This application describes embodiments of apparatuses, methods, and systems for the treatment of wounds, specifically to aid in the closure of large wounds, in conjunction with the administration of negative pressure.
Negative pressure wound therapy has been used in the treatment of wounds, and in many cases can improve the rate of healing while also removing exudates and other deleterious substances from the wound site.
Abdominal compartment syndrome is caused by fluid accumulation in the peritoneal space due to edema and other such causes, and results in greatly increased intra-abdominal pressure that may cause organ failure eventually resulting in death. Causes may include sepsis or severe trauma. Treatment of abdominal compartment syndrome may require an abdominal incision to permit decompression of the abdominal space, and as such, a large wound may be created onto the patient. Closure of this wound, while minimizing the risk of secondary infections and other complications, and after the underlying edema has subsided, then becomes a priority. However, acute open abdominal conditions may be caused by other reasons in addition to compartment syndrome, as described further below.
Other large or incisional wounds, either as a result of surgery, trauma, or other conditions, may also require closure. For example, wounds resulting from sterniotomies, fasciotomies, and other abdominal wounds may require closure. Wound dehiscence of existing wounds is another complication that may arise, possibly due to incomplete underlying fascial closure, or secondary factors such as infection.
Existing negative pressure treatment systems, while permitting eventual wound closure, still require lengthy closure times. Although these may be combined with other tissue securement means, such as sutures, there is also a risk that underlying muscular and fascial tissue is not appropriately reapproximated so as to permit complete wound closure. Further, when foam or other wound fillers are inserted into the wound, the application of negative pressure to the wound and the foam may cause atmospheric pressure to bear down onto the wound, compressing the foam downward and outward against the margins of the wound. This downward compression of the wound filler slows the healing process and slows or prevents the joining of wound margins. Additionally, inflammation of the fascia in the form of certain types of fasciitis can lead to rapid and excessive tissue loss, potentially meriting the need for more advanced negative pressure treatment systems. Accordingly, there is a need to provide for an improved apparatus, method, and system for the treatment and closure of wounds.
Embodiments of the present invention relate to negative pressure wound closure devices, methods, and systems that facilitate closure of a wound. It will be understood by one of skill in the art that the wounds described herein this specification may encompass any wound, and are not limited to a particular location or type of wound. The devices, methods, and systems may operate to reduce the need for repetitive replacement of wound filler material currently employed and can advance the rate of healing. The devices, methods, and systems may be simultaneously used with negative pressure to remove wound fluids.
In certain embodiments, an apparatus for treating a wound with negative pressure wound therapy is provided, the apparatus comprises a stabilizing structure for insertion into a wound. The stabilizing structure comprises a length corresponding to a y-direction and extending along a central longitudinal axis of the stabilizing structure between a first end and a second end of the stabilizing structure, a width corresponding to an x-direction, the width being transverse to the length and extending along a central transverse axis of the stabilizing structure between a first side and a second side of the stabilizing structure, and a height corresponding to a z-direction, the height being transverse to the length and the width and extending between a top surface and a bottom surface of the stabilizing structure. The length and width of the stabilizing structure may each be greater than the height. The stabilizing structure may further comprise a plurality of cells defined by one or more walls, the cells being provided side-by-side in a horizontal plane parallel to the x-direction and the y-direction, wherein each of the cells has a top end and a bottom end with an opening extending through the top and bottom ends in the z-direction. The stabilizing structure may also be configured such that upon application of negative pressure to the wound when the stabilizing structure is inserted into the wound, the stabilizing structure collapses more in the horizontal plane than in the z-direction, and the stabilizing structure collapses more in the x-direction than in the y-direction.
In certain embodiments, the outer cells located farther away from the central longitudinal axis of the stabilizing structure are sized and configured to collapse before inner cells located closer to the central longitudinal axis of the stabilizing structure.
In certain embodiments, the cells located closer to the central transverse axis of the stabilizing structure are sized and configured to collapse before cells located farther away from the central transverse axis of the stabilizing structure.
In certain embodiments, the cells located closer to the central transverse axis of the stabilizing structure are sized and configured to collapse at a faster rate than cells located farther away from the central transverse axis of the stabilizing structure.
In certain embodiments, the stabilizing structure has an oculiform shape.
In certain embodiments, the stabilizing structure comprises cells of uniform size.
In certain embodiments, the stabilizing structure comprises cells of different sizes. In some embodiments, the cells located closer to the central transverse axis of the stabilizing structure are larger than cells located farther away from the central transverse axis of the stabilizing structure. Additionally, in some embodiments, the cells located closer to the central longitudinal axis of the stabilizing structure are larger than cells located farther away from the central longitudinal axis of the stabilizing structure.
In certain embodiments, the cells are defined by one or more walls having varying stiffness. The one or more walls defining the cells may be made of a material having a Shore hardness of 80 or less, 60 or less, or 40 or less. The one or more walls defining the cells may be made of a material having a Young's modulus of 20 MPa or less, 12 MPa or less, 5 MPa or less, 1 MPa or less.
In certain embodiments, the stabilizing structure comprises walls of uniform wall thickness.
In certain embodiments, the stabilizing structure comprises walls of non-uniform wall thickness. The walls may taper to create a hinge and wherein the hinge is sized and configured to increase rotation at a junction between one or more walls upon application of negative pressure to the wound when the stabilizing structure is inserted into the wound.
In certain embodiments, the internal radius is sized and configured to increase cell sizes and/or collapse of the stabilizing structure upon application of negative pressure to the wound when the stabilizing structure is inserted into the wound.
In certain embodiments, an amount of cells adjacent a center portion of the stabilizing structure are greater than an amount of cells adjacent the first or second ends of the stabilizing structure.
In certain embodiments, the plurality of cells are sized and configured to increase collapse of the first and second end of the stabilizing structure upon application of negative pressure to the wound when the stabilizing structure is inserted into the wound.
In certain embodiments, the apparatus further comprises a foam layer, wherein the foam layer is seized and configured to increase the width of the stabilizing structure upon application of negative pressure to the wound when the stabilizing structure is inserted into the wound.
In certain embodiments, an apparatus for treating a wound with negative pressure wound therapy may comprise a stabilizing structure for insertion into a wound. The stabilizing structure comprises a length corresponding to a y-direction and extending along a central longitudinal axis of the stabilizing structure between a first end and a second end of the stabilizing structure, a width corresponding to an x-direction, the width being transverse to the length and extending along a central transverse axis of the stabilizing structure between a first side and a second side of the stabilizing structure, and a height corresponding to a z-direction, the height being transverse to the length and the width and extending between a top surface and a bottom surface of the stabilizing structure. The length and width of the stabilizing structure may each be greater than the height. The stabilizing structure may further comprise a plurality of cells defined by one or more walls, the cells being provided side-by-side in a horizontal plane parallel to the x-direction and the y-direction, wherein each of the cells has a top end and a bottom end with an opening extending through the top and bottom ends in the z-direction. The stabilizing structure may also be configured such that upon application of negative pressure to the wound when the stabilizing structure is inserted into the wound, the stabilizing structure collapses more in the horizontal plane than in the z-direction, and the stabilizing structure collapses more in the x-direction than in the y-direction. The apparatus may further comprise cells located farther away from the central transverse axis of the stabilizing structure that are sized and configured to cause one or both longitudinal end portions of the stabilizing structure to collapse uniformly with a central portion of the stabilizing structure between the longitudinal end portions upon application of negative pressure.
In certain embodiments, the stabilizing structure has an oculiform shape.
In certain embodiments, the stabilizing structure has cells of varying size.
In certain embodiments, the stabilizing structure has walls of varying thickness.
In certain embodiments, the stabilizing structure has cells of varying internal radius.
In certain embodiments, the stabilizing structure has walls of varying stiffness or hardness.
In certain embodiments, cells located closer to the central transverse axis of the stabilizing structure are larger than cells located farther away from the central transverse axis of the stabilizing structure.
In certain embodiments, cells located closer to the central longitudinal axis of the stabilizing structure are larger than cells located farther away from the central longitudinal axis of the stabilizing structure.
In certain embodiments, a majority of the cells are diamond-shaped.
In certain embodiments, the stabilizing structure is symmetrical about its central longitudinal axis.
In certain embodiments, the stabilizing structure is symmetrical about its central transverse axis.
In certain embodiments, at least some of the cells relatively closer to the longitudinal ends of the stabilizing structure are larger than cells relatively closer to the central longitudinal axis.
In certain embodiments, the stabilizing structure comprises a plurality of closed cells each defined by four internal walls.
In certain embodiments, the stabilizing structure comprises at least some open cells.
In certain embodiments, the open cells are located closer to the longitudinal ends of the stabilizing structure than the central longitudinal axis.
In certain embodiments, the cells of the stabilizing structure are sized and configured so that one or both longitudinal end portions of the stabilizing structure collapse to have about the same width as a width at the central transverse axis upon application of negative pressure.
Other embodiments of wound closure devices, stabilizing structures and associated apparatuses are described below.
Other features and advantages of the present invention will be apparent from the following detailed description of the invention, taken in conjunction with the accompanying drawings of which:
Embodiments disclosed in this section or elsewhere in this specification relate to apparatuses and methods of treating a wound with reduced pressure, including pump and wound dressing components and apparatuses. The apparatuses and components comprising the wound overlay and packing materials, if any, are sometimes collectively referred to in this section or elsewhere in this specification as dressings.
It will be appreciated that throughout this specification reference is made to a wound. It is to be understood that the term wound is to be broadly construed and encompasses open and closed wounds in which skin is torn, cut or punctured or where trauma causes a contusion, or any other superficial or other conditions or imperfections on the skin of a patient or otherwise that benefit from reduced pressure treatment. A wound is thus broadly defined as any damaged region of tissue where fluid may or may not be produced. Examples of such wounds include, but are not limited to, abdominal wounds or other large or incisional wounds, either as a result of surgery, trauma, sterniotomies, fasciotomies, or other conditions, dehisced wounds, acute wounds, chronic wounds, subacute and dehisced wounds, traumatic wounds, flaps and skin grafts, lacerations, abrasions, contusions, burns, electrical burns, diabetic ulcers, pressure ulcers, stoma, surgical wounds, trauma and venous ulcers or the like.
As is used in this section or elsewhere in this specification, reduced or negative pressure levels, such as −X mmHg, represent pressure levels that are below standard atmospheric pressure, which corresponds to 760 mmHg (or 1 atm, 29.93 inHg, 101.325 kPa, 14.696 psi, etc.). Accordingly, a negative pressure value of −X mmHg reflects absolute pressure that is X mmHg below 760 mmHg or, in other words, an absolute pressure of (760−X) mmHg. In addition, negative pressure that is “less” or “smaller” than −X mmHg corresponds to pressure that is closer to atmospheric pressure (e.g., −40 mmHg is less than −60 mmHg). Negative pressure that is “more” or “greater” than −X mmHg corresponds to pressure that is further from atmospheric pressure (e.g., −80 mmHg is more than −60 mmHg).
The negative pressure range for some embodiments of the present disclosure can be approximately −80 mmHg, or between about −10 mmHg and −200 mmHg. Note that these pressures are relative to normal ambient atmospheric pressure. Thus, −200 mmHg would be about 560 mmHg in practical terms. In some embodiments, the pressure range can be between about −40 mmHg and −150 mmHg. Alternatively, a pressure range of up to −75 mmHg, up to −80 mmHg or over −80 mmHg can be used. Also in other embodiments a pressure range of below −75 mmHg can be used. Alternatively, a pressure range of over approximately −100 mmHg, or even −150 mmHg, can be supplied by the negative pressure apparatus. In some embodiments, the negative pressure range can be as small as about −20 mmHg or about −25 mmHg, which may be useful to reduce fistulas. In some embodiments of wound closure devices described here, increased wound contraction can lead to increased tissue expansion in the surrounding wound tissue. This effect may be increased by varying the force applied to the tissue, for example by varying the negative pressure applied to the wound over time, possibly in conjunction with increased tensile forces applied to the wound via embodiments of the wound closure devices. In some embodiments, negative pressure may be varied over time for example using a sinusoidal wave, square wave, and/or in synchronization with one or more patient physiological indices (e.g., heartbeat).
Examples of such applications where additional disclosure relating to the preceding descriptions may be found include U.S. Pat. No. 8,235,955, titled “Wound treatment apparatus and method,” issued Aug. 7, 2012 and U.S. Pat. No. 7,753,894, titled “Wound cleansing apparatus with stress,” issued Jul. 13, 2010. Both applications are hereby incorporated by reference in their entirety. Other applications that may contain teachings relevant for use with the embodiments described in this section or elsewhere in this specification may include application Ser. No. 12/886,088, titled “Systems And Methods For Using Negative Pressure Wound Therapy To Manage Open Abdominal Wounds,” filed Sep. 20, 2010, published as US 2011/0213287; application Ser. No. 13/092,042, titled “Wound Dressing And Method Of Use,” filed Apr. 21, 2011, published as US 2011/0282309; and application Ser. No. 13/365,615, titled “Negative Pressure Wound Closure Device,” filed Feb. 3, 2012, published as US 2012/0209227, the entireties of each of which are hereby incorporated by reference. Still more applications that may contain teachings relevant for use with the embodiments described in this specification are application Ser. No. 13/942,493, titled “Negative Pressure Wound Closure Device,” filed Jul. 15, 2013, published as US 2014/0180225; PCT App. No. PCT/US2013/050619, filed Jul. 16, 2013 titled “Negative Pressure Wound Closure Device,” published as WO 2014/014871 A1; PCT App. No. PCT/US2013/050698, filed Jul. 16, 2013 titled “Negative Pressure Wound Closure Device,” published as WO 2014/014922 A1; PCT App. No. PCT/IB2013/01555, titled “Devices and Methods for Treating and Closing Wounds with Negative Pressure,” filed May 5, 2013, published as WO 2013/175309 A1; PCT App. No. PCT/US2014/025059, titled “Negative Pressure Wound Closure Device and Systems and Methods of Use in Treating Wounds with Negative Pressure,” filed Mar. 12, 2014, published as WO 2014/165275 A1; and PCT App. No. PCT/GB2014/050746, “Compressible Wound Fillers and Systems and Methods of Use In Treating Wounds With Negative Pressure,” filed Mar. 13, 2014, published as WO 2014/140578 A1, and “Negative Pressure Wound Closure Device,” filed Oct. 21, 2014, and published as PCT/US2014/061627. The entireties of the aforementioned applications are each hereby incorporated by reference and should be considered part of the present specification.
It will be understood that throughout this specification in some embodiments reference is made to an elongate, elongated or longitudinal strip or strips. It is to be understood that these terms are to be broadly construed and refer in some embodiments to an elongate material having two parallel or substantially parallel faces, where in cross-section a thickness of the material as measured perpendicular to the faces is relatively smaller than a height of the material measured parallel to the faces. While in some embodiments the strips may be constructed from discrete lengths of material, in other embodiments the strips may simply refer to elongate portions of an overall structure having two parallel or substantially parallel faces. The strips in some embodiments have a rectangular or generally rectangular-shaped faces, wherein a length of the face is longer than the height of the face. In some embodiments, the length of the face may be more than 2 times, 4 times, 6 times, 8 times, 10 times, 12 times or more greater than the height of the face.
As used in this section or elsewhere in this specification, the term “horizontal,” when referring to a wound, indicates a direction or plane generally parallel to the skin surrounding the wound. The term “vertical,” when referring to a wound, generally refers to a direction extending perpendicular to the horizontal plane. The term “longitudinal,” when referring to a wound, generally refers to a direction in the horizontal plane taken in a direction along which the wound is longest. The term “lateral,” when referring to a wound, generally refers to a direction in the horizontal plane perpendicular to the longitudinal direction. The terms “horizontal,” “vertical,” “longitudinal,” and “lateral” may also be used to describe the stabilizing structures and wound closure devices described throughout this specification. When describing these structures or devices, these terms should not be construed to require that the structures or devices necessarily be placed into a wound in a certain orientation, though in certain embodiments, it may be preferable to do so.
In some embodiments, the drape 104 may be provided with one or more corrugations or folds. Preferably, the corrugations are aligned along the longitudinal axis of the wound, and as such may support closure of the wound by preferentially collapsing in a direction perpendicular to the longitudinal axis of the wound. Such corrugations may aid in the application of contractile forces parallel to the wound surface and in the direction of wound closure. Examples of such drapes may be found in application Ser. No. 12/922,118, titled “Vacuum Closure Device,” filed Nov. 17, 2010 (published as US 2011/0054365), which is hereby incorporated by reference in its entirety.
In use, the wound 101 is prepared and cleaned. In some cases, such as abdominal wounds, a non- or minimally-adherent organ protection layer (not illustrated) may be applied over any exposed viscera. The wound packer 102 is then inserted into the wound, and is covered with the drape 104 so as to form a fluid-tight seal. A first end of the conduit 108 is then placed in fluidic communication with the wound, for example via the aperture 106. The second end of the conduit 108 is connected to the pump 110. The pump 110 may then be activated so as to supply negative pressure to the wound 101 and evacuate wound exudate from the wound 101. As will be described in additional detail below and in relation to the embodiments of the foregoing wound closure devices, negative pressure may also aid in promoting closure of the wound 101, for example by approximating opposing wound margins.
Any structure or component disclosed herein this section or elsewhere in the specification may comprise a radiopaque material. A radiopaque material advantageously allows a clinician to more easily find pieces of the wound closure device that may have come loose from the structure and become lost in the wound. Some examples of radiopaque materials include barium sulfate, bismuth trioxide, bismuth subcarbonate, bismuth oxychloride, and tungsten.
All stabilizing structures described herein this section or elsewhere in the specification may be fashioned to accommodate any size of wound. However, to better accommodate the needs of the clinical environment, in certain embodiments, the stabilizing structures described herein may be provided in a pack of two sizes, one smaller stabilizing structure and one larger stabilizing structure about 1.25 times as larger, about 1.5 times as large, about 1.75 times as large, about 2 times as larger, about 2.5 times as larger, about 3 times as large, about 4 times as large, about 5 times as large, or more than about 5 times as large. In some embodiments, the pack may comprise more than two sizes, such as three sizes, four sizes, five sizes, or more than five sizes. The stabilizing structures within the pack may be of a variety of sizes in relation to one another such as the ratios described above.
In certain embodiments, the stabilizing structure 6000 can collapse in any manner described in this section or elsewhere in this specification with or without the application of negative pressure. For example, the stabilizing structure may collapse significantly more in one plane than in another plane upon application of negative pressure. In some embodiments, the stabilizing structure is configured to collapse more in a horizontal plane parallel to the length and width of the stabilizing structure than in a vertical plane perpendicular to the horizontal plane. In embodiments, particular rows may collapse in a first direction, while another row may collapse in the same or an opposing direction. In certain embodiments, the stabilizing structure may collapse along the width of the stabilizing structure while remaining relatively rigid along the length of the stabilizing structure and in the vertical direction.
The stabilizing structure may be comprised of any materials described in this section or elsewhere in this specification, including: flexible plastics such as silicone, polyurethane, rigid plastics such as polyvinyl chloride, semi-rigid plastics, semi-flexible plastics, biocompatible materials, composite materials, metals, and foam. In certain embodiments, the stabilizing structure may comprise a radio opaque material, to more readily allow a clinician to find pieces of the stabilizing structure within the wound.
Returning to
The elongate strips 6006 may be made from one single material, such as those described elsewhere in the specification, or the elongate strips may be made from multiple materials. For example, elongate strips 6006 may comprise sections of more rigid material and sections of more flexible material. The elongate strips 6006 may be curved along their length so as to facilitate the curved outer perimeter of the stabilizing structure 6000. The elongate strips may be curved along their lengths outward away from a center of the stabilizing structure 6000. The arch of the curves of the elongate strips 6006 may vary considerably, with some strips 6006 being highly curved while other are minimally curved or even straight.
Similarly, the stabilizing structure 6000 can further comprise a plurality of intervening members 6010 connected to the elongate strips 6006. The intervening members 6010 may all be of a similar shape and size or they may be of a variety of shapes and sizes. The intervening members may be constructed from any material disclosed herein this section or elsewhere in the specification. Further, the intervening members may be constructed from multiple materials.
Advantageously, the elliptical shape of stabilizing structure 6000 may allow the structure to better accommodate the shape of the wound. Most wounds are in shapes that are rounded, thus, an elliptically shaped stabilizing structure 6000 may better fit into a wound.
In embodiments, the outer perimeter 6002 may have a reduced edge 6012 so as to facilitate collapse of the stabilizing structure. By removing mass of the stabilizing structure at reduced edge 6012, the stabilizing structure can collapse more freely at reduced edge 6012, thus allowing for a better fit within the wound. Further, by reduced the mass at reduced edge 6012, there may be less pinching of the surrounding tissue during and after collapse of the stabilizing structure 6000.
The stabilizing structure 6000 and all stabilizing structures and wound closure devices described in this section or elsewhere in this specification can collapse on a variety of timescales in a dynamic fashion. In certain embodiments, the majority of the collapse may occur within the first few minutes upon application of negative pressure. However, after the initial collapse, the stabilizing structure or wound closure device may continue to collapse at a much slower rate, thereby applying increasing longitudinal tension over a long period of time and drawing the edges of the wound closer together. By slowly drawing the wound edges closer together over time, the stabilizing structure or wound closure device allows the surrounding healing tissue to remodel synergistically with the closure of the device or stabilizing structure. Slow, dynamic wound closure may allow the surrounding tissue to heal at an accelerated rate, because the collapsing structure or device slowly brings the edges of the wound closer together without stressing the newly formed or weakened tissue too quickly.
In some embodiments, the stabilizing structures described in this section or elsewhere in this specification can be placed into a wound for a period of time and then removed or replaced with another stabilizing structure. For example, a stabilizing structure could be inserted into a wound for a period of time, promoting closure of the wound by drawing the edges closer together. After a period of time has passed, the stabilizing structure can be replaced by a stabilizing structure of a different size or collapsibility, for example a stabilizing structure of a smaller size or decreased density. This process could be repeated over and over, thereby continuously drawing the edges of the wound together over time and allowing for continuing repair and remodeling of the surrounding tissue. In certain embodiments, the stabilizing structure is configured to remain in the wound for at least about less than 1 hour, at least about 1 hour, at least about 2 hours, at least about 4 hours, at least about 6 hours, at least about 8 hours, at least about 12 hours, at least about 24 hours, at least about 2 days, at least about 4 days, at least about 6 days, at least about 1 week, at least about 2 weeks, at least about 3 weeks, or more than 3 weeks.
In certain embodiments, up to 90% of the collapse of the stabilizing structure or wound closure device may occur within the first few minutes upon application of negative pressure, while the remaining 10% of the collapse may occur slowly over a period of many minutes, hours, days, weeks, or months. In other embodiments, up to about 80% of the collapse, up to about 70%, up to about 60%, up to about 50%, up to about 40%, up to about 30%, up to about 20%, up to about 10%, or about 0% of the collapse will occur immediately within the first few minutes upon application of negative pressure while the remainder of the collapse occurs at a much slower rate such as over the course of many minutes, hours, days weeks, or months. In other embodiments, the stabilizing structure can collapse at a variable rate. In some embodiments, the entirety of the collapse occurs at a slowed rate, while in other embodiments the entirety of the collapse occurs almost immediately within the first few minutes. In further embodiments, the collapse can occur at any rate and the rate can vary over time. In certain embodiments, the rate of collapse can be altered in a variable fashion by adding and/or removing portions of the structure or by controlling the application of negative pressure and irrigant fluid.
Returning to
Any of the stabilizing structures described herein this section or elsewhere in the specification may be constructed from any suitable means. For example, the stabilizing structures may be constructed via molding or may be printed directly using 3D printing technology. In certain embodiments, the stabilizing structures of
In some embodiments, the stabilizing structure 6000 of
Applicable to all stabilizing structures or wound closure devices described in this section or elsewhere in the specification, the stabilizing structure or wound closure device may be tearable such that the stabilizing structure may be shaped into the shape of a wound. In some embodiments, the stabilizing structure may be torn at the intersections between intervening members and elongate strips, while in further embodiments, the elongate strips or intervening members may be torn at any suitable position.
As illustrated in
As illustrated in
In some embodiments, a method for generating a stabilizing structure design may include steps to speed up the initial geometry construction. For example if all members from left to right in a specific row, as visualized by intervening walls 6070, 6076 in
Similar to the embodiments illustrated in
In some embodiments, the anchoring layer 5006 comprises an elongate strip of material comprising a plurality of tissue anchors extending from a base layer 5007, wherein the tissue anchors can have different shapes and sizes as described elsewhere in the specification. The tissue anchors may extend from a first planar side of the elongate strip, and the second planar side of the elongate strip may comprise an adhesive covered by an adhesive backing layer. The structure of the anchors can have various forms depending on the tissue they are intended to bind. Longer anchors can be used for loosely bound tissues such as fat or connective tissue, while shorter anchors can be used for denser tissues such as muscle. In other embodiments, depending upon the shape of the anchor, shorter anchors may be more desirable for softer, fatty tissue, while longer anchors are utilized for denser tissues. Anchors with more rigid stems can be utilized to penetrate denser tissues. In some embodiments, anchors can have bilateral prongs that tend to collapse upon insertion in tissue and yet expand when pulled in an opposite direction such that a certain pulling force can be applied to tissue. The characteristics of the anchors or attachment mechanisms, and their resulting force profiles, can vary by a number of parameters, such as the length of the anchor, the shape of the attachment mechanisms, the structure of grasping features, the material(s) used for the attachment mechanisms, the relative flexibility/rigidity of the attachment mechanisms, and the spacing/density of the attachment mechanisms.
The anchors may have various lengths for optimal penetration of the surrounding tissue. For example, the length of the anchors may be at most about 0.01 mm, at most about 0.1 mm, at most about 0.2 mm, at most about 0.5 mm, at most about 1 mm, at most about 2 mm, at most about 3 mm, at most about 5 mm, at most about 10 mm, at most about 20 mm, at most about 30 mm, at most about 40 mm, at most about 50 mm, at most about 75 mm, at most about 100 mm, or more than 100 mm.
In some embodiments, the use of surface anchors can be used in combination with a surgical adhesive, providing a much stronger bond between tissue layers than the adhesive alone, and providing temporary adhesion while the adhesive sets. In some embodiments, the surgical adhesive can be added to the anchors themselves. In certain embodiments, the surgical adhesive may simply be applied between the anchors to coat at least a portion of the anchoring layer. In further embodiments, the anchors may be replaced with a surgical adhesive, and the surgical adhesive may act to anchor the device to the surrounding wound.
In certain embodiments, the anchors may be constructed from a variety of materials, including any materials disclosed elsewhere in the specification, such as: synthetic or natural polymers, metals, ceramics, or other suitable materials. The anchors may be constructed from biodegradable materials such as biodegradable synthetic or natural polymers. Non-limiting examples of biodegradable synthetic polymers include: polyesters such as polylactic acid or polyglycolic acid, polyanhydrides, and linear polymers with biodegradable linkages. Further, the anchors may be constructed of biodegradable biological materials, such as autografts, allografts, and/or xenografts.
Considering the anchoring layer of
In some embodiments, the bands of different tissue anchors can be organized in a vertical direction, while in other embodiments, they may be organized in a horizontal direction. They may also be organized in either the horizontal and vertical directions when considered in the xy plane, i.e. facing downward into the wound.
In certain embodiments, the different types of anchors may be interspersed with one another, rather than organized into discrete bands of specific types of anchors. For example, the longer anchors may be surrounded by smaller anchors and vice-versa. In some embodiments, the anchors may be organized randomly across the anchoring layer or in other suitable patterns.
In particular embodiments, the anchoring layer may be disposed on the inner faces of the stabilizing structure. For example, the anchoring layer may cover at most about 5%, at most about 10%, at most about 20%, at most about 30%, at most about 50%, at most about 75%, and at most about 100% of the interior surfaces of the stabilizing structure.
In further embodiments, the entire anchoring layer may be comprised of only one type of anchor, for example the entirety of the anchoring layer may be comprised of the longer hooks 5008 or the shorter hooks 5010 as depicted in
The stabilizing structures and/or wound closure devices described in this section or elsewhere in this specification may be used in conjunction with methods or systems for the closure of a wound. In some embodiments of methods of use for closure of a wound, one or more of the stabilizing structures or wound closure devices of any of the embodiments described in this section or elsewhere in this specification is placed into a wound. In some embodiments, an organ protection layer may be provided in the wound before placement of the stabilizing structure. In certain embodiments, foam or other porous material may be placed in the wound along with the stabilizing structure or wound closure device, either below, above, or surrounding the stabilizing structure or wound closure device. Foam or other porous material may also surround the perimeter of the stabilizing structure or wound closure device. The stabilizing structure or wound closure device may be configured to collapse in any manner as described in this section or elsewhere in this specification, for example by having a particular size and shape, or by comprising a certain volume of foam or other porous material within the cells of the structure. The stabilizing structure or wound closure device may further be altered in any manner described in this section or elsewhere in this specification so as to better accommodate the shape of the wound. After placement in the wound, the stabilizing structure or wound closure device can be sealed by a fluid-tight drape. The fluid-tight drape can comprise a port configured for the application of negative pressure. A source of negative pressure may then be connected to the port and negative pressure may be applied to the wound. The stabilizing structure or wound closure device may be replaced over time by stabilizing structures or wound closure devices of various shapes and sizes as desired to best promote wound healing.
In
In certain embodiments, the suction port may be placed directly over the central portion of the foam layer 5116. In such embodiments, the foam layer may collapse inward along with the stabilizing structure while under negative pressure, thereby collapsing the suction port. To avoid collapse, the suction port may be rigid in comparison to the foam and resist collapse. A washer may be placed inside, below, or around the suction port to provide rigidity and resist collapse.
In some embodiments, the suction port may be pre-attached to the top foam layer so that drapes can be positioned around the port. A hard port or a soft port may be used, such ports may further be used in combination with a washer such as described above. In further embodiments, the suction port could only partially collapse with the collapsing matrix while still maintaining the port opening for negative pressure.
Further details regarding the wound closure devices, stabilizing structures, related apparatuses and methods of use that may be combined with or incorporated into any of the embodiments described herein are found elsewhere throughout this specification and in International Application No. PCT/US2013/050698, filed Jul. 16, 2013, published as WO 2014/014922 A1, the entirety of which is hereby incorporated by reference.
In embodiments, the stabilizing structure of
As depicted in
Absent the extended section 6120, the stabilizing structure comprises non-stepped side walls along substantially the entire length of the oval. However, with the extended section, the additional rows may provide a stepped outer perimeter 6124 based on the additional rows, in contrast to the flattened oval end of the stabilizing structure 6126. Further embodiments of the extended section will be described in more detail below in relation to
The stabilizing structures of
As depicted in
In some embodiments, extended sections 6220 may comprise a first row of four cells, followed by a row of two cells, followed by another row of two cells. The row of four cells may be preceded by a row of six cells. However, in further embodiments, the extended section may comprise various numbers of cells per row and different numbers of rows. For example, extended section may comprise 1 row, 2 rows, 3 rows, 4 rows, 5 rows, 6 rows, or more than 6 rows. In embodiments, the rows may comprise 1 cell, 2 cells, 3 cells, 4 cells, 5 cells, 6 cells, 8 cells, 10 cells, 16 cells, or more than 16 cells.
Returning to
In embodiments of the stabilizing structure comprising extended sections 6220, elongate members 6206 closest to the central longitudinal axis of the stabilizing structure extend further along the longitudinal axis than embodiments of the stabilizing structure that do not comprise an extended section. For example, the innermost elongate strips are the longest strips, while the next innermost strips are the second longest and so on. The presence of the extended sections causes the stabilizing structure when viewed from above to appear to be more eye-shaped rather than more oval-shaped.
As depicted in
Stabilizing structure 6200 further comprises tabs 6212 extended outward from the outer wall of the stabilizing structure 6200. Such tabs may extend outward from the top or the bottom of the stabilizing structure or both. The tabs may extend out from all outer cells of the stabilizing structure as depicted by
The tabs 6212 may further comprise an anchoring layer, such as those described above in relation to
The stabilizing structures of
The foam layers described in this section or elsewhere in the specification may have a variety of suitable thicknesses. For example, a foam layer may have a thickness of at least about 1 mm, 3 mm, 5 mm, 10 mm, 15 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, or more than 50 mm thick. Single layers of foam may be laid atop one another to create a greater total thickness of foam, for example, a 15 mm thick layer of foam may be laid atop a 10 mm layer of foam to create a 25 mm total thickness of foam.
In certain embodiments, any of the foam layers described herein this section or elsewhere in the specification, may be pre-attached to an organ protection layer such as described above. For example, the lowest layer of foam, closest to the underlying organs, may be attached to an organ protection layer before placement within the wound, thereby saving the clinician the step of first placing an organ protection layer within the wound. In certain embodiments, the organ protection layer may be pre-attached to the underside of a stabilizing structure such as those described herein this section or elsewhere in the specification. In embodiments, the organ protection layer may be attached to the top of the bottom-most foam layer placed in the wound, thereby positioning the organ protection layer between the stabilizing structure and the bottom-most layer of foam. The organ protection layer may completely encase the bottommost layer of foam or stabilizing structure. The presence of a bottom layer of foam and/or organ protection layer may serve to protect the underlying bowel from damage due to direct interaction with the stabilizing structure.
As described elsewhere in the specification, stabilizing structure 6302 may comprise tabs 6304. These tabs advantageously provide a larger surface area for attachment of the foam layers to the stabilizing structure. Without the tabs, adhesive would necessarily need to be applied to the narrow upper edges of the stabilizing structure, potentially creating a weak or non-existent attachment. As described above, the tabs may be located on the top and bottom edges of the stabilizing structure. In embodiments, rather than adhesive, the tabs may be covered in anchors, such as those described above in relation to
In certain embodiments, the wound closure device of 6350 may be dome-shaped. In certain embodiments, the stabilizing structure may be dome shaped and/or the bottom and/or the top layer of foam may be dome shaped. The stabilizing structure may be shaped such that the upper surface is concave while the bottom surface is convex. In some embodiments the upper surface of the stabilizing structure is convex while the lower surface is concave. Any of the layers of foam (the top, bottom, middle or further layers of foam) may comprise an upper surface that is concave and a bottom surface that is convex. In some embodiments, any of the layers of foam (the top, bottom, middle or further layers of foam) may comprise an upper surface that is convex and a bottom surface that is concave.
The top layer may be sized to the top of the stabilizing structure, thereby facilitating closure of the wound to the size of the collapsed stabilizing structure. The lip extending outward from the matrix may be rounded so as to provide a better fit within the wound. In contrast, in the embodiment of
In certain embodiments, the foam layers may be of any thickness disclosed herein this section or elsewhere in the specification. The bottom layer of foam 6354 may be approximately 15 mm thick or approximately 10 mm thick. For example, the bottom foam 6354 of
In embodiments of the foam layers of
The foam layer 4600 further comprises fingers 4602 that can extend from the foam layer into the stabilizing structure or closure device. For example, the fingers 4602 may extend into and around the gaps or cells depicted in the stabilizing structures described herein this section or elsewhere in the specification. The fingers 4602 may also extend around the outside of the perimeter of the stabilizing structure. In some embodiments, the fingers 4602 from one foam layer 4600 may extend through the interior or around the outside of the stabilizing structure to meet the fingers 4602 from a second foam layer 4600. Thus, one foam layer will be facing finger-side up, while a second foam layer may be facing finger-side down.
In some embodiments, the foam layer 4600 can have perforations or pre-cuts to allow portions of the foam layer 4600 to be easily torn away to shape the foam for a particular wound. In some embodiments, the fingers 4602 can extend at least about 1 mm from the surface of the foam layer, at least about 3 mm from the surface of the foam layer, at least about 5 mm from the surface of the foam layer, at least about 7.5 mm from the surface of the foam layer, at least about 10 mm from the surface of the foam layer, at least about 12.5 mm from the surface of the foam layer, at least about 25 mm from the surface of the foam layer, at least about 17.5 mm from the surface of the foam layer, at least about 20 mm from the surface of the foam layer, at least about 25 mm from the surface of the foam layer, or more than 25 mm.
In certain embodiments, the fingers 4602 can be varied so as to control the collapse of the stabilizing structure. For example, when a finger is extended into a particular cell of the stabilizing structure, the finger will prevent collapse of that particular cell. Therefore, a larger number of foam fingers extending into the stabilizing structure will reduce collapse more than a lesser number of foam fingers. For example, the fingers may extend into at least about: 10%, 20%, 30%, 50%, 75% or even 100% of the cells of the stabilizing structure, thereby further limiting collapse of the stabilizing structure.
In certain embodiments, foam layers similar to the foam layers of
Various sensors may be placed within any of the stabilizing structures or foam layers described herein this section or elsewhere in the specification. For example, a pH, temperature, pressure sensor, or any other suitable sensor may be embedded within the stabilizing structure and/or within a foam layer. Such embodiments will advantageously allow a clinician to skip the step of removing a sensor within the wound bed, as the sensor simply be removed upon removal of the stabilizing structure or foam.
As used in this section or elsewhere in this specification, the x direction, when referring to the stabilizing structure, generally refers to a direction or plane generally parallel to the skin surrounding the wound. The y direction, when referring to the stabilizing structure, generally refers to a direction or plane generally parallel to the skin surrounding the wound and extending perpendicular to the x direction. The z direction, when referring to the stabilizing structure, generally refers to a direction or plane extending perpendicular to the x direction and the y direction. The term “width,” when referring to a stabilizing structure, generally refers to a dimension of the stabilizing structure taken in the x direction along which the stabilizing structure is longest. The term “length,” when referring to a stabilizing structure, generally refers to a dimension of the stabilizing structure taken in the y direction along which the stabilizing structure is longest. The term “height,” when referring to a stabilizing structure, generally refers to a dimension of the stabilizing structure taken in the z direction along which the stabilizing structure is longest. The terms “width,” “length,” and “height” may also be used to describe the cells within the stabilizing structures and wound closure devices described throughout this specification. When describing these structures or devices, these terms should not be construed to require that the structures or devices necessarily be placed into a wound in a certain orientation, though in certain embodiments, it may be preferable to do so.
As described above, all stabilizing structures described herein this section or elsewhere in the specification may be fashioned to accommodate any size of wound. In some embodiments the stabilizing structures may be sized to better accommodate the needs of the clinical environment. In certain embodiments, the height of the un-collapsed stabilizing structure 6500 may be at least 1 mm, 5 mm, 10 mm, 15 mm, 20 mm, 25 mm, 30 mm, 35 mm, or greater than 35 mm. For example, the height of the un-collapsed stabilizing structure 6500 may be between 25 mm and 30 mm.
Stabilizing structure 6500 may be constructed via any means described herein this section or elsewhere in the specification. The stabilizing structure 6500 may also be comprised of any materials described in this section or elsewhere in this specification. For example, the stabilizing structure 6500 may comprise polyurethane. Additionally, the stabilizing structure 6500 may be constructed via various means and/or comprised of various materials to alter the material properties throughout different portions of the stabilizing structure 6500. In some embodiments, the material may be selected based on the material's Young's modulus to optimize stiffness of the stabilizing structure 6500 and influence closure of the stabilizing structure 6500. For example, the Young's modulus may affect cell 6504 size and/or the width of the stabilizing structure 6500 upon application of negative pressure to the stabilizing structure 6500. A higher Young's modulus may generally result in less closure of the stabilizing structure 6500 and larger cell 6504 size at a given negative pressure. Additionally, material selection may take into account the affect aging and some methods of sterilization may have on the Young's modulus of the stabilizing structure 6500. As such, in some embodiments, the stabilizing structure 6500 may comprise a material with a Young's modulus that will provide sufficient stiffness in the y and z directions, while maintaining sufficient support to keep cells 6504 open for fluid management upon the application of negative pressure to the stabilizing structure 6500. In certain embodiments, the Young's modulus of the stabilizing structure 6500 may be at least 0.5 MPa, 1 MPa, 2 MPA, 3 MPa, 4 MPa, 5 MPa, 6 MPa, 7 MPa, 8 MPa, 9 MPa, 10 MPa, 11 MPa, 12 MPa, 13 MPa, 14 MPa, 15 MPa, 16 MPa. 17 MPa, 18 MPa, 19 MPa, 20 MPa, 21 MPa, 22 MPa, or greater than 22 MPa depending on the material and curing protocol selected for the stabilizing structure 6500. Additionally, the stabilizing structure 6500 may be constructed via various means and/or comprised of various materials to alter the Young's modulus throughout different portions of the stabilizing structure 6500.
In some embodiments, the material may also be selected based on the material's Shore hardness to optimize stiffness of the stabilizing structure 6500 and influence closure of the stabilizing structure 6500. In certain embodiments, the Shore hardness of the stabilizing structure 6500 may be at least 40 Shore, 50 Shore, 60 Shore, 70 Shore, 80 Shore, 90 Shore, or greater than 90 Shore depending on the material selected for the stabilizing structure 6500. Additionally, the stabilizing structure 6500 may be comprised of various materials to alter the Shore hardness throughout different portions of the stabilizing structure 6500.
The stabilizing structure 6500 may comprise a plurality of adjacent rows of cells 6504 parallel to a central transverse axis and centered along a longitudinal axis of the stabilizing structure 6500. The rows and cells may be designed in a manner to facilitate closure of the stabilizing structure 6500 upon the application of negative pressure. In some embodiments, cells 6504 of the central row may have the greatest length compared to cells 6504 of the outer rows and extends across the width of the stabilizing structure 6500. The central row may be adjacent to smaller rows, with the remaining rows getting progressively smaller row-by-row along the longitudinal axis towards the longitudinal ends 6530.
In some embodiments, the rows comprise diamond-shaped cells 6504 with various sizes. The central row may comprise smaller diamond-shaped cells 6520 within larger diamond-like shaped cells 6522. This design may provide greater overall closure of the stabilizing device 6500 to provide for maximum closure of the wound. The smaller diamond-like shapes 6520 located within larger diamonds 6522 can also spread the load over a greater area reducing the chance of damage to the tissue structures below the matrix. The central row may further comprise additional diamond-shaped cells 6504.
The remaining rows may contain diamond-shaped cells 6504 of varying sizes. Cell 6504 width may be measured across the shorter of the two diagonals for each cell 6054, as shown in
While the embodiments described herein in this section or elsewhere in this specification refer to diamond-shaped cells 6504, it will be understood that the location, shape, and relative sizes of the cells 6504 can be modified for any suitable embodiment and that their relative proportions can differ in various embodiments.
The wall thickness of the elongate strips or walls 6506 and/or intervening members or walls 6510 may be varied to affect the width of the stabilizing structure 6500 or individual cell 6504 sizes upon application of negative pressure. In some embodiments, the wall thickness may be increased to increase stiffness and bulk of the stabilizing structure 6500, thus resulting in a larger width of the stabilizing structure 6500 during closure. In certain embodiments, the wall thickness of the elongate strips or walls 6506 and/or intervening members or walls 6510 may be at least 0.5 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, or greater than 2.5 mm. For example, the wall thickness may be between 1.5 mm and 2 mm. Additionally, the stabilizing structure 6500 may comprise elongate strips or walls 6506 and/or intervening members or walls 6510 of various wall thickness to alter the collapse the stabilizing structure 6500 upon application of negative pressure to the wound when the stabilizing structure 6500 is inserted into the wound, thus facilitating closure of the stabilizing structure 6500 during collapse. In certain embodiments, the stabilizing structure 6500 may further contain wall thickness variations between walls located throughout different portions of the stabilizing structure 6500.
The stabilizing structure 6500 of
The nodes 6540 may further have various internal radii 6544 to affect the width of the stabilizing structure 6500 or individual cell 6504 sizes upon application of negative pressure. In some embodiments, the internal radii 6544 may be increased to increase the stiffness of the stabilizing structure 6500 by also increasing the wall thickness and wall stiffness, thus permitting less wall bending close to the node 6540 during collapse. This may also result in a larger width of the stabilizing structure 6500 during closure. Additionally, the increased internal radius 6544 further increases the size of fluid channels forming at the corner of the cells 6504 during collapse. In certain embodiments, the internal radii 6544 of the un-collapsed cells 6504 may be at least 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, or greater than 1.5 mm. For example, the internal radii 6544 of the un-collapsed cells 6504 may be between 0.55 mm and 1.0 mm. In certain embodiments, the stabilizing structure 6500 may further contain internal radii variations between cells located throughout different portions of the stabilizing structure 6500.
In addition to the cell 6504 arrangement within the stabilizing structure 6500 described above, the length and shape of the cell 6504 sizes of the stabilizing structure 6500 may be further designed to increase closure of the stabilizing structure 6500 upon application of negative pressure. In some embodiments, the stabilizing structure 6500 may further contain size variations between cells located within a center portion and cells located within the longitudinal end portions 6530 of the stabilizing structure 6500. Cells may be sized and configured to promote uniform collapse of the stabilizing structure within both longitudinal end portions and a central portion between the longitudinal end portions.
It may be desired to design the longitudinal edges or other outer portions of the stabilizing structure 6500 to increase collapse of the longitudinal edge portions 6530. In certain embodiments, the stabilizing structure 6500 may comprise open cells near or at the longitudinal end portions 6530 and/or outer walls of the stabilizing structure 6500. For example, as illustrated in
The stabilizing structure 6500 may be designed to collapse in any manner described in this section or elsewhere in this specification with or without the application of negative pressure. For example, the stabilizing structure 6500 may collapse in a progressive manner with increasing negative pressure. In some embodiments, particular cells 6504 may collapse before other cells 6504. For example, the cells 6504 adjacent to the outer edges of the stabilizing structure 6500 and/or cells 6504 farther away from the central longitudinal axis of the stabilizing structure 6500 may collapse before the cells 6504 adjacent to the inner portion of the stabilizing structure 6500 and/or cells 6504 closer to the central longitudinal axis of the stabilizing structure 6500. The cells 6504 within the central rows of the stabilizing structure 6500 may collapse before cells 6504 located on the longitudinal end portions 6530. Additionally, the stabilizing structure 6500 and all stabilizing structures and wound closure devices described in this section or elsewhere in this specification may collapse on a variety of timescales in a dynamic fashion. In certain embodiments, various cells 6504 may be designed to collapse at a faster rate than other cells 6504.
A method for treating a wound with a stabilizing structure may include inserting into a wound a stabilizing structure as described herein this section and elsewhere in the specification, overlaying the stabilizing structure with a wound cover, and applying negative pressure to cause the cells of the stabilizing structure to collapse. In certain embodiments, the stabilizing structure 6800 may be designed to collapse in a progressive manner with increasing negative pressure. For example, in some embodiments, as illustrated in
Although this disclosure describes certain embodiments, it will be understood by those skilled in the art that many aspects of the methods and devices shown and described in the present disclosure may be differently combined and/or modified to form still further embodiments or acceptable examples. All such modifications and variations are intended to be included herein within the scope of this disclosure. Indeed, a wide variety of designs and approaches are possible and are within the scope of this disclosure. No feature, structure, or step disclosed herein is essential or indispensable. Moreover, while illustrative embodiments have been described herein, the scope of any and all embodiments having equivalent elements, modifications, omissions, combinations (e.g., of aspects across various embodiments), substitutions, adaptations and/or alterations as would be appreciated by those in the art based on the present disclosure. While certain embodiments have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of protection.
Features, materials, characteristics, or groups described in conjunction with a particular aspect, embodiment, or example are to be understood to be applicable to any other aspect, embodiment or example described in this section or elsewhere in this specification unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive. The protection is not restricted to the details of any foregoing embodiments. The protection extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.
Furthermore, certain features that are described in this disclosure in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations, one or more features from a claimed combination can, in some cases, be excised from the combination, and the combination may be claimed as a subcombination or variation of a subcombination.
Moreover, while operations may be depicted in the drawings or described in the specification in a particular order, such operations need not be performed in the particular order shown or in sequential order, or that all operations be performed, to achieve desirable results. Other operations that are not depicted or described can be incorporated in the example methods and processes. For example, one or more additional operations can be performed before, after, simultaneously, or between any of the described operations. Further, the operations may be rearranged or reordered in other implementations. Those skilled in the art will appreciate that in some embodiments, the actual steps taken in the processes illustrated and/or disclosed may differ from those shown in the figures. Depending on the embodiment, certain of the steps described above may be removed, others may be added. Furthermore, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure. Also, the separation of various system components in the implementations described above should not be understood as requiring such separation in all implementations, and it should be understood that the described components and systems can generally be integrated together in a single product or packaged into multiple products.
For purposes of this disclosure, certain aspects, advantages, and novel features are described herein. Not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, for example, those skilled in the art will recognize that the disclosure may be embodied or carried out in a manner that achieves one advantage or a group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.
Conditional language, such as “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements, and/or steps. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements, and/or steps are included or are to be performed in any particular embodiment.
Conjunctive language such as the phrase “at least one of X, Y, and Z,” unless specifically stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.
Language of degree used herein, such as the terms “approximately,” “about,” “generally,” and “substantially” as used herein represent a value, amount, or characteristic close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, “generally,” and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount. As another example, in certain embodiments, the terms “generally parallel” and “substantially parallel” refer to a value, amount, or characteristic that departs from exactly parallel by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, 0.1 degree, or otherwise.
The scope of the present disclosure is not intended to be limited by the specific disclosures of preferred embodiments in this section or elsewhere in this specification, and may be defined by claims as presented in this section or elsewhere in this specification or as presented in the future. The language of the claims is to be interpreted broadly based on the language employed in the claims and not limited to the examples described in the present specification or during the prosecution of the application, which examples are to be construed as non-exclusive.
This application is a U.S. national stage application of International Patent Application No. PCT/US2017/059603, filed Nov. 1, 2017, which claims the benefit of U.S. Provisional Application No. 62/416,570, filed Nov. 2, 2016, the disclosure of each of which is hereby incorporated by reference in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US2017/059603 | 11/1/2017 | WO |
Publishing Document | Publishing Date | Country | Kind |
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WO2018/085457 | 5/11/2018 | WO | A |
Number | Name | Date | Kind |
---|---|---|---|
3014483 | Mccarthy et al. | Dec 1961 | A |
3194239 | Sullivan | Jul 1965 | A |
3578003 | Everett | May 1971 | A |
3789851 | Leveen | Feb 1974 | A |
3812616 | Koziol | May 1974 | A |
4467805 | Fukuda | Aug 1984 | A |
4608041 | Nielsen | Aug 1986 | A |
4699134 | Samuelsen | Oct 1987 | A |
4815468 | Annand | Mar 1989 | A |
5176663 | Svedman | Jan 1993 | A |
5264218 | Rogozinski | Nov 1993 | A |
5376067 | Daneshvar | Dec 1994 | A |
5409472 | Rawlings et al. | Apr 1995 | A |
5415715 | Delage et al. | May 1995 | A |
5423857 | Rosenman et al. | Jun 1995 | A |
5512041 | Bogart | Apr 1996 | A |
5562107 | Lavender et al. | Oct 1996 | A |
5584859 | Brotz | Dec 1996 | A |
5636643 | Argenta et al. | Jun 1997 | A |
5695777 | Donovan et al. | Dec 1997 | A |
6176868 | Detour | Jan 2001 | B1 |
6503208 | Skovlund | Jan 2003 | B1 |
6548727 | Swenson | Apr 2003 | B1 |
6566575 | Stickels et al. | May 2003 | B1 |
6685681 | Lockwood et al. | Feb 2004 | B2 |
6712839 | Lonne | Mar 2004 | B1 |
6770794 | Fleischmann | Aug 2004 | B2 |
6787682 | Gilman | Sep 2004 | B2 |
6883531 | Perttu | Apr 2005 | B1 |
6977323 | Swenson | Dec 2005 | B1 |
7004915 | Boynton et al. | Feb 2006 | B2 |
7144390 | Hannigan et al. | Dec 2006 | B1 |
7315183 | Hinterscher | Jan 2008 | B2 |
7351250 | Zamierowski | Apr 2008 | B2 |
7361184 | Joshi | Apr 2008 | B2 |
7438705 | Karpowicz et al. | Oct 2008 | B2 |
7494482 | Orgill et al. | Feb 2009 | B2 |
7615036 | Joshi et al. | Nov 2009 | B2 |
7622629 | Aali | Nov 2009 | B2 |
7625362 | Boehringer et al. | Dec 2009 | B2 |
7683667 | Kim et al. | Mar 2010 | B2 |
7700819 | Ambrosio et al. | Apr 2010 | B2 |
7754937 | Boehringer et al. | Jul 2010 | B2 |
7779625 | Joshi et al. | Aug 2010 | B2 |
7815616 | Boehringer et al. | Oct 2010 | B2 |
7857806 | Karpowicz et al. | Dec 2010 | B2 |
7863495 | Aali | Jan 2011 | B2 |
7892181 | Christensen et al. | Feb 2011 | B2 |
7896856 | Petrosenko et al. | Mar 2011 | B2 |
7909805 | Weston et al. | Mar 2011 | B2 |
7910789 | Sinyagin | Mar 2011 | B2 |
7931774 | Hall et al. | Apr 2011 | B2 |
7942866 | Radl et al. | May 2011 | B2 |
7951124 | Boehringer et al. | May 2011 | B2 |
7964766 | Blott et al. | Jun 2011 | B2 |
7976519 | Bubb et al. | Jul 2011 | B2 |
7976524 | Kudo et al. | Jul 2011 | B2 |
8030534 | Radl et al. | Oct 2011 | B2 |
8057447 | Olson et al. | Nov 2011 | B2 |
8062331 | Zamierowski | Nov 2011 | B2 |
8067662 | Aali et al. | Nov 2011 | B2 |
8070773 | Zamierowski | Dec 2011 | B2 |
8114126 | Heaton et al. | Feb 2012 | B2 |
8123781 | Zamierowski | Feb 2012 | B2 |
8142419 | Heaton et al. | Mar 2012 | B2 |
8172816 | Kazala, Jr. et al. | May 2012 | B2 |
8187237 | Seegert | May 2012 | B2 |
8188331 | Barta et al. | May 2012 | B2 |
8197467 | Heaton et al. | Jun 2012 | B2 |
8207392 | Haggstrom et al. | Jun 2012 | B2 |
8235955 | Blott et al. | Aug 2012 | B2 |
8246590 | Hu et al. | Aug 2012 | B2 |
8246606 | Stevenson et al. | Aug 2012 | B2 |
8257328 | Augustine et al. | Sep 2012 | B2 |
8273105 | Cohen et al. | Sep 2012 | B2 |
8328776 | Kelch et al. | Dec 2012 | B2 |
8337411 | Nishtala et al. | Dec 2012 | B2 |
8353931 | Stopek et al. | Jan 2013 | B2 |
8357131 | Olson | Jan 2013 | B2 |
8376972 | Fleischmann | Feb 2013 | B2 |
8430867 | Robinson et al. | Apr 2013 | B2 |
8447375 | Shuler | May 2013 | B2 |
8454990 | Canada et al. | Jun 2013 | B2 |
8460257 | Locke et al. | Jun 2013 | B2 |
8481804 | Timothy | Jul 2013 | B2 |
8486032 | Seegert et al. | Jul 2013 | B2 |
8500776 | Ebner | Aug 2013 | B2 |
8608776 | Coward et al. | Dec 2013 | B2 |
8632523 | Eriksson et al. | Jan 2014 | B2 |
8673992 | Eckstein et al. | Mar 2014 | B2 |
8679080 | Kazala, Jr. et al. | Mar 2014 | B2 |
8679153 | Dennis | Mar 2014 | B2 |
8680360 | Greener et al. | Mar 2014 | B2 |
8708984 | Robinson et al. | Apr 2014 | B2 |
8721629 | Hardman et al. | May 2014 | B2 |
8746662 | Poppe | Jun 2014 | B2 |
8764732 | Hartwell | Jul 2014 | B2 |
8791315 | Lattimore et al. | Jul 2014 | B2 |
8791316 | Greener | Jul 2014 | B2 |
8802916 | Griffey et al. | Aug 2014 | B2 |
8821535 | Greener | Sep 2014 | B2 |
8945030 | Weston et al. | Feb 2015 | B2 |
9044579 | Blott et al. | Jun 2015 | B2 |
9061095 | Adie et al. | Jun 2015 | B2 |
9180231 | Greener | Nov 2015 | B2 |
9408755 | Larsson et al. | Aug 2016 | B2 |
9421132 | Dunn et al. | Aug 2016 | B2 |
9655807 | Locke et al. | May 2017 | B2 |
9849023 | Hall et al. | Dec 2017 | B2 |
10143485 | Locke et al. | Dec 2018 | B2 |
10245185 | Hicks | Apr 2019 | B2 |
20010034499 | Sessions et al. | Oct 2001 | A1 |
20020077661 | Saadat | Jun 2002 | A1 |
20020161346 | Lockwood et al. | Oct 2002 | A1 |
20040162512 | Liedtke et al. | Aug 2004 | A1 |
20040267312 | Kanner et al. | Dec 2004 | A1 |
20050142331 | Anderson et al. | Jun 2005 | A1 |
20050267424 | Eriksson et al. | Dec 2005 | A1 |
20060020269 | Cheng | Jan 2006 | A1 |
20060058842 | Wilke et al. | Mar 2006 | A1 |
20060069357 | Marasco | Mar 2006 | A1 |
20060155260 | Blott et al. | Jul 2006 | A1 |
20060217795 | Besselink et al. | Sep 2006 | A1 |
20060271018 | Korf | Nov 2006 | A1 |
20070052144 | Knirck et al. | Mar 2007 | A1 |
20070104941 | Kameda et al. | May 2007 | A1 |
20070118096 | Smith et al. | May 2007 | A1 |
20070123973 | Roth et al. | May 2007 | A1 |
20070129660 | McLeod et al. | Jun 2007 | A1 |
20070149910 | Zocher | Jun 2007 | A1 |
20070185463 | Mulligan | Aug 2007 | A1 |
20070213597 | Wooster | Sep 2007 | A1 |
20070282309 | Bengtson et al. | Dec 2007 | A1 |
20080041401 | Casola et al. | Feb 2008 | A1 |
20080108977 | Heaton et al. | May 2008 | A1 |
20080243096 | Svedman et al. | Oct 2008 | A1 |
20080275409 | Kane et al. | Nov 2008 | A1 |
20080306456 | Riesinger | Dec 2008 | A1 |
20090005716 | Abuzaina et al. | Jan 2009 | A1 |
20090099519 | Kaplan | Apr 2009 | A1 |
20090105670 | Bentley et al. | Apr 2009 | A1 |
20090204423 | Degheest et al. | Aug 2009 | A1 |
20090312685 | Olsen et al. | Dec 2009 | A1 |
20100022990 | Karpowicz et al. | Jan 2010 | A1 |
20100047324 | Fritz et al. | Feb 2010 | A1 |
20100081983 | Zocher et al. | Apr 2010 | A1 |
20100106184 | Coward | Apr 2010 | A1 |
20100137775 | Hu et al. | Jun 2010 | A1 |
20100150991 | Bernstein | Jun 2010 | A1 |
20100160874 | Robinson et al. | Jun 2010 | A1 |
20100179493 | Heagle et al. | Jul 2010 | A1 |
20100179515 | Swain et al. | Jul 2010 | A1 |
20100198128 | Turnlund et al. | Aug 2010 | A1 |
20100262106 | Hartwell | Oct 2010 | A1 |
20100280468 | Haggstrom et al. | Nov 2010 | A1 |
20100312159 | Aali et al. | Dec 2010 | A1 |
20110021965 | Karp et al. | Jan 2011 | A1 |
20110022082 | Burke et al. | Jan 2011 | A1 |
20110059291 | Boyce et al. | Mar 2011 | A1 |
20110066096 | Svedman | Mar 2011 | A1 |
20110082480 | Viola | Apr 2011 | A1 |
20110110996 | Schoenberger et al. | May 2011 | A1 |
20110112458 | Holm et al. | May 2011 | A1 |
20110178451 | Robinson et al. | Jul 2011 | A1 |
20110213319 | Blott et al. | Sep 2011 | A1 |
20110224631 | Simmons et al. | Sep 2011 | A1 |
20110224632 | Zimnitsky et al. | Sep 2011 | A1 |
20110224634 | Locke et al. | Sep 2011 | A1 |
20110264138 | Avelar et al. | Oct 2011 | A1 |
20110270301 | Cornet et al. | Nov 2011 | A1 |
20110305736 | Wieland et al. | Dec 2011 | A1 |
20120016321 | Wu et al. | Jan 2012 | A1 |
20120029455 | Perez-Foullerat et al. | Feb 2012 | A1 |
20120059412 | Fleischmann | Mar 2012 | A1 |
20120130327 | Marquez | May 2012 | A1 |
20120136326 | Croizat et al. | May 2012 | A1 |
20120136328 | Johannsson et al. | May 2012 | A1 |
20120143113 | Robinson et al. | Jun 2012 | A1 |
20120172926 | Hotter | Jul 2012 | A1 |
20120191132 | Sargeant | Jul 2012 | A1 |
20120209226 | Simmons et al. | Aug 2012 | A1 |
20120209227 | Dunn et al. | Aug 2012 | A1 |
20120238931 | Rastegar et al. | Sep 2012 | A1 |
20120253302 | Corley | Oct 2012 | A1 |
20130012891 | Gross et al. | Jan 2013 | A1 |
20130023842 | Song | Jan 2013 | A1 |
20130066365 | Belson et al. | Mar 2013 | A1 |
20130150813 | Gordon et al. | Jun 2013 | A1 |
20130190705 | Vess et al. | Jul 2013 | A1 |
20130197457 | Kazala, Jr. et al. | Aug 2013 | A1 |
20130204213 | Heagle et al. | Aug 2013 | A1 |
20130245527 | Croizat et al. | Sep 2013 | A1 |
20130325142 | Hunter et al. | Dec 2013 | A1 |
20130331757 | Belson | Dec 2013 | A1 |
20140094730 | Greener | Apr 2014 | A1 |
20140163415 | Zaiken et al. | Jun 2014 | A1 |
20140249495 | Mumby et al. | Sep 2014 | A1 |
20150065968 | Sealy et al. | Mar 2015 | A1 |
20150100008 | Chatterjee | Apr 2015 | A1 |
20150119837 | Thompson, Jr. et al. | Apr 2015 | A1 |
20150157758 | Blücher et al. | Jun 2015 | A1 |
20150190288 | Dunn et al. | Jul 2015 | A1 |
20150216732 | Hartwell et al. | Aug 2015 | A1 |
20150320434 | Ingram | Nov 2015 | A1 |
20150320602 | Locke | Nov 2015 | A1 |
20150320603 | Locke | Nov 2015 | A1 |
20150374561 | Hubbard, Jr. et al. | Dec 2015 | A1 |
20160144085 | Melin et al. | May 2016 | A1 |
20160184496 | Jaecklein et al. | Jun 2016 | A1 |
20170065751 | Toth et al. | Mar 2017 | A1 |
20170281838 | Dunn | Oct 2017 | A1 |
20180140465 | Dunn | May 2018 | A1 |
Number | Date | Country |
---|---|---|
2012261793 | Nov 2014 | AU |
2013206230 | May 2016 | AU |
101112326 | Jan 2008 | CN |
101744688 | Jun 2010 | CN |
201519362 | Jul 2010 | CN |
102038575 | May 2011 | CN |
202568632 | Dec 2012 | CN |
103071197 | May 2013 | CN |
203408163 | Jan 2014 | CN |
2949920 | Mar 1981 | DE |
1320342 | Jun 2003 | EP |
2279016 | Feb 2011 | EP |
2567717 | Mar 2013 | EP |
2389794 | Dec 2003 | GB |
2423019 | Aug 2006 | GB |
2489947 | Oct 2012 | GB |
2496310 | May 2013 | GB |
S62-57560 | Mar 1987 | JP |
2006-528038 | Dec 2006 | JP |
2009-525087 | Jul 2009 | JP |
2012-105840 | Jun 2012 | JP |
62504 | Apr 2007 | RU |
1818103 | May 1993 | SU |
WO 0185248 | Nov 2001 | WO |
WO 0189392 | Nov 2001 | WO |
WO 0205737 | Jan 2002 | WO |
WO 03003948 | Jan 2003 | WO |
WO 03049598 | Jun 2003 | WO |
WO 2005046761 | May 2005 | WO |
WO 2005105174 | Nov 2005 | WO |
WO 2006046060 | May 2006 | WO |
WO 2008027449 | Mar 2008 | WO |
WO 2008064502 | Jun 2008 | WO |
WO 2008104609 | Sep 2008 | WO |
WO 2009112062 | Sep 2009 | WO |
WO 2010033725 | Mar 2010 | WO |
WO 2010097570 | Sep 2010 | WO |
WO-2010097570 | Sep 2010 | WO |
WO 2011023384 | Mar 2011 | WO |
WO 2012082716 | Jun 2012 | WO |
WO 2012082876 | Jun 2012 | WO |
WO-2012106590 | Aug 2012 | WO |
WO 2012136707 | Oct 2012 | WO |
WO 2012142473 | Oct 2012 | WO |
WO 2013012381 | Jan 2013 | WO |
WO 2013043258 | Mar 2013 | WO |
WO 2013071243 | May 2013 | WO |
WO 2013076450 | May 2013 | WO |
WO 2013079947 | Jun 2013 | WO |
WO 2013175309 | Nov 2013 | WO |
WO 2013175310 | Nov 2013 | WO |
WO 2014013348 | Jan 2014 | WO |
WO 2014014842 | Jan 2014 | WO |
WO 2014014871 | Jan 2014 | WO |
WO-2014014922 | Jan 2014 | WO |
WO 2014140578 | Sep 2014 | WO |
WO 2014158526 | Oct 2014 | WO |
WO 2014165275 | Oct 2014 | WO |
WO 2014178945 | Nov 2014 | WO |
WO 2014194786 | Dec 2014 | WO |
WO 2015008054 | Jan 2015 | WO |
WO-2015026968 | Feb 2015 | WO |
WO 2015061352 | Apr 2015 | WO |
WO-2015061352 | Apr 2015 | WO |
WO 2015109359 | Jul 2015 | WO |
WO 2015110409 | Jul 2015 | WO |
WO 2015110410 | Jul 2015 | WO |
WO 2015169637 | Nov 2015 | WO |
WO 2015172108 | Nov 2015 | WO |
WO 2015193257 | Dec 2015 | WO |
WO 2016018448 | Feb 2016 | WO |
WO 2016176513 | Nov 2016 | WO |
WO 2016179245 | Nov 2016 | WO |
WO-2016176513 | Nov 2016 | WO |
WO 2018038665 | Mar 2018 | WO |
WO 2018041805 | Mar 2018 | WO |
WO 2018044949 | Mar 2018 | WO |
WO 2018085457 | May 2018 | WO |
WO 2018140386 | Aug 2018 | WO |
WO 2018237206 | Dec 2018 | WO |
Entry |
---|
“Definition of 3D Printer,” American Heritage Dictionary of the English Language, Fifth Edition, accessed on Feb. 22, 2018 from URL: https://www.thefreedictionary.co, 2016, 1 page. |
“Definition of Adhere,” The Free Dictionary, accessed on Mar. 23, 2017 from http://www.thefreedictionary.com/adhere, 6 pages. |
“Definition of Oculiform,” Webster's Revised Unabridged Dictionary, accessed from The Free Dictionary on May 30, 2018 from URL: https://www.thefreedictionary.com/Oculiform, 1913, 1 page. |
“Definition of Throughout,” Merriam-Webster Dictionary, accessed on Aug. 29, 2017 from https://www.merriam-webster.com/dictionary/throughout, 11 pages. |
Hougaard, et al., “The Open Abdomen: Temporary Closure with a Modified Negative Pressure Therapy Technique,” International Wound Journal, ISSN 1742-4801, 2014, pp. 13-16. |
Kapischke M., et al., “Self-Fixating Mesh for the Lichtenstein Procedure—a Prestudy,” Langenbecks Arch Surg, 2010, vol. 395, pp. 317-322. |
International Preliminary Report on Patentability for Application No. PCT/US2017/059603, dated May 7, 2019, 9 pages. |
International Search Report and Written Opinion for Application No. PCT/US2017/059603, dated Dec. 22, 2017, 12 pages. |
Number | Date | Country | |
---|---|---|---|
20200046566 A1 | Feb 2020 | US |
Number | Date | Country | |
---|---|---|---|
62416570 | Nov 2016 | US |