Safety iv catheter with v-clip interlock and needle tip capture

Abstract

A catheter assembly (10) includes: a catheter (22); a needle (12) having a sharp distal end; a catheter seat (14) for receiving the catheter (22) having a retainer (34) including a notch (36); a needle guard (20) connected to the catheter seat (14) when the needle (12) is in a first position; and a clip (40) disposed in the needle guard (20) and cooperating with the needle (12), wherein, when the needle (12) is in the first position, the clip (40) engages the catheter seat (14), and when the needle (12) is retracted to a second position, the clip (40) disengages from the catheter seat (14) via the notch (36) thereby covering at least a portion of the needle (12). The clip (40) is mounted in the outer shell (38) of the needle guard (20) via a shovel-shaped portion (66), the shovel-shaped portion having an outer wall (70) exposed outside the needle guard (20) in order to reduce the overall width of the needle guard (20).

Description

[0001] Case Analysis

[0002] This application is a divisional application.

[0003] The original application of this divisional application was an invention patent application that entered the Chinese national phase based on the PCT Treaty. The international filing date of the PCT-based Chinese invention patent application was November 9, 2015, the international application number was PCT / US2015 / 059748, the Chinese application number was 201580069878.3, the invention title was "Safety IV Conduit with V-shaped Clamp Interlocking Member and Needle End Capturing Member", and the firm's file number was IIM171155.

[0004] The direct parent application of this divisional application is the first-generation divisional application of the aforementioned original application. The first-generation divisional application was filed on February 9, 2021, with divisional application number 202110175373.2, invention title "Safety IV Conduit with V-shaped Clamp Interlocking Member and Needle End Capturing Member", and office file number IIM210325.

[0005] On June 1, 2022, the State Intellectual Property Office issued a First Examination Opinion (hereinafter referred to as "Opinion") regarding the first-generation divisional application, pointing out that several claims of the first-generation divisional application lacked unity of claim. The applicant deleted these claims in its response to the Opinion. The Opinion is the direct basis for this (second) divisional application.

[0006] Related applications

[0007] This application claims the benefits of U.S. Provisional Patent Application Serial No. 62 / 077760, filed November 10, 2014; International Patent Application Serial No. PCT / US2015 / 026542, filed April 17, 2015; and U.S. Provisional Patent Application Serial No. 62 / 220629, filed September 18, 2015. All of these applications are hereby incorporated herein by reference. Technical Field

[0008] Various exemplary embodiments of the present invention relate to catheters. Background Technology

[0009] Catheter assemblies are used to place catheters into a patient's vascular system. Once placed, a catheter (such as an intravenous catheter) can be used to infuse fluids (including saline, medical compounds, and / or nutrients) into a patient requiring this treatment. Catheters can also remove fluids from the circulatory system and monitor the patient's vascular system. Summary of the Invention

[0010] One aspect of the invention provides a catheter assembly in which an improved clip and needle shield are used to protect the needle. This improved arrangement is more compact, provides enhanced needle protection, and reduces the size and complexity of the catheter assembly. The improved clip offers a narrower design, increased strength and flexibility, and various mounting configurations for securing the clip to the needle shield. A release notch is added to the retaining ring of the catheter seat, and the clip is disengaged via this notch, allowing the needle shield to be more compact compared to the prior art. In the prior art, without this notch, the clip has to travel a longer distance to disengage from the catheter seat. Furthermore, the width of the needle shield is reduced by an improved attachment interface between the clip and the needle shield. Specifically, a shovel-shaped portion attaches the clip to the needle shield, and the outer surface of the shovel-shaped portion is exposed to the outside of the needle shield.

[0011] The above and / or other aspects of the present invention can be achieved by providing a catheter assembly comprising: a catheter; a needle disposed in the catheter having a sharp distal end; a catheter seat receiving the catheter and the needle, the catheter seat having a notch; a needle guard connected to the catheter seat when the needle is in a first position; and a clamp disposed in the needle guard cooperating with the needle, wherein in the first position of the needle, the clamp engages a retaining ring, and when the needle is retracted to a second position, the clamp disengages from the retaining ring via the notch, thereby surrounding or covering at least a portion of the needle.

[0012] The above and / or other aspects of the present invention can also be achieved by providing a catheter assembly comprising: a catheter; a needle having a sharp distal end disposed in the catheter; a catheter seat that receives the catheter and the needle; a needle guard configured to be connected to the catheter seat; and a clip disposed in the needle guard and cooperating with the needle, the clip including a shovel-shaped portion that attaches the clip to the needle guard, wherein the outer surface of the shovel-shaped portion is exposed to the outside of the catheter assembly. Attached Figure Description

[0013] The foregoing aspects and features of the present invention will become more apparent from the description of exemplary embodiments of the invention with reference to the accompanying drawings, in which:

[0014] Figure 1 The diagram shown is a left top perspective view of a catheter assembly according to an embodiment of the present invention;

[0015] Figure 2 This is a left-side perspective view of the catheter assembly;

[0016] Figure 3 The diagram shown is an alternative left-side perspective view of the catheter assembly;

[0017] Figure 4 This is a top plan view of the catheter assembly;

[0018] Figure 5 The image shown is a front view of the right side of the catheter assembly;

[0019] Figure 6 The diagram shown is a bottom view of the catheter assembly;

[0020] Figure 7 The diagram shown is a left-side perspective view of the assembled catheter assembly, including the catheter hub, needle shield, and needle.

[0021] Figure 8 The diagram shown is a right-side perspective view of the assembled catheter assembly, including the catheter hub, needle shield, and needle.

[0022] Figure 9 The diagram shows the right-side front view of the assembled catheter assembly, including the catheter hub, needle shield, and needle.

[0023] Figure 10 The diagram shows a bottom view of the assembled catheter assembly, including the catheter hub, needle shield, and needle.

[0024] Figure 11 The diagram shows a bottom view of the assembled catheter assembly, including the catheter hub, needle shield, and needle.

[0025] Figure 12 The diagram shows a top view of the catheter hub, needle shield, and needle of the catheter assembly.

[0026] Figure 13 The diagram shows a sectional view of the right-side front view of the assembled catheter assembly, including the catheter hub, needle shield, and needle.

[0027] Figure 14 The diagram shows a left-side perspective view of the separate catheter hub, needle shield, and needle of the catheter assembly.

[0028] Figure 15 The diagram shown is a right-side perspective view of the separate catheter hub, needle shield, and needle of the catheter assembly.

[0029] Figure 16 The diagram shows a right-side front view of the separate catheter hub, needle shield, and needle assembly.

[0030] Figure 17 The diagram shows a second right-side front view of the separate catheter hub, needle shield, and needle assembly.

[0031] Figure 18 The diagram shows a bottom view of the separate catheter hub, needle shield, and needle of the catheter assembly.

[0032] Figure 19The diagram shows a top view of the separate catheter hub, needle shield, and needle of the catheter assembly.

[0033] Figure 20 The diagram shows a sectional view of the right-side front view of the catheter hub, needle shield, and needle, separated from the catheter hub.

[0034] Figure 21 The image shown is a right-side perspective view of the catheter hub of the catheter assembly;

[0035] Figure 22 The diagram shown is a top view of the catheter hub of the catheter assembly;

[0036] Figure 23 The image shown is a left-side perspective view of the catheter hub of the catheter assembly;

[0037] Figure 24 This is a front side view of the catheter hub of the catheter assembly;

[0038] Figure 25 This is a right-side view of the catheter assembly;

[0039] Figure 26 The image shown is a rear side view of the catheter hub of the catheter assembly;

[0040] Figure 27 The image shown is a left-side perspective view of the catheter hub of the catheter assembly;

[0041] Figure 28 The diagram shown is a bottom view of the catheter hub of the catheter assembly;

[0042] Figure 29 The image shown is a right-side perspective view of the catheter hub of the catheter assembly;

[0043] Figure 30 The image shown is a right perspective view of the needle sheath housing of the catheter assembly;

[0044] Figure 31 The image shown is a left perspective view of the needle sheath housing of the catheter assembly;

[0045] Figure 32 The image shown is a second left perspective view of the needle sheath housing of the catheter assembly;

[0046] Figure 33 The image shown is a second right perspective view of the needle sheath housing of the catheter assembly;

[0047] Figure 34 The image shown is a front view of the needle sheath housing of the catheter assembly;

[0048] Figure 35 The image shown is a rear front view of the needle sheath housing of the catheter assembly;

[0049] Figure 36 The image shown is a right-side front view of the needle sheath housing of the catheter assembly;

[0050] Figure 37 The image shown is a right-side front view of the needle sheath housing of the catheter assembly;

[0051] Figure 38 The diagram shown is a top plan view of the needle sheath housing of the catheter assembly;

[0052] Figure 39 The diagram shown is a bottom plan view of the needle sheath housing of the catheter assembly;

[0053] Figure 40 The image shown is a left-side perspective view of the V-shaped metal clip of the catheter assembly;

[0054] Figure 41 The image shown is a right-side perspective view of the V-shaped metal clip of the catheter assembly;

[0055] Figure 42 The image shown is a second right-side perspective view of the V-shaped metal clip of the catheter assembly;

[0056] Figure 43 The image shown is a front view of the V-shaped metal clip of the catheter assembly;

[0057] Figure 44 The image shown is a rear front view of the V-shaped metal clip of the catheter assembly;

[0058] Figure 45 The image shown is a left-side front view of the V-shaped metal clip of the catheter assembly;

[0059] Figure 46 The image shown is a right-side front view of the V-shaped metal clip of the catheter assembly;

[0060] Figure 47 The diagram shown is a top plan view of the V-shaped metal clip of the catheter assembly;

[0061] Figure 48 The diagram shown is a bottom view of the V-shaped metal clip of the catheter assembly;

[0062] Figure 49 The image shown is a right perspective view of another embodiment of the V-shaped metal clip of the catheter assembly;

[0063] Figure 50 The image shown is a right perspective view of another embodiment of the V-shaped metal clip of the catheter assembly;

[0064] Figure 51 The image shown is a left perspective view of an alternative embodiment of the V-shaped metal clip of the catheter assembly;

[0065] Figure 52 The image shown is inserted into the needle guard. Figure 51 A left-side stereoscopic view of the V-shaped metal clip;

[0066] Figure 53 The image shown is a right perspective view of an alternative embodiment of the V-shaped metal clip of the catheter assembly;

[0067] Figure 54 The image shown is inserted into the needle guard. Figure 53 A right-side stereoscopic view of the V-shaped metal clip;

[0068] Figure 55 The image shown is a left perspective view of an alternative embodiment of the V-shaped metal clip of the catheter assembly;

[0069] Figure 56 The image shown is a right perspective view of an alternative embodiment of the V-shaped metal clip of the catheter assembly;

[0070] Figure 57 The image shown is a right perspective view of an alternative embodiment of the V-shaped metal clip of the catheter assembly;

[0071] Figure 58 The image shown is inserted into the needle guard. Figure 57 A right-side stereoscopic view of the V-shaped metal clip;

[0072] Figure 59 The image shown is a right perspective view of an alternative embodiment of the V-shaped metal clip of the catheter assembly;

[0073] Figure 60 The image shown is inserted into the needle guard. Figure 59 A left-side stereoscopic view of the V-shaped metal clip;

[0074] Figure 61 The diagram shown is a left rear perspective view of an alternative embodiment of the V-shaped metal clip of the catheter assembly;

[0075] Figure 62 The diagram shows the catheter assembly. Figure 61 A left-side, upward-view stereoscopic diagram of the V-shaped metal clip;

[0076] Figure 63 The diagram shows the catheter assembly. Figure 61 A top view of the V-shaped metal clip;

[0077] Figure 64 The image shown shows the needle guard in its first and second states. Figure 61 A side sectional view of a V-shaped metal clip;

[0078] Figure 65 The image shown is inserted into the needle guard. Figure 61Left-view rear-view stereoscopic view of the V-shaped metal clip;

[0079] Figure 66 The image shown is a right perspective view of an alternative embodiment of the V-shaped metal clip of the catheter assembly;

[0080] Figure 67 The image shown is a right perspective view of an alternative embodiment of the V-shaped metal clip of the catheter assembly;

[0081] Figure 68 The image shown is a right perspective view of an alternative embodiment of the V-shaped metal clip of the catheter assembly;

[0082] Figure 69 The diagram shown is a front sectional view of an alternative embodiment of the V-shaped metal clip of the catheter assembly;

[0083] Figure 70 The image shown is a right perspective view of an alternative embodiment of the V-shaped metal clip of the catheter assembly;

[0084] Figure 71 The image shown is a right perspective view of an alternative embodiment of the V-shaped metal clip of the catheter assembly;

[0085] Figure 72 The image shown is a right perspective view of an alternative embodiment of the V-shaped metal clip of the catheter assembly;

[0086] Figure 73 The diagram shows the catheter assembly. Figure 72 Another right-side stereoscopic view of the V-shaped metal clip;

[0087] Figure 74 The image shown is a left perspective view of an alternative embodiment of the V-shaped metal clip of the catheter assembly;

[0088] Figure 75 The image shown is a right rear perspective perspective view of an alternative embodiment of the V-shaped metal clip of the catheter assembly;

[0089] Figure 76 The image shown is a right-side perspective view of the gasket of the catheter assembly;

[0090] Figure 77 The image shown is a left-side perspective view of the gasket of the catheter assembly;

[0091] Figure 78 This is a front view of the gasket of the conduit assembly;

[0092] Figure 79 The diagram shown is a bottom plan view of the gasket of the conduit assembly;

[0093] Figure 80 This is a cross-sectional view of the left front view of the gasket of the conduit assembly;

[0094] Figure 81 The image shown is a right-side perspective view of an alternative guide tube assembly with wings;

[0095] Figure 82 The diagram shown is a top plan view of the duct seat with wings;

[0096] Figure 83 The image shown is a left perspective view of the duct seat with wings;

[0097] Figure 84 The image shown is a front view of the duct seat with wings;

[0098] Figure 85 The image shown is a left-side front view of the duct seat with wings;

[0099] Figure 86 The image shown is a rear front view of the duct seat with wings;

[0100] Figure 87 The image shown is a left perspective view of the duct seat with wings;

[0101] Figure 88 The diagram shown is a bottom view of the duct seat with wings;

[0102] Figure 89 The image shown is a second right-side perspective view of the duct seat with wings;

[0103] Figure 90 The image shown is a right-side perspective view of an alternative side-port conduit fitting.

[0104] Figure 91 The diagram shown is a top view of the side port conduit seat;

[0105] Figure 92 The image shown is a left-side perspective view of the side-port conduit seat;

[0106] Figure 93 The image shown is a front view of the side port conduit seat;

[0107] Figure 94 The image shown is a right-side front view of the side-port conduit seat;

[0108] Figure 95 The image shown is a rear front view of the side port conduit seat;

[0109] Figure 96 This is a second left-side perspective view of the side-port conduit seat;

[0110] Figure 97 The diagram shown is a bottom view of the side port conduit seat;

[0111] Figure 98 This is a second right-side perspective view of the side-port conduit seat;

[0112] Figure 99 The image shown is a left perspective view of an alternative side-port catheter hub assembly with a needle shield and needle hub;

[0113] Figure 100 The image shown is a right perspective view of an alternative side-port catheter hub assembly with a needle shield and needle hub.

[0114] Figure 101 The diagram shown is a top plan view of an alternative side-port catheter hub assembly with a needle shield and needle hub.

[0115] Figure 102 The image shown is a right-side view of an alternative side-port catheter hub assembly with a needle shield and needle hub.

[0116] Figure 103 The diagram shown is a bottom plan view of an alternative side-port catheter hub assembly with a needle shield and needle hub.

[0117] Figure 104 This is shown when the inlet needle retracts. Figure 1-12 Cross-sectional view of the catheter assembly;

[0118] Figure 105 This shows the effect when the inserter needle retracts. Figure 1-12 Second sectional view of the catheter assembly;

[0119] Figure 106 This is shown when the introducer needle moves past the V-shaped metal clip and the needle guard separates from the catheter seat. Figure 1-16 Cross-sectional view of the catheter assembly;

[0120] Figure 107 This shows the situation when the introducer needle has passed the V-shaped metal clip and the needle guard has separated from the catheter hub. Figure 1-16 Second sectional view of the conduit assembly;

[0121] Figure 108 The image shows the latch of the V-shaped metal clip engaging with the conduit seat;

[0122] Figure 109 The image shows the latch of the V-shaped metal clip disengaging from the catheter seat;

[0123] Figure 110 The image shows the latch of the V-shaped metal clip disengaging from the catheter seat and separating.

[0124] Figure 111 The image shown is a view of the V-shaped metal clip that blocks the needle;

[0125] Figure 112The image shown is a view of the V-shaped metal clip in the closed position;

[0126] Figure 113 The diagram shows a schematic view of the working envelope of the conduit seat retainer without a notch and the V-shaped metal clip.

[0127] Figure 114 The diagram shows a schematic view of the working envelope of the conduit seat retainer ring and V-shaped metal clip without notches.

[0128] Figure 115 The diagram shows a schematic view of the working envelope of the V-shaped metal clip and the notched conduit seat retainer.

[0129] Figure 116 The diagram shows a schematic view of the working envelope of the conduit seat retainer ring with a notch and a V-shaped metal clip.

[0130] Figure 117 This shows the operation of the conduit seat valve actuator in its free state;

[0131] Figure 118 This illustrates the operation of the conduit seat valve actuator under pressure.

[0132] Figure 119 The diagram shows the operation of a second embodiment of the conduit seat valve actuator in a free state;

[0133] Figure 120 The diagram illustrates the operation of a second embodiment of the conduit seat valve actuator under pressure.

[0134] Figure 121 This illustrates another embodiment of the conduit seat valve actuator;

[0135] Figure 122 The illustration shown is an exemplary blood flashback component of a catheter assembly;

[0136] Figure 123 What is shown is Figure 122 The needle of the blood flashback component of the catheter assembly;

[0137] Figure 124 The second exemplary blood flashback component of the catheter assembly is shown;

[0138] Figure 125 The illustration shows two instances where blood flashbacks occurred. Figure 124 A second exemplary blood flashback component of a catheter assembly;

[0139] Figure 126 The third exemplary blood flashback component of the catheter assembly is shown in three locations where blood flashback occurs;

[0140] Figure 127 What is shown is Figure 121 A right-side view of an exemplary embodiment of the actuator;

[0141] Figure 128 The image shown is in the catheter hub assembly. Figure 127 A cross-sectional view of the actuator;

[0142] Figure 129 This shows the process of penetrating the diaphragm. Figure 128 A cross-sectional view of the conduit seat assembly;

[0143] Figure 130 This shows the process of penetrating the diaphragm. Figure 128 Left-side perspective cross-sectional view of the conduit seat assembly;

[0144] Figure 131 The diagram shown is a cross-sectional view of another exemplary embodiment of the conduit seat assembly;

[0145] Figure 132 This shows the process of penetrating the diaphragm. Figure 131 A cross-sectional view of the guide tube assembly; and

[0146] Figure 133 This shows the process of penetrating the diaphragm. Figure 131 Left-side perspective cross-sectional view of the conduit seat assembly. Detailed Implementation

[0147] The catheter assembly disclosed herein is an improvement upon the catheter assembly disclosed in U.S. Patent Application Publication No. 2014 / 0364809, which is jointly owned by the applicants.

[0148] Figure 1-12 The illustrated catheter assembly 10 includes a hollow metal introducer needle 12, a catheter hub 14, a needle seat 16, and a needle shield 20. The needle 12 has a sharp, beveled distal end and initially extends through the needle shield 20 and the catheter hub 14. A flexible catheter fitting 22 extends from the distal end of the catheter hub 14, and the introducer needle 12 passes through the catheter fitting 22. Initially, the needle 12 is inserted into the patient's blood vessel. The catheter fitting 22 is carried into the blood vessel by the needle 12. After insertion of the catheter fitting 22, the needle 12 is removed from the patient's blood vessel and the catheter hub 14. The needle shield 20 surrounds or covers the tip of the needle 12 and provides protection against needle puncture during and after retraction from the catheter hub 14. The needle shield 20 can be used with a variety of different catheters.

[0149] like Figure 12-20As shown, the catheter assembly includes a catheter seat 14 and a flexible catheter fitting 22 extending from the catheter seat 14. A metal wedge 24 is located in the catheter seat 14 to secure the catheter fitting 22. An elastic diaphragm 26 is positioned to control fluid flow through the catheter seat 14. An actuator 28 is movably located in the catheter seat 14 to engage the diaphragm 26. A biasing member 30 engages the actuator 28 to bias the actuator 28 in a proximal direction.

[0150] The resilient diaphragm 26 has one or more pre-formed slits that are normally closed, thereby selectively preventing unwanted fluid flow through the diaphragm 26. For example, the diaphragm 26 may have three slits forming three triangular lobes that open upon engagement by the actuator 28. The diaphragm 26 is made of an elastic material (e.g., silicone rubber) that provides an elastic closing force for the slits. Those skilled in the art will understand that other configurations of the diaphragm 26 may also be used.

[0151] Actuator 28 and biasing member 30 (e.g., a compression spring of metal or plastic) are located in conduit seat 14. Actuator 28 engages diaphragm 26 to open the gap and allow fluid flow through conduit seat 14. Biasing member 30 is capable of returning actuator 28 to a position that allows the gap to close, thereby preventing fluid flow through conduit seat 14.

[0152] like Figure 21-29 As best illustrated in the exemplary embodiment, the catheter seat 14 includes a proximal end having an external Luer thread 32 and a retaining ring 34 with a notch. The retaining ring 34 extends around at least a portion of the catheter seat 14 and is preferably located at the proximal end of the catheter seat 14. The retaining ring 34 has a break, an opening, or a notch 35 that separates a first end and a second end of the retaining ring 34.

[0153] A portion of the outer diameter of the retaining ring 34 is larger than the outer diameter of the portion of the retaining ring 34 adjacent to the catheter seat 14. Specifically, a portion of the outer diameter of the retaining ring 34 is raised relative to the adjacent outer diameter surface of the catheter seat 14. In addition, the outer diameter of the opening 36 of the retaining ring 34 is approximately equal to or greater than the outer diameter of the portion of the retaining ring 34 adjacent to the catheter seat 14.

[0154] In an exemplary embodiment, the needle guard 20 includes a housing 38, a resilient clip 40, and a washer 42. The housing 38 includes an aperture having a distal opening 44 and a proximal opening 46 for receiving the needle 12. The housing 38 is connected to the guide tube seat 14 and surrounds the clip 40 and the washer 42. Figures 30-39 As best shown, the distal end of the housing 38 includes a nose 48, a top flange 50, and a base 52. When the needle guard 20 is attached to the catheter seat 14, the nose 48 extends into the interior of the catheter seat 14.

[0155] In one exemplary embodiment, the nose portion 48 is sized slightly smaller than the interior of the catheter seat 14 to allow for a loose tolerance fit. The top flange 50 is spaced apart from the base 52 by a pair of side recesses that receive the Luer thread portion 32 and prevent rotation of the catheter seat 14 relative to the needle guard 20 when assembled. The base 52 includes a protrusion 54 having a curved top surface and a curved cut-off portion 56. The protrusion 54 is sized to fit within the opening 36 of the retaining ring 34, and the cut-off portion 56 is sized to allow the retaining ring 34 to pass through it.

[0156] according to Figures 40-48 In the exemplary embodiment shown, the clip 40 is a generally V-shaped resilient clip 40 having a first leg 60 and a second leg 62 connected by an angled or curved V-shaped segment 64. The first leg 60 includes a generally U-shaped shovel portion 66 having an angled guide portion 68. The shovel portion 66 includes an outer wall 70 and an inner wall 72 connected by a bottom 74. A pair of barbs 76 extend outward from the inner wall 72 of the shovel portion 66. A first baffle 78 extends from the second leg 62 toward the first leg 60, and a second baffle 80 extends from the first leg 60 toward the second leg 62. A foot 82 extends outward from the first baffle 78 away from the first leg 60 and the second leg 62, and a latch 84 extends upward from the foot 84 and is located between the first leg 60 and the second leg 62. Specifically, the latch 84 is disposed between the plane representing the first leg 60 and the plane representing the second leg 62. This configuration is desirable in order to produce a more compact clamp 40. Optional reinforcement 86 can extend downwards from the foot 82.

[0157] Figure 49-75 Some alternative embodiments of clip 710 are shown, which have the features described above. Figures 40-48 The clip 40 in the preferred embodiment has similar features. Specific details of these alternative embodiments of the clip 710 will be described below, particularly distinguishing them from… Figures 40-48 The features of clip 40 in the middle. For simplicity, with Figure 40-75 Features similar to those described above will not be repeated here, but those skilled in the art can understand them based on the previous descriptions herein. Figure 49-75 Features of exemplary embodiments may be combined with features of other exemplary embodiments disclosed herein, where appropriate.

[0158] Figure 49An alternative embodiment of the clip 710 is shown, having a generally V-shaped shape and a first leg 712 and a second leg 714 connected by a curved segment 716. The second leg 714 includes a shovel-shaped portion 718. The shovel-shaped portion 718 includes an outer wall 720 connected to the second leg 714 via a bottom portion 724. In this embodiment, no inner wall of the shovel-shaped portion 718 is present because the second leg 714 extends entirely to the top of the shovel-shaped portion 718. Therefore, the shovel-shaped portion 718 does not have a generally U-shaped shape. A pair of barbs 726 (only one barb is visible in the figure) extend outward from the outer wall 720 of the shovel-shaped portion 718.

[0159] Figure 49 The diagram also shows a foot 732 extending outwards away from the first leg 712 and the second leg 714, with a latch 734 extending upwards from the foot 732. The latch 734 is located outside the region between the first leg 712 and the second leg 714. Specifically, the latch 734 is located outside the region between the plane representing the first leg 712 and the plane representing the second leg 714. Ribs 736 extend downwards from the foot 732 to reinforce and strengthen the clamp 710.

[0160] Figure 50 An alternative embodiment of the clamp 710 is shown, comprising a U-shaped shovel portion 718 having an outer wall 720 and an inner wall 722. The shovel portion 718 is located on the bottom portions of the outer wall 720 and the inner wall 722. The inner wall 722 reduces the length of the second leg 714, and includes barbs 726 that secure the clamp 710 to the needle guard. Allowing the barbs 726 to move from the outer wall 720 to the inner wall 722 advantageously narrows the clamp 710. Specifically, the outer wall of the needle guard can be removed while still adequately securing the clamp 710. Additionally, the clamp 710 includes a foot 732 and a latch 734 disposed between the first leg 712 and the second leg 714. In other words, the foot 732 and the latch 734 are located between the plane representing the first leg 712 and the plane representing the second leg 714.

[0161] Figure 51 and Figure 52 An alternative embodiment of the clip 710 is shown, which has a longer second leg 714 that exposes to the outside of the needle guard 750. Specifically, the needle guard 750 is covered by the needle hub, so the clip 710 is not exposed to the external environment, but only to the outside of the needle guard 750. A shovel-shaped portion 718 is provided between the plane representing the first leg 712 and the plane representing the second leg 714, making the clip 710 narrower. Barbs (not shown) may be present on the inner wall 722 of the shovel-shaped portion 718 to secure the clip 710.

[0162] according to Figure 51In another alternative embodiment of the clip 710, the curved section 716 between the first leg 712 and the second leg 714 can be a flat surface. In this way, the shovel-shaped portion 718 can pinch or pull the flat surface and the bottom portion 724 together. This design can provide an improved retention effect for the clip 710.

[0163] The longer second leg 714 has several advantages. The longer spring leg creates a more flexible V-shaped spring, where the spring force is applied more evenly along the length of the second leg 714. Additionally, the more flexible clip 710 reduces stiffness and internal pressure, while improving spring life. However, in this case, the opening 752 in the needle guard 750 for facilitating assembly, access, and operation of the clip 710 reduces the stiffness and overall strength of the needle guard 750.

[0164] Figure 53 and Figure 54 An alternative embodiment of the clip 710 is shown, which has a longer second leg 714 (the advantages of which are described above). The outer wall 720 of the shovel-shaped portion 718 extends further upward to cover the modified opening 752 of the needle shield 750 during assembly. Thus, this design can prevent debris or blood from entering the clip 710 and the needle shield 750, and protect the catheter assembly from external environmental influences.

[0165] The clamp 710 includes a first baffle 728 and a second baffle 730. The first baffle 728 is directly connected to the first leg 712 and the foot 732 to achieve the following advantages: The folded design improves the overall strength of the clamp 710, simplifies manufacturing, enables a more compact design, and reduces metal scrap. On the other hand, the second baffle 730 is directly connected to only the second leg 714. The two baffles 728 and 730 cooperate to block the opening of the needle guard when the needle is in the retracted position inside the needle guard.

[0166] The shovel-shaped portion 718 is not U-shaped. More precisely, the outer wall 720 bends inward on both sides of the second leg 714 and then bends outward away from each side of the second leg 714. Therefore, the inner wall 722 is generally parallel to the outer wall 720, and the inner wall 722 is not directly connected to the width of the second leg 714. On the other hand, the inner wall 722 exists adjacent to the front and rear planes of the second leg 714. A groove 754 in the needle guard 750 engages the barb 726 and the inner wall 722 to secure the clip 710.

[0167] Although the needle shield 750 in this embodiment is compared to Figure 52 The needle shield in the embodiment is stronger, but the modified opening 752 still weakens the needle shield 750. The clip 710 also includes additional bending and increased complexity, increasing manufacturing difficulty.

[0168] Figure 55 An alternative embodiment of the clip 710 is shown, which includes ribs 736 on the outer wall 720 and ribs 736 on the foot 732. When the barbs 726 of the outer wall 720 of the shovel-shaped portion 718 engage the outer wall of the needle guard, a reaction resistance is applied to the clip 710. Depending on the magnitude of the applied reaction force, the clip 710 may plastically deform at the shovel-shaped portion 718 or even fail. Preferably, the clip 710 undergoes only elastic deformation at the shovel-shaped portion 718 to maintain an appropriate spring life.

[0169] Rib 736 serves as a reinforcing member to increase the strength of clamp 710 and reduce the likelihood of clamp 710 undergoing permanent bending or twisting. Clamp 710 also includes a baffle 728. Baffle 728 is directly connected to only the first leg 712. Therefore, a gap exists between baffle 728 and leg 732 to advantageously facilitate manufacture, shaping, and assembly using machining tools.

[0170] Figure 56 An alternative embodiment of the clip 710 is shown, comprising a shovel-shaped portion 718 having only an inner wall 722. The shovel-shaped portion 718 does not have an outer wall formed around the needle guard. The inner wall 722 includes barbs 726 that engage the needle guard when the clip 710 is assembled. Although only a single barb 726 is shown, it is conceivable that barbs would be formed on the other side of the second leg 714. A spring force in the clip 710 applies a force to secure the barbs 726 of the shovel-shaped portion 718 to the needle guard. The construction of the clip 710 advantageously provides a narrower design because the clip 710 does not wrap around the outside of the needle guard. Therefore, this design can improve assembly.

[0171] The clamp 710 also includes a baffle 728. The baffle 728 is directly connected to the first leg 712 and the foot 732. By creating a more compact design and reducing waste, the clamp 710 design advantageously improves the stamping operation during manufacturing.

[0172] Figure 57 and Figure 58 An alternative embodiment of the clip 710 is shown, which includes a shovel-shaped portion 718 disposed on the top surface of an outer wall 720. The shovel-shaped portion 718 includes the outer wall 720 and barbs 726 to secure the clip 710 to a needle guard 750. The outer wall 720 is connected to a second leg 714 via a bottom portion 724 of the shovel-shaped portion 718. This configuration of the clip 710 includes long spring legs for both the first leg 712 and the second leg 714. The advantages provided by the long spring legs are reduced pressure and increased flexibility, as described above.

[0173] Figure 59 and Figure 60An alternative embodiment of the clip 710 is shown, which does not have a shovel-shaped portion for mounting to the needle guard 50. Instead, the second leg 714 is bent at approximately 180 degrees at its bottom surface (corresponding to the folded surface) to form protrusions 723 on both sides of the second leg 714, as well as inner walls 722 and barbs 726 (on both sides, not shown).

[0174] When the clamp 710 is assembled, the protrusion 723 is located on the bottom surface of the needle guard 750. The inner wall 722 and the barb 726 engage the inner cavity of the needle guard 750 to secure the clamp 710. This configuration allows the second leg 714 to have a longer length, thus achieving the advantages described above. However, this 180-degree bend will generate greater stress during manufacturing and operation.

[0175] Figures 61-65 An alternative embodiment of the clip 710 in the needle guard 750 is shown. Figure 61 The clip 710 shown includes a long second leg 714 having a bend at its lowest portion to form a protruding edge 723. The second leg 714 has similar benefits regarding its elongated length as described above. Additionally, the clip 710 includes a mounting cavity 738 to engage the clip 710 and secure it to a needle guard (described further below).

[0176] Figure 61 and Figure 62 The foot 732 and latch 734 are shown on the bottom portion of the clip 710. A baffle 728 is directly attached to the second leg 714. The clip 710 also includes a barb 726 attached at approximately a 90-degree angle to the flange 723. The barb 726 secures the clip 710 to the needle guard 750 (described further below).

[0177] Figure 63 A top view of clip 710 is shown, illustrating how clip 710 is assembled into the needle guard. Specifically, the user applies pressure to the outer surfaces of the first leg 712 and the second leg 714 to press them together. More specifically, the user can hold clip 710 at the outer surface of foot 732 and at the outer surface of the protrusion 723 (see arrows indicating gripping areas) and pull these two surfaces together to begin assembly. This configuration facilitates the assembly of clip 710 into the needle guard.

[0178] Figure 64A clip 710 is shown mounted into the needle guard 750. The clip 710 is shown in two states. The first state is a compressed state, where the clip 710 is compressed to facilitate assembly into the needle guard 750. Additionally, the first state shows the needle of the needle guard 750 during operation. During operation, the first leg 712 contacts the needle (not shown). In the first state, the mounting cavity 738 is not engaged with the mounting protrusion 756 of the needle guard 750.

[0179] In the second state, when the needle retracts and the needle tip enters the needle guard 750, the needle no longer contacts the first leg 712 (not shown) and the clamp 710 is released. As a result, the mounting cavity 738 of the clamp 710 engages the mounting protrusion 756 in the needle guard 750. In addition, the baffle 728 blocks the needle, preventing it from exiting the needle guard 750.

[0180] Therefore, the engagement between the mounting cavity 738 and the mounting protrusion 756 advantageously prevents the clip 710 from accidentally detaching from the needle guard 750. This engagement also advantageously prevents unintended movement of the clip 710 within the needle guard 750 and prevents unauthorized tampering of the clip 710.

[0181] Figure 65 A clip 710 assembled in a needle guard 750 is shown. The needle guard 750 includes a housing slot 754 that receives a barb 726 of the clip 710. A protrusion 723 is provided on the bottom surface of the needle guard 750. Engaging the barb 726 into the housing slot 754 advantageously prevents the clip 710 from moving upward and exiting the needle guard 750. Furthermore, the barb 726 of the clip 710 eliminates the need for a shovel-shaped portion surrounding the outer wall of the needle guard 750 to secure the clip 710. Therefore, the width of the clip 710 and the needle guard assembly is reduced.

[0182] Figure 66 An alternative embodiment of the clip 710 is shown, which includes a front wall 742 and a rear wall 740. The front wall 742 and rear wall 740 are perpendicular to the longitudinal axis of the needle in the needle guard (not shown). Specifically, the outer wall 720 of the shovel-shaped portion 718 is curved inward at an angle of approximately 90 degrees on each side of the second leg 714 toward the longitudinal axis of the needle. The front wall 742 and rear wall 740 include holes 743 to allow the needle to pass through during operation. Barbs 726 are provided on the front wall 742 and rear wall 740 respectively for proper mounting into the needle guard.

[0183] Figure 67 Showing clip 710 and Figure 66An alternative embodiment similar to the previous one. The clip 710 includes a rear wall 740 but not a front wall 742. Specifically, the upper portion of the second leg 714 bends inward at an angle of approximately 80 degrees into the top wall 744. The rear end of the top wall 744 bends downward at an angle of approximately 90 degrees to form the rear wall 740. Barbs 726 are provided on the rear wall 740 for secure attachment to the needle guard.

[0184] Figure 68 An alternative embodiment of clip 710 is shown, which functions as an extension spring instead of a compression spring. In all other embodiments of the clip described herein, the needle compresses the clip during operation (like a compression spring). When the needle is removed and enters the needle guard, the clip releases and prevents the needle from exiting (release of the compression spring).

[0185] However, according to this embodiment, the clip 710 includes a first intermediate leg 746 and a second intermediate leg 748 disposed between the first leg 712 and the second leg 714. The first leg 712 and the second leg 714 are attached to the opposite surfaces of the needle guard.

[0186] When the needle is in operation, it contacts the second intermediate leg 748, causing the clamp 710 to be in the extended position. This position causes the second intermediate leg 748 to function as a tension spring. Specifically, the second intermediate leg 748 naturally tends to move toward the first leg 712, but the needle prevents this movement from occurring.

[0187] As the needle retracts into the needle guard, the second intermediate leg 748 is released and moves toward the first leg 712 (the extension spring returns to its normal position). Therefore, the baffle 728 moves in front of the needle and prevents the needle from exiting the needle guard.

[0188] Figure 69 An alternative embodiment of the clip 710 is shown, which includes an outer wall 720 of a spade-shaped portion 718 having an opening 727. When the clip 710 is assembled, the opening 727 receives the mounting protrusion 756 of the needle guard 750. This configuration advantageously provides another simple way to mount and secure the clip 710 to the needle guard 750.

[0189] according to Figure 69 In an alternative embodiment of the clip 710, the outer wall 720 may include two barbs that are vertically positioned and extend away from the outer wall 720. The two barbs clamp or latch onto the inner rib or inner wall of the needle guard. This feature advantageously allows the clip 710 to be reliably secured while minimizing the overall width of the clip 710.

[0190] Figure 70An alternative embodiment of the clip 710 is shown, which includes a modified shovel-shaped portion 718. Specifically, the shovel-shaped portion 718 includes an outer wall 720 with barbs 726 and an inner wall 722 with flaps 725. The barbs 726 and flaps 725 may also be interchanged and disposed on opposite walls 720, 722 of the shovel-shaped portion 718. When the clip 710 is installed in a needle guard, the barbs 726 and flaps 725 each contact one side of a wall of the needle guard to secure the clip 710. In other words, the contact between the barbs 726 and flaps 725 clamps and secures the clip 710 to the needle guard.

[0191] Figure 71 Showing clip 710 and Figure 70 In a similar alternative embodiment, the outer wall 720 and the inner wall 722 extend along the width direction of the clamp 710. Specifically, the outer wall 720 and the inner wall 722 extend beyond the width of the second leg 714 on both sides to advantageously provide a larger surface area for securing the clamp 710. Although not shown, the outer wall 720 and the inner wall 722 may also include, for example, Figure 70 The barb 726 and the folding piece 725 described in the text.

[0192] Figure 72 and Figure 73 An alternative embodiment of the clip 710 is shown, which includes a shorter second leg 714. A bend is provided between the second leg 714 and the inner wall 722 of the shovel-shaped portion 718, making the second leg 714 shorter. As a result, the second leg 714 advantageously provides a more robust clip 710.

[0193] Figure 74 An alternative embodiment of the clamp 710 is shown, which includes a foot 732 and a latch 734 disposed between a first leg 712 and a second leg 714. The foot 732 includes ribs 736 to provide improved rigidity and strength. Additionally, a baffle 728 is directly attached to the first leg 712; the baffle 728 is not directly attached to the foot 732 and the latch 734. This design of the clamp 710, where the baffle 728 is only attached to the first leg 712, advantageously provides additional space for machining tools during manufacturing and improves assembly.

[0194] Figure 75 An alternative embodiment of the clip 710 is shown, which includes a second leg 714 having a flange 723 at its top portion. The second leg 714 also includes a rear wall 740 disposed below the flange 723. The rear wall 740 is curved inward toward the first leg 712 at an angle of approximately 90 degrees. The rear wall 740 includes barbs 726 that attach to the needle guard to secure the clip 710.

[0195] See the previous attached image. Figures 40-48The clip 40 is connected to the outer housing 38, at which point the shovel-shaped portion 66 is positioned around the outer wall of the outer housing 38. The shovel-shaped portion 66 is attached to the outer wall of the outer housing 38, so that the outer wall 70 of the shovel-shaped portion 66 is exposed to the outside of the needle guard 20. Compared to an arrangement where the shovel-shaped portion 66 is received in the internal cavity of the outer housing 38, and thus the outer wall 70 is not exposed to the outside of the outer housing 38, this configuration advantageously reduces the width of the needle guard 20. Figure 106-112 As best shown, the inner wall 72 of the shovel-shaped portion 66 is located in the recess, and two barbs 76 extend away from the inner wall 72 to engage a pair of protrusions 89 in the needle guard 20. The two barbs 76 help to secure the clip 40 to the inner surface of the needle guard 20. The clip 40 may be formed of metal, elastomer, polymer, or composite material. In various exemplary embodiments, the clip 40 is formed of a sheet of resilient metal (e.g., stainless steel).

[0196] according to Figures 76-80 In the illustrated exemplary embodiment, washer 42 includes a base 88 and sidewalls 90 joined together to form a generally L-shaped form. Sidewalls 90 include a funnel-shaped portion 92 and an opening 94. Needle 12 includes a deformable portion 96, such as a fold or protrusion formed near the distal end of needle 12. The opening 94 in washer 42 is sized to allow the needle shaft to pass through but not the deformable portion 96. The funnel-shaped portion 92 facilitates initial insertion of the proximal end of needle 12 through washer 42 during assembly.

[0197] Figures 81-89 The illustrated alternative exemplary conduit seat 214 has a pair of stabilizing wings 216. Figures 90-103 Another alternative exemplary side-port catheter seat 314 is illustrated, which has a pair of stabilizing wings 316 and a side port 318. The side port communicates with an internal tubular valve (not shown), as described in U.S. Patent No. 4,231,367 (which is incorporated herein by reference). The alternative catheter seats 214, 314 each have retaining rings 234, 334, with openings 236, 336 to receive a latch 84 of the needle guard 20.

[0198] The catheter assembly may include a plunger 320 that is initially attached to a needle hub 16. Once the needle hub 16 and needle shield 20 have been removed from the catheter hub, the plunger 320 can be removed from the needle hub 16 and attached to the open proximal end of the catheter hub. Although drawn only with the side-port catheter 314, the plunger 320 can be used with any of catheter hubs 14, 214, and 314.

[0199] Figure 104-112 The diagram shows the operation during the period. Figure 1-12The catheter assembly 10. Initially, the needle guard 20 is connected to the catheter seat 14, and the introducer needle 12 passes through the catheter seat 14 and the needle guard 20. When the needle 12 is in use (first position), the nose 48 of the needle guard 20 (in...) Figure 30 The needle 12 (marked in the middle) may (or may not) extend into the catheter seat 14. The clamp 40 is biased into the locked position by pressing the first arm 60 and the second arm 62 toward each other, and the needle 12 cooperates with the clamp 40. Figure 108 As best shown, in the locked position, the latch 84 engages the retaining ring 34, preventing the needle guard 20 from being removed from the guide tube seat 14. Simultaneously, in the locked position, the latch 84 is biased from the retaining ring opening 36. The position of the latch 84 is off-center relative to the needle 12. The clamp 40 is also in the open position, allowing the needle 12 to pass through the clamp 40.

[0200] As the needle 12 retracts from the guide tube seat 14 into the needle guard 20, the tip of the needle 12 passes over the clamp 40, allowing the clamp 40 to extend elastically and the second arm 62 to move away from the first arm 60. When the clamp 40 extends laterally, the main baffle 78 and the secondary baffle 80 block the distal opening 44 of the housing 38 orifice, preventing the tip of the needle 12 from exiting from the distal port of the housing 38.

[0201] The movement of the second leg 62 causes the latch 84 to move laterally away from its engagement with the retaining ring 34 to a position aligned with the retaining ring opening 36, thereby disengaging or unlocking the needle guard 20 from the guide tube seat 14. The direction of movement of the latch 84 is lateral relative to the centerline of the needle 12. The movement of the latch 84 is not radial towards or away from the needle 12. Furthermore, during adjustment, the latch 84 moves to a centered position and then finally moves off-center relative to the needle 12. In the first and second positions of the needle 12, the off-center positions of the latch 84 are symmetrically opposite to each other.

[0202] With the baffles 78 and 80 blocking the needle 12, the clamp 40 moves to the closed position. Simultaneously, the needle 12 enters the second position, in which it retracts from the first needle position, preventing further use of the needle 12. The first position, as described above, is understood, for example, to refer to all positions prior to the needle 12 entering the second position.

[0203] As the needle 12 is further pulled in the proximal direction, the axis of the needle 12 slides through the needle guard 20 until the deformable portion 96 formed near the distal end of the needle 12 cooperates with and engages with the washer 42. Figure 107As shown. The opening in washer 42 is sized to allow the needle shaft to pass through, but not the deformable portion 96. Thus, when the needle 12 is in the second position, washer 42 prevents the distal end of the needle 12 and the deformable portion 96 from exiting the needle guard 20. The combination of washer 42 and needle guard 20 surrounds or covers the distal end of the needle 12 in this second position. Further proximal movement of the needle 12 causes the needle guard 20 to be pulled away from the guide tube seat 14.

[0204] The combination of clip 40 and washer 42 serves as an exemplary needle tip protection mechanism. This needle tip protection mechanism surrounds or covers the distal needle tip and deformable portion 96, preventing these portions of the needle 12 from exiting the needle guard 20.

[0205] More information regarding the needle tip protection mechanism used in this embodiment can be found in U.S. Patent Nos. 6,749,588 and 7,604,616, and U.S. Patent Application Publication No. 2,014 / 0364,809, the contents of which are incorporated herein by reference. The features described in this embodiment (including the needle protection member) can be used in combination with the features described throughout this application.

[0206] like Figures 113-116 As shown, the use of clip 40 and the notched retaining ring 34 enables a smaller, more compact design. Without the retaining ring opening 36, the latch 84 would have to move a distance B1 to traverse the retaining ring and allow the needle guard 20 to disengage. With the retaining ring opening 36, the latch 84 does not need to traverse the entire guide tube seat 14, but only needs to move a distance B2 (which is less than B1).

[0207] Figure 117 and Figure 118 The use of the catheter valve actuator 28 is illustrated. The introducer needle 12 initially extends through the actuator 28, diaphragm 26, wedge 24, and catheter fitting 22. After the introducer needle 12 and catheter fitting 22 are inserted into the patient, the needle 12 retracts, closing the diaphragm 26. When the convex Luer connector 98 is inserted into the catheter seat 14, the Luer connector 98 abuts against the actuator 28 and causes it to move distally, compressing the bias member 30. Further insertion of the Luer connector 98 causes the actuator 28 to move through the diaphragm 26, opening a slit and allowing fluid flow through the catheter seat 14.

[0208] When the Luer connector 98 is removed, the biasing member 30 moves the actuator 28 in the opposite direction, removing it from the diaphragm 26, closing the slit, and preventing fluid from flowing through the slit. This allows the catheter to be reused while it is in a patient's blood vessel, unlike single-use catheters where the actuator remains in the diaphragm when the Luer connector 98 is removed. However, single-use catheters can still be used with the needle shield 20 described herein.

[0209] Actuator 28 has an actuator tube 100 surrounding an internal channel. The actuator tube 100 is a generally tubular component, and the internal channel is generally cylindrical. A first end of the actuator tube 100 has a nose with a beveled outer surface to engage the diaphragm 26. The tubular component has one or more openings 102 to allow fluid to flow through and around the actuator tube 100. Actuator 28 includes a rear portion for engaging a convex Luer connector.

[0210] exist Figure 117 In the first exemplary embodiment shown, the actuator 28 includes a first set and a second set of openings 102 in the tube, wherein the first set of openings is located near the nose. The openings are also shown in... Figures 106-107 In actuator 28. Figure 117 The rear portion of the actuator 28 also includes a set of legs 104 that extend from the tube and connect to the ring 106. The features described in this embodiment can be used in combination with the features described throughout this application.

[0211] exist Figures 119-121 In the second exemplary embodiment shown, the actuator 28A includes a set of recesses 101A and a set of openings 102A. The recesses 101A extend from the nose toward the rear of the actuator barrel 100A. The openings 102A are positioned toward the rear of the barrel 100A. As the actuator 28A extends through the diaphragm 26, the recesses 101A direct fluid flow to the openings 102A remaining on the proximal side of the diaphragm 26. The recesses 101A may be located to one side of the openings 102A or directly aligned with them. The rear portion of the actuator includes a set of legs 104A extending from the barrel. Figure 121 As shown, ring 106A can be connected to leg 104 to engage Luer connector 98, or Luer connector 98 can directly engage leg 104A, as shown. Figure 119 and Figure 120 As shown. The features described in this embodiment can be used in combination with the features described throughout this application.

[0212] In one exemplary embodiment, the biasing member 30 is a spring, such as a helical compression spring with a distal end and a proximal end. The spring can be made of metal, plastic, elastomer, or other suitable elastic material. The distal end of the spring forms an interference fit with the inner surface of the conduit seat 14. This interference fit is sufficient to retain the spring, even during loading. The proximal end of the spring is connected to the actuator 28. The features described in this embodiment can be used in combination with the features described throughout this application.

[0213] Figures 122-126Exemplary blood flashback components of the catheter assembly are illustrated. A flashback refers to the visibility of blood as the needle tip enters the blood vessel. The initial flashback 400 is visible through the catheter fitting, at which point blood enters the open distal end of the hollow needle 12, from a notch or opening 402 near the needle tip (also possible in…). Figure 13 The blood emerges from the needle 12 and flows upward through the internal annular space between the needle 12 and the catheter fitting 22. A second flashback 404 is visible in the needle hub / gripper 16, where blood exits from the rear of the needle 12 and enters the flash chamber of the needle hub / gripper. Air is expelled through a porous membrane or microgrooves via a plug in the rear of the needle hub / gripper 16. A third flashback 406 occurs in the catheter hub 14, where blood from the initial flashback 400 flows into the catheter hub and stops at the blood control diaphragm 26. Air is expelled through microgrooves in the periphery of the blood control diaphragm 26. The features described in this embodiment can be used in combination with the features described throughout this application.

[0214] Figure 127 Show in further detail Figure 121 The actuator in the middle. Actuator 554 can be used in Figures 117-120 In the catheter assembly shown, actuator 554 includes a nose 558 that reduces friction when actuator 554 penetrates into the septum 538 of the catheter seat assembly. Actuator 554 also includes an opening 555 extending through actuator 554 in a direction perpendicular to the centerline of actuator 554. For example, actuator 554 may include two rectangular openings 555, however, more or fewer openings are contemplated.

[0215] The actuator 554 also includes a plurality of grooves 557 that extend axially along the distal portion of the outer surface of the actuator 554 in a plane parallel to the centerline of the actuator 554. For example, four grooves 557 may be arranged along the outer surface of the distal portion of the actuator 554 at approximately equal intervals in the radial direction; however, more or fewer grooves 557 are contemplated. The depth of the grooves 557 into the actuator 554 can vary. The grooves 557 differ from the openings 555 because the grooves 557 do not extend through the actuator 554.

[0216] The opening 555 and the groove 557 advantageously provide a larger area for fluid to move within the conduit seat assembly. This increased area advantageously allows for fluid flushing and prevents fluid condensation at both the proximal and distal ends of the diaphragm. Additionally, the opening 555 and the multiple grooves 557 advantageously minimize fluid resistance and allow for better mixing. The groove 57 also further prevents the diaphragm from sealing on the outer surface of the actuator during operation. In the absence of a sealing interface, fluid can leak through the groove 57 through the diaphragm, providing additional flushing.

[0217] Figure 128 Shown in the catheter seat assembly Figure 127 The actuator 554. Similar to the embodiments described above, the conduit seat assembly further includes a conduit seat 514, a diaphragm 538, and a biasing member 556. As shown, the opening 555 and the groove 557 of the actuator 554 provide more area for fluid to flow within the conduit seat 514, thereby achieving the advantages described above.

[0218] Figure 129 and Figure 130 The catheter seat assembly is shown with the biasing member 556 compressed and the actuator 554 penetrating the diaphragm 538. The catheter seat assembly can be configured such that the opening 555 and / or the groove 557 of the actuator 554 optionally penetrate the diaphragm 538. In this embodiment, the opening 555 in the actuator 554 does not penetrate the diaphragm 538. However, the groove 557 in the actuator 554 penetrates the diaphragm 538. In addition to the advantages described above, this configuration allows more fluid to flow from the proximal end to the distal end of the diaphragm 38 via the groove 557. After the catheter assembly operation is complete, the actuator 554 retracts from the diaphragm 538 under the force applied by the biasing member 556. The catheter assembly is configured to perform multiple purposes when the actuator 554 is depressed. The features described in this embodiment (including the actuator) can be used in combination with the features described throughout this application.

[0219] Figure 131 Another embodiment of the actuator 664 in the catheter seat assembly is shown. The catheter seat assembly includes a catheter seat 662 having a side port 668. The side port 668 provides a secondary passage for fluid flow into the catheter seat 662. The intersection region of the main bore of the catheter seat 662 and the side port 668 includes a sleeve 672. The sleeve 672 provides selective fluid communication between the side port 668 and the catheter seat 662. Specifically, the sleeve 672 compresses when sufficient fluid pressure is applied through the side port 668. The compression of the sleeve 672 allows fluid to enter the catheter seat 662. The catheter seat assembly also includes a diaphragm 670 and a biasing member 666 that provides tension to the actuator 664.

[0220] Actuator 664 includes a plurality of openings 665 extending through actuator 664 in a manner similar to that described above. Actuator 664 includes two rows of four openings 665 with different sizes and similar spacing; however, openings 665 with various numbers, sizes, and spacings are conceivable. As shown, openings 665 provide more area for fluid to flow within conduit seat 662, thereby achieving the effect described above. Figures 127-130 Similar advantages as described.

[0221] Figure 132 and Figure 133 The catheter seat assembly is shown, in which actuator 664 penetrates diaphragm 670 and compresses bias member 666. The catheter seat assembly is configured such that opening 665 of actuator 664 optionally penetrates diaphragm 670. In this embodiment, opening 665 in actuator 664 does not penetrate diaphragm 670. In addition to the advantages described above, this configuration can increase fluid flow between side port 668 and catheter seat 662 at the proximal end of diaphragm 670. If opening 665 in actuator 664 penetrates diaphragm 670, more fluid mixing will occur at the distal end of diaphragm 670.

[0222] When the catheter assembly operation is complete, the actuator 664 retracts from the diaphragm 670 under the force applied by the bias member 666. The catheter assembly is configured to perform multiple purposes when the actuator 664 is depressed. The features described in this embodiment (e.g., the actuator) can be used in combination with the features described throughout this application.

[0223] In another exemplary embodiment, the retaining ring of the catheter seat as described above can be replaced by any other structure defining a notch. For example, the retaining ring can be a groove or recess in the catheter seat. Thus, the groove in the catheter seat can be used to engage and disengage the clamp in a manner similar to that described above. The features described in this embodiment can be used in combination with the features described throughout this application.

[0224] The foregoing provides a detailed description of certain exemplary embodiments to illustrate the principles of the invention and its practical application, thereby enabling those skilled in the art to understand various embodiments of the invention and various modifications suitable for the contemplated particular purpose. This description is not exhaustive, nor does it limit the invention to the disclosed exemplary embodiments. Any embodiments and / or elements disclosed herein can be combined with each other to form various additional embodiments not specifically disclosed. Therefore, additional embodiments may also be included within the scope of this specification and the appended claims. The specification describes specific examples to achieve higher objectives that may also be achieved in other ways.

[0225] The terms “front,” “back,” “up,” “down,” “upward,” “downward,” and other directional descriptors used in this application are intended to facilitate the description of exemplary embodiments of the invention, and are not intended to limit the structure of exemplary embodiments of the invention to any particular location or orientation. Those skilled in the art will understand that degree terms such as “approximately” or “about” refer to reasonable ranges beyond given numerical values, such as tolerances associated with manufacturing, assembling, and using the described embodiments.

Claims

1. A catheter assembly comprising: catheter; A needle, the needle having a distal end; The catheter hub is connected to the catheter; A needle guard configured to be connected to the catheter hub; as well as The clamp includes legs connected to an outer wall, the outer wall being curved toward the inside of the clamp at an angle greater than 45° on both sides of the legs, the clamp being disposed within the needle guard and cooperating with the needle; in In the first position of the needle, the clamp engages the catheter seat; and When the needle retracts to the second position, the clamp disengages from the catheter seat to cover at least a portion of the needle.

2. The catheter assembly according to claim 1, wherein, The outer wall extends outward from the inwardly curved portion at an angle greater than 45° along each side of the leg away from the clamp to form the inner wall.

3. The catheter assembly according to claim 2, wherein, The inner wall is approximately parallel to the outer wall.

4. The catheter assembly according to claim 2, wherein, The width of the inner wall is not directly connected to the leg.

5. The catheter assembly according to claim 2, wherein, The inner wall is adjacent to the front and rear planes of the leg.

6. The catheter assembly according to claim 2, wherein, The inner wall includes barbs.

7. The catheter assembly according to claim 1, wherein, A flat surface connects the outer wall to the leg.

8. The catheter assembly according to claim 1, wherein, The outer wall is bent at an angle of approximately 90°.

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