Patent Publication Number: US-2022225913-A1

Title: Blood Draw Assembly and Related Devices and Methods

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     The present application claims priority to U.S. Provisional Application Ser. No. 63/138,169, entitled “Blood Draw Assembly and Related Devices and Methods”, filed Jan. 15, 2021, the entire disclosure of which is hereby incorporated by reference in its entirety. 
    
    
     BACKGROUND 
     A catheter is commonly used to infuse fluids into vasculature of a patient. For example, the catheter may be used for infusing normal saline solution, various medicaments, or total parenteral nutrition. 
     The catheter may include a peripheral intravenous (“IV”) catheter. In this case, the catheter may be mounted over an introducer needle having a sharp distal tip. The catheter and the introducer needle may be assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter with the bevel of the needle facing up away from skin of the patient. The catheter 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 catheter in the blood vessel, a clinician generally confirms that there is “flashback” of blood in a flashback chamber of the catheter system. Once placement of the introducer needle has been confirmed, the clinician may remove the introducer needle, leaving the catheter 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 a blood draw assembly and related devices and methods. In some embodiments, a blood draw assembly may include a needle adapter, which may include a body. In some embodiments, the body may include a distal end and proximal end. In some embodiments, the needle adapter may include a needle extending through the body. In some embodiments, the needle may include a distal tip and a proximal tip. In some embodiments, the distal tip may extend distal to the distal end of the body. In some embodiments, the proximal tip may extend proximal to the proximal end of the body. 
     In some embodiments, the needle adapter may include a sheath coupled to the body and extending over the proximal tip. In some embodiments, the needle adapter may include a hydrophobic vent element, which may surround the body. In some embodiments, the needle adapter may include a septum coupled to the distal end of the body. 
     In some embodiments, the blood draw assembly may include a Y-adapter, which may include a first proximal port, a second proximal port, and a distal port. In some embodiments, the needle adapter may be coupled to the first proximal port. In some embodiments, the septum may be aligned with the second proximal port. In some embodiments, an air vent pathway may extend proximally along an outer edge of the septum, through the hydrophobic vent element, between an outer surface of the body and an inner surface of the first proximal port, and out the first proximal port. 
     In some embodiments, the needle may include a notch. In some embodiments, the body may include a notch aligned with the notch of the needle. In some embodiments, the hydrophobic vent element may contact an outer edge of the notch of the body. In some embodiments, a blood flow pathway extends through the needle and through the notch in the body to the hydrophobic vent element. 
     In some embodiments, the body may include a collar disposed between the distal end of the body and the proximal end of the body. In some embodiments, the collar may include threading. In some embodiments, the air vent pathway may extend between an inner surface of the collar and an outer surface of the first proximal port. In some embodiments, the blood draw assembly may include an extension tube integrated with the distal port. In some embodiments, the blood draw assembly may include a catheter adapter and a catheter extending distally from the catheter. In some embodiments, a distal end of the extension tube may be integrated within a catheter adapter. In some embodiments, a proximal end of the extension tube may be integrated within the distal port. 
     In some embodiments, the hydrophobic vent element may contact a proximal end of the septum and a stepped surface in the body. In some embodiments, the body may include a catch feature configured to pull the septum. In some embodiments, the body may include a collar disposed between the distal end of the body and the proximal end of the body. In some embodiments, an outer diameter of the hydrophobic vent element may be greater than an outer diameter of the septum. 
     In some embodiments, the blood draw assembly may include a guidewire extending through the needle. In some embodiments, a distal end of the guidewire may include a groove spaced apart from a distal tip of the guidewire. In some embodiments, the guidewire may be configured to rotate. 
     In some embodiments, the hydrophobic vent element may be disposed within a wall of the body and in fluid communication with the notch. In some embodiments, the septum may be secured to the distal end of the body. In some embodiments, the septum may be secured to the distal end of the body via adhesive. In some embodiments, the septum may be proximal to the second proximal port. In some embodiments, a proximal end of the septum is flush with a proximal end of the first proximal port. 
     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 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 blood draw assembly; 
         FIG. 1B  is a cross-sectional view of a portion of the prior art blood draw assembly; 
         FIG. 2A  is an upper perspective view of an example blood draw assembly, illustrating an example needle adapter, according to some embodiments; 
         FIG. 2B  is an upper perspective view of the needle adapter of  FIG. 2A , according to some embodiments; 
         FIG. 2C  is an exploded view of the needle adapter of  FIG. 2A , according to some embodiments; 
         FIG. 2D  is a cross-sectional view of the needle adapter of  FIG. 2A  coupled to an example Y-adapter, illustrating an example air vent pathway, according to some embodiments; 
         FIG. 2E  is an enlarged cross-sectional view of a portion of the needle adapter of  FIG. 2A , according to some embodiments; 
         FIG. 2F  is a cross-sectional view of the needle adapter of  FIG. 2A  coupled to the Y-adapter, illustrating an example blood flow pathway, according to some embodiments; 
         FIG. 2G  is an enlarged cross-sectional view of a portion of the needle adapter of  FIG. 2A , according to some embodiments; 
         FIG. 3A  is an upper perspective view of the needle adapter of  FIG. 2A  and an example guidewire, according to some embodiments; 
         FIG. 3B  is an upper perspective view of an example distal end of the guidewire, according to some embodiments; 
         FIG. 4A  is an upper perspective view of the blood draw assembly, illustrating another example needle adapter, according to some embodiments; 
         FIG. 4B  is an upper perspective view of the needle adapter of  FIG. 4A  coupled to the Y-adapter, according to some embodiments; 
         FIG. 4C  is an upper perspective view of the needle adapter of  FIG. 4A , according to some embodiments; 
         FIG. 4D  is an exploded view of the needle adapter of  FIG. 2A , according to some embodiments; 
         FIG. 4E  is a cross-sectional view of the needle adapter of  FIG. 4A  coupled to the Y-adapter, according to some embodiments; 
         FIG. 4F  is an upper perspective view of the needle adapter of  FIG. 4A  removed from the Y-adapter, according to some embodiments; 
         FIG. 5A  is an upper perspective view of the blood draw assembly, illustrating another example needle adapter, according to some embodiments; 
         FIG. 5B  is an upper perspective view of the needle adapter of  FIG. 5A , according to some embodiments; 
         FIG. 5C  is an upper perspective view of the needle adapter of  FIG. 5A  removed from the blood draw assembly, according to some embodiments; 
         FIG. 5D  is a cross-sectional view of the needle adapter of  FIG. 5A  removed from an example straight luer adapter, according to some embodiments; and 
         FIG. 5E  is a cross-sectional view of the needle adapter of  FIG. 5A  coupled to the straight luer adapter, according to some embodiments. 
     
    
    
     DESCRIPTION OF EMBODIMENTS 
     Referring now to  FIGS. 1A-1B , a prior art blood draw assembly  10  is illustrated. The prior art blood draw assembly  10  includes a prior art needle adapter  12 , which tends to accumulate blood traces after blood draw through the prior art needle adapter  12 . The blood traces are difficult to flush and make the prior art needle adapter  12  prone to microbial growth. The blood traces occur in several locations, including in a space  15  between a cannula  14  and a septum  16 , at a curved or angled portion  18  of an inner surface of the prior art needle adapter  12 , and a stepped portion  20  of the inner surface of the inner surface proximate an extension tube  22 . The prior art needle adapter  12  also includes a dead space  24  created due to back pressure, and vein confirmation or blood flashback is often not be clear due to back pressure. Moreover, the prior art needle adapter  12  facilitates mixing of priming fluid and pure blood. 
     Referring now to  FIG. 2A , a blood draw assembly  26  is illustrated, according to some embodiments. In some embodiments, the blood draw assembly  26  may include a catheter assembly, which may include a catheter adapter  28  and a catheter  30  extending distally from the catheter  30 . In some embodiments, an introducer needle  31  coupled to a needle hub may extend through the catheter  30  and may be removed after insertion of the catheter  30  into the vasculature and prior to blood draw or collection. In some embodiments, the catheter  30  may include a peripheral intravenous catheter, a central catheter, or a peripherally inserted midline catheter. In some embodiments, the catheter assembly may include or correspond to any suitable catheter assembly, such as, for example, the BD NEXIVA™ Closed IV Catheter system or the BD SAF-T-INTIMA™ Closed IV Catheter System, available from Becton Dickinson &amp; Company of Franklin Lakes, N.J., or another suitable catheter assembly. 
     In some embodiments, the catheter adapter  28  may include a distal end  32 , a proximal end  34 , and a lumen extending between the distal end  32  and the proximal end  34 . In some embodiments, the catheter adapter  28  may include a side port  36  disposed between the distal end  32  and the proximal end  34 . 
     In some embodiments, the blood draw assembly  26  may include a needle adapter  38 , which may be coupled to a Y-adapter  40  of the blood draw assembly  26 . In some embodiments, the needle adapter  38  may be pre-attached to the Y-adapter  40 . In some embodiments, the Y-adapter  40  may include a distal port  42 , a first proximal port  44 , and a second proximal port  46 . In some embodiments, the Y-adapter may be replaced by an adapter that includes more ports than the distal port  42 , the first proximal port  44 , the second proximal port  46 . 
     In some embodiments, the blood draw assembly  26  may include an extension tube  39 , which may include a distal end integrated with the side port  36  and a proximal end integrated with the distal port  42 . In some embodiments, a clamp  48  may be disposed on the extension tube  39  and may move from an unclamped position to a clamped position to prevent blood flow through the extension tube  39 . In some embodiments, the needle adapter  38  may be coupled to the first proximal port  44  and a vent cap  50  configured to vent air from the blood draw assembly  26 . 
     Referring now to  FIG. 2B-2C , in some embodiments, the needle adapter  38  may include a body  52 . In some embodiments, the body  52  may include a distal end  54  and proximal end  56 . In some embodiments, the needle adapter  38  may include a needle  58  extending through the body  52 . In some embodiments, the needle  58  may include a distal tip  60  and a proximal tip  62 . In some embodiments, the distal tip  60  may extend distal to the distal end  52  of the body  54 . In some embodiments, the proximal tip  62  may extend proximal to the proximal end  56  of the body  52 . 
     In some embodiments, the needle adapter  38  may include a sheath  64  coupled to the body  52  and extending over the proximal tip  62 , which may be sharp. In some embodiments, the sheath  64  may be rubber and/or elastomeric. In some embodiments, in response to coupling a blood collection device to the needle adapter  38 , the proximal tip  62  may pierce the sheath  64 , the sheath  64  may be compressed towards the body  52 , and the needle  58  may be inserted into the blood collection device. In some embodiments, the blood collection device may include a blood collection tube or the BD VACUTAINER® Blood Collection Tube, available from Becton Dickinson &amp; Company of Franklin Lakes, N.J. 
     In some embodiments, the needle adapter  38  may include a hydrophobic vent element  66 . In some embodiments, the hydrophobic vent element  66  may include a ring and may surround the body  52 . In some embodiments, the hydrophobic vent element  66  may include a membrane. In some embodiments, the hydrophobic vent element  66  may be configured to pass air. In some embodiments, the hydrophobic vent element  66  may absorb fluid and/or prevent fluid from passing through the hydrophobic vent element  66 . 
     In some embodiments, the needle adapter  38  may include a septum  68 , which may be coupled to the distal end  54  of the body  52 . In some embodiments, the body  52  may include a catch feature  70  configured to pull the septum  68  in response to removal of the needle adapter  38  from the Y-adapter  40 . In some embodiments, the catch feature  70  may include a groove or an annular groove. In some embodiments, the septum  68  may include a protrusion, which may fit inside the catch feature  70 . In some embodiments, the distal tip  60  may be disposed distal to the septum  68 . 
     In some embodiments, the body  52  may include a collar  72  disposed between the distal end  54  of the body  52  and the proximal end  56  of the body  52 . In some embodiments, an outer surface of the body  52  may include a radial groove  74  to provide an air channel. 
     Referring now to  FIGS. 2D-2E , in some embodiments, the needle adapter  38  may be coupled to the first proximal port  44 , as illustrated, for example, in  FIG. 2D . In some embodiments, the septum  68  may be aligned with the second proximal port  46 . In some embodiments, the distal end of the septum  68  may include a larger diameter than a proximal end of the septum  68 . In some embodiments, a distal end of the septum  68  may form a seal with an inner surface of the Y-adapter  40  such that priming fluid  75  flowing proximally through the second proximal port  46  is prevented from flowing distally beyond the septum  68 . In some embodiments, a proximal end of the septum  68  may be spaced apart from the inner surface of the Y-adapter  40  to form a clearance  76  through which priming fluid  75  flowing proximally through the second proximal port  46  may flow until it reaches the hydrophobic vent element  66 . In some embodiments, the clearance  76  may be annular. 
     In some embodiments, an air vent pathway may extend proximally along an outer edge of the septum through the clearance  76 , proximally through the hydrophobic vent element  66 , into a space  78  between an outer surface of the body  52  and an inner surface of the first proximal port  44 , through the radial groove  74 , and out the first proximal port  44 . In some embodiments, the space  78  may be annular. In some embodiments, air may flow through the air vent pathway in response to priming fluid  75  flowing proximally through the second proximal port  46 . 
     In some embodiments, the distal tip  60  of the needle  58  may be disposed within a metal bushing  79  when the needle adapter  38  is coupled to the first proximal port  44 . In some embodiments, the septum  68  may provide a seal where the septum  68  contacts the metal bushing  79 . In some embodiments, the seal may be annular such that fluid is prevented from moving distal to the distal end of the septum  68 . 
     As illustrated in  FIG. 2E , a portion  80  of the hydrophobic vent element  66  may absorb the priming fluid  75  and prevent passage of the priming fluid  75  through the hydrophobic vent element  66 . In some embodiments, the portion  80  may be larger or smaller than the portion  80  illustrated in  FIG. 2E . In some embodiments, an inner surface of the collar  72  may include threading  81 . In some embodiments, the air vent pathway may extend between the inner surface of the collar  72  and an outer surface of the first proximal port  44 . 
     Referring now to  FIGS. 2F-2G , in some embodiments, the needle  58  may include a notch  82 . In some embodiments, the body  52  may include a notch  84  aligned with the notch  82  of the needle  58 . In some embodiments, the hydrophobic vent element  66  may contact an outer edge of the notch  82  of the body  52  and seal the notch  82 . In some embodiments, a blood flow pathway extends through the needle  58  and through the notch  82  in the body  52  to the hydrophobic vent element  66 . In some embodiments, a portion  86  of the hydrophobic vent element  66  may absorb blood  88 . In some embodiments, the portion  86  may be larger or smaller than the portion  86  illustrated in  FIG. 2H . In some embodiments, blood  88  may flow proximally through the blood flow pathway in response to insertion of the catheter  30  into vasculature of the patient and/or unclamping of the clamp  48  (see for example,  FIG. 2A ). 
     In some embodiments, the hydrophobic vent element  66  may contact the proximal end of the septum  68  and/or a stepped surface  90  in the body  52 . In some embodiments, the hydrophobic vent element  66  may thus be secured between the proximal end of the septum  68  and the stepped surface  90 , which may be annular. In some embodiments, an outer diameter of the hydrophobic vent element  66  may be greater than an outer diameter of the septum  68  such that the clearance  76  ends. In some embodiments, the hydrophobic vent element  66  may contact the inner surface of the Y-adapter  40 . 
     Referring now to  FIGS. 3A-3B , in some embodiments, the blood draw assembly  26  may include a guidewire  92 , which may extend through the needle  58 . In some embodiments, the guidewire  92  may be threaded through the needle  58  and the blood draw assembly  26 , which may facilitate blood draw through an occluded catheter. In some embodiments, a distal end of the guidewire  92  may include a groove  94  spaced apart from a distal tip  96  of the guidewire  92 . In some embodiments, the guidewire  92  may be configured to rotate, which may facilitate removal of a fibrin sheath inside and/or near a distal end of the catheter  30  (see, for example,  FIG. 2A ). In some embodiments, the groove  94  may facilitate pulling and/or rotation of the fibrin sheath. In some embodiments, the groove  94  may be disposed within a planar cut at the distal end of the guidewire  92 . 
     Referring now to  FIG. 4A , a blood draw assembly  100  and a needle adapter  102  are illustrated, according to some embodiments. In some embodiments, the blood draw assembly  100  and the needle adapter  102  may be similar or identical to the blood draw assembly  26  and the needle adapter  38 , respectively, of  FIGS. 2A-3B  in terms of one or more components and/or operation. In some embodiments, the needle adapter  102  may be pre-attached to the Y-adapter  40 . 
     Referring now to  FIGS. 4B-4E , in some embodiments, the hydrophobic vent element  66  may be disposed within a wall  104  of the body  52  and in fluid communication with the notch  82 . In some embodiments, the septum  68  may be secured to the distal end  54  of the body  52 . In some embodiments, the septum  68  may be secured to the distal end  54  of the body  52  via adhesive or another suitable attachment means. In some embodiments, the septum  68  may be proximal to the second proximal port  46 . 
     In some embodiments, a blood flow pathway may extend proximally through the needle  58 . In some embodiments, the blood flow pathway may also extend through the notch  82  in the needle  58  and into a tunnel  106  in the body  52  to the hydrophobic vent element  66 . In some embodiments, the tunnel  106  may extend from the needle  58  through the wall  104  of the body  52 . In some embodiments, the tunnel  106  may provide enhanced flashback for vein confirmation. 
     In some embodiments, in response to blood flowing proximally through the blood flow pathway, air may flow out the hydrophobic vent element  66 . In some embodiments, the hydrophobic vent element  66  may be configured to pass air and not liquid, such as blood. In some embodiments, the vent cap  50  may be coupled to the second proximal port  46 . In some embodiments, the blood flow pathway may also extend into the second proximal port  46 , and air may flow proximally out the vent cap  50 . In some embodiments, the blood may flow proximally through the blood flow pathway in response to insertion of the catheter  30  into vasculature of the patient and/or unclamping of the clamp  48  (see for example,  FIG. 4A ). 
     In some embodiments, in response to coupling a blood collection device to the needle adapter  102 , the proximal tip  62  may pierce the sheath  64 , the sheath  64  may be compressed towards the body  52 , and the needle  58  may inserted into the blood collection device. In some embodiments, the blood collection device may include a blood collection tube or the BD VACUTAINER® Blood Collection Tube, available from Becton Dickinson &amp; Company of Franklin Lakes, N.J. 
     In some embodiments, the distal tip  60  may be sharp, which may facilitate insertion of the needle  58  through the septum  68 . In some embodiments, the distal tip  60  may be blunt. In some embodiments, the distal tip  60  of the needle  58  may be disposed within the metal bushing  79 , which may prevent damage to the inner surface of the Y-adapter. In some embodiments, the Y-adapter may include a low or zero dead space zone  108 , which may facilitate flushing and removal of traces of blood. In some embodiments, the low or zero dead space zone  108  may extend between the distal end of the septum  68  and the metal bushing  79 . 
     Referring now to  FIG. 4F , in some embodiments, a proximal end of the septum  68  may be flush with a proximal end of the first proximal port  46 , which may facilitate cleaning and disinfection of the septum  68 .  FIG. 4F  illustrates removal of the needle adapter  102  from the Y-adapter  40  after completion of blood draw from the patient. In some embodiments, a winged needle set may be inserted through the septum  68  after the needle adapter  102  is removed from the Y-adapter  40 . In some embodiments, the vent cap  50  may be removed and replaced with a needle-free luer connector. 
     Referring now to  FIG. 5A , a blood draw assembly  110  and a needle adapter  112  are illustrated, according to some embodiments. In some embodiments, the blood draw assembly  110  may be similar or identical to the blood draw assembly  26  of  FIGS. 2A-3B  and/or the blood draw assembly  100  of  FIGS. 4A-4F  in terms of one or more components and/or operation. In some embodiments, the needle adapter  112  may be similar or identical to the needle adapter  38  of  FIGS. 2A-3B  and/or the needle adapter  102  of  FIGS. 4A-4F  in terms of one or more components and/or operation. 
     In some embodiments, the needle adapter  112  may be pre-attached to the Y-adapter  40 . In some embodiments, the body  52  may include a cylindrical portion  114 , which may extend distal to the distal tip  60 . In some embodiments, the cylindrical portion  114  may act as a needle guard to prevent an accidental stick with the distal tip  60 . 
     In some embodiments, the body  52  may be coupled to a straight luer adapter  118 , which may include the septum  68 . In some embodiments, extension tube  39  may be integrated within the straight luer adapter  118 . In some embodiments, the straight luer adapter  118  may be configured to insert into the cylindrical portion  114 . 
     In some embodiments, the catheter assembly, which may include the catheter  30  and the catheter adapter  28 , may be closed and no priming may be necessary. In some embodiments, the extension tube  39  may be shorter, such as, for example, between 1 and 4 inches. 
     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.