Patent Publication Number: US-2022226631-A1

Title: Valve retainer ring and related systems and methods

Description:
RELATED APPLICATIONS 
     This application claims benefit of U.S. Provisional Patent Application No. 63/139,640, filed on Jan. 20, 2021, entitled VALVE RETAINER RING AND RELATED SYSTEMS AND METHODS, which is incorporated herein in its entirety. 
    
    
     BACKGROUND 
     Catheters are commonly used for a variety of infusion therapies. Catheters may be used for infusing normal saline solution, various medicaments, total parenteral nutrition, or other fluids into a patient. Catheters may also be used to withdraw blood from the patient for diagnostic or other purposes. 
     A common type of catheter is a peripheral intravenous catheter (“PIVC”) that is “over-the-needle.” As its name implies, the PIVC that is over-the-needle 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 the vasculature of the patient. 
     In order to verify proper placement of the introducer needle and/or the PIVC in the blood vessel, a clinician generally confirms that there is “flashback” of blood in a flashback chamber of the catheter assembly. Once placement of the needle has been confirmed, the clinician may remove the introducer needle, leaving the PIVC in place for future fluid infusion. 
     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 vascular access devices, systems, and methods. In particular, the present disclosure relates to a retainer ring and related systems and methods to facilitate securement of a valve within a catheter adapter. In some embodiments, a catheter system may include the catheter assembly. In some embodiments, the catheter assembly may include the catheter adapter, which may include a distal end, a proximal end, an inner surface forming a lumen, the lumen extending through the distal end and the proximal end, and a side port disposed between the distal end and the proximal end. 
     In some embodiments, the catheter assembly may include an annular valve, which may be disposed within the lumen and aligned with the side port. In some embodiments, the annular valve may seal a fluid pathway from the side port to the lumen. In some embodiments, the catheter assembly may include a retainer ring disposed proximal and/or proximate the annular valve within the lumen. In some embodiments, the catheter assembly may include a catheter extending distally from the distal end of the catheter adapter. 
     In some embodiments, the inner surface of the catheter adapter may include an undercut. In some embodiments, the retainer ring may be disposed within the undercut. In some embodiments, the annular valve may include silicon. In some embodiments, the annular valve may be cylindrical. In some embodiments, the retainer ring may be formed by molding. In some embodiments, the retainer ring may be plastic. 
     In some embodiments, the catheter system may include a needle assembly. In some embodiments, the needle assembly may include a needle hub and an introducer needle extending distally from the needle hub and through the retainer ring, the annular valve, and the catheter. In some embodiments, the side port may extend from a top of the catheter adapter. In some embodiments, the side port may be configured to receive a syringe. In some embodiments, the retainer ring is configured to reduce proximal movement of the annular valve in response to fluid infusion through the side port that opens the annular valve. 
     In some embodiments, a method of flushing the catheter assembly may include coupling an infusion device to the side port of the catheter adapter of the catheter assembly. In some embodiments, the method may include activating the infusion device. In some embodiments, in response to activating the infusion device, the annular valve may be opened to allow fluid to flow from the side port into the lumen. In some embodiments, in response to activating the infusion device, a proximal end of the annular valve may be forced against the retainer ring and the retainer ring may remain in place. In some embodiments, the infusion device may include a syringe. In some embodiments, activating the infusion device may include depressing a plunger of the syringe. In some embodiments, the method may include uncoupling and removing the needle assembly from the catheter adapter. In some embodiments, the infusion device may be activated after the needle assembly is uncoupled and removed from the catheter adapter. 
     It is to be understood that both the foregoing general description and the following detailed description are examples 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 illustrated 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. 1  is a cross-sectional view of a prior art catheter system; 
         FIG. 2A  is a cross-sectional view of a catheter system, illustrating an example retainer ring, according to some embodiments; 
         FIG. 2B  is an upper perspective view of the retainer ring, according to some embodiments; 
         FIG. 2C  is an enlarged cross-sectional view of a portion of the catheter system of  FIG. 2A , according to some embodiments; 
         FIG. 2D  is a cross-sectional view of the catheter system of  FIG. 2A , illustrating an example infusion device coupled to an example side port and activated, according to some embodiments; and 
         FIG. 2E  is a top view of the catheter system following infusion through the side port, according to some embodiments. 
     
    
    
     DESCRIPTION OF EMBODIMENTS 
     Referring now to  FIG. 1 , a prior art catheter system  10  is illustrated. The prior art catheter system includes an annular valve  12  disposed in a catheter adapter lumen  14 . The annular valve  12  is often moved proximally in response to fluid infusion through a side port  16  of the prior art catheter system  10 . Proximal movement of the annular valve  12  may prevent the annular valve  12  from sealing the side port  16 , and thus may result in leakage from the catheter adapter lumen  14  through the side port  16  following fluid infusion. 
     Referring now to  FIGS. 2A-2C , a catheter system  18  is illustrated, according to some embodiments. In some embodiments, the catheter system  18  may include a catheter assembly  20 . In some embodiments, the catheter assembly  20  may include a catheter adapter  22 , which may include a distal end  24 , a proximal end  26 , an inner surface  28  forming a lumen  30 . In some embodiments, the catheter assembly  20  may include the lumen  30  extending through the distal end  24  and the proximal end  26 . In some embodiments, the catheter assembly  20  may include a side port  32  disposed between the distal end  24  and the proximal end  26 . In some embodiments, the catheter assembly  20  may include a cap  33  removably coupled to the side port  32 . 
     In some embodiments, the catheter assembly  20  may include an annular valve  34 , which may be disposed within the lumen  30  and aligned with the side port  32 . In some embodiments, the annular valve  34  may seal a fluid pathway from the side port  32  to the lumen  30 . In some embodiments, the annular valve  34  may include silicon or another suitable material that allows an edge of the annular valve  34  to depress and open the fluid pathway from the side port  32  to the lumen  30  in response to fluid infusion through the side port  32 . In some embodiments, the annular valve  34  may be cylindrical. 
     In some embodiments, the catheter assembly  20  may include a retainer ring  36  disposed proximal and/or proximate the annular valve  34  within the lumen  30 . In some embodiments, the retainer ring  36  may be contacting the annular valve  34 . In some embodiments, the catheter assembly  20  may include a catheter  38  extending distally from the distal end  24  of the catheter adapter  22 . In some embodiments, the catheter  38  may include a peripheral intravenous catheter (PIVC), a midline catheter, a peripherally-inserted central catheter, or another suitable type of catheter. 
     In some embodiments, the catheter assembly  20  may include a septum  40 , which may be disposed proximal to the retainer ring  36  and the annular valve  34 . In some embodiments, the septum  40  may include silicon or another suitable material. 
     In some embodiments, the inner surface  28  of the catheter adapter  22  may include an undercut  42 , which may be annular. In some embodiments, the retainer ring  36  may be disposed within the undercut  42 . In some embodiments, a width  44  of the retainer ring  36  may be approximately equal to a length  46  of the undercut  42  such that a distal edge  48  of the retainer ring  36  and a proximal edge  50  of the retainer ring  36  may abut edges of the undercut  42 . In some embodiments, the distal edge  48  and the proximal edge  50  may be annular. In some embodiments, the retainer ring  36  may fit snugly within the undercut  42 . In some embodiments, an outer diameter may be slightly larger than a diameter of the undercut  42  such that the retainer ring  36  snaps into the undercut  42 . 
     In some embodiments, the retainer ring  36  may be plastic, metal, or another suitable material. In some embodiments, the retainer ring  36  may be rigid or semi-rigid. In some embodiments, a durometer of the retainer ring  36  may be greater than a durometer of the annular valve  12 . In some embodiments, the retainer ring  36  may be formed by molding. In further detail, in some embodiments, the retainer ring  36  may be formed by shaping a liquid or malleable raw material by using a fixed frame, such as a mold or a matrix. In some embodiments, the mold may include a hollow cavity receptacle, wherein the liquid or malleable raw material may be poured. In some embodiments, the liquid or malleable raw material may include plastic, metal, or another suitable material. As the liquid or malleable raw material hardens inside the mold, forming the retainer ring  36 . 
     In some embodiments, the catheter system  18  may include a needle assembly  52 . In some embodiments, the needle assembly  52  may include a needle hub  54  and an introducer needle  56  extending distally from the needle hub  54  and through the retainer ring  36 , the annular valve  34 , and the catheter  38 . In some embodiments, the introducer needle  56  may include a sharp distal tip, which may facilitate placement of the catheter  38  within vasculature of a patient. 
     In some embodiments, the side port  32  may extend from a top of the catheter adapter  22  or a portion of the catheter adapter  22  opposite skin of the patient, which may be placed below the catheter adapter  22  and/or beneath one or more wings  58  extending outwardly from the catheter adapter  22 . 
     Referring now to  FIG. 2D , in some embodiments, the side port  32  may be configured to receive an infusion device  60 , which may include a syringe or another suitable infusion device configured to infuse fluid from the side port  32  into the lumen  30 . In some embodiments, the retainer ring  36  is configured keep the annular valve  34  in a same position in response to fluid infusion through the side port  32  that opens the annular valve  34 . In further detail, in some embodiments, the retainer ring  36  may be configured to reduce proximal movement of the annular valve  34  in response to fluid infusion through the side port  32  that opens the annular valve  34 . In some embodiments, in response to fluid infusion through the side port  32  that opens the annular valve  34 , a proximal end  62  of the annular valve  34  may not move in a proximal direction and/or a distal direction but may stay in place. Thus, in some embodiments, the retainer ring  36  may prevent fluid, such as blood and/or another fluid, from leaking through the annular valve  34  and out the side port  32 . 
     In some embodiments, the infusion device  60  may be activated in order to flush the catheter system  18  or inject a bolus. In some embodiments, a method of flushing the catheter assembly  20  may include coupling the infusion device  60  to the side port  32  of the catheter adapter  22  of the catheter assembly  20 . In some embodiments, the side port  32  may include a luer, such as, for example, a female luer, which may be configured to couple to a corresponding luer of the infusion device  60 . 
     In some embodiments, the method may include activating the infusion device  60 . In some embodiments, in response to activating the infusion device  60 , the annular valve  34  may be opened to allow fluid to flow from the side port  32  into the lumen  30 . In some embodiments, in response to activating the infusion device  60 , the proximal end  62  of the annular valve  34  opposite a distal end  64  of the annular valve  34  may be forced against the retainer ring  36  and the retainer ring  36  may remain in place. In these and other embodiments, the proximal end  62  of the annular valve  34  may not move in a proximal direction and/or a distal direction but may stay in place. 
     In some embodiments, the infusion device  60  may include the syringe, as illustrated, for example, in  FIG. 2D . In some embodiments, activating the infusion device  60  may include depressing a plunger  66  of the syringe or otherwise causing fluid to be expelled from the infusion device into the catheter assembly  20 . In some embodiments, the method may include uncoupling and removing the needle assembly  52  from the catheter adapter  22 , as illustrated, for example, in  FIG. 2D . In some embodiments, the infusion device  60  may be activated after the needle assembly  52  is uncoupled and removed from the catheter adapter  22 . 
     Referring now to  FIG. 2E , the catheter assembly  20  is illustrated with the cap  33  open after fluid infusion through the side port  32 . As illustrated, the annular valve  34  is still in place and sealing the side port  32  after the fluid infusion. 
     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.