Patent Publication Number: US-2021170142-A1

Title: Molded Catheter Tip

Description:
CROSS REFERENCE TO RELATED APPLICATION 
     This application is a divisional of U.S. Nonprovisional application Ser. No. 15/304,427, filed Oct. 14, 2016, which is the U.S. National Stage of PCT International Application No. PCT/US2015/023111, filed Mar. 27, 2015, which claims the benefit of U.S. Provisional Patent Application Ser. No. 61/980,412, filed Apr. 16, 2014, all of which are incorporated by reference herein. 
    
    
     FIELD OF THE DISCLOSURE 
     The present disclosure is directed generally to a catheter assembly and a method of making a catheter assembly. 
     BACKGROUND 
     A catheter is a flexible, hollow tube which can be inserted into the body for the introduction or removal of fluids. A common, but by no means exclusive, type of catheter is a urinary catheter which is used by those who suffer from various abnormalities of the urinary system. A urinary catheter is inserted through the urethra for draining urine from the bladder. 
     To facilitate insertion of a catheter into a body cavity, it is desirable to have a formed tip on one end of the catheter tube. A very common way to make this structure is to extrude tubing from a thermoplastic polymer material, and cut it to the desired length. One of the cut ends is then formed into a tip shape in a secondary operation, for example, by forcing the cut end into a heated die that has the desired tip shape. 
     Extruding the tubing section of the catheter is desirable because it is a relatively inexpensive process, and it allows for good control of the tube&#39;s outside diameter and wall thickness. Forming a tip by pushing a tube cut end into a heated die has some disadvantages, however. The die must be hot during the pushing step, in order to soften the tube material so it will form. Then the die must be cooled to allow release of the formed part. For the next cycle, the die must now be reheated. These die heating and cooling steps limit how short the process cycle time can be. Another problem with the heated die forming method concerns catheters having multiple layers. It is desirable to have a hydrophilic coating on the exterior of the catheter to add lubricity. Such coatings are not compatible with all tube materials so it is known to co-extrude the tubing from two layers of different materials, the outer of which readily accepts a hydrophilic coating. The coating is applied after formation of the tip. A problem with the heated die tip formation method arises because the heating process distorts the layers at the end of the tube. The desired outer layer material, which accepts the coating, may not remain on the outside of the tip after heated die formation of the tip. That is, the inner and outer tubing layers tend to become somewhat distorted during heated die tip formation with the result that some of the inner tubing layer material may end up exposed on the exterior of the formed tip. This can lead to failure of the hydrophilic coating to adhere fully to the tip. 
     SUMMARY 
     In one aspect, the present disclosure concerns a catheter whose shaft is formed from a tube, such as, for example, an extruded tube. A formed tip that facilitates insertion of the catheter into the body is fabricated on one end of the tube by an insert molding process. 
     A catheter for introduction into a body cavity may be fabricated by the following steps: 1) a tube is extruded from a thermoplastic polymer material, and cut to the desired catheter length; 2) one end of the length of tubing is inserted into an injection mold cavity; 3) a formed tip is created and bonded to the tubing end in an injection molding step; 4) the tubing with the formed tip is demolded; and 5) if desired, a funnel can be attached to the other end of the tubing by conventional methods such as solvent bonding, spin welding, hot melt bonding, or by the non-conventional step of injection molding the funnel onto the tubing. 
     The mold for the tip formation can be gated at the apex of the tip, and a small depression can be designed into this apex so that any gate residue in the formed part is not protruding from the surface of the part. 
     The injection molding steps are further characterized in that a plug is press fit into the lumen at one end of the tubing just prior to inserting that end into the injection mold. During the injection molding step that forms the tip on the end of the tube the plug acts as a molding shut-off to ensure proper filling of the mold. In one alternative embodiment the plug can be pre-heated, to reduce the amount of heat transfer from the injected thermoplastic polymer material needed for proper bonding to the plug and to the tubing walls. 
     In total this is a novel way to provide a formed tip on the end of an extruded tube. The strategy of using a thermoplastic plug as a pre-molding insert to provide injection shut-off is believed to be novel. The idea of injection molding on to a pre-heated plug, as an aid to good bonding, is believed to be novel as well. The injection-molded tip also maintains the integrity of a multi-layer tube construction, assuring that the outer layer material of the tubing remains on the exterior of the catheter where it can accept a hydrophilic coating. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a longitudinal cross-sectional view of an end portion of a tubing and tip of a catheter assembly according to the present disclosure. 
         FIG. 2  is a cross-sectional view similar to  FIG. 1  showing an alternate embodiment of the tubing which has a dual layer construction. 
         FIG. 3  is a cross-sectional view similar to  FIG. 2  showing an alternate embodiment further including a hydrophilic coating. 
         FIG. 4  is a diagrammatic cross-sectional view of a tubing end portion and plug inserted into the cavity of a mold, ready for injection molding of the tip. 
         FIG. 5  is a cross-sectional view similar to  FIG. 4  showing an alternate, slightly protruding axial position for the plug. 
         FIG. 6  is a cross-sectional view similar to  FIG. 4  showing a further alternate, slightly recessed axial position for the plug. 
         FIG. 7  is a cross-sectional view of a tip on an enlarged scale to illustrate the depression in the end of the tip. 
         FIGS. 8, 9 and 10  are cross-sectional views through an end portion of tubing prior to injection molding but after insertion of a plug, each showing an alternate embodiment of a plug shape. 
         FIG. 11  is a cross-sectional view similar to  FIG. 1 , showing a further alternate embodiment having a plug located at an axial position well recessed from the end face of the tubing, the plug location permitting formation of a stubshaft on the tip. 
     
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS 
     The present disclosure is directed to a catheter and a method of making it, the method including the steps of cutting tubing to the desired length, inserting a plug into one end of the tubing and injection molding a tip onto the plugged end of the tubing.  FIG. 1  illustrates an end portion of the catheter  10  according to the present disclosure. The catheter  10  has tubing  12  which is cut to length to define an end portion  14  which terminates at a radial end face  16 . Tubing  12  may be made by any suitable process, such as, for example, by an extrusion process. As is conventional, the tubing  12  defines an axial lumen  18  that extends throughout the length of the tubing  12 . There is also a radial eyelet  20  defined in one wall and in communication with the lumen  18 . For a urinary catheter, lumen  18  would serve as a urinary lumen with urine draining into the lumen  18  through the eyelet  20 . A plug  22  is provided of a suitable material, e.g., the main tubing wall component material. The plug  22  is sized to be insertable into the tubing lumen  18  with an interference fit. In its simplest form, the plug  22  can be a cut length of an extruded rod that is just larger in diameter than the tubing lumen  18 . In an alternative form, the plug can be a micro-injection molded part, and can have a taper on one end, or preferably on both ends, to aid in the insertion process. In embodiments wherein the plug has one or more tapered portions, it will be understood that a portion of the plug  22  will have a maximum outer diameter at least as large as the inside diameter of the lumen  18 , thus assuring the lumen  18  will be completely blocked during injection molding of the tip  24 . 
     The plug  22  may be inserted into the lumen  18  at the end portion  14  of the tubing  12 . This end portion  14  is inserted into an injection mold. A formed tip  24  is then injection molded onto the end portion  14  of the tubing  12  using a mold as shown in  FIG. 4 . In  FIG. 4  the end portion  14  of the tubing  12  is inserted into a mold. A first half of the mold is shown at  26 . It will be understood that a second mold half, not shown but largely a mirror image of the first mold half (with the mirror plane being the plane of the paper of the drawing), would be used in the injection molding process, although preferably the mold halves are integral. That is, they are not necessarily made to be separable, although they could be. Together the mold halves define a cavity  28 . The cavity  28  opens to the exterior of the mold at an opening  30  for receiving the end portion  14  of the tubing  12 . The cavity  28  has an inner surface  32  that has the size and shape of the finished tip  24 . Surface  32  optionally includes a slight bulge at  34  that will create a depression in the extreme end of the tip  24  as will be explained further below. A sprue  36  extends through the mold and forms a passageway through which molten thermoplastic polymer material can be introduced into the cavity  28 . 
     When molten thermoplastic polymer material is injected into the cavity  28  the plug  22  and radial end face  16  serve as a stop for the injected thermoplastic polymer material; in a sense the plug  22  and end face  16  become one wall of the injection mold while the inner surface  32  forms the other wall. This ensures that the mold cavity  28  will fill properly, resulting in a well formed tip  24  of controlled geometry. 
     The material for injection molding should be one that is compatible with the tubing material, to ensure good bonding between the molded tip  24  and the tubing  12 . Because the plug  22  is made of a suitable material, with proper selection of injection molding parameters, a strong bond forms between the plug  22  and the injected tip material along a plug-to-tip bond line  37 . Likewise a strong bond forms between the injected tip material and the end face  16  of the tubing  12 . After the injected tip material cools, optionally the mold halves are separated and the tubing and tip are removed from the cavity  28 . Alternatively, the mold may be one piece, and the tubing  12  with tip  24  may just be pulled free of the mold. The result is a formed tip  24  of desired geometry that is integral with the end  14  of the tubing  12 . 
     In one alternate embodiment of the process, the plug  22  is pre-heated before inserting it into the tubing end  14 , just prior to insertion of the tube into the injection mold. The plug will then provide a source of heat to heat the tubing walls, and in all less heat transfer from the injected thermoplastic polymer material will be needed to create the desired good bonding between the injected thermoplastic polymer material tip, the plug, and the tubing end face. Using the strategy of pre-heating the plug will reduce the melt temperature required to ensure good bonding between the injected thermoplastic polymer material tip, the plug, and the tubing end face, and may also reduce the required cycle time for the tip molding process. 
       FIG. 2  illustrates an alternate embodiment of a catheter  38  having a different kind of tubing. In this embodiment the tubing  40  has a dual layer construction including an inner wall  42  and an outer wall  44 . The tubing  40  may be made by coextrusion wherein inner wall  42  and outer wall  44  are different materials. Eyelet  46  extends through both walls. The radial end face  48  includes both walls and is covered by the tip  50 . In this embodiment, the outer wall  44 , the plug  22  and the tip  50  may be made of the same or similar materials. Alternatively, the plug  22  may be made of material the same or similar to that of the inner wall  42 . 
       FIG. 3  shows an alternate embodiment wherein the catheter  38  of  FIG. 2  has added to it an outer hydrophilic coating  52 . The coating  52  surrounds both the outer wall  44  and the tip  50 . The coating  52  may be of the type commonly used to increase the lubricity of the catheter. The tip material is preferably the same as the outer wall material so they will both accept the outer hydrophilic coating  52 . 
       FIGS. 5 and 6  are similar to  FIG. 4  but show alternate axial positions for the plug  22 . In  FIG. 5  the plug  22  protrudes axially beyond the radial end face  16 . In  FIG. 6  the plug  22  is recessed somewhat from the radial end face  16 . 
     In the enlarged view of  FIG. 7  it can be seen that the bulge  34  in the mold cavity&#39;s inner surface  32  creates a dimple or depression  54  in the apex of the tip  24 . Since the sprue  36  is gated at the apex of the tip, any gate residue in the formed tip is not protruding from the surface of the tip but instead lies within the depression  54  where it will not affect a user of the catheter. 
       FIGS. 8, 9 and 10  illustrate alternate forms that the plug could take.  FIG. 8  shows a plug  56  having a rounded inner end that assists with insertion into the lumen  18  of the tubing  12 .  FIG. 9  shows a plug  58  that is rounded on both ends so either one can be readily inserted into the lumen.  FIG. 10  shows a spherical plug  60 . 
       FIG. 11  shows yet another alternate embodiment wherein prior to molding the plug  22  is axially recessed into the lumen nearly to the eyelet  20 . With this axial placement of the plug injected thermoplastic polymer material will enter the lumen until it meets the plug  22 , thereby forming a stubshaft  62  that is integral with the tip  64 . This provides enhanced stability of the tip on the tubing  12 . The stubshaft  62  joins the plug at the plug-to-tip bond line  66 . 
     The mold desirably does not have any parting line, rather the part will demold due to the taper of the tip and material shrinkage on cooling. A possible alternate configuration during the molding step is to have the long axis of the tube protruding from the mold vertically. In this configuration gravity will help to accomplish the desired result of the mold filling before thermoplastic polymer material enters the tube lumen. The amount of injected thermoplastic polymer material entering the tube lumen is then controlled by controlling molding shot size. 
     In the catheter of the present disclosure the thermoplastic polymer material that will be injection molded to the end of the extruded tube can be kept always hot, in the molder feed system. A mold cooling step is needed, but only the heat transferred to the mold by the injected thermoplastic polymer material needs to be carried away. This will result in a shorter cycle time compared to the conventional tip forming process. 
     Another advantage of the catheter of the present disclosure is that the total length of the tipped catheter can be highly controlled. In the conventional process, the tip formed on the end of the tubing will have a much higher length variation. This variability in the tipped catheter length can cause problems in subsequent catheter converting steps. 
     A further advantage of the catheter of the present disclosure is that the proposed process will work well with coextruded tubing, such as shown in  FIG. 2  for example. This tubing  40  may have a thin outer wall  44  present for accepting a hydrophilic coating, such as at  52  in  FIG. 3 . In such an embodiment, the inner wall  42  may be made from a material that has desirable mechanical characteristics for a urinary catheter, e.g., desired stiffness/flexibility, such materials may include for example thermoplastic resins such as olefins, particularly polyethylenes, polypropylenes, polyvinylchlorides, polytetrafluoroethylenes, polyvinylacetates, polystyrenes, polyesters, polyurethane, polyamides, ethylene vinyl acetate copolymers, copolymers of ethylene with other comonomers such as acrylic acid, or combinations thereof. The outer wall  44  and tip  50  may be made from a material that is conducive to bonding or receiving the hydrophilic coating. The outer wall  44  and tip  50  may be for example made from a water-swellable polymer such as water-swellable polyamide-base copolymers, water-swellable polyester-based copolymers or water-swellable urethane-based copolymers. Other polymers may include blends of these water swellable thermoplastic polymers with non-water swellable thermoplastic polymers. Polymers can be utilized that have functional groups selected to provide bonding to specific coating chemistries. Functional groups such as carboxyl, amine, hydroxyl, and other known reactive groups can be appropriate, depending on the coating choice. The hydrophilic coating may be any coating that bonds or attaches to the outer wall  44  and tip  50 . The hydrophilic coating may be bond to outer wall  44  by any suitable, manner of attachment, such as physical anchoring via an interpenetrating polymer network or by chemical bonding. Such hydrophilic coatings may include for example, polyvinylpyrollidone, polyacrylic acid, polyvinylether maleic anhydride copolymer, or other highly hydrophilic polymers and copolymers. In the conventional forming process, the process conditions need to be adjusted and controlled to keep the desired outer layer material on the surface of the formed tip. 
     It is believed that this process of tip forming will be a lower cost option compared to conventional forming with an induction heated die. 
     An alternate embodiment of the catheter of the present disclosure has an extruded tube that is cut to length for a catheter product. At one cut end, a formed tip is made by an insert micro-injection molding step as described above. At the other end, a funnel is formed by a second insert injection molding step. Prior art catheters having a funnel are made by cutting an extruded tube to length, forming a tip by forcing one of the cut ends into a heated die, followed by cooling of the die. Separately a funnel part is injection molded. Finally, the funnel part is assembled to the other tube end using solvent bonding. These tip forming steps and the funnel solvent bonding steps involve a fair amount of labor cost, which is avoided by making the funnel-equipped catheter according to the present disclosure. The insert injection molded funnel can comprise less material compared to a conventional injection molded funnel that is assembled to an extruded tube. The methods described in this disclosure are more generally applicable to use of other materials, such as coextruded tubes and materials that do not solvent bond well. Together these can provide a fully converted catheter product, at meaningful cost savings. 
     It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modification can be made without departing from the spirit and scope of the invention disclosed herein. 
     Aspects of the present subject matter described above may be beneficial alone or in combination with one or more other aspects. Without limiting the foregoing description, in accordance with one aspect of the subject matter herein, there is provided a catheter, which includes a length of tubing with an axial lumen defined therein. The lumen has an inside diameter and the tubing terminates at an end. A plug is inserted in the lumen a distance sufficient to axially recess the plug from the end of the tubing. At least a portion of the plug has a maximum outside diameter at least as large as the inside diameter of the lumen. A tip is attached to an end of the tubing. The tip includes a stubshaft that extends into the lumen and is joined to the plug at a plug-to-tip bond line. 
     In accordance with another aspect which may be used or combined with the preceding aspect, the catheter of has a hydrophilic coating on the exterior surface of the tubing and tip. 
     In accordance with another aspect which may be used or combined with any of the preceding aspects, the catheter is provided with tubing that has an inner wall and an outer wall. 
     In accordance with another aspect which may be used or combined with any of the preceding aspects, the tubing has an inner wall and an outer wall and further includes a hydrophilic coating on the exterior surface of the outer wall and tip. 
     In accordance with another aspect which may be used or combined with any of the preceding aspects, the plug has at least one tapered end. 
     In accordance with another aspect which may be used or combined with any of the preceding aspects, the tip has an apex at the free end thereof with a depression formed in the apex. 
     In accordance with another aspect, there is provided a catheter, which includes a length of tubing with an axial lumen defined therein. The lumen has an inside diameter, and the tubing terminates at an end. A plug is inserted in the lumen. At least a portion of the plug has a maximum outside diameter at least as large as the inside diameter of the lumen. A tip is attached to an end of the tubing. The tip has an apex at its end opposite the tubing end, with a depression formed in the apex. 
     In accordance with another aspect which may be used or combined with the preceding aspect, the catheter tubing has an inner wall and an outer wall and a hydrophilic coating on the exterior surface of the outer wall and tip. 
     In accordance with another aspect, there is provided a method of making a catheter, including the steps of providing tubing having an axial lumen defined therein, the lumen having an inside diameter; cutting the tubing to the desired catheter length; forming a plug, at least a portion of the plug having an outside diameter at least as large as the inside diameter of the lumen; pre-heating the plug; inserting the pre-heated plug into the lumen at an end of the tubing; inserting the end of the tubing into an injection mold cavity; injecting molten thermoplastic polymer material under pressure into the mold cavity; cooling the mold cavity so the molten thermoplastic polymer material solidifies and forms a tip bonded to the plug and to the tubing end; and removing the tubing with the formed tip from the mold. 
     In another aspect which may be used or combined with the preceding aspect, the method may include the step of forming a depression in the apex of the tip. 
     In accordance with another aspect which may be used or combined with any of the preceding two aspects, the step of inserting the pre-heated plug into the lumen may be characterized by locating the plug so that its outer end terminates flush with the end of the tubing. 
     In accordance with another aspect which may be used or combined with any of the preceding ninth and tenth aspects, the step of inserting the pre-heated plug into the lumen is characterized by recessing the plug from the end of the tubing. 
     In accordance with another aspect, there is provided a method of making a catheter, including the steps of providing tubing having an axial lumen defined therein, the lumen having an inside diameter and the tubing having an inner wall and an outer wall; cutting the tubing to the desired catheter length; forming a plug, at least a portion of the plug having an outside diameter at least as large as the inside diameter of the lumen; inserting the plug into the lumen at an end of the tubing; inserting the end of the tubing into an injection mold cavity; injecting molten thermoplastic polymer material under pressure into the mold cavity; cooling the mold cavity so the molten thermoplastic polymer material solidifies and forms a tip bonded to the plug and to the tubing end; removing the tubing with the formed tip from the mold; and applying a hydrophilic coating to the exterior of the tubing and tip. 
     In accordance with another aspect which may be used or combined with the preceding aspect, the step of forming a depression in the apex of the tip. 
     In accordance with another aspect which may be used or combined with any of the preceding two aspects, pre-heating the plug prior to inserting it into the lumen. 
     In accordance with another aspect which may be used or combined with any of the preceding three aspects, the step of inserting the pre-heated plug into the lumen is characterized by locating the plug so that its outer end terminates flush with the end of the tubing. 
     In accordance with another aspect which may be used or combined with any of the second, third and fourth preceding aspects, the step of inserting the pre-heated plug into the lumen is characterized by recessing the plug from the end of the tubing. 
     In accordance with another aspect, there is provided a urinary catheter, which includes a length of tubing with an axial urinary lumen defined therein, the lumen having an inside diameter, and the tubing terminating at an end. A plug is inserted in the urinary lumen, at least a portion of the plug having a maximum outside diameter at least as large as the inside diameter of the urinary lumen. A tip is attached to an end of the tubing, and is joined to the plug at a plug-to-tip bond line. 
     In accordance with another aspect which may be used or combined with the preceding aspect, the plug terminates at the same location as the tubing end. 
     In accordance with another aspect which may be used or combined with the second preceding aspect, the plug may protrude from the tubing end. 
     In accordance with another aspect which may be used or combined with the third preceding aspect, the plug may be axially recessed from the tubing end.