Patent Application
20230225823
Not applicable.
Typically, surgical procedures aim to prevent materials, including pathogens, from entering the surgical site (e.g., a surgical field) of a patient. This is often accomplished by utilizing sterile drapes that cover areas surrounding the surgical site, and specialized clothing worn by personnel (e.g., gloves scrubs, gowns, masks, etc.) all of which prevent the transmission of pathogens from the exterior environment and into the surgical site of the patient. However, while these practices often mitigate transmission of pathogens into a patient, these current practices can be inadequate to protect the personnel from the transmission of materials, such as pathogens, from the patient. Thus, it would be desirable to have improved systems and methods for controlling spread of aerosolized substances (including airborne liquids and particulates, and droplets) during clinical or laboratory procedures.
The present disclosure provides systems and methods that overcome the aforementioned drawbacks by controlling or mitigating the transmission of materials, including pathogens, from an enclosed area surrounding the patient or a laboratory sample into an exterior area occupied by personnel. As will be described, systems and methods are provided to form such as enclosure using a barrier configured to form a three-dimensional (3D) structure. The 3D structure may include passages extending through the barrier to provide access from the exterior space and into the interior volume. Such passages may have further systems to control materials from exiting the interior space via the passages. The 3D structure may also include systems to restrict movement form the interior space to the exterior along joints, folds, or edges of the barrier. Thus, a new concept in clinical tool is provided that serves to control and mitigate the transmission of materials, including pathogens, from an interior space that encloses the patient or laboratory sample that is the focus of the clinical or laboratory procedure into an exterior area occupied by one of the personnel. This new paradigm seeks to not just protect the patient or laboratory sample from materials, including pathogens, in the exterior world, but to also protect the personnel form the materials, including pathogens, present with the patient or laboratory sample when performing a clinical procedure.
In some aspects of the disclosure, systems and methods are provided for controlling the spread of airborne substances during clinical or laboratory procedures. Some non-limiting examples of the disclosure provide a system for enclosing and separating one of a patient from personnel while the personnel perform a procedure on the patient, or a laboratory sample from a technician while studying the laboratory sample, the system comprising: a barrier configured to form a three-dimensional (3D) structure to define an interior volume and an exterior space and to mitigate fluid movement from the interior volume and into the exterior space thereby mitigating droplet, particulate, and aerosol movement in the flow path of the fluid from the interior volume and into the exterior space; a plurality of passages extending through the barrier to provide access from the exterior space and into the interior volume to perform the procedure on the patient or perform the study on the laboratory sample arranged in the interior volume, and the barrier is configured to be formed in the 3D structure to arrange a portion of the patient or the laboratory sample in the interior volume. The barrier can be positioned to be external to the patient if the personnel perform a procedure on the patient. In some non-limiting examples, the entire barrier can be positioned external to the patient.
In some aspects, a free end of the barrier includes a flange that extends along and engages with a portion of a patient or the laboratory sample or a structure to enclose the patient or the laboratory sample.
In some aspects, the flange includes a coupling layer that couples to the portion of a patient or the laboratory sample.
In some aspects, the flange has a first surface and a second surface. The coupling layer can be coupled to the first surface of the barrier.
In some aspects, the coupling layer includes an adhesive.
In some aspects, the isolation system can include a support structure that maintains at least a portion of the 3D structure.
In some aspects, the support structure can include a scaffold that is coupled to an interior volume of the barrier, coupled to the exterior surface of the barrier, or integrated within the barrier.
In some aspects, the scaffold includes a plurality of support beams.
In some aspects, a first support beam within the plurality of support beams is curved.
In some aspects, two adjacent support beams within the plurality of support beams are separated along an axial axis of the 3D structure.
In some aspects, a given support beam within the plurality of support beams is coupled to the two adjacent support beams.
In some aspects, the given support beam includes a resilient portion, the resilient portion configured to bend to allow the given support beam to be folded or shaped.
In some aspects, the support structure can include a sleeve coupled to at least one of the interior surface and the exterior surface of the barrier, the sleeve configured to receive a support beam.
In some aspects, the barrier can include a central region, a first region with a first free end extending from the central region, the first region having a first edge, and a second region with a second free end extending from the central region, the second region having a second edge. The first edge of the first region can be configured to be coupled to the second edge of the second region to join the first region to the second region. The coupling of the first edge to the second edge provides an adjoined edge of the barrier that mitigates fluid movement from the interior volume and into the exterior space along the adjoined edge thereby mitigating droplet, particulate, and aerosol movement from the interior volume and interior the exterior space along the adjoined edge.
In some aspects, the first edge of the first region includes a strip that extends along a portion of the first edge.
In some aspects, the strip includes and an adhesive layer configured to be secured to a surface of the second region.
In some aspects, the strip is removable coupled to a surface of the second region.
In some aspects, the strip includes at least one of a hook and a loop fastener, and the surface of the second region includes the other of the at least one of the hook and the loop fastener.
In some aspects, the first edge of the first region includes a first sleeve that extends along a portion of the first edge. The second edge of the second region can include a second sleeve that extends along a portion of the first edge. The scaffolding can include a support beam that is received though the first sleeve and though the second sleeve to couple the first region to the second region.
In some aspects, the first sleeve is positioned above the second sleeve.
In some aspects, a portion of the first sleeve and a portion of the second sleeve extend along the same axial dimension of an axial axis of the 3D structure.
In some aspects, the barrier includes the creases. The support structure can include a support layer coupled to and situated within a portion of the crease. The support layer can be configured to maintain the shape of the crease.
In some aspects, the barrier can include the creases. The creases can include a first crease being curved, and a second crease being curved. The first crease, and the second crease can be axially displaced from each other along an axial axis of the 3D structure.
In some aspects, the first crease and the second crease are coaxially aligned with each other along the axial axis.
In some aspects, the barrier includes the creases, and the creases can include a first crease being curved and extending along an axial axis of the 3D structure, and a second crease being curved and extending along the axial axis of the 3D structure. The first crease, and the second crease can emanate from the axial axis along opposing directions.
In some aspects, the barrier can include a tab emanating from an exterior surface of the barrier. The tab can have a first surface that is positioned towards the patient or the laboratory sample, and an opposite second surface that is positioned towards the exterior space. The first surface of the tab can have a coupling layer configured to be secured to a structure to couple the barrier to the structure.
In some aspects, the coupling layer includes an adhesive layer.
In some aspects, the coupling layer removably couples the tab to the structure.
In some aspects, the coupling layer is at least one of a hook and a loop fastener.
In some aspects, the barrier can include a plurality of tabs emanating from the exterior surface of the barrier. The plurality of tabs can have a coupling layer. The plurality of tabs can include the tab.
In some aspects, the barrier has a thickness. The thickness of the barrier can increase along a portion of the barrier.
In some aspects, the 3D structure has a first axial end located proximal to the patient or the laboratory sample and a second axial end opposite the first axial end. The first axial end and the second axial end can be positioned along an axial axis of the 3D structure. The portion of the barrier can have the increased thickness can be positioned closer to the first axial end than the second axial end. The portion of the barrier can have the increased thickness maintains the 3D structure of the barrier.
In some aspects, the isolation system can include a weight that is coupled to an interior surface of the barrier, coupled to the exterior surface of the barrier, or integrated within the barrier.
In some aspects, the 3D structure has a first axial end located proximal to the patient or the laboratory sample and a second axial end opposite the first axial end. The first axial end and the second axial end can be positioned along an axial axis of the 3D structure. The weight can be coupled to or integrated within the barrier at a location that is closer to the first axial end than the second axial end. The weight can maintain the 3D structure of the barrier.
In some aspects, a free end of the barrier can include a flange that extends along and engages with a portion of a patient or the laboratory sample or a structure to enclose the patient or the laboratory sample. The flange can have a first surface and a second surface. The first surface can have a coupling layer that couples to the portion of a patient or the laboratory sample or the structure. The weight can be coupled to the second surface of the flange.
In some aspects, the weight extends along a portion of the flange to reinforce the structure of the flange to maintain the shape of the 3D structure.
In some aspects, the plurality of passages include an arm port configured to receive an arm of one of the personnel.
In some aspects, the arm port includes an aperture.
In some aspects, the isolation system can include a flap that is removably coupled to the barrier. When the flap is coupled to the barrier, the flap can extend across the aperture to generate a seal.
In some aspects, the flap is magnetically coupled to the barrier.
In some aspects, the flap includes at least one of a hook and a loop fastener, and the barrier includes the other of the at least one of the hook and the loop fastener.
In some aspects, the arm port can be a valve that prevents fluid contained in the interior volume from flowing through the valve and into the exterior space. When the arm is inserted through the valve an into the interior volume, the valve can sealingly engage with the arm to prevent fluid contained in the interior volume from flowing through the valve and into the exterior space when the arm is inserted into the valve.
In some aspects, the valve includes a plurality of flaps that contact each other to generate a seal.
In some aspects, the isolation system can include a rigid attachment having a hole therethrough that interfaces with and is coupled to the boundary that defines the aperture.
In some aspects, the isolation system can include a plug removably coupled to the rigid attachment that generates a seal to prevent fluid in the interior volume from flowing through the hole of the rigid attachment and into the exterior space.
In some aspects, the plug is threadingly engaged with the rigid attachment.
In some aspects, an arm sleeve having a rigid cuff is removably coupled to the rigid attachment.
In some aspects, the isolation system can include a fastening assembly including a fastener and a strip of material. The arm sleeve can be configured to be rolled into a compact configuration. The strip of material can be wrapped around the arm sleeve in the compact configuration and fastened with the fastener.
In some aspects, the arm sleeve can include a proximal portion and a distal portion. The proximal end and the distal end can be removably coupled from each other.
In some aspects, the arm sleeve includes a clasp locker having a slider that when slid either couples or decouples the proximal portion to or from the distal end of the arm sleeve.
In some aspects, when the arm sleeve is in a first configuration the slide is positioned internally to the arm sleeve and in the exterior space. When the arm sleeve is inverted to a second configuration the slide is positioned externally to the arm sleeve and within the interior volume of the 3D structure.
In some aspects, the arm sleeve includes a proximal end and an opposite distal end. The arm sleeve can include a region of material weakness that is circumferential.
In some aspects, the region of material weakness includes a perforation.
In some aspects, the isolation system can include an arm sleeve integrally formed with the barrier. The arm sleeve can extend away from the barrier. The sleeve can be configured to be inverted when inserted into the interior volume of the 3D structure.
In some aspects, a given passage of the plurality of passages includes an instrument attachment configured to be removably coupled to an instrument.
In some aspects, the instrument is a magnifying instrument. The magnifying instrument can be at least one of a microscope, an endoscope, and an exoscope.
In some aspects, the instrument attachment can include an elastic ring that is seated within the given passage, or is coupled to the exterior surface or the interior surface of the barrier proximal to the given passage. The elastic ring is configured to expand to surround a portion of the instrument to secure the barrier to the instrument and to generate a seal that prevents fluid contained within the interior volume from flowing through the given passage and into the exterior space.
In some aspects, the instrument attachment includes a cuff extending from the exterior surface of the barrier and surrounding a portion of the given passage, the cuff having a free end that is configured to be coupled to the cuff to adjust a circumference of the cuff to couple the cuff to a portion of the instrument.
In some aspects, a given passage of the plurality of passages includes a first fluid port.
In some aspects, the isolation system can include a first filter in sealing engagement with the first fluid port The first filter can allow fluid contained in the interior volume to flow out through the first filter and into the exterior space, and fluid within the exterior space to flow through the first filter and into the exterior space.
In some aspects, the first filter is at least one of positioned within the first fluid port, or extended across the first fluid port.
In some aspects, the first filter has pores sized to block at least one of pathogens, and tissue particulates.
In some aspects, another given passage of the plurality of passages includes a second fluid port. The isolation system can include a second filter in sealing engagement with the second fluid port. The second filter can allow fluid contained in the interior volume to flow out through the second filter and into the exterior space, and fluid within the exterior space to flow through the second filter and into the interior volume. The first port can have the first filter, and the second port can have the second filter allowing the volume of the interior volume to be substantially constant.
In some aspects, the first fluid port is sized to receive a suction probe of a suction system.
In some aspects, the isolation system can include a suction attachment. The suction probe can be removably coupled to the first fluid port.
In some aspects, the suction attachment can be a valve. The valve being configured to sealingly engage the probe of the suction system when the probe is inserted through the valve and into the interior volume.
In some aspects, the first fluid port includes a rigid attachment. The suction probe can be configured to be threadingly engage with the rigid attachment to provide a sealing engagement between the first fluid port and the suction probe.
In some aspects, the 3D structure has a proximal side, a distal side, and adjacent sides between the proximal and distal sides. The proximal side can be positioned towards one of the personnel. The plurality of passages can include a first arm port, and a second arm port located on the proximal side of the 3D structure. The first fluid port can be positioned on the proximal side of the 3D structure.
In some aspects, the isolation system can include a bag extending from the exterior surface of the barrier. The bag can be in fluid communication with the interior volume of the 3D structure. The first fluid port can be located on the bag.
In some aspects, the barrier allows all wavelengths of visible light to pass through.
In some aspects, the barrier has a visible light attenuation coefficient in a range.
In some aspects, the isolation system can include a window integrated within a portion of the barrier. The window can be formed of a material that allows a visible wavelength of light to pass through.
In some aspects, a portion of an interior surface of the barrier has a coating that captures at least one of pathogens, and tissue particulates.
In some aspects, the coating is charged to attract pathogens and tissue particulates having the opposing charge, and to repel pathogens and tissue particulates having a similar charge.
In some aspects, the coating is an adhesive.
In some aspects, the coating includes at least one of a disinfectant, a medicant, or a binding agent. The at least one of the disinfectant, the medicant, or the binding agent inactivate the pathogen.
In some aspects, the isolation system can include a debris detection system positioned within the interior volume of the 3D structure.
In some aspects, the debris detection system can include a light source, an image sensor, and a processor. The processor can be configured to acquire imaging data from the image sensor, and quantify a density of particles within the interior volume from the imaging data.
In some aspects, the isolation system can include a suction probe positioned within the interior volume of the 3D structure. The processor can be further configured to compare the density of the particles to a threshold density, and activate the suction probe to provide suction based on the density of the particles exceeding the threshold density.
In some aspects, the barrier includes a series of pleats. The series of pleats can be circumferentially oriented around an axial axis of the 3D structure.
In some aspects, the pleats are at least one of: a knife pleat, a box pleat, a double box pleat, or a cartridge pleat.
In some aspects, the barrier includes a series of creases. The series of creases are curved and are oriented along an axial axis of the 3D structure, or are circumferentially positioned and separated along the axial axis.
In other aspects of the disclosure, a system is provided for enclosing and separating a patient from personnel while the personnel perform a procedure on the patient, the system comprising: a barrier configured to form a three-dimensional (3D) structure to define an interior volume and an exterior space and to mitigate fluid movement from the interior volume and into the exterior space thereby mitigating droplet, particulate, and aerosol movement in the flow path of the fluid from the interior volume and into the exterior space; a plurality of passages extending through the barrier to provide access from the exterior space and into the interior volume to perform the clinical procedure on the patient, and the barrier is configured to be formed in the 3D structure to arrange a portion of the patient in the interior volume. The barrier can be positioned external to the patient. In some non-limiting examples, the entire barrier can be positioned external to the patient.
In still other aspects of the disclosure, a system is provided for enclosing a magnifying instrument, the system comprising: a barrier configured to form a three-dimensional (3D) structure to define an interior volume and an exterior space and to mitigate fluid movement from the interior volume and into the exterior space thereby mitigating droplet, particulate, and aerosol movement in the flow path from the interior volume and into the exterior space; a plurality of passages extending through the barrier to provide access from the exterior space and into the interior volume, wherein the barrier is configured to be formed in the 3D structure to arrange a portion of a patient or a laboratory sample in the interior volume, and wherein a field of view of the magnifying instrument is located within the interior volume of the barrier.
Other aspects and features of the disclosure are provided throughout.
Current clinical practices aim to prevent the external environment (e.g., the operating room) from contaminating the surgical site of the patient. In other words, the general aim is to isolate the patient or the surgical site from the external environment, except carefully-selected and sterilized tools or resources. However, the recent emergence of patients that (potentially or that do) harbor the novel severe acute respiratory syndrome coronavirus 2 (“SARS-CoV-19” or COVID-19) in the hospital setting has revealed a gap in current operatory practices in protecting personnel from materials or pathogens associated with the patient or a laboratory sample. For example, while sterilized gowns, masks, scrubs, etc., may decrease the transmission of the virus (or other pathogens) from the patient to personnel, these protective measures are still far from perfect. In fact, these measures can be severely ineffective during procedures that generate aerosols, or other airborne tissue particulates, which are known to more effectively transmit certain pathogens (e.g., the SARS-CoV-19). These measures are even worse when the aerosolizing procedure is conducted at a location where the pathogen is known to reside.
Some non-limiting examples of the disclosure provide systems and methods for controlling the spread of airborne substances during clinical or laboratory procedures, which provide improvements over typical isolation systems. For example, some non-limiting examples of the disclosure provide a barrier that forms a three-dimensional (“3D”) structure that encloses a patient during an operatory procedure. The barrier having the 3D structure has an internal volume that encloses a surgical site of the patient, and thus mitigates fluid movement (that can contain pathogen laden aerosols, tissue particulates, etc.) from escaping into the exterior space (e.g., the operatory room). This isolation of the personnel from the potentially infected patient provides a unique change in current sanitation philosophy aimed at allowing the personnel to effectively complete a procedure, while simultaneously ensuring that the personnel are adequately protected from pathogen transmission. In some cases, this approach can be particularly helpful during clinical or laboratory procedures that produce aerosolized debris (e.g., tissue, bone, fluids such as mucosa, etc.), because some aerosolized debris (e.g., tissue) pose a greater risk to contraction of a disease as compared to other particulates (e.g., small droplets that contain the infectious agent, such as bacteria, fungi, and viruses) that are not produced during these types of procedures (e.g., aerosol producing procedures).
Some non-limiting examples of the disclosure provide components (or features) that help to effectively facilitate the procedure, or which aid in the removal (or identification) of aerosols or particulates that can be pathogen laden. For example, the barrier can include components (or can have properties) that can help to maintain the 3D structure, such as, for example, a scaffold, pleats, creases (having support layers), a folding pattern, tabs, flanges, weights, instrument attachments (e.g., for magnifying instruments, such as microscopes, endoscopes, exoscopes, etc.), etc. As another example, the barrier can include components (or features) that can help to effectively facilitate the procedure, such as, for example, passages including instruments ports, arm ports, viewing windows, suction ports, etc. These passages that extend through the barrier can provide access from the exterior space and into the interior volume of the barrier. Thus, passages extending through the barrier, can be passages that are through the material of the barrier (e.g., holes, apertures, etc.), and can be passages beneath (or underneath) the barrier (e.g., to form a non-hermetic seal, acting as a curtain over an arm of one of the personnel). As yet another example, the barrier can include components or features that can help to remove aerosols or particulates, such as, for example, suction bags, suction ports, filters, barrier coatings (or barrier properties), etc. As still another example, the barrier can include components that can help to identify (and quantify) the amount of particulates or aerosols in the interior volume defined by the 3D structure of the barrier.
In some non-limiting examples, materials of the barrier 102 can include metals (e.g., metal alloys), polymers, plastics (e.g., pressure or heat activated thermoplastics, polylactic acid plastics, polycaprolactone plastics, polyvinyl chloride plastics), silicones, glass, fiberglass, ceramics, mesh, fabric, etc. In some cases, at least one material of the barrier 102 at an appropriate portion of the barrier 102 can be partially (or fully) transparent so as to allow the personnel to view the contents of the interior volume of the 3D structure (e.g., when conducting the procedure). In some non-limiting examples, the materials of the barrier 102 can be flexible while being rigid (e.g., to define the 3D structure). For example, the barrier 102 can have a degree of flexibility and a degree of rigidity. In some non-limiting examples, the barrier 102 can have an outer surface (or inner surface) that has antireflective properties (or includes an antireflective coating), so as to reduce glare (e.g., from operating room lights).
The barrier 102 is configured to be formed into the 3D structure 104 that defines an interior volume and separates the interior volume from the exterior space. In other words, the 3D structure 104 isolates (or otherwise mitigates fluid movement) from the internal volume and into the exterior space (or vice versa). The 3D structure 104 can embody many different shapes, such as, for example, a hemisphere, a cone, a frustoconical structure, pyramidal structures (e.g., square pyramids, triangular pyramids, etc.), prisms (e.g., octagonal prisms, rectangular prisms, square prisms, etc.). In some non-limiting examples, the barrier properties 106 of the barrier 102 can help to maintain the 3D structure 104. For example, the barrier properties 106 can include a varying thickness of the barrier 102 that distributes the weight of the barrier at particular locations so as to maintain the 3D structure 104. As a more specific example, the thickness of the barrier 102 can be increased near an end of the barrier 102 that contacts the patient. This way, the inherent increased weight of the barrier 102 pulls other portions of the barrier 102 to maintain the 3D structure 104 (e.g., pulls other portions of the barrier 102 taut). In some cases, the increased thickness of the barrier 102 can be located along circumferential portions (or otherwise along portions of the perimeter) of the barrier 102. As another example, the increased thicknesses of the barrier 102 can be located near on or at opposing sides of creases, pleats, or other supporting structures such as a support beam of a scaffold. In this way, with the increased weight on opposing sides, the increased weight can further define these features or otherwise prevent changing of the 3D structure 104.
In some non-limiting examples, the barrier 102 can include flanges 108 that can also help to maintain the 3D structure 104 or facilitate maintaining a complete enclosure, without undesired gaps or passages, such as along edges of the barrier 102 (e.g., where the barrier 102 meets the floor or two walls of the barrier 102 meet). In some non-limiting examples, the flanges 108 are extensions of the barrier 102, but which are formed when the three-dimensional structure 104 is formed. In this case, for example, the flanges 108 can have a coupling layer (e.g., an adhesive layer) disposed on the exterior surface of the flange 108 (e.g., in a pre-formed or flat configuration) that engages with the patient. When this coupling layer is engaged with a subject, the barrier 102 bends to form the flange 108. Thus, the flange 108 provides a sealing engagement between the patient and the barrier to create a “floor” of the barrier that mitigates (or which can prevent) fluid flow from the interior volume and under the flange 108. In some non-limiting examples, the flange 108 can be pre-formed. For example, the flange 108 can be formed from reinforced rings, perimeters, etc., that are coupled to (or otherwise integrated within) the barrier 102. The reinforced rings, perimeters, etc., can be formed out of malleable materials (e.g., metals), so that personnel can customize the shape of the perimeter based on a particular procedure. In some cases, the reinforced rings, perimeters, etc., can be advantageous in that the flange 108 being pre-formed can be more quickly/easily installed to isolate a particular region of the patient.
In some non-limiting examples, the barrier 102 can have a single flange 108 or multiple flanges 108. For example, in the case of multiple flanges 108, the multiple flanges 108 can extend (or span) around particular regions of the perimeter of the barrier 102. This can be advantageous in that only specific locations may need flanges to provide an adequate seal that can adequately control the spread of pathogen harboring tissue particulates, or aerosols, thus minimizing installation time. In some non-limiting examples, the flange 108 can span along the entire portion of the perimeter of the barrier 102, and thus provide a higher degree of sealing (e.g., when engaged with the patient). In some non-limiting examples, a first flange 108 can extend into the interior volume, and a second flange 108 can extend away from the interior volume. In some cases, the first and second flanges 108 can be adjoining, while in other cases, the first and second flanges 108 can be separated along the perimeter of the barrier 102. By having two flanges, the surface area of the coupling layer that engages with a patient can be increased, which can provide a better seal. In some non-limiting examples, the flange 108 that extends into the interior volume can define the perimeter of the surgical opening.
In some non-limiting examples, the flange 108 can include a flap that is coupled to the barrier 102 and is situated between opposing ends of the barrier (e.g., along an axial direction of the barrier). This flap can extend around a portion or the entire perimeter of the 3D structure 104 of the barrier 102. Similarly to the other flanges, a lower surface of the flap can include a coupling layer (e.g., an adhesive). In this way, the flap can be pulled and coupled to the patient (or a structure), via the coupling layer, to help maintain the 3D structure 104 of the barrier 102. In other cases, the flap can be coupled to the patient or structure using a fastener (e.g., a clip, clamp, etc.).
In some non-limiting examples, the barrier 102 can have pleats, folds, and support layers 110 that can also help to maintain the 3D structure 104. The barrier 102 can have pleats, folds, support layers, or combinations thereof. The pleats can be implemented in many different ways. For example the pleats can be a knife pleat, a box pleat, a double box pleat, a cartridge pleat, etc. The pleats can be formed around particular regions of the barrier 102 in particular patterns to help maintain the desired 3D structure 104. For example, in the hemispherical or conical (or frustoconical) 3D structure 104, the pleats can be formed circumferentially around the barrier 102, whereas in the prisms 3D structure 104, the pleats can be formed on at or near the faces of the prims (e.g., but not on the edges of the prisms), or alternatively the pleats can be formed on at or near the edges of the prism (e.g., but not on the faces of the prisms). The folds (or creases) can also be formed in different ways. For example, the folds can be formed along an axial dimension of the 3D structure 104, and can span circumferentially (or span the perimeter) around the barrier 102 (e.g., in an accordion-like fashion). As another example, the folds can be formed along a circumferential direction (or along the perimeter) of the 3D structure 104, and can span the axial dimension (or a portion) of the 3D structure 104. The support layers can also be implemented in different ways. For example, the support layers can be formed out of strips of an adhesive (e.g., a polymer) coupled to the barrier 102 and which can alone provide rigidity and weight along specific portions of the barrier 102. For example, similarly to the pleats the support layers can be formed circumferentially, axially, along a perimeter, etc., of the barrier 102. In some non-limiting examples, the support layers can be situated within creases of the folds or pleats, which can further define the given crease, and which can maintain the structure of the crease (e.g., prevent the crease from being unfolded). In some cases, the support layer can be an adhesive that can couple together two portions of the barrier thereby forming a crease. In this case, the dimensions of the crease (e.g., how much the crease bends) can be determined based on the thickness of the support layer (or amount of material of the support layer).
In some non-limiting examples, the barrier 102 can include weights 112 (or a weight) that can also help to maintain the 3D structure 104. The weights 112 can be embodied in many different forms. For example, the weights 112 can be coupled to the interior surface of the barrier 102, coupled to the exterior surface of the barrier 102, integrated within the barrier 102 (e.g., encapsulated between two sheets), etc. The weights 112 can be formed out of various materials, such as, for example, metals, plastics, etc., and can be formed to embody different shapes and sizes. For example, the weights 112 can span a portion of the circumference (or perimeter) of the 3D structure 104. In some cases, the weights 112 can be situated near an axial end of the 3D structure 104 that is closer to the patient (e.g., than the opposing axial end of the 3D structure 104). This way, the weights 112 provide increased stability to an end of the barrier 102 that contacts the patient. In some non-limiting examples, the weights 112 can be positioned on the flanges 108 (or on the reinforcing member) to increase the bonding interface between the flange 108 and the subject. Similarly, the weights 112 can be positioned on tabs emanating from the barrier 102 (described in more detail below), that also can increase the bonding interface between the tab and the subject. In some cases, the weights can be formed out of a different material than the barrier 102. For example, density of each weight 112 can be greater than the density of the barrier 102. In addition, the mass of each weight 112 can be greater than the mass of the barrier 102. In some cases, a weight 112 can be in the form of a ring and is coupled to the barrier 102. In some cases, each of the weight(s) 112 can be rigid.
In some non-limiting examples, the barrier 102 also can include adhesive layers 114, which can also help to maintain the 3D structure 104. The adhesive layers 114 can span various portions of the barrier 102, and can have varying thicknesses. In some cases, the flanges 108 can include an adhesive layer 114 which can have a relatively large thickness to ensure proper sealing engagement with the patient. In some cases, the barrier 102 can include an aperture that defines the perimeter of the surgical opening, and can have an adhesive layer 114 that spans a surface of the barrier 102 that surrounds the aperture. This can ensure a proper securement of the aperture ensuring that the aperture does not move during the procedure. In some non-limiting examples, the barrier 102 is formed out of a contiguous piece, but which must be manipulated to form the 3D structure 104. For example, the barrier 102 can have a plurality of free ends emanating from a central region (e.g., containing the aperture). One or both of the free ends can include a strip extends from and along an edge of a given free end. The strip includes an adhesive layer 114 that can be secured to a surface of the opposing free end. This securement helps to define the 3D structure 104 and creates an adjoining edge between respective edges of respective free ends that mitigates fluid movement from the interior volume and into the exterior space along the adjoined edge. In some non-limiting examples, the barrier 102 can include tabs emanating from the exterior surface and having an adhesive layer 114 (or other coupling layer). The tabs can be situated near on or at the axial end of the 3D structure closer to the patient. The tabs can be coupled to the patient to provide additional securement locations along the patient, which can help to maintain the 3D structure.
In some non-limiting examples, the barrier 102 also can include a scaffold 116 that can also help to maintain the 3D structure 104. The scaffold 116 can generally act as a reinforcement system, a skeleton, etc., for the barrier 102 to provide a rigid support system for the barrier 102. Thus, the scaffold 116 can embody many different forms. For example, the scaffold 116 can include a plurality of support beams that can be coupled to the interior surface of the barrier 102, coupled to the exterior surface of the barrier 102, integrated within the barrier 102 (e.g., encapsulated between two sheets), etc. The support beams can be rigid, but can also be malleable so as to form different shapes for a particular procedure, such that the scaffold 116 can be customizable. The support beams can be formed out of metals, plastics, etc. The support beams can be oriented in many different ways or configurations. For example, the support beams can emanate out radially relative to an axial axis of the 3D structure 104, and can be curved along the axial axis. As another example, the support beams can be circumferentially oriented around the axial axis, and respective support beams can be separated along the axial axis. In some non-limiting examples, support beams (e.g., adjacent support beams) can be coupled together with other support beams. For example, two support beams that are circumferentially oriented around the axial axis can be coupled to a support beam that extends along the axial axis.
In some non-limiting examples, the scaffold 116 having the support beams can help to define the 3D structure 104 when the barrier 102 has a plurality of free ends emanating from a central region. For example, both of the free ends can include sleeves that are configured to (dimensioned, sized, etc.) receive a support beam. In this case, the support beam is received through both of the sleeves thus joining respective edges of the respective free ends. In some cases, one sleeve can be positioned above the other sleeve, such that the sleeves are coaxially aligned to receive a substantially straight support beam to join the respective edges of the respective free ends. In some cases, the sleeves both extend along the same axial dimension, and the support beam can have two axial portions, such that one axial portion is received through one of the sleeves, and the other axial portion is received through the other of the sleeves to join the respective edges of the respective free ends.
In some non-limiting examples, the scaffold 116, and in particular the support beams of the scaffold 116 can be formed out of a rigid material, or can be formed out of a flexible material. Regardless, the material of the scaffold 116 can be different than the material of the barrier 102. In some cases, the scaffold 116 can be formed out of a metal, a plastic, etc.
In some non-limiting examples, the barrier 102 also can include instrument attachments 118 that can also help to maintain the 3D structure 104. The instrument attachments 118 can be coupled to an interior surface of the barrier 102, an exterior surface of the barrier 102, or integrated within the barrier 102, and generally allow the barrier 102 to be secured to the particular instrument to provide a securement location that can stabilize the barrier 102 and to maintain the 3D structure 104. As an example, the instrument attachment 118 can include an elastic ring (or other shape) that can expand and retract over a portion of the instrument to generate a sealing engagement with the portion of the instrument. As another example, the instrument attachment 118 can include a cuff (e.g., of a shape corresponding to the instrument) that can be removably coupled (e.g., hook and loop fasteners, magnetically coupled, etc.) to itself to adjust the size of the perimeter of the cuff. Thus, the specific instrument can be inserted into the cuff and a free end of the cuff can be used to tighten the engagement (e.g., decrease the perimeter) and can then be coupled to a location of the cuff to securely fasten the instrument to the instrument attachment. As yet another example, the instrument attachment can be an elastic (or otherwise membranous) sheet having a hole therethrough. The particular instrument can be inserted into the hole and the elastic material retracts around the instrument to provide a sealing engagement with the portion of the instrument. In some cases, a region of material weakness (e.g., a perforation) can be located below the instrument attachment 118 so as to allow quick removal and containment of potential airborne particulates or aerosols within the interior volume when the barrier 102 is deconstructed (e.g., upon completion of the procedure). In some cases, the instrument is a magnifying instrument (e.g., a microscope, an endoscope, an exoscope, etc., such as for use in an otolaryngology procedure). In some cases, the instrument attachment 118 can be a hole with an adhesive layer that extends partially or entirely around the hole. In this way, the adhesive layer can be coupled to a portion of the instrument 118. In other cases, the instrument attachment 118 can include an adjustable tightening component (e.g., an elastic band, a cable tie, an irised mechanism, etc.). In some configurations, an adhesive layer can be positioned on the interior surface of the barrier 102, which can partially (or fully) extend around (e.g., circumferentially) the barrier 102.
In some non-limiting examples, the instrument attachment 118 can be for use with an operating room light. For example, the instrument attachment 118 can include two straps coupled to the barrier 102 that can be received around respective ends of the operating room light. In some cases, this can include the handles of the operating room lights. In some non-limiting examples, the straps can be elastic to retractably engage the operating room light (or a component thereof, such as the handles of the operating room light). The specific engagement between the instrument attachment 118 with the operating room light can be advantageous for a number of reasons. First, this is a component that is typically always present in the operating room. Second, the operating light can provide ample light to the interior volume of the 3D structure, which can prevent the need for other light sources to visualize the contents situated in the interior volume. In some non-limiting examples, the instrument attachment 118 can generally be any supporting object in an operating room (e.g., a bed, the operating room light described above, etc.).
In some non-limiting examples, the isolation system 100 can include arm ports or sleeves 120. In some non-limiting examples the arm port(s) 120 are simply apertures directed into the barrier 102 and configured (e.g., dimensioned, sized, etc.) to receive an arm of personnel conducting the procedure. In some non-limiting examples, the arm port 120 can include a flap that is removably coupled to the exterior surface of the barrier 102 (e.g., with hook and loop fasteners, magnetically coupled, etc.) and that covers (or spans across) the entire (or a portion of the) aperture to provide a seal (e.g., when not in use). In some non-limiting examples, the aperture, and more specifically the edges of the barrier 102 that define the aperture can interface with (e.g., be coupled to) a rigid attachment (e.g., having a rigidity greater than the material of the barrier 102) that can more reliably define the arm port 120. For example, the rigid attachment can have a peripheral slot that receives the edges of the barrier 102 that define the aperture, and can have a hole therethrough that can be configured to receive an arm of personnel. In some non-limiting examples, the arm port 120 can include a valve that generates a seal when the valve is not in use, and when an arm of one of the personnel is received into the valve. Thus, the valve can be integrated with the aperture, with the rigid attachment, etc. In some non-limiting examples, the valve can have a plurality of flaps that retract to generate a seal. In some non-limiting examples, the arm port can include an elastic cuff (or otherwise membranous sheet having a hole therethrough) that can provide a sealing engagement when an arm is inserted. In other words, the elastic cuff or membrane expands to retract around the arm. In some cases, the elastic cuff (or the membranous sheet) are situated entirely or partially around the arm port 120. In some non-limiting examples, the arm port 120 can include a rigid band (e.g., a ring) that can define the aperture of the arm port 120. For example, the rigid band can be coupled to or integrally formed with the barrier 102, which can make insertion and removal of an arm through the arm port 120 easier. In some cases, the arm port 120 can include a cable tie (or in other words a zip-tie). In this way, the cable tie can be coupled to the barrier 102 and can surround the aperture of the arm port 120 to be adjusted. For example, the aperture of the arm port 120 can be decreased (e.g., around the arm of the personnel) by pulling the cable tie. In some configurations, a region of material weakness of the barrier 102 can be situated between the arm port 120 (e.g., configured as a hole) and the barrier 102. For example, the region of material weakness (e.g., a perforation) can extend partially (or entirely) around the arm port 120. In this way, the arm port 120 can be decoupled from the barrier 102 (e.g., after the surgical procedure has been completed).
In some non-limiting examples, the arm ports 120 can include a plug that can be received in the arm port 120 to prevent fluid from flowing from the interior volume and into the exterior space. The plug can embody many different forms. For example, the plug can be rigid and can be inserted into the aperture so that the material of the barrier 102 or the elastic cuff (or membranous sheet) expands and contracts around the plug to provide a sealing engagement (e.g., when the arm port 120 is not in use). In some non-limiting examples, such as with the rigid attachment, the plug can be elastic to expand around the rigid attachment to provide a sealing engagement. In other non-limiting examples, such as with the rigid attachment the plug (e.g., rigid) can be removably coupled the rigid attachment (e.g., magnetically coupled, threadingly engaged, hook and loop fastened, etc.).
In some non-limiting examples, the isolation system 100 can include arm sleeve(s) 120. In some non-limiting examples, the arm sleeves 120 are integrally formed with and extend outwardly away from the barrier 102. Thus, the integrally formed arm sleeves 120 can be inverted and inserted into the interior volume of the 3D structure 104 to prevent direct contact between the arm (or hand) of personnel and the patient. In some non-limiting examples, such as with the rigid attachment, the isolation system 100 can include an arm sleeve 120 having a rigid cuff that can be removably coupled to the arm port. For example, the rigid cuff of the arm sleeve 120 can be threadingly engaged with the arm port. Then, the arm sleeve 120 can be inverted into the interior volume of the 3D structure to prevent direct contact between the arm of personnel and the patient. In some non-limiting examples, the arm sleeve 120 can have an area of material weakness (e.g., a perforation) that, for example, can allow a hand portion of the arm sleeve 120 to be removed if personnel need better gripping. Additionally or alternatively, the arm sleeve 120 can also include a first portion that is removably coupled to a second portion. Again, this can allow personnel to easily remove the first portion from the second portion of the arm sleeve 120 if personnel need better gripping. In some cases, an area of material weakness (e.g., a perforation) can extend (partially or entirely) around a portion of the barrier 102 (e.g., the sleeve 120). In this way, the arm port 120 can be created when desired (e.g., just before conducting the procedure) so that when not in use fluid flow (and thus contaminants) are mitigated from flowing through the barrier 102 (e.g., because the arm port 120 has not been opened).
In some non-limiting examples, each arm sleeve 120 can include a glove positioned at the end of the sleeve 120. In some cases, the glove can be coupled to (or integrally formed with) the arm sleeve 120. In some cases, the glove can be formed out of the same material as the sleeve 120, or can be formed out of a different material (e.g., a material that has better gripping properties, such as a rubberized material, a textured material, etc.). In some configurations, each arm port 120 can have a sleeve 120 emanating from the barrier 102 (e.g., so the arm port 120 is coaxially positioned relative to sleeve 120, so the sleeve 120 surrounds he arm port 120). In some cases, the sleeve 120 can extend into the interior volume of the barrier 102. In addition, a free end of each sleeve 120 can be truncated (e.g., with the free end, or glove removed) so that when an arm of the personnel is positioned through the arm port 120 and the sleeve 120, the hand of the personnel extends past the sleeve 120 (e.g., so that the surgeon can manipulate instruments easier). In some cases, the length of the sleeve 120 can be varied to accommodate different arm sizes, or so that different amounts of an arm of a person extend past a free end of the sleeve 120.
In some non-limiting examples, the arm ports 120, the arm sleeves 120, or both can be appropriately positioned relative to other structures of the isolation system 100. For example, the arm ports 120, the arm sleeves 120, or both can be positioned below the scaffold 116. This way, the arms of personnel have enough clearance away from the scaffold 116 that may otherwise undesirably contact a portion of the arm sleeve 120 (e.g., potentially puncture a sleeve, or impede movement of the personnel arms). As another example, the arm ports 120, the arm sleeves 120, or both can be positioned below, above, or between the weights 112. In some non-limiting examples, with the weights 112 below the arm ports (or sleeves) 120, the arm ports (or sleeves) 120 can be less prone to movement (e.g., as the weights 112 mitigate movement of the barrier 102). In some non-limiting examples, with the weights 112 above the arm ports (or sleeves) 120, the weights 112 can provide additional sealing properties for the arm ports (or sleeves) 120.
Regardless of the structure of the arm ports (or sleeves) 120, each of the arm ports (or sleeves) generally provide a passage from the exterior space and into the interior volume of the 3D structure 104 so that a practitioner (and more specifically the arm of personnel) can interact with the patient within the interior volume of the structure 104. In some non-limiting examples, a given isolation system can include two arm ports or sleeves on each side of the barrier. For example, a generally cylindrical isolation shape (or other shape) can include eight arm ports or sleeves (e.g., so that other personnel can interact with the interior volume of the 3D structure).
In some non-limiting examples, each of the arm ports 120 (and corresponding sleeves 120) can be closed when not in use. For example, the arm ports 120 can be plugged, fastened, etc., to reduce the size of the aperture of the corresponding arm port 120. In addition, the sleeves 120 can be compressed (e.g., rolled up) for later expansion during use. For example, a fastener (e.g., a clasp, a clip, etc.) can extend around the compressed arm sleeve 120.
In some non-limiting examples, the isolation system 100 can include instrument port(s) 122. The instrument ports 122 can be similarly structured as the previously described arm ports (or sleeves) 120, and the instrument attachments 118, and thus these similar structures also pertain to the discussion of the instrument ports 122. The instrument ports 122 can be configured to (e.g., dimensioned, sized, etc.) receive various instruments for manipulating structures of the patient, such as, for example, surgical instruments that have cords. In some non-limiting examples, the instruments ports 122 can have sleeves attached, which can guide the cords of the instruments. In some configurations, the instrument ports 122 can be smaller than the arm ports 120.
In some non-limiting examples, the isolation system 100 can have a sanitation system 124, which will be described in more detail below. Generally, the sanitation system 124 provides components, features, structures, etc., that aid in the removal, identification, entrapment, or inactivation of pathogen laden aerosols and tissue particulates. For example, the sanitation system 124 can include suction ports, suction attachments, suction systems (e.g., sources), suction bags, coatings, charged properties (e.g., of the barrier 102), filters, debris detections systems having light sources and image sensors, other fluid ports (including those that connect to a pump to drive a fluid, such as air, into the interior volume of the barrier), pumps (e.g., air pumps), etc.
In some non-limiting examples, the isolation system 100 can include a disposal system 126. The disposal system 126 can be embodied in many different forms, and generally the disposal system 126 encloses off the interior volume of the 3D structure 104 for disposal of the isolation system 100 (e.g., upon completion of the procedure). For example, the disposal system 126 can be a loop of material that can be tied off in many different ways. As another example, a retaining ring (e.g., situated on a flange) can be crumpled to seal off the interior volume of the 3D structure 104 (e.g., after removal from the patient). As yet another example, the disposal system 126 can include clamps that close off respective ends of the 3D structure 104. In some cases, the disposal system 126 can include zippers that can be decoupled to retain the potentially pathogen laden air within the internal volume of the 3D structure prior to disposal of the barrier. In some configurations, opposing ends of the barrier 102 can each have a closing device. For example, one end of the barrier 102 (e.g., disposed under the instrument attachment 118) that is farthest away from the patient (or sample) can include a first closing device, and an opposing end of the barrier 102 that is closest to the patient can include a second closing device. Each of the closing devices separate two volumes at the closing device, and with two closing devices deployed (e.g., closed off), the interior volume of the barrier 102 can be isolated from the ambient environment. In this way, the aerosol and other particulates can be trapped after the procedure is complete. The closure devices can be a tie, a cable tie, an adhesive layer (e.g., that circumferentially extends around a portion or all of the barrier 102), etc. In some cases, an area of material weakness (e.g., a perforation) of the barrier 102 can be situated above the first closure device, and below the second closure device. In this way, with both closure devices deployed, the trapped interior volume of the barrier 102 with the closure devices deployed can be easily separated from the other portions of the barrier 102 at the two areas of material weakness.
In some non-limiting examples, the isolation system 100 can include a viewing window 129. The viewing window 128 can be integrated within the barrier 102, or can span across a hole in the barrier 102. The viewing window 128 generally allows for a practitioner to visually see through the viewing window 128 to help to facilitate the procedure. So, the viewing window 128 can be formed out of a material that allows light of at least one wavelength within the visible spectrum (e.g., light having a wavelength between 380 nm and 790 nm) to pass through. The viewing window 128 can be located at various locations on the barrier 102. For example, the viewing window 128 can be located on an axial end of the 3D structure 104 that is farther away from the patient (e.g., the opposing axial end of the 3D structure 104 being closer to the patient). The viewing window 128 can embody many different sizes, and shapes. For example, the viewing window 128 can be circular, square, rectangular, etc. In some non-limiting examples, the viewing window 128 can be partially (or fully) transparent to allow the personnel to view the contents within the interior volume of the 3D structure. In some cases, the viewing window 128 can be formed out of a rigid material (e.g., a clear plastic material). In some configurations, the viewing window 128 (e.g., the interior surface) can be electrically charged to repel particles from being adsorbed onto the surface of the window 128. In this way, the view of the viewing window 128 is not obscured.
In some non-limiting examples, isolation system 100 can include a pocket (or multiple pockets), and a wipe situated within each pocket (e.g., each pocket configured to receive a wipe). The pocket (and the corresponding wipe) can be situated within the interior volume of the barrier 102. In this way, if condensation forms (or particulates adsorb) on the viewing window 128, a practitioner can retrieve the wipe from the pocket, remove the wipe, and wipe off the condensation (or particulates) to improve viewing through the viewing window 128. In some cases, the wipe can be a piece of cloth, fabric, etc. The wipe can be soaked in a compound (e.g., a cleaning compound to facilitate cleaning of the viewing window 128).
In some non-limiting examples, the isolation system 100 can include an additional barrier (e.g., similar to the barrier 102) that is coaxially positioned relative to the barrier 102. For example, this additional barrier can be positioned so that the barrier 102 surrounds the additional barrier. In some cases, the additional barrier can include any of the components of the isolation system 100 (or any isolation system described). For example, the additional barrier can include an instrument attachment, a flange, etc. In this way, the additional barrier can further mitigate undesirable fluid flow from the interior volume and into the exterior space.
Although the above description of the isolation system 100 was in reference to personnel conducting an operatory procedure on a patient (e.g., a surgery on a patient such as, a neurosurgical procedure, a general surgery procedure, a vascular surgery procedure, an ear nose and throat (“ENT”) surgery procedure, an internal medicine procedure, an anesthesia procedure, a gastrointestinal procedure, a genitourinary procedure, an intensive care unit (“ICU”) procedure, an emergency medicine procedure, an orthopedic procedure, other aerosol generating procedures, etc.), it can be appreciated that in alternative non-limiting examples the isolation system 100 can be utilized for laboratory procedures, experiments, tests, etc., where a practitioner may interact with a sample that can spontaneously generate pathogen laden aerosols, tissue particulates, etc., or which can generate pathogen laden aerosols, tissue particulates, etc., during manipulation of the sample (e.g., during drilling of the sample, etc.). For example, these samples can include tissue biopsies, pathology screenings, testing swabs (e.g., from the SARS-CoV-19), etc.
In some non-limiting examples, the entire (or a portion of) the interior surface of the barrier 102 can be coated with (or formed out of) a materials that entraps or inactivates pathogens, tissue particulates, and aerosols. For example, the interior surface of the barrier 102 can include an adhesive layer that can entrap tissue particulates. In some cases, the interior surface of the barrier 102 can include chemicals, drugs, a medicant, etc., that can deactivate (or otherwise “kill”) pathogens. For example, the entire (or a portion of) interior surface of the barrier 102 can be treated with an anti-infectious agent, such as antibacterial compounds, anti-viral compounds, anti-fungal compounds, a layer of (liquid) bleach (e.g., sodium hypochlorite), activated carbon, a peroxide (e.g., hydrogen peroxide), etc. In some cases, the entire (or a portion of) the interior surface of the barrier 102 can be coated with (or formed out of) a material that attracts the aerosols (or particulates), such as having an electric charge, having a particular phobicity (e.g., hydrophobic), etc.
In some non-limiting examples, the barrier coating 130, which can be applied to the exterior or interior surface of the barrier 102 can be an anti-reflective coating, where the barrier 102 allows at least some visible light through. In other cases, the barrier 102 itself can be formed of a material that allows at least some visible light through and is anti-reflective. In other cases, the isolation system can include lights (e.g., incandescent, light emitting diodes, etc.) that can either be positioned in the exterior space, or the interior volume, or both, to allow better visualization of the contents within the interior volume (e.g., especially with the anti-reflective coating(s)).
In some non-limiting examples, the sanitation system 124 can include a suction system 132. In some non-limiting examples, the suction system can be a medical aspirator, a suction machine, etc. Thus, the suction system 132 can include a suction probe that supplies a suction source, a motor, tubing, filters, etc. In some non-limiting examples, the suction system 132 is part of a high-efficiency particulate air (“HEPA”) filtration system that can include tubing that supplies the suction source (to the HEPA filter).
In some non-limiting examples, the sanitation system 124 can also include suction bags (or a suction bag) 134. In some non-limiting examples, the suction bags 134 are coupled to and are in fluid communication with the interior volume of the 3D structure 104. Each suction bag 134 can include a hole directed therethrough that can receive a component of the suction system 132 (e.g., a suction probe, tubing leading to a suction system, etc.). In some non-limiting examples, the suction bag 134 is integrally formed with the barrier 102. In other non-limiting examples, the suction bag 134 can be coupled to a rigid cuff that can interface with a port (e.g., the instrument ports, the arm ports, the suction ports, etc.). In some cases, the suction bag 134 has a cross-sectional area that decreases from the coupling location to the barrier 102 and until it reaches the hole of the suction bag 134. In some non-limiting examples, the suction bags 134 can include ports (e.g., fluid ports), coatings (e.g., barrier coatings), charged properties, etc. In some non-limiting examples, the suction bags 134 can be positioned relative to various structures of the isolation system 100. For example, a suction bag 134 can be positioned on the same side of the barrier 104 as the arm ports (or sleeves) 120. This can be advantageous at least because the fluid flow path defined by the suction source can be relatively close to the arms of personnel (e.g., that conducts the procedure). In some cases, the suction bag 134 can be positioned entirely (or partially) within the interior volume of the 3D structure 104 of the barrier 102.
In some non-limiting examples, the sanitation system 124 can include port(s) 136. The ports 136 can be similarly structured as the previously described arm ports (or sleeves) 120, the instrument attachments 118, and the instrument ports 122, and thus these similar structures also pertain to the ports 136. For example, the ports 136 can simply be apertures (of various sizes and shapes) directed into the barrier 102, the ports 136 can have rigid attachments with holes directed therethrough, or the ports 136 can be (or include) valves as previously described. In some non-limiting examples, the ports 136 can be fluid ports that allow fluid to flow from the exterior space and into the 3D structure 104 of the barrier 102. In other non-limiting examples, the ports can be suction ports that are configured to receive tubing, a probe, etc., from a suction source (e.g., a component of the suction system 132). In some configurations, a port 136 can be a one way valve that is configured to allow fluid flow from the exterior space and into the interior volume (e.g., of the 3D structure 104 of the barrier 102), but which prevents fluid flow from the interior volume and to the exterior space. In this way, the as fluid is evacuated by the suction source, fluid (e.g., air) is replenished within the interior volume of the 3D structure 104 of the barrier 102 to maintain a substantially (e.g., deviating by less than 20%) constant interior volume.
In some non-limiting examples, the sanitation system 124 can include filters 138. The filters 138 can have varying thicknesses, shapes, etc., can be coupled to the barrier 102, and can be inserted into a flow path (e.g., into the suction bag 134). In some non-limiting examples, the filters 138 can be in sealing engagement with a port 136, which can be accomplished by coupling the filter 138 to the boundary of the port, or coupling the filter 138 to the barrier 102 so that the filter 138 spans across the entire port 136. In some non-limiting examples, the filters 138 can allow a certain percentage of airborne particles to pass through (e.g., 95%, being an N95 filter), and can have pore sizes that only allow certain sized particles to pass through.
In some non-limiting examples, the sanitation system can include fluid pumps 139, which are configured to drive fluid into the interior volume of the 3D structure. This way, “clean” fluid (e.g., air) can be introduced into the interior volume of the 3D structure, can interact with the fluid within the interior volume, to be evacuated by the suction system. A conduit, attachment, etc., of the fluid pump 139 can be interfaced with one of the fluid ports 136, and can be in sealing engagement with the respective fluid port 136.
In some non-limiting examples, the sanitation system 124 can include suction attachments 140. The suction attachments 140 can be fitted attachments that allow a probe, tubing, etc., of a suction source to be temporarily coupled to the suction attachment 140. For example, the suction attachment 140 could be a female attachment that allows the component of the suction source to be temporarily snap-fitted (e.g., interfacing with a male attachment). As another example, the suction attachment 140 could be threaded to threadingly engage the component of the suction source. As yet another example, the suction attachment 140 could be spring clip that when depressed allows jaws to retractingly engage the component of the suction source (or when depressed releases the engagement of the spring clip). In some non-limiting examples, and generally, the suction attachments 140 can emanate from a port 136.
In some non-limiting examples, the sanitation system 124 can include the debris detection system(s) 142. The debris detection system 142 can be in communication with the suction system 132, such that when the debris detection system 142 determines that a density of particles of the internal volume of the 3D structure 104 exceeds a threshold value, the debris detection system 142 can turn on the suction system 132, or can increase the output of the suction system 132 (e.g., increase the volume per unit of time). As shown the debris detection system 142 includes light sources 144, and image sensors 146, although it can be appreciated that other optical components could be utilized (e.g., lenses, prisms, etc.). In some cases, the light source 144 and the image sensor 146 can be coupled to the interior surface of the barrier 102. The light sources 144 can sufficiently illuminate the interior volume of the 3D structure 104. In some cases, some light wavelengths not emitted by the light sources 144 reflects off of a surface of the barrier 102. So, in this case, the interior surface (or exterior surface) of the barrier 102 can have a reflective coating (e.g., an ultraviolet or infrared reflective coating). In some cases, the light sources 144 are ultraviolet light sources, while in other cases, the light sources 144 are infrared light sources. In some configurations, the light source 144 can be a (low powered) UV light source (e.g., a UV LED) which can be coupled to the interior surface of the barrier 102. The UV light source can thus highlight areas of particulate (or aerosol) dispersion. In some cases, the debris detection system 142 can be a spectrometer (e.g., an optical spectrometer).
The image sensor(s) 146 can be embodied in different forms, such as a charged coupled device (“CCD”), active pixel sensors (e.g., CMOS image sensors). The image sensors 146 can be selective for the light produced by the light sources 144. This way, background light that may negatively impact image data acquired from the image sensors 146 can be mitigated. The debris detection system 142, although not shown, can include processors, displays, memory, and other typically used computing components. In some non-limiting examples, the debris detection system 142 can be located within the interior volume of the 3D structure 104, or can be positioned in the exterior space but in optical communication with the interior volume of the 3D structure 104 (e.g., an aperture of the debris detection system 142 can be aligned with an aperture of the 3D structure 104). In some non-limiting examples, the components of the debris detection system 142 can be packaged together within a housing. In some cases, the debris detection system 142 can include the barrier coating 130. For example, a color-changing compound can be disposed over the entire (or portions of the) interior surface of the barrier 102, which when contacted with debris, changes from one color to a different color. In some cases, rather than a coating the barrier 102 can be formed with the color-changing compound.
In some non-limiting examples, a support beam 226 can help to define the arm port 210. For example, the support beam 226 is coupled to the interior surface and near a free end of the barrier 102. The support beam 226 can be curved as shown and can define a maximum size of the arm port 210. For example, when an arm of a practitioner enters the arm port 210, the barrier 202 can be compressed (e.g., folded) until it reaches the boundary defined by the support beam 226. Thus, the support beam 226 can limit the size of the arm port 210. As shown, the isolation system 200 can include a plurality of tabs 212 that are coupled to (or are integrally formed with) the exterior surface of the barrier 202. The tabs 212 can have a coupling layer that couples (or removably couples) the respective tab 212 to a patient, a structure (e.g., a patient bed, a operatory table), etc. In some cases, the coupling layer is a hook or a loop faster, includes a magnet, etc. In other cases, the coupling layer is an adhesive. In some configurations, although the tabs 212 are illustrated as being situated at an edge of the barrier 202, the tabs 212 can be situated between opposing ends of the barrier 202 along the axial axis 224. In this way, a free end of the barrier 202 can be folded under itself (e.g., an upper portion of the barrier 202), while the tabs 212 can decrease relative movement between the isolation system 200 and the structure (or person) that the tabs 212 are coupled thereto.
The microscope attachment 214 can be embodied in many different forms as described above. However in the illustrated non-limiting example of
As shown, the scaffold 306 also can include support beams 316, 318, which generally extend along the axial axis 326. The support beam 316, which is similar to the support beam 318, has (substantially) rigid members 320, 322 joined by a resilient member 324. The rigid members 320, 322 can be formed of various materials (e.g., plastics), and the resilient member 324 can also be formed of various materials (e.g., silicone, rubber, etc.). Additionally, the rigid members can be shared between support members, such as the rigid member 322 being shared between support beams 316, 318. The resilient member 324 allows the rigid members 320, 322 to be displaced closer or farther away from each other. For example,
The central region 356 has a first surface and an opposite second surface, and surgical opening 366 therethrough. The surgical opening 366 is illustrated as being a rectangle, although other shapes, and sizes of the surgical opening 366 are contemplated. The first surface of the central region 356 faces out of the page relative to the view of
As shown, the free end 358 can include a strip 368 that is coupled to an extends along an edge 370 of the free end 358 that has a coupling layer. In some cases, the strip 368 is the barrier 352, while in other cases, the strip is a different material than the barrier 352 that can be coupled to the edge 370. Additionally, in the case of the strip 368 not being a portion of the barrier 352, the strip 368 can be coupled to a different portion of the barrier 352 (e.g., one of the surfaces of the barrier 352). The free end 358 also can include a sleeve 372 that is coupled to and spans along a portion of the edge 374 of the free end 358. Similarly to the strip 368, the sleeve 372 can be coupled to different portions of the barrier 352.
In some non-limiting examples, the free end 360 has a first region 376 coupled to a second region 378. The free end 360 also can include sleeves 379, 380 that are coupled to respective edges of the free end 360, although other coupling locations are contemplated. The second region 378, which is situated farther away from the central region 356 than the first region 376 also can include strips 383, 384, 386 that are coupled to respective edges of the second region 378, although other coupling locations are contemplated. Each of the strips 383, 384, 386 also include a coupling layer. The second region 378 also can include a viewing window 388 that is illustrated as being rectangular, although other sizes and shapes are contemplated for he viewing window 388. The viewing window 388 can be integrated within the barrier 352, or can be coupled to respective surfaces of the barrier 352 to form a sealing engagement with the barrier 352. The barrier 352 generally allows personnel to view the contents situated within the interior volume of the 3D structure 354. Thus, the viewing window 388 can be formed out of plastics that allow visible light through.
As shown, the free end 362 also has a strip 390 having a coupling layer, which is coupled to and extends along a distal end of the free end 362. The free end 364 also has strips 392, 394, 396 that are coupled to and that extend along respective edges (or ends) of the free end 364. The strips 392, 394, 396 also have a coupling layer. The coupling layer can be embodied in many different forms. For example, the coupling layer can allow the respective component to be removably coupled to another components. Thus, the coupling layer can include a magnet, a hook and loop fastener, a different fastener (e.g., a bolt and a nut), etc. The coupling layer can also be configured to couple to components together. Thus, the coupling layer can be, for example, an adhesive layer that bonds to the other component.
In some non-limiting examples, while not illustrated in
The isolation system 500 can include weights 510, 512, 514 that can help maintain the 3D structure 504. As shown, the weight 510 is coupled to the exterior surface of the barrier 502, the weight 512 is coupled to the interior surface of the barrier 502, and the weight 514 is integrated within the barrier 502. Although the illustrated non-limiting example of
The illustrated non-limiting example of
Although
In some non-limiting examples, the arm sleeve 620 also can include a region of material weakness implemented as a perforation 632, and a clasp locker 634 (e.g., a zipper) having a slider 636. In a first configuration, similarly to the arm sleeve 600, the sleeve 624 extends away from the barrier 630 and into the exterior space (e.g., an inverted configuration to the configuration of
For example,
As shown, the HEPA filtration system 746 has tubing 758 that interfaces with a port (previously described) of the barrier 742. Similarly, the suction source 748 also integrates with a port located in a suction bag coupled to the barrier 742. In some non-limiting examples, the detection system 744 can be in communication with the HEPA filtration system 746 and the suction source 748. In some non-limiting examples, the detection system 744 is configured to acquire imaging data and to extract particle density data from the imaging data, which can be comparted to a threshold value, and if the particle density data exceeds the threshold the detection system 744 can cause the HEPA filtration system 746, or the suction source 748 to begin providing a suction (e.g., to activate) or to increase the amount of suction (e.g., increase volume per unit time).
The isolation system 802 can include a barrier 814 that defines a 3D structure 816 and which has a plurality of faces 818, 820, 822, 824, 826. Each of the faces 818, 820, 822, 824, 826 are joined together to define the 3D structure 816, which in this case is a square pyramid although other 3D shapes are contemplated. The bottom face 826 is coupled to each of the faces 818, 820, 822, 824, and can include a coupling layer (e.g., an adhesive) situated on an exterior surface. The isolation system 802 can also include a microscope attachment 828, ports 830, 832, 834, 836, 838, with the ports 830, 832 being directed into the face 820, with the port 834 being directed into the face 818, with the port 836 being directed into the face 824, and with the port 838 being directed into the face 826.
The top section 844 can also include a barrier 856 that defines a 3D structure that can enclose an object within its interior volume. Similarly to the bottom section 842, a bottom of the top section 844 is opened (e.g., exposed to the ambient environment) prior to being interfaced with the bottom section 842. As shown in
Regarding installation, with the bottom 854 coupled to the patient (or a structure) the flap 848 is radially drawn away from the barrier 846 (e.g., folded away) and is pulled (in tension) to couple the coupling layer of the flap 848 to the patient (or a structure). In this way, with the flap 848 pulled and secured in tension, the bottom section 842 is reinforced and further restricted from moving relative to the patient (or structure). Then, the top section 844 is placed into engagement with the lower section 842, or in other words the sections 842, 844 are coupled together. In some cases, the barrier 856 of the top section 844 can be slid over the barrier 846 of the bottom section 842 (or vice versa). Then, the barriers 846, 856 can be coupled together (e.g., with fasteners, such as adhesives, etc.). For example, the inner (or outer) surface of the barrier 846 can have a coupling layer, and the inner (or outer) surface of the barrier 856 can have a coupling layer. In some cases, the barriers 846, 856 can be snap-fitted together (e.g., when ends of each barrier 846, 856 have a rigid coupling). Then, the microscope attachment 864 can be coupled to a microscope and the procedure (or observation of a sample) can proceed.
In some configurations, while the upper section 844 and the lower section 842 are illustrated as having particular components, in other configurations, each of the sections can have the same components. For example, the lower section 842 can have a scaffold, arm ports, etc., while the upper section 844 can include a flap, a suction bag, a suction port, etc. In addition, while the barrier 846 of the bottom section 842 and the barrier 856 of the top section 844 are illustrated as being cylindrical, in other configurations, the barriers 846, 856 can have a similar shape, but with the similar shape differing (e.g., conical).
In some non-limiting examples, the isolation system 840 can include a plurality of weights 866 that are coupled to the barrier 846 and are situated around the periphery of the barrier 846, and a plurality of tabs 868 that are also coupled to the barrier 846 and are also situated around the periphery of the barrier 846. Each tab 868 can have a coupling layer positioned on its lower exterior surface to be secured to a patient (or a structure). As shown, in some cases, the barrier 856 can include a plurality of pleats 870, and an instrument port 872 directed into the barrier 856. Each pleat 870 can extend in an axial direction along the barrier 856 (e.g., in a direction from the free end of the barrier 856 to the microscope attachment 864).
The tubular portion 944 can be curved and an end of the tubular portion 944 defines a fluid input 946 (e.g., an air input). By manipulating the suction attachment 940, the location, orientation, etc., of the fluid input 946 can be positioned as desired (e.g., how far the fluid input 946 extends into the interior volume of the barrier 932 and how the fluid input 946 is oriented, such as by rotating the tubular portion 944). For example, in some cases, the suction attachment 940 can be advanced into the interior volume to translate the fluid input 946. In operation, the fluid (e.g., air) enters the fluid input 946 is directed through the tubular portion 944, through the rigid portion 942, and is vacated out into the suction system (e.g., as appropriately attached). As shown, a filter 948 can be located within the tubular portion 944, and the rigid portion 942. The filters 948 can be high-efficiency particulate air (“HEPA”) filters. In some cases, the suction attachment 940 can be secured to a location with fasteners (e.g., adhesive butterfly strips, clips, hook and loop fasteners, etc.).
As shown in
At 1002, the process 1000 can include deploying the barrier of the isolation system to create a 3D structure. In some cases, this can include removing the isolation system from packaging (e.g., wrapping, such as plastic wrapping). In addition, this can include expanding the barrier from a compressed state to an expanded state. This can include expanding the scaffold of isolation system (e.g., coupled to the barrier) from a compressed state (e.g., a flat, or planar state) and to an expanded state (e.g., a 3D state). In some cases, this can include simultaneously expanding the scaffold and the barrier to define the 3D structure (e.g., such as when the scaffold is coupled to or integrally formed with the barrier). In some cases, this can include separating rings of the scaffold as the scaffold expands, or straightening an arm of the scaffold as the scaffold expands. In addition, this can include bending a beam of the scaffold to reorient the beam of the scaffold.
In some configurations, this can include installing the barrier, and installing the scaffold to the barrier. For example, this can include coupling two free ends the barrier together (e.g., with an adhesive). As another example, this can include aligning a sleeve of one free end of the barrier with another sleeve of another free end of the barrier, and inserting a support beam through both sleeves.
In some configurations, this can also include setting up the port(s) of the isolation system. For example, this can include opening a flap (e.g., the flap 536) of the instrument port and securing the flap open, removing a plug from a port, such as the arm port. In some cases, this can include threadingly disengaging the plug from a rigid attachment of the port. As another example, this can include opening a port, such as tearing a piece of material off of the isolation system to define the port, such as via an area of material weakness in the barrier.
In some non-limiting examples, this can also include setting up the arm sleeves of the isolation system. For example, this can include inverting the arm sleeve so the arm sleeve is forced into the interior volume of the barrier, coupling an arm sleeve to an arm port (e.g., threadingly engaging a rigid cuff of an arm sleeve to a rigid attachment of an arm port). In some cases, this can include removing a portion of the arm sleeve from the arm sleeve (e.g., along an area of material weakness of the arm sleeve). For example, a hand portion of the arm sleeve (e.g., which can be implemented as a glove) can be decoupled from the arm sleeve.
In some non-limiting examples, this can include coupling a suction system to a tube of the isolation system, coupling a suction system to a suction attachment of the isolation system. In addition, this can include inserting a tube through a port, advancing the tube through the port, retreating the tube through the port, changing the orientation of the tube within the interior volume of the barrier, etc.
In some non-limiting examples, the can include coupling a detection system to the barrier of the isolation system. For example, this can include coupling a light source to the barrier, coupling an imaging sensor to the barrier, etc.
At 1004, the process 1000 can include securing the barrier to the patient (or a structure), and securing the barrier to an instrument. For example, this can include coupling a flange of the barrier to a patient (or a structure) to enclose the patient (or a laboratory sample) within the volume of the barrier. In particular, an adhesive backing can be removed from the flange to expose the adhesive layer of the flange to couple the flange to the patient (or a structure). In some cases, this can include coupling a tab, which is coupled to the barrier, to a patient (or a structure). In addition, this can include coupling a peripheral flange (or in other words a flap) that is coupled to the exterior surface of the barrier to the patient (or a structure). For example, the peripheral flange can be pulled in tension and then coupled to the particular object or person. In some configurations, this can include advancing a lower edge of the barrier underneath the barrier, and coupling the lower edge to the patient or a structure. In some cases, this can include folding the barrier at a crease defined by the advancement of the lower edge underneath the barrier.
In some non-limiting examples, block 1004 of the process 1000 can include coupling the instrument attachment to an instrument (e.g., a microscope). For example, this can include expanding the instrument attachment and retracting the expanded instrument attachment around the microscope (e.g., the objective of the microscope). In some cases, this can include coupling a lens to the instrument, in which case the lens can be coupled to the barrier. In other cases, this can include tightening a cuff around the instrument (e.g., the objective of the microscope).
At 1006, the process 1000 can include deploying the instruments, the sanitation systems, etc. In some cases, this can include advancing a surgical (or observation instrument) into the interior volume of the barrier so that a functional component of the surgical (or observation) instrument is situated entirely within the interior volume of the barrier. In some cases, the functional component can be implemented in various ways. For example, when a surgical instrument is used, the functional component can be a cutting edge, a drill bit, etc. As another example, when an observation instrument is used, the functional component can be an end of a tweezers, an point of probe, etc. In some non-limiting examples, this can include turning on a suction source to begin evacuating fluid (and thus other particulates) out of the interior volume of the barrier. In some configurations, this can include beginning causing the debris detection system to begin acquiring optical data of the interior volume of the barrier, and determining a current size distribution of particles within the interior volume of the barrier. In some cases, a computing device can determine the current size distribution of particles and determine whether or not the current size distribution of particles exceeds a threshold (e.g., a threshold size and a corresponding density of particles). If the computing device determines that the density of particles exceeds a threshold (and in some cases that the density of particles for a given size of a particles also exceeds a threshold), the computing device can cause the suction source to begin providing a suction source, or to increase the flow rate of the suction source.
At 1008, the process 1000 can include conducting a procedure, or an observation. In some cases, this can include conducting a surgical procedure, which can include cutting a portion of the patient and drilling a portion of the patient when the respective surgical instrument is positioned within the interior volume of the barrier. In other cases, this can include conducting an observation, which can include probing the sample, measuring features of the sample, etc.
At 1010, the process 1000 can include activating the disposal system of the isolation system. In some cases, after the procedure or observation is completed, but prior to activating the disposal system the technician or surgeon can cease operation of the instruments (e.g., a drill), an in particular, can cease the aerosol generating procedure. After ceasing the operation of the instruments, the technician or surgeon can wait a period of time (e.g., greater than one minute, two minutes, three minutes, etc.). In some cases, this can include maintaining that the instruments and arms of the personnel are maintained within the interior volume of the barrier. In this way, as the suction source continues to evacuate air out of the interior volume of the barrier, the remaining particulates and aerosols are evacuated.
In some cases, the instruments, and arms of the personnel can be removed (e.g., after the period of time has elapsed). For example, each arm can be retreated out of the respective arm port (and sleeve, if applicable), and each instrument can be retreated out of the respective instrument port. In some cases, block 1010 of the process can also include sealing each port. For example, each arm port can be resealed by engaging a plug with the arm port. In addition, each of the other ports can be resealed by engaging a plug with the respective port. In some cases, the plug can simply be a piece of material (e.g., fabric) that is coupled to the barrier to cover the port. In some configurations, only after the ports have been sealed, does the suction source turn off (e.g., after continuing evacuating material after a time period in which all the ports have been sealed). In this way, particulates and aerosols continue to be evacuated out of the interior volume of the barrier.
In some non-limiting examples, the disposal system can seal off particular portions of the barrier. For example, the disposal system can include one or more closing devices. Each closing device can decrease the cross-sectional area of the barrier to close off particular portions of the barrier. For example, a closure device can be situated below the instrument attachment and can be used to close off the interior volume of the barrier from the instrument attachment. Similarly, a closure device can be situated above the lower edge of the barrier and can be used to close off the interior volume of the barrier from the patient. In this way, with both closure devices closed, the remaining particulate and aerosols are trapped in the remaining interior volume between the closure devices. For example, the remaining interior volume of the barrier that is situated between the two closure devices can be removed from the site and disposed of, as appropriate. In some cases, closing the closure device can include tying an end of the barrier (e.g., with a tie), pulling a cable tie, etc.
At 1012, the process can include decoupling a portion of the barrier from the barrier. In some cases, this can include decoupling a portion of the barrier from the barrier along the area of material weakness (e.g., the perforation). In some non-limiting examples, this can include removing one closure device (and the remaining interior volume) form a portion of the barrier (e.g., the instrument attachment), and removing the other closure device from a portion of the barrier. In this way, the remaining interior volume of the barrier that is situated between the two closure devices can be removed from the site and disposed of, as appropriate. In some cases, closing the closure device can include tying an end of the barrier (e.g., with a tie), pulling a cable tie, etc.
At 1014, the process can include disposing the decoupled barrier. In some cases, the particulates and aerosols are trapped within the remaining interior volume of the barrier by using one or more closing devices, and thus the remaining interior volume of the barrier can be disposed of (or can be treated before being disposed of, such as using an autoclave system).
The following examples have been presented in order to further illustrate aspects of the disclosure, and are not meant to limit the scope of the disclosure in any way. The examples below are intended to be examples of the present disclosure and these (and other aspects of the disclosure) are not to be bounded by theory.
COVID-19 has caused a global pandemic with a dramatic impact on healthcare systems. Concern for viral transmission necessitates the investigation of otologic procedures that use high-speed drilling instruments, including mastoidectomies, which were hypothesized to be an aerosol generating procedure. A Mastoidectomy was simulated using a high-speed drill and fresh-frozen cadaveric heads with fluorescein solution injected into the mastoid air cells. Specimens were drilled for one minute durations, in test conditions with and without a microscope. A barrier drape (e.g., the OtoTent) was fashioned from a commercially available drape. Dispersed particulate matter was quantified in segments of an octagonal test grid measuring 60 cm in radius. Drilling without a microscope dispersed fluorescent particles 360 degrees, with the areas of highest density in quadrants near the surgeon and close to the surgical site. Using a microscope or varying irrigation rates did not significantly reduce particle density or percent surface area with particulate. Using the OtoTent significantly reduced particle density and percent surface area with particulate across the segments of the test grid beyond 30 cm (which marked the boundary of the OtoTent) compared with the microscope only and no microscope test conditions (Kruskall-Wallis test, p=0.0066). Mastoidectomy with a high-speed drill is an aerosol generating procedure, a designation that connotes the potential high risk of viral transmission and need for higher levels of personal protective equipment. The barrier significantly reduced articulate dispersion in this study and could be an effective mitigation strategy in addition to appropriate personal protective equipment.
The novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-19) causing the disease COVID-19 emerged in Wuhan, China in November 2019 and has since spread rapidly across the globe, causing the World Health Organization to declare the outbreak a pandemic on Mar. 11 2020. Hospital systems in affected regions continue to face a surge of patients and struggle in the setting of shortages of testing materials, rapid testing strategies, ventilators, and personal protective equipment (“PPE”) for hospital staff.
Early reports of healthcare worker infections in China and Italy suggested high rates of infection among otolaryngologists. COVID-19 is believed to be spread through not only droplets but also aerosols during a variety of aerosol generating procedures that otolaryngologists routinely perform. These range from office-based procedures like flexible nasopharyngoscopy and peritonsillar abscess drainage to operative procedures such as intubation/extubation, tracheotomy, maxillofacial trauma surgery, as well as endoscopic sinus and shill base surgery.
Otologic surgery including mastoidectomy has not been explicitly described as an aerosol generating procedure (“AGP”), which is an important distinction that connotes the potential increased risk of viral transmission and the need for PPE designated for AGPs. However, existing studies suggest that the use of high powered drills is associated with the generation of aerosols and small particles with the potential to transmit infectious diseases. As the airway is continuous with the middle ear and mastoid, there is potential for viral transmission of COVID-19 from otologic procedures. An improved understanding of procedures that generate aerosols and small droplets is necessary to balance the need to protect health care workers with the desire to conserve limited stocks of PPE. In this study, we sought to demonstrate that mastoidectomy is an aerosol generating procedure and explored a barrier strategy to mitigate the risk for viral transmission.
Three ears from two fresh-frozen cadaveric head specimens were prepared. Standard C-shaped postauricular skin incisions were made and anteriorly based periosteal flaps were elevated. The Fluorescein solution was created with 50 mL of sterile water mixed with 1 mg of FUL-GLO Fluorescein Sodium (Akorn, Inc., Lake Forest, Ill., USA). The mastoid cortex was drilled to expose a 4×4 mm area of air cells and 1.5 mL of fluorescein solution was injected into this well. The Midas Rex© Legend Stylus otologic drill with a compatible Xomedit) 6 mm round fluted bur (Medtronic, Inc., Minneapolis, Minn., USA) was used. Images and videos were captured on a dual-lens camera system with a 12 MP camera with a wide-angle lens with f/1.8 aperture and 4K video recording system at 60 frames per second (Apple, Inc, Cupertino, Calif., USA). The microscope was a wall-mounted Zeiss OPMI Pico (Carl Zeiss Meditec AG, Jena, Germany) with an objective lens focal distance of 250 mm. An ultraviolet light source, UV-705, 400-Watt (Altman Lighting, Yonkers, N.Y., USA) was used and all fluorescent images were taken in a darkened room. A 1060 Steri-Drape of 130 cm×130 cm in size with an incise film in the center of 10 cm×12.5 cm was used (3M©), Inc, St Paul, Minn., USA) for the barrier drape.
A separate cadaveric temporal bone was used for each primary condition. A single, right-handed surgeon drilled for one minute for each condition. The surgeons surgical gown and mask were photographed under ultraviolet light to evaluate for fluorescent debris (see,
The cadaveric head was placed in the center of a black mat in a standard surgical position. Using the external auditor canal (“EAC”) as the center point, an octagonal grid with a radius of 60 cm was marked out around the specimen (see
The drape was placed over the cadaveric head. The excess drape was loosely rolled wider and secured to the mat in four cardinal points 30 cm away from the EAC with tape: superior, inferior, posterior, and anterior (see
ImageJ software (version 2.0.0-rc-69/1.52p) was used for image manipulation and particle analysis. Images were cropped to include only the segment to be analyzed in each iteration. The background was subtracted algorithmically using a rolling ball radius of 5 pixels, with separated colors and the sliding paraboloid method to remove background reflected light and heterogeneous surface reflection. Following this, color adjustment was performed to eliminate red and blue hues. The image was checked for consistency and non-particulate edges were removed manually. The image was changed to an 8-bit image, and a binary black and white pixel threshold was applied. Particle analysis was run with a particle size 0-infinity, circularity 0.0-1.0, with particle counting and percent area calculation. GraphPad Prism version 8.0 (La Jolla, Calif.) was used for descriptive statistics. Nonparametric tests (Kmskall-Wallis test, Mann-Whitney U test, two-stage linear step up procedure of Benjamini, Krieger, Yukutieli for multiple comparisons) were used to compare particle surface density and percent surface area covered by particles in different regions of the test grid.
Videos and still images of drilling in an open field and drilling with a microscope demonstrated large plumes of fluorescent aerosolized materials (see
Fluorescein droplets and bone dust dispersed to all segments of the grid in a 360 degree fashion, with particle surface density (PSD) ranging from 0.036 to 4.0 particles/cm2 and percent surface area with particulate (% SA) ranging from 0.011 to 2.3%) (see
Fluorescein droplets and bone dust were found at low levels across all areas of the experimental grid with no areas of predominance in terms of the radial direction. PSD ranged from 0.018 to 0.29 particles/cm2 and % SA ranged from 0.008 to 0.25%. For the microscope+OtoTent condition, both PSD and % area of particulate were significantly lower in the outer circle (segments 5-8 and 13-16) (0.034+/−0.017, 0.020+/−0.010) compared to the inner circle (segments 1-4 and 9-12) (0.21+/−0.054, 0.16+/−0.065) (p<0.0001, Mann-Whitney U test). There was a large amount of fluorescent debris attached to the undersurface of the OtoTent, which may account for the apparent reduced levels of particulate debris even in the inner circle compared to other test conditions (though this did not reach statistical significance as noted below).
The Oto Tent quantitatively reduced particle dispersion beyond the boundaries of the drape. Quantitative comparisons across simulation conditions were performed by grouping the segments of the octagonal grid into inner circles (segments 1-4 and 9-12) and outer circles (segments 5-8 and 13-Hi). Since the majority of the aerosolized particulates were found in quadrants A and B of the grid, an analysis of these two quadrants was performed to compare dispersion between the inner and outer areas across test conditions. In this analysis, particles found in the inner semicircle (segments 1-4) were compared with those of the outer semicircle (segments 5-8) closest to the surgeon. Particle dispersion in terms of PSD and % SA are shown in
A subanalysis of segments 2 and 4, which had a high surface density of particulate matter was performed by further subdividing the segments into trapezoidal segments with a 10 cm radius as measured from the center to the perimeter of the octagonal grid. The central 10 cm triangular segment was not counted because this area was covered by the cadaveric head specimen. For the no microscope and microscope conditions, both PSD (see
High-flow and low-flow irrigation conditions did not significantly change particle dispersion. Conditions with high- and low-flow irrigation did not significantly impact the patterns of aerosol and particulate dispersion. In comparing non-microscope drilling conditions with different irrigation parameters (low-flow irrigation at 10 mL/min, high-How irrigation at 20 mL/min, and no irrigation), PSD and % SA following drilling did not differ significantly between irrigation conditions for the inner semicircle (Kmskall-Wallis test, p=0.86, p=0.71, respectively) or outer semicircle of segments in the test grid (Kruskal-Wallis test, p=0.63, p=0.65, respectively).
Otolaryngologists are uniquely susceptible to COVID-19 transmission due to the variety of procedures performed on areas contiguous with the upper respiratory tract where there is a viral load. During this pandemic, otolaryngologists may be required to perform common sr-genies for m.gent indications and should prepare strategies to mitigate risk. These include pre-operative COVID-19 testing, 4 if timing and resources allow, as well as procedure specific strategies to decrease the risk of transmission from patients who are at risk or positive for COVID-19. In this paper, we examined the risks of contamination with biomaterials during mastoidectomy and introduce a novel risk mitigation strategy using a modified operating room drape.
As a cortical mastoidectomy is the treatment for a number of serious complications of acute and chronic otitis media, this aimed to characterize the spread of aerosolized materials during surgery that could potentially transmit virus. The use of high-powered drills has previously been demonstrated to generate aerosol-sized particles. In this study, it was demonstrated that mastoidectomy is an aerosol generating procedure with the ability to spread small droplets more than 100 cm from the surgical site, with a predominance of spread in the areas closest to the operative site. The experimental set up was designed in a 360-degree fashion to assess risk of aerosolized debris dispersion toward all operating room staff in close proximity, including the anesthesiologist and the scrub nurse or technician. While the majority of the particulate debris was found the in the two quadrants adjacent to the surgeon, this study also demonstrates that cortical mastoidectomy may cause particulate spread in the two quadrants located opposite the surgeon. This highlights the importance of barrier drapes hung between the surgical site and the anesthesiologist. Furthermore, in this study, the right-handed surgeon spread aerosolized debris predominantly in the left lower quadrant of the field, followed by the right lower quadrant. This may have been impacted by accumulation of some particulate on the surgeon's arms and gown, reducing the measured particulate in the lower right quadrant. Aerosolized particles can be found all over the surgeon including on the gown, face shield and hair covering. These findings corroborate prior studies examining the possibility of transmission of blood borne and prion diseases during mastoidectomy, finding that drilling scatters blood-containing and neural tissue-containing material that could be detected on the surgical field and on the surgeon.
Although it is not known for certain whether aerosols generated during mastoidectomy are capable of transmitting COVID-19, existing virology literature suggests that fluid in the inner ear and mastoid can be infected with respiratory viruses. Previous studies demonstrated that viral RNA could be identified in 48% of middle ear fluid samples collected from children with an upper respiratory illness and acute otitis media when assessing for human coronavirus, respiratory syncytial virus and human rhinovirus, Similarly, another study found that viral materials could be identified with enzyme immunoassays in 74% of middle ear fluid samples in children with acute otitis media when assessing for parainfluenza, influenza, respiratory syncytial virus, enterovirus and adenovirus.
While there are no formal guidelines on the best practices to reduce viral transmission during common otology or neurotology procedures, novel techniques have recently been reported to mitigate the risk associated with oral intubation, extubation, and endoscopic sinus surgery. These strategies make use of various plastic materials to create physical barriers between the patient and the health care provider. In this study, as the microscope alone was shown to be an insufficient barrier, a barrier drape was used (the OtoTent) to limit the spread of aerosols and droplets during mastoidectomy. The drape was created and affix to the microscope. It was found that fixing the tent posteriorly with tape between the surgeon's arms was critical to keeping the OtoTent in place during surgery. The surgeon's arms and instrument cords were easily passed between points of fixation with good range of motion. The OtoTent significantly reduced droplet and particulate contamination of surfaces beyond its borders within the limits of this study design. In addition, particulate debris inside the borders of the OtoTent on the surfaces of the cadaver's head and immediate surrounding area was also significantly reduced. This is likely due to particulate debris adhering to the undersurface of the OtoTent.
The OtoTent was created from a commercially available surgical drape commonly used for ophthalmologic procedures. Hospitals with ophthalmology divisions may already carry the 1060 drape. The cost of the product is low, around $10 US dollars. A microscope drape could be used as an alternative material but may be more expensive and may require more manipulation to affix it securely to the microscope. Various improvements can be made to the simple OtoTent design presented in this study—the authors elected to tape from cardinal points on the drape to minimize movements to the drape with the surgeon's hand movements. During drilling, the surgeon may find that the microscope lens needs to be cleaned as debris and moisture circulates under the OtoTent so a wipe should be kept within easy reach. A surgical scrub technician could pass additional instruments underneath the other flaps of the OtoTent not occupied by the surgeon's two arms. At the conclusion of drilling, the OtoTent should be removed carefully so as not to dislodge and re-aerosolize particles. It may be beneficial to wait a short time to allow for settling of at least the larger aerosolized particles. A second set of surgical gloves and arm sleeves could be used under the OtoTent and removed at the conclusion of drilling to minimize dispersion of particles landing on the surgeon. Because the OtoTent is not impervious around its perimeter, it is not a substitute for appropriate personal protective equipment (“PPE”) and should only be used as an adjunct.
Even with success of a material barrier like the OtoTent, mastoidectomy may also produce microscopic aerosols that could remain airborne for an extended period of time. In this study, the visualization of plumes of fluorescent debris during mastoidectomy demonstrate that it is certainly an aerosol generating procedure despite the limitations of this study to analyze particles smaller than 100 μm. Previous studies conducted a cadaveric temporal bone study to sample aerosolized bone dust in the air during mastoidectomy and a found that the average total particulate matter concentration was 1.89 mg/m3. Although it was concluded that this was below the Occupational Health and Safety Administration's standards for respirator use, it was not explored that the idea that a small amount of particulate matter might be enough to transmit a virus.
What is yet unknown is the ability of the aerosolized materials produced during mastoidectomy (e.g. blood, bone dust, middle ear and mastoid mucosa and fluid) to transmit COVID-19 and whether the quantity and size of particles affects the transmission rate. As such, this study reinforces the recommendations in the existing literature to remain vigilant in the selection of appropriate PPE. At a minimum, for mastoidectomy surgery, basic or attire with impervious gowns, gloves, hair coverings, and shoe coverings should be supplemented with face shields, ventless or wrap-around eye protection and respirators. N95 respirators should be used as for all aerosol generating procedures as recommended by multiple medical professional societies and the World Health Organization. As mastoidectomy is an aerosol generating procedure, it is believed that N95 masks or more advanced levels of protection are warranted. Powered air purifying respirators (“PAPRs”) have been recommended in the field of orthopedic surgery to decrease the biomaterials that touch the surgeon during bone drilling procedures. Given that a high degree of spread of aerosolized debris was found in this study and that particulate debris was found even in the hair covering after 1 minute of drilling, a PAPR and an N95 mask for COVID-19 positive patients and patients with unknown COV1D-19 status is favored. This combination has been shown to have a multiplicative effect on reducing the concentration of airborne particles. However, with limited availability of PAPRs at most institutions, we recognize that obtaining PAPRs may not be possible and thus have listed the minimum recommended PPE for mastoidectomy above. The use of PAPRs with microscope oculars may also be cumbersome, although it was possible to use a face shield with the microscope in this study. Exoscopes may be an alternative option in institutions with access to this technology.
The limitations of this study stem from constraints on the materials available to conduct these time-sensitive experiments during a time of medical crisis. The bone of cadaveric models may differ from those of living patients in their biochemical properties and their reactions to drilling. Also no equipment was used to measure the smallest aerosols that remain suspended in the air; the smallest particle that could be detected using techniques described in this paper was 100 μm. Bone dust, which had significant autofluorescence, was unable to be distinguished from droplets containing fluorescein, although bone dust itself could be mixed with mastoid fluids during drilling and could also harbor viral particles. Furthermore, it was not possible to assess individual particles that may have conglomerated upon hitting experimental surfaces. Finally, alternate configurations of the operation were not tested including the use of different drill speeds, burr types/sizes, suction irrigators, other microscope sizes/configurations, other drilling techniques (including a left-handed surgeon), and the use of unconventional alternatives to high speed drills such as osteotomes or hand-operated perforators. Limiting testing conditions was necessary to conserve resources including PPE. Lastly, the OtoTent was designed to allow for easy reproduction. More elaborate designs including the incorporation of gloves into the drape to minimize the escape of even smaller aerosolized materials could also be considered.
The aerosolization of fluorescent droplets and bone particulate from cortical mastoidectomy was demonstrated on a cadaveric specimen under an ultraviolet light in a darkened room. A heat map was created that shows the surface density of fluorescent particles found in each grid segment after test conditions increasing or decreasing irrigation. The surgeon drilled for 1 minute with a 6 mm round fluted burr after injection of fluorescein. Irrigation was increased to 20 cc/min, and then irrigation was turned off.
Some non-limiting examples of the disclosure provide systems and methods for mitigating airborne aerosol dispersion during mastoidectomy and provide systems and methods for custom mitigation strategies for otologic surgery in the COVID-19 era.
During the acute phase of the COVID-19 pandemic, major disruptions occurred in the healthcare sector. The initial closure of clinics and cancellations of non-urgent operations significantly impacted otolaryngology practices. As the COVID-19 infection rate plateaus and begins to decline across the country, clinicians require strategies to safely re-open practices, particularly in the setting of persistent shortages of widely available testing, personal protective equipment (“PPE”), and a lack of contact tracing in the community as has been attempted in other countries.
Otologists and lateral skull base surgeons may be at increased risk for occupational exposure as studies show that the use of a high-powered drill is associated with aerosol generation. The Centers for Disease Control (“CDC”) and World Health Organization (“WHO”) have recommended higher levels of PPE for aerosol generating procedures. Local source control may be an effective adjunctive strategy to mitigate viral transmission risk; however, there are currently no standardized local source control strategies for otologic surgery. In a prior study, the plume of aerosolized debris generated by mastoidectomy was shown, droplet and particulate (≥100 μm) dispersion in a 360-degree field around the surgical site was quantified, and the effectiveness of a barrier drape attached to the microscope (OtoTent) for reducing large particulate and droplet dispersion was demonstrated. Herein, the generation of aerosols between 1 and 10 μm in size was investigated. Furthermore, the efficacy of two barrier strategies to decrease exposure to these intraoperatively generated aerosols, including the previously described OtoTent and a novel prototype customized for otologic surgery, the OtoShield was evaluated.
The protocol was deemed exempt by the Institutional Review Board. Surgical simulation was performed on six ears from three thawed, fresh-frozen cadaveric head specimens. All experiments were performed in a surgical laboratory set at 72° F. and equipped with air exchangers operating at a rate of six air changes in the room per hour. Specimens were prepared with a C-shaped postauricular skin incision. An anteriorly-based periosteal flap was elevated. A single, right-handed surgeon completed all surgical conditions. The surgeon performed a cortical mastoidectomy and drilled for one minute for each condition. The microscope was a wall-mounted Zeiss OPMI Pico (Carl Zeiss, Meditec AG, Jena, Germany) with an objective lens focal distance of 250 mm. The Midas Rex© Legend Stylus otologic drill with a compatible Xomed© 6 mm round fluted bur and 5 mm diamond bur (Medtronic, Inc., Minneapolis, Minn., USA) was used at 70,000 RPM for drilling. The otologic drill had an attached irrigation port set to 10 mL/min. A 12-French suction was used in the surgeon's non-dominant hand, with the suction tip maintained approximately 1 cm from the drill bur, in all conditions except the “no suction” and “suction irrigator” conditions. The 12-Fr suction connected to wall suction in the laboratory which applied 538 mmHg suction pressure, and resulted in 32 L/min air flow rate.
An optical particle sizer (OPS 3330, TSI Inc., Shoreview, Minn.) placed 30 cm from the ear canal (see
Two types of barrier drapes were fashioned. The “OtoTent” was created with a 1060 Steri-drape that enclosed the microscope lens, cadaveric head specimen, and immediate surrounding 30 cm surgical field (see
The “OtoShield” was a custom prototype drape design created from a Zeiss OPMI microscope drape (Carl Zeiss, Meditec AG, Jena, Germany; see
Where indicated, a second suction (SS, Cardinal Health, 3/16″×6′, Dublin, Ohio, USA) was attached to the cadaveric head specimen 3 cm from the surgical site at the mastoid cortex to continuously evacuate ambient particles (see
A cortical mastoidectomy was performed under the microscope (with no barrier drape) under the following conditions: 1) use of 12 French suction in the surgeon's non-dominant hand; 2) use of 12 French suction and a SS attached at a fixed position with continuous evacuation of particles; 3) no suction use; 4) use of a 10/12 French suction irrigator; 5) use of a 5 mm diamond bur with a 12 French suction. Unless noted, all mastoidectomy procedures were performed with a 6 mm round fluted (“cutting”) otologic bur.
To assess the two barrier drapes, the following conditions were tested with simulated cortical mastoidectomy: 1) no barrier drape; 2) OtoTent; 3) OtoShield (
Stata version 13 (StataCorp, College Station, Tex.) software was used for statistical analysis to assess differences in airborne aerosol generation above matched, specific pre-replicate baseline values for all test conditions. Non-parametric statistical techniques were utilized due to small sample sizes, with Bonferroni correction for multiple comparisons. Prism Version 8 (GraphPad Software, La Jolla, Calif., USA) was used to graph data. All values are reported as means with standard error.
Small particle aerosols generated by drilling without a barrier drape for multiple conditions is shown in
The average particle density across time is shown for mastoidectomy without a barrier drape in two drilling conditions: (1) cutting bur and (2) cutting bur with SS (see
Comparison of particle density generated in the mastoidectomy without a barrier drape condition and the two barrier strategies, OtoTent and OtoShield, with and without the use of SS is shown in
The effect of delaying barrier removal by 60 seconds following completion of drilling is shown in
The COVID-19 virus may be transmissible through otologic and neurotologic surgery as the fluid and mucosa of the middle ear and mastoid are contiguous with that of the upper respiratory tract where the viral load is high. Other respiratory viruses, such as human coronavirus, rhinovirus, respiratory syncytial virus, influenza, parainfluenza, enterovirus and adenovirus, have been identified in middle ear fluid samples from children with upper respiratory illnesses. Although we are unaware of studies showing Sars-CoV-2 in the middle ear, it is prudent to assume a potential risk of otologic transmission. While Sars-CoV-2 is primarily spread via droplet transmission, it can act as an opportunistic airborne infection, particularly in the setting of aerosolizing procedures.
This study confirms the generation of aerosols between 1-10 μm in size during mastoidectomy, complementing existing research of larger particles generated during mastoidectomy procedures. Within the limits of comparison given differences in experimental techniques and conditions, mastoidectomy appears to generate more aerosol dispersion than intubation (not including cough or sneeze), and anterior skull base drilling. There is a paucity of experimental data for small particulate mastoidectomy aerosolization and our data could not be compared to a prior study with a gravitational spectrometer. Modifications to surgical technique, including use of a suction irrigator and diamond bur significantly decreased total particle dispersion. The reduction in particulate with a suction irrigator may be due to increased irrigation resulting in larger droplets that contain particulate rather than small airborne droplets and particulate. Notably, there was qualitatively more visible large droplet splatter and dispersion with the suction irrigator.
Two barrier strategies were investigated to mitigate aerosols produced during mastoidectomy. The OtoTent is created from a commercially available, low cost drape that can be attached to any microscope or exoscope. The design is described in a prior study, which demonstrated a statistically significant 360-degree reduction of larger aerosols and droplets produced during mastoidectomy with use of the OtoTent compared to a microscope alone. The OtoShield is a custom prototype drape with specialized ports to accommodate the surgeon's arms and instruments. This three-dimensional design was made from clear polyethylene-based plastic and forms an enclosed space over the surgical site, including a plastic floor that is contiguous with the sides. The floor prevents larger droplets, particles, and liquids from leaking, and decreases aerosol escape through the bottom edge of the drape. The drape can include a rigid frame to keep the operating space unobstructed by drape material. The customized arm ports allow the surgeon to access the surgical field. Surgeons who trialed the OtoShield in the laboratory noted that it was comfortable to use, and did not obstruct the view of the surgical site.
The OtoShield without SS significantly reduced aerosol dispersion during drilling trials compared to mastoidectomy without a barrier (with or without SS). The use of the OtoTent without SS did not significantly decrease aerosol dispersion, which may have been from inadvertent aerosol dispersion generated by lifting the drape to access the surgical field. Notably, however, we previously described that the OtoTent decreased dispersion of large aerosols and droplets (>100 μm). Use of the SS within the drape significantly reduced particle dispersion in both the OtoTent and OtoShield. Results of the OtoTent with SS were more variable than that of the OtoShield with SS. In 75% of trials, the OtoTent with SS significantly decreased particle dispersion throughout drilling; in 25% trials, there was notable aerosol in the last 30 seconds of drilling, though these results were not statistically significant.
These variable results may be attributed to inconsistencies in drape position between trials, suggesting that a customized drape (e.g., OtoShield) may minimize variability. Of note, however, even partial mitigation of aerosol dispersion is beneficial as the infectious potential of biomaterials is related to the viral load of exposure.
Placement of the SS within the drape is critical for decreasing particle dispersion, likely due to an increased volume of air turnover within the drape. The volume of the OtoTent and OtoShield barrier drapes were 40L and 37L, respectively. The flow rate of the SS was 65 L/min, such that the entire volume within the drape exchanged during drilling. In contrast, the flow rate of the 12-Fr suction was 32 L/min; thus, the volume within the drape was not replaced during drilling. Further, the 12-French suction was employed to remove fluid, rather than open to air to scavenge aerosols. Simultaneous application of multiple strategies including (1) use of the barrier drape, (2) delaying drape removal, and (3) increased air turn over via the SS were important.
Static methods for aerosol assessment, cadaveric models, and the natural variability in aerosol generation from high speed drilling were all variable factors. This study measured optical particle size without the use an aerodynamic particle sizer or dynamic assessment techniques, and did not account for change in droplet size, dessication, or formation of droplet nuclei over time. Particulate density was measured at only one location in the surgical field. Small droplets and bone dust particulate could not be distinguished. The presence of infectious pathogens, including virus or bacteria, in the aerosol were not assessed. Longer drilling times were not included given the limited cadaveric resources, and only mastoid cortical bone was drilled in this study in order to limit variance from differences in surgical site bone. It is possible that longer drilling times could result in higher aerosol density within the barrier drapes and thus more aerosol escape despite a second suction. Further research is needed to determine the optimal length of the rest period prior to drape removal and instrument exchange, as it will depend on duration of drilling, leakage rate of barrier design, and suction air flow rate. Drilling in cadaveric bones may not be analogous to drilling in living patients as the bones have different composition and lack viable mucosa and mucous. Future studies should include use of the barrier drape strategies on patients in the operative room setting and should include testing for droplets as well as aerosols. Alternative designs of the barrier shields could be investigated, as well as different drilling conditions including a range of drilling speeds, bur sizes and types, as well as different microscopes or exoscopes. Despite the success of the barrier strategies, personal protective equipment (“PPE”) should not be reduced as this study has not been replicated in a clinical setting.
Mastoidectomy using a high-speed drill is an aerosol generating procedure with the potential to spread infectious particles smaller than 10 μm. Use of a barrier drape is an effective strategy to mitigate dispersion of aerosols. A customized OtoShield minimizes variability in aerosolization and may be preferred over the OtoTent. Other strategies, such as use of the SS and delayed removal of the drape after drilling, should be used in conjunction with a barrier drape strategy to decrease particle dispersion. Even a partial decrease in aerosol dispersion, however, is beneficial as it may decrease the viral load of exposure. These highly successful strategies may be used as an adjunctive strategy to appropriate PPE during the COVID-19 era.
Some non-limiting examples of the disclosure investigate aerosols generated for mastoidectomy relevant to viral transmission during the COVID-19 era and explore source control mitigation strategies. In some non-limiting examples, an optical particle size spectrometer was used to quantify 1-10 μm size aerosols 30 cm from mastoid cortex drilling. Two barrier strategies were evaluated: (1) “OtoTent”—a drape affixed to the microscope; (2) “OtoShield”—a customized drape which enclosed the surgical field with specialized ports. As described, mastoid drilling without a barrier drape generated significantly higher aerosol density than background levels (p<0.001, U=57). Mean particle density measured with mastoid drilling under the OtoTent with SS, OtoShield without SS, and OtoShield with SS was not statistically different from that in background levels. By contrast, OtoTent without SS showed high rates of particle aerosolization during drilling compared to background levels (p<0.001, U=107). Delaying removal of the drape for one minute after drilling did not significantly decrease aerosols in the OtoTent or OtoShield without SS conditions (p<0.001, U=0, n=10, 12 and p<0.001, U=2, n=12, 12, respectively). However, delaying barrier removal when using an OtoShield or OtoTent with SS mitigated aerosol dispersion to levels not significantly different from background. As shown, mastoidectomy without a barrier generated significant aerosols. OtoTent with SS and OtoShield with SS, with delayed drape removal, were the most effective strategies. The customized OtoShield produced less variability compared to the simple OtoTent and may be considered to reduce the potential for aerosol dispersion.
Although some of the discussion above is framed in particular around systems, such as the various isolation system, those of skill in the art will recognize therein an inherent disclosure of corresponding methods of use (or operation) of the disclosed systems, and the methods of installing the disclosed systems. Correspondingly, some non-limiting examples of the disclosure can include methods of using, making, and installing isolation systems.
Although the invention has been described and illustrated in the foregoing illustrative non-limiting examples, it is understood that the present disclosure has been made only by way of example, and that numerous changes in the details of implementation of the invention can be made without departing from the spirit and scope of the invention, which is limited only by the claims that follow. Features of the disclosed non-limiting examples can be combined and rearranged in various ways.
Furthermore, the non-limiting examples of the disclosure provided herein are not limited in application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The invention is capable of other non-limiting examples and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless specified or limited otherwise, the terms “mounted,” “connected,” “supported,” and “coupled” and variations thereof are used broadly and encompass both direct and indirect mountings, connections, supports, and couplings. Further, “connected” and “coupled” are not restricted to physical or mechanical connections or couplings.
Also, the use the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “right”, “left”, “front”, “back”, “upper”, “lower”, “above”, “below”, “top”, or “bottom” and variations thereof herein is for the purpose of description and should not be regarded as limiting. Unless specified or limited otherwise, the terms “mounted,” “connected,” “supported,” and “coupled” and variations thereof are used broadly and encompass both direct and indirect mountings, connections, supports, and couplings. Further, “connected” and “coupled” are not restricted to physical or mechanical connections or couplings.
Unless otherwise specified or limited, phrases similar to “at least one of A, B, and C,” “one or more of A, B, and C,” etc., are meant to indicate A, or B, or C, or any combination of A, B, and/or C, including combinations with multiple or single instances of A, B, and/or C.
In some non-limiting examples, aspects of the present disclosure, including computerized implementations of methods, can be implemented as a system, method, apparatus, or article of manufacture using standard programming or engineering techniques to produce software, firmware, hardware, or any combination thereof to control a processor device, a computer (e.g., a processor device operatively coupled to a memory), or another electronically operated controller to implement aspects detailed herein. Accordingly, for example, non-limiting examples of the invention can be implemented as a set of instructions, tangibly embodied on a non-transitory computer-readable media, such that a processor device can implement the instructions based upon reading the instructions from the computer-readable media. Some non-limiting examples of the invention can include (or utilize) a device such as an automation device, a special purpose or general purpose computer including various computer hardware, software, firmware, and so on, consistent with the discussion below.
The term “article of manufacture” as used herein is intended to encompass a computer program accessible from any computer-readable device, carrier (e.g., non-transitory signals), or media (e.g., non-transitory media). For example, computer-readable media can include but are not limited to magnetic storage devices (e.g., hard disk, floppy disk, magnetic strips, and so on), optical disks (e.g., compact disk (CD), digital versatile disk (DVD), and so on), smart cards, and flash memory devices (e.g., card, stick, and so on). Additionally, it should be appreciated that a carrier wave can be employed to carry computer-readable electronic data such as those used in transmitting and receiving electronic mail or in accessing a network such as the Internet or a local area network (LAN). Those skilled in the art will recognize many modifications may be made to these configurations without departing from the scope or spirit of the claimed subject matter.
Certain operations of methods according to the invention, or of systems executing those methods, may be represented schematically in the FIGS. or otherwise discussed herein. Unless otherwise specified or limited, representation in the FIGS. of particular operations in particular spatial order may not necessarily require those operations to be executed in a particular sequence corresponding to the particular spatial order. Correspondingly, certain operations represented in the FIGS., or otherwise disclosed herein, can be executed in different orders than are expressly illustrated or described, as appropriate for particular non-limiting examples of the invention. Further, in some non-limiting examples, certain operations can be executed in parallel, including by dedicated parallel processing devices, or separate computing devices configured to interoperate as part of a large system.
As used herein in the context of computer implementation, unless otherwise specified or limited, the terms “component,” “system,” “module,” etc. are intended to encompass part or all of computer-related systems that include hardware, software, a combination of hardware and software, or software in execution. For example, a component may be, but is not limited to being, a processor device, a process being executed (or executable) by a processor device, an object, an executable, a thread of execution, a computer program, or a computer. By way of illustration, both an application running on a computer and the computer can be a component. One or more components (or system, module, and so on) may reside within a process or thread of execution, may be localized on one computer, may be distributed between two or more computers or other processor devices, or may be included within another component (or system, module, and so on).
As used herein, the term, “controller” and “processor” and “computer” include any device capable of executing a computer program, or any device that includes logic gates configured to execute the described functionality. For example, this may include a processor, a microcontroller, a field-programmable gate array, a programmable logic controller, etc. As another example, these terms may include one or more processors and memories and/or one or more programmable hardware elements, such as any of types of processors, CPUs, microcontrollers, digital signal processors, or other devices capable of executing software instructions.
As used herein, the term “fluid” includes both liquids, and gases as typically used, with the property of being able to readily change its shape when acted upon by a force, and to take the shape of a container that it is situated in. Thus, flow of the fluid can include other materials that flow with the fluid, such as debris, particulates, aerosols, etc. Additionally, fluid can include more than one fluid. For example, the fluid can include air, and another fluid can include a liquid suspended in the air, such as suspended droplets. In some cases, the allowing one fluid to flow does not mean that another fluid is allowed to flow. For example, fluid ports as described herein can allow gases to readily flow through, but can prevent liquids suspended in the gasses (e.g., pathogen laden aerosols) from passing through (e.g., if for example, a filter is present).
This application claims priority to U.S. Patent Application No. 63/012,729 filed Apr. 20, 2020, and entitled, “Surgical Shields for Reduction of Particulate and Aerosolized Debris,” which is hereby incorporated by reference in its entirety. This application claims priority to U.S. Patent Application No. 63/023,615 filed May 12, 2020, and entitled, “Systems and Methods for Controlling the Spread of Airborne Materials during Clinical or Laboratory Procedures,” which is hereby incorporated by reference in its entirety. This application claims priority to U.S. Patent Application No. 63/017,551 filed Apr. 29, 2020, and entitled, “Universally Adaptable Three Dimensional Surgical Shield for Reduction of Particle and Aerosol Debris,” which is hereby incorporated by reference in its entirety. This application claims priority to U.S. Patent Application No. 63/028,840 filed May 22, 2020, and entitled, “Systems and Methods for Controlling the Spread of Airborne Materials during Clinical or Laboratory Procedures,” which is hereby incorporated by reference in its entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2021/028241 | 4/20/2021 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63012729 | Apr 2020 | US | |
| 63023615 | May 2020 | US | |
| 63017551 | Apr 2020 | US | |
| 63028840 | May 2020 | US |
