Patent Application
20230115572
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.
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 may comprise an elongate shaft. Any embodiment of the device may comprise a wound dressing. Any embodiment of the device may comprise 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.
Also provided herein is a post-operative surgical site wound treatment device, the device comprising: a housing comprising: an aperture in an outer surface of the housing; a channel extending from the aperture to an interior surface of the housing, wherein at least a portion of the channel is tapered; a spool configured to rotate relative to the housing, wherein at least a portion of the spool resides within the housing, the spool comprising: a column; a source opening on an outer surface of the spool; a catheter opening on an inner surface of the spool; and a conduit between the source opening and the catheter opening; and a catheter having a distal portion and a proximal portion, wherein the proximal portion wraps around the column of the spool, wherein a terminus of the proximal portion couples to the catheter opening of the spool, and wherein the distal portion is inserted through the aperture of the housing and into the closed wound.
In some embodiments, the taper is a linear taper. In some embodiments, the taper is a logarithmic taper In some embodiments, the taper tapers inwards from the aperture. In some embodiments, the taper has a minimum diameter of greater than an outer diameter of the catheter. In some embodiments, the housing further comprises a pressure outlet extending from the outer surface of the housing to the interior of the housing. In some embodiments, the pressure outlet is disposed proximal to the channel. In some embodiments, the pressure outlet is disposed on the channel. In some embodiments, the outer surface of the housing further comprises a flange. In some embodiments, flange is disposed about the aperture. In some embodiments, the outer surface of the spool comprises a torque grip. In some embodiments, the torque grip comprises a depression, a protuberance, or both. In some embodiments, the conduit is within the column. In some embodiments, the column and the conduit are concentric. In some embodiments, the column and the source opening are concentric. In some embodiments, the source opening, the catheter opening, or both comprise a luer connector. In some embodiments, at least one of the source opening and the catheter opening comprise a male luer connector, a female luer connector, or both. In some embodiments, at least one of the source opening and the catheter opening comprise two or more luer connectors. In some embodiments, the catheter comprises one or more perforations between an outer surface of the catheter and an inner surface of the catheter. In some embodiments, the one or more perforations are disposed about the distal portion of the catheter. In some embodiments, a flange in the spool, the housing, or both enables the spool to rotate relative to the housing. In some embodiments, a groove in the spool, the housing, or both enables the spool to rotate relative to the housing. In some embodiments, rotating the spool in a first direction relative to the housing winds the catheter onto the column, and wherein rotating the spool in a second direction opposite the first direction unwinds the catheter from the column. In some embodiments, rotating the spool in a first direction relative to the housing translates at least a portion of the catheter into the housing, and wherein rotating the spool in a second direction opposite translates at least a portion of the catheter out of the housing. In some embodiments, at least a portion of the spool contacts an inner surface of the housing when the spool rotates within the housing. In some embodiments, the device further comprises a wound dressing disposed about the distal portion of the catheter. In some embodiments, the device further comprises a mesh disposed about the wound dressing. In some embodiments, the catheter and the source opening are in two-way fluidic communication.
Another aspect provided herein is a method of post-operative surgical site treatment through a closed wound, the method comprising: providing the device of any claim; inserting the catheter into the wound; closing the wound about the catheter; and delivering an antibiotic and/or irrigation fluids, and/or suctioning exudates and/or other material from the closed wound.
In some embodiments, the antibiotic and/or irrigation fluids are delivered through the source opening. In some embodiments, exudates are suctioned through the source opening and/or the pressure outlet. In some embodiments, the method further comprises removing the catheter from the closed wound by rotating the spool. In some embodiments, the device comprises a wound dressing disposed about a first portion of the catheter, wherein the wound dressing and the first portion of the catheter are inserted into the wound. In some embodiments, the method further comprises removing the catheter and wound dressing from the closed wound by rotating the spool. In some embodiments, the method further comprises removing a material from the closed wound via a negative pressure source coupled to the source opening. In some embodiments, the method further comprises removing a material from the closed wound via a negative pressure source coupled to the pressure outlet. In some embodiments, the method further comprises removing exudates from the closed wound via the catheter. In some embodiments, the method further comprises delivering a material to the closed wound via the source opening. In some embodiments, material comprise antibiotics, irrigations fluid, or any combination thereof, to the closed wound.
Additional aspects of the invention will be apparent from the detailed descriptions and claims herein.
The novel features of the disclosure are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the disclosure are utilized, and the accompanying drawings of which:
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 invention.
As seen in
The elongate shaft 1 may have a flared 45 internal end 3 to allow dressing guidance to be slidably advanced into the lumen during removal by proximal retraction of the removal element 5. The elongate shaft 1 may have a single lumen. Optionally, in any embodiment, the elongate shaft 1 may have multiple lumens in order to provide fluid suction and/or irrigation. For example, the elongate shaft 1 may have three lumens (one lumen for suction, one lumen for irrigation, and one lumen for device retraction) or the elongate shaft 1 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 1 preferably has a circular cross-section. Optionally, in any embodiment, the elongate shaft 1 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 1 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 1 is preferably formed from a uniform material. Optionally, in any embodiment, the elongate shaft 1 may have sections of varying durometer in order to control stiffness, flexibility or other mechanical properties of the elongate shaft 1. Optionally, in any embodiment, the elongate shaft 1 may be formed from multiple materials to provide desirable mechanical properties to the elongate shaft.
The wound dressing 2 is preferably a sterile, open cell reticulated, hydrophobic, polyurethane foam. The wound dressing 2 preferably has pore sizes of approximately 400 to 600 microns. Optionally, in any embodiment, the dressing 2 may have silver or antimicrobial agents added thereto. Optionally, in any embodiment, the dressing 2 may be non-open cell reticulated foam. Optionally, in any embodiment, the dressing 2 may be polyvinyl alcohol foam or any other material. Optionally, in any embodiment, the dressing 2 may have pore sizes of approximately 60 to 400 microns. Optionally, in any embodiment, the dressing 2 may have pore sizes that vary along the length of the dressing 2. Optionally, in any embodiment, the dressing 2 may have pore sizes that vary along the circumference of the dressing 2. Optionally, in any embodiment, the dressing 2 may have pore sizes that vary along any other direction. Optionally, in any embodiment, the dressing 2 may have multiple stacked layers with different materials to change the suction and dispersion properties of the dressing 2. For example, the dressing 2 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 2 sizes may have surface areas up to 1000-1500 cm2. The dressing 2 may be cylindrically shaped. Optionally, in any embodiment, the dressing 2 may be rectangular or another shape. The dressing 2 may have a long side (i.e. long length) and two short sides (i e small width and height). The dressing 2 may be collapsed with a narrowing of the width and height. Optionally, in any embodiment, the dressing 2 may be flexible so that it may be manipulated. The dressing 2 may be fabricated to allow equal distribution of negative pressure across the wound. The dressing 2 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 5 may be a type of helical braid woven such that as the braid lengthens, it narrows. The removal element 5 may have a distal end 8 that is configured to be disposed in the wound and a trailing end 6 that extends proximally from the wound toward an external surface of the patient. The removal element 5 may be collapsible. The distal end 8 may be of diameter or width greater than the lumen of the elongate shaft 1 in its expanded state. The distal end 8 may be of diameter or width less than the lumen of the elongate shaft 1 in its collapsed state. Optionally, in any embodiment, the distal end 8 may conform to the wound dressing 2 contour. Optionally, in any embodiment, the distal end 8 may be bulbous, cylindrical, rectangular, or any other shape. The components of the removal element 5 may come together on one end of the distal end 8 to create a trailing end 6 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 6 may be a tight braid or bonded components that extend from distal end 8. Optionally, in any embodiment, the trailing end 6 may be a continuation of the distal end 8 helical braid.
The removal element 5 preferably encompasses the dressing 2 with a tight fit such that the dressing is entrapped by the removal element. Optionally, in any embodiment, the removal element 5 may be woven into the periphery of the dressing 2. Optionally, in any embodiment, the removal element 5 may be woven through the center of the dressing 2. Optionally, in any embodiment, the removal element 5 may be woven around the dressing 2, woven into the periphery of the dressing, and/or woven through the center of the dressing 2, or any combination thereof. The long-side of the dressing 2 may be aligned or substantially parallel with the removal element 5 longitudinal axis. The trailing end 6 of the removal element 5 may span the length of the elongate shaft 1 from the internal end 3, through the external end 4 with an additional length extending therepast that may be grasped by an operator or coupled to an actuation mechanism for retraction. The trailing end 6 may be pulled taut so that the removal element 5 captures the dressing 2 and also so that the internal end 3 of the elongate shaft 1 abuts the wound dressing 2. Optionally, in any embodiment, the elongate shaft 1 may be connected to the wound dressing 2 with adhesive or other method of bonding.
The elongate shaft 1 preferably has a length of 0.5 m to 3 m. More preferably, the elongate shaft 1 has a length of 1 m to 2 m. The elongate shaft 1 preferably has an inner diameter of 2 mm to 10 mm More preferably, the elongate shaft 1 has an inner diameter of 3 mm to 5 mm. The elongate shaft 1 preferably has an outer diameter of 4 mm to 15 mm More preferably, the elongate shaft 1 has an outer diameter of 5 mm to 7 mm. The elongate shaft 1 may have a flared 45 internal end 3 to allow dressing guidance into the lumen during removal by proximal retraction of the dressing into the lumen of the elongate shaft 1. The flared diameter 45 is preferably 5 mm to 20 mm More preferably, the flared diameter 45 is 7 mm to 15 mm Optionally, in any embodiment and as illustrated in
The elongate shaft 28 may have an internal end 3 that is disposed in the wound in the patient and a y-split 9 diverging into two external arms 10, 11 with two external ends 32, 33 preferably disposed outside of the wound and externally to the patient. Optionally, in any embodiment, the y-split 9 may be a t-split or any other divergence of one member into two. For example, the first external arm 11 may extend in a direction substantially parallel with the internal tubing axis and the second external arm 10 may diverge at a 20 to 60-degree angle. More preferably, the second external arm 10 diverges at a 30 to 40-degree angle. The elongate shaft 28 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 28 preferably has an approximate length of 0.5 m to 3 m (from internal end to each external end). More preferably, the elongate shaft 28 has a length of 1 m to 2 m. Optionally, in any embodiment, the elongate shaft 28 may have any length to accommodate varying patient anatomy and use. The elongate shaft 28 preferably has an inner diameter of 2 mm to 10 mm More preferably, the elongate shaft 28 has an inner diameter of 3 mm to 5 mm. The elongate shaft 28 preferably has an outer diameter of 4 mm to 15 mm More preferably, the elongate shaft 28 has an outer diameter of 5 mm to 7 mm. The y-split 9 may allow the trailing end 6 of the removal element 5 to exit the external end 32 of the tubing without interfering with the connection to the external device for suction and irrigation.
The wound dressing 2 and removal element 5 may be the same as those described in
The fitting 12 may be any medical tubing standard fitting known in the art such as a cylindrical shape. The fitting 12 may be configured to mate with commercial suction and/or irrigation device tubing. The fitting 12 outer diameter may be stepped. The fitting 12 preferably has a first outer diameter 34 of approximately 8 mm to 17 mm More preferably, the fitting 12 has a first outer diameter 34 of 10 mm to 15 mm. The outer diameter 34 may have surface features such as ridges 47 around the circumference to help an operator grasp the fitting. The ridges 47 may have a square shape. Optionally, in any embodiment, the ridges 47 may be any shape. The ridges 47 preferably have widths of approximately 0.1 mm to 1 mm More preferably, the ridges 47 have widths of 0.2 mm to 0.5 mm. The fitting 12 preferably has a second outer diameter 35 of approximately 5 mm to 13 mm More preferably, the fitting 12 has a second outer diameter 35 of 7 mm to 10 mm. The second outer diameter 15 may have a locking pin 46 so that an external device female fitting can slide into the fitting 12 with the locking pin 46 entering a channel on the external fitting such that as the fitting is rotated, the locking pin 46 locks to the fitting. Optionally, in any embodiment, the outer diameter 35 may have any locking feature such as a threaded region as used in a Luer lock. The fitting 12 preferably has an inner diameter of 4 mm to 8 mm More preferably, the fitting 12 has an inner diameter of 5 mm to 7 mm. The fitting 12 is preferably sterile acrylonitrile butadiene styrene (ABS) or another suitable polymer. Optionally, in any embodiment, the fitting 12 may be any suitable metal, ceramic, or other material.
A stopper 13 is preferably disposed in the opposite arm 10 of the y-split 9. The stopper 13 may be of cylindrical shape or any other shape. The stopper 13 preferably has a diameter of approximately 2 mm to 6 mm More preferably, the stopper 13 has a diameter of 2.5 mm to 4.5 mm. The stopper 13 preferably has a length of 5 mm to 25 mm More preferably, the stopper 13 has a length of 10 mm to 20 mm. The stopper 13 body is preferably sterile acrylonitrile butadiene styrene (ABS) or a comparable suitable polymer. Optionally, in any embodiment, the stopper 13 body may be any suitable metal, ceramic or other material. The stopper 13 preferably has multiple circumferential grooves 36 disposed therearound and sized to fit an external O-ring 14 in each. The circumferential grooves 36 may have rectangular cross-sections. Optionally, in any embodiment, the circumferential grooves 36 may be semi-circles or any shape. Optionally, in any embodiment, the stopper 13 may have other mechanical features to capture an O-ring 14. Optionally, in any embodiment, the O-rings 14 may be bonded to the stopper 13. The O-rings 14 preferably have outer diameters of approximately 2 mm to 6 mm More preferably, the O-rings 14 have outer diameters of 3.1 mm to 5.1 mm. The O-rings 14 preferably have circular cross-sections. Optionally, in any embodiment, the O-rings 14 may have any shape cross-section. The O-rings 14 may have a press fit with the inner lumen of the arm 10 of the elongate shaft 28 to provide a seal. The O-rings 14 are preferably sterile rubber. Optionally, in any embodiment, the O-rings 14 may be any suitable elastomer.
The removal element 5 preferably encompasses the dressing 2 with a tight fit such that the dressing is entrapped by the removal element. The long-side of the dressing 2 may be aligned or substantially parallel with the removal element 5 longitudinal axis. The first external end 33 has a fitting 12 to connect to a suction and/or irrigation device canister tubing. The fitting 12 may be bonded to the external end 33 of the elongate shaft 28 using an adhesive. Optionally, in any embodiment, the fitting 12 may be connected to the external end 33 of the elongate shaft 28 by any bonding method including but not limited to mechanical bonding, chemical bonding, adhesives, ultrasound welding, solvent bonding, etc. The trailing end 6 of the removal element 5 spans the length of the lumen of the elongate shaft 28 from the internal end 3, through the second external arm 10, exiting through the second external end 32, disposed external to the patient. The trailing end 6 is pulled taut so that the removal element 5 captures the dressing 2 and also so that the internal end 3 of the elongate shaft 3 abuts the wound dressing 2. Optionally, in any embodiment, the elongate shaft 28 may be connected to the wound dressing 2 with adhesive or other method of bonding. A stopper 13 captures the trailing end 6 of the removal element 5 in the second external arm 10 of the elongate shaft 28 such that as the trailing end 6 is pulled axially, the stopper 13 also moves axially, allowing for removal element 5 collapse and subsequent collapse of the dressing 2 for device removal. The trailing end 6 may be captured by the stopper 13 during a molding process. Optionally, in any embodiment, the trailing end 6 may be captured by the stopper 13 by mechanical mechanisms or bonding. The stopper 13 may maintain the seal within the elongate shaft 28 through a press fit between the O-rings 17 and the inner lumen of the elongate shaft 28.
The externally threaded fitting 15 is preferably of cylindrical shape. The fitting 15 preferably has an inner diameter of approximately 4 mm to 8 mm More preferably, the fitting 15 has an inner diameter of 5 mm to 7 mm. The fitting 15 preferably has an external diameter of 6 mm to 10 mm More preferably, the fitting 15 has an external diameter of 7 mm to 9 mm. The internally threaded cap 16 is preferably of cylindrical shape. Optionally, in any embodiment, the cap 16 may be any shape. The cap 16 preferably has a cylindrical lumen sized to mate with the externally threaded fitting 15. The fitting 15 preferably has external threads 48 along a portion of the length of the tubular body. Optionally, in any embodiment, the fitting 15 may be threaded along its entire length. The cap 16 preferably has internal threads 49 along a portion of the length of the tubular body. Optionally, in any embodiment, the cap 16 may be threaded along its entire length. The fitting 15 length is preferably 5 mm to 100 mm More preferably, the fitting 15 length is 5 mm to 20 mm. The cap 16 length is preferably 5 mm to 100 mm More preferably, the cap 16 length is 5 mm to 20 mm. The trailing end 6 of the removal element 5 may be attached to the inner end 37 of the cap 16 by being molded into it. Optionally, in any embodiment, the trailing end 6 may be attached to the cap 16 by any mechanical mechanism or bonding. The fitting 15 is preferably acrylonitrile butadiene styrene (ABS). Optionally, in any embodiment, the fitting 15 is any suitable polymer. The cap 16 is preferably acrylonitrile butadiene styrene (ABS). Optionally, in any embodiment, the cap 16 is any suitable polymer.
The removal element 5 preferably encompasses the dressing 2 with a tight fit such that the dressing is entrapped by the removal element. The long-side of the dressing 2 may be aligned or substantially parallel with the removal element 5 longitudinal axis. The first external end 33 may have a fitting 12 to connect to suction and/or irrigation device canister tubing. The fitting 12 may be bonded to the external end 33 of the elongate shaft 28 using adhesive. Optionally, in any embodiment, the fitting 12 may be connected to the external end 33 of the elongate shaft 28 by any bonding method. The second external end 32 may have an externally threaded fitting 15. The fitting 15 may be bonded to the second external end 32 using adhesive. Optionally, in any embodiment, the fitting 15 may be bonded to the second external end 32 by any bonding method. The trailing end 6 of the removal element 5 may span the length of the lumen of the elongate shaft 28 from the internal end 3, through the second external arm 10, through the second external end 32, to attach to the internally threaded cap 16. As the cap 16 is unscrewed from the fitting 15, the trailing end 6 of the removal element 5 is pulled axially. The trailing end 6 may be pulled taut by unthreading the cap 16 so that the removal element 5 captures the dressing 2 and also so that the internal end 3 of the elongate shaft 28 abuts the wound dressing 2. Optionally, in any embodiment, the elongate shaft 28 may be connected to the wound dressing 2 with adhesive or other method of bonding. The fitting 15 and cap 16 may have mating threads 48, 49 so that when engaged, a seal is maintained within the elongate shaft 28.
The ratcheted fitting 17 may be bonded to one external arm 10 of the elongate shaft 28. The ratcheted fitting 17 is preferably of cylindrical shape. Optionally, in any embodiment, the ratcheted fitting 17 may be any shape. The fitting 17 may have an inner diameter of approximately 5 to 7 mm. The fitting 17 preferably has ratchets 39 along a portion of the length of the tubular body. Optionally, in any embodiment, the fitting 17 may have ratchets (not pictured) along its entire length. The ratchet fitting 17 length is preferably 5 mm to 100 mm More preferably, the fitting 17 length is 5 mm to 20 mm. The ratchet cap 18 is preferably of cylindrical shape. Optionally, in any embodiment, the ratchet cap 18 may be any shape. The cap 18 preferably has an inner diameter that provides for a sliding fit with the fitting 17. The cap 18 length is preferably 5 mm to 100 mm More preferably, the cap 18 length is 5 mm to 20 mm. The ratchet cap 18 preferably has an actuatable arm 19 that is rotated about a pin 20. Optionally, in any embodiment, the cap 18 may also have an actuation mechanism 19 that moves by any mechanism such as a button, a lever, or any other mechanism. The actuation mechanism 19 may be an elongate rectangular shape with two ends 42, 43 on opposite sides of the pin 20. Optionally, in any embodiment, the actuation mechanism 19 may be any shape. The trailing end 6 of the removal element 5 may be attached to the inner end 40 of the cap 18 by being molded into it. Optionally, in any embodiment, the trailing end 6 may be attached to the cap 18 by any mechanical mechanism or bonding. The fitting 17 is preferably sterile acrylonitrile butadiene styrene (ABS). Optionally, in any embodiment, the fitting 17 may be any suitable polymer. The cap 18 is preferably sterile acrylonitrile butadiene styrene (ABS). Optionally, in any embodiment, the cap 18 may be any suitable polymer. The cap 18 is able to move axially along the fitting 17 when the actuation mechanism 19 is disengaged, pulling the trailing end 6 of the biaxial braid 5 axially thereby pulling the dressing 2 out of the wound into the elongate shaft 28.
The removal element 5 preferably encompasses the dressing 2 with a tight fit such that the dressing is entrapped by the removal element. The long-side of the dressing 2 may be aligned or substantially parallel with the removal element 5 longitudinal axis. The first external end 33 may have a fitting 12 to connect to suction and/or irrigation device canister tubing. The fitting 12 may be bonded to the external arm 10 of the elongate shaft 28 using adhesive. Optionally, in any embodiment, the fitting 12 may be bonded by any bonding method. The second arm 10 has a ratcheted fitting 17. The fitting 17 may be bonded using adhesive. Optionally, in any embodiment, the fitting 17 may be bonded by any bonding method. The trailing end (not pictured) of the removal element 5 may span the length of the lumen of the elongate shaft 28 from the internal end 3, through the second external arm 10, through the second external end (not pictured) disposed external to the patient, to attach to the ratchet cap 18. The trailing end may be pulled taut so that the removal element 5 captures the dressing 2 and also so that the removal element 5 captures the dressing 2 and also so that the internal end 3 of the elongate shaft 28 abuts the wound dressing 2. Optionally, in any embodiment, the elongate shaft 28 may be connected to the wound dressing 2 with adhesive or other method of bonding. The cap 18 actuation mechanism 19 may disengage, enabling the cap 18 to move axially, pulling the trailing end of the biaxial braid 5 axially thereby pulling the dressing 2 out of the wound into the elongate shaft 28.
Optionally in any embodiment, the external ratchets 39 may be molded as part of the external surface of the second external arm 10 of the elongate shaft 28.
Optionally in any embodiment, there may be a stopper 30 in the inner lumen of the second external arm 10 of the elongate shaft 28, as described in
Optionally in any embodiment, the stopper 30 may also have a cone-shaped custom O-ring 21. The O-ring 21 preferably has an inner diameter of 0.1 to 0.8 mm. The O-ring 21 may be captured in the stopper 30 by bonding or adhesive. Optionally, in any embodiment, the O-ring 21 may be captured by any mechanical feature. The axis of the O-ring 21 may be aligned with the center axis of the stopper 30. The trailing end 6 of the removal element (not fully pictured) may be able to pass through the center axis of the stopper 30 and custom O-ring 21 while maintaining the seal with a tight fit between the trailing end 6 and the O-ring 21.
The cap 18 actuation mechanism 19 may disengage to cause the cap ratchets 38 to release the fitting ratchets 39, enabling the cap 18 to move axially, pulling the trailing end 6 of the biaxial braid (not pictured) axially thereby pulling the dressing (not pictured) out of the wound into the elongate shaft 28.
The wound dressing 50 is preferably a sterile, open cell reticulated, hydrophobic, polyurethane foam. The wound dressing 50 preferably has pore sizes of approximately 400 to 600 microns. Optionally, in any embodiment, the dressing 50 may have silver or antimicrobial additions. Optionally, in any embodiment, the dressing 50 may be non-open cell reticulated foam. Optionally, in any embodiment, the dressing 50 may be polyvinyl alcohol foam. Optionally, in any embodiment, the dressing 50 may have pore sizes of approximately 60 to 400 microns. Optionally, in any embodiment, the dressing 50 may have multiple layers with different materials to change the suction and dispersion properties of the dressing 50. For example, the dressing 50 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 50 sizes may have surface areas up to 1000-1500 cm2. The dressing 50 may be cylindrically shaped. Optionally, in any embodiment, the dressing 50 may be rectangular or another shape. The dressing 50 may have a long side (i.e. long length) and two short sides (i e small width and height). The dressing 50 may be collapsed with a narrowing of the width and height. The dressing 50 may be cannulated through the center axis, along the long side, to allow for a hollow shaft to pass through. The cannula 51 may extend through the entire dressing 50. Optionally, in any embodiment, the cannula 51 may extend only partially through the dressing 50. Optionally, in any embodiment, the dressing 50 may be flexible so that it may be manipulated. The dressing 50 may be fabricated to allow equal distribution of negative pressure across the wound. The dressing 50 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 29 may have an internal end 3 that is disposed in the patient's wound and an external end (not pictured) that is disposed outside the patient. The elongate shaft 29 may be a tube, cannula, catheter, or other hollow structure that is sized to receive the wound dressing 50 and removal element in a compressed configuration. The elongate shaft 29 may have a flared 45 internal end 3 to allow dressing guidance to be slidably advanced into the lumen during removal by proximal retraction of the removal element 5. Optionally, in any embodiment, the elongate shaft 29 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 29 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 29 is preferably formed from a uniform material. Optionally, in any embodiment, the elongate shaft 29 may have sections of varying durometer in order to control stiffness, flexibility or other mechanical properties of the elongate shaft 29. Optionally, in any embodiment, the elongate shaft 29 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 29 extends distally from the internal end 3 to form a hollow extension 22. The hollow extension 22 is preferably tubular with a diameter of 0.5 mm to 5 mm More preferably, the hollow extension 22 diameter is 1 mm to 3 mm Optionally, in any embodiment, the hollow extension 22 may have any shape. For example, the lumen of the elongate shaft 29 may be divided into two equal lumens down with the hollow extension 22 having a D-shaped half-circle cross-section. The hollow extension 22 may extend internally into the wound dressing 50. The hollow extension 22 may extend distally the length of the wound dressing 50. Optionally, in any embodiment, the hollow extension 22 may extend distally partially across the wound dressing 50. The hollow extension 22 may have an open proximal tip. Optionally, in any embodiment, the hollow extension 22 may have a closed tip. The hollow extension 22 may have a plurality of holes 23 distributed circumferentially. The hollow extension 22 may have a plurality of holes 23 distributed axially. Optionally, in any embodiment, the hollow extension 22 may have a plurality of holes 23 distributed circumferentially and axially in any pattern. The plurality of holes 23 may provide more distributed suctioning of exudates and/or distribution of irrigating fluids. The holes 23 preferably have a diameter of 0.1 mm to 1.5 mm More preferably, the holes 23 have a diameter of 0.2 mm to 0.8 mm in diameter. Optionally, in any embodiment, the holes 23 may be various sizes. The hollow extension 22 is preferably of the same material as the body of the elongate shaft 29. Optionally, in any embodiment, the hollow extension 22 is a different material than that of the elongate shaft 29. Optionally, in any embodiment, the hollow extension 22 is a different durometer than that of the elongate shaft 29.
With reference to
With reference to
As shown per
As shown in
In some embodiments, per
As shown in
Per any one or more of
In some embodiments, the conduit 124 is disposed between the source opening 121 and the catheter opening 123. In some embodiments, the column 125 extends from the bottom surface of the spool 120. In some embodiments, the source opening 121, the catheter opening 123, the column 125, or any combination thereof is generally concentric to an axis of symmetry of the spool 120. In some embodiments, the source opening 121, the catheter opening 123, the column 125, or any combination thereof is generally perpendicular to an axis of symmetry of the spool 120. In some embodiments, the source opening 121, the catheter opening 123, the column 125, or any combination thereof are generally concentric to each other. In some embodiments, the source opening 121, the catheter opening 123, the column 125, or any combination thereof are generally perpendicular to each other. In some embodiments, the column 125 has a maximum outer width or diameter of about 15 mm to about 40 mm, including increments therein.
In some embodiments, per
Per
As shown in
In some embodiments, the catheter 130 comprises one or more perforations between an outer surface of the catheter 130 and an inner surface of the catheter 130. In some embodiments, the one or more perforations are disposed about the distal portion of the catheter 130. In some embodiments, such perforations enable fluids and/or other materials enter the catheter 130. In some embodiments, such perforations enable fluids and/or other materials to exit from the catheter 130 and into the closed wound. In some embodiments, the fluids and/or materials must pass through the wound dressing to enter the catheter from the closed wound, and/or to enter the closed wound from the catheter. In some embodiments, the wound dressing comprises a porous foam. In some embodiments, the device further comprises a mesh element disposed about the wound dressing 132. In some embodiments, the mesh element is configured to capture any portion of the wound dressing that separates into the closed wound. In some embodiments, the mesh element is configured as a removal element as described in
Also provided herein is a post-operative surgical site wound treatment device, the device comprising: a housing comprising: an aperture in an outer surface of the housing; a channel extending from the aperture to an interior surface of the housing, wherein at least a portion of the channel is tapered; a spool configured to rotate relative to the housing, wherein at least a portion of the spool resides within the housing, the spool comprising: a column; a source opening on an outer surface of the spool; a catheter opening on an inner surface of the spool; and a conduit between the source opening and the catheter opening; and a catheter having a distal portion and a proximal portion, wherein the proximal portion wraps around the column of the spool, wherein a terminus of the proximal portion couples to the catheter opening of the spool, and wherein the distal portion is inserted through the aperture of the housing and into the closed wound.
In some embodiments, at least one of the housing 110, the spool 120, and the catheter 130, are formed of plastic, metal, carbon fiber, fiberglass, or any combination thereof. In some embodiments, at least one of the housing 110, the spool 120, and the catheter 130, is transparent. In some embodiments, at least one of the housing 110, the spool 120, and the catheter 130, is translucent. In some embodiments, at least one of the housing 110, the spool 120, and the catheter 130, is opaque. In some embodiments, at least one of the housing 110, the spool 120, and the catheter 130, are formed by stamping, blow molding, injection molding, or any combination thereof.
Also provided herein is a method of post-operative surgical site treatment through a closed wound, the method comprising: providing the device described in
The spool 1120 can be configured to rotate relative to a housing 1110. In some embodiments, at least a portion of the spool 1120 is configured to rotate relative to the housing 1110. In some embodiments, the entire spool 1120 rotates relative to the housing 1110. In some embodiments, the housing 1110 includes a rotational mechanism 1115 such as a bearing, an O-ring, a seal, or any combination thereof, to enable the spool 1120 to rotate within the housing. As shown here, the rotational mechanism 1115 can be an O-ring. A post-operative wound treatment device can also include a spool pad 1220.
Although the preceding description contains significant detail in relation to certain preferred embodiments, it should not be construed as limiting the scope of the invention but rather as providing illustrations of the preferred embodiments.
Embodiments of the present invention encompass kits having one or more components of a post-operative surgical site wound treatment device as disclosed herein. In some embodiments, the kit includes one or more post-operative surgical site wound treatment device components, along with instructions for using the device(s) for example according to any of the methods disclosed herein.
All features of the described systems and devices are applicable to the described methods mutatis mutandis, and vice versa.
In addition, each reference provided herein in incorporated by reference in its entirety to the same extent as if each reference were individually incorporated by reference. Relatedly, all publications, patents, patent applications, journal articles, books, technical references, and the like mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, patent application, journal article, book, technical reference, or the like was specifically and individually indicated to be incorporated by reference.
While preferred embodiments of the present disclosure have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.
This application claims the benefit of U.S. Provisional Patent Application No. 62/982,653 filed Feb. 27, 2020, the disclosure of which is incorporated herein by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2021/019852 | 2/26/2021 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 62982653 | Feb 2020 | US |
