Deeply extendable dressing with transparency capabilities

Abstract

An exemplary device for treating a tissue site with negative pressure can include a primary manifold configured to move between a retracted state and an extended state. The primary manifold can include a top surface and a bottom surface positioned opposite the top surface and configured to face the tissue site. Further, the primary manifold can include a pleat positioned proximate an extension zone configured to extend outward from the bottom surface of the primary manifold toward the tissue site when the primary manifold is in the extended state. Other devices, dressings, systems, and methods are also disclosed.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Application 63 / 122,341, filed December 7, 2020, the full text of which is incorporated herein by reference. Technical Field

[0003] The invention as set forth in the appended claims relates generally to tissue treatment systems, and more specifically, but not in a limiting way, to dressings for tissue treatment and methods of performing tissue treatment using negative pressure. Background Technology

[0004] Clinical research and practice have shown that reducing pressure near tissue sites can enhance and accelerate the growth of new tissue at those sites. This phenomenon has numerous applications, but it has proven particularly beneficial for wound management. Regardless of the cause of the wound—whether trauma, surgery, or other reasons—proper wound care is crucial for outcome. Treating wounds or other tissues with reduced pressure is generally referred to as "negative pressure therapy," but it is also known by other names, including "negative pressure wound therapy," "reduced pressure treatment," "vacuum therapy," "vacuum-assisted closure," and "local negative pressure." Negative pressure therapy offers numerous benefits, including the migration of epithelial and subcutaneous tissues, improved blood flow, and microdeformation of tissues at the wound site. These benefits can work together to increase granulation tissue development and reduce healing time.

[0005] It is also widely recognized that cleaning tissue sites is highly beneficial for new tissue growth. For example, for therapeutic purposes, wounds or cavities can be cleaned with liquid solutions. These practices are generally referred to as “irrigation” and “drenching,” respectively. “Infusion” is another practice, which typically refers to the slow introduction of fluid into the tissue site and the retention of the fluid for a specified period of time before removal. For example, infusing a local therapeutic solution into a wound can be combined with negative pressure therapy to further promote wound healing by loosening soluble contaminants and removing infectious material from the wound surface. Thus, the soluble bacterial load is reduced, contaminants are removed, and the wound is cleaned.

[0006] While the clinical benefits of negative pressure therapy and / or infusion therapy are well-known, improvements to treatment systems, components, and processes could benefit both healthcare providers and patients. Summary of the Invention

[0007] The appended claims set forth novel and useful systems, apparatuses, and methods for treating tissues in a negative pressure therapeutic environment. Exemplary embodiments are also provided to enable those skilled in the art to make and use the claimed subject matter.

[0008] In some implementations, dressings characterized by reduced tensile strength, increased flexural strength, and / or improved conformability relative to the tissue site can be advantageously used to provide negative pressure therapy. For example, the increased flexural strength and / or improved conformability of the dressing can provide better contact between the tissue site and the tissue-facing surface of the dressing. This improved contact between the dressing and the tissue site can have the effect of inducing microstrain at substantially all tissue sites, thereby subjecting cells at the tissue site to strain and thus improving the outcome of negative pressure therapy.

[0009] In some exemplary embodiments, an apparatus for treating a tissue site using negative pressure may include a main manifold configured to move between a retracted state and an extended state. The main manifold may include a top surface and a bottom surface, the bottom surface being positioned opposite the top surface and configured to face the tissue site. In some exemplary embodiments, the main manifold may include folds positioned adjacent to an extended region. The extended region may be configured to extend outward from the bottom surface of the main manifold toward the tissue site when the main manifold is in the extended state. For example, in some embodiments, the bottom surface of the main manifold may be configured to form a convex shape conforming to the tissue site when the main manifold is in the extended state. Furthermore, in some embodiments, the folds may include folds or undulations located in the main manifold, the folds or undulations being configured to allow multiple portions of the main manifold to move away from each other as the main manifold moves from the retracted state to the extended state.

[0010] Furthermore, in some exemplary embodiments, a system for treating a tissue site using negative pressure may include the device, which includes the main manifold. The system may also include a cover configured to be positioned over at least a portion of the device and the main manifold. The cover may be configured to seal against tissue adjacent to the tissue site to form a sealed space. The system may also include a negative pressure source configured to provide negative pressure to the sealed space.

[0011] Furthermore, in some exemplary embodiments, a method of treating a tissue site using negative pressure may include positioning the device including the main manifold close to the tissue site; applying negative pressure to a sealed space at the tissue site including the device and the main manifold; and moving the main manifold to the extended state by operating the negative pressure, wherein the bottom surface of the main manifold is configured to form a convex shape consistent with the tissue site when the main manifold is in the extended state.

[0012] Furthermore, in some exemplary embodiments, a method of treating a tissue site using negative pressure may include positioning the device including the main manifold close to the tissue site; applying negative pressure to a sealed space at the tissue site including the device and the main manifold; and extending one or more extension areas outward from the bottom surface of the main manifold toward the tissue site.

[0013] In some exemplary embodiments, a method of treating a tissue site according to the present disclosure may include viewing the tissue site through one or more openings provided through the main manifold. Alternatively or additionally, some exemplary methods for treating a tissue site according to the present disclosure may include viewing the tissue site through a transparent material forming at least a portion of the main manifold.

[0014] The objectives, advantages, and preferred modes of making and using the subject matter protected by the claims can be best understood by referring to the accompanying drawings in conjunction with the following detailed description of exemplary embodiments. Attached Figure Description

[0015] Figure 1 This is a block diagram of an exemplary embodiment of a treatment system that can provide negative pressure therapy and infusion therapy according to this specification;

[0016] Figure 2 This is an exploded diagram of an exemplary implementation of an organizational interface, illustrating how it can be used with... Figure 1 Additional details related to some implementation schemes of the treatment system;

[0017] Figure 3 yes Figure 2 An isometric view of an assembly example of the organization interface;

[0018] Figure 4 It was captured at point 4-4 online. Figure 3 A cross-sectional view of an exemplary organizational interface;

[0019] Figure 5 The diagram can be compared with Figure 2 A bottom view of some implementation details associated with an exemplary organizational interface;

[0020] Figure 6 The diagram can be compared with Figure 2 A bottom view of some implementation details associated with an exemplary organizational interface;

[0021] Figure 7A This is a top view of an exemplary embodiment of the main manifold according to this specification;

[0022] Figure 7B yes Figure 7A Isometric partial views of some implementation schemes of the main manifold;

[0023] Figure 8A This is a top view of another exemplary embodiment of a main manifold according to this specification;

[0024] Figure 8B yes Figure 8A Isometric partial views of some implementation schemes of the main manifold;

[0025] Figure 9A This is a bottom view of another exemplary embodiment of a main manifold according to this specification;

[0026] Figure 9B yes Figure 9A Isometric partial views of some implementation schemes of the main manifold;

[0027] Figure 10A This is a bottom view of another exemplary embodiment of a main manifold according to this specification;

[0028] Figure 10B yes Figure 10A Isometric partial views of some implementation schemes of the main manifold;

[0029] Figure 11 It includes Figure 2 An exploded view of an exemplary embodiment of a dressing for an organizational interface, illustrating that it can be used with Figure 1 Additional details related to some implementation schemes of the treatment system;

[0030] Figure 12 yes Figure 11 An isometric view of an example of dressing assembly;

[0031] Figure 13 The sample taken at point 13-13 in this instruction manual is the tissue site to which the sample was applied. Figure 12 A cross-sectional view of an exemplary dressing, and illustrating its compatibility with... Figure 1 Additional details related to the treatment system;

[0032] Figure 14A Is Figure 13 label in Figure 14A The detailed image captured here illustrates what can be compared to... Figure 13 Additional details associated with some exemplary embodiments of the exemplary dressing;

[0033] Figure 14B The illustration shows that Figure 13 Some implementation schemes for dressings can be combined with Figure 14A Additional details associated with the detailed drawing;

[0034] Figure 15 It is based on this instruction manual. Figure 2An isometric view of an assembly example of the organization interface;

[0035] Figure 16 This is an isometric view of an exemplary embodiment of the main manifold according to this specification;

[0036] Figure 17 yes Figure 1 An exploded view of an example dressing, illustrating additional details that may be associated with some implementation schemes;

[0037] Figure 17A yes Figure 17 An isometric view of an example of dressing assembly;

[0038] Figure 18 It is already assembled. Figure 17 A top view of the dressing, illustrating details that may be associated with some implementation schemes;

[0039] Figure 19 It is already assembled. Figure 17 The bottom view of the dressing illustrates details that can be associated with some implementation schemes;

[0040] Figure 20 This is a schematic diagram illustrating an exemplary construction of a fluid channel that can be associated with some embodiments of a dressing according to this specification;

[0041] Figure 21 This is a schematic diagram of another exemplary construction of a fluid channel;

[0042] Figure 22 This is a schematic diagram of another exemplary construction of a fluid channel;

[0043] Figure 23 This is a schematic diagram of another exemplary construction of a fluid channel;

[0044] Figure 24 This is a schematic diagram of another exemplary construction of a fluid channel;

[0045] Figure 25 This is a schematic diagram of another exemplary construction of a fluid channel;

[0046] Figure 26 This is a schematic diagram of another exemplary construction of a fluid channel;

[0047] Figure 27 This is a schematic diagram of another exemplary construction of a fluid channel;

[0048] Figure 28 This is a schematic diagram of another exemplary construction of a fluid channel;

[0049] Figure 29This is a schematic diagram of another exemplary construction of a fluid channel;

[0050] Figure 30 This is a schematic diagram of another exemplary construction of a fluid channel;

[0051] Figure 31 This is a schematic diagram of another exemplary construction of a fluid channel;

[0052] Figure 32 The image taken at line 32-32 of this specification shows the application to an exemplary tissue site. Figure 17A A cross-sectional view of an exemplary dressing, and illustrated with... Figure 1 Additional details related to the treatment system;

[0053] Figure 32A Is Figure 32 label in Figure 32A The detailed image captured here illustrates what can be compared to... Figure 32 Details associated with some exemplary embodiments of the exemplary dressing;

[0054] Figure 32B The illustration shows that Figure 32 Some implementation schemes for dressings can be combined with Figure 32A Additional details associated with the detailed drawing;

[0055] Figure 33A This is a top plan view of another exemplary embodiment of the main manifold according to this specification;

[0056] Figure 33B yes Figure 33A An isometric view of an exemplary main manifold;

[0057] Figure 34A In such Figure 33A The section shown, intercepted at line 34A-34A, is in a retracted state. Figure 33A A cross-section of an exemplary main manifold;

[0058] Figure 34B It is depicted as shown in an extended state. Figure 34A The cross-section of the main manifold;

[0059] Figure 35A Is Figure 33A The exemplary fold shown in a retracted state, taken at line 35A-35A, can form including Figure 33A The main manifold and membrane device;

[0060] Figure 35B It includes those shown in an extended state. Figure 33A Exemplary wrinkles and membranes Figure 35AThe cross-section of the device;

[0061] Figure 36A This is another exemplary cross-section of a fold shown in a retracted state, which can be associated with some embodiments of the main manifold and devices including the main manifold and the membrane layer;

[0062] Figure 36B It is shown in the extended state of the film layer. Figure 36A The cross-section of an exemplary fold; and

[0063] Figure 37 This is in accordance with the instructions and includes applications to tissue sites. Figure 33A A cross-sectional view of an exemplary dressing for an exemplary main manifold, and illustrating the relationship with... Figure 1 Additional details related to the treatment system. Detailed Implementation

[0064] The following description of exemplary embodiments provides information that enables those skilled in the art to make and use the subject matter set forth in the appended claims, but certain details well known in the art may be omitted. Therefore, the following detailed description should be considered exemplary and not restrictive.

[0065] Figure 1 This is a block diagram of an exemplary embodiment of a treatment system 100 according to this specification, which provides negative pressure therapy by instilling a local treatment solution into a tissue site.

[0066] In this context, the term "tissue site" broadly refers to a wound, defect, or other therapeutic target located on or within a tissue, including but not limited to bone, adipose tissue, muscle tissue, nerve tissue, dermis, vascular tissue, connective tissue, cartilage, tendons, or ligaments. Wounds can include, for example, chronic wounds, acute wounds, traumatic wounds, subacute wounds, and dehiscences, partial skin burns, ulcers (such as diabetic ulcers, pressure ulcers, or venous insufficiency ulcers), flaps, and grafts. The term "tissue site" can also refer to an area of ​​any tissue that is not necessarily injured or defective, but rather an area where it may be desirable to add or promote the growth of additional tissue. For example, negative pressure can be applied to a tissue site to encourage the growth of additional tissue, which can then be harvested and transplanted.

[0067] Treatment system 100 may include a negative pressure source or negative pressure supply device such as negative pressure source 105, and one or more dispensing components. The dispensing components are preferably removable and may be disposable, reusable, or recyclable. Dressings (such as dressing 110) and fluid containers (such as container 115) are examples of dispensing components that may be associated with some examples of treatment system 100. Figure 1As shown in the examples, in some embodiments, dressing 110 may include tissue interface 120, cover 125, or both, or substantially consist of them.

[0068] A fluid conductor is another exemplary example of a dispensing component. In this context, "fluid conductor" broadly includes tubes, pipes, hoses, conduits, or other structures having one or more lumens or open paths suitable for conveying fluid between two ends. Typically, a tube is an elongated cylindrical structure with a degree of flexibility, but its geometry and stiffness can vary. Furthermore, some fluid conductors may be molded into other components or otherwise integrally combined with other components. Dispensing components may also include or contain interfaces or fluid ports to facilitate attachment and disengagement from other components. In some embodiments, for example, a dressing interface or connector may facilitate attachment of the fluid conductor to the dressing 110. For example, such a dressing interface may be SENSAT.RAC, available from Kinetic Concepts, Inc., San Antonio, Texas. TM pad.

[0069] The treatment system 100 may also include a regulator or controller, such as controller 130. Additionally, the treatment system 100 may include sensors to measure operating parameters and provide feedback signals indicative of these operating parameters to controller 130. Figure 1 As shown, for example, the treatment system 100 may include a first sensor 135 and a second sensor 140 connected to the controller 130.

[0070] The treatment system 100 may also include an infusion solution source. For example, the solution source 145 may be fluidly coupled to the dressing 110, such as... Figure 1 The exemplary embodiments are illustrated. In some embodiments, the solution source 145 may be fluidly coupled to a positive pressure source (such as positive pressure source 150), a negative pressure source (such as negative pressure source 105), or both. A regulator (such as an infusion regulator 155) may also be fluidly coupled to the solution source 145 and the dressing 110 to ensure an appropriate dose of the infusion solution (e.g., saline) to the tissue site. For example, the infusion regulator 155 may include a piston that may be pneumatically actuated by the negative pressure source 105 to draw the infusion solution from the solution source during a negative pressure interval and to infuse the solution into the dressing during a discharge interval. In addition or alternatively, a controller 130 may be coupled to the negative pressure source 105, the positive pressure source 150, or both to control the dose of the infusion solution to the tissue site. In some embodiments, the infusion regulator 155 may also be fluidly coupled to the negative pressure source 105 via the dressing 110, such as... Figure 1 As shown in the example.

[0071] Some components of the treatment system 100 may be housed within or combined with other components, such as sensors, processing units, alarm indicators, memory, databases, software, display devices, or further user interfaces that facilitate treatment. For example, in some embodiments, the negative pressure source 105 may be combined with the controller 130, the solution source 145, and other components to form a treatment unit.

[0072] Generally, components of the treatment system 100 can be directly or indirectly coupled. For example, a negative pressure source 105 can be directly coupled to a container 115 and indirectly coupled to a dressing 110 via the container 115. Couplings can include fluid couplings, mechanical couplings, thermal couplings, electrical couplings, or chemical couplings (such as chemical bonds), or in some cases, a combination of couplings. For example, the negative pressure source 105 can be electrically coupled to a controller 130 and fluidly coupled to one or more dispensing components to provide a fluid pathway to the tissue site. In some embodiments, components may also be coupled by means of physical proximity, integral integration with a single structure, or formation from the same material.

[0073] For example, a negative pressure supply device (such as negative pressure source 105) may be a reservoir of air under negative pressure, or it may be a manual or electric device, such as a vacuum pump, a suction pump, a wall suction port, or a micropump available in many healthcare facilities. "Negative pressure" or "reduced pressure" generally refers to a pressure less than the local ambient pressure, such as the ambient pressure in a local environment outside a sealed treatment environment. In many cases, the local ambient pressure may also be the atmospheric pressure at the tissue site. Alternatively, the pressure may be less than the hydrostatic pressure associated with the tissue at the tissue site. Unless otherwise specified, the pressure values ​​described herein are gauge pressures. A reference to an increase in negative pressure generally refers to a decrease in absolute pressure, while a decrease in negative pressure generally refers to an increase in absolute pressure. Although the amount and nature of the negative pressure provided by negative pressure source 105 may vary depending on the treatment requirements, the pressure is typically a low vacuum (often also referred to as a rough vacuum) between -5 mmHg (-667 Pa) and -500 mmHg (-66.7 kPa). Common treatment ranges are between -50 mmHg (-6.7 kPa) and -300 mmHg (-39.9 kPa).

[0074] Container 115 refers to a container, canister, pouch, or other storage component that can be used to manage exudates and other fluids aspirated from tissue sites. In many environments, rigid containers may be preferred or necessary for the collection, storage, and disposal of fluids. In other environments, fluids may be properly disposed of without rigid container storage devices, and reusable containers can reduce waste and costs associated with negative pressure therapy.

[0075] A controller (such as controller 130) may be a microprocessor or computer programmed to operate one or more components of the treatment system 100 (such as negative pressure source 105). In some embodiments, for example, controller 130 may be a microcontroller that typically includes an integrated circuit including a processor core and memory programmed to directly or indirectly control one or more operating parameters of the treatment system 100. Operating parameters may include, for example, power applied to negative pressure source 105, pressure generated by negative pressure source 105, or pressure distributed to tissue interface 120. Controller 130 is also preferably configured to receive one or more input signals (such as feedback signals) and is programmed to modify one or more operating parameters based on the input signals.

[0076] Sensors (such as first sensor 135 and second sensor 140) are generally known in the art as any device capable of operating to detect or measure a physical phenomenon or property, and typically provide a signal indicating the detected or measured phenomenon or property. For example, first sensor 135 and second sensor 140 may be configured to measure one or more operating parameters of the treatment system 100. In some embodiments, first sensor 135 may be a transducer configured to measure pressure in a pneumatic passage and convert the measurement into a signal indicating the measured pressure. In some embodiments, for example, first sensor 135 may be a piezoresistive strain gauge. In some embodiments, second sensor 140 may optionally measure operating parameters of the negative pressure source 105, such as voltage or current. Preferably, the signals from first sensor 135 and second sensor 140 are suitable as input signals to controller 130, but in some embodiments, some signal conditioning may be appropriate. For example, the signal may need to be filtered or amplified before it can be processed by controller 130. Typically, the signal is an electrical signal, but may be represented in other forms, such as an optical signal.

[0077] The tissue interface 120 is typically adapted to partially or completely contact the tissue site. In some embodiments, the tissue interface 120 may include or be substantially composed of a manifold. In this context, a manifold may include or be substantially composed of means for collecting or distributing fluid at the tissue interface 120 under pressure. For example, a manifold may be adapted to receive negative pressure from a source and distribute negative pressure at the tissue interface 120, which can have the effect of collecting fluid from the tissue site and drawing fluid toward the source. In some embodiments, the fluid path may be reversed or an auxiliary fluid path may be provided to facilitate the delivery of fluid, such as fluid from an infusion solution source, to the tissue site.

[0078] In some embodiments, the cover 125 provides a bacterial barrier and protection against physical trauma. The cover 125 may also be constructed of a material that reduces evaporation loss and provides a fluid seal between two components or two environments, such as between a treatment environment and a local external environment. The cover 125 may include, for example, an elastomeric membrane or film, or be composed of therein, which provides a seal sufficient to maintain negative pressure at the tissue site against a given negative pressure source. The cover 125 may be substantially light-transmitting or optically transparent. In some applications, the cover 125 may have a high moisture vapor transmission rate (MVTR). For example, in some embodiments, the MVTR may be at least 250 g / m² / 24h, a value measured using the upright cup technique at 38°C and 10% relative humidity (RH) according to the ASTM E96 / E96M positive cup method. In some embodiments, an MVTR of up to 5,000 g / m² / 24h provides effective breathability and mechanical properties.

[0079] Attachment devices can be used to attach cover 125 to an attachment surface, such as undamaged epidermis, a gasket, or another cover. Attachment devices can take many forms. For example, an attachment device can be a medically acceptable pressure-sensitive adhesive configured to bond cover 125 to the epidermis surrounding a tissue site. In some embodiments, for example, some or all of cover 125 may be coated with an adhesive, such as an acrylic adhesive, with a coating weight between 25 g / m² and 65 g / m². In exemplary embodiments, the adhesive may be substantially light-transmitting or optically transparent. In some embodiments, a thicker adhesive or combination of adhesives may be applied to improve sealing and reduce leakage. Exemplary embodiments of attachment devices may include double-sided tape, paste, aqueous colloid, hydrogel, silicone gel, or organic gel.

[0080] Solution source 145 may also refer to a container, canister, pouch, bag, or other storage component that can provide a solution for infusion therapy. The composition of the solution may vary depending on the prescribed therapy, but examples of some prescribed solutions include hypochlorite-based solutions, silver nitrate (0.5%), sulfur-based solutions, biguanide, cation solutions, and isotonic solutions.

[0081] During operation, the tissue interface 120 can be placed within, on, or otherwise close to the tissue site. For example, if the tissue site is a wound, the tissue interface 120 can partially or completely fill the wound, or it can be placed on top of the wound. A covering 125 can be placed on top of the tissue interface 120 and sealed to the attachment surface near the tissue site. For example, the covering 125 can be sealed to the undamaged epidermis surrounding the tissue site. Thus, the dressing 110 provides a sealed therapeutic environment close to the tissue site and substantially isolated from the external environment, and the negative pressure source 105 reduces the pressure within the sealed therapeutic environment.

[0082] The fluid dynamics of using a negative pressure source to reduce pressure in another component or location (such as within a sealed treatment environment) can be mathematically complex. However, the basic principles of fluid dynamics applicable to negative pressure therapy and infusion are generally well known to those skilled in the art, and the process of reducing pressure can be exemplarily described herein as, for example, “delivering,” “distributing,” or “generating” negative pressure.

[0083] Generally, exudates and other fluids flow towards lower pressure along the fluid path. Therefore, the term "downstream" typically means something relatively closer to a negative pressure source or further away from a positive pressure source within the fluid path. Conversely, the term "upstream" means something relatively further away from a negative pressure source or closer to a positive pressure source. Similarly, certain features can conveniently be described according to the fluid's "inlet" or "outlet" in this frame of reference. This orientation is generally assumed for the purpose of describing the various features and components described herein. However, in some applications, the fluid path may be reversed, such as by replacing the negative pressure source with a positive pressure source, and this descriptive convention should not be construed as restrictive.

[0084] The negative pressure applied to the tissue site by the tissue interface 120 within the sealed treatment environment can induce macro- and micro-strains within the tissue site. The negative pressure can also remove exudates and other fluids from the tissue site, which can be collected in container 115.

[0085] In some embodiments, controller 130 may receive and process data from one or more sensors, such as first sensor 135. Controller 130 may also control the operation of one or more components of treatment system 100 to manage pressure delivered to tissue interface 120. In some embodiments, controller 130 may include input for receiving a desired target pressure and may be programmed to process data associated with the setting and input of the target pressure to be applied to tissue interface 120. In some exemplary embodiments, the target pressure may be a fixed pressure value set by an operator as the desired negative pressure for treatment at the tissue site and then provided as input to controller 130. The target pressure may vary depending on the tissue site, based on the type of tissue forming the tissue site, the type of injury or wound (if any), the patient's medical condition, and the attending physician's preference. After selecting the desired target pressure, controller 130 may operate negative pressure source 105 in one or more control modes based on the target pressure and may receive feedback from one or more sensors to maintain the target pressure at tissue interface 120.

[0086] In some implementations, controller 130 may have a continuous pressure mode, wherein negative pressure source 105 is operated to provide a constant target negative pressure for the duration of treatment or until manual deactivation. Alternatively, controller 130 may have an intermittent pressure mode. For example, controller 130 may operate negative pressure source 105 to cycle between a target pressure and atmospheric pressure. For example, the target pressure may be set at a value of 135 mmHg for a specified duration (e.g., 5 minutes), followed by a specified deactivation duration (e.g., 2 minutes). This cycle can be repeated by activating negative pressure source 105, which may form a square wave pattern between the target pressure and atmospheric pressure.

[0087] In some exemplary embodiments, the increase in negative pressure from ambient pressure to the target pressure may not be instantaneous. For example, the negative pressure source 105 and dressing 110 may have an initial rise time. The initial rise time may vary depending on the type of dressing and treatment device used. For example, the initial rise time of one treatment system may be in the range of about 20 mmHg / s to 30 mmHg / s, and the initial rise time of another treatment system may be in the range of about 5 mmHg / s to 10 mmHg / s. If the treatment system 100 operates in intermittent mode, the repeated rise time may be a value substantially equal to the initial rise time.

[0088] In some exemplary dynamic pressure control modes, the target pressure may vary over time. For example, the target pressure may vary in the form of a triangular waveform, alternating between a negative pressure of 50 mmHg and 135 mmHg, with the rise time set at a rate of +25 mmHg / min and the fall time set at -25 mmHg / min. In other embodiments of the treatment system 100, the triangular waveform may vary between a negative pressure of 25 mmHg and 135 mmHg, with the rise time set at a rate of +30 mmHg / min and the fall time set at -30 mmHg / min.

[0089] In some embodiments, the controller 130 can dynamically control or determine a variable target pressure, which can vary between a maximum pressure value and a minimum pressure value, which can be set as inputs specified by the operator as the desired negative pressure range. The variable target pressure can also be processed and controlled by the controller 130, which can change the target pressure according to a predetermined waveform (such as a triangular waveform, a sine waveform, or a sawtooth waveform). In some embodiments, the waveform can be set by the operator to a predetermined or time-varying negative pressure required for treatment.

[0090] In some embodiments, controller 130 may receive and process data such as data relating to: the volume of the infusion solution prescribed by the clinician, the volume of fluid or solution to be infused into the tissue site (“fill volume”), and the prescribed amount of time the solution remains at the tissue site before negative pressure is applied (“residence time”). The fill volume may be, for example, between 10 mL and 500 mL, and the residence time may be between one second and 30 minutes. Controller 130 may also control the operation of one or more components of treatment system 100 to infuse the solution. For example, controller 130 may manage the dispensing of fluid from solution source 145 to tissue interface 120. In some embodiments, fluid may be infused into the tissue site by applying negative pressure from negative pressure source 105 to reduce the pressure at the tissue site, thereby aspirating the solution into tissue interface 120. In some embodiments, the solution may be infused into the tissue site by applying positive pressure from positive pressure source 150 to move the solution from solution source 145 to tissue interface 120. Alternatively, the solution source 145 may be raised to a height sufficient to allow gravity to move the solution into the tissue interface 120.

[0091] The controller 130 can also control the hydrodynamic characteristics of the infusion by providing a continuous or intermittent flow of the solution. Negative pressure can be applied to provide either a continuous or intermittent flow of the solution. The application of negative pressure can be implemented to provide a continuous pressure operating mode, thereby achieving a continuous flow rate of the infused solution through the tissue interface 120, or it can be implemented to provide a dynamic pressure operating mode, thereby varying the flow rate of the infused solution through the tissue interface 120. In intermittent mode, a specific fill volume and residence time can be provided based on, for example, the type of tissue site being treated and the type of dressing used. Negative pressure therapy can be applied after or during the solution infusion. The controller 130 can be used to select the operating mode and duration of negative pressure therapy before starting another infusion cycle.

[0092] Figure 2 yes Figure 1 An exploded view of an example of an organization interface 120 illustrates additional details that can be associated with some implementations in which the organization interface 120 includes more than one layer. Figure 2 In the example, tissue interface 120 includes a first polymer membrane or first membrane layer 205, a main manifold 210, and a second polymer membrane or second membrane layer 215. In some embodiments, the first membrane layer 205 may be disposed adjacent to the main manifold 210, and the second membrane layer 215 may be disposed opposite to the first membrane layer 205 adjacent to the main manifold 210. For example, the first membrane layer 205 and the main manifold 210 may be stacked such that the first membrane layer 205 contacts the main manifold 210. The second membrane layer 215 and the main manifold 210 may be stacked such that the second membrane layer 215 contacts the main manifold 210. In some embodiments, at least a portion of the first membrane layer 205 may be bonded to at least a portion of the second membrane layer 215. In an exemplary embodiment, at least a portion of the main manifold 210 may be bonded to at least a portion of at least one of the first membrane layer 205 and / or the second membrane layer 215.

[0093] The first membrane layer 205 may include a suitable structure for controlling or managing fluid flow. In some embodiments, the first membrane layer 205 may be a fluid control layer that may include a liquid-impermeable, vapor-permeable elastomeric material. In exemplary embodiments, the first membrane layer 205 may include a polymer membrane. For example, the first membrane layer 205 may include a polyolefin membrane, such as a polyurethane membrane. In exemplary embodiments, the first membrane layer 205 may be substantially light-transmitting or optically transparent. In some embodiments, the first membrane layer 205 may include the same material as the cover 125. In exemplary embodiments, the first membrane layer 205 may include a biocompatible polyurethane membrane tested and certified according to USP Class VI standards. In some embodiments, the first membrane layer 205 may also have a smooth or matte surface texture. Glossy or glossy surfaces of grade B3 or better according to SPI (Plastics Industry Association) standards may be particularly advantageous for some applications. In some embodiments, variations in surface height may be limited to acceptable tolerances. For example, the surface of the first membrane layer 205 may be a generally flat surface, where variations in height are limited to 0.2 mm per centimeter.

[0094] In some embodiments, the first membrane layer 205 may be hydrophobic. The hydrophobicity of the first membrane layer 205 may vary, but in some embodiments, it may have a contact angle with water of at least ninety degrees. In some embodiments, the first membrane layer 205 may have a contact angle with water of no more than 150 degrees. For example, in some embodiments, the contact angle of the first membrane layer 205 may be in the range of at least 90 degrees to about 120 degrees, or in the range of at least 120 degrees to 150 degrees. The water contact angle can be measured using any standard apparatus. While a manual goniometer can be used to visually approximate the contact angle, contact angle measuring instruments may generally include integrated systems involving a water platform, a liquid dropper (such as a syringe), a camera, and software designed to calculate the contact angle more accurately and precisely. Non-limiting examples of such integrated systems may include all commercially available from First Ten Angstroms, Inc., Portsmouth, VA. and The system, as well as the DTA25, DTA30, and DTA100 systems, are all commercially available from Kruss GmbH, Hamburg, Germany. Unless otherwise specified, the water contact angles described herein were measured using deionized and distilled water in air at 20°C to 25°C and 20% to 50% relative humidity for fixative droplets added from a height not exceeding 5 cm onto a horizontal sample surface. The contact angles described herein represent the average of 5 to 9 measurements, discarding the highest and lowest measurements. The hydrophobicity of the first film layer 205 can be further enhanced by hydrophobic coatings of other materials, such as silicone resins and fluorocarbons.

[0095] The first membrane layer 205 can also be adapted to be welded to other layers, including the main manifold 210 and the second membrane layer 215. For example, the first membrane layer 205 can be adapted to be welded to polymers such as polyurethane, polyurethane membranes, and polyurethane foams using thermal, radio frequency (RF) welding, or other methods such as ultrasonic welding. RF welding is particularly suitable for materials with higher polarity, such as polyurethane, polyamide, polyester, and acrylate. Sacrificial polar interfaces can be used to facilitate RF welding of membrane materials with lower polarity, such as polyethylene.

[0096] The areal density of the first membrane layer 205 may vary depending on the prescribed treatment or application. In some embodiments, an areal density of less than 40 g / m² may be suitable, and an areal density of about 20 g / m² to 30 g / m² may be particularly advantageous for some applications.

[0097] In some embodiments, for example, the first membrane layer 205 may comprise a hydrophobic polymer, such as a polyethylene membrane. The simple and inert structure of polyethylene provides a surface with minimal (if any) interaction with biological tissues and fluids, thus providing a surface that promotes free flow of liquids and low adhesion, which can be particularly advantageous for many applications. Other suitable polymer membranes include polyurethanes, acrylic resins, polyolefins (such as cyclic olefin copolymers), polyacetates, polyamides, polyesters, copolyesters, PEBAX block copolymers, thermoplastic elastomers, thermoplastic vulcanizates, polyethers, polyvinyl alcohol, polypropylene, polymethylpentene, polycarbonate, styrene resins, silicones, fluoropolymers, and acetates. Thicknesses between about 20 micrometers and about 500 micrometers are suitable for many applications. For example, thicknesses of 23 micrometers, 25 micrometers, 100 micrometers, 250 micrometers, 300 micrometers, and 500 micrometers are suitable for specific applications. Highly polar membranes suitable for lamination onto polyethylene membranes include polyamides, copolyesters, ionomers, and acrylic resins. To facilitate adhesion between the polyethylene and the polar membrane, bonding layers such as ethylene-vinyl acetate or modified polyurethane can be used. For some configurations, methyl acrylate (EMA) membranes may also possess suitable hydrophobicity and weldability.

[0098] like Figure 2 As illustrated in the example, the first membrane layer 205 may have one or more fluid channels 220, which may be uniformly or randomly distributed on the first membrane layer 205. The fluid channels 220 may be bidirectional and pressure-responsive. For example, each fluid channel 220 may generally be an elastic channel that is normally strain-free to substantially reduce fluid flow and may expand or open in response to a pressure gradient. In some embodiments, the fluid channels 220 may include or may be perforations in the first membrane layer 205. The fluid channels 220 or perforations may be formed by removing material from the first membrane layer 205. For example, the fluid channels 220 or perforations may be formed by cutting through the first membrane layer 205, which in some embodiments may also deform the edges of the perforations. Where there is no pressure gradient on the perforation, the channel may be small enough to form a seal or fluid confinement that can significantly reduce or prevent fluid flow. Alternatively, one or more fluid channels in fluid channel 220 may include or may be openings configured as elastomeric valves, which are normally closed to substantially prevent fluid flow when unstrained and may open in response to a pressure gradient. Openings may also be formed by removing material from the first membrane layer 205, but the amount of material removed and the size of the resulting opening may be up to an order of magnitude smaller than a perforation, and may not deform the edges.

[0099] For example, some embodiments of the fluid channel 220 may include one or more slits, slots, or combinations of slits and slots in the first membrane layer 205. In some examples, the fluid channel 220 may include linear slots with a length less than about 5 mm and a width less than about 2 mm. In some embodiments, the length may be at least 2 mm and the width may be at least 0.5 mm. Lengths ranging from about 2 mm to about 5 mm and widths ranging from about 0.5 mm to about 2 mm are particularly suitable for many applications, and tolerances of about 0.1 mm are also acceptable. For example, a length of 3 mm may be suitable. Such dimensions and tolerances can be achieved, for example, using a laser cutting machine. Such constructed slots can act as imperfect valves, significantly reducing fluid flow in a normally closed or quiescent state. For example, such slots can form flow restriction without completely closing or sealing. The slots may expand or open wider in response to a pressure gradient to allow increased fluid flow. In exemplary embodiments, the fluid channel 220 may include or consist of linear slits with a length less than 5 mm. For example, the length may be at least 2 mm. Lengths ranging from about 2 mm to about 5 mm are particularly suitable for many applications, and tolerances of about 0.1 mm are also acceptable. For example, a length of 3 mm may be appropriate. In some examples, the first membrane layer 205 may include a top surface 225 opposite to the bottom surface 230. The first membrane layer 205 may additionally include a periphery 235 at the outer periphery of the first membrane layer 205. In exemplary embodiments, the fluid channel 220 may be circular or any other suitable shape.

[0100] In some examples, the main manifold 210 may be or may include a flexible mesh structure. The flexible mesh structure may be formed of or comprise a variety of materials, such as, but not limited to, polymers, foams, or combinations of polymers and foams. Some examples of the main manifold 210 may include multiple segments of polymer and / or foam material that do not form multiple manifold openings or windows 240. Manifold openings or windows 240 may be formed through the main manifold 210, thereby allowing a user to see through the main manifold 210. In exemplary embodiments, the manifold openings or windows 240 may be defined as areas of the main manifold 210 that do not contain material. For example, the manifold openings or windows 240 may also form flow channels, thereby facilitating fluid communication and flow through the top surface 255 and bottom surface 260 of the main manifold 210. In exemplary embodiments, the main manifold 210 comprises a molded or cast polymer, including but not limited to polyurethane or silicone-based materials having a hardness in the range of about 10 A to about 60 A. For example, the main manifold 210 can be formed of a polyurethane or silicone-based material having a hardness in the range of Shore 20A to 40A. Polymers with a Shore hardness of 10A may be suitable for certain applications. According to exemplary embodiments, the window 240 can have a polygonal or circular frame. For example, the window 240 can have a cross-shaped frame or a four-leaf frame. In exemplary embodiments, the frame of the window 240 can be formed of a regular shape, such as a triangle, square, pentagon, hexagon, or any other regular shape. In some embodiments, the frame of the window 240 can be formed of an irregular shape. According to exemplary embodiments, the window 240 can have a width in the range of about 8 mm to about 15 mm.

[0101] like Figure 2 As shown in the example, the main manifold 210 may be formed of a single, substantially homogeneous material. The main manifold 210 may include a plurality of main nodes 245 arranged in a grid pattern. For example, the plurality of main nodes 245 may be arranged in a row and column pattern. Each main node 245 in a row may be connected to at least one adjacent main node 245 via a connector 250. The centroid of each main node 245 in a row may be aligned with the major axis of each connector 250 connecting the main nodes 245 in the row. In an exemplary embodiment, each main node 245 in a column may be connected or coupled to at least one adjacent main node 245 via a connector 250. The centroid of each main node 245 in a column may be aligned with the major axis of each connector 250 connecting the main nodes 245 in a row. In an exemplary embodiment, a connector 250 in each row may be parallel to a connector 250 in each other row. In an exemplary embodiment, a connector 250 in each column may be parallel to a connector 250 in each other column. For example, the connector 250 in each column can be substantially orthogonal to the connector 250 in each row. Figure 2As shown in the example, the top surfaces of the main node 245 and the connector 250 may be substantially coplanar with the top surface 255 of the main manifold 210. In some embodiments, the bottom surfaces of the main node 245 and the connector 250 may be substantially coplanar with the bottom surface 260 of the main manifold 210. In an exemplary embodiment, the plane formed by the top surface 255 of the main manifold 210 may be substantially parallel to the plane formed by the bottom surface 260 of the main manifold 210. The main manifold 210 may additionally include a periphery 265 formed at the outer periphery of the main manifold 210.

[0102] According to an exemplary embodiment, the main node 245 may have a generally circular profile in the plane formed by the top surface 255 of the main manifold 210. For example, the circular profile of the main node 245 may have a diameter ranging from about 4 mm to about 12 mm. In an exemplary embodiment, the connector 250 may have a generally rectangular profile in the plane formed by the top surface 255 of the main manifold 210. For example, the generally rectangular profile of the connector 250 may have a length ranging from about 8 mm to about 15 mm.

[0103] In some implementations, the master node 245 can be arranged in a hexagonal or circular pattern or any suitable pattern. In exemplary implementations, the master node can be any suitable three-dimensional shape. In some implementations, the window 240 can be framed by a triangle, square, rectangle, cross, polygon, clover, or any other suitable shape.

[0104] In exemplary embodiments where the main manifold 210 includes foam, a porous foam with an open-cell structure can be used. For example, felted foam can be used. Porous or felted foams can have interconnected fluid pathways, such as channels. Examples of suitable foams can include porous foams, including open-cell foams such as mesh foams; porous tissue collections; and other porous materials that typically include pores, edges, and / or walls, such as gauze or felt pads. In some embodiments, the main manifold 210 can be formed by a felting process. Any porous foam suitable for felting can be used, including exemplary foams mentioned herein, such as GRANUFOAM. TM Felting involves a thermoforming process that permanently compresses foam to increase its density while maintaining interconnected channels. Felting can be performed by any known method, which may include applying heat and pressure to a porous or foamed material. Some methods may involve compressing a foam preform at a specified temperature for a specified period of time between one or more heated plates or molds (not shown). The direction of compression may be along the thickness of the foam preform. For example, the main manifold 210 may be compressed in a direction substantially perpendicular to the plane formed by the top surface 255 or bottom surface 260 of the main manifold 210.

[0105] The compression period can range from 10 minutes to 24 hours, although it can be longer or shorter depending on the specific type of porous material used. Furthermore, in some examples, the temperature can range from 120°C to 260°C. Generally, the lower the temperature of the pressure plate, the longer the porous material must remain compressed. After the specified time period, the pressure and heat will form a felted structure or surface on or through the porous material, or on or through a portion of the porous material.

[0106] The felting process can alter certain properties of the original material, including pore shape and / or pore size, elasticity, density, and density distribution. For example, the struts defining the pores in a foam can deform during the felting process, resulting in a flattened pore shape. The deformed struts may additionally reduce the elasticity of the foam. The density of the foam is typically increased through felting. In some embodiments, contact with a hot press plate during felting can also create a density gradient, where the density is greater and the pore size is smaller at the surface. In some embodiments, the felted structure may be relatively smoother than any unfinished or unfelted surface or portion of the porous material. Furthermore, the pores in the felted structure may be smaller than the pores throughout any unfinished or unfelted surface or portion of the porous material. In some examples, the felted structure may be applied to all surfaces or portions of the porous material. Furthermore, in some examples, the felted structure may extend into or through the entire thickness of the porous material, such that all of the porous material is felted.

[0107] The characteristic of felted foam may be an indicator of the solidity factor of the foam compression. The solidity factor of felted foam may be specified as the ratio of the initial thickness to the final thickness. Compressed foam or felted foam may have a solidity factor greater than 1. Compressibility can affect the physical properties of felted foam. For example, felted foam has an increased effective density compared to unfelt foam of the same material. The felting process can also affect the interaction between the fluid and the foam. For example, as density increases, compressibility or collapseability may decrease. Therefore, foams with different compressibility or collapseability may have different solidity factors. In some exemplary embodiments, the solidity factor may be in the range of about 2 to about 10, preferably about 3 to about 5. For example, in some embodiments, the solidity factor of the felted foam of main manifold 210 may be about 5. There is a generally linear relationship between solidity level, density, pore size (or number of pores per inch) and compressibility. For example, foam felted to a solidity factor of 3 will show a three-fold increase in density and compress to about one-third of its initial thickness.

[0108] As by Figure 2As illustrated in the examples, the second membrane layer 215 may include or be substantially composed of means for controlling or managing fluid flow. In some embodiments, the second membrane layer 215 may be a fluid control layer comprising or substantially composed of a liquid-impermeable, vapor-permeable elastomeric material. In some embodiments, the second membrane layer 215 may include or substantially consist of a polymer membrane. For example, the second membrane layer 215 may include or substantially consist of a polyolefin membrane (such as a polyurethane membrane). In some embodiments, the second membrane layer 215 may contain or substantially consist of the same material as the first membrane layer 205. In some embodiments, the second membrane layer 215 may also have a smooth or matte surface texture. Glossy or glossy surfaces of grade B3 or better, according to SPI (Plastics Industry Association) standards, may be particularly advantageous for some applications. In some embodiments, variations in surface height may be limited to acceptable tolerances. For example, the surface of the second membrane layer 215 may be a generally flat surface, where variations in height are limited to 0.2 mm per centimeter. In exemplary embodiments, the second membrane layer 215 may be hydrophobic. For example, the second membrane layer 215 may have a contact angle with water of no more than 150 degrees. For example, the contact angle of the second membrane layer 215 may be in the range of at least 90 degrees to about 120 degrees, or in the range of at least 120 degrees to 150 degrees.

[0109] The second membrane layer 215 can also be adapted to be welded to other layers, including the first membrane layer 205 and the main manifold 210. For example, the second membrane layer 215 can be adapted to be welded to polymers, such as polyurethane, polyurethane membranes, and polyurethane foams, using thermal, radio frequency (RF) welding, or other methods such as ultrasonic welding. RF welding can be particularly suitable for materials with greater polarity, such as polyurethane, polyamide, polyester, and acrylate. Sacrificial polar interfaces can be used to facilitate RF welding of membrane materials with less polarity, such as polyethylene. The areal density of the second membrane layer 215 can vary depending on the specified treatment or application. In some embodiments, an areal density of less than 40 g / m² may be suitable, and an areal density of about 20 g / m² to 30 g / m² may be particularly advantageous for some applications. In some embodiments, for example, the second membrane layer 215 may comprise or be substantially composed of a hydrophobic polymer (such as a polyethylene membrane). Other suitable polymers include the polymer membranes previously described with respect to the first membrane layer 205. Thicknesses between about 20 micrometers and about 500 micrometers are suitable for many applications. For example, a thickness of 23 micrometers may be suitable for certain applications. In exemplary embodiments, a thickness of 25 micrometers may be suitable for specific applications. In some embodiments, the thickness of the second film layer 215 may be less than the thickness of the first film layer 205. The second film layer 215 may be substantially light-transmitting or optically transparent. Figure 2As shown in the example, the second membrane layer 215 may have one or more fluid channels 270. The fluid channels 270 may be substantially similar to or identical to the fluid channels 220 previously described with respect to the first membrane layer 205. In some examples, the second membrane layer 215 may include a top surface 275 opposite the bottom surface 280. The second membrane layer 215 may additionally include a periphery 285 at its outer periphery.

[0110] Figure 3 Isometric views of some embodiments of a tissue interface 120 having a first membrane layer 205, a main manifold 210, and a second membrane layer 215 in an assembled form are shown. In an exemplary embodiment, the periphery 235 of the first membrane layer 205 may be substantially co-extended with the periphery 285 of the second membrane layer 215. In some embodiments, a portion of the first membrane layer 205 adjacent to the periphery 235 of the first membrane layer 205 may be joined, bonded, welded, or adhered at a boundary region 305 to a portion of the second membrane layer 215 adjacent to the periphery 285 of the second membrane layer 215 to define an internal space 310 of the tissue interface 120. In some cases, the connection may also include a mechanical connection, a thermal connection, or a chemical connection (such as a chemical bond). The main manifold 210 may be positioned within the internal space of the tissue interface 120.

[0111] Figure 4 The image shown is taken at point 4-4 online. Figure 3 A cross-sectional view of an exemplary tissue interface 120. After assembly, the top surface 225 of the first membrane layer 205 may be adjacent to the bottom surface 260 of the main manifold 210. The top surface 255 of the main manifold 210 may be adjacent to the bottom surface 280 of the second membrane layer 215. A portion of the first membrane layer 205 joined, bonded, welded, or adhered to a portion of the second membrane layer 215 may form a boundary region 305 of the tissue interface 120. In an exemplary embodiment, the main manifold 210 may be positioned within the interior space 310 of the tissue interface 120. For example, the periphery 265 of the main manifold 210 may be included within the boundary region 305 and the interior space 310. For example, the main manifold 210 may be included by the top surface 225 of the first membrane layer 205, the bottom surface 280 of the second membrane layer 215, and the boundary region 305. In the assembled configuration, the user can see through the tissue interface 120 in a direction substantially perpendicular to the plane formed by the top surface 275 of the second membrane layer 215 or the bottom surface 230 of the first membrane layer 205. For example, the user can see through the substantially light-transmitting or optically transparent first membrane layer 205, see into and through the window 240 of the main manifold 210, and see through the window, and see through the substantially light-transmitting or optically transparent second membrane layer 215.

[0112] In an exemplary embodiment, fluid may be delivered through the fluid channel 220 of the first membrane layer 205 and into the window 240 of the main manifold 210, and from the window 240 through the fluid channel 270 of the second membrane layer 215. In an exemplary embodiment, fluid may be delivered through the fluid channel 270 of the second membrane layer 215 and into the window 240 of the main manifold 210, and from the window 240 through the fluid channel 220 of the first membrane layer 205. In some embodiments, fluid may be delivered through tissue interface 120. In an exemplary embodiment where the main manifold 210 comprises a porous material, fluid may be delivered through flow channels formed within the porous material of the main manifold 210. In an exemplary embodiment, the main manifold 210 may be sufficiently rigid to resist significant deformation when the first force 405 and the second force 410 are applied to the manifold. For example, the first force 405 may be substantially perpendicular to the top surface 255 of the main manifold 210, and the second force 410 may be substantially perpendicular to the bottom surface 260 of the main manifold 210. In an exemplary embodiment, the first force 405 and the second force 410 may be substantially opposite vectors. By preventing the main manifold 210 from deforming in response to the first force 405 and / or the second force 410, the main manifold 210 may keep the window 240 substantially open in response to the applied forces 405 and / or 410.

[0113] Figure 5 The diagram can be compared with Figure 2 A bottom view of some embodiments of the exemplary organizational interface 120, showing details associated with them. For example, Figure 5 Additional details that can be associated with some embodiments of the first membrane layer 205 are illustrated. For example... Figure 5 As shown in the example, the fluid channels 220 may each consist essentially of one or more slits having a length l1. A length of approximately 3 mm may be particularly suitable for some embodiments. Additionally, Figure 5 An example of a uniformly distributed pattern in the fluid channel 220 is also shown. Figure 5 In this structure, fluid channels 220 are substantially co-extended with the first membrane layer 205 and are distributed on the first membrane layer 205 in a grid of parallel rows and columns, in which the slits are also parallel to each other. In some embodiments, these rows may be spaced apart by a distance d1. A center-to-center distance of approximately 3 mm may be suitable for some embodiments. Fluid channels 220 within each of these rows may be spaced apart by a distance d2, and in some examples, the center-to-center distance may be approximately 3 mm. In some embodiments, fluid channels 220 in adjacent rows may be aligned or offset. For example, adjacent rows may be offset, such as... Figure 5As shown, the fluid channels 220 are aligned in alternating rows and spaced apart by a distance d3, which in some embodiments may be approximately 6 mm. In some embodiments, the spacing of the fluid channels 220 may be varied according to treatment requirements to increase the density of the fluid channels 220. In some embodiments, when the tissue interface 120 is assembled, a plurality of fluid channels 220 may be aligned with the window 240 of the main manifold 210. For example, most of the fluid channels 220 may be aligned with the window 240 of the main manifold 210 to improve moisture migration through the tissue interface 120 and to facilitate improved manifolding through the tissue interface 120. In an exemplary embodiment, a majority of the fluid channels 220 may be aligned with a plurality of master nodes 245 to improve manifolding around the master nodes 245 by means of fluid channels 220 extending on the arc of the master nodes 245.

[0114] Figure 6 The diagram can be compared with Figure 2 A bottom view of some embodiments of the exemplary organizational interface 120, showing details associated with them. For example, Figure 6 Additional details that can be associated with some embodiments of the second membrane layer 215 are illustrated. For example... Figure 6 As shown in the example, the fluid channels 270 may each consist essentially of one or more slits having a length of l2. A length of approximately 3 mm may be particularly suitable for some embodiments. Additionally, Figure 6 An example of a uniformly distributed pattern in the fluid channels 270 is also shown. Figure 6 In this structure, fluid channels 270 are substantially co-extended with the second membrane layer 215 and are distributed on the second membrane layer 215 in a grid of parallel rows and columns, in which the slits are also parallel to each other. In some embodiments, these rows may be spaced apart by a distance d4. A center-to-center distance of approximately 3 mm may be suitable for some embodiments. Fluid channels 270 within each of these rows may be spaced apart by a distance d5, and in some examples, the center-to-center distance may be approximately 3 mm. In some embodiments, fluid channels 270 in adjacent rows may be aligned or offset. For example, adjacent rows may be offset, such as... Figure 6 As shown, the fluid channels 270 are aligned in alternating rows and spaced apart by a distance d6, which in some embodiments may be approximately 6 mm. In some embodiments, the spacing of the fluid channels 270 may be varied according to treatment requirements to increase the density of the fluid channels 270. In some embodiments, when the tissue interface 120 is assembled, a plurality of the fluid channels 270 may be aligned with the window 240 of the main manifold 210. For example, most of the fluid channels 270 may be aligned with the window 240 of the main manifold 210 to improve moisture migration through the tissue interface 120 and to facilitate improved manifolding through the tissue interface 120.

[0115] Figure 7AThis is a top view of an exemplary embodiment of the main manifold 210, illustrating its ability to interact with... Figure 1 Additional details associated with some embodiments of the treatment system. For example, the main manifold 210 may include a plurality of main nodes 245 arranged in a grid pattern. In some embodiments, the main nodes 245 may be interconnected via a network of connectors 250. For example, each main node 245 may be connected to at least one other main node 245 via a connector 250. In an exemplary embodiment, each connector 250 may be substantially parallel to or substantially orthogonal to each other connector 250 in a plane. For example, each connector 250 connected to any one of the main nodes 245 may be orthogonal to adjacent connectors 250 connected to the same main node 245. In an exemplary embodiment, the main nodes 245 are generally hemispherical, and the main manifold 210 may also include cap-shaped portions 705 at the poles of the main nodes 245. In an exemplary embodiment, each main node 245 may be spaced apart from adjacent main nodes 245 by a central distance d7 in a first direction. Each main node 245 may be spaced apart from adjacent main nodes 245 by a central distance d8 in a second direction. In exemplary embodiments, the first direction may be orthogonal to the second direction in the same plane. In some embodiments, each main node 245 may have a diameter w1. In exemplary embodiments, each connector 250 may have a width w1. In some embodiments, the main manifold 210 may have a total length L1 and a total width W1. For example, according to some embodiments, d7 may be about 13 mm, d8 may be about 13 mm, w1 may be about 8 mm, w2 may be about 2 mm, L1 may be about 182 mm, and W1 may be about 117 mm. According to exemplary embodiments, the main manifold 210 may include a plurality of windows 240 defined by negative space or portions of which are free of material when the main manifold 210 is viewed from above.

[0116] Figure 7B yes Figure 7A An isometric partial view of the main manifold 210. In an exemplary embodiment, each hemispherical main node 245 may include a chamfered or rounded portion 710 surrounding the base of the main node 245. In some embodiments, each component of the main manifold 210, such as each main node 245, each connector 250, and each cap portion 705, may include the same material. For example, the main manifold 210 may be formed of a molded or cast polymeric material, such as a polyurethane or silicone-based material having a hardness between approximately Shore A 20A and approximately Shore A 40A. For example, a silicone material having a hardness of approximately Shore A 10A may be suitable for a particular application. In an exemplary embodiment, the main manifold 210 may have a total height H1. For example, H1 may be approximately 4 mm.

[0117] Figure 8AThis is a top view of an exemplary embodiment of the main manifold 210, illustrating its ability to interact with... Figure 1 Additional details related to some implementation schemes of the treatment system. Figure 8B yes Figure 8A An isometric partial view of the main manifold 210. In an exemplary embodiment, each main node 245 may be formed of a polymer having a lower Shore hardness level than each connector 250 and each cap portion 705. For example, each main node 245 may be formed of silicone having a hardness of about Shore 10A, and each connector 250 and each cap portion 705 may be formed of silicone having a hardness in the range of about Shore 20A to about Shore 40A.

[0118] Figure 9A This is a bottom view of an exemplary embodiment of the main manifold 210, illustrating its compatibility with... Figure 1Additional details associated with some embodiments of the treatment system. For example, the main manifold 210 may be formed as a generally sheet-like structure including a top surface 255 (not shown) and a bottom surface 260. For example, the main manifold 210 may be formed of a polyurethane sheet, such as a vacuum-formed polyurethane sheet with a thickness of about 0.5 mm. In an exemplary embodiment, the main manifold 210 may be formed of a substantially light-transmitting or optically transparent polymer material, thereby allowing the user to see through the main manifold 210. Multiple portions of the main manifold 210 may be removed to form windows 240 in a grid pattern within the main manifold 210. Multiple supports 905 may be formed on the main manifold 210. The multiple supports 905 may be formed around the perimeter 265 of the main manifold 210 and between each window in the windows 240. For example, the multiple supports 905 and the multiple windows 240 may be arranged in a grid pattern. In an exemplary embodiment, the supports 905 and the windows 240 may be arranged in a row and column pattern. For example, the center of each support 905 may be aligned with the center of each window 240 in a row. For example, the center of each support 905 in a column may be aligned with the center of each window 240 in the same row. In an exemplary embodiment, the rows and columns closest to the perimeter 265 may be substantially composed of supports 905. In an exemplary embodiment, on the inner side of the rows and columns closest to the perimeter 265 of the supports 905, a pattern may alternate between supports 905 and windows 240 in each row. In an exemplary embodiment, on the inner side of the rows and columns closest to the perimeter 265 of the supports 905, a pattern may alternate between supports 905 and windows 240 in each column. In some embodiments, the pattern may be arbitrarily chosen or random. In an exemplary embodiment, the outline of each support 905 in the plane of the bottom surface 260 of the main manifold 210 may be generally circular and have a diameter w3. In an exemplary embodiment, the outline of each window 240 in the plane of the bottom surface 260 of the main manifold 210 may be generally circular and have a diameter w4. In an exemplary embodiment, w3 can be substantially equal to w4. In some embodiments, window 240 can be a square or any suitable shape.

[0119] Figure 9B yes Figure 9A A partial isometric view of the main manifold 210. In some embodiments, a plurality of supports 905 comprise straight cylinders formed on and projecting substantially away from the bottom surface 260 of the main manifold 210 in a direction substantially perpendicular to the bottom surface 260. In exemplary embodiments, supports 905 may comprise any suitable shape.

[0120] Figure 10A This is a bottom view of an exemplary embodiment of the main manifold 210, illustrating its compatibility with... Figure 1Additional details associated with some embodiments of the treatment system. For example, the main manifold 210 may be formed as a generally sheet-like structure including a top surface 255 and a bottom surface 260 (not shown). For example, the main manifold 210 may be formed of a polyurethane sheet, such as a vacuum-formed polyurethane sheet with a thickness of about 0.5 mm. In an exemplary embodiment, the main manifold 210 may be formed of a substantially light-transmitting or optically transparent polymer material, thereby allowing the user to see through the main manifold 210. Windows 240 may be removed from the main manifold and formed in a grid pattern. For example, a plurality of windows 240 may be arranged in a row and column pattern. The center of each window 240 may be aligned with the center of each other window 240 in a row. The center of each window 240 may also be aligned with the center of each other window 240 in a column. In an exemplary embodiment, a plurality of supports 905 may be formed on the main manifold 210. The plurality of supports 905 may be formed in a grid pattern. For example, the plurality of supports 905 may be arranged in a row and column pattern. The center of each support 905 in a row can be aligned with the center of every other support 905 in that row. The center of each support 905 in a column can be aligned with the center of every other support 905 in that column. In some embodiments, each row of the plurality of windows 240 can be positioned between two adjacent rows of the plurality of supports 905. In an exemplary embodiment, each column of the plurality of windows 240 can be positioned between two adjacent columns of the plurality of supports 905. In some embodiments, the pattern of the plurality of windows 240 can be arbitrarily chosen or random. In an exemplary embodiment, the pattern of the plurality of supports 905 can be arbitrarily chosen or random. In an exemplary embodiment, the outline of each support 905 in the plane of the bottom surface 260 of the main manifold 210 can be generally circular and have a diameter w3. In an exemplary embodiment, the outline of each window 240 in the plane of the top surface 255 of the main manifold 210 can be generally circular and have a diameter w4. In an exemplary embodiment, w3 can be substantially smaller than w4. For example, in a particular embodiment, w3 may be approximately 3 mm, and w4 may be approximately 8 mm. In an exemplary embodiment, each support 905 in a row may be spaced approximately 4 mm apart from the center of its adjacent support 905 in that row. In an exemplary embodiment, each support 905 in a column may be spaced approximately 4 mm apart from the center of its adjacent support 905 in that column. In some embodiments, window 240 may be square or any suitable shape.

[0121] Figure 10B yes Figure 10AAn isometric view of the main manifold 210. In some embodiments, the plurality of supports 905 include straight cylinders having hemispherical ends (such as hemispherical sacs) formed on and projecting substantially away from the bottom surface 260 of the main manifold in a direction substantially perpendicular to the bottom surface 260. In exemplary embodiments, each of the plurality of supports 905 may have a height h1. For example, in some embodiments, a height h1 in the range of about 2.5 mm to about 3 mm may be suitable for a particular application. In exemplary embodiments, the supports 905 may include any suitable shape.

[0122] Figure 11 It includes Figure 2 An exploded view of an exemplary embodiment of the dressing 110 at the organization interface 120, illustrating that it can be used with... Figure 1 Additional details associated with some embodiments of the treatment system 100. In exemplary embodiments, dressing 110 may include a cover 125 and a submanifold 1105. In exemplary embodiments, cover 125 may be substantially translucent or optically transparent. In some embodiments, submanifold 1105 typically includes or is substantially composed of a manifold or manifold layer, which provides means for collecting or dispensing fluid on dressing 110 under pressure. In some exemplary embodiments, the pathways of submanifold 1105 may be interconnected to improve fluid dispensing or collection. In some exemplary embodiments, submanifold 1105 may include or is substantially composed of a porous material having interconnected fluid pathways. Examples of suitable porous materials that include or may be adapted to form fluid pathways (e.g., channels) may include porous foams (including open-cell foams, such as mesh foams), porous tissue aggregates, and other porous materials (such as gauze or felt pads that typically include pores, edges, and / or walls). Liquids, gels, and other foams may also include or be solidified to include orifices and fluid pathways. In some embodiments, the sub-manifold 1105 may additionally or alternatively include protrusions forming interconnected fluid passages. For example, the sub-manifold 1105 may be molded to provide surface protrusions defining interconnected fluid passages.

[0123] In some embodiments, the secondary manifold 1105 may comprise or be substantially composed of a mesh foam having a pore size and free volume that can vary depending on the requirements of the prescribed treatment. For example, a mesh foam with a free volume of at least 90% is suitable for many therapeutic applications, and foam with an average pore size in the range of 400 to 600 micrometers is particularly suitable for certain types of treatment. The tensile strength of the secondary manifold 1105 may also vary depending on the requirements of the prescribed treatment. For example, the tensile strength of the foam may be increased for use in infusing topical therapeutic solutions. The 25% compressive load flexure of the secondary manifold 1105 may be at least 0.35 psi, and the 65% compressive load flexure may be at least 0.43 psi. In some embodiments, the tensile strength of the secondary manifold 1105 may be at least 10 psi. The secondary manifold 1105 may have a tear strength of at least 2.5 psi. In some embodiments, the secondary manifold 1105 can be a foam composed of polyols (such as polyesters or polyethers), isocyanates (such as toluene diisocyanate), and polymerization modifiers (such as amines and tin compounds). In some examples, the secondary manifold 1105 can be a mesh polyurethane foam, such as that used in Granufoam. TM Dressing or VACVERAFLO TM Both the mesh polyurethane foam in the dressing and the material were available from KCI, a company based in San Antonio, Texas.

[0124] Other materials suitable for the sub-manifold 1105 may include, for example, nonwoven fabrics (Libeltex, Freudenberg), three-dimensional (3D) polymer structures (molded polymers, embossed and shaped films and fusion-bonded films [Supracor]), and mesh.

[0125] In some examples, the submanifold 1105 may comprise a 3D textile, such as various textiles commercially available from Baltex, Muller, and Heathcoates. For some embodiments, a 3D textile of polyester fibers may be particularly advantageous. For example, the submanifold 1105 may comprise or be substantially composed of a three-dimensional braid of polyester fibers. In some embodiments, the fibers may be elastic in at least two dimensions. For some embodiments, a puncture-resistant fabric of polyester and cotton fibers having a weight of about 650 g / m² and a thickness of about 1 mm to 2 mm may be particularly advantageous. In some embodiments, such a puncture-resistant fabric may have a warp tensile strength of about 330 kg to 340 kg and a weft tensile strength of about 270 kg to 280 kg. In some embodiments, another particularly suitable material may be a polyester insulating fabric having a weight of about 470 g / m² and a thickness of about 4 mm to 5 mm. Such an insulating fabric may have a compressive strength of about 20 kPa to 25 kPa (at 40% compression). Alternatively or in addition to this, the sub-manifold 1105 may comprise or be composed of a material having substantially linear tensile properties, such as a polyester insulating fabric having biaxial tensile strength and a weight of approximately 380 g / m². In some embodiments, a suitable insulating fabric may have a thickness of approximately 3 mm to 4 mm and may have a warp and weft tensile strength of approximately 30 kg to 40 kg. In some examples, the fabric may have tightly woven polyester layers on one or more opposing surfaces.

[0126] The submanifold 1105 typically has a first flat surface, such as a top surface 1110 opposite a second flat surface (such as a bottom surface 1115). The thickness of the submanifold 1105 between the top surface 1110 and the bottom surface 1115 can also vary depending on the needs of the prescribed treatment. For example, the thickness of the submanifold 1105 can be reduced to alleviate stress on other layers. The submanifold 1105 also includes a periphery 1120 surrounding the outer periphery of the submanifold 1105. In some embodiments, a suitable foam submanifold 1105 may have a thickness ranging from about 5 mm to about 10 mm. In exemplary embodiments, a fabric submanifold 1105 (including 3D textiles and insulating fabrics) may have a thickness ranging from about 2 mm to about 8 mm.

[0127] Cover 125 typically has a first flat surface, such as a top surface 1125 opposite to the bottom surface 1130. In an exemplary embodiment, at least a portion of the bottom surface 1130 of cover 125 may be coated with an adhesive, such as an acrylic adhesive. Cover 125 may also include a periphery 1135 surrounding the outer perimeter of cover 125. An orifice 1140 may be formed in cover 125. In some embodiments, the periphery 1135 of cover 125 may be larger than the periphery 1120 of sub-manifold 1105, the periphery 285 of second membrane layer 215, the periphery 265 of main manifold 210, and the periphery 235 of first membrane layer 205. For example, the periphery 1120 of sub-manifold 1105, the periphery 285 of second membrane layer 215, the periphery 265 of main manifold 210, and the periphery 235 of first membrane layer 205 may be contained within the periphery 1135 of cover 125. In an exemplary embodiment, the periphery 1120 of the sub-manifold 1105 may be included within the periphery 1135 of the cover 125 and the periphery 285 of the second membrane layer 215.

[0128] Figure 11 An example of a fluid conductor 1145 and a dressing interface 1150 is also illustrated. Figure 11 As shown in the example, the fluid conductor 1145 can be a flexible tube that is fluidly connected at one end to the dressing interface 1150. The dressing interface 1150 can be an elbow connector, such as... Figure 11 As shown in the example, the elbow connector can be placed over the orifice 1140 in the cover 125 to provide a fluid path between the fluid conductor 1145 and the sub-manifold 1105.

[0129] Figure 12 yes Figure 11 An isometric view of an assembly example of dressing 110. Figure 12 As shown in the example, the cover 125 may be substantially light-transmitting or optically transparent, thereby allowing the layers of dressing 110 and visualization through dressing 110. In an exemplary embodiment, the periphery 1135 of the cover 125 extends beyond the periphery 235 of the first film layer 205 and the periphery 285 of the second film layer 215, thereby defining a boundary region 1205 of the cover 125.

[0130] Figure 13 The image taken at point 13-13 online shows the sample applied to the exemplary tissue site. Figure 12 A cross-sectional view of an exemplary dressing 110, and illustrated with... Figure 1Additional details associated with the treatment system 100. In some embodiments, the dressing 110 may be configured to interface with the tissue site 1305. For example, the dressing 110 may typically be configured to be positioned adjacent to and / or in contact with a portion of, substantially all of, or the entire tissue site 1305, or the tissue site 1305 or surrounding tissue. In some examples, the tissue site 1305 may be or may include a defect or targeted treatment site (such as a wound) that may be partially or completely filled or covered by the dressing 110. In various embodiments, the dressing 110 may take many forms and may have a variety of sizes, shapes, or thicknesses, depending on various factors such as the type of treatment achieved or the nature and size of the tissue site 1305. For example, the size and shape of the dressing 110 may be adapted to the contours of deeper and irregularly shaped tissue sites and / or may be configured to fit a given shape or contour. Furthermore, in some embodiments, any or all surfaces of the dressing 110 may include protrusions or uneven, rough, or serrated contours that can, for example, cause strain and stress on the tissue site 1305, which can effectively promote granulation tissue formation at the tissue site 1305. In some embodiments, the tissue site 1305 may include a wound 1310 extending through the epidermis 1315 and into the dermis 1320. In some examples, such as Figure 13 As shown, tissue site 1305 may include wound 1310 extending through epidermis 1315 and dermis 1320 and into subcutaneous tissue 1325.

[0131] In some embodiments, dressing 110 may be applied to tissue site 1305 and cover wound 1310. In exemplary embodiments, first membrane 205 may be placed within, on, against, or otherwise close to tissue site 1305. For example, at least a portion of the bottom surface 230 of first membrane 205 may be placed within, on, against, or otherwise close to wound 1310. Submanifold 1105 may be placed across wound 1310 or epidermis 1315 over first membrane 205. For example, at least a portion of the bottom surface 1115 of submanifold 1105 may contact at least a portion of the top surface 275 of first membrane 205. A cover 125, which can be coated with adhesive 1330 onto at least a portion of the bottom surface 1130, can be positioned over the submanifold and tissue interface 120 such that the bottom surface 1130 or at least a portion of the adhesive 1330 contacts at least a portion of the top surface 1110 of the submanifold 1105 and at least a portion of the top surface 275 of the second membrane layer 215. In some embodiments, at least a portion of the cover 125 can adhere to at least a portion of the submanifold 1105 and at least a portion of the tissue interface 120.

[0132] In some embodiments, adhesive 1330 may be present on the bottom surface 1130 of the cover 125 at the boundary region 1205 of the cover 125. For example, the boundary region 1205 of the cover 125 may be adhered to the epidermis 1315 by adhesive 1330. The cover 125 may seal to the undamaged epidermis 1315 surrounding the wound 1310 at least at the boundary region 1205. Thus, the dressing 110 provides a sealed therapeutic environment 1335 close to the wound 1310. The sealed therapeutic environment 1335 may be substantially isolated from the external environment, and a negative pressure source 105 may be fluidly coupled to the sealed therapeutic environment 1335. For example, a dressing interface 1150 may be disposed above or received through an opening 1140 formed in the cover 125. The dressing interface 1150 can be used, for example, to achieve a fluid seal against the top surface 1125 of the cover 125 via an adhesive seal, and the dressing interface 1150 can be in fluid communication with the sealed treatment environment 1335. In an exemplary embodiment, the dressing interface 1150 can be fluidly coupled to a negative pressure source 105 via a fluid conductor 1145. In an exemplary embodiment, a canister (such as container 115) can be positioned in the fluid path between the dressing interface 1150 and the negative pressure source 105. Negative pressure can be applied to the wound 1310 via the sub-manifold 1105, and the first membrane layer 205 can induce macro- and micro-strains at the wound 1310, and remove or reduce exudates and other fluids from the tissue site 1305. The removed exudates and other fluids can be collected in container 115 and appropriately treated. In an exemplary embodiment, fluid, moisture, and exudate can travel from wound 1310 through fluid channels 220 in the first membrane layer 205 and into window 240, from window 240 through fluid channels 270 in the second membrane layer 215, and through submanifold 1105 to reach dressing interface 1150.

[0133] Figure 14A Is Figure 13 label in Figure 14A The detailed image captured here illustrates what can be compared to... Figure 13 Details associated with some exemplary embodiments of the dressing 110 and system 100. Figure 14AAn embodiment of dressing 110 is shown, wherein the cover 125 and the second membrane layer 215 are not dragged into window 240. For example, the bottom surface 280 of the second membrane layer 215 may remain substantially separate from the top surface 225 of the first membrane layer 205. In an exemplary embodiment, the second membrane layer 215 may be attached to (e.g., welded to) at least a portion of the main manifold 210. In the example where the second membrane layer 215 is welded to the main manifold 210, the weld may substantially prevent the second membrane layer 215 and the cover 125 from being dragged into window 240 under decompression. In an exemplary embodiment, the second membrane layer 215 may not be attached to or welded to the main manifold 210. In the example where the second membrane layer 215 is not welded to the main manifold 210, it is not necessary to prevent the second membrane layer 215 from being dragged into window 240. Figure 14A Some embodiments can be illustrated, in which, for example, when no negative pressure is provided to the occlusive treatment environment 1335, the second membrane layer 215 and the cover 125 are not dragged into the window 240. For example, the pressure inside the occlusive treatment environment 1335 may be substantially the same as the ambient pressure outside the dressing 110, such as in the region of the top surface 1125 facing the cover 125. Without a pressure gradient being created on the cover 125 and the second membrane layer 215, no resultant force is generated, and the cover 125 and the second membrane layer 215 are not dragged into the window 240.

[0134] Figure 14B The illustration shows that Figure 13 In some embodiments of the dressing 110 and system 100, it can be used with Figure 14A Additional details associated with the detailed diagram. For example, the pressure within the sealed treatment environment 1335 can be reduced to a suitable negative pressure, thereby creating a low-pressure area within the main manifold 210 (such as within the window 240). In an exemplary embodiment, a pressure gradient can be created on the cover 125 and the second membrane 215, wherein the area of ​​higher ambient pressure is opposite the top surface 1125 of the cover 125, and the area of ​​lower negative pressure is opposite the bottom surface 280 of the second membrane 215. The resultant force from the pressure difference on the cover 125 and the second membrane 215 can drag at least a portion of the cover 125 and the second membrane 215 into the window 240. For example, a portion of the bottom surface 280 of the second membrane 215 can contact the top surface 225 of the first membrane 205. In an exemplary embodiment, at least a portion of the bottom surface of the first membrane 205 can contact the epidermis 1315 or the wound 1310. Figure 14B(Not shown in the image). In some embodiments, the cover 125, adhesive 1330, second film layer 215, and first film layer 205 may be substantially translucent or optically transparent and exhibit substantially similar refractive indices. In an exemplary embodiment, the main manifold 210 may be sufficiently rigid in a direction substantially perpendicular to the plane formed by the top surface 1125 of the cover 125 to resist compression or deformation under negative pressure.

[0135] Figure 15 yes Figure 2 An isometric view of an assembled example of tissue interface 120 illustrates additional details that may be associated with some embodiments. For example, a plurality of main manifolds 210 may be disposed between a first membrane layer 205 and a second membrane layer 215. In some embodiments, a boundary region 305 may be formed around each of the plurality of main manifolds 210. In an exemplary embodiment, the first membrane layer 205 and the second membrane layer 215 may be perforated in the boundary region 305 between the main manifolds 210. For example, the size of tissue interface 120 may be adjusted by selectively removing one or more of the main manifolds 210.

[0136] Figure 16 This is an isometric view of an exemplary embodiment of the main manifold 210, illustrating its compatibility with... Figure 1 Additional details associated with the treatment system 100. For example, the main manifold 210 may be formed as a generally sheet-like structure including a top surface 255, a bottom surface 260, and a periphery 265. In some embodiments, the periphery 265 may be stadium-shaped, disc-rectangle-shaped, or oblong. The main manifold 210 may be formed from a polyurethane sheet, such as a vacuum-formed polyurethane sheet with a thickness of about 0.5 mm. In an exemplary embodiment, the main manifold 210 may be formed from a substantially light-transmitting or optically transparent polymer material, thereby allowing the user to see through the main manifold 210. Figure 16 As depicted, based on some examples, window 240 and support 905 can be similar to those previously described. Figure 10AThe pattern described is arranged in a grid pattern. Windows 240 can be removed from the main manifold 210 to form a grid pattern. In some embodiments, the plurality of windows 240 can be arranged in a row and column pattern. The center of each window 240 can be aligned with the center of each other window 240 in a row. The center of each window 240 can also be aligned with the center of each other window 240 in a column. In an exemplary embodiment, a plurality of supports 905 can be formed on the bottom surface 260 of the main manifold 210. For example, the plurality of supports 905 can form a grid pattern. In an exemplary embodiment, the plurality of supports 905 can be arranged in a row and column pattern. The center of each support 905 in a row can be aligned with the center of each other support 905 in that row. The center of each support 905 in a column can be aligned with the center of each other support 905 in that column. In some embodiments, each row of the plurality of windows 240 can be positioned between two adjacent rows of the plurality of supports 905. In an exemplary embodiment, each column of the plurality of windows 240 can be positioned between two adjacent columns of the plurality of supports 905. In some embodiments, the patterns of the plurality of windows 240 can be arbitrarily selected or randomized. In an exemplary embodiment, the patterns of the plurality of supports 905 can be arbitrarily selected or randomized.

[0137] Similar to previous statements Figure 10A In the exemplary embodiments described, each support 905 may have a generally circular outline and project outwardly from the plane of the bottom surface 260 of the main manifold 210 in a substantially orthogonal manner, and have a diameter w3. In the exemplary embodiments, each window 240 may have a generally circular outline in the plane of the top surface 255 of the main manifold 210 and have a diameter w4. In the exemplary embodiments, w3 may be substantially smaller than w4. For example, in a particular embodiment, w3 may be about 3 mm, and w4 may be about 8 mm. In the exemplary embodiments, each support 905 in a row may be spaced apart from the center of adjacent supports 905 in that row by about 4 mm. In the exemplary embodiments, each support 905 in a column may be spaced apart from the center of adjacent supports 905 in that column by about 4 mm. In some embodiments, the window 240 may be square or any suitable shape. Figure 16 As shown, an exemplary embodiment of the main manifold 210 may also include a protrusion, such as a lip, a boss, or a fold 1605. For example, the fold 1605 may project outwardly from the plane of the top surface 255 of the main manifold 210 in a substantially orthogonal manner. In an exemplary embodiment, the fold 1605 may have a shape similar to the perimeter 265. For example, the fold 1605, such as... Figure 16As shown, in examples where the perimeter 265 is stadium-shaped, disk-shaped, or oblong, the fold 1605 can be a scaled-down stadium-shaped, disk-shaped, or oblong shape similar to the perimeter 265. Examples of the main manifold 210 may also include a boundary region 1610 between the fold 1605 and the perimeter 265. For example, the boundary region 1610 may lack the window 240 or the support 905.

[0138] Figure 17 yes Figure 1 An exploded view of an example of dressing 110, illustrating additional details that may be associated with some implementation schemes. Figure 17 In the example, dressing 110 includes a sealing layer 1705, a first membrane layer 205, a main manifold 210, a second membrane layer 215, a cover 125, a secondary manifold 1105, and a dressing interface 1150. In some embodiments, the sealing layer 1705 may be formed of a soft, flexible material (such as a suitable gel material) suitable for providing a fluid seal with the tissue site and may have a generally flat surface. The sealing layer 1705 may include, but is not limited to, silicone gels, soft silicones, aqueous colloids, hydrogels, polyurethane gels, polyolefin gels, hydrogenated styrene copolymer gels, foamed gels, soft closed-cell foams (such as polyurethanes and polyolefins coated with adhesives), polyurethanes, polyolefins, or hydrogenated styrene copolymers. In some embodiments, the sealing layer 1705 may have a thickness between about 200 micrometers and about 1000 micrometers. Furthermore, the sealing layer 1705 may be formed of a hydrophobic or hydrophilic material.

[0139] In some embodiments, the sealing layer 1705 may be a material with a hydrophobic coating. For example, the sealing layer 1705 may be formed by coating spaced materials (such as, for example, woven, nonwoven, molded, or extruded meshes) with a hydrophobic material. The hydrophobic material used for coating may be, for example, soft silicone.

[0140] The sealing layer 1705 may have a top surface 1710 opposite to the bottom surface 1715, a periphery 1720 defined by the outer periphery of the sealing layer 1705, and a treatment port 1725 formed through the sealing layer 1705. In some examples, the treatment port 1725 may have a profile complementary to or corresponding to the periphery 265 of the main manifold 210. For example, the treatment port 1725 may form a frame, window, or other opening around a surface such as the boundary region 1610 of the main manifold 210. The sealing layer 1705 may also have a plurality of orifices 1730 formed through the sealing layer 1705 in a region defined between the treatment port 1725 and the periphery 1720 of the sealing layer 1705. The sealing layer 1705 may have an inner boundary 1735 surrounding the treatment port 1725, which may be substantially free of orifices 1730. In some examples, such as Figure 17As shown, the treatment port 1725 can have a shape similar to the periphery 265 of the main manifold 210, and can be symmetrically and centrally positioned within the sealing layer 1705, thereby forming an open central window. For example, the treatment port 1725 can have a stadium-shaped, disk-rectangular, or oblong shape similar to the periphery 265, scaled down proportionally.

[0141] The orifice 1730 may be formed by cutting, perforation; or by applying, for example, localized RF or ultrasonic energy; or by other suitable techniques for forming an opening or perforation in the sealing layer 1705. The orifice 1730 may have a uniform distribution pattern or may be randomly distributed on the sealing layer 1705. The orifice 1730 formed through the sealing layer 1705 may have a number of shapes, including, for example, circular, square, star-shaped, elliptical, polygonal, slit, complex curve, straight line shape, triangle, or some combination of such shapes.

[0142] Each orifice in orifice 1730 may have uniform or similar geometric characteristics. For example, in some embodiments, each orifice in orifice 1730 may be a circular orifice having substantially the same diameter. In some embodiments, each orifice in orifice 1730 may have a diameter of about 1 mm to about 50 mm. In other embodiments, the diameter of each orifice in orifice 1730 may be about 1 mm to about 20 mm.

[0143] In some embodiments, the geometry of the orifice 1730 can vary. For example, the diameter of the orifice 1730 can vary depending on its location within the sealing layer 1705. For instance, some orifices of the orifice 1730 may have a diameter between about 5 mm and about 10 mm. A range of about 7 mm to about 9 mm is applicable to some examples. In some embodiments, the orifice 1730 located at or near a corner 1740 of the sealing layer 1705 may have a diameter between about 7 mm and about 8 mm.

[0144] At least one of the orifices 1730 may be located near the periphery 1720 of the sealing layer 1705 and may have an internal cutout that is open or exposed at the periphery 1720, the internal cutout communicating laterally with the periphery 1720 in a lateral direction. The lateral direction may refer to a direction toward the periphery 1720 and coplanar with the sealing layer 1705. Figure 17 As illustrated in the example, an orifice 1730 in the region between the treatment port 1725 of the sealing layer 1705 and the periphery 1720 may be located close to or at the periphery 1720 and in lateral communication with the periphery 1720. The orifices 1730 located close to or at the periphery 1720 may be spaced substantially equidistantly around the periphery 1720, such as... Figure 17As shown in the example. Alternatively, the spacing of the openings 1730 near or at the periphery 1720 may be irregular.

[0145] like Figure 17 As shown, according to some embodiments of the dressing 110, the first membrane layer 205 may have a periphery 235 coexisting with the periphery 265 of the main manifold 210. The second membrane layer 215 may have a periphery 285 coexisting with the periphery 265 of the main manifold 210. In some examples, such as Figure 17 As shown, the second membrane layer 215 may include apertures 1745 formed through the second membrane layer 215, but the second membrane layer 215 may also be solid and contain no other apertures or channels. For example, Figure 17 The second membrane layer 215 in the example may not include any fluid channels 270 shown in other examples (such as...). Figure 2 (The fluid channel in the main manifold). In the assembled configuration, a portion of the top surface 225 of the first membrane layer 205 may be attached to a portion of the bottom surface 260 of the main manifold 210, for example, by RF welding. For example, a portion of the top surface 225 near its periphery 235 may be attached to a portion of the bottom surface 260 near its periphery 265 of the main manifold 210, for example, at a boundary region 1610. In the assembled configuration, a portion of the bottom surface 215 280 may be attached to a portion of the top surface 255 of the main manifold 210, for example, by RF welding. For example, a portion of the bottom surface 280 near its periphery 285 may be attached to a portion of the top surface 255 near its periphery 265 of the main manifold 210, for example, at a boundary region 1610.

[0146] like Figure 17As shown, an example of dressing 110 may include a cover 125 having a central opening 1750 formed through a cover 125. The perimeter of the central opening 1750 may substantially coexist with the perimeter of the treatment opening 1725. The shapes of the perimeters of the treatment opening 1725 and the central opening 1750 may resemble the shapes of peripheries 235, 265, and 285. The perimeters of the treatment opening 1725 and the central opening 1750 may be scaled to define an area smaller than the area defined by peripheries 235, 265, and 285. For example, in an assembled configuration, a portion of the bottom surface 230 of the first membrane layer 205 near the periphery 235 may be coupled or adhered to a portion of the top surface 1710 of the sealing layer 1705 near the treatment opening 1725. In the assembled configuration, a portion of the bottom surface 1130 of the cover 125 near the central opening 1750 may be attached or adhered, for example, by an adhesive 1330 disposed on the bottom surface 1130 of the cover 125 to a portion of the top surface 275 near the periphery 285 of the second film layer 215. A portion of the bottom surface 1130 of the cover 125 may also be attached or adhered, for example, by an adhesive 1330 disposed on the bottom surface 1130 of the cover 125 to a portion of the top surface 1710 of the sealing layer 1705.

[0147] Some examples of dressing 110 may also include a sub-manifold 1105 and a dressing interface 1150. In an exemplary embodiment, the dressing interface 1150 may also include a connector cover 1755. The connector cover 1755 may include a top surface 1760, a bottom surface 1765, and a periphery 1770, and is formed of a material similar to that of the cover 125. The bottom surface 1765 may be coated with an adhesive, and a portion of the bottom surface 1765 may adhere to a portion of the dressing interface 1150. In an assembled configuration, the centroid of the orifice 1745 may be aligned along axis 1775 with the centroids of the sub-manifold 1105, the dressing interface 1150, and the connector cover 1755. Axis 1775 may be substantially perpendicular to the plane defined by top surface 1710, top surface 225, top surface 255, top surface 275, top surface 1125, and / or top surface 1110. In the assembled configuration, a portion of the sub-manifold 1105 near the periphery 1120 of the bottom surface 1115 may contact a portion of the top surface 275 of the second diaphragm 215 and / or a portion of the top surface 1125 of the cover 125 surrounding the orifice 1745. A dressing interface 1150 may be disposed adjacent to and in fluid communication with the top surface 1110 of the sub-manifold 1105. The bottom surface 1765 of the connector cover 1755 may be coupled to or adhered to a portion of the connector 1170, the top surface 1110 of the sub-manifold 1105, the top surface 1125 of the cover 125, and / or the top surface 275 of the second diaphragm 215.

[0148] like Figure 17 As illustrated in the examples, in some embodiments, dressing 110 may include a release liner 1780 to protect sealing layer 1705 and adhesive 1330 prior to use. The release liner 1780 may also provide stiffness to facilitate, for example, deployment of dressing 110. Release liner 1780 may be, for example, cast paper, film, or polyethylene. Furthermore, in some embodiments, release liner 1780 may be a polyester material, such as polyethylene terephthalate (PET) or a similar polar semi-crystalline polymer. Using a polar semi-crystalline polymer for release liner 1780 can substantially eliminate wrinkling or other deformation of dressing 110. For example, the polar semi-crystalline polymer may be highly oriented and resistant to softening, swelling, or other deformation that may occur when an object comes into contact with layers and / or components of dressing 110, or when dressing 110 is subjected to temperature or environmental changes, or during sterilization. Additionally, a release agent may be applied to the top surface 1785 of the release liner 1780, which is configured to contact the bottom surface 1715 of the sealing layer 1705 and the adhesive 1330. For example, the release agent may be a silicone coating and may have a release coefficient suitable for easy manual removal of the release liner 1780 without damaging or deforming the dressing 110. In some embodiments, the release agent may be, for example, a fluorocarbon compound or a fluorosiloxane. In other embodiments, the release liner 1780 may be uncoated or otherwise used without a release agent.

[0149] Figure 17A yes Figure 17 An isometric view of an assembly example of dressing 110. Figure 17A As shown in the example, the connector cover 1755, cover 125, second membrane layer 215 and / or first membrane layer 205 may be substantially light-transmitting or optically transparent, thereby allowing visualization of the layers of dressing 110 as well as visualization through the window 240 of the main manifold 210 of dressing 110.

[0150] Figure 18 It is already assembled. Figure 17 A top view of the dressing 110, illustrating details that may be associated with some implementation schemes. Figure 19 It is already assembled. Figure 17 The bottom view of the dressing 110 illustrates details that can be associated with some implementation schemes. For example... Figure 18 and Figure 19As shown, in some examples of dressing 110, the periphery 1135 of the cover 125 may coexist with the periphery 1720 of the sealing layer 1705. The periphery 235 of the first membrane layer 205 may coexist with the periphery 265 of the main manifold 210 and the periphery 285 of the second membrane layer 215. The periphery of the central orifice 1750 may coexist with the periphery of the treatment orifice 1725 in the plane defined by the top surface 1125 of the cover 125 or the bottom surface 1715 of the sealing layer 1705. As previously mentioned... Figure 17 The shapes of the perimeters of the treatment orifice 1725 and the central orifice 1750 may be similar to those of the perimeters 235, 265, and 285, but scaled down, such that in the assembled configuration, a portion of the sealing layer 1705 surrounding the treatment orifice 1725 overlaps with a portion of the first membrane layer 205 surrounding the perimeter 235, and a portion of the cover 125 surrounding the central orifice 1750 overlaps with a portion of the second membrane layer 215 surrounding the perimeter 285.

[0151] Figures 20 to 27 This is a top view illustrating additional details that can be associated with some embodiments of the first film layer 205. For example, as Figure 17 As shown, the fluid channel 220 may include a first plurality of perforations 2005 and a second plurality of perforations 2010. Each of the first plurality of perforations 2005 and the second plurality of perforations 2010 may be a straight or curved perforation, such as a slot or slit. In some embodiments where the perforation is a straight slot or slit, each of the first plurality of perforations 2005 may have a length L1 and each of the second plurality of perforations 2010 may have a length L2. In some embodiments where the perforation is a curved slot or slit, each of the first plurality of perforations may have a length L1 measured from one end of the curved slot or slit to the other end, and each of the second plurality of perforations may have a length L2 measured from one end of the curved slot or slit to the other end. In some embodiments, length L1 may be equal to length L2. The first plurality of perforations 2005 and the second plurality of perforations 2010 may be distributed in one or more rows on the second layer in one or more directions.

[0152] In an exemplary embodiment, each of the first plurality of perforations 2005 may have a first major axis. In some embodiments, the first major axis may be parallel to a first reference line 2015 traveling in a first direction. In an exemplary example, each of the second plurality of perforations 2010 may have a second major axis. In an exemplary embodiment, the second major axis may be parallel to a second reference line 2020 traveling in a second direction. In some embodiments, one or both of the first reference line 2015 and the second reference line 2020 may be defined relative to an edge 2025 or a line of symmetry of the first film layer 205. For example, one or both of the first reference line 2015 and the second reference line 2020 may be parallel to or coincide with an edge 2025 or a line of symmetry of the first film layer 205. In some exemplary embodiments, one or both of the first reference line 2015 and the second reference line 2020 may be rotated by an angle relative to an edge 2025 of the first film layer 205. In an exemplary embodiment, angle α may define the angle between the first reference line 2015 and the second reference line 2020.

[0153] In some exemplary embodiments, the centroid of each of the first plurality of perforations 2005 in a row may intersect a third reference line 2030 traveling in a third direction. In an exemplary embodiment, the centroid of each of the second plurality of perforations 2010 in a row may intersect a fourth reference line 2035 traveling in a fourth direction. Generally, the centroid refers to the center of mass of a geometric object. In the case of a substantially two-dimensional object such as a straight slit, the centroid of the straight slit would be the midpoint.

[0154] The pattern of the fluid channels 220 can also be characterized by a spacing that indicates the interval between corresponding points on the fluid channels 220 within the pattern. In an exemplary embodiment, the spacing may indicate the interval between the centroids of the fluid channels 220 within the pattern. Some patterns may be characterized by a single spacing value, while others may be characterized by at least two spacing values. For example, if the interval between the centroids of the fluid channels 220 is the same in all orientations, the spacing may be characterized by a single value indicating the interval between the centroids in adjacent rows. In an exemplary embodiment, a pattern including a first plurality of perforations 2005 and a second plurality of perforations 2010 may be characterized by two spacing values ​​P1 and P2, where P1 is the interval between the centroids of each perforation in the first plurality of perforations 2005 in adjacent rows, and P2 is the interval between the centroids of each perforation in the second plurality of perforations 2010 in adjacent rows.

[0155] In exemplary embodiments, within each row of the first plurality of perforations 2005, each perforation may be separated from adjacent perforations by a distance D1. In some embodiments, within each row of the second plurality of perforations 2010, each perforation may be separated from adjacent perforations by a distance D2. In some patterns, the rows may be staggered. This staggering can be characterized by the orientation of corresponding points in consecutive rows relative to an edge or other reference line associated with the first film layer 205. In some embodiments, the rows of the first plurality of perforations 2005 may be staggered. For example, a fifth reference line 2040 in a fifth direction passes through the centroid of the corresponding perforation in an adjacent row of the first plurality of perforations 2005. In some exemplary embodiments, the staggering of the rows of the first plurality of perforations 2005 can be characterized by an angle β formed between the first reference line 2015 and the fifth reference line 2040. In additional exemplary embodiments, the rows of the second plurality of perforations 2010 may also be staggered. For example, a sixth reference line 2045 in a sixth direction passes through the centroid of the corresponding perforation in an adjacent row of the second plurality of perforations 2010. In some implementations, the staggering of the rows of the second plurality of perforations 2010 can be characterized by the angle γ formed between the first reference line 2015 and the sixth reference line 2045.

[0156] Figure 20 Examples of patterns that can be associated with some embodiments of fluid channel 220 are illustrated. Figure 20 In the example, each of the first plurality of perforations 2005 and the second plurality of perforations 2010 can be a straight slot or slit. The first reference line 2015 may be parallel to the edge 2025, and the second reference line 2020 may be orthogonal to the edge 2025. In an exemplary embodiment, the third reference line 2030 is orthogonal to the first reference line 2015, and the fourth reference line 2035 is orthogonal to the second reference line 2020. For example, the third reference line 2030 may coincide with the centroid of a corresponding perforation in an alternating row of the second plurality of perforations 2010, and the fourth reference line 2035 may intersect with the centroid of a corresponding perforation in an alternating row of the first plurality of perforations 2005. Figure 20 In the example, the fluid channels 220 are arranged in a cross-spacing pattern, wherein each of the first plurality of perforations 2005 is orthogonal along its first major axis to each of the second plurality of perforations 2010 along its second major axis. For example, in Figure 20In this diagram, P1 equals P2 (within acceptable manufacturing tolerances), and the cross-spacing pattern can be characterized by a single spacing value. Additionally, L1 and L2 can be substantially equal, and D1 and D2 can also be substantially equal, both within acceptable manufacturing tolerances. The rows of the first plurality of perforations 2005 and the rows of the second plurality of perforations 2010 can be characterized as staggered. For example, in some exemplary embodiments illustrated, α can be approximately 90°, β can be approximately 135°, γ can be approximately 45°, P1 can be approximately 4 mm, P2 can be approximately 4 mm, L1 can be approximately 3 mm, L2 can be approximately 3 mm, D1 can be approximately 5 mm, and D2 can be approximately 5 mm.

[0157] Figure 21 This is a schematic diagram of another exemplary pattern that can be associated with some exemplary embodiments of fluid channel 220. Figure 21 In an exemplary example, each of the first plurality of perforations 2005 and the second plurality of perforations 2010 may be a straight slit. The first reference line 2015 may be parallel to the edge 2025, and the second reference line 2020 may be orthogonal to the edge 2025. In some exemplary embodiments, the third reference line 2030 is orthogonal to the first reference line 2015, and the fourth reference line 2035 is orthogonal to the second reference line 2020. Figure 21 In the example, the third reference line 2030 does not intersect or contact any of the second plurality of perforations 2010, and the fourth reference line 2035 may intersect the centroid of the corresponding perforation in the alternating rows of the first plurality of perforations 2005. In an exemplary embodiment, the third reference line 2030 may be equidistant from the centroid of the corresponding adjacent perforation in each row of the second plurality of perforations 2010. Figure 21 The pattern can also be represented as a cross-spacing pattern, where P1 is not equal to P2. Figure 21 In the example, P1 is greater than P2. Additionally, in... Figure 21 In the example, L1, L2, D1, and D2 are substantially equal. In some implementations, α can be approximately 90°, β can be approximately 0°, such that the first reference line 2015 coincides with the fifth reference line 740, γ can be approximately 90°, P1 can be approximately 6 mm, P2 can be approximately 3 mm, L1 can be approximately 3 mm, L2 can be approximately 3 mm, D1 can be approximately 3 mm, and D2 can be approximately 3 mm.

[0158] Figure 22 Additional examples of patterns that can be associated with some embodiments of fluid channel 220 are illustrated. Figure 22In the example, each of the first plurality of perforations 2005 and the second plurality of perforations 2010 can be a straight slit. The first reference line 2015 may be parallel to the edge 2025, and the second reference line 2020 may be orthogonal to the edge 2025. In an exemplary embodiment, the third reference line 2030 is orthogonal to the first reference line 2015, and the fourth reference line 2035 is orthogonal to the second reference line 2020. Figure 22 In the example, the third reference line 2030 does not intersect or contact any of the second plurality of perforations 2010, and the fourth reference line 2035 does not intersect or contact any of the first plurality of perforations 2005. In an exemplary embodiment, the third reference line 2030 may be equidistant from the centroid of the corresponding adjacent perforation in each row of the second plurality of perforations 2010, and the fourth reference line 2035 may be equidistant from the centroid of the corresponding adjacent perforation in each row of the first plurality of perforations 2005. Figure 22 The pattern can be characterized as a cross-spacing pattern, where P1 is essentially equal to P2. Additionally, in Figure 22 In the example, L1, L2, D1, and D2 are substantially equal. In some implementations, α can be approximately 90°, β can be approximately 0°, such that the first reference line 2015 coincides with the fifth reference line 740, γ can be approximately 90°, P1 can be approximately 6 mm, P2 can be approximately 6 mm, L1 can be approximately 3 mm, L2 can be approximately 3 mm, D1 can be approximately 3 mm, and D2 can be approximately 3 mm.

[0159] Figure 23 Additional embodiments of the pattern are illustrated, which can be associated with some embodiments of the fluid channel 220. Figure 23 In the example, each of the first plurality of perforations 2005 and the second plurality of perforations 2010 can be a straight slit. The first reference line 2015 can form an angle θ with the edge 2025, and the second reference line 2020 can form an angle with the edge 2025. In an exemplary embodiment, the third reference line 2030 is orthogonal to the first reference line 2015, and the fourth reference line 2035 is orthogonal to the second reference line 2020. Figure 23 In the example, the third reference line 2030 does not intersect or contact any of the second plurality of perforations 2010, and the fourth reference line 2035 does not intersect or contact any of the first plurality of perforations 2005. In an exemplary embodiment, the third reference line 2030 may be equidistant from the centroid of the corresponding adjacent perforation in each row of the second plurality of perforations 2010, and the fourth reference line 2035 may be equidistant from the centroid of the corresponding adjacent perforation in each row of the first plurality of perforations 2005. Figure 23 The pattern can be characterized as a cross-spacing pattern, where P1 is essentially equal to P2. Additionally, in Figure 23In the example, L1 can be substantially equal to L2, and D1 can be substantially equal to D2. In some implementations, β can be approximately 0°, such that the first reference line 2015 coincides with the fifth reference line 2040, γ can be approximately 90°, θ can be approximately 45°, and It can be approximately 135°.

[0160] Figure 24 Examples that can be associated with some implementations of fluid channel 220 are illustrated. Figure 24 In some embodiments, each of the first plurality of perforations 2005 and the second plurality of perforations 2010 can be a straight slit. The first reference line 2015 may be parallel to the edge 2025, and the second reference line 2020 may be orthogonal to the edge 2025. In an exemplary embodiment, the third reference line 2030 is orthogonal to the first reference line 2015, and the fourth reference line 2035 is orthogonal to the second reference line 2020. For example, the third reference line 2030 may coincide with the centroid of a corresponding perforation in an alternating row of the second plurality of perforations 2010, and the fourth reference line 2035 may coincide with the centroid of a corresponding perforation in an alternating row of the first plurality of perforations 2005. Figure 24 In the example, the centroid of each perforation of the first plurality of perforations 2005 coincides with the centroid of the perforations of the second plurality of perforations 2010. The fluid channels 220 are arranged in a cross-spacing pattern, wherein each perforation of the first plurality of perforations 2005 along its first major axis is orthogonal to each perforation of the second plurality of perforations 2010 along its second major axis. For example, in Figure 24 In this context, P1 is substantially equal to P2, and the cross spacing pattern can be characterized by a single spacing value. Furthermore, L1 and L2 can be substantially equal, and D1 and D2 can also be substantially equal, all within acceptable manufacturing tolerances. The rows of the first plurality of perforations 2005 and the rows of the second plurality of perforations 2010 can be characterized as staggered. Figure 24 In some exemplary embodiments, α can be about 90°, β can be about 135°, and γ can be about 45°.

[0161] Figure 25 Additional embodiments associated with certain exemplary embodiments of fluid channel 220 are shown. Figure 25 In the example, each of the first plurality of perforations 2005 and the second plurality of perforations 2010 can be a straight slit. The first reference line 2015 can form an angle θ with the edge 2025. The second reference line 2020 can form an angle with the edge 2025. exist Figure 25 In an exemplary embodiment, the third reference line 2030 and the fourth reference line 2035 may be orthogonal to the edge 2025. Figure 25In the example, the row of the first plurality of perforations 2005 and the row of the second plurality of perforations 2010 can be characterized as mirror rows traveling in a direction parallel to the edge 2025 of the first film layer 205. For example, within acceptable manufacturing tolerances, L1 and L2 can be substantially equal, D1 and D2 can be substantially equal, and P1 and P2 can be substantially equal. In some embodiments, θ can be approximately 45°, and It can be approximately 135°. Figure 25 The pattern can be represented as a herringbone pattern.

[0162] Figure 26 Additional exemplary embodiments associated with certain exemplary embodiments of fluid channel 220 are shown. Figure 26 In the example, each of the first plurality of perforations 2005 and the second plurality of perforations 2010 can be a curved slit. The first reference line 2015 can form an angle θ with the edge 2025. The second reference line 2020 can form an angle with the edge 2025. exist Figure 26 In an exemplary embodiment, the third reference line 2030 and the fourth reference line 2035 may be parallel to the edge 2025. Figure 26 In the example, the row of the first plurality of perforations 2005 and the row of the second plurality of perforations 2010 can be characterized as mirror rows traveling in a direction parallel to the edge 2025 of the first film layer 205. The row of the first plurality of perforations 2005 and the row of the second plurality of perforations 2010 can be as follows: Figure 26 The implementation scheme is characterized as described above. For example, within acceptable manufacturing tolerances, L1 and L2 can be substantially equal, D1 and D2 can be substantially equal, and P1 and P2 can be substantially equal. In some implementation schemes, θ can be approximately 45°. It can be approximately 225°.

[0163] Figure 27 Additional embodiments associated with certain embodiments of fluid channel 220 are shown. Figure 27In the example, each of the first plurality of perforations 2005 and the second plurality of perforations 2010 can be characterized as a V-shaped slit. Each V-shaped slit can be formed by two orthogonal straight slits of the same length coinciding at their endpoints. The V-shaped slit can be characterized as pointing in a direction defined by a vector drawn from the centroid of the V-shaped slit to the coinciding endpoints. Within each row of the first plurality of perforations 2005, the V-shaped slits point in the same direction. Within each row of the second plurality of perforations 2010, the V-shaped slits point in the same direction. In an exemplary embodiment, the V-shaped slits of the first plurality of perforations 2005 and the V-shaped slits of the second plurality of perforations 2010 point in opposite directions. In an exemplary embodiment, the first reference line 2015 and the second reference line 2020 can be parallel to the edge 2025. In an exemplary embodiment, the third reference line 2030 and the fourth reference line 2035 can be orthogonal to the first reference line 2015. Figure 27 In the example, the row of the first plurality of perforations 2005 and the row of the second plurality of perforations 2010 can be characterized as a mirror row traveling in a direction orthogonal to the edge 2025 of the first membrane layer 205.

[0164] Figure 28 Further illustrations show exemplary embodiments that can be associated with some embodiments of the fluid channel 220. Certain patterns of the fluid channel 220 may include a third plurality of perforations 2805, a fourth plurality of perforations 2810, a fifth plurality of perforations 2815, and a sixth plurality of perforations 2820. Each of the third plurality of perforations 2805 may be a straight slit substantially orthogonal to the edge 2025 along its long axis. Each of the fourth plurality of perforations 2810 may be a straight slit substantially orthogonal to the long axis of the third plurality of perforations 2805 along its long axis. Each of the fifth plurality of perforations 2815 may be a curved slit whose long axis is rotated to form a 45° angle with the edge 2025. Each of the sixth plurality of perforations 2820 may be a curved slit whose long axis is rotated to form a 225° angle with the edge 2025. Within each row, the pattern of the fluid channel 220 can be a repeating pattern of one perforation from the fifth plurality of perforations 2815, one perforation from the third plurality of perforations 2805, one perforation from the sixth plurality of perforations 2820, one perforation from the fifth plurality of perforations 2815, one perforation from the third plurality of perforations 2810, and one perforation from the sixth plurality of perforations 2820 arranged in sequence. Each alternating row of the pattern of the fluid channel 220 can be offset by three positions in any direction.

[0165] Figures 29 to 31 This is a schematic diagram illustrating additional details that can be associated with some embodiments of the fluid channel 220. For example, as Figure 17As shown, fluid channels 220 can be patterned in rows on the first membrane layer 205. In some embodiments, each fluid channel 220 along a row can be rotated approximately 90° relative to its adjacent fluid channel 220. Each fluid channel 220 along a row can be rotated approximately 90° clockwise or approximately 90° counterclockwise relative to its preceding adjacent fluid channel 220 in that row. In an exemplary embodiment of the pattern of the fluid channels 220, every other row can be offset by one fluid channel 220 relative to the previous row. Figures 29 to 31 The pattern can be characterized as an offset row pattern. Figures 29 to 31 Exemplary embodiments of the pattern can also be characterized as the pattern of the rotating fluid channel 22.

[0166] Figure 29 An exemplary embodiment of the fluid channel 220 including a curved slit is illustrated. In some exemplary embodiments, the fluid channels 220 in a row alternate between being parallel to the edge 2025 of the first membrane layer 205 along the long axis of the fluid channel 220 and being orthogonal to the edge 2025 of the second membrane layer 205 along the long axis.

[0167] Figure 30 Some embodiments of the fluid channel 220 including a V-shaped slit are shown. In some exemplary embodiments, the fluid channels 220 in a row alternate between being parallel to the edge 2025 of the first membrane layer 205 along the long axis of the fluid channel 220 and being orthogonal to the edge 2025 of the first membrane layer 205 along the long axis.

[0168] Figure 31 An exemplary embodiment of the fluid channel 220 comprising split V-shaped slits is further described. Each split V-shaped slit may be formed by two orthogonal, non-random, straight slits that are mirror images of each other about an axis that bisects the angle formed by the intersection of the orthogonal long axes of the straight slits. In some exemplary embodiments, the fluid channel 220 within a row alternates between being parallel to the edge 2025 of the first membrane layer 205 along the long axis of the fluid channel 220 and being orthogonal to the edge 2025 of the second layer along the long axis.

[0169] In an additional embodiment, P1 may range from about 4 mm to about 6 mm, and P2 may range from about 3 mm to about 6 mm. In an exemplary embodiment, D1 may range from about 3 mm to about 5 mm, and D2 may range from about 3 mm to 5 mm. In some embodiments, the number of fluid channels 220 in the first plurality of perforations 2005 may be equal to the number of fluid channels 220 in the second plurality of perforations 2010.

[0170] Figure 32 It is an application taken at point 32-32 on the web to the exemplary tissue site 1305. Figure 17AA cross-sectional view of an exemplary dressing 110, and illustrated with... Figure 1 Additional details associated with the treatment system 100. In some embodiments, a dressing 110 may be applied to a tissue site 1305 and cover a wound 1310. For example, an occlusive layer 1705 may be placed on a portion of the tissue site 1305 surrounding the wound 1310. At least a portion of the bottom surface 1715 of the occlusive layer 1705 may contact a portion of the epidermis 1315 surrounding the wound 1310. At least a portion of the bottom surface 230 of the first membrane layer 205 may be placed within, on, against, or otherwise close to the wound 1310, and a portion of the bottom surface 230 of the first membrane layer 205 may be coupled to or adhered to a portion of the top surface 1710 of the occlusive layer 1705 near the treatment opening 1725. A cover 125 (which may have an adhesive 1330 coated on at least a portion of its bottom surface 1130) may be positioned over the second membrane layer 215, the main manifold 210, and the first membrane layer 205 such that at least a portion of the bottom surface 1130 or the adhesive 1330 contacts at least a portion of the top surface 275 of the second membrane layer 215 and a portion of the top surface 1710 of the sealing layer 1705. A secondary manifold 1105 may be disposed over the orifice 1745 of the second membrane layer 215 such that at least a portion of the bottom surface 1115 of the secondary manifold 1105 contacts at least a portion of the top surface 275 of the second membrane layer 215 surrounding the orifice 1745. The dressing interface 1150 may be disposed on at least a portion of the top surface 1110 of the sub-manifold 1105, and the connector cover 1755 may be coupled to or adhered to at least a portion of the surface of the dressing interface 1150, at least a portion of the surface of the top surface 1110 of the sub-manifold 1105, at least a portion of the top surface 275 of the second membrane layer 215, and / or at least a portion of the top surface 1125 of the cover 125. Therefore, the dressing 110 provides a sealed therapeutic environment 1335 close to the wound 1310.

[0171] During operation, negative pressure can be provided to wound 1310 and / or fluid can be removed from wound 1310 from sealed treatment environment 1335 via negative pressure source 105. For example, fluid can travel from wound 1310 through at least one of fluid channel 220, first plurality of perforations 2005, second plurality of perforations 2010, third plurality of perforations 2805, fourth plurality of perforations 2810, fifth plurality of perforations 2815 and / or sixth plurality of perforations 2820 into a portion of sealed treatment environment 1335 defined by the space between the top surface 225 of first membrane layer 205, the bottom surface 260 of main manifold 210 and support 905. Fluid can then travel through window 240 and enter a portion of sealed treatment environment 1335 defined by the space between the top surface 255 of main manifold 210, the bottom surface 280 of second membrane layer 215 and folds 1605. The fluid can then travel through orifice 1745 and into a portion of the sealed treatment environment 1335, defined as the space between the top surface 275 of the second membrane layer 215, the bottom surface 1765 of the connector cover 1755, the surface of the dressing interface 1150 facing the sub-manifold 1105, and / or the space within the empty space of the sub-manifold 1105. Fluid can be removed from the dressing 110 through the dressing interface 1150, and optionally collected in container 115.

[0172] Figure 32A Is Figure 32 label in Figure 32A The detailed image captured here illustrates what can be compared to... Figure 32Additional details associated with some exemplary embodiments of the exemplary dressing 110. For example, the sealing layer 1705 may have sufficient adhesiveness at the bottom surface 1715 to hold the dressing 110 in place relative to the epidermis 1315 and wound 1310, while also allowing the dressing 110 to be removed or repositioned without damaging the epidermis 1315, wound 1310, and / or tissue site 1305. For example, the sealing layer 1705 may be formed of a silicone polyurethane material that forms a sealant bond with the epidermis 2110 at the bottom surface 1715. In some embodiments, based on ASTM D3330, the bond strength or adhesion of the sealant bond on a stainless steel substrate may have a peel adhesion or peel resistance between about 0.5 N / 25 mm and about 1.5 N / 25 mm. The sealing layer 1705 may achieve this bond strength after a contact time of less than 60 seconds. Adhesion can be considered as the bond strength between the adhesive and the substrate after a very short contact time. In an exemplary embodiment, the sealant 1705 may have a thickness ranging from about 200 micrometers to about 1,000 micrometers. Removing the release liner 1780 may also expose the adhesive 1330 through the orifices 1730 of the sealant 1705. In the assembled state, the thickness of the sealant 1705, through the orifices 1730, can create a gap between the adhesive 1330 and the skin 1315, preventing the adhesive 1330 from contacting the skin 1315.

[0173] Figure 32B The illustration shows that Figure 32 In some implementations of the dressing 110, it can be used with Figure 32A Additional details associated with the detailed drawing. Figure 32B The adhesive is shown after the adhesive 1330 has been brought into contact with the skin 1315 by a force 3205 applied to the top surface 1125 of the cover 125 at the orifice 1730. In use, if the assembled dressing 110 is in the desired position, the force 3205 can be applied to the top surface 1125 at the orifice 1730 such that the adhesive 1330 is at least partially pressed into contact with the skin 1315 to form an adhesive bond. The adhesive bond provides a strong, releasable mechanical fixation of the dressing 110 to the skin 1315. The sealing bond between the sealing layer 1705 and the skin 1315 may not be as strong mechanically as the adhesive bond between the adhesive 1330 and the skin 1315. The adhesive bond anchors the dressing 110 to the skin 1315, thereby inhibiting the migration of the dressing 110.

[0174] In an exemplary embodiment, the main manifold 210 may be formed as a polymer mesh structure made of a gel elastomer. For example, the mesh members of the main manifold 210 may be formed in the shape of a brush and a comb, or any combination of geometries. The window 240 may be square, rectangular, circular, or any other suitable shape.

[0175] The systems, apparatus, and methods described herein offer significant advantages. For example, providing a dressing 110 having a substantially light-transmitting or optically transparent first membrane 205, an adhesive 1330, a second membrane 215, and a covering 125 facilitates observation of the wound 1310 through the window 240. In exemplary embodiments, for example, such as Figure 14B As shown, when negative pressure is introduced into the sealed treatment environment 1335, multiple portions of the second membrane 215 can contact multiple portions of the first membrane 205. In the example where at least a portion of the second membrane 215 contacts the first membrane 205, which can contact the epidermis 1315 or the wound 1310, the optical clarity of the epidermis 1315 or the wound 1310 when viewed through the window 240 is improved. Generally, a higher level of optical clarity can be achieved when the refractive index of the lens material is constant in the viewing direction. In exemplary embodiments of viewing the wound 1310 through the cover 125, adhesive 1330, second membrane 215, air gaps in the window 240, and first membrane 205, for example, as Figure 14A As shown, the optical quality may be reduced due to the air gap in window 240 and the different refractive indices of cover 125, adhesive 1330, second film layer 215, and first film layer 205. However, by bringing the second film layer 215 into contact with the first film layer 205, the air gap can be eliminated or minimized. In an exemplary embodiment where at least a portion of the second film layer 215 is in contact with the first film layer 205 and the refractive indices of these layers are substantially the same, high optical clarity can be achieved when observing the wound 1310 through window 240.

[0176] In an exemplary embodiment, when the system 100 is under negative pressure, increasing the thickness of the first membrane layer 205 can reduce the stress exerted on the wound 1310 by the master node 245 or the support 905. For example, when a therapeutic level of negative pressure is introduced into the sealed therapeutic environment 1335, the pressure within the sealed therapeutic environment 1335 below the bottom surface 1130 of the cover 125 can be lower than the ambient atmospheric pressure outside the dressing 110 (such as adjacent to the top surface 1125 of the cover 125). The resultant force from the pressure gradient drags the cover 125 toward the wound 1310, and also drags the main manifold 210 toward the wound 1310. Therefore, the master node 245 or the support 905 can be dragged toward the wound 1310. In the example with a thicker first membrane layer 205, a larger portion of the stress field generated by the master node 245 being dragged toward the wound 1310 can be contained within the first membrane layer 205 and not transmitted to the wound 1310. The thickness of the first membrane layer 205 and the size of the slot or slit forming the fluid channel 220 can be selected to selectively introduce a larger or smaller stress field into the wound 1310. For example, a wider slot can be selected for the fluid channel 220 having a thicker first membrane layer 205 to prevent a narrower slot or slit from remaining closed under negative pressure. For example, in some applications where the first membrane layer 205 or the second membrane layer 215 has a thickness of less than about 100 micrometers, a slit may be suitable as the fluid channel 220, and in some applications where the first membrane layer 205 or the second membrane layer 215 has a thickness greater than about 100 micrometers, a slot may be suitable as the fluid channel 220.

[0177] refer to Figures 33A to 34B This presents another exemplary embodiment of a main manifold 210 suitable for use with devices, dressings, and systems for treating tissue sites according to this disclosure. In some exemplary embodiments, the main manifold 210 may be configured to... Figure 34A The retraction state 3405 shown is related to Figure 34B The extension states 3410 shown move between. The main manifold 210 may include a top surface 255 and a bottom surface 260, the bottom surface being positioned opposite the top surface 255 and configured to face tissue sites, such as… Figure 37 The tissue portion 1305 is shown. In some exemplary embodiments, the main manifold 210 may include a fold 1605, which may be positioned adjacent to the extension region 3305. The extension region 3305 may be configured to extend outward from the bottom surface 260 of the main manifold 210 toward the tissue portion 1305 when the main manifold 210 is in the extension state 3410. Figure 34A In the retracted state 3405 shown, the bottom surface 260 of the main manifold 210 may have a generally planar shape 3415 compared to the shape of the bottom surface 260 in the extended state 3410.

[0178] For example, in some embodiments, the bottom surface 260 of the main manifold 210 can be configured to form a convex shape 3420, such as Figure 34B As shown, when the main manifold 210 is in the extended state 3410, the convex shape can be positioned to correspond to the tissue site 1305 and the wound 1310, such as... Figure 37 As shown. In some embodiments, the main manifold 210 may be configured to move from a retracted state 3405 to an extended state 3410 when negative pressure is applied to the manifold 210 (e.g., when positioned at tissue site 1305). Alternatively, in some embodiments, the main manifold 210 may be configured to move from a retracted state 3405 to an extended state 3410 when an external force 3425 is applied to the top surface 255 and / or the bottom surface 255 of the main manifold 210. The external force 3425 may be a thrust on the top surface 255 and / or a pull on the bottom surface 260 of the main manifold 210.

[0179] refer to Figures 33A to 35B In some embodiments, the fold 1605 may include a fold 3310 or undulation in the main manifold 210, which is configured to allow multiple portions of the main manifold 210 to move away from each other, unfold, or extend as the main manifold 210 moves from a retracted state 3405 to an extended state 3410. For example, Figures 34A to 35B The cross-sectional view of the fold 1605 shown illustrates a fold 3310 between a first portion 3430 of each fold 1605 in the main manifold 210 and a second portion 3435 of each fold 1605 in the main manifold 210. At least a portion of the first portion 3430 may be configured to overlap with the second portion 3435 in the cross-section of each fold 1605 when the main manifold 210 is in the retracted state 3405. Furthermore, at least a portion of the first portion 3430 may be configured to move away from or extend away from the second portion 3435 in the cross-section of each fold 1605 when the main manifold 210 is in the extended state 3410.

[0180] For more specific reference Figures 35A to 35B The diagram shows a cross-section of one embodiment of the pleats 1605, wherein the first film layer 205 and the second film layer 215 were previously in... Figures 2 to 6 and Figure 17 As described in the implementation plan (but not limited to this implementation plan). Figures 35A to 35B As shown, the first film layer 205 and / or the second film layer 215 may optionally be attached to the fold 1605 and configured to move together with the fold from the retracted state 3405 to the extended state 3410.

[0181] refer to Figures 36A to 36BIn some exemplary embodiments, the pleat 1605 may have an undulating or wave-like shape. For example, the fold 3310 may have a peak and valley shape located between the first portion 3430 and the second portion 3435 of the pleat 1605. The fold 3310, the first portion 3430, and the second portion 3435 of the pleat 1605 may together form an undulating or wave-like shape, which may be adapted to... Figures 33A to 35B The implementation scheme is constructed in a similar or analogous manner to allow multiple portions of the main manifold 210 to move, unfold, or extend away from each other as the main manifold 210 moves from the retracted state 3405 to the extended state 3410. Furthermore, similar to... Figures 35A to 35B Implementation plan, Figures 36A to 36B The embodiment illustrates a first film layer 205 and / or a second film layer 215, which may optionally be coupled to a pleat 1605 and configured to move together with the pleat from a retracted state 3405 to an extended state 3410.

[0182] Refer again Figures 33A to 35B In some exemplary embodiments, a second portion 3435 of the fold 3310 in the main manifold 210 may be positioned between the first portion 3430 of the fold 3310 and the extension region 3305. Furthermore, in some exemplary embodiments, the fold 1605 may be positioned around the extension region 3305.

[0183] Furthermore, in some exemplary embodiments, the main manifold 210 may include a plurality of pleats 1605 and a plurality of extension regions 3305. In some examples, the plurality of pleats 1605 and the plurality of extension regions 3305 may alternate on the top surface 255 and the bottom surface 260 of the main manifold 210. In some examples, one of the extension regions 3305 may be positioned between two pleats of pleats 1605 located on the top surface 255 and the bottom surface 260 of the main manifold 210. In some examples, the plurality of pleats 1605 and the plurality of extension regions 3305 may be positioned on the top surface 255 and the bottom surface 260 of the main manifold 210 in alternating concentric rings. In some examples, one or more pleats of the plurality of pleats 1605 may be circumferentially positioned around one or more extension regions of the plurality of extension regions 3305. In some examples, when the main manifold 210 is in the extended state 3410, one or more of the extension regions 3305 may extend further outward from the bottom surface 260 of the main manifold 210 than another extension region in the extension region 3305.

[0184] In some exemplary embodiments, the main manifold 210 may include or may be a polymer with a hardness in the range of about 10 A to about 40 A Shore A. Alternatively, in some examples, the main manifold 210 may include or may be polyurethane or silicone. Alternatively, in some examples, the main manifold 210 may include or may be formed of a transparent material configured to provide visual perception of the tissue site 1305 through the main manifold 210.

[0185] In addition, as previously stated Figures 9A to 10B as well as Figures 16 to 17 The implementation plan (but not limited to the implementation plan) described therein, Figures 33A to 37 Some examples of the main manifold 210 shown in the embodiments may include a plurality of supports 905 that may extend outward from one or both of the top surface 255 and / or the bottom surface 260 of the main manifold 210. Although not shown, multiple portions of the folds 1605 may include surface features, such as supports 905 or similar features, that are configured to create a flow channel or passage on the surface of the main manifold 210.

[0186] In addition, as previously stated Figures 9A to 10B as well as Figures 16 to 17 The implementation plan (but not limited to the implementation plan) described therein, Figures 33A to 37 Some examples of the main manifold 210 shown in the embodiments may include a plurality of manifold openings 240 through the top surface 255 and bottom surface 260 of the main manifold 210. In some examples, the manifold openings 240 may be configured to provide fluid communication through the top surface 255 and bottom surface 260 of the main manifold 210. Furthermore, some examples of the manifold openings 240 may be constructed or positioned on the main manifold 210 in a grid pattern.

[0187] Alternatively, the manifold opening 240 may be configured as a window providing visual perception of the tissue site 1305 through the top surface 255 and bottom surface 260 of the main manifold 210. Furthermore, Figures 33A to 37 In one implementation, the main manifold 210 may include a plurality of main nodes 245 interconnected to define a window and a plurality of connectors 250, such as Figure 2 Similar to the example shown. Furthermore, in some examples, each master node in master node 245 may include at least one of the supports in support 905.

[0188] In addition, as previously stated Figures 2 to 6 and Figure 17 The implementation plan (but not limited to the implementation plan) described therein, Figures 33A to 37Some exemplary embodiments of the main manifold 210 may include a polymer membrane adjacent to at least the bottom surface 260. The polymer membrane may include a plurality of fluid channels 220, 270, which may be or may include slits, slots, windows, or perforations as described above. For example, as Figures 35A to 36B and Figure 37 As shown, the first polymer film 205 may be positioned adjacent to the bottom surface 260 of the main manifold 210, and the second polymer film 215 may be positioned adjacent to the top surface 255 of the main manifold 210.

[0189] At least the first polymer membrane 205 may include a plurality of fluid channels 220. Figures 33A to 37 In some examples of the implementation scheme, the first polymer membrane 205 may include a plurality of first fluid channels 220, and the second polymer membrane 215 may include [missing information - likely related to fluid flow patterns]. Figures 2 to 6 and Figure 17 The multiple second fluid channels 270 shown are similar to those shown.

[0190] Furthermore, similar to but not limited to Figures 2 to 6 and Figure 17 Exemplary implementations, in Figures 33A to 37 In some embodiments, the first polymer film 205 may have a first thickness and the second polymer film 215 may have a second thickness. Furthermore, the first thickness of the first polymer film 205 may be greater than the second thickness of the second polymer film 215. In some examples, the second thickness of the second polymer film 215 may range from about 20 micrometers to about 500 micrometers.

[0191] Furthermore, similar to but not limited to Figures 2 to 6 and Figure 17 Exemplary implementations, Figures 33A to 37 The main manifold 210 can be bonded to at least one of the first polymer membrane 205 and the second polymer membrane 215. Furthermore, the first polymer membrane 205 can be at least partially bonded to the second polymer membrane 215 around the main manifold 210. Additionally, the main manifold 210, the first polymer membrane 205, and the second polymer membrane 215 can each have a periphery that extends into each other.

[0192] refer to Figure 37 In some exemplary embodiments, the treatment system 100 may include Figures 33A to 36BThe example includes the main manifold 210 or a device including the main manifold 210. As previously described, the treatment system 100 may include a cover drape configured to be positioned over or form part of the dressing 110 or another device including the main manifold 210. The cover drape may be configured to seal to tissue adjacent to tissue site 1305 to form a sealed environment 1335. The cover drape may be one or more of the following: a cover 125, a second membrane layer 215, or a connector cover drape 1755, such as Figure 37 As shown. Although the cover 125, the second membrane layer 215, and the connector cover 1755 are shown as separate components, in other embodiments, the cover 125, the second membrane layer 215, and the connector cover 1755 may instead be a single cover or sealing structure, or a combination of one or more of the cover 125, the second membrane layer 215, and the connector cover 1755 constructed in any suitable manner to form a sealed environment 1335. Furthermore, one or more of the cover 125, the second membrane layer 215, and the connector cover 1755 may be omitted in various configurations. The treatment system 100 may also include a negative pressure source 105 configured to provide negative pressure to the sealed environment 1335.

[0193] As previously described, in some exemplary embodiments, the treatment system 100 may include a secondary manifold 1105 configured to be positioned adjacent to the main manifold 210, or a device comprising the main manifold 210 opposite to the tissue site 1305. Furthermore, in some exemplary embodiments, the treatment system 100 may include a first polymer membrane 205 positioned adjacent to the bottom surface 260 of the main manifold 210 and a second polymer membrane 215 positioned adjacent to the top surface 255 of the main manifold 210. The first polymer membrane 205 may be configured to be positioned adjacent to the tissue site 1305, and the secondary manifold 1105 may be configured to be positioned adjacent to the second polymer membrane 215. In some embodiments, a portion of a cover (e.g., connector cover 1755) may be configured to be positioned adjacent to a portion of the second polymer membrane 215. Additionally, in some embodiments, the secondary manifold 1105 may be configured to be positioned between the cover and the second polymer membrane 215.

[0194] Furthermore, in some exemplary embodiments, a method of treating tissue site 1305 using negative pressure may include positioning a main manifold 210 or a device including the main manifold 210 close to the tissue site 1305; applying negative pressure to a sealed environment 1335 including the main manifold 210 at the tissue site 1305; and moving the main manifold 210 to an extended state 3410 by operating the negative pressure, such that the bottom surface 260 of the main manifold 210 is configured to form a convex shape 3420 consistent with the tissue site 1305 when the main manifold 210 is in the extended state 3410.

[0195] Furthermore, in some exemplary embodiments, a method of treating tissue site 1305 using negative pressure may include positioning a main manifold 210 or a device including the main manifold 210 close to the tissue site 1305; applying negative pressure to the tissue site 1305 to a sealed environment 1335 including the main manifold 210; and extending one or more extension regions 3305 outward from the bottom surface 260 of the main manifold 210 toward the tissue site 1305.

[0196] Furthermore, in some exemplary embodiments, a method for treating tissue site 1305 according to the present disclosure may include viewing tissue site 1305 through one or more openings 240 provided through the main manifold 210. Alternatively or additionally, some exemplary methods for treating tissue site 1305 according to the present disclosure may include viewing tissue site 1305 through a transparent material forming at least a portion of the main manifold 210.

[0197] In some embodiments, the main manifold 210 or dressing 110 or one or more components of a device including the main manifold 210 may be subjected to a thermoforming process. For example, one or more of the cover, covering 125, main manifold 210, first membrane 205, and second membrane 215 may be thermoformed to impart the previously described features and constructions to the main manifold 210 and dressing 110 or device, such as, but not limited to, one or more of pleats 1605, extensions 3305, and supports 905.

[0198] In some embodiments, two or more components of dressing 110 may be joined together prior to thermoforming. Alternatively, in some embodiments, two or more components of dressing 110 may be thermoformed separately from each other and then joined together after thermoforming. For example, in some embodiments, cover 125, main manifold 210, first membrane 205, and second membrane 215 may be joined together first and then subjected to thermoforming. Alternatively, in some embodiments, two or more of cover 125, main manifold 210, first membrane 205, and second membrane 215 may be thermoformed prior to being joined to adjacent components of dressing 110.

[0199] In some implementations, the thermoforming process includes heating the precursor material to a temperature at which the precursor material becomes pliable. In various implementations, the parameters associated with heating the precursor material can be selected based on factors including the material to be thermoformed.

[0200] Additionally, in some embodiments, the heated precursor material may be shaped to a model or mold, such as a mandrel. Typically, the model to which the heated precursor material is shaped may be selected based on the desired characteristics of the resulting component (such as the main manifold 210) of the tissue interface 120. For example, the model may include a portion of the inner or outer surface of a three-dimensional shape, such as a sphere, ellipsoid, torus, cylinder, parabola, hyperboloid, cone, prism, pyramid, tetrahedron, or a combination thereof. The heated precursor material may be shaped by any suitable method. For example, in some embodiments, the heated precursor material may be shaped to a model or mold by vacuum. Additionally, in some embodiments, the heated precursor material may be cooled while shaping the model, and after cooling, one or more surface features may be imparted to one or more of the cover 125, the main manifold 210, the first membrane layer 205, and the second membrane layer 215.

[0201] In some embodiments, in addition to or as an alternative to imparting one or more surface features to components of dressing 110, the thermoforming process can also effectively modify one or more parameters associated with dressing 110, tissue interface 120, or one or more of its components (e.g., cover 125, main manifold 210, first film 205, and second film 215). For example, in some embodiments, dressing 110, one or more of its components, or combinations thereof can be characterized as exhibiting a reduction in tensile strength after and / or due to the thermoforming process. For example, dressing 110, one or more of its components, or combinations thereof can be characterized as exhibiting a reduction in tensile strength compared to an otherwise similar, non-thermoformed dressing. In some embodiments, dressing 110, one or more components of dressing 110, or some combination of components of dressing 110 may exhibit a reduction in tensile strength of at least 10%, or at least 15%, or at least 20%, or at least 25%, or at least 30%, or at least 35%, or at least 40% due to thermoforming or compared to a non-thermoformed dressing that is otherwise similar.

[0202] In addition or alternatively, in some embodiments, dressing 110, one or more components of dressing 110, or combinations of components of dressing 110 may be characterized as exhibiting increased flexurality after and / or due to the thermoforming process. For example, dressing 110, one or more components of dressing 110, or combinations of components of dressing 110 may be characterized as exhibiting increased flexurality compared to otherwise similar dressings that have not been thermoformed.

[0203] In addition or alternatively, in some embodiments, dressing 110, one or more components of dressing 110, or combinations of components of dressing 110 may be characterized as exhibiting improved conformity relative to the tissue site after and / or due to the thermoforming process. For example, dressing 110, one or more components of dressing 110, or combinations of components of dressing 110 may be characterized as exhibiting improved conformity with respect to the tissue site compared to an otherwise similar, non-thermoformed dressing.

[0204] For example, increased flexural strength and / or improved conformability may be caused by a decrease in the tensile strength of dressing 110, one or more components or features of dressing 110, or some combination of components of dressing 110. (Reference) Figure 37 , Figure 17 A cross-sectional view of the embodiment of the dressing 110 is illustrated, positioned relative to the patient's tissue site 1305. (As shown) Figure 37 As shown, when positioned relative to tissue site 1305, dressing 110 can extend over tissue site 1305, such that dressing 110 is supported by surrounding tissue around its periphery. In some embodiments, such as, for example, combined with Figure 34B The application of an external force 3425 to the dressing 110 in the direction of the tissue site 1305 can subject a region of the dressing 110, one or more components of the dressing 110, or a combination of components of the dressing 110 to tension. In some embodiments, a decrease in the tensile strength of the dressing 110, one or more components of the dressing 110, or a combination of components of the dressing 110 (e.g., caused by a thermoforming process) can cause the dressing 110, one or more components of the dressing 110, or a combination of components of the dressing 110 to exhibit increased flexural strength and / or improved conformability.

[0205] In some embodiments, for example, dressing 110 may be subjected to a thermoforming process as a whole, such that all various components of dressing 110 may be subjected to a thermoforming process. Alternatively, in some embodiments, less than all of dressing 110 may be subjected to a thermoforming process. For example, in some embodiments, less than all of one or more components of dressing 110 may be subjected to a thermoforming process. In addition or alternatively, in some embodiments, for example, dressing 110 and / or one or more components of dressing 110 may include various regions that have undergone thermoforming processes to varying degrees, such that dressing 110 and / or one or more components of dressing 110 may exhibit variations in tensile strength, flexural strength, and / or conformability at their various regions. For example, in some embodiments, dressing 110 and / or one or more components of dressing 110 may include one or more thermoformed regions, such as one or more tension-relief regions. Figures 33A to 37In one implementation, such a tension-relieving area can be configured, for example, as a fold 1605, which allows an extension area 3305 to extend outward from the bottom surface 260 of the main manifold 210 to coincide with the tissue site 1305, as described herein.

[0206] In some embodiments, dressing 110 may be advantageously used to provide negative pressure therapy, for example, due to the reduced tensile strength, increased flexure, and / or improved conformability exhibited by dressing 110 relative to the tissue site. For example, the increased flexure and / or improved conformability of dressing 110 may allow dressing 110 to provide better contact between tissue site 1305 and the tissue site-facing surface of dressing 110. The improved contact between dressing 110 and tissue site 1305 may have the effect of inducing microstrain on substantially all tissue sites 1305, thereby subjecting cells on tissue site 1305 to strain, thus improving the outcome of negative pressure therapy.

[0207] Although illustrated in several exemplary embodiments, those skilled in the art will recognize that the systems, apparatuses, and methods described herein are readily adaptable to various changes and modifications that fall within the scope of the appended claims. Furthermore, the descriptions using various alternative terms such as “or” need not be mutually exclusive unless the context explicitly requires it, and the indefinite articles “a” or “an” do not limit the subject matter to a single instance unless the context explicitly requires it. Components may also be combined or eliminated in various configurations for purposes of sale, manufacture, assembly, or use. For example, in some configurations, any combination of dressing 110, container 115, tissue interface 120, cover 125, or components may be eliminated or separated from the manufacture or sale of other components. In other exemplary configurations, controller 130 may also be manufactured, configured, assembled, or sold independently of other components. Additional features, elements, and aspects described herein in the context of some embodiments may also be omitted, combined, or replaced by alternative features for the same, equivalent, or similar purposes without departing from the scope of the invention as defined by the appended claims.

[0208] This invention also provides the following items:

[0209] 1. A device for treating tissue sites using negative pressure, the device comprising:

[0210] A main manifold, configured to move between a retracted state and an extended state, the main manifold comprising:

[0211] A top surface and a bottom surface, the bottom surface being positioned opposite the top surface and configured to face the tissue portion, and

[0212] A fold, the fold being positioned adjacent to an extension region, wherein the extension region is configured to extend outward from the bottom surface toward the tissue portion when the main manifold is in the extended state.

[0213] 2. The apparatus according to item 1, wherein the bottom surface of the main manifold is configured to form a convex shape consistent with the tissue portion when the main manifold is in the extended state.

[0214] 3. The apparatus according to Item 1, wherein the main manifold is configured to move from the retracted state to the extended state when a negative pressure is applied at the tissue site.

[0215] 4. The apparatus according to item 1, wherein the main manifold is configured to move from the retracted state to the extended state when an external force is applied to the top surface of the main manifold.

[0216] 5. The apparatus according to item 1, wherein the folds include a fold located in the main manifold.

[0217] 6. The apparatus according to item 1, wherein the cross-section of the fold includes a fold located between a first portion and a second portion of the main manifold, wherein at least a portion of the first portion is configured to overlap with the second portion when the main manifold is in the retracted state, and wherein at least a portion of the first portion is configured to move away from the second portion in the extended state.

[0218] 7. The apparatus according to item 6, wherein the second portion of the main manifold is positioned between the first portion of the main manifold and the extension region.

[0219] 8. The apparatus according to item 1, wherein the folds are positioned around the extension region.

[0220] 9. The apparatus according to item 1, wherein the folds include a plurality of folds, wherein the extension regions include a plurality of extension regions, and wherein the plurality of folds and the plurality of extension regions alternate on the top and bottom surfaces of the main manifold.

[0221] 10. The apparatus according to item 1, wherein the folds include a plurality of folds, wherein the extension regions include a plurality of extension regions, and wherein one of the extension regions is positioned between two folds on the top and bottom surfaces of the main manifold.

[0222] 11. The apparatus according to item 1, wherein the folds include a plurality of folds, wherein the extension regions include a plurality of extension regions, and wherein the plurality of folds and the plurality of extension regions are positioned in alternating concentric rings on the top and bottom surfaces of the main manifold.

[0223] 12. The apparatus according to item 1, wherein the folds include a plurality of folds, wherein the extension regions include a plurality of extension regions, and wherein one or more of the plurality of folds are circumferentially positioned around one or more of the plurality of extension regions.

[0224] 13. The apparatus according to item 1, wherein the folds include a plurality of folds, wherein the extension regions include a plurality of extension regions, and wherein when the main manifold is in the extended state, one or more of the extension regions extend further outward from the bottom surface of the main manifold than another of the extension regions.

[0225] 14. The apparatus of claim 1, further comprising a plurality of manifold openings through the top surface and the bottom surface, wherein the manifold openings are configured to provide fluid communication through the top surface and the bottom surface of the main manifold.

[0226] 15. The apparatus according to item 1, wherein the main manifold comprises a polymer with a hardness in the range of about Shore 10A to about Shore 40A.

[0227] 16. The apparatus according to item 1, wherein the main manifold further includes a plurality of supports extending outwardly from one or both of the top surface and the bottom surface.

[0228] 17. The apparatus according to item 1, the apparatus further comprising a first polymer membrane and a second polymer membrane, the first polymer membrane being positioned adjacent to the bottom surface of the main manifold and the second polymer membrane being positioned adjacent to the top surface of the main manifold, wherein at least the first polymer membrane includes a plurality of fluid channels.

[0229] 18. A system for treating tissue sites using negative pressure, the system comprising:

[0230] The apparatus according to any of the foregoing items;

[0231] A cover cloth, configured to be positioned over at least a portion of the device and sealed to tissue adjacent to the tissue site to form a sealed environment; and

[0232] A negative pressure source, which is configured to provide negative pressure to the sealed environment.

[0233] 19. A method for treating tissue sites using negative pressure, the method comprising:

[0234] The device described in any of the foregoing items will be positioned close to the tissue site;

[0235] Apply negative pressure to the sealed environment including the device at the tissue site; and

[0236] The main manifold is moved to the extended state by the operation of the negative pressure, wherein the bottom surface of the main manifold is configured to form a convex shape consistent with the tissue region when the main manifold is in the extended state.

[0237] 20. A method for treating tissue sites using negative pressure, the method comprising:

[0238] The device described in any of the foregoing items will be positioned close to the tissue site;

[0239] Apply negative pressure to the sealed environment including the device at the tissue site; and

[0240] One or more extension zones extend outward from the bottom surface of the main manifold toward the tissue site.

[0241] 21. The method according to item 19 or item 20, the method further comprising viewing the tissue site through one or more openings provided through the main manifold.

[0242] 22. The method according to item 19 or item 20, the method further comprising viewing the tissue site through a transparent material forming at least a portion of the main manifold.

[0243] 23. The apparatus of claim 1, wherein the main manifold is formed of a transparent material configured to provide visual perception of the tissue site through the main manifold.

[0244] 24. The apparatus according to item 1, wherein the main manifold comprises polyurethane or silicone with a hardness in the range of about Shore 10A to about Shore 40A.

[0245] 25. The apparatus of claim 14, wherein the manifold opening is a window, the window being further configured to provide visual perception of the tissue site through the top and bottom surfaces of the main manifold.

[0246] 26. The apparatus according to item 14, wherein the manifold opening is constructed in a grid pattern.

[0247] 27. The apparatus of claim 25, wherein the main manifold further includes a plurality of main nodes and a plurality of connectors interconnected to define the window.

[0248] 28. The apparatus of claim 25, wherein the main manifold further includes a plurality of supports extending outwardly from one or both of the top surface and the bottom surface, wherein the main manifold includes a plurality of main nodes interconnected to define the window and a plurality of couplings, and wherein each of the main nodes includes at least one of the supports.

[0249] 29. The apparatus according to item 1, further comprising a polymer membrane adjacent to the bottom surface of the main manifold, the polymer membrane comprising a plurality of fluid channels.

[0250] 30. The apparatus of claim 17, wherein the first polymer membrane includes a plurality of first fluid channels and the second polymer membrane includes a plurality of second fluid channels.

[0251] 31. The apparatus according to item 17, wherein:

[0252] The first polymer film has a first thickness;

[0253] The second polymer film has a second thickness; and

[0254] The first thickness is greater than the second thickness.

[0255] 32. The apparatus according to item 31, wherein the second thickness is in the range of about 20 micrometers to about 500 micrometers.

[0256] 33. The apparatus according to item 17, wherein the main manifold is bonded to at least one of the first polymer membrane and the second polymer membrane.

[0257] 34. The apparatus of claim 17, wherein the first polymer membrane is at least partially bonded to the second polymer membrane around the main manifold.

[0258] 35. The apparatus according to item 17, wherein the main manifold, the first polymer membrane, and the second polymer membrane each have a periphery that extends into each other.

[0259] 36. The apparatus according to item 17, wherein the plurality of fluid channels comprises a plurality of slots, each of the slots having a length of less than 5 mm and a width of less than 2 mm.

[0260] 37. The apparatus according to item 17, wherein the plurality of fluid channels comprises a plurality of slits, each of the slits having a length of less than 5 millimeters.

[0261] 38. The system according to item 18, the system further comprising a submanifold configured to be positioned relative to the tissue site and adjacent to the device.

[0262] 39. The system according to item 38, the system further comprising a first polymer membrane positioned adjacent to the bottom surface of the main manifold and a second polymer membrane positioned adjacent to the top surface of the main manifold, wherein the first polymer membrane is configured to be positioned adjacent to the tissue site, and wherein the sub-manifold is configured to be positioned adjacent to the second polymer membrane.

[0263] 40. The system according to item 39, wherein a portion of the cover is configured to be positioned adjacent to a portion of the second polymer film.

[0264] 41. The system according to item 39, wherein the sub-manifold is configured to be positioned between the cover and the second polymer film.

[0265] 42. Systems, apparatus and methods substantially as described herein.

Claims

1. A device for treating tissue sites using negative pressure, the device comprising: A main manifold, formed of a gel elastomer material and configured to move between a retracted state and an extended state, the main manifold comprising: A top surface and a bottom surface, the bottom surface being positioned opposite the top surface and configured to face the tissue portion, and A fold, the fold being positioned adjacent to an extension region, wherein the cross-section of the fold includes a fold in the gel elastomer located between a first portion and a second portion of the main manifold, wherein at least a portion of the first portion is configured to overlap with the second portion when the main manifold is in the retracted state, and wherein at least a portion of the first portion is configured to move away from the second portion in the extended state, and wherein the extension region is configured to extend outward from the bottom surface toward the tissue site when the main manifold is in the extended state.

2. The apparatus of claim 1, wherein the bottom surface of the main manifold is configured to form a convex shape consistent with the tissue portion when the main manifold is in the extended state.

3. The apparatus of claim 1, wherein the second portion of the main manifold is positioned between the first portion of the main manifold and the extension region.

4. The apparatus of claim 1, wherein the folds are positioned around the extension region.

5. The apparatus of claim 1, wherein the folds comprise a plurality of folds, wherein the extension regions comprise a plurality of extension regions, and wherein one of the extension regions is positioned between two folds located on the top and bottom surfaces of the main manifold.

6. The apparatus of claim 1, wherein the folds comprise a plurality of folds, wherein the extension regions comprise a plurality of extension regions, and wherein the plurality of folds and the plurality of extension regions are positioned in alternating concentric rings on the top and bottom surfaces of the main manifold.

7. The apparatus of claim 1, wherein the folds comprise a plurality of folds, wherein the extension regions comprise a plurality of extension regions, and wherein when the main manifold is in the extended state, one or more of the extension regions extend further outward from the bottom surface of the main manifold than another of the extension regions.

8. The apparatus of claim 1, wherein the main manifold further includes a plurality of manifold openings through the top surface and the bottom surface, wherein the manifold openings are configured to provide fluid communication through the top surface and the bottom surface of the main manifold.

9. The apparatus of claim 1, wherein the main manifold further comprises a plurality of supports extending outwardly from one or both of the top surface and the bottom surface.

10. The apparatus of claim 1, further comprising a first polymer membrane and a second polymer membrane, the first polymer membrane being positioned adjacent to the bottom surface of the main manifold and the second polymer membrane being positioned adjacent to the top surface of the main manifold, wherein at least the first polymer membrane includes a plurality of fluid channels.

11. The apparatus of claim 1, wherein the main manifold is formed of a transparent material configured to provide visual perception of the tissue site through the main manifold.

12. The apparatus of claim 8, wherein the manifold opening is a window, the window being further configured to provide visual perception of the tissue site through the top and bottom surfaces of the main manifold.

13. The apparatus of claim 12, wherein the main manifold further comprises a plurality of supports extending outwardly from one or both of the top surface and the bottom surface, wherein the main manifold includes a plurality of main nodes interconnected to define the window and a plurality of connectors, and wherein each of the main nodes includes at least one of the supports.

14. The apparatus of claim 1, further comprising a polymer membrane adjacent to the bottom surface of the main manifold, the polymer membrane comprising a plurality of fluid channels.

15. The apparatus according to claim 10, wherein: The first polymer film has a first thickness; The second polymer film has a second thickness; and The first thickness is greater than the second thickness.

16. The apparatus of claim 10, wherein the plurality of fluid channels comprises a plurality of slots, each of the slots having a length of less than 5 mm and a width of less than 2 mm.

17. The apparatus of claim 10, wherein the plurality of fluid channels comprises a plurality of slits, each of the slits having a length of less than 5 millimeters.

18. A system for treating tissue sites using negative pressure, the system comprising: The apparatus according to any of the preceding claims; A cover cloth is configured to be positioned over at least a portion of the device and sealed to tissue adjacent to the tissue site to form a sealed environment; as well as A negative pressure source, which is configured to provide negative pressure to the sealed environment.

19. The system of claim 18, further comprising a submanifold configured to be positioned adjacent to the device relative to the tissue site.

20. The system of claim 19, further comprising a first polymer membrane positioned adjacent to the bottom surface of the main manifold and a second polymer membrane positioned adjacent to the top surface of the main manifold, wherein the first polymer membrane is configured to be positioned adjacent to the tissue site, and wherein the sub-manifold is configured to be positioned adjacent to the second polymer membrane.

21. The system of claim 20, wherein the sub-manifold is configured to be positioned between the cover and the second polymer film.

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