Existing devices, compositions, and methods for closing and treating a wound may range from simple over-the-counter products, such as dressings, wraps, bandages, adhesive bandages, butterfly strips, and surgical tape, to more specialized products, such as sutures and staples, depending on the type and severity of the wound, the skill of the caregiver, etc. While these treatments are promising, there may be challenges associated with some, and thus improved wound treatment devices are desirable.
In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having different letter suffixes may represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.
Examples of devices and packaging are described herein and generally relate to systems, apparatus, and methods for wound closure, and in particular to a wound closure device having one or more microstructures. However, one of skill in the art will appreciate that is it not intended to be limiting and the devices and packaging described herein may be used for other purposes.
Existing devices, compositions, and methods for closing and treating a wound may range from simple over-the-counter products, such as dressings, wraps, bandages, adhesive bandages, butterfly strips, and surgical tape, to more specialized products, such as sutures and staples, depending on the type and severity of the wound, the skill of the caregiver, etc. Although sutures and staples can be quite effective at closing wounds, proper application requires a trained specialist. Additionally, the application of sutures or staples is an invasive and painful procedure that frequently requires the use of an anesthetic. Furthermore, these procedures can leave unsightly scars, both from secondary insertion holes and from varying tensions applied to the laceration or surgical incision as a result of variations in suture or staple spacing and depth. For sutures, tension also can vary depending how tightly the suture is tied. Moreover, these skin closure techniques necessitate follow-up visits to a hospital or doctor's office for removal of the sutures or staples. This can be a problem not only for scheduled removal, but an even bigger issue if infection occurs since this requires removal of the sutures or sutures to reopen and clean the wound. Additionally, simply covering the wound with a bandage, such as an adhesive bandage, a butterfly closure strip, or surgical tape, is usually not sufficient to close more severe or deeper wounds, such as dermal wounds, because the adhesives used to attach devices such as adhesive bandages, butterfly closure strips, and surgical tape are not adequate to close these wounds without detaching or creep which reduces of eliminates the force drawing the edges of the tissue around the wound into apposition. Skin moisture adds to the problem by further reducing adherence of the adhesive-based bandages to the skin, which may lead to the premature release of the bandage from the skin and wound site before closure of the wound and proper healing. Also, for larger wounds, adhesive bandages may not conform to the contours of the anatomy such as an incision around a knee or a hip, resulting in reduced adherence of the device to the wound. Adhesives used can induce symptomatic allergic and inflammatory reactions and therefore in some situations it may be desirable to include other means for attaching the wound closure device to the wound. For at least some of these reasons, improved wound closure devices are desirable. At least some of these issues will be addressed by the examples of wound closure devices described herein.
Wider or longer devices containing microstructures may be desirable for several reasons. To produce wider devices, more than one microstructure array is attached to the backing. Doing so can produce devices that are a broad range of widths from 2 times to up to 50 times, the width of a device with one microstructure. Such wider devices have several advantages. First, they may enable more rapid closure of wounds. Faster procedures save time. Since operating rooms and emergency rooms cost roughly $50 and $20 per minute, respectively, saving a few minutes can translate into savings of hundreds of dollars per procedure. Saving time also allows more procedures to be performed per day which increases throughput and thus revenue for practitioners and medical facilities. More rapid procedures are a particular advantage in surgeries where extended time in the OR is associated with more complications. Second, closure is more consistent since fewer devices are placed reducing variability when closing wounds. Third, fatigue resulting from placing many devices results in increasingly poor placement during placement of latter devices applied to close the wound. The examples of devices disclosed herein may address at least some of these challenges.
Some aspects of the device may take a form similar to other devices disclosed in US Patent Publication Nos. 2015/0305739 and 2017/0333039, previously incorporated by reference, except that it has been modified to treat longer wounds. Thus, the device 100 may include an upper stretchable substrate layer 104 and a lower set of one or more arrays 106 with microstructures 108 such as microstaples that attach the device to the skin or tissue adjacent the wound. Further details on the structure of the device which distinguish it from previously disclosed examples are discussed below.
In this example, the length of the device may vary depending on the length of the wound being treated and thus may be any length, and this distance will be referred to as the length of the device. The length of the device extends in the direction substantially parallel to the wound, and is represented by dimension x in
In
Additionally, rows 110 of microstaples or microstructures 108 may be connected together with a sinusoidal or undulating strut 114 that similarly can expand and collapse under tension or compression, respectively, thereby moving the rows 110 of microstaples or microstructure 108 inward toward one another or outward away from one another. The undulating strut 114 may include a peak and a valley (when
A linear connector bridge 116 connects the rows 110 of microstaples or microstructure 108 on one side of the wound to the two rows 110 of microstaples or microstructure 108 on the opposite side of the wound, and therefore linear connector bridge 116 spans the wound 102 or incision. Because the connector bridge 116 is a straight rigid connector, it does not expand or contract, and therefore the rows 110 of microstaples immediately on either side of the wound maintain their linear position and distance from one another in the width direction (y-axis), but the rows may expand or collapse in the length direction (x-axis) due to the undulating connector. Thus, in this example, each array 106 includes two rows 110 of microstaples or microstructures 108 on either side of the wound 102, and each row 110 includes two microstaples or microstructure 108. This configuration allows the microstaples or microstructures 108 to move in the x and y directions in the plane of the substrate as needed. Additionally, in this example, the wound device 100 includes three arrays 106 of microstaples or microstructures 108, however this is not intended to be limiting and any number of arrays may be used in a wound closure device depending on how long and wide the device is. Or, in alternative examples, a multiple devices such as the device of
Thus, one, two, three, four, five, six, seven, eight, nine, ten, or more wound closure devices may be applied to a patient.
The microstaples or microstructures 108 may be formed of any material including metals, polymers, or other materials known in the art. The microstaples or microstructures 108 may be elongate protrusions extending from the row of microstructures or microstaples, and have a tissue piercing tip that can extend into tissue to anchor the device to the patient's skin. The depth of penetration is deep enough to ensure adequate retention strength yet not so deep that pain, inflammation, scarring, bleeding, etc. become an issue. Optionally, in any example the distance between microstaples along the length of the device is also constant between microstaples so that when the device is applied to a wound, any force transmitted from the wound closure device to the wound will be evenly distributed along the wound, at least initially unless there is expansion or contraction of the microstaples during application. However, in some circumstances, it may be desirable to have the microstaples spaced at varying distances from one another. In this example there are three arrays 106 in the device but this is not intended to be limiting, the device may have 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more arrays depending on the size of the device and the wound to be treated. Additionally, any number of rows 110 of microstaples or microstructure 108, or any number of microstaples or microstructures 108 per row 110 may be used in order to ensure that the device does not fall away from the wound. The arrays, microstaples, microstructures or any other aspects of lower arrays may take the form of any of those disclosed in US Patent Publication Nos. 2015/0305739 and 2017/0333039, previously incorporated herein by reference.
The upper substrate may be any material such as a fabric or polymer with an adhesive layer or adhesive backing on the tissue facing side to allow the device to be secured to tissue in conjunction with the microstaples or microstructures which engage tissue. The adhesive may be applied uniformly across the entire backing or only around the perimeter of the substrate to ensure good adhesion and sealing against the wound. Other adhesive patterns may also be used and in this application the terms adhesive, adhesive layer and adhesive backing are used interchangeably. The microstaples or microstructures are applied to the tissue facing side of the adhesive layer of the upper substrate 104. In this example, the outer-most corners of the upper substrate may be rounded with a large radius in order to avoid having sharp ninety-degree corners. This helps reduce the chance that the sharp corners will catch on clothing or other objects resulting in unwanted peeling of the device away from the skin. The sides of the device parallel to the width of the device are generally linear although they may be any shape. A linear edge allows an adjacent device to appose the linear edge of an adjacent device, thereby allowing the device to cover the wound without unwanted gaps between adjacent devices. The sides of the device that extend along the length of the device (or transverse to or orthogonal to the width of the device) may have a series of cutouts 118 between the arrays 106. When a large adhesive bandage is applied to a wound having contours or that flexes (e.g. around the knuckles, the knee, etc.), the adhesive bandage may not always conform to the contours of the anatomy and the bandage may ripple, buckle or tent outward thereby creating additional stress on the adhesive and allowing the device to more easily fall off the patient. Therefore, adding the slots or cutouts 118 (sometimes also referred to as apertures) along the sides or edges of the upper substrate allows the substrate to better conform to the native anatomy reducing local stress on adhesive and thus reducing risk of local adhesive failure. The slots 118 may be any shape such as rectangular, square, oval, elliptical, circular, round, etc. and combinations thereof. Here the slots are arcuate with a narrow neck region and an enlarged head region, and this results in undulating or scalloped edges. Square or rectangular slots along the edge wound result in a castellated edge. In this example there are two slots on either side of the middle array, although there may be more or less, and this also depends on the overall length of the device. The cutouts may be used on the upper and lower edges of the device.
The upper substrate 104 may be a continuous flat planar sheet of material that covers the wound to help seal the wound and prevent infection. The upper substrate 104 may optionally include one or more slits 120 (sometimes also referred to as an aperture or a slot) extending through the substrate to improve flexibility and help the substrate conform to the contours of the wound as well as allowing an aperture through which fluid from the wound may drain while still substantially covering and protecting the wound.
In the example of
Device 100 includes cutouts 118 to allow the device to conform to the anatomy and prevent peel away as well as wound drainage slots 120. The device has three arrays 106, each with two rows 110 of microstructure 108 on each side of the wound (not shown in this figure). Therefore, each array 106 has a total of four rows 110 of microstructures. The two rows 110 of microstructures are separated from the corresponding two rows 110 of microstructure on the other side of the wound by linear bridge 116. Also, each row 110 of microstructures 108 are separated from the adjacent row by an undulating connector 114.
Microstructures 108 in a row are separated by undulating connector or bridge 112. Rounded corners on the upper substrate 104 prevent sharp edges from catching on clothing or other objects thereby reducing the chance that the device will peel away from the wound. The skin facing side of the substrate may be coated with an adhesive to help the device stick to skin. Any number of arrays of microstructures may be included to provide a longer or shorter device, therefore three arrays is not intended to be limiting.
The application tab may also be tapered to provide a tab 310 that is easy to grasp between a thumb and finger or between fingers and also avoids having sharp corners which could catch on the operator's fingers, surgical gloves, or other adjacent objects. Thus, the example in
Optional slits or slots 608 may be disposed anywhere on the device to facilitate wound drainage. Here the slots 608 are elliptical in shape and are generally oriented so that the longitudinal axis of the slot 608 is transverse to the wound 610. This ensures that at least some portion of the slot will be disposed easily over the wound 610 to allow fluid drainage without requiring precise application of the device to the wound. The slots 608 or slits may be any of shapes or orientations previously described above in
The wound closure device 600 may also optionally include any of the slots 604 disposed in the upper and lower edges of the device. In this example the upper and lower edges run generally the same direction as the wound. This is not intended to be limiting and the slots 604 may be disposed on any edge of the device 600. The slots 604 as previously described allow the upper layer to flex and conform to the patient where the anatomy is not flat, or where the anatomy moves, thereby helping to reduce the possibility that the device will peel away and separate from the patient. The shape of the slots 604 may be any of the shapes previously described above in
Unlike previous examples where the device is attached to the skin with microstructures that are coupled to one another with struts or connectors, in this example the wound closure device is coupled to the skin of a patient with individual microstructures 606 or microstaples that are coupled to the adhesive layer on the skin contacting surface of the upper layer 602. Here, there are two rows of microstructures 606 on either side of the wound 610. Each row has at least one microstructure. In this example the row farthest away from the wound has two microstructures separated by a gap and the row closest to the wound has three microstructures separated by a gap. The rows may be staggered relative to one another or they may be in phase with one another. The microstructures or microstaples may be any of the microstructures of microstaples disclosed herein. Therefore, the array of microstructures is a plurality of unconnected, discrete, or independent microstructures.
In
Optional slits or slots 808 may be disposed anywhere on the device to facilitate wound drainage. Here the slits or slots 808 are thin and linear in shape and are generally oriented so that the longitudinal axis of the slit or slot 808 is transverse to the wound 810. This ensures that at least some portion of the slot will be disposed easily over the wound 810 to allow fluid drainage without requiring precise application of the device to the wound. The slits or slots 808 or slits may be any of shapes or orientations previously described above in
The wound closure device 800 may also optionally include any of the slots 804 disposed in the lateral edges of the device, which here run generally transverse or orthogonal to the wound 810. This is not intended to be limiting and the slots 804 may be disposed on any edge of the device 800. The slots 804 as previously described allow the upper layer to flex and conform to the patient where the anatomy is not flat, or where the anatomy moves, thereby helping to prevent the device from peeling away and separating from the patient. The shape of the slots 804 may be any of the shapes previously described above in
Unlike previous examples where the device is coupled to the skin with microstructures that are coupled to one another with struts or connectors, in this example the wound closure device is coupled to the skin of a patient with one or more arrays of microstructures or microstaples that are not coupled together. The individual microstructures 806 or microstaples are coupled to the adhesive layer on the skin contacting surface of the upper layer 802. Here, there are two rows of microstructures 806 on either side of the wound 810, or this may also be described as a column of microstructures that span across the wound 810. Each row has at least one microstructure. In this example the row above the wound has two microstructures separated by a gap and the row below the wound has two microstructures separated by a gap. The rows here are aligned with one another so that the microstructure in one row are directly over or under the microstructure in the adjacent row. However, this is not intended to be limiting the rows may also be staggered relative to one another. The microstructures or microstaples may be any of the microstructures of microstaples disclosed herein.
In
In any of the examples described in
The following, non-limiting examples, detail certain aspects of the present subject matter to solve the challenges and provide the benefits discussed herein, among others.
Example 1 is a wound closure device, comprising an elastic substrate having a first axis and a second axis, the first axis configured to extend along a length of a wound and the second axis configured to extend transversely across the wound; an adhesive layer coupled to the elastic substrate; and one or more microstructure arrays each having a length along a longitudinal axis of the one or more microstructure arrays, the one or more microstructure arrays coupled to the elastic substrate via the adhesive layer, wherein the length of the one or more microstructure arrays is oriented transversely to the first axis of the elastic substrate and substantially parallel to the second axis of the substrate.
Example 2 is the device of Example 1, wherein the elastic substrate comprises four corners, and at least some of the four corners are rounded.
Example 3 is the device of any of Examples 1-2, wherein the elastic substrate comprises two side edges that extend in a direction transversely to the wound, and wherein the elastic substrate comprises top and bottom edges that extend in a substantially similar direction as the wound, the top and bottom edges having slots disposed therein.
Example 4 is the device of any of Examples 1-3, wherein the slots form a scalloped or castellated edge along the top or bottom edges, the slots configured to impart flexibility to the device so that it is configured to conform to a patient's skin.
Example 5 is the device of any of Examples 1-4, wherein the elastic substrate comprises a plurality of slots disposed therethrough, the plurality of slots configured to allow fluid drainage from the wound through the wound closure device, or wherein the plurality of slots facilitate conformance of the wound closure device to skin on a patient and flexibility of the wound closure device.
Example 6 is the device of any of Examples 1-5, wherein the plurality of slots is oriented in a direction substantially parallel with the second axis of the elastic substrate.
Example 7 is the device of any of Examples 1-6, wherein the plurality of slots is oriented in a direction substantially parallel with the first axis of the elastic substrate.
Example 8 is the device of any of Examples 1-7, wherein at least one of the one or more microstructure arrays comprise a first end and second end opposite the first end, the first end having a plurality of rows of microstaples and the second end having a plurality of rows of microstaples, the first end configured to be disposed on one side of the wound and the second end disposed on an opposite side of the wound.
Example 9 is the device of any of Examples 1-8, wherein the plurality of rows of microstaples on the one end are separated from the plurality of rows of microstaples on the second end by a rigid connector disposed across the wound.
Example 10 is the device of any of Examples 1-9, wherein a row of microstaples from the plurality of rows of microstaples comprises two microstaples separated by a flexible connector configured to expand or collapse thereby moving the two microstaples closer together or farther apart.
Example 11 is the device of any of Examples 1-10, wherein two rows of microstaples from the plurality of rows of microstaples are separated by a flexible connector configured to expand or collapse thereby moving the two rows of microstaples closer together or further apart.
Example 12 is the device of any of Examples 1-11, further comprising an applicator tab releasably coupled to the elastic substrate.
Example 13 is the device of any of Examples 1-12, wherein the applicator tab comprises a plurality of legs releasably coupled to the elastic structure and a tab configured to be grasped by an operator.
Example 14 is the device of any of Examples 1-13, further comprising a release liner releasably coupled to the elastic substrate.
Example 15 is the device of any of Examples 1-14, wherein the release liner comprises a plurality apertures therethrough, the plurality of apertures configured to receive at least a portion of the plurality of microstructure arrays.
Example 16 is the device of any of Examples 1-15, wherein the one or more microstructure arrays comprise a plurality of microstructure arrays.
Example 17 is the device of any of Examples 1-16, wherein the one or more microstructure arrays comprise a plurality of discrete unconnected microstructures.
Example 18 is a method of treating a wound, the method comprising: providing wound closure device, the wound closure device comprising an elastic substrate with an adhesive layer coupled thereto, and one or more microstructure arrays coupled to the elastic substrate via the adhesive layer; anchoring one end of the wound closure device to tissue adjacent a first side of the wound, wherein anchoring comprises attaching a plurality of arrays of microstructures to the tissue adjacent the first side of the wound; applying tension to the wound closure device and drawing opposite ends of the wound together; disposing the wound closure device across the wound; and anchoring a second end of the wound closure device opposite the first end to tissue adjacent a second side of the wound opposite the first side of the wound, wherein anchoring the second end comprises attaching a second plurality of arrays of microstructures to the tissue adjacent the second side of the wound.
Example 19 is the method of Example 18, further comprising applying the wound closure device uniformly over the wound, wherein slits, slots, or cutouts in the device allow the wound closure device to conform to contours of the wound.
Example 20 is the method of any of Examples 18-19, further comprising allowing fluids to drain from the wound via slits or an aperture disposed through the wound closure device.
Example 21 is the method of any of Examples 18-20, wherein anchoring the one end or anchoring the second end comprises engaging a microstructure or a microstaple on the wound closure device with tissue adjacent the wound.
Example 22 is the method of any of Examples 18-21, wherein applying tension to the wound closure device comprises grasping and pulling on an application tab releasably coupled to the wound closure device.
Example 23 is the method of any of Examples 18-22, further comprising removing the wound closure device from a release liner having a plurality of apertures that receive at least a portion of the plurality of microstructure arrays.
Example 24 is the method of any of Examples 18-23, wherein the one or more microstructure arrays comprise a plurality of microstructure arrays.
Example 25 is the method of any of Examples 18-24, wherein the one or more microstructure arrays comprise a plurality of discrete unconnected microstructures.
In Example 26, the apparatuses or method of any one or any combination of Examples 1-25 can optionally be configured such that all elements or options recited are available to use or select from.
The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.
In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls.
In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.
The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.
The present application is a continuation-in-part of U.S. patent application Ser. No. 17/249,083 filed Feb. 19, 2021, which is a non-provisional of, and claims the benefit of U.S. Provisional Patent Application No. 62/978,454 (Attorney Docket No. 5173.008PRV) filed on Feb. 19, 2020; the entire contents of these applications are incorporated herein by reference. The present application is a continuation-in-part of U.S. patent application Ser. No. 17/163,756 (Attorney Docket No. 5173.003US2) filed Feb. 1, 2021, which is a continuation of U.S. patent application Ser. No. 15/446,999 filed on Mar. 1, 2017, now issued as U.S. Pat. No. 10,939,912; the entire contents of these applications are incorporated herein by reference.
Number | Date | Country | |
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62978454 | Feb 2020 | US |
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Parent | 17249083 | Feb 2021 | US |
Child | 18140822 | US | |
Parent | 15446999 | Mar 2017 | US |
Child | 17163756 | US |
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Parent | 17163756 | Feb 2021 | US |
Child | 17249083 | US |