Patent Description:
This invention relates endotracheal breathing tubes, in particular, tracheostomy tubes with improved suction and rinsing features.

Intubation refers to the placement of an endotracheal breathing tube into a patient's airway, terminating in the trachea. The breathing tube may be inserted orally, nasally, or via tracheostomy - an insertion route through the skin and soft tissues of the neck - through and ultimately terminating within the trachea. These measures are taken to either temporarily or permanently support breathing or ventilation. Risks and problems associated with placement, use, and care of an endotracheal breathing tube range from discomfort and inconvenience to serious medical risks and poor health outcomes.

Tracheostomy tube care requires regular evacuation of secretions from within the innermost lumen of the tube (i.e., "intraluminal") for safe use and comfort. In some situations, evacuation may need to be performed as frequently as every <NUM> minutes. Even when not sedated, few patients are able to perform effective, safe, regular catheter-based intraluminal suctioning without assistance, thus rendering them dependent upon others to perform this vital task, often leading to depression, anxiety, and agitation. Even with assistance, patients frequently experience discomfort during suctioning procedures. The reasons for this are two-fold: first, frequent misuse of suction catheter (i.e., suction catheter is applied too deep/proximal within the airway); and second, patient's inability to time application of suction (negative pressure) during their breath cycle, leading to "surprise" suctioning and its resultant breathlessness sensation, change in airway pressures, and elicitation of cough reflex.

<FIG> illustrate various aspects of relevant basic anatomy of endotracheal tubes, and prior art tracheostomy tube features. <FIG> is a cross-sectional side view diagram of patient <NUM> showing various types of endotracheal tubes. <FIG> is a perspective view of a tracheostomy tube with an inner cannula, and <FIG> is a perspective view of a fenestrated tracheostomy tube and inner cannula. <FIG> are best viewed together in the following discussion.

A patient <NUM> has a trachea <NUM> that is part of the airway to the lungs (not shown) of patient <NUM>. To support breathing, patient <NUM> may be intubated in several ways that are illustrated in <FIG>. Intubation may be achieved by a longer nasotracheal tube via path <NUM> inserted through the nasal passages, past vocal cords <NUM>, and into trachea <NUM>. Alternatively, a similar length oral endotracheal tube via path <NUM> may be inserted through the oral cavity and into trachea <NUM>. Further, a shorter tracheostomy tube <NUM> may be inserted directly into trachea <NUM> through a surgical tracheostomy, region <NUM>.

During positive pressure or mechanical ventilation, an inflatable cuff <NUM> surrounding tracheostomy tube <NUM> may be inflated via cuff inflation valve <NUM>, external monitoring balloon <NUM>, and associated tubing <NUM> to provide a seal between tracheostomy tube <NUM> and trachea <NUM> to prevent air leak around the tube. This is referred to as a "cuffed" tube. Cuff <NUM> may be either inflated or deflated, depending on the needs of patient <NUM>. A comparable tube without such a cuff is referred to as an "uncuffed" tube as shown, in <FIG>.

As shown in <FIG>, tracheostomy tube <NUM> includes a flange <NUM> which is placed against the neck of patient <NUM> to maintain tracheostomy tube <NUM> in the correct position and provide certain functionality. A removable inner cannula <NUM> is an additional feature of some prior art tracheostomy tubes, and may be incorporated with either cuffed or uncuffed tracheostomy tubes. Air is exchanged with patient <NUM> through hub <NUM> via the innermost lumen of tracheostomy tube <NUM> (or inner aspect, or lumen, of the inner cannula <NUM>, if present). Hub <NUM> of inner cannula <NUM> includes clips <NUM> that engage with clip attachments <NUM> on flange <NUM>.

<FIG> illustrates principles of a fenestrated tracheostomy tube. A fenestration <NUM> is included in tracheostomy tube <NUM> above a region <NUM> where an inflatable cuff would be located. A corresponding fenestration <NUM> may be included in inner cannula <NUM>, if used. Fenestrations <NUM> and <NUM> permit airflow, which allows patient <NUM> to speak and cough more effectively. The methodologies, concepts, and designs, herein applied to and described using tracheostomy tubes, may also be applied to nasotracheal tubes and oral endotracheal tubes.

Most prior art secretion management processes use only suction to clear secretions from a tracheostomy tube. At present, there is no manner to safely rinse the inner lumen of a tracheostomy tube to prevent build-up of secretions, clogging, and acute loss of airway. As a result, the patient may be subjected to more advanced intervention or additional procedures due to inadequate clearing of the tracheostomy tube.

Prior art intraluminal tracheostomy secretion clearance through manual suction-based catheters may also introduce risk of infection to the patient and frequently causes airway trauma. It can also cause significant patient and caretaker psychosocial distress, displaced patient autonomy, taxed healthcare personnel resources, and burdened caretakers, all of whom may be exposed to airborne pathogens from the patient's airway. Such secretion clearance also needs to be performed frequently, thus further taxing healthcare personnel and/or caretaker time and resources as well as making the patient passive in their own care.

Presently available tracheostomy tubes that incorporate irrigation and/or suction functions do so at a single site within the airway (i.e., subglottic/ "above the cuff", or proximal tip) and most commonly, not within the lumen of the tube. Those that evacuate the lumen of the tube do not address the distal tip or the extraluminal sections, and furthermore, do so without irrigation, thus making them prone to imminent airway loss from clogging. None of these devices have gained widespread acceptance in clinical use, and thus, clogging/airway loss, infection, and the burdens of standard, manual, catheter-based intraluminal suction systems remain the mainstay of tracheostomy tube care. Additionally, failure or clogging of these designs typically requires removal of the entire tracheostomy tube to cure, which can be dangerous.

<CIT> describes a suctioning removable inner cannula tracheotomy tube. Suction is applied at the proximal end of the tube only, and there is no provision for rinsing the tube with a fluid.

<CIT> describes a tracheostomy tube having windows that control air flow so that speech is possible regardless of the position of the tube.

<CIT> describes a suctioning endotracheal tube that evacuates extraluminal secretion above the first cuff, between the cuffs, and below the lower cuff at single points.

<CIT> describes a retaining ring for preventing the unwanted separation of an inner cannula from an outer cannula in tracheostomy devices.

The invention is defined in the appended independent claim <NUM>. Preferred embodiments are matter of the dependent claims.

An irrigating intraluminal suction inner cannula system for a tracheostomy tube may be a suction-powered system that may be used for suction alone or a combination of rinse and intraluminal suction for tracheostomy tubes in place of conventional catheter-based intraluminal suction. An inner cannula includes chambers, or regions, and holes that facilitate intraluminal suction and cleaning at multiple locations within the tracheostomy tube. It may be applied/actuated by a patient, healthcare worker, caretaker, or via an electronic system either on-demand or on regular or triggered intervals, in either inpatient/hospital or outpatient/ambulatory care setting.

In a first aspect, the present invention provides an inner cannula for use with a tracheostomy tube, the inner cannula including a first tube having a first diameter for insertion in the tracheostomy tube, said first tube further comprising a plurality of holes between an intraluminal space of the first tube and an outer surface of the first tube, and a continuous elevated ridge on the outer surface of the first tube, the continuous elevated ridge having a height that abuts an inner lumen of the tracheostomy tube, wherein the continuous elevated ridge extends at least along a first length of the first tube in a proximal direction, around a circumference of the first tube, and along a second length of the first tube in the distal direction, the continuous elevated ridge dividing an airspace surrounding the outer surface into a plurality of separate regions including at least a first region and a second region; and a second tube fused to a distal end of the first tube and having a second diameter larger than the first diameter, the second tube comprising a first passage between an outer surface of the second tube and a first region of the plurality of regions and a second passage between an outer surface of the second tube and a second region of the plurality of regions.

In a second aspect, the present invention provides an irrigating intraluminal suction inner cannula system including an outer tracheostomy tube and the inner cannula of the first aspect of the invention positioned inside the outer tracheostomy tube. The system also includes an irrigant line attached to the first passage in the second tube and in communication with the first region, a suction line attached to the second passage in the second tube and in communication with the second region; and an actuating device coupled between the irrigant line and a source of irrigant and coupled between the suction line and a vacuum source, said actuating device controllably connecting the irrigant line to the source of irrigant and the suction line to the vacuum source.

Use of the irrigating intraluminal suction inner cannula system does not preclude the use of present standard catheter-based intraluminal suctioning, if needed or desired. The use of the irrigating intraluminal suction inner cannula system also does not limit the use of existing subglottic extraluminal (e.g., subglottic) suctioning systems, and may also incorporate these designs.

In the event of suboptimal performance of the irrigating intraluminal suction inner cannula system, the inner cannula may be removed and replaced without removing the tracheostomy tube. Lastly, in certain situations (e.g., when attached to mechanical ventilation, or when using a filter or other such cap externally to limit secretions) the irrigating intraluminal suction inner cannula system achieves both irrigation and suction within a "closed system," thus reducing or eliminating potentially infectious aerosols and/or particulates that result from existing "open" type catheter-based tracheostomy suctioning, and thereby reducing the risk to health care workers and caretakers to respiratory-borne pathogens.

Embodiments of the irrigating intraluminal suction inner cannula system disclosed herein address these concerns via its novel design and use in a closed system, as described hereinbelow. For example, by creating separate chambers for suction and irrigation within the tracheostomy tube - the irrigating intraluminal suction inner cannula system achieves intraluminal tracheostomy suction and irrigation in a way that is presently unavailable. As a result, the shortcomings and risks of prior art technology are avoided.

The principles according to the present disclosure may have particular application in a tracheostomy tube, and thus will be described below chiefly in this context. It is also understood, however, that principles and aspects according to the present disclosure may be applicable to oral endotracheal or nasotracheal tubes, or other irrigating suction catheters used in healthcare or industry.

In the discussion above and to follow, the term "proximal" is used to indicate closer toward the lung of a patient and/or toward the lung-side tip of a tracheostomy tube. The term "distal" is used to indicate farther away from a patient and/or toward the equipment outside the patient or the external end of the tracheostomy tube. Other terms used herein may be defined as follows:.

The innermost airway lumen of an endotracheal tube, including tracheostomy tubes, ranges in inner diameter from <NUM> in neonatal tubes, and up to approximately <NUM> inner diameter in adults, with the lower range being limited by effective airflow/ventilation to and from the patient's airway. The upper range of size is impacted by the outer diameter of an endotracheal tube or tracheostomy tube, and its ability to fit in the airway - specifically, beyond the vocal cords/glottis and into the trachea - generally limited in size to no larger than approximately <NUM>.

An irrigating intraluminal suction inner cannula system as discussed herein generally includes a tracheostomy tube and inner cannula. The inner cannula is inserted within the tracheostomy tube and provides both suction and irrigation of the tracheostomy tube. <FIG> depict inner cannula <NUM>, in an embodiment, while <FIG> depict inner cannula <NUM> in combination with a tracheostomy tube to form an irrigating intraluminal suction inner cannula system <NUM>, in embodiments.

<FIG> shows a side view of inner cannula <NUM> with intraluminal suction and irrigation, in embodiments. <FIG> show oblique, top, and bottom views of inner cannula <NUM>, respectively. <FIG> is a cross-sectional view of <FIG> at line 1E-1E. <FIG> are best viewed together in the following description.

Inner cannula <NUM> includes a single curved semi-rigid plastic tube <NUM> fused to rigid plastic tube <NUM>. Inner cannula <NUM> may fit into a patient's existing tracheostomy tube <NUM> (as shown in FIGS. 2A - 2D) or into a tracheostomy tube specifically designed for use with inner cannula <NUM>. The outer tracheostomy tube <NUM> may or may not be equipped with a balloon cuff (such as cuff <NUM> of <FIG>) for use with positive pressure ventilation (i.e., "cuffed" or "uncuffed" tracheostomy tubes) known in prior art. Inner cannula <NUM> may be secured with appropriate retaining clips <NUM> for patient's native tracheostomy tube <NUM> or accompanying specifically designed tracheostomy tube. Inner cannula <NUM> may have a variety of diameters, thicknesses and lengths depending on the needs of the patient or its use in an endotracheal tube. In embodiments, semi-rigid plastic tube <NUM> has a smaller diameter than rigid plastic tube <NUM>. Intraluminal space <NUM> is formed throughout the interior of inner cannula <NUM>.

Inner cannula <NUM> includes a continuous elevated ridge <NUM> on an outer surface of tube <NUM>, in a specific arrangement and height as to abut the inner lumen of a rigid outer tracheostomy tube <NUM>. Ridge <NUM> divides the outer surface of tube <NUM> into several regions <NUM>, <NUM>, or chambers. Starting from point <NUM> where tube <NUM> is fused to tube <NUM>, ridge <NUM> extends along the length of tube <NUM> in the proximal direction, around the circumference of tube <NUM> at point <NUM>, then back along tube <NUM> in the distal direction. Before reaching tube <NUM>, ridge <NUM> again goes around the circumference of tube <NUM> at point <NUM>, extends in the proximal direction to point <NUM> then back up tube <NUM> to culminate at point <NUM> where tube <NUM> is fused to tube <NUM>.

The regions <NUM>, <NUM> of tube <NUM> formed by ridge <NUM> each contain a series of openings between the outer surface and intraluminal space <NUM> to allow for the movement of air and/or fluid. Region <NUM> includes holes <NUM> and is located on either side of tube <NUM> while region <NUM> includes slots <NUM> and is located on the top and bottom of tube <NUM>. Although holes and slots are shown, this is for purposes of illustration. In embodiments, the locations of holes and slots may be reversed. In addition, all of the openings may be slots, or all may be holes, or holes <NUM> and <NUM> may be of varying sizes or other shapes to facilitate function. Similarly, the shapes and orientations of the ridges are shown in <FIG> for purposes of illustration only and may be configured differently to facilitate the functions described herein.

In embodiments, the rigid plastic tube <NUM> includes passages <NUM> and <NUM> positioned <NUM> degrees from retaining clips <NUM>, although other locations are contemplated as long as passages <NUM> and <NUM> connect to regions <NUM> and <NUM>, respectively. Passages <NUM> and <NUM> may be slots or enclosed passages through tube <NUM>. Passage <NUM> extends at an angle from an upper external surface of tube <NUM> to an opening in the proximal end of tube <NUM> adjacent to tube <NUM>. In embodiments, passage <NUM> communicates with the airspace created by ridge <NUM> between tube <NUM> and an abutting inner surface of an outer tracheostomy tube <NUM> in region <NUM>. Holes <NUM> communicate between the airspace of region <NUM> and intraluminal space <NUM>. In a similar way, passage <NUM> extends at an angle from a lower external surface of tube <NUM> opposite of passage <NUM> to an opening in the proximal end of tube <NUM> adjacent to tube <NUM> but opposite from the opening of passage <NUM>. In embodiments, passage <NUM> also communicates with an airspace created between ridge <NUM> between tube <NUM> and an abutting inner surface of an outer tracheostomy tube <NUM> but in region <NUM> instead of region <NUM>. Region <NUM> includes slots <NUM>, which also communicate between the airspace of region <NUM> and intraluminal space <NUM>.

As discussed in more detail in connection with <FIG>, flexible plastic tubing having a varying diameter, thickness, and length may be connected to passage <NUM> on the upper surface of tube <NUM>. As further discussed below, flexible plastic tubing having a varying diameter, thickness, and length may be connected to passage <NUM> on the lower surface of tube <NUM>. References to upper surface and lower surface are for purposes of illustration and passages <NUM>, <NUM> may be located at any position around tube <NUM>.

<FIG> show inner cannula <NUM> as it would be inserted into an outer tracheostomy tube <NUM>, creating irrigating intraluminal suction inner cannula system <NUM>. Components of <FIG> not specifically addressed below are the same as components described above in connection with <FIG>.

System <NUM> includes an outer tracheostomy tube <NUM>, which represents either the patient's existing tracheostomy tube or one specifically designed for use with inner cannula <NUM>. In embodiments, a specifically-designed outer tracheostomy tube <NUM> may fit with inner cannula <NUM> as part of a kit. In embodiments, outer tracheostomy tube <NUM> is configured to have indentations in its inner surface that engage with ridge <NUM> and improve the function of inner cannula <NUM>. As depicted in <FIG>, only a portion of outer tracheostomy tube <NUM> is shown. A portion of outer tracheostomy tube <NUM> is cutaway to show tube <NUM> and the engagement between ridge <NUM> and an internal surface of outer tracheostomy tube <NUM>. In addition, outer tracheostomy tube <NUM> would extend towards tube <NUM> and provide a mechanism for engaging retaining clips <NUM>. This mechanism could have several different forms and is omitted for clarity of illustration. <FIG> shows system <NUM> with a full outer tracheostomy tube <NUM>.

The length of outer tracheostomy tube <NUM> is approximately equal to tube <NUM> of inner cannula <NUM> as shown in <FIG>. The diameter of outer tracheostomy tube <NUM> is selected such that ridge <NUM> abuts the inner surface of outer tracheostomy tube <NUM> as shown at point <NUM> to form an airspace divided into regions <NUM> and <NUM>. End <NUM> of passage <NUM> in tube <NUM> communicates with region <NUM> while end <NUM> of passage <NUM> communicates with region <NUM> in tube <NUM>. As shown more clearly in <FIG>, region <NUM> includes areas on opposite sides of tube <NUM>. In embodiments, ridge <NUM> may be formed on the inner aspect as part of outer tracheostomy tube <NUM> while still providing the regions or chambers discussed above. Alternatively, ridge <NUM> may be formed as part of both inner cannula <NUM> and outer tracheostomy tube <NUM> creating a single inseparable device.

In operation, inner cannula <NUM> may be used for suctioning and clearance of secretions in a patient's tracheostomy tube. Secretions build up on a regular basis and often require the use of intraluminal catheter based suctioning procedures, typically performed by another individual at present and often too viscous to be easily retrieved. Inner cannula <NUM> may fit into an existing tracheostomy tube or specifically designed accompanying tracheostomy tube. Once secured with retaining clips <NUM> for the patient's native tracheostomy tube (or accompanying tracheostomy tube), then either suction alone, or suction along with irrigation can be applied to remove secretions from the intraluminal space as well as the adjacent proximal end of the patient's tracheostomy tube. In embodiments, suction, or suction and irrigation, may also be applied to an extraluminal subglottic region. Irrigation may be performed with an irrigant solution. In embodiments, the irrigant solution is saline. In embodiments, other solutions may be used, such as mucolytics, antibiotics, antifungals, steroids, or other medications. The irrigation combination with suction application also washes the inner lumen of the tracheostomy tube and suction chamber and therefore thins (decreases viscosity) the secretions to allow for easier suctioning and clearance of these secretions to prevent build-up and blockage, as well as to decrease the burden of pathogenic microbial colonization of the tube and airway tissues.

In embodiments, a system incorporating any of the cannulas disclosed herein is described in connection with <FIG> and <FIG>, which are best viewed together in the following description. For purposes of illustration, inner cannula <NUM> is depicted without outer tracheostomy tube <NUM>. Inner cannula <NUM> fits into either a) the patient's existing tracheostomy tube or into b) an accompanying specifically designed tracheostomy tube - both a and b options represented by irrigating intraluminal suction inner cannula system <NUM> as disclosed herein. Once secured with retaining clips <NUM> for patient's native tracheostomy tube or accompanying specifically designed tracheostomy tube, the proximal end of suction line <NUM> is received by passage <NUM>. Suction line <NUM> may be a flexible plastic tubing terminating in fusion with a standard suction application tip <NUM>. The proximal end of irrigant line <NUM> is received by passage <NUM>. Irrigant line <NUM> may be a flexible plastic tubing terminating in fusion with a with standard intravenous (IV) tubing connection <NUM>. In embodiment, connection <NUM> is a luer lock. In embodiments, suction line <NUM> and irrigation line <NUM> have a resting/failsafe closed position which prevent: a) loss of positive pressure (i.e., a leak) in the setting of mechanical ventilation, b) spontaneous flow of irrigant, and c) spontaneous application of suction to the device.

<FIG> shows irrigating intraluminal suction inner cannula system <NUM> connected with additional apparatus to form active use system <NUM>. Active use system <NUM> is an example of system <NUM> in use. A distal end of suction line <NUM> is applied to suction line input <NUM> on actuating device <NUM>. Suction line <NUM> distal to actuating device <NUM> is coupled to input <NUM> of vacuum source receptacle <NUM>. Receptacle <NUM> may be connected to a continuous suction/negative pressure source such as, for example, a hospital wall-mount vacuum fitting or portable suction unit.

Similarly, irrigant line <NUM> from inner cannula <NUM> is coupled to the appropriate irrigant line input <NUM> on actuating device <NUM>. Irrigant line <NUM> that is distal to the actuator device <NUM> is applied to irrigant bottle <NUM> through cap <NUM> with a straw to the bottom of irrigant bottle <NUM>. A vent <NUM> on cap <NUM> may be opened for ease of use and facilitation of irrigant flow with less resistance. Irrigant bottle <NUM> must either be placed on the floor near the patient or kept at least one vertical foot (or other determined distance as to prevent gravity flow when actuating device is open) below the patient's tracheostomy tube at all times. In embodiments, irrigant bottle <NUM> may be, for example, a vent-option irrigant bottle or a hanging bag attached to a patient bed or independent stand.

Once all components of <FIG> are appropriately secured, actuating device <NUM> is controlled to perform an operation of either suction only, or a combination of suction and irrigation through the actuation of buttons <NUM> and <NUM>. Suction-only actuation using button <NUM> will draw air and secretions from within the intraluminal space <NUM> of inner cannula <NUM>, through the region <NUM> formed by ridge <NUM> between inner cannula <NUM> and the inner surface outer tracheostomy tube <NUM> (FIGS. 2A - 2D), and out distally through lines <NUM> and <NUM> eventually ending in the vacuum source receptacle <NUM>, thus clearing intraluminal secretions. Although actuating device <NUM> is described in connection with buttons, any mechanism for controlling the operation of actuating device <NUM> and active use system <NUM> to provide the functions described herein may be used. Additional buttons and functions may also be provided as part of actuating device <NUM> and active use system <NUM>.

If both suction button <NUM> and irrigation button <NUM> are actuated at the same time, irrigant originating distally in irrigant bottle <NUM> will be drawn through lines <NUM> and <NUM> by negative pressure applied through suction lines <NUM> and <NUM>. Irrigant will be drawn into region <NUM> formed by ridge <NUM> between inner cannula <NUM> and the inner surface of outer tracheostomy tube <NUM>. Irrigant will enter the intraluminal space <NUM> of inner cannula <NUM> through holes <NUM>, mix with intraluminal air and secretions, and then exit through slots <NUM> (<FIG>) into region <NUM>. This flow of irrigant will thin secretions and rinse the intraluminal space <NUM> of inner cannula <NUM>, and eventually end in the vacuum source receptacle <NUM>.

Actuating device <NUM> may be designed in a number of ways, as long as it provides control buttons or other actuators and a connection between suction and irrigant lines from a tracheostomy cannula, and sources of irrigant and suction, respectively. In embodiments, actuating device <NUM> includes buttons <NUM> and <NUM>, which are able to be moved/depressed into alignment. More or fewer buttons may be provided. An outer plastic housing of actuating device <NUM> is shown as including input <NUM> for has suction line <NUM> and an output on the opposite side for line <NUM> provide suction to inner cannula <NUM>. Outer plastic housing of actuating device <NUM> also has an input <NUM> for irrigant line <NUM> and an output for irrigant line <NUM> on the opposite side which passes through cap <NUM> into standard irrigant bottle <NUM>. These inputs and outputs may be provided at any convenient location on actuating device <NUM>. Actuating device <NUM> functions such that only when button <NUM> is depressed are the lumens of the two lines <NUM> and <NUM> aligned to allow flow, otherwise preventing flow when the button <NUM> is not actuated. Likewise, only when button <NUM> is depressed are the lumens of lines <NUM> and <NUM> aligned to allow flow. In embodiments, actuating device <NUM> prevents the flow of irrigant without application of suction; however, it will accommodate use of suction only. Other actuating device mechanisms for connecting lines <NUM> and <NUM> with lines <NUM> and <NUM>, respectively, are contemplated. Further, actuating device may be provided as a component of another medical device.

The patient is protected from irrigant-only flow into the intraluminal space <NUM> of inner cannula <NUM> by both actuating device <NUM> which prevents irrigant flow in the absence of suction, and by ensuring that the irrigant bottle <NUM> is kept at least one foot (twelve inches) - or other determined distance as to prevent spontaneous flow. In other words, irrigant bottle <NUM> as well as hanging bag or any apparatus for providing irrigant must be located below the vertical height of the tracheostomy tube at all times in the absence of any other mechanism to limit flow of irrigant. Other means of controlling the flow of irrigant are contemplated. For example, possibly via use of a variant of actuating device <NUM>, irrigant may be actively pushed through the same flow pattern described previously, but done so by means of a pump, or pressurized irrigant canister, in a continuous or pulsating fashion, rather than simply drawn through solely by the negative pressure created by vacuum source <NUM>. This pump could be placed either proximal or distal to the actuating device. In embodiments, the holes <NUM> in inner cannula <NUM> may include a one-way valve or pressure relief type valve, such as a simple slit or defect in the material in this region which remains closed at baseline and opens with increases in pressure in the irrigant line proximal to the actuating device.

In embodiments, active use system <NUM> may include additional safeguards against failure. In the event of failure of irrigation or suction, a flow sensor (not shown) would monitor if excessive or unexpected flow of irrigant is detected and provide an alarm, or other notification, or means of cessation. Excessive flow of irrigant may alternatively be immediately stopped by removal of the inner cannula. Valves, flow-limiters, and mechanical or electrical flow and pressure sensors are also contemplated.

In the event of malfunction, or for regular interval care, inner cannula <NUM> may be unclipped, removed, discarded, and replaced with a new cannula. Conventional catheter-based intraluminal suctioning may be performed with or without inner cannula <NUM> in place. It is also notable that operation can be performed while connected to a ventilator/source of positive pressure, or not. Furthermore, operation can be performed with either a cuffed or uncuffed tube or with a fenestrated or non-fenestrated tracheostomy tube. Control of actuating device <NUM> may be performed by the patient, healthcare provider or caretaker. In embodiments, actuating device <NUM> may also be actuated by a mechanism designed to hold and apply actuation/depression of buttons <NUM> and <NUM> by means of an electronically controlled device either on-demand by patient, healthcare provider, caretaker, or on an automated schedule, or at points where certain monitoring input conditions are met and recognized by an electronic monitoring system. Irrigant bottle <NUM> may be replaced as it is depleted or as part of a set schedule. Furthermore, any component may be removed and replaced as part of a set schedule or as deemed necessary by patient, healthcare worker, caretaker, as indicated by an electronic monitoring system, or established protocol.

A variety of methods may be used to manufacture an irrigating intraluminal suction inner cannula system, in embodiments. In embodiments, inner cannula <NUM> or system <NUM> may be created by mold extrusion or by thermally and/or chemically affixing solid plastic roll material onto the cannula to give its configuration of raised ridges. Holes <NUM> and slots <NUM> on tube <NUM> may be created by mold extrusion or via heat, drilling, cutting, grinding, or otherwise subtracting material. Tube <NUM> may be thermally and/or chemically fused with rigid plastic tube <NUM>. Tubes <NUM> and <NUM> may also be manufactured as one piece. Irrigant/irrigation line <NUM> and suction line <NUM> may be thermally and/or chemically fused in place to the rigid plastic tube <NUM>. Additive methods, such as 3D printing, are also contemplated.

<FIG> is a flowchart illustrating a method <NUM> of using an irrigating intraluminal suction inner cannula system <NUM>. Method <NUM> includes steps <NUM> and <NUM>. The method <NUM> may also include at least one of steps <NUM> and <NUM>.

In step <NUM>, inner cannula <NUM> is inserted into an outer tracheostomy tube <NUM> to create irrigating intraluminal suction inner cannula system <NUM>. In an example of step <NUM>, inner cannula <NUM> fits into an existing outer tracheostomy tube <NUM> or a specifically designed accompanying tracheostomy tube. Inner cannula <NUM> is secured with retaining clips <NUM> to patient's native tracheostomy tube <NUM> or accompanying tracheostomy tube.

In step <NUM>, suction and irrigant lines are connected to inner cannula <NUM>. In an example of step <NUM>, suction line <NUM> is attached to passage <NUM> in tube <NUM>. In embodiments, irrigant line <NUM> is attached to passage <NUM> in tube <NUM>. In embodiments, one or both of suction line <NUM> and irrigant line <NUM> may be permanently attached, or fused, to tube <NUM>.

In step <NUM>, suction and irrigant lines are connected to vacuum and irrigant sources through an actuating device. In an example of step <NUM>, suction line <NUM> is connected through actuating device <NUM> and suction line <NUM> to vacuum source receptacle <NUM>. Irrigant line <NUM> is connected through actuating device <NUM> and irrigant line <NUM> to irrigant bottle <NUM>.

In step <NUM>, actuating device <NUM> is used to perform suction alone, or suction along with irrigation of inner cannula <NUM> or system <NUM>. In an example of step <NUM>, button <NUM> on actuating device <NUM> may be pressed to connect suction line <NUM> with suction line <NUM> to remove secretions from the intraluminal space <NUM> of the patient's tracheostomy tube <NUM>. In addition, irrigant button <NUM> may be pressed to combine irrigant/irrigation with suction to wash the intraluminal space <NUM> of the tracheostomy tube and region <NUM> by thinning the secretions to allow for easier suctioning and clearance within a closed system. Actuating device <NUM> may be controlled by the patient, hospital personal or other caregiver. Actuating device <NUM> may be incorporated within a ventilator (not shown) and programmed to coordinate with the operation of the ventilator. Further, actuating device <NUM> may be used with an electronically controlled device to apply actuation/depression of actuator buttons (or other method). An additional example would be control via ocular control device or neural integrated device as used by immobile patients such as those with neurodegenerative or paralytic conditions (e.g., Amyotrophic Lateral Sclerosis - ALS, trauma, etc). In any of these embodiments, actuating device may be actuated either on-demand by patient, healthcare provider, caretaker, either on an automated schedule, or at points where certain monitoring input conditions are met and recognized by an electronic monitoring system. In embodiments, this would provide additional flexibility, decrease care-burden and resources, and minimize exposure of others to aerosolized particles.

Accumulation of oral cavity and pharyngeal secretions in the region above an inflated cuff of an outer tracheostomy tube can lead to micro aspiration of secretions into the lungs and has been associated with the development of ventilator assisted pneumonia (VAP. ) For this reason, several additional embodiments are contemplated to incorporate extraluminal subglottic suction alone, or irrigation and suction combined, in this region while still incorporating the intraluminal irrigation and suction described herein. These embodiments are demonstrated in <FIG>. Additionally, an irrigating intraluminal suction inner cannula system as described herein may also be used with fenestrated outer tracheostomy tubes and additional embodiments are shown in <FIG>.

<FIG> shows that inner cannula <NUM> as shown in <FIG> may be used with an outer tracheostomy tube with cuff <NUM> that is provided with additional suction holes <NUM>. Single or multiple suction holes <NUM> are provided in cuffed outer tracheostomy tube <NUM> in the region of the subglottis, that is, above cuff <NUM> of a cuffed outer tracheostomy tube <NUM>, and below the vocal cords, as shown in <FIG>. Suction holes <NUM> may be positioned on the superior surface of cuffed outer tracheostomy tube <NUM> so as to overly corresponding region <NUM> of inner cannula <NUM> and thus, extend the intraluminal suction to the subglottic space. Additional suction holes <NUM> (not shown) may be provided on the opposite side of cuffed outer tracheostomy tube <NUM> aligning with the corresponding region <NUM>. However, because the airspace of the lumen of the tracheostomy tube used for ventilation is contiguous with this extraluminal suction corridor created by this design, during positive pressure ventilation, an air leak into the subglottic space may exist, leading to discomfort or otherwise problematic side effects. Additionally, this may create a pathway for subglottic secretions to enter the intraluminal space and lead to aspiration of the secretions into the lower airways. Because of these shortcomings, two additional subglottic suction and subglottic irrigation and suction combination embodiments are contemplated and demonstrated in <FIG> and <FIG>.

In the embodiment of <FIG>, inner cannula <NUM> is a modified version of inner cannula <NUM>. An additional passage <NUM> is created in tube <NUM> for the attachment of a subglottic suction line (not shown). Passage <NUM> is an example of passage <NUM>. Subglottic suction occurs in region <NUM> created by ridge <NUM> on the inner cannula. Ridge <NUM> is similar to ridge <NUM> in that is creates a region, or chamber, between inner cannula <NUM> and outer tracheostomy tube <NUM>. Ridge <NUM> starts at tube <NUM>, extends along the length of inner cannula <NUM> in the proximal direction, around the circumference of inner cannula <NUM> at point <NUM>, then extends along the length of inner cannula <NUM> in the distal direction back to terminate at tube <NUM>. Ridge <NUM> is reconfigured as shown in <FIG> so that intraluminal suction, or irrigation and suction, may be provided with inner cannula <NUM> as described above.

Notably, there are no holes or slots region <NUM> as there are in region <NUM> and therefore, no communication between region <NUM> or extraluminal space outside outer tracheostomy tube <NUM> and the intraluminal space of inner cannula <NUM>. Instead, a slot <NUM> is located in outer tracheostomy tube <NUM> so that it overlies region <NUM>. By separate or similar control of an actuating device as described in connection with <FIG>, when suction is applied through passage <NUM>, secretions in the extraluminal subglottic space will be removed by suction. The embodiment of <FIG> only provides suction to the extraluminal subglottic space. Passage <NUM> in tube <NUM> may be shifted from its position as shown in <FIG>, but still is contiguous with the region <NUM>, and communicates with the opposite side of inner cannula <NUM> irrigation space via passthrough region <NUM>. Therefore, a new path of suction is created, while still suppling suction and irrigation to all of the previously described holes in the inner cannula for purposes of intraluminal irrigation. A small area of superior intraluminal suction is sacrificed in this design.

The embodiment of <FIG> incorporates both irrigation and suction to the extraluminal subglottic region, while again still achieving both intraluminal suction and irrigation. In this embodiment, passage <NUM> in tube <NUM> is again shifted to the side, but in the same manner as <FIG>, it remains contiguous with the region <NUM> via the same design of ridge <NUM> as shown in <FIG>. In <FIG>, ridge <NUM> is replaced with two parallel raised ridges including inner ridge <NUM> and outer ridge <NUM>. Both inner ridge <NUM> and outer ridge <NUM> originate from tube <NUM> and terminate again at tube <NUM> as described above for ridge <NUM>. This creates region <NUM> within inner ridge <NUM> and region <NUM> between inner ridge <NUM> and outer ridge <NUM>. Like regions <NUM> and <NUM>, regions <NUM> and <NUM> create a chamber between inner cannula <NUM> and outer tracheostomy tube <NUM>. There are no holes or slots in either of regions <NUM> or <NUM> for communication with the intraluminal space of inner cannula <NUM>. Passage <NUM> in tube <NUM> is connected to a suction line (not shown) and contiguous with region <NUM> for providing suction to extraluminal subglottic region through opening <NUM> in outer tracheostomy tube <NUM>. Passage <NUM> in tube <NUM> is connected to an irrigation line (not shown) and contiguous with region <NUM> for providing irrigation to the extraluminal subglottic region through openings <NUM> and <NUM> in outer tracheostomy tube <NUM>. As described above in connection with <FIG>, an actuating device may cause the flow of irrigant from the supply/bottle <NUM> to be drawn through passage <NUM> to mix with secretions in the extraluminal subglottic space, then be drawn out through passage <NUM> to terminate in the same or separate suction canister or vacuum source receptacle <NUM>. Other similar variations and relocations of the raised ridges and entry defects on inner cannula <NUM> and tube <NUM> for subglottic suction are contemplated. Therefore, a new path of irrigant flow is created, while still suppling suction and irrigation to all of the previously described holes in the inner cannula for purposes of intraluminal irrigation.

<FIG> shows an embodiment of an irrigating intraluminal suction inner cannula <NUM> for use with a fenestrated outer tracheostomy tube <NUM>. Fenestrated outer tracheostomy tube <NUM> may be desired in certain clinical scenarios to assess breathing and speaking capabilities. Inner cannula <NUM> is compatible with this type of outer tracheostomy tube design, or a specifically designed accompanying outer tracheostomy tube. Outer tracheostomy tube <NUM> may be either cuffed as shown or uncuffed. A raised, solid, block-like platform <NUM> is created on inner cannula <NUM> in the region of fenestration <NUM> of outer tracheostomy tube <NUM>. Platform <NUM> is sized to abut the inner surface of outer tracheostomy tube <NUM>. In this manner, the flow of air to and from the patient's airway to and from the subglottic region is blocked while irrigation and suction may still be provided using ridge <NUM> and regions <NUM> and <NUM> as described above. This blockage is sometimes desired.

Alternatively, flow of air to and from the patient's airway through the fenestration in an outer tracheostomy tube to and from the subglottic region is sometimes desired. To address this, an alternate embodiment shown in <FIG> is contemplated for use in fenestrated outer tracheostomy tubes that allows for this passage of air through fenestration <NUM>. In <FIG>, irrigation intraluminal inner cannula <NUM> includes a roughly circular or ovoid raised ridge <NUM> in the same area and shape of overlying fenestration <NUM> on outer tracheostomy tube <NUM>. In this embodiment, an accompanying opening within ridge <NUM> to the intraluminal space inside inner cannula <NUM> is intentional.

None of the embodiments in <FIG> compromise the irrigation or suction function of the intraluminal space described previously herein.

Active use system <NUM> decreases aerosolized airway particles because it is a closed system when used with a ventilator or a tracheostomy tube filter or nearly closed system when used without one. Either way this reduces respiratory aerosols and particles as well as the infection risk to others, an inherent risk of standard tracheostomy care.

In the event of malfunction, or for regular interval care, inner cannula <NUM> may be unclipped, removed, discarded, and replaced with a new cannula without need for replacement of the outer tracheostomy tube. Conventional catheter-based intraluminal suctioning may be performed with or without inner cannula <NUM> in place.

A number of changes may be made to inner cannula <NUM> or system <NUM>. In embodiments, additional ridges may be used on tube <NUM> to create further regions, or chambers/conduits for monitoring equipment and/or medication delivery. Ridge <NUM> on tube <NUM> may be reconfigured for different patterns and subsequently different shapes of the irrigation and vacuum chambers, which may change their function. Similarly, passages in tube <NUM> may be reconfigured for different patterns or shapes to permit functions of irrigation in suction chambers. Ridges <NUM> may allow for communication between the patient's airway to the external environment for the purpose(s) of airway monitoring devices and/or measurements or to deliver medications (droplet, aerosol, etc.).

Outer tracheostomy tube <NUM> may be configured with grooves or reliefs to help facilitate ease of insertion, different or improved function, or cleaning. The holes and/or slot locations, sizes, patterns, and shapes on tube <NUM> may be reconfigured for varying flow of liquids and suction performance. In embodiments, inner cannula <NUM> may be lengthened (beyond tip of the outer tracheostomy tube <NUM>), or shortened (to within the lumen of <NUM>) to further enhance operational capabilities.

The lines for irrigation and suction may be altered to achieve the same suction by means of different locations on the hard plastic lumen of the invention, diameters, lengths, and connections. The shape and configurations of retaining clips, lumen and ridge sizes, lengths, and existing fenestrations could be applied to work with different existing tracheostomy tubes presently available, which vary in some or all of these regards.

An irrigating intraluminal suction inner cannula system may be used in other applications or areas of technology that requires the frequent replacement of inner lumens of a tube as a result of build-up of debris, secretions, or other matter; or, a similar system that does not have a replaceable inner lumen/cannula but could benefit from such to prevent clogging which results in damage or failure of the system as may presently be managed by intraluminal catheter-based suction. This could be in either medical or non-medical settings.

In healthcare environments, an irrigating intraluminal suction inner cannula system may be applied to other medical device/implant tubes which communicate with the external environment - such as oral endotracheal tubes, nasotracheal tubes, gastrostomy, colostomy, or nephrostomy tubes, intraperitoneal lumens, surgical drains, or other such applications in healthcare. The irrigating intraluminal suction inner cannula system could be used in many different settings, including both inpatient and ambulatory/portable settings.

This function of an irrigating intraluminal suction inner cannula system may be directed to or performed by a computer, machine, or other electronic means of monitoring and/or actuation of described functions.

An irrigating intraluminal suction inner cannula system, and the described, implied, or resultant use can produce compositions that may be of use or value. Monitoring of the secretions produced by its use may be of diagnostic use to healthcare providers. It may also provide for testing secretions for the presence of certain pathogens which can be detected or cultured, without introduction of additional instrumentation within the patient's airway, thus reducing risks from additional procedures.

The health outcomes data obtained by any regularly implemented or automated use of an irrigating intraluminal suction inner cannula system, with or without a machine or electronic control, may be a useful item in the creation of patient care protocols, reduction of patient morbidity and/or mortality, and development of patient care algorithms. Patient health outcomes may be improved as result of improved airway hygiene, which is a recognized standard of care in patients with tracheostomy tubes.

Claim 1:
An inner cannula (<NUM>) for use with a tracheostomy tube, comprising:
a first tube (<NUM>) having a first diameter for insertion in the tracheostomy tube, a distal end and a proximal end, said first tube further comprising a plurality of holes (<NUM>, <NUM>) between an intraluminal space of the first tube and an outer surface of the first tube; and
a second tube (<NUM>) fused to the distal end of the first tube and having a second diameter larger than the first diameter;
characterized in that
the first tube (<NUM>) further comprises a continuous elevated ridge (<NUM>) on the outer surface of the first tube, the continuous elevated ridge (<NUM>) having a height that abuts an inner lumen of the tracheostomy tube, wherein the continuous elevated ridge starts at the second tube (<NUM>), extends at least along a first length of the first tube in a proximal direction, around a circumference (<NUM>) of the first tube, and along a second length of the first tube in the distal direction, and terminates at the second tube (<NUM>), the continuous elevated ridge dividing an airspace surrounding the outer surface into a plurality of separate regions including at least a first region (<NUM>) and a second region (<NUM>);
and the second tube (<NUM>) further comprises a first passage (<NUM>) between an outer surface of the second tube and the first region (<NUM>) and a second passage (<NUM>) between an outer surface of the second tube (<NUM>) and the second region (<NUM>).