Patent Publication Number: US-2020282182-A1

Title: Catheter securing system and methods of use

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims priority to U.S. Provisional Application Ser. No. 62/813,230, filed Mar. 4, 2019, entitled “CATHETER SECURING SYSTEM AND METHODS OF USE,” the contents of which are fully incorporated as if fully set forth herein. 
    
    
     FIELD OF THE DISCLOSURE 
     The present disclosure relates to catheter securing systems for use in medical settings. More particularly the present disclosure relates to devices and methods to aid in securing a catheter to a patient&#39;s body and prevent accidental removal. 
     BACKGROUND OF THE DISCLOSURE 
     Medical procedures may require the use of devices for intravenous access for prolonged periods of time. In some cases, percutaneous catheters may be used to access the patient&#39;s vasculature. Examples of such catheters may include central venous catheters (i.e., central lines), peripherally inserted central catheters (PICCs), midlines, and dialysis/apheresis catheters. 
     In some cases, a substantial portion of the catheter will hang loosely from a patient&#39;s body. This makes the catheter prone to breakage, damage, displacement and inadvertent removal when a portion of the device becomes hooked on the patient&#39;s clothing or bedding, or on other medical devices. One common technique to secure a catheter is to secure a portion of it via sutures. This is uncomfortable for the patient, time-consuming for the physician and altogether unreliable. 
     SUMMARY OF THE DISCLOSURE 
     In some embodiments, a catheter securing device includes a housing having an upper arm, a lower arm and a hinge disposed between the upper arm and the lower arm and capable of transitioning the housing between a closed condition and an open condition, the upper arm having a recess, an adhesive layer disposed on the lower arm, a first adapter configured to be at least partially disposed within the housing, the first adapter having an upper member, a lower member and a hinge disposed between the upper member and the lower member and capable of transitioning the first adapter between a closed condition and an open condition, the lower member defining a lower concavity, and the upper member defining an upper concavity, the lower concavity and the upper concavity collectively defining a first lumen sized to accept a portion of a catheter. 
    
    
     
       BRIEF DESCRIPTION OF THE DISCLOSURE 
       Various embodiments of the presently disclosed catheter securing devices are shown herein with reference to the drawings, wherein: 
         FIG. 1A  is a schematic front view of an adapter of a catheter securing device in the closed condition according to one embodiment of the present disclosure; 
         FIG. 1B  is a schematic front view of the adapters of  FIG. 1A  in an open condition; 
         FIG. 1C  are schematic front views of adapter similar to those of  FIG. 1A  having differently-sized lumens; 
         FIG. 2A  is a schematic front view of a housing of a catheter securing device in the open condition capable of accepting the adapter of  FIG. 1A  according to one embodiment of the present disclosure; 
         FIG. 2B  is a schematic front view of the catheter securing device including the adapter and the housing in a closed condition; 
         FIGS. 3A-B  are schematic top views of the catheter securing device of  FIGS. 1A-2B  being used to secure a catheter in the open and closed conditions; 
         FIG. 4  is a schematic top view of another catheter securing device of being used to secure a catheter. 
     
    
    
     Various embodiments of the present invention will now be described with reference to the appended drawings. It is to be appreciated that these drawings depict only some embodiments of the invention and are therefore not to be considered limiting of its scope. 
     DETAILED DESCRIPTION 
     Despite the various improvements that have been made to catheter securing devices and their methods of use, conventional devices suffer from some shortcomings as described above. 
     There therefore is a need for further improvements to the devices, systems, and methods of securing and stabilizing catheters, such as catheters that are at least partially placed within the body. These catheters may include abscess drainage catheters, chest tubes, nephrostomy tubes, biliary drainage catheters, cholecystostomy tubes, or other percutaneous drainage catheters. Among other advantages, the present disclosure may address one or more of these needs. 
     The present disclosure relates to a catheter securing system that lowers the possibility of displacement or accidental removal from a patient. The catheter securing system may also improve patient comfort and allow for rapid exchange of catheters within the system. A catheter securing system according to the present disclosure includes two main portions in the form of an adapter and a housing capable of accepting the adapter. 
       FIG. 1A  shows one example of an adapter  100  according to the present disclosure. Adapter  100  extends between proximal end  102  and distal end  104 , and includes a lower member  110 , an upper member  112  and a hinge  114  coupling the lower member to the upper member adjacent distal end  104 . Hinge  114  allows the adapter to transition from a closed condition in which the upper and lower members are substantially parallel to an open condition in which the upper and lower members are angled relative to one another and spaced apart to accept a portion of a catheter. In some examples, the hinge  114  may allow the upper and the lower members to form a 180-degree angle in the open condition such that the two members are capable of laying completely flat next to one another with the hinge therebetween. 
     As shown, upper member  112  may include a raised center  113  to provide additional spacing for forming a lumen, although it will be understood that entire upper member may instead be flat. A pair of lower slots  120  are defined in lower member  110 , which are openings defined in a bottom surface of the lower member sized to receive pins of the housing as will be described in greater detail with respect to the housing. Lower slots  120  may be spaced apart as shown so that they are disposed on either side of a lumen  130 . A pair of upper slots  122  may be formed in upper member  112  and spaced from the lumen as shown. In at least some examples, slots  120 , 122  are formed of the same shape and size. Alternatively, slots  102  may be formed of different shapes and/or sizes than slots  122  as desired. 
     As shown in  FIG. 1B , lower member  110  may define a curved concavity  132  on a surface opposite the slots  120 . As shown, curved concavity  132  is shaped as a semi-circle although it will be understood that other shapes are possible. Upper member  112  may define an upper concavity  134  similar to lower concavity  132  positioned directly above the lower concavity  132  when the device is in the closed condition, the two concavities collectively defining a lumen  130  having a circular cross-section through the adapter in the closed condition. The size of lumen  130  may be varied as desired and may be sized to accept common diameters of catheters, the size being fractionally smaller than a given catheter to ensure a secure fit. For example, lumen  130  may be configured to accept catheters of sizes, for example, from 4 French to 30 French. In some examples, the lumen is configured to accept catheters larger than 30 French. The lumen may be large enough to accommodate the catheter within impinging on the lumen of the catheter, but small enough to properly secure the catheter and prevent it from sliding back and forth through the lumen. An adhesive  140   a , 140   b  may be applied to the inside surface of concavities  132 , 134 , the adhesive being strong enough to secure a portion of a catheter within the lumen and prevent the catheter from moving relative to the adapter. 
     Suitable materials for the adapter may include a polymeric material, such as silicone, thermoplastic polyurethanes (TPU), rubber, metal, plastic, polypropylene, polyethylene, acrylonitrile butadiene styrene (ABS), high impact polystyrene (HIPS), polyvinyl chloride (PVC) polycarbonate, thermoplastic elastomers, polybutylene terephthalate, ethylene vinyl acetate, nylon a low-density polyethylene, linear low-density polyethylene, and suitable combinations thereof. Alternatively, adapter  100  may also be formed at least partially or entirely of a metal such a stainless steel, titanium, or other biocompatible metal. 
     As shown in  FIG. 1C , a plurality of adapters  100   a , 100   b , 100   c  may be formed, each having the same-sized lower and upper members, and the same configuration of slots  120 , 122  so that the adapter are all interchangeable and coupleable to the same housing. The only difference between the adapters  100 , 100   b , 100   c  are the sizes of the concavities defined by the upper and lower members that form the lumen for accepting differently-sized catheters. Specifically, the length, width and height of adapters  100   a , 100   b , 100   c  are all the same, and the location of the slots  120 , 122  are also the same. In some examples, the raised center  113  provides a larger area into which the concavities will be defined to accommodate catheters of a larger size. 
       FIGS. 2A-B  illustrate a housing  150  that may be used with adapters  100 . Housing  150  extends between a proximal end  152 , and a distal end  154 , and includes a hinge  164  adjacent the distal end that couples a lower arm  160  to an upper arm  162 , the upper arm having a recess  163  tailored to match the curvature of raised center  113  of adapter  100 . Hinge  164  may allow the housing to transition between a closed condition and an open condition similar to the hinge of adapter  100 . In some cases, hinge  164  may allow the upper and lower arms of the housing to open a full 180 degrees such that the two arms are capable of laying completely flat next to one another with the hinge therebetween as shown, for example, in  FIGS. 3A-B . 
     Housing  150  may be formed of the same materials as adapter  100 . In other examples, the adapter and the housing are formed of different materials. Housing may further have a low profile so that, even when an adapter is disposed therein, the housing has a profile of ¼ inches or less, ½ inches or less, or ¾ inches or less. 
     Housing  150  further includes a pair of lower pins  170  and a pair of upper pins  172 , the lower and upper pins being sized, spaced and capable of mating with slots  120 , 122  of the adapter, which receive the pins therein. Housing  150  further includes a lower clasp  180   a , and an upper clasp  180   b  that mate to lock the housing in the closed condition and secure the adapter therein. 
     Coupled to lower arm  160  on a surface furthest from the upper arm is an adhesive layer  190  configured to attached the housing to the patient&#39;s skin. Suitable materials for adhesive layer  190  may include adhesives, glues and materials such as acrylate, including methacrylates and/or epoxy diacrylates. 
       FIG. 2B  illustrates a housing  150  that is in the closed position, with an adapter  100  nested therein. As shown, pins  170 , 172  are coupled to slots  120 , 122 , and recess  163  receives raised center  113  therein. Clasps  180   a , 180   b  are also coupled together to lock the housing in the closed condition and prevent the housing or adapter from being opened. 
     In use, a catheter securing device  300  including the adapter  100  and the housing  150  may be placed in the open configuration ( FIG. 3A ), and the housing may be coupled to the patient&#39;s skin at a predetermined location via adhesive layer  190 . Lower arm  160  of housing  150  may be coupled to lower member  110  of adapter  100 . A portion of a catheter  500  may be placed in the lower concavity of adapter  100 . Upper member  112  of adapter  100  may be coupled to upper arm  162  of housing  150  as shown in  FIG. 3A , and both the upper member and the upper arm may be rotated over their respective hinges to close the device by bringing the upper member  112  over the lower member  110  and the upper and lower concavities together to form the lumen. It will be noted that in some examples, adapter  100  may be transitioned to the closed condition, and housing  150  may be closed thereafter (e.g., the two portions may be closed sequentially instead of being closed together). Clasps  180   a , 180   b  of housing  150  may mate with one another to secure the catheter within lumen  130 . Additionally, adhesive material  140   a , 140   b  surrounding the catheter may prevent the catheter  500  from sliding relative to the catheter securing device  300  so that with the housing being secured to the patient&#39;s body, and the catheter secured within the lumen of the adapter, the distal end of catheter that is within the body is affixed at a spaced distance with respect to the catheter securing device  300  and the device is incapable of being inadvertently pushed further into the body or out of the body. If a physician or caretaker decides to exchange a catheter or use the securing system for a different purpose, another adapter may be interchanged with the first adapter, the second adapter having an appropriate lumen size for securing the new catheter. In this manner, catheters of different sizes may be secured to the same device, and the housing may be coupled to the patient once without having to secure it via sutures or otherwise cause discomfort to the patient. 
     It will be understood that the shape and/or size of the adapter and/or housing may be varied as needed. For example,  FIG. 4  illustrates a housing/adapter combination each having a clam-shaped perimeter of the upper and lower portions. Other shapes are possible such as generally circular, oval, square-shaped, triangular or diamond-shaped upper and lower portions of the housing and/or adapters. Additionally, in addition to or instead of the adhesive materials, eyelets  410  may be formed in, for example, the lower arm of the housing to help secure the housing to the patient&#39;s skin. As shown, the lower arm of the housing of device  400  is oversized in comparison to the upper arm so that the eyelets are exposed when the device is in the closed position. Various sizes, shapes of the eyelets, and two or more eyelets may be disposed at other positions on the housing, instead of or in addition to the adhesive. 
     Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims. 
     It will be appreciated that the various dependent claims and the features set forth therein can be combined in different ways than presented in the initial claims. It will also be appreciated that the features described in connection with individual embodiments may be shared with others of the described embodiments.