Abstract:
An endotracheal tube assembly is disclosed. The endotracheal tube assembly includes an elongate tube having an outer wall, and a first connector disposed on the outer wall. The outer wall defines a generally cylindrical elongate central lumen therein, an elongate suction lumen therein, and a first suction lumen aperture therethrough, the first suction lumen aperture being in fluid communication with the elongate suction lumen. The first connector includes a first annular wall disposed within a second annular wall, where the first annular wall and the second annular wall extend away from a longitudinal axis of the elongate tube in a radial direction. An internal surface of the first annular wall defines a first flow passage, and a rim of the first annular wall defines a first connection aperture. The first connection aperture is in fluid communication with the elongate suction lumen through the first flow passage.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
       [0001]    This application is a continuation of U.S. application Ser. No. 13/093,083, filed on Apr. 25, 2011, which claims the benefit of U.S. Provisional Application No. 61/327,857, filed on Apr. 26, 2010, the disclosures of which are hereby incorporated by reference, in their entireties. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention generally relates to an endotracheal tube. More particularly, the present invention pertains to an endotracheal tube with subglottic secretion suction and a detachable suction connection line. 
       BACKGROUND OF THE INVENTION 
       [0003]    Endotracheal tubes are commonly used for airway management, mechanical ventilation, and as a drug delivery device when intravenous delivery cannot be established. An endotracheal tube is inserted through a process called intubation. During intubation, the endotracheal tube is inserted into the trachea through the patient&#39;s mouth, in order to keep the airway open and to allow air to reach the lungs. Endotracheal tubes often include a cuff to prevent air leaks during mechanical ventilation. This cuff is most commonly positioned at the distal end of the tube and can be inflatable. 
         [0004]    Additionally, it is possible for undesirable subglottic secretions to collect around the top of the cuff. In order to prevent ventilator-associated pneumonia (VAP), it can be beneficial to remove these secretions by some means. One way to remove these secretions is to remove the endotracheal tube and then re-intubate the patient. However, continued re-intubation can be traumatic to the patient&#39;s trachea and is therefore not preferable. Alternatively, suction can be applied to remove these secretions through an additional lumen in the ET tube post intubation. 
         [0005]    It is therefore desirable to provide a device and method for suctioning these subglottic secretions from the tracheal mucosa without having to remove the endotracheal tube. 
       SUMMARY OF THE INVENTION 
       [0006]    The foregoing needs are met, to a great extent, by the present invention, wherein in some embodiments an endotracheal tube that is capable of overcoming the disadvantages described herein at least to some extent is provided. 
         [0007]    In accordance with an embodiment of the present invention a connector to couple a suction lumen of an endotracheal tube to a source of suction includes a first connector component coupled to an opening in the suction lumen defined by an outer wall of the endotracheal tube. The connector also can include a second connector component having a first face configured to couple to the first connector component and having a second face configured to couple to a source of suction. The first connector component and the second connector component can be in fluid communication. Additionally, the first and second connector components can define a flow path for the suction of secretions from the suction lumen of the endotracheal tube. 
         [0008]    In accordance with another embodiment of the present invention, The first connector can include a detent and the second connector can include a groove. The detent can then couple with the groove to lock the first connector to the second connector. The first connector component can also include an end cap. 
         [0009]    Additionally, the second face of the second connector component is coupled to a first end of a tube. The second end of the tube is coupled to a third connector component, which is configured to couple to a source of suction. 
         [0010]    In accordance with another embodiment of the present invention, the connector assembly can include a flange that is configured to obstruct at least a portion of the suction lumen proximal to the suction lumen opening. The first and second connector components can be made from a plastic, resin, or any other suitable material. The first connector can include a detent and the second component can include a corresponding groove, such that the groove and the detent couple to lock the first and second connector together. The detent and groove can further be configured to provide an air tight seal between the first connector and the second connector. 
         [0011]    In accordance with another embodiment of the present invention an endotracheal tube includes an elongate tube having an outer wall. The outer wall defines a generally cylindrical elongate central lumen and an elongate suction lumen. The endotracheal tube can also include an inflatable cuff attached near a distal end of the elongate tube. The inflatable cuff can include a proximal end and a distal end and an inner surface and an outer surface. A connector to couple the suction lumen of the endotracheal tube to a source of suction includes a first connector component coupled to an opening in the suction lumen defined by an outer wall of the endotracheal tube. The connector also can include a second connector component having a first face configured to couple to the first connector component and having a second face configured to couple to a source of suction. The first connector component and the second connector component can be in fluid communication. Additionally, the first and second connector components can define a flow path for the suction of secretions from the suction lumen of the endotracheal tube. The first connector can also define an opening for passage of fluid in communication with the suction lumen. The connector opening can be equal to or larger than a width of the suction lumen. 
         [0012]    In accordance with another embodiment of the present invention The first connector can include a detent and the second connector can include a groove. The detent can then couple with the groove to lock the first connector to the second connector. The first connector component can also include an end cap. 
         [0013]    Additionally, the second face of the second connector component is coupled to a first end of a tube. The second end of the tube is coupled to a third connector component, which is configured to couple to a source of suction. The inner surface of the proximal end of the cuff is attached to the outer wall of the endotracheal tube and the outer surface of the distal end of the cuff is attached to the endotracheal tube. 
         [0014]    In accordance with another embodiment of the present invention, the connector assembly can include a flange that is configured to obstruct at least a portion of the suction lumen proximal to the suction lumen opening. The first and second connector components can be made from a plastic, resin, or any other suitable material. The first connector can include a detent and the second component can include a corresponding groove, such that the groove and the detent couple to lock the first and second connector together. The detent and groove can further be configured to provide an air tight seal between the first connector and the second connector. 
         [0015]    In accordance with yet another embodiment of the present invention, an endotracheal tube assembly includes an elongate tube having an outer wall defining an elongate central lumen, an elongate suction lumen, and a first and second suction lumen opening. An inflatable cuff can be attached near a distal end of the elongate tube just distal to the second suction lumen opening defined by the outer wall of the elongate tube. Additionally, a connector assembly can be included to couple the suction lumen of the endotracheal tube to a source of suction. The connector assembly can have a first end that couples to the first suction lumen opening. The first end can also define an opening for passage of fluid that is equal to or larger than a width of the first suction lumen opening and can be in communication with the suction lumen via the first suction lumen opening. The connector assembly can also have a second end that defines an opening in fluid communication with the opening defined by the first end of the connector assembly and the suction lumen. The second end can be configured to be connected to the source of suction. 
         [0016]    In accordance with another embodiment of the present invention, the first end of the connector can include a flange that is configured to obstruct at least a portion of the suction lumen proximal to the first suction lumen opening. The connector assembly can be configured to provide an unobstructed fluid flow path from the suction lumen to the source of suction. Additionally, the connector assembly can be configured to provide an air tight seal between the suction lumen and the source of suction. 
         [0017]    An aspect of the disclosure provides endotracheal tube assembly including an elongate tube having an outer wall, and a first connector disposed on the outer wall. The outer wall defines a generally cylindrical elongate central lumen therein, an elongate suction lumen therein, and a first suction lumen aperture therethrough, the first suction lumen aperture being in fluid communication with the elongate suction lumen. The first connector includes a first annular wall disposed within a second annular wall, where the first annular wall and the second annular wall extend away from a longitudinal axis of the elongate tube in a radial direction. An internal surface of the first annular wall defines a first flow passage, and a rim of the first annular wall defines a first connection aperture. The first connection aperture is in fluid communication with the elongate suction lumen through the first flow passage. 
         [0018]    Another aspect of the disclosure provides an endotracheal tube assembly including an elongate tube having an outer wall, an inflatable cuff attached near a distal end of the elongate tube, and a connector assembly to couple the elongate suction lumen to a source of suction. The outer wall of the elongate tube defines a generally cylindrical elongate central lumen and also defines an elongate suction lumen. The inflatable cuff has a proximal end and a distal end and an inner surface and an outer surface. The connector assembly includes a connector component coupled to an opening in the elongate suction lumen defined by an outer wall of the elongate tube. The connector component is in fluid communication with the suction lumen and defines a closed flow path for drawing secretions from the elongate suction lumen of the elongate tube. The connector component defines an opening for passage of fluid in communication with the elongate suction lumen. The connector component includes a flange that extends radially into the suction lumen, the flange being configured to seal the suction lumen against passing a flow through the suction lumen in a longitudinal direction. 
         [0019]    There has thus been outlined, rather broadly, certain embodiments of the invention in order that the detailed description thereof, herein may be better understood, and in order that the present contribution to the art may be better appreciated. There are, of course, additional embodiments of the invention that will be described below as part of the disclosure. 
         [0020]    In this respect, before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of embodiments in addition to those described and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein, as well as the abstract, are for the purpose of description and should not be regarded as limiting. 
         [0021]    As such, those skilled in the art will appreciate that the conception upon which this disclosure is based may readily be utilized as a basis for the designing of other structures, methods and systems for carrying out the several purposes of the present invention. It is important, therefore, that the disclosure be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present invention. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0022]      FIG. 1  illustrates a side view of an endotracheal tube in accordance with an embodiment of the invention. 
           [0023]      FIG. 2  illustrates a sectional view along axis ‘B’ of the endotracheal tube shown in  FIG. 1 . 
           [0024]      FIG. 3  illustrates a partially sectional view along axis ‘A’ of the endotracheal tube shown in  FIG. 1 . 
           [0025]      FIG. 4  illustrates ends of a connector assembly for a detachable suction connection line for an endotracheal tube in accordance with an embodiment of the invention. 
           [0026]      FIG. 5  illustrates a sectional view of the connector assembly along section line I-I and section line II-II for the detachable suction connection line for an endotracheal tube. 
           [0027]      FIG. 6  illustrates another view of ends of a connector assembly for a detachable suction connection line for an endotracheal tube in accordance with an embodiment of the invention. 
           [0028]      FIG. 7  illustrates a view of the ends of a connector assembly for a detachable suction connection line for an endotracheal tube in a first coupled position, in accordance with an embodiment of the invention. 
           [0029]      FIG. 8  illustrates ends of a connector assembly for a detachable suction connection line for an endotracheal tube in a second coupled position, in accordance with an embodiment of the invention. 
           [0030]      FIG. 9  illustrates another view of the coupled ends of a connector assembly for a detachable suction connection line for an endotracheal tube in accordance with an embodiment of the invention, as shown in  FIG. 8 . 
           [0031]      FIG. 10  illustrates a proximal end of a suction connection line for an endotracheal tube in accordance with an embodiment of the invention. 
           [0032]      FIG. 11  illustrates a suction connection line coupled to an endotracheal tube in accordance with an embodiment of the invention. 
           [0033]      FIG. 12  illustrates another view of a suction connection line for an endotracheal tube in accordance with an embodiment of the invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0034]    The present invention provides in some embodiments, an endotracheal tube with subglottic secretion suction and a detachable suction line. The endotracheal tube is an elongate tube having an outer wall defining an elongate central lumen and an elongate suction lumen. An inflatable cuff is attached near a distal end of the elongate tube. The endotracheal tube also includes a connector to couple the suction lumen to a source of suction to remove subglottic secretions from the area above the cuff. 
         [0035]    The invention will now be described with reference to the drawing figures, in which like reference numerals refer to like parts throughout.  FIG. 1  illustrates an endotracheal tube  10  in accordance with the invention. The endotracheal tube  10  includes an outer wall  12  which defines a generally cylindrical central lumen  14 . The outer wall  12  also defines an elongate suction lumen  16 . The endotracheal tube  10  has a longitudinal axis ‘A’ extending through the length of the tube  10  and one or more latitudinal axis ‘B’ extending across the tube  10 . The endotracheal tube has a distal end  18 , which is inserted into the patient&#39;s trachea during the intubation procedure, and a proximal end  20 , which is coupled to the respirator or other source of air for the patient. The endotracheal tube  10  can also include a connector  22  mounted on the outer wall  12  of the endotracheal tube. As shown in  FIG. 1 , the connector can also include a cover  24  shown in a closed position in  FIG. 1 . 
         [0036]      FIG. 1  also illustrates an inflation cuff  26  positioned proximate to the distal end  18  of the endotracheal tube  10 . The inflation cuff  26  can be inflated via an inflation lumen  28  defined by the outer wall  12  of the endotracheal tube  10 . As shown in  FIG. 1 , an inflation tube  30  extends from the inflation lumen  28 . A distal end of the inflation tube  30  is inserted into the inflation lumen  28  and a proximal end  34  can be coupled to a source of air for inflation. A pilot  36  and a valve  38  can be coupled to the proximal end  34  of the inflation tube in order to keep air in the cuff  26 , once it is inflated. The endotracheal tube  10  can also include an x-ray opaque stripe  40  extending through the outer wall  12  of the endotracheal tube  10 , so that proper placement of the tube  10  can be confirmed via x-ray, if necessary. 
         [0037]      FIG. 2  illustrates a sectional view of an endotracheal tube taken along axis ‘B’ illustrated in  FIG. 1 . As illustrated in  FIG. 2 , the endotracheal tube  10  includes a central lumen  14 , a suction lumen  16 , an inflation lumen  28  defined by the outer wall  12  of the endotracheal tube  10 . The x-ray opaque stripe  40  also extends through the outer wall  12  of the tube  10 . The central lumen  14  is shown as generally circular in cross-sectional shape, while the suction lumen  16  is shown as generally elliptical in cross-sectional shape. However, the central lumen  14  and the suction lumen  16  can take any shape which allows for the passage of air or secretions. Additionally, the endotracheal tube  10  can be formed from polyvinyl chloride or any other suitable material for forming an endotracheal tube. 
         [0038]      FIG. 3  illustrates a partial sectional view of the endotracheal tube and inflation lumen taken along axis ‘A,’ illustrated in  FIG. 1 .  FIG. 3  shows the suction lumen  16  extending through the length of the endotracheal tube  10 . The outer wall  12  of the endotracheal tube  10  defines a suction lumen first opening  42  in the suction lumen  16 , just proximal of a proximal end  44  of the inflation cuff  26 . A plug  46  can be positioned in the suction lumen  16  just distal to a distal end  48  of the suction lumen first opening  42 . The plug  46  can be formed from UV glue or any other suitable material for sealing off the portion of the suction lumen  16  distal to the distal end  48  of the suction lumen first opening  42 . In this way, the suction lumen  16  effectively terminates at the opening  42 , where secretions accumulating around the proximal end of cuff  26  can be suctioned. 
         [0039]      FIG. 3  also illustrates the inflation cuff  26 . The cuff can include a distal end  50  and a proximal end  44 , as well as an inner surface  52  and an outer surface  54 . The inner surface  52  of the distal end  50  of the cuff  26  is bonded to the endotracheal tube  10  near its distal end  18 . Preferably, the proximal end  44  of the cuff  26  can be folded in, or inverted, such that the outer surface  54  is bonded to the endotracheal tube  10 . The bond can be formed by a suitable adhesive, melting, or any other form of bond that will connect the cuff  26  to the tube  10 . Inverting the proximal end  44  of the cuff  26 , but not the distal end  50 , allows for the cuff  26  to increase in diameter from its distal end  50  to its proximal end  44 . Additionally, the outer wall  12  of the endotracheal tube  10  defines an inflation lumen first opening  56  and an inflation lumen second opening  58  to allow fluid communication between the inflation lumen  28  and the inflation cuff  26 . 
         [0040]      FIGS. 4 and 5  illustrate ends of a connector assembly including a connector  22  and the detachable suction connection line  62  for an endotracheal tube  10  in accordance with an embodiment of the invention. The connector  22  on tube  10  defines a connector opening  64  which extends into the suction lumen  16  through a suction lumen second opening  66  defined by the outer wall  12  of the endotracheal tube  10 . The connector opening  64  on connector  22  is, as wide or, preferably, wider than the suction lumen  16  to allow for unobstructed suctioning, when the connector  22  is attached. The invention thereby provides for a way to suction secretions from the subglottic space proximal to the inflation cuff, through a lumen to an ultimate suction source, where the suction pathway from the patient end starting at the suction lumen first opening  42  does not contract or narrow to impede suctioning all the way through the endotracheal tube  10  and out of the device. The connector  22  can also include a flange  68  which blocks off the portion of the suction lumen  16  proximal to the suction lumen second opening  66 . A distal end  67  of the detachable suction connection line  62 , also defines a first opening  70  on a first face  72  and a second opening  74  on a second face  76 , such that an elongate tube  77  of the detachable suction line  62  inserted into second opening  74  is in fluid communication with the suction lumen  16  when the suction connection line  62  is coupled to connector  22 , as described further below. The detachable suction line  62  can be coupled to the connector  22  with a detent locking mechanism or any other suitable means of connection, and is designed to create an air tight seal when connected. As illustrated in the embodiment of  FIGS. 4 and 5 , the connector  22  includes detents  78  and the detachable suction line includes grooves  80  to form the detent locking mechanism. The connector  22  can also include a cover  24  shown in the open position in  FIG. 4 . 
         [0041]      FIGS. 6 ,  7 ,  8  and  9  illustrate the coupling of a connector  22  and the detachable suction connection line  62  for an endotracheal tube  10  in accordance with an embodiment of the invention. As shown in  FIG. 6 , the grooves  80  are lined up with the detents  78  and the detachable suction connection line  62  is lowered onto the connector  22  in the direction of arrows  82 . As shown in  FIG. 7 , the detachable suction connection line  62  is then turned in the direction of arrow  84 , so that the detents  78  slide through grooves  80  and into the notch  86 , as shown in  FIG. 8 . To remove the detachable suction line  62  it is turned in the direction of arrow  88 , as shown in  FIG. 9 . Additionally, the connector  22  can include the cover  24 , shown in its open position in  FIGS. 6 ,  7 ,  8 , and  9 . The cover  24  can be used to cover the connector  22  when suction is not in use. 
         [0042]      FIGS. 10 and 11  illustrate a proximal end  92  of a suction connection line  62  for an endotracheal tube  10  in accordance with an embodiment of the invention. The proximal end  92  of the suction connection line  62  includes a coupler  94  to couple the suction connection line  62  to a source of suction. As shown in  FIG. 10 , the coupler  94  can be connected to a suction line  96  from a suction unit. Alternately, as shown in  FIG. 11  the coupler  94  can be connected to a suction syringe  98 . Proximal end  92  can have a flattened shape defining lateral extensions  93  for allowing enhanced gripping to connect and disconnect to external suction source line  96 . 
         [0043]      FIG. 12  illustrates a proximal end  92  of a suction connection line  62  for an endotracheal tube  10  in accordance with an embodiment of the invention. The coupler  94  can also include a suction line end cap  100  and a coupler end cap  102 . The suction line end cap  100  can be used to cover the distal end  67  of the suction connection line  62 . The coupler end cap  102  can be used to cover a proximal end  104  of the coupler  94 . When not in use the coupler end cap  102  also can include a clip  106  to connect the coupler end cap  102  to the elongate tube  77  of the suction connection line  62 . 
         [0044]    In one embodiment, the invention provides the ability to attach and detach a suction line to a standard endotracheal tube allowing the tube to be used as either a standard tube or as a subglottic secretion suction tube. The detachable suction line has been designed with a detent locking device for ease of connection and to reduce accidental disconnection. This reduces suction line restrictions, improving the suctioning rate of the subglottic secretions that normally pool above the cuff. 
         [0045]    An embodiment of the invention modifies the standard endotracheal tube by adding the dorsal suction lumen and a sealable connection port thereto. The inflation cuff can be modified by inverting the top sleeve of the cuff when bonding to the tube, and is intended to decrease the space between the top of the cuff and the suction port for more efficient subglottic suctioning. 
         [0046]    The parts utilized can consist of a conventional PVC tube with the various connectors made of common resins. The injection molded plastic connectors are designed with a detent locking mechanism that is used for the suction accessory line. The suction lumen line is typically bonded into the suction lumen which restricts the inner diameter (ID) of the tube. Thus, the suction tube ID is not restricted thus improving the suction capability. The interference between the suction lumen and the suction line is minimized with the interlocking systems, reducing the restrictions to the flow of secretions and making the device less prone for occlusions. 
         [0047]    In one embodiment, the male connector is preferably placed at a dorsal side of the endotracheal tube centered with the upper opening of the suction lumen. It is preferred to be located above the 24 cm mark which prevents the male connector having contact with the mouth or teeth when the Endotracheal tube is in place. The suction line accessory has the female connector that is packaged separately and attach to the endotracheal tube male connector. 
         [0048]    The design allows the attachment and detachment of the suction line connector from a standard endotracheal tube allowing the tube to be used as either a standard tube or as a subglottic secretion suction tube. This allows for subglottic secretion removal without re-intubation. The design features a connector with a sealing cap, permanently attached to the dorsal lumen, which can be opened and used with a separately packaged suction line with mating connector. The design of the tube port and extension line connectors improve the suction function through the endotracheal tube suction lumen by maintaining a constant lumen geometry, thus reducing the restriction to the flow of secretions. 
         [0049]    The subject invention improves patient safety by providing the ability to attach the suction accessory line separately. This allows the use of a standard endotracheal tube across all patient populations and provide for subglottic secretion removal only where necessary without re-intubation. A classic example would be the patient that goes into surgery intubated with a standard ET tube, and subsequently requires unanticipated subglottic secretion removal. Currently this would require the patient to be extubated and re-intubated with an ET tube having a suction lumen. Clinical practice discourages extubating the patient except in the most serious cases due to the hazards involved with re-intubation which include but are not limited to increase risk of infection, loss of airway, and tracheal trauma The subject invention makes the subglottic suctioning more efficient. The male connector is attached to the upper opening of the dorsal lumen; and does not occlude or restrict the suction lumen as is evident with the competitor&#39;s design. The fluids and secretions are removed with less suctioning vacuum pressure which reduces the potential for tracheal hematomas. This will provide a cost-effective standard Endotracheal tube and a suction line accessory that can be used as is needed during any procedure. 
         [0050]    The many features and advantages of the invention are apparent from the detailed specification, and thus, the disclosure is intended to cover all such features and advantages of the invention which fall within the true spirit and scope of the invention. Further, because numerous modifications and variations will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation illustrated and described, and accordingly, all suitable modifications and equivalents may be resorted to falling within the scope of the invention.