CN108187181A

CN108187181A - Needle guard

Info

Publication number: CN108187181A
Application number: CN201810145667.9A
Authority: CN
Inventors: T·C·库拉辛纳; T·L·基钦
Original assignee: Injectimed Inc
Current assignee: Injectimed Inc
Priority date: 2012-08-27
Filing date: 2013-08-27
Publication date: 2018-06-22
Also published as: AU2013308991A1; JP6147344B2; BR112015004357A2; CN104684478B; WO2014035970A1; AU2018200868A1; AU2018200868B2; JP2017185250A; EP2887979A4; JP2015530150A; CA2881423C; MX2015002672A; JP6019184B2; CA2881423A1; EP2887979A1; JP2016137230A; CN104684478A; BR112015004357A8; AU2013308991B2

Abstract

A kind of Needle hub assembly, the Needle hub assembly have the elastic arm extended from bottom, and the elastic arm is oriented to slide along the bar of needle.In one embodiment, needle guard has elongated accommodating part, and the elastic arm moves in the elongated accommodating part, and the elongated holding part and elastic arm cooperation are so as to covering of the realization to the entire distal needle of needle when needle is retracted into needle guard.

Description

Needle guard

The application is application number 201380045114.1, the patent Shen of the applying date in August, 2013 entitled " needle guard " of 27 days Divisional application please.

Inventor：State of Nevada Carson City Thomas C.Kuracina and Barcelona, ESP Tim L.Kitchen； Two inventors are United States citizens.

Cross reference to related applications

Parent application be on 2 28th, the 2011 Serial No. No.13/037 submitted, the Shen of continuing of 164 U. S. application Please.

Technical field

The present invention disclosed herein is related to a kind of safety needle device.

Background technology

Many United States Patent (USP)s describe safe vein injection (IV) conduit, and the conduit is in the needle point of distal end after usage Place provides a degree of protection, and the patent includes but not limited to：McLees, U.S.Pat.No.5,135,504； Erskine, U.S.Pat.No.5,797,880；Woehr, et al., U.S.Pat.No.6,287,278；Bialecki, et Al., U.S.Pat.No.6,652,486；McGurk, U.S.Pat.No.7,291,130；Rhad, et al., U.S.Pat.No.7,303,548；Menzi, et al., U.S.Pat.No.7,731,687；And Harding, et al., U.S.Pat.No.7,828,774.

The conduit of the safety of these prior arts all shows one or more shortcomings：When needle point covers it by release mechanism Afterwards, it is possible to by medical worker or other people be placed in the risk that is exposed under percutaneous or non-percutaneous blood or body fluid.To the greatest extent Needle point is capped pipe in itself after use on many safe vein injection catheters, but entire needle point after usage not by It accommodates completely, spills into so as to cause blood or the liquid leakage for being present in the end of pin inner chamber or in other ways workplace And contact healthcare givers.For example, the blood to splash can enter extremely close to eyes, the nose of any medical staff at splashing Or the mucosal areas of mouth.Then the exposure will be reported, and will occur, to exposed treatment, prevention and tracking, to cause Medical institutions incur loss and to the personal worries for being exposed to blood.In addition, unintentional incident can make some markets On the needle guard bought can easily fail, Needle hub assembly no longer protects or protects contaminated needle point.

Fig. 1-5 shown with United States Patent (USP) 6, the similar safe needle sleeve 10 of needle guard disclosed in 287,278.Needle guard 10 passes through Single piece of material shown in Fig. 1 constructs and forms the construction shown in Fig. 2-5 when in use.Fig. 2 and Fig. 3 show in standard The different side views of the needle guard 10 of standby position, wherein, unprotect at the needle point 18 of the distal end of needle 15.Fig. 4 and Fig. 5, which is shown, to be worked as The needle guard has been actuated to after the needle point 18 for covering the distal end, the different side views of the needle guard 10.Such as Fig. 4 and figure Shown in 5, although the needle point 18 of the farthest distal end of the needle 15 is protected, the open lumen 17 in the chamfered region of needle Still it is exposed.It is relevant with the needle guard 10 another problem is that power may be applied at the position of needle guard arm 11 and 12, Distal arm portion 13 and 14 is caused to be pushed outwards dynamic.This, which causes, makes the tip arm section 13 and/or 14 described in protected The risk that the needle point 18 of distal end leaves.

Invention content

According to some embodiments, a kind of IV conduit tube components are provided, the IV conduit tube components include：Conduit bushing has Conduit proximally and distally, the needle and needle guard with shank and the needle point of distal end, the conduit bushing include having proximal end and The hollow body of distal end, the hollow body limit an inner space；The proximal end of the conduit is connected to the conduit bushing On proximal end；The needle can move between ready position and retracted position, in the ready position, the needle point of the distal end of the needle Distally extending from the distal end of the conduit, in the retracted position, the needle point of the distal end of the needle is located at one leads close to described At the position of the proximal end of pipe, the shank has at profile variations；The needle guard includes arm, and the arm distad prolongs from bottom It stretches, hole is formed in the bottom, the needle guard is slidably mounted on the shank, and the shank is described across forming in The hole of bottom, the size in the hole make to engage to limit the needle relative to the needle guard at its profile variations with the shank Movement to nearside；The arm includes elastic material and with proximal part, middle part and distal portions, when the needle is in described The distal portions of the arm are located at the side edge of the shank and are resisted against on the side of the shank during ready position；It is described Needle guard further comprises elongated member, the elongated member have the elongated member proximally and distally between extend pass through Logical channel, the elongated member is distally extending at the position of the bottom or close at the position of the bottom, and As the needle guard moves between the ready position and the enabling position, the elongated member can be moved along the shank Dynamic, length possessed by the elongated member causes the same of the hole generally in the engagement bottom at the profile variations When, the entire distal needle of the needle is arranged in the channel of the perforation of the elongated member, and the arm is remote End is partially disengaged the shank to move radially inward to cover the distal end of the elongated member at least partly；It is described elongated Component it is hard enough to cover the distal end of the elongated member at least partly in the distal portions of the arm when limitation described in Needle relative to the needle guard longitudinal movement.

According to other embodiments, a kind of IV conduit tube components are provided, the IV conduit tube components include：Conduit bushing has Conduit proximally and distally, the needle and needle guard with shank and the needle point of distal end, the conduit bushing include having proximal end and The hollow body of distal end, the hollow body limit an inner space；The proximal end of the conduit is connected to the conduit bushing On proximal end；The needle can move between ready position and retracted position, in the ready position, the needle point of the distal end of the needle Distally extending from the distal end of the conduit, in the retracted position, the needle point of the distal end of the needle is located at one leads close to described At the position of the proximal end of pipe, the shank has at profile variations；The needle guard includes the first arm and the second arm, first arm Distally extending from bottom with the second arm, the bottom, which has, forms in hole therein, and the needle guard is slidably mounted in institute It states on shank, the shank passes through the hole for forming in the bottom, is connect at the size in the hole and the profile variations of the shank It closes to limit the movement of the needle relative to the needle guard proximally；Each in first arm and the second arm includes bullet Property material and with proximal part, middle part and distal portions；First arm and second arm are at the different location of bottom Extend and intersect along their middle part, so the first arm described in when the needle is in the ready position and the The distal portions of two arms are located at the side edge of the shank and are pushed against on the opposite side of the shank；The needle guard into One step includes elongated member, the elongated member have the elongated member proximally and distally between extend perforation it is logical Road.The elongated member is distally extending from the bottom or close to the position of the bottom, and as the needle is described It is moved between ready position and the retracted position, the elongated member can be slided along the shank, and the elongated member is had While some length causes the hole generally in the engagement bottom at the profile variations, the entire distal end of the needle Needle point is located in the channel of the perforation of the elongated member, and the distal portion of at least one of first arm and second arm Divide the distal end for being detached from the shank and radially moving inwardly so as to cover the elongated member at least partly, it is described thin Long component is hard enough to cover institute at least partly in the distal portions of at least one of first arm and the second arm Longitudinal movement of the needle relative to the needle guard is limited during the distal end for stating elongated member.

According to some embodiments, the needle guard is included the integrally formed whole knot in the bottom of the needle guard and elongated member Structure.

According to some embodiments, make the needle by backstop in the retracted position, the spy by component or features Sign portion merges by the distal end of the elongated member or close to the far-end of the elongated member or makes the feature in other ways The distal end or the far-end close to the elongated member that portion is located at the elongated member.

According to some embodiments, the proximal part of the elongated member includes the part of diameter diminution and/or available for auxiliary Help the needle self centering frusto-conical portions on the needle guard.

A kind of safety needle device according to another embodiment of the present invention is provided, including：Needle, the needle set have shank and Distal needle, shank have near the distal needle at profile variations；Needle guard, the needle guard can prepare state and enabling Change between state, in the preparation state, the distal needle of the needle is in unprotect state, in the enabling state, institute The distal needle for stating needle is in guard mode, and the needle guard includes being formed with from the distally extending arm in bottom, the bottom Hole, the needle guard are slidably mounted on the shank, and the shank passes through and forms in the hole in the bottom, described Arm includes elastic material and with proximal part, and the needle guard further comprises elongated member, and the elongated member is from described It is distally extending at the position of bottom or close at the position of the bottom, and with the needle guard in the ready position and It is moved between the enabling position, the elongated member can be moved along the shank, and the elongated member has proximal end, distal end And the elongated member proximally and distally between the channel of perforation that extends, the channel of the perforation is located near or at The size of the first part of the proximal end of the elongated member to connect at the first part and the profile variations of the shank It closes and is moved with limiting the needle relative to the needle guard to nearside, length possessed by the elongated member causes generally in institute State the first part of the channel that the perforation is engaged at profile variations simultaneously, the entire distal needle of the needle is by positioned at described thin In the channel of the perforation of long component；The elongated member includes proximal part and distal portions, the close end of the elongated member Divide and be arranged in the hole of the bottom, and the bottom can be on the proximal part of the elongated member in the needle guard It slides between enabling position when ready position and the needle guard during preparation state are in enabling state, prepares when needle guard is in During state, the distal portions of the arm are located on the distal portions close to the distal end of the elongated member of the elongated member, institute At least part of arm is stated against the outside of the elongated member, the needle guard is configured to：As it is from the preparation state The enabling state is converted to, causes the arm by movement of the bottom from the first position to the second position Distal portions are distally moved on the outside of the distal portions to the distal end of the elongated member, the distal portions of the arm It is moved to the distal end for covering the elongated member at least partly radially inward in the far-end of the elongated member, it is described thin Long component is hard enough to limit institute to be covered at least partly in the distal portions of the arm during distal end of the elongated member State longitudinal movement of the needle relative to the needle guard.

In further embodiments, in the needle guard provided such as in the case where being in preparation state when needle guard, bias Component acts on one or more arms of the needle guard to help to push the arm against shank or elongated member.

It is disclosed herein and considers many other embodiments.Furthermore, it is necessary to important point to note is that the present invention is not limited to pacify Full intravenous injection catheter, and can be applied to any kind of needle product.

Description of the drawings

Fig. 1 to Fig. 5 shows the needle guard of the prior art；

Fig. 6 A to Fig. 6 C show the embodiment of flat material, and the flat material, which can be used to form, to be disclosed herein and be expected Needle guard；

Fig. 7 to Figure 10 shows the Needle hub assembly according to an embodiment；

Figure 11 is to Figure 17 shows the elongated members of protection according to various embodiments；

Figure 18 and Figure 19 shows Needle hub assembly according to another embodiment；

Figure 20 to Figure 23 shows Needle hub assembly according to another embodiment；

Figure 24 shows Needle hub assembly according to another embodiment；

Figure 25 A-D show the needle guard elongated member according to various embodiments；

Figure 26 to Figure 31 shows Needle hub assembly according to another embodiment；

Figure 32 to Figure 34 shows Needle hub assembly according to another embodiment；

Figure 35 to Figure 37 shows Needle hub assembly according to another embodiment；

Figure 38 shows the safe vein injection catheter component according to one embodiment；

Figure 39 and Figure 40 shows safe vein injection catheter component according to another embodiment；

Figure 41 shows Needle hub assembly according to another embodiment；

Figure 42 A-42D show safe vein injection catheter component according to another embodiment；

Figure 43 A-43D show the mode that the needle guard of Figure 42 can be activated；

Figure 44 A-44D are shown using the needle guard according to another embodiment in intravenous injection catheter component；

Figure 45 A-45D are shown using the needle guard according to another embodiment in intravenous injection catheter component；

Figure 46 shows the elongated member according to one embodiment；

Figure 47 shows the elongated member according to one embodiment；

Figure 48 shows the elongated member according to one embodiment；

Figure 49 A-49D show safe vein injection catheter component according to another embodiment；

Figure 50 shows the elongated member according to one embodiment；

Figure 51 shows the elongated member according to one embodiment；

Figure 52 shows the elongated member according to one embodiment；

Figure 53 shows the elongated member according to one embodiment；

Figure 54 shows the elongated member according to one embodiment；

Figure 55 A show the elongated member according to one embodiment；

Figure 55 B show the bottom of spring clip according to the embodiment, and the bottom of the spring clip has to accommodate Figure 55 A Elongated member proximal end keyhole；

Figure 56 A show the elongated member according to one embodiment；

Figure 56 B show the bottom of spring clip according to the embodiment, and the bottom of the spring clip has to accommodate Figure 56 A Elongated member proximal end keyhole；

Figure 57 A and Figure 57 B show the spring clip bottom according to other embodiments；

Figure 58 A-58C show the elongated member with the seal member positioned at its far-end；

Figure 59 shows seal member according to another embodiment；

Figure 60 A-60C show the Needle hub assembly according to another embodiment merged in guide wire introducer；

Figure 61 shows Needle hub assembly according to another embodiment；

Figure 62 A-62D show Needle hub assembly according to another embodiment, wherein, spring assembly is integral with spring clip；

Figure 63 A-63D show needle guard according to another embodiment；

Figure 64 A-64C show needle guard according to another embodiment；

Figure 65 shows needle guard according to another embodiment；

Figure 66 A-66C show needle guard according to another embodiment；

Figure 67 A-67B show needle guard according to another embodiment；

Figure 68 A-68B show needle guard according to another embodiment；

Figure 69 A-69C show needle guard according to another embodiment；

Figure 70 A-70B show needle guard according to another embodiment；

Figure 71 shows needle guard according to another embodiment.

Specific embodiment

Fig. 6 to Figure 11 shows needle guard 100 in accordance with some embodiments.According to one embodiment, as shown in Figure 6 A and 6B, The first part 110 of needle guard 100 is manufactured by flexible flat material, and is shaped as in presentation Fig. 7-10 and is used structure It makes, the second part 150 (see Figure 11 and Figure 12) of needle guard 100 limits elongated member 152, and the elongated member 152 has near The channel 153 of perforation extended between end 154 and distal end 156.Fig. 7 and Fig. 8 shows the needle guard 100 on injection needle 130 Different side views in the first axial position, the distal end 134 of the needle are not protected.Fig. 9 and Figure 10 are shown positioned at needle The different side views of the needle guard 100 of the second axial position on 130, the distal end 134 including entire inclined-plane 136 all by Protection.

In one embodiment, the first part 110 of needle guard 100 has the first elastic arm 101 and the second elastic arm 102, Each arm respectively includes proximal part 103,104；Middle part 105,106 and distal portions 107,108.First arm 101 Distally extend from the different location of bottom 118 with the second arm 102 and cross one another along their middle part 105,106, so The lip portion 111,112 of the distal portions 107,108 is located at shank when the needle guard is located at the first axial position 131 offside and offside against the shank 131 is pushed.The first part 110 of the needle guard 100 is slidably mounted in On the shank 131, the shank is passed through the hole 119 in the bottom 118.In one embodiment, when the needle When set is located at the second axial position, the size in hole 119 engages to limit the needle at the profile variations on the needle 132 Movement between 130 and the needle guard 100 along the first direction.The variation of the profile 132 may include the volume on the shank 131 The enlarged (describing in such as Figure 33 and Figure 35) of bent or any other form.

As shown in fig. 7, when the needle guard is in ready position, the elongated member 152 is located in the needle guard 100, The proximal end 154 of the elongated member 152 is placed at the bottom 118 or close to the bottom 118 and the elongate portion The distal end 156 of part 152 is placed on the lip portion 111 at the lip portion 111 of the arm 101 or close to the arm 101. In some embodiments, the elongated member 152 is generally coaxial with the needle 130, the diameter or horizontal stroke of the channel 153 of the perforation Enough big of sectional area is slided so that the elongated member is allowed to circumvent at the profile variations 132.In other embodiments, The elongated member 152 is generally coaxial with the needle 130, all parts of the channel 153 of the perforation or proximal part Diameter or cross-sectional area are less than at the profile variations 132 cross-sectional area.Such as shown in Fig. 9, in embodiment, The cross-sectional area of all parts of the channel 153 of wherein described perforation or a part be less than at the profile variations 132 it is transversal Area, the channel 153 of the perforation is expandable to be overlying at the variation on profile 132 (example as shown in Figure 9).At some In embodiment, the elongated member 152 is elastic with lower part：The channel 153 of i.e. described perforation is less than the profile variations The part of the cross-sectional area at place 132 is elastic, and the elastic part for allowing for the channel of the perforation in this way passes through the variation Place's profile after cause the perforation channel 153 cross-sectional area to contract.In some embodiments, following article is more detailed It carefully discusses, the proximal part of only described expandable member 152 has the transverse cross-sectional area reduced, the cross section of the diminution Region can be overlying on 132 at the profile variations to elasticity expansion.In use, the elongated member 152 is together with the needle The first part 110 of set 100 axially advances together along the shank.In some embodiments, the adjoining bottom 118 is utilized Proximal end 154, the elongated member 152 drives the first part 110 of the needle guard.In other embodiments, it is described elongated The proximal end 154 of component 152 is attached on the bottom 118.In other embodiments, the proximal end of the elongated member 152 Elongated member 152 described in part or whole is integral with the bottom 118.

Fig. 9 and Figure 10 shows the second axial position that needle guard 100 is on the needle 130, exists including entire inclined-plane 136 The interior needle point 134 is all protected.In one embodiment, as the needle guard advances on the needle 130 and described The needle point 134 of lip portion 111 and 112 towards distal end moves, and passes through at the profile variations on the needle 132 and the bottom The engagement in 118 hole 119, the needle guard 100 is by backstop in the second axial position.The implementation that will hereafter other backstops be disclosed Example.The length of the elongated member 152 is chosen to be：Generally at the profile variations 132 with (for example) described bottom 118 In hole 119 while engage, the needle point 134 and chamfered region 136 of the entire distal end of the needle 130 are placed as being located at institute It states in the channel 153 of perforation, and causes the distal portions 107 of the arm 101,102, described at least one of 108 disengagings Needle simultaneously advances to the distal end 156 for completely or at least partially covering the elongated member 152.

In one embodiment, as shown in fig. 7, the distal portions 107 of the arm 101 are configured as the needle guard 100 With the axis of the needle into first jiao during in ready position, and the distal portions 108 of the arm 102 be configured as it is described With the axis of the needle into second jiao when needle guard 100 is in the ready position, described second jiao is more than described first jiao.This Outside, as shown in figure 9, when the needle guard 100 is in the second axial position, the distal portions 107 of the arm 101 are directed And be biased, vertical relationship generally is presented with the longitudinal axis of the elongated member 152.In some embodiments, institute The cross-sectional area for stating distal portions 107 covers the entire distal end 156 of the elongated member 152 enough.In other embodiments, The part that the elongated member 152 is covered by the distal portions 107 is less than entire distal end 156.

As described above, the distal portions 107 of the arm 101 can be biased so that when the needle guard 100 is in described second During axial position the distal end 156 of the distal portions 107 to the elongated member 152 apply downwards/to the active force of nearside. In one embodiment, the bias is generated by the resilient hinge in the region 117.The application of the active force of downwards/lower part Help to be formed complete or partial sealing, the sealing can the needle guard 100 be in the second axial position it Hinder or prevent the pollutant of interior intracavitary of the needle 130 and the elongated member 152 from being leaked out from the needle guard 100 afterwards Come.In some embodiments, the distal portions 108 of the arm 102 are directed and are biased, with the distal portions 107 into One oblique angle and the power for applying the direction towards the distal end 156 of the elongated member 152 on the distal portions 107.

As shown in figure 38, in embodiment, it is prominent wherein the needle guard 100 forms a part for intravenous injection catheter 700 Part 116 and 117 may be formed on the arm 101 and 102, when conduit tube component 700 is in ready position, the protrusion 117 and 117 engage respectively with the features of one or more of the inside of conduit bushing 702 703, by the needle guard 100 are releasably fixed in the conduit bushing.

As described above, the spring clip type needle guard device with the prior art is that power may be applied to spring the problem of related On the component of clamp arm and that the Distal arm portion is caused to be pushed outwards is dynamic.This cause the needle guard be in protective position it Afterwards, the Distal arm portion is removed from the needle point protected.In order to solve described problem, in some embodiments, it is described The first part 110 of needle guard 100 includes straight or generally straight arm section 113 and 114, the arm section 113 and 114 by with It is set to respectively close to the Distal arm portion 107 and 108.As shown in figure 9, the arm section 113 and 114 is arranged to when described For needle guard 100 when being in the second axial position on the needle 130, the arm section 113 and 114 abuts the elongated member 152 outer surface is simultaneously configured on the offside of outer surface of the elongated member 152.The arm section 113 and 114 is configured To occupy the friendship of the distal portions 107,108 and the arm 101 and 102 when the needle guard is in the second axial position Position between crunode 126.In one embodiment, the arm section 113 and 114, which is located at, is respectively adjacent to the distal portions At 107 and 108, and it is configured as separating in the crosspoint 126 of the distal portions and the arm 101 and 102.In an implementation In example, distance (D that part 113 and the crosspoint 126 are distally separated₁) more than or equal to L₁Sin β, L₁For the intersection Approximate distance between the position that point 126 and the arm 101 intersect with the excircle of the elongated member 152, β are the arm Angle between 101 and the line of the longitudinal axis perpendicular to the elongated member 152 at the crosspoint 126.It although should not It asks, it is preferable that the part 114 is distally separated with the crosspoint 126, so as to the generally longitudinal upper and part 113 alignments.

In some embodiments, the part 113 and 114 is respectively provided with big with the width of the distal portions 107 and 108 Identical width on body.In other embodiments, as shown in Figure 6B, the width that the part 113 and 114 has is respectively smaller than The width of distal portions 107 and 108.In other embodiments, one in described part 113 and 114 or both may include The arcuate section consistent with the outer curvature of the elongated member 152 at least partly.The advantages of configuration is if not Appropriate power is applied to the arm 101 and/or 102, the part 113,114 and the outer surface of the elongated member 152 At least partly unanimously play the role of that the part 13,114 is made to be stabilized in around the elongated member.In other words, when not When appropriate power is applied on the arm 101 and/or 102, it is described it is at least part of unanimously reduce the arm 101 and/or 102 on the outer surface of the elongated member 152 towards the possibility of a Slideslip.It is described as an example and with reference to figure 6A The outer rim 121 and 122 of part 113 and 114 can be respectively cut line 123 and 124 and curve inwardly, the configuration of part bending is presented.

Any various structures can be presented in the first part 110 of the needle guard 100 and second part 150.Again Fig. 6 A and Fig. 6 B are returned to, in one embodiment, when the first part 110 forms the spring clip that example as is seen in figs 7-10 goes out When, the middle part 105 and 106 of the arm is sufficiently narrow to be located at the middle part 105 and 106 and the outer surface of the elongated member to use Between gap accommodate the elongated member 152.Dotted line in Fig. 6 A and Fig. 6 B is depicted during spring clip manufacturing process For manufacturing the folding position of bending section and/or articulated section.

In some embodiments, the elongated member 152 include with the one or more material of enough hardness with Bending is resisted during use.One or more material may include the combination of any kind of material or material, for example, golden Belong to, elastomer/plastics, braiding structure, arbitrary strand structure, combination thereof etc..Elongated member 152 may include multiple be connected in Part together and section, to form the elongated member.

For example, the elongated member 152 can be manufactured by using deep-draw manufacturing process, wherein, metal was stretching Processing hardening occurs in journey, there is no need to secondary heat treatment is carried out on completed part.The elongated member 152 can also wrap It includes, for example, the part that elastomer/plastic tube is extruded.

According to some embodiments, adjacent or proximate to the perforation in the proximal part of the elongated member 152 of the bottom 118 Channel 153 has the cross-sectional area/diameter reduced, and cross-sectional area/diameter of the diminution causes the channel 153 of the perforation Proximal part is engaged at the profile variations on the shank 131 132.In one embodiment, the channel 153 of the perforation Diameter reduction part replace the bottom 118 in hole 119 act as limiter, to limit the needle guard on the needle 130 100 towards the second axial position movement.In other embodiments, the bushing or sleeve for reducing diameter can be placed on institute It states at the proximal end 154 of elongated member 152 or is connect with the proximal end 154 of the elongated member 152, to play the role of limiting.

According to other embodiments, the proximal part of the elongated member 152 include can in a manner that Fig. 9 is discribed The material for expanding on 132 at profile variations or shrinking.In one embodiment, the proximal part of the elongated member includes allowing The elongated member 132 at the profile variations on expand and apply restraining force/radial direction at the profile variations 132 simultaneously The elastic material of power.The advantages of embodiment be after the needle guard 100 is placed the distal portions to cover the needle, The elastic restraint power being applied on 132 at the profile variations plays the work for the transverse movement for limiting the elongated member 152 With.It is complete or partial when requiring between the distal portions 107 or the arm 101 and the distal end 156 of the elongated member 152 Sealing when, this embodiment is particularly advantageous.According to other embodiments, elongated member 152 is whole to include flexible material, with The elongated member slides or is moved to the distal portions of the needle, and the flexible material allows the elongated member in the needle Expand on 132 at 130 profile variations or shrink.

Figure 13 is the cross-sectional side view of the embodiment of the elongated member 152 of the proximal part 155 with reduced inner diameter.Institute Absorbability or infiltrative inner coating/Bao Mo/liner or like 158 can also be had by stating elongated member 152, with the needle It is slided across the elongated member or mobile, the size of the absorbability or permeability component 158 makes it contact the needle 130 Outer diameter simultaneously absorbs or eliminates blood or body fluid from the outer surface of the needle.The absorbability or permeability component 158 may be used also Absorb the blood or body fluid for being present in pin inner chamber.In some embodiments, the absorbability or permeability component 158 include medicine Object, the drug, such as antiseptic or antibiotic.

Figure 14 is the cross-sectional side view of one embodiment of elongated member 152, and the elongated member 152 includes being located at institute State part or frusto-conical portions 159 that diameter at the proximal end 154 of elongated member 152 reduces and positioned at the elongated member 152 Distal end 156 at distal flange 157.According to one embodiment, the distal flange 157 provides the contact surface of bigger 179, to make distal portions 107 and the institute of the arm 101 in the second axial position being on the needle 130 when the needle guard The sealing stated between the distal end 156 of elongated member is more likely to form.In other embodiments, the distal flange 157 and institute The antelabium 111 for stating arm 101 is configured such that when the needle guard 100 is in the second axial position on the needle 130, described Antelabium 111 engages to help the distal portions 107 of the arm 101 being fixed to the elongated member 152 with the flange 157 Distally on 156.In the described embodiment, institute's distal flange 157 can be ring-shaped, continuous or segmentation.

Figure 15 is the cross-sectional view strength of another embodiment of elongated member 152, and the elongated member 152 includes having straight The part or the proximal part of frusto-conical portions 160 that diameter reduces, the part 160 are transitioned into part or the set for terminating that diameter reduces At cylinder 161.The elongated member 152 may also include distal flange 157.In one embodiment, the proximal part 161 by with It is attached on the bottom 118 in by the proximal end of the elongated member 152.Described attach can pass through punching press, hot pressing or other machines Tool fastening procedure is completed.For example, the proximal part 161 can be segmented to be formed fixed to hole 119 or other offers in institute State protrusion in the opening in bottom 118 or the like.In other embodiments, the shape of the proximal part 161 and It is fixed that size allows the proximal part 161 to be pressed into the hole 119.It should be noted that emphasis be, it is any other various attached Even the combination of method or method can be used to that the bottom for being attached to the needle guard with expected elongated member 152 will be disclosed On 118.These methods may include using adhesive, soldering, welding, mechanical attachment etc..What following article will be discussed in more detail, In some embodiments, the elongated member 152 is integrally once-forming with the first part 110 of the needle guard 100.

There is provided the advantages of reducing region/part of diameter along the length of the elongated member 152 is：These region/parts Help to safeguard the elongated member being coaxially arranged on the needle 130, when the elongated member 152 is along the shank During 131 movement, these described regions reduce frictional force or in other forms existing resistance.These region/parts also help The elongated member 152 of coaxial relation is in the shank 131 in promotion or maintenance.

Figure 16 is the isometric side view of an embodiment of elongated member 152, and the elongated member 152 is increased with diameter The proximal part 163 of distal portions 164 and minor diameter.Figure 17 is the cross section according to one embodiment of the elongated member of Figure 16 View, the elongated member includes being maintained at the increase inner ring of intracavitary of part 164 of diameter or bushing 165, described interior Circle or bushing 165, which are arranged to, to be coaxially located at the needle 130 in the elongated member 152, and as the needle is worn It crosses the elongated member 152 to slide or axially move, the inner ring or bushing 165 are wiped from the outer surface of the needle 130 Blood or body fluid.One advantage of the increased distal portions 164 of diameter is：The distal portions 164 provide one Liquid storage device, the liquid storage device for collect wiped from the outer surface of the needle and/or blood derived from the inner cavity of the needle or Body fluid.In one embodiment, the liquid storage device includes the coating or material for absorbing blood or body fluid.In one embodiment In, absorbent material occupy the liquid storage device it is all partially or mostly, and the liquid storage device is deformable or can Pierce so as to provide space to be inserted into the distal portions to the liquid storage device region of the elongated member of the needle.In embodiment In, wherein sealing is configured between the distal end of the elongated member and the Distal arm portion 107, one or more openings It can be configured on the wall of institute's liquid storage device to inhibit the formation of hydraulic locking.In one embodiment, in the wall of the liquid storage device On one or more openings it is enough it is small with prevent or inhibit blood or body fluid from the opening across.

In some embodiments, internal or external seal member is configured at the proximal end 154 of the elongated member Or close at the position of the proximal end 154 of the elongated member.

In other embodiments, the elongated member 152 include it is one or more enclose internal annular rings, floor or Segment, annular ring, floor or segment can go forward and then in the profile with the needle guard 100 in the needle 130 It deforms or shrinks on 132 at variation.In some embodiments, the elongated member 152 is included along all of the elongated member Part or the part of the elongated enclosed inside of part extension.In the described embodiment, the enclosed structure can utilize pressure Casting process shapes.The enclosed component may include chemical substance, as one or more of enclosed components are described Expand on 132 at profile variations so that interact and solidify between the chemical substance with by the near of the elongated member 152 154 lock of end 132 at the profile variations of the needle 130 on.

As described above, when the needle guard 100 is in the second axial position, the distal portion in the arm 101 it is expected The place of joining of the distal end 156 of 107 and the elongated member 152 is divided to form part or complete sealing.According to some embodiments, The inner surface coating of the distal portions 107 is laminated with a kind of material, compound or reagent, when the distal portions 107 with The material, compound or reagent advantageously form close to the distal end 156 of the elongated member 152 when the distal end 156 contacts Envelope.On the contrary, or coated or be laminated with the inner surface in Distal arm portion 107 and be combined, the elongated member 152 Distal end 156 can also coat or be laminated the material for advantageously forming sealing, compound or reagent.For example, in some embodiments In, the distal portions 107 and/or the distal end 156 include being used to implement complete or partial close between the component The formable material of envelope, such as elastomer.Other examples are including coating, lamination or by sticky matter or glue in other ways Mixture handles a contact surface or two contact surfaces of the distal portions 107 and the distal end 156.Others are shown Example may include being fixed on resilient, elastomeric on the distal end 156 of the elongated member 152 so that at least part of the O-ring On the end 156 so that remote O-ring can be fitted close with the contact surface of the Distal arm portion 107. It is also possible to consider other encapsulating methods.

Figure 18 and Figure 19 shows needle guard 200 according to another embodiment.In addition to arm 102 terminated at part 114 and Except being attached on the outer surface of elongated member 152 at the part 114, the needle guard 200 and above-described needle guard 100 It is similar.In one embodiment, the part 114 is curved to generate the curvature phase with the outer surface of the elongated member 152 Same or approximate attachment surface.In substantially all of other aspects, the first part 110 of the needle guard 200 and second part 150 Embodiment by with it is described above it is identical in a manner of realize the covering of the distal end to the needle 130.It is important to note that The arm 102 can be fixed at closer proximity on the outer surface of the elongated member 152.For example, the arm 102 can wrap The shorter end section of the length of the arm 102 is included, the end section is attached to along the length of the elongated member 152 Any position.In other embodiments, the arm 102 and the distal end 154 of elongated member 152 being secured on bottom 118 It is integrally removed together.

According to other embodiments, the first part 110 of the needle guard 100 and elongated member 152 are integrally formed ground structure It makes.In one embodiment, the monolithic molding is described to be formed by the progress deep-draw processing of bottom 118 to the needle guard Elongated member 152 is realized.In this way, prolong in the hole 119 that the elongated member 152 can be described as in bottom 118 It stretches.According to one embodiment, monolithic molding construction process starts from being formed the metal strip 50 with region 52 as shown in Figure 6 C, The region 52 is designated as being used to form the bottom 118 of needle guard 100.In some embodiments, the metal strip 50 has equal Even thickness, however in other embodiments, the item 50 is configured as having increased thickness gauge at least at region 54 Very little, deep-draw processing will be used at the region 54 to form the elongated member 152.In some embodiments, such as such as Shown in Fig. 6 A, the arm section 101 and/or 102 is shaped before elongated member described in deep-draw 152, however in others In embodiment, the part 101 and/or 102 is shaped after the elongated member 152 forming.In some embodiments, it makes Process is made since with the uniform and increased metallic plate of thickness, followed by metal described in flattening area 56 and 58 The processing of plate, the arm section 101 and/or 102 are designated as being located at the region 56 and 58.Described flatten is processed and can used Deep-draw is processed to form the elongated member 152 before or after occur.Carry out flatten processing with generate thickness reduction one or While multiple regions or after this, at least part in the region of the thickness reduction is cut off to generate the arm section 101 and/or 102 at least part.

Referring to figs. 13 through Figure 17, by using being sized and shaped to be formed one or more of one or more features portion A mold, one or more features 155,159,160,161,163 can be shaped into described elongated during deep-draw is processed In component 152.For example, in one embodiment, the frusto-conical portions 160 and diameter of the elongated member 152 reduce end part 161 are shaped during the stretch process.The features 160 and/or 161 are merged into the elongated member 152 Advantage is：The features 160 and 161 lead to the proximal part of the elongated member 152 during assembling process with automatically fixed The method of the heart is assembled on the needle 130.

According to another manufacturing process, the metallic plate is divided it in order to form the first part 110 of the needle guard 100 Before, multiple elongated members 152 are deep-drawn from metallic plate described in monolithic or are deep-drawn at least partly first.

Figure 20 to Figure 23 shows Needle hub assembly 300 according to another embodiment.In addition to arm section 113 and 114 has been changed The needle guard 300 is similar with above-described needle guard 100 except, and the arm section 113 and 114 is modified to include being configured For arc-shaped recess 313 and 314 consistent with the curvature of the outer surface of the elongated member 152 at least partly.In a reality It applies in example, the arc-shaped recess 313 and/or 314 is configured as semicircle, when the needle guard 300 is in the second axial position During protecting the distal end of the needle 130, the shape of the semicircle is consistent with the outer profile of the elongated member 152.In discomfort When power be applied to two arms or on one of them in the case of, when the needle guard 300, to be in described second axial The circumferential edges of the arc-shaped recess 313 and 314 are resisted against on the outer surface of the elongated member 152 to press down during position (Figure 23) Make the distal portions 107 and 108 of the arm 101 and 102 from the position for the distal end for covering the needle 130 be pushed outwards from.

As shown in figure 21, it is according to the method for embodiment manufacture needle guard for being disclosed and considering：First punching press, cutting or The first part 310 of the needle guard is shaped from one block of flat flexible material of example as shown in figure 20 in other ways.Institute State after first part 310 shaped, the elongated member 152 can be placed so that the channel 153 of perforation in bottom 118 Hole 119 axially aligns.The fixed of at least part extension of channel 153 across the hole 119 and across the perforation fills Putting can be used to support the elongated member 152.According to other methods, as shown in figure 21, the elongated member 152 it is near The parts 169 that end 154 is configured with reduced diameter, the part 169 extend through the hole 119 or in other ways by It is installed on the hole 119, completely or partially to support the elongated member that vertical relation is in the first part 310 152.In one embodiment, the annular ring reduced positioned at the diameter close to the proximal end 154 of the elongated member 152 provides one The elongated member 152 is fixed to the method on the bottom 118 by kind：The proximal end of the elongated member is slided into described It is fixed so as to which the elongated member 152 is fixed on the bottom 118 in base apertures 119.In other embodiments, from institute The side for stating bottom extends to the seam in the hole 119 or slot is configured in the bottom 118.In this way, it is described elongated Component 152 can be configured with the annular ring that the diameter close to the proximal end 154 of the elongated member 152 reduces, the annular Circle allows the elongated member to be laterally packed into and is fixed in the hole 119 to be attached to the elongated member 152 to realize The bottom 118.Described is properly supported in the first part 310 or is attached in the elongated member 152 On the basis of in a part 310, the first part can be bent or part is bent to generate or partly generate required arm Part and articulated section.In this stage, the first part 310 and the elongated member 152 can be loaded onto on the needle 130, The first part 310 is further bent (if necessary) and the needle is disposed in a manner that Figure 22 is discribed On 130.

According to some embodiments, the first part 310 of the needle guard 300 and the elongated member 152 by integral into Construct to shape.

Figure 24 shows needle guard 350 according to another embodiment.In addition to arm 102 along dotted line 320 just terminates at recess portion 314 Distal end, the needle guard 350 is similar with needle guard 300 described above.In the described embodiment, when the needle guard 350 is located at institute When stating the second axial position on needle 130, the recess portions 314 are constantly pushed into outer with the elongated member 152 Surface contacts, and the distal end 156 of the elongated member is individually covering positioned at the distal portions 107 of the arm 101.Be disclosed and The arm 101 and 102 of the needle guard of consideration may include the different types of feature of example as shown in figure 24, and wherein arm 102 is included for neighbour It connects the recess portion 314 of the outer surface of the elongated member 152 and wherein arm 101 includes abutting the elongated member 152 The elongate surface 113 of outer surface.

According to some embodiments, the first part of the needle guard of Figure 24 and elongated member construct with being integrally formed.

According to some embodiments, as shown in fig. 25 a, the elongated member 152 includes elastic construction 170, the elasticity knot Structure 170 has a longitudinal component 171 and 172 of overlapping, and the longitudinal component 171 and 172 of the overlapping is separable with along described The length of elongated member forms the seam or slot of temporary longitudinal direction, the elastic construction 170 to be allowed laterally to be loaded into the needle 130 On.Figure 25 A depict the vertical view of the elongated member 152.The elongated member 152 is laterally loaded on the shank it Afterwards, the elastic construction 170 restores or generally restores its initial structure with the circumference completely about the shank 131. In one embodiment, the elastic construction 170 includes a kind of elastic material, when the longitudinal component 171 and 172 of the overlapping The surface characteristic of the elastic material is conducive to 171 and 172 shape of longitudinal component along the overlapping when contact surface contacts with each other Into sealing.In other embodiments, institute's elastic construction 170 includes a kind of metal.In some embodiments, the part 171 And/or the contact surface of 172 overlapping passes through processing or in other ways coating substance, so that along the elongated member 152 Length formed sealing.In other embodiments, using ultrasonic welding process or similar technique come in the overlapping Sealing is formed between part 171 and 172.

In other embodiments, as shown in Figure 25 B-D, the elongated member 152 includes one or more seam 175a, 175b, the seam 175a, 175b are separable in favor of the elongated member is laterally loaded on the shank.Such as figure Some embodiments in 25A, the elongated member 152 may include a kind of elastic material, when the mating surface of the seam contacts with each other The characteristic of Shi Suoshu elastic materials is conducive to form sealing between the mating surface of the seam.In other embodiments, it is described One contact surface of seam or two contact surfaces pass through processing or in other ways coating substance, so that along the elongate portion The length of part 152 forms sealing.In other embodiments, using ultrasonic welding process or similar technique come in the seam Mating surface between formed sealing.

Figure 26 to Figure 31 shows Needle hub assembly 400 according to another embodiment.In addition to arm section 113 and 114 has been changed The needle guard 400 is similar with needle guard 100 described above except, arm section 113 and 114 be modified to include to be configured as to The partially part 413 and 414 of the forming consistent with the curvature of the outer surface of the elongated member 152.The elongate portion The proximal part of part 152 further includes the part 161 that the frusto-conical portions 160 similar in Figure 15 and diameter reduce.At one In embodiment, when the needle guard 400 is in the second axial position to protect the distal end of the needle 130, the forming The shape of one and the outer profile phase of the elongated member 152 in proximal edge 415 and 416 of part 413,414 or both Unanimously.As shown in figure 29, in fact, in the case where unsuitable power is applied on the arm 101 and/or 102, when described The inner surface of the part 413 and 414 of forming when needle guard 400 is in the second axial position leans against the elongated member On 152 outer surface, to inhibit the distal portions 107 and 108 of the arm 101 and 102 from the distal end of the needle 130 of covering Position is pushed outwards dynamic.Figure 30 is the isometric side view of the Needle hub assembly 400 in the first axial position on the needle 130 Figure.Figure 31 is the isometric side view of the Needle hub assembly 400 in the second axial position on the needle 130.

According to some embodiments, the first part 410 of the needle guard 400 and the elongated member 152 by integral into Construct to shape.

As explained above with Figure 24 the embodiment described, it will be appreciated that, the needle guard 400 can be modified to so that arm 102 remote location in the part of forming 414 terminates.In the described embodiment, when the needle guard is located on the needle 130 During the second axial position, the part 414 of the forming is constantly pushed to be contacted with the outer surface of the elongated member 152, The distal end 156 of the elongated member is individually covering positioned at the distal portions 107 of the arm 101.

Figure 61 shows the Needle hub assembly similar with Figure 30, but there are multiple distinguishing characteristics.First distinguishing characteristics It is the construction of needle.In the component of Figure 30,132 are configured at discrete profile variations：Needle is located near distal needle Distal portion office limiting device；And in the component of Figure 61, limiting device includes the diameter increase of the far-end positioned at needle Elongated portion 401 proximal shoulder 402.Another distinguishing characteristics is the construction of elongated member.In the embodiment of Figure 30, The proximal part of elongated member 152 includes the part 161 that diameter reduces, and the part 161 that the diameter reduces is configured to：In needle Set be enabled as covering needle distal needle 134 when acted on at the profile variations on needle 132, with to the needle guard on needle into Whereabouts are kept off.In the embodiment of Figure 61, elongated member 408 is constructed including uniform diameter, and tongue piece 409 is cut into the near of elongated member It holds in part.Once being formed, tongue piece 409 is by inside bending or bending, so that at least part of tongue piece is located at elongate portion The inside of part 408.The part being located inside elongated member of tongue piece 409 is configured to engage with the shoulder of needle 402, so as in needle Backstop is carried out to the needle guard on needle when set is enabled as the distal needle 403 of covering needle.In some embodiments, there are two settings Or more tongue piece.

It is important to note that herein (above and below) disclosed in a large amount of needle guard feature, can be public in the text It opens and is exchanged between a large amount of embodiment that considers.For example, although some embodiments disclose features 113,114 and other spies Sign portion 313,314 and the use in other feature portion 413,414, it will be appreciated that, the combination of these features can be formed According to a part for the needle guard of the present invention disclosed herein.In addition, as an example, elongated member disclosed herein 152 and elongated The type of features can disclose in the text exchanges between a large amount of embodiment that considers.

Figure 32 to Figure 34 shows Needle hub assembly 500, the Needle hub assembly 500 and 300 class of Needle hub assembly described above Seemingly, the Needle hub assembly 500 and the Needle hub assembly 300 the difference lies in：It wraps the distal end 502 of the elongated member 152 The inclined-plane of the inclined orientation of the longitudinal axis relative to the elongated member is included, and when the Needle hub assembly 500 is in as schemed The distal portions 107 of the arm 101 are angularly directed to adapt to the elongate portion during the second axial position shown in 34 The distal end 502 of the inclined orientation of part.The proximal part of the elongated member 152 further includes the frusto-conical shape similar in Figure 15 Divide the part 161 of 160 and diameter diminution.Preferably, distal portions 107 are configured as the needle guard and are in described second axially During position on the distal end 502 of the elongated member 152 applied force.Antelabium 504 positioned at the far-end of the part 107 goes back quilt Being orientated makes the opening of its distal end across the elongated member 152 in face of the position of downward position and the antelabium 504 Inclined-plane is to provide mechanical position limitation, and when pressure or " extruding " are applied on arm 101 and/or 102, the mechanical position limitation inhibits institute State Distal arm portion 107 and the separation of the distal end 502 of the elongated member.

According to some embodiments, the first part of the needle guard 500 and elongated member 152 construct with being integrally formed.

In various embodiments disclosed in the text, when pressure or " extruding " are applied on arm 101 and/or 102, downwards The antelabium faced can be configured in the far-end of the distal portions 107 with inhibit the Distal arm portion 107 with it is described elongated The separation of the distal end of component 152.In some embodiments, the distal end of the elongated member 152 is configured with recess or cuts Mouth is with being configured the antelabium interlocking in the far-end of the part 107.

Figure 35 to Figure 37 shows needle guard 600 according to another embodiment.The needle guard include first part 610, first Part 610 has the elongated member 652 being integrated in.In one embodiment, the first part 610 is included respectively the bottom of from The first arm 601 and the second arm 602 of the offside extension in portion 618.Preferably, the first part is made of piece of elastic material, The piece of elastic material is bent to form the bottom 618, arm 601,602 and Distal arm portion 607,608.The bottom Hole (not shown) in 618 into certain size to accommodate the proximal part 136 of the needle 130, and as the needle guard is from One axial position is transitioned into the second axial position to accommodate the distal end 134 of the needle (such as Figure 37 institutes (as shown in Figure 35 and Figure 36) Show), the hole is oriented to the needle guard along shank.The arm 601,602 is hinged at the bottom 618, and by It is configured to outer with the needle 130 when the needle guard 600 is in the not protected the first axial position in distal end 134 of the needle Syntople is presented in surface.The elongated member 652 for being respectively provided with proximal end 654 and distal end 656 is configured at the both ends Between the inner passage 653 of perforation that extends.The needle 130 includes gradually increased outside with proximal stem portion 136 and diameter Gradually thicker distal end bar portion 138.In use, the elongated member 652 is positioned as being located in first part 610, The first part 610 is between the bottom 618 and the Distal arm portion 608.In one embodiment, in bottom 618 Pore size it is engaged with gradually thicker distal end bar portion 118 with by needle guard 600 in discribed second axis of such as Figure 37 To at position, wherein, diameter possessed by the entire inner passage 653 of elongated member 652 is sufficient to make the distal end of elongated member 656 extend to the needle point of the distal end of the needle or cross the needle point of the distal end of the needle.In other embodiments, the elongate portion The proximal end of part 652 is configured with the part of internal diameter diminution, and the part that the internal diameter reduces is risen the needle guard backstop in institute State the effect of the second axial position.In another embodiment, sleeve or bushing are located at the proximal end 654 of the elongated member 652 And including endoporus, the endoporus has the diameter for being enough the limiter for taking on the second axial position.

As shown in figure 37, generally it is positioned as covering the needle 130 in the distal end 656 with the elongated member 652 Distally 134 while, energy that the arm 601 and 602 is detached from and is stored from the shank inwardly pushes described to cover The distal end of elongated member.According to one embodiment, the Distal arm portion 608 is hinged at position 620 with described elongated Downward/lower reaction power is provided on the distal end 656 of component 652.In one embodiment, the arm 601 and 602 is configured as With protruding portion 619 and 620, the function of the protruding portion 619 and 620 is：With one or more internal features of conduit bushing Portion's interaction by the needle guard 600 by with being releasably fixed at the conduit bushing in a manner of with similar described in Figure 38 It is interior.

According to some embodiments, the first part of the needle guard 600 and elongated member 652 construct with being integrally formed.

As described above, Figure 38 is to be injected according to the safe vein in the position for being ready for operation of one embodiment The side view of conduit tube component 700.The component 700 includes having needle 130, and the needle 130 has the needle point 134 of sharp distal end Proximally 140 inner cavity for extending to the needle point 134.As previously mentioned, it 132 is risen at profile variations on shank by the needle guard 100 backstops are in the effect of the second axial position.The proximal part of the needle 130 is attached to near projections 706 Needle sleeve 704 on, with attach convex female Luer (luer fitting).The proximal part 140 of the needle 130 is located at the needle In the flash back chamber 708 of bushing 704.As discussed earlier, by protruding portion 117 and 116 with being located in the conduit bushing The engagement in the one or more features portion 703 on wall, the needle guard 100 are releasably secured in the conduit bushing 702. The proximal end of the conduit bushing 702 is effectively engaged with the distal end of the Needle sleeve 704.The conduit 710 of tubulose from the needle 130 for coaxial relation conduit bushing 702 distal end towards the proximal end for distally extending and terminating at the needle point 134, this causes The needle point is exposed to pierce through blood vessel and the conduit 710 is made to enter the blood vessel.In use, it is suitable in the conduit 710 On the basis of locality is entered in the blood vessel of patient, the Needle sleeve 704 is by towards proximal end pull, so that the needle point 134 is from trouble It recalls and enters in the needle point sleeve 100 in person's body.As needle is removed, by from the protruding portion 117 and 116 apply to Outer power, the needle guard 100 are fixed in the Needle sleeve 702.Generally at the profile variations 132 by backstop in institute While stating on needle guard, 132 position is combined with the size characteristic of the needle guard 100 at the profile variations on the needle 130 So that the needle point 134 of the distal end is completely enclosed in the elongated member 152.Needle point 134 in the distal end enters On the basis of the distal end of the elongated member 152, the Distal arm portion 107 and 108 in the arm 101 and 102 by storing Energy be detached from the shank and be pushed inwardly distal end 156 to cover the elongated member.Meanwhile the protruding portion 116 and 117 are detached to allow the needle guard 100 and the needle 130 by fully from the conduit bushing with the conduit bushing 702 remove.

Figure 39 and Figure 40 shows intravenous injection catheter component 800 according to another embodiment.The component 800 with it is above-mentioned Component 700 it is similar.Difference is that the needle guard 100 is releasably secured the mode in conduit bushing 802.At described group In part 800, the elastic protrusion portion 810 and 811 of bottom of the needle guard 100 is located on or near instead of to forming in the arm The use of protruding portion 117,118 on 101,102, the elastic protrusion part 810 and 811 is protruding to be served as a contrast with engaging the conduit The one or more features portion 803 of the inner wall of set 802.Preferably, the outer engagement surfaces of the protrusion 810 and 811 are bows The curvature with the inner wall with the conduit bushing 802 of shape is consistent.One or more of features 803 may include recess portion, Notch, hole, slot, prominent features portion etc., these described features are configured as around inner wall circlewise or for segmentation.When described group When part 800 is in ready position or during the needle 130 is retracted into the needle guard 130,810 He of elastic protrusion portion 811 are configured as applying outside power so that the engagement surface is engaged with one or more of features 803.When inside 132 when being applied to needle guard at the profile variations engaged with needle guard stopper section that the power of side passes through needle, and protrusion 810 and 811 connects Resultant force is as low as enough protrusion is allowed to be detached from (see Figure 40) from one or more features portion 803.

Figure 41 shows the Needle hub assembly 900 for being located at protective position on Huber needles (Huber needle), described Huber needles are characterized by the axis changed or close to the bending section of the distal end of needle 190.The Needle hub assembly 900 is in many aspects It is similar with the Needle hub assembly in disclosed above and description embodiment, but the difference lies in：With the needle 190 be reduced to it is described Protective position in elongated member 952 is configured as allowing the elongated member through the inner passage that elongated member 952 extends Distal portions 958 arrange and tilt around the variation of axis.In one embodiment, the close end of the elongated member 952 960 are divided to be configured with the part that the appropriate internal diameter of length reduces, the injection is covered backstop by the part that the internal diameter reduces At axis variation.In other embodiments, the sleeve that the internal diameter with sufficient length reduces is attached to or with other sides Formula is connected on the proximal end of the elongated member 952.In other embodiments, at the profile variations or amplification unit in Axis variation, which is sentenced, plays limiter.

Figure 42 A and Figure 42 D show intravenous injection catheter component 210 according to another embodiment.Intravenous injection catheter group The intravenous injection catheter component 700 of part 210 and Figure 38 the difference lies in, when needle guard 100 is in ready position, elastic arm 101,102 distal portions 107,108 not against shank 131 but as shown in Figure 42 as against elongate portion Part 212.As shown in Figure 42 D, in one embodiment, elongated member 212 includes the close end that distal portions 214 and diameter reduce Divide 216.The outer diameter of proximal part 216 is as low as enough in the hole being located in bottom 118 119, and distal portions 214 are most At least part of outer diameter close to proximal part 216 is more than the diameter in hole 119.As it will be explained in more detail hereinafter, proximal part 216 at least part of outer diameter is enough to allow the bottom 118 of spring clip 220 axially to be slided along the length of proximal part 216.

As shown in Figure 42 A and 42B, in ready position, the bottom 118 of spring clip 220 is close to the position of distal portions 214 Place is provided with distance D1 so that bottom 118 to be allowed diametrically to contract on the proximal part 216 that the diameter of elongated member 212 reduces Small proximal part 216 is axially advanced.In some embodiments, when in ready position, by lip portion 111,112 with One or more is located at the engagement of the recess portion 217,218 of the proximate distal ends of elongated member 212, and spring clip 220 is in elongated member 212 On axial position be releasably secured.In other embodiments, other mating features are arranged on elongated member 212 Distal end for being engaged with lip portion 111 and 112, so as in ready position help limit spring clip 220 in elongate portion Axial position and angle position on part 212.In some embodiments, recess portion 217,218 obstructions or limited spring are clipped in elongated The ability rotated on component 212, to maintain being properly oriented within for elastic arm 101,102 and the distal end of elongated member.In some realities It applies in example, is only provided with single recess portion (or single other limited features portions) in the proximate distal ends of elongated member 212 to limit Position of the spring clip on elongated member.

In some embodiments, as shown in Figure 52, the mating features on elongated member includes having proximal shoulder 222 Annular ring 213, the top of lip portion 111,112 is rested on the proximal shoulder 222.In one embodiment, as schemed Shown in 52, the longitudinal axis of elongated member is favoured by 213 perforative plane of endless loop.In further embodiments, elongate portion Part includes the distal end 223 being substantially orthogonal with the longitudinal axis of elongated member.In this embodiment, as shown in figure 53, it is cyclic annular The longitudinal axis for favouring elongated member can be also arranged to by enclosing 224 perforative planes.In the embodiment of Figure 52 and Figure 53, ring Shape circle can be replaced by independent the first projection portion and the second projection portion, first projection portion and the second projection portion It angularly and is longitudinally oriented on the surface of elongated member to corresponding engagement lips 111 and 112.Do not show in the accompanying drawings In the other embodiments gone out, the protruding features portion on the surface of elongated member forms the bag for accommodating lip portion 111,112 Shape portion, to hinder axial movement and rotary motion of the spring clip 220 on elongated member when spring clip is in ready position.

As discussed earlier, pass through protruding portion 116 and 117 and one on the inner wall of the conduit bushing 702 Or the engagement of multiple features 703, the spring clip 220 are releasably secured in the conduit bushing 702.The conduit The proximal end of bushing 702 is effectively engaged with the distal end of the Needle sleeve 704.The conduit 710 of tubulose is from being coaxial with the needle 130 Towards the proximal end for distally extending and terminating at the needle point 134, this causes the needle point quilt for the distal end of the conduit bushing 702 of relationship It exposes to pierce through blood vessel and the conduit 710 is made to enter blood vessel.In use, patient is properly entered in the conduit 710 Blood vessel on the basis of, the Needle sleeve 704 is by towards proximal end pull, so that the needle point 134 is recalled from patient's body and gone forward side by side Enter in the needle guard.As needle is retracted, needle guard is fixed on conduit lining by the outside power that protruding portion 116,117 applies The inside of set 702, simultaneously, spring clip 220 are applied by the corresponding antelabium 111 and 112 being located in recess portion 217 and 218 Inward force and be axially retained on elongated member 212.At the profile variations of needle 130 132 by backstop in elongate portion During the inside of part 212, lasting on Needle sleeve 704 causes the bottom 118 of spring clip 220 in elongated member to the pull of nearside It is distally moved on the part that 212 diameter reduces, until bottom 118 is against shoulder/protrusion 219 or positioned at elongated member The proximal end similar portions of 212 distal portions 214.(in further embodiments, as shown in figure 54, annular ring form only Stopper 219a extends from the outer surface radial direction degree of the distal portions 21 of elongated member 212, so that limited spring folder 220 is elongated Axial advancement on component 212.) at the same time, the power M applied to the pull of nearside is enough lip portion 111 and 112 is caused to be slided Go out their own recess portion 217 and 218 and be distally advanced so that the Distal arm portion 107 and 108 of spring clip 101 and 102 Advance and be more than the distal end 221 of elongated member 212.In one embodiment, bottom 118 is in the proximal part of elongated member 212 Entire be distally advanced on 216 substantially occurs simultaneously with the distal end 221 of needle 130 into elongated member 212.Meanwhile the protrusion Portion 116 and 117 is detached from that the needle guard is allowed fully to be removed from the conduit bushing 702 with the conduit bushing.Figure 42 C In the component shown, the distal needle 134 of needle 130 is securely affixed inside the elongated member 212 of needle guard.

In one embodiment, as shown in Figure 43 A to 43D, at the profile variations of needle 130 132 by backstop in elongate portion During the inside of part 212, spring clip 220 is suitable for being elongated by being applied to the power to nearside of Needle sleeve 704.The elongation When at the time of initially betiding shoulder/protrusion 219 of the engagement of bottom 118 elongated member 212 of spring clip 220 or being happened at this Before quarter.As shown in Figure 43 B, the resistance between features 703 due to spring clip 220 and on conduit bushing 702 and cause Make the generation of elongation.Initial elongation is indicated in Figure 43 B by explaining L1.In the embodiment of Figure 43, when spring clip 220 Bottom 118 when engaging shoulder/protrusion 219, axial advancement of the spring clip on the diameter diminution part point of elongated member 212 is led to Cross its own distal end 221 that covering elongated member is advanced to insufficient for lip portion 111 and 112.This is instead of bottom 118 The group of the elongation (being indicated by the note L2 in Figure 43 C) of axial advancement and spring clip 220 on the proximal end of elongated member 212 It closes, the combination causes lip portion 111,112 to advance and more than the distal end 221 of elongated member.Spring clip 220 is actuated to cover The distal end 221 of lid elongated member 212, by the elongation of the spring clip during startup, the distal portions 117 of elastic arm 101 will Apply additionally downward power on the distal end of elongated member 221, because elastic arm flexibly attempts the length shorter than L2 is presented. This closing realizes the accommodating of reinforcement of the distal end 134 of needle 130 in elongated member 212.

In another embodiment, as shown in Figure 44 A to 44D, elongated member 230 is not configured with the part 216 of diameter diminution. Alternatively, in ready position, the bottom 118 of spring clip 220 is against the bottom 118 of 118 inner surface of bottom or spring clip 220 It is fixed in the proximal end of elongated member 230 or near proximal ends.According to this embodiment, the size and material of spring clip 220 are special The power between protruding portion 116 and 117 and the wall features 703 of conduit bushing 702 is levied and is applied to be selected to：Cause spring 220 elongations of itself of folder cause lip portion 111,112 to be advanced and cover the distal end of elongated member 230, so that needle point 134 is pacified It is contained in the inside of elongated member entirely.Figure 44 A to Figure 44 D show the bottom for the needle folder 220 for being attached to elongated member 230 118, wherein, the proximal part 232 of elongated member 232 extends through the hole 119 of bottom.Figure 45 A to Figure 45 D show a replacement Property embodiment, wherein, elongated member 230 (have shorter length) is integrally disposed on the distal side of bottom 118.In the implementation In example, the end 236 of elongated member 230 can be attached to bottom 118 or can be only only against bottom 118.

In some embodiments, the proximal part of bottom 118 along the elongated member of spring clip 220 moves to lead to needle guard group The enabling of part, content as escribed above simultaneously combine Figure 42 and Figure 43, and alternative elongated member construction is considered.For example, scheming In 42 embodiment, lip portion 111,112 and the recess portion 217,218 of the proximate distal ends positioned at elongated member by spring clip Between interaction, axial position of the spring clip 220 on elongated member 212 be maintained at ready position.In other implementations In example, by the interaction of the proximal part of the bottom 118 and elongated member 212 of spring clip, spring clip is by fully or extremely Partially it is maintained at ready position.In some embodiments, pass through the bottom of spring clip 118 and the proximal end of elongated member 212 Partial interaction, spring clip are retained completely in ready position, then the recess portion 217 on the distal portions of elongated member, 218 or other limit features portions are not essential.

In embodiment shown in Figure 46, one or more projection portions 238 reduce near around the diameter of elongated member 212 Hold part 216 circumferentially.The size of one or more projection portions 238 causes in its bottom 118 with spring clip 220 Hole 119 interacts, to hinder axial advancement distad of the bottom 118 on proximal part 216 sufficiently large until applying Power overcome the resistance between the circumferential area in hole 119 and one or more projection portion 238.In some embodiments, bottom The part that the device to hole 119 in portion 118 is defined can be deformed based on the power that one or more projection portions 238 are applied thereto, So that hole 119 is contributed to advance when elongated member is by nearside pull and is more than one or more projection portions 238.At some In embodiment, one or more independent projection portions 238 are substituted by the annular ring of protrusion.

In further embodiments, by using the annular recess 254 on the proximal part of elongated member, spring clip 220 are, at least partly, kept in ready position on elongated member.Figure 47 is shown with distal portions 251 and diameter diminution Proximal part 252 elongated member 250.The diameter for the proximal part 252 that diameter reduces is typically larger than the bottom of spring clip 220 The diameter in the hole 119 in 118.Within the proximal part 252 reduced positioned at diameter is annular recess 254, and the annular is recessed Portion 254 is dimensioned to accommodate the part that the device to hole 119 of the bottom 118 of spring clip 220 is defined.Bottom 118 it is complete The part that device to hole 119 is defined entirely or partly has enough elasticity, elongated to be initially loaded into spring clip 220 Allow the enlarged-diameter in hole 119 during the proximal part 252 of component 250.The part that the device to hole 119 of bottom 118 is defined also has There is enough elasticity, to allow the enlarged-diameter in hole 119 when sufficiently large power is applied on bottom 118 and move out annular Recess portion 254 and along elongated member 250 diameter reduce proximal part 252 be distally advanced.The advantages of this construction, exists In：When spring clip 220 is activated the distal end 225 to cover elongated member 250, the bottom 118 of spring clip 220 and proximal part Extrusion fit between 252 axial movement of the spring clip 220 on elongated member 250 and moves radially to be obstructed or by most Smallization.

Figure 48 shows the elongated member 260 similar to the elongated member of Figure 47 250, wherein, elongated member 260 possesses ring Shape recess portion 264, the annular recess 264 are used to accommodate the part that the device to hole 119 of bottom 118 is defined.260 He of elongated member It is between elongated member 250 the difference is that, elongated member 260 along its length have substantially uniform section.

Figure 49 A show the elongated member 270 according to another embodiment.Elongated member 270 has 271 He of distal portions Proximal part 272.Proximal part 272 includes proximal part 273 and the frusto-conical portions 274 that diameter reduces, the frusto-conical shape The diameter dimension of points 274 diameter from the diminution at its proximal end 275 transits to the larger diameter at its distal end 276.At one In embodiment, diameter at the distal end 276 is at least equal to the diameter of the distal portions 271 of elongated member 270.In Figure 49 B Shown, in one embodiment, spring clip 220 is assembled on elongated member 270 so that the proximal part 273 that diameter reduces Extend through the hole 119 in bottom 118.In some embodiments, the diameter in hole 119 is only slightly larger than the outer of proximal part 273 Diameter.In further embodiments, the outer diameter of the diameter in hole 119 and proximal part 273 is selected such that at the edge in hole 119 Frictional fit is generated between the outer surface of proximal part 273, the edge and proximal part in hole 119 are allowed by frictional fit Sliding relation between 273 outer surface.In further embodiments, spring clip 220 and elongated member 270 are being assembled into one Before rising, the diameter in hole 119 is less than the outer diameter of proximal part 273.By to it is aforementioned it is similar in a manner of, in this embodiment, bottom 118 part that at least completely or partially device to hole 119 is defined is deformable (plasticity and/or elastic), so as to The diameter in hole 119 is allowed to match with the outer diameter of proximal part 273.Bottom 118 and the material and size characteristic of proximal part 273 Allow to realize the sliding relation between bottom 118 and proximal part 273 by applying minimum axial force.

In one embodiment, in ready position, the bottom 118 of spring clip 220 is located at the proximal end of frusto-conical portions 274 At 275, and in further embodiments, bottom 118 is located on proximal part 273 (as shown in Figure 49 C).In use, in institute It states on the basis of conduit 710 properly entered in the blood vessel of patient, the Needle sleeve 704 is by towards proximal end pull, so that described Needle point 134 is recalled from patient's body and is entered in the needle guard.As needle is retracted, needle guard is applied by protruding portion 116,117 Outside power and be fixed on the inside of conduit bushing 702, simultaneously, spring clip 220 passes through bottom 118 and elongated member The interaction of 270 proximal part 272 and be axially retained on elongated member 270.At the profile variations of needle 130 132 by backstop at the inside of elongated member 270, by the deformability characteristics as described above of bottom 118, be applied to needle lining The lasting of set 704 causes the bottom 118 of spring clip 220 to be distally advanced on frusto-conical portions 274 to the power M of nearside. In one embodiment, bottom 118 distad constantly advances up to the distal end 276 for reaching frusto-conical portions 274 or distal portion Divide 271 proximal end.Just it is before the position of the farthest side of its proximal part 272 in elongated member 270 is reached in bottom or same When, the distal needle of needle 130 is advanced and is surpassed completely into the lip portion 111 and 112 of elongated member 270 and spring clip 220 The distal end 278 (as shown in Figure 49 D) of elongated member is crossed, so that part needle point 134 is securely fastened within elongated member.This structure The advantages of making is：When spring clip 220 is activated the distal end 278 to cover elongated member 270, the bottom 118 of spring clip 220 Extrusion fit between the distal end 276 of frusto-conical portions 274 causes axial movement of the spring clip 220 on elongated member 270 It is obstructed or is minimized with moving radially.

Elongated member 280 shown in Figure 50 has the construction similar to elongated member 270.The difference lies in include position Stopper section 284 at distal portions 274 or near distal portions 274.Stopper section 284 can be annular as shown in Figure 50 The form of circle or the projection portion that one or more peripheral distributions around elongated member 280 can be included.Stopper section 284 Diameter is large enough to that spring clip bottom 118 is utterly prevented to advance beyond the stopper section.

Elongated member 290 shown in Figure 51 is similar to elongated member 270, in addition to entire nearside distal portions 272 are in butt Cone construction.

According to some embodiments, as shown in Figure 55 A, the proximal part of elongated member is equipped with one or more elongated diameters To extension protruding portion 295 (only on the protruding portion shown in Figure 55 A).In this embodiment, as shown in Figure 55 B, spring clip 220 Hole 119 in bottom 118, which has, to be used to accommodate the recess of one or more of radially protruding parts 295 or recess 296 accordingly. A variety of constructions are all possible.The proximal part of elongated member is inserted into 118 mesoporous 119 of bottom of spring clip 220 to be realized Multiple advantages.First, during operation, with spring clip on elongated member before so that hinder spring clip 220 in elongate portion Rotation on part.Secondly, during manufacture/assembling process, it is easy to spring clip being properly oriented on elongated member.Third, It can prevent spring clip and elongated member from undeservedly being matched during assembly.According to one embodiment, one or more of diameters It is selected to the length of protruding portion 295：So that preventing whenever spring clip 200 from rotating on elongated member.That is, When needle guard is in preparation state and enables state.In further embodiments, the length of one or more of radially protruding parts 295 Degree is selected to more shorter so that allows spring clip 220 in the case where needle guard obtains enabling state on elongated member Rotary motion, and when needle guard be in preparation state or from preparation state to enable status transition when hinder the rotary motion.

Figure 56 A and Figure 56 B show another infix form, and Figure 56 A show the elongated member with planar side 296, and And Figure 56 B show the bottom 118 with hole 119 of spring clip 220, the section matching of the hole and elongated member.

As described above, according to some embodiments, when the distal portions by elongated member act on and cause the diameter in hole 119 During expansion, at least part of deformation in bottom 118 of spring clip 220 occurs.In further embodiments, as shown in Figure 57 A, bottom Portion 118 includes multiple deformable protruding portions 298 along the circumference of opening 119.The material and size characteristic of protruding portion 298 are chosen It is selected to：When the selected part of the proximal part of elongated member by proximally pull acts on protruding portion with elongated member When upper so that the bending and/or extruding of the protruding portion generate.For example, in the embodiment of Figure 49, the bottom 118 of Figure 57 A can be used In the similar result of acquisition.Starting point is that the size of protruding portion 298 causes what the circle for connecting the vertex of these protruding portions had Diameter allows bottom 118 to be slided along the proximal part 272 of elongated member 270, until bottom meets with the proximal end of frusto-conical portions 274 275.Preferably, but not necessarily, three or more protruding portions that the circumference around hole 119 is equally spaced are provided with 298, so as to contribute to device assembling and maintain during use between the longitudinal axis of bottom 118 and elongated member 270 Orthogonality relation.In other words, bottom is preferably maintained relative to axially aligning for elongated member.During enabling, it is applied to The power M proximally of Needle sleeve 740 causes the bottom 118 of spring clip 220 in frusto-conical portions 274 to be to be pushed distally.Institute The power of application causes deformable protruding portion 298 to deform (that is, by squeezing and/or being bent), to allow bottom 118 along butt The outer surface of wimble fraction 274 is advanced, until bottom reaches distal end 276, and by backstop at distal end 276.In other aspects, needle group Part is similar in a manner of to above-mentioned and combination Figure 49 A to Figure 49 D.

In further embodiments, as shown in Figure 57 B, pass through the slit being cut into comprising one or more in bottom 118 299 obtain the widened ability in hole 119 (being in some cases the ability of diminution).In addition to being suitable for use in such as Figure 49 A Except into the embodiment of Figure 49 D, 118/ hole 119 of bottom of Figure 57 A and Figure 57 B are constructed in the adaptation diameter change by hole 119 The ability (by expanding or shrinking) of change is particularly useful when being combined and the elongated member shown in Figure 46 to Figure 48.

Figure 58 A to Figure 58 C show the elongated member 301 according to another embodiment.For purposes of clarity, these are attached Figure illustrates only elongated member 301 and spring clip is not shown.Figure 58 A are the isometric view of the individual elongated member 301. Figure 58 B are shown is mounted on the elongated member 301 on shank 131 in ready position.Figure 58 B show, in Needle hub assembly It is activated and the distal needle of needle 130 134 is fully located at after the inside of elongated member 301, the elongated member on shank 131 301.Distinguishing characteristics between elongated member 301 and before those disclosed elongated member is, comprising be arranged in far-end or The seal member 302 of proximate distal ends.After distal needle is fully retracted to elongated member, seal member 302 is remote by needle 130 End needle point 134 is advantageously sealed in the inside of elongated member 301.This to be disposed with conducive to the accommodating of body fluid, the body fluid is at it Being introduced in 301 inside of elongated member can flow later from needle point 134.

Seal member 302 may include any kind of form.In one embodiment, as shown in the figure, seal member 302 wraps Include the elastic insertion section 303 of the inside for the distal end for being arranged in elongated member.In some embodiments, elastic insertion section 303 is outer Diameter is more than the internal diameter of the distal end of elongated member 301.In this embodiment, elastic insertion section 303 is applied by elastic insertion section The inside of elongated member 301 is maintained to the extruding force of the inner wall of elongated member.In further embodiments, using bonding Or bonding is used in combination with to replace above-mentioned attachment method or bond or bond with above-mentioned attachment method.In other realities It applies in example, seal member includes spring caps 305, and as shown in figure 59, it is more than elongated member 301 that the spring caps 305, which stretch ground, On external and outside positioned at elongated member 301.In some embodiments, it is above-mentioned to replace using bonding or heat bonding It stretches attachment method or bonds or be thermally bonded and be used in combination with above-mentioned stretching attachment method.

In the embodiment of Figure 58 and Figure 59, the slit 304 that the face of seal member 302 is traversed in diametric(al) is conducive to Needle 130 passes through seal member.It is also contemplated that the features other than self-closing slit.As shown in Figure 58 B and 58C, needle 130 distal needle 134 is in the position of the inside for the elongated member 301 for being located at slit closing.In some embodiments, elongate portion The distal end of part 301 includes elongated distal portions 306, and the elongated distal portions 306 are for receiving or have in other aspects Elongated member is attached to conducive to by seal member 302 (such as Figure 58 and as shown in 59).In the embodiment of Figure 59, the distal end that becomes larger Part 306 is provided with proximal annular rim shoulder 307, and the proximal part of spring caps 302 can rest on the proximal annular rim shoulder 307 On.The shell on distal portions 36 of spring caps 305 provides the fixation of reinforcement of the spring caps on elongated member.

In the preceding description to Figure 42 to Figure 49, it has been described that be limited in the range of intravenous injection catheter and include bullet Spring folder portion point and the Needle hub assembly of elongated member part.But, it will be appreciated that, the needle assemblies of Figure 42 to Figure 59 can with it is a variety of its The needle product of its type is combined, a variety of other types of needle products include but not limited to syringe, guide wire introducer, Blood collection device etc..In some cases, it is by what these other types of needle products and intravenous injection catheter were mutually distinguished Such a way, i.e. needle assemblies are advanced on shank.For example, in some cases, the machinery that Needle hub assembly is made to advance along shank Motive force is directly provided by the hand of user, spring, compressed air or other pushing meanss.In Figure 42 shown before to Figure 59 In, disclosed spring clip includes the first elastic arm and the second elastic arm 101 and 102.It is but it is important to note that any The folder construction of type is all possible, such as the single armed folder as shown in Figure 18,19 and 24.In addition, as hereinafter Figure 60 A and figure The embodiment of 60B, other than elasticity, the arm of folder can be closed by other devices on the distal end of elongated member. It should also be important to note that, many and spring clip and the relevant spy of elongated member disclosed in (above or hereinafter) herein Sign can be interchanged and/or combine, to formulate diversified needle assemblies and safty pin product.

Figure 60 A- Figure 60 C show guide wire introducer according to another embodiment.Guide wire introducer 360 includes needle 361, the proximal end of the needle 361 is fixed on the inside of Needle sleeve 364.Needle includes on its distal end close to the distal needle of needle 362 at profile variations.When in the ready position, Needle hub assembly is located at the inside of housing 367, and the housing 367 is at its proximal end Place is attached to Needle sleeve 364.Needle hub assembly includes first part 370 and second part 380.First part 370 includes only part Define the middle part of the bar of needle 361 in ground.Second part 380 is located within the middle part, and second part 380 is in entirely around shank The form of cylindrical elongate component.In one embodiment, the proximal end of elongated member 380 includes the endless loop 381 of protrusion, described Elongated member 380 to be fixed in the annular recessed portion 373 of bottom that the endless loop 381 of protrusion is installed in first part 370 First part 370.In one embodiment, first part 370 includes having from the distally extending arm 371 in hinged bottom Molded plastic structure.Arm 371 has distal portions 372, and distal portions 372 are configured to：It is in Needle hub assembly and prepares position (see Figure 60 A) against the bar of needle 361 when putting, and elongated member 380 is covered (see Figure 60 B) when Needle hub assembly has been activated Distal end.When in the ready position, the holding meanss of power applied by resisting helical spring or other elastic constructions (are not shown Go out) Needle hub assembly 370 is maintained to the inside of housing 367, the helical spring or other elastic constructions are positioned at it Needle guard is distad pushed when being discharged from holding meanss.In the example of Figure 60 A and Figure 60 B, the proximal end of spring 374 is attached to shell The bottom of body 367, and at least part of its distal end surrounds a part for molded plastic structure 370, the besieged portion Divide at least part for including arm 371.In use, when needle guard is discharged from holding meanss, compressed spring 374 distad expands It opens to push shank forward, until the distal needle 363 of needle 361 is fully located at the inside of elongated member 380.In addition to along needle 361 It pushes except needle guard forward, spring 374 is also compressively acted on radially to push arm 371 inwardly on arm 371, so that arm Distal portions 372 cover elongated member 380 distal end.

In further embodiments, the first part 370 of needle guard and second part 380 include with hereinbefore or hereinafter disclosed in Spring clip and the similar or identical spring clip and elongated member of elongated member.In these embodiments, spring 374 can be arranged In the lower section of the bottom of spring clip 118, so as to be positioned along shank, distad push the spring is pressed from both sides.

Needle hub assembly shown in Figure 62 A to Figure 62 D is similar to such as Fig. 6 extremely schemes to Figure 10, Figure 20 to Figure 23 and Figure 26 The Needle hub assembly illustrated in 29.Figure 62 A and Figure 62 B are respectively to form the needle before spring clip in folded elastic arm 422 and 423 The vertical view and side view of set.In Figure 62 A and Figure 62 B, the elongated member 430 shown is upwardly extended from bottom 118.As above institute State, elongated member 430 may include the part separated with first part, elongated member 430 by the part be attached to bottom 118 or Only it is seated against bottom 118 and the distal end of elastic arm 422,423.Elongated member 430 also using the drawing technique of the foregoing description by First part 420 is formed.It for above-disclosed guide wire introducer 360, is desirable in some cases, needle guard is along needle Bar is pushed distally so that it, which is presented, in it enables position.In the embodiment shown in Figure 60 A to 60C, helical spring 374 is in folder It itself separates and the motive force is provided.In the Needle hub assembly of Figure 62 A to Figure 62 D, spring assembly is not separately formed with folder, But by being formed with pressing from both sides itself identical materials in storage.In other words, spring assembly and folder are integral.As shown in Figure 62 A and 62B, Elongate projection 440 extends from the side of bottom 118 and is configured with multiple longitudinally aligned elongated holes 441.Similar to bullet Property arm 422 and 423, protruding portion 440 also have elasticity with when protruding portion 440 is folded along straight line 433 formed spring 422 (such as Shown in Figure 62 C and Figure 62 D) hole 446 in the bottom 445 of protruding portion 440 is aligned with hole 441 so that and Needle hub assembly is in protruding portion It can be loaded onto on shank when being folded.For example, in the guide wire introducer as shown in Figure 60, the bottom of protruding portion 440 445 can be attached to the bottom of housing 367.When needle guard is in ready position, the spring formed is in housing 367 in compression It state and acts on bottom 118, is distad pushed including spring clip 421 and thin towards the distal end of needle along shank with pushing The needle guard of long component 430.In the case where needle guard is discharged from housing 367, spring 422 distad pushes needle guard remote until needle End needle point is fully located at the inside of elongated member 430 (as shown in Figure 62 C and 62D).

In further embodiments, elongate projection 440 be used only as be to what advance of the needle guard on shank was limited Chain (tether).And in further embodiments, protruding portion is used to form spring 442, and is additionally operable to serve as limits device Limit advance of the needle guard on shank distad.

Figure 63 A- Figure 63 D show needle guard 510 according to another embodiment.Needle guard can be by flexible general flat Material manufacture, and needle guard has and the same or similar construction shown in Fig. 6 A, 6B, 20,26 and 32.For the mesh of explanation , the identical component shown in Figure 63 A- Figure 62 D employs the reference numeral identical with Fig. 6 A.But should it is important to note that It is that construction is not limited to Fig. 6 A, the construction shown in 6B, 20,26,32 and 42 in any form.

As shown in Figure 63 A, in cutting or punching press construction, needle guard is elongated equipped with the first elongated biasing member and second Biasing member 513 and 514.In one embodiment, the first elongated biasing member and the second elongated biasing member 513 and 514 are big Cause relatively positions and is basically parallel to the first elastic arm respectively and the second elastic arm 101 and 102.At least the first biasing member 513 distal end 515 and at least part of the second elastic arm 102 are longitudinally aligned so that when needle guard 510 is formed and is arranged in needle Distal end 515 abuts the second elastic arm 102 (see Figure 63 B) to generate biasing force when on 130, and the biasing force is (together with the second elasticity The intrinsic biasing force of arm 102 is together) contribute to the bar 131 for pushing the second elastic arm 102 against needle 130.In an identical manner, 516 at least part of distal end and at least part of the first elastic arm 101 of two biasing members 514 are longitudinally aligned so that work as needle Distal end 516 abuts the first elastic arm 101 (see Figure 63 B) to generate biasing force when set 510 is formed and is arranged on needle 130, described Biasing force contributes to the bar for pushing the first elastic arm 101 against needle 130 (together with the intrinsic biasing force of the first elastic arm 101) 131。

And Figure 63 B and 63C show that the needle guard in ready position is activated the distal needle 134 to cover needle 130, figure 63D shows the needle guard in enabling state, wherein, the needle guard by backstop 132 at the profile variations of shank 131 on and bullet Property arm 101,102 distal end 107,108 are arranged to more than distal needle 134.As shown in Figure 63 D, enabled when needle guard is in During state, the distal end 515,516 of biasing member 513,514 is constantly engaged with arm 101,102.Advantageously, the engagement helps Enable position in arm 101,102 is maintained it and resist outside power, once needle point 134 suitably covered it is described outward Power be applied on arm 101,102.

Backstop and/or engagement feature can be integrated on arm 101,102 and/or biasing member 513 or backstop and/or Engagement feature can be integrated among arm 101,102 and/or biasing member 513 so that had when needle guard enables position in it Help maintain biasing member 513,514 on arm 101,102.Figure 64 to Figure 68 shows the example of the features.Attached In some embodiments being not shown in figure, come by at least part of track of the length along arm 101,102 in arm 101,102 On the distal end 515,516 of biasing member 513,514 is guided.In the embodiment of Figure 64, notch/recess 531 and 532 points It is not arranged in the inner circumferential of arm 101 and 102.In use, (such as Figure 64 B institutes at least when needle guard 530 is in enabling state Show), at least part of the distal end 515 and 516 of biasing member is located in recess 532 and 531 respectively, to contribute to arm 101 and 102 maintain place in place and thereby cover the distal needle 134 of needle 130.In one embodiment, such as Figure 64 C Shown in (along the sectional view of straight line A-A), the inward flange of arm 101 and/or 102 is bent over forming strongback and thereby carrying to arm For additional rigidity.In the embodiment of Figure 65, protrusion/shoulder 534,535 is respectively formed in the inward flange of arm 101,102 On, described at least part of the distal end 516 and 517 of biasing member 514 and 513 is abutted when needle guard 540 is in enabling state The inward flange of arm 101,102.In one embodiment, the distal end 515 and 516 of at least biasing member 513 has than 101 He of arm The width dimensions W1 of 102 width dimensions W2 biggers.Each in the embodiment of Figure 66 A to Figure 66 C, in arm 101 and 102 At least part all along its length has a pair of punching press recess 551a, 551b being longitudinally arranged so that recess portion 552 is present in institute It states between recess.As shown in Figure 63 D, at least when needle guard is in enabling state, at least part of biasing member 513,514 Within recess portion 552.In the embodiment of Figure 67 A and Figure 67 B, the protrusion on the outside of each of arm 101 and 102 Features 555 provide a surface, and at least part of the distal end 515,516 of biasing member 513,514 is in needle guard to be enabled It is leaned on said surface (as shown in Figure 67 B) during state.It is every in arm 101,102 in the embodiment of Figure 68 A and Figure 68 B One is equipped with hole 556, and the hole 556 is suitable for accommodating the protrusion being formed on the distal end 515,516 of biasing member 513,514 Portion 557.As shown in Figure 68 B, at least when needle guard, which is in, enables position, protrusion 557 is located within hole 556.

Figure 69 A to Figure 69 C show the needle guard similar to the needle guard shown in Figure 67 A and Figure 67 B.The difference lies in inclined The construction of the distal end of splenium part 514.As shown in Figure 69 A and 69B, protrusion or protrusion 518 from distal end 516 radially inward Extension, and be configured to：Needle 130 being covered when needle guard enables state in it at least partly (as shown in Figure 69 B and 69C) Inclined-plane 136.

As the embodiment of Figure 24, one can also only be included suitable for covering needle by merging the needle guard of the feature of biasing member The arm 101 of distal needle.As shown in Figure 70 A and Figure 70 B, in this embodiment, arm 102 is terminated at part 560 and needle guard Without biasing member 513.Embodiment just as the aforementioned, biasing member 514 are arranged on the outer surface for acting on arm 101.

Biasing member can also be integrated into the needle guard including elongated member (as shown in Figure 74).The example of Figure 71 is shown The needle guard 400 of Figure 30 has the version of biasing member 513 and 514.

Many exemplary embodiments have been herein disclosed and described.However, it is necessary to understand, the present invention never should It is understood to be limited to the example.

Claims

1. a kind of safety needle device, including：

Needle, the needle set have shank and distal needle；And

Needle guard, the needle guard change between preparation state and enabling state, in the preparation state, the distal needle of the needle In unprotect state, in the enabling state, the distal needle of the needle is in guard mode, and the needle guard includes having remote The arm of part is held, the needle guard further comprises elongated member, as the needle guard is in the preparation state and the enabling shape Moved between state, the elongated member can be moved along the side of the shank, the elongated member have proximal end, distally with And the channel of the perforation extended between the proximal end and the distal end, the arm is distally extending from bottom, in the bottom Hole is formed with, the shank, which passes through, forms in the hole in the bottom, and the elongated member includes being arranged in the bottom Hole in proximal part, the proximal part of the elongated member includes fisrt feature portion and a part for the bottom includes Second feature portion, the fisrt feature portion and the second feature portion are configured to be fitted to each other to be in described in the needle guard Rotary motion of the bottom relative to the elongated member is prevented during preparation state.

2. safety needle device according to claim 1, wherein, the fisrt feature portion and the second feature portion are configured Into being fitted to each other to prevent rotation of the bottom relative to the elongated member when the needle guard is in the enabling state Movement.

3. safety needle device according to claim 1, wherein, the fisrt feature portion includes protruding portion and described second Features include recess, and the protruding portion is in the recess.

4. safety needle device according to claim 2, wherein, the fisrt feature portion includes protruding portion and described second Features include recess, and the protruding portion is in the recess.

5. safety needle device according to claim 3, wherein, the second feature portion at least partially defines the bottom In hole.

6. safety needle device according to claim 4, wherein, the second feature portion at least partially defines the bottom In hole.

7. safety needle device according to claim 1, wherein, in the preparation state, the distal portions of the arm are in institute The proximate distal ends for stating elongated member are located at the outside of the elongated member, the needle guard be configured so that with the needle guard from The preparation state is converted to the enabling state, and the distal portions of the arm can be along the outer lateral remote of the elongated member Side is moved across the distal end of the elongated member, and when the needle guard is in the enabling state arm distal portions It can radially inward be moved on the distal end for being at least partially situated at the elongated member.

8. safety needle device according to claim 7, wherein, the outside of the elongated member is in the remote of the elongated member End nearby includes recess portion, and at least part of the distal portions of the arm is located at institute when the needle guard is in the preparation state It states in recess portion.

9. safety needle device according to claim 8, wherein, the recess portion is configured to accommodate the arm as follows Distal portions at least part, that is, so that resisting the arm when the needle guard is in the preparation state described thin Rotary motion on long component.

10. safety needle device according to claim 7, wherein, the bottom can be in the close end of the elongated member When first position when the needle guard is in the preparation state and the needle guard are in the enabling state on point in institute It states and slides between the second position in first position distal side.

11. safety needle device according to claim 1, wherein, the arm includes elastic material and with proximal part And middle part, the middle part are arranged between the proximal part and the distal portions.

12. safety needle device according to claim 1, wherein, the proximal part of the elongated member extends through described Hole in bottom.

13. safety needle device according to claim 1, wherein, the shank has near the distal needle of the needle At profile variations, and the inner wall of the proximal end for being located near or at the elongated member of the channel of the perforation is configured to and institute It states to engage at the profile variations of shank and be moved with limiting the needle relative to the needle guard to nearside.

14. safety needle device according to claim 13, wherein, length possessed by the elongated member causes when described When the inner wall of the channel of the perforation is engaged at profile variations, the entire distal needle of the needle is located at passing through for the elongated member In logical channel.

15. safety needle device according to claim 10, wherein, the elongated member includes outer shoulder, the outside Shoulder is configured to engage with the bottom to limit the bottom on the elongated member towards the second position to remote The movement of side.

16. safety needle device according to claim 10, wherein, it is disposed with diameter on the proximal part of the elongated member To extension component, to limit the bottom on the elongated member towards the movement distad of the second position.

17. safety needle device according to claim 11, wherein, the distal portions of the arm include the wall portion with distal end Point, it is arranged in the middle part of the wall part and the arm relative to the into different angle direction of the elongated member, the wall It is angled inward partially towards the elongated member, the wall part is remote when the needle guard is in the preparation state End is against the outside of the elongated member, when the distal end of the wall part is configured as the needle guard and is in the enabling state The elongated member is detached from, to be at least partially situated on the distal end of the elongated member.

18. safety needle device according to claim 11, wherein, the distal portions of the arm include the wall portion with distal end Point, it is arranged in the middle part of the wall part and the arm relative to the into different angle direction of the elongated member, the wall It is angled inward partially towards the elongated member, the wall part is remote when the needle guard is in the preparation state End is against the outside of the elongated member, when the distal end of the wall part is configured as the needle guard and is in the enabling state The elongated member is detached from, fully to cover the distal end of the elongated member.