Patent Description:
The present disclosure relates generally to wound closure and methods and devices for improving same. More specifically, the present disclosure relates to a deformable partially elevated suture bridge device and methods for facilitating wound closure.

Sutures are stitches used to close open wounds and/or surgical incisions of a patient. A medical practitioner generally uses a needle with an attached thread to substantially sew two adjacent sections of skin together to close the wound or incision. Surgical knots are often used to secure the sutures and ensure proper healing.

Effective surgical knots may be difficult to tie, thereby potentially allowing reopening of the wound or incision. In such cases, the patient may be at risk of infection if the wound or incision reopens. In another example, sutures and surgical knots contacting the skin can be inflammatory and/or become "ingrown" and actually impede healing of the wound or incision. Additionally, complications may arise if the suture is tied too tightly or too loosely.

For example, wound eversion may be a desired outcome of suture technique, especially in high-tension areas of the skin, such where skin overlies the shoulder, knee, angle of the mandible, etc. Wound eversion occurs when the two wound surfaces are horizontally opposed into one another such that the closed incision is under no tension and topographically lies in a plane above the resting horizontal skin plane. Wound closures with maximal eversion resist excessive widening of the scar due to ongoing ambient stresses in the high-tension area during the wound healing and scar maturation processes. However, wound eversion can be technically difficult to achieve for less skilled operator, and a device to facilitate this is desirable. Further, there may be excessive tension on closures where an excisional defect is present in the skin. When suture is placed under excessive tension to close such wounds, the suture itself can slice through the skin ("cheesewiring"). In this setting, a surgical device interposed between the skin and suture for the purpose of spreading the suture's force over a broader area is desirable. The embodiments in the following descriptions integrate these two important functions into a single device, that is the achievement of maximal wound eversion closure with prevention of suture-induced trauma to the skin. Thus, there exists a need for suture devices that improve upon and advance the design of known suture devices.

<CIT> discloses a retention suture bridge device comprising an arch which has feet which pivot about axes transverse of the arch. The use of feet in the bridge in <CIT> allows the device to react to and accommodate movement of the patient.

According to claim <NUM> a suture bridge includes an elongated rigid insert including a first material, and a deformable shell including a second material, the second material being different than the first material, the insert and the shell collectively forming a bridge body having a first leg including a first patient contacting surface configured to contact a patient's skin, a second leg spaced from the first leg and including a second patient contacting surface configured to contact the patient's skin, a first support connected to the first leg, a second support connected to the second leg, a first slot at least partially formed through a portion of the first leg, and a portion of the first support, a second slot at least partially formed through a portion of the second leg, and a portion of the second support, and a traversing member extending between the first support and the second support such that the shell partially surrounds the rigid insert, the shell covers the surface of the rigid insert on a patient contacting surface side.

Various embodiments of the presently disclosed suture bridges are disclosed herein with reference to the drawings, wherein:.

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.

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.

The disclosed suture bridges will become better understood through review of the following detailed description in conjunction with the figures. The detailed description and figures provide merely examples of the various inventions described herein. Those skilled in the art will understand that the disclosed examples may be varied, modified, and altered without departing from the scope of the inventions described herein. Many variations are contemplated for different applications and design considerations; however, for the sake of brevity, each and every contemplated variation is not individually described in the following detailed description.

These and other advantages will become more fully apparent to one of skill in the art upon consideration and review of this disclosure. While this disclosure describes various detailed embodiments, it is not intended to be limited to only the illustrated and described embodiments. The disclosed embodiments may be varied, modified, and altered without departing from the scope of the inventions described herein. Further, while many variations are contemplated for different applications and design considerations, for the sake of brevity each and every contemplated variation is not individually described.

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 or flaps to close relatively large wounds.

<FIG> are photographs showing a wound that is sutured together via a conventional technique (<FIG>), and the resulting cheesewiring that may occur from such techniques (<FIG>). Specifically, <FIG> shows a wound disposed between two portions of skin, and tied together via a suture. <FIG> shows the same after thirty minutes, after the suture has been removed. As shown, high tension in suture has caused the suture to damage some of the soft tissue ("cheesewiring"). To address this problem, solutions have been proposed which include reengineering the materials and configurations of the suture itself. Additionally, in certain clinical applications, it may be desirable to apply greater tension than usual on the suture, for example, to avoid the need for a skin graft. In such examples, high tension on the suture may result in lacerations and tearing of the skin. The present suture bridges may allow for high-tension closure of wounds while protecting the patient's tissue.

With reference to <FIG>, a first example of a suture bridge, suture bridge <NUM>, will now be described. Suture bridge <NUM> includes a first leg <NUM>, a second leg <NUM>, a first support <NUM>, a second support <NUM>, a traversing member <NUM>, and a spacing, often referred to as a "wound eversion void" or "void" <NUM> disposed below the traversing member. A ridge <NUM> is formed in at least portions of the traversing member, the supports, and the legs and this will be described in greater detail below. Suture bridge <NUM> also includes a bottom surface <NUM> and a top surface <NUM> opposite of bottom surface <NUM>. Suture bridge <NUM> functions to extend the useful life of sutures and to reduce damage to skin while being employed by the most common suture patterns.

At ends opposite first leg <NUM> and second leg <NUM>, first support <NUM> and second support <NUM> are connected together by traversing member <NUM> at obtuse angles. Together, first leg <NUM>, second leg <NUM>, first support <NUM>, second support <NUM>, and traversing member <NUM> define a bridge structure. Traversing member <NUM> is located in between first leg <NUM> and second leg <NUM> and is elevated away from first leg <NUM> and second leg <NUM> by first support <NUM> and second support <NUM> to form an elevated wound eversion void <NUM>.

Wound eversion void <NUM> is formed beneath traversing member <NUM> and is configured to accept an everting wound <NUM>. Similar to first support <NUM> and second support <NUM>, traversing member <NUM> may be thicker, as measured from top surface <NUM> to bottom surface <NUM>, than first leg <NUM> and second leg <NUM>. The added thickness of traversing member <NUM>, along with first support <NUM> and second support <NUM>, provide a greater stiffness for suture bridge <NUM> in its elevated portion. The increased stiffness helps withstand forces of different suture patterns and helps resist suture bridge <NUM> collapsing or bending at wound eversion void <NUM>. In alternate embodiments, first support <NUM>, second support <NUM> and traversing member <NUM> increase stiffness by incorporating alternate or additional materials, in addition to or instead of adjusting the overall thickness of the device. Thus, a suture bridge may be formed having a relatively constant thickness but different stiffness and deformation characteristics along its length.

As can be seen in <FIG>, traversing member <NUM> is elevated away from a patient's skin <NUM> and wound <NUM>. Traversing member being elevated and rigid helps facilitate wound eversion into wound eversion void <NUM> as wound <NUM> is pressed together by suture bridge <NUM> and the accompanying suture. When suture bridge <NUM> is used with a suture on a wound, wound eversion void <NUM> is positioned generally above the wound to facilitate wound eversion. Wound <NUM> may or may not contact bottom surface <NUM> in wound eversion void <NUM>.

First leg <NUM> and first support <NUM> connect to form an obtuse angle at inflection point <NUM>. Likewise, second leg <NUM> and second support <NUM> connect to form an obtuse angle at inflection point <NUM>. Inflection points <NUM> and <NUM> cradle and trap sutures, for example, horizontal mattress sutures, that apply a downward and inward force on suture bridge <NUM>. In some examples, inflection points <NUM> and <NUM> form defined angles to entrap and restrict movement of the suture. Inflection points <NUM> and <NUM> help enable common suture patterns, like a horizontal mattress suture, to be used with suture bridge <NUM>.

Ridge <NUM> is located on top surface <NUM> of suture bridge <NUM> primarily along the length of traversing member <NUM>. In some examples the ridge extends down the length of the first support and the second support <NUM>. Ridge <NUM> may provide added strength, rigidity, and stiffness to suture bridge <NUM> to help withstand inward and downward forces applied by a suture.

Suture bridge <NUM> addresses many of the shortcomings existing with current suture techniques and devices. For example, suture bridge <NUM> extends the useful life of sutures. By elevating the sutures away from a patient's skin, the suture may last longer without causing irritation to the skin. Additionally, because pressure from the suture is reduced and more evenly spread across the surface of a patient's skin, a suture can stay in longer, allowing a wound more time to heal while avoiding conditions such as necrosis of the skin. In at least some examples, suture bridge <NUM> is approximately <NUM> in length and <NUM> at its greatest width. Alternatively, a larger suture bridge <NUM> may formed in the same proportions described herein, the suture bridge being approximately <NUM> in length by <NUM> in width. In one example, the length of the suture bridge may be formed in a length of between <NUM> and <NUM>, and the width may be adjusted accordingly. It will be understood that all of the other elements of the suture bridge (e.g., legs, traversing member, supports and slots) may be scaled accordingly.

Suture bridge <NUM> may also be used in conjunction with many common types of suture patterns, including a simple interrupted suture, buried dermal suture, pulley ("far-near-near-far") suture, horizontal mattress suture, and a vertical mattress suture. Suture bridge <NUM> is sturdy and rigid enough to not collapse under the forces of any common type of suture while still gathering the wound, encouraging wound eversion and proper healing of the wound.

As can be seen in <FIG>, suture bridge <NUM> includes at least two legs, where first leg <NUM> and second leg <NUM> are located at opposite ends of the bridge. Located on bottom surface <NUM> of suture bridge <NUM> at first leg <NUM> and second leg <NUM> are patient contacting surfaces <NUM>. Patient contacting surfaces <NUM> reduce the overall pressure on a patient's skin <NUM> that would normally occur without suture bridge <NUM>, allowing for longer use of the suture. In alternate embodiments, there may be multiple legs and multiple patient contacting surfaces. In at least some variants, legs <NUM>,<NUM> are curved at the terminal ends as shown in <FIG>. Specifically, the patient contacting surfaces <NUM> may themselves be rounded and the distalmost portion <NUM> of the leg <NUM> may curve away from the patient's body.

First leg <NUM> and second leg <NUM> are of a sufficient thickness to be sturdy, yet still flexible. In some examples, the two legs are symmetric, formed of the same materials in the same configuration and behave in the same or in similar manners. Alternatively, a different and more flexible material could be used for the first leg and the second leg to allow for different degrees of flexibility in each of the legs.

The flexibility of first leg <NUM> and second leg <NUM> allows them to contort and adapt to a patient's skin <NUM> as the patient moves. The legs are flexible to reduce skin irritation and pressure necrosis and allow movement of the patient's skin. Additionally, the flexibility of first leg <NUM> and second leg <NUM> provides for better patient comfort and reduces annoyances, such as suture bridge <NUM> catching on articles of clothing.

As shown in <FIG>, first leg <NUM> and second leg <NUM> each contain an elongated slot <NUM>. Slots <NUM> on first leg <NUM> and second leg <NUM> extend fully through suture bridge <NUM> from top surface <NUM> to bottom surface <NUM>. Slots <NUM> can be used with a simple interrupted suture to secure suture bridge <NUM> to a patient over a wound <NUM> to extend the life of the suture and to encourage proper healing of the wound. As shown, slots <NUM> have a length and a width, the length of the slots being chosen to allow travel of the suture when gathering tissue to form the wound eversion as described above. In at least some example, the length, "LS", of the slots <NUM> will determine how much wound eversion is permitted. Specifically, slots <NUM> may have length "LS" that is approximately <NUM>%, <NUM>%, <NUM>%, <NUM> or <NUM>% of the overall length "LB" of the suture bridge. Alternatively, because the tissue being pulled together will also be gathered into the wound eversion void and up toward the traversing member, slots <NUM> may be proportional to the height of the wound eversion void <NUM> (e.g., <NUM>. 25x, <NUM>. 3x, or <NUM>. 5x the height of the wound eversion void).

When using the slots <NUM>, even the inexperienced operator can achieve maximal eversion closure by placing the suture at the outermost space within the slot (e.g., at a point farthest away from the traversing member within slot <NUM> such as point P1 in <FIG>). As tension is placed on the suture, tissue is gathered and the suture will travel within the slot inwardly toward the traversing member (e.g., travel closer to point P2 in <FIG>, and bringing with it the coupled tissue), allowing for eversion of the wound within the wound eversion void <NUM> below the traversing member <NUM>.

In alternate embodiments, slots <NUM> may be configured as circular holes in first leg <NUM> and second leg <NUM>. In some examples, instead of elongated slots on each leg <NUM>,<NUM>, one, two, three or more circular or oval apertures may be provided on each leg. In at least some examples, slots <NUM> on opposing legs may be spaced from one another by approximately <NUM>. In at least some examples, the distance between the slots may be between <NUM> and <NUM>. Additionally, each slot may be between <NUM> and <NUM> in width and between <NUM> and <NUM> in length.

Optionally, and as shown in phantom lines only in <FIG> for the sake of clarity, a central aperture <NUM> may be formed in the center of the traversing member <NUM> and define a passage from the top to the bottom of the device. Central aperture <NUM> may be substantially circular, or oval, and may be equidistant from slots <NUM>. In examples having central aperture <NUM>, the physician may thread a suture through this passage according to his need. Suture patterns utilizing this central aperture will best be shown near the end of this disclosure with reference to <FIG>. In embodiments having both a central aperture <NUM> and slots <NUM>, the physician may thus select the most desirable suture configuration. For example, to obtain maximal wound eversion, slots <NUM> may be used to allow the suture to travel therethrough when gathering tissue to evert it. Alternatively, if wound eversion is not a priority, central aperture may sufficiently accomplish the task of closing the wound.

As shown in <FIG>, a suture bridge <NUM> may instead include multiple central apertures 121a-c in the traversing member. Thus, the traversing member may have no central apertures, a single central aperture, or multiple (e.g., two, three, four or more) central apertures. It will be understood that the shape and/or size of the central apertures may be the same or different from others.

First leg <NUM> is connected to a first support <NUM>, and second leg <NUM> is connected to a second support <NUM>. First support <NUM> and second support <NUM> rise up and slope inwardly at an angle a1 of between <NUM> and <NUM> degrees with respect to first leg <NUM> and second leg <NUM> (See <FIG>). More specifically, in some examples, the angle a1 may be between <NUM> and <NUM> degrees, which allows for a raised traversing member for maximal wound eversion. Alternatively, the angle a1 may be between <NUM> and <NUM>, such an angle allowing the traversing member to be closer to the wound, which results in smaller forces between the legs and the patient's skin. Such an embodiment may be useful for high-tension wound closure in clinical settings such as when a skin graft is avoidable. For example, it is believed that with an angle a1 of between <NUM> and <NUM> degrees, it may be possible to apply a force of between <NUM> and <NUM> Newtons, which is an amount that may injure the adjacent tissue if applied via a suture only without the suture bridge. In at least some examples, the angle is selected so that a force of at least <NUM> Newtons may be applied to a suture without damaging the tissue. Additionally, it will be appreciated that raising the traversing member away from the wound may result in greater pressure on the tissue below the legs so that other components are used to alleviate this pressure as will be discussed shortly. In at least some examples, the angle a1 may be closer to <NUM> degrees (e.g., between <NUM> degrees and <NUM> degrees) and the traversing member is either completely aligned with the legs, or slightly raised by a distance of between <NUM> and <NUM> from the wound underneath.

In some examples, first support <NUM> and second support <NUM> may be thicker, as measured from top surface <NUM> to bottom surface <NUM>, than first leg <NUM> and second leg <NUM>. The thickness of first support <NUM> and second support <NUM> increase the stiffness of first support <NUM> and second support <NUM> as compared to first leg <NUM> and second leg <NUM>. In alternate embodiments, first support <NUM> and second support <NUM> are of roughly the same thickness as the legs but incorporate different materials. These materials may be incorporated by creating first support <NUM> and second support <NUM> entirely from different materials, or alternatively they may have an internal or external support structures as will be described in greater detail with references to <FIG>.

In some embodiments of the suture bridge, the entire suture bridge or a portion, for example, the bottom surface <NUM> may include a coating of additional medications. In these embodiments, a coating of one or a combination of growth factors, antimicrobials, or other agents for transfer to a patient's skin and wound to assist in proper healing of the wound. Alternatively, in some embodiments, the suture bridge may entirely or partially be impregnated with one or more additional medications to assist in proper healing of the wound.

Suture bridge <NUM> may be formed partially or entirely from any sturdy and resilient material, such as silicone, thermoplastic polyurethanes (TPU), rubber, metal, plastic, polypropylene, polyethylene, acrylonitrile butadiene styrene (ABS), high impact polystyrene (HIPS), poly vinyl chloride (PVC) polycarbonate, thermoplastic elastomers, polybutylene terephthalate, ethylene vinyl acetate, nylon a low-density polyethylene, linear low-density polyethylene, and suitable combinations thereof. The suture bridge may also be made of one material of varying thickness, or by using a spine or ridge, to provide support for the traversing member while remaining flexible at the first leg and the second leg.

Alternatively, the suture bridge may be formed of multiple portions that are coupled together, the inner and outer portions including different materials to provide support and strength for the traversing member while remaining flexible at the first leg and the second leg. For example, any number of bodies may be used to form the suture bridge entirely, the support structures, and the legs, such bodies being formed of different material and being configured to house or otherwise couple to one another. One example of such a bridge is shown in <FIG> having two components. Examples of these components will be described in more detail below. In the example shown, suture bridge includes an inner portion or insert <NUM> (<FIG>) and an outer portion or shell <NUM> (<FIG>), the insert <NUM> and the shell <NUM> being formed of different materials and collectively forming the bridge body that includes the legs, supports and traversing member. Shell <NUM> partially covers insert <NUM> so that the upper surface of insert <NUM> is not covered, for example, at the top of the device, but the bottom surface is covered to provide comfort to the patient. Details of insert <NUM> will best be understood with reference to <FIG>. Insert <NUM> may be formed of a material that is more rigid than shell <NUM>. Insert <NUM> may extend between a first end <NUM> and a second end <NUM> and form a general bridge shape having slots <NUM> defined therethrough on opposing ends. It will be understood by looking at <FIG>, for example, that insert <NUM> forms portions of the legs, supports and traversing member of suture bridge <NUM>. Although not shown, insert <NUM> may also include one or more apertures in the traversing members as desired. The thicknesses of insert <NUM> "TI" will vary along its length as will be discussed in greater detail below. Sufficient to say at this point that the insert will be thickest at its center and thinnest near the first and second ends <NUM>,<NUM>. Additionally, it will be understood that multiple inserts may be provided within the body of the suture bridge instead of a single insert. In some examples, the insert <NUM> may be overmolded with an elastomer, such as a silicone, and the material of the insert <NUM> may be selected from a heat tolerant material that is not likely to melt during the overmolding of the shell <NUM>. For example, an insert <NUM> covered by silicone may require a hot mold, and the insert <NUM> may be tolerant to heat up to the temperature necessary for the hot mold. Suitable materials for the insert <NUM> may include any of those discussed above, or high temperature tolerant materials having a relatively high flexural modulus (e.g., <NUM>-<NUM> GPa), such as polyether ether ketone (PEEK) and polyetherimide (e.g., Ultem). Thus, in some examples, the insert <NUM> may be formed of Polyether ether ketone (PEEK), and shell <NUM> may be formed of a soft silicone.

Turning now to shell <NUM>, the details of which will best be understood with reference to <FIG>. Shell <NUM> may extend between a first end <NUM> and a second end <NUM> and have the same general bridge shape as insert <NUM> and suture bridge <NUM>. Shell <NUM> may also include slots <NUM> defined therethrough on opposing ends, the slots <NUM> being shaped, sized and spaced to align with slots <NUM> of insert <NUM>. Although not shown, shell <NUM> may also include one or more apertures in the traversing members to align with the apertures of the insert <NUM> so that a suture may be passed through the traversing member. In at least some examples, shell <NUM> is thickest at first and second ends <NUM>,<NUM>. For example, shell <NUM> may have a thickness "TS" of between <NUM> and <NUM> at the legs such thickness being capable of relieving pressure on the patient's skin when tension is applied to a suture. In at least some examples, shell <NUM> forms <NUM>%, <NUM>, <NUM>% or more of the total volume of the legs of the suture bridge. Additionally, as shown in <FIG>, shell <NUM> forms bulbous, almost circular, curved contacting members <NUM> that are wider than the rest of the device. This feature is optional, and it will be understood that in other embodiments, the shell is substantially stadium-shaped when seen from above as illustrated in <FIG>.

In at least some examples, the insert <NUM> and the shell <NUM> are first co-molded, and the slots are simultaneously formed through the two members after the molding process. It will be understood by looking at <FIG>, for example, that shell <NUM> forms portions of the legs, supports and traversing member of suture bridge <NUM>. The thicknesses of shell <NUM> "TS" will vary along its length as will be discussed in greater detail below, and in some cases this thickness will vary according to a mathematical relationship with the thickness of the insert <NUM>.

Shell <NUM> may be selected from a relatively soft material that allows for dissipation of pressure and that can be molded without sharp edges to prevent damage or laceration of the skin. The softness or hardness of the material for the shell may be measured with Shore scales. For example, hard plastics are typically measured on the Shore D scale. Softer materials on the Shore A and A00 scales may be used. In some examples, the shell may be formed of a silicone with Shore A hardness of <NUM> or less. In at least some examples, the shell may be formed with a material having a Shore A hardness of <NUM> or less. In at least some example, the material should have a Shore A hardness of equal to or less than <NUM> or a Shore A00 hardness of equal to or less than <NUM>. In some examples, shell <NUM> is formed by overmolding a biocompatible material chosen from ones that are easily sterilized via steam or an autoclave, such as soft silicone overmolded over the insert <NUM>.

In some other examples, a biocompatible thermoplastic elastomer (TPE) or biocompatible thermoplastic urethane (TPU), or combinations thereof may be used for the shell. In such examples, the materials of the insert may not necessarily need to be a high tolerant material, and the insert may be formed of such materials as common types of plastics, nylon, polypropylene, polyoxymethylene (e.g. Delrin or Acetal), Acrylonitrile butadiene styrene (ABS), and the like. Thus, devices having a Delrin insert and a TPU shell may be used.

In some examples, the device <NUM> has a substantially equal total thickness in the traversing member <NUM> as the legs <NUM>, the thicknesses being measured from the top surface to the bottom surface (i.e., T114 = T106 as shown in <FIG>). Though these thicknesses are equal, the portions of the thicknesses attributable to the insert and the shell may be different. For example, at thickness T114 near the traversing member, the shell may form a minority of the thickness, for example, between <NUM>% and <NUM> of the thickness, while the insert forms the remaining portion of the thickness (e.g., <NUM>% to <NUM>% of the thickness). Conversely, at thickness T106 near the legs, the shell may form a majority of the thickness, for example, between <NUM>% and <NUM>% of the thickness, while the insert forms the remaining portion of the thickness.

<FIG> will be understood in conjunction with <FIG> above it, and shows the thicknesses of the shell (and implicitly the insert) at certain points along the length of the suture bridge shown directly above it and aligned therewith. As shown in <FIG>, possible ranges of the percentage of the bridge body thickness attributable to the shell may vary along the length of the body from one end to the other. To better understand <FIG>, three vertical lines are shown with labels "T1", "T2" and "T3". "T1" shows possible thicknesses at point "<NUM>" along the traversing member so that it will be understood by looking at the corresponding shaded region that the shell may form between <NUM>% and <NUM> of the total thickness of the bridge at this location. "T2" shows possible thicknesses at point "T2" along the leg so that it will be understood by looking at the corresponding shaded region that the shell may form between <NUM>% and <NUM>% of the total thickness of the bridge at this location. "T3" shows possible thicknesses at point "T3" along the leg so that it will be understood by looking at the corresponding shaded region that the shell may form <NUM>% of the total thickness of the bridge at this location. Thus, the graph shows some possible configurations in which the shell forms a percentage of the bridge body, the shaded region showing certain possible makeups of the shell within the bridge body. At extremes of the bridge body, the shell makes up <NUM>% of the thickness of the bridge body (e.g., in one example, the insert does not extend to the outermost portion of the leg). The shell percentage decreases and increases along the body as desired to obtain a bridge body having the preferred deflection and deformation properties.

It will be understood that the percentage thickness of the insert will simply be equal to <NUM>% minus the percentage thickness of the shell, so that a shell thickness of <NUM>% equates to an insert thickness of <NUM>. Specific thickness ratios of shell: insert may depend on the stiffness of the materials selected.

In at least some examples, the shell is thickest adjacent the legs of the device, and thinnest adjacent the traversing member. Conversely, the rigid insert may be thickest adjacent the traversing member, and thinnest adjacent the legs. It will be understood that the suture bridge thicknesses may vary with materials. For example, a less stiff insert, such as polypropylene, may be used instead of PEEK, but the central portion may need to be thicker to compensate for the lack of stiffness of the material.

By varying the thicknesses of insert <NUM> and shell <NUM> in this manner, the deformation characteristics of the device <NUM> may be carefully chosen. In the example shown in <FIG>, the increased thickness of the deformable shell <NUM> may help relieve some of the pressure of the device at the legs of the bridge, while the increased thickness of the rigid insert <NUM> at the traversing member may provide strength, rigidity, and stiffness to suture bridge <NUM> to help withstand inward and downward forces applied by a suture.

With reference to <FIG>, two examples of using the suture bridge are shown. In <FIG>, the physician has opted to use central aperture <NUM> instead of the slots <NUM> for this specific application, and the suture "S1" generally pierces through two portions of the skin on either side of the wound and the two tails of the suture extend vertically away from the skin through the central aperture <NUM>. Conversely, in <FIG>, the physician has elected to use the slots <NUM> instead of the central aperture, passing the suture "S2" through the two portions of the skin on either side of the wound, and passing each tail of the suture through one of the slots on either side of the central aperture.

At least portions of the suture bridges of the instant disclosure may be flexible and have spring-like properties. <FIG> illustrates one example of a suture bridge according to the present disclosure during use. For the sake of simplicity, the suture bridge <NUM> is shown as a single component, although it will be understood that suture bridges having both an insert and a shell are contemplated and that the instant description applies to both unitary and multi-component bridges.

<FIG> illustrates suture bridge <NUM> in a rest ("or resting") condition on a patient surface "PS1" (i.e., with no external force applied thereto), the suture bridge having a pair of legs <NUM>,<NUM>, a pair of supports <NUM>,<NUM> and a traversing member <NUM> extending between the two supports. The patient surface may be, for example, the patient's skin at the site of a wound. As shown, the legs <NUM>,<NUM> may form a leg resting angle defined as the angle between the two legs of the bridge, of, for example, approximately <NUM> degrees when the suture bridge is at rest, the legs and supports serving to elevate the traversing member away from patient surface PS1.

As shown in <FIG>, an external force "F1" may be applied to a portion of the suture bridge <NUM>, such as the traversing member <NUM>. In at least some examples, this external force "F1" may be a force applied by the tightening of a suture. The external force "F1" may flatten the suture bridge <NUM> so that the angle between the legs increases to <NUM> degrees. Note in <FIG>, that the traversing member <NUM> is closer to patient surface "PS1" when the external force is applied than at rest. In this flattened condition, the physician may begin to couple the suture bridge to the wound via a suture using any of the techniques described above.

At least portions of suture bridge <NUM> may be formed of a material that returns to its original condition after the external force "F1" has been removed. Thus, the suture bridge <NUM> may act as a spring and may have a memory to return to its resting condition absent any external force. Specifically, when external force "F1" is removed, suture bridge may return to the same or a similar condition shown in <FIG>. Because the bridge is coupled to the patient's skin, the returning of the suture bridge <NUM> to its rest condition, will gather patient surface "PS1" and pull it up to the cavity underneath the traversing member (<FIG>). There are at least two advantages to this technique. First, gathering of the patient's skin in this manner results in wound eversion, which is believed to provide at least some of the benefits previously discussed. Additionally, deep dermal and superficial subcutaneous tissue apposition is possible from the inward compressive forces, which partially compress the device. Additionally, wounds may be closed under very high tension without apparent damage to the tissue. This is believed to be the result of both the angle of the suture coming out of the skin and from the increased surface area of the device when compared with the same suture performed without the device.

Additionally, without being bound by any particular theory, it is believed that the degrees to which the suture bridge springs back to its resting condition when an external force is removed is related to the hardness (i.e., durometer) of the material of either the shell or the insert. In at least some examples, the shell of the suture bridge has a lower hardness than the insert. In at least some examples, the shell includes an elastomer having a Shore A durometer of <NUM>-<NUM> or a Shore A durometer of <NUM>.

To illustrate the memory of the device, a suture bridge was formed having legs and a leg resting angle of <NUM> degrees. A compressive force "F1" of <NUM>. 5N was applied to the suture bridge for <NUM> minutes. When the compressive force "F1" was relieved, the suture bridge returned to a leg angle of <NUM> degrees. In a clinical setting, this rebound would occur after suturing, and after the external force is removed, and would gather the tissue with it.

In addition to the memory properties of the suture bridge, additional features may be included to improve the gathering of the patient's skin. For example, as shown in the detailed view of <FIG>, suture bridge <NUM> includes a leg <NUM> having a skin-contacting portion <NUM>. Skin-contacting portion <NUM> may be formed as part of the shell. Additionally, in at least some examples, skin-contacting portions <NUM> on each leg may include a "tacky" material or a rough surface with a rough topography that provides a prerequisite coefficient of friction with the patient surface "PS1" so that the skin-contacting portions aid in the gathering of the tissue. In at least some examples, the coefficient of friction of the skin-contacting portions will be chosen based on the intended application. In at least some examples, the coefficient of friction is between <NUM> to <NUM> or from <NUM> to <NUM>.

In use, any of the suture bridges described herein may help close a wound. Turning to <FIG>, a series of screenshots from an animation is presented which show the use of the device. The suture bridges may be used to aid in the closure of a large wound <NUM> formed after Mohs surgery. The wound <NUM> may begin as a relatively large wound, in this example, shown as being substantially oval. To close the wound, a surgeon may first perform a large bite procedure with the needle and suture <NUM>, passing the suture on either side of the wound approximately <NUM> from the skin edge without undermining using <NUM>-<NUM> or larger nylon suture (<FIG>). The physician may then place the suture bridge <NUM> in the resting condition across the wound with the legs of the suture bridge being disposed on either side of the wound, the traversing member being disposed directly above the wound, and the longitudinal axis of the bridge being substantially perpendicular to the wound. The ends or tails of the suture <NUM> may be brought together and then inserted through the slots of the suture bridge <NUM>, the ends of the suture then crossing over the traversing member (<FIG>). An appropriate tension may be applied, for example, via a clamp <NUM> to secure the suture, this tension causing the suture bridge to flatten, increasing the angle between the legs, the traversing member now being closer to the wound than in the resting condition (<FIG>). At this point, once the clamp <NUM> is secured the suture bridge <NUM> will continue to exert pressure on the wound <NUM> to stretch the skin and the clamp may be used to hold the suture for approximately <NUM>-<NUM> minute intervals (<FIG>). The suture <NUM> may be successively unclamped and retightened to allow for successive Mohs layers to be taken after the initial tightening. The tightening of the suture causes the wound to come together more easily after tissue expansion, and fully stretching may be achieved in approximately <NUM>-<NUM> minutes. Additionally, the suture bridge returns to its elevated resting condition, gathering and everting the wound and bringing it into the wound void and up toward the traversing member (<FIG>). Finally, after an appropriate amount of time, the device can be removed (<FIG>), the wound being substantially smaller than it was originally (<FIG>). A linear closure may then be performed using staples, <NUM>, or sutures, adhesive or other suitable method (<FIG>). This technique may be used to minimize the presence and/or appearance of scars. Specifically, by using one of the suture bridges disclosed herein, the skin may be stretched allowing a closure under lower tension, the stretching of the skin helping to reduce the possibility of conspicuous scars. Thus, a method is contemplated of reducing scars using the steps outlined above, and scar revision surgery may also be possible using the bridges and techniques disclosed herein.

Other variations of the bridges are also possible as shown in <FIG>. For example, <FIG> is a schematic top view of an H-shaped suture bridge <NUM> that may be useful for larger wounds "W1". The H-shaped bridge <NUM> is generally formed as two bridge members <NUM>,<NUM>, such as those shown in <FIG>, joined together by a connecting member <NUM>. <FIG> show top views where the elevation of the bridge is not possible to see, although it will be understood that each bridge member in these figures may be formed similar to the bridges described above which include legs, support members, traversing member that are elevated from the wound. Additionally, each of the bridge members may include an insert and a shell as described above. Connecting member <NUM> of <FIG> may include at least some of the materials used for the insert or at least some of the materials used for the shell, or a combination of them. In at least some examples, the H-shaped bridge includes a unitary shell that forms both shells of the bridge members <NUM>,<NUM> and the connecting member <NUM>.

In some examples, the connecting member <NUM> may be flexible so that the two bridge members <NUM>,<NUM> may angle toward or away from each other as desired. As shown in <FIG>, bridge member <NUM> is disposed at an angle of approximately <NUM> degrees with respect to bridge member <NUM> so that the bridge members remain perpendicular to a curved wound "W2" at more than one location. In at least some examples, bridge members <NUM>,<NUM> are parallel to one another, but are capable of flexing to form an angle of <NUM> to <NUM> degrees therebetween. Additionally, instead of an H-shaped suture bridge, variations such as a three-member bridge <NUM> with three bridge members <NUM>,<NUM>,<NUM> are also possible, each bridge member being connected by flexible or rigid connecting members <NUM>,<NUM> as desired and disposed over wound "W3" (<FIG>). It will be understood that variations are also possible with four, five or more bridge members.

<FIG> is a schematic top view of an X-shaped suture bridge <NUM>, the bridge having two bridge members <NUM>,<NUM> that are perpendicular to one another and intersect (or are joined together) at a central eyelet <NUM>. An X-shaped suture bridge <NUM> may provide greater stability of a traversing member over the wound, and may provide flexibility to the physician in choosing an appropriate configuration or layout for the bridge and the suture pattern. It will be understood that this embodiment also contemplates raised traversing members so that central eyelet <NUM> is elevated above the wound similar to that described above. One possible suture pattern SP14 is shown, although it will be understood that other suture patterns are possible including those that pass through the central eyelet <NUM> of the X-shaped suture bridge.

<FIG> are schematic top and side views of another variant of a suture bridge <NUM>. Suture bridge <NUM> is similar to suture bridge <NUM> of <FIG> and may have both an insert <NUM> and an outer shell <NUM> forming a bridge body having a pair of legs, a pair of supports and a traversing member, and include some or any of the features of the previous embodiments. Suture bridge <NUM> may also be formed using the material(s) discussed above in any of the configurations. Suture bridge <NUM> is slightly different from other embodiments in that the insert <NUM> has a substantially uniform thickness from one end of the insert to the other (i.e., portions of the insert adjacent the legs, the supports and the traversing member are made of a same thickness) (See, <FIG>). Instead, rigidity of insert <NUM> is varied by changing its width. Specifically, as shown in the top view of <FIG>, insert <NUM> has varying widths adjacent the legs, and steadily increases in width toward a midline of the insert, reaching a maximum width "WMAX" at the traversing member. Thus, even though the insert has a constant thickness (<FIG>), it also may have a greatest rigidity at the traversing member and a decreasing rigidity along its length as it approaches the legs. Shell <NUM> may also have varying widths to properly house the insert therein, the shell's width being tailored to match that of the insert.

Any of the suture bridges described above may be provided as part of a kit <NUM> as shown in <FIG>. Kit <NUM> include any of the suture bridges described herein, such as suture bridge <NUM> having an insert and a shell (the insert not shown in <FIG>), a retainer member <NUM> in the form of a washer, a surgical needle <NUM>, and a strand of suture <NUM> coupled to the needle. In at least some examples, a hybrid suture <NUM> having flat portions <NUM> that transition to round portions <NUM> may be provided instead of a traditional suture <NUM>. Hybrid sutures such as these are available through TELEFLEX MEDICAL (TM) under the mark FORCE FIBER FUSION (TM). In at least some examples, the flat portions of such as suture will be disposed adjacent the skin, and aligning parallel to the incision margins while the round portions will be disposed adjacent the traversing member.

A number of suture patterns may be used in connection with the kit of <FIG> such as, for example, a simple interrupted suture pattern. <FIG> shows one possible suture pattern SP16 for use with the kit. As shown, a suture retainer member <NUM> is placed on top of suture bridge <NUM>. Suture pattern SP16 passes through the slots of the suture bridge and are threaded through an aperture <NUM> of the retainer (e.g., washer). In this embodiment, retainer <NUM> serves to keep the suture tails together and in place above the suture bridge so that a clamp <NUM> (<FIG>) can be used to easily grasp the suture tails.

<FIG> are schematic perspective views of a suture bridge <NUM> similar to that described above but having an integrated retainer member <NUM>. For the sake of clarity, the insert is not shown in this figure. Suture bridge <NUM> may include a retainer member <NUM> in the form of a substantially rectangular flap attached to the traversing member at one edge via a living hinge <NUM>. Living hinge <NUM> may include a scored or thinned portion that allows the flap to open (<FIG>) and close (<FIG>). Additionally, retainer member <NUM> may include an eyelet <NUM> as shown. By having an integrated retainer member <NUM>, a separate washer may be eliminated from the kit. As shown in <FIG>, a simple suture pattern SP17 is shown in connection with the bridge <NUM>. The tails of the suture may pass through the eyelet <NUM> of retainer member <NUM>. With the integrated retainer in the closed position, the tails of the suture are gathered together and it is easier to grasp both tails of the suture with a clamp <NUM>. Because the method may include several iterations of tightening and releasing the suture tails, the integrated retainer may make it easier to locate and grasp the suture tails quickly.

Two additional suture patterns are shown in <FIG>, the two suture patterns utilizing "pulley" mechanisms. The bridges are disposed directly above a wound (not shown for clarity) substantially perpendicular thereto. In the suture patterns below, a solid line indicates a portion of the pattern that is disposed above the skin and visible to the physician, and dotted line indicates a portion of the suture pattern that is below the skin's surface. As shown in <FIG>, a first cis-pulley suture pattern SP18A includes a suture pattern that forms two substantially vertical sections (i.e., aligned with the longitudinal axis of the bridge), one between the two slots, and the other coupling the two suture tails T1, T2, and an X-shaped arrangement under the patient's skin. Alternatively, a trans-pulley suture pattern SP18B may be used, which includes a vertical section formed between the two slots and a diagonal formed from the coupling of the two suture tails.

<FIG> shows another bird's eye view of a suture bridge 1800C having two central eyelets and a simple pattern SP18C that utilizes the two central eyelets. In this example, the two tails T1, T2 of pattern SP18C extend out of the central eyelets and are coupled together. Note that a similar cross-sectional view of this configuration is also shown in <FIG>.

<FIG> are schematic cross-sectional views showing some possible suture patterns that utilize one or more central eyelets. In <FIG>, a single central eyelet <NUM> is shown, and two possible patterns SP18D,SP18E are shown that utilize the central eyelet <NUM>. Variations of the suture patterns may also be possible which utilize both the central eyelet <NUM> and the slots (not shown). In <FIG>, two central eyelets 1822a,1822b are formed in the traversing member and spaced apart from one another, and two possible patterns SP18F,SP18G are shown that utilize the eyelets. Variations of the suture patterns may also be possible which utilize two of the central eyelets and the slots (not shown).

Finally, in at least some examples, a combined clamp-washer may be used as shown in <FIG>. Clamp <NUM> may generally include the traditional elements of a pair of ring handles <NUM> a ratchet <NUM>, a shank <NUM>, a pivot <NUM> and jaw tips <NUM>. As shown, a retainer <NUM> is unitarily formed with one of the jaw tips. Retainer <NUM> may be formed of the same material (e.g., stainless steel) or a different material (e.g., a polymer) as the jaws, and may be coupled thereto or unitarily formed. This integrated configuration of clamp <NUM> may allow for easier capture and manipulation of a suture SP19. As shown in the detailed view, the retainer <NUM> is disposed slightly below the jaw tips <NUM> such that a suture passing through the central opening in the retainer may be grasped between the two jaw tips of the clamp.

Claim 1:
A suture bridge (<NUM>), comprising:
an elongated rigid insert (<NUM>) including a first material; and
a deformable shell (<NUM>) including a second material, the second material being differentthan the first material, the insert (<NUM>) and the shell (<NUM>) collectively forming a bridge body having a first leg (<NUM>) including a first patient contacting surface configured to contact a patient's skin, a second leg (<NUM>) spaced from the first leg (<NUM>) and including a second patient contacting surface configured to contact the patient's skin, a first support (<NUM>) connected to the first leg (<NUM>), a second support (<NUM>) connected to the second leg (<NUM>), a first slot at least partially formed through a portion of the first leg (<NUM>), and a portion of the first support (<NUM>), a second slot at least partially formed through a portion of the second leg (<NUM>), and a portion of the second support (<NUM>), and a traversing member (<NUM>) extending between the first support (<NUM>) and the second support (<NUM>) wherein the shell partially surrounds the rigid insert, the shell (<NUM>) covers the surface of the rigid insert (<NUM>) on a patient contacting surface side.