Patent Description:
Surgical drains are often used to treat deep post-operative wounds. Surgical drains are tubes commonly placed by surgeons to remove blood, pus, and infected fluids from a wound bed and to prevent the accumulation of air, or formation of dead space. If allowed to accumulate, the fluids or air can put pressure on the surgical site and adjacent areas, causing pain. There are several types of surgical drains including open or closed, and suction or passive drains. Closed-suction drains are maintained under low or high pressure to create a suction and drain into a bag or bottle.

The general surgical drain protocol involves inserting a drain into the wound and attaching the external end to a suction source. The negative pressure from the suction source removes exudates from the cavity. The wound can be closed around the drain. Surgical drains may fail to suction over the entire wound area and when removed, often still leave a relatively large dead space.

Negative-pressure wound therapy (NPWT) is used to promote healing in acute or chronic wounds. A sealed wound dressing fills the wound, attaching to a vacuum pump to apply reduced pressure, such as sub-atmospheric pressure. The vacuum acts as a suction device, removing fluid from the wound and drawing the edges of the wound inward. Additionally, sub-atmospheric pressure assists in wound closure by promoting blood flow to the area and stimulating granulation tissue formation. NPWT systems can also provide irrigation or antibiotics to the wound.

The general NPWT protocol involves placing the wound dressing in the wound and placing a flexible cover layer over the wound to create a seal, or vacuum reservoir, where the reduced pressure can be applied. The NPWT tubing can then be attached to the wound dressing at the skin level with an adhesive transfer pad.

NPWT systems can also be used for deep post-operative wound closure. The wound dressing is packed into the deep wound and is attached to a suction drainage system that can provide irrigation and remove exudates through the negative pressure system. The wound can be closed temporarily but a removal surgery is necessary to remove the dressing from the wound, leaving a relatively large dead space.

Therefore, there is a need for improved surgical site wound management devices, systems and methods that overcome some of the challenges associated with commercially available technology. The present disclosure describes improvements over existing technologies to allow for more complete post-operative surgical site wound management.

<CIT> describes a system and method for a vacuum wound device. The system includes a wound vacuum device. The vacuum device includes a compressible sponge, vacuum tubing, and a delivery tube sized to house the wound vacuum device. The wound vacuum device is connected to a vacuum pump which creates and delivers the vacuum.

<CIT> relates to a vacuum sponge unit for use in human or animal bodies, comprising a fluid collecting member, in particular a sponge unit, and a fluid communication member, in particular a drainage tube, which is disposed at least partially in the fluid collecting member and is connected in fluidic communication to the fluid collecting member. The fluid collecting member has a channel for guiding a guide member, in particular a guide wire, and/or a delivery member, in particular a probe unit and/or an endoscope, through the fluid collecting member.

<CIT> relates to a surgical suction device that provides a controlled negative pressure to a surgical site. The device includes a tubular body with a distal absorbent material and a handle manually grasped by the user to control levels of negative pressure at the surgical site to adjust the flow rate of fluid during removal.

The present disclosure generally relates to medical devices, systems and methods and more particularly relates to post-operative wound closure devices, systems and treatment methods.

A combination of closed-suction drains and a NPWT system for deep post-operative wound closure can be beneficial. It may be desirable to have a system that includes drains to reach deep into surgical wounds with NPWT dressings at the wound surface. It may be beneficial if the drain could provide suction. It may be beneficial for the NPWT dressing to help close the wound. It may be beneficial for the wound to be closed around the drain. It may be desirable for devices, systems, and methods to eliminate the problem of the drain leaving a relatively large space between tissues that are normally anatomically connected (e.g. dead space). It may be desirable for devices, systems, and methods to eliminate the problem of the drain failing to provide a large surface area over which suction and/or irrigation can occur. Such a device may be beneficial for infection cases, spine surgeries, orthopedic fracture surgeries, plastic surgeries, or any other surgeries.

It may be desirable to provide deep-wound suction over a greater area. It may be desirable to provide complete wound irrigation at a local level. It may be desirable to deliver high-concentrations of local antibiotics to deep wounds. It may be desirable to promote wound closure with negative pressure. It may be desirable to treat post-operative wounds through a NPWT system without having to re-open the wound for component removal.

Any embodiment of the device comprises an elongate shaft. Any embodiment of the device comprises a wound dressing. Any embodiment of the device comprises a removal element. The elongate shaft is preferably hollow, such as a tube, cannula, or catheter. The elongate shaft may have an external end disposed outside the patient and an internal end disposed in the patient's wound. The wound dressing may be an open pore, reticulated, hydrophobic foam sponge or may take any other form known in the art. The removal element may be a braid, cage, radially expandable member, or take any other form. The removal element may have any number of patterns but in preferred embodiments may be a helical braid with a distal end that is disposed in the wound and a trailing end that extends proximally outward toward a location external of the patient, away from the wound. The removal element may be collapsible. The distal end of the removal element may be of diameter or width greater than the elongate hollow tube in its expanded state. The distal end of the removal element may be of a diameter or width less than the lumen of the elongate hollow tube in its collapsed state. The distal end of the removal element may be a bulbous shape, cylindrical shape, or any other shape. The distal end of the removal element may conform to the contour of the wound dressing. The wound dressing may expand until constrained by the shape of the removal element. The internal end of the elongate shaft may abut the wound dressing. The removal element components may join to make up the trailing end. The trailing end of the removal element may span the length of the lumen of the elongate shaft, through the external end disposed outside the patient. The external end of the elongate shaft may connect to a suction and/or irrigation system with a fitting. The suction and/or irrigation system may be a NPWT system. The fitting may be a Luer lock or a custom fitting.

Optionally in any embodiment, the elongate shaft may have a y-split near the external end disposed outside the patient's wound, with two external arms. The first external arm end may connect to a suction and/or irrigation system with a fitting. The suction and/or irrigation system may be a NPWT system. The fitting may be a Luer lock or a custom fitting. A stopper of cylindrical shape may have a tight fit with the lumen of the elongate shaft. The stopper may have O-rings sized to maintain the negative-pressure seal in the elongate shaft. The stopper may reside in the second external arm of the elongate shaft. The removal element trailing end may extend past the second external arm end disposed outside the patient. The stopper may capture the trailing end of the removal element. The removal element may be captured by molding processes, mechanical mechanisms, bonding, or any other processes. The removal element may be pulled axially, causing the stopper to move accordingly.

Optionally in any embodiment, the elongate shaft may have a y-split near the external end disposed outside the patient's wound, with two external arms. One external arm end may connect to a suction and/or irrigation system with a fitting. The suction and/or irrigation system may be a NPWT system. The fitting may be a Luer lock or a custom fitting. An externally threaded cylindrical fitting may be bonded to the second external arm end. A cylindrical cap may have internal threads that mate with those of the fitting. The cap and the fitting threads may mate to maintain the negative-pressure seal in the elongate shaft. The removal element trailing end may extend into the second external arm of the elongate shaft, connecting to the threaded cap. The trailing end may connect to the threaded cap by molding processes, mechanical mechanisms, bonding, or any other processes. The cap may be unthreaded from the fitting, such that the removal element is pulled axially.

Optionally in any embodiment, the elongate shaft may have a y-split near the external end disposed outside the patient's wound, with two external arms. One external arm end may connect to a suction and/or irrigation system with a fitting. The suction and/or irrigation system may be a NPWT system. The fitting may be a Luer lock or a custom fitting. The outer diameter of the second external arm end may have cylindrical ratchets. The ratchets may be molded onto the elongate shaft or may be a fitting bonded onto the elongate shaft. A cylindrical cap may have a sliding fit with the ratcheted fitting. The cap may have an actuation mechanism that interfaces with the fitting ratchets. The actuation mechanism may be pushed to release the ratcheting to allow for axial movement. The cap and the fitting may maintain the negative-pressure seal in the elongate shaft. The cap may be moved axially along the fitting, such that the removal element is pulled axially.

Optionally in any embodiment, the elongate shaft may be multi-lumen. The elongate shaft may have one lumen that extends distally into the wound dressing. The extended lumen may have a closed tip or an open tip. The extended lumen may have a plurality of holes. The holes may be patterned axially and/or radially along the lumen. The holes may allow for removal of suctioned exudate along the length of the dressing. The holes may allow for distribution of irrigating fluids along the length of the dressing.

Optionally in any embodiment, the elongate shaft may be multi-lumen to provide separate pathways for suction and irrigation.

Optionally in any embodiment, there may be multiple elongate shafts that are connected along their length to provide separate pathways for irrigation and suction.

In some embodiments, there may be a series of wound dressings. The wound dressings may be captured in the removal element in order to fill a larger wound space.

Preferably the device may insert the wound dressing into the wound space of a clean wound for treatment. The elongate shaft may span from the wound bed to a suction and/or irrigation system disposed external of the patient. The wound may be closed around the elongate shaft. The device may be used with the external system to provide irrigation. The device may be used with the external system to suction exudates. The device may be used with the external system to instill antibiotics.

Preferably this device may remove the wound dressing after treatment through a closed-wound, without the need for a removal surgery. A removal mechanism may be used for device collapse and retraction. The trailing end of the removal element may be pulled axially, causing the distal end of the removal element to lengthen and narrow. The narrowed removal element may collapse the wound dressing. The trailing end of the removal element may continue to be pulled axially to retract the wound dressing into the elongate shaft. The device may be removed through a closed wound.

Optionally in any embodiment, the method for removal may include incremental collapse of the wound dressing with continued therapy.

Additional aspects of the invention will be apparent from the claims herein.

Specific embodiments of the disclosed device, system and method of use will now be described with reference to the drawings. Nothing in this detailed description is intended to imply that any particular component, feature, or step is essential to the claimed invention.

<FIG> are a preferred embodiments of a device that may be used for post-operative wound treatment with an elongate shaft <NUM>, wound dressing <NUM>, and removal element <NUM>. <FIG> each illustrate an embodiment with optional features, any of which may be used or substituted with other features in other embodiments discussed herein. In particular, <FIG> shows a side view of an exemplary embodiment of a device for post-operative wound treatment having a removal element that encompasses a sponge, in accordance with some embodiments. Additionally, <FIG> shows a side view of an exemplary embodiment of a device for post-operative wound treatment having a removal element that is woven through a sponge, in accordance with some embodiments. Further, <FIG> shows a side view of an exemplary embodiment of a device for post-operative wound treatment having radiopaque markers <NUM> on components of the device, in accordance with some embodiments.

As seen in <FIG>, the elongate shaft <NUM> may have an internal end <NUM> that is disposed in the patient's wound and an external end <NUM> that is disposed outside the patient. The elongate shaft <NUM> may be a tube, cannula, catheter, or other hollow structure preferably having a lumen extending the length thereof and that is sized to receive the wound dressing <NUM> and removal element <NUM> in a compressed configuration. As seen in <FIG> and <FIG>, removal element <NUM> may be wrapped around wound dressing <NUM>. As seen in <FIG>, removal element <NUM> may be woven through wound dressing <NUM>. In some embodiments, wound dressing <NUM> may comprises a sponge. Further, as seen in <FIG>, elongate shaft <NUM>, wound dressing <NUM>, and removal element <NUM> may each comprise radiopaque markers.

The elongate shaft <NUM> may have a flared <NUM> internal end <NUM> to allow dressing guidance to be slidably advanced into the lumen during removal by proximal retraction of the removal element <NUM>. The elongate shaft <NUM> may have a single lumen. Optionally, in any embodiment, the elongate shaft <NUM> may have multiple lumens in order to provide fluid suction and/or irrigation. For example, the elongate shaft <NUM> may have three lumens (one lumen for suction, one lumen for irrigation, and one lumen for device retraction) or the elongate shaft <NUM> may have three or more lumens (one or more lumens for suction, one or more lumens for irrigation, and one lumen for device retraction). The elongate shaft <NUM> preferably has a circular cross-section. Optionally, in any embodiment, the elongate shaft <NUM> may have various cross-sectional shapes known to those skilled in the art, such as an ovular cross-section or a rectangular cross-section. The elongate shaft <NUM> is preferably formed from a sterile flexible polymer. Any suitable material may be used including elastomeric or polymeric materials including, but not limited to, silicone or medical-grade polyvinyl chloride (PVC). The elongate shaft <NUM> is preferably formed from a uniform material. Optionally, in any embodiment, the elongate shaft <NUM> may have sections of varying durometer in order to control stiffness, flexibility or other mechanical properties of the elongate shaft <NUM>. Optionally, in any embodiment, the elongate shaft <NUM> may be formed from multiple materials to provide desirable mechanical properties to the elongate shaft.

The wound dressing <NUM> is preferably a sterile, open cell reticulated, hydrophobic, polyurethane foam. The wound dressing <NUM> preferably has pore sizes of approximately <NUM> to <NUM> microns. Optionally, in any embodiment, the dressing <NUM> may have silver or antimicrobial agents added thereto. Optionally, in any embodiment, the dressing <NUM> may be non-open cell reticulated foam. Optionally, in any embodiment, the dressing <NUM> may be polyvinyl alcohol foam or any other material. Optionally, in any embodiment, the dressing <NUM> may have pore sizes of approximately <NUM> to <NUM> microns. Optionally, in any embodiment, the dressing <NUM> may have pore sizes that vary along the length of the dressing <NUM>. Optionally, in any embodiment, the dressing <NUM> may have pore sizes that vary along the circumference of the dressing <NUM>. Optionally, in any embodiment, the dressing <NUM> may have pore sizes that vary along any other direction. Optionally, in any embodiment, the dressing <NUM> may have multiple stacked layers with different materials to change the suction and dispersion properties of the dressing <NUM>. For example, the dressing <NUM> may have a silver-coated polyurethane layer, a polyvinyl alcohol foam layer, and a waterproof adhesive layer. The stacked layers may be the same thickness or have varying thicknesses. The dressing <NUM> sizes may have surface areas up to <NUM>-<NUM><NUM>. The dressing <NUM> may be cylindrically shaped. Optionally, in any embodiment, the dressing <NUM> may be rectangular or another shape. The dressing <NUM> may have a long side (i.e. long length) and two short sides (i.e. small width and height). The dressing <NUM> may be collapsed with a narrowing of the width and height. Optionally, in any embodiment, the dressing <NUM> may be flexible so that it may be manipulated. The dressing <NUM> may be fabricated to allow equal distribution of negative pressure across the wound. The dressing <NUM> materials and configurations will be apparent to those skilled in the art and may vary depending on factors including patient's anatomy, exudate quantity, and/or state of the wound.

The removal element <NUM> may be a type of helical braid woven such that as the braid lengthens, it narrows. The removal element <NUM> may have a distal end <NUM> that is configured to be disposed in the wound and a trailing end <NUM> that extends proximally from the wound toward an external surface of the patient. The removal element <NUM> may be collapsible. The distal end <NUM> may be of diameter or width greater than the lumen of the elongate shaft <NUM> in its expanded state. The distal end <NUM> may be of diameter or width less than the lumen of the elongate shaft <NUM> in its collapsed state. Optionally, in any embodiment, the distal end <NUM> may conform to the wound dressing <NUM> contour. Optionally, in any embodiment, the distal end <NUM> may be bulbous, cylindrical, rectangular, or any other shape. The components of the removal element <NUM> may come together on one end of the distal end <NUM> to create a trailing end <NUM> which forms a tether that may be retracted proximally by a physician or other operator when removal is desired. The components may come together in a knot, be bonded together, or any other known processes of joining. The trailing end <NUM> may be a tight braid or bonded components that extend from distal end <NUM>. Optionally, in any embodiment, the trailing end <NUM> may be a continuation of the distal end <NUM> helical braid.

The removal element <NUM> preferably encompasses the dressing <NUM> with a tight fit such that the dressing is entrapped by the removal element. Optionally, in any embodiment, the removal element <NUM> may be woven into the periphery of the dressing <NUM>. Optionally, in any embodiment, the removal element <NUM> may be woven through the center of the dressing <NUM>. Optionally, in any embodiment, the removal element <NUM> may be woven around the dressing <NUM>, woven into the periphery of the dressing, and/or woven through the center of the dressing <NUM>, or any combination thereof. The long-side of the dressing <NUM> may be aligned or substantially parallel with the removal element <NUM> longitudinal axis. The trailing end <NUM> of the removal element <NUM> may span the length of the elongate shaft <NUM> from the internal end <NUM>, through the external end <NUM> with an additional length extending therepast that may be grasped by an operator or coupled to an actuation mechanism for retraction. The trailing end <NUM> may be pulled taut so that the removal element <NUM> captures the dressing <NUM> and also so that the internal end <NUM> of the elongate shaft <NUM> abuts the wound dressing <NUM>. Optionally, in any embodiment, the elongate shaft <NUM> may be connected to the wound dressing <NUM> with adhesive or other method of bonding.

<FIG> are preferred embodiments of the elongate shaft <NUM>, as depicted in <FIG> and may be used in this or any other embodiment of the device. In particular, <FIG> shows a side view of an exemplary embodiment of the internal end of the elongate shaft, the internal end having a flare in accordance with some embodiments. Additionally, <FIG> shows a side view of an exemplary embodiment of the internal end of the elongate shaft, the internal end having an external chamfer <NUM> in accordance with some embodiments. Further, <FIG> shows a side view of an exemplary embodiment of the internal end of the elongate shaft, the internal end having no flare in accordance with some embodiments.

The elongate shaft <NUM> preferably has a length of <NUM> to <NUM>. More preferably, the elongate shaft <NUM> has a length of <NUM> to <NUM>. The elongate shaft <NUM> preferably has an inner diameter of <NUM> to <NUM>. More preferably, the elongate shaft <NUM> has an inner diameter of <NUM> to <NUM>. The elongate shaft <NUM> preferably has an outer diameter of <NUM> to <NUM>. More preferably, the elongate shaft <NUM> has an outer diameter of <NUM> to <NUM>. The elongate shaft <NUM> may have a flared <NUM> internal end <NUM> to allow dressing guidance into the lumen during removal by proximal retraction of the dressing into the lumen of the elongate shaft <NUM>. The flared diameter <NUM> is preferably <NUM> to <NUM>. More preferably, the flared diameter <NUM> is <NUM> to <NUM>. Optionally, in any embodiment and as illustrated in <FIG>, the flared <NUM> internal end <NUM> may be flexible so that it easily collapses as it is pulled through the wound during removal. Optionally, in any embodiment, the internal end <NUM> may be the same diameter as the rest of the elongate shaft <NUM>. Optionally, in any embodiment and as illustrated in <FIG>, end <NUM> may have an external chamfer. Optionally, in any embodiment and as illustrate din <FIG>, end <NUM> may have no flare.

<FIG> is a preferred embodiment of the removal element <NUM>, as depicted in <FIG> and may be used in this or any other embodiment of the device. The removal element <NUM> may be a type of helical braid woven such that as the braid lengthens, it narrows due to the reduced angle <NUM> between the warp <NUM> and weft <NUM> components at their crossing points. The removal element <NUM> may be composed of any type of fiber, wire, or tube. Optionally, in any embodiment, the removal element <NUM> may be a cage, expandable member, or take any other form. The removal element <NUM> is preferably a biaxial braid. <FIG> shows a flat-version of a biaxial braid, as a preferred embodiment of the removal element shown in <FIG>. The removal element <NUM> may be composed of a plurality of intertwining components. The removal element <NUM> preferably is composed of between <NUM> and <NUM> intertwining components. More preferably, the removal element <NUM> is composed of <NUM> to <NUM> intertwining components. The fibers may be hollow. The removal element <NUM> may be woven in any pattern. The removal element <NUM> is preferably woven with pairs of warp <NUM> and weft <NUM> components that alternatively pass over and under each other, with one pair spiraling clockwise and the other pair spiraling counter-clockwise. The removal element <NUM> preferably has a <NUM> to <NUM>-degree angle <NUM> between the warp <NUM> and weft <NUM> components. More preferably, the angle <NUM> between the warp <NUM> and weft <NUM> components is <NUM> to <NUM>-degrees. The intertwining components are preferably flat with widths of <NUM> to <NUM>. More preferably, the intertwining components have widths of <NUM> to <NUM>. Optionally, in any embodiment, the removal element <NUM> may be multi-directional or unidirectional braids. Optionally, in any embodiment, the removal element <NUM> may have lower angle <NUM> orientations to change the expansion and compression properties of the removal element. Optionally, in any embodiment, the removal element <NUM> may have higher angle <NUM> orientations to change the expansion and compression properties of the removal element. The removal element <NUM> may be self-expanding. The removal element <NUM> may be sterile polypropylene fiber or any suitable fiber. The removal element <NUM> may be a flexible wire. The removal element <NUM> may have a trailing end <NUM> at one end that is of smaller diameter or width than the elongate shaft <NUM> (shown in <FIG>). The distal end <NUM> may be woven to conform to the wound dressing <NUM> contour. The distal end <NUM> may have a bulbous shape that is slightly larger than the corresponding wound dressing <NUM>. The distal end <NUM> may have a cylindrical shape or any other shape. The distal end <NUM> may be larger in diameter or width than the lumen of the elongate shaft <NUM> (shown in <FIG>) in its expanded shape. The distal end <NUM> may be collapsible to a diameter or width smaller than the lumen of the elongate shaft <NUM> (shown in <FIG>). The intertwining components of the removal element <NUM> may come together on a proximal portion of the distal end <NUM> to create a trailing end <NUM> that acts as a tether so the removal element may be pulled proximally. The intertwining components may come together in a knot, be bonded together, or any other known processes of joining, or they may be twisted or braided together to form a single tether. The trailing end <NUM> may be a tight braid or bonded components that extend proximally from the distal end <NUM>. The trailing end <NUM> may have a circular cross-section. Optionally, in any embodiment, the trailing end <NUM> may have a rectangular cross-section forming a flat ribbon or any other shape. The trailing end <NUM> preferably has a diameter or maximum width of <NUM> to <NUM>. More preferably, the diameter or maximum width is <NUM> to <NUM>. The removal element <NUM> may be woven so that as the trailing end <NUM> is pulled axially, the circumference of the distal end <NUM> narrows and the distal end <NUM> collapses to engage and capture the dressing <NUM> (not pictured) so that as the removal element is retracted proximally it will also carry the dressing <NUM> with it in the proximal direction.

<FIG> and <FIG> and <FIG> each illustrate a preferred embodiment of a device that may be used for post-operative wound treatment with elongate shaft <NUM>, wound dressing <NUM>, removal element <NUM>, external fitting <NUM>, and stopper <NUM>. <FIG> shows a side view of the embodiment and <FIG> shows a cross-section view of the embodiment. Additionally, <FIG> shows a side view of the embodiment having a y-fitting <NUM>. <FIG> and <FIG> and <FIG> each illustrate an embodiment with optional features, any of which may be used or substituted with other features in other embodiments discussed herein.

The elongate shaft <NUM> may have an internal end <NUM> that is disposed in the wound in the patient and a y-split <NUM> diverging into two external arms <NUM>, <NUM> with two external ends <NUM>, <NUM> preferably disposed outside of the wound and externally to the patient. Optionally, in any embodiment, the y-split <NUM> may be a t-split or any other divergence of one member into two. For example, the first external arm <NUM> may extend in a direction substantially parallel with the internal tubing axis and the second external arm <NUM> may diverge at a <NUM> to <NUM>-degree angle. More preferably, the second external arm <NUM> diverges at a <NUM> to <NUM>-degree angle. The elongate shaft <NUM> is preferably formed from a sterile flexible polymer. Any suitable material may be used including elastomeric or polymeric materials including, but not limited to, silicone or medical-grade polyvinyl chloride (PVC). The elongate shaft <NUM> preferably has an approximate length of <NUM> to <NUM> (from internal end to each external end). More preferably, the elongate shaft <NUM> has a length of <NUM> to <NUM>. Optionally, in any embodiment, the elongate shaft <NUM> may have any length to accommodate varying patient anatomy and use. The elongate shaft <NUM> preferably has an inner diameter of <NUM> to <NUM>. More preferably, the elongate shaft <NUM> has an inner diameter of <NUM> to <NUM>. The elongate shaft <NUM> preferably has an outer diameter of <NUM> to <NUM>. More preferably, the elongate shaft <NUM> has an outer diameter of <NUM> to <NUM>. The y-split <NUM> may allow the trailing end <NUM> of the removal element <NUM> to exit the external end <NUM> of the tubing without interfering with the connection to the external device for suction and irrigation.

The wound dressing <NUM> and removal element <NUM> may be the same as those described in <FIG>.

The fitting <NUM> may be any medical tubing standard fitting known in the art such as a cylindrical shape. The fitting <NUM> may be configured to mate with commercial suction and/or irrigation device tubing. The fitting <NUM> outer diameter may be stepped. The fitting <NUM> preferably has a first outer diameter <NUM> of approximately <NUM> to <NUM>. More preferably, the fitting <NUM> has a first outer diameter <NUM> of <NUM> to <NUM>. The outer diameter <NUM> may have surface features such as ridges <NUM> around the circumference to help an operator grasp the fitting. The ridges <NUM> may have a square shape. Optionally, in any embodiment, the ridges <NUM> may be any shape. The ridges <NUM> preferably have widths of approximately <NUM> to <NUM>. More preferably, the ridges <NUM> have widths of <NUM> to <NUM>. The fitting <NUM> preferably has a second outer diameter <NUM> of approximately <NUM> to <NUM>. More preferably, the fitting <NUM> has a second outer diameter <NUM> of <NUM> to <NUM>. The second outer diameter <NUM> may have a locking pin <NUM> so that an external device female fitting can slide into the fitting <NUM> with the locking pin <NUM> entering a channel on the external fitting such that as the fitting is rotated, the locking pin <NUM> locks to the fitting. Optionally, in any embodiment, the outer diameter <NUM> may have any locking feature such as a threaded region as used in a Luer lock. The fitting <NUM> preferably has an inner diameter of <NUM> to <NUM>. More preferably, the fitting <NUM> has an inner diameter of <NUM> to <NUM>. The fitting <NUM> is preferably sterile acrylonitrile butadiene styrene (ABS) or another suitable polymer. Optionally, in any embodiment, the fitting <NUM> may be any suitable metal, ceramic, or other material.

A stopper <NUM> is preferably disposed in the opposite arm <NUM> of the y-split <NUM>. The stopper <NUM> may be of cylindrical shape or any other shape. The stopper <NUM> preferably has a diameter of approximately <NUM> to <NUM>. More preferably, the stopper <NUM> has a diameter of <NUM> to <NUM>. The stopper <NUM> preferably has a length of <NUM> to <NUM>. More preferably, the stopper <NUM> has a length of <NUM> to <NUM>. The stopper <NUM> body is preferably sterile acrylonitrile butadiene styrene (ABS) or a comparable suitable polymer. Optionally, in any embodiment, the stopper <NUM> body may be any suitable metal, ceramic or other material. The stopper <NUM> preferably has multiple circumferential grooves <NUM> disposed therearound and sized to fit an external O-ring <NUM> in each. The circumferential grooves <NUM> may have rectangular cross-sections. Optionally, in any embodiment, the circumferential grooves <NUM> may be semi-circles or any shape. Optionally, in any embodiment, the stopper <NUM> may have other mechanical features to capture an O-ring <NUM>. Optionally, in any embodiment, the O-rings <NUM> may be bonded to the stopper <NUM>. The O-rings <NUM> preferably have outer diameters of approximately <NUM> to <NUM>. More preferably, the O-rings <NUM> have outer diameters of <NUM>. <NUM> to <NUM>. The O-rings <NUM> preferably have circular cross-sections. Optionally, in any embodiment, the O-rings <NUM> may have any shape cross-section. The O-rings <NUM> may have a press fit with the inner lumen of the arm <NUM> of the elongate shaft <NUM> to provide a seal. The O-rings <NUM> are preferably sterile rubber. Optionally, in any embodiment, the O-rings <NUM> may be any suitable elastomer.

The removal element <NUM> preferably encompasses the dressing <NUM> with a tight fit such that the dressing is entrapped by the removal element. The long-side of the dressing <NUM> may be aligned or substantially parallel with the removal element <NUM> longitudinal axis. The first external end <NUM> has a fitting <NUM> to connect to a suction and/or irrigation device canister tubing. The fitting <NUM> may be bonded to the external end <NUM> of the elongate shaft <NUM> using an adhesive. Optionally, in any embodiment, the fitting <NUM> may be connected to the external end <NUM> of the elongate shaft <NUM> by any bonding method including but not limited to mechanical bonding, chemical bonding, adhesives, ultrasound welding, solvent bonding, etc. The trailing end <NUM> of the removal element <NUM> spans the length of the lumen of the elongate shaft <NUM> from the internal end <NUM>, through the second external arm <NUM>, exiting through the second external end <NUM>, disposed external to the patient. The trailing end <NUM> is pulled taut so that the removal element <NUM> captures the dressing <NUM> and also so that the internal end <NUM> of the elongate shaft <NUM> abuts the wound dressing <NUM>. Optionally, in any embodiment, the elongate shaft <NUM> may be connected to the wound dressing <NUM> with adhesive or other method of bonding. A stopper <NUM> captures the trailing end <NUM> of the removal element <NUM> in the second external arm <NUM> of the elongate shaft <NUM> such that as the trailing end <NUM> is pulled axially, the stopper <NUM> also moves axially, allowing for removal element <NUM> collapse and subsequent collapse of the dressing <NUM> for device removal. The trailing end <NUM> may be captured by the stopper <NUM> during a molding process. Optionally, in any embodiment, the trailing end <NUM> may be captured by the stopper <NUM> by mechanical mechanisms or bonding. The stopper <NUM> may maintain the seal within the elongate shaft <NUM> through a press fit between the O-rings <NUM> and the inner lumen of the elongate shaft <NUM>.

<FIG> is a cross-section view of the stopper <NUM> as described in <FIG> and <FIG> with multiple circumferential grooves <NUM> and multiple O-rings <NUM> to provide a press fit with the second external arm <NUM> of the elongate shaft <NUM>.

<FIG> and <FIG> each illustrate a preferred embodiment of a device that may be used for post-operative wound treatment with elongate shaft <NUM>, wound dressing <NUM>, removal element <NUM>, external fitting <NUM>, threaded fitting <NUM>, and threaded cap <NUM>. <FIG> shows a side-view of the embodiment and <FIG> shows a cross-sectioned view of the embodiment. <FIG> and <FIG> each show the elongate shaft <NUM> with y-split <NUM> and external fitting <NUM> on one external arm <NUM> as described in <FIG> and <FIG> and the wound dressing <NUM> and removal element <NUM> as described in <FIG>. <FIG> and <FIG> each illustrate an embodiment with optional features, any of which may be used or substituted with other features in other embodiments discussed herein.

The externally threaded fitting <NUM> is preferably of cylindrical shape. The fitting <NUM> preferably has an inner diameter of approximately <NUM> to <NUM>. More preferably, the fitting <NUM> has an inner diameter of <NUM> to <NUM>. The fitting <NUM> preferably has an external diameter of <NUM> to <NUM>. More preferably, the fitting <NUM> has an external diameter of <NUM> to <NUM>. The internally threaded cap <NUM> is preferably of cylindrical shape. Optionally, in any embodiment, the cap <NUM> may be any shape. The cap <NUM> preferably has a cylindrical lumen sized to mate with the externally threaded fitting <NUM>. The fitting <NUM> preferably has external threads <NUM> along a portion of the length of the tubular body. Optionally, in any embodiment, the fitting <NUM> may be threaded along its entire length. The cap <NUM> preferably has internal threads <NUM> along a portion of the length of the tubular body. Optionally, in any embodiment, the cap <NUM> may be threaded along its entire length. The fitting <NUM> length is preferably <NUM> to <NUM>. More preferably, the fitting <NUM> length is <NUM> to <NUM>. The cap <NUM> length is preferably <NUM> to <NUM>. More preferably, the cap <NUM> length is <NUM> to <NUM>. The trailing end <NUM> of the removal element <NUM> may be attached to the inner end <NUM> of the cap <NUM> by being molded into it. Optionally, in any embodiment, the trailing end <NUM> may be attached to the cap <NUM> by any mechanical mechanism or bonding. The fitting <NUM> is preferably acrylonitrile butadiene styrene (ABS). Optionally, in any embodiment, the fitting <NUM> is any suitable polymer. The cap <NUM> is preferably acrylonitrile butadiene styrene (ABS). Optionally, in any embodiment, the cap <NUM> is any suitable polymer.

The removal element <NUM> preferably encompasses the dressing <NUM> with a tight fit such that the dressing is entrapped by the removal element. The long-side of the dressing <NUM> may be aligned or substantially parallel with the removal element <NUM> longitudinal axis. The first external end <NUM> may have a fitting <NUM> to connect to suction and/or irrigation device canister tubing. The fitting <NUM> may be bonded to the external end <NUM> of the elongate shaft <NUM> using adhesive. Optionally, in any embodiment, the fitting <NUM> may be connected to the external end <NUM> of the elongate shaft <NUM> by any bonding method. The second external end <NUM> may have an externally threaded fitting <NUM>. The fitting <NUM> may be bonded to the second external end <NUM> using adhesive. Optionally, in any embodiment, the fitting <NUM> may be bonded to the second external end <NUM> by any bonding method. The trailing end <NUM> of the removal element <NUM> may span the length of the lumen of the elongate shaft <NUM> from the internal end <NUM>, through the second external arm <NUM>, through the second external end <NUM>, to attach to the internally threaded cap <NUM>. As the cap <NUM> is unscrewed from the fitting <NUM>, the trailing end <NUM> of the removal element <NUM> is pulled axially. The trailing end <NUM> may be pulled taut by unthreading the cap <NUM> so that the removal element <NUM> captures the dressing <NUM> and also so that the internal end <NUM> of the elongate shaft <NUM> abuts the wound dressing <NUM>. Optionally, in any embodiment, the elongate shaft <NUM> may be connected to the wound dressing <NUM> with adhesive or other method of bonding. The fitting <NUM> and cap <NUM> may have mating threads <NUM>, <NUM> so that when engaged, a seal is maintained within the elongate shaft <NUM>.

<FIG> is a preferred embodiment of the externally threaded fitting <NUM> and the internally threaded cap <NUM>, as described in <FIG>. The fitting <NUM> attaches to the end <NUM> of one external arm <NUM>. The fitting <NUM> and cap <NUM> may have mating threads <NUM>, <NUM>. The trailing end <NUM> of the removal element (not fully pictured) may attach to the inner end <NUM> of the cap <NUM>. As the cap <NUM> is unscrewed from the fitting <NUM>, the trailing end <NUM> of the removal element is pulled axially thereby pulling the dressing (not pictured) out of the wound into the elongate shaft <NUM>.

<FIG> is a preferred embodiment of a device that may be used for post-operative wound treatment with elongate shaft <NUM>, wound dressing <NUM>, removal element <NUM>, external fitting <NUM>, ratcheted fitting <NUM>, and cap <NUM>. <FIG> shows the elongate shaft <NUM> with y-split <NUM> and external fitting <NUM> on one external arm <NUM> as described in <FIG> and <FIG> and the wound dressing <NUM> and removal element <NUM> as described in <FIG>. <FIG> illustrates an embodiment with optional features, any of which may be used or substituted with other features in other embodiments discussed herein.

The ratcheted fitting <NUM> may be bonded to one external arm <NUM> of the elongate shaft <NUM>. The ratcheted fitting <NUM> is preferably of cylindrical shape. Optionally, in any embodiment, the ratcheted fitting <NUM> may be any shape. The fitting <NUM> may have an inner diameter of approximately <NUM> to <NUM>. The fitting <NUM> preferably has ratchets <NUM> along a portion of the length of the tubular body. Optionally, in any embodiment, the fitting <NUM> may have ratchets (not pictured) along its entire length. The ratchet fitting <NUM> length is preferably <NUM> to <NUM>. More preferably, the fitting <NUM> length is <NUM> to <NUM>. The ratchet cap <NUM> is preferably of cylindrical shape. Optionally, in any embodiment, the ratchet cap <NUM> may be any shape. The cap <NUM> preferably has an inner diameter that provides for a sliding fit with the fitting <NUM>. The cap <NUM> length is preferably <NUM> to <NUM>. More preferably, the cap <NUM> length is <NUM> to <NUM>. The ratchet cap <NUM> preferably has an actuatable arm <NUM> that is rotated about a pin <NUM>. Optionally, in any embodiment, the cap <NUM> may also have an actuation mechanism <NUM> that moves by any mechanism such as a button, a lever, or any other mechanism. The actuation mechanism <NUM> may be an elongate rectangular shape with two ends <NUM>, <NUM> on opposite sides of the pin <NUM>. Optionally, in any embodiment, the actuation mechanism <NUM> may be any shape. The trailing end <NUM> of the removal element <NUM> may be attached to the inner end <NUM> of the cap <NUM> by being molded into it. Optionally, in any embodiment, the trailing end <NUM> may be attached to the cap <NUM> by any mechanical mechanism or bonding. The fitting <NUM> is preferably sterile acrylonitrile butadiene styrene (ABS). Optionally, in any embodiment, the fitting <NUM> may be any suitable polymer. The cap <NUM> is preferably sterile acrylonitrile butadiene styrene (ABS). Optionally, in any embodiment, the cap <NUM> may be any suitable polymer. The cap <NUM> is able to move axially along the fitting <NUM> when the actuation mechanism <NUM> is disengaged, pulling the trailing end <NUM> of the biaxial braid <NUM> axially thereby pulling the dressing <NUM> out of the wound into the elongate shaft <NUM>.

The removal element <NUM> preferably encompasses the dressing <NUM> with a tight fit such that the dressing is entrapped by the removal element. The long-side of the dressing <NUM> may be aligned or substantially parallel with the removal element <NUM> longitudinal axis. The first external end <NUM> may have a fitting <NUM> to connect to suction and/or irrigation device canister tubing. The fitting <NUM> may be bonded to the external arm <NUM> of the elongate shaft <NUM> using adhesive. Optionally, in any embodiment, the fitting <NUM> may be bonded by any bonding method. The second arm <NUM> has a ratcheted fitting <NUM>. The fitting <NUM> may be bonded using adhesive. Optionally, in any embodiment, the fitting <NUM> may be bonded by any bonding method. The trailing end (not pictured) of the removal element <NUM> may span the length of the lumen of the elongate shaft <NUM> from the internal end <NUM>, through the second external arm <NUM>, through the second external end (not pictured) disposed external to the patient, to attach to the ratchet cap <NUM>. The trailing end may be pulled taut so that the removal element <NUM> captures the dressing <NUM> and also so that the removal element <NUM> captures the dressing <NUM> and also so that the internal end <NUM> of the elongate shaft <NUM> abuts the wound dressing <NUM>. Optionally, in any embodiment, the elongate shaft <NUM> may be connected to the wound dressing <NUM> with adhesive or other method of bonding. The cap <NUM> actuation mechanism <NUM> may disengage, enabling the cap <NUM> to move axially, pulling the trailing end of the biaxial braid <NUM> axially thereby pulling the dressing <NUM> out of the wound into the elongate shaft <NUM>.

<FIG> is a preferred embodiment of the ratcheted fitting <NUM> and cap <NUM> from <FIG>. The cap <NUM> may have a cutout <NUM> that the actuation mechanism <NUM> can rotate into, about pin <NUM>. The actuation mechanism <NUM> may have one or more ratchets <NUM> on one end <NUM>. The actuation mechanism <NUM> may have ratchets <NUM> on one end <NUM>. The ratchets <NUM> may be shaped to engage with the fitting ratchets <NUM>. The actuation mechanism <NUM> ratchets <NUM> and fitting ratchets <NUM> may be a triangular shape or form steps. The pitch of the ratchets <NUM>, <NUM> may be adjusted to any desired spacing in order to control coarseness or fineness of adjustment. Optionally, in any embodiment, the actuation mechanism <NUM> ratchets <NUM> and fitting ratchets <NUM> may be any mating shape. The cap <NUM> is able to move axially along the fitting <NUM> when the actuation mechanism <NUM> is disengaged by pushing on one end <NUM>, pulling the trailing end <NUM> of the biaxial braid (not fully pictured) axially thereby pulling the dressing (not pictured) out of the wound into the elongate shaft <NUM>.

Optionally in any embodiment, the external ratchets <NUM> may be molded as part of the external surface of the second external arm <NUM> of the elongate shaft <NUM>.

Optionally in any embodiment, there may be a stopper <NUM> in the inner lumen of the second external arm <NUM> of the elongate shaft <NUM>, as described in <FIG> and <FIG>. The stopper <NUM> maintains the pressure seal in the elongate shaft <NUM>.

Optionally in any embodiment, the stopper <NUM> may also have a cone-shaped custom O-ring <NUM>. The O-ring <NUM> preferably has an inner diameter of <NUM> to <NUM>. The O-ring <NUM> may be captured in the stopper <NUM> by bonding or adhesive. Optionally, in any embodiment, the O-ring <NUM> may be captured by any mechanical feature. The axis of the O-ring <NUM> may be aligned with the center axis of the stopper <NUM>. The trailing end <NUM> of the removal element (not fully pictured) may be able to pass through the center axis of the stopper <NUM> and custom O-ring <NUM> while maintaining the seal with a tight fit between the trailing end <NUM> and the O-ring <NUM>.

The cap <NUM> actuation mechanism <NUM> may disengage to cause the cap ratchets <NUM> to release the fitting ratchets <NUM>, enabling the cap <NUM> to move axially, pulling the trailing end <NUM> of the biaxial braid (not pictured) axially thereby pulling the dressing (not pictured) out of the wound into the elongate shaft <NUM>.

<FIG> is a preferred embodiment of the internal end <NUM> of a multi lumen elongate shaft <NUM> and a cannulated wound dressing <NUM> with the removal element removed for convenient illustrative purposes although it is appreciated that the removal element is preferably included. The elongate shaft <NUM> may have two members, one that is connected to an inlet and one that is connected to an outlet. Each of the two members may be movable relative to one another. The two members may comprise a same material. The two members may comprise a similar material. The two members may be bonded together with adhesive. The two members may be bonded together using any known bonding process. The internal end <NUM> is flared to allow guidance into the lumen, as described in <FIG>.

The wound dressing <NUM> is preferably a sterile, open cell reticulated, hydrophobic, polyurethane foam. The wound dressing <NUM> preferably has pore sizes of approximately <NUM> to <NUM> microns. Optionally, in any embodiment, the dressing <NUM> may have silver or antimicrobial additions. Optionally, in any embodiment, the dressing <NUM> may be non-open cell reticulated foam. Optionally, in any embodiment, the dressing <NUM> may be polyvinyl alcohol foam. Optionally, in any embodiment, the dressing <NUM> may have pore sizes of approximately <NUM> to <NUM> microns. Optionally, in any embodiment, the dressing <NUM> may have multiple layers with different materials to change the suction and dispersion properties of the dressing <NUM>. For example, the dressing <NUM> may have a silver-coated polyurethane layer, a polyvinyl alcohol foam layer, and a waterproof adhesive layer. The stacked layers may be the same thickness or have varying thicknesses. Dressing <NUM> sizes may have surface areas up to <NUM>-<NUM><NUM>. The dressing <NUM> may be cylindrically shaped. Optionally, in any embodiment, the dressing <NUM> may be rectangular or another shape. The dressing <NUM> may have a long side (i.e. long length) and two short sides (i.e. small width and height). The dressing <NUM> may be collapsed with a narrowing of the width and height. The dressing <NUM> may be cannulated through the center axis, along the long side, to allow for a hollow shaft to pass through. The cannula <NUM> may extend through the entire dressing <NUM>. Optionally, in any embodiment, the cannula <NUM> may extend only partially through the dressing <NUM>. Optionally, in any embodiment, the dressing <NUM> may be flexible so that it may be manipulated. The dressing <NUM> may be fabricated to allow equal distribution of negative pressure across the wound. The dressing <NUM> materials and configurations will be apparent to those skilled in the art and may vary depending on factors including patient's anatomy, exudate quantity, and/or state of the wound.

The elongate shaft <NUM> may have an internal end <NUM> that is disposed in the patient's wound and an external end (not pictured) that is disposed outside the patient. The elongate shaft <NUM> may be a tube, cannula, catheter, or other hollow structure that is sized to receive the wound dressing <NUM> and removal element in a compressed configuration. The elongate shaft <NUM> may have a flared <NUM> internal end <NUM> to allow dressing guidance to be slidably advanced into the lumen during removal by proximal retraction of the removal element <NUM>. Optionally, in any embodiment, the elongate shaft <NUM> may have various cross-sectional shapes known to those skilled in the art, such as an ovular cross-section or a rectangular cross-section. The elongate shaft <NUM> is preferably formed from a sterile flexible polymer. Any suitable material may be used including elastomeric or polymeric materials including, but not limited to, silicone or medical-grade polyvinyl chloride (PVC). The elongate shaft <NUM> is preferably formed from a uniform material. Optionally, in any embodiment, the elongate shaft <NUM> may have sections of varying durometer in order to control stiffness, flexibility or other mechanical properties of the elongate shaft <NUM>. Optionally, in any embodiment, the elongate shaft <NUM> may be formed from multiple materials to provide desirable mechanical properties to the elongate shaft.

A piece of tubing from one of the lumens from the elongate shaft <NUM> extends distally from the internal end <NUM> to form a hollow extension <NUM>. The hollow extension <NUM> is preferably tubular with a diameter of <NUM> to <NUM>. More preferably, the hollow extension <NUM> diameter is <NUM> to <NUM>. Optionally, in any embodiment, the hollow extension <NUM> may have any shape. For example, the lumen of the elongate shaft <NUM> may be divided into two equal lumens down with the hollow extension <NUM> having a D-shaped half-circle cross-section. The hollow extension <NUM> may extend internally into the wound dressing <NUM>. The hollow extension <NUM> may extend distally the length of the wound dressing <NUM>. Optionally, in any embodiment, the hollow extension <NUM> may extend distally partially across the wound dressing <NUM>. The hollow extension <NUM> may have an open proximal tip. Optionally, in any embodiment, the hollow extension <NUM> may have a closed tip. The hollow extension <NUM> may have a plurality of holes <NUM> distributed circumferentially. The hollow extension <NUM> may have a plurality of holes <NUM> distributed axially. Optionally, in any embodiment, the hollow extension <NUM> may have a plurality of holes <NUM> distributed circumferentially and axially in any pattern. The plurality of holes <NUM> may provide more distributed suctioning of exudates and/or distribution of irrigating fluids. The holes <NUM> preferably have a diameter of <NUM> to <NUM>. More preferably, the holes <NUM> have a diameter of <NUM> to <NUM> in diameter. Optionally, in any embodiment, the holes <NUM> may be various sizes. The hollow extension <NUM> is preferably of the same material as the body of the elongate shaft <NUM>. Optionally, in any embodiment, the hollow extension <NUM> is a different material than that of the elongate shaft <NUM>. Optionally, in any embodiment, the hollow extension <NUM> is a different durometer than that of the elongate shaft <NUM>.

With reference to <FIG>, in one embodiment, there may be two identical elongate shafts <NUM> that are bonded together along their length. The elongate shafts <NUM> may be bonded together with adhesive or any processes of bonding. The elongate shaft <NUM> may have a flared <NUM> internal end <NUM>. The elongate shafts <NUM> may be a tube, cannula, catheter, or other hollow structure. The elongate shafts <NUM> may have a single lumen extending the length of the shaft. The elongate shafts <NUM> may have a circular cross-section. The elongate shafts <NUM> may be a sterile flexible polymer or other material. The identical elongate shafts <NUM> may be pulled apart for convenience while attaching to an external system for separate inlet and outlet channels, one for suction and one for irrigation. The removal element (not pictured) may span either channel. Alternatively, the construct of the two elongate shafts may be co-extruded to form a single integral component with two lumens/channels.

With reference to <FIG>, in one embodiment, there is one elongate shaft <NUM> with a y-connection that allows for two end-connections to external system tubing, one for inlet and the other for outlet, one for suction and one for irrigation. The removal element (not pictured) may span either channel. The elongate shafts <NUM> may have a flared <NUM> internal end <NUM>. The elongate shafts <NUM> may be a tube, cannula, catheter, or other hollow structure. The elongate shafts <NUM> may have a single lumen that span the length of the shaft. The elongate shafts <NUM> may have a circular cross-section. The elongate shafts <NUM> may be a sterile flexible polymer or any material.

<FIG> is a preferred embodiment of a series of wound dressings <NUM>, <NUM> captured by the removal element <NUM> to fill a larger wound space. Optionally, in any embodiment, wound dressings <NUM>, <NUM> in various configurations may be captured by the removal element <NUM>. The elongate shaft <NUM> and removal element <NUM> may be the same as those previously described in <FIG>. The wound dressings <NUM>, <NUM> may be a sterile, open cell reticulated, hydrophobic, polyurethane foam. The wound dressings <NUM>, <NUM> may have pore sizes of approximately <NUM> to <NUM> microns. Optionally, in any embodiment, the dressings <NUM>, <NUM> may be polyvinyl alcohol foam or any other material. Optionally, in any embodiment, the dressings <NUM>, <NUM> may have pore sizes of approximately <NUM> to <NUM> microns. Optionally, in any embodiment, the dressings <NUM>, <NUM> may have pore sizes that vary along the length of the dressings <NUM>, <NUM>. Optionally, in any embodiment, the dressings <NUM>, <NUM> may have pore sizes that vary along the circumference of the dressings <NUM>, <NUM>. Optionally, in any embodiment, the dressings <NUM>, <NUM> may have pore sizes that vary along any other direction. Optionally, in any embodiment, the dressings <NUM>, <NUM> may have multiple stacked layers with different materials to change the suction and dispersion properties of the dressings <NUM>, <NUM>. For example, the dressings <NUM>, <NUM> may have a silver-coated polyurethane layer, a polyvinyl alcohol foam layer, and a waterproof adhesive layer. The stacked layers may be the same thickness or have varying thicknesses. The dressings <NUM>, <NUM> sizes may have surface areas up to <NUM>-<NUM><NUM>. The dressings <NUM>, <NUM> may be cylindrically shaped. Optionally, in any embodiment, the dressings <NUM>, <NUM> may be rectangular or another shape. The dressings <NUM>, <NUM> may have a long side (i.e. long length) and two short sides (i.e. small width and height). The dressings <NUM>, <NUM> may be collapsed with a narrowing of the width and height. The dressings <NUM>, <NUM> may be flexible so that they may be manipulated. The dressings <NUM>, <NUM> may be fabricated to allow equal distribution of negative pressure across the wound. The removal element <NUM> may encompasses the dressings <NUM>, <NUM> with a tight fit such that the dressing is entrapped by the removal element. The long-side of the dressings <NUM>, <NUM> may be aligned or substantially parallel with the removal element <NUM> longitudinal axis. Operation of the device in <FIG> is generally the same as previously described in other embodiments. Retraction of the removal element <NUM> collapses the removal element <NUM> and captures the dressings <NUM>, <NUM> which are then pulled into the internal end <NUM> of the elongate shaft <NUM> which can then be easily removed from the patient without requiring removal surgery.

<FIG> is a preferred embodiment of the removal element <NUM> being intertwined into the wound dressing <NUM> with the elongate shaft removed for convenient illustrative purposes although it is appreciated that the elongate shaft is preferably included. The removal element <NUM> may be the same as that described in <FIG>. The removal element <NUM> may be a helical braid, such as a biaxial braid, with a trailing end <NUM>. Optionally, in any embodiment, the removal element <NUM> may be woven into the periphery of the dressing <NUM>. Optionally, in any embodiment, the removal element <NUM> may be woven through the center of the dressing <NUM>. Optionally, in any embodiment, the removal element <NUM> may be woven around the dressing <NUM>, woven into the periphery of the dressing, and/or woven through the center of the dressing <NUM>, or any combination thereof.

<FIG> is a preferred embodiment of the removal element <NUM>, as shown in <FIG>, composed of hollow components <NUM>. The hollow components <NUM> may be tubular or any shape. The hollow components <NUM> may be any type of fiber, metal, or other material. The hollow components <NUM> may be flexible. The hollow components <NUM> may have a plurality of ports <NUM> located along the length of the component at the distal end <NUM>. The ports <NUM> may be holes. The ports <NUM> may be mesh. The ports <NUM> may be any other form that allows for fluid diffusion. Antibiotics may be distilled from the trailing end <NUM> (proximal end), to the distal end <NUM>, exiting the plurality of ports <NUM> for even distribution in the wound.

<FIG> is a schematic of a preferred embodiment of the device, as shown in <FIG> and <FIG>, being used with suction and/or irrigation therapy. The device fitting <NUM> (as described in <FIG> and <FIG>) may connect to the suction and/or irrigation therapy system tubing. The suction and/or irrigation therapy may be an NPWT system. The suction therapy may be delivered from a portable or central suction system. The suction and/or irrigation may be provided from any system that is able to provide suction and/or irrigation through an elongate hollow shaft.

<FIG> shows a lateral view of the spine with vertebrae <NUM>, disc space <NUM>, and tissue <NUM>. The device from <FIG> and <FIG>, including an elongate shaft <NUM>, removal element 5with trailing end <NUM>, and wound dressing <NUM>, is placed in the wound space <NUM> next to existing instrumentation, including rods <NUM> and screws <NUM>. This device may be used with a suction and/or irrigation system or any of the other therapies described in this specification.

<FIG> shows a superior view of the spine with vertebra <NUM>. The device from <FIG> and <FIG>, including an elongate shaft <NUM>, removal element 5with trailing end <NUM>, and wound dressing <NUM>, is placed in the wound space <NUM>.

<FIG> illustrate a method for device removal. In particular, <FIG> shows the trailing end <NUM> of the removal element <NUM> being pulled axially (in the direction of the arrow). The trailing end <NUM> of the removal element <NUM> spans the length of the lumen of the elongate shaft <NUM>. The distal end <NUM> of the removal element <NUM> encompasses the wound dressing <NUM>. The elongate shaft <NUM> internal end <NUM> abuts the wound dressing <NUM>. <FIG> shows the device as described in <FIG> and <FIG>.

<FIG> shows the distal end <NUM> of the removal element <NUM> narrowing, collapsing the wound dressing <NUM>. The trailing end <NUM> of the removal element <NUM> spans the length of the lumen of the elongate shaft <NUM>. The distal end <NUM> of the removal element <NUM> encompasses the wound dressing <NUM>. The elongate shaft <NUM> internal end <NUM> abuts the wound dressing <NUM>. <FIG> shows the device as described in <FIG> and <FIG>.

<FIG> shows a device having a partially retracted sponge in an initial position. <FIG> shows the device as described in <FIG> and <FIG>.

<FIG> shows the fully collapsed removal element <NUM> and wound dressing <NUM> after having been collapsed and retracted into the elongate shaft <NUM>, proximally past the internal end <NUM> having a flare. <FIG> shows the device as described in <FIG> and <FIG>.

<FIG> shows the fully collapsed removal element <NUM> and wound dressing <NUM> after having been collapsed and retracted into the elongate shaft <NUM>, proximally past the internal end <NUM> having an internal chamfer <NUM>. <FIG> shows the device as described in <FIG> and <FIG>.

<FIG> shows the elongate shaft <NUM> being removed through the closed wound. The removal element <NUM> is fully collapsed around the wound dressing <NUM> and has been retracted into the elongate shaft <NUM>. The trailing end <NUM> of the biaxial braid spans the length of the lumen of the elongate shaft <NUM>. <FIG> shows the device as described in <FIG> and <FIG>.

Claim 1:
A post-operative surgical site wound treatment device, the device comprising:
an elongate shaft (<NUM>) with a lumen;
a wound dressing (<NUM>), the elongate shaft (<NUM>) having a flared (<NUM>) internal end (<NUM>) to allow wound dressing guidance into the lumen during removal by proximal retraction; and
a removal element (<NUM>) to remove the wound dressing (<NUM>),
wherein the device is configured to be used with an external system to provide irrigation, to suction exudates or to instill antibiotics.