentration, therefore in certain embodiments, the wound bed is exposed to O throughout the pressure cycle ₂ A fluid at a concentration greater than atmospheric air, which may increase the supply of oxygen to the wound bed during treatment, resulting in therapeutic benefits. Applying multiple O's to a wound bed ₂ The pressure circulation of the air with concentration higher than the atmospheric air can increase the O content of the wound bed ₂ Exposure time, and thus, increased oxygen therapy time provided to the wound bed. It should be noted that the pressure cycles 500, 550, 600, 650, 700, 750, 800, 850, 900, 950 are exemplary only and not limiting, and in certain embodiments, these are exemplaryOne or more of these exemplary pressure cycles, various combinations of these exemplary pressure cycles, or other pressure cycles, may be provided to the wound bed within the enclosed space under the control of control group 130.

In certain embodiments, the control group includes a controller, such as controller 87, 165, and the pressure cycle includes a period, an amplitude, and other characteristics of the pressure cycle based on data (e.g., data 74) that data from a user via a user I/O (e.g., I/O86, 145) may communicate with the controller. Thus, a user may use the user I/O to select a pressure cycle, a series of pressure cycles, and characteristics, such as the amplitude and period of the pressure cycles, to deliver to the wound bed within the enclosed space. The controller may store preprogrammed pressure cycles in memory, which may include other programs or data in memory to determine the data to implement the pressure cycles, by using pumps, such as pumps 89, 168, valves, such as valves 88, 172, 173, 174, and pressure sensors, such as pressure sensors 91, 176, 178, which may be included in the control group.

As shown in FIG. 9A, the pressure cycle 500 is at time t ₀ At the beginning, pressure p ₀ ＝p _max . It should be noted that throughout the pressure cycle 500, the actual pressure p in the enclosed space is controlled by the control group _a May be substantially equal to the target pressure p ₀ (i.e. p) _a ≈p ₀ ). According to an exemplary pressure cycle 500, pressure p ₀ From time t ₀ To time t ₁ At a rate S ₁ Linearly decreasing, then the pressure p ₀ At time t ₁ And time t ₂ At a rate S ₂ Linear decrease at time t ₂ When it reaches p _min . Then pressure p ₀ At time t ₂ And time t ₃ Is maintained at p _min . As shown, then the pressure p ₀ At time t ₃ And time t ₄ At a rate S ₃ From p _min Linear increase to p _max . At time t ₃ And time t ₄ In the closed space, a fluid is introduced to bring the pressure p ₀ From p _min Increase to p _max The fluid may have a greater O than atmospheric air ₂ And (4) concentration. Thus, during the continuous pressure cycle 500, when O is passed ₂ A fluid at a concentration greater than atmospheric air so that the wound bed may be exposed to O as the pressure increases in each such pressure cycle ₂ A concentration greater than atmospheric air. Thus, in this embodiment, at time t ₃ And time t ₄ Pressure p between _max The wound bed may be exposed to O ₂ In an environment with a concentration greater than atmospheric air.

By directing the output fluid out of the enclosed space without any input fluid entering the enclosed space, the control group can be controlled at time t ₀ And t ₂ Between the actual pressure p _a . Similarly, by introducing the input fluid into the enclosed space while no fluid is being directed out of the enclosed space, the control group can control the flow rate at time t ₃ And t ₄ Increase the actual pressure p therebetween _a . Finally, in certain embodiments of the pressure cycle 500, at time t ₂ And t ₃ In between, no input fluid is introduced into the enclosed space, while no output fluid is directed out of the enclosed space. In certain embodiments of the pressure cycle 500, at time t ₂ And t ₃ Substantially no fluid is introduced into the enclosed space and substantially no fluid (other than exudate) is removed from the enclosed space. A controller, such as controller 480 of wound treatment apparatus 400, may control the output fluid at time t ₀ And t ₂ And the input fluid is led out at time t ₃ And t ₄ In the process of introducing.

In pressure cycle 500, for example, p _max ≈p _amb ，p _min ＝p _amb -85mm Hg. Time period t ₂ -t ₀ May be about 40s, pressure p ₀ Then kept at p _min t ₃ -t ₂ 240s followed by a period t ₄ -t ₃ 80s, so that the time period of the pressure cycle 500 is t ₄ -t ₀ 360s (6 minutes or 10 pressure cycles per hour). A variety of other implementations may be provided in accordance with the exemplary pressure cycle 500 approachFor example, 12 pressure cycles per hour, 4 pressure cycles per hour, or 3 pressure cycles per hour. The slope S can be selected ₁ And S ₂ To avoid the production of pain, S ₂ Can be compared with S ₁ Small because of the pressure p ₀ Rapid decrease below p _max It can be painful. For example, over a time period t ₁ -t ₀ 10s, pressure p ₀ From p _amb Down to p _amb Can be generally painless at-40 mm Hg, and then again at a pressure time t ₂ -t ₁ 30s, applying pressure p ₀ From p _amb Reduction of-40 mm Hg to p _amb At-85 mm Hg, pain can be minimized. It should be noted that the pressure cycle 500 may be asymmetric, at time period t ₃ -t ₀ Greater than a time period t ₄ -t ₃ 。

In various other embodiments, the pressure p ₀ May be at time t ₀ And time t ₂ At a single constant rate (i.e., S) ₁ ＝S ₂ ) Or the pressure p ₀ May be at time t ₀ And time t ₂ At three or more rates. The pressure cycle 500 may be at time t ₄ Start to repeat (i.e. time t) ₄ Is set to time t ₀ ) Or then some other pressure cycle, such as pressure cycles 550, 600, 650, 700, 750, 800, 850, 900, 950, may be taken from time t ₄ The start-up is started. The pressure cycle 500 may remain substantially constant over successive cycles, or various parameters of the pressure cycle 500 may be varied over successive cycles, such as p _max ，p _min ，S ₁ ，S ₂ ，t ₃ -t ₂ ，t ₄ -t ₀ . The control group can determine various parameters of the pressure cycle 500, such as p, by communicating data with the user I/O into which the data is entered by the user _max ，p _min ，S ₁ ，S ₂ ，t ₃ -t ₂ ，t ₄ -t ₀ 。

Fig. 9B illustrates an exemplary pressure cycle 550. It should be noted that, throughout the pressure cycle, the pressure is measured byActual pressure p in the enclosed space controlled by the control group _a May be substantially equal to the target pressure p ₀ (i.e. p) _a ≈p ₀ ). As shown in FIG. 9B, the pressure cycle 550 is at time t ₁₀ At the beginning, pressure p ₀ ＝p _min . Target pressure p ₀ From time t ₁₀ To time t ₁₁ At a rate S ₁₁ Linearly increasing, at time t ₁₁ To reach p _max . As shown, the target pressure p ₀ Then at time t ₁₁ And time t ₁₂ Is maintained at p _max Then target pressure p ₀ At time t ₁₂ And time t ₁₃ At a rate S ₁₂ From p to p _max To p _min The linearity decreases. At time t ₁₀ And time t ₁₁ To increase the actual pressure p by introducing a fluid into the enclosed space _a From p to p _min Increase to p _max The input fluid may have a higher O than atmospheric air ₂ And (4) concentration. Thus, in exemplary pressure cycle 550, at time period t ₁₃ -t ₁₀ The wound bed may be greater than p _min Actual pressure p of _a Next, exposure to enhanced oxygen. In exemplary pressure cycle 550, at time period t ₁₂ -t ₁₁ Due to the fact that in general p _amb ≤p _max Thus, the wound bed may be at a pressure substantially greater than or equal to ambient pressure p _amb Actual pressure p of _a Next, exposure to enhanced oxygen.

By introducing the input fluid into the enclosed space without any output fluid being conducted out of the enclosed space, the actual pressure p in the enclosed space _a May be at time t ₁₀ And t ₁₁ Increases in between. Similarly, by directing output fluid out of the enclosed space without any input fluid being directed into the enclosed space, the actual pressure p within the enclosed space _a May be at time t ₁₂ And t ₁₃ Is reduced. The control group can control the input fluid at time t ₁₀ And t ₁₁ In between, and controlling the output fluid at time t ₁₂ And t ₁₃ Is derived from the other. Finally, in some implementations of pressure cycle 550In a manner that at time t ₁₁ And t ₁₂ In between, no input fluid is introduced into the enclosed space, while no output fluid is directed out of the enclosed space.

In the pressure cycle 550, for example, approximately, p _max ＝p _amb +40mm Hg，p _min ＝p _amb ,. Time period t ₁₁ -t ₁₀ May be about 40s and then about t ₁₂ -t ₁₁ 240s target pressure p ₀ Is maintained at p _max Following about time period t ₁₃ -t ₁₂ 80s, so that the time period of the pressure cycle 550 is t ₁₃ -t ₁₀ 360s (6 minutes or 10 pressure cycles per hour). In certain embodiments, the pressure p of the pressure cycle 550 _max May be limited by the ability of the adhesive (e.g., adhesive 190, 290, 390, 490) to secure the wound interface to a skin surface (e.g., skin surface 211, 311, 411) from pressure p _max The wound interface 15 is forced away from the skin surface.

The pressure cycle 550 may be at time t ₁₃ Start to repeat (i.e. time t) ₁₃ Is set to a time t ₁₀ ) Or then some other pressure cycle, such as pressure cycles 500, 600, 650, 700, 750, 800, 850, 900, 950, may be at time t ₁₃ The start-up is started. The pressure cycle 550 may remain substantially constant over successive cycles, or various parameters of the pressure cycle 550, such as p, may be varied over successive cycles _max ，p _min ，S ₁₁ ，S ₁₂ ，t ₁₁ -t ₁₀ ，t ₁₂ -t ₁₁ ，t ₁₃ -t ₁₂ 。

For example, in some embodiments, the control group may deliver several pressure cycles based on pressure cycle 550, and then deliver one pressure cycle based on pressure cycle 500, such that the actual pressure p _a At a pressure p above ambient _amb Next, enhanced oxygen (high pressure), and sub-ambient pressure p is delivered to the wound bed _amb To remove exudate from the wound bed or to change between resealing the wound interface to the skin surface. Generally, several minutes of pressurized topical oxygen may be beneficialE.g. about 40mmHg, which is well below MAP (mean arterial perfusion pressure). For example, the pressure cycles 500, 550 may be combined such that the time period t ₁₃ -t ₁₀ Is about 4 minutes, time period t ₄ -t ₀ About 2 minutes, hyperbaric oxygen therapy was delivered to the wound bed at a pressure cycle of about 2/3 (about 6 minutes), and negative pressure therapy was performed for a pressure cycle time of about 1/3. In this example, when the pressure cycles 500, 550 are so combined, the resulting pressure cycle is asymmetric, taking longer periods of time in delivering hyperbaric treatments and fewer periods of time in delivering negative pressure treatments.

Another exemplary pressure cycle 600 is illustrated in FIG. 9C, where the actual pressure p is over the pressure cycle 600 _a May be substantially equal to the target pressure p ₀ . In the exemplary pressure cycle 600, the target pressure p ₀ Decreases and increases in a sinusoidal manner (non-linear) as shown in fig. 9C, so that the actual pressure p _a Decreasing and increasing continuously in a sinusoidal manner. As shown in FIG. 9C, the pressure cycle 600 is at time t ₂₀ At the beginning, the target pressure p ₀ ＝p _max . In this embodiment, the target pressure p ₀ From time t ₂₀ To time t ₂₁ Internal decrease at time t ₂₁ To p is reached _min Target pressure p ₀ Then at time t ₂₁ And time t ₂₂ From p to p _min Rise to p _max Then pressure p ₀ At time t ₂₂ And time t ₂₃ From p to p _max Is reduced to p _min . As shown, in the exemplary pressure cycle 600, the target pressure p ₀ Continuously decreasing and increasing. Pressure cycle 600 may be repeated any number of times. The pressure cycle 600 may remain substantially constant over successive cycles, or various parameters of the pressure cycle 600, such as p _max ，p _min Or a time period t ₂₂ -t ₂₀ And may be changed in successive cycles. In certain embodiments, the target pressure p ₀ May increase sinusoidally and then remain at a constant p for a period of time _max Eventually decreasing in a sinusoidal manner.

Fig. 9D illustrates another exemplary pressure cycle 650. As shown in FIG. 9D, in the exemplary pressure cycle 650, the target pressure p ₀ Continuously decreasing and then increasing in the form of a triangular waveform, the actual pressure p throughout the pressure cycle 650 _a May be substantially equal to the target pressure p ₀ . As shown in FIG. 9D, the pressure cycle 650 at time t ₃₀ At the beginning, the target pressure p ₀ ≈p _max . In this embodiment, the target pressure p ₀ From time t ₃₀ To time t ₃₁ Linear decrease at time t ₃₁ To reach p _min Then target pressure p ₀ At time t ₃₁ And time t ₃₂ From p to p _min Linear increase to p _max Thereby completing one pressure cycle. The next pressure cycle starts at the target pressure p ₀ From time t ₃₂ To time t ₃₃ Linearly decrease at time t ₃₃ To p is reached _min . In the exemplary pressure cycle 650, the target pressure p ₀ Decreasing in a triangular waveform and then increasing continuously as shown. The pressure cycle 650 may be repeated any number of times. Increasing the actual pressure p by controlling the introduction of an input fluid _a To p _max The introduced fluid may contain O ₂ Greater than atmospheric air, this increased O ₂ Several consecutive deliveries may be made by successive waveforms, thereby continuously exposing the wound bed to an oxygen-rich environment.

Fig. 9E illustrates another exemplary pressure cycle 700. As shown in fig. 9E, the target pressure p ₀ At p _min And p _max Stepwise (pulsed) variation between, by control group, the actual pressure p in the enclosed space throughout the pressure cycle 700 _a Corresponding to the target pressure p ₀ But is changed. In the pressure cycle 700, the target pressure p ₀ From p _min Stepwise increase to p _max Any residual exudate may be blown out of the lumens connected to the enclosed space, such as lumens 245, 345, 347, 445, including fluid passageways communicating with the lumens to eliminate clogging due to solidification of the exudate including drugs and other potential clottingA solid substance.

A commonly encountered problem is that the concentrated protein exudate from the wound bed becomes increasingly concentrated, forming a plug that blocks the lumen, including the fluid pathways communicating with the lumen. When this occurs, not only does exudate cease to be discharged, but exudate clogging can also interfere with pressure sensing. This hinders treatment, and the entire wound interface may have to be replaced in advance (assuming that medical personnel can do so), resulting in increased costs and increased pain to the patient. To address this problem, in some embodiments, the pressure p may be suddenly or rapidly released at the end of the pressure cycle by infusing a bolus of gas or liquid _min Towards the ambient pressure p _amb To start. This can prevent clogging of the lines by exudate clogging or, if they do form, by pressure alone, or in combination with liquid dissolution, result in forced drainage of exudate clogs. The result may be elimination or prevention of lumen blockage and more accurate sensing and delivery of negative pressure therapy.

In some embodiments, the control group may deliver a pulsed input fluid to remove blockages from the lumen, including fluid pathways communicating with the lumen or enclosed space, according to the pressure cycle 700. This can maintain the patency of the drain tube, and can accurately detect the target pressure p in the closed space ₀ . The magnitude of this step can be created, for example, by a high fluid flow rate or by a highly elastic storage bladder interposed between the fluid source and the valve for regulating the flow delivered to the enclosed space. Maximum pressure p _max Should be less than the pressure that would break the fluid-tight nature of the wound interface. This depends on many factors, including the nature of the adhesive used to anchor the wound interface to the skin. Typically, such a pulsating maximum pressure p _max Can be higher than the ambient pressure p _amb About 30-40mm Hg high.

Another exemplary pressure cycle 750 is illustrated in fig. 9F. As shown in fig. 9F, the target pressure p ₀ From p to p _max Linear reduction to p _min Then target pressure p ₀ From p to p _min Exponentially (non-linearly) increasing to p _max . The actual pressure p during the entire pressure cycle 750 _a Is substantially equal to the target pressure p ₀ . In the exemplary pressure cycle 750, a fluid having an oxygen concentration greater than atmospheric air may be present at time t ₅₂ And t ₅₁ Is introduced to adjust the actual pressure p _a From p to p _min Increase to p _max Then actual pressure p _a At a time period t ₅₃ -t ₅₂ Is kept constant at p _max To be in a time period t ₅₃ -t ₅₂ At a pressure p _max Oxygen is delivered down the wound bed. Loop 750 at time t ₅₃ Repeat the beginning at time t ₅₃ And t ₅₄ Target pressure p ₀ From p _max To p _min Linearly decreasing, then, the target pressure p ₀ From p to p _min Increase to p in exponential form _max As shown in fig. 9F.

Fig. 9G illustrates another exemplary pressure cycle 800. The actual pressure p throughout the pressure cycle 800 _a May be substantially equal to the target pressure p ₀ Due to the control of the control group, the target pressure p ₀ From p _min To p _max And from p _max To p _min And (4) linearly changing. By controlling the group, at time t ₆₀ And t ₆₁ In between, a fluid having an oxygen concentration greater than atmospheric air may be introduced to bring the actual pressure p _a Increase to a maximum pressure p _max . In this exemplary pressure cycle, the target pressure p ₀ And the actual pressure p _a Thus during the time period t ₆₂ -t ₆₁ Is kept constant at p _max E.g. at pressure p _max Oxygen is delivered to the wound bed. In the exemplary pressure cycle 800, the target pressure p ₀ At a time period t ₆₄ -t ₆₃ Is internally kept constant at p _min For example to remove exudate from a wound bed.

Another exemplary pressure cycle 850 is illustrated in fig. 9H. The actual pressure p is over the entire pressure cycle 850 as controlled by the control group _a May be substantially equal to the target pressure p ₀ In the exemplary pressure cycle 850, the target pressure p ₀ From p to p _max Sinusoidally varying to p _min And from p _min Sinusoidal variation as p _max ,. At exemplary pressure cycle 850, target pressure p ₀ At a time period t ₇₂ -t ₇₁ Is maintained constant at p _min E.g. to drain exudate from a wound bed, and a target pressure p ₀ At a time period t ₇₄ -t ₇₃ Is kept constant at p _max E.g. at pressure p _max Oxygen is delivered to the wound bed.

In the exemplary pressure cycle 900, as shown in FIG. 9I, the target pressure p ₀ Continuously linearly decreasing and increasing in a zigzag fashion, the actual pressure p during the entire pressure cycle 900 _a May be substantially equal to the target pressure p ₀ . It is noted that in the exemplary pressure cycle 900, the maximum pressure p _max Greater than ambient pressure p _amb 。

In an exemplary pressure cycle 950, as shown in FIG. 9J, at time t ₉₀ Pressure p ₀ Initially p is _min . The control group is controlled at t by introducing an input flow of liquid into the enclosed space ₉₀ And t ₉₁ In the meantime, the actual pressure p _a From p _min Increase to p _max Actual pressure p _a With a target pressure p ₀ And (4) correspondingly. In this embodiment, the control group controls the input of liquid as the input fluid and the output of liquid as at least a portion of the output fluid. In this embodiment, the liquid, which constitutes at least a portion of the input fluid, may provide a variety of therapeutic benefits. The liquid may include, for example, saline solution, proteolytic enzyme solution, biofilm degrading solution, antibiotic lavage, amniotic fluid, platelet rich plasma, antibiotics, anesthetics, or other liquids having therapeutic benefit. In certain embodiments, at time t ₉₀ And t ₉₁ In between, 50cc or more of liquid may be introduced into the enclosed space. At time t ₉₁ And t ₉₂ In that an input fluid in liquid form is retained within the enclosed space to provide therapeutic benefits to the wound bed due to the actual pressure p _a With a target pressure p ₀ Correspondingly, at time t ₉₂ And t ₉₃ From p to p _max Reduced to p _min The liquid is then substantially directed out of the enclosed space, including from any pads, such as pads 250, 450 or dressings, such as dressing 350, within the enclosed space. In certain embodiments, the therapeutic benefit may include debridement.

At time t ₉₂ And t ₉₃ Target pressure p between ₀ The decrease in pressure may be marked as the beginning of a pressure cycle, such as pressure cycles 500, 550, 600, 650, 700, 750, 850, 900. In certain embodiments, at time t ₉₂ And t ₉₃ Of target pressure p ₀ From p _max To p _min Can remove 90% or more of the liquid from the enclosed space, including from any dressing, pad or layer in the enclosed space, such as layers 460, 470, 480 disposed therein. Liquid under pressure p _max Time period t of lower part in closed space ₉₂ -t ₉₁ May be, for example, in the range of about 2 minutes to about 1 hour. Time period t of less than 1 hour ₉₂ -t ₉₁ Or a time period t of only a few minutes ₉₂ -t ₉₁ Maceration can be prevented, particularly when the skin surface is coated with an adhesive such as cyanoacrylate. In certain embodiments, at time t ₉₁ And t ₉₂ In between, no input fluid is introduced into the enclosed space, or output fluid is withdrawn from the enclosed space, i.e. at time t ₉₁ And t ₉₂ In between, no fluid passes through the enclosed space.

In other embodiments, the liquid may pass through the enclosed space as both the input fluid and the output fluid, i.e., at time t ₉₁ And t ₉₂ Meanwhile, liquid is led in and out simultaneously. The pressure cycle 950, for example, may be intermittently interposed between other pressure cycles, such as pressure cycles 500, 550, 600, 650, 700, 750, 800, 850, 900, or the pressure cycle 950 may be repeated several times in succession.

The wound treatment device may deliver a treatment protocol to the wound bed. The treatment regime may include an actual pressure p in the enclosed space _a With a target pressure p ₀ And correspondingly. The pressure cycle may be, for example, an exemplary pressure cycleAny of the rings 500, 550, 600, 650, 700, 750, 800, 850, 900, 950, the series of pressure cycles may include several consecutive pressure cycles.

Example I

Example I presents a series of pressure cycles used in an exemplary wound treatment protocol delivered to a wound bed by a wound treatment apparatus. Example I demonstrates exemplary applications of these exemplary wound treatment protocols to wound treatment of a wound bed.

In this example, a dressing, such as dressing 50, 250, may be omitted from the wound bed during at least a portion of the healing process. The absence of a dressing eliminates the need to change dressings, as well as the associated pain and disruption of the healing process due to tearing of granulation tissue, as well as the attendant costs of medical personnel and various consumables, and may allow visual inspection of the wound bed and surrounding skin through a transparent portion of the wound interface. Since no dressing is used in this embodiment, the wound therapy device can be used until complete healing of the wound bed is achieved. The absence of a dressing, except possibly during the initial exudation phase of the wound bed, may allow, for example, lavage of the wound bed and incubation of tissue stromal stem cells, proteolytic enzyme soaking, medical maggot debridement or skin grafting. The wound treatment apparatus may be used until complete healing of the wound bed is achieved.

In example I, N represents pressure therapy, according to an exemplary pressure cycle 500, at time t ₃ And t ₄ O is ₂ Is fed into the enclosed space to increase the pressure in the enclosed space to p _max . Note that in some pressure cycles, moisture may be added to the O ₂ Or other gases to prevent drying of the wound bed. O denotes pressure therapy, according to exemplary pressure cycle 550, at time t ₁₀ And t ₁₁ O is ₂ Is input into the enclosed space to increase the pressure in the enclosed space to p _max Wherein p is _max Greater than ambient pressure p in the example I pressure cycle 550 _amb 。

The treatment regimen was a combination of four pressure cycles (four therapies) as follows:

treatment regimen 1-N/N/N/N (4 consecutive N treatments)

Treatment regimen 2-N/N/N/O (three N treatments in succession followed by one O treatment)

Treatment regimen 3-N/O/N/O (N therapy alternating with O therapy)

Treatment regimen 4-N/O/O/O (one N therapy followed by three O therapies)

If the delivery time is 6 minutes per pressure cycle (O-therapy or N-therapy), for example, each treatment regimen is then delivered for 24 minutes, allowing 60 treatment regimens to be delivered per day. Generally, more N therapy may be used during the early stages of wound treatment, as exemplified in treatment protocol 1 and treatment protocol 2, in order to remove exudates, such as exudates 51, 151, 251, 351, 419, and improve circulation, relatively speaking. Once the exudation phase is over, the need for N therapy is diminished. At this point the treatment regimen can be switched to N/O/N/O as in exemplary treatment regimen 3, and finally O treatment will become the primary treatment. Occasional N-therapies may be inserted in a series of O-therapies, such as exemplary therapy regime 4, for re-securing the wound interface to the skin. Exemplary weeks of a guided treatment regimen may be:

day 1-2: treatment protocol 1

Day 3-4: treatment protocol 2

Day 5-6: treatment protocol 3

Day 7: treatment protocol 4

According to example I, all N-therapy treatment regimen 1 was used at the beginning of wound treatment, since there may be interstitial edema with large amounts of exudate. Negative pressure of treatment protocol 1 p ₀ Exudate may be directed away from the wound bed, and edema may be reduced by removing the exudate causing edema from the wound bed. Two days after treatment regimen 1, the wound treatment was changed from treatment regimen 1 to treatment regimen 2 with the insertion of O treatment in N treatment. In O therapy, at a pressure p ₀ In general, a pressure p greater than or equal to ambient is used _amb O of (a) ₂ Introducing O into ₂ Delivered to the wound bed, can help healing, and N therapy can continue throughExudate is drawn from the wound bed to treat the edema.

After two days of treatment regimen 2, the wound treatment changed from treatment regimen 2 to treatment regimen 3, with O and N treatments alternating and the wound continued to heal. In O therapy, the composition containing O is used ₂ The use of gases at concentrations greater than atmospheric air may aid healing, and continued N therapy may continue to treat edema by drawing exudate from the wound bed.

Finally, on day 7 of example I, the wound therapy changed from treatment regime 3 to treatment regime 4, which was primarily O-therapy, with one N therapy cycle in every four cycles. The negative pressure of N therapy can re-adhere the wound interface to the skin, thereby prolonging the fluid-tight time.

Based on the duration and magnitude of the O-therapy, there may be a possibility that the seal between the wound interface and the skin surface may be compromised or even broken. The loss of adhesive integrity, during subsequent suction cycles, allows inflow of external air, which may blow the wound tissue dry, detrimental to wound healing. To prevent this from happening, except that a suitable maximum pressure p is selected _max And beyond the duration, the use of at least a brief N therapy as the end of the O treatment sequence may allow the adhesive of the wound interface to be repositioned again and thus fixed to the skin surface again. The frequency ratio of such negative pressure cycles to positive pressure cycles may be 1: 1, 1: 2 or some other suitable ratio, depending on a number of parameters, including the duration and magnitude of the positive pressure cycles.

Once the wound interface fails to maintain a seal (typically due to skin peeling or adhesive failure), the wound interface may need to be replaced. Replacement was estimated to occur every 5 to 7 days, depending on the location of the wound bed and individual variability. It is noted that in any of treatment protocol 1, treatment protocol 2, treatment protocol 3, and treatment protocol 4, a pressure cycle, such as pressure cycle 950, may be included from time to provide treatment fluid to the wound bed. The liquid may be, for example, saline solution, proteolytic enzyme solution, biofilm degrading solution, antibiotic lavage solution, amniotic fluid, platelet rich plasma, antibiotics, anesthetics, or other liquids having therapeutic benefit.

Thus, in example I, the procedure is from the initial use of N therapy to treat edema, a mix of N therapy and O therapy, which can both treat edema and promote healing, and finally, as the wound bed heals and edema subsides, primarily O therapy to promote healing. For example, treatment regimen 4 may be used when the wound is at least half healed and there is no longer any significant exudate.

For the purpose of explanation, it is assumed in example 1 that the wound bed gradually heals between day 1 and day 7. Of course, healing may take a time other than one week, and, accordingly, a plurality of treatment protocols, such as treatment protocols 1, 2, 3 and 4, may last for different lengths of time, and may be appropriately combined according to the condition of the wound bed. In certain embodiments, treatment regimens 1, 2, 3, and 4 can be connected to each other, or to other treatment regimens, in a variety of ways. In certain embodiments, a treatment regimen, such as treatment regimens 1, 2, 3, 4, can have other modes of pressure cycling, such as O/O/O/O/. In certain embodiments, the treatment protocol may have different numbers and types of cycles, such as pressure cycles 500, 550, 600, 650, 700, 750, 800, 850, 900, 950.

****

The wound treatment device can deliver a liquid, which can have a variety of therapeutic purposes, into the enclosed space of the wound interface, guided by a control group that includes a controller. The operation of the wound therapy device may include: a liquid from a liquid source, such as liquid source 84, is selected as the input fluid. The operation of the wound therapy device may include: the introduction of input fluid into, or the removal of output fluid from, the enclosed space of the wound interface is controlled in a manner suitable for therapeutic purposes by use of a control group. For example, a liquid may be introduced into the enclosed space as an input fluid and then withdrawn from the enclosed space as an output fluid to irrigate the wound bed to remove bacterial infection or to wet the wound bed. As another example, when the liquid has healing or antiseptic properties, the liquid as an input fluid may be introduced into the enclosed space and allowed to remain within the enclosed space. As another example, a liquid as an input fluid may be introduced into the enclosed space and directed out of the enclosed space as an output fluid to flush various fluid pathways in communication with the input fluid or the output fluid. Using user I/O, a user can select to direct fluid into or out of the enclosed space through data communicated to the controller. Using the user I/O, the user may select the input of liquid or gas through data communicated with the control group 65.

Fig. 10 illustrates, via a flow chart, another exemplary method of using a wound therapy device. The method of operation 2000 as shown in fig. 10 and the associated description are merely exemplary. As shown in fig. 10, the method of operation 2000 begins at step 2001. In step 2002, the wound interface of the wound treatment device is secured to the skin surface, forming an enclosed space above the wound bed. In step 2003, the output fluid is directed from the enclosed space, thereby reducing the pressure p in the enclosed space ₀ Up to p ₀ Equal to the minimum pressure p _min .. According to step 2004, the pressure p in the enclosed space ₀ Can then be maintained at a minimum pressure p _min Duration T ₁ . For example, the time period T ₁ And may be about 3 to 5 minutes. In step 2005, an input fluid is introduced into the enclosed space, thereby bringing about a pressure p ₀ From the minimum pressure p _min Increase to a maximum pressure p _max . Input into the enclosed space in exemplary step 2005, pressure p is applied ₀ From the minimum pressure p _min Increase to a maximum pressure p _max Comprising an input fluid having a ratio O ₂ A gas having a concentration greater than atmospheric air.

In step 2006, in certain embodiments, the maximum pressure p _max May be about equal to ambient pressure p _amb Maximum pressure p _max May be greater than ambient pressure p _amb Or maximum pressure p _max May be less than ambient pressure p _amb . According to an exemplary step 2006, the pressure p in the enclosed space ₀ May then be in the time period T ₂ Maintaining a maximum pressure p _max . For example, the time period T ₂ Can be about 1-3 minutes。

As shown in FIG. 10, in step 2007, output fluid is directed from the enclosed space to reduce the pressure p in the enclosed space ₀ Up to p ₀ Equal to the minimum pressure p _min . According to step 2008, the pressure p in the enclosed space ₀ Can then be maintained at a minimum pressure p _min Lower duration T ₃ . In exemplary method of operation 2000, since in step 2005 the fluid input into the enclosed space contains O ₂ Gas at a concentration greater than atmospheric air, the wound bed is exposed to O throughout steps 2006, 2007 and 2008 ₂ A gas with a concentration greater than atmospheric air.

In step 2009, an input fluid is introduced into the enclosed space to establish a pressure p ₀ From the minimum pressure p _min Increase to a maximum pressure p _max . In the exemplary method of operation 2000, the input fluid in step 2009 comprises a liquid.

In exemplary method of operation 2000, in performing steps 2003, 2004, 2005, 2006, 2007, 2008 and 2009, the output fluid is directed out of the enclosed space and the input fluid is directed into the enclosed space in sequence such that either the input fluid is being input or the output fluid is being directed out, whichever is the case. In performing steps 2003, 2004, 2005, 2006, 2007, 2008, and 2009 of exemplary method of operation 2000, the input fluid introduction and the output fluid introduction are not performed simultaneously.

In step 2010, for a time period T ₄ The liquid passes through the enclosed space. In step 2010, the liquids may be sequentially introduced into the enclosed space and then removed from the enclosed space, or the liquids may be simultaneously introduced into and removed from the enclosed space. In step 2010, liquid may be pulsed to clear a variety of blockages in the channels in fluid communication with the enclosed space. In step 2010, for example, the liquid may irrigate the enclosed space containing the wound bed and dressing, remove bacterial infection or exudate, clean the wound bed, wet the wound bed. At step 2010, liquid may be introduced and removed by perfusion (steady flow). The control group can limit the actual liquid in the closed spacePressure p _a E.g. approximately equal to ambient pressure p _amb To prevent movement of the wound interface. For example, the actual pressure p of the liquid in the enclosed space, detected by a pressure sensor _a Is substantially equal to ambient pressure p _amb In this case, the control group can reduce or stop the introduction of liquid into the enclosed space.

The exemplary method of operation 2000 then terminates at step 2011. Exemplary method 2000 may be repeated any number of times using various combinations of steps 2003, 2004, 2005, 2006, 2007, 2008, 2009, 2010. It is to be noted that the minimum pressure p _min And maximum pressure p _max May be performed at step 2003, 2004, 2005, 2006, 2007, 2008, 2009, 2010 and time T, T ₂ ，T ₃ ，T ₄ And a minimum pressure p _min And maximum pressure p _max May be changed during various iterations of method 2000.

A method of wound treatment may comprise the steps of: the wound interface is connected to the skin surface surrounding the wound bed, thereby forming an enclosed space above the wound bed. The method of wound treatment may comprise the steps of: fluid communication is established between the wound interface, control group, liquid source and gas source. A method of wound treatment may comprise the steps of: the control group is used for controlling the operation of the controller to sequentially regulate the input fluid to be led into the closed space and the output fluid to be led out of the closed space, so as to change the actual pressure p in the closed space _a With a target pressure p ₀ Correspondingly, the pressure cycle has a minimum pressure p _min And a maximum pressure p _max The input fluid comprising an O having a higher level than atmospheric air ₂ A concentration of gas.

The method of wound treatment may comprise the steps of: exudate is removed from the output fluid by flowing the output fluid through a container, such as containers 81, 150.

A method of wound treatment may comprise the steps of: the data is received using an I/O interface in operable communication with the controller and transmitted to the controller to change the pressure cycle or change the input fluid between liquid and gas.

Wound healing deviceThe method of treatment may comprise the steps of: delivering a treatment protocol to the wound bed, the treatment protocol comprising an actual pressure p within the enclosed space _a A series of pressure cycles.

A method of wound treatment may comprise the steps of: delivering a treatment protocol to the wound bed, the treatment protocol comprising inputting a liquid into the enclosed space, and may include exporting the liquid from the enclosed space.

The method of wound treatment may comprise the steps of: programmed to deliver a plurality of gases and liquids to the wound bed under the control of a controller

The method of wound treatment may comprise the steps of: when other gases and liquids are not available, air is delivered to the enclosed space. The method of wound treatment may comprise the steps of: in the event of a power failure of the wound therapy device, gas is delivered to the enclosed space to create a pressure p equal to the ambient pressure within the enclosed space _amb Actual pressure p of _a 。

The foregoing discussion, in conjunction with the accompanying drawings, discloses and describes various exemplary embodiments. These embodiments are not meant to limit the scope of coverage, but rather, to facilitate an understanding of the language used in the specification and claims. Upon studying the disclosure and the exemplary implementations herein, one of ordinary skill in the art will readily recognize various changes, modifications and variations, which may be made without departing from the spirit and scope of the invention as defined in the following claims.

Claims (29)

1. A wound treatment apparatus comprising:

a wound interface that forms a fluid-tight enclosed space over a wound bed when secured to a skin surface surrounding the wound bed; and

a control group cooperating with the wound interface for regulating the introduction of an input fluid into the enclosed space and for regulating the discharge of an output fluid from the enclosed space to be at substantially a minimum pressure p _min And maximum pressure p _max Of the actual pressure p in the enclosed space is varied _a And changing at a minimum pressureForce p _min And maximum pressure p _max Actual pressure p between _a So that it substantially continuously coincides with a target pressure specified continuously over time, said input fluid comprising O therein ₂ A gas having a concentration greater than atmospheric air; and is provided with

Wherein the minimum pressure p _min Less than ambient pressure p _amb The maximum pressure p _max Greater than ambient pressure p _amb And the target pressure is a minimum pressure p within the pressure cycle _min And maximum pressure p _max Continuously changing therebetween.

2. The device of claim 1, wherein there is O ₂ The gas at a concentration greater than atmospheric air further comprises humidity.

3. The apparatus of claim 1, wherein at least a portion of the output fluid is vented to atmosphere through the control group.

4. The device of claim 3, wherein when the actual pressure p in the enclosed space is _a Exceeding the maximum pressure p _max The control group vents the gaseous portion of the output fluid to atmosphere.

5. The device according to claim 1, wherein the control group comprises a pressure sensor to detect the actual pressure p within the enclosed space _a 。

6. The device according to claim 1, wherein the control group comprises a pressure sensor detecting the actual pressure p in the enclosed space during the introduction of the input fluid, and a second pressure sensor _a (ii) a The second pressure sensor detects the actual pressure p in the enclosed space during the output fluid is being conducted out _a 。

7. The device of claim 1, wherein the input fluid further comprises a liquid that is directed into the enclosed space while being directed out of the enclosed space.

8. The device of claim 1, wherein the input fluid further comprises a liquid that is sequentially introduced into and withdrawn from the enclosed space.

9. The device of claim 1, wherein fluid is introduced into the enclosed space in pulses to remove exudate from a lumen in fluid communication with the enclosed space.

10. The apparatus of claim 1, further comprising:

an I/O interface for receiving data from a user to at least partially control the introduction of an input fluid into the enclosed space or to at least partially control the removal of an output fluid from the enclosed space.

11. The device of claim 1, wherein the introduction of the fluid and the removal of the fluid occur sequentially.

12. The device of claim 1, further comprising: a treatment protocol delivered by the wound therapy device, the treatment protocol comprising a number of pressure cycles.

13. The apparatus of claim 1, further comprising:

said actual pressure p _a Greater than ambient pressure p for at least half of the time period of the pressure cycle _amb 。

14. The apparatus of claim 11, further comprising:

said actual pressure p _a Less than ambient pressure p for at least half of the time period of the pressure cycle _amb 。

15. The apparatus of claim 1, wherein the control group comprises:

a controller operatively connected to the pump and the one or more valves to regulate the introduction of the input fluid into the enclosed space and to regulate the removal of the output fluid from the enclosed space.

16. The apparatus of claim 1, further comprising:

a container removably connected with the control group to capture liquid including exudate from the output fluid.

17. A wound treatment apparatus comprising:

a wound interface that forms a fluid-tight enclosure over a wound bed when secured to a skin surface surrounding the wound bed; and

a control group cooperating with the wound interface for regulating the introduction of an input fluid into the enclosed space and for regulating the discharge of an output fluid from the enclosed space to be at substantially the minimum pressure p _min And a maximum pressure p _max Of the actual pressure p in the enclosed space is varied _a And said minimum pressure p _min Less than ambient pressure p _amb The maximum pressure p _max Greater than said minimum pressure p _min And varying the actual pressure p _a So that it is brought into contact with a target pressure p specified continuously over time ₀ Substantially continuously, said input fluid comprising O therein ₂ A gas having a concentration greater than atmospheric air; and is provided with

Wherein O is ₂ The input of a gas having a concentration greater than atmospheric air, and O ₂ The removal of gases with a concentration greater than atmospheric air is carried out sequentially.

18. A wound treatment apparatus comprising:

a wound interface that forms a fluid-tight enclosed space over a wound bed when secured to a skin surface surrounding the wound bed; and

a control group cooperating with the wound interface for regulating the introduction of an input fluid into the enclosed space and for regulating the discharge of an output fluid from the enclosed space to be at substantially the minimum pressure p _min And a maximum pressure p _max In the closed space, varying the actual pressure p in the closed space _a And said minimum pressure p _min Less than ambient pressure p _amb Said maximum pressure p _max Not greater than ambient pressure p _amb And varying the actual pressure p _a So that it is in contact with a target pressure p specified continuously over time ₀ Substantially continuously, said input fluid comprising O therein ₂ A gas having a concentration greater than atmospheric air; and is provided with

Wherein O is ₂ The input of a gas having a concentration greater than atmospheric air, and O ₂ The removal of gases with a concentration greater than atmospheric air is carried out sequentially.

19. The apparatus of claim 17 or 18, further comprising: removing exudate from the output fluid by flowing the output fluid through a container.

20. The apparatus of claim 17 or 18, further comprising:

a microprocessor, an I/O interface in operative communication with the microprocessor for receiving user input; the microprocessor receives the user input, thereby changing the pressure cycle.

21. The apparatus of claim 17 or 18, further comprising:

a treatment protocol delivered by the wound therapy device to the wound bed, the treatment protocol comprising the actual pressure p within the enclosed space _a Several pressure cycles.

22. The apparatus of claim 21, wherein the treatment protocol further comprises:

introducing a liquid into the enclosed space after the step of delivering a treatment regimen to the wound bed.

23. A wound treatment apparatus comprising:

a wound interface connectable with a skin surface surrounding a wound bed to form an enclosed space over the wound bed, the enclosed space being fluid-tight;

an actuation group cooperating with the liquid source, the gas source, and the enclosed space to selectively direct input fluid into the enclosed space and output fluid out of the enclosed space to be at substantially the minimum pressure p _min And a maximum pressure p _max Of the actual pressure p in the enclosed space is varied _a And changing at a minimum pressure p _min And maximum pressure p _max Actual pressure p between _a So that it substantially continuously coincides with a target pressure that is continuously specified over time, the input fluid comprising a liquid and a gas; and is provided with

Wherein the minimum pressure p _min Less than ambient pressure p _amb Said maximum pressure p _max Greater than ambient pressure p _amb And the target pressure is within the pressure cycle at a minimum pressure p _min And maximum pressure p _max Continuously changing between them.

24. A wound treatment apparatus comprising:

a wound interface connectable with a skin surface surrounding a wound bed to form an enclosed space over the wound bed, the enclosed space being fluid-tight;

a control group cooperating with the liquid source, the gas source and the enclosed space to selectively direct input fluid into the enclosed space and output fluid out of the enclosed space to be at substantially a minimum pressure p _min And maximum pressure p _max Of the actual pressure p in the enclosed space is varied _a And the change is at the mostSmall pressure p _min And maximum pressure p _max Actual pressure p between _a So as to be substantially continuously coincident with a target pressure that is continuously specified over time, the input fluid comprising a liquid and a gas; and is provided with

Wherein the minimum pressure p _min Less than ambient pressure p _amb The maximum pressure p _max Greater than said minimum pressure p _min And not greater than ambient pressure p _amb And the target pressure is a minimum pressure p within the pressure cycle _min And maximum pressure p _max Continuously changing therebetween.

25. Apparatus according to claim 23 or 24, wherein the introduction of the gas and the removal of the gas are sequential to substantially vary the actual pressure p in the enclosed space _a So that it substantially continuously coincides with the target pressure.

26. The apparatus of claim 23 or 24, wherein the introduction of the liquid and the removal of the liquid are performed simultaneously to irrigate the wound bed.

27. The device of claim 23 or 24, further comprising: a treatment protocol delivered to the wound bed by the wound therapy device, the treatment protocol comprising a number of pressure cycles.

28. The apparatus of claim 23 or 24, further comprising:

a container in fluid communication with the output fluid to capture liquid including exudate from the output fluid.

29. The apparatus of claim 23 or 24, further comprising:

an atmosphere operatively connected to the control group, the control group selectively selecting an input liquid, gas, and gas from the atmosphere to enter the wound interface.

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