Manual catheter insertion device for medicament delivery device

Abstract

A catheter insertion device including a housing having a cam member, a needle hub having an introducer needle, and a catheter hub having a catheter. The catheter hub has a fluid opening fluidly communicable with the catheter. The needle hub or the catheter hub includes at least one operation pin, and the needle hub and the catheter hub move together from initial to extended positions. The device includes an insertion unit to move the needle hub and the catheter hub, and at least one spring. During movement toward the extended position, the operation pin engages the cam member to rotate the needle hub or the catheter hub, freeing relative securement of the needle hub and the catheter hub, enabling the at least one spring to withdraw the introducer needle from the catheter, establishing fluid communication between the fluid opening and a distal end of the catheter.

Description

MANUAL GATHER INSERTION DEVICE FOR MEDICAMENT DELIVERY DEVICEField of the Invention

[0001] The present invention relates to medical devices, and more particularly, to medicament delivery devices having an insertable catheter and an adhesive for securing the device to a patient’s skin.Background of the Invention

[0002] Infusion pump therapy generally requires an infusion cannula, typically in the form of an infusion needle or a flexible catheter, that pierces the patient's skin and through which infusion of a medicament takes place. Infusion pump therapy offers the advantages of continuous infusion, precision dosing, and programmable delivery schedules.

[0003] To facilitate infusion therapy, there are generally two types of pumps, namely, conventional pumps and patch pumps. Conventional pumps often use a disposable component, typically referred to as an infusion set, tubing set, or pump set, which conveys the medicament from a reservoir within the pump into the skin of the user. The infusion set includes a pump connector, a length of tubing, and a hub or base from which a cannula, in the form of a hollow metal infusion needle or flexible plastic catheter extends. The base typically has an adhesive that retains the base on the skin surface during use. The cannula can be inserted onto the skin manually or with the aid of a manual or automatic insertion device. The insertion device may be a separate unit required by the user.

[0004] Another type of pump is a patch pump. Unlike a conventional infusion pump and infusion set combination, a patch pump is an integrated device that combines most or all of the fluidic components, including the fluid reservoir, pumping mechanism, and mechanism for inserting the cannula, in a single housing that is adhesively attached to an infusion site on the patient's skin, and does not require the use of a separate infusion or tubing set. A patch pump containing a medicament adheres to the patient’s skin and delivers the medicament over a period of time or at a selected time via an integrated subcutaneous cannula. Some patch pumps may wirelessly communicate with a separate controller device, while others are completely self- contained. Such devices can be replaced on a frequent basis, such as every three days, when themedicament reservoir is exhausted or when complications may otherwise occur, such as restriction in the cannula or the infusion site.

[0005] As patch pumps are designed to be a self-contained unit that is worn by the user (e.g., patient), it is preferable to be as small as possible so that it does not interfere with the activities of the user. Thus, to minimize discomfort to the user, it would be preferable to minimize the overall thickness of the patch pump. To minimize the thickness of the patch pump, the constituent parts of the patch pump should be reduced in size and possibly in number as much as possible.

[0006] In minimizing constituent parts, however, the flow rate of medicament to a patient can be affected. A need exists for a mechanism to provide for increased medicament flow rate while minimizing the profde of the medicament delivery device.Summary of Embodiments of the Invention

[0007] Accordingly, it is an aspect of the present invention to provide a catheter insertion device permitting large volume medicament delivery therethrough.

[0008] The foregoing and / or other general aspects of the present invention are achieved by providing a catheter insertion device. The catheter insertion device includes a housing having a cam member. The device also includes a needle hub having an introducer needle affixed thereto, and being movably disposed within the housing. The device also includes a catheter hub having a catheter affixed thereto, and being movably disposed within the housing, the catheter hub having a fluid opening fluidly communicable with the catheter, where one of the needle hub and the catheter hub includes at least one operation pin extending from a side of the one of the needle hub and the catheter hub, and the needle hub and the catheter hub are releasably secured to move together from an initial position to an extended position. The device also includes an insertion unit movable relative to the housing by a user, and operable to move the needle hub and the catheter hub from the initial position to the extended position. The device also includes at least one spring disposed in the housing. During movement of the catheter and introducer needle toward the extended position by user operation of the insertion unit, engagement of the operation pin with the cam member rotates the one of the needle hub and the catheter hub, thereby freeing relative securement of the needle hub and the catheter hub as the catheter hub and the needle hub reach the extended position, enabling the at least one spring to move the needle hub and theintroducer needle from the extended position to withdraw the introducer needle from the catheter, establishing fluid communication between the fluid opening and a distal end of the catheter.

[0009] The foregoing and / or other general aspects of the present invention are also achieved by providing a catheter insertion device that includes a housing having an axial passage. The device also includes a catheter hub disposed within the axial passage and having a catheter, the catheter hub being movable relative to the housing between an initial position within the housing and an extended position in which a portion of the catheter extends outside of the housing, the catheter hub having a fluid pathway connecting a fluid opening on an outside of the catheter hub with a distal end of the catheter. The device also includes a needle hub disposed within the axial passage and having an introducer needle, the needle hub being movable relative to the housing from an initial needle position to an extended needle position in which a portion of the introducer needle extends outside of the housing, to a withdrawn needle position disposed within the housing and not blocking the fluid pathway, the introducer needle blocking a portion of the fluid pathway in the initial and extended needle positions. The device also includes at least one spring, disposed within the housing and biasing the needle hub toward the withdrawn position when the needle hub is in the extended position.

[0010] Additional and / or other aspects and advantages of the present invention will be set forth in the description that follows, or will be apparent from the description, or may be learned by practice of the invention.Brief Description of the Drawings

[0011] The above and / or other aspects and advantages of embodiments of the invention will be more readily appreciated from the following detailed description, taken in conjunction with the accompanying drawings, of which:Figs. 1 and 2 are, respectively, a top perspective and a side view of an example patch pump as a wearable fluid delivery device;Fig. 3 is an exploded perspective view of a catheter insertion device in accordance with a first embodiment of the present invention;Fig. 4 is a perspective view of the device of Fig. 3;Fig. 5 is cross-sectional view of the device of Fig. 3;Fig. 6 is a perspective view of a catheter hub and a needle hub of the device of Fig. 3;Fig. 7 is a top perspective view of the device of Fig. 3 with a button omitted for clarity;Figs. 8, 9 and 10 are cross-sectional views illustrating operation of the device of Fig. 3;Fig. 11 is an exploded perspective view of a catheter insertion device in accordance with a second embodiment of the present invention;Fig. 12 is a perspective view of a housing of the device of Fig. 11Fig. 13 is a perspective view of a needle hub and introducer needle of the device of Fig. 11;Fig. 14 is a perspective cross-sectional view of the needle hub of Fig. 13;Fig. 15 is a perspective view of a catheter hub, hollow catheter, wedge cap, and septum of the device of Fig. 11;Figs. 16-, 17 and 18 are cross-sectional views illustrating operation of the device of Fig. 11;Fig. 19 is a perspective view of a catheter insertion device in accordance with a third embodiment of the present invention;Fig. 20 is an exploded perspective view of the device of Fig. 19;Figs. 21 and 22 are respective top and bottom perspective views of a needle hub and introducer needle of the device of Fig. 19;Fig. 23 is a perspective cross-sectional view of the needle hub and introducer needle of Figs. 21 and 22;Fig. 24 is a perspective view of a cover of the device of Fig. 19;Figs. 25, 26 and 27 are cross-sectional views illustrating operation of the device of Fig. 19;Fig. 28 is a perspective view of a catheter insertion device in accordance with a fourth embodiment of the present invention;Fig. 29 is a perspective cross-sectional view of the device of Fig. 28;Fig. 30 is a perspective view of a housing of the device of Fig. 28;Fig. 31 is a perspective view of a button of the device of Fig. 28;Fig. 32 is a perspective view of a needle hub and a catheter hub of the device of Fig.28;Fig. 33 is a perspective view of a post, spring, and guide member of the device of Fig. 28;Fig. 34 is a perspective cross-sectional view of the needle hub and the catheter hub of Fig. 32;Figs. 35 and 36; are partial perspective views illustrating interaction between the needle hub and catheter hub of Fig. 32 during operation of the device of Fig. 28;Figs. 37, 38 and 39 are cross-sectional views illustrating operation of the device of Fig- 28;Fig. 40 is a perspective view of a catheter insertion device in accordance with a fifth embodiment of the present invention;Fig. 41 is a perspective cross-sectional view of the device of Fig. 40;Fig. 42 is an exploded view of the device of Fig. 40Fig. 43 is a perspective view of a housing of the device of Fig. 40;Fig. 44 is a another perspective view of a housing of Fig. 42;Fig. 45 is a perspective view of a button of the device of Fig. 40;Fig. 46 is a perspective view of a needle hub and introducer needle of the device of Fig. 40;Fig. 47 is a perspective view of a catheter hub, catheter, septum, and wedge cap of the device of Fig. 40;Figs. 48, 49 and 50 are cross-sectional views illustrating operation of the device of Fig.40;Fig. 51 is a perspective view of a catheter insertion device in accordance with a sixth embodiment of the present invention;Fig. 52 is a perspective view of a housing, arm, guide member, spring, needle hub, and catheter hub of the device of Fig. 51;Fig. 53 is a perspective view of the housing of Fig. 52;Fig. 54 is a perspective view of the arm of Fig. 52;Fig. 55 is a perspective view of the needle hub and catheter hub of Fig. 52;Fig. 56 is a perspective view of the guide member and spring of Fig. 52;Fig. 57 is a perspective cross-sectional view of the catheter hub of Fig. 52;Figs. 58, 59 and 60 are cross-sectional views illustrating operation of the device ofFig.51;Fig. 61 is a perspective view of a catheter insertion device in accordance with a seventh embodiment of the present invention;Fig. 62 is a perspective cross-sectional view of a housing of the device of Fig. 61;Fig. 63 is a perspective view of a button of the device of Fig. 61;Fig. 64 is a perspective view of a needle hub and introducer needle of the device of Fig. 61;Fig. 65 is a perspective view of a catheter hub and catheter of the device of Fig. 61;Fig. 66 is a perspective cross-sectional view of the catheter hub and catheter of Fig. 65;Fig. 67 is a perspective view of the device of Fig. 61 in an initial state depicting the housing of Fig. 62 as transparent;Fig. 68 is a cross-sectional view of the device of Fig. 61 in the initial state;Fig. 69 is a partial perspective view of the device of Fig. 61 during operation; and Figs. 70 and 71 are cross-sectional views illustrating operation of the device of Fig.61.Detailed Description of Embodiments of the Present Invention

[0012] Reference will now be made in detail to embodiments of the present invention, which are illustrated in the accompanying drawings, wherein like reference numerals refer to like elements throughout. The embodiments described herein exemplify, but do not limit, the present invention by referring to the drawings.

[0013] The embodiments are not intended to be mutually exclusive so that the features of one embodiment can be combined with other embodiments as long as they do not contradict each other.

[0014] It will be understood by one skilled in the art that this disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The embodiments herein are capable of other embodiments, and capable of being practiced or carried out in various ways. Phraseology andterminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.

[0015] Unless limited otherwise, the terms “connected,” “coupled,” and “mounted,” and variations thereof herein are used broadly and encompass direct and indirect connections, couplings, and mountings. In addition, the terms “connected” and “coupled”" and variations thereof are not restricted to physical or mechanical connections or couplings. Further, terms such as “up,” “down,” “bottom,” “top,” “front,” “rear,” “upper,” “lower,” “upwardly,” “downwardly,” and other orientational descriptors are intended to facilitate the description of the exemplary embodiments of the present invention, and are not intended to limit the structure of the exemplary embodiments of the present invention to any particular position or orientation. Terms of degree, such as “substantially” or “approximately,” are understood by those skilled in the art to refer to reasonable ranges around and including the given value and ranges outside the given value, for example, general tolerances associated with manufacturing, assembly, and use of the embodiments. The term “substantially,” when referring to a structure or characteristic, includes the characteristic that is mostly or entirely present in the characteristic or structure.

[0016] ‘A”, “an”, and “the” as used herein refers to both singular and plural referents unless the context clearly dictates otherwise. By way of example, “a processor” programmed to perform various functions refers to one processor programmed to perform each and every function, or more than one processor collectively programmed to perform each of the various functions.

[0017] Figs. 1 and 2 illustrate an example patch pump 10 for use as a wearable fluid delivery device. The patch pump 10 comprises an enclosure or housing 12 with activation buttons 20 and an insertion mechanism 22. The housing 12 can have an adhesive pad 16 provided on its baseplate 14 and a liner 18 that are configured to allow a user to remove the liner 18 and place a tacky side of the adhesive pad 16 on a patient’s skin to adhere the patch pump 10 to the patient. The insertion mechanism 22 is shown in an undeployed position in Fig. 1. In Fig. 2, the adhesive pad 16 and liner 18 are not shown for clarity to depict the insertion mechanism 22 in a deployed position whereby a needle 26 and / or catheter 24 extend from the housing 12 for insertion into a patient’s skin. The example patch pump has a catheter 24 and needle 26 assembly for insertion of the catheter and needle into a patient and then retraction of the needle.

[0018] Example insertion mechanisms are described in greater detail in PCT international application WO 2015 / 164653, which is incorporated herein by reference in its entirety. In several of the described insertion mechanisms, after the catheter is inserted into the patient via the introducer needle, the introducer needle is withdrawn from the catheter but the introducer needle remains part of the fluid pathway between the medicament reservoir and the catheter.

[0019] Because the introducer needle must fit within the catheter and therefore necessarily has a smaller diameter than the catheter, the introducer needle can be a major source of restriction in the flow rate or delivery rate of medicament. Poiseuille’s equation yields the pressure drop of a laminar flow fluid across a length of pipe

[0020] Thus, the pressure drop across a pipe is inversely proportional to the radius to the 4thpower. In other words, a smaller pipe radius causes a significant increase in pressure differential between the two ends of the pipe.

[0021] But enlarging the diameter of the catheter and the insertion needle could increase a patient’s discomfort and / or pain. Accordingly, one way to address this issue and maintain the diameter of the catheter and introducer needle is to remove the introducer needle as a portion of the fluid pathway from the medicament reservoir to the catheter.

[0022] Fig. 3 is an exploded perspective view of a catheter insertion device 100 in accordance with a first embodiment of the present invention, and Fig. 4 is a perspective view of the catheter insertion device 100, which includes a housing 102 having a cam member 104. According to one embodiment, as best shown in Figs. 3 and 4, the cam member 104 includes a cam guide 103 or cam guide surface 103. The cam guide 103 includes an upper portion 148, and lower portion 152, and a slanted portion 150 connecting the upper and lower portions 148 and 152.

[0023] The catheter insertion device 100 (hereinafter device 100 for brevity) also includes a needle hub 106 having an introducer needle 108 or needle 108 affixed to the needle hub 106. The needle hub 106 is movably disposed in the housing 102. According to one preferable embodiment, the introducer needle 108 is solid. According to another embodiment, the introducer needle 108 is hollow. If hollow, it is preferable that at least the proximal end of the introducer needle 108 is closed, for example, where it connects with the needle hub 106, to prevent fluid flow through the introducer needle 108.

[0024] The device 100 also includes a release collar 110 or catheter hub 110 with a hollow catheter 112 affixed to the catheter hub 110. The catheter hub 110 is movably disposed in the housing 102. The catheter hub 110 includes an operation pin 114 extending from a side of the catheter hub. As will be subsequently described in greater detail, during operation of the device 100, the operation pin 114 contacts and rides along the cam guide 103, thereby controlling rotation of the catheter hub 110.

[0025] In this embodiment, the catheter hub 110 has a fluid opening 116 (best shown in Fig. 6) that is fluidly communicable with the catheter and is disposed on the operation pin 114.Although not shown in this embodiment, tubing fluidly connects the operation pin 114 with the pump and / or the reservoir of the medicament delivery device or patch pump. According to one embodiment, the fluid opening 116 is the exterior presentation of a fluid pathway directly through the catheter hub 110 to the catheter 112. Preferably, according to another embodiment, there are additional elements in the device 100 that intervene on the fluid pathway between the fluid opening 116 and the catheter 112. For example, according to one embodiment, the device 100 has a wedge cap 118 that includes a portion of the fluid pathway between the fluid opening 116 and the catheter 112.

[0026] In greater detail, according to one embodiment, the device 100 includes a securing means 120 or securing member 120 or wedge 120 securing the catheter 112 to the catheter hub 110. . The securing means 120 or securing member 120 or wedge 120 provides a mechanical anchor and fluidic tightness for the catheter 112 with respect to the catheter hub 110 to prevent leakage. The device 100 also includes a septum 122, and the wedge cap 118 disposed within the catheter hub 110 and securing the septum 122 and the wedge 120 within the catheter hub 110. As best shown in Fig. 10, the wedge cap 118 has a first fluid pathway 156 portion and a wedge capfluid opening 121 aligned with the fluid pathway of the catheter hub 110 that includes the fluid opening 116. The wedge cap 118 also has a second fluid pathway portion 158 that connects with the first fluid pathway portion at an angle, and is coaxial with the catheter 112. According to one embodiment, the angle is approximately 90 degrees, but one skilled in the art will understand that other angles may be employed without departing from the present invention’s scope.

[0027] In an initial position, as best shown in Figs. 4-6, the catheter hub 110 and the needle hub 106 are both disposed within the housing 102, and are releasably secured to move together to an extended position or inserted position in which a portion of the needle 108 and the catheter 112 are disposed outside of the housing. As illustrated in Fig. 6, in this embodiment, the catheter hub 110 is releasably secured directly to the needle hub 106 by one or more securing protrusions 124 disposed on the catheter hub 110 engaging with securing areas 126 or securing recesses 126 disposed on the needle hub 106. One skilled in the art will appreciate that another embodiment of the present invention includes securing protrusions 124 being disposed on the needle hub 106 and securing areas 126 or securing recesses 126 being disposed on the catheter hub 110.

[0028] In the initial position, the introducer needle 108 is disposed within the catheter 112, and a portion of the introducer needle 108 extends distally from a distal end of the catheter 112. In such a configuration, the introducer needle 108 at least limits or reduces a portion of the fluid pathway between the fluid opening 116 and the distal end of the catheter 112. According to one embodiment, the introducer needle blocks a portion of the fluid pathway between the fluid opening 116 and the distal end of the catheter 112.

[0029] The device 100 also includes a user-operable insertion unit 128 or button 128 that is movable relative to the housing 102 by a user and is operable to move the needle hub 106 and the catheter hub 110 from the initial position to the extended position. According to one embodiment, the button 128 is constrained to move substantially linearly by the shape of the housing 102. At least one spring 130 is also included in the device 100, and is disposed in the housing 102. According to one embodiment, the at least one spring 130 is a pair of springs 130, and in the extended position, the springs 130 bias the needle hub 106 toward a withdrawn position, as subsequently described in greater detail.

[0030] Fig. 7 is a perspective view of the device 100 with the button 128 removed for illustrative purposes. Referring to Figs. 3 and 7, the housing 102 includes a central core 132 oraxial passage 132 in which the catheter hub 110 is disposed, and at least one guiding core 134 disposed adjacent to the central core 132. In the depicted embodiment, the at least one guiding core 134 is a pair of guiding cores 134. Each guiding core 134 includes a guiding slot 136 on a side thereof. As best shown in Fig. 5, the distal end of the central core 132 includes a distal opening 142 through which the catheter 112 and introducer needle 108 can extend.

[0031] Referring to Figs. 3, 6, and 7, the needle hub 106 includes at least one guiding tab 138. In the depicted embodiment, the at least one guiding tab 138 is a pair of guiding tabs 138, which are respectively disposed in the guiding slots 136 to prevent rotation of the needle hub relative to the housing 102 and constrain the needle hub 106 to travel substantially linearly.

[0032] According to one embodiment, the needle hub 106 includes at least one distal protuberance 140. In the depicted embodiment, the at least one distal protuberance 140 is a pair of distal protuberances 140, which are respectively disposed in the guiding cores 134. The springs 130 are respectively disposed in the guiding cores 134. Proximal ends of the springs 130 are respectively configured to receive the distal protuberances 140.

[0033] As shown in Fig. 7, the wedge cap 118 includes a key 144 seated in a keyway 146 of the catheter hub 110 to prevent or limit rotation of the wedge cap 118 relative to the catheter hub 110. One skilled in the art will appreciate that the key 144 could be disposed on the catheter hub 110 and the keyway 146 could be disposed on the wedge cap 118 without departing from the present invention’s scope.

[0034] With reference to Figs. 5 and 8-10, operation of the catheter insertion device 100 will now be described. As shown in Fig. 5, in the initial position, a majority of the button 128 extends proximally out of the housing and is accessible to the user (e.g., patient). Additionally, the needle hub 106 is releasably secured with the catheter hub 110, and the introducer needle 108 is disposed within the catheter 112. Further, the introducer needle 108 blocks fluid communication between the fluid opening 116 and a distal end of the catheter 112.

[0035] As the user depresses the button 128, the button 128, needle hub 106, and the catheter hub 110 travel distally together. During movement of the needle hub 106 and the catheter hub 110 (and the catheter 112 and introducer needle 108) toward the extended position, the needle hub 106 compresses the springs 130 and the operation pin 114 engages the slanted portion 150 of the cam guide 103 and rotates the catheter hub 110 about the introducer needle 108 relative to thebutton 128, the needle hub 106, and the housing 102. This rotation causes the disengagement of the securing protrusions 124 and the securing recesses 126, thereby freeing needle hub 106 from the catheter hub 110 as the catheter hub 110 and the needle hub 106 reach the extended position (Fig. 8). This enables the springs 130 to move the needle hub 106 and the introducer needle 108 from the extended position to withdraw the introducer needle 108 from the catheter 112 (Figs. 9 and 10). This withdrawal of the introducer needle 108 from the catheter 112 establishes fluid communication between the fluid opening 116 and a distal end of the catheter 112.

[0036] According to one embodiment, a portion of the introducer needle 108 remains disposed in the septum 122 when withdrawn, as shown in Fig. 10. According to another embodiment, no portion of the introducer needle 108 remains disposed in the septum 122 when withdrawn.

[0037] Because the medicament does not have to flow through the introducer needle 108, the diameter of the fluid pathway between the fluid opening 116 and a distal end of the catheter 112 can be larger, thus permitting greater fluid flow and a greater rate of medicament delivery. In addition, in comparison to designs in which an introducer needle is part of a medicament flow path, the present design provides reduced pressure losses because the medicament can enter laterally through a larger tubing close to the catheter 112.

[0038] For subsequently-described embodiments, unless otherwise noted, reference characters designating corresponding parts of the embodiments will be the same as the embodiment of Figs. 1-10, except that they will be in a different series, for example, in the 200 series, or the 300 series. The differences of the second embodiment with respect to the first embodiment will now be described.

[0039] Fig. 11 is an exploded perspective view of a catheter insertion device 200 in accordance with a second embodiment of the present invention. The catheter insertion device 200, includes a housing 202 having a cam member 204. According to one embodiment, as best shown in Fig. 12, the cam member 204 includes a cam guide 203 or cam guide surface 203. The cam guide 203 includes an upper portion 248, and lower portion 252, and a slanted portion 250 connecting the upper and lower portions 248 and 252.

[0040] The catheter insertion device 200 (hereinafter device 200 for brevity) also includes a needle hub 206 having an introducer needle 208 or needle 208 affixed to the needle hub 206. Theneedle hub 206 is movably disposed in the housing 202. According to one preferable embodiment, the introducer needle 208 is solid. According to another embodiment, the introducer needle 208 is hollow. If hollow, it is preferable that at least the proximal end of the introducer needle is closed, for example, where it connects with the needle hub 206, to prevent fluid flow through the introducer needle 208.

[0041] In this embodiment, as best shown in Fig. 13, the needle hub 206 includes a ring 207 having a central bar 209 across a diameter thereof. The introducer needle 208 is affixed to the central bar 209. The needle hub 206 also includes one or more securing recesses 226 or securing areas 226 for releasably securing the needle hub 206 with the release collar 210 or catheter hub 210, as subsequently described in greater detail.

[0042] With reference to Figs. 11, 13, and 14, the device 200 includes a cover 211, which has one or more cover brackets 213 corresponding to one or more tension springs 230. According to one embodiment, the one or more springs 230 have securing clips 231 disposed at opposing ends of the springs 230. One securing clip 231 secures to a cover bracket 213, and the opposing securing clip on the tension spring 230 secures through a clip opening 254 in the needle hub 206 and into a clip recess 256. According to one embodiment, the one or more springs 230 is a pair of springs 230, and in the extended position (see Fig. 17), the springs 230 bias the needle hub 206 toward the withdrawn position, as subsequently described in greater detail.

[0043] The device 200 also includes a release collar 210 or catheter hub 210 with a hollow catheter 212 affixed to the catheter hub 210. The catheter hub 210 is movably disposed in the housing 202. The catheter hub 210 includes an operation pin 214 extending from a side of the catheter hub 210. As will be subsequently described in greater detail, during operation of the device 200, the operation pin 214 contacts and rides along the cam guide 203, thereby controlling rotation of the catheter hub 210. According to one embodiment, the cover 211 includes a corresponding cam surface 258 (see Fig. 11) that corresponds to and cooperates with the cam guide 203 to form a cam track for guiding the operation pin 214.

[0044] According to one embodiment, the device 200 includes a securing means 220 or securing member 220 or wedge 220 securing the catheter 212 to the catheter hub 210. The securing means 220 or securing member 220 or wedge 220 provides a mechanical anchor and fluidic tightness for the catheter 212 with respect to the catheter hub 210 to prevent leakage. Thedevice 200 also includes a septum 222, and the wedge cap 218 disposed within the catheter hub 210 and securing the septum 222 and the wedge 220 within the catheter hub 210.

[0045] As shown in Figs. 11 and 15, the wedge cap 218 has a fluid opening 216, through which tubing 217 passes. The tubing 217 connects with a wedge cap fluid opening 221, and fluidly connects the wedge cap 218 with the pump and / or the reservoir of the medicament delivery device or patch pump.

[0046] The wedge cap 218 has a first fluid pathway portion 260 with the wedge cap fluid opening 221 aligned with the fluid opening 216 of the catheter hub 210, and a second fluid pathway portion 262 that connects with the first fluid pathway portion 260 at an angle, and is coaxial with the catheter 212. According to one embodiment, the angle is approximately 90 degrees, but one skilled in the art will understand that other angles may be employed without departing from the present invention’s scope.

[0047] Fig. 15 also illustrates one or more securing protrusions 224 on the catheter hub 210. Similar to the first embodiment, the securing protrusions 224 interact with the securing areas 226 or securing recesses 226 of the needle hub 206 to releasably secure the catheter hub 210 and the needle hub 206. One skilled in the art will appreciate that another embodiment of the present invention includes securing protrusions 224 being disposed on the needle hub 206 and securing areas 226 or securing recesses 226 being disposed on the catheter hub 210.

[0048] In the initial position, as shown in Fig. 16, the introducer needle 208 is disposed within the catheter 212, and a portion of the introducer needle 208 extends distally from a distal end of the catheter 212. In such a configuration, the introducer needle 208 at least limits or reduces a portion of the fluid pathway between the fluid opening 216 and the distal end of the catheter 212. According to one embodiment, the introducer needle blocks a portion of the fluid pathway between the wedge cap fluid opening 221 and the distal end of the catheter 212.

[0049] The device 200 also includes a user-operable insertion unit 228 or button 228 that is movable relative to the housing 202 by a user and is operable to move the needle hub 206 and the catheter hub 210 from the initial position to the extended position. According to one embodiment, the button 228 is constrained to move substantially linearly by the shape of the housing 202.

[0050] With reference to Figs. 16-18, operation of the catheter insertion device 200 will now be described. As shown in Fig. 16, in the initial position, a majority of the button 228 extends proximally out of the housing 202 and is accessible to the user (e.g., patient). Additionally, the needle hub 206 is releasably secured with the catheter hub 210, and the introducer needle 208 is disposed within the catheter 212. A portion of the introducer needle 208 is also disposed in the septum 222. Further, the introducer needle 208 blocks fluid communication between the wedge cap fluid opening 221 and a distal end of the catheter 212, and therefore blocks fluid communication between the fluid opening 216 and a distal end of the catheter 212.

[0051] As the user depresses the button 228, the button 228, the needle hub 206, and the catheter hub 210 travel distally together. During movement of the needle hub 206 and the catheter hub 210 (and the catheter 212 and introducer needle 208) toward the extended position, the movement of the needle hub 206 extends the springs 230 because the opposing ends of the springs 230 are respectively secured to the needle hub 206 and the cover 211, which remains stationary atop the housing 202. Additionally, during movement of the needle hub 206 and the catheter hub 210 toward the extended position, the operation pin 214 engages the slanted portion 250 of the cam guide 203 and rotates the catheter hub 210 about the introducer needle 208 relative to the button 228, the needle hub 206, and the housing 202. This rotation causes the disengagement of the securing protrusions 224 and the securing recesses 226, thereby freeing needle hub 206 from the catheter hub 210 as the catheter hub 210 and the needle hub 206 reach the extended position (Fig. 17). This enables the springs 230 to move the needle hub 206 and the introducer needle 208 from the extended position to withdraw the introducer needle 208 from the catheter 212. This withdrawal of the introducer needle 208 from the catheter 212 establishes fluid communication between the wedge cap fluid opening 221 and a distal end of the catheter 212, and therefore establishes fluid communication between the fluid opening 216 and a distal end of the catheter 212 (Fig. 18).

[0052] According to one embodiment, a portion of the introducer needle 208 remains disposed in the septum 222 when withdrawn, as shown in Fig. 18. According to another embodiment, no portion of the introducer needle 208 remains disposed in the septum 222 when withdrawn.

[0053] Because the medicament does not have to flow through the introducer needle 208, the diameter of the fluid pathway through the catheter hub 210 and the wedge cap 218 to a distal end of the catheter 212 can be larger, thus permitting greater fluid flow and a greater rate of medicament delivery. In comparison to the first embodiment, there is a reduced system footprint for the catheter insertion device 200.

[0054] Fig. 19 is a perspective view of a catheter insertion device 300 in accordance with a third embodiment of the present invention. The third embodiment is similar to the second embodiment in many respects, and for brevity, the differences will be described.

[0055] With reference to Figs. 19 and 20, catheter insertion device 300 (hereinafter device 300 for brevity) includes a housing 302 having a cam member 304. The cam member 304 includes a cam guide 303 or cam guide surface 303. The cam guide 303 includes an upper portion 348, and lower portion 352, and a slanted portion 350 connecting the upper and lower portions 348 and 352.

[0056] The device 300 also includes a needle hub 306 having an introducer needle 308 or needle 308 affixed to the needle hub 306. The needle hub 306 is movably disposed in the housing 302. According to one preferable embodiment, the introducer needle 308 is solid. According to another embodiment, the introducer needle 308 is hollow. If hollow, it is preferable that at least the proximal end of the introducer needle is closed, for example, where it connects with the needle hub 306, to prevent fluid flow through the introducer needle 308.

[0057] As best shown in Figs. 21-23, the needle hub 306 includes a ring 307 having a central bar 309 across a diameter thereof. The introducer needle 308 is affixed to the central bar 309.The needle hub 306 also includes one or more securing recesses 326 or securing areas 326 for releasably securing the needle hub 306 with the release collar 310 or catheter hub 310, as subsequently described in greater detail.

[0058] The needle hub 306 also has a pathway 305 from a proximal surface 303 through the ring 307 to a distal surface 309 of the needle hub 306. According to one embodiment, the pathway 305 is helical. A distal end of the spring 330 is disposed in the pathway 305 to secure the spring 330 with the needle hub 306.

[0059] With reference to Figs. 19, 20, and 24, the device 300 includes a cover 311, which has a distally open annular space 319 therein for housing a portion of the spring 330, which, according to one embodiment, is a tension spring 330. The cover 311 also has a securing opening 329 in a side thereof. Similar to the second embodiment, the cover further has a distal portion 315 with a corresponding cam surface 358 that, in conjunction with the cam guide 303 of the housing 302, guides the rotation of the catheter hub 310 during insertion of the catheter 312, as subsequently described in greater detail. Additionally, the tension spring 330 has a securing clip 331 disposed at end thereof for securing the spring 330 to the cover 311 through the securing opening 329. Thus, the spring 330 is secured to both the needle hub 306 and the cover 311.

[0060] The device 300 also includes a release collar 310 or catheter hub 310 with a hollow catheter 312 affixed to the catheter hub 310. The catheter hub 310 is movably disposed in the housing 302, and includes an operation pin 314 extending from a side of the catheter hub 310. As will be subsequently described in greater detail, during operation of the device 300, the operation pin 314 contacts and rides along the cam guide 303, thereby controlling rotation of the catheter hub 310. As previously noted, the cover 311 includes a corresponding cam surface 358 (see Fig. 24). The corresponding cam surface 358 corresponds to and cooperates with the cam guide 303 to form a cam track for guiding the operation pin 314.

[0061] According to one embodiment, the device 300 includes a securing means 320 or securing member 320 or wedge 320 securing the catheter 312 to the catheter hub 310. The securing means 320 or securing member 320 or wedge 320 provides a mechanical anchor and fluidic tightness for the catheter 312 with respect to the catheter hub 310 to prevent leakage. The device 300 also includes a septum 322, and a wedge cap 318 disposed within the catheter hub 310 and securing the septum 322 and the wedge 320 within the catheter hub 310.

[0062] As shown in Figs. 20 and 25-27, the wedge cap 318 has a fluid opening 316, through which tubing 317 passes and connects to wedge cap fluid opening 221. The tubing 317 fluidly connects the wedge cap 318 with the pump and / or the reservoir of the medicament delivery device or patch pump.

[0063] The wedge cap 318 has a first fluid pathway portion 360 with the wedge cap fluid opening 321 aligned with the fluid opening 316 of the catheter hub 310, and a second fluid pathway portion 362 that connects with the first fluid pathway portion 360 at an angle, and iscoaxial with the catheter 312 (see Fig. 27). According to one embodiment, the angle is approximately 90 degrees, but one skilled in the art will understand that other angles may be employed without departing from the present invention’s scope.

[0064] Similar to the second embodiment, securing protrusions 324 on the catheter hub 310 interact with the securing areas 326 or securing recesses 326 of the needle hub 306 to releasably secure the catheter hub 310 and the needle hub 306. Although not depicted, one skilled in the art will appreciate that another embodiment of the present invention includes securing protrusions 324 being disposed on the needle hub 306 and securing areas 326 or securing recesses 326 being disposed on the catheter hub 310.

[0065] In the initial position, as shown in Fig. 25, the introducer needle 308 is disposed within the catheter 312, and a portion of the introducer needle 308 extends distally from a distal end of the catheter 312. In such a configuration, the introducer needle 308 at least limits or reduces a portion of the fluid pathway between the fluid opening 316 and the distal end of the catheter 312. According to one embodiment, the introducer needle 308 blocks a portion of the fluid pathway between the wedge cap fluid opening 321 and the distal end of the catheter 312, and thus, blocks a portion of the fluid pathway between the fluid opening 316 and the distal end of the catheter 312.

[0066] The device 300 also includes a user-operable insertion unit 328 or button 328 that is movable relative to the housing 302 by a user and is operable to move the needle hub 306 and the catheter hub 310 from the initial position to the extended position. According to one embodiment, the button 328 is constrained to move substantially linearly by the shape of the housing 302.

[0067] With reference to Figs. 25-27, operation of the catheter insertion device 300 will now be described. As shown in Fig. 25, in the initial position, a majority of the button 328 extends proximally out of the housing 302 and is accessible to the user (e.g., patient). Additionally, the needle hub 306 is releasably secured with the catheter hub 310, and the introducer needle 308 is disposed within the catheter 312. A portion of the introducer needle 308 is also disposed in the septum 322.

[0068] As the user depresses the button 328, the button 328, the needle hub 306, and the catheter hub 310 travel distally together. During movement of the needle hub 306 and thecatheter hub 310 (and the catheter 312 and introducer needle 308) toward the extended position, the movement of the needle hub 306 extends the tension spring 330 because the opposing ends of the spring 330 are respectively secured to the needle hub 306 and the cover 311, which remains stationary atop the housing 302. Additionally, during movement of the needle hub 306 and the catheter hub 310 toward the extended position, the operation pin 314 engages the slanted portion 350 of the cam guide 303 and rotates the catheter hub 310 about the introducer needle 308 relative to the button 328, the needle hub 306, and the housing 302. This rotation causes the disengagement of the securing protrusions 324 from the securing recesses 326, thereby freeing needle hub 306 from the catheter hub 310 as the catheter hub 310 and the needle hub 306 reach the extended position (Fig. 26). This enables the spring 330 to move the needle hub 306 and the introducer needle 308 from the extended position to withdraw the introducer needle 308 from the catheter 312. This withdrawal of the introducer needle 308 from the catheter 312 establishes fluid communication between the wedge cap fluid opening 321 and a distal end of the catheter 312, and therefore establishes fluid communication between the fluid opening 316 and a distal end of the catheter 312 (Fig. 27).

[0069] According to one embodiment, a portion of the introducer needle 308 remains disposed in the septum 322 when withdrawn, as shown in Fig. 27. According to another embodiment, no portion of the introducer needle 308 remains disposed in the septum 322 when withdrawn.

[0070] Because the medicament does not have to flow through the introducer needle 308, the diameter of the fluid pathway through the catheter hub 310 and the wedge cap 318 to a distal end of the catheter 312 can be larger, thus permitting greater fluid flow and a greater rate of medicament delivery. This embodiment provides for a reduced system footprint, and in comparison to the first and second embodiments, employs a single spring, thereby potentially simplifying manufacturing.

[0071] Fig. 28 is a perspective view of a catheter insertion device 400 in accordance with a fourth embodiment of the present invention. With reference to Figs. 28-33, the catheter insertion device 400 (hereinafter device 400 for brevity) includes a housing 402 having a cam member 404. The cam member 404 includes a cam guide 403 or cam guide surface 403. The cam guide403 includes an upper portion 448, and lower portion 452, and a slanted portion 450 connecting the upper and lower portions 448 and 452.

[0072] The device 400 also includes a needle hub 406 having an introducer needle 408 or needle 408 affixed to the needle hub 406. The needle hub 406 is movably disposed in the housing 402. According to one preferable embodiment, the introducer needle 408 is solid. According to another embodiment, the introducer needle 408 is hollow. If hollow, it is preferable that at least the proximal end of the introducer needle is closed, for example, where it connects with the needle hub 406, to prevent fluid flow through the introducer needle 408.

[0073] The device 400 includes a cover 411, with a distally extending portion 415, and also includes a release collar 410 or catheter hub 410 with a hollow catheter 412 affixed to the catheter hub 410. The catheter hub 410 is movably disposed in the housing 402, and includes an operation pin 414 extending from a side of the catheter hub 410. As will be subsequently described in greater detail, during operation of the device 400, the operation pin 414 contacts and rides along the cam guide 403, thereby controlling rotation of the catheter hub 410.

[0074] Like the first embodiment, the catheter hub 410 has a fluid opening 416 that is fluidly communicable with the catheter and is disposed on the operation pin 414. Tubing 417 fluidly connects the operation pin 414 with the pump and / or the reservoir of the medicament delivery device or patch pump. According to one embodiment, the fluid opening 416 is the exterior presentation of a fluid pathway directly through the catheter hub 410 to the catheter 412.According to another embodiment, there are additional elements in the device 100 that are part of the fluid pathway between the fluid opening 416 and the catheter 412. For example, according to one embodiment, the device 400 includes a securing means 420 or securing member 420 or wedge 420 securing the catheter 412 to the catheter hub 410. . The securing means 420 or securing member 420 or wedge 420 provides a mechanical anchor and fluidic tightness for the catheter 412 with respect to the catheter hub 410 to prevent leakage. The device 400 also includes a septum 422, and a wedge cap 418 disposed within the catheter hub 410 and securing the septum 422 and the wedge 420 within the catheter hub 410. In the present embodiment, the fluid pathway extends from the fluid opening 416, through the operation pin 414, through the wedge cap 418, and into the catheter 412.

[0075] As best shown in Fig. 34, the wedge cap 418 has a first fluid pathway portion 460 with a wedge cap fluid opening 421 aligned with and fluidly connected to the fluid opening 416, and a second fluid pathway portion 462 that connects with the first fluid pathway portion 460 at an angle and is coaxial with the catheter 412. According to one embodiment, the angle is approximately 90 degrees, but one skilled in the art will understand that other angles may be employed without departing from the present invention’s scope.

[0076] Also like the first embodiment, the wedge cap 418 includes a key 444 seated in a key way 446 of the catheter hub 410 to prevent or limit rotation of the wedge cap 418 relative to the catheter hub 410. One skilled in the art will appreciate that the key 444 could be disposed on the catheter hub 410 and the keyway 446 could be disposed on the wedge cap 418 without departing from the present invention’s scope. In other words, as shown in Fig. 34, one of the catheter hub 410 and the wedge cap 418 includes a key way 444 and a remaining one of the catheter hub 410 and the wedge cap 418 comprises a key 446 seated in the keyway to limit relative rotation between the catheter hub 410 and the wedge cap 418.

[0077] Similarly, one of the catheter hub 410 and the wedge cap 418 includes a groove 443 and the remaining one of the catheter hub 410 and the wedge cap 418 includes a groove protrusion 445 seated in the groove 443 to prevent relative translation between the catheter hub 410 and the wedge cap 418. In the embodiment depicted in Fig. 34, the groove 443 is disposed on the catheter hub 410 and the groove protrusion 445 is disposed on the wedge cap 418. But one skilled in the art will appreciate that the positioning of the groove 443 and the groove protrusion 445 could be reversed without departing from the scope of the present invention.

[0078] As best shown in Fig. 32, the catheter hub 410 includes securing protrusions 424 that interact with securing lugs 426 of the needle hub 406 to releasably secure the catheter hub 410 and the needle hub 406. Although not depicted, one skilled in the art will appreciate that another embodiment of the present invention includes securing protrusions 424 being disposed on the needle hub 406 and securing lugs 426 being disposed on the catheter hub 410.

[0079] Referring back to Fig. 30, the housing 402 includes a main column 461 in which the needle hub 406 and the catheter hub 410 are movably disposed. The housing 402 also includes a retainer 463 disposed adjacent to the main column 461, and a pivot anchor 465 disposed adjacent to the retainer 463.

[0080] As seen in 28-30 and 33, the device 400 includes a post 467 and a guide member 469 slidably disposed on the post 467. The post 467 is disposed in an inner mount 471 in the retainer 463, and a spring 430 is disposed in an outer mount 473 about the post 467 and concentric therewith. The spring 430 is disposed between the retainer 463 and the guide member 469, biasing the guide member 469 proximally. The device 400 also includes an arm 475 that is pivotally connected to the housing 402 at the pivot anchor 465 by, for example, a pin 477. According to one embodiment, the arm 475 includes a pair of extension arms 478, 479 fixedly connected to each other at an arm base 481 through which the pin 477 is disposed.

[0081] The securing lugs 426 of the needle hub 406 and guide member lugs 483 of the guide member 469 are rotatably connected with the extension arms 478, 479 at different locations along the extension arms 478, 479 as shown, for example, in Fig. 28.

[0082] The device 400 also includes a user-operable insertion unit 428 or button 428 that is movable relative to the housing 402 by a user and is operable to move the needle hub 406 and the catheter hub 410 from the initial position to the extended position. According to one embodiment, the button 428 is constrained to move substantially linearly by the shape of the housing 402. As shown in Fig. 31, the button 428 includes a pair of button legs 429 that bear on the catheter hub 410 to move the needle hub 406 and the catheter hub 410 from the initial position to the extended position.

[0083] In the initial position, as shown, for example, in Figs. 29 and 37, the introducer needle 408 is disposed within the catheter 412, and a portion of the introducer needle 408 extends distally from a distal end of the catheter 412. In such a configuration, the introducer needle 408 at least limits or reduces a portion of the fluid pathway between the fluid opening 416 and the distal end of the catheter 412. According to one embodiment, the introducer needle 408 blocks a portion of the fluid pathway between the fluid opening 416 and the distal end of the catheter 412.

[0084] With reference to Figs. 37-38, operation of the catheter insertion device 400 will now be described. As shown in Fig. 37, in the initial position, a majority of the button 428 extends proximally out of the housing 402 and is accessible to the user (e.g., patient). Additionally, the needle hub 406 is releasably secured with the catheter hub 410, and the introducer needle 408 is disposed within the catheter 412. A portion of the introducer needle 408 is also disposed in the septum 422.

[0085] As the user depresses the button 428, the button 428, the needle hub 406, and the catheter hub 410 travel distally together, the arm 475 pivots about the pin 477, and the guide member 469 travels distally and compresses the spring 430. Additionally, during movement of the needle hub 406 and the catheter hub 410 toward the extended position, the operation pin 414 engages the slanted portion 450 of the cam guide 403 and rotates the catheter hub 410 about the introducer needle 408 relative to the button 428, the needle hub 406, and the housing 402. This rotation causes the disengagement of the securing protrusions 424 from the securing lugs 426 (see Figs. 35 and 36), thereby freeing needle hub 406 from the catheter hub 410 as the catheter hub 410 and the needle hub 406 reach the extended position (Fig. 38). This enables the spring 430 to rotate the arm 475 about the pin 477 and proximally move the guide member 469, the needle hub 406 and the introducer needle 408 from the extended position to withdraw the introducer needle 408 from the catheter 412. This withdrawal of the introducer needle 408 from the catheter 412 establishes fluid communication between the fluid opening 416 and a distal end of the catheter 412 (Fig. 39).

[0086] According to one embodiment, a portion of the introducer needle 408 remains disposed in the septum 422 when withdrawn, as shown in Fig. 39. According to another embodiment, no portion of the introducer needle 408 remains disposed in the septum 422 when withdrawn.

[0087] Because the medicament does not have to flow through the introducer needle 408, the diameter of the fluid pathway between the fluid opening 416 and a distal end of the catheter 412 can be larger, thus permitting greater fluid flow and a greater rate of medicament delivery. And although this embodiment has a larger footprint than the first through third embodiments, the offset spring of this embodiment (offset from the axis of travel of the catheter 412 and the introducer needle 408) reduces system complexity, thereby potentially simplifying manufacturing.

[0088] Fig. 40 is a perspective view of a catheter insertion device 500 in accordance with a fifth embodiment of the present invention. The fifth embodiment is similar to the second and third embodiments in many respects, and for brevity, the differences will be described.

[0089] With reference to Figs. 40-47, catheter insertion device 500 (hereinafter device 500 for brevity) includes a housing 502 having a cam member 504. The cam member 504 includes acam guide 503 or cam guide surface 503. The cam guide 503 includes an upper portion 548, and lower portion 552, and a slanted portion 550 connecting the upper and lower portions 548 and 552. As best shown in Figs. 41 and 44, the housing 502 includes a pocket 505 in which a spring 530 resides, disposed between an interior bottom surface 513 of the housing 502 and a distal surface of a needle hub 506.

[0090] The needle hub 506 has an introducer needle 508 or needle 508 affixed to the needle hub 506. The needle hub 506 is movably disposed in the housing 502. According to one preferable embodiment, the introducer needle 508 is solid. According to another embodiment, the introducer needle 508 is hollow. If hollow, it is preferable that at least the proximal end of the introducer needle is closed, for example, where it connects with the needle hub 506, to prevent fluid flow through the introducer needle 508.

[0091] Similar to the second and third embodiments, the needle hub 506 includes a ring 507 having a central bar 509 across a diameter thereof (see Fig. 46). The introducer needle 508 is affixed to the central bar 509. The needle hub 506 also includes one or more securing recesses 526 or securing areas 526 for releasably securing the needle hub 506 with the release collar 510 or catheter hub 510, as subsequently described in greater detail.

[0092] Also similar to the second and third embodiments, the device 500 includes a cover 511, which has a distal portion 515 with a corresponding cam surface 558 that, in conjunction with the cam guide 503 of the housing 502, guides the rotation of the catheter hub 510 during insertion of the catheter 512, as subsequently described in greater detail.

[0093] The device 500 also includes a release collar 510 or catheter hub 510 with a hollow catheter 512 affixed to the catheter hub 510. The catheter hub 510 is movably disposed in the housing 502, and includes an operation pin 514 extending from a side of the catheter hub 510. As will be subsequently described in greater detail, during operation of the device 500, the operation pin 514 contacts and rides along the cam guide 503, thereby controlling rotation of the catheter hub 510. As previously noted, the cover 511 includes a corresponding cam surface 558 (see Fig. 42). The corresponding cam surface 558 corresponds to and cooperates with the cam guide 503 to form a cam track for guiding the operation pin 514.

[0094] According to one embodiment, the device 500 includes a securing means 520 or securing member 520 or wedge 520 securing the catheter 512 to the catheter hub 510. Thesecuring means 520 or securing member 520 or wedge 520 provides a mechanical anchor and fluidic tightness for the catheter 512 with respect to the catheter hub 510 to prevent leakage. The device 500 also includes a septum 522, and a wedge cap 518 disposed within the catheter hub 510 and securing the septum 522 and the wedge 520 within the catheter hub 510.

[0095] As shown in Figs. 41, 42, and 47, the wedge cap 518 has a fluid opening 516, through which tubing 517 passes and connects to wedge cap fluid opening 521. Unlike previously described embodiments, the tubing 517 passes through a top of the catheter hub 510 rather than a side thereof. The tubing 517 fluidly connects the wedge cap 518 with the pump and / or the reservoir of the medicament delivery device or patch pump.

[0096] The wedge cap 518 has a first fluid pathway portion 560 with the wedge cap fluid opening 521 that communicates with the fluid opening 516 of the catheter hub 510, and a second fluid pathway portion 562 that connects with the first fluid pathway portion 560 at an angle, and is coaxial with the catheter 512 (see, e.g., Fig. 50). According to one embodiment, the angle is approximately 90 degrees, but one skilled in the art will understand that other angles may be employed without departing from the present invention’s scope.

[0097] Similar to the second and third embodiments, securing protrusions 524 on the catheter hub 510 interact with the securing areas 526 or securing recesses 526 of the needle hub 506 to releasably secure the catheter hub 510 and the needle hub 506. Although not depicted, one skilled in the art will appreciate that another embodiment of the present invention includes securing protrusions 524 being disposed on the needle hub 506 and securing areas 526 or securing recesses 526 being disposed on the catheter hub 510.

[0098] In the initial position, as shown in Figs. 41 and 48, the introducer needle 508 is disposed within the catheter 512, and a portion of the introducer needle 508 extends distally from a distal end of the catheter 512. In such a configuration, the introducer needle 508 at least limits or reduces a portion of the fluid pathway between the fluid opening 516 and the distal end of the catheter 512. According to one embodiment, the introducer needle 508 blocks a portion of the fluid pathway between the wedge cap fluid opening 521 and the distal end of the catheter 512, and thus, blocks a portion of the fluid pathway between the fluid opening 516 and the distal end of the catheter 512.

[0099] The device 500 also includes a user-operable insertion unit 528 or button 528 that is movable relative to the housing 502 by a user and is operable to move the needle hub 506 and the catheter hub 510 from the initial position to the extended position. According to one embodiment, the button 528 is constrained to move substantially linearly by the shape of the housing 502. Referring to Figs. 40 and 45, the button 528 includes a pair of button legs 529 that bear on the catheter hub 510 to move the needle hub 506 and the catheter hub 510 from the initial position to the extended position. The button 528 also has a notch 531 housing a portion of the tubing 517.

[0100] With reference to Figs. 48-50, operation of the catheter insertion device 500 will now be described. As shown in Fig. 48, in the initial position, a majority of the button 528 extends proximally out of the housing 502 and is accessible to the user (e.g., patient). Additionally, the needle hub 506 is releasably secured with the catheter hub 510, and the introducer needle 508 is disposed within the catheter 512. A portion of the introducer needle 508 is also disposed in the septum 522.

[0101] As the user depresses the button 528, the needle hub 506, the catheter hub 510, and the button 528, travel distally together. During movement of the needle hub 506 and the catheter hub 510 (and the catheter 512 and introducer needle 508) toward the extended position, the movement of the needle hub 506 compresses the compression spring 530. Additionally, during movement of the needle hub 506 and the catheter hub 510 toward the extended position, the operation pin 514 engages the slanted portion 550 of the cam guide 503 and rotates the catheter hub 510 about the introducer needle 508 relative to the button 528, the needle hub 506, and the housing 502. This rotation causes the disengagement of the securing protrusions 524 from the securing recesses 526, thereby freeing needle hub 506 from the catheter hub 510 as the catheter hub 510 and the needle hub 506 reach the extended position (Fig. 49). This enables the spring 530 to move the needle hub 506 and the introducer needle 508 from the extended position to withdraw the introducer needle 508 from the catheter 512. This withdrawal of the introducer needle 508 from the catheter 512 establishes fluid communication between the wedge cap fluid opening 521 and a distal end of the catheter 512, and therefore establishes fluid communication between the fluid opening 516 and a distal end of the catheter 512 (Fig. 50).

[0102] According to one embodiment, a portion of the introducer needle 508 remains disposed in the septum 522 when withdrawn, as shown in Fig. 50. According to another embodiment, no portion of the introducer needle 508 remains disposed in the septum 522 when withdrawn.

[0103] Because the medicament does not have to flow through the introducer needle 508, the diameter of the fluid pathway through the catheter hub 510 and the wedge cap 518 to a distal end of the catheter 512 can be larger, thus permitting greater fluid flow and a greater rate of medicament delivery. This embodiment provides for a reduced system footprint, and in comparison to the first and second embodiments, employs a single spring, thereby potentially simplifying manufacturing.

[0104] Fig. 51 is a perspective view of a catheter insertion device 600 in accordance with a sixth embodiment of the present invention. In many respects, the sixth embodiment is similar to the fourth embodiment of Figs. 28-39. Differences will be described for brevity.

[0105] Among other elements, Fig. 51 illustrates that the catheter insertion device 600 (hereinafter device 600 for brevity) includes a housing 602, a housing cap 601 secured with the housing 602, and a user-accessible pull tab 628 that is movably disposed with respect to the housing cap 601. In Fig. 51, the housing cap 601 is depicted as being transparent to aid understanding of the embodiment, but one skilled in the art will appreciate that the opacity of the housing cap 601 could differ without departing from the present invention’s scope.

[0106] In an initial position, as shown, e.g., in Fig. 51, the pull tab 628 has a grasping portion 660 extending outside the housing cap 601 at a first end of the pull tab 628. The opposing end of the pull tab 628 has a wedge portion 662. The pull tab 628 also has a pair of longitudinal wings 664 that respectively ride along corresponding longitudinal slots 666 in the housing cap 601 during movement of the pull tab 628. The interior top of the housing cap 601 has a longitudinal rail 668 depending distally therefrom, and the pull tab 628 has a corresponding longitudinal groove 670 that rides along the rail 668 during movement of the pull tab 628. Collectively, the wings 664, slots 666, rail 668, and the groove 670 work together to constrain the movement of the pull tab 628 to be substantially linear relative to the housing cap 601.

[0107] With reference to Figs. 51-57, the device 600 includes a housing 602 having a cam member 604. The cam member 604 includes a cam guide 603 or cam guide surface 603. The camguide 603 includes an upper portion 648, and lower portion 652, and a slanted portion 650 connecting the upper and lower portions 648 and 652.

[0108] The housing 602 includes a main column 661 in which the needle hub 606 and the catheter hub 610 are movably disposed. The housing 602 also includes a post 667 disposed adjacent to the main column 661, and a pivot anchor 665 disposed adjacent to the post 667. The housing 602 also includes a ramp portion 663 that functions as a stop when engaged by the wedge portion 662 of the pull tab 628.

[0109] The device 600 also includes a needle hub 606 having an introducer needle 608 or needle 608 affixed to the needle hub 606. The needle hub 606 is movably disposed in the main column 661 of the housing 602. According to one preferable embodiment, the introducer needle 608 is solid. According to another embodiment, the introducer needle 608 is hollow. If hollow, it is preferable that at least the proximal end of the introducer needle 608 is closed, for example, where it connects with the needle hub 606, to prevent fluid flow through the introducer needle 608.

[0110] The device 600 additionally includes a release collar 610 or catheter hub 610 with a hollow catheter 612 affixed to the catheter hub 610. The catheter hub 610 is movably disposed in the housing 602, and includes an operation pin 614 extending from a side of the catheter hub 610. As will be subsequently described in greater detail, during operation of the device 600, the operation pin 614 contacts and rides along the cam guide 603, thereby controlling rotation of the catheter hub 610.

[0111] Like the first and fourth embodiments, the catheter hub 610 has a fluid opening 616 that is fluidly communicable with the catheter 612 and is disposed on the operation pin 614. Tubing 617 fluidly connects the operation pin 614 with the pump and / or the reservoir of the medicament delivery device or patch pump. According to one embodiment, the fluid opening 616 is the exterior presentation of a fluid pathway directly through the catheter hub 610 to the catheter 612. According to another embodiment, there are additional elements in the device 100 that are part of the fluid pathway between the fluid opening 616 and the catheter 612. For example, according to one embodiment, the device 600 includes a securing means 620 or securing member 620 or wedge 620 securing the catheter 612 to the catheter hub 610. The securing means 620 or securing member 620 or wedge 620 provides a mechanical anchor andfluidic tightness for the catheter 612 with respect to the catheter hub 610 to prevent leakage. The device 600 also includes a septum 622, and a wedge cap 618 disposed within the catheter hub 610 and securing the septum 622 and the wedge 620 within the catheter hub 610. In the present embodiment, the fluid pathway extends from the fluid opening 616, through the operation pin 614, through the wedge cap 618, and into the catheter 612.

[0112] As best shown in Fig. 57, the wedge cap 618 has a first fluid pathway portion 660 with a wedge cap fluid opening 621 aligned with and fluidly connected to the fluid opening 616, and a second fluid pathway portion 662 that connects with the first fluid pathway portion 660 at an angle and is coaxial with the catheter 612. According to one embodiment, the angle is approximately 90 degrees, but one skilled in the art will understand that other angles may be employed without departing from the present invention’s scope.

[0113] Also like the first and fourth embodiments, the wedge cap 618 includes a key 644 seated in a key way 646 of the catheter hub 610 to prevent or limit rotation of the wedge cap 618 relative to the catheter hub 610. One skilled in the art will appreciate that the key 644 could be disposed on the catheter hub 610 and the keyway 646 could be disposed on the wedge cap 618 without departing from the present invention’s scope. In other words, as shown in Fig. 57, one of the catheter hub 610 and the wedge cap 618 includes a key way 644 and a remaining one of the catheter hub 610 and the wedge cap 618 comprises a key 646 seated in the keyway 644 to limit relative rotation between the catheter hub 610 and the wedge cap 618.

[0114] Similarly, one of the catheter hub 610 and the wedge cap 618 includes a groove 643 and the remaining one of the catheter hub 610 and the wedge cap 618 includes a groove protrusion 645 seated in the groove 643 to prevent relative translation between the catheter hub 610 and the wedge cap 618. In the embodiment depicted in Fig. 57, the groove 643 is disposed on the catheter hub 610 and the groove protrusion 645 is disposed on the wedge cap 618. But one skilled in the art will appreciate that the positioning of the groove 643 and the groove protrusion 645 could be reversed without departing from the scope of the present invention.

[0115] As best shown in Figs. 55 and 57, the catheter hub 610 includes securing protrusions 624 that interact with securing lugs 626 of the needle hub 606 to releasably secure the catheter hub 610 and the needle hub 606. Although not depicted, one skilled in the art will appreciate thatanother embodiment of the present invention includes securing protrusions 624 being disposed on the needle hub 606 and securing lugs 626 being disposed on the catheter hub 610.

[0116] The device 600 further includes a guide member 669 slidably disposed on the post 667. A spring 630 is disposed about the post 667 between a base of the housing 602 and the guide member 669, biasing the guide member 669 proximally. The device 600 also includes an arm 675 that is pivotally connected to the housing 602 at the pivot anchor 665 by, for example, a pin 677 or axle 677. According to one embodiment, best shown in Fig. 54, the arm 675 includes a pair of extension arms 678, 679 fixedly connected to each other at an arm base 681 through which the pin 677 is disposed.

[0117] The extension arms 678 and 679 each have a pair of elongated slots 682, 684, 685, and 687. As best shown in Figs. 51 and 52, guide member slots 682 and 684 slidably house guide member lugs 683 of the guide member 669, and needle hub slots 685 and 687 slidably house securing lugs 626 of the needle hub 606.

[0118] In the initial position, as shown, for example, in Figs. 51 and 58, the introducer needle 608 is disposed within the catheter 612, and a portion of the introducer needle 608 extends distally from a distal end of the catheter 612. In such a configuration, the introducer needle 608 at least limits or reduces a portion of the fluid pathway between the fluid opening 616 and the distal end of the catheter 612. According to one embodiment, the introducer needle 608 blocks a portion of the fluid pathway between the fluid opening 616 and the distal end of the catheter 612.

[0119] With reference to Figs. 58-60, operation of the catheter insertion device 600 will now be described. As shown in Fig. 58, in the initial position, the grasping portion 660 of the pull tab 628 extends out of the housing cap 601 and is accessible to the user (e.g., patient). Additionally, the needle hub 606 is releasably secured with the catheter hub 610, and the introducer needle 608 is disposed within the catheter 612. A portion of the introducer needle 608 is also disposed in the septum 622.

[0120] As the user pulls the pull tab 628 laterally, the arm 675 pivots about the pin 677, and the wedge portion 662 engages the extension arms 678 and 679, thereby causing increasingly distal travel of the guide member 667 (compressing the spring 630) and the needle hub 606 and the catheter hub 610.

[0121] Additionally, during movement of the needle hub 606 and the catheter hub 610 toward the extended position, the operation pin 614 engages the slanted portion 650 of the cam guide 603 and rotates the catheter hub 610 about the introducer needle 608 relative to the button 628, the needle hub 606, and the housing 602. This rotation causes the disengagement of the securing protrusions 624 from the securing lugs 626, thereby freeing needle hub 606 from the catheter hub 610 as the catheter hub 610 and the needle hub 606 reach the extended position (Fig. 59). Once the movement of the wedge portion laterally passes the end of the arm 675, this enables the proximal force of the spring 630 on the guide member 669 to rotate the arm 675 about the pin 677 and proximally move the needle hub 606 and the introducer needle 608 from the extended position to withdraw the introducer needle 608 from the catheter 612. This withdrawal of the introducer needle 608 from the catheter 612 establishes fluid communication between the fluid opening 616 and a distal end of the catheter 612 (Fig. 60). The wedge portion engaging the ramp 663 (or stopping member 663) prevents further lateral movement of the pull tab 628.

[0122] According to one embodiment, a portion of the introducer needle 608 remains disposed in the septum 622 when withdrawn, as shown in Fig. 60. According to another embodiment, no portion of the introducer needle 608 remains disposed in the septum 622 when withdrawn.

[0123] Because the medicament does not have to flow through the introducer needle 608, the diameter of the fluid pathway between the fluid opening 616 and a distal end of the catheter 612 can be larger, thus permitting greater fluid flow and a greater rate of medicament delivery. And although this embodiment has a larger footprint than others of the described embodiments, the offset spring of this embodiment (offset from the axis of travel of the catheter 612 and the introducer needle 608) reduces system complexity, thereby potentially simplifying manufacturing.

[0124] Fig. 61 is a perspective view of a catheter insertion device 700 (hereinafter device 700 for brevity) in accordance with a seventh embodiment of the present invention;

[0125] With reference to Figs. 61-66, the device 700 for brevity includes a housing 702 having one or more cam members 704 or cam protrusions 704. Preferably, there are a pair of cam members 704 protruding inwardly on opposing interior sides of the housing 702. Each cammember 704 includes a cam guide 703 or cam guide surface 703 having a sloped face. And as subsequently described in greater detail, the housing 702 also includes one or more locking openings 725 or locking recesses 725. Preferably, the housing 702 includes a pair of locking openings 725 disposed through opposing portions of the wall of the housing 702. The housing 702 also has a distal flange 724, which aids stability of the device 700.

[0126] The device 700 also includes a user-operable insertion unit 728 or button 728 that is movable relative to the housing 702 by a user and is operable to move the needle hub 706 and the catheter hub 710 from an initial position to an extended position in which a portion of the needle 708 and the catheter 712 are disposed outside of the housing 702. According to one embodiment, as depicted in Fig. 63, the button 728 includes a button body 709 and a button cap 711 secured to the button body 709. The button body 709 includes a cam track 715, and preferably includes a pair of cam tracks 715 through opposing sides of the button body 709. Each cam track 715 has a horizontal portion 713, a vertical portion 721, and a sloped portion 719 joining the horizontal and vertical portions 713 and 721.

[0127] In the initial position, a proximal portion of the vertical portion 721 also serves as a security opening through which a user-removable security part 707 is disposed, as shown in Figs. 61 and 67. The security part 707 prevents depression of the button 728 until the security part 707 is removed from the security opening.

[0128] The button body 709 further includes at least one, and preferably a pair of lock clips 723. As best shown in Figs. 67 and 69, a distal end of the button body 709 has a floor 727 with a recess 729 on a proximal side thereof for receiving a distal end of the spring 730. A central distal protrusion 731 on a distal side of the floor 727 forms an annular recess on the distal side to receive the catheter hub 710.

[0129] The needle hub 706 has an introducer needle 708 or needle 708 affixed to the needle hub 506. The needle hub 706 is movably disposed in the housing 702. According to one preferable embodiment, the introducer needle 708 is solid. According to another embodiment, the introducer needle 708 is hollow. If hollow, it is preferable that at least the proximal end of the introducer needle 708 is closed, for example, where it connects with the needle hub 706, to prevent fluid flow through the introducer needle 708. In addition to an annular distal recess 705 that receives a proximal end of the spring 730, the needle hub 706 also has at least one, andpreferably, a pair of operation pins 714 extending laterally from a proximal end of the needle hub 706.

[0130] Figs. 65 and 66 are perspective and cross-sectional views of the catheter hub 710, the catheter 712, the tubing 717, and the septum 722. The catheter hub 710 with a hollow catheter 712 affixed to the catheter hub 710, and is movably disposed in the housing 702. A distal flange 735 of the catheter hub 710 has at least one notch or channel 737 that engages an internal vertical rail 739 of the housing 702 to prevent rotation of the catheter hub 710 relative to the housing 702 (see Fig. 67).

[0131] As shown in Figs. 65 and 66 the catheter hub 710 has a fluid opening 716, through which tubing 717 passes, a first fluid pathway portion 760 in fluid communication with the fluid opening 716, and a second fluid pathway portion 762 that connects with the first fluid pathway portion 760 at an angle, and is coaxial with the catheter 712. According to one embodiment, the angle is approximately 90 degrees, but one skilled in the art will understand that other angles may be employed without departing from the present invention’s scope.

[0132] In the initial position, as shown in Figs. 61, 67, and 68, the introducer needle 708 is disposed within the catheter 712, and a portion of the introducer needle 708 extends distally from a distal end of the catheter 712. A portion of the introducer needle 708 is also disposed in the septum 722. In such a configuration, the introducer needle 708 at least limits or reduces a portion of the fluid pathway between the fluid opening 716 and the distal end of the catheter 712.According to one embodiment, the introducer needle 708 blocks a portion of the fluid pathway between the fluid opening 716 and the distal end of the catheter 712. Additionally, as best shown in Fig. 67, in the initial position, the lock clip 723 of the button 728 is vertically aligned with the locking opening 725, and the operation pin 714 is vertically aligned with the sloped face of the cam guide 703.

[0133] With reference to Figs. 68-71, operation of the catheter insertion device 700 will now be described. In the initial position, the needle hub 706 is releasably secured with the catheter hub 710, the introducer needle 708 is disposed within the catheter 712, and the security part 707 prevents depression of the button 728. The button 728 extends proximally out of the housing 702 and is accessible to a user (e g., a patient), who must remove the security part 707, to enableoperation of the device 700. In the initial position, the security part 707 is also accessible to the user. Additionally, the spring 730 is compressed.

[0134] After removing the security part 707, the user depresses the button 728, and the needle hub 706, the catheter hub 710, and the button 728, travel distally together. During movement of the needle hub 706 and the catheter hub 710 (and the catheter 712 and introducer needle 708) toward the extended position.

[0135] Fig. 69 depicts the moment just prior to the operation pin 514 engaging the cam member 704. As the needle hub 706 and the catheter hub 710 reach the extended position, the operation pin 714 engages the slanted face of the cam guide 703 thereby rotating the needle hub 706 relative to the button 728, the housing 702, and the catheter hub 710, and the lock clip 723 extends into or engages the locking opening 725 to prevent proximal movement of the button 728 (see Fig. 70).

[0136] The rotation of the needle hub 706 moves of the operation pin 714 from the horizontal portion 713 to the sloped portion 719 of the button body 709, thereby permitting the compressed spring 730 to expand and move the operation pin 714 along the sloped portion 719 until the operation pin 714 aligns with the vertical portion 721. At that point, the spring 730 expands further, proximally moving the needle hub 706 and withdraws the introducer needle 708 from the catheter 712 (Fig. 71). This withdrawal of the introducer needle 708 from the catheter 712 establishes fluid communication between the fluid opening 716 and a distal end of the catheter 712.

[0137] According to one embodiment, a portion of the introducer needle 708 remains disposed in the septum 722 when withdrawn, as shown in Fig. 71. According to another embodiment, no portion of the introducer needle 708 remains disposed in the septum 722 when withdrawn.

[0138] Because the medicament does not have to flow through the introducer needle 708, the diameter of the fluid pathway through the catheter hub 710 to a distal end of the catheter 712 can be larger, thus permitting greater fluid flow and a greater rate of medicament delivery. This embodiment provides for a reduced system footprint, and in comparison to the first and second embodiments, employs a single spring, thereby potentially simplifying manufacturing.

[0139] Although only a few embodiments of the present invention have been shown and described, the present invention is not limited to the described embodiments. It will be appreciated by those skilled in the art that other changes may also be made to the disclosed embodiments without departing from the scope of the invention. In addition, any of the embodiments, features and / or elements disclosed herein may be combined with one another to form various additional combinations not specifically disclosed, as long as the embodiments, features and / or elements being combined do not contradict each other. In other words, various aspects of the multiple embodiments may be employed independently or in combinations thereof. All such changes and combinations are considered to be within the scope of the invention as defined by the appended claims and their equivalents.

Claims

Claims1. A catheter insertion device, comprising: a housing having a cam member; a needle hub having an introducer needle affixed thereto, and being movably disposed within the housing; a catheter hub having a catheter affixed thereto, and being movably disposed within the housing, the catheter hub having a fluid opening fluidly communicable with the catheter, wherein one of the needle hub and the catheter hub includes at least one operation pin extending from a side of the one of the needle hub and the catheter hub, and the needle hub and the catheter hub are releasably secured to move together from an initial position to an extended position; an insertion unit movable relative to the housing by a user, and operable to move the needle hub and the catheter hub from the initial position to the extended position; and at least one spring disposed in the housing; wherein during movement of the catheter and introducer needle toward the extended position by user operation of the insertion unit, engagement of the operation pin with the cam member rotates the one of the needle hub and the catheter hub, thereby freeing relative securement of the needle hub and the catheter hub as the catheter hub and the needle hub reach the extended position, enabling the at least one spring to move the needle hub and the introducer needle from the extended position to withdraw the introducer needle from the catheter, establishing fluid communication between the fluid opening and a distal end of the catheter.

2. The device according to claim 1, further comprising a septum disposed in the catheter hub, wherein upon reaching a fully withdrawn position, the introducer needle remains engaged with the septum.

3. The device according to claim 1, wherein the operation pin is disposed on the catheter hub; and the cam member comprises a cam guide guiding motion of the catheter hub during travel toward the extended position.

4. The device according to claim 1, wherein the introducer needle is solid.

5. The device according to claim 1, further comprising: a wedge securing the catheter to the catheter hub; a septum; and a wedge cap securing the septum and the wedge within the catheter hub, the wedge cap having a wedge cap fluid opening in fluid communication with the fluid opening of the catheter hub.

6. The device according to claim 5, wherein one of the catheter hub and the wedge cap comprises a key way and a remaining one of the catheter hub and the wedge cap comprises a key seated in the keyway to limit relative rotation between the catheter hub and the wedge cap.

7. The device according to claim 5, wherein one of the catheter hub and the wedge cap comprises a groove and the remaining one of the catheter hub and the wedge cap comprises a protrusion seated in the groove to prevent relative translation between the catheter hub and the wedge cap.

8. The device according to claim 1, wherein the fluid opening is disposed on the operation pin.

9. The device according to claim 1, wherein the insertion unit comprises a button engaged with the catheter hub.

10. The device according to claim 9, wherein the housing comprises a main column in which the needle hub and the catheter hub are movably disposed, a retainer disposed adjacent to the main column, and a pivot anchor disposed adjacent to the retainer; and the device further comprises: a post disposed in the retainer; a guide member slidably disposed on the post; and at least one arm, pivotally connected to the pivot anchor, the guide member, and the needle hub; wherein the at least one spring comprises a single spring disposed about the post between the retainer and the guide member, and in the extended position, the single spring biases guide member and arm to withdraw the introducer needle from the catheter.

11. The device according to claim 1, further comprising a housing cap secured with the housing; wherein the insertion unit comprises a user-accessible pull tab slidably mounted in the housing cap to laterally displace with respect to the housing, the pull tab comprising a wedge portion;wherein the housing comprises a main column in which the needle hub and the catheter hub are movably disposed, a post disposed adjacent to the main column, and a pivot anchor disposed adjacent to the post; the device further comprises: a guide member slidably disposed on the post; and at least one arm, pivotally connected to the pivot anchor and slidably connected to the guide member and the needle hub; wherein laterally displacing the pull tab from an initial pull tab position to an extended pull tab position causes the wedge portion to contact and pivot the arm and thereby drive the needle hub and the catheter hub toward the extended position; and wherein the at least one spring comprises a single spring disposed about the post between a base of the housing and the guide member, and in the extended position, the single spring biases guide member and arm to withdraw the introducer needle from the catheter.

12. The device according to claim 11, wherein the housing further comprises a stopping member having a shape corresponding to the wedge portion, and preventing the pull tab from being removed from the housing.

13. The device according to claim 1, wherein: the housing comprises a central core in which the catheter hub is disposed, and at least one guiding core disposed adjacent to the central core, the at least one guiding core having a guiding slot through a side thereof; and the needle hub comprises at least one guiding tab respectively disposed in the guiding slots.

14. The device according to claim 13, wherein: the needle hub comprises at least one distal protuberance disposed in the at least one guiding core; the at least one spring is disposed in the at least one guiding core, the at least one spring being configured to receive the at least one distal protuberance; and in the extended position, the at least one spring is compressed and pushes the needle hub to withdraw the introducer needle from the catheter.

15. The device according to claim 1, wherein the needle hub comprises a ring having a central bar across a diameter thereof, the introducer needle being affixed to the central bar.

16. The device according to claim 15, further comprising a cover covering a portion of a top of the housing; wherein the at least one spring is secured to the needle hub and the cover; and in the extended position, the at least one spring is extended and pulls the needle hub to withdraw the introducer needle from the catheter.

17. The device according to claim 15, further comprising a cover covering a portion of a top of the housing; wherein the at least one spring is disposed between the housing and a distal side of the needle hub; and in the extended position, the at least one spring is compressed and pushes the needle hub to withdraw the introducer needle from the catheter.

18. The device according to claim 1, wherein the fluid opening is disposed in a side of the catheter hub.

19. The device according to claim 1, wherein the fluid opening is disposed in a top of the catheter hub.

20. The device according to claim 9, wherein: the cam member comprises at least one cam protrusion disposed on an inner wall of the housing protruding inwardly, and having a sloped face; the button comprises at least one cam track defined through a side of the button and having a horizontal portion, a vertical portion, and a sloped portion joining the vertical and horizontal portions, the button being secured to the catheter hub; the needle hub includes the operation pin extending through the cam track and engaged with the horizontal portion in the initial position to releasably secure the needle hub to the button; the at least one spring is disposed between the button and a distally facing surface of the needle hub; during movement of the catheter and the introducer needle toward the extended position by user operation of the button, engagement of the operation pin with the sloped face of the cam protrusion rotates the needle hub relative to the button and the catheter hub as the catheter hub and the needle hub reach the extended position, moving the operation pin to the sloped portion and enabling the at least one spring to move the operation pin to the vertical portion and move the needle hub and the introducer needle from the extended position to withdraw the introducer needle from the catheter; andin the extended position, the at least one spring is compressed and pushes the needle hub to withdraw the introducer needle from the catheter.

21. The device according to claim 9, wherein: the housing includes at least one of a locking opening or a locking recess; the button includes at least one lock clip extending from an exterior thereof, biased by contact with a button inner wall; and upon the catheter hub and the needle hub reaching the extended position, freed from contact with the button inner wall, the at least one lock clip aligns with and extends into the at least one of the locking opening or the locking recess, preventing retraction of the button.

22. The device according to claim 9, wherein: the button includes a security opening; and the device includes a user-removable security part, removably disposed in the security opening and extending across a top of the housing, thereby preventing operation of the button.

23. A medicament delivery device, comprising: the device according to claim 1; a base, to which the housing is connected; a medicament reservoir; and a tube connected with the medicament reservoir and the fluid opening of the catheter hub, the tube traveling with the catheter hub.

24. The medicament delivery device according to claim 23, further comprising: a cover engageable with the base and having a guiding portion that, in conjunction with the cam guide of the housing, forms a guide path configured to guide the operation pin.

25. A catheter insertion device, comprising: a housing having an axial passage; a catheter hub disposed within the axial passage and having a catheter, the catheter hub being movable relative to the housing between an initial position within the housing and an extended position in which a portion of the catheter extends outside of the housing, the catheter hub having a fluid pathway connecting a fluid opening on an outside of the catheter hub with a distal end of the catheter; a needle hub disposed within the axial passage and having an introducer needle, the needle hub being movable relative to the housing from an initial needle position to an extended needle position in which a portion of the introducer needle extends outside of the housing, to a withdrawn needle position disposed within the housing and not blocking the fluid pathway, the introducer needle blocking a portion of the fluid pathway in the initial and extended needle positions; and at least one spring, disposed within the housing and biasing the needle hub toward the withdrawn position when the needle hub is in the extended position.

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