Patent Publication Number: US-6210372-B1

Title: Storage and delivery device for a catheter or needle

Description:
BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates generally to a storage and delivery system for a highly viscous material. More specifically, the invention relates to a delivery system which supplies a highly viscous material from a syringe to a catheter or a needle for injection purposes. 
     2. Description of the Related Art 
     FIG. 1 shows a prior art device for supplying a fluid to a catheter or needle. The barrel  12  of the syringe  10  has a conical hub  14  formed at an end thereof for dispensing a material  16  stored in the syringe to a catheter or needle  18 . The hub  14  is connected to the catheter or needle  18  through a cap  20  which is threadedly attached to the inside portion of an extended portion  21  of the barrel  12 . The cap  20  is also cone-shaped and a seal is formed between the two mating conical surfaces of the hub and cap. The seal is tightened by further rotation of the cap  20 . This type of device is sometimes referred to as a Luer lock fitting. 
     The problem with this device is as follows. Prior to the step of attaching the cap  20  to the hub  14 , the material  16  may inadvertently contaminate the outer conical shape of the hub  14 . In certain applications, the material  16  includes a viscous gel with coarse particles  24  suspended therein such as CoapTite™. The presence of the particles  24  on the conical surface of the hub prevents a tight seal from being formed by the mating conical surfaces of the cap  20  and hub  14 . As a result, when the plunger (not shown) of the syringe  10  is actuated to force the material  16  into the catheter or needle  18 , some of the gel leaks out through a narrow gap  22  between the conical surfaces of the hub  14  and the cap  20 . When this occurs, the relative concentration of coarse particles in the viscous material that travels into the catheter or needle increases, which increases the viscosity substantially. When certain materials are used, the viscosity increases to a level at which the material may not be able to travel through the catheter or needle. That is, even if the force exerted on the plunger of the syringe is increased dramatically, the material cannot be forced into the catheter or needle. Also, this excessive force may damage or break the syringe. If this happens, the catheter/needle delivery system must be replaced, which is expensive, inconvenient and potentially dangerous if the catheter/needle is being used for emergency treatment. 
     Also, in this prior art device, the end of the syringe where the material is dispensed to the catheter or needle has a reduced diameter A. When the viscous material travels through this reduced diameter portion, the pressure is increased, which further restricts the flow of the material to the catheter or needle. 
     Further, because the cap  20  is threadedly attached to the hub  14 , in order to remove the syringe, it is necessary to rotate the cap  20 , which is time consuming and cumbersome. 
     As an alternative to using screw threads, it is known in the art to utilize a locking slide to secure members in syringe devices. For example, U.S. Pat. No. 2,737,950 (Berthiot) discloses a cooperating lock  18  for securing a needle  10 . As shown in FIG. 3 of Berthiot, the lock  18  has a large diameter portion and a narrow diameter portion formed by two web-shaped branches  19 . When the needle  10  is moved down towards its operational position, the lower end  14  of the needle passes through the large diameter portion of the lock  18 . When the needle reaches its operational position, the lock  18  is pushed so that the groove  20  of the needle is locked firmly into position by the two web-shaped branches  19 . 
     Also, U.S. Pat. No. 5,158,569 (Strickland), discloses a slide plate  84  for securing a catheter  9 . As shown in FIG. 3 of Strickland, the slide plate  84  includes a circular opening  94  having a diameter which is greater than the diameter of the catheter  9  and a slot  96  having a width which is less than the diameter of the catheter  9 . When the slide plate is in a first, or retracted, position, the catheter  9  passes freely through the circular opening  94  (see FIGS. 4 and 5 of Strickland). When the slide plate is in a second, or inserted, position, the slot  96  frictionally engages the catheter, thereby restraining the catheter  9  in the slide plate  84  (see FIGS. 2 and 6 of Strickland). 
     When the slide locks disclosed by Berthiot and Strickland are moved to the locked position, these slide locks do not provide any positive indication to the user that the slide locks are properly engaged in the locked position. Therefore, there exists the possibility that the needle  10  and catheter  9  may be improperly secured by the slide lock. 
     SUMMARY OF THE INVENTION 
     The present invention has been made in view of these problems associated with the prior art. Accordingly, one of the objects of the present invention is to provide a delivery system which can reliably deliver a highly viscous material, even if the material contains coarse particles, to a needle or catheter which exhibits minimal or no leakage of the highly viscous material. 
     A second object of the present invention is to provide a delivery system in which it is easy to change the syringe. 
     A third object of the present invention is to provide a delivery system which can positively inform the user that the syringe is properly attached and locked thereto. 
     To achieve these objects, the delivery system of the present invention comprises a delivery cap for connecting a catheter or needle to a cartridge, an interconnect insert and a compression sleeve disposed within the delivery cap which create a leak proof seal between the cartridge and the delivery cap, and a slide lock to reliably lock the cartridge to the delivery cap. 
     With this configuration, the delivery system of the present invention can reliably supply a highly viscous material to a catheter or a needle with minimal leakage between the syringe and the delivery cap. Also, the syringe can be replaced easily without rotating the syringe. Further, when a syringe is attached to the delivery cap, the slide-lock assembly positively informs the use that the syringe is properly attached and locked to the delivery cap. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a cross-sectional view of a prior art device; 
     FIGS. 2A,  2 B and  2 C show the main components of a first embodiment of the present invention; 
     FIGS. 3A,  3 B and  3 C show the locking clamp; 
     FIGS. 4A and 4B show the operation of the locking clamp; 
     FIG. 5 is a cross-sectional view of the delivery cap; 
     FIG. 6 is a cross-sectional view of the interconnect insert; 
     FIG. 7 is a cross-sectional view of the compression sleeve; 
     FIG. 8 is a cross-sectional view of the delivery cap attached to a cartridge; 
     FIG. 9 shows the raised sealing surfaces of the cartridge mating with the raised sealing surfaces of the compression sleeve; 
     FIG. 10 shows the main components of a second embodiment of the present invention; 
     FIG. 11 is a cross-sectional view of the injection needle assembly; 
     FIG. 12 is a cross-sectional view of the cannula insert of the injection needle assembly; 
     FIG. 13 is a cross-sectional view the injection needle assembly attached to a cartridge. 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     The details of the present invention will be described below. 
     As shown in FIGS. 2A-2C, the main components of a first embodiment of the present invention include a delivery cap  100 , a main housing or cartridge  200  which fits into an opening  110  of the delivery cap  100 , and a locking clamp  300  provided in the delivery cap  100  for locking the cartridge  200  to the delivery cap  100 . The cartridge stores a viscous material  210  which is supplied to the delivery cap  100  by the action of a plunger  220 . A catheter  50  is attached to a distal end of the delivery cap  100  for supplying the viscous material  210  from the cartridge  200  to a needle  40  disposed at the end of the catheter  50 . 
     The delivery cap  100  includes a soft rubber compressive sleeve  140  disposed therein for creating a tight seal with a distal end  270  of the cartridge  200  which becomes pressed against the compressive sleeve  140  when the cartridge  200  is inserted into the delivery cap  100 . As discussed above in the description of the prior art device, it is possible that the compressive sleeve  140  or distal end  270  will become contaminated with the particles of the gel material. Because the compressive sleeve  140  is made of soft rubber, these particles become embedded therein, thereby preventing the degradation of the seal between the cap  100  and cartridge  200  which occurred in the prior art device. Further, raised sealing ribs  144  and  280  are formed on the lower face of the compressive sleeve  140  and distal end  270  of the cartridge  200  (see FIGS. 2A,  7  and  9 ). These raised sealing ribs  144  and  280 , which are offset from one another as shown in FIG. 9, further create a tight seal between the delivery cap and the cartridge. 
     As shown in FIGS. 2A and 2C, a compression sleeve  140  is positioned adjacent to the interconnect insert  150  for forming a seal between a distal end  270  of the cartridge  200  and the delivery cap  100 . As shown in FIG. 7, the compression sleeve  140  has a wide diameter cutout portion  142  for receiving a flange portion  158  of the interconnect insert  150 , thereby to attach the interconnect insert  150  to the compression sleeve  140 . The interconnect insert  150  and compression sleeve  140  do not necessarily have to be separate components and could be combined as one component. As shown in FIG. 6, a raised sealing rib  153  is formed on the lower surface of the interconnect insert  150 . The raised sealing rib  153  improves the seal between the interconnect insert  150  and the compression sleeve  140 . 
     As shown in FIG. 8, when the cartridge  200  is attached to the delivery cap  100  with the locking clamp  300 , the distal end  270  of the cartridge  200  abuts against the compression sleeve  140 . Accordingly, the diameter of the cartridge  200  at the dispensing site is the same as the inner diameter of the remaining portions of the cartridge  200 . This large opening at the delivery end promotes the delivery of the viscous material to the catheter  50  and eliminates the need to increase the pressure substantially. In standard syringes which taper down into a slip-fit or luer lock fitting, it is necessary to increase the pressure substantially. 
     As shown in FIG. 7, a raised sealing rib  144  is formed on the lower face of the compression sleeve  140 . Similarly, as shown in FIG. 2A, a raised sealing rib  280  is formed on the distal end  270  of the cartridge  200 . As shown in FIG. 9, the diameter of the raised sealing rib  144  is greater than the diameter of the raised sealing rib  280  so that when the when the cartridge  200  presses against the compression sleeve  140 , the raised sealing ribs  144  and  280  are offset. This offsetting of the raised sealing ribs  144  and  280  creates a tight seal between the cartridge  200  and the compression sleeve  140 , thereby establishing a leak-proof connection between the cartridge  200  and the delivery cap  100 . 
     As shown in FIG. 5, the delivery cap  100  includes a base  120 , a central portion  160 , and a nose portion  170 . As presented above, a slot  130  is formed in the base  120  for accommodating the locking clamp  300 . Sealing surfaces  172  and  174  are formed in conical cut-out section  176  of the nose portion  170 . 
     As shown in FIGS. 2A-2C, an interconnect insert  150  is positioned inside the central portion  160  adjacent to the nose portion  170 . As shown in FIG. 6, a raised central portion  152  is formed on the upper circular face of the interconnect insert  150 . When the interconnect insert  150  is positioned in the delivery cap  100 , the raised central portion  152  fits into the conical cut-out section  176  (see FIGS.  2  and  5 ). The diameter of the conical cut-out section  176  is larger than the diameter of the raised central portion  152 , thereby forming a conical-shaped gap between the nose portion  170  and the interconnect insert  150 . As shown in FIGS. 2A and 2C, this conical-shaped gap accommodates a flared-out end portion  52  of the catheter  50 . When the interconnect insert  150  is fixed to the inside edge of the nose portion  170  by ultrasonic welding or the like, the flared-out end portion  52  of the catheter  50  are pressed firmly between the raised central portion  152  and the sealing surfaces  172  and  174 , thereby forming a leak-proof seal between the interconnect insert  150  and the catheter  50 . 
     As shown in FIG. 6, the interconnect insert  150  has a centrally located cylindrical cut-out portion  154  and conical cut-out portion  156  which together form a passageway between the catheter  50  and the interior of the delivery cap  100 . 
     As shown in FIGS. 2A-2C,  4 A and  4 B, a locking clamp  300  is slidably disposed in a slot  130  formed in a base  120  of the delivery cap  100 . The slot  130  extends completely through the delivery cap  100  in a transverse direction so that the locking clamp  300  slides back and forth in a plane which is substantially perpendicular to the direction of insert of the cartridge  200 . 
     As shown in FIG. 2A, the cartridge  200  includes a barrel  230  a distal end of which is inserted into the delivery cap  100 . The barrel  230  includes a narrow neck portion  240  and a widened portion  250 . A raised ridge portion  260  is formed adjacent to the narrow neck portion  240 . The narrow neck portion  240 , the widened portion  250 , and the raised ridge portion  260  are integrally formed with the barrel  230  when the barrel is formed by injection molding. 
     As shown in FIG. 3B, the locking clamp  300  is substantially rectangular shaped and includes two circular holes  320  and  330  formed in a plate  310  such that a portion of the areas of the circular holes overlap, thereby forming a “figure eight” shape. The diameter of the circular hole  320  is larger than the diameter of the widened portion  250  of the barrel  230  (see FIG. 2) so that cartridge  200  can be inserted easily through the hole  320 . The diameter of the circular hole  330  is slightly larger than the diameter of the narrow neck portion  240  of the barrel  230 , but smaller than the diameter of the widened portion  250  and raised ridge portion  260 , so that the widened portion and raised ridge portion cannot slide through the circular hole  330 . 
     As shown in FIGS. 4A and 4B, the locking clamp  300  is movable between a first position in which the center of the large hole  320  is substantially concentric with the center of the delivery cap  100 , and a second position in which the center of the small hole  330  is substantially concentric with the center of the delivery cap  100 . Accordingly, when the locking clamp  300  is in the first position, the cartridge  200  can be inserted into the opening  110  of the delivery cap  100 . 
     The locking clamp  300  is located at a position within the delivery cap  100  such that when the cartridge  200  is fully inserted into the delivery cap  100 , the locking clamp  300  lines up with the narrow neck portion  240 . When the locking clamp  300  is moved to the second position with the cartridge  200  fully inserted in the delivery cap  100 , the small hole  330  moves over the narrow neck portion  240  so that the narrow neck portion becomes disposed within the small hole  330 . Since the diameters of the widened portion  250  and raised ridge portion  260  are greater than the diameter of the small hole  330 , the cartridge  200  becomes locked in the delivery cap  100  and cannot be removed. 
     The distance between the points at which the circumferences of the large hole  320  and small hole  330  meet (i.e., the length of an imaginary line that connects the discontinuous points of the figure-eight shape, points A and B, and extends across the figure-eight shape) is slightly smaller than the diameter of the narrow neck portion  240 . Therefore, when the locking clamp  300  is moved from the first position to the second position, these points contact the narrow neck portion  240 . As the locking clamp  300  is further pushed toward the second position, a force is exerted on the small hole  330  at points A and B, thereby expanding the small hole  330 . As the locking clamp  300  is further pushed towards the second position, such that the contact points clear the narrow neck portion  240 , the locking clamp  300  makes a distinct snapping sound. Further, the user can feel when the locking clamp  300  snaps into the second or locked position. Accordingly, the locking clamp  300  provides the user with a positive indication that the cartridge  200  has been inserted properly into the delivery cap  100  and securely locked. 
     As shown in FIG. 3A, the locking clamp  300  includes a projection  340  disposed on one side of the clamp. When the locking clamp  300  is disposed in the slot  130  in the delivery cap  100 , the projection  340  extends higher than the slot  130  so that the projection  340  prevents the locking clamp  300  from sliding out of the slot  130  in direction of arrow A (see FIGS.  4 A and  4 B). The locking clamp  300  also includes two outer projections  350  which prevent the locking clamp from sliding out of the delivery cap  100  in a direction opposite to the direction of arrow A. As shown in FIG. 3C, the outer projections  350  include an orthogonal surface  351  which is perpendicular to the side surface of the locking clamp  300 , a flat surface  352  which extends parallel to a side surface of the locking clamp and a ramped surface  353  which extends from the flat surface  351  to the side of the locking clamp  300 . 
     As shown in FIG. 4B, the slot  130  has a narrow portion  132  having a width that is less than the distance between the outermost edges of the flat surfaces  352 , and a widened portion  134  having a width that is greater than the distance between the outermost edges of the flat surfaces  352 . A stepped portion  136  is formed at the junction between the narrow portion  132  and the widened portion  134 . 
     When the locking clamp  300  is inserted into the delivery cap  100 , the ramped surfaces  353  engage the narrow portion  132 . As the locking clamp  300  is further inserted into the slot  130 , a force is exerted on the ramping surfaces  353  which causes the locking clamp  300  to deflect inward and slide through the narrow portion  132 . When the outer projections  350  reach the widened portion  134 , the locking clamp  300  snaps back to its original width and is freely slidable in the slot  130 . If the locking clamp  300  is moved in a direction opposite to direction A, the orthogonal surfaces  351  engage the stepped surfaces  136 , thereby preventing the locking clamp  300  from sliding out of the slot in the delivery cap  100 . The locking clamp  300  can be removed from the delivery cap  100  by forcibly sliding the locking clamp  300  in a direction opposite to arrow A. 
     A second embodiment of the present invention is shown in FIGS. 10-13. The second embodiment is an injection needle assembly which is used to deliver a highly viscous material directly to a needle. The main difference between the second embodiment and the first embodiment is that the delivery cap is connected directly to a needle rather than a catheter. Accordingly, many of the components in the second embodiment are identical to those of the first embodiment Identical components will be denoted by identical reference numerals. 
     As shown in FIGS. 10-12, the delivery system of the second embodiment comprises sheath  400 , a delivery cap  100  having a locking clamp  300 , a cannula insert  500 , a compression sleeve  140 , and a stylet insert  600 . As shown in FIG. 12, the cannula insert  500  comprises a polysulfone hub  510  molded onto a needle  520 . A flange portion  512  of the hub  510  is inserted in the wide diameter cut-out portion  142  of the compression sleeve  140 , thereby attaching the cannula insert  500  to the compression sleeve  140 , as shown in FIG.  11 . The cannula insert  500  is contained within, and bonded to, the delivery cap  100  using a solvent bond. The hub  510  has a raised sealing rib  530  for forming a tight seal with the compression sleeve  140 . A locking clamp  300  is inserted into the delivery cap  100  to form a needle assembly. 
     As shown in FIGS. 10 and 11, the stylet  600  is inserted into the cannula insert  500  for minimizing tissue coring during insertion of the needle. The stylet  600  is secured to the delivery cap  100  by locking the locking clamp  300  to a narrow portion  610  of the stylet. The raised sealing rib  144  of the compression sleeve  140  holds the stylet  600  in the proper position. After insertion, the stylet  600  is removed and the injection needle assembly is connected to a cartridge  200  in order to deliver a material to the needle  520 , as shown in FIG.  13 . 
     The above described delivery cap  100 , cartridge  200 , locking clamp  300  and interconnect insert  150  can be made by injection molding using thermoplastics such as polysulfone, polyetherimide, polypropylene, polycarbonate, etc. which have high hardness and strength and which can withstand sterilization. The compression sleeve  140  can be manufactured from silicone rubber. 
     Although the present invention is directed to a delivery system for a viscous material, it can also be used to deliver non-viscous materials. For example, the present invention could be used to join IV tubes, instead of using a needle. 
     As described above, the present invention makes it easy to change syringes and needles due to the easy-to-use sliding lock which does not require a twisting motion. The sliding lock positively notifies the user that the cartridge has been attached properly due to the audible click of the sliding clamp, which ensures that the cartridge will be attached properly. Also, the raised sealing ribs of the compression sleeve and cartridge create a leak-resistant seal between the cartridge and the delivery cap, thereby eliminating leakage of the viscous material. Further, the delivery cap creates a leak-resistant seal between the delivery cap and the catheter.