Patent Publication Number: US-2023158274-A1

Title: Protection Against Unauthorized Access to Intravenous Catheter While Infusion In-Progress

Description:
TECHNICAL FIELD 
     This invention relates generally to intravenous catheters, and more particularly to accessory devices to prevent unauthorized use thereof for self-administering illicit drugs. 
     BACKGROUND 
     Medical treatment often involves the infusion of medications through an intravenous (IV) catheter. However, many drug abusers see this IV catheter as a convenient access for self-administering illicit drugs. While the medication infusion is in-progress, and when medical personnel are not watching, they may covertly detach the IV catheter from the medication infusion and quickly use the IV catheter to self-administer an unauthorized drug. Thus, there is a need for making IV catheters more resistant to unauthorized use, while allowing an infusion to proceed. 
     SUMMARY 
     This invention is used for patients who have a venous catheter inserted into a venous blood vessel. The patient receives a medical fluid through this venous catheter. Examples of medical fluids include cancer chemotherapy, antibiotic/antifungal medications, nutrients, immunoglobulins, etc. This invention could be used with any of various types of venous catheters such as standard peripheral venous catheters (i.e. IV lines), or long-term indwelling catheters such as central venous access catheters, hemodialysis catheters, peripherally inserted central catheters (PICC), or midline catheters. 
     The medical fluid is administered through an infusion line (e.g. a conventional IV line connected to an IV fluid bag), which comprises an infusion tubing. The infusion line has a connector (e.g. a luer-type adaptor); and the venous catheter has a counterpart connector (e.g. a luer fitting that screws into a luer adaptor). The connector for the infusion line is coupled to the counterpart connector for the patient&#39;s venous catheter to create an infusion catheter coupling. This invention is designed to prevent, discourage, or detect unauthorized access to this catheter coupling. 
     In one aspect, this invention is a temporary catheter security device for temporarily locking an infusion catheter coupling while an infusion is in-progress. The infusion catheter coupling is placed inside the catheter security device and locked therein to prevent unauthorized access. Enclosure Design: In one embodiment, the security device comprises a cover piece and a base piece that are designed to mate with each other to form an enclosure. The security device has an open configuration and a closed configuration. When the cover piece and base piece are not mated, the security device is in open configuration. 
     The catheter security device has a locking mechanism to lock the device in closed configuration. For the locking mechanism, there is a locking part on the cover piece and a locking counterpart on the base piece. The locking part and the locking counterpart engage with each other as the locking mechanism. When the cover piece and base piece are locked together in closed configuration, they form an enclosure within. The locking mechanism is designed to be breakable by manual force with or without a hand tool (with no additional force provided by electric power, such as a motor). See more details below about breaking the locking mechanism. 
     The catheter security device could have any suitable shape for holding an infusion catheter coupling therein. For example, the device could have a rectangular or cylindrical shape. The catheter security device could have any suitable dimensions. In some cases, the enclosure (formed by the cover piece and a base piece) has a length in the range of 5-15 cm. In some cases, the enclosure has a width in the range of 1-5 cm. In some cases, the enclosure has a depth in the range of 1-5 cm. 
     The enclosure (formed by the locking of the cover piece to the base piece) has a first opening at one end and a second opening at another end. These openings are where the infusion tubing (of the infusion line) and the catheter tubing (of the venous catheter) exit from the enclosure. The catheter security device is designed to allow an infusion to continue while the infusion catheter coupling is enclosed therein. Thus, the tubings should not be pinched closed. As such, the catheter security device has openings that sufficiently wide to avoid obstruction of the medical fluid infusion. In some cases, the first and second openings each independently have a width in the range of 1.0-6.0 mm wide; and in some cases, width in the range of 2.0-4.0 mm wide; and 
     In some embodiments, the catheter security device is a clamshell design with the cover piece being a first shell and the base piece being a second shell, and the device further comprises a hinged spine connecting the first shell and the second shell. In some cases, the first shell comprises a first pair of notches and the second shell comprises a second pair of notches. The first pair of notches and the second pair of notches are configured to match to form the openings for the enclosure. 
     In some embodiments, the catheter security device is a box design with the cover piece being a top lid and the base piece being a bottom box having a compartment. The top lid is configured to be fitted over the bottom box. In some cases, the bottom box has a pair of notches that form openings for the enclosure. The top lid may or may not have a counterpart notch. 
     Method of Use: In another aspect, this invention is a method of infusing a medical fluid through a patient&#39;s venous catheter while locking the catheter coupling inside an enclosure. The above-described catheter security device could be used. The catheter coupling is placed onto the base piece. The cover piece is mated to the base piece so that the catheter security device is in closed configuration. The locking part and the locking counterpart are engaged to lock the catheter security device in closed configuration and form the enclosure. With this, the catheter coupling is contained in the enclosure and locked therein. The catheter tubing exits out of the enclosure at the one opening. The infusion tubing exits out of the enclosure at the other opening. The medical fluid is infused through the infusion line and into the venous catheter while the catheter security device is locked in closed configuration. The infusion may be started before or after implementing the security device. 
     When the infusion is completed, administration of the medical fluid is stopped and the catheter coupling is ready to be released. This is done by permanently breaking the locking mechanism on the security device. There are a variety of ways to permanently break the locking mechanism, such as cutting a part of the locking mechanism (e.g. with scissors or cutting forceps) or manually deforming the locking mechanism with a tool (twisting off with pliers or forceps clamp). The catheter coupling is removed from the security device, which may be performed before or after stopping administration of the medical fluid. Further post-infusion steps may include uncoupling the infusion line from the venous catheter. 
     Bag-Type Design: In another embodiment, the security device comprises a pouch having a main body and one or more detachment portions. The detachment portion is demarcated from the main body by an indicia line or dividing line. The indicia line may be any type of marking on the pouch, such as printed ink lines or scratches made into the surface. The dividing line may be any type of structural alteration to the pouch to facilitate breaking off the detachment portion. Examples of dividing lines include grooves, scorings, perforations, etc. 
     The security device further comprises one or more fasteners on a first side of the pouch, and one or more fasteners on a second side of the pouch. Adjacent or between the fasteners, there is a first opening at the first side of the pouch, and a second opening at the second side of the pouch. The catheter security device is designed to allow the infusion to continue while the catheter coupling is locked therein. As such, the openings are sufficiently wide to avoid obstruction of the medical fluid infusion. In some cases, the first and second openings each independently have a width in the range of 1.0-7.0 mm wide; and in some cases, in the range of 2.0-5.0 mm wide. 
     Method of Use: In another aspect, this invention is a method of infusing a medical fluid through a patient&#39;s venous catheter while locking the catheter coupling inside a bag-type security device. The catheter coupling is placed inside the pouch. This could be done by making the catheter coupling outside of the pouch (e.g. connecting the venous catheter to the infusion line outside the pouch), and after the catheter coupling is made, putting the catheter coupling inside the pouch. 
     The fasteners on both sides are engaged to lock the pouch. With this, the catheter coupling is contained in the pouch and locked therein. The catheter tubing exits out of the pouch at the one opening. The infusion tubing exits out of the pouch at the other opening. The medical fluid is infused through the infusion line and into the venous catheter while the catheter security device is locked. The infusion may be started before or after implementing the security device. 
     When the infusion is completed, administration of the medical fluid is stopped and the catheter coupling is ready to be released. This is done by detaching the detachment portion of the pouch. Detaching may be performed in any suitable manner, such as cutting, tearing, splitting, cracking, fracturing, etc. The catheter coupling is removed from the security device, which may be performed before or after stopping administration of the medical fluid. Further post-infusion steps may include uncoupling the infusion line from the venous catheter. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1    shows a conventional coupling of a PICC line to an IV infusion line. 
         FIG.  2    shows an example of a temporary catheter security device. 
         FIGS.  3 - 5    show the security device in closed configuration to form an enclosure containing the catheter coupling.  FIG.  3    shows a top view;  FIG.  4    shows a perspective view from the IV line side;  FIG.  5    shows a different perspective view from the PICC line side. 
         FIG.  6    shows an alternate configuration for using the same security device. 
         FIG.  7    shows a different locking mechanism that could be used. 
         FIG.  8    shows another locking mechanism that could be used. 
         FIGS.  9 A-C  show an alternate box-type design for the security device.  FIG.  9 A  is a side view;  FIG.  9 B  is an end-on view;  FIG.  9 C  shows the locking parts engaged. 
         FIGS.  10 A and  10 B  show a bag-type security device that comprises a plastic pouch.  FIG.  10 A  shows a top view;  FIG.  10 B  shows a left side end-on view. 
         FIG.  11    shows the bag-type security device when the infusion is finished. 
         FIG.  12    shows a different design for a bag-type security device. 
     
    
    
     DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS 
     To assist in understanding the invention, reference is made to the accompanying drawings to show by way of illustration specific embodiments in which the invention may be practiced. The drawings herein are not necessarily made to scale or actual proportions. For example, lengths and widths of the components may be adjusted to accommodate the page size. 
       FIG.  1    shows a conventional coupling of a PICC (peripherally inserted central catheter) line  10  to an IV line (intravenous) line  20 . IV line  20  has a tubing  22  and a luer-type connector  24 . PICC line  10  has a tubing  12  and a luer-fitting  14 . The engagement of luer-type connector  24  of IV line  20  to luer-fitting  14  of PICC line  10  makes a catheter coupling  26 . IV line  20  is attached to a source of medication fluid (e.g. an infusion bag) and PICC line  10  has already been inserted into the patient&#39;s vein. Thus, the medical fluid flows through IV line  20 , into PICC line  10 , and then into the patient&#39;s vein. 
       FIG.  2    shows an example of a temporary catheter security device  30  (perspective view). Security device  30  is a clamshell design with a top shell  32  and a bottom shell  34 . Top shell  32  and bottom shell  34  are connected by a flexible hinge  36  that runs along the spine of the back side. Here, security device  30  is shown in open configuration with the catheter coupling  26  laid onto the bottom compartment of bottom shell  34 . Top shell  32  and bottom shell  34  and have ridges  38  to support the various parts of the infusion setup. 
     Top shell  32  has a pair of small half-circle notches  40 . Likewise, bottom shell  34  has a pair of small half-circle notches  42 . IV tubing  22  and PICC line tubing  12  are set into notches  42  of the bottom shell  34 . As will be seen later, these notches  40  and  42  will make exit holes where IV tubing  22  and PICC line tubing  12  exit. 
     Security device  30  has a locking mechanism. There is a top locking lip  44  at the front side edge of top shell  32 . At the bottom side of top locking lip  44 , there is a barbed protrusion  46  that works as a snap lock. There is a counterpart bottom locking lip  48  at the front side edge of bottom shell  34 . Bottom locking lip  48  has a small hole  47  for receiving barbed protrusion  46 . 
     Top locking lip  44  and bottom locking lip  48  are designed to mate to form a snap lock for security device  30 . 
       FIGS.  3 - 5    show security device  30  in closed configuration to form an enclosure  50  containing catheter coupling  26  (hidden inside).  FIG.  3    shows a top view;  FIG.  4    shows a perspective view from the IV line side;  FIG.  5    shows a different perspective view from the PICC line side.  FIG.  3    shows top locking lip  44  and bottom locking lip  48  mated to form a snap lock  52 . Dashed line  54  indicates where the snap lock  52  can be cut by scissor  56  or knife to sever snap lock  52  and allow opening of enclosure  50  to expose catheter coupling  26 . Dashed line  54  could also be an actual indicia marking on top locking lip  44  (e.g. a line drawn on it, accompanied by print stating “cut here”). In closed configuration for security device  10 , enclosure  50  has a length (L) of about 9 cm, a width (W) of about 2 cm, and a depth (D) of about 2 cm. 
       FIG.  4    shows how the notch  40  of top shell  32  and counterpart notch  42  of bottom shell  34  match to form an exit hole for IV tubing  22 . At the other end of enclosure  50 ,  FIG.  5    shows how the notch  40  of top shell  32  and counterpart notch  42  of bottom shell  34  match to form an exit hole for PICC line tubing  12 . The exit holes have a width of about 3 mm. With catheter coupling  26  locked inside security device  30 , the patient is prohibited from unauthorized access to the catheter coupling  26 . 
       FIG.  6    shows an alternate configurations in which the same security device  30  is used, but the catheter coupling  26  is laid onto the top compartment of top shell  32  (instead of on bottom shell  34 ). In this instance, top shell  32  is the base piece and bottom shell  34  is the cover piece. Otherwise, security device  30  operates in the same way as above. Note that in  FIGS.  4 - 6   , IV tubing  22  and PICC line tubing  12  are not pinched closed. That is, the exits holes at both ends of enclosure  50  are wide enough to freely accommodate IV tubing  22  and PICC line tubing  12 . Thus, the medical fluid can continue flowing through IV line  20 , into the PICC line  10 , and then into the patient&#39;s vein, even with security device  30  locked shut. The infusion may be started before or after security device  30  is locked shut. 
     When the infusion is finished, snap lock  52  is cut in the manner shown in  FIG.  3    above. This exposes catheter coupling  26 , which is removed from security device  30 . Thus, security device  30  is only for temporary use during the infusion procedure. After the infusion procedure is complete and security device  30  is removed, a more long-term catheter enclosure device could be used, such as those described in U.S. Patent Application Pub. No. 2019/0381305 (date 19 Dec. 2019 to Justus), or US 2020/0391001 (date 17 Dec. 2020 to Justus et al.); or U.S. Pat. No. 8,858,505 (date 14 Oct. 2014 to Justus et al.). 
       FIG.  7    shows a different locking mechanism that could be used. In locking mechanism  60 , there is an anchor part  62  of the locking mechanism, which can be considered as having two sections. There is an upper section  76  and a lower section  68 . These two sections are connected by bridge segments  66  on each lateral side. The bridge segments  66  follow a path that creates a void window  70 . Lower section  68  of the anchor part  62  has two flexible arms  72  that are designed to flex inward and then snap outward. 
     The bottom part of locking mechanism  60  is a slot piece  64 , which is designed to receive anchor part  62  for a snap lock mechanism. Slot piece  64  has two hooks  74  for engaging with the two flexible arms  72  of the anchor part  62 . As slot piece  64  moves downward, flexible arms  72  slides against hooks  74  and flex inward. When fully inserted into slot piece  64 , flexible arms  72  snap outward to become retained within slot piece  64 . This locks anchor part  62  and slot piece  64  together. Dashed lines  78  indicates where bridge segments  66  can be cut by a scissor or knife. This severs the connection between upper section  76  of anchor part  62  and slot piece  64 . This allows opening of the enclosure to expose the catheter coupling so that it can be removed. 
       FIG.  8    shows another locking mechanism that could be used. In locking mechanism  80 , there is a pawl spear  82  and a slot  84 . Pawl spear  82  has a series of teeth  86 . Slot  84  has a ratchet  88 . As pawl spear  82  is inserted into slot  84 , teeth  86  get caught in ratchet  88 . This pawl-ratchet mechanism locks pawl spear  82  and slot  84  together. 
     The catheter security device does not necessarily have to be a clamshell design.  FIGS.  9 A-C  show an alternate design in which there is a bottom box  90  and a top lid  92 .  FIG.  9 A  is a side view showing when the bottom box  90  is open for receiving the catheter coupling in the compartment therein. There is no hinge connecting bottom box  90  and top lid  92 . Top lid  92  has upper locking parts  93  on each side; bottom box  90  has lower locking parts  94  on each side. Locking parts  93  and  94  are designed to engage and make a secure lock. 
       FIG.  9 B  is an end-on view showing a V-shaped notch  95  at each end wall of bottom box  90 . The IV line and the PICC line are put into V-shaped notches  95  at each end. After the catheter coupling and infusion lines are put in place, top lid  92  is fitted onto bottom box  90 . As shown in  FIG.  9 C  (end-on view), locking parts  93  and  94  engage to make a secure lock, thereby making an enclosure for the catheter coupling and infusion lines. The infusion lines exit bottom box  90  out of notches  95 , which are partially covered by top lid  92 . 
     The catheter security device does not have to be a rigid box-like design.  FIGS.  10 A and  10 B  show a bag-type security device  100  that comprises a transparent, rectangular-shaped plastic pouch that is of sufficient size to contain catheter coupling  24  held inside. The pouch has a main body  102  and two detachment portions  116 . There are two tear-off lines  112  that demarcate main body  102  of the pouch from the two detachment portions  116 . The pouch is fully open on each side (left/right) so that catheter coupling  24 , IV line tubing  22 , and PICC line tubing can be placed inside. 
     On each side (left/right), security device  100  has a set of fasteners to lock the catheter coupling  24  inside. On the left side, there are fasteners  104  and  105 . On the right side, there are fasteners  106  and  107 . Any suitable type of fastening mechanism may be used for security device  100 , such as those described in U.S. Patent Application Pub. No. US 2019/0381305 (19 Dec. 2019), which is incorporated by reference herein. 
     With catheter coupling  24  placed inside the pouch, all of fasteners  104 ,  105 ,  106 , and  107  are fastened to close-off the pouch on the left and right sides. Note that there is a small opening  108  between the two fasteners  104  and  105 . This is where the IV line tubing  22  exits. Note that there is a small opening  110  between the two fasteners  106  and  106 . This is where the catheter line tubing  12  exits. In use, the catheter coupling  24  is made outside of the pouch, and after the catheter coupling  24  is made, it is and then pulled into the pouch compartment. 
       FIG.  10 B  shows a left side end-on view of security device  100 . As seen here, fastener  104  has two parts  120  and  122  that lock together. Likewise, fastener  105  has two parts  124  and  126  that lock together. Opening  108  is where IV line tubing  22  exits. Thus, security device  100  is designed to allow the infusion is continue while the catheter coupling  24  is locked inside security device  100 . 
       FIG.  11    shows when the infusion is finished. To remove catheter coupling  24 , security device  100  is torn along tear lines  112  and detachment portions  116  are detached. This leaves openings  114  where the pouch is open. From openings  114 , catheter coupling  24  can be pulled out of the pouch. With the infusion completed, the catheter coupling  24  is uncoupled and the luer fitting of the PICC line is capped. 
       FIG.  12    shows a different design for a bag-type security device in which there is only a single tear line. Here, security device  120  comprises a transparent plastic pouch with a main body  122  and a detachment part  124 . The pouch has a bulge  130  to give extra room for accommodating the catheter coupling. Tear-off line  136  demarcates main body  122  of the pouch from detachment part  124 . On the left side, there is a single fastener  124 . On the right side, there is a single fastener  128 . Fasteners  124  and  128  do not extend along the entire side to allow openings  132  and  134  on each side where the infusion tubings can exit. When the infusion is finished, security device  120  is torn along tear line  126  and detachment portion  124  is detached. This allows the catheter coupling to be removed from security device  120 . 
     The descriptions and examples given herein are intended merely to illustrate the invention and are not intended to be limiting. Each of the disclosed aspects and embodiments of the invention may be considered individually or in combination with other aspects, embodiments, and variations of the invention. In addition, unless otherwise specified, the steps of the methods of the invention are not confined to any particular order of performance. Modifications of the disclosed embodiments incorporating the spirit and substance of the invention may occur to persons skilled in the art, and such modifications are within the scope of the invention. 
     Any use of the word “or” herein is intended to be inclusive and is equivalent to the expression “and/or,” unless the context clearly dictates otherwise. As such, for example, the expression “A or B” means A, or B, or both A and B. Similarly, for example, the expression “A, B, or C” means A, or B, or C, or any combination thereof. 
     The terms “first, second, etc.” with respect to elements are being used herein only to distinguish one element from another element. But these are not intended to limit the elements in an ordinal fashion, such as defining the order, position, or priority of the elements. For example, a first element could be alternately be called a second element, and, similarly, a second element could alternately be called a first element, without departing from the scope of the present invention. The first element and the second elements are not the same element. The terms “first, second, etc.” may refer to different elements in different embodiments.