Patent Publication Number: US-2023147836-A1

Title: Catheter assembly

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims priority to International Pat. Application No. PCT/SE2021/050310 filed Apr. 7, 2021, which also claims priority to Sweden Patent Application No. SE 2050419-7 filed Apr. 14, 2020, each of which is hereby incorporated by reference in its entirety. 
    
    
     TECHNICAL FIELD 
     The present disclosure relates to a catheter assembly having a catheter hub rotatable part. Further, the disclosure relates to a catheter instrument, comprising said catheter assembly and a needle assembly. 
     BACKGROUND 
     Intravenous catheters are used to administer fluids and/or drugs to patients regularly. Fluids are supplied through the catheter through an extension tube, coupled to the catheter through an extension tube coupling present and extending from the catheter hub body. 
     When a catheter instrument is to be applied to a patient, by for instance a caretaker, a needle extending through the catheter tube is used to insert the catheter intravenously. Once the catheter tube is in place, the needle is extracted and the catheter tube remains intravenously. 
     However, a common issue when applying catheters to various positions on the patient, is that features of the catheter instrument obstruct the application process for the caretaker. Alternatively, the patient is surrounded by additional medical equipment, forcing the application of the catheter to be conducted using only either the right or left hand. Moreover, intravenous catheters are in general adapted for use by right handed people. 
     In US 20170120009 A1, the grip of the needle assembly is moveable in relation to the extension tube of the catheter, in an attempt to make the catheter instrument more adaptable to different situations. However, this solution still does not mitigate the above mentioned issues. US 20190275297 A1 discloses a catheter assembly with a rotatable flow housing, but the structure of the catheter comprises various parts. Hence, the production process is complex and cumbersome. 
     Hence, an improved catheter assembly which is easier to use and simple to manufacture is desired. 
     OVERVIEW 
     It is an object of the present disclosure , considering the disadvantages mentioned above, to provide a catheter assembly, extending along a longitudinal axis A, and the catheter assembly comprises a catheter hub, comprising a base part and a catheter hub rotatable part which is rotatable about the axis A in relation to a fixation element. A coupling element is connected to the catheter hub rotatable part, and the fixation element is connected to the catheter hub and comprises a first recess and a second recess configured to fit the coupling element. This catheter assembly is advantageous in that it allows the coupling element to rotate about the axis A such that easy access and handling of the catheter assembly is facilitated. 
     In a second aspect, there is provided a catheter instrument, comprising the catheter assembly and a needle assembly. 
     Further features of the disclosure and its embodiments are set forth in the appended claims. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       These and other aspects, features and advantages of which the disclosure is capable will be apparent and elucidated from the following description of non-limiting embodiments of the present disclosure, reference being made to the accompanying drawings, in which 
         FIG.  1   a    is an isometric view of a catheter assembly having an extension tube in a left hand side configuration; 
         FIG.  1   b    is the catheter assembly shown in  FIG.  1   a    seen from above; 
         FIG.  2   a    is an isometric view of the catheter assembly having the extension tube in an intermediate configuration; 
         FIG.  2   b    is the catheter assembly shown in  FIG.  2   a    seen from above; 
         FIG.  3   a    is an isometric view of a catheter assembly having an extension tube in a right hand side configuration; 
         FIG.  3   b    is the catheter assembly shown in  FIG.  3   a    seen from above; and 
         FIG.  4    is a longitudinal cross section of the catheter assembly. 
     
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS 
     Embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings in order for those skilled in the art to be able to carry out the disclosure. The disclosure may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art. The embodiments do not limit the disclosure, but the invention is only may be limited by the appended patent claims, the specification and the prior art. Furthermore, the terminology used in the detailed description of the particular embodiments illustrated in the accompanying drawings is not intended to be limiting of the disclosure. 
     Embodiments of the present disclosure will now be described below with reference to  FIGS.  1  to  4   . 
     Referring to  FIGS.  1   a  to  3   b   , there is provided a catheter assembly  100  comprising a catheter hub  110 , an extension tube coupling  120 , also referred to as a coupling element  120  herein, a fixation element in the form of a pair of wings  130  and a hollow catheter tube  140 . The hollow catheter tube  140  is configured to house a needle (not shown). 
     The catheter assembly  100  extends along a longitudinal central axis A in a proximodistal direction. The catheter assembly  100  has a catheter proximal end  101 , facing towards the catheter tube  140  and an oppositely facing catheter distal end  102 . 
     A right hand side R is defined as the right lateral side of the axis A when viewing the catheter assembly from the distal end  102 . A left hand side L is defined as the left lateral side of the axis A when viewing the catheter assembly  100  from the proximal end  102 . The right versus left lateral directions are indicated in  FIGS.  1   b ,  2   b  and  3   b    with a double ended arrow. 
     The catheter assembly  100  disclosed herein has a left hand side configuration (shown in  FIGS.  1   a  and  1   b   ), an intermediate configuration (shown in  FIGS.  2   a  and  2   b   ) and a right hand side configuration (shown in  FIGS.  3   a  and  3   b   ). 
     In turn, the catheter hub  110  comprises a catheter hub base part  112  and a catheter hub rotatable part  115 . The catheter hub base part  112  is also referred to as a catheter hub front part  112  herein. At the catheter distal end  102 , the catheter hub  110  is equipped with a connection portion  118 , to which a needle shield assembly (not shown) may be coupled. 
     The extension tube coupling  120  is connected to the catheter hub rotatable rotable part  115 , and an extension tube  125  is attached to the coupling element  120 . Further, the coupling means  120  may be connected to other features than the extension tube  125 . 
     Preferably, the extension tube coupling  120  extends from the catheter hub  110  at an angle α between the extension tube coupling  120  and the distal end  102  of the catheter hub  110 . The angle α shown in  FIG.  1   b    is smaller than 90 degrees. However, the angle α may be 160 degrees or smaller than 160 degrees, such as for instance 140, 120, 100, 80, 70, 60, 45 or 30 degrees. 
     The catheter hub rotatable part  115  is rotatable about said axis A and in relation to the catheter hub front part  112 . Hence, when the catheter hub rotatable part  115  is moved and turned about the axis A, the extension tube coupling  120  and the extension tube  125  attached thereto will also be displaced about the axis A in relation to the catheter hub front part  112  and in relation to the pair of wings  130 . The catheter tube  140  is connected to the catheter hub front part  112  and will thus not rotate together with the catheter hub rotatable rotable part  115 . 
     The pair of wings  130  extends laterally to the right hand side R and to the left hand side L from the central axis A. The pair of wings  130  is formed from a right wing  130   a  and a right wing  130   b . 
     The wing pair  130  comprises a distal coupling means  132  and a proximal coupling means  134 . Both coupling means  132 ,  134  are in the form of an aperture formed integrally with the pair of wings  130 , and which each circumvents the catheter hub  110  and joins the catheter hub  110  and the pair of wings  130  together. 
     Left Hand Side Configuration 
     With reference to  FIGS.  1   a  and  1   b   , the left hand side configuration of the catheter assembly  100  will be further explained. The extension tube coupling  120  is arranged on a left hand side L of the axis A. 
     As shown in  FIG.  1   b   , the right wing  130   a  of the pair of wings  130  is provided with a right wing recess  135   a , also referred to as a right recess  135   a  herein. The right wing recess  135   a  is also partly visible in  FIG.  1   a    (but is partly covered by the catheter hub  110  due to the perspective of  FIG.  1   a   ). The left wing  130   b  of the wing pair  130  is also provided with such recess, being a left wing recess  135   b  (shown in  FIGS.  2   a  to  3   b   ), also referred to as a left recess  135   b  herein. However, the extensions tube coupling  120  is fitted in said left wing recess  135   b , and hence cannot be seen in  FIGS.  1   a  and  1   b   . The left and right wing recesses  135   a ,  135   b  are shaped and designed such that the extension tube coupling  120  will fit within the recesses  135   a ,  135   b . 
     Intermediate Configuration 
     The catheter assembly  100  is shown in its intermediate configuration in  FIGS.  2   a  and  2   b   . The catheter hub rotatable part  115  has been moved approximately 90 degrees about the axis A from the left hand side L towards the right hand side R. By turning the catheter hub rotatable part  115  additionally approximately 90 degrees about the axis A towards the right hand side R from the intermediate configuration, the catheter assembly  100  will conform into its right hand side configuration. The intermediate configuration is a type of transformation state between the left hand side and right hand side configurations, which are the two optional configurations available for the user. Both the right wing recess  135   a  and the left wing recess  135   b  are visible in  FIG.  2   b   . 
     Right Hand Side Configuration 
     The right hand side configuration is shown in  FIGS.  3   a  and  3   b   . The catheter hub rotatable part  115  has been moved about the axis A approximately 180 degrees from its left hand side configuration to its right hand side configuration. The extension tube coupling  120  is fitted in the right hand side recess  135   a  (shown in  FIGS.  1   a - 2   b   ). 
     The catheter assembly  100  may further comprise a seal (not shown) between the catheter hub rotatable part  115  and the catheter hub front part  112  to avoid liquids to penetrate and/or leak out of the catheter hub  110 . Such seal may be in the form of a round elastomeric seal. 
     Second Embodiment - Catheter Tube Movable With Rotatable Part 
     In a second embodiment, the catheter hub rotatable part  115  and the catheter hub front part  112  are integral with one another, such that the catheter hub front part  112  rotates together with the catheter hub rotatable part  115 . In such case, the catheter tube  140  will also rotate when the rotatable part  115  rotates about the axis A. 
     Common Features 
     The rotation of the catheter rotatable part  115  can be conducted either before or after the catheter assembly  100  has been connected to a patient. This facilitates the use of the catheter assembly  100  for left and right handed users and/or caretakers. 
     The disclosed catheter assembly  100  is a closed system, i.e. a system wherein a septum is provided in the catheter hub  110 , and fluids are withdrawn or introduced through the lateral extension tube  125 . In such systems, the extension tube coupling  120  is commonly placed on a left hand side L, since this simplifies the use of the catheter assembly  100  for right handed people, which in general represent the majority of people. However, for left handed people, the use of such catheter devices are cumbersome and inconvenient. 
     The pair of wings  130  disclosed herein will act as a fixation element when the catheter assembly  100  is to be attached to the patient. The catheter assembly  100  is for instance attached by covering the wing pair  130  with medical tape which is attached to the skin of the patient. However, such fixation element may have another shape than that of the wing pair  130  and be used together with the catheter hub  110  having a catheter rotatable part  115  as disclosed herein. For instance, each wing of the pair of wings  130  may have a round or rectangular shape. 
     The rotation angle of the catheter rotatable part  115  about the axis A depend on the flexibility of the pair of wings  130  and the surface which they are attached to. For instance, when using a pair of wings  130  of a highly flexible material and when the wings  130  are attached to a thin object, such as a child’s finger, the rotation angle may be as high as 320 degrees. 
     The pair of wings  130  are made of a flexible, resilient material, for instance a plastic (such as an elastomer) or a silicone. 
     Moreover, the distal coupling means  132  and the proximal coupling means  134  need not be integrally formed with the wing pair  130 , but may be formed separately from the wing pair  130  and connected to the pair of wings  130  and the catheter hub  110  respectively. Also, in one embodiment, the wing pair  130  only comprises one coupling means  132 ,  134 . 
     Further, the catheter assembly  100  may be connected through the connection portion  118  to a needle assembly (not shown) to form a catheter instrument. Such needle assembly may be any needle assembly known in the art. 
     In the claims, the term “comprises/comprising” does not exclude the presence of other elements or steps. Furthermore, although individually listed, a plurality of means, elements or method steps may be implemented by e.g. a single unit or processor. Additionally, although individual features may be included in different claims, these may possibly advantageously be combined, and the inclusion in different claims does not imply that a combination of features is not feasible and/or advantageous. In addition, singular references do not exclude a plurality. The terms “a”, “an”, “first”, “second” etc. do not preclude a plurality. Reference signs in the claims are provided merely as a clarifying example and shall not be construed as limiting the scope of the claims in any way.