Patent Publication Number: US-2013245612-A1

Title: Medical coupling system

Description:
FIELD OF THE INVENTION 
     The present invention relates to connectors for a fluid path, and more particularly an adapter for coupling a medication providing device with a connector for providing medication to a patient. 
     BACKGROUND OF THE INVENTION 
     To prevent mis-connection of a fluid line to a device containing a particular medication, it has been shown in the prior art that a connector may be made up of two portions, with the portions being connected by complementary configured opposing surfaces. Such two portions connector ensures that the one line from one portion of the connector would not be wrongly connected to a different medication line. A fastening mechanism comprised of such complementary connecting portions is disclosed in U.S. Pat. No. 6,612,624 and its parent U.S. Pat. No. 6,402,207. The &#39;624 patent discloses in particular a ratchet mechanism, as part of the connector, that prevents or impedes the uncoupling of one portion of the connector from a syringe to which the other portion may be connected. In practice, since the ratchet mechanism is dependent on the interaction of the teeth on the inner surface of an outer sleeve with a pawl of an inner body that fits into the outer sleeve, if the syringe were to be tightened too forcefully, the inner body would pop out of the outer sleeve. Moreover, as disclosed in the &#39;624 patent, the ratchet mechanism is a portion of the connector that does not fully isolate the relative rotation of the outer sleeve and the inner body. 
     SUMMARY OF THE PRESENT INVENTION 
     The instant invention adapter is adapted to be interposed between a medication providing device and a connector. The adapter is designed to prevent the medication providing device from being removed therefrom, once the device is secured to one end of the adapter. The other end of the adapter is configured to accept a connector. The connector is rotatably connected to the adapter in one direction. Once fully connected, any further rotational movement along the same direction would simply cause the connector to rotate freely relative to the adapter. With a rotational motion in a counter direction, the connector can be removed from the adapter. 
     The adapter of the instant invention includes an outer cylindrical sleeve or a housing shroud that has an internal circumferential hub catch. In addition, a plurality of bumps extend from the inner wall of the housing shroud toward the central axis of the shroud. Fitted to this housing shroud is a cylindrical inner shroud that has a protrusion circumferentially formed proximate to its distal end that snap-mates to a circumferential groove formed at the distal end of the shroud. The inner shroud and the housing shroud are rotatable relative to each other. 
     A plurality of teeth extend from the proximal end of the inner shroud. When biased by a given force, these teeth of the inner shroud would act against the bumps extending from the inner wall of the housing shroud to prevent the inner shroud from rotating relative to the housing shroud. The extending teeth have inclining ramps that prevent the teeth from acting against the bumps, thereby allowing the two shrouds to rotate freely relative to each other when the biasing force is removed. The inner shroud may be internally threaded for accepting a specially designed connecting end of the connector. 
     A third component of the adapter of the instant invention is a core that fits to the housing shroud from the latter&#39;s other end. The core has a cylindrical central portion defined by a chamfered flange and a ring-shaped flange. This cylindrical central portion mates with the hub catch of the housing shroud that has a number of fingers configured to allow the chamfered flange to pass through but prevent the chamfered flange, the back of which is flat, from passing in the reverse direction. Thus, once the central portion of the core mates with the hub catch, the core is non-removably fitted to, but rotatable freely relative with, the housing shroud. The respective dimensions of the cylindrical central portion of the core and the opening formed by the hub catch fingers are configured to allow the core to rotate freely relative to the housing shroud. With the core fitted to the housing shroud, a medication providing device can be mated to the proximal end of the core. 
     The connector, for example a luer connector, of the medication providing device allows the medication providing device such as a syringe to be mated to the proximal connector of the core. Once the medication providing device is mated to the core, if a user were to try to remove the medication providing device from the core by applying a counter torque to the medication providing device, the core will rotate freely along the direction of the counter torque. The medication providing device is therefore prevented from being removed from the adapter. Additional torque in the direction that mates the medication providing device to the core does not cause any additional tightening, as the core will also rotate freely relative to the shroud. Thus, once the medication providing device is mated to the core, it could not be removed therefrom. 
     The instant invention therefore relates to an adapter for use with a medication providing device and a connector for providing medication to a patient. The adapter includes a housing shroud and an inner shroud fitted to the housing shroud. The inner shroud has an opening for accepting a connecting end of the connector such that the connector, once mated to the inner shroud, is freely rotatable in one direction and is removable from the inner shroud when rotated in a counter direction. The adapter further includes a core fitted in the housing shroud to allow the medication to be routed from the medication providing device to the connector. The core has a proximal end for enabling the medication providing device to be connected to the adapter. The medication providing device is not removable from the adapter once it is connected thereto. 
     The present invention also relates to a combination of a shroud having two open ends and an inner shroud non-removably fitted into one of the open ends of the shroud. The inner shroud has a connector end for enabling it to be mated to a given medication conveying connector. The inner shroud is rotatable freely in one direction once the given connector is mated thereto. The given connector is removable from the inner shroud when it is rotated in a counter direction. The combination further includes a core that is non-removably fitted to the other end of the shroud. The core has a through passage and a connector end for enabling the core to be mated to a luer connector of a medication providing device. The medication providing device, once mated to the connector end of the core, is not removable from the core. 
     The instant invention also relates to a method of routing a medication from a given medication providing device that includes the steps of providing a given medication conveying connector, providing an adapter having a shroud with one and other open ends, non-removably fitting an inner shroud into one end of the shroud and non-removably fitting a core into the other end of the shroud. The inner shroud has a connector end that enables the inner shroud to be mated to the given medical conveying connector, while the core has a through passage and a connector end for enabling it to be mated to the connector of the medication providing device that, once mated to the connector end of the core, is not removable from the core. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
       The present invention will become apparent and the invention itself will be best understood with reference to the following description of the present invention taken in conjunction with the accompanying drawings, wherein: 
         FIG. 1  is an illustration of an exemplar overall path through which a medication is provided to a patient, with the various components being shown; 
         FIG. 2  is a perspective view of the adapter of the instant invention, with its components in alignment but not assembled, and a connector for conveying fluid to a patient; 
         FIG. 3  is a perspective view of the adapter of the instant invention in which the components have been assembled; 
         FIGS. 4A-4D  are different views of the housing shroud of the adapter of the instant invention; 
         FIGS. 5A-5D  are different views of the inner shroud of the adapter of the instant invention; and 
         FIGS. 6A-6D  are different views of the core of the adapter of the instant invention. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     As shown in  FIG. 1 , the adapter of the instant invention, designated  2 , is connected to a connector  4 , which is shown to include two portions  6  and  8 . Portion  6  has a given connector end  10  that has a pair of projections  12  that enable connector end  10  to be mated to adapter  2 . Connector end  10  may also be connected to a female end of a connector such as luer connector  16  of filter  14  shown in  FIG. 1 . Filter  14  is interposed between connector  4  and adapter  2  for filtering out contaminants that may be present in the medication or fluid that passes from a medication providing device, such as for example a syringe or a pump, to connector  4 . Filter  14 , in addition to luer connector  16 , also has a second connector  18  that has a configuration similar to that of connector end  10  of connector  4 , so as to enable filter  14  to be coupled to adapter  2 . 
     In the embodiment shown in  FIG. 1 , the end of portion  8  of connector  4  that is not connected to portion  6  has an opening  20  to which one end of a catheter is fitted. The other end of the catheter is connected to a patient. Thus, a fluid such as medication may be conveyed from connector  4  to a patient. Portions  6  and  8  of connector  4  have respective complementary opposing surfaces so that only portions  6  and  8  may be coupled to each other. This is to avoid mistaken coupling of either one of those portions with a different half portion, so as to prevent the conveying of an incorrect medication to the patient via the catheter. Filter  14  is provided in the  FIG. 1  embodiment for filtration purposes and is not necessary for the practice of the instant invention, as evidenced by the direct coupling of connector  4  to adapter  2  as shown in the  FIG. 2  embodiment. 
     During transport and before use, to maintain sterility, a cap  22  may be used to cover connector end  10  of connector  4 . Similarly, connector  18  of filter  14  may be covered by a cap  24 . A plug  26  that has a connector end that may have the same configuration as connector end  10  is used to cover the end opening of adapter  2 , that, as shown in  FIG. 1 , faces connector  18  of filter  14 . A more detailed discussion of the complementary opposing surfaces of portions  6  and  8  of connector  4  may be gleaned from the disclosure of the above-mentioned U.S. Pat. No. 6,612,624, the disclosure of which being incorporated by reference herein. 
     With reference to  FIG. 2 , adapter  2  is shown to include an outer housing sleeve or a housing shroud  30  that has the shape of a cylinder with two opposed open ends  32  and  34 . Adapter  2  further has an insert or an inner shroud  36  that fits into housing shroud  30  by way of its opening  32 . A third component of the adapter  2  of the instant invention comprises a core insert, or simply core  38  that fits into housing shroud  30  by way of the latter&#39;s opening  34 . 
       FIG. 3  shows adapter  2  in its assembled form with inner shroud  36  and core  38  respectively fittingly mated to housing shroud  30 . 
     A perspective view of housing shroud  30  is shown in  FIG. 4A . Together with the sectional views of  FIGS. 4B and 4C  and the end view of  FIG. 4D , housing shroud  30  is shown to have a first or distal opening  32  and a second or proximal opening  34 . As best shown in the sectional views of  FIGS. 4B and 4C , a hub catch  40  made up of extending fingers  42  is provided at the proximal portion of housing shroud  30 . Each of fingers  42  has a finger tip  44  that extends toward the longitudinal axis  46  of cylindrical housing shroud  30  to form an opening  48  that has a smaller diameter than proximal opening  34 . Finger tips  44  of the fingers  42  that make up hub catch  48  are chamfered in the direction of opening  34  and yet are flat when viewed from the direction of opening  32 . At distal opening  32  of housing shroud  30  there is a lip  50 . Opening  32  is reduced in diameter at location  52 . As can be seen from the end view of  FIG. 4D , which is viewed from opening  32 , each of fingers  42 , best represented by fingertips  44 , is separated from its adjacent fingers by a notch  54  that provides additional flexibility to the fingers when core  38  is inserted to housing shroud  30  via opening  34 . Also shown in  FIG. 4D , as well as the cross-sectional views of  FIGS. 4B and 4C , are a plurality of bumps  56  that extend inwardly toward longitudinal axis  46 . 
       FIGS. 5A-5D  show inner shroud  36  of the instant invention adapter. As shown, inner shroud  36  has a through bore  53  that extends from its distal end  54  to its proximal end  56 . At its distal end there is a protrusion  58  formed circumferentially at its outer surface. Outer wall  60  extends from distal end  54  to proximal end  56 , ending with a plurality of teeth  62  that extend longitudinally away from proximal end  56 . Each of the teeth has an apex  62   a , a ramp portion  62   r  and an upright portion  62   u.  Each of the teeth is separated from its adjacent teeth by a space  64 . Inner shroud  36  is internally threaded from its proximal opening  54  through a major portion of the shroud, per indicated by designation  66 . 
     Core  38  of the adapter of the instant invention is best shown in  FIGS. 6A-6D . Core  38  comprises at its proximal portion a connector end, in the form of a luer fitting  68  that allows it to be coupled to a luer end of a medication providing device such as for example a syringe or medication pump. Extending from the proximal portion of core  38  is a circumferential flange  70  that has a diameter substantially the size of proximal opening  34  of housing shroud  30 . A cylindrical central portion  72  extends from flange  70  to a shoulder flange  74  that has a flat rear surface  76  facing flange  70 . Shoulder flange  74  is chamfered at an angle along its surface  78  so that the widest portion of shoulder flange  74  extends at an angle inwards towards longitudinal axis  46  until it joins the distal male portion  80 . A bore  82  through core  38  extends from the tip of distal portion  80  to opening  84  at the proximal end of core  38 . 
     In combination, the adapter of the instant invention has fitted into housing shroud  30  at its proximal opening  34  core  38  and at its distal opening  32  inner shroud  36 . With reference to  FIGS. 4A-4D ,  5 A- 5 D and  6 A- 6 C, it can be seen that inner shroud  36  is mated to housing shroud  30 . More particularly, the circumferential protuberance  58  of inner shroud  36  is press or snap fitted to space  51  at the distal end of housing shroud  30 . Since the cross dimension of inner shroud  36  is configured to fit within space  51  of housing shroud  30 , once protuberance  58  is movably mated to space  51  and is retained by lip  50 , inner shroud  26  is no longer removable from housing shroud  30 . Protuberance  58  of inner shroud  36  is slidably movable within space  51  between reduced diameter location  52  and lip  50 , per shown by bi-directional arrows  59 . Inner shroud  36  therefore is movable axially relative with housing shroud  30 . 
     Inner shroud  36  may be biased relative to housing shroud  30  in the direction indicated by directional arrow  86  ( FIG. 4B ) when connector  4  is being coupled to adapter  2  via opening  54  of inner shroud  36 . When connector  4  is being threadingly mated to inner shroud  36 , a force is applied by the user, i.e., a torque in the direction to lock connector end  10  of connector  4  to the internal threaded portion  66  of inner shroud  36 . The torque force, which is combined with a biasing forward force, causes inner shroud  36  to be pushed along the direction of directional arrow  86  so that teeth  62  of inner shroud  36  would come into contact with bumps  56  formed internally at housing shroud  30 . Bumps  56  then act as a backstop to enable the user to threadingly mate connector  10  to inner shroud  36 , and therefore adapter  2 . 
     Once connector end  10  is fully mated to the threaded portion  66  of inner shroud  36 , if connector  4  is rotated further in the direction of the locking torque movement, inner shroud  36  would pull away and rotate freely, as ramp portion  62   r  of teeth  62  would guide teeth  62  away from bumps  56 . But if a counter torque were to be applied to connector  4  to rotate inner shroud  36  in a direction opposite to that of mating connector  4  to inner shroud  36 , connector  4  is removable from inner shroud  36 , as back portion  62   b  of each of teeth  62  acts against a side of a corresponding bump  56  to thereby prevent rotation of inner shroud  36  relative to housing shroud  30 . As a result, connector  4  is removable from adapter  2  when it is rotated in a direction counter to the rotation needed to thread it into adapter  2 . 
     Core  38  is fitted to housing shroud  30  via its proximal opening  34 . As core  38  is pushed into housing shroud  30 , the chamfered surface  78  of shoulder  74 , since it is at a forward incline, is able to readily cause catch fingers  44  of housing shroud  30  to slightly flex, particularly since the adjacent fingers  44  are separated by slots  54 , so that shoulder  76  would pass opening  48  of catch hub  48 . Once shoulder  74  fully passes the catches  44  of fingers  42 , since its back surface is flat, core  38  is prevented by catch hub  48 , more specifically by the plurality of fingers  42 , from being removed or separated from housing shroud  30 . 
     Distal opening  34 , as best shown in the cross-sectional views of  FIGS. 4B and 4C , has a cross section  35  that has the same diameter as flange  70 . A ledge  37  at opening  34  prevents flange  70  from being pushed further into housing shroud  30 , per directional arrow  88 . Thus, once core  38  is fitted to housing shroud  30 , it is non-removably fitted thereto. The cylindrical central portion  72 , which is sandwiched by shoulder  76  and flange  70 , is positioned within the proximal portion of housing shroud  30 . 
     The nose portion  80  of core  38  is configured to have a length that allows it to be positioned within space  51  of housing shroud  30 , as best shown in  FIG. 3 . Thus positioned, nose portion  80  is adaptable to mate with connector end  10  of connector  4 , when connector  4  is mated to inner shroud  36 . Once connector  4  is mated to inner shroud  36 , a through path extending from opening  20  of connector  4  to opening  84  of core  38  is established to thereby enable fluid such as medication to pass from a medication providing device to the connector, and from there through the catheter connected thereto to the patient. 
     As core  38  is non-removably connected to housing shroud  30  by central portion  72  being rotatably mounted to catch hub  42 , core  38  is rotatable freely either clockwise or counterclockwise relative to housing shroud  30 . The respective dimensions of proximal opening  34  of housing shroud  30  and flange  70  may be manufactured to establish a predetermined friction between housing shroud  30  and core  38  to enable a user to readily connect a medication providing device, such as for example a conventional syringe or the connector of a medication pump, to luer connector  68  of core  38 . But once the syringe is fully connected to core  38 , due to the fact that core  38  is freely rotatable relative to housing shroud  30 , the medication providing device could no longer be removed from adapter  2 , as any rotational movement applied to the medication providing device would cause core  38  to rotate freely relative to housing shroud  30 . 
     By thus preventing the detachment of the medication providing device from adapter  2  once it is connected to the luer connector end  68  of core  38 , the adapter of the instant invention ensures that the medication in the medication providing device could only be conveyed to the connector that has a connector end that could mate correctly only with the connector end of the adapter, i.e., threaded connector portion  66  of inner shroud  36  for the embodiment being discussed. Of course, if connector  4  has a differently configured connector end  10 , a corresponding connector end is needed at inner shroud  36  for properly mating therewith. Adapter  2  of the instant invention is therefore able to provide a bridge for connecting a medication providing device to the proper connector, to thereby ensure that a correct fluid pathway is established to convey the correct medication to the patient.