Patent Publication Number: US-2022233812-A1

Title: Urinary catheter drainage members and catheters having the same and methods of forming catheters

Description:
The present application claims the benefit of and priority to U.S. Provisional Application No. 62/883,719, filed Aug. 7, 2019, which is hereby incorporated herein by reference. 
    
    
     FIELD OF THE DISCLOSURE 
     The present disclosure generally relates to urinary catheters. More particularly, the present disclosure relates to urinary catheter drainage members. 
     DESCRIPTION OF RELATED ART 
     Catheters are used to treat many different types of medical conditions and typically include an elongated tube that is inserted into and through a passageway or lumen of the body. Catheters, and in particular intermittent catheters, are commonly used by those who suffer from various abnormalities of the urinary system, such as urinary incontinence. Urinary catheters generally comprise a tube surface with two ends. A first end has a catheter tip; the tip may be inserted into a user&#39;s urethra. A second end generally has a funnel that is used to help facilitate drainage of bodily fluids. 
     Because urinary catheter drainage members are meant to be inundated with fluids, their connections to the catheter tube must be strong. Single use catheters are known to be manufactured with techniques such as insert molding and glue bonding, using UV curable glues. These glues help connect the catheter tube to the drainage member. When applying glues there are two methods known in the prior art: vertical manufacture and horizontal manufacture. 
     A problem with the current known manufacturing methods is that they produce imprecise and inefficient results. For example, when catheter sizes are large (i.e. Ch 18), currently known catheter drainage member designs do not have enough space for receiving the glues. Because of current drainage members&#39; deficient designs, glue often overflows from the drainage member during manufacturing and this overflow creates a defective part. Additionally, current catheter drainage members do not have a design that allows for consistent and even application of glue when the vertical and horizontal dispensing methods are used. Uneven application may result in contamination of the catheter, rendering the catheter inoperable. Consequently, there is a need for new catheter drainage members which yield more viable connections using both the horizontal and vertical adhesive distribution methods. 
     SUMMARY 
     There are several aspects of the present subject matter which may be embodied separately or together in the devices and systems described and claimed below. These aspects may be employed alone or in combination with other aspects of the subject matter described herein, and the description of these aspects together is not intended to preclude the use of these aspects separately or the claiming of such aspects separately or in different combinations as set forth in the claims appended hereto. 
     In one aspect, the catheter drainage member is configured to be attached to a catheter tube and includes a body having an inner surface and a well that is defined by the inner surface of the body. The well is configured to receive the catheter tube and an adhesive. The well is also configured to selectively distribute the adhesive between the inner surface and the tube. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1A  is a side cross-sectional view of an embodiment of a urinary catheter showing a catheter shaft connected to a drainage member; 
         FIG. 1B  is a cross-sectional view of an embodiment of a catheter drainage member having a non-symmetrical well; 
         FIG. 1C  is an elevated view of the proximal end of the drainage member; 
         FIG. 1D  is a cross-sectional view of the catheter tube attached to the catheter drainage member; 
         FIG. 2A  is a cross-sectional view of an embodiment of a catheter drainage member having a well including a symmetrical conical cavity; 
         FIG. 2B  is a cross-sectional view of an embodiment of a catheter drainage member having a well including a concave profile; 
         FIG. 2C  is a cross-sectional view of an embodiment of a catheter drainage member having a well including a convex profile; 
         FIG. 3  is a perspective view of an embodiment of a catheter drainage member having axial channels; 
         FIG. 4A  is a cross-sectional view of an embodiment of a catheter drainage member, showing a profile change from a circular configuration to an oblong configuration; 
         FIG. 4B  is an enlarged perspective view of the drainage member of  FIG. 4A , showing the drainage member without an inserted catheter tube; 
         FIG. 4C  is an enlarged perspective view of the drainage member of  FIG. 4B , showing the drainage member with the catheter tube inserted. 
         FIG. 5A  shows a side view of an embodiment of a catheter drainage member having a sloped diagonal end profile; 
         FIG. 5B  shows a perspective view of the drainage member of  FIG. 5A ; 
         FIG. 6A  is a perspective view of an embodiment of a catheter drainage member with a slot; 
         FIG. 6B  is a cross-sectional side view of an embodiment of a catheter drainage member showing glue placed on peaks between slots. 
     
    
    
     DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS 
     The embodiments disclosed herein are for the purpose of providing a description of the present subject matter, and it is understood that the subject matter may be embodied in various other forms and combinations not shown in detail. Therefore, specific embodiments and features disclosed herein are not to be interpreted as limiting the subject matter as defined in the accompanying claims. 
     Urinary catheter drainage members according to the present disclosure and their individual components may be variously configured without departing from the scope of the present disclosure, but in one embodiment, a urinary catheter drainage member is configured as shown in  FIG. 1 . 
       FIG. 1A  shows an example of an embodiment of a urinary catheter  100  including a drainage member  112  connected to a catheter tube  116 . The drainage member  112  includes a body  115  having a proximal  115   a  end and a distal end  115   b . The catheter shaft  116  includes a proximal portion, a distal portion, and a drainage lumen  111 . The drainage member  112  includes a lumen  113  that is fluidically connected to the catheter drainage lumen  111 . 
       FIGS. 1B and 10  show an embodiment of a urinary catheter drainage member  112  configured to be attached to a catheter tube  116 . The drainage member  112  comprises a body  115  having an inner surface  114 . The inner surface  114  defines a well  120  that is configured to receive the catheter tube  116  and an adhesive  122 . The adhesive  122  may be any suitable adhesive for attaching the catheter tube  116  and drainage member  112  to each other. For example, the adhesive  112  may comprise a UV-light curable glue, such as Dymax adhesives  111 -MSK,  1072 -M,  1180 -M-UR,  1406 -M or Henkel adhesives Loctite  3951 ,  3921  or  3922 . The well  120  is configured to selectively distribute the adhesive  122  between the inner surface  114  and the tube  116 . The well  120  also may be configured to evenly distribute the adhesive  122 . The adhesive  122  may bond the catheter tube  116  to the inner surface  114 , forming a joint between the tube  116  and the drainage member  112 . A gap  136  is defined between the inner surface  114  and the tube  116  ( FIG. 1D ). The gap  136  may be configured to receive the adhesive  122 . The adhesive  122  moves or is distributed throughout the gap  136  (throughout the space between the inner surface  114  of the drainage member and the outer surface of the tube  116 ), as the tube  116  is inserted into the well  120 . Consequently, more selectively distributed and/or evenly distributed adhesive  122  is located between the inner surface  114  and the tube  116 , which assists in creating a stronger and more durable bond. This distribution of the adhesive occurs with very minimal movement between the tube  116  and the drainage member  112 . For example, this distribution occurs from inserting the tube  116  into the well  120  the drainage member  112 , with little or no rotation of the tube or the drainage member to distribute the adhesive within the gap  136 . 
     As shown in  FIGS. 1B and 1C , a portion of the inner surface  114  is tapered (the tapered portion  118 ). The tapered portion  118  tapers outwardly from shoulder  119  to end wall  121 . The tapered portion  118  of the inner surface  114  results in the inner surface  114  defining a non-symmetrical well  120  that has a wider side  118   b  and a narrower side  118   a . The tapered portion  118  may be configured such that when the tube  116  is inserted angular momentum is applied to the adhesive  122  to distribute adhesive  122  about the well  120 . 
     The tapered portion  118  controls the motion and flow of the adhesive  122  relative to the inner surface  114 . Specifically, in the embodiment shown in  FIG. 1 , before the catheter tube  116  is inserted into the drainage member  112 , adhesive  122  is placed on one side of the catheter tube  116 , the adhesive side  116   a . The adhesive side  116   a  is aligned with the wider side  118   b  of the tapered portion  118 . The catheter tube  116  is then inserted into the drainage member  112 . As the drainage member  112  and catheter tube  116  are coupled for attachment, the motion between the adhesive  122 , the inner surface  114 , and the tube  116  applies angular, axial, and radial momentum to the adhesive  122 . The angular momentum distributes adhesive  122  about the well  120  and moves the adhesive  122  around the circumference or periphery of the tube  116 , increasing the contact area between the adhesive  122  and the catheter tube  116 , as well as increasing contact area between the adhesive  122  and the drainage member  112 . Thus, the tapered portion  118 , which defines the non-symmetrical well  120 , facilitates increased adhesive coverage of the inner surface  114  with little or no rotation of the catheter tube  116  relative to the drainage member  112 . The increased contact area caused by the tapered portion  118 , leads to a stronger joint and a more efficient and effective manufacturing process. 
       FIG. 1  shows the drainage member  112  just prior to being assembled using a horizontal method. In the horizontal method the catheter tube  116  is placed horizontally relative to the drainage member  112  and adhesive  122  is applied directly onto the catheter tube  116 . In the embodiment shown a small continuous amount of adhesive  122  is placed on the catheter tube  116 . Alternatively, in other embodiments, a plurality of discontinuous dots of adhesive  122  may be placed on the catheter tube  116 . The number of adhesive  122  dots may be any appropriate number. For example, two dots of adhesive may be placed on the catheter tube  116 . The distance apart of the dots may be any appropriate distance. For example, when the tube  116  is cylindrical, the dots may be placed at 120 degrees from each other. In one embodiment, the dots may be placed at 2 and 10 o&#39;clock wherein the reference point 12 o&#39;clock is at the top of the tube. The tube  116  is attached to the drainage member by pushing the catheter tube  116  into the well  120  of the drainage member  112 . The attachment also may occur by pushing the drainage member  112  into the catheter tube  116 . When a UV cured adhesive  122  is used, after insertion of the tube and distribution of the adhesive, the joint may be formed by applying UV light  126  to cure the adhesive  122 . 
       FIG. 2A  shows an embodiment of the drainage member  212  where the drainage member  212  has a well  220  that includes a symmetrical conical cavity  224 . The symmetrical conical cavity  224  facilitates adhesive  222  dispensing, while minimizing the amount of adhesive  222  used. Dispensing of adhesive  222  is controlled by positioning the adhesive dispensing needle in the well  220 . The well  220  reduces and/or contains spillage and enables the adhesive  222  to flow into the adhesive gap  136  (or  236 ) where the adhesive is effective to bond the two components. Moreover, when a UV light  226  is present to cure the adhesive  222 , the symmetrical conical cavity  224  may optimize UV light  226  penetration and curing speed. Curing speed is optimized due to the design of the symmetrical conical cavity  224 . The symmetrical conical  224  cavity minimizes the volume of adhesive needed to affect a secure bond between the funnel  212  and the catheter tube  216 . Smaller amounts of adhesive  222  require less UV energy to cure, so minimizing the amount of adhesive  222  can speed up the curing process, since less UV light energy is needed. 
     A gap  236  is defined in the space between the catheter tube  216  and the inner surface  214 . The gap  236  is configured to receive adhesive  222  and allow bonding and an interference fit between the catheter tube  216  and the drainage member  212 . The gap  236  is wider when the catheter tube  216  is smaller in size and narrower when the catheter tube  216  is larger in size. 
       FIG. 2B  shows an embodiment of the drainage member  212  where the drainage member  212  has a well  220  that includes a concave profile  242  and the inner surface  214  of the drainage member  212  has a convex profile. The concave profile  242  is configured to facilitate dispensing of the adhesive  222  and may minimize the amount of the adhesive  222  needed for attachment. Additionally, the concave profile  242  reduces the penetration length of UV light  226  beams, making it easier to cure the adhesive  222  at the joint  228 . This embodiment also includes a gap  236 , similar to that described above. 
       FIG. 2C  shows an embodiment of the drainage member  212  where the drainage member  212  has a well  220  that includes a convex profile  244  and the inner surface  214  of the drainage member  212  has a concave profile. The convex profile  244  is configured to facilitate dispensing of the adhesive  222  and may be used in those embodiments wherein additional adhesive  222  is desired. 
       FIG. 3  shows an embodiment of the drainage member  312  where the drainage member  312  includes a body  315  having a longitudinal axis L. The inner surface  314  includes at least one channel  334  extending in the direction of the longitudinal axis L. The at least one channel  334  is in communication with the well  320 . Additionally, the at least one channel  334  may include a plurality of channels  334 . 
     In the embodiment shown in  FIG. 3 , the drainage member  312  has four channels  334 . Though this embodiment has four channels  334 , other embodiments may have more than four channels  334  or less than four channels. The number of channels  334  may be selected according to the desired use. In  FIG. 3  the channels  334  are axial channels that are aligned with the long axis L. At least one channel  334  extends from a proximal opening  319  in the drainage member  312 . The channels  334  are configured to communicate with the well  320  and may be configured to communicate between the well  320  and the gap between the inner surface  314  of the drainage member  312  and the catheter tube  316 , when the catheter tube  316  is located within the well  320 . Furthermore, the channels  334  may communicate with each other. For example, the inner surface  314  of the drainage member  312  may include additional channels (not shown) that extend about the circumference of the inner surface  314  and connect the channels  334 . 
     The channels  334  increase the volume of the well  320  by creating a pathway for a greater amount of adhesive  322  to fit between the catheter tube  316  and the drainage member  312 . The increased amount of space created by the channels  334  allows a larger quantity of adhesive  322  to be moved into the gap between the inner surface  314  and the catheter tube  316  and to fill the surface area between the catheter tube  316  and the inner surface  314  of the drainage member  312 . The greater amount of adhesive  322  in the gap may assist in creating a stronger bond between the catheter tube  316  and the drainage member  312 . Thus, the channels  334  improve the distribution of adhesive  322  in the gap. 
     Any suitable method may be used to create the channels  334 . One method may include using a profiled core pin to create the channels  334  in the long axis L of the drainage member  312 . The channels  334  may be created as the drainage member  312  is being molded. 
       FIGS. 4A-4C  show an embodiment of the drainage member  412  where the well  420  defines an opening  421  and the inner surface  414  defines a profile  425 . The profile  425  changes from a circular configuration  437  at the well opening  421  to an oblong configuration  438  at a section  427  distal from the opening  421 . Thus, the profile  425  of the inner surface  414  is configured to change from the circular configuration  437  at the well opening  421  (without an inserted catheter tube  416 ) to the oblong configuration  438  when a catheter tube  416  is inserted into the drainage member  412 . Thus, the drainage member  412  has different cross-sectional profiles at the well  420  and the distal section  427 . 
     An enlarged view of the difference in profile shapes is shown in  FIG. 4A . The shape of the well opening  421  with the circular configuration  437  is visible, and the shape of the distal section  427  with the oblong configuration  438  is visible. 
       FIG. 4B  shows the drainage member  412  without the catheter tube  416  inserted. The circular profile  437  of the well  420  is visible, and the change to an oblong profile  438  at the distal section  427  is visible. 
       FIG. 4C  illustrates the well  420  with the catheter tube  416  inserted. As shown in  FIG. 4C , the catheter tube  416  and/or the well  420  may change shape as the catheter tube  416  passes through the oblong profile  438  of the distal section  427 . The catheter tube  416  is compressed by the distal section  427 . The compression causes the catheter tube  416  to make contact with the sides of the drainage member  412 . The compressed catheter tube  416  also creates two spaces at the top and bottom of the well  420  (the glue gaps  436 ): a top gap  436   a  and a bottom gap  436   b . Adhesive  422  may be placed on one or both sides of the catheter tube  416 —the catheter tube top  416   a  and the catheter tube bottom  416   b . A strong interference fit may be formed between the drainage member  412  and the catheter tube  416 . The oblong profile  438  creates a mechanical bond between the sides of the compressed drainage member  412  which directly contact the catheter tube  416 , while the gaps  436   a ,  436   b  create increased space for containing adhesive  422  to bond the top  416   a  and/or bottom  416   b  of the catheter tube  416  to the drainage member  412 . Additionally, in one embodiment the oblong profile  438  may cause two gaps, such that one of the gaps ( 436   a ,  436   b ) is larger than the other. For example, in one embodiment the top gap  436   a  may be larger than the bottom gap  436   b  so that the top gap  436   a  has more space for receiving adhesive  422  than the bottom gap  436   b . The uneven gap sizes create two different sized sites for dispensing adhesive  422 . The different sized sites lend versatility to the drainage member  412 . 
       FIGS. 5A and 5B  show an embodiment of the drainage member  512 , where the drainage member  512  includes a proximal end portion  540  that has a sloped diagonal profile which defines a well  520  having a sloped diagonal end profile.  FIG. 5A  shows a side view of the drainage member  512  and  FIG. 5B  shows a perspective view of the drainage member  512 . The sloped diagonal end  540  increases the volume of a standard circular shaped well by increasing the length of one side of the well  520 . The diagonal end  540  deepens one side of the well  520  and creates a bigger space so that the well  520  is able to receive an increased amount of adhesive  522 . The diagonal end  540  may be used with the horizontal dispensing method and in situations where a larger catheter tube  516  is attached to the drainage member  512 . 
       FIG. 6A  shows an embodiment of the drainage member  612  wherein the proximal end  621  of the drainage member  612  includes at least one slot  660 . The slot  660  may be configured to extend from the proximal end  621  of the drainage member  612  toward the distal end. Using a slot  660  increases portions of the well  620  without having to increase the entire portion of the drainage member  612  defining the well  620 . That is, the slot  660  provides the benefits of a larger well  620  with use of less material. Also, the increased portions of the well  620  provide an increase in volume of the well  620 , which in turn allows for the well  620  to receive an increased amount of adhesive  622 . The slot  660  may be utilized with the horizontal dispensing method wherein the axis of the catheter tube  616  and the axis of the drainage member  612  are horizontal to the ground when being assembled and the adhesive  622  is dispensed onto the tube  616  and in line with the slot  660 . As shown in  FIG. 6B , the drainage member  612  may also be used with a vertical method of adhesive  622  dispensing. In the vertical method, the catheter tube  616  is inserted into the well  620  of the drainage member  612 , followed by dispensing the adhesive  622  into the well  620 .  FIG. 6B  shows the adhesive  622  being dispensed by two glue dispensers  664  on at least one peak  662  between the slot  660 . After the adhesive  622  is dispensed, the adhesive  622  moves around the catheter tube  616  and then may move along the gap  636 . The flow of adhesive  622  is driven primarily by gravity, excess surface free energy of the adhesive  622 , and injection pressure of the adhesive  622 . Adhesives  622 , with appropriate surface viscosity and surface tension may be selected. Once the adhesive  622  is dispensed, a UV light  626  may be used to cure the adhesive  622 . 
     The drainage member ( 112 ,  212 ,  312 ,  412 ,  512 ,  612 ) embodiments described above may be at least partially made of a rigid polymeric material. For example, at least a surface of the drainage member may be molded or extruded from plasticized polyvinyl chloride (PVC), polyethylene, polypropylene, or other suitable, biocompatible polymeric materials. 
     It will be understood that the embodiments described above are illustrative of some of the applications of the principles of the present subject matter. Numerous modifications may be made by those skilled in the art without departing from the spirit and scope of the claimed subject matter, including those combinations of features that are individually disclosed or claimed herein. For these reasons, the scope hereof is not limited to the above description but is as set forth in the following claims, and it is understood that claims may be directed to the features hereof, including as combinations of features that are individually disclosed or claimed herein.