Patent Publication Number: US-2022233813-A1

Title: Blood control septum and related systems

Description:
RELATED APPLICATIONS 
     This application is a continuation of U.S. application Ser. No. 16/515,962, filed Jul. 18, 2019, and entitled BLOOD CONTROL SEPTUM AND RELATED SYSTEMS, which claims the benefit of U.S. application Ser. No. 62/716,723, filed Aug. 9, 2018, and entitled BLOOD CONTROL SEPTUM AND RELATED SYSTEMS, which are incorporated herein in their entirety. 
    
    
     BACKGROUND 
     Catheters are commonly used for a variety of infusion therapies. For example, catheters may be used for infusing fluids, such as normal saline solution, various medicaments, and total parenteral nutrition, into a patient. Catheters may also be used for withdrawing blood from the patient. 
     A common type of catheter is an over-the-needle peripheral intravenous catheter (“PIVC”). As its name implies, the over-the-needle PIVC may be mounted over an introducer needle having a sharp distal tip. The PIVC and the introducer needle may be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the PIVC with the bevel of the needle facing up away from skin of the patient. The PIVC and introducer needle are generally inserted at a shallow angle through the skin into vasculature of the patient. 
     In order to verify proper placement of the introducer needle and/or the PIVC in the vein, a user generally confirms that there is “flashback” of blood in a flashback chamber of a PIVC assembly. Once placement of the needle has been confirmed, the user may temporarily occlude flow in the vein and remove the introducer needle, leaving the PIVC in place within the vein. The user may also attach a device to the PIVC assembly for fluid infusion and/or blood withdrawal. This process has been somewhat difficult in practice since many PIVC placement sites simply do not allow easy occlusion of the vein. Additionally, even when such occlusion is achieved, it may be imperfect, resulting in blood leaking from the PIVC assembly housing the PIVC and endangering medical personnel. 
     PIVC assemblies have thus been provided in the art that provide a variety of seals or “septa” for preventing outflow of fluid during and following removal of the introducer needle from the vein. However, in some instances, blood may leak through a particular septum after the introducer needle is removed and before the user has time to connect the device to the PIVC assembly for fluid infusion or blood withdrawal. Leakage through the septum may occur more quickly particularly when the introducer needle has a large outer diameter. Accordingly, it would be an advancement in the art to provide a septum that controls the flow of blood and reduces leakage during the steps surrounding placement and use of a PIVC. 
     The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is only provided to illustrate one example technology area where some implementations described herein may be practiced. 
     SUMMARY 
     The present disclosure relates generally to septa for blood control, as well as related devices, systems, and methods. In some embodiments, a catheter assembly may include a catheter adapter, which may include a distal end, a proximal end, and a lumen extending therethrough. In some embodiments, the catheter assembly may also include a septum slidably disposed within the lumen. In some embodiments, the septum may include a distal end, a proximal end, and a barrier disposed between the distal end of the septum and the proximal end of the septum. In some embodiments, the barrier may divide an interior of the septum into a distal cavity and a proximal cavity. In some embodiments, a distal face of the barrier may include a protrusion. In some embodiments, the barrier may include a slit extending through the protrusion for selectively opening fluid communication between the distal cavity and the proximal cavity. 
     In some embodiments, in response to reflux blood flowing against the protrusion, opposing faces of the slit may press against each other more tightly to seal the slit. This may be due to radial forces of the reflux blood on the protrusion as well as axial forces of the reflux blood on the protrusion. In some embodiments, as the axial forces act on a center portion of the protrusion, pushing the center portion of the protrusion axially in a proximal direction, the opposing faces of the slit move toward each other in greater interference. 
     In some embodiments, the protrusion may be disposed at a center of the distal face. In some embodiments, the slit may extend through a center of the protrusion. In some embodiments, a proximal face of the barrier may be flat. In some embodiments, the protrusion may be symmetric. 
     In some embodiments, at least a portion of an outer surface of the protrusion may be disposed at an acute angle with respect to a transverse axis of the catheter assembly. For example, the protrusion may include a dome. In some embodiments, a diameter of the dome may be greater than a diameter of the slit. As another example, the protrusion may include a truncated dome. In some embodiments, a diameter of a truncated portion of the truncated dome may be greater than a diameter of the slit. As yet another example, the protrusion may include a truncated cone. In some embodiments, a diameter of a truncated portion of the truncated cone may be greater than the diameter of the slit. 
     In some embodiments, a septum actuator may be fixed within the lumen of the catheter adapter. In some embodiments, the septum may be configured to move between a proximal position and a distal position in response to insertion of a separate device into the proximal end of the catheter adapter. In some embodiments, the septum actuator may penetrate the slit in response to movement of the septum from the proximal position to the distal position. In some embodiments, the slit may extend through a center of the protrusion, and the septum actuator may be disposed within the slit and the center of the protrusion when the septum is disposed in the distal position. 
     In some embodiments, the protrusion may be spaced apart from and adjacent the septum actuator when the septum is in the proximal position prior to insertion of the separate device. In other embodiments, the septum actuator may contact an outer surface of the protrusion but may not penetrate the slit when the septum is in the proximal position prior to insertion of the separate device. 
     It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are not restrictive of the invention, as claimed. It should be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings. It should also be understood that the embodiments may be combined, or that other embodiments may be utilized and that structural changes, unless so claimed, may be made without departing from the scope of the various embodiments of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense. 
    
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
       Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which: 
         FIG. 1A  is a cross-sectional view of an example catheter assembly of the prior art, illustrating the catheter assembly in an insertion or ready for use position, according to some embodiments; 
         FIG. 1B  is another cross-sectional view of the catheter assembly of  FIG. 1A , illustrating the catheter assembly in a safe position, according to some embodiments; 
         FIG. 1C  is another cross-sectional view of the catheter assembly of  FIG. 1A  with an example safety coupling and example introducer needle removed, according to some embodiments; 
         FIG. 1D  is a cross-sectional view of the catheter assembly of  FIG. 1C  along the line  1 D- 1 D of  FIG. 1C , according to some embodiments; 
         FIG. 2A  is a cross-sectional view of another example catheter assembly, illustrating an example septum having an example protrusion, according to some embodiments; 
         FIG. 2B  is an enlarged cross-sectional view of a portion of the catheter assembly of  FIG. 2A , according to some embodiments; 
         FIG. 2C  is a cross-sectional view of the catheter assembly of  FIG. 2A , illustrating example opposing slits of the septum pressed against each other more tightly in response to forces from reflux blood flowing proximally through an example septum actuator, according to some embodiments; 
         FIG. 2D  is a cross-sectional view of the catheter assembly of  FIG. 2A  along the line  2 D- 2 D, according to some embodiments; 
         FIG. 2E  is a cross-sectional view of the catheter assembly of  FIG. 2A , illustrating the septum in a distal position, according to some embodiments; 
         FIG. 3  is a cross-sectional view of the catheter assembly of  FIG. 2A , illustrating another example protrusion, according to some embodiments; 
         FIG. 4  is a cross-sectional view of the catheter assembly of  FIG. 2A , illustrating another example protrusion, according to some embodiments; and 
         FIG. 5  is a cross-sectional view of the catheter assembly of  FIG. 2A , illustrating another septum having a duckbill valve, according to some embodiments. 
     
    
    
     DESCRIPTION OF EMBODIMENTS 
     The present disclosure relates generally to a septum for blood control, as well as related devices, systems, and methods. Referring now to  FIGS. 1A-1B , a catheter assembly  10  of the prior art is illustrated.  FIG. 1A  illustrates the catheter assembly  10  in a first, ready for use position. The catheter assembly  10  may correspond to Smiths Medical ViaValve® Safety IV Catheter with Blood Control. The catheter assembly  10  generally includes a catheter  12  coupled to a distal end  14  of a catheter adapter  16 . In the ready for use position, the catheter  12  is positioned over an introducer needle  17  with the sharp tip of the introducer needle  17  extending from a distal end of the catheter  12 . 
     The catheter assembly  10  generally includes a safety coupling  18 , which includes an actuator  20 , a nose  22 , and an engagement arm  24 . A collar  26  of the safety coupling  18  is positioned about a proximal portion of the catheter adapter  16 , the engagement arm  24 , and the actuator  20 . In this respect, the collar  26  can inhibit access to these components or portions thereof. The safety coupling  18  is constructed to engage the catheter adapter  16  with the engagement arm  24  when the catheter assembly  10  is in the ready for use position with the actuator  20  shifted to a distal, engaged position. In the ready for use position, the engagement arm  24  is held in contact with the catheter adapter  16  by an engaging portion  27  of the actuator  20 . 
     Referring now to  FIG. 1B , the catheter assembly  10  is illustrated in a second, safe position. When the catheter assembly  10  is in the safe position, the actuator  20  is shifted to a proximal, disengaged position. In the safe position, the engagement arm  24  is released from engagement with the catheter adapter  16 , thereby enabling the safety coupling  18  and the introducer needle  17  to be removed from the catheter  12  and the catheter adapter  16 . 
     Referring now to  FIG. 1C , the catheter assembly  10  is illustrated with the safety coupling  18  and the introducer needle  17  removed. A lumen  29  of the catheter adapter  16  is in fluid communication with a lumen  28  of the catheter  12 . Once inserted into a patient, the catheter  12  and the catheter adapter  16  provide a fluid conduit to facilitate delivery of a fluid to and/or retrieval of a fluid from a patient. 
     The catheter assembly  10  includes a septum  30  slidably housed with the lumen  29  of the catheter adapter  16 . The catheter assembly  10  also includes a septum actuator  32 , which is generally fixedly positioned within a distal fluid chamber  34 . The septum  30  is tube shaped having a barrier  36  disposed between a distal end and a proximal end of the septum  30 . The barrier  36  divides an interior of the septum  30  into the distal fluid chamber  34  and a proximal fluid chamber  38 . A distal face  40  of the barrier  36  is flat. Referring now to  FIG. 1D , a Y-shaped slit  42  is formed in the barrier  36  for selectively opening fluid communication between the distal fluid chamber  34  and the proximal fluid chamber  38 . However, in some instances, when the slit  42  is closed, fluid may leak through the slit  42 . 
     Referring now to  FIG. 2A , a catheter assembly  50  is illustrated, according to some embodiments. In some embodiments, the catheter assembly  50  may include or correspond to the catheter system  10 . In some embodiments, the catheter assembly  50  may include one or more features or elements of the catheter system  10 . In some embodiments, the catheter system  50  may include the safety coupling  18  and/or the introducer needle  17 . 
     In some embodiments, the catheter assembly  50  may include a catheter adapter  52 , which may include a distal end  54 , a proximal end  56 , and a lumen  58  extending therethrough. In some embodiments, a catheter  59  may extend distally from the catheter adapter  52 . In some embodiments, the catheter  59  may include a peripheral intravenous catheter (“PIVC”). 
     In some embodiments, the catheter assembly  50  may also include a septum  60  slidably disposed within the lumen  58 . In some embodiments, the septum  60  may be constructed of an elastomeric or resilient material. In some embodiments, a septum actuator  61  may be fixed within the lumen  58  of the catheter adapter  52 . In some embodiments, the septum  60  may include a distal end  62 , a proximal end  64 , and a barrier  66  disposed between the distal end  62  of the septum  60  and the proximal end  64  of the septum  60 . In some embodiments, the barrier  66  may divide an interior of the septum  60  into a distal cavity  68  and a proximal cavity  70 . In some embodiments, the septum  60  may control or limit passage of fluid between the distal cavity  68  and the proximal cavity  70 . 
     In some embodiments, the septum  60  may include a flexible or semi-flexible polymer plug having an outer diameter that is configured to fit within the lumen  58 . In some embodiments, the septum  60  may be held in place within the lumen  58  via contact with one or more inner surfaces of the internal lumen, contact with anti-pathogenic material, or another suitable means. In some embodiments, the barrier  66  may be disposed at or near the distal end  62  or proximal end  64  of the septum  60 . In some embodiments, the septum  60  may have a substantially H-shaped cross section. 
     In some embodiments, a distal face  72  of the barrier  66  may include a protrusion  74 . In some embodiments, the barrier  66  may include a slit  76  extending through the protrusion  74  for selectively opening fluid communication between the distal cavity  68  and the proximal cavity  70 . In some embodiments, the protrusion  74  may be disposed at a center of the distal face  72 . In some embodiments, the slit  76  may extend through a center of the protrusion  74 . In some embodiments, a proximal face  80  of the barrier  66  may be flat. In some embodiments, the protrusion  74  may be symmetric. 
     Referring now to  FIG. 2B , in some embodiments, at least a portion of an outer surface of the protrusion  74  may be disposed at an acute angle a with respect to a transverse axis  82  of the catheter assembly  50 . In some embodiments, the transverse axis may be perpendicular to a longitudinal axis of the catheter assembly  50 . In some embodiments, the protrusion  74  may include a dome, as illustrated, for example, in  FIG. 2B . In some embodiments, a diameter  84  of the dome may be greater than a diameter  86  of the slit  76 . 
     In some embodiments, reflux blood may flow from the vein of the patient through the catheter  59  and into the distal cavity  68 . The reflux blood may include a radial component  88  and an axial component  90  which may apply a radial force and an axial force, respectively, on the protrusion  74 . 
     Referring now to  FIG. 2C , in some embodiments, in response to the reflux blood flowing against the protrusion  74 , opposing faces of the slit  76  may press against each other more tightly to seal the slit  76 , as illustrated, for example, in  FIG. 2C . This may be due to the radial forces of the reflux blood on the protrusion as well as the axial forces of the reflux blood on the protrusion  74 . As the axial forces act on a center portion of the protrusion  74 , pushing the center portion of the protrusion  74  axially in a proximal direction, the opposing faces of the slit  76 , particularly distal ends of the opposing faces, move toward each other in greater interference. 
     Referring now to  FIG. 2D , the slit  76  may include any number of configurations. For example, as illustrated in  FIG. 2D , the slit  76  may be Y-shaped. In other embodiments, the slit  76  may be X-shaped. In some embodiments, the slit  76  may be linear. 
     Referring now to  FIG. 2E , in some embodiments, the septum actuator  61  may be fixed within the lumen  58  of the catheter adapter  52 . In some embodiments, the septum  60  may be configured to move between a proximal position and a distal position in response to insertion of a separate device into the proximal end  56  of the catheter adapter  52 . The separate device may include a luer adapter  96 , as illustrated, for example, in  FIG. 2E . 
     In some embodiments, the septum actuator  61  may penetrate the slit  76  when the septum  60  is in the distal position, as illustrated, for example, in  FIG. 2E . In some embodiments, the slit  76  may extend through a center of the protrusion  74  such that the septum actuator  61  is disposed within the center of the protrusion  74  when the septum  60  is disposed in the distal position. In some embodiments, the protrusion  74  may be adjacent the septum actuator  61  when the septum  60  is in the proximal position prior to insertion of the separate device, as illustrated, for example, in  FIGS. 2A-2C . In some embodiments, the protrusion  74  may contact the septum actuator  61  when the septum  60  is in the proximal position prior to insertion of the separate device. 
     In some embodiments, the septum actuator  61  may be fixedly positioned within the distal cavity  68  and may include a portion that is positioned adjacent the septum  60  prior to activation of the catheter assembly  50 . In some instances, the septum actuator  61  may include a base  98  that is coupled to the catheter adapter  52 . For example, as shown, the base  98  can be at least partially inserted into a proximal end of the catheter  59 . In some embodiments, the base  98  may act as a wedge forming a press fit between the catheter  59  and the catheter adapter  52  to, at least partially, retain the catheter  59  and the base  98  in place. In some embodiments, the base  98  can be coupled directly to the catheter adapter  52  via a fastener, adhesive, bonding technique, or molding. As shown, the septum actuator  61  may have a tubular configuration with a hollow interior that forms a lumen  100  in fluid communication with a lumen  102  of the catheter  59 . 
     In some embodiments, the proximal end  56  of the catheter adapter  52  includes a flange  104 . The flange  104  provides a positive surface which may be configured to enable coupling of intravenous tubing or the luer adapter  96  to the catheter assembly  50 . In some embodiments, the flange  104  further includes threading to accept the luer adapter  96  via a threaded connection. 
     Referring now to  FIG. 3 , in some embodiments, the protrusion  74  may include a truncated dome. In some embodiments, a diameter  92  of a truncated portion of the truncated dome may be greater than the diameter  86  of the slit  76 . 
     Referring now to  FIG. 4 , in some embodiments, the protrusion  74  may include a truncated cone. In some embodiments, a diameter  94  of a truncated portion of the truncated cone may be greater than the diameter  86  of the slit  76 . 
     Referring now to  FIG. 5 , in some embodiments, another septum  93  that may be used with the catheter assembly  50  may include a duckbill valve  96 . A non-limiting example of a duckbill valve is described in U.S. Pat. No. 9,126,012, filed Oct. 3, 2012, entitled “INTRAVENOUS CATHETER WITH DUCKBILL VALVE,” which is hereby incorporated by reference in its entirety. In some embodiments, flaps of the duckbill valve  96  may extend inwardly and proximally. In some embodiments, the two inwardly oriented flaps may be pushed apart by the septum actuator  61  to open a gap between the flaps in response to insertion of a luer device, such as, for example, the luer device  96  of  FIG. 2E , and movement of the septum  93  to a distal position. In some embodiments, the septum  93  may include or correspond to the septum  60  described with respect to  FIGS. 2-5 . In further detail, in some embodiments, the septum  93  may include one or more features of the septum  60 . 
     It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are not restrictive of the invention, as claimed. It should be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings. It should also be understood that the embodiments may be combined, or that other embodiments may be utilized and that structural changes, unless so claimed, may be made without departing from the scope of the various embodiments of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense. 
     All examples and conditional language recited herein are intended for pedagogical objects to aid the reader in understanding the invention and the concepts contributed by the inventor to furthering the art, and are to be construed as being without limitation to such specifically recited examples and conditions. Although embodiments of the present inventions have been described in detail, it should be understood that the various changes, substitutions, and alterations could be made hereto without departing from the spirit and scope of the invention.