Perfused Intraluminal Suction Inner Cannula System

Abstract

The perfused endoluminal suction inner cannula system for tracheostomy tubes can be a suction-powered system that can be used to suction tracheostomy tubes alone or in combination with rinsing and endoluminal suction, replacing traditional catheter-based endoluminal suction. The inner cannula contains chambers, or regions, and holes that facilitate endoluminal suction and irrigation at multiple locations within the tracheostomy tube. It can be applied / activated by the patient, a healthcare professional, a caregiver, or via an electronic system in either an inpatient / hospital or outpatient / ambulatory care setting, on an as-needed basis, or periodically or at set activation intervals.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 124,599, filed December 11, 2020, which is incorporated herein by reference in its entirety. [Background technology]

[0002] Endotracheal intubation is the insertion of an endotracheal tube into a patient's airway, terminating in the trachea. The breathing tube may be inserted orally, nasally, or via a tracheostomy (an insertion pathway through the skin and soft tissue of the neck) and ultimately terminate in the trachea. These procedures are performed to provide temporary or permanent breathing or ventilation support. The risks and problems associated with the placement, use, and care of an endotracheal breathing tube range from discomfort and inconvenience to serious medical risks and poor health outcomes.

[0003] For safe and comfortable use, tracheostomy tubes require regular drainage of secretions from the innermost lumen (i.e., "intraluminal"). In some circumstances, drainage may be required as frequently as every 30 minutes. Even without sedation, few patients are able to perform effective and safe routine intraluminal suctioning without assistance, resulting in dependency on others for this important task, often leading to depression, anxiety, and agitation. Even with assistance, patients often experience discomfort during suctioning procedures. This is due to two factors: first, suction catheter misuse is common (i.e., placement of the suction catheter too deep / proximal to the airway); and second, patients are unable to synchronize suction (negative pressure) with the respiratory cycle, resulting in "surprise" suctioning, which can cause choking, changes in airway pressure, and trigger a cough reflex.

[0004] Figures 7A-7C illustrate various aspects of the relevant basic anatomy of an endotracheal tube, as well as features of prior art tracheostomy tubes. Figure 7A is a side cross-sectional view of a patient 700 showing various types of endotracheal tubes. Figure 7B is a perspective view of a tracheostomy tube with an inner cannula, and Figure 7C is a perspective view of a fenestrated tracheostomy tube and inner cannula. For the following discussion, it will be best to view Figures 7A-7C together.

[0005] Patient 700 has a trachea 702, which is part of the patient's 700 airway to their lungs (not shown). To assist breathing, patient 700 may be intubated in several ways, as shown in FIG. 7A . Intubation may be accomplished with a long nasotracheal tube via pathway 704 inserted through the nasal cavity, past the vocal cords 710, and into the trachea 702. Alternatively, an oral endotracheal tube of similar length via pathway 706 may be inserted through the oral cavity into the trachea 702. Additionally, a short tracheostomy tube 708 may be inserted directly into the trachea 702 through a surgical tracheotomy area 712.

[0006] During positive pressure or mechanical ventilation, an inflatable cuff 714 surrounding the tracheostomy tube 708 can be inflated via a cuff inflation valve 716, an external monitoring balloon 718, and associated tubing 720 to provide a seal between the tracheostomy tube 708 and the trachea 702 and prevent air leakage around the tube. This is referred to as a "cuffed" tube. The cuff 714 can be inflated or deflated depending on the needs of the patient 700. An equivalent tube without such a cuff would be referred to as an "uncuffed" tube, as shown, for example, in FIG. 7C.

[0007] As shown in FIG. 7B, the tracheostomy tube 708 includes a flange 722 that rests against the patient's 700 neck to maintain the tracheostomy tube 708 in position and provide consistent functionality. A removable inner cannula 724 is an added feature of some prior art tracheostomy tubes and can be incorporated into either cuffed or uncuffed tracheostomy tubes. Air is exchanged with the patient 700 through the innermost lumen of the tracheostomy tube 708 (the inner side, or lumen, of the inner cannula 724, if present) and through a hub 726. The hub 726 of the inner cannula 724 includes a clip 728 that engages with a clip attachment 730 on the flange 722.

[0008] 7C illustrates the principles of a fenestrated tracheostomy tube. Fenestrations 732 are included in the tracheostomy tube 708 above the region 734 where the inflatable cuff will be placed. If used, corresponding fenestrations 736 may be included in the inner cannula 724. The fenestrations 732 and 736 allow airflow, thereby allowing the patient 700 to speak and cough more effectively. The methodologies, concepts, and designs or configurations applied to and described with tracheostomy tubes herein can also be applied to nasotracheal tubes and orotracheal tubes.

[0009] Most prior art secretion management processes use only suction to remove secretions from tracheostomy tubes. Currently, there is no method to safely clean the lumen of a tracheostomy tube and prevent secretion buildup, clogging, and acute airway loss. As a result, patients may undergo more advanced interventions or additional procedures due to inadequate tracheostomy tube cleaning.

[0010] Prior art manual suction-based catheter-based removal of intraluminal tracheostomy secretions also poses a risk of infection to patients and can often result in airway trauma. It also increases psychosocial distress for patients and caregivers, loss of patient autonomy, strains healthcare provider resources, and caregiver burden, all of whom may be exposed to airborne pathogens from the patient's airway. Furthermore, the frequent need to remove secretions not only places additional strain on healthcare provider and caregiver time and resources, but also discourages patients from self-medicating.

[0011] Currently available tracheostomy tubes that incorporate irrigation and / or suction capabilities do so at a single site within the airway (i.e., subglottis / "above the cuff" or proximal tip) and most commonly, not within the tube lumen. Those that vent the tube lumen do not address the distal tip or extralumen, and further, do so without irrigation, making them prone to impending airway loss due to clogging. Because none of these devices have been widely accepted for clinical use, clogging / airway loss, infection, and the burden of standard manual catheter-based intraluminal suction systems remain the mainstay of tracheostomy tube treatment. Furthermore, correcting a malfunction or blockage in these configurations typically requires removal of the entire tracheostomy tube, which is dangerous. Summary of the Invention [Problem to be solved by the invention]

[0012] The perfusion endoluminal suction inner cannula system for tracheostomy tubes may be a suction-powered system that can be used for tracheostomy tube suction alone or for combined perfusion and endoluminal suction in place of traditional catheter-based endoluminal suction. The inner cannula includes chambers, or regions, and holes that facilitate endoluminal suction and irrigation at multiple locations within the tracheostomy tube. It can be applied / activated by the patient, a healthcare professional, a caregiver, or via an electronic system in either an inpatient / hospital or outpatient / ambulatory care setting on an as-needed basis, or periodically or at a set activation interval.

[0013] In a first aspect, an inner cannula for use with a tracheostomy tube includes a first tube having a first diameter for insertion into the tracheostomy tube, and a second tube fused to the distal end of the first tube and having a second diameter larger than the first diameter, the first tube further comprising a plurality of holes between the intraluminal space of the first tube and an outer surface of the first tube, and one or more protrusions on the outer surface of the first tube dividing a space surrounding the outer surface into a plurality of regions, and the second tube comprising a first passage between the outer surface of the second tube and a first region of the plurality of regions, and a second passage between the outer surface of the second tube and a second region of the plurality of regions.

[0014] In a second aspect, a perfused intraluminal suction inner cannula system includes an outer tracheostomy tube and an inner cannula disposed inside the outer tracheostomy tube, the inner cannula including a first tube having a first diameter for insertion into the outer tracheostomy tube and a second tube fused to a distal end of the first tube and having a second diameter larger than the first diameter, the first tube further including a plurality of holes between the intraluminal space of the first tube and an outer surface of the first tube and one or more protrusions on the outer surface of the first tube dividing a space surrounding the outer surface into a plurality of regions, and the second tube including a first passage between the outer surface of the second tube and a first region of the plurality of regions and a second passage between the outer surface of the second tube and a second region of the plurality of regions. The system also includes an irrigation fluid line attached to a first passage in the second tubing and communicating with the first region, an aspiration line attached to a second passage in the second tubing and communicating with the second region, and an actuator connected between the irrigation fluid line and the irrigation fluid source and between the aspiration line and the vacuum source, the actuator controllably connecting the irrigation fluid line to the irrigation fluid source and the aspiration line to the vacuum source.

[0015] In a third aspect, a perfused intraluminal suction and extraluminal suction inner cannula system includes an outer tracheostomy tube including one or more openings along its length, and an inner cannula positioned inside the outer tracheostomy tube, the inner cannula comprising: a first tube having a length and diameter for insertion into the outer tracheostomy tube; and a second tube fused to the distal end of the first tube and having a larger diameter than the first tube, the first tube further comprising a plurality of openings between the intraluminal space of the first tube and its outer surface, a first protrusion dividing the outer surface of the first tube into a perfusion region and a first suction region, and a second protrusion forming a second suction region on the outer surface of the first tube. The system also includes a perfusion fluid line attached to the perfusion fluid passage in the second tube and communicating with a gap formed between the inner surface of the outer tracheostomy tube and the outer surface of the first tube at the perfusion region; a first suction line attached to the first suction passage in the second tube and communicating with a gap formed between the inner surface of the outer tracheostomy tube and the outer surface of the first tube at the first suction region; a second suction line attached to the second suction passage in the second tube and communicating with a gap formed between the inner surface of the outer tracheostomy tube and the outer surface of the first tube at the second suction region; and an actuator connected between the perfusion fluid line and a perfusion fluid source and between the first and second suction lines and a vacuum source, the actuator controllably connecting the perfusion fluid line to the perfusion fluid source and the first and second suction lines to the vacuum source.

[0016] In another aspect, a method for irrigating a tracheostomy tube having an outer tracheostomy tube and an inner cannula having a plurality of holes and one or more protrusions that divide a space between the outer tracheostomy tube and the inner cannula into a plurality of regions when the inner cannula is inserted into the outer tracheostomy tube includes attaching a suction line to the inner cannula so as to communicate with a first region of the plurality of regions, attaching an actuator between the suction line and a vacuum source, the actuator controllably connecting the suction line to the vacuum source, and controlling the actuator to draw suction from the lumen of the inner cannula through a first portion of the plurality of holes, the first region, and the suction line.

[0017] The method may further include attaching a perfusion fluid line to the inner cannula so as to communicate with a second region of the plurality of regions, and attaching an actuator between the perfusion fluid line and a perfusion fluid source, the actuator controllably connecting the perfusion fluid line to the perfusion fluid source, and controlling the actuator to supply perfusion fluid to the lumen of the inner cannula through a second portion of the plurality of holes, the second region, and the perfusion fluid line.

[0018] The use of the perfused endoluminal suction inner cannula system does not preclude the use of current standard catheter-based endoluminal suction, if necessary or desired. The use of the perfused endoluminal suction inner cannula system also does not limit the use of existing extraglottic (e.g., subglottic) suction systems, and these configurations may be incorporated.

[0019] If the perfused intraluminal suction inner cannula system's performance is suboptimal, the inner cannula can be removed and replaced without removing the tracheostomy tube. Finally, in certain situations (e.g., when attached to a mechanical ventilator or when an external filter or other similar cap is used to restrict secretions), the perfused intraluminal suction inner cannula system achieves both perfusion and suction within a "closed system," thereby reducing or eliminating potentially infectious aerosols and / or particulates that arise from existing "open" catheter-based tracheostomy suction systems, thereby reducing the risk of respiratory-borne pathogens to healthcare workers and caregivers.

[0020] The embodiments of the perfused endoluminal suction inner cannula system disclosed herein address these problems through its novel configuration and use in a closed system, as described herein below. For example, by creating separate chambers for suction and irrigation within the tracheostomy tube, the perfused endoluminal suction inner cannula system achieves suction and irrigation of endoluminal tracheostomies in a manner not currently available. As a result, the shortcomings and risks of the prior art are avoided. [Brief explanation of the drawings]

[0021] [Figure 1A] FIG. 1A is a side view of an embodiment of a perfused intraluminal suction inner cannula.

[0022] [Figure 1B] FIG. 1B is a perspective view of the cannula of FIG. 1A.

[0023] [Figure 1C] FIG. 1C is a top view of the cannula of FIG. 1A.

[0024] [Figure 1D] FIG. 1D is a bottom view of the cannula of FIG. 1A.

[0025] [Figure 1E] FIG. 1E is a cross-sectional view of the inner cannula of FIG. 1A.

[0026] [Figure 2A] FIG. 2A is a side cross-sectional view of an embodiment of a perfused intraluminal aspiration cannula having an outer lumen.

[0027] [Figure 2B] FIG. 2B is a perspective view of the cannula system of FIG. 2A.

[0028] [Figure 2C] FIG. 2C is an enlarged view of a portion of the cannula system of FIG. 2A.

[0029] [Figure 3] FIG. 3 is a side view of an embodiment of a cannula having a perfusion fluid connection and a suction connection.

[0030] [Figure 4] FIG. 4 illustrates an embodiment of a perfused intraluminal suction inner cannula system.

[0031] [Figure 5] FIG. 5 is a flow chart illustrating a method of using the perfused intraluminal suction inner cannula system.

[0032] [Figure 6A] FIG. 6A is a perspective view of an embodiment of a perfused intraluminal suction inner cannula system incorporating additional extraglottic suction functionality and an associated cuffed outer tracheostomy tube.

[0033] [Figure 6B] FIG. 6B is a perspective view of an alternative perfused intraluminal suction inner cannula system incorporating additional extraglottic suction capability and an associated cuffed outer tracheostomy tube, according to an embodiment.

[0034] [Figure 6C] FIG. 6C is a perspective view of an embodiment of a perfused intraluminal suction inner cannula system incorporating both perfusion and suction of the extra-subglottic region with a specially designed cuffed tracheostomy tube.

[0035] [Figure 6D] FIG. 6D is a perspective view of an embodiment of a perfused intraluminal suction inner cannula system for use with a fenestrated outer tracheostomy tube. [Figure 6E] FIG. 6E is a perspective view of an embodiment of a perfused intraluminal suction inner cannula system for use with a fenestrated outer tracheostomy tube.

[0036] [Figure 7A] FIG. 7A is a cross-sectional side view of a patient showing various types of prior art endotracheal tubes, according to an embodiment.

[0037] [Figure 7B] FIG. 7B is a perspective view of a prior art tracheostomy tube having an inner cannula, according to an embodiment.

[0038] [Figure 7C] FIG. 7C is a perspective view of a prior art fenestrated tracheostomy tube and inner cannula, in an embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0039] The principles of the present disclosure have particular application to tracheostomy tubes and will be described primarily in this regard below, although it should be understood that the principles and aspects of the present disclosure may also be applied to oral or nasotracheal tubes or other irrigation and suction catheters used in medicine or industry.

[0040] Above and below, the term "proximal" is used to indicate closer to the patient's lungs and / or closer to the pulmonary tip of the tracheostomy tube. The term "distal" is used to indicate further from the patient and / or toward the outer end of the device or tracheostomy tube outside the patient. Other terms used herein are defined as follows:

[0041] Cannula - a tube inserted into a body cavity, duct, or blood vessel

[0042] Lumen - the space inside the cannula

[0043] Intraluminal - the innermost lumen between the two ends of the cannula.

[0044] Extraluminal - Outside the cannula, or at either or both ends of the cannula As used herein, extraluminal refers to the outermost tube or either end of a tube or cannula in any situation.

[0045] Subglottic - generally located below the glottis. As used herein, the subglottis refers to the extraluminal region of the trachea located above the inflatable cuff of the tracheal tube and below the vocal cords.

[0046] The innermost airway lumen of endotracheal tubes, including tracheostomy tubes, ranges from an internal diameter of 2 mm in neonatal tubes to approximately 14 mm in adults, with the lower range limited by effective airflow / ventilation into and out of the patient's airway. The upper size limit is influenced by the external diameter of the endotracheal or tracheostomy tube, and its ability to fit into the airway (specifically the trachea beyond the vocal cords / glottis) generally limits sizes to approximately 15 mm or less.

[0047] The perfused endoluminal suction inner cannula systems described herein generally include a tracheostomy tube and an inner cannula. The inner cannula is inserted into the tracheostomy tube and provides both suction and perfusion for the tracheostomy tube. FIGS. 1A-1D illustrate an embodiment of inner cannula 100, while FIGS. 2A-2C illustrate an embodiment of inner cannula 100 in combination with a tracheostomy tube to form perfused endoluminal suction inner cannula system 200.

[0048] Figure 1A is a side view of an embodiment of inner cannula 100 with intraluminal suction and perfusion. Figures 1B, 1C, and 1D are perspective, top, and bottom views, respectively, of inner cannula 100. Figure 1E is a cross-sectional view of Figure 1A taken along line 1E-1E. Figures 1A-1E are best viewed together in the following discussion.

[0049] The inner cannula 100 includes a single curved, semi-rigid plastic tube 102 fused to a rigid plastic tube 104. The inner cannula 100 may fit over the patient's existing tracheostomy tube 202 (as shown in FIGS. 2A-2D ) or over a tracheostomy tube specially designed for use with the inner cannula 100. The outer tracheostomy tube 202 may or may not include a balloon cuff (such as cuff 604 in FIG. 6 ) for use with positive pressure ventilation (i.e., “cuffed” or “uncuffed” tracheostomy tubes) as known in the art. The inner cannula 100 may be secured to the patient's original tracheostomy tube 202 or to an attached, specially designed tracheostomy tube with an appropriate retaining clip 106. The inner cannula 100 may have a variety of diameters, thicknesses, and lengths depending, for example, on the patient's needs or for use with an endotracheal tube. In an embodiment, the semi-rigid plastic tube 102 has a smaller diameter than the rigid plastic tube 104. An intraluminal space 132 is formed throughout the interior of the inner cannula 100.

[0050] The inner cannula 100 includes a continuous, raised protrusion 112 on the outer surface of the tube 102 at a specific location and height to interface with the lumen of the rigid outer tracheostomy tube 202. The protrusion 112 divides the outer surface of the tube 102 into several regions 124, 126, or chambers. Starting at point 114 where the tube 102 fuses with the tube 104, the protrusion 112 extends proximally along the length of the tube 102, wraps around the circumference of the tube 102 at point 116, and then returns distally along the tube 102. Before reaching the tube 104, the protrusion 112 again wraps around the circumference of the tube 102 at point 118, extends proximally to point 120, then back down the tube 102, terminating at point 122 where the tube 102 fuses with the tube 104.

[0051] Regions 124 and 126 of tube 102 formed by protrusions 112 each include a series of openings between the outer surface and intraluminal space 132, allowing for the transfer of air and / or fluid. Region 124 includes holes 125 and is located on both sides of tube 102, while region 126 includes slots 127 and is located on the top and bottom of tube 102. While holes and slots are shown, this is for illustrative purposes. In embodiments, the positions of holes and slots may be reversed. Furthermore, all of the openings may be slots or all may be holes, and holes 125 and 127 may be of various sizes or other shapes to facilitate function. Similarly, the shapes and orientations of the protrusions are shown in FIGS. 1A-1E for illustrative purposes only and may be configured differently to facilitate the functions described herein.

[0052] In the embodiment, the rigid plastic tube 104 includes passages 128 and 130 positioned 90 degrees from the retaining clip 106, although other arrangements are contemplated so long as the passages 128 and 130 connect to regions 124 and 126, respectively. The passages 128 and 130 may be slots or sealed passages through the tube 104. The passage 128 extends obliquely from the upper outer surface of the tube 104 to an opening at the proximal end of the tube 104 adjacent the tube 102. In the embodiment, the passage 128 communicates with the gap formed by the protrusion 112 between the tube 102 at region 124 and the adjacent inner surface of the outer tracheostomy tube 202. The hole 125 communicates the gap in region 124 with the intraluminal lumen 132. Similarly, passageway 130 extends diagonally from the lower outer surface of tube 104 opposite passageway 128 to an opening at the proximal end of tube 104 adjacent tube 102 but opposite the opening of passageway 128. In embodiments, passageway 130 communicates with the gap formed between protrusions 112 between tube 102 and the adjacent inner surface of outer tracheostomy tube 202 in region 126 rather than region 124. Region 126 includes slot 127, which also communicates the gap in region 126 with intraluminal space 132.

[0053] 3, flexible plastic tubing having various diameters, thicknesses, and lengths may be connected to passageways 128 on the top surface of tube 104. As will be further described below, flexible plastic tubing having various diameters, thicknesses, and lengths may be connected to passageways 130 on the bottom surface of tube 104. The references to the top and bottom surfaces are for illustrative purposes only, and passageways 128 and 130 may be located anywhere around the circumference of tube 104.

[0054] 2A-2C show an inner cannula 100 inserted into an outer tracheostomy tube 202 to form a perfused intraluminal suction inner cannula system 200. Components in FIGS. 2A-2C not specifically addressed below are the same as those described above in connection with FIGS. 1A-1E.

[0055] The system 200 includes an outer tracheostomy tube 202, which may represent either the patient's existing tracheostomy tube or a tracheostomy tube specially designed for use with the inner cannula 100. In embodiments, the specially designed outer tracheostomy tube 202 may fit onto the inner cannula 100 as part of a kit. For example, the outer tracheostomy tube 202 may have indentations on its inner surface that engage with the protrusions 112 to improve the function of the inner cannula 100. In FIG. 2A , only a portion of the outer tracheostomy tube 202 is shown. A portion of the outer tracheostomy tube 202 has been cut away to show the tube 102 and the engagement between the protrusions 112 and the inner surface of the outer tracheostomy tube 202. Additionally, the outer tracheostomy tube 202 extends toward the tube 104 and provides a mechanism for engaging the retaining clip 106. This mechanism may have several different forms and has been omitted for clarity of illustration. FIG. 2B shows a system 200 with an integral outer tracheostomy tube 202 .

[0056] The length of the outer tracheostomy tube 202 is approximately equal to the length of the tube 102 of the inner cannula 100, as shown in FIG. 2B. The diameter of the outer tracheostomy tube 202 is selected so that the protrusion 112 abuts the inner surface of the outer tracheostomy tube 202, as indicated by point 134, to form a space divided into regions 124 and 126. An end 136 of the passageway 128 in the tube 104 communicates with region 124, while an end 138 of the passageway 130 communicates with region 126 in the tube 104. As shown more clearly in FIGS. 1C and 1D, region 126 comprises a region on the opposite side of the tube 102. In embodiments, the protrusion 112 may be formed on the inner surface as part of the outer tracheostomy tube 202 while still providing the regions or chambers described above. Alternatively, the protrusions 112 may be formed as part of both the inner cannula 100 and the outer tracheostomy tube 202 to form a single, inseparable device.

[0057] In operation, the inner cannula 100 may be used to suction and remove secretions from a patient's tracheostomy tube. Secretions periodically accumulate, often necessitating the use of an intraluminal catheter-based suction procedure, which is currently typically performed by a separate individual and is often too viscous to be easily retrieved. The inner cannula 100 may be adapted to an existing tracheostomy tube or a specially designed accessory tracheostomy tube. Once secured with the retaining clip 106 for the patient's native tracheostomy tube (or an accessory tracheostomy tube), either suction alone or suction with irrigation may then be applied to remove secretions from the intraluminal lumen, 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 the extrabronchial subglottic region. Irrigation may be performed using an irrigation solution, such as saline. In embodiments, other solutions, such as mucolytics, antibiotics, antifungals, steroids, or other medications, may also be used. The combination of irrigation and suction also cleanses the lumen of the tracheostomy tube and suction chamber, thus thinning (reducing viscosity) secretions, facilitating aspiration and clearance of these secretions, preventing accumulation and obstruction, and reducing the burden of pathogenic microbial colonization of the tube and airway tissue.

[0058] In embodiments, a method of using any of the cannulas disclosed herein is described in connection with FIGS. 3 and 4. These figures are best referenced together in the following description. For purposes of illustration, inner cannula 100 is depicted without outer tracheostomy tube 202. Inner cannula 100 fits either (a) the patient's existing tracheostomy tube or (b) an attached specially designed tracheostomy tube (both options (a) and (b) are represented by perfused intraluminal suction inner cannula system 200, as disclosed herein). Once secured with retaining clip 106 on the patient's original tracheostomy tube or the attached specially designed tracheostomy tube, the proximal end of suction line 302 is received in passage 130. Suction line 302 may be a flexible plastic tube terminating integrally with a standard suction application tip 304. The proximal end of irrigation fluid line 306 is received by passage 128. Perfusate line 306 may be, for example, flexible plastic tubing terminating integrally with a standard intravenous (IV) tubing connection 308, such as a Luer lock. In embodiments, suction line 302 and perfusate line 306 have static / fail-safe closed positions that prevent (a) loss of positive pressure (i.e., leakage) in the setting of mechanical ventilation, (b) spontaneous flow of perfusate, and (c) spontaneous application of suction to the device.

[0059] 4 illustrates perfused intraluminal suction inner cannula system 200 connected to additional devices to form an active use system 400. Active use system 400 is an example of system 200 in use. The distal end of suction line 302 is applied to a suction line input 402 of actuator 404. A suction line 406 distal to actuator 404 is connected to an input 408 of a vacuum source container 410. Container 410 may be connected to a continuous suction / negative pressure source, such as, for example, a hospital wall vacuum fitting or a portable suction unit.

[0060] Similarly, the perfusate line 306 from the inner cannula 100 is connected to an appropriate perfusate line input 412 on the actuator 404. The perfusate line 414, distal to the actuator 404, is applied to the perfusate bottle 416 via a cap 418 with a straw that extends to the bottom of the perfusate bottle 416. A vent 420 on the cap 418 may be opened for ease of use and to facilitate low-resistance perfusate flow. The perfusate bottle 416 should be placed on the floor near the patient or kept at all times at least one vertical foot below the patient's tracheostomy tube (or other distance determined to prevent gravity flow when the actuator is open). In embodiments, the perfusate bottle 416 may be, for example, a perfusate bottle with a vent option or a hanging bag attached to the patient bed or a freestanding stand.

[0061] Once all components of FIG. 4 are properly secured, actuator 404 is controlled to perform either suction-only or combined suction and irrigation through the operation of buttons 422 and 424. Suction-only operation using button 424 aspirates air and secretions from within the intraluminal space 132 of inner cannula 100, through region 126 formed by protrusion 112 between inner cannula 100 and the inner surface of tracheostomy tube 202 (FIGS. 2A-2D), and distally through lines 302 and 406, ultimately leading to vacuum source container 410, which removes the intraluminal secretions. While actuator 404 is described in connection with a button, any mechanism for controlling the operation of actuator 404 and active use system 400 to provide the functionality described herein can be used. Additional buttons and functions can also be provided as part of actuator 404 and active use system 400.

[0062] When both the suction button 424 and the irrigation button 422 are simultaneously activated, irrigation fluid originating from the distal side of the irrigation fluid bottle 416 is aspirated through lines 414 and 306 due to the negative pressure applied through suction lines 302 and 406. The irrigation fluid is drawn into region 124 formed by protrusion 112 between inner cannula 100 and the inner surface of outer tracheostomy tube 202. The irrigation fluid enters intraluminal space 132 of inner cannula 100 through hole 125, mixes with intraluminal air and secretions, and exits region 126 through slot 127 (FIGS. 1A-1D). This flow of irrigation fluid dilutes the secretions, rinses intraluminal space 132 of inner cannula 100, and ultimately reaches vacuum source container 410.

[0063] Actuator 404 can be designed in many ways, so long as it provides control buttons or other actuators and connections between the suction and irrigation lines from the tracheostomy cannula and the respective sources of irrigation fluid and suction. In embodiments, actuator 404 includes buttons 422 and 424, which can be moved / depressed to align them. More or fewer buttons may be provided. The outer plastic housing of actuator 404 is shown as including an input 402 for suction line 302 and, on the opposite side, an output for line 406, providing suction to inner cannula 100. The outer plastic housing of actuator 404 also has an input 412 for irrigation fluid line 306 and, on the opposite side, an output for irrigation fluid line 414, which passes through cap 418 and enters a standard irrigation fluid bottle 416. These inputs and outputs may be provided in any convenient location on actuator 404. Actuator 404 functions to allow flow through the lumens of the two aligned lines 302 and 406 only when button 424 is pressed, and to prevent flow when button 424 is not actuated. Similarly, the lumens of aligned lines 306 and 414 allow flow only when button 422 is pressed. In embodiments, actuator 404 prevents the flow of irrigation fluid without the application of suction, but is compatible with suction-only use. Other actuator mechanisms for connecting lines 302 and 3064 to lines 406 and 414, respectively, are also contemplated. Additionally, actuators may be provided as components of other medical devices.

[0064] The patient is protected from the flow of perfusate alone into the intraluminal space 132 of the inner cannula 100 by both activating the device 404, which prevents the flow of perfusate in the absence of suction, and by ensuring that the perfusate bottle 416 is kept at least 1 foot (12 inches) above the tracheostomy tube (or at some other predetermined distance to prevent gravity flow). In other words, the perfusate bottle 416, as well as any hanging bag or other device for delivering perfusate, must always be positioned below the vertical height of the tracheostomy tube if no mechanism for restricting the flow of perfusate is in place. Other means of controlling the flow of perfusate are also contemplated. For example, in some cases, by using a variation of the actuator 404, the perfusate is actively pushed, either continuously or pulsatilely, by a pump or pressurized perfusate canister through the same flow pattern described above, rather than simply being drawn in by the negative pressure generated by the vacuum source 411 alone. This pump may be located either proximal or distal to the actuator. In embodiments, the hole 125 in the inner cannula 100 may comprise a one-way or pressure relief type valve, such as a simple slit or defect in the material in this area that remains closed at baseline and opens as pressure in the perfusate line proximal to the actuator increases.

[0065] In embodiments, the active use system 400 may include additional safeguards against failure. A flow sensor (not shown) monitors whether excessive or unexpected flow of perfusion fluid is detected and provides an alarm or other notification or means of stopping if perfusion or aspiration fails. Excessive perfusion fluid flow may be immediately stopped by removing the inner cannula. Valves, flow restrictors, and mechanical or electrical flow and pressure sensors are also contemplated.

[0066] In the event of malfunction or for routine care, the inner cannula 100 may be unclipped, removed, discarded, and replaced with a new cannula. Traditional catheter endoluminal suction can be performed with or without the inner cannula 100. It is also noteworthy that operation is possible with or without the inner cannula 100 connected to a ventilator / positive pressure source. Furthermore, operation can be performed with cuffed or uncuffed tubing, or with barred or uncuffed tracheostomy tubes. Control of the actuator 404 can be performed by the patient, a healthcare professional, or a caregiver. In embodiments, the actuator 404 can also be activated by a mechanism designed to hold and apply activation / depression of buttons 422 and 424 by an electronic controller upon request by the patient, healthcare professional, or caregiver; on an automated schedule; or when certain monitoring input conditions are met and recognized by the electronic monitoring system. The perfusate bottle 416 may be replaced when it is depleted or as part of a set schedule. Additionally, any component can be removed and replaced as part of a set schedule, or when deemed necessary by the patient, healthcare professional, or caregiver, or as directed by an electronic monitoring system or established protocol.

[0067] In embodiments, various methods may be used to manufacture the perfused intraluminal aspiration inner cannula system. For example, inner cannula 100 or system 200 may be fabricated by die extrusion or by thermally and / or chemically depositing solid plastic roll material onto the cannula to provide a raised protrusion configuration. Holes 125 and slots 127 on tube 102 may be fabricated by die extrusion or by thermally, drilling, cutting, grinding, or otherwise reducing material. Tube 102 may be thermally and / or chemically fused to rigid plastic tube 104. Tubes 102 and 104 may also be fabricated as a single unit. Irrigation fluid / irrigation line 306 and aspiration line 302 may be thermally and / or chemically fused in place to rigid plastic tube 104. Additional methods, such as 3D printing, are also contemplated.

[0068] 5 is a flow chart illustrating a method 500 of using the perfused intraluminal suction inner cannula system 200. Method 500 includes steps 506 and 508. In an embodiment, method 500 also includes at least one of steps 502 and 504.

[0069] In step 502, the inner cannula 100 is inserted into the outer tracheostomy tube 202 to create the perfused intraluminal suction inner cannula system 200. In one example of step 502, the inner cannula 100 fits over an existing outer tracheostomy tube 202 or a specially designed accessory tracheostomy tube. The inner cannula 100 is secured to the patient's original tracheostomy tube 202 or accessory tracheostomy tube with a retaining clip 106.

[0070] In step 504, the suction line and the irrigation fluid line are connected to inner cannula 100. In one example of step 504, suction line 302 is attached to passageway 130 in tubing 104. In embodiments, irrigation fluid line 306 is attached to passageway 128 in tubing 104. In embodiments, one or both of suction line 302 and irrigation fluid line 306 may be permanently attached or fused to tubing 104.

[0071] In step 506, the aspiration line and the irrigation fluid line are connected via actuators to a vacuum source and a irrigation fluid source. In one example of step 506, the aspiration line 302 is connected via actuator 404 and the aspiration line 406 to a vacuum source container 410. The irrigation fluid line 306 is connected via actuator 404 and the irrigation fluid line 414 to a irrigation fluid bottle 416.

[0072] In step 508, the actuator 404 is used to suction only or suction in conjunction with irrigation of the inner cannula 100 or system 200. In one example of step 508, a button 424 on the actuator 404 is pressed to connect the suction line 302 to the suction line 406 and remove secretions from the intraluminal space 132 of the patient's tracheostomy tube 202. Additionally, the irrigation button 422 is pressed to combine irrigation / irrigation with suction to irrigate the intraluminal space 132 and area 126 of the tracheostomy tube and thin the secretions, allowing for easy suction and irrigation in a closed system. The actuator 404 may be controlled by the patient, hospital personnel, or other caregiver. In embodiments, the actuator 404 may be integrated into a ventilator (not shown) and programmed to coordinate with the operation of the ventilator. Additionally, the actuator 404 may be used in conjunction with an electronic controller to apply activation / pressing of an operation button (or otherwise). Further examples include control via ocular control or neurointegrated devices, such as those used by immobile patients with neurodegenerative or paralytic conditions (e.g., amyotrophic lateral sclerosis - ALS, trauma, etc.). In any of these embodiments, the actuator can be activated upon request by the patient, healthcare provider, or caregiver, or on an automated schedule, or when certain monitoring input conditions are met and recognized by the electronic monitoring system. In embodiments, this provides additional flexibility, reduces care burden and resources, and minimizes exposure of others to aerosolized particles.

[0073] Accumulation of oral and pharyngeal secretions in the area above the inflated cuff of a tracheostomy tube can lead to microaspiration of secretions into the lungs and is associated with the development of ventilator-assisted pneumonia (VAP). For this reason, several additional embodiments are contemplated that incorporate the intraluminal perfusion and suction described herein while providing extraluminal subglottic suction alone or a combination of perfusion and suction in this area. These embodiments are illustrated in Figures 6A-6C. Furthermore, the perfused intraluminal suction inner cannula system as described herein may also be used with fenestrated outer tracheostomy tubes, additional embodiments of which are illustrated in Figures 6D-6E.

[0074] FIG. 6A illustrates that the inner cannula 100, as shown in FIGS. 1A-1D, may be used with an outer tracheostomy tube having a cuff 604 with additional suction holes 606. Single or multiple suction holes 606 are provided in the cuffed outer tracheostomy tube 602 in the subglottic region, i.e., above the cuff 604 and below the vocal cords, as shown in FIG. 7. The suction holes 606 are positioned on the upper surface of the cuffed outer tracheostomy tube 602 so as to overlap the corresponding region 126 of the inner cannula 100, thereby extending intraluminal suction to the subglottic space. An additional suction hole 606 (not shown) may be provided on the opposite side of the cuffed outer tracheostomy tube 602, aligned with the corresponding region 126. However, because the intraluminal space of the tracheostomy tube used for ventilation is continuous with the extraluminal suction passage created by this design, air leakage into the subglottic space may occur during positive pressure ventilation, resulting in discomfort and other problematic side effects. Furthermore, this creates a pathway for subglottic secretions to enter the intraluminal space, potentially leading to aspiration of secretions into the lower airway. Because of these drawbacks, two additional embodiments have been considered: subglottic suction and combined subglottic irrigation and suction, as shown in Figures 6B and 6C.

[0075] In the embodiment of FIG. 6B, inner cannula 608 is a modified version of inner cannula 100. The following description refers to the accompanying drawings, in which like numerals in different drawings represent the same or similar elements unless otherwise noted. Tube 104 is formed with an additional passageway 610 for attaching a subglottic suction line (not shown). Passageway 610 is an example of passageway 130. Subglottic suction occurs in region 612 formed by protrusion 614 on the inner cannula. Protrusion 614 is similar to protrusion 112 in that it forms a region, or chamber, between inner cannula 608 and outer tracheostomy tube 616. Protrusion 614 originates from tube 104, extends proximally along the length of inner cannula 608, circles the circumference of inner cannula 608 at point 618, then extends distally back along the length of inner cannula 608, terminating at tube 104. The protrusions 112 can be reconfigured as shown in FIG. 6B to provide intraluminal suction or

[0076] Notably, region 612 lacks holes or slots like those found in region 126, and therefore there is no communication between region 612 or the extraluminal space outside of outer tracheostomy tube 616 and the intraluminal space of inner cannula 608. Instead, slot 620 is positioned in outer tracheostomy tube 616 to cover region 612. When suction is applied through passageway 610, via separate or similar control of an actuator such as that described in connection with FIG. 4, secretions in the extraluminal subglottic space are removed by suction. The embodiment of FIG. 6B provides suction only to the extraluminal subglottic space. Passageway 128 in tube 104 may be shifted from its position shown in FIGS. 1A-1D but still be continuous with region 124 and communicate with the opposite side of the perfusion space of inner cannula 608 via passageway region 622. Thus, for purposes of intraluminal perfusion, a new suction pathway is created while providing suction and perfusion to all of the previously described holes in the inner cannula. This design sacrifices a small area of ​​good intraluminal suction.

[0077] The embodiment of FIG. 6C incorporates both perfusion and suction to the extraluminal subglottic region while still achieving both intraluminal suction and perfusion. In this embodiment, the passageway 128 in the tube 104 is again moved laterally but remains continuous with region 124 in the same manner as in FIG. 6B via the same design of the protrusion 112 as shown in FIG. 6B. In FIG. 6C, protrusion 614 is replaced with two parallel, raised protrusions, including an inner protrusion 624 and an outer protrusion 626. Both inner protrusion 624 and outer protrusion 626 originate from and terminate again at the tube 104, as described above for protrusion 614. This creates region 628 within inner protrusion 624 and region 630 between inner protrusion 624 and outer protrusion 626. Similar to regions 124 and 126, regions 628 and 630 form a chamber between the inner cannula 632 and the outer tracheostomy tube 634. Neither region 628 nor region 630 has holes or slots for communication with the intraluminal space of inner cannula 632. A passageway 638 in tube 104 is connected to a suction line (not shown) and is continuous with region 628 for providing suction to the extraluminal subglottic region via opening 640 in outer tracheostomy tube 634. A passageway 642 in tube 104 is connected to a perfusion line (not shown) and is continuous with region 630 for providing perfusion to the extraluminal subglottic region via openings 644 and 646 in outer tracheostomy tube 634. As discussed above in connection with FIG. 4 , the actuator may draw a flow of perfusion fluid from supply / bottle 416 through passageway 642, mix with extraglottic secretions, and then draw it through passageway 638 to terminate in the same or a separate suction canister or vacuum source container 410. Other similar modifications and rearrangements of the raised protrusions and entry defects of the inner cannula 632 and tube 104 for subglottic suction are possible. Thus, for purposes of intraluminal perfusion, new paths for perfusion fluid flow are created while providing suction and perfusion to all previously described holes in the inner cannula.

[0078] FIG. 6D illustrates an embodiment of a perfused intraluminal suction inner cannula 648 for use with a fenestrated outer tracheostomy tube 650. The fenestrated outer tracheostomy tube 650 may be desired in certain clinical scenarios to assess breathing and speaking ability. The inner cannula 648 corresponds to this type of outer tracheostomy tube design or to a specially designed accessory outer tracheostomy tube. The outer tracheostomy tube 650 may be cuffed, as shown, or uncuffed. A raised, solid, block-like platform 652 is formed on the inner cannula 648 in the region of the fenestration 654 of the outer tracheostomy tube 650. The platform 652 is sized to contact the inner surface of the outer tracheostomy tube 650. In this manner, airflow from the patient's airway to and from the subglottic region is blocked, while perfusion and suction can still be provided using the protrusion 112 and regions 124 and 126, as described above. This blocking is sometimes desirable.

[0079] Alternatively, air flow may be desired through fenestrations in the outer tracheostomy tube to the patient's airway and from there to the subglottic region. To address this, an alternative embodiment shown in Figure 6E is contemplated for use with a fenestrated outer tracheostomy tube that allows air to pass through fenestrations 654. In Figure 6E, a perfused intraluminal inner cannula 656 includes a generally circular or oval protrusion 658 of the same area and shape as the fenestrations 654 that overlie the outer tracheostomy tube 650. In this embodiment, the associated opening in protrusion 658 to the intraluminal space inside the inner cannula 656 is intentional.

[0080] None of the embodiments of Figures 6A-6E compromise the perfusion or aspiration functions for the intraluminal space as previously described herein.

[0081] The active use system 400 reduces aerosolized airway particles because it is a closed system when used with a ventilator or tracheostomy tube filter, or a near-closed system when used without a filter, thereby reducing respiratory aerosols and particles and the risk of transmission to others that is an inherent risk of standard tracheostomy care.

[0082] In the event of malfunction or for routine care, inner cannula 100 can be unclipped, removed, discarded, and replaced with a new cannula without having to replace the outer tracheostomy tube. Conventional catheter endoluminal suction can be performed with or without inner cannula 100 in place.

[0083] Many modifications may be made to inner cannula 100 or system 200. For example, additional protrusions may be used on tube 102 to form additional regions or chambers / conduits for monitoring devices and / or drug delivery. Protrusions 112 on tube 102 may be reconfigured for different patterns and subsequent shapes of perfusion and vacuum chambers, which may change their function. Similarly, passages in tube 104 may be reconfigured into different patterns or shapes to enable perfusion functionality in the suction chamber. Protrusions 112 may allow communication between the patient's airway and the external environment for purposes of airway monitoring devices and / or measurements, or for delivery of drugs (droplets, aerosols, etc.).

[0084] The outer tracheostomy tube 202 may be configured with grooves or indentations to aid in ease of insertion, different or improved functionality, or ease of cleaning. The position, size, pattern, and shape of the holes and / or slots in the tube 102 may be reconfigured to vary fluid flow and suction performance. In embodiments, the inner cannula 100 may be lengthened (beyond the tip of the outer tracheostomy tube 202) or shortened (into the lumen of 202) to further enhance maneuverability.

[0085] The lines for irrigation and suction can be modified to achieve the same suction by different locations, diameters, lengths, and connections on the rigid plastic lumens of the present invention. The shape and configuration of the retaining clip, the size and length of the lumens and protrusions, and the existing fenestrations can be adapted to work with existing currently available tracheostomy tubes that differ in some or all of these respects.

[0086] The perfused endoluminal suction inner cannula system may be used in other applications or technical fields where frequent replacement of the lumens of the tubing is required as a result of the accumulation of debris, secretions, or other materials; or in similar systems that do not have replaceable lumens / cannulae but have the advantage of preventing clogging that can lead to system damage or failure, such as those currently managed by endoluminal catheter-based suction. This can be done in both medical and non-medical settings.

[0087] In a medical environment, the perfused endoluminal suction inner cannula system may be applied to other medical devices / implant tubes that communicate with the external environment, such as oral endotracheal tubes, nasotracheal tubes, gastrostomy tubes, colostomy tubes, or nephrostomy tubes, intraperitoneal lumens, surgical drains, or other such applications in medicine. The perfused endoluminal suction inner cannula system may be used in many different settings, including both inpatient and outpatient / portable settings.

[0088] This function of the perfused intraluminal suction inner cannula system is directed to or performed by a computer, machine, or other electronic means that monitors and / or operates the described functions.

[0089] The perfused intraluminal suction inner cannula system and its described, implied, or resulting uses may produce useful or valuable compositions. Monitoring of secretions produced by its use may be diagnostically useful to health care providers. Furthermore, secretions may also be tested for the presence of specific pathogens that can be detected or cultured without introducing additional equipment into the patient's airway, thereby reducing the risks of additional procedures.

[0090] Health outcome data obtained through routine or automated use of a perfused intraluminal suction inner cannula system, whether mechanically or electronically controlled, can be useful in creating patient care protocols, reducing patient morbidity and / or mortality, and developing patient care algorithms. Improved airway hygiene can result in improved patient health, which is accepted as the standard of care for patients with tracheostomy tubes.

[0091] The functionality of the perfusion lumen suction inner cannula system requires only that the perfusion fluid source or other perfusion solution source and negative pressure (vacuum) source are properly secured and connected. Safe and comfortable function can be enhanced by operational control of the perfusion fluid and suction.

[0092] The above-described methods and systems may be modified without departing from the scope of the present specification. It should therefore be noted that the matter contained in the above description or shown in the accompanying drawings should be construed as illustrative and not limiting. Herein, unless otherwise noted: (a) the adjective "exemplary" means serving as an example, instance, or illustration; and (b) the phrase "in an embodiment" is equivalent to the phrase "in a particular embodiment" and does not refer to all embodiments. The following claims are intended to cover all general and specific features described herein, as well as all statements regarding the scope of the present methods and systems that may, as a matter of language, fall therebetween.

[0093] Those skilled in the art may rearrange the location or size of the fenestrations / configurations / passages / volumes / shapes of the described perfusion and suction chambers, as alternative configurations for various intended functions are possible that are still within the scope of the principles discussed herein.

[0094] Combination of features The features described above and claimed below can be combined in various ways without departing from the scope of the present invention. The examples listed below illustrate some possible non-limiting combinations.

[0095] (A1) An inner cannula for use with a tracheostomy tube, comprising: a first tube having a first diameter for insertion into the tracheostomy tube; and a second tube fused to the distal end of the first tube and having a second diameter larger than the first diameter, wherein the first tube further comprises a plurality of holes between the intraluminal space of the first tube and an outer surface of the first tube; and one or more protrusions on the outer surface of the first tube dividing a space surrounding the outer surface into a plurality of regions, and the second tube comprises a first passage between the outer surface of the second tube and a first region of the plurality of regions, and a second passage between the outer surface of the second tube and a second region of the plurality of regions.

[0096] (A2) The inner cannula of (A1), wherein the second tube further comprises a retaining clip for attaching the inner cannula to the tracheostomy tube.

[0097] (A3) In the inner cannula of (A1) or (A2), the first passage extends between the first region and the outer surface of the second tube and is connectable to a line connected to a source of irrigation fluid.

[0098] (A4) In the inner cannula of (A1) to (A3), the second passage extends between the second region and the outer surface of the second tube and is connected to a line connected to a vacuum source.

[0099] (B1) A perfused intraluminal suction inner cannula system comprising an outer tracheostomy tube, an inner cannula of (A1), a perfusion fluid line attached to the first passage of the second tube and communicating with the first region, a suction line attached to the second passage of the second tube and communicating with the second region, and an actuator connected between the perfusion fluid line and a perfusion fluid source and between the suction line and a vacuum source, wherein the actuator controllably connects the perfusion fluid line to the perfusion fluid source and the suction line to the vacuum source.

[0100] (B2) In the cannula system (B1), the outer tracheostomy tube further comprises depressions on its inner surface in the same pattern as the one or more protrusions, and the one or more protrusions engage with the depressions when the inner cannula is inserted into the outer tracheostomy tube.

[0101] (B3) In the cannula system (B1) or (B2), the actuator may be connected only between the suction line and the inner cannula.

[0102] (B4) In any of the cannula systems (B1) to (B3), the actuator may be incorporated into an artificial respirator.

[0103] (B5) In the cannula system of any one of (B1) to (B4), the perfusion fluid source is positioned at a distance below the vertical height of the inner cannula to prevent gravity flow.

[0104] (B6) The cannula system (B5) further includes a flow sensor for monitoring excessive or unexpected flow of perfusate or aspiration.

[0105] (B7) The cannula system (B6), further comprising a valve, a flow restrictor, a mechanical flow / pressure sensor, or an electrical flow / pressure sensor.

[0106] (B8) Further including an alarm or notification if excessive or unexpected flow of perfusate or suction is detected in the cannula system (B7).

[0107] (B9) In the cannula system of any one of (B1) to (B8), the second tube further comprises a retaining clip for attaching the second tube to an outer tracheostomy tube.

[0108] (B10) In the cannula system of any one of (B1) to (B9), the outer tracheostomy tube and the inner cannula form a single device.

[0109] (B11) In the cannula system of any one of (B1) to (B10), the outer tracheostomy tube is a cuffed or uncuffed tracheostomy tube.

[0110] (B12) In the cannula system of any one of (B1) to (B11), the outer tracheostomy tube is a fenestrated or non-fenestrated tracheostomy tube.

[0111] (B13) A method for cleaning the intraluminal space of a tracheostomy system comprising an outer tracheostomy tube and an inner cannula inserted into the outer tracheostomy tube, using the perfused intraluminal suction inner cannula system described in any one of (B1) to (B12).

[0112] (C1) An inner cannula comprising: an outer tracheostomy tube having one or more openings along its length; a first tube having a length and diameter for insertion into the outer tracheostomy tube, the first tube further comprising a plurality of openings between the intraluminal space of the first tube and the outer surface of the first tube; a first protrusion dividing the outer surface of the first tube into a perfusion region and a first suction region; and a second tube fused to the distal end of the first tube and having a larger diameter than the first tube; and a second tube attached to a perfusion fluid passage in the second tube, the second protrusion dividing the inner surface of the outer tracheostomy tube in the perfusion region and the outer surface of the first tube. a first suction line attached to a first suction passage in the second tube and communicating with the gap formed between the inner surface of the outer tracheostomy tube at the first suction region and the outer surface of the first tube; a second suction line attached to a second suction passage in the second tube and communicating with the gap formed between the inner surface of the outer tracheostomy tube at the second suction region and the outer surface of the first tube; and an actuator connected between the perfusion fluid line and a perfusion fluid source and between the first and second suction lines and a vacuum source, the actuator controlling to connect the perfusion fluid line to the perfusion fluid source and the first and second suction lines to the vacuum source.

[0113] (C2) In the cannula system of (C1), the first tube further comprises a third protrusion parallel to the second protrusion dividing the second suction region into an extraluminal perfusion region and an extraluminal suction region, the second suction passage communicating with the extraluminal suction region, and the inner cannula further comprises a second perfusion line attached to the second perfusion passage in the second tube and communicating with a gap formed between the inner surface of the outer tracheostomy tube and the outer surface of the first tube in the extraluminal suction region.

[0114] (C3) A method for cleaning the extraluminal / subglottic space of a tracheostomy system comprising an outer tracheostomy tube and an inner cannula inserted into the outer tracheostomy tube, using the perfusion type intraluminal suction / extraluminal suction inner cannula system described in any one of (C1) to (C3).

[0115] (D4) A method for irrigating a tracheostomy tube comprising an outer tracheostomy tube and an inner cannula, the inner cannula having a plurality of holes and one or more protrusions that divide a gap between the outer tracheostomy tube and the inner cannula into a plurality of regions when the inner cannula is inserted into the outer tracheostomy tube, the method comprising: attaching a suction line to the inner cannula so as to communicate with a first region of the plurality of regions; attaching an actuator between the suction line and a vacuum source; the actuator controllably connecting the suction line to the vacuum source; and controlling the actuator to suction from the lumen of the inner cannula through a first portion of the plurality of holes, the first region, and the suction line.

[0116] The method of (D2) (D4) further includes attaching a perfusion fluid line to the inner cannula so as to communicate with a second region of the plurality of regions, and attaching an actuator between the perfusion fluid line and a perfusion fluid source, the actuator controllably connecting the perfusion fluid line to the perfusion fluid source, and controlling the actuator to provide perfusion fluid to the lumen of the inner cannula through a second portion of the plurality of holes, the second region, and the perfusion fluid line.

Claims

1. 1. An inner cannula for use with a tracheostomy tube, comprising: a first tube having a first diameter for insertion into the tracheostomy tube, the first tube having one or more protrusions on an outer surface thereof dividing a gap between the outer surface thereof and an inner surface of the tracheostomy tube into a plurality of regions, each of the plurality of regions having a plurality of holes between the intraluminal space of the first tube and the outer surface of the first tube; a second tube fused to a distal end of the first tube and having a second diameter greater than the first diameter, the second tube comprising a first passageway between an outer surface of the second tube and a first region of the plurality of regions, and a second passageway between an outer surface of the second tube and a second region of the plurality of regions; a perfusion fluid line attached to a first passage of the second tube and communicating with the first region; an inner cannula attached to the second passage of the second tube and in communication with the second region; and

2. The inner cannula of claim 1 , wherein the second tube further comprises a retaining clip for attaching the inner cannula to the tracheostomy tube.

3. an external tracheostomy tube; an inner cannula disposed inside the outer tracheostomy tube, an inner cannula comprising: a first tube having a first diameter for insertion into the outer tracheostomy tube, the first tube having one or more protrusions on an outer surface thereof dividing a gap between the outer surface thereof and an inner surface of the outer tracheostomy tube into a plurality of regions, each of the plurality of regions having a plurality of holes between the intraluminal space of the first tube and the outer surface of the first tube; 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 having a first passage between the outer surface of the second tube and a first of the plurality of regions, and a second passage between the outer surface of the second tube and a second of the plurality of regions; a perfusion fluid line attached to the first passage of the second tube and communicating with the first region; a suction line attached to the second passage of the second tube and communicating with the second region; an actuator connected between the perfusion fluid line and a perfusion fluid source and between the aspiration line and a vacuum source, the actuator controllably connecting the perfusion fluid line to the perfusion fluid source and the aspiration line to the vacuum source.

4. 4. The cannula system of claim 3, wherein the outer tracheostomy tube further comprises indentations on an inner surface in a pattern similar to the one or more protrusions, the one or more protrusions engaging the indentations when the inner cannula is inserted into the outer tracheostomy tube.

5. The cannula system of claim 3 , wherein the actuator can be connected only between the aspiration line and the inner cannula.

6. The cannula system of claim 3 , wherein the actuator is integrated into a ventilator.

7. The cannula system of claim 3 , wherein the irrigation fluid source is positioned at a distance below the vertical height of the inner cannula to prevent gravity flow.

8. The cannula system of claim 7, further comprising a flow sensor for monitoring excessive or unexpected flow of irrigation fluid or aspiration.

9. The cannula system of claim 8, further comprising a valve, a flow restrictor, a mechanical flow and pressure sensor, or an electrical flow and pressure sensor.

10. 10. The cannula system of claim 9, further comprising an alarm or notification if excessive or unexpected flow of irrigation fluid or suction is detected.

11. The cannula system of claim 3 , wherein the second tube further comprises a retaining clip for attaching the second tube to the outer tracheostomy tube.

12. The cannula system of claim 3 , wherein the outer tracheostomy tube and the inner cannula form a single device.

13. The cannula system of claim 3 , wherein the outer tracheostomy tube is a cuffed tracheostomy tube or an uncuffed tracheostomy tube.

14. The cannula system of claim 3 , wherein the outer tracheostomy tube is a fenestrated or non-fenestrated tracheostomy tube.

15. an outer tracheostomy tube having one or more openings along its length; an inner cannula disposed inside the outer tracheostomy tube, a first tube having a length and diameter for insertion into the outer tracheostomy tube, the first tube having a first protrusion dividing an outer surface of the first tube into a perfusion region and a first suction region, and a second protrusion forming a second suction region on the outer surface of the first tube, each of the first suction region and the second suction region having a plurality of openings between the intraluminal space of the first tube and the outer surface of the first tube; an inner cannula comprising: a second tube fused to a distal end of the first tube and having a larger diameter than the first tube; a perfusion fluid line attached to the perfusion fluid passage in the second tube and communicating with a gap formed between the inner surface of the outer tracheostomy tube in the perfusion region and the outer surface of the first tube; a first suction line attached to a first suction passage in the second tube and communicating with a gap formed between an inner surface of the outer tracheostomy tube in the first suction region and an outer surface of the first tube; a second suction line attached to the second suction passage in the second tube and communicating with a gap formed between the inner surface of the outer tracheostomy tube in the second suction region and the outer surface of the first tube; an actuator connected between the perfusion fluid line and a perfusion fluid source and between the first and second suction lines and a vacuum source, the actuator controllably connecting the perfusion fluid line to the perfusion fluid source and the first and second suction lines to the vacuum source.

16. 16. The cannula system of claim 15, wherein the first tube further comprises a third protrusion parallel to the second protrusion and dividing the second suction region into an extraluminal perfusion region and an extraluminal suction region, the second suction passage communicating with the extraluminal suction region, and the inner cannula further comprises a second perfusion line attached to the second perfusion passage in the second tube and communicating with a gap formed between an inner surface of the outer tracheostomy tube and an outer surface of the first tube in the extraluminal suction region.

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