Patent Grant
12070565
The present disclosure relates to irrigation and debridement of wounds, and more particularly to an assembly for irrigation of wounds, containment of wound debris and irrigation fluid, and mechanical debridement of wounds.
This section provides background information related to the present disclosure which is not necessarily prior art.
Wounds are often managed using local wound care with dressing changes, irrigation and debridement. Irrigation or hydrotherapy (with a saline or antibiotic solution) can clean the wound by flushing out foreign matter, such as dirt and bacteria. Irrigation can also debride the wound by washing away wound debris, such as dead or non-viable tissue. In addition to hydrotherapy, the wound may also be treated via mechanical debridement (e.g., scrubbing or surgical intervention). Advantageously, irrigation and debridement of wounds may be performed concurrently.
This section provides a general summary of the disclosure, and is not a comprehensive disclosure of its full scope or all of its features.
Advantageously, the present disclosure in certain variations provides a device for wound irrigation and debridement comprising a body. The body extends along a longitudinal axis. The body comprises an interior region and a first opening such that that the interior region and the first opening are configured to transfer an irrigation fluid. The body comprises a compliant region and a debridement region. The compliant region has a first stiffness. The compliant region includes a distal surface. The debridement region has a second stiffness different than the first stiffness. In a first configuration, the compliant region defines a first axial dimension along the longitudinal axis, the distal surface of the compliant region engages a target region, and the debridement region is axially offset from the distal surface and disengaged from the target region. In a second configuration, the compliant region is compressed along the longitudinal axis to define a second axial dimension less than the first axial dimension, thereby engaging the debridement region with the target region, and the distal surface of the compliant region engages the target region.
In one aspect, the second stiffness is greater than the first stiffness.
In one aspect, the compliant region is porous and defines a plurality of pores.
In one aspect, the compliant region comprises an open cell foam comprising the plurality of pores.
In one aspect, the pores of the plurality of pores have an average diameter of greater than or equal to about 0.2 mm to less than or equal to about 1 mm.
In one aspect, the compliant region has a porosity of greater than or equal to about 80%.
In one aspect, the compliant region comprises a polymer selected form the group consisting of: polyurethane, polyethylene, cellulose, silicone, thermoplastic elastomer, thermoplastic polyurethane, polyvinyl chloride (PVC), and combinations thereof.
In one aspect, the compliant region comprises a first material and the debridement region comprises a second material. The first and second materials are distinct from one another.
In one aspect, the compliant region further comprises an inner surface at least partially defining the interior region. The debridement region is coupled to the inner surface and extends inward toward the longitudinal axis from the inner surface. The debridement region defines a central opening substantially coaxial with the first opening.
In one aspect, the compliant region defines a cavity extending from the distal surface. The cavity is disposed outward of the interior region with respect to the longitudinal axis. The debridement region is disposed within the cavity.
In one aspect, at least a portion of the body defines a substantially cylindrical shape.
In one aspect, the debridement region defines a substantially annular shape and has a second opening substantially coaxial with the first opening.
In one aspect, the debridement region comprises a plurality of discrete debridement regions distributed about the longitudinal axis.
In one aspect, the debridement region comprises at least one of: a plurality of bristles, a plurality of protrusions, a plurality of non-woven fibers, a plurality of woven fibers, a mesh, an open cell foam, a closed cell foam, a plurality of particles, or a surface coating.
In one aspect, the device further comprises a frame embedded in the compliant region. The frame is disposed outward of the interior region with respect to the longitudinal axis. The frame comprises a ductile material. The frame is configured to be deformed to modify a shape of the compliant region.
In one aspect, the device further comprises a fastener engaging the body.
In one aspect, the fastener extends around an outer surface of the body. The fastener is configured to compress the body to reduce a dimension of the body.
In one aspect, the device further comprises an impermeable layer disposed on at least a portion of an outer surface of the body.
Advantageously, the present disclosure in certain variations provides a device for wound irrigation and debridement comprising a body. The body extends along a longitudinal axis. The body comprises an interior region and an opening such that that the interior region and the opening are configured to transfer an irrigation fluid. The body comprises a compliant region and a debridement region. The compliant region has a first density and defines a distal surface. The debridement region has a second density greater than the first density. In a first configuration, the compliant region defines a first axial dimension along the longitudinal axis, the distal surface of the compliant region engages a target region, and the debridement region is axially offset from the distal surface and disengaged from the target region. In a second configuration, the compliant region is compressed along the longitudinal axis to define a second axial dimension less than the first axial dimension, thereby engaging the debridement region with the target region, and the distal surface of the compliant region engages the target region.
Advantageously, the present disclosure in certain variations provides a device for wound irrigation and debridement comprising a body. The body extends along a longitudinal axis. The body comprises an interior region and an opening such that that the interior region and the opening are configured to transfer an irrigation fluid. The body comprises a compliant region and a debridement region. The compliant region comprises a first material and defines a distal surface. The debridement region is coupled to a surface of the compliant region. The debridement region comprises a second material different from the first material. In a first configuration, the compliant region defines a first axial dimension along the longitudinal axis, the distal surface of the compliant region engages a target region, and the debridement region is axially offset from the distal surface and disengaged from the target region. In a second configuration, the compliant region is compressed along the longitudinal axis to define a second axial dimension less than the first axial dimension, thereby engaging the debridement region with the target region, and the distal surface of the compliant region engages the target region.
Advantageously, the present disclosure in certain variations provides a device and nozzle assembly for wound irrigation. The assembly comprises a nozzle and a device. The nozzle is configured to receive irrigation fluid and deliver the irrigation fluid to a target region. The device is coupled to the nozzle. The device comprises a body extending along a longitudinal axis. The body includes an interior region and an opening, such that the interior region and the opening are configured to transfer the irrigation fluid. The device comprises a compliant region defining a first stiffness. The compliant region defines a distal surface. At least one of the nozzle and the device comprises a debridement region defining a second stiffness different than the first stiffness. In a first configuration, the compliant region defines a first axial dimension along the longitudinal axis, the distal surface of the compliant region engages the target region, and the debridement region is axially offset from the distal surface and disengaged from the target region. In a second configuration, the compliant region is compressed along the longitudinal axis to define a second axial dimension less than the first axial dimension, thereby engaging the debridement region with the target region, and the distal surface of the compliant region engages the target region.
In one aspect the nozzle comprises the debridement region. The debridement region is disposed on a distal end of the nozzle.
In one aspect, the body defines the debridement region. The body is configured to engage the target region in the first configuration, the second configuration, and a third configuration. In the third configuration, the compliant region is compressed along the longitudinal axis to define a third axial dimension less than the second axial dimension, thereby engaging the nozzle with the debridement region and the debridement region with the target region, and the distal surface of the compliant region engages the target region.
In one aspect, the interior region of the body is configured to receive a vacuum port. The compliant region is configured to conform to the target region to create a fluid seal and pull negative pressure.
In one aspect, the device further comprises a tip. The tip defines a passage. The tip is in fluid communication with the nozzle. The tip is disposed at least partially within the interior region of the body.
In one aspect, at least a portion of the debridement region circumferentially surrounds at least a portion of the tip.
In one aspect, a portion of the debridement region is disposed within the passage.
Advantageously, the present disclosure in certain variations provides a method of irrigating and debriding a target region. The method comprises engaging a distal surface of an assembly with the target region. The assembly includes a nozzle and a device coupled to the nozzle. The device comprises a body extending along a longitudinal axis. The body includes an interior region. The distal surface comprises an opening. The body comprises a compliant region having a first stiffness and defining the distal surface and a debridement region having a second stiffness different than the first stiffness. The debridement region being disengaged from the target region. The method further includes discharging an irrigation fluid from the nozzle. The irrigation fluid is transferred through the interior region and the opening to contact the target region. The method further includes containing at least a portion of the irrigation fluid within one or both of the interior region and the compliant region. The method further includes compressing the device along the longitudinal axis such that the debridement region engages the target region.
In one aspect, the target region is a wound bed.
Advantageously, the present disclosure in certain variations provides an irrigation and debridement assembly comprising a nozzle, a suction port, a tip, and a device. The nozzle is configured to receive irrigation fluid and deliver the irrigation fluid to a target region. The suction port is configured to remove irrigation fluid from the target region. The tip is coupled to the suction port and the nozzle. The tip defines a passage in fluid communication with the suction port and the nozzle. The device is coupled to the tip. The device is configured to transfer irrigation fluid between the passage and the target region. The device comprises a compliant region and a debridement region. The compliant region includes a distal surface. The debridement region is coupled to the compliant region. The debridement region includes a debridement surface. In a first configuration, at least a portion of the debridement surface is offset from the distal surface by a distance. In a second configuration, the debridement surface and the distal surface cooperate to define a contact surface. The contact surface is configured to engage at least a portion of the target region. The device is movable between the first configuration and the second configuration by translating the at least a portion of the debridement surface with respect to the distal surface.
In one aspect, at least a portion of the debridement region circumferentially surrounds at least a portion of a periphery of the tip.
In one aspect, in a wrapped position, a surface of the compliant region is substantially cylindrical. In a relaxed position, the surface is substantially planar.
In one aspect, at least a portion of the debridement region is disposed in the passage of the tip.
Further areas of applicability will become apparent from the description provided herein. The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.
The drawings described herein are for illustrative purposes only of selected embodiments and not all possible implementations, and are not intended to limit the scope of the present disclosure.
Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings.
Example embodiments are provided so that this disclosure will be thorough, and will fully convey the scope to those who are skilled in the art. Numerous specific details are set forth such as examples of specific compositions, components, devices, and methods, to provide a thorough understanding of embodiments of the present disclosure. It will be apparent to those skilled in the art that specific details need not be employed, that example embodiments may be embodied in many different forms and that neither should be construed to limit the scope of the disclosure. In some example embodiments, well-known processes, well-known device structures, and well-known technologies are not described in detail.
The terminology used herein is for the purpose of describing particular example embodiments only and is not intended to be limiting. As used herein, the singular forms “a,” “an,” and “the” may be intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms “comprises,” “comprising,” “including,” and “having,” are inclusive and therefore specify the presence of stated features, elements, compositions, steps, integers, operations, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. Although the open-ended term “comprising,” is to be understood as a non-restrictive term used to describe and claim various embodiments set forth herein, in certain aspects, the term may alternatively be understood to instead be a more limiting and restrictive term, such as “consisting of” or “consisting essentially of.” Thus, for any given embodiment reciting compositions, materials, components, elements, features, integers, operations, and/or process steps, the present disclosure also specifically includes embodiments consisting of, or consisting essentially of, such recited compositions, materials, components, elements, features, integers, operations, and/or process steps. In the case of “consisting of,” the alternative embodiment excludes any additional compositions, materials, components, elements, features, integers, operations, and/or process steps, while in the case of “consisting essentially of,” any additional compositions, materials, components, elements, features, integers, operations, and/or process steps that materially affect the basic and novel characteristics are excluded from such an embodiment, but any compositions, materials, components, elements, features, integers, operations, and/or process steps that do not materially affect the basic and novel characteristics can be included in the embodiment.
Any method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order discussed or illustrated, unless specifically identified as an order of performance. It is also to be understood that additional or alternative steps may be employed, unless otherwise indicated.
When a component, element, or layer is referred to as being “on,” “engaged to,” “connected to,” or “coupled to” another element or layer, it may be directly on, engaged, connected or coupled to the other component, element, or layer, or intervening elements or layers may be present. In contrast, when an element is referred to as being “directly on,” “directly engaged to,” “directly connected to,” or “directly coupled to” another element or layer, there may be no intervening elements or layers present. Other words used to describe the relationship between elements should be interpreted in a like fashion (e.g., “between” versus “directly between,” “adjacent” versus “directly adjacent,” etc.). As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items.
Although the terms first, second, third, etc. may be used herein to describe various steps, elements, components, regions, layers and/or sections, these steps, elements, components, regions, layers and/or sections should not be limited by these terms, unless otherwise indicated. These terms may be only used to distinguish one step, element, component, region, layer or section from another step, element, component, region, layer or section. Terms such as “first,” “second,” and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first step, element, component, region, layer or section discussed below could be termed a second step, element, component, region, layer or section without departing from the teachings of the example embodiments.
Spatially or temporally relative terms, such as “before,” “after,” “inner,” “outer,” “beneath,” “below,” “lower,” “above,” “upper,” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. Spatially or temporally relative terms may be intended to encompass different orientations of the device or system in use or operation in addition to the orientation depicted in the figures.
Throughout this disclosure, the numerical values represent approximate measures or limits to ranges to encompass minor deviations from the given values and embodiments having about the value mentioned as well as those having exactly the value mentioned. Other than in the working examples provided at the end of the detailed description, all numerical values of parameters (e.g., of quantities or conditions) in this specification, including the appended claims, are to be understood as being modified in all instances by the term “about” whether or not “about” actually appears before the numerical value. “About” indicates that the stated numerical value allows some slight imprecision (with some approach to exactness in the value; approximately or reasonably close to the value; nearly). If the imprecision provided by “about” is not otherwise understood in the art with this ordinary meaning, then “about” as used herein indicates at least variations that may arise from ordinary methods of measuring and using such parameters. For example, “about” may comprise a variation of less than or equal to 5%, optionally less than or equal to 4%, optionally less than or equal to 3%, optionally less than or equal to 2%, optionally less than or equal to 1%, optionally less than or equal to 0.5%, and in certain aspects, optionally less than or equal to 0.1%.
In addition, disclosure of ranges includes disclosure of all values and further divided ranges within the entire range, including endpoints and sub-ranges given for the ranges.
Example embodiments will now be described more fully with reference to the accompanying drawings.
As noted above, wounds are commonly managed using irrigation and debridement. However, many existing irrigation procedures release contaminated irrigation fluid, aerosols, and wound debris into the surrounding environment (e.g., the floor, the air, nearby medical equipment, and healthcare professionals and staff in proximity to the area where the procedures are performed), onto medical personnel, and onto the patient. The release of irrigation fluid and wound debris can lead to health hazards related to microorganism contamination, exposure to healthcare staff, and other environmental hazards, such as pooled water on the floor of a high-traffic area and droplet exposure to reused medical devices and equipment. The environmental hazards frequently necessitate time-consuming clean-up procedures after the irrigation and debridement procedure. Furthermore, many wounds receiving irrigation and debridement treatment are associated with multi-drug-resistant organisms. The Center for Disease Control recommends several precautions for the performance of procedures that could release multi-drug-resistant organisms into the air, such as the use of private medical rooms, limitations on medical personnel present, the use of personal protective equipment for medical personnel, and intense cleaning and disinfecting procedures after the treatment. These time-consuming and often complex requirements may deter medical personnel from performing irrigation and debridement treatments adequately and efficiently. Other aspects of wound irrigation and debridement treatment present different challenges. For example, mechanical debridement of a wound bed without the medical professional's hands while performing concurrent irrigation can lead to accidental sticking of the debridement device to the wound bed and injuries to the medical professional, especially on sharp wound beds such as bony edges and exposed infected structures or hardware.
Additional procedures are available to mitigate the environmental contamination caused by typical irrigation and debridement procedures. One method of reducing environmental contamination is through the use of suction to remove excess irrigation fluid and wound debris. To be effective, suction requires a device to be in direct contact with the wound bed and create an adequate seal with the wound bed. However, achieving constant and direct contact sufficient to minimize contamination is difficult due to typically uneven surfaces of wound beds and rigidity of most suction devices, as well as the inability to apple these rigid structure close to vital organs, such as the heart or major blood vessels. Another method of mitigation is the use of flexible tips for containment of wound debris, and optionally to create a seal for application of suction. However, such tips do not perform well on uneven surfaces. Additionally, the tips inhibit visibility of the wound bed, which can lead to inadequate wound debridement. Yet another method of mitigation is securing a bag around a portion of the patient's body that includes the body area to be treated, or a bag around the irrigation device being used. These procedures are often cumbersome and require long set-up times and unrealistic patient positioning. Furthermore, visibility during irrigation and debridement is reduced, access to the wound site for additional mechanical debridement is limited, and irrigation fluid and wound debris may pool within the bag, limiting the quality and efficiency of the process. Accordingly, improved methods and tools for irrigation and debridement of wound beds would be desirable.
In various aspects, the present disclosure provides an assembly for irrigation of a target body region (e.g., a wound bed), mechanical debridement of the target body region, and containment of irrigation fluid and/or wound debris. In certain aspects, the assembly may be referred to as an “irrigation and debridement assembly” or “assembly.” The assembly includes a nozzle that discharges irrigation fluid (e.g., saline or antibiotic solution) to the target body region, and a device that contains the irrigation fluid. In certain aspects, the device may be referred to as a “containment device” or a “containment and debridement device,” depending on whether the device includes a debridement region. The device may at least partially surround the nozzle and include an outlet to transfer the irrigation fluid to the target body region. The device includes a compliant region that can maintain contact with the target body region to act as a barrier to the release of irrigation fluid and wound debris. The assembly also includes a debridement region that can selectively debride the target body region, such as by compressing the compliant region of the device. The debridement region may be coupled to at least one of the nozzle or the device. In certain variations, the assembly may also include a vacuum port. Maintaining contact between the compliant region of the device and the target body region may also facilitate the build-up of negative pressure for use of the vacuum port to remove irrigation fluid and/or wound debris. In certain embodiments, the compliant region is porous and capable of absorbing irrigation fluid and/or wound debris.
The assembly and device according to various aspects of the present disclosure can minimize release (e.g., splash, aerosolizing) of the irrigation fluid and wound debris into the surrounding environment, thereby reducing contamination and spread of bacteria. The assembly can be operated by a medical technician using a single hand to increase ease of access to difficult-to-reach wound beds and leave another hand free to perform other tasks. Due to elimination of a bag for containment of irrigation fluid and wound debris, visibility during the procedure is improved compared to other methods of irrigation. The debridement region allows the medical personnel to perform selective physical debridement via the same device as irrigation, without the need for direct contact by the technician (e.g., hand-scrubbing), thereby reducing or avoiding accidental exposures and occupational injuries. The compliant region may reduce suction pressure and resulting sticking to the wound bed.
The containment device can be used with various sizes, shapes, and types of irrigation nozzles and optional vacuum ports, and can be efficiently installed and removed from the nozzle, optionally with customizable positioning. A size and shape of the containment device may be tailored to a particular wound type. In certain variations, the containment device may be disposable. A procedure to use the assembly may be simple, and similar to other existing irrigation tools. Furthermore, a single technician can readily perform both irrigation and mechanical debridement. Additionally, due to the ease of use and decreased environmental contamination, the assembly and device may encourage increased use of irrigation and debridement treatment in locations that would have previously been infeasible, such as ancillary healthcare facilities and homes.
Target Body Regions
The assembly and device according to various aspects of the present disclosure may be used for irrigation and debridement of a target body region (also referred to as a “target region”). As used herein, “target body region” includes wound beds (e.g., pressure sores or tissue damage resulting from a cut, an impact, a burn, or frostbite), surgical sites, skin conditions (e.g., infection), and skin areas to receive hygiene-, cosmetic-, or maintenance-related procedures. The target body region can be on a human or an animal.
Wound Irrigation Systems
The assembly can include a nozzle from any type of irrigation system. Irrigation systems include low-pressure irrigation systems or high-pressure irrigation systems. Examples of low pressure irrigation systems include bulb-type irrigation systems (see, e.g.,
With reference to
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With reference to
Irrigation and Debridement Assemblies
Referring to
The first opening and the second opening 80 are in fluid communication with the interior region 77. The interior region 77 and the first opening are configured to transfer irrigation fluid to the target body region. The second opening 80 is configured to receive at least a portion of the nozzle 58. The nozzle 58 and the suction port are in fluid communication with the interior region 77.
Irrigation and debridement assemblies according to various aspects of the present disclosure generally include a wound irrigation system and a containment device At least one of the irrigation system and the containment device may include a debridement region for performing mechanical debridement of a target body region. Containment devices according to various aspects of the present disclosure may be used with any suitable wound irrigation system, such as the bulb-type irrigation system 10 of
First or Compliant Region
A containment device according to various aspects of the present disclosure includes a compliant region. The compliant region engages the target body region to minimize release of irrigation fluid and/or wound debris from the target body region. Engagement of the compliant region with the target body region can create a fluid seal between a suction port and the target body region to facilitate effective removal of irrigation fluid and/or wound debris from the target body region. The compliant region can compress, bend, or otherwise deform to maintain contact with the target body region during irrigation and debridement. At least a portion of the compliant region is disposed axially between the vacuum port during irrigation and debridement to reduce or prevent sticking of the vacuum port to the target body region. Furthermore, the compliance allows a medical technician to modify an angle and a height of the nozzle and/or vacuum port during irrigation and debridement, while maintaining engagement between the containment device and the target body region. The compliant region may be soft so that it does not damage sensitive portions of the target body region.
In certain variations, the compliant region may comprise a foam, such as a low-density foam, or a foam-like material. In certain variations, the compliant region may comprise a soft silicone or silicone-like material. By way of example, the silicone may have a Shore A hardness of less than or equal to about 10. In certain variations, the compliant region is gel-like and deformable. In certain variations, the compliant region has a bellows or bellows-like design.
In one example, a density of the compliant region is greater than or equal to about 0.5 lb/ft3 to less than or equal to about 20 lb/ft3, optionally greater than or equal to about 0.75 lb/ft3 to less than or equal to about 1.5 lb/ft3, or optionally about 0.85 lb/ft3. The foam may be open-cell foam or closed-cell foam. In some variations, the compliant region comprises an open-cell foam. The open-cell foam may allow irrigation fluid to be absorbed into the compliant region from any direction. The compliant region may comprise a polymer selected from the group consisting of: polyurethane, polyethylene, cellulose, silicone, thermoplastic elastomer, thermoplastic polyurethane, polyvinyl chloride (PVC), and combinations thereof.
In various aspects, the compliant region may be porous. Accordingly, the compliant region may comprise a plurality of pores. The plurality of pores may include a plurality of internal pores and external pores that are open to one another and form continuous flow paths or channels extending from an inlet to an exit. As used herein, the terms “pore” and “pores” refer to pores of various sizes, including so-called “macropores” (pores of greater than 50 nm diameter), “mesopores” (pores having diameter between 2 nm and 50 nm), and “micropores” (pores having diameter of less than 2 nm), where the pore size refers to an average or median value, including both the internal and external pore diameter sizes. The pores may thus be randomly disposed throughout while being interconnected and permitting fluid flow therethrough. In one example, the plurality of pores comprises greater than or equal to about 70% macropores, optionally greater than or equal to about 75% macropores, optionally greater than or equal to about 80% macropores, optionally greater than or equal to about 85% macropores, optionally greater than or equal to about 90% macropores, or optionally greater than or equal to about 95% macropores. In some examples, an average pore diameter is greater than or equal to about 0.05 mm to less than or equal to about 2 mm greater than or equal to about 0.1 mm to less than or equal to about 1.5 mm, optionally greater than or equal to about 0.2 mm to less than or equal to about 1 mm, optionally greater than or equal to about 0.3 mm to less than or equal to about 0.9, optionally greater than or equal to about 0.4 mm to less than or equal to about 0.8 mm, optionally greater than or equal to about 0.5 mm to less than or equal to about 0.7, or optionally about 0.6 mm. In some examples, a porosity is greater than or equal to about 50%, optionally greater than or equal to about 60%, optionally greater than or equal to about 70%, optionally greater than or equal to about 75%, optionally greater than or equal to about 80%, optionally greater than or equal to about 85%, optionally greater than or equal to about 90%. For example, the porosity may be greater than or equal to about 85% to less than or equal to about 95%.
In certain aspects, the compliant region may be non-homogeneous, such that certain portions are more compliant than other portions. A non-homogeneous compliant region may facilitate sequential compression of the different portions. In one example, a non-homogeneous compliant region includes variable porosity, with a more porous portion being configured to compress first, and a less porous portion being configured to compress second. In another example, a non-homogeneous compliant region includes variable density, with a less dense portion being configured to compress first, and a denser portion being configured to compress second. In yet another example, a non-homogeneous compliant region includes variable stiffness, with a less stiff portion being configured to compress first, and a stiffer portion being configured to compress second. In certain aspects, the sequentially-compressible portions may be distributed axially (e.g., such that a distal end of the compliant region compresses first).
Second or Debridement Region
As noted above, the irrigation and debridement assembly includes a debridement region. The debridement region may be coupled to at least one of the nozzle or the containment device. The debridement region may be integrally formed with the nozzle and/or the containment device, or the debridement region may be separately formed and subsequently coupled to the nozzle and/or containment device. As used herein, “coupled” means that the debridement region is associated with the nozzle and/or containment device (e.g., the compliant region). In certain variations, the debridement region may be coupled to nozzle and/or containment device with a fastener, such as hook-and-loop fastener (e.g., VELCRO®), one or more snaps, one or more staples, adhesive (e.g., a flexible adhesive), stitching, any other suitable fastener, or combinations thereof. In certain variations, the debridement region may free of a distinct fastener such that it is coupled to the nozzle and/or containment device by mechanical interlock, friction fit, heat bonding, combinations thereof, or any other suitable method. In certain variations, the debridement region may be directly connected to the nozzle and/or containment device.
In certain variations, the debridement region is coupled to the compliant region of the containment device. In certain aspects, a joint between the debridement region and the compliant region may be compressible, such as when the device includes a flexible adhesive or when the device is free of a distinct fastener. In certain variations, at least a portion of the debridement region or the compliant region may be configured to move with respect to at least a portion of the other of the debridement region or the compliant region (e.g., by compressing the compliant region). For example, the debridement region may be coupled to the compliant region at a discrete axial location (e.g., by an adhesive strip or threads) such that other portions of the debridement and/or compliant regions may slide and/or compress with respect to one another. In certain aspects, the entire debridement region may be configured to move with respect to the compliant region. For example, the debridement region may be disposed within an interior region and configured to translate axially with respect to the compliant region, such as when the debridement region is coupled to the compliant region via a fiction fit.
The debridement region is configured to selectively engage the target body region, such as by compressing the compliant region of the containment device, to mechanically debride the target body region. In certain aspects, the debridement region may also be flexible and/or compressible. Mechanical debridement may be used, for example, to remove dead and non-viable tissue from the target body region.
Compared to the compliant region, the debridement region may have a different stiffness (e.g., a higher stiffness), a different density (e.g., a higher density), a different roughness (e.g., a higher roughness), a different firmness (e.g., a higher firmness), and/or a different compliance (e.g., a lower compliance). The above characteristics may be based on respective bulk structures of the compliant region and the debridement region. In one example, the compliant region has a first stiffness, and the debridement region has a second stiffness that is greater than the first stiffness. The debridement region may comprise a variety of structures and materials to form the requisite composite stiffness.
In certain aspects, compositions of the debridement region and the compliant region may be similar or identical. In one example, the debridement and compliant regions have the same composition, with the debridement region having a lower porosity. In another example, the debridement and compliant regions comprise the same material, with a surface of the debridement region further comprising a rough surface coating, such as a resin with optional abrasive particles. In yet another example, the debridement and compliant regions comprise the same material, and the debridement region has a higher stiffness due to geometries of the respective regions.
In certain variations, the compliant region and the debridement region have similar structures (e.g., open-cell foam), but comprise different materials having corresponding different properties. For example, each material may have a distinct stiffness, density, and/or porosity. The debridement region may comprise a polymer such as cellulose, nylon, polypropylene, silicone, polyurethane, thermoplastic polyurethane, thermoplastic elastomer, PVC, or combinations thereof. In one example, the debridement region comprises a polymer selected form the group consisting of cellulose, nylon, polypropylene, silicone, polyurethane, thermoplastic polyurethane, thermoplastic elastomer, PVC, or combinations thereof.
In certain aspects, the compliant region and the debridement region have distinct structures. In one example, the debridement region comprises a plurality of bristles (e.g., thick silicone bristles, thin nylon bristles, and/or looped bristles) having free ends that are configured to engage the target body region. In other examples, the debridement region comprises a plurality of fibers, such as woven fibers and/or non-woven fibers. In one example, the debridement region comprises a mesh fabric. In yet other examples, the debridement region comprises a foam, such as an open-cell foam and/or a closed cell foam. In yet another example, the debridement region includes a polymer having embedded abrasive particles. In yet other examples, the debridement region comprises a plurality of protrusions that are configured to engage the target body region, such as nubs, spikes, or rollers. In yet other examples, the debridement region comprises a textured surface, defining a plurality of waveforms or ridges. In various aspects, the debridement region comprises at least one of a plurality of bristles, a plurality of protrusions, a plurality of non-woven fibers, a plurality of woven fibers, a mesh, an open cell foam, a closed cell foam, a plurality of particles, or a surface coating.
In certain aspects, distal surface of the debridement region may be recessed with respect to a distal surface of the compliant region so that the compliant region may be compressed to engage the debridement region with the target body region. However, in various alternative aspects, the distal surface of the debridement region may extend past the distal surface of the compliant region, or be disposed substantially flush with respect to the distal surface of the compliant region. The debridement region may comprise a single region (see, e.g., debridement region 154 of
In various aspects, a second region may be suitable for a different purpose than debridement or may have additional utility. For example, a second region may reduce or prevent sticking of a suction port and/or tip to a target body region. In certain aspects, the second region may cooperate with a first or compliant region to reduce or prevent sticking. In one example, a distal surface of a second region is substantially planar and smooth such that it would not perform substantial debridement. In another example, a distal surface of a second region defines a circumferential waveform (see, e.g., discussion accompanying
Example Wound Irrigation and Debridement Assemblies
Examples of irrigation and debridement assemblies according to various aspects of the present disclosure are shown in
Three-Configuration Containment and Debridement Device
With reference to
The device 114 includes a body 126. The body 126 extends along a longitudinal axis 128. The body 126 comprises an interior region or void space 130. The body 126 also defines a distal surface 132 comprising a first opening 134, and a proximal surface 136 defining a second opening 138. The distal surface 132 and the proximal surface 136 may be disposed opposite one another. In some examples, the distal surface 132 and the proximal surface 136 are disposed substantially parallel one another and substantially perpendicular to the longitudinal axis 128. However, in some other examples, one or both of the distal and proximal surfaces 132, 136 is disposed non-perpendicular to the longitudinal axis 128, is curved or contoured, or includes multiple facets.
The body 126 also includes an outer surface 140 and an inner surface 142. The outer and inner surfaces 140, 142 may extend substantially perpendicular to the distal and proximal surfaces 132, 136. In certain variations, the outer and inner surfaces 140, 142 may each be substantially cylindrical. The inner surface 142 at least partially defines the interior region 130 of the body 126. The longitudinal axis 128 may extend through a center of the interior region 130. The first and second openings 134, 138 are fluidly connected to the interior region 130.
The body 126 may comprise a seam 146, which extends radially between the outer and inner surfaces 140, 142, and axially between the distal and proximal surfaces 132, 136. The body 126 may include a first seam surface 148 and a second seam surface 150. The first and second seam surfaces 148, 150 may be separated to place the body 126 in an open configuration, such as during assembly of the device 114 to the nozzle 118 and removal of the device 114 from the nozzle 118. The first and second seam surfaces 148, 150 may engage one another when the body is in a closed configuration, such as during use of the assembly 110.
The device 114 may further comprise a fastener (not shown) to maintain the body 126 in the closed configuration. The fastener may engage the outer surface 140 (see, e.g., peripheral fastener 548 of
The body 126 includes a first or compliant region 152 and a second or debridement region 154. Each of the compliant region 152 and the debridement region 154 may define a substantially annular shape, with the compliant region 152 being disposed at least partially outward of the debridement region 154 with respect to the longitudinal axis 128 (e.g., radially outward). The tip 124 of the wound irrigation system 112 engages the inner surface 142 of the body 126 in an interference fit to couple the device 114 to the nozzle 118. More particularly, the tip 124 may engage the compliant region 152. In various alternative aspects, a tip may engage a debridement region (see, e.g.,
In certain aspects, the compliant region 152 includes the distal surface 132 of the body 126. The compliant region 152 may include a first portion 156 disposed axially between the debridement region 154 and the distal surface 132. The compliant region 152 may define a second portion 158 disposed axially between the nozzle 118 and the debridement region 154.
The debridement region 154 is coupled to an interior surface 155 of the compliant region 152. The inner surface 142 of the body 126 may include at least a portion of the interior surface 155 of the compliant region 152. The debridement region 154 may be fluidly connected to the interior region 130. The debridement region 154 may extend inward toward the longitudinal axis 128. A central opening 160 of the debridement region 154 may be substantially coaxial with the interior region 130 such that the longitudinal axis 128 extends through a center of the central opening 160.
The device 114 can be used in a first configuration (
In the first configuration, the device 114 is primarily used for irrigation. At least a portion of a debridement surface 157 of the debridement region 154 (e.g., substantially the entire debridement surface 157) is axially offset from the distal surface 132 of the body. Accordingly, when the distal surface 132 engages a target body region, the debridement region 154 remains disengaged from the target body region. The debridement surface 157 is axially offset from the distal surface 132 of the body 126. In the first configuration, the compliant region 152 may define the first axial dimension 162 substantially parallel to the longitudinal axis 128. The compliant region 152 may be substantially uncompressed, or minimally compressed such that the distal surface 132 maintains contact with the target body region, while the debridement region 154 remains disengaged from the target body region and the nozzle 118. Depending on the stiffness of the compliant region 152 and a pressure applied by a medical technician, engagement between the distal surface 132 and the target body region may provide gentle mechanical debridement.
In the second configuration, at least the first portion 156 of the compliant region 152 is compressed along the longitudinal axis 128 such that the debridement region 154 engages the target body region to perform mechanical debridement. In certain aspects, in the second configuration, the debridement surface 157 is substantially coplanar from the distal surface 132 of the body 126. The compliant region 152 may define the second axial dimension 164. The second axial dimension 164 is less than or equal to a difference between the first axial dimension 162 and a fourth axial dimension 166 of the first portion 156 of the compliant region 152 (e.g., the second axial dimension 164 may be less than the difference when the debridement region 154 is also axially compressed). In the second configuration, the distal surface 132 remains engaged with the target body region.
In the third configuration, at least the first portion 156 and the second portion 158 of the compliant region 152 are compressed along the longitudinal axis 128 such that the debridement region 154 engages both the target body region and the nozzle 118. In certain configurations, the debridement surface 157 may be substantially coplanar with the distal surface 132 of the body 126. Engagement between the nozzle 118 (e.g., through the tip 124) and the debridement region 154 allows the medical technician to increase an applied force along the longitudinal axis 128, thereby increasing a pressure of the mechanical debridement. In the third configuration, the compliant region 152 may define the third axial dimension. The third axial dimension may be less than or equal to a difference between the first axial dimension 162 and a sum of the fourth axial dimension 166 and a fifth axial dimension 168 of the second portion 158 of the compliant region 152. In the third configuration, the distal surface 132 remains engaged with the target body region.
During use of the assembly 110, the irrigation fluid is transferred from the nozzle 118, through the interior region 130 and the first opening 134 to the target body region. The compliant region 152 may engage the target body region to form a fluid seal and/or facilitate the application of negative pressure (i.e., vacuum) via the suction port 122. The body 126 can be axially compressed between configurations to selectively perform mechanical debridement at varying intensities. Thus, the assembly 110 can be used to perform both irrigation and mechanical debridement. In all three configurations, the suction port 122 and tip 124 remain spaced apart from the target body region to reduce or prevent sticking.
Two-Configuration Containment and Debridement Device
With reference to
The device 184 includes a body 188 extending along a longitudinal axis 190. The body 188 comprises an interior region 192, a first or compliant region 194, and a second or debridement region 196. The compliant region 194 includes a distal surface 198 comprising an opening 200 through which irrigation fluid may be transferred. The debridement region 196 is substantially annular, and is coupled to an inner surface 201 of the compliant region 194. The debridement region 196 engages the nozzle 186. The debridement region 196 is coupled to at least one of the nozzle 186 an the inner surface 201 of the compliant region 194.
The device can be used in a first configuration (
In the second configuration, the assembly 180 may be used for mechanical debridement and optional irrigation. In the second configuration, the compliant region 194 is compressed along the longitudinal axis 190 to engage the debridement region 196 with the target body region. The compliant region 194 may be compressed to a second axial dimension 204 less than the first axial dimension 202. A third axial dimension 206 corresponds to a portion 208 of the compliant region 194 disposed axially between the distal surface 198 and the debridement region 196 (i.e., an amount that the debridement region 196 is recessed). The second axial dimension 204 may be less than or equal to a difference between the first axial dimension 202 and the third axial dimension 206. Notably, in the first configuration, the debridement region 196 is axially offset from the target body region by the third axial dimension 206.
Single-Configuration Containment and Debridement Device
Referring to
The device 224 includes a body 228 extending along a longitudinal axis 230. The body 228 comprises an interior region 232, a first or compliant region 234, and a second or debridement region 236. The compliant region 234 includes a distal surface 238 comprising an opening 240. The interior region 232 and the opening 240 are configured to transfer irrigation fluid from the nozzle 226 to the target body region.
The debridement region 236 has a substantially annular shape. The debridement region 236 is in fluid communication with the interior region 232 of the body 228. The debridement region 236 engages both the nozzle 226 and an interior surface 242 of the compliant region 234. The debridement region 236 is coupled to at least one of the nozzle 226 and the interior surface 242. A debridement surface 244 of the debridement region 236 is disposed substantially flush with the distal surface 238 of the compliant region 234 along the longitudinal axis 230. Accordingly, the device 224 is configured to be operated in a single configuration in which both the debridement region 236 and the compliant region 234 engage the target body region. In various alternative aspects, a single-configuration containment and debridement device includes a debridement region coupled to a distal surface of the compliant region (not shown) rather than an interior surface of the compliant region.
In various aspects, the present disclosure provides another containment device (not shown). The containment device includes a body extending along a longitudinal axis and having a distal surface. The containment device comprises a compliant region and a debridement region. At least a portion of the distal surface of the body comprises the debridement region. The compliant region may be compressed along the longitudinal axis to increase an intensity of debridement.
Nozzle Including Debridement Region
With reference to
The device 264 comprises a body 272 extending along a longitudinal axis 274. The body 272 comprises an interior region 276 and a first or compliant region 278. The compliant region 278 includes a distal surface 280 and an opening 282. The nozzle 266 and the debridement region 268 are disposed at least partially within the interior region 276. The debridement region 268 may engage an interior surface 284 of the interior region 276.
The assembly 260 can be used in a first configuration or a second configuration. In the first configuration, the assembly 260 is primarily used for irrigation. In the first configuration, the debridement region 268 is axially offset from the distal surface 280. The compliant region 278 defines a first axial dimension 286. The distal surface 280 is configured to engage the target body region.
In the second configuration, the compliant region 278 is axially compressed such that the debridement region 268 engages the target body region. The compliant region 278 has a second axial dimension 288 less than the first axial dimension 286. The second axial dimension 288 may be less than or equal to a difference between the first axial dimension 286 and a third axial dimension 290. The third axial dimension 290 corresponds to a portion 292 of the compliant region 278 disposed axially between the distal surface 280 and the debridement region 268. The distal surface 280 may remain in contact with the target body region while the debridement region 268 selectively engages the target body region. A medical technician may increase axial applied force to increase a corresponding pressure of mechanical debridement.
Containment and Debridement Device with Embedded Debridement Region
Referring to
The device 314 comprises a body 318 extending along a longitudinal axis 320. The body 318 comprises an interior region 322, a first or compliant region 324, and a second or debridement region 326. The compliant region 324 includes a distal surface 328. An opening 330 extends into the distal surface 328 and is in fluid communication with the interior region 322. The nozzle 316 is in fluid communication with the interior region 322 such that the interior region 322 and the opening 330 are configured to transfer irrigation fluid to the target body region.
The compliant region 324 also includes a cavity 332 extending into the distal surface 328. The cavity 332 is disposed outward of the interior region 322 with respect to the longitudinal axis 320 (e.g., radially outwardly). In certain aspects, the cavity 332 may be substantially annular.
The debridement region 326 may be disposed within the cavity 332. The debridement region 326 may define a substantially annular shape. However, in various alternative aspects, the debridement region 326 may define other shapes (e.g., a plurality of discrete debridement regions, see, e.g.,
The assembly 310 may be configured to be used in a first configuration and a second configuration. In the first configuration, the assembly 310 is primarily used for irrigation. The compliant region 324 defines a first axial dimension 334. The distal surface 328 is configured to engage the target body region. The debridement region 326 is axially offset from the distal surface 328.
In the second configuration, the assembly 310 may be used for mechanical debridement. The compliant region 324 is axially compressed such that the debridement region 326 engages the target body region. The compliant region 324 defines a second axial dimension 336. The second axial dimension 336 is less than or equal to a difference between the first axial dimension 334 and a third axial dimension 338. The third axial dimension 338 corresponds to a portion 340 of the compliant region 324 disposed axially between the debridement region 326 and the distal surface 328. In the second configuration, the distal surface 328 can remain engaged with the target body region while the debridement region 326 selectively engages the target body region via axial compression.
Containment and Debridement Device with Discrete Debridement Regions
With reference to
The device 354 comprises a body 358 extending along a longitudinal axis 360. The body 358 comprises an interior region 362, a first or compliant region 364, and a second or debridement region 366. The compliant region 364 includes a distal surface 368 having an opening 370. The opening 370 is in fluid communication with the interior region 362. The nozzle 356 is in fluid communication with the interior region 362 such that the interior region 362 and the opening 370 are configured to transfer irrigation fluid to the target body region.
The debridement region 366 comprises a plurality of discrete debridement regions or elements 372. Each debridement element 372 may be coupled to an interior surface 374 of the compliant region 364. The debridement elements 372 are distributed about the longitudinal axis 360. In certain variations, each debridement element 372 is substantially the same distance (e.g., radius) from the longitudinal axis 360 as the other debridement elements 372. Thus, the debridement elements 372 may be distributed in an annular configuration. In certain variations, the debridement elements 372 may be substantially equally spaced about the longitudinal axis 360. In certain other variations, discrete debridement elements may be non-uniformly distributed about a longitudinal axis.
The assembly 350 may be configured to move through first, second, and third configurations in a manner similar to the assembly 110 of
Containment and Debridement Device with Multi-Intensity Debridement
In various aspects, a debridement region of a wound irrigation assembly may be configured to provide different intensities of debridement. The debridement region may define a first portion disposed at a first axial distance from a distal surface of a compliant region, and a second portion disposed at a second distinct axial distance from the distal surface. A medical technician can selectively modify the intensity of mechanical debridement by changing an applied axial force to engage (1) neither of the first portion and the second portion, (2) one of the first portion and the second portion, or (3) both of the first portion and the second portion. The debridement region may be compliant such that can compress axially.
Containment and Debridement Device with Connecting Region
In certain aspects, a body according to various aspects of the present disclosure may consist essentially of an interior region, a compliant region, and a debridement region. However, in various alternative aspects, a body may further include one or more additional regions, such as a connecting region. Referring to
The device 414 comprises a body 418 extending along a longitudinal axis 420. The body 418 comprises an interior region 422, a first or compliant region 424, a second or debridement region 426, and a connecting region 428. The compliant region 424 may extend axially between a distal surface 430 of the body 418 and a nozzle surface 432. Accordingly, the body 418 is compressible to selectively engage the debridement region 426 with the target body region, and to selectively engage the nozzle 416 with the debridement region 426. The connecting region 428 may be disposed axially between the nozzle surface 432 and a proximal surface 434 of the body 418.
The connecting region 428 may comprise any suitable material for coupling the device 414 to the wound irrigation system 412. In one example, the connecting region 428 comprises a substantially rigid material, such as a substantially rigid thermoplastic material. In another example, the connecting region 428 comprises an elastomer to improve engagement and fluid sealing between the nozzle 416 and the device 414. In yet another example, the connecting region 428 comprises a transparent material to improve visibility of the target body region when a medical technician operates the assembly 410.
With reference to
The device 444 includes a body 448 extending along a longitudinal axis 450. The body 448 comprises an interior region 452, a first or compliant region 454, a second or debridement region 456, and a connecting region 458. The compliant region 454 extends axially between a distal surface 460 of the body 448 and a debridement surface 462 of the debridement region 456, such that the compliant region 454 can be axially compressed to selectively engage the debridement region 456 with the target body region.
The connecting region 458 extends axially between the debridement surface 462 and a proximal surface 464 of the body 448. In certain variations, the connecting region 458 may be substantially incompressible such that the device 480 can be used in first and second configurations, but not in a third configuration wherein the nozzle engages the debridement region. In certain alternative embodiments, a debridement region may be in constant engagement with a nozzle or coupled to the nozzle (such as in the device 224 of
The assembly 440 may further comprise a sealing ring 466 disposed at a joint between an outlet tube 468 of the nozzle 446 and the connecting region 458 of the device 444. The sealing ring 466 may improve a fluid seal at the joint. Similar sealing rings may be used on the other devices described herein.
Wrap-Around Containment and Debridement Devices
Containment and debridement devices according to various aspects of the present disclosure may be fabricated in substantially the desired shape (e.g., cylindrical), while being flexible enough to permit coupling to a wound irrigation system. The devices may be referred to as “pre-shaped” containment and debridement devices. In certain aspects, containment regions of pre-shaped devices are free of substantial compressive or tensile stresses.
In various alternative aspects, containment and debridement devices may be fabricated as substantially planar structures or including one or more substantially planar portions. Such devices may be movable between a relaxed or unassembled position to a wrapped or assembled position. In the wrapped position, the device may be wrapped around a portion of a wound irrigation system. Accordingly, the devices may be referred to as “wrap-around” containment and debridement devices.
Wrap-around devices may be fabricated in the relaxed position and therefore manufacturing may be simplified compared to fabrication of pre-shaped devices. In the wrapped position, a compliant region may be subject to compressive and/or tensile stresses (e.g., compressed radially inward regions). A device may be retained in the wrapped position by an external force, such as a fastener, and automatically return to the relaxed position absent the external force. Although the containment and debridement devices described above (e.g., in the discussions accompanying
With reference to
In the relaxed position, the compliant region 812 may be substantially planar. The complaint region 812 may include a first surface 816 and a second surface 818 disposed opposite the first surface 816. When the device 810 is in the relaxed position, both of the first and second surfaces 816, 818 are substantially planar. When the device 810 is in the wrapped position, the first surface 816 may be an interior surface and the second surface 818 may be an exterior surface.
The debridement region 814 is coupled to the first surface 816 of the compliant region 812. The debridement region 814 may be non-coextensive with the compliant region 812. For example, the debridement region 814 may have a first width 820 that is smaller than a second width 822 of the complaint region 812 in the relaxed position so that the debridement region 814 has a smaller radius than the compliant region 812 in the wrapped position.
The debridement region 814 may include a main portion 830 and a flange portion 832. In the relaxed position, both the main portion 830 and the flange portion 832 are substantially planar. The flange portion 832 may have a first height 834 that is greater than a second height 836 of the main portion 830 in the relaxed position. In the wrapped position, the flange portion 832 extends radially inward of the main portion 830.
With reference to
The compliant region 812 may further include a third surface 856 and a fourth surface 858. When the device 810 is in the relaxed position, the fourth surface 858 may be disposed opposite the third surface 856. When the device 810 is in the wrapped position, the third and fourth surfaces 856, 858 may be coupled to one another at a seam 860. For example, the device 810 may include one or more fasteners 862 coupled to the third surface 856 and/or the fourth surface 858. The fastener 862 may include any of the fasteners described herein (see discussion accompanying
In the wrapped position (
The device 810 may extend along a longitudinal axis 865 (
The assembly 840 can be used in a first configuration (a first assembled configuration), as shown in
In various aspects, the present disclosure provides a method of assembling the irrigation and debridement assembly 840. The method generally includes providing the device 810 having a substantially planar structure or portion. The method further includes engaging the tip 850 of the wound irrigation system 838 with the debridement region 814. For example, the tip 850 may engage the flange portion 832 of the debridement region 814. The method further includes wrapping the device 810 circumferentially around at least a portion of the wound irrigation system 838. The method further includes coupling the device 810 to the wound irrigation system 838. Coupling the device 810 to the wound irrigation system 838 may include coupling the third and fourth surfaces 856, 858 to one another, such as via the fastener 862, to form the seam 860. Coupling the device 810 to the wound irrigation system 838 may include forming an interference fit between the device 810 and the tip 850.
Referring to
The compliant region 882 includes a first surface 886 and a second surface 888 opposite the first surface 886. When the device 880 is in the wrapped position, the first surface 886 may be an interior surface and the second surface 888 may be an exterior surface. The compliant region 882 includes a main portion 890 and one or more projection portions 892. In the relaxed configuration, the main portion 890 and the projection portions 892 are substantially planar. When the device 880 is in the wrapped position, the projection portions 892 are disposed radially inward of the main portion 890. In the example shown, the device 880 includes two projection portions 892, each having a substantially rectangular prism shape. The projection portions 892 are separated by a first channel 894, which may be an axial channel.
The debridement region 884 is coupled to the compliant region 882. When the device 880 is in the wrapped position, the debridement region 884 is disposed radially inward of the projection portions 892 of the compliant region 882. In certain aspects, the debridement region 884 and the projection portions 892 may have substantially the same height perpendicular to the main portion 890 of the compliant region 882. A second channel 896 may be defined between the debridement region 884 and the projection portions 892 of the compliant region 882.
Referring to
The device 880 may be coupled to the wound irrigation system 902 in a similar manner as described above with respect to the irrigation and debridement assembly 840 of
In the wrapped position, the device 880 may have a substantially cylindrical structure and extend between fifth and sixth opposing surfaces 912, 914. The fifth surface 912 may be a proximal surface and the sixth surface 914 may be a distal surface. The assembly 900 may be used in a first configuration or a second configuration. The first and second configurations may be similar to the first and second configurations of the device 184 of
With reference to
The compliant region 942 includes a main portion 946 and one or more projection portions 948. The main portion 946 and the projection portions 948 may be substantially planar when the device 940 is in the relaxed position. In certain aspects, each of the projection portions 948 may include tapered distal surfaces 950. In the example shown, the device 940 includes two projection portions 948 that are separated by a first channel 952, which may be an axial channel.
The debridement region 944 is coupled to the compliant region 942. The debridement region 944 may define an undercut 954. The undercut 954 of the debridement region 944 may cooperate with the tapered distal surfaces 950 of the projection portions to at least partially define a second channel 956.
Referring to
The wound irrigation system 962 may be at least partially disposed in the first and second channels 952, 956. In certain aspects, the flange 966 may be at least partially disposed in the undercut 954 of the second channel 956. In the example shown, a shape of the undercut 954 is not complementary to the flange 966; however, in other examples, an undercut may be shaped to be complementary to a portion of a wound irrigation system, such as a tip. A portion of the debridement region 944, such as a lip 968, is disposed at least partially within a passage 970 of the tip 964. In various alternative aspects, instead of the undercut 954, a debridement region may be similar to the debridement region 884 of
The device 940 may be coupled to the wound irrigation system 962 in a similar manner as described above with respect to the irrigation and debridement assembly 840 of
In the wrapped position, the device 940 may have a substantially cylindrical structure and extend between fifth and sixth opposing surfaces 976, 978. The fifth surface 976 may be a proximal surface and the sixth surface 978 may be a distal surface. The assembly 960 may be used in a first configuration and a second configuration. The first and second configurations may be similar to the first and second configurations of the device 184 of
Containment Device—Other Features and Characteristics
Fasteners
In certain aspects, a containment device is compliant enough to be stretched over a nozzle of a wound irrigation system. However, in various alternative aspects, a device includes a seam (see, e.g., seam 146 of
Referring to
With reference to
Referring to
Outer Layer
Some containment and debridement devices according to various aspects of the present disclosure include an outer layer, such as an impermeable outer layer. With reference to
In various alternative aspects, an outer layer may have regions with differing levels of permeability. For example, the outer layer formed from an impermeable material may define interruptions in impermeability. These interruptions can be in the form of, for example, slits or cutouts in the impermeable material. The interruptions may act to focus vacuum power from the suction port radially inward to facilitate more efficient removal of the irrigation fluid and/or wound debris from the target body region while still allowing compliant region 566 to absorb fluid through the exterior surface 574 towards the interior surface 570.
Frame
With reference to
The device 590 further comprises an frame 602. The frame 602 comprises a ductile material that can be deformed and maintain a deformed shape. The frame 602 may define a closed curve (e.g., a ring). The frame 602 is coupled to the compliant region 598. For example, the frame 602 is embedded within the compliant region 598 and disposed outward of the interior region 596 with respect to the longitudinal axis 594. However, in various alternative aspects, the frame may be coupled to an exterior surface 604 of the compliant region 598.
The frame 602 may be movable between an undeformed configuration (
Size and Shape
Containment devices according to various aspects of the present disclosure can be a variety of shapes and sizes, depending on the wound irrigation device to which they are coupled, and the target body region with which they will interact. In certain variations, the containment device is configured to work in conjunction with a handheld wound irrigation device. In certain variations, the containment device is configured to engage a substantial portion of a large body part, such as a leg. An outer dimension (e.g., diameter) of a containment device may be greater than or equal to about 2 cm to less than or equal to about 50 cm, optionally greater than or equal to about 5 cm to less than or equal to about 20 cm (e.g., 10 cm). In one example, the outer dimension is 6 cm and a dimension of an opening to transfer irrigation fluid (e.g., first opening) is about 3 cm. A portion of a compressible region between a debridement region and a distal surface may be greater than or equal to about 0.25 inches to less than or equal to about 2 inches, optionally greater than or equal to about 0.5 inches to less than or equal to about 1.5 inches, or optionally about 1 inch. However, in certain other embodiments, a portion of a debridement region extends beyond a distal surface of a compliant region. In still other embodiments, a debridement region may be disposed on a distal surface of a compliant region. In certain variations a containment device may have a shape tailored to the particular application (see, e.g.,
Joint Between Containment Device and Wound Irrigation System
A containment device according to various aspects of the present disclosure is removably or permanently coupled to the nozzle. In certain aspects, a body of a containment device extends around at least a portion of an outer surface of a nozzle (e.g., around a circumference of the nozzle). In certain aspects, a containment device is coupled to a distal end of a nozzle.
A position of a containment device with respect to a nozzle may be adjustable along a longitudinal axis of the containment device. The position of the containment device on the nozzle affects the distance between an outlet of the nozzle and the target body region. It may be desirable to modify the distance based sensitivity of the target body region, condition of the target body region, desired pressure, or preference of the medical technician. The containment device may include features to facilitate adjustment of its position with respect to the nozzle. For example, in inner surface of the body, may define grooves or other features at sequential predetermined axial locations.
In certain aspects, the containment device may be coupled to the nozzle such that a fluid seal is formed at a joint (e.g., the second opening 80 of the containment device 72 of
A nozzle according to various aspects of the present disclosure may be used with or without a tip, such as the tip 60 of the pulse lavage system 50 of
As previously noted, a wound irrigation system may optionally include a suction port. The suction port may be in fluid communication with an interior region of a body of a containment device (see, e.g., suction port 122 of
Methods of Using Wound Irrigation and Debridement Assemblies
In various aspects, the present disclosure provides a method of irrigating and mechanically debriding a target body region. The method is described on the context of the assembly 110 of
The method may include assembling the device 114 to the wound irrigation system 112 by placing the device 114 into the open configuration, inserting the nozzle 118 an the suction port 122 at least partially into the interior volume 130, and then placing the device 114 in the closed configuration. The method may including fastening the device 114 in the closed configuration by engaging the fastener with the body 126 of the device 114. In certain variations, the method may further include adjusting an axial position of the device 114 with respect to the nozzle 118, and/or adjusting a dimension of the device 114 using the fastener. In certain aspects, assembling the device 114 to the wound irrigation system 112 can be performed one-handed.
The method includes engaging the distal surface 132 of the device 114 with the target body region in the first configuration. The method further includes discharging the irrigation fluid from the nozzle 118 and transferring the irrigation through the interior region 130 and the first opening 134 such that the irrigation fluid contacts the target body region. In various aspects, the method may further including modifying a velocity or flow of the irrigation fluid via a suction port (not shown).
The assembly 110 may optionally be translated with respect to the target body region while the distal surface 132 maintains engagement with the target body region. In certain aspects, engagement of the compliant region 152 including the distal surface 132 with the target body region may provide a gentle mechanical debridement. The suction port 122 and tip 124 remain disengaged from the target body region to prevent sticking of the wound irrigation system 112 to the target body region.
The method further includes containing at least a portion of the irrigation fluid within the device 114. For example, the irrigation fluid and/or wound debris may be contained within the interior region 130 and/or pores of the compliant region 152. The method may further include absorbing irrigation fluid from the target body region into the pores of the compliant region 152. In certain aspects, the method may include containing substantially all of the irrigation fluid and wound debris within the device 114, such as when the device further comprises an impermeable outer layer (see, e.g., outer layer 572 of
The method further includes engaging the device 114 with the target body region in the second configuration to perform mechanical debridement. The method includes compressing the compliant region 152 along the longitudinal axis 128 such that the debridement region 154 engages the target body region. The tip 124 may be translated with respect to the target body region while the compliant region 152 maintains contact with the target body region. In certain aspects, the proximal surface 136 translates together with the tip 124 while the distal surface 132 remains substantially axially fixed. A medical technician performing the method may shift the device 114 between the first and second configurations, depending on whether mechanical debridement is desired. Additionally or alternatively, the method may include rocking the device 114 side-to-side to create a scrubbing motion with the debridement region 154 while maintaining contact between the complaint region 152 and the target body region. In certain aspects, the device 114 may be shifted between configurations without changing a suction pressure. More particularly, the device 114 may be manipulated to bring the debridement region 154 into contact with the target wound region rather than applying pressure to drawn the target body region toward the debridement region 154.
The method may further include selectively engaging the device 114 with the target body region in the third configuration to increase an intensity of the mechanical debridement. The method may include compressing the compliant region 152 along the longitudinal axis 128 to engage the nozzle 118 with the debridement region 154. The method may further include applying a force to the assembly (e.g., through the wound irrigation system 112) to increase a pressure of the mechanical debridement, or removing or reducing the force to decrease the pressure. The method may include returning the device 114 to the first or second configuration, and repeating the configurations as desired.
The method may further include actuating a vacuum to remove at least a portion of the irrigation fluid and/or wound debris from the target body region. The method may include maintaining engagement between the distal surface 132 and the target body region. The method may further include axially compressing the compliant region 152 to improve a fluid seal between the device 114 and the target body region. The method may include applying negative pressure to the interior region 130 to draw the irrigation fluid and wound debris inward toward the suction port 122 and through the inlet tube 120.
The method may include disengaging the device 114 from the target body region. The method may further comprise disassembling the device 114 from the wound irrigation system 112. The method may further comprise cleaning the device 114, or optionally disposing of the device 114.
All possible combinations discussed and enumerated above and herein as optional features of the inventive devices and assemblies of the present disclosure are specifically disclosed as embodiments. In various aspects, the present disclosure contemplates a device for wound irrigation and debridement comprising a body. The body extends along a longitudinal axis. The body comprises an interior region comprising a first opening such that that the interior region and the first opening are configured to transfer an irrigation fluid. The body comprises a compliant region and a debridement region. The compliant region has a first stiffness and defines a distal surface. The compliant region includes the distal surface. The debridement region has a second stiffness different than the first stiffness. In a first configuration, the compliant region defines a first axial dimension along the longitudinal axis, the distal surface of the compliant region engages a target region, and the debridement region is axially offset from the distal surface and disengaged from the target region. In a second configuration, the compliant region is compressed along the longitudinal axis to define a second axial dimension less than the first axial dimension, thereby engaging the debridement region with the target region, and the distal surface of the compliant region engages the target region. Also specifically disclosed are combinations including this device optionally with any one or any combination of more than one of the enumerated features (1)-(12).
The device of the first embodiment optionally has any one or any combination of more than one of the following features: (1) the second stiffness is greater than the first stiffness; (2) the compliant region is porous and defines a plurality of pores, optionally the compliant region comprises an open cell foam comprising the plurality of pores, optionally the pores of the plurality of pores have an average diameter of greater than or equal to about 0.2 mm to less than or equal to about 1 mm, optionally the compliant region has a porosity of greater than or equal to about 80%; (3) the compliant region comprises a polymer selected form the group consisting of: polyurethane, polyethylene, cellulose, silicone, thermoplastic elastomer, thermoplastic polyurethane, polyvinyl chloride (PVC), and combinations thereof; (4) the compliant region comprises a first material and the debridement region comprises a second material, the first and second materials being distinct from one another; (5) the compliant region further comprises an inner surface at least partially defining the interior region, the debridement region is coupled to the inner surface and extends inward toward the longitudinal axis from the inner surface, and the debridement region defines a central opening substantially coaxial with the first opening; (6) the compliant region defines a cavity extending from the distal surface, the cavity is disposed outward of the interior region with respect to the longitudinal axis, and the debridement region is disposed within the cavity; (7) at least a portion of the body defines a substantially cylindrical shape, optionally the debridement region defines a substantially annular shape and has a second opening substantially coaxial with the first opening; (8) the debridement region comprises a plurality of discrete debridement regions distributed about the longitudinal axis; (9) the debridement region comprises at least one of: a plurality of bristles, a plurality of protrusions, a plurality of non-woven fibers, a plurality of woven fibers, a mesh, an open cell foam, a closed cell foam, a plurality of particles, or a surface coating; (10) the device further comprises a frame embedded in the compliant region, the frame is disposed outward of the interior region with respect to the longitudinal axis, the frame comprises a ductile material, and the frame is configured to be deformed to modify a shape of the compliant region; (11) the device further comprises a fastener engaging the body, optionally the fastener extends around an outer surface of the body and the fastener is configured to compress the body to reduce a dimension of the body; and/or (12) the device further comprises an impermeable layer disposed on at least a portion of an outer surface of the body.
In various aspects, the present disclosure contemplates a device for wound irrigation and debridement comprising a body. The body extends along a longitudinal axis. The body comprises an interior region and an opening such that that the interior region and the opening are configured to transfer an irrigation fluid. The body comprises a compliant region and a debridement region. The compliant region has a first density and defines a distal surface. The debridement region has a second density greater than the first density. In a first configuration, the compliant region defines a first axial dimension along the longitudinal axis, the distal surface of the compliant region engages a target region, and the debridement region is axially offset from the distal surface and disengaged from the target region. In a second configuration, the compliant region is compressed along the longitudinal axis to define a second axial dimension less than the first axial dimension, thereby engaging the debridement region with the target region, and the distal surface of the compliant region engages the target region. Also specifically disclosed are combinations including this device optionally with any one or any combination of more than one of the enumerated features (2)-(12) above.
In various aspects, the present disclosure contemplates a device for wound irrigation and debridement comprising a body. The body extends along a longitudinal axis. The body comprises an interior region and an opening such that that the interior region and the opening are configured to transfer an irrigation fluid. The body comprises a compliant region and a debridement region. The compliant region comprises a first material and defines a distal surface. The debridement region is coupled to a surface of the compliant region. The debridement region comprises a second material different from the first material. In a first configuration, the compliant region defines a first axial dimension along the longitudinal axis, the distal surface of the compliant region engages a target region, and the debridement region is axially offset from the distal surface and disengaged from the target region. In a second configuration, the compliant region is compressed along the longitudinal axis to define a second axial dimension less than the first axial dimension, thereby engaging the debridement region with the target region, and the distal surface of the compliant region engages the target region. Also specifically disclosed are combinations including this device optionally with any one or any combination of more than one of the enumerated features (2)-(3) and (5)-(12) above.
In various aspects, the present disclosure contemplates in certain variations a device and nozzle assembly for wound irrigation. The assembly comprises a nozzle and a device. The nozzle is configured to receive irrigation fluid and deliver the irrigation fluid to a target region. The device is coupled to the nozzle. The device comprises a body extending along a longitudinal axis. The body includes an interior region and an opening, such that the interior region and the opening are configured to transfer the irrigation fluid. The device comprises a compliant region defining a first stiffness and defining a distal surface. At least one of the nozzle and the device comprises a debridement region defining a second stiffness different than the first stiffness. In a first configuration, the compliant region defines a first axial dimension along the longitudinal axis, the distal surface of the compliant region engages the target region, and the debridement region is axially offset from the distal surface and disengaged from the target region. In a second configuration, the compliant region is compressed along the longitudinal axis to define a second axial dimension less than the first axial dimension, thereby engaging the debridement region with the target region, and the distal surface of the compliant region engages the target region. Also specifically disclosed are combinations including this assembly optionally with any one or any combination of more than one of the enumerated features (2)-(12) as described below and (13)-(16) as described below.
The assembly optionally has any one or any combination of more than one of the following features: (13) the nozzle comprises the debridement region and the debridement region is disposed on a distal end of the nozzle; (14) the body defines the debridement region, the body is configured to engage the target region in the first configuration, the second configuration, and a third configuration, and in the third configuration, the compliant region is compressed along the longitudinal axis to define a third axial dimension less than the second axial dimension, thereby engaging the nozzle with the debridement region and the debridement region with the target region, and the distal surface of the compliant region engages the target region; (15) the interior region of the body is configured to receive a vacuum port, and the compliant region is configured to conform to the target region to create a fluid seal and pull negative pressure; and/or (16) the device further comprises a tip defining a passage, the tip is in fluid communication with the nozzle, and the tip is disposed at least partially within the interior region of the body, optionally the debridement region circumferentially surrounds at least a portion of the tip, optionally a portion of the debridement region is disposed within the passage.
In various aspects, the present disclosure provides a method of irrigating and debriding a target region. The method comprises engaging a distal surface of an assembly with the target region. The assembly includes a nozzle and a device coupled to the nozzle. The device comprises a body extending along a longitudinal axis. The body includes an interior region and an opening. The body comprises a compliant region having a first stiffness and a debridement region having a second stiffness different than the first stiffness. The compliant region defines a distal surface. The debridement region is disengaged from the target region. The method further includes discharging an irrigation fluid from the nozzle. The irrigation fluid is transferred through the interior region and the opening to contact the target region. The method further includes containing at least a portion of the irrigation fluid within one or both of the interior region and the compliant region. The method further includes compressing the device along the longitudinal axis such that the debridement region engages the target region. Optionally, the target region comprises a wound bed. Also specifically disclosed are combinations including the assembly of this method optionally with any one or any combination of more than one of the enumerated features (2)-(16).
In various aspects, the present disclosure provides an irrigation and debridement assembly comprising a nozzle, a suction port, a tip, and a device. The nozzle is configured to receive irrigation fluid and deliver the irrigation fluid to a target region. The suction port is configured to remove irrigation fluid from the target region. The tip is coupled to the suction port and the nozzle. The tip defines a passage in fluid communication with the suction port and the nozzle. The device is coupled to the tip. The device is configured to transfer irrigation fluid between the passage and the target region. The device comprises a compliant region and a debridement region. The compliant region defines a distal surface. The debridement region is coupled to the compliant region. The debridement region defines a debridement surface. In a first configuration, at least a portion of the debridement surface is offset from the distal surface by a distance. In a second configuration, the debridement surface and the distal surface cooperate to define a contact surface. The contact surface is configured to engage at least a portion of the target region. The device is movable between the first configuration and the second configuration by translating the at least a portion of the debridement surface with respect to the distal surface. Also specifically disclosed are combinations including this stretchable composite material optionally with any one or any combination of more than one of the enumerated features (2)-(16) above and (17)-(19) as described below.
The assembly optionally has any one or any combination of more than one of the following features: (17) the debridement region circumferentially surrounds at least a portion of a periphery of the tip; (18) in a wrapped position, a surface of the compliant region is substantially cylindrical and in a relaxed position, the surface is substantially planar; and/or (19) at least a portion of the debridement region is disposed in the passage of the tip.
The details, examples and preferences provided above in relation to any particular one or more of the stated aspects of the present invention, and described and exemplified below in relation to any particular one or more of the stated aspects of the present invention, apply equally to all aspects of the present invention.
The foregoing description of the embodiments has been provided for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosure. Individual elements or features of a particular embodiment are generally not limited to that particular embodiment, but, where applicable, are interchangeable and can be used in a selected embodiment, even if not specifically shown or described. The same may also be varied in many ways. Such variations are not to be regarded as a departure from the disclosure, and all such modifications are intended to be included within the scope of the disclosure.
This application is the U.S. National Phase Application under 35 U.S.C. 371 of International Application No. PCT/US2020/016594 filed on Feb. 4, 2020, which claims the benefit of U.S. Provisional Application No. 62/800,794, filed on Feb. 4, 2019. The entire disclosures of the above applications are incorporated herein by reference.
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| PCT/US2020/016594 | 2/4/2020 | WO |
| Publishing Document | Publishing Date | Country | Kind |
|---|---|---|---|
| WO2020/163343 | 8/13/2020 | WO | A |
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