Automatic cannula inserter with reusable and disposable parts

Abstract

A cannula insertion system includes a disposable part (and, optionally, a site base releasably connectable to the disposable part), and a reusable part. The disposable part includes a needle hub that is moveable in a needle carriage by a needle retraction spring from an insertion position in which the needle protrudes through the needle carriage to insert a cannula, to a retraction position in which the needle is fully retracted into in the needle carriage after having deployed the cannula. The reusable part includes a housing to releasably engage with the disposable part, a spring to insert the needle, an actuation cap for triggering the deployment of the cannula, and a safety member enabling a user to select a first option in which the cannula insertion system is "unlocked" and ready for cannula deployment, or a second option in which the cannula insertion system is "locked" to prevent cannula deployment.

Description

AUTOMATIC CANNULA INSERTER WITH REUSABLE AND DISPOSABLE PARTSFIELD OF THE INVENTION

[0001] The present invention generally relates to cannula inserters. More specifically, the present invention relates to a fully automatic cannula insertion system for subcutaneously inserting an infusion cannula, which includes a disposable part and a reusable part. The present invention also relates to a reusable cannula inserter and to a safety member for use with the reusable cannula inserter.BACKGROUND

[0002] Many people, for example diabetic people, people suffering from Parkinson disease, etc., use (or may use in the future) some form of subcutaneous infusion therapy. The therapeutic drug to be used during therapy may be stored, for example, in a syringe-type reservoir, and subcutaneously delivered to the user by an infusion pump. Depending on the kind of therapy recommended or prescribed for patients, infusion pumps may subcutaneously deliver the therapeutic drug intermittently or continuously.

[0003] The use of an infusion pump requires the use of a disposable component, typically referred to as an “infusion set”, which conveys the therapeutic drug from a reservoir within the pump device into, or through, the skin of the user. An infusion set typically consists of a pump connector, a cannula / needle hub from which an infusion needle or cannula extends, and a length of tubing via which the pump connector is connected to the infusion needle or cannula. Usually, the cannula / needle hub, which has an adhesive layer to retain the hub / base on the skin surface of the user during use, may be attached to the patient’s skin with the aid of a manual or automatic cannula insertion device (‘cannula inserter’).

[0004] Currently, most infusion sets deliver therapeutic drug using flexible plastic cannulas, and they are inserted through the patient’ s skin by using a manual or automatic cannula inserter. Such cannula inserters are usually disposable, which is wasteful because they typically cost about 5 -6 US dollars apiece, and chronic patients may need many devices during the course of their life.

[0005] Cannula insertion is usually performed by using an insertion needle. Manually operated cannula inserters are inferior in comparison to automatic cannula inserters, for example in terms of ease of use, reduced pain during needle / cannula insertion, and willing to use them due, for example, to needle phobia. Needle phobia, also known as Trypanophobia, is a fear of medical procedures involving hypodermic needles or injections. Trypanophobia has been on a steady rise amongst both adults and children and has become quite common. Trypanophobia can significantly interfere with people’s life because, for example, people with this phobia may delay or avoid receiving medical treatment.

[0006] Another problem that exists with some cannula inserters is that the needle used to insert the cannula through the patient’s skin is exposed, at least to some extent, before the cannula insertion takes place, or after insertion of the cannula takes place, or both before and after the cannula is inserted. This may result in increased potential risk for needlestick injuries and crosscontamination.

[0007] In some conventional cannula inserters, cannula insertion is automatic while retraction of the needle is manual. In some other conventional cannula inserters cannula insertion is manual while the needle retraction is automatic.

[0008] A need, therefore, exists for a fully automatic cannula insertion system, namely for a cannula insertion system that enables both automatic cannula insertion and automatic needle retraction, and for a cannula insertion system that includes a reusable inserter. Another need exists for a cannula insertion system that reduces Trypanophobia, and provides patients with increased safety of use, for example by eliminating exposure of the needle and potential needlestick injuries.SUMMARY OF THE INVENTION

[0009] A cannula insertion system (1001) for deploying an infusion cannula (1230) through a skin of a user includes a reusable part (100) and a disposable part (200) that is releasably engageable with the reusable part (100), with both parts sharing a common centerline (an axis 101). The reusable part (100) includes, among other things, an actuation cap (110), a housing (120), a safety member (130) adapted to concentrically receive (contain) the housing (120), a cap spring (102), and a needle insertion spring (104). The cap spring (102) may be placedbetween the actuation cap (110) and the housing (120) to axially bias cap spring (102) away from the housing (120) prior to, and in preparation for, deployment of the cannula.

[0010] The disposable part (200) includes, among other things, a needle hub (210) including a needle (812), a needle carriage (220) adapted to concentrically receive (contain) the needle hub (210), a needle retraction spring (1500) that is initially compressed by, and between, the needle hub (210) and the needle carriage (220), and a sleeve (230) adapted to concentrically receive (contain) the needle carriage (220). To effect a cannula insertion, the needle insertion spring (104) moves the needle carriage (220) in a needle insertion direction (141). After the cannula is inserted, the needle hub (210), with the needle (812), is retracted. Retraction of the needle hub (210) and the needle (812) includes moving the needle hub (210) in the needle carriage (220) by the needle retraction spring (1500) from an axial insertion position (986), in which the insertion needle (812) protrudes through a distal base (930) of the needle carriage (220), to an axial retraction position (988), in which the needle (812) is fully contained in the needle carriage (220).

[0011] The actuation cap (110) may include cam fins (112,114) for cammingly rotating the needle carriage (220) and the needle hub (210) in unison in the sleeve (230) from a “standby angular position preventing axial movement of the needle carriage (220) relative to the sleeve (230), to an “insertion” angular position enabling axial movement of the needle carriage (220) in the needle insertion direction (141) relative to the sleeve (230).

[0012] The housing (120) may be couplable to the actuation cap (110) by a first snap-fit arrangement enabling constrained bi-directional axial movement of the actuation cap (110) relative to the housing (120). The housing (120) is configured to concentrically receive and releasably connect to the sleeve (230) by a second snap-fit arrangement. The housing (120) may include the needle insertion spring (104) to axially move the needle carriage (220) and the needle hub (210) in unison in the sleeve (230) in the needle insertion direction (141) when the needle carriage (220) is in the ‘insertion’ angular position in the sleeve (230).

[0013] The safety member (130) enables the actuation cap (110) and the housing (120) to rotate therein in unison about the centerline (101) between a “lock” angular position, in which the actuation cap (110) is axially locked in a “pre-activation” state in which axial movement ofthe actuation cap (110) towards the housing (120) is prevented, and an “ unlock angular position, in which the actuation cap (110) is free to axially move towards the housing (120) from the “pre-activation” state to an “activation” state to effect the cannula deployment by cammingly rotating the needle carriage (220) in the sleeve (230) from the “standby” angular position to the “insertion” angular position.

[0014] When the housing (120) is in the safety member (130) and coupled to the actuation cap (110), the actuation cap (110) and the housing (120) are rotatable in unison in the safety member (130) between the “lock” angular position and the “unlock” angular position.

[0015] The actuation cap (110) may have a generally cylindrical chamber (113) between a cap proximal base (115) and a cap distal opening (117), and the cam fins (112,114) may be semicircular and coaxially extend from the cap proximal base (115) through the chamber (113) and past the cap distal opening (117).

[0016] The housing (120) may have a generally cylindrical chamber (133) between a proximal base (135) and an open distal end (152) to concentrically receive the sleeve (230), and the housing (120) may include curved apertures (137,139) to enable axial insertion therethrough of the semi-circular cam fins (112,114) into the housing (120), proximal snap-fit windows (128,142) to facilitate coupling of the actuation cap (110) with the housing (120), guide slots (126,149) to guide the sleeve (230) into the housing (120), middle snap-fit windows (154,156) to facilitate releasable locking of the sleeve (230) in, and to, the housing (120), and ejection members (122,158) to eject the sleeve (230) from the housing (120).

[0017] The safety member (130) may have a generally cylindrical through bore (148) for concentrically receiving the housing (120). The safety member (130) may include guide slots (168,170) to guide the ejection members (122,158) of the housing (120), hence housing 120, into the safety member (130). The safety member (130) may also include “stop” surfaces (172,174) to prevent the axial movement of the actuation cap (110) towards the housing (120) when the actuation cap (110) and the housing (120) are in the “lock” angular position in the safety member (130), one-sided open windows (176,178) to enable the axial movement of the actuation cap (110) from the “pre-activation” state to the “activation” state, and concealing chambers (188,190) to conceal the ejection members (122,158) of the housing (120) at leasttactily (and, optionally, also visually) when the actuation cap (110) and the housing (120) are in the “lock” angular position in the safety member (130).

[0018] The needle hub (210) is releasably attachable to the needle carriage (220) in the axial insertion position (986) by a snap-fit arrangement. The snap-fit arrangement may include snap- fit openings (960,962) of the needle carriage (220), and snap-fit structures (854,864) of the needle hub (210), wherein the snap-fit structures (854,864) are configured to releasably snap- fit into the snap-fit openings (960,962). The needle hub (210) may also include elongated guide rails (850,860) to guide the needle hub (210) into the needle carriage (220).

[0019] The needle carriage (220) includes a chamber (910) for containing the needle hub (210) while providing limited axial freedom of movement (£) to the needle hub (210) between an insertion position (“INS”) (986) and a retraction position (“RTR”) (988) in the needle carriage (220). The needle carriage (220) also includes cam members (980,982) that outwardly extend from the needle carriage (220) to cammingly co-act with the cam fins (112,114) of the cap (110) to rotate the needle carriage (220) in the sleeve (230) from the “standby” angular position to the “insertion” angular position.

[0020] The needle sleeve (230) includes an elongated body (1000) to concentrically receive the needle carriage (220) from one side thereof and the cam fins (112,114) from the opposite side thereof, cantilever snaps (217,214) to releasably connect the sleeve (230) to the housing (120), and “L”-shaped guideway cutouts (1060,1070) to guide the cam members (980,982) of the needle carriage (220) from the “standby” angular position to the “insertion” angular position. The “L”-shaped guideway cutouts (1060,1070) may include an “axial” section (1062) defining the “insertion” angular position of the needle carriage (220) relative to the sleeve (230), and a “lateral” section (1068) defining the “standby” angular position of the needle carriage (220) relative to the sleeve (230), the lateral section (1068) configured to rotationally guide the needle carriage (220) in the sleeve (230) to the “axial” section (1062), hence to the “insertion” angular position.

[0021] Also provided is a reusable part (100) of a cannula insertion system (1001), which includes a housing (120) provided with ejection members (122,158) to eject a disposable part (200) that is releasably connected to the housing (120), an actuation cap (110) that is connectable to the housing (120), and an elongated safety member (130) that receives thehousing (120). The elongated safety member (130) may include longitudal guide slots (168,170) to guide the ejection members (122,158), hence the housing (120), into the safety member (130). Each longitudal guide slot (168,170) may include (for example by being divided to) a concealment chamber (188,190) and an open window (189,191). The safety member (130) and the housing (120) are structured in a way that when the housing (120) is (resides) in the safety member (130) and connected to the actuation cap (110), the actuation cap (110) is rotatable (105,109) in the safety member (130) in unison with the housing (120) between a “lock” angular position, in which the safety member (130) axially locks the actuation cap (110) in a pre-activation” state preventing activation of the cannula insertion system, and the ejection members (122,158) of the housing (120) are at least tactily (and, optionally, also visually) concealed in the concealment chambers (188,190), and an “unlock” angular position in which the actuation cap (110) is axially moveable towards the housing (120) from the “preactivation” state to an “activation” state to activate the cannula insertion system (1001), and the ejection members (122,158) of the housing (120) are accessible to a user via the open windows (189,191) for releasing the disposable part (200) from the housing (120).

[0022] Also provided is a safety member (130) for a reusable part (100) of an automatic cannula insertion system (1001). The safety member (130) may include a generally cylindrical through bore (148) for concentrically receiving a housing (120) of the reusable part (100) of a cannula insertion system (1001). The housing (120) may include ejection members (122,158) for ejecting a disposable part (200) of the cannula insertion system (1001) from the housing (120) after use. The safety member (130) may include concealment chambers (188,190) to prevent unintentional activation of the ejection members (122,158) by a user, and open windows (189,191) to enable manual activation of the ejection members (122,158) by the user.

[0023] The safety member (130) and the housing (120) are structured in a way that when the housing (120) is in the safety member (130), the housing (120) is connectable to an actuation cap (110) of the reusable part (100) in a way that the housing (120) is rotatable (105,109) in unison with the actuation cap (110) relative to the safety member (130) between a “lock” angular position in which the safety member (130) prevents axial movement of the actuation cap (HO) towards the housing (120) from a “pre-activation” state (i.e., the safety member (130) axially retains the actuation cap (110) in its “pre-activation” state), thus preventing activation of the cannula insertion system, and in which the ejection members (122,158) of thehousing (120) are concealed in the concealment chambers (188,190), and an “ unlock angular position in which the actuation cap (110) is axially moveable towards the housing (120) from the pre-activatior' state to an “activation” state to activate the cannula insertion system (1001), and in which the ejection members (122,158) of the housing (120) are tactily accessible to a user via the open windows (189,191) for releasing (ejecting) the disposable part (200) from the housing (120).BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Various exemplary embodiments and aspects are illustrated in the accompanying figures with the intent that these examples be not restrictive. It will be appreciated that for simplicity and clarity of the illustration, elements shown in the figures referenced below are not necessarily drawn to scale. Also, where considered appropriate, reference numerals that are repeated among the figures indicate like, corresponding or analogous elements. Of the accompanying figures:

[0025] Fig. 1 depicts a cannula inserter system including a reusable part and a disposable part, according to an example embodiment;

[0026] Figs. 2A-2F depict an actuation cap according to an example embodiment;

[0027] Figs. 3A-3D depict a housing according to an example embodiment;

[0028] Fig. 4 depicts the actuation cap of Fig. Figs. 2A-2F assembled to the housing of Figs. 3A-3D;

[0029] Figs. 5A-5C depict a safety member according to an example embodiment;

[0030] Fig. 5C schematically illustrates a cross-sectional view of the safety member of Figs. 5A-5B;

[0031] Fig. 6 depicts an exploded view of the reusable part of Fig. 1;

[0032] Fig. 7 is a cross-sectional view of the reusable part of Fig. 1;

[0033] Figs. 8A-8B depict a needle hub according to an example embodiment;

[0034] Figs. 9A-9E depict a needle carriage according to an example embodiment;

[0035] Figs. 10A-10C depict a sleeve according to an example embodiment;

[0036] Figs. 11A-11B depict the needle carriage of Figs. 9A-9E assembled to the sleeve of Figs. 10A-10C;

[0037] Figs. 12A-12B depict a cannula hub according to an example embodiment;

[0038] Figs. 13A-13B depict a site base according to an example embodiment;

[0039] Figs. 14A-14B depict the cannula hub of Figs. 12A-12B assembled to the site base Figs. 13A-13B;

[0040] Fig. 15 depicts an exploded view of the disposable part of Fig. 1;

[0041] Fig. 16 is a cross-sectional view of the disposable part of Fig. 1;

[0042] Figs. 17A-17B depict a first step of using the cannula insertion system of Fig. 1;

[0043] Fig. 18 is a cross-sectional view of the cannula insertion system of Figs. 1 showing the cannula insertion system at pre-deployment state;

[0044] Fig. 19 depicts a second step of using the cannula insertion system of Fig. 1 including preparation of the cannula insertion system for deployment;

[0045] Fig. 20 is a cross-sectional view of the cannula insertion system of Fig. 1 depicting a third step of using the cannula insertion system of Fig. 1, at post-deployment state;

[0046] Fig. 21 depicts a fourth step of using the cannula insertion system of Fig. 1 and a cross- sectional view of the cannula insertion system of Figs. 1 at a needle retraction state;

[0047] Fig. 22 depicts a fifth step of using the cannula insertion system of Fig. 1 including detaching the cannula insertion system from the cannula hub and site base;

[0048] Figs. 23A-23C depict a cannula hub and a site base according to an example embodiment; and

[0049] Figs. 24A-24C illustrate detachment of a site base from a cannula insertion system according to an example embodiment.DETAILED DESCRIPTION OF THE INVENTION

[0050] The description that follows provides various details of example embodiments. However, this description is not intended to limit the scope of the claims but instead to explain various principles of the invention and exemplary manners of practicing it.

[0051] Fig. 1 depicts a cannula inserter system for inserting an infusion cannula through a skin surface of a user to deliver medicament to the user, according to an example embodiment. The cannula inserter system includes, among other things, a reusable part 100 and a disposable part 200, both of which have the same axis (centerline) 101. Reusable part 100 includes, among other things, three main parts: an actuation cap 110, an elongated housing 120, and a safety member 130. Disposable part 200 also includes, among other things, three main parts: a cannula arrangement including a needle hub (210, not shown in Fig. 1) including a needle (812, notshown in Fig. 1) and a cannula hub (1200, not shown in Fig. 1) including a cannula (1230, not shown in Fig. 1), a needle carriage 220, and a sleeve 230. An infusion site base (port) 1100 is shown releasably coupled to disposable part 200.

[0052] To use the cannula inserter system, disposable part 200 is inserted (103) into reusable part 100 by manually pushing it into reusable part 100 while compressing (loading) a needle insertion spring (104, not shown in Fig. 1). Sleeve 230 of disposable part 200 includes, among other things, guiding ribs 212 and 213 to longitudinally / axially (e.g., along a centerline 101) guide disposable part 200 into / in housing 120 of reusable part 100 by guideway cutouts (126 and 149, not shown in Fig. 1) of / in housing 120. The guided movement of disposable part 200 in reusable part 100 results in snapping cantilever snaps 214 and 217 of sleeve 230 into snap- fit windows (154 and 156, not shown in Fig. 1) of housing 120, where snap-fit hooks 216 and 218 of cantilever snaps 214 and 217 are releasably snap-fittingly locked in the snap-fit windows (154,156) of housing 120. Using this type of snap-fit arrangement, disposable part 200 is releasably connected to reusable part 100. The terms “axial movement” (of an object) and (an object being) "axially guide(d)”, as used herein, refer to movement and guidance of an object, relative to another object, along centerline (axis) 101.

[0053] When the two parts (100,200) of the cannula insertion system (1001) are connected, snap-fit hooks 216 and 218 of sleeve 230 (conditionally) secure the axial / longitudinal position of sleeve 230 in housing 120 during use of the cannula insertion system. (The ‘condition’ being intentional disconnection of disposable part 200 from reusable part 100 by manually pushing ejection members 122 and 158 of housing 120 inward, towards centerline 101.) In addition, guiding ribs 212 and 213 of sleeve 230, in conjunction with the guideway cutouts 126 and 149 (not shown in Fig. 1) of housing 120, prevent sleeve 230 (hence disposable part 200 as a whole) from rotating, about centerline 101, relative to housing 120. When the two parts (100,200) are connected, recesses 202 and 204 in the proximal end of guiding ribs 212 and 213 of sleeve 230 provide additional structure elements that axially engage with corresponding bulges or protrusions in housing 120. The additional structure elements 202 and 204 provide additional means that prevent sleeve 230 from rotating relative to housing 120. So, when the two parts (100,200) are connected, sleeve 230 can neither move axially nor rotationally relative to housing 120.

[0054] Before the two parts (100,200) of the cannula insertion system (1001) are connected, the user may rotate actuation cap 110 about 45° about axis 101 and relative to safety member 130 in a counterclockwise (CCW) direction 105 to a ''lock' angular position to prevent unintentional activation of actuation cap 110. While actuation cap 110 is in the ''lock' angular position, the user may peel off an adhesive protective film to expose the adhesive layer of infusion site base (port) 1100 and attach cannula insertion system (1001) perpendicularly to the user’ s skin / body . Then (when the user and the system are ready for insertion of the cannula), the user may rotate actuation cap 110, relative to safety member 130, about 45° in the opposite direction (i.e., clockwise direction 109, see Figs. 1 and 19) to an ^unlock' angular position to enable manual activation of actuation cap 110. Finally, the user may activate actuation cap 110 by pushing actuation cap 110 in a needle insertion direction 141 relative to housing 120 (and also relative to safety member 130).Reusable part 100

[0055] Figs. 2A-2F depict an actuation cap 110 according to an example embodiment. Actuation cap 110 has a generally cylindrical wall 111 that defines a chamber 113 between a cap proximal base 115 and a cap distal opening 117. Actuation cap 110 includes, among other things, diametrically opposed semi-circular (curved) cam fins 112 and 114. Semi-circular cam fins 112 and 114 coaxially extend from cap proximal base 115 through chamber 113 past cap distal opening 117. Semi-circular cam fin 112 includes cam surface 119. Similarly, semicircular cam fin 114 includes cam surface 121. Since cam fins 112 and 114 are semi-circular, cam surfaces 119 and 121 are also curved around centerline (axis) 101.

[0056] In reference to Figs. 2B, 2C and 2D, cam surface 119 may include two or more discrete (distinct) cam segments, where each cam segment may have a different slant angle relative to a common reference line, for example relative to centerline 101. For example, Fig. 2D shows cam surface 119 with (including) two example cam segments - cam segment 119 / 1 with slant angle a relative to centerline (axis) 101, and cam segment 119 / 2 with slant angle ft relative to centerline 101, where > a. For example, a = 45° and ft = 60°. (Angle a and angle ft may have different values.) Similarly, Figs. 2B, 2C and 2F show cam surface 121 that has similar two example cam segments - cam segment 121 / 1 with the same slant angle a relative to centerline 101 as cam segment 119 / 1, and cam segment 121 / 2 with the same slant angle ft relative to centerline 101 as cam segment 119 / 2 (again, ft > a). Cam fin 112 has a tapereddistal tip 150. Similarly, cam fin 114 has a tapered distal tip 153. Since cam surfaces 119 and 121 are curved around centerline (axis) 101, so are their cam segments.

[0057] The function of cam surfaces 119 and 121 (and cam segments 119 / 1, 119 / 2, 121 / 1 and 121 / 2) is described further below in connection with Fig. 9C and Fig. 1 IB, which are described below. In general, the function of cam surfaces 119 and 121 is to cammingly rotate (974, Fig. 9C) a needle carriage (e.g., needle carriage 220, Fig. 9A) about the centerline 101 and relative to a sleeve (e.g., sleeve 230, Fig. 10C) from a “standby angular position to an “insertion” angular position. In the “standby” angular position, a pre-compressed spring 104 (see, for example, Fig. 6) is prevented from axially extending, and therefore from axially moving needle carriage 220, hence needle 812 (see, for example, Figs. 8A and 15), in the needle insertion direction 141 (see, for example, Figs. 1 and 2D). In the “insertion” angular position, the precompressed spring 104 is no longer prevented from extending, so it extends in needle insertion direction 141 to deploy the cannula (by using an insertion needle).

[0058] The reason that each of cam surfaces 119 and 121 includes two cam segments (‘two’ being an example number of cam segments) generally has to do with the camming action resulting in the generation of axial force and tangential force that simultaneously act on cam members 980 and 982. The camming action is described first. Referring to, for example, Fig. 1, Fig. 2D, Fig. 2F and Fig. 9C, and to example cam member 980, when actuation cap 110 is manually pushed in needle insertion direction 141 against housing 120, each of cam fins 112 and 114 simultaneously applies an axial force and a tangential force to a respective cam member (980,982). Referring to Fig. 9C, cam surface 119 of cam fin 112 applies to cam member 980 an axial force 902 in the needle insertion (i.e., deployment) direction 141, and a tangential (lateral) force 904 that acts to rotate needle carriage 220 in sleeve 230 about centerline (axis) 101, in direction 974. Similarly, cam surface 121 of cam fin 114 applies to cam member 982 an axial force that is substantially identical in magnitude and direction to axial force 902, and a tangential force that is substantially identical in magnitude to tangential force 904 and interacts with cam member 982 to rotate needle carriage 220 about centerline 101, in the same rotational direction 974.

[0059] In reference to Fig. 2D and Fig. 2F, when actuation cap 110 is manually pushed in needle insertion direction 141 against housing 120, the first contact that cam fins 112 and 114respectively make with cam members 980 and 982 of needle carriage 220 is between the portion of cam segments 119 / 1 and 121 / 1 closest to tapered distal tips 150 and 153, respectively. So, each of cam segments 119 / 1 and 121 / 1 is primarily used to generate the tangential force to rotate (974, Fig. 9C) needle carriage 220 in sleeve 230 from the “standby angular position to the “insertion” angular position. Each of cam segments 119 / 1 and 121 / 1 also generates an axial force, but this axial force is minor, for example relatively to the tangential force, and counteracted by needle carriage 220, as described, for example, further below. Each of cam segments 119 / 2 and 121 / 2 is primarily used to generate an axial force similar to axial force 902 as an auxiliary force to support (add onto) the axial force that needle insertion spring 104 applies to needle carriage 220 when needle carriage 220 is already in the “insertion” angular position. A secondary use of cam segments 119 / 2 and 121 / 2 may be providing a relatively small tangential force to ensure, for example, that cam members 980 and 982 respectively get to axial “insertion” segments 1062 and 1073 of “L”-shaped guideway cutouts 1060 and 1070 in sleeve 230.

[0060] Each of lateral segments 1068 and 1075 of “L”-shaped guideway cutouts 1060 and 1070, respectively, includes a sliding-preventing protrusion to prevent unintentional sliding of cam members 980 and 982 in lateral segments 1068 and 1075, hence unintentional rotation of needle carriage 220 from the “standby” angular position to the “insertion” angular position. For example, lateral segment 1068 of “L”-shaped guideway cutout 1060 includes sliding- preventing protrusion 1078 (Fig. 10A), and lateral segment 1075 of “L”-shaped guideway cutout 1070 includes sliding -preventing protrusion 1079 (Fig. 10C). The function of sliding- preventing protrusions 1078 and 1079 is, therefore, to respectively restrain, or secure, cam members 980 and 982 in place in lateral segments 1068 and 1075 until actuation cap 110 is manually activated (i.e., pushed by a person in needle insertion direction 141) to deploy the cannula. So, when actuation cap 110 is manually pressed by a person against (towards) housing 120, cam segments 119 / 1 and 121 / 1 are the first cam segments that are encountered by cam members 980 and 982. As a result of this, cam segments 119 / 1 and 121 / 1, by selecting a suitable value for angle a (for example a = 45°), provide a tangential force (904, Fig. 9C) that is big enough to cause cam members 980 and 982 to laterally move over and passed sliding- preventing protrusions 1078 and 1079 towards axial “insertion” segments 1062 and 1073 of “L”-shaped guideway cutouts 1060 and 1070 (see, for example, Figs. 10A and 10C).

[0061] Fig. 2D and Fig. 2F show cam fins 112 and 114 with two cam segments, i.e., cam segments 119 / 1 and 119 / 2 for cam fin 112, and cam segments 121 / 1 and 121 / 2 for cam fin 114. However, each of cam fins 112 and 114 may include more than two cam segments, for example three distinct cam segments, or four distinct cam segments, or five distinct cam segments etc. For example, a cam fin may have a cam segment with gradually changing slant angles.

[0062] Actuation cap 110 also includes cantilever snaps 123 and 125. Cantilever snap 123 includes a distal hook and “stop” surface 127. Similarly, cantilever snap 125 includes a distal hook and “stop” surface 129. Cantilever snaps 123 and 125 of actuation cap 110 are used to couple actuation cap 110 to housing 120 by snapping into snap windows 128 and 142 in housing 120, which are shown in, for example, Figs. 3A-3D and described below.

[0063] Figs. 3A-3D depict a housing (120) according to an example embodiment. Elongated housing 120 has a cylindrical wall 131 that defines a chamber 133 between a proximal base 135 and an open distal end 152. Chamber 133 of housing 120 is dimensioned to concentrically receive sleeve 230 through open distal end 152 of housing 120, and, using a snap-fit arrangement, sleeve 230 of disposable part 200 is releasably connectable to housing 120 of reusable part 100.

[0064] Proximal base 135 of housing 120 comprises peripheral apertures 137 and 139. Peripheral apertures 137 and 139 have a complementary arcuate shape to enable axial insertion, at least partly, of cam fins 112 and 114 of actuation cap 110 into housing 120 in needle insertion direction 141 yet resisting rotation of actuation cap 110 relative to housing 120. Axial insertion of cam fins 112 and 114 of actuation cap 110 into housing 120 in needle insertion direction 141 results in a camming co-action between cam surfaces 119 and 121 of cam fins 112 and 114 and guiding members 980 and 982 of needle carriage 220. (Guiding members 980 and 982 of needle carriage 220 are shown, for example, in Figs. 9A-9E.)

[0065] In reference to Figs. 3A-3D, housing 120 also includes diametrically opposed proximal snap-fit windows 128 and 142 at a proximal portion of housing 120. Proximal snap-fit windows 128 and 142 of housing 120 respectively snap-fittingly co-act with cantilever snaps 123 and 125 of actuation cap 110 to irreversibly couple actuation cap 110 to housing 120 while enabling, in an “unlock” angular position of actuation cap 110, a limited axial (longitudinal)travel 145 (Fig. 4) of actuation cap 110 relative to housing 120 between a “pre-activatioii state and an “activation” state.

[0066] Housing 120 also includes diametrically opposed guideway cutouts 126 and 149. Guideway cutouts 126 and 149 longitudinally extend a partial length of housing 120 from open distal end 152 of housing 120 towards proximal base 135 of housing 120. Guideway cutouts 126 and 149 of housing 120 are respectively bridged by lateral “bridges” 124 and 143 that respectively form with part of guideway cutouts 126 and 149 snap-fit windows 154 and 156 in a longitudinally midsection of housing 120. For example, bridge 124 and part of guideway cutout 126 jointly form middle snap-fit windows 154.

[0067] Guideway cutouts 126 and 149 of housing 120 respectively guide guiding ribs 212 and213 (Figs. 10A-10C) of sleeve 230 into / in housing 120 and, therefore, cantilever snaps 217 and214 (Figs. 10A-10C) of sleeve 230 into middle snap-fit windows 154 and 156 of housing 120 (hence in reusable part 100). Cantilever snaps 217 and 214 of sleeve 230 co-act with middle snap-fit windows 154 and 156 of housing 120 are releasably snap-fittingly lockable in the middle snap-fit windows 154 and 156 of housing 120 to releasably secure sleeve 230 in / to housing 120, hence disposable part 200 in / to reusable part 100.

[0068] Housing 120 also includes diametrically opposed manually operated ejection members 122 and 158 to release and eject sleeve 230 from housing 120, hence disposable part 200 from reusable part 100. Ejection members 122 and 158, guideway cutouts 126 and 149 and proximal snap-fit windows 128 and 142 of housing 120 may be lengthwise aligned, in which case none of them is laterally, or angularly, biased or displaced with respect to the others.

[0069] Fig. 4 partially depicts the actuation cap (110) of Fig. Figs. 2A-2F assembled to the housing (120) of Figs. 3A-3D. In reference to Fig. 4, housing 120 includes cylindrical wall portions 165 and 167 that respectively define snap-fit windows 128 and 142. To irreversibly couple actuation cap 110 to housing 120, actuation cap 110 is pushed in needle insertion direction 141 until cantilever snaps 123 and 125 snap into the respective snap-fit windows 128 and 142. (Fig. 4 shows cantilever snaps 123 and 125 snapped into snap-fit windows 128 and 142.

[0070] Cap proximal base 115 of actuation cap 110 includes an internal cavity 147 for accommodating a first end of a cap spring 102. Proximal base 135 of housing 120 includes an external cavity 103 for accommodating a second end of cap spring 102. Cap spring 102 functions as a bias spring, and it is naturally relaxed, or compressed lightly between cavity 147 of cap proximal base 115 and cavity 103 of housing 120, so that actuation cap 110 is axially biased away (145) from housing 120, at a “pre -activation” state, as a matter of default. To complete actuation of the cannula inserter system, a person using the cannula inserter system pushes cap proximal base 115 of actuation cap 110 in the needle insertion direction 141, against cap spring 102, all the way (145) down until the cap proximal base 115 of actuation cap 110 reaches the “activation” state. The downward motion of actuation cap 110 (in direction 141) is restrained by co-action between “stop” surfaces 127 and 129 of cantilever snaps 123 and 125, and proximal snap-fit windows 128 and 142 of housing 120. Namely, the longest longitudinal distance “stop” surfaces 127 and 129 of cantilever snaps 123 and 125 can travel in the proximal snap-fit windows 128 and 142 of housing 120 is the longitudinal length of snap-fit windows 128 and 142.

[0071] Figs. 5A-5C depict a safety member 130 according to an example embodiment. Safety member 130 has a generally cylindrical body with a through bore 148 between a proximal opening 164 and a distal opening 166. Through bore 148 is dimensioned to concentrically receive and contain cylindrical housing 120.

[0072] Safety member 130 includes, among other things, diametrically opposed inner partial cylindrical walls 160 and 162. Inner partial cylindrical walls 160 and 162 have a diameter dl and they axially extend from proximal portion 164 to distal portion 166 of safety member 130. Inner partial cylindrical walls 160 and 162 form, therebetween, diametrically opposed ‘windows’ that serve as longitudal guide slots 168 and 170. Guide slots 168 and 170 longitudinally guide ejection members 122 and 158 of housing 120, hence housing 120, into safety member 130.

[0073] Inner partial cylindrical walls 160 and 162 respectively include, at proximal portion 164 of safety member 130, diametrically opposed “stop” surfaces 172 and 174 to prevent, by co-acting with “stop” surfaces 127 and 129 of actuation cap 110, axial movement of actuationcap 110 relative to housing 120, from “ Pre-activation state to an “activation” state (cf. Fig.4) when actuation cap 110 is in the “lock” angular position relative to safety member 130.

[0074] Inner partial cylindrical walls 160 and 162 also respectively include, at proximal portion 164 of safety member 130, diametrically opposed one-sided open windows 176 and 178. One-sided open windows 176 and 178 are respectively adjacent to the “stop” surfacesl72 and 174 and, in general, in longitudinal alignment with guide slots 168 and 170 of safety member 130. In the “unlock” angular position of actuation cap 110 relative to safety member 130, the one-sided open windows 176 and 178 can axially receive “stop” surfaces 127 and 129 and cantilever snaps 123 and 125 of actuation cap 110 to enable actuation cap 110 to axially move in the needle insertion direction 141 relative to housing 120, from the “pre-activation” state to the “activation” state along the activation travel length (145)

[0075] Safety member 130 also includes diametrically opposed outer partial cylindrical walls 180 and 182 having a diameter d2 (d2>dl). Outer partial cylindrical walls 180 and 182 axially extend a partial length of safety member 130 from distal portion 166 towards proximal portion 164. Outer partial cylindrical walls 180 and 182 respectively partly arcuately / angularly overlap ( SI ; 184,186) the diametrically opposed peripheral guide slots 168 and 170 that are peripherally formed by, and in-between, inner partial cylindrical walls 160 and 162.

[0076] Having a diameter d2 that is greater than the diameter dl of inner partial cylindrical walls 160 and 162, outer partial cylindrical wall 180, by partly overlapping (51; 184) guide slot 168, functionally divides longitudal guide slot 168 into two longitudinal segments, or parts. One segment or part (the overlapped segment / part, SI ) that forms, or defines, a first concealment chamber (a “stow” recess) 188, and another segment or part (non-overlapped segment / part 52, or the remainder of guide slot 168) that forms, or defines, a first open (an “access”) window 189. Similarly, outer partial cylindrical wall 182, by partly overlapping (51; 186) guide slot 170, functionally divides longitudal guide slot 170 into two longitudinal segments / parts. One segment / part (the overlapped segment / part) that forms, or defines, a second concealment chamber (a “stow” recess) 190, and another segment / part (non-overlapped segment / part 52, or the remainder of guide slot 170) that forms, or defines, a second open (an “access”) window 191. Concealment chambers 188 and 190 may be located diametrically opposite to one another with respect to centerline 101. Open windows 189 and 191 (alsoreferred to herein as ‘access windows’ and as windows enabling access) may also be located diametrically opposite to one another with respect to centerline 101.

[0077] The function of peripheral longitudinal concealment chambers 188 and 190 is to conceal (at least tactily and, optionally, also visually) ejection members 122 and 158 of housing 120 when actuation cap 110 is in the ''lock' angular position relative to safety member 130. This is beneficial because disposable part 200 cannot be inadvertantly, or unintentionally, ejected (disconnected) from reusable part 100 by a user (e.g., patient) when actuation cap 110 is in this angular position. The function of peripheral longitudinal open windows 189 and 191 is to respectively expose ejection members 122 and 158 of housing 120 to make them accessible to the user when actuation cap 110 is in the ^unlock' angular position relative to safety member 130. This is beneficial because when ejection members 122 and 158 are exposed, they can be pushed inwardly by the user to eject disposable part 200 from reusable part 100 (which facilitates withdrawal of the disposable part 200 from reusable part 100 after the cannula is deployed) when actuation cap 110 is in the ^unlock' angular position. So, the ^lock' angular position of actuation cap 110 relative to safety member 130 serves two purposes: (1) preventing unintentional activation of cannula insertion system 1001, and (2) preventing withdrawal of disposable part 200 from reusable part 100 before the cannula is deployed. Rotating actuation cap 110 (relative to safety member 130) to the ^unlock' angular position enables both functions, i.e., activation of cannula insertion system 1001 and withdrawal of disposable part 200 from reusable part 100 for disposal.

[0078] In reference to Fig. 5C, inner partial cylindrical wall 162 and outer partial cylindrical wall 180 have different radius (dl / 2 and d2 / 2, respectively) and are radially connected by a sidewall 136. Similarly, inner partial cylindrical wall 160 and outer partial cylindrical wall 182 have different radius (dl / 2 and d2 / 2, respectively) and are radially connected by a sidewall 157.

[0079] In reference to Fig. 3B and Fig. 5C, a diametrical distance D3 (cf. Fig. 3B) between ejection members 122 and 158 of housing 120 is selected such that its value is larger than the value of dl and smaller than the value of d2 (i.e., dl<D3<d2). While the diametrical difference d2-dl and the overlap angle SI provide the concealment chambers 188 and 190 for ejection members 122 and 158 of housing 120, the value of D3 is selected (dl<D3<d2) to enableejection members 122 and 158 to be accommodated by, or in, concealment chambers 188 and190. In addition, the value selected for D3 enables housing 120 to rotate relative to safety member 130, about centerline 101, between a concealment chamber (for example, concealment chamber 188, 51) and the respective open segment (for example, open segment 189, 52). Sidewalls 136 and 138 on one side and sidewalls 155 and 157 on the diametrically opposite side limit rotation of ejection members 122 and 158 of housing 120 (hence the rotation of housing 120 and actuation cap 110) to rotation angle y (y = 51 + 52). Rotation angle y is the angular range of motion corresponding to the rotation of actuation cap 110 (relative to safety member 130) between the “unlock” angular position and the “lock” angular position. (As described herein, actuation cap 110 and housing 120 are rotatable in unison relative to safety member 130.)

[0080] Safety member 130 provides two aspects of safety: (1) it provides the “lock” angular position that prevents inadvertent or unintentional activation of actuation cap 110, hence activation of cannula insertion system 1001, and, at the same time (i.e., when in the “lock” angular position), (2) it provides concealing chambers 188 and 190 for hiding ejection members 122 and 158 of housing 120 to prevent inadvertent or unintentional disconnection of disposable part 200 from reusable part 100. Rotating actuation cap 110 (and housing 120) to the “unlock” angular position relative to safety member 130 makes actuation cap 110 axially pushable (e.g., by a person) against housing 120 to trigger the automatic activation of cannula insertion system 1001. At the same time, rotating actuation cap 110 (and housing 120) to the “unlock” angular position also rotates ejection members 122 and 158 of housing 120 out of concealing chambers 188 and 190, so that the user can eject disposable part 200 from reusable part 100 by pressing ejection members 122 and 158 via longitudinal open windows 189 and191.

[0081] Fig. 6 depicts an exploded view of reusable part 100. To assemble reusable part 100, needle insertion spring 104 may be inserted into housing 120 such that proximal portion 107 of needle insertion spring 104 sits on internal protrusion 108 (cf. Fig. 3D) that protrudes from proximal base 135 of housing 120 into housing 120. Then, housing 120 may be inserted, proximal base 135 first, into safety member 130 until circumferential annular shoulder 140 of safety member 130 prevents stop surfaces 161 and 163 (cf. Fig. 3D) of ejection members 122 and 158 of housing 120 from moving further in the insertion direction.

[0082] When stop surfaces 161 and 163 (cf. Fig. 3D) of ejection members 122 and 158 of housing 120 touch circumferential annular shoulder 140, proximal base 135 of housing 120 has moved past proximal end 164 of safety member 130. At this stage, actuation cap 110 may be pushed towards proximal base 135 of housing 120, with cap spring 102 locked between cavity 147 in actuation cap 110 and cavity 103 in housing 120, so that cam fins 112 and 114 of actuation cap 110 enter housing 120 through peripheral apertures 137 and 139 of housing 120, and cantilever snaps 123 and 125 of actuation cap 110 snap fit into snap-fit windows 128 and 142 of housing 120 to, thus, irreversibly lock actuation cap 110 to housing 120. When the assembly process of reusable part 100 is completed, safety member 130 is locked (‘sandwiched’) between stop surfaces 161 and 163 of housing 120 on one side, and actuation cap 110 on the other side. If the assembly process concludes with actuation cap 110 in the "unlock' angular position relative to safety member 130, actuation cap 110 can be easily rotated to the ' lock' angular position relative to safety member 130. Since at this stage actuation cap 110 is coupled to housing 120 in the way described herein, actuation cap 110 and housing 120 rotate in unison relative to safety member 130.

[0083] Fig. 7 is a cross-sectional view of the assembled reusable part 100. Fig. 7 shows reusable part 100 in the pre-activation state in which housing 120 is concentrically housed by safety member 130, and actuation cap 110 is coupled with housing 120 (by means of cantilever snaps 123 and 125 of actuation cap 110 and snap-fit windows 128 and 142 of housing 120) in the "Pre-activation state (cf. Fig. 4). Cap spring 102 is shown in Fig. 7 in its extended (relaxed, or somewhat relaxed) state that loosely maintain actuation cap 110 in the "Pre- activation state. If actuation cap 110 is in the "lock' angular position in, and relative to, safety member 130, actuation cap 110 cannot be axially moved (relative to safety member 130) to the "activation state (cf. Fig. 4). Rotating actuation cap 110 (for example clockwise, in direction 109, cf. Fig. 19), relative to safety member 130, to the "unlock' angular position enables (for example a person using the device) to axially move actuation cap 110 to the "activation state. Needle insertion spring 104 is shown in Fig. 7 in its extended state inside housing 120. Needle insertion spring 104 is compressed (energized) by inserting disposable part 200 into reusable part 100. That is, being axially positioned between housing 120 of reusable part 100 and needle carriage 220 of disposable part 200, the more disposable part 200 is pushed (inserted) into reusable part 100, the greater the compression of needle insertion spring 104, hence the potential energy stored in needle insertion spring 104. Fig. 7 does not show the needleretraction spring (1500), as this spring is part of disposable part 200. Reusable part 100 is assembled before it is shipped to the end user (e.g., a patient).Disposable part 200

[0084] Disposable part 200 includes, among other things, a needle hub. Figs. 8A-8B depict a needle hub (210) according to an example embodiment. Needle hub 210 may have an elongated cylindrical body 800 that extend along centerline 101. Needle hub 210 may include a concentric internal protrusion 810 that axially extend along a length of elongated body 800 from a proximal base 820 of elongated body 800 towards a distal open end 830 of elongated body 800. Internal protrusion 810 defines an annular space 840 in elongated body 800 for accommodating the needle retraction spring 1500.

[0085] Needle hub 210 may also include diametrically opposed elongated guide rails 850 and 860, which extend in parallel to centerline 101 on external surface 870 of elongated body 800 from proximal base 820 of elongated body 800 towards and passed distal open end 830 of elongated body 800. Each of guide rails 850 and 860 includes a trailing detent surface (852,862) at the proximal base (820) of elongated body 800, and a leading, or distal, snap-fit (e.g., “U-shaped snap fit”) structure (854,864). Snap-fit structures 854 and 864 distally extend away from open distal end 830, in a direction opposite to that of proximal base 820. (Snap-fit structures 854 and 864 can have different shapes, namely, they need not necessarily be “U”- shape.)

[0086] Needle hub 210 may also include a needle 812 that is integrally held by concentric protrusion 810 and partially extend through open distal end 830 of elongated body 800 past distal ends 878 and 880 of snap-fit structures 854 and 864.

[0087] Disposable part 200 may also include a needle carriage. Figs. 9A-9E depict a needle carriage (220) according to an example embodiment. Needle carriage 220 is dimensioned to concentrically receive and house needle hub 210. Needle carriage 220 may have an elongated cylindrical body 900 that extend along centerline 101 and define a chamber 910 between a proximal open end 920 and a distal base 930 of needle carriage 220.

[0088] Needle carriage 220 may also include diametrically opposed snap-fit tabs 940 and 950 that are adjacent to open proximal end 920 of needle carriage 220. Snap-fit tabs 940 and 950of needle carriage 220, in conjunction with detent surfaces 852 and 862 of needle hub 210, enable concentric irreversible insertion of needle hub 210, snap-fit structures 854 and 864 inserted first, into chamber 910 of needle carriage 220. After the insertion of needle hub 210 into needle carriage 220, snap-fit tabs 940 and 950 of needle carriage 220 provide limited axial freedom of movement (£, Fig. 9D) of needle hub 210 inside chamber 910 of needle carriage 220, between an initial insertion position 986 (“INS”) in needle carriage 220 and a retraction position 988 (“RTR”). To enable insertion of needle hub 210 into needle carriage 220, snap-fit tabs 940 and 950 of needle carriage 220 are provided with ramped (cam) surfaces 942 and 952, respectively. Ramped surfaces 942 and 952 are deflectable by guide rails 850 and 860 of needle hub 210 away from centerline 101 (from chamber 910) to allow insertion of needle hub 210 into needle carriage 220, for example during the assembly process of disposable part 200. To limit the axial freedom of movement (£, Fig. 9D) of needle hub 210 in needle carriage 220, snap-fit tabs 940 and 950 of needle carriage 220 are additionally provided with stop surfaces 944 and 954, respectively. When needle hub 210 is fully inserted into needle carriage 220, linear (axial) movement of needle hub 210 inside needle carriage 220 is restrained between stop surfaces 944 and 954 of snap-fit tabs 940 and 950 (see axial position 988), respectively, on the one hand, and distal base 930 (Figs. 9A, 9C) of needle carriage 220 (axial position 986), on the other hand.

[0089] Needle carriage 220 includes snap-fit openings 960 and 962 (Figs. 9A, 9D and 9E) at distal base 930 of needle carriage 220. Snap-fit openings 960 and 962 snap-fittingly co-act with snap-fit structures 854 and 864, respectively, of needle hub 210 to initially lock needle hub 210 axially in needle carriage 220 before and during insertion of cannula 1230 (Figs. 12A-12B) into the user’s body. When needle hub 210 is snap-fittingly locked in needle carriage 220, needle retraction spring 1500 is compressed by (and between) them, thus storing in needle retraction spring 1500 a potential energy that is required to fully retract needle hub 210 in, and relative to, needle carriage 220 after the cannula is deployed. After insertion of cannula 1230, snap-fit structures 854 and 864 of needle hub 210 are respectively snapped out from snap-fit openings 960 and 962 of needle carriage 220 as needle insertion spring 104 axially pushes needle carriage 220 against infusion site base (port) 1100. Pushing needle carriage 220 against infusion site base (port) 1100 causes snap-fit structures 854 and 864 of needle hub 210, which are respectively aligned with snap-out openings 1340 and 1350 of infusion site base 1100 (Fig. 13A and Fig. 14A), to be respectively pushed against snap-out openings 1340 and 1350 ininfusion site base 1100. Pushing snap-fit structures 854 and 864 of needle hub 210 against snap-out openings 1340 and 1350 in infusion site base 1100, respectively, causes snap-out openings 1340 and 1350 of infusion site base 1100 to release snap-fit structures 854 and 864 of needle hub 210 from snap-fit openings 960 and 962 of needle carriage 220. Ejection snap- fit structures 854 and 864 of needle hub 210 from snap-fit openings 960 and 962 of needle carriage 220 is facilitated, for example, in the way described below.

[0090] Snap-fit structure 854 of needle hub 210 includes cam surfaces 874 and 876, and snap- fit structure 864 of needle hub 210 includes cam surfaces 867 and 869. Pushing snap-fit structures 854 and 864 of needle hub 210 against snap-out openings 1340 and 1350, respectively, in infusion site base (port) 1100 results in camming co-action between cam surfaces 874 and 876 of snap-fit structure 854 and the funnel like entrance portion (‘mouth’) of snap-out opening 1340 of infusion site base 1100, and, similarly, between cam surfaces 867 and 869 of snap-fit structure 864 and the funnel like entrance portion of snap-out opening 1350 of infusion site base 1100. The camming co-action between each pair of cam surfaces (e.g., pair of cam surfaces 874 and 876, and pair of cam surfaces 867 and 869) and the respective snap-out opening (1340,1350) in infusion site base 1100 causes snap-fit structures 854 and 864 of needle hub 210 to be released (snapped out) from snap-fit openings 960 and 962 of needle carriage 220, hence needle hub 210 to be released from needle carriage 220). Ejection of needle hub 210 from needle carriage 220 enables needle retraction spring 1500, which is initially compressed by and between needle hub 210 and needle carriage 220, to extend and move needle hub 210 in needle carriage 220, in a needle retraction direction opposite needle insertion direction 141, while keeping needle 812 fully contained in needle carriage 220.

[0091] As part of the needle and cannula insertion process, needle carriage 220, with needle hub 210 snap-fitted in it, is pressed (by initially compressed needle insertion spring 104) against infusion site base 1100. As a result of this pressure, snap-fit structures 854 and 864 of needle hub 210, which are respectively aligned with snap-out openings 1340 and 1350 of infusion site base 1100, are pushed against snap-out openings 1340 and 1350 (Fig. 13A and Fig. 14A) in infusion site base (port) 1100.

[0092] Needle carriage 220 also includes a first set of alignment ribs 964 and a second set of alignment ribs 966 (cf. Fig. 9B). First alignment ribs 964 and second alignment ribs 966 extendfrom open proximal end 920 of needle carriage 220 along a length of elongated body 900 towards distal base 930 of needle carriage 220. First alignment ribs 964 and second alignment ribs 966 respectively form two channels to longitudinally guide rails 850 and 860 of needle hub 210 in needle carriage 220, hence snap-fit structures 854 and 864 of needle hub 230 to snap-fit openings 960 and 962 of needle carriage 220, to enable locking needle hub 210 in needle carriage 220 in releasable manner.

[0093] Needle carriage 220 also includes a cylindrical wall 970. Cylindrical wall 970 partially extend from distal base 930 of needle carriage 220 along a length of elongated body 900 towards proximal end 920 of needle carriage 220. Cylindrical wall 970 circumferentially surround cylindrical body 900 of needle carriage 220, and form therewith a one-sided open annular channel 972 for receiving a first end portion of needle insertion spring 104.

[0094] Needle carriage 220 may also include diametrically opposed cam members 980 and 982 that outwardly extend from cylindrical wall 970. Cam members 980 and 982 are configured to cammingly co-act with cam surfaces 119 and 121 of actuation cap 110 when actuation cap 110 axially move in needle insertion direction 141. Camming co-action between cam surfaces 119 and 121 of actuation cap 110 and cam members 980 and 982 of needle carriage 220 rotates needle carriage 220 about centerline 101 in, and relative to, sleeve 230 from an angular “standby position to an angular “insertion” position, as described below. Referring to, for example, Fig. 9C and assuming that actuation cap 110 is in the “lock” angular position in safety member 130, when actuation cap 110 moves in needle insertion direction 141, cam fin 112 moves in the same direction and cam surface 119 applies to cam member 980 a lateral force 151. Applying lateral force 151 on cam member 980 causes needle carriage 220 to rotate (974) about centerline 101.

[0095] Needle carriage 220 also includes a concentric needle opening 984 at distal base 930. Needle 812 protrudes through needle opening 984 when snap-fit structures 854 and 864 of needle hub 230 are snap-fitted into snap-fit openings 960 and 962 of needle carriage 220 in preparation for a needle insertion and prior to a needle retraction by needle retraction spring 1500. Needle retraction coil spring 1500 is initially compressed by, and between, proximal base 820 of needle hub 210 and distal base 930 of needle carriage 220 when snap-fit structures 854 and 864 of needle hub 230 are snap-fitted into snap-fit openings 960 and 962 of needle carriage 220.

[0096] Fig. 9E shows snap-fit structures 854 and 864 of needle hub 210 snap-fitted into (and protruding from) snap-fit openings (mounting holes) 960 and 962 of needle carriage 220. This is the initial axial position of needle hub 210 in needle carriage 220, that is, ready for insertion but before insertion of the needle and cannula takes place. The initial axial position of needle hub 210 in needle carriage 220 is shown at “A” in Fig. 9D and corresponds to insertion line 986. (Needle hub 210 completely resides in needle carriage 220 but it is shown in Fig. 9D beside needle carriage 220 only for reference to illustrate the two extreme axial positions of needle hub 210 relative to needle carriage 220.)

[0097] Upon, and during, activation of cannula insertion system 1001 (by manually pushing actuation cap 110 against housing 120, in needle insertion direction 141), needle hub 210 and needle carriage 220 move in unison relative to sleeve 230, in needle insertion direction 141, when needle insertion spring 104 pushes (drives) needle carriage 220 from a “standby position (1064, Figs. 10A and 10C) in sleeve 230 to a cannula (and needle) “insertion” position (1066, Figs. 10A and 10C) in sleeve 230. Needle insertion spring 104 can axially (distally) move needle carriage 220 in sleeve 230 up to a point where distal base 930 (Figs. 9A and 9C) of needle carriage 220 is counteracted by “stop” ridge(s) or protrusion(s) 1076.

[0098] Also shown in Fig. 9E are cannula 1230 and needle 812. After cannula 1230 is inserted by using needle 812, cannula 1230 remains in the user’s body, cannula base 1232 remains in infusion site base (port) 1100, and needle 812 is fully retracted back into needle carriage 220 by retraction spring 1500 when snap-fit structures 854 and 864 of needle hub 210 are snapped out of snap-fit openings (mounting holes) 960 and 962 of needle carriage 220. (Retraction spring 1500 is not shown in Fig. 9D.) The retraction direction of needle hub 210 in needle carriage 220 and the maximal retraction travel distance of needle hub 210 therein is shown at “L” . The retraction axial position of needle hub 210 relative to needle carriage 220 is shown at “B” in Fig. 9D, which corresponds to retraction line 988. (As mentioned herein, needle hub 210 completely resides in needle carriage 220 but is shown in Fig. 9D beside needle carriage 220 only for reference to illustrate an axial position of the needle hub relative to the needle carriage.)

[0099] Disposable part 200 may also include a hollow cylindrical sleeve. Figs. 10A-10C (for example) show a hollow cylindrical sleeve (230) according to an example embodiment. Sleeve 230 is configured to concentrically receive and house needle carriage 220, and to permitrestrained axial movement of needle carriage 220 in sleeve 230 between an axial “standby” position 1064 (Figs. 10A and 10C), which corresponds to a “standby” angular position of needle carriage 220 relative to sleeve 230, and an axial “insertion” position 1066 (Figs. 10A and 10C), which corresponds to an “insertion” angular position of needle carriage 220 relative to sleeve 230.

[0100] Sleeve 230 has an elongated body 1000 that extends along centerline 101 and defines a through bore 1010 between a proximal open end 1020 and a distal open end 1022 of elongated body 1000 (hence distal open end 1022 of sleeve 230). Sleeve 230 may include diametrically opposed parallel guiding rails 212 and 213. Guiding rails 212 and 213 are external to (they outwardly protrude from) elongated body 1000, and longitudinally extend a partial length of elongated body 1000 from proximal open end 1020 towards distal open end 1022 of sleeve 230.

[0101] Sleeve 230 may also include diametrically opposed cantilever snaps 214 and217 that are respectively lengthwise aligned with guiding ribs 212 and 213. Cantilever snaps 214 and 217 longitudinally extend a partial length of elongated body 1000 of sleeve 230 from distal open end 1022 of elongated body 1000 towards proximal open end 1020 of elongated body 1000. Cantilever snaps 214 and 217 respectively include rigid portions 1042 and 1052 that may be integrated into, fixed to, or molded as part of open distal end 1022 of elongated body 1000. Cantilever snaps 214 and 217 may also respectively include snap-fit hooks 216 and218 that are inwardly deflectable by lateral “bridges” 124 and 143 of housing 120. Snap-fit hooks 216 and 218 are dimensioned to respectively snap-fit into middle snap-fit windows 154 and 156 of housing 120, to snap fittingly couple sleeve 230 with housing 120, and, thus, disposable part 200 with reusable part 100. After sleeve 230 is inserted into, and snap fittingly coupled with, housing 120 for inserting a cannula, sleeve 230 is detachable from housing 120, for example after the insertion of the cannula (1230), by manually pushing ejection members 122 and 158 of housing 120 inwardly (towards centerline 101), which action releases snap-fit hooks 216 and 218 of sleeve 230 from snap-fit windows 154 and 156 of housing 120, hence disposable part 200 from reusable part 100.

[0102] Sleeve 230 also includes “L”-shaped guideway cutouts 1060 and 1070. “L”- shaped guideway cutouts 1060 and 1070 extend a partial length of elongated body 1000, fromdistal open end 1022 of elongated body 1000 towards proximal open end 1020 of elongated body 1000. Each “L”-shaped guideway cutout (1060,1070) includes an axial section and a lateral section. The axial section defines an axial “insertion” section / path corresponding to an “insertion” angular position of needle carriage 220 (relative to sleeve 230) that enables axial movement of needle carriage 220 (hence of needle 812) in sleeve 230 in needle insertion direction 141. The lateral section defines a “standby” section / path (a restraining feature) corresponding to an angular position of needle carriage 220 (relative to sleeve 230) that, on the one hand, inhibits axial movement of needle carriage 220 (hence of needle 812) in sleeve 230 in needle insertion direction 141, and, on the other hand, enables needle carriage 220 to be rotationally guided, or moved (by cam fins 112 and 114 of actuation cap 110), to the “insertion” angular position of needle carriage 220 in sleeve 230.

[0103] By way of example, “L”-shaped guideway cutout 1060 includes an “axial” section 1062 and a “lateral” section 1068. Similarly, “L”-shaped guideway cutout 1070 includes an “axial” section 1073 and a “lateral” section 1075 that respectively function in the same way as “axial” section 1062 and “lateral” section 1068 of “L”-shaped guideway cutout 1060. The function of the “axial” section and the “lateral” section is described below with reference to “L”-shaped guideway cutout 1060 as an example.

[0104] “Axial” section 1062 of “L”-shaped guideway cutout 1060 defines an axial “insertion” path that corresponds to an angular position of needle carriage 220 (relative to sleeve 230) that enables needle carriage 220 (hence of needle 812) to be axially moved (by needle insertion spring 104) in sleeve 230 in needle insertion direction 141. “Lateral” section 1068 of “L”-shaped guideway cutout 1060 defines a “standby” angular position of needle carriage 220 relative to sleeve 230. “Lateral” section 1068 is configured to rotationally (laterally) guide needle carriage 220 in sleeve 210 to “axial” section 1062, hence to the “insertion” path.

[0105] In the “insertion” angular position of needle carriage 220 relative to sleeve 230, needle carriage 220, with the needle hub (210) snap-fitted to it, is axially drivable in unison in needle insertion direction 141 by enabling the initially compressed insertion spring (104) to linearly extend and drive (push) needle carriage 220 from an initially withdrawn position (WDN, 1064), in which needle 812 completely resides in sleeve 230, to an insertion position(INS2, 1066), in which needle 812 protrudes (at least partly) from distal end 1022 of sleeve 230 to pierce through the skin of a person using cannula insertion system 1001.

[0106] In the ^standby angular position of needle carriage 220 relative to sleeve 230, lateral section 1068 inhibits axial movement of needle carriage 220 (hence of needle 812) in sleeve 230 in needle insertion direction 141, and, on the other hand, enables needle carriage 220 to be rotationally guided (for example by cam fins 112 and 114 of actuation cap 110) to the insertion path (insertion angular position).

[0107] Needle carriage 220 is rotatable in, and relative to, sleeve 230 from the standby " angular position to the insertion " angular position by camming co-action between cam fins 112 and 114 of actuation cap 110 and cam members 980 and 982 of needle carriage 220. Referring, for example, to Fig. 9C, linear movement of cam fin 112 (and 114) of actuation cap 110 in needle insertion direction 141 is converted into rotational movement of needle carriage 220 in sleeve 230, in the counterclockwise direction (CCW, 974).

[0108] Referring again to housing 120, ejection members 122 and 158 of housing 120 perform the following functions, two of which are performed simultaneously:(i) ejection members 122 and 158, in conjunction (by co-acting) with longitudal guide slots 168 and 170 of safety member 130, angularly align housing 120 relative to safety member 130 during insertion of housing 120 into safety member 130;(ii) when housing 120 resides in safety member 130, ejection members 122 and 158 lock safety member 130 from one side, while actuation cap 110 locks safety member 130 from the opposite side. More specifically, circumferential annular shoulder 140 of safety member 130 is ‘sandwiched’ between ejection members 122 and 158 of housing 120 and actuation cap 110;(iii) ejection members 122 and 158 respectively push cantilever snaps 214 and 217 of sleeve 230 inwardly (laterally) out of snap-fit windows 154 and 156 of housing 120 by cammingly co-acting with cam surfaces 216 and 218 of cantilever snaps 214 and 217, and, at the same time,(iv) ejection members 122 and 158 also co-act with cam surfaces 216 and 218 to push cantilever snaps 214 and 217 of sleeve 230 axially (in the needle insertion direction 141). Simultaneously pushing cantilever snaps 214 and 217 of sleeve 230 inwardly (e.g., radially inward) and axially causes sleeve 230 to be ejected (withdrawn) fromhousing 120. The ejected disposable part (200) may, then, be disposed of and replaced with a new disposable part similar to disposable part 200.

[0109] Upon activation of cannula insertion system 1001, needle carriage 220 is moved (by insertion spring 104) in sleeve 230 from a “retraction position (line 1064, Fig. 10A) to an “insertion” position (line 1066, Fig. 10A), and needle carriage 220 remains in this position. Concurrently to the insertion stage, needle hub 210 is moved (by retraction spring 1500), in needle carriage 220 from a second “insertion” position (line 986, Fig. 9D) to a second “retraction” position (line 988, Fig. 9D), and needle hub 210 remains in this position for safety reasons. So, the invention embodies two distinct instances of “retraction” positions and processes, and two distinct instances of “insertion” positions and processes.

[0110] Figs. 11 A- 1 IB depict the needle carriage (220) of Figs. 9A-9E assembled to the sleeve (230) of Figs. 10A-10C. Needle carriage 220 is shown in the initial “standby” position in sleeve 230, ready for activation of cannula insertion system 1001. (Needle hub 210 resides in needle carriage 220, though it is not shown in Figs. 11A-11B.) In this position, each of the cam members 980 and 982 of needle carriage 220 ‘sits’ in, and axially retrained by, a lateral section (1068,1075) of the respective “L”-shaped guideway cutout (1060,1070). Saying that needle carriage 220 is in the initial “standby” position in sleeve 230 is equivalent to saying that needle carriage 220 is in a “standby” angular position relative to sleeve 230.

[0111] Figs. 12A-12B depict a cannula hub 1200 according to an example embodiment. Cannula hub 1200 may include a hub body 1210, a through hole 1220 in body 1210, and a cannula 1230. Hub body 1210 may take different forms and formfactors, depending on the design of site base 1100. Initially (prior to activation of cannula insertion system 1001), needle 812 is inserted through hole 1220 and through the tubelike cannula 120, passed exit opening 1240 of cannula hub 1200.

[0112] Figs. 13A-13B depict a site base 1100 according to an example embodiment. Site base 1100 may include a thin flat body 1310 that may be slightly rigid yet adapted for adherence to a person’s skin, and a body 1320. Site base body 1320 may include a socket 1330 for receiving hub body 1210 of cannula hub 1200. Site base body 1320 may also include snap- out openings 1340 and 1350 for snapping snap-fit structures 854 and 864 of needle hub 210out of needle carriage 220. Site base body 1320 may also include a flat surface 1380. Flat body 1310 and flat surface 1380 of site base 1100 may be perpendicular to centerline 101, as illustrated in, for example, Fig. 14A. Site base body 1320 may also include snap-fit ridges, or protrusions, 1360 and 1362. Protrusions 1360 and 1362 may have hemispherical shape and are designed to snap-fit into snap holes 1072 and 1074 in distal end 1022 of sleeve 230. Protrusions 1360 and 1362 are shown in Fig. 16 respectively snap fitted into snap holes 1072 and 1074. Using protrusions such as protrusions 1360 and 1362, site base 1100 can be releasably attached to sleeve 230. Following insertion of cannula 1230, needle 812 is fully retracted into needle carriage 220, after which sleeve 230 (hence cannula insertion system 1001) can be pulled away from site base 1100, leaving cannula 1230 in the person’s body. Protrusions 1360 and 1362 of site base 1100 are shown in Fig. 16 respectively snap fitted into snap holes 1072 and 1074 of sleeve 230. Pulling sleeve 230 away from site base 1100 causes protrusions 1360 and 1362 of site base 1100 to snap out from snap holes 1072 and 1074 of sleeve 230. After sleeve 230 is pulled out and away from site base 1100, disposable part 200 can be manually ejected (pulled out) from reusable part 100 and disposed of.

[0113] Figs. 14A-14B depict the cannula hub 1200 of Figs. 12A-12B assembled to the site base 1100 of Figs. 13A-13B after insertion of cannula 1230. An adhesive layer 1370 is, on the one hand, adhesively attached to the bottom side (the ‘patient’s side) of site base 1100, and, on the other hand, it is adhesively attachable to the patient’s skin.

[0114] Fig. 15 depicts an exploded view 1510 of disposable part 200. To assemble disposable part 200, proximal portion 1520 of needle retraction spring 1500 may be inserted into annular space 840 in needle hub 210, and distal portion 1530 of needle retraction spring 1500 may be inserted into chamber 910 (Fig. 9D) of needle carriage 220. Then, needle hub 210 may be inserted into needle carriage 210 until needle hub 210 is (releasably) locked in, and to, needle carriage 220 by snap-fit structures 854 and 864 of needle hub 210 being snapped into snap-fit openings 960 and 962 of needle carriage 220. Fig. 9E shows needle hub 210 locked in, and to, needle carriage 220. Inserting needle hub 210 into needle carriage 220 compresses (energizes) needle retraction spring 1500 between proximal base 820 of needle hub 210 on one side, and distal base 930 of needle carriage 220 on the other side. That is, being axially positioned between needle hub 210 and needle carriage 220, the more needle hub 210 is pushed (inserted) into needle carriage 220, the greater the compression of needle retraction spring1500, hence the potential energy stored in needle retraction spring 1500, with the maximal potential energy being obtained when needle hub 210 is locked in and to needle carriage 220.

[0115] The next assembly step may include attaching cannula hub 1200 to distal base 930 of needle carriage 220 in a way that needle 812 is inserted into cannula 1230 and extends passed exit opening 1240 of cannula hub 1200, as shown, for example, in Fig. 9E. The next assembly step may include inserting needle carriage 220 into sleeve 230 in a way that “L”- shaped guideway cutouts 1060 and 1070 of sleeve 230 respectively guide cam members 980 and 982 of needle carriage 220 into sleeve 230. Guiding cam members 980 and 982 of needle carriage 220 into sleeve 230 includes guiding cam members 980 and 982 of needle carriage 220 linearly, along the axial sections (1062,1073) of “L”-shaped guideway cutouts 1060 and 1070, and then, rotationally in, or into, the lateral sections (1068,1075) of “L”-shaped guideway cutouts 1060 and 1070. Needle carriage 220 is in the “standby angular position in sleeve 230 when cam members 980 and 982 of needle carriage 220 sit in, and axially restrained by, the lateral sections (1068,1075) of “L”-shaped guideway cutouts 1060 and 1070. Figs. 11A-11B show needle carriage 220 in the “standby angular position in sleeve 230.

[0116] When needle carriage 220 is in the “standby angular position in sleeve 230, needle 812 protrudes from needle carriage 220, yet it is completely contained within sleeve 230. However, as another assembly step includes coupling site base 1100 to sleeve 230 (an example coupling is shown in Fig. 16) before insertion of the cannula, distal open end 1022 of sleeve 230 is sealed in a way that needle 812 is inaccessible (intentionally or unintentionally) to a patient using cannula insertion system 1001. During insertion of cannula 1230, needle carriage 220 moves from the “standby position (line 1064, Fig. 10 A) to the “insertion” position (line 1066, Fig. 10A), and, after the insertion, remains in the “insertion” position. However, at this stage needle hub 210 is automatically retracted (by spring 1500) in needle carriage 220 in a way that needle 812 completely resides in needle carriage 220, which, again, makes needle 812 inaccessible (intentionally or unintentionally) to the patient using cannula insertion system 1001. Coupling site base 1100 to sleeve 230 may be the last assembly step of disposable part 200.

[0117] Fig. 16 is a cross-sectional view of the assembled disposable part 200. Fig. 16 shows disposable part 200 in the pre-activation state where needle hub 210 is releasably lockedin needle carriage 220 (by means of snap-fit structures 854 and 864 of needle hub 210 and snap-fit openings 960 and 962 of needle carriage 220) in the “insertion” position (position 986 in Fig. 9D), needle carriage 220 is axially restrained in the “standby” position in sleeve 230, cannula hub 1200 is coupled to needle carriage 220, and site base 1100 is coupled to sleeve 230. Fig. 16 does not show needle insertion spring 104, as this spring is part of reusable part 100. Disposable part 200 is assembled before it is shipped to the end user (e.g., a patient).

[0118] Figs. 17A-17B, and 18-22 show steps of using cannula insertion system 1001. Figs. 17A-17B depict a first step associated with using cannula insertion system 1001 of Fig.1 (connecting disposable part 200 to reusable part 100). Since, by definition, reusable part 100 can be used multiple times, the person using it can make sure that actuation cap 110 is always in the “lock” angular position (relative to safety member 130) before inserting into reusable part 100 a new disposable part, for example disposable part 200. If actuation cap 110 is initially in the “unlock” angular position (relative to safety member 130), it can be rotated CCW (in direction 105, Figs. 1, 17A) to the “lock” angular position to prevent unintentional activation of cannula insertion system 1001. Then, the person using the system connects (103) disposable part 200 to reusable part 100. Referring to Fig. 17B, cap spring 102 and needle insertion spring 104 are shown at their initially relaxed (extended, de-energized) state. Being initially in the relaxed state, spring 102 maintains actuation cap 110 at its axial “Pre-activation” state, ready to be pushed by the user using the system.

[0119] Needle retraction spring 1500 is shown initially at its compressed (energized) state in preparation for the needle retraction step. Also shown in Fig. 17B is needle hub 210, which is initially snap fitted to needle carriage 220 (as shown, for example, in Fig. 9E) and, therefore, axially positioned at the “INS” position 986 in needle carriage 220 (as shown, for example, in Fig. 9D). By way of example, Fig. 17B shows one of the two cam members of needle carriage 220 (e.g., cam member 980) initially ‘resting’ in the “standby” section 1068 of “L”-shaped guideway cutout 1060 of sleeve 230. The other cam member of needle carriage 220 (e.g., cam member 982) is not shown in Fig. 17B, though it initially ‘rests’ in the “standby” section of the other “L”-shaped guideway cutout of sleeve 230 (e.g., “L”-shaped guideway cutout 1070).

[0120] Fig. 18 is a cross-sectional view of the assembled cannula insertion system 1001 of Fig. 1 showing disposable part 200 inserted into (connected to) reusable part 100, and cannula insertion system 1001 in the ‘pre-deployment’ (pre-activation) state. As described herein, insertion of disposable part 200 into reusable part 100 compresses (energizes) needle insertion spring 104 in preparation for the of needle and cannula insertion step. Needle insertion spring 104 is shown in Fig. 18 in its compressed (energized) state. Similarly to Fig. 4, Fig. 18 shows actuation cap 110 coupled with housing 120 by snapping cantilever snaps 123 and 125 of actuation cap 110 into snap-fit windows 128 and 142 of housing 120, and in the ^reactivation ' state. Fig. 18 also shows diametrically opposed “stop” surfaces 172 and 174 that prevent, by co-acting with ” top” surfaces 127 and 129 of actuation cap 110, axial movement of actuation cap 110 relative to housing 120, from the “pre-activation” state of actuation cap 110 to the “activation” state (cf. Fig. 4) of actuation cap 110 when actuation cap 110 is in the “lock” angular position relative to safety member 130.

[0121] Fig. 19 depicts a second step of using cannula insertion system 1001 of Fig. 1. The second step of using cannula insertion system 1001 of Fig. 1 may include two substeps. A first substep may include peeling (1900) a protective layer off to expose the adhesive layer of site base 1100 before site base 1100 can be adhesively attached to the patient’s skin. A second substep may include unlocking actuation cap 110. Unlocking actuation cap 110 is performed by rotating it clockwise (CW), for example 45° about centerline 101, in direction 109 and relative to safety member 130, to the “unlock” angular position. Fig. 19 shows actuation cap 110 in the “unlock” angular position relative to safety member 130, in which: (1) actuation cap 110 can be axially pushed manually in the needle insertion direction 141 to trigger the insertion (and needle retraction) process, and (2) ejection members 122 and 158 of housing 120 are exposed to the user (at least tactily) to enable the user to eject disposable part 200 from reusable part 100 by pushing ejection members 122 and 158 inwardly. (Fig. 19 shows only ejection member 122 of housing 120.)

[0122] Fig. 20 is a cross-sectional view of cannula insertion system 1001 of Fig. 1 depicting a third step of using cannula insertion system 1001 of Fig. 1 (automatic deployment / activation). Now that actuation cap 110 is in the “unlock” angular position relative to safety member 130, the user may axially push actuation cap 110 (against cap spring 102 and relative to housing 120 of reusable part 100) in needle insertion direction 141. As describedherein, when actuation cap 110 is pushed in this direction, cam fins 112 and 114 of actuation cap 110 cammingly co-act with cam members 980 and 982 of needle carriage 220 to rotate needle carriage 220, in sleeve 230, from the “standby angular position to the “insertion” angular position. In the “insertion” angular position needle insertion spring 104 axially extends to axially move needle carriage 220 (hence needle hub 210) to the axial “insertion” position (1066, Fig. 10A) in sleeve 230.

[0123] Fig. 20 shows needle insertion spring 104 extended (at least partly relaxed), and needle carriage 220 at its lowest possible location (e.g., axial “insertion” position 1066, Fig. 10A) in sleeve 230 as a result of the extension of spring 104. As variously described herein, automatic activation of cannula insertion system 1001 means automatic insertion of needle 812 and cannula 1230 by needle insertion spring 104, and, in addition, automatic retraction of needle 812 by needle retraction spring 1500. Fig. 20 shows needle 812 and the cannula 1230 after automatic insertion and before automatic needle retraction takes place. Accordingly, both needle 812 and the cannula 1230 are shown in Fig. 20 still protruding from site base 1100, as is the case at the moment of insertion of the needle and cannula into the skin of a person. Accordingly, while needle insertion spring 104 is shown in Fig. 20 extended (relaxed), needle retraction spring 1500 is shown in Fig. 20 still compressed (energized).

[0124] Cap spring 102 is still shown compressed in Fig. 20 only for the sake of illustration, as retraction of needle 812 by retraction spring 1500 at this stage is independent of the state of actuation cap 110 (i.e., “Pre-activation” state or “Activation” state, per Fig. 4), and done automatically and concurrently to, and as a result of, the insertion of needle 812 and cannula 1230 into the patient’s skin. In other words, after cannula insertion system 1001 is activated (after the cannula is deployed), the axial position of actuation cap 110 relative to housing 120 (i.e., “Pre-activation” state or “Activation” state, cf. Fig. 4) has no bearing on the automatic retraction of the needle. That is, retraction of needle 812 is done automatically following the needle (and cannula) insertion, regardless of the state of actuation cap 110.

[0125] Cam member 980 of needle carriage 220 is shown in Fig. 20 after cam surface 119 of cam fin 112 of actuation cap 110 has cammingly moved it away from lateral section 1068 of “L”-shaped guideway cutout 1060 (i.e., from its ‘standby position in sleeve 230) to axial section 1062 of “L”-shaped guideway cutout 1060. (Only part of axial section 1062 of“L”-shaped guideway cutout 1060 is shown in Fig. 20.) Similarly, cam member 982 of needle carriage 220 is shown in Fig. 20 after cam surface 121 of cam fin 114 of actuation cap 110 has cammingly moved it away from lateral section 1075 of “L”-shaped guideway cutout 1070 (i.e., from its 'standby' position in sleeve 230) to axial section 1073 of “L”-shaped guideway cutout 1070. (Lateral section 1075 of “L”-shaped guideway cutout 1070 and cam surface 121 of cam fin 114 are not shown in Fig. 20. Only part of axial section 1073 of “L”-shaped guideway cutout 1070 is shown in Fig. 20.) As described herein, simultaneously pushing cam members 980 and 982 of needle carriage 220 away from their ' tandby' positions in sleeve 230 causes needle carriage 220 to rotate in direction 974 (see, for example, Fig. 11B), to the angular insertion position in sleeve 230 where needle insertion spring 104 can apply its stored energy to move needle carriage 220, hence needle 812, in needle insertion direction 141. Fig. 20 shows needle hub 210 before it is retracted by needle retraction spring 1500 in needle carriage 220 in direction 159. Retraction line 988 is the highest axial position of needle hub 210 in needle carriage 220 after needle hub 210 has completed its linear travel in needle hub 210.

[0126] Fig. 21 is a cross-sectional view of cannula insertion system 1001 of Fig. 1 depicting a fourth step of using cannula insertion system 1001 of Fig. 1 (automatic needle retraction). As shown in Fig. 21, needle hub 210 is axially retracted by being moved (by needle retraction spring 1500) in needle carriage 220 in direction 159, from the initial axial "insertion" (INS) position 986 to the axial "retraction" (RTR) position 988 in needle carriage 220. (The axial retraction travel "L" of needle hub 210 in, and relative to, needle carriage 220 in direction 159 is limited by snap-fit tabs 940 and 950 of needle carriage 220.) Accordingly, needle retraction spring 1500 is shown in Fig. 21 in its extended state, and needle 812 is shown fully contained in (retracted into) needle carriage 220 to prevent, for example, potential needlestick injuries and cross -contamination due to mishandling of disposable part 200 after use. At this point, disposable part 200 may be withdrawn (ejected) from reusable part 100 and thrown away. (Figs. 24A-24C demonstrate how cannula insertion system 1001 assists the user in detaching it from site base 1100 before disposable part 200 can be disposed of.) Fig. 21 also shows cannula 1230 inserted through the patient’s skin. (The patient’s skin or body is neither shown in Fig. 21, nor in any other drawing.)

[0127] After the needle and cannula insertion and needle retraction process is completed, the user can release actuation cap 110 to let it resume its “Pre- activation” state (bycap ‘bias’ spring 102) for the next use of reusable part 100. Then, cannula insertion system 1001 may be removed from site base 1100, leaving site base 1100 adhesively attached to the patient’s skin with example cannula hub 1200 mounted thereon, as shown in Fig. 22.

[0128] Figs. 23A-23C depict a cannula hub 2300 and a site base 2310 according to an example embodiment. Cannula hub 2300 may include a rounded base 2302, and a cannula 2304. Site base 2310 may include a site base body 2312, and a thin flat body 2314. Site base 2310 may be coupled to cannula hub 2300 by using an annular snap fit structure. The annular snap fit structure includes a circumferential ridge 2306 in base body 2312, which defines therein a funnel like ‘mouth’ suitable for receiving rounded base 2302 of cannula hub 2300. Rounded base 2302 of cannula hub 2300 includes an annular shoulder 2316, and site base 2310 includes a circumferential ridge 2306. Circumferential ridge 2306 of site base 2310 is designed to lock into annular shoulder 2316 of rounded base 2302. Fig. 23A shows cannula hub 2300 and site base 2310 before hub 2300 is mounted to site base 2310. Fig. 23B shows cannula hub 2300 abutting site base 2310, and Fig. 23C shows cannula hub 2300 snap fitted to (locked in) site base 2310. Another example of a cannula hub (1232) is shown in Fig. 9E. The site base and the cannula hub are designed such that whatever cannula hub is used, it can functionally be snap fitted to a corresponding socket in the site base.

[0129] All, or some, parts of the reusable part 100 and disposable part 200 may be made of thermoplastic material(s), and manufactured by using any suitable plastic injection molding technique, a 3-D printing technique, etc. Any of the three springs mentioned herein (cap spring 102, needle insertion spring 104 and needle retraction spring 1500) may be made of, for example, plastic or steel.

[0130] Figs. 24A-24C are cross-sectional views of cannula insertion system 1001 illustrating detachment of site base 1100 from cannula insertion system 1001 according to an example embodiment. Fig. 24A shows cannula insertion system 1001 at the time of deployment of cannula 1230, with needle 812 still residing in cannula 1230, that is, prior to retraction of insertion needle 812. (The user’s skin / body pierced by needle 812 is not shown in Figs. 24A- 24C.) In Fig. 24A, needle carriage 220 is shown after having axially moved to a position where distal base 930 of needle carriage 220 contacts flat surface 1380 of site base 1100, namely, prior to drive spring 104 axially moving needle carriage 220 its full span, which is a travel pathlimited by “stop” ridges 1076 and 2410 of sleeve 230. When needle carriage 220 first contacts site base 1100, base 930 of needle carriage 220 is axially spaced away from “stop” ridges 1076 and 2410 of sleeve 230 by a gap, or distance, 2420, which is referred to herein as ‘detachment distance’.

[0131] As needle carriage 220 continues to move (by needle insertion spring 104) the detachment distance 2420 (that is, until needle carriage 220 is stopped by “stop” ridges 1076 and 2410 of sleeve 230), base 930 of needle carriage 220 axially pushes site base 1100 distally away, out of sleeve 230, leaving a separation gap 2430 between flat body 1310 (Fig. 13A) of site base 1100 and distal end 1022 of sleeve 230. Referring also to Fig. 24C, when base 930 of needle carriage 220 distally moves site base 1100 the detachment distance 2420, snap-fit ridges 1360 and 1362 of site base 1100 are snapped out of (i.e., released from) snap holes 1072 and 1074 of sleeve 230, which results in the detachment of site base 1100 from sleeve 230, hence from cannula insertion system 1001. (Fig. 16, for example, shows site base 1100 coupled to sleeve 230, hence to disposable part 200, prior to activation of cannula insertion system 1001 by snap-fitting ridges 1360 and 1362 into snap holes 1072 and 1074 of sleeve 230.)

[0132] In Figs. 24B and 24C cannula insertion system 1001 is shown in a state where cannula 1230 is deployed, needle 812 is fully retracted back into needle carriage 220, and site base 1100 is detached (2430), or decoupled, from cannula insertion system 1001 as a result of needle insertion spring 104 extending to a maximal length permitted by the design of spring 104, and of cannula insertion system 1001 in general. So, needle insertion spring 104 not only drives needle 812 and cannula 1230 to deploy cannula 1230, but it also releases cannula insertion system 1001 from site base 1100 immediately following the cannula deployment. The ability of cannula insertion system 1001 to detach itself from site base 1100 in the way described herein is beneficial because when a person pulls cannula insertion system 1001 off site base 1100 after the cannula is deployed, the risk that the person would unintentionally pull site base 1100 (and cannula 1230) together with cannula insertion system 1001 is reduced to non-existent. That is, if a conventional cannula insertion system is still attached to site base 1100 after the cannula is deployed, trying to separate between the two might tamper with the cannula deployment, for example it might destabilize the cannula positioning in the person’s body, which might result in, for example, unnecessary injuries. So, using needle insertion spring 104 to also eject site base 1100 in the way described herein solves this problem.

[0133] The articles "a" and "an" are used herein to refer to one or to more than one (e.g., to at least one) of the grammatical object of the article, depending on the context. By way of example, depending on the context, "an element" can mean one element or more than one element. The term "including" is used herein to mean, and is used interchangeably with, the phrase "including but not limited to". The terms "or" and "and" are used herein to mean, and are used interchangeably with, the term "and / or," unless context clearly indicates otherwise. The term "such as" is used herein to mean, and is used interchangeably, with the phrase "such as but not limited to".

[0134] Having thus described exemplary embodiments of the invention, it will be apparent to those skilled in the art that modifications of the disclosed embodiments will be within the scope of the invention. Alternative embodiments may, accordingly, include functionally equivalent objects / articles. For example, the actuation cap (110) may include a different number of cam fins than those described herein and shown in the pertinent drawings; a cam fin may include a different number of cam surfaces than those described herein and shown in the pertinent drawings; the housing (120) may include a different number of ejection members than those described herein and shown in the pertinent drawings, and the safety member (130) may include a corresponding number of guiding slots (hence concealment chambers and open windows); the needle hub (210) may include a different number of snap- fit structures than those described herein and shown in the pertinent drawings, and the needle carriage (220) and site base (1100) may respectively have a corresponding number of snap-fit openings and snap-out openings; the needle carriage (220) may include a different number of cam members than those described herein and shown in the pertinent drawings, provided that their number corresponds to the number of cam fins (a cam fin per cam member) and to the number of “L”-shaped guideway cutouts, and so on.

[0135] The cannula insertion system (1001) disclosed herein is described and shown in connection with site base 1100 (Fig. 14A) and cannula hub 1200 (Fig. 14A). However, the cannula insertion system or any part thereof may be adapted to other types of site bases (for example to site base 2310, Fig. 23A-23C) and to other types of cannula hubs (for example to cannula hub 2300, Fig. 23A-23C). In addition, an infusion tube connecting a drug delivery pump (for example) to a site base of choice may be connected to the site base using anyconventional, or non-conventional but suitable, technique. Hence the scope of the claims that follow is not limited by the disclosure herein.

Claims

CLAIMS1. A reusable part (100) of a cannula insertion system (1001) for deploying an infusion cannula (1230) through a skin of a user, the reusable part (100) having an axis (101) and comprises: an actuation cap (110) comprising, cam fins (112,114) for cammingly rotating a needle carriage (220) comprising a needle hub (210) in a sleeve (230) from a “standby angular position preventing axial movement of the needle carriage (220) relative to the sleeve (230), to an “insertion” angular position enabling axial movement of the needle carriage (220) in a needle insertion direction (141) relative to the sleeve (230); a housing (120) couplable to the actuation cap (110) by a first snap-fit arrangement enabling constrained bi-directional axial movement of the actuation cap (110) relative to the housing (120), the housing (120) configured to concentrically receive and releasably connect to the sleeve (230) by a second snap-fit arrangement, the housing (120) comprising a needle insertion spring (104) to axially move the needle carriage (220) and the needle hub (210) in unison in the sleeve (230) in a needle insertion direction (141) when the needle carriage (220) is in the ‘insertion’ angular position in the sleeve (230); and a safety member (130) enabling the actuation cap (110) and the housing (120) to rotate therein about the axis (101), in unison, between: a “lock” angular position, in which the actuation cap (110) is axially locked in a “pre-activation” state in which axial movement of the actuation cap (110) towards the housing (120) is prevented, and an “unlock” angular position, in which the actuation cap (110) is free to axially move towards the housing (120) from the “pre-activation” state to an “activation” state to cammingly rotate the needle carriage (220) in the sleeve (230) from the “standby ” angular position to the “insertion ” angular position.

2. The reusable part (100) of claim 1, wherein when the housing (120) is in the safety member (130) and coupled to the actuation cap (110), the actuation cap (110) and the housing (120) are rotatable in unison in the safety member (130) between the “lock” angular position and the “unlock” angular position.

3. The reusable part (100) of claim 1, wherein the actuation cap (110) has a generally cylindrical chamber (113) between a cap proximal base (115) and a cap distal opening (117), wherein the cam fins (112,114) are semi-circular and coaxially extend from the cap proximal base (115) through the chamber (113) and past the cap distal opening (117), and wherein the actuation cap (110) comprises cantilever snaps (123,125) as part of the first snap-fit arrangement.

4. The reusable part (100) of claim 3, wherein the housing (120) has a generally cylindrical chamber (133) between a proximal base (135) and an open distal end (152) to concentrically receive the sleeve (230), the housing (120) further comprising:(i) apertures (137,139) in the proximal base (135), the apertures (137,139) having a complementary arcuate shape to the semi-circular cam fins (112,114) of the actuation cap (110) to enable axial insertion therethrough of the cam fins (112,114) into the housing (120);(ii) proximal snap-fit windows (128,142) as part of the first snap-fit arrangement, to coact with the cantilever snaps (123,125) of the actuation cap (110) to couple the actuation cap (110) with the housing (120);(iii) longitudinal guide slots (126,149), to axially guide the sleeve (230) into the housing (120);(iv) middle snap-fit windows 154 and 156 as part of second snap-fit arrangement, to releasably lock the sleeve (230) in, and to, the housing (120); and(v) ejection members (122,158), to eject the sleeve (230) from the housing (120).

5. The reusable part (100) of claim 3, wherein the safety member (130) has a generally cylindrical through bore (148) for concentrically receiving the housing (120), the safety member (130) comprising guide slots (168,170) to longitudinally guide the ejection members (122,158) of the housing (120), hence housing 120, into the safety member (130) through a distal end (166) of the safety member (130).

6. The reusable part (100) of claim 3, wherein the safety member (130) further comprises:(i) “stop” surfaces (172,174) at a proximal portion (164) of the safety member (130), to co-act with counter “stop” surfaces (127,129) of the cantilever snaps (123,125) of the actuation cap (110) to prevent the axial movement of the actuation cap (110) towardsthe housing (120) when the actuation cap (110) and the housing (120) are in the “lock” angular position in the safety member (130);(ii) one-sided open windows (176,178) at the proximal portion (164) of the safety member (130), to receive the cantilever snaps (123,125) of the actuation cap (110) when the actuation cap (110) is in the “unlock” angular position in the safety member (130), to enable the axial movement of the actuation cap (110) from the “pre-activation” state to the “activation” state, and(iii) concealing chambers (188,190) to conceal the ejection members (122,158) of the housing (120) at least visually and, optionally, tactily when the actuation cap (110) and the housing (120) are in the “lock” angular position in the safety member (130).

7. The reusable part (100) of claim 1, wherein the cannula insertion system (1001) further comprises a disposable part (200), the disposable part (200) releasably engageable with the reusable part (100) and comprising:- the needle hub (210), wherein the needle hub (210) comprises a needle (812);- the needle carriage (220);- a needle retraction spring (1500) initially compressed by, and between, the needle hub (210) and the needle carriage (220), and- the sleeve (230), wherein the needle hub (210) is moveable in the needle carriage (220) by the needle retraction spring (1500) from an axial insertion position (986), in which the needle (812) protrudes through a distal base (930) of the needle carriage (220), to an axial retraction position (988), in which the needle (812) is fully contained in the needle carriage (220).

8. The disposable part (200) of claim 7, wherein the needle hub (210) is releasably attachable to the needle carriage (220) in the axial insertion position (986) by a third snap-fit arrangement.

9. The disposable part (200) of claim 8, wherein the third snap-fit arrangement comprises snap- fit openings (960,962) of the needle carriage (220), and snap-fit structures (854,864) of the needle hub (210), wherein the snap-fit structures (854,864) are configured to snap-fit into the snap-fit openings (960,962).

10. The disposable part (200) of claim 9, wherein the needle hub (210) further comprises:(i) a concentric internal protrusion (810) defining an annular chamber (840) in the needle hub (210) for accommodating a portion of the needle retraction spring (1500); and(ii) elongated guide rails (850,860) extending in parallel to the axis (101) from a proximal base (820) of the needle hub (210) towards and past a distal open end (830) of the needle hub (210), to guide the needle hub (210) into the needle carriage (220).

11. The disposable part (200) of claim 10, wherein the elongated guide rails (850,860) of the needle hub (210) comprise the snap-fit structures (854,864).

12. The disposable part (200) of claim 7, wherein the needle carriage (220) comprises a chamber (910) for containing the needle hub (210) while providing limited axial freedom of movement (£) to the needle hub (210) between an insertion position (“INS”) (986) and a retraction position (“RTR”) (988) in the needle carriage (220).

13. The disposable part (200) of claim 7, wherein the needle carriage (220) further comprises:(i) a one-sided open annular channel (972) for receiving a first end portion of the needle insertion spring (104), a second end portion of the needle insertion spring (104) internally attached to the proximal base (135) of the housing (120), and(ii) cam members (980,982) outwardly extending from the needle carriage (220) to cammingly co-act with the cam fins (112,114) of the actuation cap (110) in response to axial movement of the actuation cap (110) relative to the housing (120), to rotate the needle carriage (220) in the sleeve (230) from the “standby” angular position to the “insertion” angular position.

14. The disposable part (200) of claim 7, wherein the needle sleeve (230) comprises:(i) an elongated body (1000) defining a through bore (1010) between a proximal open end (1020) and a distal open end (1022) of the elongated body (1000), to concentrically receive the needle carriage (220) from the distal open end (1022), and the cam fins (112,114) from the proximal open end (1020);(ii) cantilever snaps (217,214), as part of the second snap-fit arrangement, to snap fit into snap windows (128,142) of the housing (120), and, thus, releasably connect the sleeve (230) to the housing (120); and(iii) “L”-shaped guideway cutouts (1060,1070) extending a partial length of the elongated body (1000) from the distal open end (1022) of the elongated body towards the proximal open end (1020) of the elongated body (1000), each of the “L”-shaped guideway cutouts (1060,1070) comprises: an “axial” section (1062) defining the “insertion” angular position of the needle carriage (220) relative to the sleeve (230), wherein, in said angular position, the needle carriage (220) and the needle hub (210) snap-fitted to the needle carriage (220) are axially drivable in unison in the needle insertion direction (141) by the needle insertion coil spring (104) from the “standby” axial position (1064), in which the needle (812) completely resides in the sleeve (230), to the “insertion” axial position (1066) in which the needle (812) protrudes (at least partially) from the distal end (1022) of the sleeve (230), and a “lateral” section (1068) defining the “standby” angular position of the needle carriage (220) relative to the sleeve (230), the lateral section (1068) configured to rotationally guide the needle carriage (220) in the sleeve (230) to the “axial” section (1062), hence to the “insertion” angular position.

15. The disposable part (200) of claim 7, wherein the sleeve (230) is releasably connectable to an infusion site base (1100) by snap-fit means.

16. The disposable part (200) of claim 15, wherein the infusion site base (1100) comprises snap-out opening (1340,1350) to snap the snap-fit structures (854,864) of the needle hub (210) out of the snap-fit openings (960,962) in needle carriage 220, to facilitate retraction of the needle hub (210) in the needle carriage (220) by the needle retraction spring (1500).

17. The disposable part (200) of claim 15, wherein the infusion site base (1100) comprises snap-fit protrusions (1360,1362) to attach the infusion site base (1100) to the disposable part (200) by snap-fitting snap-fit protrusions (1360,1362) into snap holes (1072,1074) in sleeve 230, and wherein the needle insertion spring (104) is configured to detach the disposable part (200), or to facilitate deployment of the disposable part (200) from the infusion sitebase (1100) during deployment of the cannula (1230), concurrently to the deployment of the cannula, or after the cannula is deployed.

18. A reusable part (100) of a cannula insertion system, the reusable part (100) comprising a housing (120), the housing (120) comprising ejection members (122,158) to eject a disposable part (200) connected to the housing (120), an actuation cap (110) connectable to the housing (120), and an elongated safety member (130) to receive the housing (120), the elongated safety member (130) comprising: longitudal guide slots (168,170) to guide the ejection members (122,158), hence the housing (120), into the safety member (130), each longitudal guide slot (168,170) comprises a concealment chamber (188,190) and an open window (189,191), wherein when the housing (120) is in the safety member (130) and connected to the actuation cap (110), the actuation cap (110) is rotatable (105,109) in the safety member (130) in unison with the housing (120) between: a “lock” angular position, in which the safety member (130) axially locks the actuation cap (110) in a “pre-activation” state preventing activation of the cannula insertion system, and the ejection members (122,158) of the housing (120) are at least visually and, optionally, tactily concealed in the concealment chambers (188,190), and an “unlock” angular position, in which the actuation cap (110) is axially moveable towards the housing (120) from the “pre -activation” state to an “activation” state to activate the cannula insertion system, and the ejection members (122,158) of the housing (120) are accessible to a user via the open windows (189,191) for releasing the disposable part (200) from the housing (120).

19. A safety member (130) for a reusable part (100) of an automatic cannula insertion system, the safety member (130) comprising:(i) a generally cylindrical through bore (148) for concentrically receiving a housing (120) of the reusable part (100) of a cannula insertion system, the housing (120) comprising ejection members (122,158) for ejecting a disposable part (200) of the cannula insertion system from the housing (120) after use;(ii) concealment chambers (188,190), to prevent activation of the ejection members (122,158); and(iii) open windows (189,191), to enable activation of the ejection members (122,158) by a user; wherein when the housing (120) is in the safety member (130), the housing (120) is connectable to an actuation cap (110) of the reusable part (100) in a way that the housing (120) is rotatable (105,109) in unison with the actuation cap (110) relative to the safety member (130) between: a “lock” angular position, in which the safety member (130) prevents axial movement of the actuation cap (110) towards the housing (120) from a ^preactivation state, thus preventing activation of the cannula insertion system, and in which the ejection members (122,158) of the housing (120) are concealed in the concealment chambers (188,190), and an “unlock” angular position, in which the actuation cap (110) is axially moveable towards the housing (120) from the “pre -activation” state to an “activation” state to activate the cannula insertion system, and in which the ejection members (122,158) of the housing (120) are accessible to a user via the open windows (189,191) for releasing the disposable part (200) from the housing (120).

Images