Blood collection devices, systems, and methods facilitating blood flashback

Abstract

A catheter system may include a catheter adapter, a catheter extending distally from the distal end of the catheter adapter, and a needle hub coupled to the catheter adapter. The needle hub may be transparent, and a needle may be secured within the needle hub. The catheter system may also include a flow control plug coupled to the proximal end of the needle hub. In some embodiments, a flashback pathway may be disposed between an outer surface of the flow control plug and an inner surface of the needle hub. In some embodiments, the catheter system may include an inner barrel and an outer barrel, and the inner barrel and the needle hub may be configured to move proximally within the outer barrel to retract the needle. The flashback pathway may be disposed between an outer surface of the needle hub and an inner surface of the inner barrel.

Claims

1. A catheter system, comprising: a catheter adapter, comprising a distal end, a proximal end, and a lumen extending through the distal end and the proximal end; a catheter extending distally from the distal end of the catheter adapter; a needle hub, comprising a distal end and a proximal end, wherein the distal end of the needle hub is coupled to the proximal end of the catheter adapter, wherein the needle hub is transparent; a needle, comprising a distal end and a proximal end, wherein the proximal end of the needle comprises a portion secured within the needle hub and a remaining portion not contacting the needle hub; a flow control plug coupled to the proximal end of the needle hub, wherein a distal end of the flow control plug comprises a male luer, wherein the male luer is a slip male luer or a threaded male luer; and a flashback pathway disposed between an outer surface of the flow control plug and an inner surface of the needle hub, wherein the outer surface of the flow control plug comprises a channel, wherein the flashback pathway extends through the channel between the channel and the inner surface of the needle hub, wherein the outer surface of the flow control plug further comprises a pocket proximate and distal to the channel, wherein the remaining portion of the needle is within the pocket, wherein the pocket is deeper than the channel.

2. The catheter system of claim 1, wherein the channel is formed by a plurality of side walls that extend from a bottom of the channel to the inner surface of the needle hub and contact the inner surface of the needle hub.

3. The catheter system of claim 1, further comprising a vent disposed proximate the channel and at an interface between the proximal end of the needle hub and the flow control plug.

4. The catheter system of claim 1, wherein the outer surface of the flow control plug comprises a plurality of other channels, further comprising a plurality of other flashback pathways extending through the plurality of other channels between the plurality of other channels and the inner surface of the needle hub.

5. The catheter system of claim 4, wherein the outer surface of the flow control plug further comprises a plurality of grooves extending from the plurality of channels inwardly towards a longitudinal axis of the flow control plug.

6. The catheter system of claim 4, wherein a proximal end of the channel is formed by a proximal wall, wherein the proximal wall comprises a vent configured to allow air but not blood to pass, wherein the proximal wall interferes with the inner surface of the needle hub.

Description

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

(1) Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

(2) FIG. 1A is an upper perspective view of an example catheter system, according to some embodiments;

(3) FIG. 1B is an exploded view of the catheter system of FIG. 1A, according to some embodiments;

(4) FIG. 1C is an upper perspective view of an example flow control plug, according to some embodiments;

(5) FIG. 1D is an upper perspective view of another example flow control plug, according to some embodiments;

(6) FIG. 1E is a cross-sectional view of the catheter system of FIG. 1A, according to some embodiments;

(7) FIG. 1F is an enlarged cross-sectional view of a portion of the catheter system of FIG. 1A, according to some embodiments;

(8) FIG. 1G is a cross-sectional view of the catheter system of FIG. 1A along the line 1G-1G of FIG. 1A, according to some embodiments;

(9) FIG. 2A is an upper perspective view of another example flow control plug, according to some embodiments;

(10) FIG. 2B is a cross-sectional view of the flow control plug of FIG. 2A coupled to the catheter system of FIG. 1A, according to some embodiments;

(11) FIG. 2C is an upper perspective view if the flow control plug of FIG. 2A coupled to an example needle assembly, according to some embodiments;

(12) FIG. 2D is a transverse cross-sectional view along the line 2D-2D of FIG. 2C, according to some embodiments;

(13) FIG. 3A is an upper perspective view of another example flow control plug, according to some embodiments;

(14) FIG. 3B is a cross-sectional view of the flow control plug of FIG. 3A coupled to the catheter system of FIG. 1A, according to some embodiments;

(15) FIG. 3C is a transverse cross-sectional view of the flow control plug of FIG. 3A coupled to the catheter system of FIG. 1A, according to some embodiments;

(16) FIG. 4A is an upper perspective view of another catheter system, according to some embodiments;

(17) FIG. 4B is a cross-sectional view of the catheter system of FIG. 4A, according to some embodiments;

(18) FIG. 4C is an upper perspective view of an example needle hub of the catheter system of FIG. 4A, according to some embodiments;

(19) FIG. 4D is an enlarged cross-sectional view of an example pocket, according to some embodiments;

(20) FIG. 4E is an enlarged upper perspective view of an example microgroove, according to some embodiments;

(21) FIG. 4F is an upper perspective view of an example inner barrel, according to some embodiments;

(22) FIG. 5A is a cross-sectional view of another example catheter system, according to some embodiments;

(23) FIG. 5B is an upper perspective view of the catheter system of FIG. 5A, illustrating an example outer barrel removed, according to some embodiments;

(24) FIG. 5C is a cross-sectional view of a proximal end of the catheter system of FIG. 5A, according to some embodiments;

(25) FIG. 5D is an enlarged cross-sectional view of an example pocket of the catheter system of FIG. 5A, according to some embodiments;

(26) FIG. 5E is a transverse cross-sectional view of the catheter system of FIG. 5A, according to some embodiments;

(27) FIG. 6A is a cross-sectional view of an example needle hub being inserted into an example barrel, according to some embodiments;

(28) FIG. 6B is an enlarged cross-sectional view of a portion of the needle hub of FIG. 6A, according to some embodiments;

(29) FIG. 6C is an upper perspective view of the needle hub of FIG. 6A, according to some embodiments; and

(30) FIG. 6D is a lower perspective view of a portion of the needle hub of FIG. 6A, according to some embodiments.

DESCRIPTION OF EMBODIMENTS

(31) 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.

(32) Referring now to FIG. 1A-1G, in some embodiments, a catheter system 10 may include a catheter adapter 12 which may include a distal end 14, a proximal end 16, and a lumen 18 extending through the distal end 14 and the proximal end 16. In some embodiments, the catheter system 10 may include a catheter 20 extending distally from the distal end 14 of the catheter adapter 12. In some embodiments, the catheter system 10 may include a needle hub 22, which may include a distal end 24 and a proximal end 26. In some embodiments, the distal end 24 of the needle hub 22 may be coupled to the proximal end 16 of the catheter adapter 12.

(33) In some embodiments, the catheter system 10 may include a peripheral intravenous catheter system, such as, for example, the BD NEXIVA™ Closed IV Catheter system, the BD CATHENA™ Catheter system, the BD VENFLON™ Pro Safely Shielded IV Catheter system, the BD NEOFLON™ IV Cannula system, the BD INSYTE™ AUTOGUARD™ BC Shielded IV Catheter system, or another suitable peripheral intravenous catheter system. In some embodiments, the catheter system 10 may include a PICC system or a midline catheter system.

(34) In some embodiments, the catheter system 10 may include a needle 28 which may include a distal end 30 and a proximal end 32. In some embodiments, the needle 28 may include an introducer needle, which may include a sharp distal tip. In some embodiments, the needle 28 may be secured within the needle hub 22. In some embodiments, the catheter system 10 may include a flow control plug 34, which may be coupled to the proximal end 26 of the needle hub 22. In some embodiments, the flow control plug 34 may block a proximal opening 36 of the needle hub 22 such that blood does not exit the proximal opening 36 of the needle hub 22. In some embodiments, the flow control plug 34 may include one or more vents 38, which may include a porous membrane or a microgroove that may vent air while containing blood. In some embodiments, a cap 35 may be coupled to a proximal end of the flow control plug 34.

(35) In some embodiments, the catheter system 10 may include a flashback pathway 40 disposed between an outer surface of the flow control plug 34 and an inner surface of the needle hub 22. In some embodiments, the needle hub 22 may be constructed of a clear or transparent material, which may facilitate observation blood within the flashback pathway 40. In some embodiments, the needle hub may include a lens 42, which may facilitate observation of blood within the flashback pathway 40. In some embodiments, the flow control plug 34 may be constructed of a white material, which may provide a sharp contrast when blood flows into the flashback pathway 40.

(36) In some embodiments, the lens 42 may be disposed above a proximal end 32 of the needle 28. In some embodiments, the lens 42 may be integrated within the needle hub 22. In some embodiments, the lens 42 may be convex or another suitable shape. In some embodiments, an outer surface of the lens 42 may generally conform to a shape of an outer surface of the needle hub 22.

(37) In some embodiments, the outer surface of the flow control plug 34 may include a channel 44. In some embodiments, the flashback pathway 40 may extend through the channel 44 between the channel 44 and the inner surface of the needle hub 22. In some embodiments, the channel 44 may provide a high area-to-volume ratio and may include a small height compared to its width. In some embodiments, a velocity of blood travelling within the channel 44 may be between 1 mm/s and 2 mm/s. In some embodiments, a velocity of blood travelling within the channel 44 may between 0.22 mm/s and 2 mm/s, which may create a continuous motion indicative of vein access in a real-time or near real-time manner. In some embodiments, it may take greater than 1 s for blood to move from one end of the channel 44 to the other. For example, it may take between 5 s and 20 s for blood to move through the channel 44. In some embodiments, the channel 44 may be axially aligned with a longitudinal axis of the catheter system 10.

(38) In some embodiments, the flashback pathway 40 may provide an unobstructed, sharp-contrast visualization of a small volume of blood. In some embodiments, the catheter system 10 may provide an effective signal for vein confirmation with a small amount of blood, such as approximately 10 mL. In some embodiments, the channel 44 may be disposed on a top of the flow control plug 34, as illustrated, for example, in FIG. 1A, to ease visibility of the flashback pathway 40. A bevel of the sharp distal tip of the needle 28 may face toward a top of the catheter system 10 when the catheter system 10 is in an insertion position, ready for insertion into a patient, as illustrated, for example, in FIG. 1A.

(39) In some embodiments, the outer surface of the flow control plug 34 may include a pocket 46 proximate the channel 44. In some embodiments, the proximal end 32 of the needle 28 may be disposed within the pocket 46. In some embodiments, the pocket 46 may be deeper than the channel 44. Blood travelling through the flashback pathway 40 may be forced from the pocket 46 to an outside of the flow control plug 34, which may improve visibility of the blood within the flashback pathway 40 to the clinician.

(40) In some embodiments, the channel 44 may be formed by multiple side walls 48, which may extend from a bottom of the channel 44 to the inner surface of the needle hub 22 and may contact the inner surface of the needle hub 22. Thus, blood may be contained within the channel 44 as it travels proximally through the channel 44. In some embodiments, the vents 38 may be disposed proximate the channel 44, such as at a proximal end of the channel 44. In some embodiments, the vents 38 may be disposed at an interface between the proximal end 26 of the needle hub 22 and the flow control plug 34.

(41) In some embodiments, the side walls 48 may include elongated ribs. In some embodiments, a height of the side walls 48 from a bottom of the channel 44 and/or a width of the channel 44 from one of the side walls 48 to the an opposite of the side walls 48 may increase with an increased gauge size of the catheter 20. For example, the flow control plug 34 illustrated in FIG. 1D may be used with a larger gauge catheter than the flow control plug 34 illustrated in FIG. 1C. As another example, the flow control plug 34 illustrated in FIG. 3A may be used with a larger gauge catheter than the flow control plug 34 illustrated in FIGS. 1C and 1D. In some embodiments, the distal end of the flow control plug 34 may include a male luer. In some embodiments, the male luer may include a slip male luer or a threaded male luer.

(42) Referring now to FIGS. 2A-2D, in some embodiments, the outer surface of the flow control plug 34 may include multiple channels 44, and the flashback pathway 40 may extend through the channels 44 between the channels 44 and the inner surface of the needle hub 22. In some embodiments, a number of the channels 44 may vary. In some embodiments, the outer surface of the flow control plug 34 may include one or more grooves 50 extending from the channels 44 inwardly towards a longitudinal axis of the flow control plug 34. In some embodiments, the grooves 50 may be generally perpendicular to the channels 44.

(43) In some embodiments, a proximal end of each of the channels 44 may be formed by a proximal wall 52. In some embodiments, the proximal wall 52 may include one or more microgrooves configured to allow air but not blood to pass. In some embodiments, the proximal wall 52 may interfere with an inner surface of the needle hub 22, which may prevent blood from exiting the proximal end of the channel 44.

(44) In some embodiments, the needle hub 22 may be constructed of a clear or transparent material, which may facilitate observation blood within the flashback pathway 40. In some embodiments, the needle hub 22 may include one or more lenses, which may facilitate observation of blood within the flashback pathway 40. In some embodiments, the flow control plug 34 may be constructed of a white material, which may provide a sharp contrast when blood flows into the flashback pathway 40.

(45) Referring now to FIGS. 3A-3C, in some embodiments, a tip 54 of the male luer may include a generally planar surface 56, which may extend across the tip 54 such that a shape of the flashback pathway 40 is generally semi-circular. In some embodiments, the flow control plug 34 illustrated in FIG. 3A may be used with an 18 or 20 gauge catheter or another suitable size catheter.

(46) Referring now to FIGS. 4A-4D, in some embodiments, a catheter assembly 58 of a catheter system 60 may include the catheter adapter 12 and the catheter 20. In some embodiments, the catheter system 60 may include or correspond to the catheter system 10 of one of more of FIGS. 1A-3C. In some embodiments, a needle assembly 62 of the catheter system 60 may include one or more of the following: the needle hub 22, the needle 28, an inner barrel 64, and an outer barrel 66. In some embodiments, the inner barrel 64 may surround the needle hub 22. In some embodiments, the needle hub 22 may be secured within the inner barrel 64. In some embodiments, the flashback pathway 40 may be disposed between an outer surface of the needle hub 22 and an inner surface of the inner barrel 64. In some embodiments, the flow control plug 34 may be constructed of a white material, which may provide a sharp contrast when blood flows into the flashback pathway 40.

(47) In some embodiments, the outer barrel 66 may surround the inner barrel 64. In some embodiments, the inner barrel 64 and the needle hub 22 may be configured to move proximally within the outer barrel 66 to retract the needle 28. In some embodiments, the needle assembly 62 may include a button 68 and/or a spring 70. In some embodiments, the inner barrel 64 and the needle hub 22 may move proximally within the outer barrel 66 in response to depression of the button 68 and actuation of the spring 70. In some embodiments, a needle retraction mechanism of the catheter system 60 may operate similar to the BD INSYTE™ AUTOGUARD™ BC Shielded IV Catheter System or another suitable catheter system.

(48) In some embodiments, the inner barrel 64 may include a generally hour-glass shape so that its medial portion has a smaller diameter than either end. This shape facilitates engagement between an opening 71 in the button 68 and the inner barrel 64. In some embodiments, when the button 68 or activation latch is not depressed or is “up” in a non-activated position, a projection 73 may be located inside the catheter adapter 12. Thus, when the catheter 20 is still located on the needle 28 with the catheter adapter 12, the projection 73 may prevent the button 68 from being moved “down” into the activated position.

(49) When the catheter 20 is moved off the needle 28 so the catheter adapter 12 is not adjacent to the projection 73, the button 68 may be moved “down,” i.e. activated, because the catheter adapter 12 no longer interferes with the movement of the projection 73. In this position, the opening 71 is larger than a maximum diameter of inner barrel 64. The spring 70 can thus force the needle hub 22 and the inner barrel 64 to a proximal end of the outer barrel 66 and withdraw the distal end 30 of the needle 28 into the outer barrel 66. In some embodiments, the inner barrel 64 and the needle hub 22 may be integrally formed or monolithically formed as a single unit.

(50) In some embodiments, the needle hub 22 may include a channel 44, and the flashback pathway 40 may extend through the channel 44 between the channel 44 and the inner surface of the inner barrel 64. In some embodiments, the needle hub 22 may include a pocket 46 proximate the channel 44. In some embodiments, the proximal end of the needle 28 may be disposed within the pocket 46. In some embodiments, the pocket 46 may be deeper than the channel 44. In some embodiments, a proximal end of the channel 44 may be formed by a proximal wall 52 of the needle hub 22. In some embodiments, the proximal wall 52 may include one or more vents, which may include a microgroove configured to allow air but not blood to pass. In some embodiments, the proximal wall 52 may interfere with an inner surface of the inner barrel 64. In some embodiments, the inner surface of the inner barrel 64 may include one or more alignment ridges 74. In some embodiments, the outer surface of the needle hub 22 may include one or more other alignment ridges 76, which may contact the alignment ridges 74 to facilitate orientation of the needle hub 22 with respect to the inner barrel 64.

(51) Referring now to FIGS. 5A-5E, in some embodiments, the needle assembly 62 may include a middle barrel 78. In some embodiments, the inner barrel 64 may include a first hole 80 and/or the middle barrel 78 may include a second hole 82 aligned with the first hole 80 of the inner barrel 64. In some embodiments, the flashback pathway 40 may include the first hole 80 and the second hole 82 and may extend between an outer surface of the middle barrel 78 and an inner surface of the outer barrel 66.

(52) In some embodiments, a pocket 46 may be proximate the first hole 80. In some embodiments, the inner barrel 64 and the needle hub 22 may be configured to move proximally within the middle barrel 78 to retract the needle 28. In some embodiments, the inner barrel 64 and the needle hub 22 may move proximally in response to depression of the button 68 and actuation of the spring 70.

(53) In some embodiments, the outer surface of the middle barrel 78 may include a channel 44, and the flashback pathway 40 may extend through the channel 44 between the channel 44 and the inner surface of the inner barrel 64. In some embodiments, the needle hub 22 may include a pocket 46 proximate the channel 44. In some embodiments, the proximal end 32 of the needle 28 may be disposed within the pocket 46. In some embodiments, a proximal end of the channel 44 may be formed by a proximal wall 52 of the middle barrel 78. In some embodiments, the proximal wall 52 may include one or more vents, which may each include a microgroove configured to allow air but not blood to pass. In some embodiments, the proximal wall 52 may interfere with an inner surface of the outer barrel 66.

(54) In some embodiments, the channel 44 may be formed by multiple side walls 48, which may extend from a bottom of the channel 44 to the inner surface of the outer barrel 66 and may contact the inner surface of the outer barrel 66. Thus, blood may be contained within the channel 44 as it travels proximally through the channel 44.

(55) Referring now to FIGS. 6A-6B, the needle hub 22 is illustrated being inserted into the inner barrel 64 during assembly of a catheter system. The catheter system may include or correspond to the catheter system 60 of FIGS. 4A-4F and/or FIGS. 5A-5E. In some embodiments, the proximal end 32 of the needle 28 may contact and be secured within the needle hub 22, but a remaining portion of the needle 28 may not contact the needle hub 22 and/or any portion of the catheter system. In some embodiments, the proximal end 32 of the needle 28 may be pinched and/or glued within the needle hub 22, as illustrated, for example, in FIG. 6B.

(56) Referring now to FIGS. 6C-6D, in some embodiments, the vents 38 may be disposed on a bottom of the needle hub 22, which may facilitate better fluid containment. In some embodiments, flashback may flow proximally through the channel 44 and then down one or more sides of the needle hub 22 to a location proximate the vents 38. In some embodiments, a proximal end of the needle hub 22 may include a seal 84, which may include a rib and/or may extend from one side of the vents 38 to the other.

(57) 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.