Patent Publication Number: US-2023149664-A1

Title: Sheath/catheter securing device

Description:
FIELD OF THE INVENTION 
     The invention relates to a device that holds a catheter in position relative to a catheter sheath during a procedure. 
     BACKGROUND OF THE INVENTION 
     Interventional radiologist and vascular surgeons perform procedures on patients including those who have acute blood clot formation in the vascular system. This disease entity is referred to as a thromboembolism. Often, a catheter designed to slowly infuse thrombolytic medication into the occluded vessel is positioned and left in place from 2 to 24 hours for the medication to adequately dissolve the blood clot. During this period of time, the patient is closely monitored in an acute care setting (ICU) for unexpected bleeding that may require the medication to be discontinued. The risk of life threatening bleeding is decreased by decreasing the dose of medication delivered, which is made possible by maintaining the exact positioning of the catheter throughout the treatment. The most common cause of catheter dislodgement is movement at the junction of the catheter and vascular sheath at the vascular access site of the patient. One known practice is to wrap tape around the catheter and then suture the tape to the sheath. This is often ineffective and increases the risk of needle stick injury to the physician. Accordingly, there is room for improvement in the art. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The invention is explained in the following description in view of the drawings that show: 
         FIG.  1    shows an example embodiment of the securing device disclosed herein and in a disassembled condition. 
         FIG.  2    shows the example embodiment of the securing device of  FIG.  1    in an assembled condition and in an open configuration with a catheter sheath and a catheter disposed therein. 
         FIG.  3    shows the example embodiment of the securing device of  FIG.  1    in an assembled condition and in a closed configuration with the catheter sheath and the catheter disposed therein. 
         FIG.  4    shows the securing device of  FIG.  1    with example embodiments of anchoring devices. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       FIG.  1    shows a securing device  100  that includes a first body  102 , a second body  104 , and a securing arrangement  106 . The securing arrangement may be any arrangement that is configured to secure the first body  102  to face the second body  104  when the securing device  100  is in a closed configuration ( FIG.  3   ). In the example embodiment shown, the securing arrangement  106  includes a rotatable joint  108  that pivotally folds the first body  102  onto the second body  104  into the closed configuration ( FIG.  3   ), and a securing feature  110  that maintains the closed configuration. In this example embodiment, the rotatable joint  108  includes a hinge  112  with a hinge pin  114  and knuckles  116 . In this example embodiment, the securing feature  110  includes a snap having interlocking elements. The artisan will recognize that any suitable mechanism may be used as the securing feature, including physically interlocking configurations as well as magnetic etc. The folding action disclosed in this example embodiment to reach the closed configuration is, however, not necessary. The securing arrangement  106  is, at a minimum, configured to secure the first body  102  to face the second body  104  in the closed configuration. For example, the first body  102  may be disconnected from the second body  104  when not in the closed configuration. Hence, the rotatable joint is optional. The artisan will appreciate that there are other securing arrangements  106  suitable for holding the first body  102  to face the second body  104  and those are intended to be within the scope of the disclosure. For example, the rotatable joint could be replaced with a second snap. In an alternate example, the entire securing feature  110  could be, for example, a band or clamp that holds the first body  102  facing a discrete second body  104  etc. 
     The first body  102  and the second body  104  can be made of any suitable material known to the artisan. For example, the first body  102  and the second body  104  can be made of a plastic. In an example embodiment, the material of the first body  102  and/or the second body  104  is transparent. This may aid in being able to observe the catheter sheath and catheter during a procedure. Being able to observe the catheter sheath and catheter makes it possible to detect, for example, unexpected bleeding. 
     The first body  102  includes a first body cooperating surface  120 . The second body  104  includes a second body cooperating surface  122 . The securing device  100  further includes a catheter sheath feature  124  and a catheter feature  126 . The catheter sheath feature  124  is configured to geometrically lock the catheter sheath between the first body  102  and the second body  104  in the closed configuration. As show in  FIG.  1   , the catheter sheath feature  124  is a catheter sheath compartment  130  that is distributed between the first body  102  and the second body  104 . The catheter sheath compartment  130  in this example embodiment is composed of a first body catheter sheath recess  132  recessed into in the first body cooperating surface  120  plus a second body catheter sheath recess  134  recessed into the second body cooperating surface  122 . In this example embodiment, the entire catheter sheath compartment  130  has a shape that is a negative of a shape of the catheter sheath. This enables a form fit of the catheter sheath within the catheter sheath compartment  130  without collapsing the catheter sheath. In this embodiment, the shape of the catheter sheath includes a shape  136  of a hub of the catheter sheath plus a shape  138  of a side port of the catheter sheath. While there may be friction between the catheter sheath and the first body cooperating surface  120  and/or the second body cooperating surface  122 , this friction is wholly unnecessary to retain the catheter sheath in the catheter sheath compartment  130 . The geometric interlocking between the catheter sheath and the catheter sheath compartment  130  is the mechanism that traps the catheter sheath in the catheter sheath compartment  130  between the first body  102  and the second body  104 . 
     While the catheter sheath compartment  130  is shown as being distributed between the first body  102  and the second body  104 , it is also envisioned that the catheter sheath compartment  130  may be disposed solely in the first body  102 , and hence formed solely by the first body cooperating surface  120 . Likewise, it is envisioned that the catheter sheath compartment  130  may be disposed solely in the second body  104 , and hence formed solely by the second body cooperating surface  122 . In these latter two embodiments, the catheter sheath compartment  130  may have shape in which only a portion is a negative of the catheter sheath. This would be necessary to allow the catheter sheath to be lowered into the catheter sheath compartment  130 . Moreover, it is possible that the catheter sheath compartment  130  has a shape that is entirely unrelated to the shape of the catheter sheath, but which nonetheless creates a geometric interlock with the catheter sheath and thereby traps the catheter sheath between the first body  102  and the second body  104 . 
     The catheter feature  126  shown in this example embodiment is configured such that the first body  102  and/or the second body  104  directly contact the catheter and lock the catheter in position relative to the catheter sheath via friction between the first body cooperating surface  120  and/or the second body cooperating surface  122  in the closed configuration. However, it is also envisioned that a material  150  may be disposed between the first body  102  and/or the second body  104  and the catheter. In an embodiment, the material  150  may be disposed in some or all of the catheter sheath feature  124 , in some or all of the catheter feature  126 , or in some or all of both. The material  150  may enhance friction between the device and the catheter sheath and the catheter. In an example embodiment, the material  150  is a resilient material (e.g. silicone). The material  150  may also be clear. 
     As shown in  FIG.  1   , the catheter feature  126  is a catheter compartment  140  that is distributed between the first body  102  and the second body  104 . The catheter compartment  140  in this example embodiment is composed of a first body catheter recess  142  recessed into in the first body cooperating surface  120  plus a second body catheter recess  144  recessed into the second body cooperating surface  122 . 
     In this example embodiment, the entire catheter compartment  140  has a shape that is a negative of a shape of the catheter. This enables a form fit of the catheter within the catheter compartment  140  without collapsing/occluding the catheter. Since the catheter is an elongated element of relatively uniform and smooth shape, and since the catheter may be repositioned, a friction fit is preferred. 
     An amount of friction between the catheter compartment  140  and the catheter can be selected. In one embodiment, the amount of friction is selected to be relatively high so that the catheter cannot be moved manually by a technician when the securing device  100  is closed. In such an example embodiment, a portion of the catheter outside/upstream of the securing device  100  would buckle if a technician tried to push the catheter further into the patient. In another embodiment, the amount of friction is selected to be relatively lower so that the catheter remains in place during conditions encountered during normal treatment, but which can be moved/repositioned manually by a technician even when the securing device  100  is closed. In such an example embodiment, a portion of the catheter outside/upstream of the securing device  100  would not buckle if a technician tried to push the catheter further into the patient. 
     While the catheter compartment  140  is shown as being distributed between the first body  102  and the second body  104 , it is also envisioned that the catheter compartment  140  may be disposed solely in the first body  102 , and hence formed solely by the first body cooperating surface  120 . Likewise, it is envisioned that the catheter compartment  140  may be disposed solely in the second body  104 , and hence formed solely by the second body cooperating surface  122 . In these latter two embodiment, the catheter sheath compartment  130  may have shape in which only a portion is a negative of the catheter. This would be necessary to allow the catheter to be lowered into the catheter sheath compartment  130 . Moreover, it is possible that the catheter compartment  140  has a shape that is entirely unrelated to the shape of the catheter, but which nonetheless creates a frictional fit with the sheath and thereby traps the catheter between the first body  102  and the second body  104 . It is also envisioned that material between the first body  102  and the second body  104  could have a shape that is a negative of the shape of the catheter. In such an embodiment, the first body  102  and the second body  104  may or may not also have a shape that is a negative of the shape of the catheter. In other words, the catheter compartment  140  may be disposed in any or all of the first body  102 , the second body  104 , and the material between the first body  102  and the second body  104  and the catheter. 
       FIG.  2    shows the example embodiment of the securing device  100  of  FIG.  1    in an assembled condition and in an open configuration  200  and disposed in which is a catheter sheath  202  having a hub  204  and a side port  206 , and a catheter  208  disposed in the catheter sheath  202 . The hub  204  of the catheter sheath  202  is shown disposed in the second body catheter sheath recess  134  and the catheter  208  is shown disposed in the second body catheter recess  144 . A position of the catheter  208  relative to the catheter sheath  202  can be set before and/or after the catheter sheath  202  and the catheter  208  are positioned as shown. To secure the catheter  208  in a fixed position relative to the catheter sheath  202 , the first body  102  is folded onto the second body  104  until the securing feature  110  engages and thereby holds the first body  102  in a fixed position relative to the second body  104 , which traps the catheter sheath  202  and the catheter  208  therebetween. 
       FIG.  3    shows the example embodiment of the securing device  100  of  FIG.  1    in an assembled condition and in a closed configuration  300  with the catheter sheath  202  and the catheter  208  disposed therein. In the closed configuration  300 , the catheter sheath  202  is geometrically interlocked in the catheter sheath feature  124  and the catheter  208  is frictionally locked in position relative to the catheter sheath  202  by the catheter feature  126 . In embodiments where the first body  102  and/or the second body  104  are made of transparent material like that shown, the transparent material enables one to see the catheter sheath  202  and the catheter  208  and thereby monitor conditions associated therewith. 
       FIG.  4    shows the securing device  100  of  FIG.  1    with example embodiments of anchoring devices. In an example embodiment, an anchoring device  400  includes adhesive that is secured to the first body  102 , the second body  104 , or both (which allows for a choice of which side to face the patient). The anchoring device  400  can also be adhesively secured to a patient so that the securing device  100  does not move relative to an insertion site on the patient. The anchoring device  400  can be as simple as a layer of adhesive that adheres directly to the first body  102 , the second body  104 , or both (which allows for choice of which side to face the patient) and directly to the patient. In such a configuration, there may or may not be an elevated platform on the apparatus  100  intended to receive the adhesive. The anchoring device  400  can be a double-sided adhesive (substrate with adhesive material on opposite sides). The double-sided adhesive may include a removable cover on a side to be adhered to the patient that can be removed immediately prior to being adhered to the patient. The anchoring device  400  may also include a combination of an adhesive and a mechanical connection. In such an example embodiment, the anchoring device  400  is adhesively secured to the first body  102 , the second body  104 , or both and mechanically secured to the patient via, for example, straps (elastic or inelastic) or the like. 
     In an alternate example embodiment, an anchoring device  402  includes an adhesive that is secured to the patient and includes a mechanical connection  404  configured to be secured to the first body  102 , the second body  104 , the catheter sheath  202 , the hub  204 , the side port  206 , and/or the catheter  208  so that the securing device  100  does not move relative to an insertion site on the patient. 
     Examples of suitable anchoring devices include: the Stayfit® Fixation device manufactured by Merit Medical of Jordan Utah; the Statlock® Foley Stabilization Device manufactured by Bard Medical of Covington Ga.; the Statlock® PICC Plus Stabilization Device manufactured by Bard Medical of Covington Ga.; and the Revolution™ catheter securement device manufactured by Merit Medical of Jordan Utah. 
     In an alternate example embodiment, there may be one or more anchoring devices  406 , each including an anchor tab  408  secured to the first body  102 , the second body  104 , or both so that the securing device  100  does not move relative to an insertion site on the patient. The anchor tab  408  may be suture-permeable so that the anchor tab  408  can be sutured directly to a patient through any part of the anchor tab  408 . Alternately, or in addition, the anchor tab  408  may include a through-opening  410  through which a suture may pass and anchor the anchor tab  408  to the patient. The securing device  100  may include any combination of the anchoring devices disclosed above. 
     From the foregoing, it can be seen that the Inventor has devised an effective device that can hold a catheter in position relative to a catheter sheath during a procedure, which represents an improvement in the art. 
     While various embodiments of the present invention have been shown and described herein, it will be obvious that such embodiments are provided by way of example only. Numerous variations, swapping of features among embodiments, changes, and substitutions may be made without departing from the invention herein. Accordingly, it is intended that the invention be limited only by the spirit and scope of the appended claims.