Abstract:
An endotracheal intubation apparatus provides for controlled articulation of tip and central portions of a stylet having an endotracheal tube specifically configured for use therewith mounted thereon. The endotracheal intubation apparatus includes a stylet with tip and central portions that each have a curvature that is selectively and independently adjustable through one or more controls at a handle of the stylet. Through adjustment of the curvature of the tip and central portions of the stylet, a curvature of overlying portions of an endotracheal tube mounted on the stylet can be selectively and independently adjusted. Advantageously, such selectively and independently adjustment of the curvature of the tip and central portions of the stylet allows a contour of the endotracheal tube to be selectively adjusted for accommodating a particular airway anatomy of a patient without requiring removal of the endotracheal intubation apparatus.

Description:
FIELD OF THE DISCLOSURE 
       [0001]    The disclosures made herein relate generally to endotracheal tubes and their method of placement and, more particularly, to a steerable endotracheal intubation apparatus, endotracheal intubation apparatus and endotracheal tube of same. 
       BACKGROUND 
       [0002]    Medical professionals such as, for example, anesthesiologists, emergency responders and clinicians have one common denominator, which is the need to intubate a patient. Intubation is the placement of a tube into a patient&#39;s airway in order to allow for gas exchange into the lungs, such as the placement of a patient onto a ventilator. Placing an endotracheal tube is frequently done without difficulty. However, at times, there are more challenging cases and a key consideration in these cases is that failure to properly place the endotracheal tube in a timely manner can yield catastrophic results to the patient. 
         [0003]    A device such as, for example, a laryngoscope, video-glidescope or the like is used to allow the medical professional to visualize the anatomy of an airway of a patient. The endotracheal tube remains in the patient after the process is completed for allowing airflow through the patient&#39;s respiratory system. A traditional stylet (e.g., prior art) is a manually malleable piece of metal that slides into the endotracheal tube (i.e. the endotracheal intubation apparatus) to allow the endotracheal tube to be maintained in the bend contour (i.e., curvature) of the stylet to assist in placing the endotracheal tube thereby matching the contour of the endotracheal tube to that of the anatomy of the airway of the patient. 
         [0004]    Intubation is relatively simplistic in terms of what is needed to place the endotracheal tube in a patient. The process of intubation typically involves using a device to visualize the back of the patient&#39;s throat and the airway in order to find the place to put the endotracheal tube. Once the anatomy is seen, the endotracheal intubation apparatus is placed, and the stylet is then removed leaving the endotracheal tube in place. One known device for visualizing the back of the throat is a laryngoscope, which is a special curved piece of metal with a flashlight, which is used to retract the necessary anatomy and illuminate the airway. In some cases, the laryngoscope includes a camera at the tip (i.e., a glidescope) so the medical professional can watch the endotracheal tube placement process on a screen rather than needing to look directly into the patient&#39;s mouth. Fiberoptic intubation devices (e.g., a bronchoscope) can also be used in combination with a stylet, which allow for the camera to be placed directly into the endotracheal tube thereby allowing the process of intubation to be performed via direct visualization of the path of the endotracheal tube. In this case, once the target is visualized, the endotracheal tube is slid off of the fiberoptic intubation device once it is in its target location. 
         [0005]    A common occurrence when attempting to place an endotracheal tube is the need to pull the entire endotracheal intubation apparatus out of the patient&#39;s body and bend the stylet in order to achieve a more optimal angle so that the tip of the endotracheal tube can properly reach the entry point of the larynx. Oftentimes, the stylet needs to be bent in a certain way, and it can be difficult or impossible to know the optimal bend prior to visualizing and/or experiencing the anatomy. For example, sometimes a central portion of the stylet needs to be curved significantly and, depending on the anatomy, the tip sometimes needs to be curved differently. 
         [0006]    Removing the endotracheal intubation apparatus (i.e., stylet with mounted endotracheal tube) and needing to change its contour through manual bending of the stylet requires time, which puts the patient at risk of further deoxygenation secondary to a lack of oxygen during the process. Furthermore, changing the contour of the endotracheal intubation apparatus often requires the medical professional to use both hands and, thus, requires them to let go of any device they are using to separately visualize the patient&#39;s airway anatomy. The time taken with this process is invaluable and can lead to an adverse situation associated with the patient&#39;s oxygen level declining. In addition to the patient&#39;s oxygen level declining, there can also be other adverse situations that take place such as, for example, the patient&#39;s airway anatomy being distorted from bleeding from the initial attempts secondary to trauma to the airway. 
         [0007]    Therefore, an endotracheal intubation apparatus that provides for controlled articulation of tip and central portions of the stylet and an endotracheal tube specifically configured for use therewith would be advantageous, desirable and useful. 
       SUMMARY OF THE DISCLOSURE 
       [0008]    Embodiments of the present invention are directed to an endotracheal intubation apparatus that provides for controlled articulation of tip and central segments (i.e., portions) of the stylet and an endotracheal tube specifically configured for use therewith. More specifically, embodiments of the present invention are directed to an endotracheal intubation apparatus including a stylet with tip and central segments having a curvature that can be selectively and independently adjustable through one or more controls at a handle of the stylet. Through adjustment of the curvature of the tip and central segments of the stylet, a curvature of overlying portions of an endotracheal tube mounted on the stylet can be selectively and independently adjusted. Advantageously, such selectively and independently adjustment of the curvature of the tip and central portions of the stylet allows a contour of the endotracheal tube to be selectively adjusted for accommodating a particular airway anatomy of a patient without requiring removal of the endotracheal intubation apparatus. 
         [0009]    In one embodiment of the present invention, an endotracheal intubation tube comprises a main body having an end segment, a base segment and a middle segment between the end and base segments. A central passage extends through the end segment, the base segment and the middle segment. The end segment has a unit length flexural stiffness substantially less than a unit length flexural stiffness of the middle segment. A length of the end segment is substantially less than a length of the middle segment. 
         [0010]    In another embodiment of the present invention, an endotracheal intubation apparatus comprises an endotracheal tube and an endotracheal tube stylet. The endotracheal tube includes a main body having an end segment, a base segment and a middle segment between the end and base segments. A central passage extends through the end segment, the base segment and the middle segment. The endotracheal tube stylet includes a hand-gripping portion and a multi-segment extension portion. The multi-segment extension portion is attached to the hand-gripping portion. The multi-segment extension portion includes a tip segment and a central segment connected to the tip segment. The hand-gripping portion includes at least one curvature adjuster coupled to the tip and central segments for enabling a curvature of each one of the segments to be independently and selectively adjusted. The multi-segment extension portion is positioned within the central passage of the endotracheal tube. The tip segment extends along at least a portion of the length of the end segment of the endotracheal tube. The central segment extends along at least a portion of the length of the middle segment of the endotracheal tube. 
         [0011]    In another embodiment of the present invention, an endotracheal intubation component system comprises an endotracheal tube and an endotracheal tube stylet. The endotracheal tube includes a main body having an end segment, a base segment and a middle segment between the first and base segments. A central passage extends through the end segment, the base segment and the middle segment. The endotracheal tube stylet including a hand-gripping portion and a multi-segment extension portion. The multi-segment extension portion is attached to the hand-gripping portion. The multi-segment extension portion includes a tip segment and a central segment connected to the tip segment. The hand-gripping portion includes at least one curvature adjuster coupled to the tip and central segments for enabling a curvature of each one of the segments to be independently and selectively adjusted. The multi-segment extension portion and the central passage of the endotracheal tube are jointly configured for enabling the tip and central segments of the endotracheal tube stylet to be positioned within the central passage of the endotracheal tube such that the tip segment extends along at least a portion of a length of the end segment of the endotracheal tube and the central segment extends along at least a portion of a length of the middle segment of the endotracheal tube. 
         [0012]    An endotracheal tube stylet comprises a hand-gripping portion and a multi-segment extension portion. The multi-segment extension portion is attached to the hand-gripping portion. The multi-segment extension portion includes a tip segment and a central segment connected to the tip segment. Both the tip segment and the central segment are movable. The hand-gripping portion includes a curvature adjusting mechanism that is coupled to the tip and central segments for enabling a curvature of each one of the segments to be selectively adjusted. 
         [0013]    These and other objects, embodiments, advantages and/or distinctions of the present invention will become readily apparent upon further review of the following specification, associated drawings and appended claims. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0014]      FIG. 1  is a side view of an endotracheal tube configured in accordance with an embodiment of the present invention. 
           [0015]      FIG. 2  is an end view at a connector portion of the endotracheal tube shown in  FIG. 1 . 
           [0016]      FIG. 3  is a cross-sectional view taken along the line  3 - 3  in  FIG. 1 . 
           [0017]      FIG. 4  is a cross-sectional view taken along the line  4 - 4  in  FIG. 1 . 
           [0018]      FIG. 5  is a side view of an endotracheal intubation apparatus configured in accordance with an embodiment of the present invention wherein the endotracheal tube thereof is in a first curvature configuration. 
           [0019]      FIG. 6  is a side view of the endotracheal intubation apparatus of  FIG. 5  wherein the endotracheal tube thereof is in a second curvature configuration. 
           [0020]      FIG. 7  is a side view of the endotracheal intubation apparatus of  FIG. 5  wherein the endotracheal tube thereof is in a third curvature configuration. 
           [0021]      FIG. 8  is a side view of an endotracheal tube stylet configured in accordance with an embodiment of the present invention. 
           [0022]      FIG. 9  is a cross-sectional view taken along the line  9 - 9  in  FIG. 8 . 
           [0023]      FIG. 10  is a cross-sectional view taken along the line  10 - 10  in  FIG. 8 . 
       
    
    
     DETAILED DESCRIPTION 
       [0024]      FIGS. 1-4  show various aspects of an endotracheal tube  10  configured in accordance with an embodiment of the present invention. As will be discussed in greater detail herein, the endotracheal tube  10  is specifically configured for use with a stylet configured in accordance an embodiment of the present invention. Jointly, an endotracheal tube and stylet configured in accordance with the present invention jointly define an endotracheal intubation apparatus configured in accordance with an embodiment of the present invention and are components of an endotracheal intubation component system configured in accordance with an embodiment of the present invention. 
         [0025]    With reference to  FIGS. 1-4 , the endotracheal tube  10  is defined by an elongated main body  12  having a proximal end  14  that is attached (e.g., removably) to a connector portion  16 , and a distal tip end  18 . An inflatable cuff or balloon  24  is provided adjacent distal end  18  and is coupled to an inflation port  26  as is typical for standard, adult endotracheal tubes. For smaller size endotracheal tubes, the cuff  24  and port  26  may be eliminated. 
         [0026]    The main body  12  can be formed to have an as-manufactured arcuate shape (e.g., as shown in  FIG. 1 ). The main body  12  includes an end segment  28 , a middle segment  30  and a base segment  32 . A central passage  22  of the main body  12  (i.e., a gas flow lumen) extends through the end segment  28 , the middle segment  30 , and the base segment  32 . In this regard, the end segment  28 , the middle segment  30  and the base segment  32  jointly define an interior surface  34  of the main body  12  that in turn defines the central passage  22  of the main body  12 . The central passage  22  provides for flow of gas, such as oxygen, to ventilate a patient. Preferably, but not necessarily, the balloon  24  is not expose to the central passage  22  (e.g., is externally mounted). 
         [0027]    The end segment  28  and the middle segment  30  are both flexible for allowing them to be bent into different curvatures (i.e., flexibility provides for selective curvature). Preferably, but not necessarily, the end segment  28  has a unit length flexural stiffness substantially less than a unit length flexural stiffness of the middle segment  30 . In one implementation, as shown in  FIGS. 1 and 4 , the end segment  28  can include one or more recesses  36  in an exterior surface and/or interior surface thereof and a length of the end segment  28  is substantially less than a length of the middle segment  30 . The recesses  36  are configured for causing the unit length flexural stiffness of the end segment  28  to be substantially less than the unit length flexural stiffness of the middle segment  30  (e.g., an exterior surface and interior surface of the middle segment  30  is devoid of such recesses). Unit length flexural stiffness refers to a degree of stiffness over a particular unit length (e.g., over 1-inch). Optionally or alternatively, a thickness of at least a portion of the end segment can be substantially less than a thickness of the middle segment thereby causing the unit length flexural stiffness of the end segment to be substantially less than the unit length flexural stiffness of the middle segment. Optionally or alternatively, the end segment  28  can be made from a first polymeric material and the middle segment  30  can be made from a second polymeric material different than the first polymeric material for causing the unit length flexural stiffness of the end segment  28  to be substantially less than the unit length flexural stiffness of the middle segment  30 . 
         [0028]    As shown in  FIGS. 2 and 3 , the connector portion  16  of the main body  12  includes a first stylet engagement structure  38  within a ventilator mounting nipple  39  of the connector portion  16  and a second stylet engagement structure  40  within a flange  41  of the connector portion  16 . The first stylet engagement structure  38  is a feature (e.g., channel) configured for being engaged by a mating structure of an endotracheal tube stylet for defining a clocked orientation of the endotracheal tube  10  with the endotracheal tube stylet (e.g., defines a relative angular orientation and inhibits unrestricted rotation of the endotracheal tube  10  relative to an attached an engaged endotracheal tube stylet). The second stylet engagement structure  40  is a feature (e.g., slot) configured for being engaged by a mating structure of the endotracheal tube stylet for inhibiting unrestricted translation of the main body  12  with respect to the endotracheal tube stylet, rotation of the main body  12  with respect to the endotracheal tube stylet, or both. 
         [0029]    Turning now to  FIGS. 5-7 , an endotracheal intubation apparatus  50  configured in accordance with an embodiment of the present invention is shown. The endotracheal intubation apparatus  50  includes the endotracheal tube  10  disclosed above in reference to  FIGS. 1-4  (i.e., an endotracheal tube configured in accordance with an embodiment of the present invention) and an endotracheal tube stylet  52 , which is configured in accordance with an embodiment of the present invention. It is disclosed herein that the endotracheal tube  10  disclosed above in reference to  FIGS. 1-4  is one example of an endotracheal tube suitable for use with an endotracheal tube stylet configured in accordance with an embodiment of the present invention. It is disclosed herein that certain standard (e.g., prior art/commercially available) endotracheal tubes may be used in combination with an endotracheal tube stylet configured in accordance with an embodiment of the present invention. 
         [0030]    As best shown in  FIG. 8 , the endotracheal tube stylet  52  includes a hand-gripping portion  54  and a multi-segment extension portion  56 . The multi-segment extension portion  56  is attached to the hand-gripping portion  54 . The multi-segment extension portion  56  includes a tip segment  58  and a central segment  60  connected to the tip segment  58 . The hand-gripping portion  54  includes a tube release mechanism (e.g., button  61 ) that enables a tube engagement structure  63  to be selectively disengaged from the second stylet engagement structure  40  thereby allowing the endotracheal tube  10  to be detached from the endotracheal tube stylet  52 . A mounting portion  65  of the endotracheal tube stylet  52  is configured for having the connector portion  16  of the endotracheal tube  10  mounted thereon. In certain embodiments, the tube release mechanism (e.g., a structure connected to the button  61 ) can be configured for urging the connector portion  16  of the endotracheal tube  10  out of engagement with the mounting portion  65 . Optionally, the mounting portion  65  can include an alignment feature  67  that engages the first stylet engagement structure  38  of the connector portion  16  of the endotracheal tube  10  for providing a clocked orientation of the endotracheal tube  10  with respect to the endotracheal tube stylet  52 . It is disclosed herein that all of the alignment features (e.g., first stylet engagement structure  38 , a second stylet engagement structure  40 , the tube engagement structure  63 , and alignment feature  67 ) can be omitted without departing from the spirit or advantageous functionality of the present invention. It is also disclosed herein that the tube engagement structure  63  in conjunction with the second stylet engagement structure  40  can solely provide for clocked orientation functionality of the endotracheal tube  10  with respect to the endotracheal tube stylet  52 . Furthermore, in view of the disclosures made herein, a skilled person will appreciate that the design of the hand-gripping portion  54  can be implemented in a manner allowing use with an endotracheal tube having a connector  16  that is conventionally configured (e.g., a connector configured in accordance with a prior art endotracheal tube). 
         [0031]    Referring back to  FIGS. 5-7 , the multi-segment extension portion  56  is positioned within the central passage of the endotracheal tube  10  such that the tip segment  58  extends along at least a portion of the length of the end segment  18  of the endotracheal tube  10  and the central segment  60  extends along at least a portion of the length of the middle segment  20  of the endotracheal tube  10 . The hand-gripping portion  54  includes a first curvature adjuster  62  and a second curvature adjuster  64 . The first curvature adjuster  62  is coupled to the tip segment  58  of the multi-segment extension portion  56  for enabling curvature of the tip segment  58  to be selectively altered through movement of the first curvature adjuster  62 . The second curvature adjuster  64  is coupled to the central segment  60  of the multi-segment extension portion  56  for enabling curvature of the central segment  60  to be selectively altered through movement of the second curvature adjuster  64 . The first curvature adjuster  62  and the second curvature adjuster  64  are independently operable for enabling curvature of the tip segment  58  and the central segment  60 , respectively, to be both independently and simultaneously altered. 
         [0032]    As shown in  FIG. 5 , the tip segment  58  is in a first tip segment orientation T1 when the first curvature adjuster  62  is in a first position CA1-P1 and central segment  60  is in a first central segment orientation C1 when the second curvature adjuster  64  is in a first position CA2-P1. As shown in  FIG. 6 , the tip segment  58  remains in the first tip segment orientation T1 when the first curvature adjuster  62  is in the first position CA1-P1 and central segment  60  moves to a second central segment orientation C2 when the second curvature adjuster  64  is in a second position CA2-P2. As shown in  FIG. 7 , the tip segment  58  moves to a second tip segment orientation T2 when the first curvature adjuster  62  is in a second position CA1-P2 and central segment  60  moves to a third central segment orientation C3 when the second curvature adjuster  64  is in a third position CA2-P3. These curvature adjuster positions and the relative orientation of the tip segment  58  and central segment  60  of the multi-segment extension portion  56  are for illustrative purposes in the depicted embodiment. A skilled person will appreciate that different control conditions can be implemented and that other configures of curvature adjusters can be implemented. For example, it is disclosed herein that the first curvature adjuster  62  can be a dual-direction adjuster configured in the same or similar manner as the second curvature adjuster  64  thereby allowing for curvature adjustment of the tip segment  58  in opposing directions from a baseline orientation (e.g., opposite the displaced orientation shown in  FIG. 7 ). 
         [0033]    Referring now to  FIGS. 9 and 10 , implementations of mechanisms for providing selective curvature of the multi-segment extension portion  56  is shown. The middle segment  56  includes a first control wire lumen  68 , a second control wire lumen  70  and a third control wire lumen  72 . A first control wire  74  extends through the first control wire lumen  68 , a second control wire  76  extends through the second control wire lumen  70  and a third control wire  78  extends through the third control wire lumen  72 . The first and second control wires  74 ,  76  are each connected to a distal end portion  80  ( FIG. 8 ) of the central segment  60  and to the second curvature adjuster  64  for enabling curvature adjustment of the central segment  60 . The third control wire  78  is connected to a distal end portion  82  ( FIG. 8 ) of the tip segment  58  and to the first curvature adjuster  62  for enabling curvature adjustment of the tip segment  58 . In the case of the first curvature adjuster  62  being configured for dual-direction adjustment of the tip segment  58 , a fourth control wire lumen having a fourth control wire therein can be implemented in conjunction with the third control wire lumen  72  and the third control wire  78  (e.g., adjacent to the first control wire lumen  68  along a first plane P1) for enabling such dual-direction adjustment of the tip segment  58 . 
         [0034]    The tip segment  58  and the central segment  60  of the multi-segment extension portion  56  each include a central passage  84  having an oblong cross-sectional profile. The oblong cross-sectional profile of the central passage  84  serves to define a preferential direction of curvature of the tip segment  58  and the central segment  60 . Specifically, a long axis L1 of the central passage  84  causes the tip segment  58  and the central segment  60  to each preferentially bend within the common plane P1. In this regard, preferably, the tip segment  58  and the central segment  60  each include a structure that limits their flexure only within the common plane P1. In this regard, the curvature adjusters  62 ,  64 , the control wire lumens  68 ,  70 ,  72 , the control wires  74 ,  76 ,  78 , and the oblong shaped central passage  84  jointly define a curvature adjusting mechanism. It is disclosed herein that a curvature adjusting mechanism configured in accordance with the present invention is limited to enabling the curvature of the tip and central segments of a multi-segment extension portion of an endotracheal tube stylet configured in accordance with an embodiment of the present invention to be independently and selectively adjusted (i.e., flexed) only within a common plane. Preferably, such adjustment would be inhibited outside of the common plane. In view of the disclosures made herein, a skilled person will appreciate various implantations of a curvature adjusting mechanism for enabling selective and independent control of a tip and central segments of a multi-segment extension portion of an endotracheal tube stylet. For example, U.S. Pat. Nos. 7,008,401; 6,783,510; 6,610,058; and 5,254,088 each disclose subject matter that a skilled person privy to the disclosures made herein would consider (e.g., jointly consider) for implementing one or more suitable approaches for enabling selective and independent control of a tip and central segments of a multi-segment extension portion of an endotracheal tube stylet. 
         [0035]    It is disclosed herein that endotracheal tubes in the context of the present invention can be of different lengths. To this end, it is desirable for an endotracheal tube stylet configured in accordance with the present invention to accommodate such different length endotracheal tubes. For example, the mounting portion  65  of the endotracheal tube stylet  52  can be adjustable along a length of the multi-segment extension portion  56 . In another example, interposers of different length can be provided for being engaged between the mounting portion  65  of the endotracheal tube stylet  52  and the connector portion  16  of the endotracheal tube  10 . Accordingly, in view of the disclosures made herein, a skilled person will appreciate various of approaches for enabling the use of different length endotracheal tubes with an endotracheal tube stylet configured in accordance with the present invention. 
         [0036]    Although the invention has been described with reference to several exemplary embodiments, it is understood that the words that have been used are words of description and illustration, rather than words of limitation. Changes may be made within the purview of the appended claims, as presently stated and as amended, without departing from the scope and spirit of the invention in all its aspects. Although the invention has been described with reference to particular means, materials and embodiments, the invention is not intended to be limited to the particulars disclosed; rather, the invention extends to all functionally equivalent technologies, structures, methods and uses such as are within the scope of the appended claims.