Abstract:
A receiver for securing at least one tube in a patient includes a shell operable in a first position for receiving the tube and a second position for securing the tube, and a compressible member supported by the shell for contacting the tube in the second position. A bridle looped around the patient&#39;s septum may also be secured in the second position. A system for securing the tube includes a receiver and an applier. The applier supports the receiver in the first position and transitions the receiver from the first position to the second position after the tube is positioned within the receiver. A method of securing a tube includes positioning the tube in a patient, placing a flexible member around the patient&#39;s nasal septum, receiving the tube and flexible member in a shell supported by an applier, and operating the applier to move the shell to a closed position.

Description:
[0001]    This application is the national stage of international patent application no. PCT/US2015/62468 filed on Nov. 24, 2015, which in turn claims priority from U.S. Provisional Patent Application Ser. No. 62/083,446 filed on Nov. 24, 2014, the disclosures of each of which are incorporated herein by reference in their entirety. 
     
    
     TECHNICAL FIELD 
       [0002]    This document relates generally to a system for securing a tube positioned in a patient, and more specifically to a receiver and an applier for use in such a system. 
       BACKGROUND 
       [0003]    A magnetic nasal tube bridle system has been previously described in U.S. Pat. Nos. 6,631,715 &amp; 6,837,237. This system involves creating a loop of flexible material around the nasal septum. While the systems described in these patents are illustrative, a loop of flexible material can be positioned around a patient&#39;s nasal septum in any number of ways. The two ends of the loop are then anchored to a medical tube, whether a nasal tube or otherwise, to be retained by a clip. Existing clips are a bi-fold plastic design which clamps one or two ends of the flexible member extending around the septum and the tube together, often in a central channel. Such clips must be sized to fit the tube being retained as it must tightly adhere to the tube without slipping. In order to accommodate the multiple sized medical tubes in use, however, multiple corresponding clip sizes are manufactured and the user must select the appropriate size clip to retain a desired tube. Accordingly, there is a need for a clip which can accommodate multiple tube sizes, including non-standard tube sizes such as are commonly utilized in pediatric and neonatal applications. 
         [0004]    Further, for neonatal and infant applications, there is need for a clip of overall smaller dimensions than existing models. In order to provide sufficient mechanical resistance against pulling of the tube, currently available clips can be difficult to close and potentially compress the lumen of the tube. Thus, an easier way to close and safely manipulate the small clip is needed. 
         [0005]    The present invention seeks to provide a clip or receiver which accommodates multiple tube diameters and is sized appropriately for neonatal and newborn use. An applier may be included with this design to make positioning and closure of the clip easier. Retaining the clip within the applier until it is deployed, yields a safety benefit by minimizing the chance that the user will drop the clip into the patient (e.g., the patient&#39;s airway). Further, the clip may be re-opened, also using the application tool, re-loaded into the tool and re-applied to the tube as needed. 
       SUMMARY OF THE INVENTION 
       [0006]    In accordance with the purposes and benefits described herein, a receiver for securing at least one tube in a patient is provided. The receiver includes a shell operable in a first position for receiving the at least one tube and a second position for securing the at least one tube, and a compressible member positioned supported by the shell for contacting the at least one tube in the second position. 
         [0007]    In another possible embodiment, a first portion of the compressible member forms a recess for receiving the at least one tube in the first position. 
         [0008]    In yet another possible embodiment, the first portion of the member contacts a first portion of the at least one tube through contact therewith and a second portion of the member contacts a second portion of the at least one tube in the second position. 
         [0009]    In still another possible embodiment, the receiver further includes at least one band formed around the shell to secure the compressible member in position. In another, the at least one band includes a first band securing a distal end of the first portion of the compressible member and a second band securing a distal end of the second portion of the compressible member. In yet another, the at least one band includes first and second bands which are integrally formed with the compressible member. 
         [0010]    In one other possible embodiment, the shell includes at least one boss. 
         [0011]    In another possible embodiment, the shell includes a curved outer surface and first and second ends and the at least one boss includes at least a first boss extending from the first end and at least a second boss extending from the second end. 
         [0012]    In one other possible embodiment, a system for securing at least one tube positioned in a patient includes a shell having at least one boss protruding therefrom, and an applier having at least one recess corresponding to the at least one boss for orienting the shell within the applier. 
         [0013]    In yet another possible embodiment, the system further includes a compressible member supported by the shell for contacting the at least one tube in an engaged position. 
         [0014]    In still another possible embodiment, the system further includes at least one band formed around the shell to secure the compressible member in position. 
         [0015]    In another possible embodiment, the applier comprises first and second jaws. In still another, the first jaw is a moving jaw. In another, finger loops extend from the first and second jaws. 
         [0016]    In one additional possible embodiment, the system further includes a closing member extending from the first jaw for contacting the shell and moving the shell from an open position to a closed position. 
         [0017]    In one possible embodiment, a method of securing at least one tube positioned in a patient includes the steps of positioning a tube in a patient, placing a flexible member around the patient&#39;s nasal septum, receiving the at least one tube and at least one end of the flexible member in a shell supported by an applier, and operating the applier to move the shell from a first position for receiving the at least one tube and at least one end of the flexible member to a second position for securing the at least one tube and at least one end of the flexible member. 
         [0018]    In another possible embodiment, the applier includes first and second jaws, and the step of operating the applier includes moving one of the first and second jaws causing contact with the receiver sufficient to move the receiver from the first position to the second position. 
         [0019]    In still another possible embodiment, the method further includes the step of ejecting the receiver from the applier. 
         [0020]    In yet another possible embodiment, the applier includes first and second jaws, and the step of operating the applier includes moving one of the first and second jaws from an initial position to an intermediary position such that contact between the one of the first and second jaws and the receiver during movement between the initial position and the intermediary position causes the receiver to move from the first position to the second position, and subsequently moving the one of the first and second jaws from the intermediary position to a final position such that contact between the first and second jaws during movement between the intermediary position and the final position causes the receiver to be ejected from the applier. 
         [0021]    In one other possible embodiment, the receiver includes at least one boss and the applier includes at least one recess for receiving the boss. 
         [0022]    In the following description, there are shown and described several possible embodiments of the receiver, system and related method of securing a tube positioned in a patient. As it should be realized, the receivers, systems and methods are capable of other, different embodiments and their several details are capable of modification in various, obvious aspects all without departing from the invention as set forth and described in the following claims. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not as restrictive. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWING FIGURES 
         [0023]    The accompanying drawing figures incorporated herein and forming a part of the specification, illustrate several aspects of the receiver, system and related method of securing a tube positioned in a patient, and together with the description serve to explain certain principles thereof. In the drawing figures: 
           [0024]      FIGS. 1A and 1B  are an illustrated perspective views of a receiver in a first open position; 
           [0025]      FIG. 2  is a side elevational view of the receiver in the first open position; 
           [0026]      FIG. 3  is a side elevational view showing the receiver in a second closed position; 
           [0027]      FIG. 4  is an illustrated perspective view of an applier supporting the receiver in the first open position; 
           [0028]      FIG. 5  is an illustrated perspective view of the applier supporting the receiver and a medical tube in the second closed position; 
           [0029]      FIG. 6  is an illustrated perspective view of the applier supporting the receiver after closure of the receiver showing the flexing of the applier to allow the receiver to be ejected after closure; 
           [0030]      FIG. 7A  is a side elevational view showing the applier in a first position with the receiver in the first open position; 
           [0031]      FIG. 7B  is a side elevational view showing the applier in a second position with the receiver in the second closed position; 
           [0032]      FIG. 7C  is a side elevational view showing the applier in a third position to allow the receiver to be ejected after closure; 
           [0033]      FIG. 8  is a side elevational view showing a first moving jaw of the applier; 
           [0034]      FIG. 9  is a side elevational view showing a second static jaw of the applier; and 
           [0035]      FIG. 10  is an illustrated perspective view of the second static jaw of the applier. 
       
    
    
       [0036]    Reference will now be made in detail to the present described embodiments of the receivers, systems and related methods of securing a tube positioned in a patient, examples of which are illustrated in the accompanying drawing figures, wherein like numerals are used to represent like elements. 
       DETAILED DESCRIPTION 
       [0037]    Broadly speaking, the described invention includes a receiver or clip  10  for securing at least one tube positioned in a patient. The at least one tube may be a temporary tube placed into the gastrointestinal or respiratory tracts of the patient or otherwise. Such tubes typically enter the patient via the nose or mouth. A system for placing securing at least one tube in a patient includes the receiver  10  and an application tool or applier  12 . Each of the receiver  10  and the applier  12  have multiple component parts and features as described below. 
         [0038]    As shown in  FIGS. 1A and 1B , the receiver  10  includes a shell  14  operable in a first position to receive at least one tube and a second position to secure the at least one tube, and a member or insert  16  supported by or positioned within the shell and contacting the at least one tube in the second position. The shell  14  further includes a hinge  18 , a locking mechanism  20 , and bosses  22  protruding from the shell to orient or locate the shell in the application tool or applier  12 . More specifically, a molded plastic shell  14  includes first and second pivotally connected parts  24 ,  26 . In the described embodiment, the hinge  18  is a living hinge integrally formed with the first and second parts  24 ,  26  which allows the shell  14  to move from the first to the second position. 
         [0039]    The shell  14  is generally U-shaped in the first, or open, position, in the described embodiment, as best shown in  FIG. 2 . In this position, the shell  14  is open for receiving a tube  28  and at least one end of bridle flexible members. In the second, or closed, position shown in  FIG. 3 , the first and second parts  24 ,  26  are further connected by the locking mechanism  20  and the tube  28  and the bridle flexible members  30  may reside centrally within the receiver  10  when in the second or closed position. 
         [0040]    The described locking mechanism  20 , shown in  FIGS. 2 and 3 , is a snap joint including a hook  32  positioned along a distal end of the first part  24  of the shell  14  and a depression  34  formed in a distal end of the second part  26  of the shell for receiving the hook in the closed position. In this position, the shell  14  is substantially cylindrical or circular in shape and the first and second parts  24 ,  26  of the shell  14  form a substantially wedge shaped aperture  36  used to unlock the receiver to remove the tube and bridle flexible member(s). 
         [0041]    The described insert  16  is made of a compressible material. In this embodiment, the compressible material is a silicone rubber in order to be inert to the human body. The geometry of the insert  16  can vary so long as the insert may be maintained in position within the shell  14 . A recess  38  in the insert  16  may be sized to fit a single tube size or a range of sizes. For example, one insert  16  will accommodate size 8 French tubes while another may accommodate 5 and 6 French tubes. Due to the compressible nature of the silicone rubber, the insert  16  may also accommodate tubes of non-standard size. An 8 French insert  16 , for example, should fit a tube having an OD just larger or just smaller than that of an 8 Fr. tube. In the described embodiment, the recess  38  is designed to accommodate a range of tube sizes. For instance, one insert  16  having recess  38  may accommodate a 5, 6, or 8 French tubes. This may be accomplished by increasing an amount of silicone behind the recess  38 . 
         [0042]    Referring back to  FIG. 2 , the insert  16  includes first and second portions  40 ,  42  which substantially conform to mating surfaces on inner surfaces of the first and second parts  24 ,  26  of shell  14 . Adhesives may, as well as friction due to compression, serve to keep the insert  16  in place. In the described embodiment, however, the first and second portions  40 ,  42  include bands  44  formed around the shell  14  during a second molding step to secure the insert  16  in position. In an alternate embodiment, the first and second parts  24 ,  26  of shell  14  and insert  16  may be integrally molded utilizing an insert molding technique. 
         [0043]    The compressible nature of the silicone rubber used for the insert  16  allows insertion of the tube  28  and the end(s) of the flexible member  30  in any order or position within the space available for them. Further, the silicone rubber grips the tube  28  and flexible member end(s)  30  with greater friction than a harder plastic thereby providing greater resistance against the tube and/or the flexible member ends slipping out. This allows the overall size of the receiver  10  to be minimized while providing sufficient retentive force without compressing the lumen of tube  28 . 
         [0044]    The application tool  12  is shown partially transparent in  FIG. 4  with the receiver  10  retained. This is an “as supplied” configuration in the described embodiment. The described application tool  12  consists of two components including a static jaw  50  and moving jaw  52 . The static jaw  50  holds the receiver  10  in the first open position and the moving jaw  52  moves the second shell part  26  to the second closed position when the user moves the finger loops  56  closer together. Guides  58  are provided to guide or facilitate insertion of the tube  28  and the flexible member end(s)  30  into the proper location for closure of the receiver  10 . The application tool  12  also includes a wedge  60  for opening the receiver  10 . The wedge  60  fits into the substantially wedge shaped aperture  36  to unlock or disengage the locking mechanism  20  and open the receiver  10 . 
         [0045]    As shown in  FIGS. 5 and 6 , the static jaw  50  is divided into a left half  62  and a right half  64  on one end to provide a retention clamp for receiver  10 . Living hinges  66  allow the left half  62  and right half  64  to spread apart allowing for insertion or removal of the receiver  10 . The bosses  22  on the sides of the shell  14  fit into corresponding recesses  68  (best shown in  FIG. 10 ) on an interior aspect of the left half  62  and the right half  64 . Ramps  70 , shown in  FIG. 6 , spread the left half  62  and the right half  64  apart so that the receiver  10  may be ejected from the application tool  12 . A distal portion of the moving jaw  52  impinges upon the ramps  70  to spread the left and right halves  62 ,  64  apart. Eject stop  72  provides a limit to maximum opening. 
         [0046]      FIG. 7  illustrates three positions of the system with the static jaw  50  shown semi-transparent for illustrative purposes. More specifically,  FIG. 7A  shows the receiver  10  and applier  12  in an “as supplied” position.  FIG. 7B  shows the applier  12  after closing the receiver  10  around a tube and  FIG. 7C  shows the applier  12  in an ejection position where the closed receiver may be ejected from the applier. 
         [0047]    As shown in  FIGS. 4, 8, and 9 , the static jaw  50  and moving jaw  52  are connected via axle  74 . The axle  74  fits into an open recess  76  on the static jaw  50  allowing for rotational motion between the two jaws. A neck  78  of the recess  76  is slightly narrower than the axle  74  thereby maintaining the axle within the recess  76  and concentric within the larger circular apex  80  of the recess. The axle  74  is integrally molded in the moving jaw  52 . This arrangement provides easy assembly and minimizes the cost of manufacture rather than, for example, heat staking or need of a separate hinge pin part. Nonetheless, these alternate embodiments are encompassed in the broader invention. An axle stop  82  limits the rotational range of motion of the two jaws  50 ,  52  relative to one another to prevent excessive closing or opening/eject. The axle stop  82  impinges on the sides of the recess  76  to limit the motion. 
         [0048]    As shown in  FIG. 8 , the moving jaw  52  includes a closing arc  84  which moves or pushes the shell  14  closed after insertion of the tube  28  and the flexible member end(s)  30 . An integrally molded indexing detent  88  is located on arcuate projection  86 . The detent  88  prevents unwanted motion of the two jaws  50 ,  52  in the “as supplied” position and gives the user a definitive feedback which is palpable and audible when transitioning from open, to closed, to eject positions. 
         [0049]    As shown in  FIG. 9 , the static jaw  50  includes guides  58  to guide or facilitate insertion of the tube  28  and the flexible member end(s)  30  into the proper location for closure of the receiver  10 . The static jaw  50  further includes the recess  76  which receives the axle  74  and allows for rotational motion between the two jaws. 
         [0050]    An interior surface  90  of the static jaw  50  is partially shown in  FIG. 10 . The recesses  68  receive the bosses  22  on the sides of the shell  14  and it is of note that the recesses are at two levels. Thus, the shell  14  is removably retained in this area in the open position until the moving jaw  52  is activated. A shell retention boss  92  prevents the moving portion of the shell  14  from falling down and partially closing. The left half  62  and the right half  64  are connected distal to the static jaw living hinge  66  by connection bar  94 . A first portion  96  of the connection bar  94  serves as an index point against the arcuate projection  86 . The eject ramp  70  and stop  72  are also shown. 
         [0051]    As indicated above, the system is supplied to the user with the receiver  10  positioned in the open position in the applier  12 . In addition to the mechanism utilizing the arcuate projection  86  and its index system, the system may also be shipped in a custom package to avoid premature closure. Prior to using the receiver  10  and the applier  12 , a bridle loop and tube have already been inserted into the patient. The user then selects an appropriately sized receiver. The only difference from one size to the next is a configuration of the insert  16 . Specifically, the diameter of the recess  38  and the thickness of the insert are sized to a specific tube size or a range of tube sizes. 
         [0052]    The user then positions the application  12  tool such that the tube slides in between the guides  58 . Likewise, bridle flexible members are positioned using the guides  58 . When all three components are in position within the shell  14 , the user closes the receiver  10  by moving finger loops  56  of the two jaws  50 ,  52  together. An audible clicking sound is heard as well as a tactile signal felt indicating that the receiver  10  has reached the closed position. 
         [0053]    Next, the user will move the finger loops  56  apart, first back to the open position and then further motion in the same direction forces the moving jaw  52  between ramps  70  thereby spreading apart the left half  62  and the right half  64  of the static jaw  50  to an ejection position. In this ejection position, the receiver  10  is now free to exit the application tool  12  and can move out of the recesses  68  which have been holding it in place. Thus, the tube and the bridle loop flexible members are locked in place in the receiver  10 . For added security, the user may choose to tie a knot in the flexible members or may tie the flexible members together and secure only one end within the receiver  10 . Of course, redundant length of the flexible member(s) may be trimmed. 
         [0054]    Should the user wish to open the receiver  10 , for example to reposition the tube  28 , opening wedge  60  may be used. Opening wedge  60  is inserted into the substantially wedge shaped aperture  36  used to unlock the receiver which forces the locking mechanism  20  open and the receiver  10  to return to the first or open position. The receiver may then be replaced into application tool  12  for replacement if desired. The user could also place and close the receiver  10  manually, however this is not recommended. 
         [0055]    The foregoing has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the embodiments to the precise form disclosed. Obvious modifications and variations are possible in light of the above teachings. For example, the insert may generally take the shape of a tongue which extends outward from a main body. The tongue may be designed to wrap around the tube and at least one of the ends of the flexible member when the shell is in the closed position. The tongue may be held captive and guided by the shell to bend around the tube and flexible members by stabilizing rails during closing. All such modifications and variations are within the scope of the appended claims when interpreted in accordance with the breadth to which they are fairly, legally and equitably entitled.