Abstract:
An airway manifold includes a manifold body having an upper body portion and a lower body portion. The body portions are engaged such that the upper body portion is rotatable relative to the lower body portion, whereby a generally hollow interior space is defined. The lower body portion has a port open to the interior space, and the upper body portion includes a plurality of ports open to the interior space. A first upper body port is axially alignable with the lower body port to define a substantially linear passageway therebetween when the upper body portion is at a first rotatable position relative to the lower body portion. A second upper body port is axially alignable with the lower body port to define a substantially linear passageway therebetween when the upper body portion is at a second rotatable position.

Description:
BACKGROUND OF THE INVENTION 
     Technical Field 
     The present invention relates generally to multi-port medical devices. More particularly, the invention relates to a medical manifold having rotatable ports. 
     Background Information 
     During the course of a medical or surgical treatment, a patient may be incapable of adequately breathing on his/her own. In order to ensure that a sufficient supply of oxygen is provided to the patient, the physician may initiate a period of artificial ventilation. Artificial ventilation is typically carried out by inserting an endotracheal tube into the trachea of the patient via the mouth or nose, a process referred to as intubation. A mechanical ventilator supplies oxygen through the endotracheal tube (ETT) to the patient&#39;s lungs. 
     During management of such patients, it may be desirable to coaxially insert one or more catheters, etc., into the patient&#39;s trachea through the ETT. Such devices may be positioned to carry out a medical procedure, or as a diagnostic tool. Examples of medical procedures include placement of a balloon-tipped catheter (e.g., an endobronchial blocker) for lung isolation, as well as other procedures such as jet ventilation, etc. Examples of diagnostic procedures include monitoring of bodily temperature, pressure, gas composition, etc. In such cases, the distal end of the catheter typically extends beyond the distal end of the ETT, and in many instances, is inserted into either the right or left mainstem bronchus. To ensure adequate placement, the position of the catheter is generally viewed through the endotracheal tube with an elongated viewing instrument, such as a fiberoptic bronchoscope. 
     A multi-port manifold may be engaged with the proximal end of the ETT to allow for simultaneous placement through the ETT of a plurality of different medical devices. Examples of such devices include a catheter (such as the endobronchial blocker catheter described above), various diagnostic tools, a bronchoscope, and a wire guide. Additionally, the manifold provides a conduit for ventilation of the patient. In some manifolds, each of these features is carried out through a separate port. 
     A distal port of the manifold is connected to the ETT. Another port is generally positioned in-line with the distal port, and with the lumen of the ETT. When introducing a bronchoscope into the airway, the bronchoscope is inserted through the in-line port, and extended through the distal port to ensure suitable visualization into the trachea. In some applications, a wire guide is inserted through a working channel of the bronchoscope, and directed into the desired right or left mainstem bronchus under visualization through the bronchoscope. 
     Once the wire guide is positioned in the desired region, the bronchoscope is removed from the in-line port. The catheter (e.g., an endobronchial blocker) is inserted over the wire guide in the in-line port, and advanced in the direction of the desired mainstem bronchus. The bronchoscope is then inserted through a side (angled) port to visualize the advancement of the catheter, and to verify that the catheter has entered the proper mainstem bronchus. Difficulties may be encountered when advancing a bronchoscope through a side port. A bronchoscope is typically a delicate instrument which has the ability to be tip deflected from the proximal end. However, the tip deflecting ability of such instruments can be impaired if the proximal end of the scope is at an acute angle with respect to the distal tip. In addition, when the bronchoscope is inserted through an angled port, the optics are generally not as suitable when compared to entry and advancement through an in-line port. In addition to the bronchoscope, other delicate and/or fragile instruments may be subject to impairment or damage if inserted through an angled port. 
     It would be desirable to overcome the problems encountered in the art by providing a manifold having multiple entry ports, wherein such ports are rotatable such that more than one port can be selectively axially aligned with the lumen of the ETT. It would further be desirable to provide rotatable entry ports wherein each port is arranged on the manifold in a manner such that each said port maintains access to the target site, to allow simultaneous passage of a respective medical device through each of said ports. 
     BRIEF SUMMARY 
     The present invention addresses the shortcomings of the prior art. In one form thereof, the invention comprises an airway manifold having a manifold body comprising an upper body portion and a lower body portion. The body portions are engaged such that the upper body portion is rotatable relative to the lower body portion, whereby a generally hollow interior space is defined thereby. The lower body portion has a port open to the interior space, and the upper body portion includes a plurality of ports open to the interior space. A first upper body port is axially alignable with the lower body port to define a substantially linear passageway therebetween when the upper body portion is at a first rotatable position relative to the lower body portion. A second upper body port is axially alignable with the lower body port to define a substantially linear passageway therebetween when the upper body portion is at a second rotatable position relative to the lower body portion. 
     In another form thereof, the invention comprises an airway system, wherein a manifold comprises an upper body and a lower body. The upper body and the lower body are engaged such that the upper body is rotatable relative to the lower body, and a generally hollow interior space is defined thereby. The lower body includes a first port and a second port, wherein each of the lower body ports is open to the interior space. The upper body includes a first port and a second port, wherein each of the upper body ports is open to the interior space. The upper body first port is axially alignable with the lower body first port to define a substantially linear passageway therebetween when the upper body is at a first rotatable position relative to the lower body. The upper body second port is axially alignable with the lower body first port to define a substantially linear passageway therebetween when the upper body is at a second rotatable position relative to the lower body. An airway tube is engaged with the lower body first port. A ventilator is engaged with the lower body second port. A viewing device is insertable through the upper body first port and the lower body first port when the upper body is at the first rotatable position relative to the lower body, and insertable through the upper body second port and the lower body first port when the upper body is at the second rotatable position relative to the lower body. A guide device is insertable through one of the first and second upper body ports and extendable therefrom through the airway tube. 
     In still another form, the invention comprises a method of introducing a medical device into a mainstem bronchus of a patient. A manifold is positioned at a proximal end of an airway tube. The manifold comprises an upper body and a lower body engaged such that the upper body is rotatable relative to the lower body, and such that a generally hollow interior space is defined thereby. The lower body includes a first port and a second port, each of which opens to the interior space. The upper body includes a first port and a second port, each of which opens to the interior space. The upper body first port is axially alignable with the lower body first port to define a substantially linear passageway therebetween when the upper body is at a first rotatable position relative to the lower body. The upper body second port is axially alignable with the lower body first port to define a substantially linear passageway therebetween when the upper body is at a second rotatable position relative to the lower body. The airway tube proximal end is positioned at the lower body first port, and the airway tube distal end extends into the trachea of the patient. The respective distal ends of a viewing device and a guide device are introduced through the upper body first port when the upper body is at the first rotatable position relative to the lower body, and the distal ends are advanced through the lower body first port and airway tube, and into the trachea. The distal ends are advanced toward a target mainstem bronchus, and the guide device distal end is advanced into the target bronchus under visualization from the viewing device. The viewing device is withdrawn through the upper body first port, and a position of the guide device is maintained along the first port and the target bronchus. The upper body is rotated to the second rotatable position relative to the lower body. The viewing device distal end is introduced through the upper body second port, and advanced through the lower body first port and airway tube toward the target mainstem bronchus. The distal end of the medical device is introduced through the upper body first port, and advanced toward the target bronchus. The medical device may comprise an endobronchial blocking device having an inflatable balloon at a distal end thereof, and the viewing device may comprise a bronchoscope. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a side view of a prior art multi-port manifold; 
         FIG. 2  is a perspective view of a manifold having rotational ports according to an embodiment of the present invention; 
         FIG. 3  is a longitudinal sectional view of the manifold shown in  FIG. 2 ; 
         FIG. 4  is another perspective view of the manifold of  FIG. 2 , after a rotation of the upper body ports of the manifold; 
         FIG. 5  is a view of the upper body portion of the manifold; 
         FIG. 6  is a view of the lower body portion of the manifold; 
         FIG. 7  is a view of the manifold connected to an endotracheal tube, wherein a first upper body port is axially in-line with a lower body port, and a bronchoscope extends through the axially aligned ports; 
         FIG. 8  is a view of the manifold connected to an endotracheal tube as in  FIG. 7 , wherein the bronchoscope has been withdrawn and the upper body ports have been rotated such that a second upper body port is axially in-line with the lower body port; 
         FIG. 9  is a view as in  FIG. 8 , wherein the bronchoscope has been inserted through the second upper body port, and an endobronchial blocking device has been inserted through the first upper body port; 
         FIG. 10  is a view as in  FIG. 9 , wherein the balloon of the blocking device has been inflated in a target bronchus; and 
         FIG. 11  is a view of an alternative embodiment wherein the manifold has three upper body ports. 
     
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     For purposes of promoting an understanding of the present invention, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It should nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated device, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates. 
     In the following discussion, the terms “proximal” and “distal” will be used to describe the opposing axial ends of the manifold, as well as the axial ends of various component features. The term “proximal” is used in its conventional sense to refer to the end of the manifold (or component) that is closest to the operator during use of the manifold. The term “distal” is used in its conventional sense to refer to the end of the manifold (or component) that is initially inserted into the patient, or that is closest to the patient during use. 
       FIG. 1  depicts an airway manifold  100  of a type known in the art. Manifold  100  includes a plurality of ports open to the interior of the manifold. A mechanical ventilation port  102  is configured for connection to a mechanical ventilator (not shown). An endotracheal tube connection port  104  is configured for connection to the proximal end of the endotracheal tube (not shown). A bronchoscope port  106  having an end cap  107  is positioned opposite to, and in-line with, the endotracheal tube connection port  104 . An auxiliary port  108  is positioned at an angle with reference to the bronchoscope port. The auxiliary port may be configured to receive a wire guide, a catheter, or other treatment or diagnostic device. One example of a prior art manifold as shown in  FIG. 1  is described in U.S. Pat. No. 6,086,529, incorporated by reference herein. 
       FIG. 2  is a perspective view of a manifold  10  according to an embodiment of the present invention.  FIG. 3  is a longitudinal sectional view of the manifold of  FIG. 2 . As described herein, and as further shown in  FIGS. 5 and 6 , manifold  10  comprises an upper, or proximal portion  12  ( FIG. 5 ), and a lower, or distal portion  30  ( FIG. 6 ). Upper and lower portions  12 ,  30  are engaged to form manifold  10 , and are configured to permit relative rotation between upper portion  12  and lower portion  30 . In the non-limiting embodiment described in greater detail herein, manifold portions  12 ,  30  are rotatably engaged via a snap fit. 
     Upper portion  12  comprises an annular ledge  14 , and includes ports  20 ,  24  extending in a proximal direction from ledge  14 . As shown in  FIG. 3 , annular ledge  14  includes an internal slot  16  formed circumferentially therearound. Ports  20 ,  24  comprise respective generally tubular body members, and are spaced at an angle of, e.g., about 30-60 degrees relative to each other. 
     In the preferred embodiment shown, ports  20 ,  24  have a proximal end provided with external threads  22 ,  26 , respectively. Respective end caps  21 ,  25  are sized and aligned for threaded connection with the external threads of ports  20 ,  24  via corresponding internal threads (not shown). An opening  23 ,  27  extends through each of the end caps and communicates with the hollow interior of manifold  10 . In a preferred embodiment, a conventional valve member, such as check-flow valve  29  ( FIG. 3 ) or a Tuohy valve, is provided internally of end cap  21 ,  25  in well-known fashion to establish a fluid-tight connection with a device extending through respective opening  23 ,  27 . 
     Lower portion  30  includes a ring-like tab  32  at its upper, or proximal, end. In the embodiment shown, tab  32  is sized and configured to be received in internal slot  16  by conventional means, such as a snap fit. Tab  32  is dimensioned relative to slot  16  in a manner to inhibit disengagement of the respective upper and lower manifold portions  12 ,  30  during normal usage, but to permit relative rotation therebetween. Those skilled in the art will appreciate that other means for engagement of the respective upper and lower portions  12 ,  30  may be substituted, as long as such alternative means is structured to provide secure engagement between the respective upper and lower portions, while at the same time permitting relative rotation therebetween as described herein. 
     As shown, e.g., in  FIGS. 4 and 6 , lower portion  30  comprises a generally elongated body  34 . Elongated body  34  preferably tapers from the proximal end to at least a side port  40  that extends at an angle from elongated body  34 . Port  40  may extend at an angle of about 90 degrees from body  34  as shown. Those skilled in the art will appreciate that although this angle is preferred, other angles, such as angles between about 30 and 60 degrees, may be substituted for the angle shown, as long as the position of port  40  does not functionally interfere with the remaining ports, as described herein. Port  40  may be configured to include a conventional 15 mm ventilator fitting portion  41  for connection to a mating fitting of a ventilation apparatus. Although port  40  is shown herein as having a fitting portion configured for engagement to a conventional 15 mm ventilator, this is not required. As a further alternative, port  40  may be configured for engagement with connectors of other configurations, for example, as a luer lock fitting for engagement with a corresponding connector of a jet ventilation device. 
     A distal port  36  is provided at the distal end of elongated body  34 . Distal port  36  is configured for engagement with, e.g., a proximal end of an airway tube, such as an endotracheal tube or other breathing tube capable of supplying a ventilating fluid to the patient. In one embodiment, distal port  36  may be provided with external threads  38  that are sized and aligned for threaded connection with corresponding internal threads (not shown) of a connector  37 . Connector  37  may be sized and configured for engagement in conventional manner with a proximal end of the endotracheal tube. 
     Upper and lower manifold portions  12 ,  30  are preferably formed of a generally rigid polymeric composition, such as a polycarbonate, polyamide (nylon), polyethylene, propylene, or other thermoplastic composition. Upper and lower portions  12 ,  30  may be formed and shaped by conventional processes, e.g., injection molding, insert molding, or conventional machining techniques. Those skilled in the art will appreciate that the compositions and forming techniques described herein are only intended to represent non-limiting examples, and that other known compositions and techniques may be suitable for a particular application. 
     An example illustrating the use of manifold  10  will now be provided. This example describes the use of manifold  10  for introducing an endobronchial blocker into a mainstem bronchus of a patient, in this case, into the right mainstem bronchus. Those skilled in the art will appreciate that this example is not intended to be limiting in any manner. Thus, the manifold may likewise be utilized for the introduction of other medical and diagnostic devices, and for introducing such devices at other target sites in the body of the patient. 
     As described above, it is generally desirable to insert a device, such as a bronchoscope  200 , through a proximal port of the manifold that is axially in-line with the distal port  36 , and with the lumen of an endotracheal tube  220  that extends in a distal direction from distal port  36 . This arrangement is shown in  FIG. 7 , wherein proximal port  20  is axially in-line with distal port  36  and endotracheal tube  220 . Endotracheal tube  220  extends into the trachea  230  of the patient, in well-known manner. Only the distal portion of trachea  230  that branches into the right and left mainstem bronchus  240 ,  245 , respectively, is shown in  FIGS. 7-10 . A ventilator  90  is schematically shown functionally engaged with port  40  in  FIGS. 7-10 . Ventilators, e.g., mechanical ventilators, jet ventilators, etc., are well known in the art, and those skilled in the art can readily select an appropriate ventilator for use herein. The remaining body portions of the patient are not shown, as they are not necessary for understanding the example described herein. 
     Upon insertion of bronchoscope  200  into port  20  as described, the distal end  202  of the bronchoscope extends beyond distal end  222  of the endotracheal tube, and is directed in a conventional manner to approach the selected right  240  or left  245  mainstem bronchus. In this example, the bronchoscope distal end  202  is deflected toward right mainstem bronchus  240  in well-known fashion, e.g., utilizing conventional articulating features of the bronchoscope. 
     A guide device, such as wire guide  210 , is also inserted into port  20 . Preferably, wire guide  210  is inserted via a lumen extending through bronchoscope  200 . Under visualization provided by the bronchoscope, the distal end of wire guide  210  is advanced into right mainstem bronchus  240 , as shown in  FIG. 7 . As described herein, it is desirable to obtain wire guide access to the selected bronchus, and to maintain such wire guide access during the period of time in which the medical device, e.g., the endobronchial blocker, is introduced and positioned in the selected mainstem bronchus. In addition, it is generally desirable to maintain wire guide access for a period of time thereafter, until it is confirmed that proper access has been achieved and that the device is functioning in a desired manner. By maintaining wire guide access to the target site, rapid reinsertion of a misplaced or non-functioning device, or rapid insertion of a replacement device, can be achieved if deemed necessary by the physician without the necessity to re-establish wire guide access to the target site, in this case, the right mainstem bronchus. Although referred to herein as a wire guide, those skilled in the art will appreciate that in some instances other thin-walled flexible devices, e.g., a thin-walled catheter or cannula, capable of carrying out the function of a wire guide as described herein may be substituted for a conventional wire guide. 
     Once it is confirmed that the wire guide has accessed the right mainstem bronchus, the bronchoscope may be withdrawn over the wire guide, leaving the wire guide in place. At this time, the proximal ports  20 ,  24  of the upper manifold portion  12  may be rotated to a second position, as shown in  FIG. 8 . Following rotation of the ports, port  24  is now in-line with distal port  36  and the lumen of endotracheal tube  220 . Although wire guide  210  and port  20  are no longer in-line with the distal port  36 , the wire guide continues to extend beyond the distal port and secure access into the mainstem bronchus  240 . 
     At this time, bronchoscope  200  may be inserted into newly-aligned port  24  such that bronchoscope distal end  202  once again extends beyond distal end  222  of the endotracheal tube, and is directed toward right mainstem bronchus  240  as before. A medical device, such as endobronchial blocker  236 , may be inserted into port  20  over wire guide  210 . Endobronchial blocker  236  includes a blocker balloon  237  at its distal end. 
     Endobronchial blocker  236  is advanced in the right mainstem bronchus under visualization provided by the bronchoscope until the balloon is determined to be in a suitable location for inflation. If desired, blocker  236  can be provided with a distal loop  238  as described, e.g., in U.S. Pat. Nos. 5,904,648 and 7,578,295, both incorporated by reference herein. In this example, the distal loop receives the bronchoscope, so that as the bronchoscope advances into the right mainstem bronchus, the blocker may be advanced along with the bronchoscope. This is shown in  FIG. 9 . 
     Once the distal end of the endobronchial blocker enters the bronchus, the bronchoscope may be partially withdrawn, e.g., approximately to the entry position of the bronchus or proximal of the entry point. The blocker may then be advanced to the desired position in the bronchus, under continued visualization by the bronchoscope. Once the balloon is deemed to be in a favorable position in the bronchus, the balloon is inflated, as shown in  FIG. 10 . Further discussion of the positioning of an endobronchial blocker in a desired mainstem bronchus is provided in the incorporated-by-reference patents. 
     Maintaining bronchoscopic visualization upon inflation of the balloon enables the physician to confirm proper placement, and inflation, of the balloon prior to removing the bronchoscope. Maintaining wire guide access to the target site enables the physician to quickly initiate remedial measures, such as replacement of the blocker, if deemed necessary, e.g., due to dislodgement or puncture of the balloon, etc. The rotatable features of the manifold enable the bronchoscope to be initially introduced, and re-introduced, through a port of the manifold that is axially in-line with the distal port, as described above. 
       FIG. 11  illustrates an alternate embodiment of a rotational manifold  70 . Manifold lower portion  30  may be formed to have the same configuration as the lower portion in the preceding embodiment, and similar reference numbers are utilized to describe the features of the lower portion. In this embodiment, upper portion  72  has three upper ports  76 ,  80 ,  84  extending from annular ridge  74 . Each of upper ports  76 ,  80 ,  84  may include a respective end cap  77 ,  81 ,  85 , and may be provided with external threads  78 ,  82 ,  86 , as described in the previous embodiment. Ports  76 ,  80 ,  84  may include respective openings  79 ,  83 ,  87  extending through each of the end caps. 
     In this embodiment, each of ports  76 ,  80 ,  84  communicates with the hollow interior of manifold  70 . Upper manifold portion  72  is rotatable in the manner of upper manifold portion  12 , such that a selected one of ports  76 ,  80 ,  84  may be axially in-line with port  36  at any particular time. As with the previous embodiments, a valve member (not shown) may be provided internally of the respective end cap to establish a fluid-tight connection. Those skilled in the art will appreciate that the presence of an additional port provides the opportunity to introduce additional devices, etc., to the target site without losing the access to that site provided by the wire guide. 
     It is therefore intended that the foregoing detailed description be regarded as illustrative rather than limiting, and that it be understood that it is the following claims, including all equivalents, that are intended to define the spirit and scope of this invention.