Manual catheter insertion device for a drug delivery device

Abstract

A catheter insertion device includes a housing having a cam member, a needle hub having a introducer needle, and a catheter hub having a catheter. The catheter hub has a fluid opening that is fluidly communicable with the catheter. The needle hub or the catheter hub includes at least one operating peg and the needle hub and the catheter hub are moved together from an initial position to an extended position. The device further 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 operating peg engages the cam member to cause the needle hub or the catheter hub to rotate, thereby releasing the relative fixation between the needle hub and the catheter hub, thereby enabling the at least one spring to withdraw the introducer needle from the catheter, thereby establishing fluid communication between the fluid opening and a distal end of the catheter.

Description

Technical Field

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

[0002] Infusion pump therapy typically requires an infusion cannula, usually in the form of an infusion needle or flexible catheter, which is inserted through the patient's skin to deliver the medication. Infusion pump therapy offers the advantages of continuous infusion, precise drug delivery, and programmable delivery protocols.

[0003] To facilitate infusion therapy, two types of pumps are generally available: conventional pumps and patch pumps. Conventional pumps typically use disposable components, generally referred to as infusion kits, tubing kits, or pump kits, which deliver medication from a reservoir within the pump to the user's subcutaneous tissue. The infusion kit includes a pump connector, tubing segments, and a base or socket from which a cannula, in the form of a hollow metal infusion needle or a flexible plastic catheter, extends. The base typically has an adhesive that holds it on the skin surface during use. The cannula can be inserted into the skin manually or using a manual or automated insertion device. This insertion device can be a standalone unit as needed by the user.

[0004] Another type of pump is the patch pump. Unlike traditional infusion pumps and infusion kits, patch pumps are integrated devices that combine most or all fluid components (including a fluid reservoir, pumping mechanism, and cannula insertion mechanism) into a single housing. This housing is adhesively attached to the infusion site on the patient's skin, eliminating the need for separate infusion kits or tubing kits. The patch pump, containing the medication, is attached to the patient's skin and delivers the medication over a period of time or at selected intervals via an integrated subcutaneous cannula. Some patch pumps can communicate wirelessly with a separate controller device, while others are completely self-contained. These devices are frequently replaced, for example, every three days, when the medication reservoir is depleted or complications may arise (e.g., cannula or infusion site limitations).

[0005] Since the patch pump is designed as a self-contained unit worn by a user (e.g., a patient), it is preferable to be as small as possible so as not to interfere with the user's activities. Therefore, to minimize user discomfort, it is preferable to minimize the overall thickness of the patch pump. To minimize the thickness of the patch pump, the components of the patch pump should be as small in size and as few in number as possible.

[0006] However, minimizing the components may affect the flow rate of the drug to the patient. A mechanism is needed to provide increased drug flow rate while minimizing the profile of the drug delivery device. Summary of the Invention

[0007] Therefore, an aspect of the present invention is to provide a catheter insertion device that allows for the delivery of large quantities of medication.

[0008] The above 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 seat having a guide needle attached thereto and the needle seat being movably disposed within the housing. The device further includes a catheter seat having a catheter attached thereto and the catheter seat being movably disposed within the housing, the catheter seat having a fluid opening in fluid communication with the catheter, wherein one of the needle seat and the catheter seat includes at least one operating pin extending from a side of said one of the needle seat and the catheter seat, and the needle seat and the catheter seat are releasably secured so as to move together from an initial position to an extended position. The device also includes an insertion unit that a user can move relative to the housing and that is operable to move the needle seat and the catheter seat from the initial position to the extended position. The device also includes at least one spring disposed within the housing. During the movement of the catheter and guide needle toward the extended position by the user operating the insertion unit, the engagement of the operating pin with the cam member causes one of the needle seat and the catheter seat to rotate, thereby releasing the relative fixation of the needle seat and the catheter seat when the catheter seat and the needle seat reach the extended position, so that at least one spring can move the needle seat and the guide needle from the extended position in order to retract the guide needle from the catheter, thereby establishing fluid communication between the fluid opening and the distal end of the catheter.

[0009] The above and / or other general aspects of the present invention are also achieved by providing a catheter insertion device comprising a housing having an axial channel. The device further includes a catheter seat disposed within the axial channel and having a catheter, the catheter seat 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 the housing, the catheter seat having a fluid passage connecting a fluid opening on the outer side of the catheter seat to a distal end of the catheter. The device further includes a needle seat disposed within the axial channel and having a guide needle, the needle seat being movable relative to the housing from an initial needle position to an extended needle position and to a retracted needle position, in which a portion of the guide needle extends outside the housing, and in the retracted needle position disposed within the housing and not obstructing the fluid passage, in which the guide needle obstructs a portion of the fluid passage in both the initial needle position and the extended needle position. The device further includes at least one spring disposed within the housing and biasing the needle seat toward the retracted position when the needle seat is in the extended position.

[0010] Additional and / or other aspects and advantages of the invention will be set forth in the description which follows, or will be apparent from the description, or may be learned by practicing the invention. Attached Figure Description

[0011] The above and / or other aspects and advantages of the embodiments of the present invention will be more readily understood from the following detailed description taken in conjunction with the accompanying drawings, wherein:

[0012] Figure 1 and Figure 2 These are, respectively, a top perspective view and a side view of an example patch pump used as a wearable fluid delivery device;

[0013] Figure 3 This is an exploded perspective view of a catheter insertion device according to a first embodiment of the present invention;

[0014] Figure 4 yes Figure 3 A perspective view of the device;

[0015] Figure 5 yes Figure 3 A cross-sectional view of the device;

[0016] Figure 6 yes Figure 3 A perspective view of the catheter hub and needle hub of the device;

[0017] Figure 7 yes Figure 3 The top perspective view of the device, in which buttons are omitted for clarity;

[0018] Figure 8 , Figure 9 and Figure 10 It shows Figure 3 A cross-sectional view of the device in operation;

[0019] Figure 11 This is an exploded perspective view of a catheter insertion device according to a second embodiment of the present invention;

[0020] Figure 12 yes Figure 11 A perspective view of the housing of the device;

[0021] Figure 13 yes Figure 11 A perspective view of the needle hub and guide needle of the device;

[0022] Figure 14 yes Figure 13 A perspective sectional view of the needle holder;

[0023] Figure 15 yes Figure 11 A perspective view of the device's conduit seat, hollow conduit, wedge cap, and diaphragm;

[0024] Figure 16 , Figure 17 and Figure 18 It is shown Figure 11 A cross-sectional view of the device in operation;

[0025] Figure 19 This is a perspective view of a catheter insertion device according to a third embodiment of the present invention;

[0026] Figure 20 yes Figure 19 An exploded perspective view of the device;

[0027] Figure 21 and Figure 22 They are Figure 19 Top and bottom perspective views of the needle hub and guide needle of the device;

[0028] Figure 23 yes Figure 21 and Figure 22 A perspective sectional view of the needle hub and guide needle;

[0029] Figure 24 yes Figure 19 A perspective view of the cover of the device;

[0030] Figure 25 , Figure 26 and Figure 27 It shows Figure 19 A cross-sectional view of the device in operation;

[0031] Figure 28 This is a perspective view of a catheter insertion device according to a fourth embodiment of the present invention;

[0032] Figure 29 yes Figure 28 A perspective sectional view of the device;

[0033] Figure 30 yes Figure 28 A perspective view of the housing of the device;

[0034] Figure 31 yes Figure 28 A perspective view of the buttons on the device;

[0035] Figure 32 yes Figure 28 A perspective view of the needle hub and catheter hub of the device;

[0036] Figure 33 yes Figure 28 A perspective view of the rods, springs, and guide components of the device;

[0037] Figure 34 yes Figure 32A perspective sectional view of the needle hub and the guide hub;

[0038] Figure 35 and Figure 36 It is shown in Figure 28 During the operation of the device Figure 32 A partial perspective view of the interaction between the needle hub and the catheter hub;

[0039] Figure 37 , Figure 38 and Figure 39 It shows Figure 28 A cross-sectional view of the device in operation;

[0040] Figure 40 This is a perspective view of a catheter insertion device according to a fifth embodiment of the present invention;

[0041] Figure 41 yes Figure 40 A perspective sectional view of the device;

[0042] Figure 42 yes Figure 40 An exploded view of the device;

[0043] Figure 43 yes Figure 40 A perspective view of the housing of the device;

[0044] Figure 44 yes Figure 42 Another perspective view of the casing;

[0045] Figure 45 yes Figure 40 A perspective view of the buttons on the device;

[0046] Figure 46 yes Figure 40 A perspective view of the needle hub and guide needle of the device;

[0047] Figure 47 yes Figure 40 A perspective view of the device's conduit seat, conduit, diaphragm, and wedge cap;

[0048] Figure 48 , Figure 49 and Figure 50 It is shown Figure 40 A cross-sectional view of the device in operation;

[0049] Figure 51 This is a perspective view of a catheter insertion device according to a sixth embodiment of the present invention;

[0050] Figure 52 yes Figure 51 A perspective view of the housing, arm, guide member, spring, needle seat, and guide tube seat of the device;

[0051] Figure 53 yes Figure 52 A perspective view of the casing;

[0052] Figure 54 yes Figure 52 Perspective view of the arm;

[0053] Figure 55 yes Figure 52 Perspective view of the needle hub and catheter hub;

[0054] Figure 56 yes Figure 52 Perspective view of the guide component and spring;

[0055] Figure 57 yes Figure 52 A perspective sectional view of the conduit seat;

[0056] Figure 58 , Figure 59 and Figure 60 It is shown Figure 51 A cross-sectional view of the device in operation;

[0057] Figure 61 This is a perspective view of a catheter insertion device according to a seventh embodiment of the present invention;

[0058] Figure 62 yes Figure 61 A perspective sectional view of the housing of the device;

[0059] Figure 63 yes Figure 61 A perspective view of the buttons on the device;

[0060] Figure 64 yes Figure 61 A perspective view of the needle hub and guide needle of the device;

[0061] Figure 65 yes Figure 61 A perspective view of the catheter seat and catheter of the device;

[0062] Figure 66 yes Figure 65 A perspective sectional view of the catheter hub and the catheter;

[0063] Figure 67 yes Figure 61 A perspective view of the device in its initial state, in which Figure 62 The shell is depicted as transparent;

[0064] Figure 68 yes Figure 61 A cross-sectional view of the device in its initial state;

[0065] Figure 69 yes Figure 61 A partial perspective view of the device during operation;

[0066] Figure 70 and Figure 71 It is shown Figure 61 A cross-sectional view of the operation of the device. Detailed Implementation

[0067] The embodiments of the present invention will now be described in detail with reference to the accompanying drawings, which are illustrated in the accompanying drawings, wherein the same reference numerals refer to the same elements throughout the drawings. The embodiments described herein are illustrated by way of example with reference to the accompanying drawings, but do not constitute a limitation thereof.

[0068] These embodiments are not intended to be mutually exclusive, and features of one embodiment can be combined with those of other embodiments as long as they do not contradict each other.

[0069] Those skilled in the art will understand that the application of this disclosure is not limited to the construction details and component arrangements set forth in the following description or shown in the accompanying drawings. The embodiments described herein can also have other embodiments and can be practiced or performed in various ways. The wording and terminology used herein are for descriptive purposes only and should not be considered limiting. The use of “comprising,” “including,” or “having,” and variations thereof herein will cover the items listed thereafter and their equivalents, as well as additional items.

[0070] Unless otherwise limited, the terms “connection,” “link,” and “installation,” and variations thereof, used herein, should be interpreted broadly and encompass both direct and indirect connections, links, and installations. Furthermore, the terms “connection,” “link,” and variations thereof are not limited to physical or mechanical connections or links. Further, terms such as “upper,” “lower,” “bottom,” “top,” “front,” “back,” “above,” “below,” “upward,” “downward,” and other orientational descriptors are intended to facilitate the description of exemplary embodiments of the invention, and not to limit the structure of exemplary embodiments of the invention to any particular location or orientation. For example, degree terms such as “approximately” or “about” are understood by those skilled in the art to refer to a reasonable range around and including a given value, as well as ranges beyond the given value, for example, general tolerances associated with the manufacture, assembly, and use of the embodiments. When referring to a structure or feature, the term “substantial” includes features that are substantially or wholly present in the feature or structure.

[0071] As used herein, “a,” “one,” and “the” refer to both the singular and the plural, unless the context clearly specifies otherwise. For example, “a processor” programmed to perform various functions refers to one processor programmed to perform each function, or to more than one processor collectively programmed to perform each of the functions.

[0072] Figure 1 and Figure 2 An exemplary patch pump 10 is shown for use as a wearable fluid delivery device. The patch pump 10 includes a housing or casing 12, which has an activation button 20 and an insertion mechanism 22. The casing 12 may have an adhesive pad 16 and a liner 18 disposed on its base plate 14, configured to allow a user to remove the liner 18 and place the adhesive side of the adhesive pad 16 onto the patient's skin to attach the patch pump 10 to the patient. Figure 1 The insertion mechanism 22 shown is in the undeployed position. Figure 2 For clarity, the adhesive pad 16 and liner 18 are not shown in order to depict the insertion mechanism 22 in the deployment position, whereby the needle 26 and / or catheter 24 extend from the housing 12 for insertion into the patient's skin. This exemplary patch pump has a catheter 24 and needle 26 assembly for inserting the catheter and needle into the patient, followed by needle retraction.

[0073] An exemplary insertion mechanism is described in more 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 a guide needle, the guide needle remains as part of the fluid passage between the drug reservoir and the catheter, even though it has been withdrawn from the catheter.

[0074] Because the guide needle must be fitted inside the catheter and therefore its diameter must be smaller than the catheter diameter, the guide needle can become a major factor limiting drug flow rate or delivery rate. The Poiseuille equation gives the pressure drop of a laminar fluid over a section of pipe:

[0075] Δp=

[0076] Δp = pressure difference between the two ends

[0077] μ = dynamic viscosity

[0078] L = pipe length

[0079] Q = Volumetric flow rate

[0080] π = pi

[0081] R = pipe radius

[0082] Therefore, the pressure drop across the pipe is inversely proportional to the fourth power of the radius. In other words, a smaller pipe radius results in a significantly increased pressure difference between the two ends of the pipe.

[0083] However, increasing the diameter of the catheter and insertion needle may increase patient discomfort and / or pain. Therefore, one way to address this issue and maintain the diameter of the catheter and guide needle is to remove the guide needle as part of the fluid pathway from the drug reservoir to the catheter.

[0084] Figure 3 This is an exploded perspective view of the catheter insertion device 100 according to a first embodiment of the present invention. Figure 4 This is a perspective view of a catheter insertion device 100, which includes a housing 102 with a cam member 104. According to one embodiment, as... Figure 3 and Figure 4 As best shown, the cam member 104 includes a cam guide 103 or a cam guide surface 103. The cam guide 103 includes an upper portion 148, a lower portion 152, and an inclined portion 150 connecting the upper portion 148 and the lower portion 152.

[0085] The catheter insertion device 100 (hereinafter referred to as device 100 for simplicity) also includes a needle hub 106 having a guide needle 108 or needle 108 attached to the needle hub 106. The needle hub 106 is movably arranged in the housing 102. According to a preferred embodiment, the guide needle 108 is solid. According to another embodiment, the guide needle 108 is hollow. If the guide needle 108 is hollow, it is preferable that at least its proximal end is closed (e.g., at the proximal end, it is connected to the needle hub 106) to prevent fluid flow through the guide needle 108.

[0086] The device 100 also includes a release collar 110 or a conduit seat 110, to which the hollow conduit 112 is attached. The conduit seat 110 is movably disposed within the housing 102. The conduit seat 110 includes an operating pin 114 extending from its side. As will be described in more detail later, during operation of the device 100, the operating pin 114 contacts and rides along a cam guide 103, thereby controlling the rotation of the conduit seat 110.

[0087] In this embodiment, the catheter seat 110 has a fluid opening 116 (e.g., Figure 6(As best shown), the fluid opening is in fluid communication with the catheter and is disposed on the operating pin 114. Although not shown in this embodiment, the catheter fluidly connects the operating pin 114 to the pump and / or reservoir of a drug delivery device or patch pump. According to one embodiment, the fluid opening 116 is an external presentation of the fluid passage directly through the catheter seat 110 to the catheter 112. Preferably, according to another embodiment, the device 100 is provided with additional elements that are located within the fluid passage 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 passage located between the fluid opening 116 and the catheter 112.

[0088] More specifically, according to one embodiment, device 100 includes a fixing device 120, a fixing member 120, or a wedge 120 that secures conduit 112 to conduit seat 110. The fixing device 120, fixing member 120, or wedge 120 provides mechanical anchoring and fluid sealing of conduit 112 relative to conduit seat 110 to prevent leakage. Device 100 also includes a diaphragm 122 and a wedge cap 118 disposed within conduit seat 110 and securing the diaphragm 122 and wedge 120 within conduit seat 110. Figure 10 As best shown, the wedge cap 118 has a first fluid passage portion 156 and a wedge cap fluid opening 121, the fluid opening of which is aligned with the fluid passage of the conduit seat 110, which includes the fluid opening 116. The wedge cap 118 also has a second fluid passage portion 158, which is connected to the first fluid passage portion at an angle and coaxial with the conduit 112. According to one embodiment, this angle is approximately 90 degrees, but those skilled in the art will understand that other angles may be used without departing from the scope of the invention.

[0089] In the initial position, such as Figures 4 to 6 As best shown, both the catheter seat 110 and the needle seat 106 are arranged within the housing 102 and are releasably secured so as to move together to an extended or inserted position, in which the needle 108 and a portion of the catheter 112 are arranged outside the housing. Figure 6 As shown, in this embodiment, the catheter seat 110 is releasably and directly fixed to the needle seat 106 by engaging one or more fixing protrusions 124 disposed on the catheter seat 110 with fixing regions 126 or fixing recesses 126 disposed on the needle seat 106. Those skilled in the art will understand that another embodiment of the invention includes fixing protrusions 124 disposed on the needle seat 106, while fixing regions 126 or fixing recesses 126 are disposed on the catheter seat 110.

[0090] In the initial position, a guide needle 108 is disposed within the catheter 112, and a portion of the guide needle 108 extends distally from the distal end of the catheter 112. In this configuration, the guide needle 108 at least restricts or narrows a portion of the fluid passage located between the fluid opening 116 and the distal end of the catheter 112. According to one embodiment, the guide needle blocks a portion of the fluid passage located between the fluid opening 116 and the distal end of the catheter 112.

[0091] The device 100 also includes a user-operable insertion unit 128 or button 128, which the user can move relative to the housing 102 and which is operable to move the needle seat 106 and the guide tube seat 110 from an initial position to an extended position. According to one embodiment, the button 128 is constrained by the shape of the housing 102 to allow for substantially linear movement. The device 100 also includes at least one spring 130, which is arranged within 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 seat 106 toward the retracted position, as described in more detail below.

[0092] Figure 7 This is a perspective view of device 100, in which button 128 has been removed for illustrative purposes. Reference Figure 3 and Figure 7 The housing 102 includes: a central core 132 or axial channel 132, in which a conduit seat 110 is disposed; and at least one guide core 134 arranged adjacent to the central core 132. In the illustrated embodiment, the at least one guide core 134 is a pair of guide cores 134. Each guide core 134 includes a guide slot 136 on its side. Figure 5 As shown in the best embodiment, the distal end of the central core 132 includes a distal opening 142 through which the conduit 112 and the guide needle 108 extend.

[0093] refer to Figure 3 , Figure 6 and Figure 7 The needle hub 106 includes at least one guide tab 138. In the illustrated embodiment, the at least one guide tab 138 is a pair of guide tabs 138, which are respectively arranged in the guide slots 136 to prevent the needle hub from rotating relative to the housing 102 and to constrain the needle hub 106 to travel substantially linearly.

[0094] According to one embodiment, the needle hub 106 includes at least one distal protrusion 140. In the illustrated embodiment, the at least one distal protrusion 140 is a pair of distal protrusions 140, each disposed in a guide core 134. Springs 130 are disposed in the guide core 134. The proximal ends of the springs 130 are respectively configured to receive the distal protrusions 140.

[0095] like Figure 7 As shown, the wedge cap 118 includes a key 144 disposed in a keyway 146 of the conduit seat 110 to prevent or limit rotation of the wedge cap 118 relative to the conduit seat 110. Those skilled in the art will understand that the key 144 can also be disposed on the conduit seat 110, and the keyway 146 can be disposed on the wedge cap 118, without departing from the scope of the invention.

[0096] refer to Figure 5 as well as Figures 8 to 10 The operation of the catheter insertion device 100 will now be described. Figure 5 As shown, in the initial position, most of button 128 extends proximally beyond the housing and is accessible to the user (e.g., a patient). Furthermore, needle hub 106 is releasably secured to catheter hub 110, and guide needle 108 is disposed within catheter 112. Further, guide needle 108 obstructs fluid communication between fluid opening 116 and the distal end of catheter 112.

[0097] When the user presses button 128, button 128, needle seat 106, and guide tube seat 110 travel distally together. During the movement of needle seat 106 and guide tube seat 110 (as well as guide tube 112 and guide needle 108) toward the extended position, needle seat 106 compresses spring 130 and actuates pin 114 to engage inclined portion 150 of cam guide 103, causing guide tube seat 110 to rotate about guide needle 108 relative to button 128, needle seat 106, and housing 102. This rotation causes retaining protrusion 124 to disengage from retaining recess 126, thereby allowing guide tube seat 110 and needle seat 106 to reach the extended position ( Figure 8 When the needle hub 106 disengages from the catheter seat 110, the spring 130 allows the needle hub 106 and the guide needle 108 to move from the extended position, thereby retracting the guide needle 108 from the catheter 112. Figure 9 and Figure 10 This withdrawal of the guide needle 108 from the catheter 112 establishes fluid communication between the fluid opening 116 and the distal end of the catheter 112.

[0098] According to one embodiment, such as Figure 10As shown, when the guide needle 108 is retracted, a portion of it remains disposed within the diaphragm 122. According to another embodiment, when the guide needle 108 is retracted, no portion of it remains disposed within the diaphragm 122.

[0099] Because the drug does not have to flow through the guide needle 108, the diameter of the fluid passage between the fluid opening 116 and the distal end of the catheter 112 can be larger, allowing for a greater fluid flow rate and a faster drug delivery rate. Furthermore, this design provides reduced pressure loss compared to designs that incorporate the guide needle as part of the drug flow path, as the drug can enter laterally through a larger tube closer to the catheter 112.

[0100] In the embodiments described below, unless otherwise stated, the reference numerals used to refer to corresponding parts of the embodiments will be consistent with those used to refer to the embodiments. Figure 1-10 The markings in the embodiments are the same, but their numbering series will be different, for example, using the 200 series or the 300 series. The differences between the second embodiment and the first embodiment will be described next.

[0101] Figure 11 This is an exploded perspective view of a catheter insertion device 200 according to a second embodiment of the present invention. The catheter insertion device 200 includes a housing 202 provided with a cam member 204. According to one embodiment, such as... Figure 12 As best shown, the cam member 204 includes a cam guide 203 or a cam guide surface 203. The cam guide 203 includes an upper portion 248, a lower portion 252, and an inclined portion 250 connecting the upper portion 248 and the lower portion 252.

[0102] The catheter insertion device 200 (hereinafter referred to as device 200 for simplicity) also includes a needle hub 206 to which a guide needle 208 or a needle 208 is attached. The needle hub 206 is movably arranged within the housing 202. According to a preferred embodiment, the guide needle 208 is solid. According to another embodiment, the guide needle 208 is hollow. If hollow, it is preferable that at least the proximal end of the guide needle 208 (e.g., where it is connected to the needle hub 206) is closed to prevent fluid from flowing through the guide needle 208.

[0103] In this embodiment, as Figure 13 As best shown, needle hub 206 includes an annular member 207 having a central strip 209 spanning its diameter. Guide needle 208 is attached to the central strip 209. Needle hub 206 also includes one or more retaining recesses 226 or retaining regions 226 for releasably securing needle hub 206 to release collar 210 or catheter hub 210, as described in more detail later.

[0104] refer to Figure 11 , Figure 13 and Figure 14 The device 200 includes a cover 211 having one or more cover supports 213 corresponding to one or more tension springs 230. According to one embodiment, the one or more springs 230 have retaining clamps 231 arranged at opposite ends of the springs 230. One retaining clamp 231 is secured to the cover support 213, while opposing retaining clamps on the tension springs 230 are secured to clamp recesses 256 through clamp openings 254 in the needle holder 206. According to one embodiment, the one or more springs 230 are a pair of springs 230, and in the extended position (see...) Figure 17 Spring 230 biases pin seat 206 toward the retracted position, as described in more detail later.

[0105] The device 200 also includes a release collar 210 or a conduit seat 210, wherein a hollow conduit 212 is attached to the conduit seat 210. The conduit seat 210 is movably arranged within the housing 202. The conduit seat 210 includes an operating pin 214 extending from the side of the conduit seat 210. As will be described in more detail later, during operation of the device 200, the operating pin 214 contacts and rides along the cam guide 203, thereby controlling the rotation of the conduit seat 210. According to one embodiment, the cover 211 includes a corresponding cam surface 258 (see...). Figure 11 The cam surface corresponds to and cooperates with the cam guide 203 to form a cam track for guiding the operating pin 214.

[0106] According to one embodiment, device 200 includes a fixing device 220, a fixing member 220, or a wedge 220 that secures conduit 212 to conduit seat 210. The fixing device 220, fixing member 220, or wedge 220 provides mechanical anchoring and fluid sealing of conduit 212 relative to conduit seat 210 to prevent leakage. Device 200 also includes a diaphragm 222 and a wedge cap 218 disposed within conduit seat 210 and securing the diaphragm 222 and wedge 220 within conduit seat 210.

[0107] like Figure 11 and Figure 15 As shown, the wedge cap 218 has a fluid opening 216 through which a tube 217 passes. The tube 217 is connected to the fluid opening 221 of the wedge cap and fluidly connects the wedge cap 218 to the pump and / or reservoir of a drug delivery device or patch pump.

[0108] The wedge cap 218 has: a first fluid passage portion 260, wherein the fluid opening 221 of the wedge cap is aligned with the fluid opening 216 of the conduit seat 210; and a second fluid passage portion 262, which is connected to the first fluid passage portion 260 at an angle and is coaxial with the conduit 212. According to one embodiment, this angle is approximately 90 degrees, but those skilled in the art will understand that other angles may be used without departing from the scope of the invention.

[0109] Figure 15 One or more retaining protrusions 224 on the catheter seat 210 are also shown. Similar to the first embodiment, the retaining protrusions 224 interact with the retaining region 226 or retaining recess 226 of the needle seat 206 to releasably secure the catheter seat 210 and the needle seat 206. Those skilled in the art will understand that another embodiment of the invention includes retaining protrusions 224 disposed on the needle seat 206, while retaining region 226 or retaining recess 226 is disposed on the catheter seat 210.

[0110] In the initial position, such as Figure 16 As shown, a guide needle 208 is disposed within the conduit 212, and a portion of the guide needle 208 extends distally from the distal end of the conduit 212. In this configuration, the guide needle 208 at least restricts or narrows a portion of the fluid passage located between the fluid opening 216 and the distal end of the conduit 212. According to one embodiment, the guide needle blocks a portion of the fluid passage located between the wedge-shaped cap fluid opening 221 and the distal end of the conduit 212.

[0111] The device 200 also includes a user-operable insertion unit 228 or button 228, which the user can move relative to the housing 202 and which is operable to move the needle hub 206 and the catheter hub 210 from an initial position to an extended position. According to one embodiment, the button 228 is constrained by the shape of the housing 202 to allow it to move substantially linearly.

[0112] refer to Figure 16-18 The operation of the catheter insertion device 200 will now be described. Figure 16 As shown, in the initial position, a large portion of button 228 extends proximally beyond housing 202 and is accessible to a user (e.g., a patient). Furthermore, needle hub 206 is releasably secured to catheter hub 210, and guide needle 208 is disposed within catheter 212. A portion of guide needle 208 is also disposed within diaphragm 222. Further, guide needle 208 obstructs fluid communication between wedge cap fluid opening 221 and the distal end of catheter 212, and thus also obstructs fluid communication between fluid opening 216 and the distal end of catheter 212.

[0113] When the user presses button 228, button 228, needle seat 206, and guide tube seat 210 will travel distally together. During the movement of needle seat 206 and guide tube seat 210 (as well as guide tube 212 and guide needle 208) toward the extended position, the movement of needle seat 206 causes spring 230 to extend because the opposite ends of spring 230 are respectively fixed to needle seat 206 and cap 211, which remains stationary on top of housing 202. Furthermore, during the movement of needle seat 206 and guide tube seat 210 toward the extended position, actuating pin 214 engages the inclined portion 250 of cam guide 203 and causes guide tube seat 210 to rotate about guide needle 208 relative to button 228, needle seat 206, and housing 202. This rotation causes retaining protrusion 224 to disengage from retaining recess 226, thereby allowing the guide tube seat 210 and needle seat 206 to reach the extended position ( Figure 17 This causes the needle seat 206 to disengage from the catheter seat 210. This allows the spring 230 to move the needle seat 206 and the guide needle 208 from the extended position, so as to retract the guide needle 208 from the catheter 212. This retraction of the guide needle 208 from the catheter 212 establishes fluid communication between the wedge cap fluid opening 221 and the distal end of the catheter 212, and therefore also establishes fluid communication between the fluid opening 216 and the distal end of the catheter 212. Figure 18 ).

[0114] According to one embodiment, such as Figure 18 As shown, when the guide needle 208 is retracted, a portion of it remains disposed within the diaphragm 222. According to another embodiment, when the guide needle 208 is retracted, no portion of it remains disposed within the diaphragm 222.

[0115] Since the drug does not need to flow through the guide needle 208, the diameter of the fluid passage through the catheter seat 210 and wedge cap 218 to the distal end of the catheter 212 can be larger, allowing for greater fluid flow and faster drug delivery rates. The system footprint for the catheter insertion device 200 is reduced compared to the first embodiment.

[0116] Figure 19 This is a perspective view of a catheter insertion device 300 according to a third embodiment of the present invention. The third embodiment is similar to the second embodiment in many respects, and for the sake of brevity, the differences will be described.

[0117] refer to Figure 19 and Figure 20The catheter insertion device 300 (hereinafter referred to as device 300 for simplicity) includes a housing 302 having a cam member 304. The cam member 304 includes a cam guide 303 or a cam guide surface 303. The cam guide 303 includes an upper portion 348, a lower portion 352, and an inclined portion 350 connecting the upper portion 348 and the lower portion 352.

[0118] The device 300 also includes a needle holder 306 to which a guide needle 308 or a needle 308 is attached. The needle holder 306 is movably arranged within the housing 302. According to a preferred embodiment, the guide needle 308 is solid. According to another embodiment, the guide needle 308 is hollow. If hollow, it is preferable that at least the proximal end of the guide needle (e.g., where it is connected to the needle holder 306) is closed to prevent fluid from flowing through the guide needle 308.

[0119] like Figure 21-23 As best shown, needle hub 306 includes an annular member 307 having a central strip 309 spanning its diameter. Guide needle 308 is attached to the central strip 309. Needle hub 306 also includes one or more retaining recesses 326 or retaining regions 326 for releasably securing needle hub 306 to release collar 310 or catheter hub 310, as described in more detail later.

[0120] The needle holder 306 also has a passage 305 that extends from the proximal surface 303 of the needle holder 306 through the annular member 307 to the distal surface 309 of the needle holder 306. According to one embodiment, the passage 305 is helical. The distal end of the spring 330 is disposed in the passage 305 to secure the spring 330 to the needle holder 306.

[0121] refer to Figure 19 , 20 In embodiment 24, device 300 includes a cover 311 having an annular space 319 that opens distally therein for receiving a portion of a spring 330, which, according to one embodiment, is a tension spring 330. The cover 311 also has a fixing opening 329 on its side. Similar to the second embodiment, the cover also has a distal portion 315 with a corresponding cam surface 358 that engages with a cam guide 303 of the housing 302 to guide rotation of the catheter seat 310 during insertion of the catheter 312, as described in more detail later. Furthermore, the tension spring 330 has a fixing clamp 331 at its end for securing the spring 330 to the cover 311 through the fixing opening 329. Thus, the spring 330 is secured to both the needle seat 306 and the cover 311.

[0122] The device 300 also includes a release collar 310 or a conduit seat 310, wherein a hollow conduit 312 is attached to the conduit seat 310. The conduit seat 310 is movably disposed within the housing 302 and includes an operating pin 314 extending from the side of the conduit seat 310. As will be described in more detail later, during operation of the device 300, the operating pin 314 contacts and rides along a cam guide 303, thereby controlling the rotation of the conduit seat 310. As previously mentioned, the cover 311 includes a corresponding cam surface 358 (see...). Figure 24 The corresponding cam surface 358 corresponds to and cooperates with the cam guide 303 to form a cam track for guiding the operating pin 314.

[0123] According to one embodiment, the device 300 includes a fixing device 320, a fixing member 320, or a wedge 320 that secures the conduit 312 to the conduit seat 310. The fixing device 320, fixing member 320, or wedge 320 provides mechanical anchoring and fluid sealing of the conduit 312 relative to the conduit seat 310 to prevent leakage. The device 300 also includes a diaphragm 322 and a wedge cap 318 disposed within the conduit seat 310 and securing the diaphragm 322 and the wedge 320 within the conduit seat 310.

[0124] like Figure 20 and Figure 25-27 As shown, the wedge cap 318 has a fluid opening 316, through which a tube 317 passes and connects to the fluid opening 221 of the wedge cap. The tube 317 fluidly connects the wedge cap 318 to the pump and / or reservoir of a drug delivery device or patch pump.

[0125] The wedge cap 318 has: a first fluid passage portion 360, wherein the fluid opening 321 of the wedge cap is aligned with the fluid opening 316 of the conduit seat 310; and a second fluid passage portion 362, which is connected to the first fluid passage portion 360 at an angle and is coaxial with the conduit 312 (see [reference]). Figure 27 According to one embodiment, the angle is approximately 90 degrees; however, those skilled in the art will understand that other angles may be used without departing from the scope of the invention.

[0126] Similar to the second embodiment, the fixing protrusion 324 on the catheter seat 310 interacts with the fixing region 326 or fixing recess 326 of the needle seat 306 to releasably secure the catheter seat 310 and the needle seat 306. Although not shown in the figures, those skilled in the art will understand that another embodiment of the invention includes a fixing protrusion 324 disposed on the needle seat 306 and a fixing region 326 or fixing recess 326 disposed on the catheter seat 310.

[0127] In the initial position, such as Figure 25 As shown, a guide needle 308 is disposed within the conduit 312, and a portion of the guide needle 308 extends distally from the distal end of the conduit 312. In this configuration, the guide needle 308 at least restricts or narrows a portion of the fluid passage located between the fluid opening 316 and the distal end of the conduit 312. According to one embodiment, the guide needle 308 blocks a portion of the fluid passage located between the wedge-shaped cap fluid opening 321 and the distal end of the conduit 312, and thus blocks a portion of the fluid passage located between the fluid opening 316 and the distal end of the conduit 312.

[0128] The device 300 also includes a user-operable insertion unit 328 or button 328, which the user can move relative to the housing 302 and which is operable to move the needle hub 306 and the guide tube hub 310 from an initial position to an extended position. According to one embodiment, the button 328 is constrained by the shape of the housing 302 to allow it to move substantially linearly.

[0129] refer to Figures 25 to 27 The operation of the catheter insertion device 300 will now be described. Figure 25 As shown, in the initial position, most of button 328 extends proximally beyond housing 302 and is accessible to the user (e.g., a patient). Furthermore, needle hub 306 is releasably secured to catheter hub 310, and guide needle 308 is disposed within catheter 312. A portion of guide needle 308 is also disposed within diaphragm 322.

[0130] When the user presses button 328, button 328, needle seat 306, and guide tube seat 310 will travel distally together. During the movement of needle seat 306 and guide tube seat 310 (as well as guide tube 312 and guide needle 308) toward the extended position, the movement of needle seat 306 causes tension spring 330 to extend because the opposite ends of spring 330 are respectively fixed to needle seat 306 and cap 311, while the cap remains stationary on top of housing 302. Furthermore, during the movement of needle seat 306 and guide tube seat 310 toward the extended position, actuating pin 314 engages the inclined portion 350 of cam guide 303 and causes guide tube seat 310 to rotate about guide needle 308 relative to button 328, needle seat 306, and housing 302. This rotation causes retaining protrusion 324 to disengage from retaining recess 326, thereby allowing the guide tube seat 310 and needle seat 306 to reach the extended position ( Figure 26This causes the needle seat 306 to disengage from the catheter seat 310. This allows the spring 330 to move the needle seat 306 and the guide needle 308 from the extended position to retract the guide needle 308 from the catheter 312. This retraction of the guide needle 308 from the catheter 312 establishes fluid communication between the wedge cap fluid opening 321 and the distal end of the catheter 312, and thus establishes fluid communication between the fluid opening 316 and the distal end of the catheter 312. Figure 27 ).

[0131] According to one embodiment, when the guide needle 308 is retracted, a portion of it remains disposed within the diaphragm 322, such as... Figure 27 As shown. According to another embodiment, when the guide needle 308 is retracted, none of its parts remain disposed in the diaphragm 322.

[0132] Because the drug does not need to flow through the guide needle 308, the diameter of the fluid passage through the catheter seat 310 and wedge cap 318 to the distal end of the catheter 312 can be larger, allowing for greater fluid flow and faster drug delivery rates. This embodiment provides a reduced system footprint and, compared to the first and second embodiments, employs a single spring, potentially simplifying manufacturing.

[0133] Figure 28 This is a perspective view of a catheter insertion device 400 according to a fourth embodiment of the present invention. (Reference) Figures 28 to 33 The catheter insertion device 400 (hereinafter referred to as device 400 for simplicity) includes a housing 402 having a cam member 404. The cam member 404 includes a cam guide 403 or a cam guide surface 403. The cam guide 403 includes an upper portion 448, a lower portion 452, and an inclined portion 450 connecting the upper portion 448 and the lower portion 452.

[0134] The device 400 also includes a needle holder 406 to which a guide needle 408 or a needle 408 is attached. The needle holder 406 is movably arranged within the housing 402. According to a preferred embodiment, the guide needle 408 is solid. According to another embodiment, the guide needle 408 is hollow. If hollow, it is preferable that at least the proximal end of the guide needle (e.g., where it is connected to the needle holder 406) is closed to prevent fluid from flowing through the guide needle 408.

[0135] The device 400 includes a cover 411 with a distally extending portion 415 and a release collar 410 or conduit seat 410 to which a hollow conduit 412 is attached. The conduit seat 410 is movably disposed within a housing 402 and includes an operating pin 414 extending from the side of the conduit seat 410. As will be described in more detail later, during operation of the device 400, the operating pin 414 contacts and rides along a cam guide 403, thereby controlling the rotation of the conduit seat 410.

[0136] As in the first embodiment, the catheter seat 410 has a fluid opening 416 that is in fluid communication with the catheter and is disposed on an operating pin 414. A tube 417 fluidly connects the operating pin 414 to a pump and / or reservoir of a drug delivery device or patch pump. According to one embodiment, the fluid opening 416 is an external presentation of the fluid passage directly through the catheter seat 410 to the catheter 412. According to another embodiment, the device 100 also includes an additional element that is a portion of the fluid passage located between the fluid opening 416 and the catheter 412. For example, according to one embodiment, the device 400 includes a fixing device 420, a fixing member 420, or a wedge 420 that secures the catheter 412 to the catheter seat 410. The fixing device 420, the fixing member 420, or the wedge 420 provides mechanical anchoring and a fluid seal for the catheter 412 relative to the catheter seat 410 to prevent leakage. The device 400 also includes a diaphragm 422 and a wedge cap 418, the wedge cap being disposed within the conduit seat 410 and securing the diaphragm 422 and the wedge 420 within the conduit seat 410. In this embodiment, a fluid passage extends from the fluid opening 416 through the operating pin 414, through the wedge cap 418, and into the conduit 412.

[0137] As Figure 34 As best shown, the wedge cap 418 has: a first fluid passage portion 460, which has a wedge cap fluid opening 421 aligned with and fluidly connected to a fluid opening 416; and a second fluid passage portion 462 connected to the first fluid passage portion 460 at an angle and coaxial with a conduit 412. According to one embodiment, this angle is approximately 90 degrees, but those skilled in the art will understand that other angles may be used without departing from the scope of the invention.

[0138] Similarly, as in the first embodiment, the wedge cap 418 includes a key 444 disposed in a keyway 446 of the conduit seat 410 to prevent or limit rotation of the wedge cap 418 relative to the conduit seat 410. Those skilled in the art will understand that, without departing from the scope of the invention, the key 444 can be arranged on the conduit seat 410, and the keyway 446 can be arranged on the wedge cap 418. In other words, as... Figure 34 As shown, one of the conduit seat 410 and the wedge cap 418 includes a keyway 444, while the other of the conduit seat 410 and the wedge cap 418 includes a key 446 disposed in the keyway to restrict relative rotation between the conduit seat 410 and the wedge cap 418.

[0139] Similarly, one of the conduit seat 410 and the wedge cap 418 includes a groove 443, while the other includes a groove protrusion 445 disposed in the groove 443 to prevent relative translation between the conduit seat 410 and the wedge cap 418. Figure 34 In the illustrated embodiment, the groove 443 is arranged on the guide seat 410, while the groove protrusion 445 is arranged on the wedge cap 418. However, those skilled in the art will understand that the positioning of the groove 443 and the groove protrusion 445 can be interchanged without departing from the scope of the invention.

[0140] like Figure 32 As best shown, the catheter seat 410 includes a retaining protrusion 424 that interacts with a retaining lug 426 of the needle seat 406 to removably secure the catheter seat 410 and the needle seat 406. Although not shown in the figures, those skilled in the art will understand that another embodiment of the invention includes a retaining protrusion 424 disposed on the needle seat 406 and a retaining lug 426 disposed on the catheter seat 410.

[0141] review Figure 30 The housing 402 includes a main post 461, a needle seat 406, and a guide seat 410 movably disposed within the main post. The housing 402 also includes a retainer 463 disposed adjacent to the main post 461 and a pivot anchor 465 disposed adjacent to the retainer 463.

[0142] like Figures 28-30As shown in Figure 33, the device 400 includes a column 467 and a guide member 469 slidably disposed on the column 467. The column 467 is disposed in an inner mounting seat 471 in a retainer 463, and a spring 430 is disposed in an outer mounting seat 473 surrounding and concentric with the column 467. The spring 430 is disposed between the retainer 463 and the guide member 469, thereby biasing the guide member 469 proximally. The device 400 also includes an arm 475 pivotally connected to the housing 402 at a pivot anchor 465 by, for example, a pin 477. According to one embodiment, the arm 475 includes a pair of extension arms 478, 479, which are fixedly connected to each other at an arm base 481, through which the pin 477 is disposed.

[0143] The fixing lug 426 of the needle holder 406 and the guide member lug 483 of the guide member 469 are rotatably connected to the extension arms 478 and 479 at different locations along the extension arms 478 and 479, for example, Figure 28 As shown.

[0144] The device 400 also includes a user-operable insertion unit 428 or button 428, which the user can move relative to the housing 402 and which is operable to move the needle hub 406 and the catheter hub 410 from an initial position to an extended position. According to one embodiment, the button 428 is constrained by the shape of the housing 402 to allow for substantially linear movement. Figure 31 As shown, button 428 includes a pair of button legs 429 supported on guide tube seat 410 so as to move needle seat 406 and guide tube seat 410 from an initial position to an extended position.

[0145] In the initial position, for example, Figure 29 and 37 As shown, a guide needle 408 is disposed within the conduit 412, and a portion of the guide needle 408 extends distally from the distal end of the conduit 412. In this configuration, the guide needle 408 at least restricts or narrows a portion of the fluid passage located between the fluid opening 416 and the distal end of the conduit 412. According to one embodiment, the guide needle 408 blocks a portion of the fluid passage located between the fluid opening 416 and the distal end of the conduit 412.

[0146] refer to Figures 37 to 38 The operation of the catheter insertion device 400 will now be described. Figure 37 As shown, in the initial position, most of button 428 extends proximally beyond housing 402 and is accessible to the user (e.g., a patient). Furthermore, needle hub 406 is releasably secured to catheter hub 410, and guide needle 408 is disposed within catheter 412. A portion of guide needle 408 is also disposed within diaphragm 422.

[0147] When the user presses button 428, button 428, needle seat 406, and guide seat 410 move distally together, arm 475 pivots about pin 477, guide member 469 moves distally, and compresses spring 430. Furthermore, during the movement of needle seat 406 and guide seat 410 toward the extended position, operating pin 414 engages the inclined portion 450 of cam guide 403 and causes guide seat 410 to rotate about guide needle 408 relative to button 428, needle seat 406, and housing 402. This rotation causes retaining protrusion 424 to disengage from retaining lug 426 (see [link]). Figure 35 and Figure 36 ), thereby reaching the extended position at the catheter hub 410 and needle hub 406 ( Figure 38 When the needle seat 406 disengages from the catheter seat 410, the spring 430 rotates the arm 475 about the pin 477, causing the guide member 469, needle seat 406, and guide needle 408 to move proximally from the extended position, thus retracting the guide needle 408 from the catheter 412. This retraction of the guide needle 408 from the catheter 412 establishes fluid communication between the fluid opening 416 and the distal end of the catheter 412. Figure 39 ).

[0148] According to one embodiment, such as Figure 39 As shown, when the guide needle 408 is retracted, a portion of it remains disposed within the diaphragm 422. According to another embodiment, when the guide needle 408 is retracted, no portion of it remains disposed within the diaphragm 422.

[0149] Since the drug does not need to flow through the guide needle 408, the diameter of the fluid passage between the fluid opening 416 and the distal end of the catheter 412 can be larger, allowing for a greater fluid flow rate and a faster drug delivery rate. Furthermore, although this embodiment occupies more space than the first to third embodiments, the offset spring used in this embodiment (offset relative to the travel axes of the catheter 412 and guide needle 408) reduces system complexity, potentially simplifying manufacturing.

[0150] Figure 40 This is a perspective view of a catheter insertion device 500 according to a fifth embodiment of the present invention. The fifth embodiment is similar to the second and third embodiments in many respects, and for the sake of brevity, only the differences are described below.

[0151] refer to Figures 40 to 47The catheter insertion device 500 (hereinafter referred to as device 500 for simplicity) includes a housing 502 having a cam member 504. The cam member 504 includes a cam guide 503 or a cam guide surface 503. The cam guide 503 includes an upper portion 548, a lower portion 552, and an inclined portion 550 connecting the upper portion 548 and the lower portion 552. Figure 41 and 44 As shown, the housing 502 includes a recess 505 in which a spring 530 is disposed, the spring being arranged between the inner bottom surface 513 of the housing 502 and the distal surface of the needle seat 506.

[0152] The needle holder 506 has a guide needle 508 or a needle 508 attached to it. The needle holder 506 is movably arranged within the housing 502. According to a preferred embodiment, the guide needle 508 is solid. According to another embodiment, the guide needle 508 is hollow. If hollow, it is preferable that at least the proximal end of the guide needle (e.g., where it is connected to the needle holder 506) is closed to prevent fluid from flowing through the guide needle 508.

[0153] Similar to the second and third embodiments, the needle holder 506 includes an annular member 507 having a central strip 509 spanning its diameter (see...). Figure 46 The guide needle 508 is attached to the central bar 509. The needle seat 506 also includes one or more retaining recesses 526 or retaining regions 526 for releasably securing the needle seat 506 to the release collar 510 or the catheter seat 510, as will be described in more detail later.

[0154] Similar to the second and third embodiments, the device 500 includes a cover 511, the distal portion 515 of which is provided with a corresponding cam surface 558, which engages with a cam guide 503 of the housing 502 to guide the rotation of the catheter seat 510 during the insertion of the catheter 512, as described in more detail below.

[0155] The device 500 also includes a release collar 510 or a conduit seat 510 to which a hollow conduit 512 is attached. The conduit seat 510 is movably disposed within the housing 502 and includes an operating pin 514 extending from the side of the conduit seat 510. As will be described in more detail later, during operation of the device 500, the operating pin 514 contacts and rides along a cam guide 503, thereby controlling the rotation of the conduit seat 510. As previously mentioned, the cover 511 includes a corresponding cam surface 558 (see...). Figure 42 The corresponding cam surface 558 corresponds to and cooperates with the cam guide 503 to form a cam track for guiding the operating pin 514.

[0156] According to one embodiment, the device 500 includes a fixing device 520, a fixing member 520, or a wedge 520 that secures the conduit 512 to the conduit seat 510. The fixing device 520, fixing member 520, or wedge 520 provides mechanical anchoring and fluid sealing of the conduit 512 relative to the conduit seat 510 to prevent leakage. The device 500 also includes a diaphragm 522 and a wedge cap 518 disposed within the conduit seat 510 and securing the diaphragm 522 and the wedge 520 within the conduit seat 510.

[0157] like Figure 41 , 42 As shown in Figure 47, the wedge cap 518 has a fluid opening 516 through which a tube 517 passes and connects to the fluid opening 521 of the wedge cap. Unlike the previously described embodiments, the tube 517 passes through the top of the catheter seat 510, rather than its side. The tube 517 fluidly connects the wedge cap 518 to the pump and / or reservoir of a drug delivery device or patch pump.

[0158] The wedge-shaped cap 518 has: a first fluid passage portion 560, which has a wedge-shaped cap fluid opening 521 connected to a fluid opening 516 of the conduit seat 510; and a second fluid passage portion 562, which is connected to the first fluid passage portion 560 at a certain angle and coaxial with the conduit 512 (see example). Figure 50 According to one embodiment, the angle is approximately 90 degrees, but those skilled in the art will understand that other angles may be used without departing from the scope of the invention.

[0159] Similar to the second and third embodiments, the fixing protrusion 524 on the catheter seat 510 interacts with the fixing region 526 or fixing recess 526 of the needle seat 506 to releasably secure the catheter seat 510 and the needle seat 506. Although not shown in the figures, those skilled in the art will understand that another embodiment of the invention includes a fixing protrusion 524 disposed on the needle seat 506 and a fixing region 526 or fixing recess 526 disposed on the catheter seat 510.

[0160] In the initial position, such as Figure 41 and Figure 48As shown, a guide needle 508 is disposed within the conduit 512, and a portion of the guide needle 508 extends distally from the distal end of the conduit 512. In this configuration, the guide needle 508 at least restricts or narrows a portion of the fluid passage located between the fluid opening 516 and the distal end of the conduit 512. According to one embodiment, the guide needle 508 blocks a portion of the fluid passage located between the wedge cap fluid opening 521 and the distal end of the conduit 512, and thus blocks a portion of the fluid passage located between the fluid opening 516 and the distal end of the conduit 512.

[0161] The device 500 also includes a user-operable insertion unit 528 or button 528, which the user can move relative to the housing 502 and which is operable to move the needle hub 506 and the guide tube hub 510 from an initial position to an extended position. According to one embodiment, the button 528 is constrained by the shape of the housing 502, allowing it to move substantially linearly. (Reference) Figure 40 and 45 Button 528 includes a pair of button legs 529 supported on guide tube seat 510 to move needle seat 506 and guide tube seat 510 from an initial position to an extended position. Button 528 also has a slot 531 that receives a portion of tube 517.

[0162] refer to Figures 48-50 The operation of the catheter insertion device 500 will now be described. Figure 48 As shown, in the initial position, most of button 528 extends proximally beyond housing 502 and is accessible to the user (e.g., a patient). Furthermore, needle hub 506 is releasably secured to catheter hub 510, and guide needle 508 is disposed within catheter 512. A portion of guide needle 508 is also disposed within diaphragm 522.

[0163] When the user presses button 528, needle seat 506, guide tube seat 510, and button 528 will travel distally together. During the movement of needle seat 506 and guide tube seat 510 (as well as guide tube 512 and guide needle 508) toward the extended position, the movement of needle seat 506 compresses compression spring 530. Furthermore, during the movement of needle seat 506 and guide tube seat 510 toward the extended position, actuating pin 514 engages the inclined portion 550 of cam guide 503 and causes guide tube seat 510 to rotate about guide needle 508 relative to button 528, needle seat 506, and housing 502. This rotation causes retaining protrusion 524 to disengage from retaining recess 526, thereby allowing guide tube seat 510 and needle seat 506 to reach the extended position (…). Figure 49When the needle seat 506 disengages from the catheter seat 510, the spring 530 moves the needle seat 506 and the guide needle 508 from the extended position to retract the guide needle 508 from the catheter 512. The retraction of the guide needle 508 from the catheter 512 establishes fluid communication between the wedge cap fluid opening 521 and the distal end of the catheter 512, and thus also establishes fluid communication between the fluid opening 516 and the distal end of the catheter 512. Figure 50 ).

[0164] According to one embodiment, when the guide needle 508 is retracted, a portion of it remains disposed within the diaphragm 522, as... Figure 50 As shown. According to another embodiment, when the guide needle 508 is retracted, none of its parts are retained in the diaphragm 522.

[0165] Because the drug does not need to flow through the guide needle 508, the diameter of the fluid passage through the catheter seat 510 and wedge cap 518 to the distal end of the catheter 512 can be larger, allowing for greater fluid flow and faster drug delivery rates. This embodiment provides a reduced system footprint and, compared to the first and second embodiments, employs a single spring, potentially simplifying manufacturing.

[0166] Figure 51 This is a perspective view of a catheter insertion device 600 according to a sixth embodiment of the present invention. In many respects, the sixth embodiment is similar to... Figures 28-39 The fourth embodiment is similar. For the sake of brevity, only the differences are described here.

[0167] Among other components, Figure 51 The catheter insertion device 600 (hereinafter referred to as device 600 for simplicity) includes a housing 602, a housing cap 601 fixed to the housing 602, and a user-accessible pull tab 628, which is movably arranged relative to the housing cap 601. Figure 51 In this illustration, the housing cap 601 is depicted as transparent to aid in understanding this embodiment. However, those skilled in the art should understand that the light transmittance of the housing cap 601 may vary without departing from the scope of protection of this invention.

[0168] In the initial position, for example, as Figure 51As shown, the pull tab 628 has a gripping portion 660 extending to the outside of the housing cap 601 at its first end. The opposite ends of the pull tab 628 have wedge-shaped portions 662. The pull tab 628 also has a pair of longitudinal wings 664 that ride along corresponding longitudinal slots 666 in the housing cap 601 during movement. The inner top of the housing cap 601 has a longitudinal guide rail 668 hanging distally therefrom, and the pull tab 628 has a corresponding longitudinal slot 670 that rides along the guide rail 668 during movement. In summary, the wings 664, slots 666, guide rails 668, and slots 670 work together to constrain the movement of the pull tab 628 to a substantially linear motion relative to the housing cap 601.

[0169] refer to Figures 51 to 57 The device 600 includes a housing 602 having a cam member 604. The cam member 604 includes a cam guide 603 or a cam guide surface 603. The cam guide 603 includes an upper portion 648, a lower portion 652, and an inclined portion 650 connecting the upper portion 648 and the lower portion 652.

[0170] The housing 602 includes a main post 661, a needle seat 606, and a guide seat 610 movably disposed within the main post. The housing 602 also includes a column 667 disposed adjacent to the main post 661 and a pivot anchor 665 disposed adjacent to the column 667. The housing 602 further includes a ramp portion 663, which acts as a stop when the wedge-shaped portion 662 of the pull tab 628 engages with it.

[0171] The device 600 also includes a needle holder 606 to which a guide needle 608 or a needle 608 is attached. The needle holder 606 is movably arranged in the main post 661 of the housing 602. According to a preferred embodiment, the guide needle 608 is solid. According to another embodiment, the guide needle 608 is hollow. If hollow, it is preferable that at least the proximal end of the guide needle 608 (e.g., where it is connected to the needle holder 606) is closed to prevent fluid from flowing through the guide needle 608.

[0172] The device 600 further includes a release collar 610 or a conduit seat 610 to which a hollow conduit 612 is attached. The conduit seat 610 is movably disposed within the housing 602 and includes an operating pin 614 extending from the side of the conduit seat 610. As will be described in more detail later, during operation of the device 600, the operating pin 614 contacts and rides along a cam guide 603, thereby controlling the rotation of the conduit seat 610.

[0173] Similar to the first and fourth embodiments, the catheter seat 610 is provided with a fluid opening 616 that is in fluid communication with the catheter 612 and is disposed on an operating pin 614. A tube 617 fluidly connects the operating pin 614 to a pump and / or reservoir of a drug delivery device or patch pump. According to one embodiment, the fluid opening 616 is an external presentation of the fluid passage directly through the catheter seat 610 to the catheter 612. According to another embodiment, the device 100 also includes an additional element that is a portion of the fluid passage located between the fluid opening 616 and the catheter 612. For example, according to one embodiment, the device 600 includes a fixing device 620, a fixing member 620, or a wedge 620 that secures the catheter 612 to the catheter seat 610. The fixing device 620, the fixing member 620, or the wedge 620 provides mechanical anchoring and a fluid seal for the catheter 612 relative to the catheter seat 610 to prevent leakage. The device 600 also includes a diaphragm 622 and a wedge cap 618, the wedge cap being disposed within the conduit seat 610 and securing the diaphragm 622 and the wedge 620 within the conduit seat 610. In this embodiment, the fluid passage extends from the fluid opening 616, passes through the operating pin 614, passes through the wedge cap 618, and enters the conduit 612.

[0174] like Figure 57 As best shown, the wedge cap 618 has: a first fluid passage portion 660 having a wedge cap fluid opening 621 aligned with and fluidly connected to a fluid opening 616; and a second fluid passage portion 662 connected to the first fluid passage portion 660 at an angle and coaxial with the conduit 612. According to one embodiment, this angle is approximately 90 degrees, but those skilled in the art will understand that other angles may be used without departing from the scope of the invention.

[0175] Furthermore, as in the first and fourth embodiments, the wedge cap 618 includes a key 644 disposed in a keyway 646 of the conduit seat 610 to prevent or limit rotation of the wedge cap 618 relative to the conduit seat 610. Those skilled in the art will understand that, without departing from the scope of the invention, the key 644 can be arranged on the conduit seat 610, and the keyway 646 can be arranged on the wedge cap 618. In other words, as... Figure 57 As shown, one of the conduit seat 610 and the wedge cap 618 includes a keyway 644, while the other of the conduit seat 610 and the wedge cap 618 includes a key 646, which is disposed in the keyway 644 to restrict relative rotation between the conduit seat 610 and the wedge cap 618.

[0176] Similarly, one of the conduit seat 610 and the wedge cap 618 includes a groove 643, while the other of the conduit seat 610 and the wedge cap 618 includes a groove protrusion 645, which is disposed in the groove 643 to prevent relative translation between the conduit seat 610 and the wedge cap 618. Figure 57 In the illustrated embodiment, the groove 643 is arranged on the guide seat 610, while the groove protrusion 645 is arranged on the wedge cap 618. However, those skilled in the art will understand that the positioning of the groove 643 and the groove protrusion 645 can be interchanged without departing from the scope of the invention.

[0177] like Figure 55 and 57 As best shown, the catheter seat 610 includes a retaining protrusion 624 that interacts with a retaining lug 626 of the needle seat 606 to releasably secure the catheter seat 610 and the needle seat 606. Although not shown in the figures, those skilled in the art will understand that another embodiment of the invention includes a retaining protrusion 624 disposed on the needle seat 606, while a retaining lug 626 is disposed on the catheter seat 610.

[0178] The device 600 also includes a guide member 669 slidably disposed on a post 667. A spring 630 is disposed around the post 667 between the base of the housing 602 and the guide member 669, thereby biasing the guide member 669 proximally. The device 600 also includes an arm 675 pivotally connected to the housing 602 at a pivot anchor 665 by, for example, a pin 677 or a shaft 677. According to one embodiment, as Figure 54 As best shown, the arm 675 includes a pair of extension arms 678, 679, which are fixedly connected to each other at the arm base 681, with a pin 677 arranged through the arm base.

[0179] Each of the extenders 678 and 679 has a pair of elongated slots 682, 684, 685, and 687. For example... Figure 51 and 52 As shown in the best embodiment, guide member slots 682 and 684 slidably accommodate guide member lugs 683 of guide member 669, while needle seat slots 685 and 687 slidably accommodate fixing lugs 626 of needle seat 606.

[0180] In the initial position, for example, Figure 51 and 58As shown, a guide needle 608 is disposed within the conduit 612, and a portion of the guide needle 608 extends distally from the distal end of the conduit 612. In this configuration, the guide needle 608 at least restricts or narrows a portion of the fluid passage located between the fluid opening 616 and the distal end of the conduit 612. According to one embodiment, the guide needle 608 blocks a portion of the fluid passage located between the fluid opening 616 and the distal end of the conduit 612.

[0181] refer to Figures 58 to 60 The operation of the catheter insertion device 600 will now be described. Figure 58 As shown, in the initial position, the gripping portion 660 of the pull tab 628 extends from the housing cap 601 and is accessible to the user (e.g., a patient). Furthermore, the needle hub 606 is releasably secured to the catheter hub 610, and the guide needle 608 is disposed within the catheter 612. A portion of the guide needle 608 is also disposed within the diaphragm 622.

[0182] When the user pulls the 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 the guide member 667 (with its compression spring 630), as well as the needle seat 606 and the guide tube seat 610, to gradually move toward the distal side.

[0183] Furthermore, during the movement of the needle seat 606 and the catheter seat 610 toward the extended position, the operating pin 614 engages the inclined portion 650 of the cam guide 603 and causes the catheter seat 610 to rotate about the guide needle 608 relative to the button 628, the needle seat 606, and the housing 602. This rotation causes the retaining protrusion 624 to disengage from the retaining lug 626, thereby allowing the catheter seat 610 and the needle seat 606 to reach the extended position. Figure 59 The needle seat 606 disengages from the conduit seat 610. Once the movement of the wedge portion laterally passes the end of the arm 675, the proximal force of the spring 630 acts on the guide member 669, causing the arm 675 to rotate about the pin 677 and moving the needle seat 606 and guide needle 608 proximal from the extended position, so that the guide needle 608 is withdrawn from the conduit 612. This withdrawal of the guide needle 608 from the conduit 612 establishes fluid communication between the fluid opening 616 and the distal end of the conduit 612. Figure 60 The wedge-shaped portion that engages with the ramp 663 (or the stop member 663) prevents the pull tab 628 from moving further laterally.

[0184] According to one embodiment, such as Figure 60 As shown, when the guide needle 608 is retracted, a portion of it remains disposed within the diaphragm 622. According to another embodiment, when the guide needle 608 is retracted, no portion of it remains disposed within the diaphragm 622.

[0185] Because the drug does not need to flow through the guide needle 608, the diameter of the fluid passage between the fluid opening 616 and the distal end of the catheter 612 can be larger, allowing for a greater fluid flow rate and a faster drug delivery rate. Furthermore, although this embodiment occupies more space than other embodiments described, the offset spring (offset relative to the travel axis of the catheter 612 and guide needle 608) reduces system complexity, potentially simplifying the manufacturing process.

[0186] Figure 61 This is a perspective view of a catheter insertion device 700 (hereinafter referred to as device 700) according to a seventh embodiment of the present invention;

[0187] refer to Figures 61 to 66 For simplicity, the device 700 includes a housing 702 having one or more cam members 704 or cam protrusions 704. Preferably, a pair of inwardly projecting cam members 704 are provided on opposite inner portions of the housing 702. Each cam member 704 includes a cam guide 703 or a cam guide surface 703 having an inclined surface. As will be described in more detail later, 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 arranged through opposite portions of the wall of the housing 702. The housing 702 also has a distal flange 724, which contributes to the stability of the device 700.

[0188] The device 700 also includes a user-operable insertion unit 728 or button 728, which the user can move relative to the housing 702 and which 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 the housing 702. According to one embodiment, as... Figure 63 As shown, button 728 includes a button body 709 and a button cap 711 fixed to the button body 709. The button body 709 includes cam tracks 715, and preferably includes a pair of cam tracks 715 passing through opposite sides of the button body 709. Each cam track 715 has a horizontal portion 713, a vertical portion 721, and an inclined portion 719 connecting the horizontal portion 713 and the vertical portion 721.

[0189] In the initial position, the proximal portion of the vertical section 721 also serves as a safety opening through which a user-removable safety component 707 is arranged, such as... Figure 61 and Figure 67As shown. The safety component 707 prevents the button 728 from being pressed until the safety component 707 is removed from the safety opening.

[0190] The button body 709 further includes at least one, preferably a pair, locking clips 723. For example... Figure 67 and Figure 69 As best shown, the distal end of the button body 709 has a bottom surface 727, which has a recess 729 on its proximal side for receiving the distal end of the spring 730. A central distal protrusion 731 on the distal side of the bottom surface 727 forms an annular recess on the distal side to receive the guide seat 710.

[0191] The needle holder 706 has a guide needle 708 or a needle 708 attached to the needle holder 706. The needle holder 706 is movably arranged in the housing 702. According to a preferred embodiment, the guide needle 708 is solid. According to another embodiment, the guide needle 708 is hollow. If hollow, preferably at least the proximal end of the guide needle 708 (e.g., where it is connected to the needle holder 706) is closed to prevent fluid from flowing through the guide needle 708. In addition to the annular distal recess 705 receiving the proximal end of the spring 730, the needle holder 706 also has at least one, and preferably a pair, operating pins 714 that extend laterally from the proximal end of the needle holder 706.

[0192] Figure 65 and Figure 66 These are perspective and sectional views of the conduit seat 710, conduit 712, tube 717, and diaphragm 722, respectively. The conduit seat 710 has a hollow conduit 712 attached to it and movably arranged within the housing 702. The distal flange 735 of the conduit seat 710 has at least one slot or channel 737 that engages with an internal vertical guide rail 739 of the housing 702 to prevent rotation of the conduit seat 710 relative to the housing 702 (see [reference]). Figure 67 ).

[0193] like Figure 65 and 66 As shown, the conduit seat 710 has: a fluid opening 716 through which a conduit 717 passes; a first fluid passage portion 760 in fluid communication with the fluid opening 716; and a second fluid passage portion 762 connected at an angle to the first fluid passage portion 760 and coaxial with the conduit 712. According to one embodiment, this angle is approximately 90 degrees, but those skilled in the art will understand that other angles may be used without departing from the scope of the invention.

[0194] In the initial position, such as Figure 61 , 67As shown in Figure 68, a guide needle 708 is disposed within the catheter 712, and a portion of the guide needle 708 extends distally from the distal end of the catheter 712. A portion of the guide needle 708 is also disposed within the diaphragm 722. In this configuration, the guide needle 708 at least restricts or narrows a portion of the fluid passage located between the fluid opening 716 and the distal end of the catheter 712. According to one embodiment, the guide needle 708 blocks a portion of the fluid passage located between the fluid opening 716 and the distal end of the catheter 712. Furthermore, as... Figure 67 As shown in the optimal configuration, in the initial position, the locking clamp 723 of button 728 is vertically aligned with the locking opening 725, and the operating pin 714 is vertically aligned with the inclined surface of cam guide 703.

[0195] refer to Figures 68 to 71 The operation of the catheter insertion device 700 will now be described. In the initial position, the needle hub 706 is releasably secured to the catheter hub 710, the guide needle 708 is disposed within the catheter 712, and the safety element 707 prevents the button 728 from being pressed. The button 728 extends proximally beyond the housing 702 and is accessible to a user (e.g., a patient), who must remove the safety element 707 to enable operation of the device 700. The safety element 707 is also accessible to the user in the initial position. Furthermore, the spring 730 is compressed.

[0196] After the safety component 707 is removed, the user presses button 728, and the needle hub 706, catheter hub 710, and button 728 move distally together. During this process, the needle hub 706 and catheter hub 710 (as well as the catheter 712 and guide needle 708) move toward the extended position.

[0197] Figure 69 The scene depicts the instant before the actuating pin 514 engages with the cam member 704. As the needle seat 706 and guide seat 710 reach the extended position, the actuating pin 714 engages the inclined surface of the cam guide 703, causing the needle seat 706 to rotate relative to the button 728, housing 702, and guide seat 710. The locking clamp 723 extends into or engages the locking opening 725 to prevent the button 728 from moving proximally (see [link]). Figure 70 ).

[0198] Rotation of the needle holder 706 moves the operating pin 714 from the horizontal portion 713 of the button body 709 to the inclined portion 719, thereby allowing the compressed spring 730 to expand and move the operating pin 714 along the inclined portion 719 until the operating pin 714 is aligned with the vertical portion 721. At this point, the spring 730 expands further, moving the needle holder 706 proximally and retracting the guide needle 708 from the guide tube 712. Figure 71This withdrawal of the guide needle 708 from the catheter 712 establishes fluid communication between the fluid opening 716 and the distal end of the catheter 712.

[0199] According to one embodiment, such as Figure 71 As shown, during retraction, a portion of the guide needle 708 remains disposed within the diaphragm 722. According to another embodiment, during retraction, no portion of the guide needle 708 remains disposed within the diaphragm 722.

[0200] Because the drug does not need to flow through the guide needle 708, the diameter of the fluid passage through the distal end of the catheter seat 710 to the catheter 712 can be larger, allowing for greater fluid flow and faster drug delivery rates. This embodiment provides a reduced system footprint and, compared to the first and second embodiments, uses only a single spring, potentially simplifying the manufacturing process.

[0201] Although only a few embodiments of the invention have been shown and described, the invention is not limited to the described embodiments. Those skilled in the art will understand that other modifications can be made to the disclosed embodiments without departing from the scope of the invention. Furthermore, any of the embodiments, features, and / or elements disclosed herein can be combined with each other to form various additional combinations not specifically disclosed, provided that the combined embodiments, features, and / or elements do not contradict each other. In other words, various aspects of the multiple embodiments can be used individually or in combination with each other. All such modifications and combinations are considered to fall within the scope of the invention as defined by the appended claims and their equivalents.

Claims

1. A catheter insertion device, the catheter insertion device comprising: Housing, the housing having a cam member; A needle hub having a guide needle attached thereto and movably disposed within the housing; A catheter seat having a catheter attached thereto and movably disposed within the housing, the catheter seat having a fluid opening capable of fluid communication with the catheter, wherein one of the needle seat and the catheter seat includes at least one operating pin extending from a side of the needle seat or the catheter seat, and the needle seat and the catheter seat are releasably secured so as to move together from an initial position to an extended position; An insertion unit that the user can move relative to the housing, and the insertion unit is operable to move the needle hub and the catheter hub from the initial position to the extended position; and At least one spring, said spring being arranged in the housing; During the movement of the catheter and the guide needle toward the extended position by the user operating the insertion unit, the engagement of the operating pin with the cam member causes one of the needle seat and the catheter seat to rotate, thereby releasing the relative fixation of the needle seat and the catheter seat when the catheter seat and the needle seat reach the extended position. This allows the at least one spring to move the needle seat and the guide needle from the extended position to retract the guide needle from the catheter, thereby establishing fluid communication between the fluid opening and the distal end of the catheter.

2. The apparatus of claim 1, further comprising a diaphragm disposed in the catheter seat, wherein, When the guide needle reaches the fully retracted position, the guide needle remains engaged with the diaphragm.

3. The apparatus according to claim 1, wherein, The operating pin is arranged on the guide tube seat; and The cam component includes a cam guide that guides the movement of the catheter seat as it travels toward the extended position.

4. The apparatus according to claim 1, wherein, The guide needle is solid.

5. The apparatus according to claim 1, further comprising: The wedge-shaped member secures the catheter to the catheter seat; Diaphragm; as well as The diaphragm and the wedge are fixed within the conduit seat by a wedge cap, the wedge cap having a wedge cap fluid opening in fluid communication with the fluid opening of the conduit seat.

6. The apparatus according to claim 5, wherein, One of the conduit seat and the wedge cap includes a keyway, and the other of the conduit seat and the wedge cap includes a key located in the keyway to restrict relative rotation between the conduit seat and the wedge cap.

7. The apparatus according to claim 5, wherein, One of the conduit seat and the wedge cap includes a groove, and the other of the conduit seat and the wedge cap includes a protrusion located in the groove to prevent relative translation between the conduit seat and the wedge cap.

8. The apparatus according to claim 1, wherein, The fluid opening is located on the operating pin.

9. The apparatus according to claim 1, wherein, The insertion unit includes a button that engages with the catheter seat.

10. The apparatus according to claim 9, wherein, The housing includes: a main post in which the needle seat and the catheter seat are movably disposed; a retainer disposed adjacent to the main post; and a pivot anchor disposed adjacent to the retainer; and The device further includes: A column rod arranged in the retainer; Guide members slidably arranged on the column; and At least one arm, said arm being pivotally connected to the pivot anchor, the guide member, and the needle seat; The at least one spring includes a single spring arranged around the post between the retainer and the guide member, and in the extended position, the single spring biases the guide member and the arm to retract the guide needle from the conduit.

11. The apparatus of claim 1, further comprising a housing cap fixed together with the housing; in, The insertion unit includes a user-accessible pull tab that is slidably mounted in the housing cap for lateral displacement relative to the housing, the pull tab including a wedge-shaped portion; The housing includes: a main column, in which the needle seat and the guide seat are movably arranged; a column rod, which is arranged adjacent to the main column; and a pivot anchor, which is arranged adjacent to the column rod. The device further includes: Guide members slidably arranged on the column; and At least one arm, said arm being pivotally connected to the pivot anchor and slidably connected to the guide member and the needle seat; The lateral displacement of the pull tab from its initial pull tab position to its extended pull tab position causes the wedge-shaped portion to contact the arm and pivot the arm, thereby driving the needle seat and the catheter seat toward the extended position; and The at least one spring comprises a single spring arranged around the post between the base of the housing and the guide member, and in the extended position, the single spring biases the guide member and arm to retract the guide needle from the conduit.

12. The apparatus according to claim 11, wherein, The housing also includes a stop member having a shape corresponding to the wedge-shaped portion and preventing the pull tab from being removed from the housing.

13. The apparatus according to claim 1, wherein: The housing includes: a central core in which the catheter seat is disposed; and at least one guide core disposed adjacent to the central core, the at least one guide core having a guide slot extending through its side; and The needle hub includes at least one guide tab, which is disposed in the guide slot.

14. The apparatus according to claim 13, wherein: The needle hub includes at least one distal protrusion, which is disposed in the at least one guide core; The at least one spring is disposed in the at least one guide core, and the at least one spring is configured to receive the at least one distal protrusion; and In the extended position, the at least one spring is compressed and pushes the needle seat to retract the guide needle from the catheter.

15. The apparatus according to claim 1, wherein, The needle hub includes an annular member having a central strip spanning its diameter, to which the guide needle is attached.

16. The apparatus of claim 15, further comprising a cover covering a portion of the top of the housing; in, The at least one spring is fixed to the needle seat and the cover; and In the extended position, the at least one spring extends and pulls the needle seat to retract the guide needle from the catheter.

17. The apparatus of claim 15, further comprising a cover covering a portion of the top of the housing; in, The at least one spring is arranged between the housing and the distal side of the needle seat; and In the extended position, the at least one spring is compressed and pushes the needle seat to retract the guide needle from the catheter.

18. The apparatus according to claim 1, wherein, The fluid opening is located on the side of the conduit seat.

19. The apparatus according to claim 1, wherein, The fluid opening is located on top of the conduit seat.

20. The apparatus according to claim 9, wherein: The cam component includes at least one cam protrusion disposed on the inner wall of the housing, protruding inward and having an inclined surface; The button includes at least one cam track defined through a side of the button and having a horizontal portion, a vertical portion, and an inclined portion connecting the vertical portion and the horizontal portion; the button is fixed to the guide seat. The needle holder includes the operating pin, which extends through the cam track and engages with the horizontal portion in the initial position to releasably secure the needle holder to the button; The at least one spring is arranged between the button and the distal surface of the pin seat; During the movement of the catheter and the guide needle toward the extended position by the user operating the button, the engagement of the actuating pin with the inclined surface of the cam protrusion causes the needle seat to rotate relative to the button and the catheter seat when the catheter seat and the needle seat reach the extended position, thereby moving the actuating pin to the inclined portion and enabling the at least one spring to move the actuating pin to the vertical portion and move the needle seat and the guide needle from the extended position to retract the guide needle from the catheter; and In the extended position, the at least one spring is compressed and pushes the needle seat to retract the guide needle from the catheter.

21. The apparatus 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 locking clamp that extends from the outside of the button and is biased by contacting the inner wall of the button; and When the guide seat and the needle seat reach the extended position, the at least one locking clamp disengages from the inner wall of the button and aligns with and extends into at least one of the locking opening or the locking recess, thereby preventing the button from retracting.

22. The apparatus according to claim 9, wherein: The button includes a safety opening; and The device includes a removable safety component that is removably disposed in the safety opening and extends across the top of the housing to prevent operation of the button.

23. A drug delivery device, the drug delivery device comprising: The apparatus according to claim 1; Base, the housing is connected to the base; Drug storage container; as well as A tube, which is connected to the fluid opening of the drug reservoir and the catheter seat, and which travels with the catheter seat.

24. The drug delivery device according to claim 23, wherein the drug delivery device further comprises: A cover, which is capable of engaging with the base and has a guide portion that engages with the cam guide of the housing to form a guide path configured to guide the operating pin.

25. A catheter insertion device, the catheter insertion device comprising: A housing having an axial channel; A conduit seat, disposed within the axial channel and having a conduit, the conduit seat being movable relative to the housing between an initial position within the housing and an extended position in which a portion of the conduit extends outside the housing, the conduit seat having a fluid passage connecting a fluid opening on the outer side of the conduit seat to the distal end of the conduit; A needle hub, disposed within the axial channel and having a guide needle, is movable relative to the housing from an initial needle position to an extended needle position where a portion of the guide needle extends outside the housing, and to a retracted needle position disposed within the housing and not obstructing the fluid passage, wherein in the initial needle position and the extended needle position, the guide needle obstructs a portion of the fluid passage; as well as At least one spring is arranged within the housing and biases the needle holder toward the retracted position when the needle holder is in the extended needle position.

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