Patent ID: 12226094

Various embodiments of the present invention will now be described with reference to the appended drawings. It is to be appreciated that these drawings depict only some embodiments of the invention and are therefore not to be considered limiting of its scope.

DETAILED DESCRIPTION

Despite the various improvements that have been made to wound closure devices, conventional methods suffer from some shortcomings as discussed above.

There therefore is a need for further improvements to the devices and methods used to help facilitate proper and quicker healing of a wound. Among other advantages, the present disclosure may address one or more of these needs.

FIG.1is schematic cross-sectional view of a hemi-bridge100. Hemi-bridge100generally extends between a proximal end102and a distal end104, the proximal end being relatively closer to the wound, and the distal end being relatively farther from the wound. Hemi-bridge may include an insert105sandwiched between two layers of material. As shown, the insert is sandwiched between two layers of material include a lower layer106, and an upper layer108. In some variations, one or more waterproof layers may be disposed above the upper or lower layers so that a total of two, three, or four layers may be formed, not including the insert.

Insert105may be formed of a rigid material. In some examples, the insert is formed of a thermoplastic material such as polypropylene, polyethylene terephthalate, polyethylene (LDPE and HDPE), polymethylmethacrylate, polyethylene terepthalate glycol (PTG) such as 10 MIL or 20 MIL PETG or as low as 1 MIL PETG, polydimethyl siloxane, polyoxymethylene, polycarbonate, polyamide and nylon, polyvinyl chloride, polyphenylene sulfide, acrylonitrilebutadienestyrene, polystyrene, polytetrafluoroethylene or polyurethane. Preferably the thermoplastic material may have a suitable melting temperatures. Insert105may be formed of other suitable materials such as metals.

As shown, insert105may be stair-shaped, including a lower step110, an inclined ramp112and an upper step114, the inclined ramp connecting the two steps together. Insert105may have a length of approximately 5-20 mm, and preferably about 10 mm. Insert105may have a width that is approximately 2-6 mm, and a thickness of approximately 0.025 to 2 mm, depending on the material chosen. For example, a 20 MIL PETG insert may be 0.5 mm thick, a 10 MIL PETG insert may be 0.25 mm thick and a 1 MIL PETG insert may be 0.025 mm thick. In at least some examples, the upper step may be elevated by approximately 2 to 5 mm. In at least some examples, the lower and upper steps are of a same length, or approximately a same length. Insert105may have a generally constant single thickness along the lower step, the inclined ramp and the upper step. As best shown inFIG.2, each of the upper and lower steps110,114may include a respective eyelet120,124for receiving a suture. In at least some examples, the eyelets are circular and of a same size as shown. Alternatively, eyelets may be formed of other shapes, such as oval, rectangular, triangular, etc. Eyelets120,124may allow the hemi-bridge to be used with various suturing configurations including simple, pulley and vertical mattress configurations, as will be described in more detail below. It will be understood that an insert may instead include only a single eyelet, or more than two eyelets (e.g., three, four, five or more eyelets).

Insert105may be disposed on one end of the device, in this case adjacent the proximal end102, and may be substantially or entirely covered by lower and upper layers106,108. Lower and upper layers106,108may be formed of rectangular strips of material, such as those typically used as a dressing. In some examples, the lower and upper layers or strips are approximately 50 mm in length, and 5-25 mm in width. In at least some other examples, the lower layer is approximately 80 mm in length, and approximately 30 mm in width. In some examples, the lower and upper layers have the same width as the insert or are slightly wider than the insert. In some examples, the lower and/or upper layers are substantially longer than they are wide (e.g., 2×, 3×, 4×, 5× or 6× longer than they are wide). This length to width ratio may provide adequate surface area of adhesion over which to spread the tension. A longer upper and/or lower material may also reduce and/or eliminate the tilting effect of the insert's upper step falling over to contact the lower layer of material.

The upper and lower layers106,108may be formed of the same or similar material, size and/or configuration. Alternatively, the upper and lower layer may share some characteristics or may be formed of a different material, size and/or configuration.

Lower layer106may be formed of a woven, or non-woven material. One example of a suitable material is STERI-STRIP® reinforced adhesive skin closures. In some examples, the lower layer includes a suitable non-woven material that prevents the absorption of blood and/or fluids, such as a polyurethane material. In some examples, lower layer106may have an adhesive lower surface that will be in contact with the skin. Alternatively, both surfaces of the lower layer106may have an adhesive. The material of lower layer106may be isotropic (i.e., it has equal elasticity in any direction along its plane). Alternatively, the material of lower layer106may be anisotropic (i.e., it has variable elasticity in at least two directions along its plane). For example, the lower layer106may have a first elasticity along its longitudinal axis, and a second elasticity perpendicular to its longitudinal axis, the first elasticity being greater than the second elasticity, or vice versa.

In some examples, lower layer106may be reinforced with longitudinally-oriented polymer filaments or fiberglass strands (e.g., filaments130inFIG.2) that results in anisotropic characteristics so that the material does not stretch along its longitudinal axis, but does stretch in lateral directions.FIG.2shows one example of a hemi-bridge having an insert105disposed on a lower layer106, the lower layer having longitudinally-oriented filaments130. For the sake of simplicity, the upper layer is not shown. As shown inFIG.2, the filaments may be located along only a portion of the length of the lower layer. Thus, filaments130may extend along the entire length of the lower layer, more than half of the length of the lower layer, half of the lower layer, or less than half of the length of the lower layer (e.g., the filaments may extend along 100%, 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20% or less of the length of the lower layer). Alternatively, lower layer106may include no filaments at all. That is, lower layer may be isotropic, or may be anisotropic without the use of filaments through the use of other techniques. The lower layer may be isotropic at one end, and anisotropic at another end (e.g., it may include filaments at the proximal end where the insert is disposed, and no filaments on the opposite end). In some example, the lower layer may be selected to prevent or reduce the possibility of skin maceration.

Upper layer108may be formed of a woven, or non-woven material. In some examples, the upper layer includes a suitable non-woven material that prevents the absorption of blood and/or fluids. In some examples, upper layer108may have an adhesive lower surface that will be in contact with the insert or the lower layer. The material of upper layer108may be isotropic (i.e., it has equal elasticity in any direction along its plane). Alternatively, the material of upper layer108may be anisotropic (i.e., it has no stretch in at least one direction along its plane).

In some example, upper layer108may also be reinforced with longitudinally-oriented polymer filaments or fiberglass strands that results in anisotropic characteristics so that the material does no stretch along its longitudinal axis, but does stretch in lateral directions. Filaments130may extend along the entire length of the upper layer, more than half of the length of the upper layer, half of the upper layer, or less than half of the length of the upper layer (e.g., 100%, 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20% or less). Alternatively, upper layer108may include no filaments at all. That is, upper layer may be isotropic, or may be anisotropic without the use of filaments. The upper layer may be isotropic at one end, and anisotropic at another end (e.g., it may include filaments at the proximal end where the insert is disposed making it inelastic or less elastic in a longitudinal direction, and no filaments on the opposite end making it more elastic in the longitudinal direction).

By choosing the appropriate elasticity for the upper and/or lower layers (e.g., isotropic vs. anisotropic), an impedance mismatch between the skin and the lower layer of material may be lowered, reducing the possibility of blister formation. Blister formation may result from non-yielding materials adherent to the skin as tension imparted to the skin creates shearing forces in the horizontal plane of the skin that separate layers of the skin from one another (e.g., separating the epidermis from the dermis). In some examples, the presence of anisotropic segments that can mimic the elasticity of the underlying skin at predefined locations within the upper and/or lower layer may alleviate the shearing forces at certain positions. In some examples, the presence of isotropic segments at predefined locations within the upper and/or lower layer may alleviate the shearing forces at certain positions. Additionally, filaments in the upper and/or lower layers may serve to stabilize the insert to keep it upright, and prevent it from tipping.

As previously noted, upper and lower layers may share some or all of the characteristics. For examples, the two layers may be formed of the same material, may have the same non-woven construction, may include the same type of adhesive, may have the same elasticity profile, and/or the same extent, direction, amount and/or orientation of filaments.

In use, a hemi-bridge100may be laid flat on the skin surface on both sides of the wound, the lower layer of material contacting the skin surface. The edge of the hemi-bridge100may be disposed at the edge of the wound, or may be set back from the wound by 2 to 5 mm. Preferably, an adhesive on the lower surface of the lower layer couples the lower layer to the skin. The stair-shaped insert105is disposed above the lower layer and covered by the upper layer. In at least some examples, two hemi-bridges100are used, the two bridges facing one another and being disposed on either side of a wound “W” (FIG.3). A suture pattern may be used to gather the ends of the wound with the hemi-bridges. Details of the various patterns will be described below. However, generally, the hemi-bridges may be brought together such that the upper steps of the two hemi-bridges come in contact with one another when gathered by the sutures. Alternatively, only a single pair of hemi-bridges may be used. Multiple pairs of hemi-bridges (e.g.,4hemi-bridges) may also be used in some examples.

FIGS.4A-Cillustrate various suture patterns P1-P5being used to gather ends of a wound using exemplary hemi-bridges. InFIG.4A, a far-near-near-far pulley suture pattern P1is formed with the suture. In this case, far refers to passing through an eyelet120on the lower step, while near refers to passing through an eyelet124on the upper step, and the “far-near-near-far” refers to the sequence in which the suture passes through these eyelets. In this and other examples, a dotted line indicates that the suture is under the skin and/or hemi-bridge and cannot be seen from a top view. InFIG.4B, a far-far-near-near vertical mattress suture pattern P2is shown. InFIG.4C, two possible suture patterns P3,P4are shown, the first being a simple interrupted near-near suture pattern P3, and the second being a simple interrupted far-far suture pattern P4. Finally, inFIGS.4D-E, horizontal mattress suture patterns P5are shown. InFIG.4D, two hemi-bridges are disposed on either side of the wound, for a total of four hemi-bridges, each hemi-bridge being vertically aligned with another hemi-bridge adjacent to it, and horizontally aligned with an opposing hemi-bridge opposite the wound. Instead of using multiple hemi-bridges on either side of the wound, a compound hemi-bridge may be formed as shown inFIG.4E, the compound hemi-bridge having widened upper and lower layers of material, and two or more inserts sandwiched between the layers (e.g., two, three, four, five or more inserts) and aligned with one another. Optional filaments are shown in this configuration, the filaments being located on one or two sides of the either the upper layer, the lower layer, or both.

Using any of the suture patterns described above, or other suitable one, a physician may apply tension to the suture of up to 10 or 20 Newtons, or between 5 and 30 Newtons, to gather the two ends of the wound together. The hemi-bridges, and specifically the inserts, may act to elevate the suture above the wound, and may allow the physician to apply more force than possible without the use of the hemi-bridges. Moreover, the use of device having a rigid insert as described may prevent cheesewiring of a suture closing a wound under tension. For example, a wound closed under 20 Newtons of force without the present devices would likely suffer from cheesewiring of the suture through the skin. However, by using any of the present devices and techniques, the force of the suture may be substantially borne by the insert, and then transmitted to the entire area of the device, the relatively large surface area of the device being helpful in prevent injury or damage to the patient's skin. Additionally, elevation of the suture may reduce the likelihood of “track marks” on the patient's skin.

In some examples, the shape of the insert may be different. For example,FIG.5Ashows a hemi-bridge structure500ahaving a proximal end502and a distal end504, a wedge-shaped insert505ahaving a step and upper and lower layers of materials506,508sandwiching the insert.FIG.5Bshows a hemi-bridge structure500bhaving a proximal end502and a distal end504, a ramp-shaped insert505band upper and lower layers of materials506,508sandwiching the insert. Any of the inserts inFIGS.1-6may be used to elevated the suture above the wound surface.

FIG.5Cshows another example in which two separate steps are formed instead of a continuous hemi-bridge. Specifically, bridge500cincludes a first step150aand a second step150b,the height of the first step being greater than the height of the second step. Alternatively, the first and second steps150a,150bmay be of a same height. Each step may include an eyelet as described above. The two steps are not directly connected to another, but are both sandwiched by upper and lower layers of material. In at least some examples, the upper and/or the lower layer of material includes sets of filaments130a,130bdisposed adjacent each of the steps, but the spacing between the two steps does not include such materials. One example of this embodiment in use is shown inFIG.4F, in which bridge500cis being used in a pulley suture arrangement P6.

Additionally, the top step of the insert may have interdigitation including a series of spaced projections606and depressions607so that two opposing hemi-bridges605a,605bmay mate together with the projections and valleys of the two hemi-bridges interlocking with one another when the two components come together (FIG.6).FIG.7illustrates another example of interdigitation where the hemi-bridges705a,705binclude a high-low tooth configuration arranged to mate with one another and form a complete bridge.

To manufacture the hemi-bridges, a rigid or substantially rigid insert such as those described above (e.g., a thermoplastic insert) may be sandwiched between upper and lower layers in a large sheet. The components may be die cut to the appropriate size, and holes may be formed in the insert to create eyelets. The assembly may be placed in a heated press, the press having a temperature that exceeds the melting temperature of the insert, but be below the safe temperature of the upper and lower layers. The heated press may also include an elevated portion to create the step in the insert. In addition to forming the step in the insert, the heated press may also reduce the presence of sharp edges at the bottom of the hemi-bridge by curling the sides of the device upward to redirect lower edges away from the skin of the patient. After proper heating, the assembly may be removed and cooled. The finished device may then be used to close a wound as described above. Alternatively, the insert may be formed separately (via injection molding, 3D printing or other techniques) and later coupled to the upper and lower layers.

The suture securing devices, systems, and methods described herein may be used to secure a suture and reduce or eliminate the likelihood that a suture may become inflamed, infected, ingrown, and/or reopened and increase the length of time that the suture can remain in place, among other purposes. Additionally, the devices disclosed herein may be capable of allowing a physician to apply a large force when tying a suture without damaging nearby tissue, and in some cases may be used to avoid the usage of skin grafts to close relatively large wounds.

FIG.8is schematic cross-sectional view of a hemi-bridge800according to yet another embodiment. Hemi-bridge800generally extends between a proximal end802and a distal end804, the proximal end being relatively closer to the wound, and the distal end being relatively farther from the wound. Hemi-bridge may include an insert805sandwiched between two layers of material. Specifically, the two layers of material include a lower layer806, and an upper layer808. Lower and upper layers806,808may be coupled together via an adhesive where they are in contact. Additionally, insert805may be coupled via adhesive, or other suitable means, to the top of the lower layer806and/or the bottom of the upper layer808.

Insert805may be formed of any of the materials discussed above with reference to insert105, such as various thermoplastics and/or metals, and lower and upper layers806,808may be formed of the same materials as lower and upper layers106,808. As shown, insert805may be stair-shaped and includes a lower step, an inclined ramp and an upper step similar to the configuration ofFIG.1. As best shown inFIG.9, each of the upper and lower steps may include a respective eyelet820,824for receiving a suture. In at least some examples, the eyelets are circular and of a same size as shown, or may be in any of the configurations previously described.

Hemi-bridge800may be divided into three zones, z1,z2,z3. First zone z1may include insert805sandwiched between lower and upper layers806,808. Second zone z2may include only the lower and upper layers806,808without the insert805. Third zone z3may include only a single material, such as lower layer806. The three zones z1-z3may form differential stiffness zones that become less stiff further from the wound edge (e.g., greatest stiffness at proximal end802and smallest stiffness at distal end804). First zone z1provides the greatest stiffness, primarily due to the presence of the essentially inelastic insert805. Second zone z2may be less stiff with its bi-layer of non-woven material (e.g., lower layer806and upper layer808), which may be fused with an adhesive or coupled together in any suitable manner. Third zone z3may be the least stiff with a monolayer of non-woven material (e.g., only lower layer806or only upper layer808) and may serve as the most reliable adhesive zone.

Without being bound by any particular theory, it is believed that in the vicinity of the wound (i.e., closer to first zone z1) will be exposed to more fluid. All dressings have a tendency to lose adhesion with a certain distance of the edge of the dressing. For example, a 10 mm dressing may have 1-2 mm of loss of edge adhesion due to moisture, etc. Thus, after a few days, a 10 mm wide strip may really only have 6-8 mm of useful adhesion with further deterioration thereafter. Thus, having a wider and longer third zone, z3, may provide much more width prior to losing adhesion and will also tend to reduce shear through higher cross-sectional surface area.

In some examples, insert805may be formed as a flat piece that is bent to include a step as previously discussed. In at least some examples, the step forms an angle θ of between 20 and 60 degrees. In at least some examples, the angle θ is between 30 and 50 degrees. In at least some examples, the angle θ is equal to or approximately 40 degrees as shown inFIG.10.

As shown in the perspective views, the lower and upper layers806,808and the insert805may have a shape and a size that matches other components adjacent thereto. For example, both the lower and upper layers806,808may have a generally rectangular stepped-shape that matches the insert805at first zone z1. Both lower and upper layers806,808may have a narrowed neck at second zone z2, and lower layer806may have a wider and longer rectangular shape at third zone z3.

In at least some examples, the hemi-bridge has a total length of approximately 2 to 3 cm, or about 2.3 to 2.4 cm. Third zone z3may have a length that is 40% to 50% of the total length of the hemi-bridge. First and second zones z1,z2may be approximately equal in length, or first zone z1may be slightly longer than second zone z2. Third zone z3may be the widest of the three zones, and may have a width of between 0.5 and 0.6 cm. Second zone z2may be the narrowest and may have a width of between 0.3 and 0.35 cm. First zone z1may be wider than second zone z2and narrower than third zone z3and may have a width of between 0.4 and 0.5 cm. The surface area may be greatest in third zone z3and smallest in second zone z2. Insert805may have a thickness of between 0.010 cm and 0.030 cm and specifically about 0.020 cm.

In at least some examples, two hemi-bridges800are used, the two bridges facing one another and being disposed on either side of a wound “W” (FIG.12). A suture pattern may be used to gather the ends of the wound with the hemi-bridges using any of the suturing techniques and patterns described above with reference to the other embodiments. However, generally, the hemi-bridges may be brought together such that the upper steps of the two hemi-bridges approach each other, or come in contact with one another when gathered by the sutures.

Although the hemi-bridges have been disclosed as having an insert including an upper step, a lower step and a connecting ramp, other variations are possible. For example, instead of having an inclination angle as previously described, the insert may be completely flat. For example, hemi-bridge900extends between ends902,904and includes a planar insert905that is covered by lower layer906and upper layer908(FIGS.13A-B). It will be understood that in manufacturing the device, upper and lower layers of material may sandwich an insert and form a configuration similar to the flat configuration ofFIGS.13A-B. The flat sandwich of lower layer-insert-upper layer may be collectively die cut before thermoforming at a high temperature (e.g., 200 degrees F.) to form an inclined angle and any number of steps. It will be understood that the flat configuration may be used in certain applications, and that other applications may require thermoforming to provide an angle of 10, 20, 30, 40, 50 or 60 degrees. Thus, the angle of inclination may be formed as desired for a specific application.

Even without an inclination, the flat configuration of hemi-bridge900may elevate a suture or other fastening element via insert905to achieve one or more of the advantages described above. In at least some examples, the lower layer906is formed of a non-woven polyester with an adhesive backing, insert905is formed of PETG, and upper layer908is formed of polyethylene. In at least some examples, the lower layer906may also partially or entirely include an elastic tape having variable thickness such as Microfoam tape made by 3M®, the tape being capable of having variable elasticity due to the variable thickness. The non-woven polyester lower layer906may have the PETG insert adhered to its top surface at one end, the inert having one or more (e.g., two) eyelets. Due to the layering of material, a stepped configuration having three zones, z1,z2,z3is formed, first zone z1having all three layers, second zone z2having two layers, and third zone z3having only the lower layer.

As shown inFIG.13B, third zone z3may be the widest portion of the device900with only a single layer of stretchable and absorbent adhesive material. The material of lower layer may experience a high amount of strain under force, so an elastic material may be used to allow less shear force on the trailing edge, a common problem in adhesive dressings. Second zone z2may be a narrowed central portion of two layers. In addition to the lower layer, the second zone may have a polyethylene upper layer908to resist blood and fluid from being absorbed into the dressing. The polyethylene layer may also provide strength and reinforcement for the narrow central zone. First zone z1may be the strongest and most rigid due to the presence of the insert905. Insert905may resist tearing under high tension (e.g., up to 20N or 30N of force) and may also elevate the suture material above the skin.

First and second zones z1,z2may allow blood to be wiped off the device and provide a stiff connection to third zone z3, where shear forces are reduced by the single layer of lower stiffness material. Thus, different regions may be formed with increasing elasticity from first zone z1closer to the wound toward third zone z3farthest from the wound. That is, first zone z1may have the lowest elasticity, second zone z2may have an intermediate elasticity, and third zone z3may have the greatest elasticity. Conversely, first zone z1may have the greatest stiffness, second zone z2may have an intermediate stiffness that is less than the stiffness of first zone z1, and third zone z3may have the lowest stiffness compared to the other three zones. The device900also increases in height as it gets closer to the wound to provide elevation.

Without being bound by any particular theory, it is the believed that the suture acts to not only apply tension to gather the wound, but also applies a downward force on the rigid insert. This downward force is helpful to keep a consistent contact of the adhesive of the lower layer with the skin. Additionally, a planar rigid insert may evenly distribute this pressure on the skin, and the downward force may reduce the likelihood of maceration.

FIGS.13C-Fare schematic top and side views showings several variations of the flat hemi-bridge ofFIGS.13A-B. InFIG.13C, a hemi-bridge device900C is formed that is similar to that ofFIGS.13A-B, but excludes the tailored or narrowed neck in second zone z2. Instead, the lower and upper layers present a continuous width that is present in first and second zones z1,z2as shown, while third zone z3is wider than both.

InFIG.13D, a hemi-bridge900D includes the narrowed neck formed in second zone z2, but the upper layer908C partially extends over the wider portion of lower layer906as shown so that second zone z2having two layers of material is slightly longer than the embodiment ofFIGS.13A-B. In this example, upper layer908C may have three widths including a first width adjacent the insert, a second width at the tailored neck and a third width at the wider region of the lower layer. It will be understood that the embodiments ofFIGS.13C and13Dmay be combined so that the upper layer only includes a constant first width adjacent the insert and a majority of the second zone z2, and a second width overlying the wider region of the lower layer.

FIG.13Eillustrates yet another embodiment of a hemi-bridge900E, the hemi-bridge having a lower layer906, an insert905and an upper layer908as described above. Hemi-bridge900E further includes a covering layer912, formed of a waterproof material, the covering layer912being disposed on and partially or fully extending over the upper layer908. Covering layer912may be of the same length as upper layer908and may be disposed in first zone z1, and extend into second zone z2to provide additional stiffness to second zone z2.

InFIG.13F, yet another embodiment is shown, which is similar to that ofFIG.13B, except that hemi-bridge900F includes a rigid member905F embedded and/or affixed between the lower and upper layers, the rigid member being configured and arranged so that the user can pass a suture over or around it. In some examples, the rigid member is staple-shaped as shown, or curvilinear. Rigid member905F may be formed of any of the materials described herein for the inserts such as, for example, thermoplastics or metals. It will be understood that this feature may be combined with any of the embodiments described herein, and that the rigid members may be substituted for the inserts described in any of the disclosed embodiments.

In use, two hemi-bridge devices900may be laid flat on the skin surface on either side of the wound, the lower layer of the device contacting and being adhered the skin surface (FIG.14A). The edge of the hemi-bridge900may be disposed at the edge of the wound W14, or may be set back from the wound W14by 2 to 5 mm. A suture S14may enter a first eyelet of the first hemi-bridge, pierce the skin and traverse the wound through the underlying tissue, exiting the first eyelet of the second hemi-bridge as shown inFIG.14A. Suture S14may be used to gather the margins of the wound and a knot may be tied (FIG.14B). Generally, the hemi-bridge devices are disposed near the middle of the wound as shown, although different configurations are possible. With the center of the wound gathered (FIG.14B), additional sutures S14′ may be used to gather edges of the wound and completely close the wound (FIG.14C).

FIG.14Dis an illustration of a finite element analysis showing stress profiles of a wound closed with a hemi-bridge device (left image), and a wound closed without a hemi-bridge device (right image). In a wound closed with only sutures, stress is concentrated near the wound edge. The stress is greatest at the wound edge and decreases radially outward from the wound edge. As shown, the use of a hemi-bridge device allows for stress to be dispersed over a larger area away from the wound in a profile that mimics the perimeter of the device. Specifically, the hemi-bridge device substantially reduces or practically eliminates stress at the wound edge with the greatest stress being experienced near the eyelet of the device. A substantial portion of the total is stress is distributed over the area of the hemi-bridge device.

It will be understood that other ways of using the hemi-bridge devices are possible. For example, as shown inFIGS.15A-C, surgical staples S15or clips may be used instead of sutures to close wound W15and may extend through any of the eyelets of the insert. Additionally, combinations of various kinds of fastening elements (e.g., sutures, clips, staples, etc.) may be used, and the eyelets of the device may be configured to accept any or all kinds of fastening elements.

In another example (FIG.16A-B), hemi-bridge devices may be used to close larger wounds W16. In this example, wound W16may have missing underlying tissue such that piercing and traversing the underlying tissue is difficult or impossible. In such a case, a suspended suture S16may be used to gather tissue without traversing the underlying tissue. In one example, skin may be missing below zone z1of the device, but may be present in zones z2and z3. In such a situation, a suture may not pierce the skin adjacent first zone z1, but the hemi-bridge device may remain secured to the skin via zones z2and z3only.

FIG.17Ais a schematic top view of another embodiment of a hemi-bridge, andFIG.17Bis a side view of same. Generally, hemi-bridge1000extends between proximal and distal ends1002,1004and includes a planar insert1005disposed between lower layer1006and upper layer1008. It will be understood that in manufacturing the device, upper and lower layers of material may sandwich the insert and form a configuration similar to the flat configuration ofFIGS.13A-B. It will be understood that the flat configuration may be used in certain applications, and that other applications may require thermoforming to provide an angle of 10, 20, 30, 40, 50 or 60 degrees as previously described. Thus, the angle of inclination may be formed as desired for a specific application.

Each of the lower layer, the upper layer and the insert may be formed of any of the materials described above. For example, the upper and/or lower layers may be formed of any one of polyethylene, polyurethane, nylon, natural and/or synthetic materials, fabrics, cotton or suitable combinations thereof. In at least some examples, the upper and/or lower layer may be formed of a transparent material so that the wound may be inspected without removing the device. Due to the layering of materials, a stepped configuration having three zones, z1,z2,z3is formed, first zone z1having all three layers, second zone z2having two layers, and third zone z3having only the lower layer.

Notably inFIG.17A, second zone z2includes a transitioning edge1009that gradually widens from the first zone z1to the third zone z3. Specifically, second zone z2may include both the lower layer1006and the upper layer1008so that the two layers extend along the transitioning edge1009. In at least some other examples, insert1005also extends, partially or fully along, transitioning edge1009.

As shown inFIG.17C, hemi-bridge devices1000may be used to close large wounds W17, similar to the devices previously described. In this example, wound W17may have missing underlying tissue such that piercing and traversing the underlying tissue is difficult or impossible. In such a case, a suspended suture S17may be used to gather tissue without traversing the underlying tissue through eyelets1020. In one example, skin may be missing below zone z1of the device, but may be present in zones z2and z3. In such a situation, a suture may not pierce the skin adjacent first zone z1, but the hemi-bridge devices1000may remain secured to the skin via zones z2and z3only. The gradual widening (e.g., linear or non-linear increase of the width) along transitioning edge1009may reduce the risk of tearing in the second zone or failure of the device and may allow for elongation of the device under high tension.

FIGS.17D-Eare schematic top and side views of another embodiment of a hemi-bridge. Hemi-bridge1000D is similar to hemi-bridge1000ofFIG.17A, but has slightly different proportions. Generally, hemi-bridge1000D includes a lower layer1006, an upper layer1008and an insert1005disposed between lower layer1006and upper layer1008. The proportions and dimensions of one possible hemi-bridge are provided herein, but it will be understood that the hemi-bridge may be scaled up or down as desired. For example, the hemi-bridge may be scaled down to ⅕, ¼, ⅓, ½, or ⅔ of the dimensions disclosed. Alternatively, the hemi-bridge may be scaled up to be 1.5×, 2×, 2.5×, 3× or 4× larger than the disclosed dimensions.

In the example shown, the total length, LTotal, of hemi-bridge1000D may be approximately 80 mm, and the total width, WTotal may be about 30 mm. L1may be about 35 mm, and each of L2, L3, L4may be about 15 mm. The hemi-bridge may be symmetric about the longitudinal axis so that W1and W3are equal and about 10 mm each. In this example, W2is also about 10 mm so that the insert is approximately 10 mm in width by 15 mm in length. The lower layer may be thicker than the upper layer or vice versa, and the insert may be thicker than either the upper or lower layers, or both layers combined. In some examples, the lower layer has a thickness between 1 mil and 20 mil and the upper layer has a thickness between 1 mil and 20 mil. The insert may have a thickness of between 5 mil and 100 mil. In this example, the transition angle β of the transitioning edge is approximately 30 degrees, although it will be understood that the transitioning edge may form a steeper or shallower angle as desired by varying the length L3. In at least some examples, the transition angle β is less than 45 degrees.

Optionally, a reinforcement1011may be disposed in certain sections (e.g., adjacent the transitioning edge) to prevent tearing of the hemi-bridge. As shown inFIG.17F, hemi-bridge1000F is shown that has a reinforcement layer1011disposed on top of upper layer1008and at least partially covering the upper layer1008. Alternatively, reinforcement layer1011may be tucked beneath the upper layer1008as shown inFIG.17G. In both cases, the reinforcement layer1011is shown as being shorter than the upper layer1008, although it is understood that the upper layer and the reinforcement layer may be of a same length or coterminous. Reinforcement layer1011may be of a same material as the upper layer or the lower layer, or both. For example, in one embodiment all of upper layers1008, lower layer1006and reinforcement layer1011may be formed of polyurethane.

FIGS.18A-Care schematic side and top views of other embodiments of a hemi-bridge having waterproof coverings. As previously described, hemi-bridge1100extends between proximal and distal ends1102,1104and includes a planar insert1105that is covered by lower layer1106and upper layer1108. It will be understood that in manufacturing the device, upper and lower layers of material may sandwich an insert and form a configuration similar to the flat configuration previously discussed. In these examples, additional upper and lower coverings1112a,1112bformed of waterproof materials that envelope all surfaces and edges of the enclosed bridge assembly.FIG.18Bshows the covering1112. It will be understood that the upper and lower coverings1112a,1112bmay be of the same shape and/or size, and may be conterminous with one another. As shown, the coverings1112may have a footprint that is slightly larger than all of the lower layer, upper layer, and insert so that an enclosing border1113ais formed all around the assembly. This enclosing border may extend between 1/16 and ¼ inches farther out from the assembly. Additionally, it will be understood that the upper and lower coverings1112a,1112bmay be coupled (e.g., joined, adhered, secured, ultrasonically welded, melted, etc.) together at the enclosing border to envelop the assembly.FIG.18Cillustrates an embodiment in which the hemi-bridge ofFIG.17Ais enveloped with upper and lower coverings and a border1113bis formed. Thus, any of the embodiments described herein may be fully covered or enveloped in this manner. Additionally, an adhesive may be disposed on the bottom of the device in second and/or third zones z2,z3to allow the device to be coupleable to patient tissue. In at least some examples, instead of adding discrete waterproofing layers that create an envelope, a spray-on material may be applied to all or some surface of the bridge to waterproof it. This may include, for example, avocado oils, plant or animal-derived oils, beeswax, silicone, resins and suitable combinations thereof.

FIGS.19A-Dare schematic top views of several examples of eyelet arrangements on a hemi-bridge. Each of the eyelet arrangements described herein may be combined with any of the bridge configurations described in this disclosure. InFIG.19A, a hemi-bridge1200A includes an insert having a single eyelet1220acentered vertically and horizontally within the insert. InFIG.19B, a hemi-bridge1200B includes an insert having eyelets1220barranged in a row of multiple eyelets (e.g., two, three or more eyelets) along the longitudinal axis of the device. InFIG.19C, a hemi-bridge1200C includes an insert having eyelets1220carranged in a column of multiple eyelets (e.g., two, three or more eyelets) arranged on a line perpendicular to the longitudinal axis of the device. InFIG.19D, a hemi-bridge1200D includes an insert having eyelets1220darranged in at least one row and at least one column of eyelets (e.g., two, three or more eyelets in each row and/or column).

FIG.20Ais a schematic top view of another embodiment of a hemi-bridge having a plurality of distinct digits. As shown, bridge1300may extend between proximal end1302and distal end1304and have three zones z1-z3including an upper layer, a lower layer and one or more inserts as previously described. In this embodiment, bridge1300may include a plurality of digits1310a,1310b,1310c(e.g., three digits) in first zone z1, each of the digits having an insert1305sandwiched between upper and lower layers1308,1306. Each of the digits1310a-cmay include one or more eyelets1320defined therein. In second zone z2, an upper layer and a lower layer may be coupled together. In third zone z3, only a lower layer1306is present. As shown, third zone z3includes the lower layer being divided into a plurality of tabs1330a-c.As shown, three parallel tabs1330a,1330care formed, each tab being aligned with one of the digits. In this example, the first and third tabs1330a,care of a same length, and second tab1330bis longer than each of them. Alternatively, it will be understood that all three tabs1330a-cmay be formed of a same length. Without being bound by any particular theory, it is believed that by having distinct digits and/or tabs, movement of the patient's skin at one location will not translate to other locations and that the device may be better adhered and more securely close the wound.

FIG.20Bis a schematic top view of a hemi-bridge having a plurality of digits. As shown, bridge1400may extend between proximal end1402and distal end1404and have three zones z1-z3including an upper layer, a lower layer and one or more inserts as previously described. Bridge1400is substantially similar to bridge1300except that it includes two tabs1430a,1430binstead of three tabs at the distal end. The two tabs1430a,1430bare generally symmetrical about the central axis of the bridge, and include a cutout1431or concavity therebetween. In a third embodiment, shown inFIG.20C, bridge1500has a number of digits1510adjacent proximal end1502, but only a single curved tab1530adjacent distal end1504.

As shown inFIG.20D-E, bridges1300may be used to close large wounds W18. In this case, two bridges1300are disposed on opposite sides of the wound with their digits facing and aligned with one another. A suture S18including three loops may be used to gather tissue to close the wound (FIG.20E). Other suture patterns are also possible. For example, a suture pattern S18′ having a single continuous thread may be used as shown inFIG.20F.

Instead of having two separate bridges disposed on either side of the wound, a unibody bridge1600may be formed having five zones z1-z5.FIGS.21A-Billustrate one such embodiment in which a bridge1600extends between first end1602and second end1604. Bridge1600may include a plurality of digits1610on each of the two ends at zones z1,z5, each of the digits having the three layers previously described (i.e., lower layer, insert, upper layer). A transitioning section1615having only the upper and lower layers may be disposed adjacent the digits in zones z2,z4. An elongated body1630composed of only the lower layer (or the upper and the lower layer) stretching across all five zones may extend between the two transition sections. The length and/or width of the elongated body1630may be varied as desired. In use, unibody bridge1600may be wrapped around a body part (e.g., arm, shoulder, knee, or some other body part or joint) so that the two ends are disposed on opposite sides of a wound W19and the digits on either side of the bridge are coupled together via a suture (FIG.21B).

In at least some embodiments, hemi-bridges may have features, such as openings, to allow for the passage of air and/or liquid therethrough. For example,FIG.22Ais a schematic top view of one example of a hemi-bridge1700A having openings in the form of slits1751athat extend parallel to the longitudinal axis of the device. Slits1751aare arranged in rows as shown, and each row may include one or more slits. In at least some examples, the slits are offset in adjacent rows. Alternatively, a hemi-bridge1700B may include slits1751bthat are perpendicular to the longitudinal axis of the device (i.e., parallel to the wound edge) and arranged columns, each column having one or more slits. Instead of slits, a hemi-bridge1700C may include circular apertures1751carranged in rows and/or columns. Any of these features (or combinations of them) may be disposed in one of the zones (e.g., limited to one or more locations in the second zone) or in multiple zones (e.g., the second and third zones). Features such as slits or openings in the second zone may allow air to flow therethrough and allow moisture to escape the wound to prevent or reduce the possibility of maceration. It will be understood that these features may be included and combined with any of the embodiments described herein.

Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.

It will be appreciated that the various dependent claims and the features set forth therein can be combined in different ways than presented in the initial claims. It will also be appreciated that the features described in connection with individual embodiments may be shared with others of the described embodiments.