Patent Publication Number: US-11648377-B2

Title: Catheter securement device including a guiding nose

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Patent Application No. 62/336,496, filed May 13, 2016, and titled “Catheter Securement Device Including Guiding Nose,” which is incorporated herein by reference in its entirety. 
    
    
     BRIEF SUMMARY 
     Briefly summarized, embodiments of the present invention are directed to a securement device configured to secure an external portion of a medical device to the skin surface of a patient after an internal portion of the device has been placed in the patient. The securement device includes a catheter retainer that is employed to securely but removably retain the external portion of the catheter assembly in place. In one embodiment, the catheter retainer is attached to a base, such as an adhesive pad that adhesively attaches to the skin surface, to form the securement device, also referred to herein as a catheter retainer system or catheter retainer assembly. 
     In one embodiment, therefore, a retainer for retaining an external portion of a medical device after insertion of an internal portion of the medical device into a body of a patient via a skin insertion site comprises a body defining a channel configured to receive therein a portion of the external portion of the medical device, and at least one foot extending from the body. The foot is configured to stabilize the retainer with respect to a skin surface of the patient. The retainer body further includes a nose that is configured to deflect a strain relief portion (or other portion) of a catheter assembly (for instance) toward the skin insertion site. Such deflection lessens the incidence of kinking in the medical device, such as a catheter tube, proximate the skin insertion site. 
     These and other features of embodiments of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of embodiments of the invention as set forth hereinafter. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       A more particular description of the present disclosure will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. Example embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which: 
         FIGS.  1 A- 1 C  are: various views of a catheter retainer according to one embodiment, 
         FIGS.  2 A- 2 D  show the catheter retainer of  FIGS.  1 A- 1 C  engaged with a catheter assembly; 
         FIGS.  3 A and  3 B  depict various views of a catheter retainer assembly according to one embodiment; 
         FIGS.  4 A- 4 C  depict various stages of insertion of a catheter assembly and use of a catheter retainer assembly according to one embodiment; 
         FIGS.  5 A and  5 B  depict various views of a catheter retainer according to one embodiment; 
         FIG.  6    is a top view of a catheter retainer according to one embodiment; 
         FIG.  7    is a top view of the catheter retainer of  FIG.  6    engaged with a catheter assembly according to one embodiment; and 
         FIG.  8    is a top view of a catheter retainer according to one embodiment. 
     
    
    
     DETAILED DESCRIPTION OF SELECTED EMBODIMENTS 
     Reference will now be made to figures wherein like structures will be provided with like reference designations. It is understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the present invention, and are neither limiting nor necessarily drawn to scale. 
     For clarity it is to be understood that the word “proximal” refers to a direction relatively closer to a clinician using the device to be described herein, while the word “distal” refers to a direction relatively further from the clinician. For example, the end of a catheter placed within the body of a patient is considered a distal end of the catheter, while the catheter end remaining outside the body is a proximal end of the catheter. Also, the words “including,” “has,” and “having,” as used herein, including the claims, shall have the same meaning as the word “comprising.” 
     Embodiments of the present invention are generally directed to a securement device that is configured to secure an external portion of a catheter assembly to the skin surface of a patient after an internal portion of the catheter assembly has been placed in the patient to establish vascular access, or for some other suitable purpose. The securement device includes a catheter retainer that is employed to securely but removably retain the external portion of the catheter assembly in place. In one embodiment, the catheter retainer is attached to a base, such as an adhesive pad that adhesively attaches to the skin surface, to form the securement device, also referred to herein as a catheter retainer system or catheter retainer assembly. It is appreciated that, though the discussion to follow focuses on a midline catheter, catheters and other tubular or elongate medical devices that are configured for attachment or may be attached to a skin surface of the patient may also benefit from the teachings herein, including dialysis catheters, Foley and urinary catheters, feeding tubes, balloon catheters, PIVs, etc. 
     Reference is made to  FIGS.  1 A- 1 C  in describing various details of a catheter retainer (also “retainer”), generally designated at  18 , according to one embodiment. The retainer  18  includes a body  20  extending between a proximal end  20 A and a distal end  20 B. The body  20  includes a central portion  22  and two feet  24  that extend from the central portion. As shown, the feet  24  each arcuately sweep distally to provide a stable base for the retainer  18  and reduce rocking of the retainer when the securement device is positioned on the skin of the patient. As will be seen, the feet  24  are configured to attach to adhesive anchor pads for adhesively attaching the retainer to a skin surface of a patient. In addition, each of the feet  24  includes a longitudinally extending living hinge  40  that enables the feet to bend to conform to the contour of the skin surface of the patient when the retainer, as part of a below-discussed securement device, is disposed on the patient. For instance, the living hinges  40  enable the feet  24  to bend around the skin surface of a patient arm in one embodiment. Note that the size and position of the living hinges  40  can vary from what is shown and described herein. Also, more than one living hinge can be included on each foot  24  to further enhance bending ability of the feet. 
     The retainer body  20  defines a longitudinally extending channel  26  sized and configured to receive therein portions of a strain relief  48  and a hub  46  of a catheter assembly (also “catheter”)  42 , as will be discussed below in connection with  FIGS.  2 A- 2 D . The channel  26  includes art opening, as seen in the bottom view of  FIG.  1 B , and the body  20  is elastically deformable sufficient to enable the catheter to be retained in the channel  26  in a snap-fit configuration in the present embodiment. Though a variety of suitable materials can be employed, in the present embodiment the retainer body  20  is composed of polycarbonate. Note that the particular size, shape, and configuration of the channel  26  can vary to accommodate the shape and configuration of a particular catheter or other medical device. Details regarding the catheter shown and described herein can be found in U.S. patent application Ser. No. 14/702,580, filed May 1, 2015, and entitled “Catheter Placement Device Including Guidewire and Catheter Control Elements,” which is incorporated herein by reference in its entirety. 
     Two pockets  28  are included with the channel  26  and are sized and positioned to receive therein two nubs  49  of the catheter strain relief  48  ( FIGS.  2 B,  2 C ), which assists in preventing undesired rotation of the catheter  42  within the retainer  18  after placement therein. 
       FIG.  1 C  shows that the retainer body  20  further defines a notch  30  that provides a space to be occupied by a skin-placed dressing when the retainer  18  is placed proximate the skin surface of the patient. An upper surface  30 A of the notch  30  is configured at a predetermined height above the skin surface of the patient such that a slight compression of the skin-placed dressing is imposed by the retainer body  20  when the securement device is placed on the skin. Again, the size, shape, and configuration of the notch  30  can vary according to the type of dressing to be received therein. In one embodiment, the skin-placed dressing is an antimicrobial disk  60  ( FIG.  3 A,  3 B ), such as a GUARDIVA® antimicrobial haemostatic dressing sold by Bard Access Systems, Inc. of Salt Lake City, Utah (also referred to herein as a “GUARDIVA® dressing”). A variety of other dressings and components can be included instead of or in addition to the skin-placed dressing. 
     In the present embodiment, the retainer body  20  further includes a nose  32  that is angled downward so as to constrain the catheter strain relief  48  of the catheter hub  46  ( FIG.  2 A ) disposed within the channel  26  and deflect it in a slightly downward direction. The angle of the downward bend imposed by the nose  32  is predetermined and can vary according to various factors. This deflection of the catheter strain relief  48  in turn helps to provide a non-abrupt direction change for the catheter tube  44  as it enters the skin insertion site on the patient skin surface, thus avoiding undesired kinking of the catheter tube  44  or the strain relief  48 . In one embodiment, the magnitude of the angle change imposed on the catheter strain relief  48 /catheter tube  44  by the angled nose  32  is about 14 degrees, but it is appreciated that the nose can be configured to impose other angles. Also, note that other portions of the external portion of the catheter (or other elongate/suitable medical device) can be deflected by the nose  32 , including the hub and the catheter tube. As such, the description herein should not be considered limiting. 
       FIG.  1 C  shows that the nose  32 , together with corresponding surfaces of the retainer body  20  (including portions of the body that define the pockets  28 ) cooperate to define the upper surface  30 A of the notch  30 . Indeed, the downward angle of the nose  30  assists in providing the predetermined slight compression on the skin-placed dressing when disposed in the notch. 
       FIGS.  2 A- 2 D  depict various views of the catheter  42  and its insertion into the retainer  18  according to one embodiment. As shown, the catheter  42  is inserted into the retainer by a portion of the hub  46  and strain relief  48  being received into the channel  26  of the retainer body  20 .  FIG.  2 B  shows the insertion of the catheter  42  in this manner such that the nubs  49  of the strain relief  48  are received into the pockets  28  of the retainer body channel  26 . As mentioned, the retainer body  20  is sufficiently resilient to deform sufficient to receive the catheter hub  46  and strain relief  48  therein in a snap-fit configuration. 
       FIGS.  2 B- 2 D  show that the catheter hub  46  includes a radially extending alignment ring  50  and a lock tab  52  extending further therefrom. The alignment ring  50  is configured to be received within a lock channel  36  of the retainer body channel  26  when the catheter hub  46  is received with the channel  26 . When this occurs, the lock tab  52  is configured to be received into a lock window  34  defined by the retainer body  20 . This in turn prevents unintended rotation of the catheter hub  46  and within the retainer body channel  26  about its longitudinal axis when received therein, as well as preventing related kinking of the catheter tube  44  when undesired rotation is experienced. Note that in one embodiment the lock tab  52  can be colored a color different from surrounding catheter assembly structure so as to highlight it and provide easy confirmation to a clinician as to when the lock tab has been received in the lock window  34 . 
     In the present embodiment, unintended catheter hub rotation is further assisted by the receipt of the strain relief nubs  49  within the pockets  28  of the retainer body channel  26 .  FIG.  2 D  further shows that the retainer body defines a view window  38  through which the strain relief  48  of the catheter can be viewed. In addition to these, other modes for preventing unintended rotation of the catheter hub within the retainer body channel are also contemplated. It is further appreciated that the engagement of the nubs  49  within the pockets  28  of the retainer body channel  26 , together with the engagement of the alignment ring  50  with the lock channel  26 , assists in preventing undesired movement of the catheter assembly  42  along its longitudinal axis while the catheter is received within the retainer. Note that the lock channel  36  is tapered at the point of entrance of the alignment ring  50  to ease the insertion of the alignment ring therein. 
       FIGS.  3 A and  3 B  depict the retainer  18  incorporated into a securement device  10  as an assembly for retaining a portion of a catheter assembly or other suitable medical device in a secured position on or proximate the skin surface of the patient. As shown, the securement device  10  is shown in the configuration as applied to the skin surface of a patient and includes the retainer  18  as described above retaining the hub  46 /strain relief  48  of the catheter assembly  42  as described above. The retainer  18  is permanently affixed (such as via adhesive or mechanical fixation) to a pair of adhesive anchor pads  64 , themselves including a central foam portion  66  and an overlying fabric portion  68  such as polyester fiber. Adhesive is placed on the bottom, skin-facing surface of the anchor pads  64  and a release liner placed on the adhesive surface. The anchor pads  64  extend out from either side of the bottom opening of the retainer body channel  26  so as to not interfere with the insertion and removal of the catheter hub  46 /strain relief  48  into and from the retainer body channel  26 . In the present embodiment, the anchor pads  64  are permanently affixed to the bottom, skin-facing surfaces of the two feet  24 . The anchor pads can, of course, include various sizes, shapes, and configurations. Note that the foam portion  66  and the fabric portion  68  can include other materials in other embodiments, such as non-woven materials, synthetic and natural materials, etc. 
       FIGS.  3 A and  3 B  further show an antimicrobial disk  60  as an example of a skin-placed dressing, as described further above, in place with respect to the securement device  10 . The antimicrobial disk  60  is positioned about the skin insertion site to prevent the occurrence of infection at/via the insertion site and, as already mentioned, the retainer body  20  defines the notch  30  to provide space in which a corresponding portion of the antimicrobial disk  60  can reside. Also, as mentioned, the upper surface  30 A of the notch  30  is sized to desirably provide slight compression on the antimicrobial disk. As mentioned, in one embodiment the antimicrobial disk  60  is a GUARDIVA® antimicrobial haemostatic dressing. The antimicrobial disk  60  is understood to include any one of a variety of components placed at or near the insertion site of the catheter (or other medical device), including dressings, pads, antimicrobial devices, bandages, etc. 
       FIGS.  2 A,  2 C, and  3 B  depict the manner of deflection (as discussed above) of the strain relief  48  and catheter tube  44  downward toward the skin insertion site so as to prevent kinking of the catheter tube proximal and/or distal to the skin insertion site.  FIG.  3 B  further depicts the strain relief  48  passing through a central hole of the antimicrobial disk  60 , directing the catheter tube  44  to the insertion site in a desirable low-kink configuration. The inclusion of the notch  30  in the retainer body for the antimicrobial disk  60 , together with the downward-angling nose  32  for angling the catheter strain relief  48  and catheter tube  44  toward the skin insertion site, in turn enables the strain relief  48  and hub  46  of the catheter  42  to be positioned relatively closer to the insertion site of the catheter without kinking than would otherwise be possible. Note that in the configuration shown in  FIG.  3 B  when the securement device  10  is placed on a skin surface of the patient, the hub  46  of the catheter assembly is substantially parallel to the skin surface while the strain relief  48  and external portion of the catheter tube  44  proximal to the skin insertion site  72  ( FIGS.  4 A,  4 B ) is angled downward, as described above. Maintenance of the catheter hub  46  in a substantially parallel position with respect to the skin surface by the securement device  10  in turn helps to prevent cantilevered movement of the catheter hub on the securement device and undesired movement of the catheter tube with respect to the skin insertion site. 
       FIGS.  4 A- 4 C  depict various stages showing the application of the securement device  10  in securing the catheter assembly  42  to a patient, according to one embodiment.  FIG.  4 A  shows an external portion of the catheter assembly  42 , including the hub  46 , the strain relief  48 , and a proximal portion of the catheter tube  44  passing through an insertion site  72  on a skin surface  76 . An extension set  70  is shown attached to the hub  46 . 
       FIG.  4 B  shows the antimicrobial disk  60  disposed about the insertion site  72  on the skin surface, such as a portion of the patient arm. The insertion device  10  is also shown, positioned over the catheter such that the hub  46  and strain relief  48  are received into the channel  26  thereof in a snap-fit arrangement. The adhesive anchor pads  64  are also adhered to the skin surface  76  on either side of the retainer  18  (after removal of a release layer covering the adhesive) to secure the catheter assembly  42  to the skin surface and to prevent inadvertent removal of the catheter tube  44  from the insertion site. A non-adhesive comfort pad  73  extends from one of the anchor pads to be interposed between the catheter assembly  42  and the skin surface  76  so as to prevent abrasion therebetween. The comfort pad  73  in the present embodiment includes polyester fiber layer overlying a foam layer and includes a perforation in one embodiment so as to enable its removal from the insertion device when not desired. Note that the anchor pads  64  and the feet  24  are shaped to enable the antimicrobial disk  60  to be received into the notch  30  of the retainer body in the manner shown in  FIGS.  3 A and  3 B . 
     Note also that the arcuately and distally extending feet  24 , together with the adhesive attachment to the patient skin surface  76  of the anchor pads  64  to points distally past and to either side of the insertion site  72 , enables the securement device  10  to move in concert with the skin surface  76  proximate the insertion site  72 , thus further reducing chances of kinking of the catheter tube  44  or undesired relative movement of the catheter tube with respect to the insertion site. In light of this, it is appreciated that the feet  24  can extend in different shapes and to different distances with respect to the central portion  22  of the retainer body  20 . An example of this is shown in  FIG.  8   , which depicts the feet  24  arcuately extending distally with respect to the central portion  22  of the retainer body  20  to form a near circular footprint about the insertion site for the catheter to enhance the ability of the securement device and the skin surface to move in concert with one another and prevent relative movement between the catheter tube and the insertion site. These and other possible foot configurations are therefore contemplated. 
     In  FIG.  4 C , an adhesive cover dressing  74  is adhered to the skin surface  76  to cover the aforementioned components and protect them from contamination. It is appreciated that different or additional components can be employed in concert with the catheter assembly and insertion device shown and described herein. 
       FIGS.  5 A and  5 B  depict details of the retainer  18  according to another embodiment wherein the feet  24  are shaped so as to extend more proximally with respect to the central portion  22  of the retainer body  20 . Guidance arrows  78  are also included to assist the clinician in knowing the proper direction for placement of the retainer  18 . 
       FIGS.  6  and  7    depict the retainer  18  according to yet another embodiment, wherein the feet  24  extend proximally to the retainer body  20  to provide stability for the inserted catheter  42 . The retainer body  20  further includes a base portion that is configured to be disposed underneath the entirety of the strain relief  48  and hub  46  of the catheter  42  so as to prevent abrasion of the patient skin by these or other components attached to the catheter. The retainer  18  of further includes a cap  80  that covers a portion of the channel  26 , the cap being attached to the retainer body  20  by a living hinge  82 , or other suitable attachment mode. As with the previous embodiment the guidance arrow  78  is provided on the retainer  18 . 
     Embodiments of the invention may be embodied in other specific forms without departing from the spirit of the present disclosure. The described embodiments are to be considered in all respects only as illustrative, not restrictive. The scope of the embodiments is, therefore, indicated by the appended claims rather than the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope. 
     Embodiments of the invention may be embodied in other specific forms without departing from the spirit of the present disclosure. The described embodiments are to be considered in all respects only as illustrative, not restrictive. The scope of the embodiments is, therefore, indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.