CATHETER SYSTEM HAVING BLOOD SHIELD - Patent application

Abstract

The catheter system may include a blood shield secured within the catheter hub. The blood shield may include a distal end, a proximal end, a blood shield lumen extending through the distal end and the proximal end, and an inner wall forming the blood shield lumen. The inner wall may include a narrowed inner diameter portion or shield bump. The catheter system may include an introducer needle having a sharpened distal tip and a needle bump. The introducer needle may extend through the catheter and the blood shield. In response to proximal retraction of the introducer needle, the needle bump may be configured to contact the narrowed inner diameter portion or shield bump to withdraw the blood shield proximally from the catheter hub. The sharpened distal tip may be disposed within the blood shield when the needle bump contacts the narrowed inner diameter portion or shield bump.

Description

[Background technology]

[0001] A common type of catheter system includes an over-the-needle peripheral intravenous catheter ("PIVC"). As the name suggests, an over-the-needle PIVC may be mounted on an introducer needle with a sharp distal tip. The catheter system may include a catheter hub, a PIVC that extends distally from the catheter hub, and an introducer needle that extends through the PIVC. The PIVC and introducer needle may be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the PIVC with the bevel of the needle facing up and away from the patient's skin just prior to insertion into the skin. The PIVC and introducer needle are typically inserted at a shallow angle through the skin into the patient's vasculature.

[0002] To confirm proper placement of the introducer needle and / or PIVC in the blood vessel, the practitioner may observe blood flashback in the flashback chamber of the catheter system. In some cases, blood may enter the introducer needle and exit the introducer needle's flashback notch to the flashback chamber where blood is visible to the practitioner. Once placement of the introducer needle is confirmed by observation of blood, the practitioner may advance the catheter further along the introducer needle, creating a space between the catheter hub and the needle housing. The practitioner may remove the introducer needle from the catheter system, leaving the PIVC in place in the blood vessel for future blood withdrawal or infusion. When the introducer needle is removed from the catheter system, blood may splash from the flashback notch or sharp distal tip due to the space between the catheter hub and the needle housing. Blood splashing poses a danger to the practitioner and / or the patient.

[0003] The subject matter claimed herein is not limited to embodiments that solve any disadvantages, nor does it operate exclusively in the environments described above. Rather, this background is only provided to illustrate one example technology area where some embodiments described herein may be practiced. Summary of the Invention

[0004] The present disclosure relates generally to vascular access devices. More specifically, in some embodiments, the present disclosure relates to a catheter assembly configured to shield an introducer needle. In a first set of embodiments, a catheter system may include a catheter hub, which may include a distal end, a proximal end, and a catheter hub lumen extending through the distal end of the catheter hub and the proximal end of the catheter hub. The catheter may extend from the distal end of the catheter hub to a distal end.

[0005] The catheter system may include a blood shield secured within a catheter hub lumen. The blood shield may include a distal end, a proximal end, a blood shield lumen extending through the distal end of the blood shield and the proximal end of the blood shield, and an inner wall forming the blood shield lumen. The inner wall may include a shield bump, which may be annular.

[0006] The catheter system may include an introducer needle, which may include a sharp distal tip and a needle bump. The introducer needle may extend through the catheter and the blood shield. In response to proximal retraction of the introducer needle, the needle bump may be configured to contact the shield bump to proximally retract the blood shield from the proximal end of the catheter hub. The sharp distal tip may be disposed within the blood shield when the needle bump contacts the shield bump. The introducer needle may include a notch proximal to the needle bump. The notch may be disposed within the blood shield when the needle bump contacts the shield bump.

[0007] The catheter system may include a septum disposed within the catheter hub lumen. The catheter system may include a septum actuator disposed within the catheter hub lumen and configured to open the septum. At least a portion of the blood shield may be disposed within the septum actuator. A distal end of the blood shield may be positioned to have an interference fit with an inner surface of the septum actuator. The distal end of the blood shield may be angled.

[0008] The catheter system may include a housing, which may include a barrel. The catheter system may include a needle hub coupled to the introducer needle and movably disposed within the barrel. The catheter system may include a spring disposed within the housing. The catheter system may include a push button. In response to depression of the push button, the spring may be configured to proximally expand to move the needle hub proximally within the barrel and proximally retract the introducer needle.

[0009] A portion of the needle hub may be disposed within the catheter hub. A proximal end of the blood shield may be disposed within a portion of the needle hub. An inner wall of the blood shield may include a distal cylindrical portion distal to the shield bump and a proximal cylindrical portion proximal to the shield bump. The sharp distal tip may be disposed within the proximal cylindrical portion when the needle bump contacts the shield bump. The introducer needle may include a notch proximal to the needle bump. The notch may be disposed within the proximal cylindrical portion when the needle bump contacts the shield bump.

[0010] In a second set of embodiments, a catheter system may include a catheter hub, which may include a distal end, a proximal end, and a catheter hub lumen extending through the distal end of the catheter hub and the proximal end of the catheter hub. The catheter system may include a catheter extending from the distal end of the catheter to a distal end. The catheter system may include a blood shield secured within the catheter hub lumen. The blood shield may include a distal end, a proximal end, a blood shield lumen extending through the distal end of the blood shield and the proximal end of the blood shield, and an inner wall forming the blood shield lumen. The inner wall may include a narrowed inner diameter portion.

[0011] The catheter system may include a septum disposed within the proximal end of the blood shield. The septum may be in an interference fit with an inner wall of the blood shield to secure the septum within the blood shield lumen. The catheter system may include an introducer needle, which may include a sharpened distal tip and a needle bump. The introducer needle may extend through the catheter and the blood shield. In response to proximal retraction of the introducer needle, the needle bump may be configured to contact the narrowed inner diameter portion to proximally retract the blood shield from the proximal end of the catheter hub. The sharpened distal tip may be disposed within the blood shield when the needle bump contacts the narrowed inner diameter portion.

[0012] The septum may include a plurality of vent holes extending therethrough and spaced apart from an outer edge of the septum. Air may be configured to travel proximally through the introducer needle, the vent holes, and the blood shield. The septum may include a slit configured to receive the introducer needle therethrough. The vent holes may be arranged in a symmetrical pattern, and the slit may be located at the center of the symmetrical pattern.

[0013] An outer edge of the septum may include a vent hole to allow air to pass between the septum and an inner wall of the catheter hub. The inner wall of the blood shield may include an annular protrusion. An outer surface of the septum may include an annular recess. The annular protrusion may be disposed within the annular recess.

[0014] The narrowed inner diameter portion may include a shield bump. The proximal end of the blood shield may include an annular flange. The annular flange may include a plurality of vent holes configured to allow air to pass between the septum and the inner wall of the catheter hub. The inner wall of the blood shield may include an annular protrusion. The annular protrusion may include a plurality of vent slots configured to allow air to pass through the blood shield.

[0015] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory, and are not intended to limit the invention as claimed. It is to be understood that the various embodiments are not limited to the arrangement and instrumentality illustrated in the drawings. It is also to be understood that the embodiments may be combined or other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the invention, unless so claimed. Therefore, the following detailed description is not to be taken in a limiting sense. [Brief description of the drawings]

[0016] Example embodiments are described with additional specificity and detail through the use of the accompanying drawings.

[0017] [Figure 1] FIG. 1 is a top perspective view of a prior art catheter system. [Diagram 2] FIG. 2 is another top perspective view of a prior art catheter system. [Diagram 3] FIG. 3 is a partial cutaway view of an exemplary catheter hub according to some embodiments. [Figure 4] FIG. 4 is a top perspective view of an exemplary catheter system including a catheter hub, according to some embodiments. [Figure 5A] FIG. 5A is a top perspective view of an exemplary blood shield, according to some embodiments. [Figure 5B] FIG. 5B is a distal end view of the blood shield of FIG. 5A, according to some embodiments. [Figure 5C] FIG. 5C is a cross-sectional view of the blood shield of FIG. 5A according to some embodiments. [Figure 6] FIG. 6 is a cross-sectional view of a catheter hub, according to some embodiments. [Figure 7] FIG. 7 is an enlarged cross-sectional view of an exemplary distal end of the blood shield of FIG. 5A with an interference fit with an exemplary septum actuator, according to some embodiments. [Figure 8A] FIG. 8A is a top perspective view of an exemplary introducer needle, according to some embodiments. [Figure 8B] FIG. 8B is a cross-sectional view of an introducer needle in the blood shield of FIG. 5A and an exemplary needle bump contacting an exemplary shield bump, according to some embodiments. [Figure 8C] FIG. 8C is a cross-sectional view of an introducer needle disposed within an exemplary catheter when the catheter system of FIG. 4 is in the ready position, according to some embodiments. [Figure 9] FIG. 9 is a cross-sectional view of the catheter system of FIG. 4 in a ready position, according to some embodiments. [Figure 10] FIG. 10 is a cross-sectional view of the catheter system of FIG. 4 showing the catheter hub advanced distally along an introducer needle, according to some embodiments. [Figure 11] FIG. 11 is a cross-sectional view of the catheter system of FIG. 4 showing the introducer needle partially retracted, according to some embodiments. [Figure 12] 12 is a cross-sectional view of the catheter system of FIG. 4 showing the introducer needle further retracted from FIG. 11 to a position where the needle bump contacts the shield bump, according to some embodiments. [Figure 13] 13 is a cross-sectional view of the catheter system of FIG. 4 showing the introducer needle further retracted from FIG. 12, according to some embodiments. [Figure 14]FIG. 14 is a top perspective view of the blood shield and introducer needle in a shielding position where the needle bump contacts the shield bump, according to some embodiments. [Figure 15] 15 is a cross-sectional view of the catheter system of FIG. 4 showing the introducer needle further retracted from FIG. 13, according to some embodiments. [Figure 16] FIG. 16 is a cross-sectional view of an exemplary mold that may be used to form the blood shield of FIG. 5A, according to some embodiments. [Figure 17A] FIG. 17A is a top perspective view of another exemplary blood shield showing an internal introducer needle, according to some embodiments. [Figure 17B] FIG. 17B is another top perspective view of the blood shield of FIG. 17A showing an internal introducer needle, according to some embodiments. [Figure 17C] FIG. 17C is a cross-sectional view of the blood shield of FIG. 17A, according to some embodiments. [Figure 17D] FIG. 17D is a distal end view of an exemplary septum, according to some embodiments. [Figure 17E] FIG. 17E is a top perspective view of the blood shield of FIG. 17A with the septum removed for illustrative purposes, according to some embodiments. [Figure 17F] FIG. 17F is a cross-sectional view of an exemplary distal end of the blood shield of FIG. 17A with the septum removed for illustrative purposes, according to some embodiments. [Figure 17G] FIG. 17G is another top perspective view of the blood shield apparatus of FIG. 17A showing an exemplary vent hole, according to some embodiments. [Figure 18A] FIG. 18A is a cross-sectional view of an exemplary catheter system including the blood shield of FIG. 17A, according to some embodiments. [Figure 18B] FIG. 18B is a cross-sectional view of the catheter system of FIG. 18A, according to some embodiments. [Figure 19A] FIG. 19A is a cross-sectional view of the catheter system of FIG. 18A, according to some embodiments. [Figure 19B] FIG. 19B is a cross-sectional view of the catheter system of FIG. 18A, according to some embodiments. [Figure 19C] FIG. 19C is a cross-sectional view of the catheter system of FIG. 18A, according to some embodiments. [Figure 20A] FIG. 20A is a top perspective view of another exemplary blood shield, according to some embodiments. [Figure 20B] FIG. 20B is a cross-sectional view of the blood shield of FIG. 20A according to some embodiments. [Figure 21A] FIG. 21A is a top perspective view of another exemplary blood shield, according to some embodiments. [Figure 21B] FIG. 21B is a cross-sectional view of the blood shield of FIG. 20A according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] 1A-1B, there is illustrated a prior art catheter system 10. The prior art catheter system 10 includes a catheter assembly 12 coupled to a needle assembly 14. The catheter assembly 12 includes a catheter 16 extending distally from a distal end of a catheter hub 18. The needle assembly 14 includes an introducer needle 20 that extends through the catheter 16 to facilitate insertion of the catheter 16 through a patient's vein.

[0019] The needle assembly 14 includes a push button 22 configured to retract the introducer needle 20 into the barrel 24 of the needle assembly 14 when the push button 22 is pressed or depressed. Examples of catheter assemblies that may include the push button 22 are the BD INSYTE™ AUTOGUARD™ Shielded IV Catheter, the BD INSYTE™ AUTOGUARD™ BC Shielded IV Catheter, and the AcuCath ACE™ Intravascular Catheter, available from Becton Dickinson & Co., Franklin Lakes, NJ. Another example of a catheter assembly that may include the push button 22 is the SUPERCATH™ 5 Safety IV Catheter, available from ICU Medical, San Clemente, CA.

[0020] The push button 22 and retraction of the introducer needle 20 helps to reduce needle stick injuries. In some cases, after the catheter 16 is in the vein and blood flashback is observed, the catheter 16 may be advanced distally relative to the introducer needle 20 and further into the vein to create a space between the catheter hub 18 and the needle assembly 14, as shown in FIG. 2. Unfortunately, in some cases, when the practitioner activates the push button 22 with the catheter hub 18 and needle assembly 14 spaced apart, inertia can cause blood from the introducer needle 20 to splash, endangering the practitioner and / or the patient.

[0021] 3-8, in some embodiments, the catheter system 30 may reduce the risk of blood splash or ejection towards the practitioner. In some embodiments, the catheter system 30 may include a catheter hub 32, which may include a distal end 34, a proximal end 36, and a catheter hub lumen 38 extending through the distal end 34 of the catheter hub 32 and the proximal end 36 of the catheter hub 32. In some embodiments, a catheter 40 may extend from the distal end of the catheter hub 32 to a distal end. In some embodiments, the catheter 40 may include a peripheral intravenous catheter, a midline catheter, or a peripherally inserted central catheter.

[0022] In some embodiments, the catheter system 30 may include a blood shield 42 secured within the catheter hub lumen 38. In some embodiments, the blood shield 42 may include a distal end 44, a proximal end 46, a blood shield lumen 48 extending through the distal end 44 of the blood shield 42 and the proximal end 46 of the blood shield 42, and an inner wall 50 that defines the blood shield lumen 48.

[0023] In some embodiments, the catheter system 30 may include a septum 52 disposed within the catheter hub lumen 38. In some embodiments, the catheter system 30 may include a septum actuator 54 disposed within the catheter hub lumen 38 and configured to open the septum 52. In some embodiments, the septum 52 may be in an interference fit with an inner wall 50 of the catheter hub 32 to secure the septum 52 within the catheter hub lumen 38. In some embodiments, after the blood shield 42 is removed from the catheter hub 18, a male luer may be inserted into the proximal end 36 of the catheter hub 18. In some embodiments, the male luer may contact the septum actuator 54 to move the septum actuator 54 distally through the septum 52.

[0024] In some embodiments, at least a portion of the blood shield 42 may be disposed within the septum actuator 54. In some embodiments, the distal end 44 of the blood shield 42 may be disposed in an interference fit with an inner surface 56 of the septum actuator 54, as illustrated, for example, in FIG. 7. More specifically, in some embodiments, the outer diameter of the distal end 44 of the blood shield 42 may be slightly larger than the inner diameter of the septum actuator 54 such that the distal end 44 of the blood shield 42 fits snugly within the septum actuator 54. In some embodiments, the interference fit between the inner surface 56 of the septum actuator 54 and the distal end 44 of the blood shield 42 may secure the blood shield 42 within the catheter hub lumen 38. In some embodiments, the distal end 44 of the blood shield 42 may be angled, which may match the inner profile of the septum actuator 54 to facilitate securing the distal end 44 within the septum actuator 54.

[0025] In some embodiments, the inner wall 50 may include a shield bump 58, which may include a protrusion. In some embodiments, the blood shield 42 may be barrel-shaped or generally cylindrical. In some embodiments, the inner wall 50 of the blood shield 42 may further include a distal cylindrical portion 60 distal to the shield bump 58 and a proximal cylindrical portion 62 proximal to the shield bump 58.

[0026] As shown in FIG. 8C, in some embodiments, the catheter system 30 may include an introducer needle 64, which may include a sharpened distal tip 66 and a needle bump 68. In some embodiments, the introducer needle 64 may extend through the catheter 40 and the blood shield 42 when the catheter system 30 is in a prepared position ready for insertion into a patient's vein. As shown in FIG. 8B, in some embodiments, in response to proximal retraction of the introducer needle 64, the needle bump 68 may be configured to contact the shield bump 58 to proximally retract the blood shield 42 from the proximal end 36 of the catheter hub 32. In some embodiments, the sharpened distal tip 66 may be disposed within the blood shield 42 when the needle bump 68 contacts the shield bump 58.

[0027] In some embodiments, the introducer needle 64 may include a notch 70 proximal to the needle bump 68. In some embodiments, the notch 70 may include a flashback notch that provides a fluid path from the interior lumen of the needle to the exterior of the introducer needle 64 and is disposed within the catheter 40 when the catheter system is in the ready position. In some embodiments, the notch 70 may be disposed within the blood shield 42 when the needle bump 68 contacts the shield bump 58. In some embodiments, the shield bump 58 and / or the needle bump 68 may be annular, which may facilitate catching the needle bump 68 on the shield bump 58 as the introducer needle 64 is retracted proximally. In some embodiments, the needle bump 68 may be oval, and the shield bump 58 may be annular to facilitate interference with the needle bump 68.

[0028] In some embodiments, the sharp distal tip 66 may be disposed within the proximal cylindrical portion 62 when the needle bump 68 contacts the shield bump 58. In some embodiments, the notch 70 may be disposed within the proximal cylindrical portion 62 when the needle bump 68 contacts the shield bump 58. Thus, in some embodiments, both the sharp distal tip 66 and the notch 70 may be shielded within and covered by the blood shield 42, which may protect the practitioner from blood splatter exiting the sharp distal tip 66 and / or the notch 70.

[0029] 9-10, in some embodiments, the catheter system 30 may include a needle assembly, which may include a housing 72. In some embodiments, the housing 72 may include a barrel 74. In some embodiments, the needle assembly may include an introducer needle 64, which may include a sharpened distal tip 66 and a proximal end 76. In some embodiments, the needle assembly may include a needle hub 78 coupled to the introducer needle 64 and movably disposed within the barrel 74, which may shield the user from the introducer needle 64 and / or blood following retraction of the introducer needle 64 into the barrel 74. In some embodiments, the needle assembly may include a spring 80 disposed within the housing 72. In some embodiments, the needle assembly may include a push button 81.

[0030] In some embodiments, the push button 81 may operate similarly to the actuation latch described in U.S. Patent No. 5,501,675, filed Dec. 27, 1994, entitled "Safety Catheter With Safety Catheter System," which is incorporated herein by reference. In some embodiments, the push button 81 may operate in a different manner to shield a particular introducer needle. In some embodiments, the spring 80 may be disposed around the introducer needle 64, and the spring 80 may extend between the needle hub 78 and the distal end of the barrel 74. In some embodiments, the push button 81 may extend into the barrel 74 via a cavity or slot formed in the barrel 74 adjacent the distal end of the barrel 74. In some embodiments, the push button 81 may be configured to include an opening 82 to allow the introducer needle 64 and the needle hub 78 to extend through the push button 81. In some embodiments, the opening 82 may be keyhole shaped. In some embodiments, the push button 81 may include a protrusion that extends toward the distal end of the catheter 40 and the catheter system 30.

[0031] In some embodiments, when the push button 81 is in the unactuated position "up," a smaller portion of the opening 82 may communicate with the lumen 86 of the barrel 74. In some embodiments, in this position, the smaller portion of the opening 82 may engage the needle hub 78 to hold the needle hub 78 adjacent the distal end of the barrel 74 against the force of the spring 80. In some embodiments, the needle hub 78 may include a distal flare such that a middle portion of the needle hub 78 has a smaller diameter than the distal flare. In some embodiments, the needle hub 78 may include an hourglass shape. In some embodiments, the distal flare and / or the hourglass shape may facilitate engagement between the smaller portion of the opening 82 and the needle hub 78. In some embodiments, when the push button 81 is in the unactuated position, the protrusion may be disposed inside the catheter hub 32. Thus, in some embodiments, when the catheter 40 is still positioned over the introducer needle 64 with the catheter hub 32 adjacent the distal end of the housing 72, the protrusion may prevent the push button 81 from being depressed or moved "down" to the actuated position.

[0032] In some embodiments, when the catheter 40 is removed from or moved along the introducer needle 64 such that the catheter hub 32 is not adjacent the distal end of the housing 72, the push button 81 may be moved "down" or actuated because the catheter hub 32 no longer impedes the movement of the protrusion. In some embodiments, in this position, a larger portion of the opening 82 may no longer engage the needle hub 78. In some embodiments, the larger portion of the opening 82 should be larger than the maximum diameter of the needle hub 78. In some embodiments, the spring 80 thus biases the needle hub 78 toward the proximal end of the barrel 74, allowing the sharp distal tip 66 of the introducer needle 64 to be withdrawn into the barrel 74.

[0033] 9, a portion 88 of the needle hub 78 may be disposed within the catheter hub 32 when the catheter system 30 is in the ready position. In some embodiments, the proximal end 46 of the blood shield 42 may be disposed within the portion 88 of the needle hub 78 when the catheter system 30 is in the ready position, which may facilitate stability or fixation of the blood shield 42. The above description of a needle assembly is only one example of a needle assembly in which the blood shield 42 may be used.

[0034] 11, according to some embodiments, the introducer needle 64 is shown moving proximally from the ready position. Now referring to FIG. 12, according to some embodiments, the introducer needle 64 is shown moved more proximally than in FIG. 11 so that the needle bump 68 contacts the shield bump 58. Now referring to FIG. 13, according to some embodiments, the introducer needle 64 is shown moved more proximally than in FIG. 13 so as to pull the blood shield 42 proximally from the catheter hub 32 where the blood shield 42 was in a fixed position. In some embodiments, the needle bump 68 contacting and interfering with the shield bump 58 facilitates the proximal movement of the blood shield 42 from the fixed position.

[0035] 14, according to some embodiments, when needle bump 68 contacts shield bump 58, sharp distal tip 66 is shielded within blood shield 42. Referring now to FIGURE 15, blood shield 42 and introducer needle 64 are shown shielded within housing 72. In some embodiments, in response to depression of a push button, spring 80 may be configured to expand proximally, for example as shown in FIGURE 15, causing needle hub 78 to move proximally within barrel 74 and retract introducer needle 64 and blood shield 42 proximally.

[0036] 14, in some embodiments, the proximal end 46 of the blood shield 42 may include a conical taper feature 89 to guide the blood shield 42 into the housing 72 during proximal retraction of the introducer needle 64. In these embodiments, the conical taper feature 89 may taper inwardly in the proximal direction. In some embodiments, the outer surface of the distal end 44 and / or the outer surface of the proximal end 46 may be stepped or chamfered, which may reduce the outer diameter of the blood shield 42. In some embodiments, the blood shield 42 may be constructed of polypropylene, such as PH592 or RP142, or other suitable material.

[0037] 16, according to some embodiments, a first half 90 of a mold for molding the proximal end 46 of the blood shield 42 is illustrated. In some embodiments, a second half 92 of a mold for molding the distal end 44 of the blood shield 42 is illustrated according to some embodiments. In some embodiments, both the first half 90 and the second half 92 may include cut-out portions to form a portion of the shield bump 58. In some embodiments, the blood shield 42 may be monolithically formed as a single unit and may include a single molded piece.

[0038] 17A-19C, a catheter system 100 is illustrated according to some embodiments. In some embodiments, the catheter system 100 may be similar or identical to the catheter system 30 in one or more components and / or operation. In some embodiments, the catheter system 100 may include a catheter hub 32, which may include a distal end, a proximal end 36, and a catheter hub lumen 38 extending through the distal end of the catheter hub and the proximal end 36 of the catheter hub 32. In some embodiments, the catheter system 100 may include a catheter 40 extending from the distal end of the catheter hub 32 to a distal end.

[0039] In some embodiments, the catheter system 100 may include a blood shield 102 secured within the catheter hub lumen 38. In some embodiments, the blood shield 102 may be monolithically formed as a single unit and may include a single molded piece. In some embodiments, the blood shield 102 may be similar or identical in one or more components and / or operation to the blood shield 42 of FIGS. 3-16. In some embodiments, the blood shield 102 may include a distal end 104, a proximal end 106, a blood shield lumen 108 extending through the distal end 104 of the blood shield 102 and the proximal end 106 of the blood shield 102, and an inner wall 110 that defines the blood shield lumen 108.

[0040] In some embodiments, the inner wall 110 may include a narrowed inner diameter portion 112. In some embodiments, the catheter system 100 may include a septum 114 disposed within the proximal end 106 of the blood shield 102. In some embodiments, the septum 114 may have an interference fit with the inner wall 110 of the blood shield 102 to secure the septum 114 within the blood shield lumen 108. In some embodiments, the septum 114 may prevent blood from leaking out of the distal end 104 of the blood shield 102 and may help avoid blood exposure.

[0041] In some embodiments, the catheter system 100 may include an introducer needle 64, which may include a sharpened distal tip 66 and a needle bump 68. In some embodiments, the introducer needle 64 may extend through the catheter 40 and the blood shield 102 when the catheter system 100 is in a ready position ready for insertion into a patient's vein. In some embodiments, in response to proximal retraction of the introducer needle 64, the needle bump 68 may be configured to contact the narrowed inner diameter portion 112 to proximally retract the blood shield 102 from the proximal end 36 of the catheter hub 32.

[0042] In some embodiments, the sharpened distal tip 66 may be disposed within the blood shield 102 when the needle bump 68 contacts the narrowed inner diameter portion 112. In some embodiments, both the sharpened distal tip 66 and a notch (such as notch 70 in FIGS. 8A-8C ) may be shielded within the blood shield 42, which may protect the practitioner from blood splatter exiting the sharpened distal tip 66 and / or the notch.

[0043] In some embodiments, the septum 114 may include a plurality of vent holes 116 extending therethrough and spaced apart from an outer edge 118 of the septum 114. In some embodiments, the vent holes 116 may facilitate the flashback of blood entering the catheter system 100 when the introducer needle 64 and / or the catheter 40 are inserted into a patient's vein. In some embodiments, air may be configured to travel proximally through the introducer needle 64, the vent holes 116, and the blood shield 102. In some embodiments, the vent holes 116 may be sized and configured to pass air but not liquids such as blood. In some embodiments, the septum 114 may include a slit 120 configured to receive through the introducer needle 64. In some embodiments, the vent holes 116 may be arranged in a symmetrical pattern, such as a triangle. In some embodiments, the slit 120 may be located in the center of the symmetrical pattern, as illustrated, for example, in FIG. 17B.

[0044] As shown in FIG. 17G, in some embodiments, the outer edge 118 of the septum 114 may include a vent 116 to allow air to pass between the septum 114 and the inner wall 50 of the catheter hub 32. In some embodiments, the outer edge 118 may have an interference fit with the inner wall 50 of the catheter hub 32. More specifically, in some embodiments, the circumference of the outer edge 118 may be slightly larger than the circumference of the catheter hub lumen 38, and the septum 114 may be compressed to secure the septum 114 within the catheter hub 32. In some embodiments, the outer edge may be circular to facilitate alignment within the catheter hub 32.

[0045] 17C and 17E-17F, in some embodiments, the inner wall 50 of the blood shield 102 may include an annular protrusion 122. In some embodiments, the outer surface of the septum 114 may include an annular recess 124. In some embodiments, the annular protrusion 122 may be disposed within the annular recess 124, which may secure a distal portion of the septum 114 within the blood shield 102.

[0046] In some embodiments, the narrowed inner diameter portion 112 may be disposed proximally to a larger diameter 126 at the distal end 104. In some embodiments, the larger diameter 126 may receive the septum 114. In some embodiments, the narrowed inner diameter portion 112 may have a diameter 125 that is slightly larger than the outer diameter of the introducer needle 64 at the needle bump 68 to allow the introducer needle 64 to slide within the blood shield 42 but limit the space through which blood can leak.

[0047] FIG. 18A illustrates the passage of air through the vent 116 in response to blood flashback and entry of the introducer needle 64 and catheter into the patient's vein. FIG. 18B is an enlarged cross-sectional view of FIG. 18A. FIGS. 18A-18B illustrate the blood shield 102 secured within the catheter hub 32 due to an interference fit between the septum 114 and the catheter hub 32, according to some embodiments. Although both vent holes 116 on the outer edge of the septum 114 and spaced apart from the outer edge of the septum 114 are illustrated, which may provide greater porosity, it will be understood that in some embodiments the septum 114 may include vent holes 116 on the outer edge 118 of the septum 114 or spaced apart from the outer edge 118 of the septum 114.

[0048] Figure 19A shows the blood shield 102 secured within the catheter hub 32 in an initial or first position. In Figure 19A, the catheter hub 32 is advanced distally along the introducer needle 64 after the introducer needle 64 is positioned within the patient's vein to form a space between the catheter hub 32 and the housing 72. In some embodiments, the initial or first position may correspond to the position of the blood shield 102 when the catheter system 100 is in the ready position.

[0049] FIG. 19B illustrates the introducer needle 64 being retracted proximally following the configuration of FIG. 19A. In some embodiments, in response to the proximal retraction of the introducer needle 64, the needle bump 68 may contact the narrowed inner diameter portion 112 to retract the blood shield 102 from the catheter hub 32 and into the housing 72. In some embodiments, further proximal retraction of the introducer needle 64 may move the blood shield 102 into the housing 72, as shown in FIG. 19C. In some embodiments, the septum 114 may seal the opening 125 in the housing 72 through which the blood shield 102 enters the housing 72, preventing blood leakage from the housing 72. In some embodiments, the position of the blood shield 102 in FIG. 19C may correspond to the final position of the blood shield 102 when the introducer needle 64 is fully retracted.

[0050] In some embodiments, the proximal end 46 of the blood shield 42, or an outer surface of the blood shield aligned with the narrowed inner diameter portion 112, may include a conical taper feature 89 to guide the blood shield 42 into the opening 125 of the housing 72 during proximal retraction of the introducer needle 64. In these embodiments, the conical taper feature 89 may taper inwardly in the proximal direction.

[0051] 20A-20B, a blood shield is illustrated according to some embodiments. In some embodiments, the blood shield of FIGs. 20A-20B may be similar or identical in one or more components and / or operation to the blood shield of FIGs. 17-19. In some embodiments, the narrowed inner diameter portion 112 may include a shield bump, for example similar to the shield bump 58 of FIGs. 3-15.

[0052] In some embodiments, the shield bump may include an annular protrusion, for example as illustrated in FIG. 20B. In some embodiments, the annular protrusion may include a plurality of thru-hole slots 128 configured to allow air to pass through the blood shield 102 to the catheter hub 32. In some embodiments, the thru-hole slots 128 may be sized and configured to allow air to pass but not liquids, such as blood. In some embodiments, the thru-hole slots 128 may be disposed generally parallel to the longitudinal axis of the blood shield 102, which may avoid the thru-hole slots 128 interfering with the function of the narrowed inner diameter portion 112 in preventing the passage of the needle bump 68.

[0053] In some embodiments, the distal end 104 may include an annular flange. In these embodiments, the distal end 104 may be disk-shaped. In some embodiments, the outer edge of the distal end 104 may be an interference fit with the inner wall 50 of the catheter hub 32, similar to the outer edge 118 of FIG. 18A.

[0054] 21A-21B, a blood shield according to some embodiments is illustrated. In some embodiments, the blood shield of FIGS. 20A-20B may be similar or identical to the blood shield 102 of FIGS. 17-19 and / or the blood shield of FIGS. 20A-20B in one or more components and / or operation. In some embodiments, the narrowed inner diameter portion 112 may include a shield bump, for example similar to the shield bump 58 of FIGS. 3-15. In some embodiments, the air vent 116 may be disposed at an outer edge of the distal end 104 of the blood shield 102. In some embodiments, the distal end 104 may include an annular flange. In these embodiments, the distal end 104 may be disk-shaped. In some embodiments, the air vent 116 may be disposed at an outer edge of the annular flange. In some embodiments, the air vent 116 may be configured to allow air to pass between the septum 114 and the inner wall 50 of the catheter hub 32. In some embodiments, the outer edge of the distal end 104 may be an interference fit with the inner wall 50 of the catheter hub 32, similar to the outer edge 118 of FIG. 18A.

[0055] All examples and conditional language incorporated herein are intended for educational purposes to aid the reader in understanding the concepts contributed by the inventors to further develop the present invention and the art, and are not to be construed as being limited to such specifically incorporated examples and conditions. Although the embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions, and alterations can be made herein without departing from the spirit and scope of the present invention.

Claims

1. The catheter system a catheter hub having a distal end, a proximal end, and a catheter hub lumen extending through the distal end of the catheter hub and through the proximal end of the catheter hub; a catheter extending distally from the distal end of the catheter hub; a blood shield secured within the catheter hub lumen, the blood shield comprising a distal end, a proximal end, a blood shield lumen extending through the distal end of the blood shield and the proximal end of the blood shield, and an inner wall forming the blood shield lumen, the inner wall comprising a shield bump; and an introducer needle having a sharp distal tip and a needle bump, the introducer needle extending through the catheter and the blood shield, and configured such that in response to proximal retraction of the introducer needle, the needle bump contacts the shield bump to proximally retract the blood shield from the proximal end of the catheter hub, the sharp distal tip being disposed within the blood shield when the needle bump contacts the shield bump; A catheter system comprising:

2. The catheter system of claim 1 , wherein the introducer needle includes a notch proximal to the needle bump, the notch being disposed within the blood shield when the needle bump contacts a shield bump.

3. 10. The catheter system of claim 1, further comprising a septum disposed within the catheter hub lumen and a septum actuator disposed within the catheter hub lumen and configured to open the septum, wherein at least a portion of the blood shield is disposed within the septum actuator.

4. The catheter system of claim 3 , wherein the distal end of the blood shield is disposed in an interference fit with an inner surface of the septum actuator.

5. The catheter system of claim 4 , wherein the distal end of the blood shield is beveled.

6. The catheter system of claim 1 , wherein the shield bump is annular.

7. A housing having a barrel; a needle hub coupled to the introducer needle and movably disposed within the barrel; A spring disposed within the housing; and a push button, the spring configured to expand proximally in response to depression of the push button to move the needle hub proximally within the barrel and retract the introducer needle proximally; The catheter system of claim 1 , further comprising:

8. The catheter system of claim 7 , wherein a portion of the needle hub is disposed within the catheter hub and a proximal end of the blood shield is disposed within the portion of the needle hub.

9. The catheter system of claim 1 , wherein the inner wall of the blood shield further comprises a distal cylinder distal to the shield bump and a proximal cylinder proximal to the shield bump.

10. The catheter system of claim 9 , wherein the sharp distal tip is disposed within the proximal cylindrical portion when the needle bump contacts the shield bump.

11. 10. The catheter system of claim 9, wherein the introducer needle includes a notch proximal to the needle bump, the notch being disposed within the proximal cylindrical portion when the needle bump contacts the shield bump.

12. The catheter system a catheter hub having a distal end, a proximal end, and a catheter hub lumen extending through the distal end of the catheter hub and through the proximal end of the catheter hub; a catheter extending distally from the distal end of the catheter hub; a blood shield secured within the catheter hub lumen, the blood shield having a distal end, a proximal end, a blood shield lumen extending through the distal end of the blood shield and the proximal end of the blood shield, and an inner wall forming the blood shield lumen, the inner wall having a narrowed inner diameter portion; a septum disposed within the proximal end of the blood shield; an introducer needle having a sharp distal tip and a needle bump, the introducer needle extending through the catheter and the blood shield, the needle bump configured to contact the narrowed bore portion in response to proximal retraction of the introducer needle to withdraw the blood shield proximally from the proximal end of the catheter hub, the sharp distal tip being disposed within the blood shield when the needle bump contacts the narrowed bore portion; A catheter system comprising:

13. The catheter system of claim 12 , wherein the septum has an interference fit with the inner wall of the blood shield to secure the septum within the blood shield lumen.

14. 13. The catheter system of claim 12, wherein the septum includes a plurality of vent holes extending therethrough and spaced from an outer edge of the septum, and wherein air is configured to travel through the introducer needle, the plurality of vent holes, and the blood shield to the proximal end.

15. The catheter system of claim 14 , wherein the septum further comprises a slit configured to receive the introducer needle therethrough.

16. The catheter system of claim 15, wherein the plurality of vents are arranged in a symmetrical pattern and the slit is located at the center of the symmetrical pattern.

17. 13. The catheter system of claim 12, wherein an outer edge of the septum includes a plurality of vents that allow air to pass between the septum and the inner wall of the catheter hub.

18. The catheter system of claim 12 , wherein the inner wall of the blood shield comprises an annular protrusion and an outer surface of the septum comprises an annular recess, the annular protrusion being disposed within the annular recess.

19. 13. The catheter system of claim 12, wherein the narrowed inner diameter portion comprises a shield bump and the proximal end of the blood shield comprises an annular flange, the annular flange comprising a plurality of vent holes configured to allow air to pass between the septum and the inner wall of the catheter hub.

20. The catheter system of claim 12, wherein the inner wall of the blood shield comprises an annular protrusion, the annular protrusion comprising a plurality of thru-hole slots configured to allow air to pass through the blood shield.

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