Patent Publication Number: US-2022233822-A1

Title: Catheter assembly having an injection port and related methods

Description:
RELATED APPLICATIONS 
     This application is a continuation of United States Patent Application No. 16/878,359, filed May 19, 2020, and entitled CATHETER ASSEMBLY HAVING AN INJECTION PORT AND RELATED METHODS, which claims the benefit of United States Provisional Patent Application No. 62/854,123, filed May 29, 2020, and entitled CATHETER ASSEMBLY HAVING AN INJECTION PORT AND RELATED METHODS, which are incorporated herein in their entirety. 
    
    
     BACKGROUND 
     Catheters are generally used for parenteral nutrition, intravenous fluid replacement, and administering analgesics and antibiotics. Catheters are also used for blood draw. Catheters can be inserted at the bedside using sterile techniques and can remain in place for several weeks. 
     A common type catheter is an over-the-needle catheter. As its name implies, a catheter that is “over-the-needle” may be mounted over an introducer needle having a sharp distal tip. The sharp distal tip may be used to pierce skin and a vein of a patient. Insertion of the catheter into the vein may follow the piercing of the vein by the introducer needle. The introducer needle typically has the sharp distal tip to pierce skin and the vein of the patient with minimal resistance to minimize the pain to the patient. 
     The introducer needle is generally placed at a steep inclined angle with respect to a surface of the skin and a longitudinal dimension of the vein to be pierced to allow penetration through the skin and a wall of the vein. The needle and the catheter are generally inserted with a bevel of the introducer needle facing away from the skin of the patient. After the tip of the introducer needle pierces the wall, the angle of the insertion is lowered to be able to slide the introducer needle and the catheter into the vein a distance sufficient to properly position the catheter in the vein. Once placement of the introducer needle within the vein has been confirmed, the user may temporarily occlude flow in the vein and withdraw the introducer needle, leaving the catheter in place for future fluid infusion and/or blood withdrawal. 
     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 OF THE INVENTION 
     The present disclosure relates generally to a catheter assembly that may be used for power injection, as well as related devices, systems, and methods. “Power injection” may refer to infusion of large amounts of fluid in a short period of time. In some embodiments, a catheter assembly of the present disclosure may facilitate high flow rates and maintenance of a high pressure within a catheter adapter of the catheter assembly while also maintaining an integrity of a valve disposed within the catheter adapter. In some embodiments, the catheter assembly may increase a breaking threshold (i.e. burst value) of the valve, allowing fluid to be infused into the catheter adapter at high pressures. 
     In some embodiments, the catheter adapter may include a body, which may include a distal end, a proximal end, and a first lumen extending through the distal end and the proximal end. In some embodiments, a side port of the catheter adapter may extend outwardly from the body and may be disposed between the distal end and the proximal end. In some embodiments, the side port may include a second lumen perpendicular to the first lumen. 
     In some embodiments, the catheter assembly may include a catheter, which may extend distally from the distal end of the body. In some embodiments, the catheter assembly may include a valve disposed within the first lumen. In some embodiments, the valve may seal the first lumen from the second lumen. In some embodiments, an outer surface of the valve may be cylindrical. 
     In some embodiments, the catheter assembly may include a divider, which may be disposed with the second lumen. In some embodiments, the catheter adapter and the divider may be monolithically formed as a single unit. In some embodiments, the divider may divide the second lumen into multiple openings. In some embodiments, the divider may be proximate the first lumen. In some embodiments, the divider may contact the valve. In some embodiments, the divider may be symmetrical. In some embodiments, one or more of the multiple openings may be identical. In some embodiments, the divider may include various shapes and patterns. 
     In some embodiments, the catheter adapter may include an inner surface, which may form the second lumen. In some embodiments, outer edges of the plurality of openings may form or be aligned with a shape, which may be symmetrical. In some embodiments, the divider may be linear and may extend from one side of the shape to another side of the shape. In some embodiments, the divider may be perpendicular to a longitudinal axis of the catheter adapter. In some embodiments, the divider may be parallel to the longitudinal axis of the catheter adapter. 
     In some embodiments, the divider may include multiple arms, which may extend from the shape to a central axis of the second lumen. In some embodiments, the divider may include X-shape. In these embodiments, the multiple arms may include a first arm, a second arm, a third arm, and a fourth arm. In some embodiments, two of the first arm, the second arm, the third arm, and the fourth arm may be parallel to the longitudinal axis of the catheter adapter. In some embodiments, the first arm, the second arm, the third arm, and the fourth arm may be offset from the longitudinal axis of the catheter adapter. 
     In some embodiments, the divider may include a Y-shape. In these embodiments, the multiple arms may include the first arm, the second arm, and the third arm. In some embodiments, one of the first arm, the second arm, and the third arm may be parallel to the longitudinal axis of the catheter adapter and may point distally. In some embodiments, one of the first arm, the second arm, and the third arm may be parallel to the longitudinal axis of the catheter adapter and may point proximally. 
     In some embodiments, a method of delivering fluid into the catheter adapter may include coupling a power injection device to the side port of the catheter adapter. In some embodiments, the method may include delivering fluid, via the power injection device, into the side port at a pressure. In some embodiments, an integrity of the valve may be maintained in response to delivering the fluid into the side port at the pressure. In some embodiments, the pressure may not exceed a burst value of the valve. 
     In some embodiments, the pressure may be greater than 348 psi. In some embodiments, the pressure may be between 348 psi and 478 psi. In some embodiments, the pressure may be between 348 psi and 728 psi. In some embodiments, the pressure may be between 300 psi and 800 psi. In some embodiments, the pressure may be between 350 psi and 800 psi. In some embodiments, the pressure may be between 700 psi and 1000 psi. In some embodiments, the pressure may be between 300 psi and 400 psi, between 400 psi and 500 psi, between 500 psi and 600 psi, between 600 psi and 700 psi, between 700 psi and 800 psi, or between 800 psi and 900 psi. In some embodiments, in response to delivering the fluid into the side port at the pressure, the divider may inhibit expansion of the valve and/or shifting of the valve in a proximal direction and a distal direction. 
     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 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 an upper perspective view of a prior art catheter assembly; 
         FIG. 1B  is a top view of the prior art catheter assembly, illustrating an example cap removed; 
         FIG. 1C  is a cross-sectional view of the prior art catheter assembly; 
         FIG. 1D  is a cross-sectional view of the prior art catheter assembly, illustrating an example power injection device delivering fluid into the catheter assembly; 
         FIG. 2  is a cross-sectional view of another catheter assembly, according to some embodiments; 
         FIG. 3A  is a top view of the catheter assembly of  FIG. 2 , illustrating an example divider and an example power injection device removed, according to some embodiments; 
         FIG. 3B  is an enlarged top view of the catheter assembly of  FIG. 2 , illustrating the divider, according to some embodiments; 
         FIG. 4A  is a top view of the catheter assembly of  FIG. 2 , illustrating another example divider and the power injection device removed, according to some embodiments; 
         FIG. 4B  is an enlarged top view of the catheter assembly of  FIG. 2 , illustrating the other divider of  FIG. 4A , according to some embodiments; 
         FIG. 5A  is a top view of the catheter assembly of  FIG. 2 , illustrating another example divider and the power injection device removed, according to some embodiments; 
         FIG. 5B  is an enlarged top view of the catheter assembly of  FIG. 2 , illustrating the other divider of  FIG. 5A , according to some embodiments; 
         FIG. 6A  is a top view of the catheter assembly of  FIG. 2 , illustrating another example divider and the power injection device removed, according to some embodiments; 
         FIG. 6B  is an enlarged top view of the catheter assembly of  FIG. 2 , illustrating the other divider of  FIG. 6A , according to some embodiments; 
         FIG. 7A  is a top view of the catheter assembly of  FIG. 2 , illustrating another example divider and the power injection device removed, according to some embodiments; and 
         FIG. 7B  is an enlarged top view of the catheter assembly of  FIG. 2 , illustrating the other divider of  FIG. 7A  and the power injection device removed, according to some embodiments; 
         FIG. 8A  is a top view of the catheter assembly of  FIG. 2 , illustrating another example divider and the power injection device removed, according to some embodiments; and 
         FIG. 8B  is an enlarged top view of the catheter assembly of  FIG. 2 , illustrating the other divider of  FIG. 8A  and the power injection device removed, according to some embodiments. 
     
    
    
     DESCRIPTION OF EMBODIMENTS 
     Referring now to  FIGS. 1A-1B , a prior art catheter assembly  10  is illustrated. The prior art catheter assembly  10  may correspond to the BD VENFLON TM  Pro Safety Shielded IV Catheter or another catheter assembly. The prior art catheter assembly  10  includes a catheter adapter  12  and a catheter  13  extending distally from the catheter adapter  12 . The catheter adapter  12  includes a body  16 , which includes a distal end  18 , a proximal end  20 , and a lumen  22  extending through the distal end  18  and the proximal end  20 . The catheter adapter  12  includes a side port  14  extending outwardly from the body  16  and may be covered by a removable cap  15 . A valve  24  is disposed in the lumen  22  and seals the side port  14  from the lumen  22 . 
     The prior art catheter assembly  10  may be unable to withstand the pressure that is delivered by a power injection device  26  coupled to the side port  14 , which may be used for power injection. The minimum pressure required for power injection, according to ISO 10555-1, is 300 psi. However, it has been shown that even pressures below 300 psi may exceed the burst value of the valve  24  in the prior art catheter assembly  10 , resulting in a rupture or break  25  of the valve  24 , as illustrated, for example, in  FIG. 1B . The valve  24  may be the weakest component of the prior art catheter assembly  10 . 
     Further, the valve  24  may shift in a distal direction or a proximal direction in response to power injection. Referring now to  FIGS. 1C-1D , in response to the power injection device  26  delivering the fluid at a high pressure, such as above 300 psi, the fluid may flow between an inner surface of the catheter adapter  12  and an outer surface of the valve  24  in a manner that shifts the valve  24  from its original position, illustrated in  FIG. 1C , to a distal position, illustrated in  FIG. 1D , or a proximal position. Thus, the valve  24  may be prevented from resealing the side port  14  from the lumen  22  after completion of the power injection and may no longer be functional. 
     In some embodiments, the prior art catheter assembly  10  may be removably coupled to a prior art needle assembly  28 , which may include a needle hub  30  and an introducer needle  32 . In some embodiments, the introducer needle  32  may include a sharp distal tip  34 . In some embodiments, a proximal end of the introducer needle  32  may be secured within the needle hub  30 . In some embodiments, the introducer needle  32  may extend through the catheter  13  when the prior art catheter assembly  10  is in an insertion position ready for insertion into vasculature of a patient, as illustrated, for example, in  FIG. 1A . 
     In some embodiments, in response to the introducer needle  32  being inserted into the vasculature of the patient, flashback of blood may flow through the sharp distal tip  34  of the introducer needle  32  and may be visible to a clinician between the introducer needle  32  and the catheter  13  and/or at another location within the prior art catheter assembly  10 . 
     In some embodiments, in response to confirmation via the blood flashback that the catheter  13  is positioned within vasculature of the patient, the prior art needle assembly  28  may be removed from the prior art catheter assembly  10 , as illustrated in  FIG. 1B . In some embodiments, when the prior art needle assembly  28  is coupled to the prior art catheter assembly  10 , as illustrated, for example, in  FIG. 1A , the introducer needle  32  of the prior art needle assembly  28  may extend through the valve  24  disposed within the lumen  22  of the catheter adapter  12 . 
     Referring now to  FIG. 2 , a catheter assembly  29  is illustrated, according to some embodiments. In some embodiments, the catheter assembly  29  may include or correspond to the prior art catheter assembly  10 . For example, one or more components of the catheter assembly  29  may include or correspond to one or more components of the prior art catheter assembly  10 . 
     In some embodiments, the catheter assembly  29  may include a catheter adapter  36 . In some embodiments, the catheter adapter  36  may include a body  38 , which may include a distal end  40 , a proximal end  42 , and a first lumen  44  extending through the distal end  40  and the proximal end  42 . In some embodiments, the catheter adapter  36  may include a side port  46  extending outwardly from the body  38 . In some embodiments, the side port  46  may be disposed between the distal end  40  and the proximal end  42 . In some embodiments, the side port  46  may include a second lumen  48 , which may be perpendicular to the first lumen  44 . In some embodiments, the second lumen  48  may extend through the side port  46  to the first lumen  44 . In some embodiments, the first lumen  44  may be generally cylindrical, and the second lumen  48  may be generally cylindrical. 
     In some embodiments, the catheter assembly  29  may include a catheter  50 , which may extend distally from the distal end  40  of the body  38  and may be secured within the catheter adapter  36 . In some embodiments, the catheter assembly  29  may include a valve  52  disposed within the first lumen  44 . In some embodiments, the valve  52  may seal the first lumen  44  from the second lumen  48 , preventing fluid from travelling between the first lumen  44  and the second lumen  48 . In some embodiments, an outer surface of the valve  52  may be cylindrical. In some embodiments, the valve  52  may be solid. In other embodiments, the valve  52  may include an opening extending through a distal end of the valve  52  and a proximal end of the valve  52 . In some embodiments, the valve  52  may be constructed of silicon or another suitable material. 
     In some embodiments, the catheter assembly  29  may include a divider  54 , which may be disposed within the second lumen  48 . In some embodiments, the catheter adapter  36  and the divider  54  may be monolithically formed as a single unit, which may secure the divider  54  in response to power injection through the side port  46 . In some embodiments, the divider  54  may divide the second lumen  48  into multiple openings  56 . In some embodiments, the divider  54  may be constructed of plastic, metal, or another suitable material. In some embodiments, the divider  54  may be rigid. 
     In some embodiments, the divider  54  may be proximate the first lumen  44 . In some embodiments, the divider may be disposed between an outer surface  58  of the body  38  and an inner surface  60  of the body  38  forming the first lumen  44 . In some embodiments, the divider  54  may be disposed between the side port  46  and the inner surface  60  of the body  38 . In some embodiments, the divider  54  may be disposed within the side port  46  or a portion of the second lumen  48  disposed within the side port  46 . 
     In some embodiments, the divider  54  may contact the valve  52 . In some embodiments, the divider  54  may be symmetrical, which may provide an evenly distributed amount of pressure on the valve  52  during power injection. In some embodiments, the divider  54  may be asymmetrical. In some embodiments, one or more of the multiple openings  56  may be identical. In some embodiments, the divider  54  may include various shapes and patterns. 
     In some embodiments, the divider  54  may facilitate high flow rates and maintenance of a high pressure within the catheter adapter  36  while also maintaining the integrity of the valve  52 . In some embodiments, the divider  54  may increase a burst value of the valve  52  such that the valve  52  is able to withstand high pressure during power injection into the catheter adapter  36  without breaking. Thus, in some embodiments, the valve  52  may include a multi-use valve usable for multiple power injections. 
     In some embodiments, in response to delivering the fluid into the side port  46  at a pressure during power injection, the divider  54  may reduce or eliminate expansion of the valve  52  as the valve  52  contacts and presses upon the divider  54 . In some embodiments, in response to delivering the fluid into the side port  46  at the pressure during power injection, the divider  54  may reduce or eliminate shifting of the valve  52  in a proximal direction and a distal direction. 
     In some embodiments, the pressure may be greater than 348 psi. In some embodiments, the pressure may be between 348 psi and 478 psi. In some embodiments, the pressure may be between 348 psi and 728 psi. In some embodiments, the pressure may be between 300 psi and 800 psi. In some embodiments, the pressure may be between 350 psi and 800 psi. In some embodiments, the pressure may be between 700 psi and 1000 psi. In some embodiments, the pressure may be between 300 psi and 400 psi, between 400 psi and 500 psi, between 500 psi and 600 psi, between 600 psi and 700 psi, between 700 psi and 800 psi, or between 800 psi and 900 psi. In some embodiments, in response to delivering the fluid into the side port  46  at the pressure, the divider  54  may inhibit expansion of the valve  52  and/or shifting of the valve  52  in the proximal direction and the distal direction. In some embodiments, the multiple openings  56  may be configured to allow fluid to flow from the side port  46  to the body  38  at a flow rate of between about  3  mL and  8  mL per second and/or at the pressure. In some embodiments, the multiple openings  56  may be configured to allow fluid to flow from the side port  46  to the body  38  at another suitable flow rate. 
     In some embodiments, the burst value of the valve  52  may be greater than 348 psi. In some embodiments, the burst value of the valve  52  may be between 348 psi and 478 psi. In some embodiments, the burst value of the valve  52  may be between 348 psi and 728 psi. In some embodiments, the burst value of the valve  52  may be between 300 psi and 800 psi. In some embodiments, the burst value of the valve  52  may be between 350 psi and 800 psi. In some embodiments, the burst value of the valve  52  may be between 700 psi and 1000 psi. In some embodiments, the burst value of the valve  52  may be between 300 psi and 400 psi, between 400 psi and 500 psi, between 500 psi and 600 psi, between 600 psi and 700 psi, between 700 psi and 800 psi, or between 800 psi and 900 psi. In some embodiments, the valve  52  may be stronger than body  38 , which may rupture or break at a lower pressure than the valve  52 . 
     Referring now to  FIGS. 3-4 , in some embodiments, the catheter adapter  36  may include another inner surface  62 , which may form the second lumen  48 . In some embodiments, outer edges  64  of the multiple openings  56  may form or be aligned with a shape  66  which may be an ellipse or a geometric shape, such as a circle or triangle. In some embodiments, the shape  66  may be symmetric. In some embodiments, the outer edges  64  may include arcs, which may connect two lines forming inner edges of the multiple openings  56  or ends of a single line forming an inner edge of the multiple openings  56 . In some embodiments, the two lines may intersect at a corner or a rounded edge. 
     In some embodiments, a diameter of the shape  66 , which may include a maximum diameter of the shape  66 , may be less than a diameter of a portion of the other inner surface  62  that is proximate the shape  66  and closer to an outer opening  68  of the side port  46 , as illustrated, for example, in  FIGS. 3-4 . Thus, in some embodiments, the second lumen  48  may be stepped and the divider  54  may extend from a stepped surface. In other embodiments, the diameter of the shape  66  may be equal to the diameter of the portion of the other inner surface  62  that is proximate the shape  66  and closer to an outer opening  68  of the side port  46 . In these embodiments, the divider  54  may not extend from a stepped surface. 
     In some embodiments, the divider  54  may include multiple arms  70 , which may extend from the shape  66  to a central axis  72  (see also  FIG. 2 ) of the second lumen  48 . In some embodiments, the divider  54  may include X-shape. In these embodiments, the multiple arms  70  may include a first arm  70   a,  a second arm  70   b,  a third arm  70   c,  and a fourth arm  70   d.  In some embodiments, two of the first arm  70   a,  the second arm  70   b,  the third arm  70   c,  and the fourth arm  70   d  may be parallel to a longitudinal axis  74  (see also  FIG. 2 ) of the catheter adapter  36 , as illustrated in  FIGS. 3A-3B . As illustrated in  FIGS. 4A-4B , in some embodiments, the first arm  70   a,  the second arm  70   b,  the third arm  70   c,  and the fourth arm  70   d  may be offset from the longitudinal axis  74  of the catheter adapter  36 , such as, for example, by about 45° or another suitable angle. 
     Referring now to  FIGS. 5-6 , in some embodiments, the divider  54  may include a Y-shape. In these embodiments, the multiple arms  70  may include the first arm  70   a,  the second arm  70   b,  and the third arm  70   c.  In some embodiments, one of the first arm  70   a,  the second arm  70   b , and the third arm  70   c  may be parallel to the longitudinal axis  74  of the catheter adapter  36  and may point distally, as illustrated in  FIGS. 5A-5B . As illustrated in  FIGS. 6A-6B , in some embodiments, one of the first arm  70   a,  the second arm  70   b,  and the third arm  70   c  may be parallel to the longitudinal axis  74  of the catheter adapter  36  and may point proximally. In some embodiments, none of the first arm  70   a,  the second arm  70   b,  or the third arm  70   c  may be aligned with the longitudinal axis  74  of the catheter adapter  36 . 
     Referring now to  FIGS. 7-8 , in some embodiments, the divider  54  may be linear and may extend from one side of the shape  66  to another side of the shape  66 . In some embodiments, the divider  54  that is linear and/or oriented perpendicular to the longitudinal axis  74  of the catheter adapter  36  may reduce leakage of fluid between the outer surface of the valve  52  and the inner surface  60  of the body  38  that might otherwise shift the valve  52  in the proximal direction or the distal direction during power injection. In some embodiments, the divider  54  may be perpendicular to the longitudinal axis  74  of the catheter adapter  36 , as illustrated in  FIGS. 7A-7B . In some embodiments, the divider  54  may be parallel to the longitudinal axis  74  of the catheter adapter  36 , as illustrated in  FIGS. 8A-8B . 
     In some embodiments, a method of delivering fluid into the catheter adapter  36  may include coupling the power injection device  26  to the side port  14  of the catheter adapter  12 . In some embodiments, the method may include delivering fluid, via the power injection device  26 , into the side port  14  at the pressure. In some embodiments, an integrity of the valve  52  may be maintained in response to delivering the fluid into the side port  14  at the pressure. In some embodiments, the pressure may not exceed the burst value of the valve  52 . 
     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.