Subcutaneous insertion mechanism with automatic traction via preloading release and lockout member

Abstract

An insertion mechanism is provided having improved reliability and reduced components. The insertion mechanism uses a single engagement and release clip that is compressed within a housing of the insertion mechanism to engage a needle hub and a catheter hub. A button is provided to move the catheter hub and needle hub in a distal direction until the engagement and release clip reaches a release window in the mechanism housing. The engagement and release clip expands in the release window to release the needle hub from the catheter hub, allowing a reset spring to move the insertion needle proximally while leaving the inserted catheter, and also holding the catheter hub in a deployed position.

Description

[0001] Related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 214,545, filed June 24, 2021, including the specification, drawings and abstract, the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] The present invention generally relates to medical infusion systems, such as insulin infusion devices or insertion devices, wherein a simple, low-profile, and few-part manual insertion device is provided for subcutaneous insertion of a cannula with the automatic guide needle retracted. Background Technology

[0004] Diabetes is a group of diseases characterized by high levels of blood sugar, caused by the inability of people with diabetes to maintain adequate levels of insulin production when needed. People with diabetes will require some form of daily insulin therapy to maintain control of their glucose levels. Untreated, diabetes can be dangerous for affected patients and can lead to serious health complications and premature death. However, by utilizing one or more treatment options to help control diabetes and reduce the risk of complications, such complications can be minimized.

[0005] Treatment options for people with diabetes include special diets, oral medications, and / or insulin therapy. The primary goal of diabetes treatment is to control blood glucose or sugar levels. However, maintaining proper diabetes management can be complex because it must be balanced with the individual's activity levels.

[0006] There are two main types of daily insulin therapy for the treatment of type 1 diabetes. In the first method, the diabetic patient injects insulin themselves using a syringe or insulin pen as needed. This method requires a needle prick for each injection, and the diabetic patient may need to inject three to four times a day. The syringes and insulin pens used for injecting insulin are relatively simple to use and inexpensive.

[0007] Another effective method for insulin therapy and management of diabetes is infusion therapy using an insulin pump, or infusion pump therapy. An insulin pump can deliver a continuous infusion of insulin to a diabetic patient at varying rates to more closely match the function and behavior of a normally functioning pancreas in a non-diabetic patient who produces the required insulin. Furthermore, an insulin pump can help a diabetic patient maintain their blood glucose levels within the target range based on their individual needs.

[0008] Infusion pump therapy requires an infusion cannula, typically in the form of an infusion needle or flexible catheter, which punctures the skin of the diabetic patient to deliver insulin. Infusion pump therapy offers the advantages of continuous insulin infusion, precise dosing, and programmable delivery schedules.

[0009] In infusion therapy, insulin doses are typically administered at a basal rate and as a bolus dose. When insulin is administered at a basal rate, it is delivered continuously over 24 hours to maintain blood glucose levels in diabetic patients within a consistent range between meals and rest (usually at night). Insulin pumps can also be programmed to vary the basal rate of insulin according to different times of day and night. Conversely, bolus doses are typically given with meals and usually provide a single additional insulin injection to balance carbohydrate consumption. Insulin pumps can be configured to allow diabetic patients to program the amount of bolus dose based on the quantity or type of meals they consume. Furthermore, insulin pumps can be configured to allow diabetic patients to infuse modified or supplemental insulin bolus doses to compensate for low blood glucose levels when the diabetic patient is calculating the bolus dose for a specific meal to eat.

[0010] Insulin pumps advantageously deliver insulin over time rather than in a single injection, typically resulting in smaller variations within the recommended blood glucose range. Furthermore, insulin pumps can reduce the number of needle pricks that people with diabetes must endure and improve diabetes management to enhance their quality of life.

[0011] Typically, regardless of whether a diabetic patient uses multiple direct injections (MDIs) or a pump, they take their fasting glucose medication (FBGM) upon waking from sleep and also test their blood glucose during or after each meal to determine if dose adjustments are needed. Additionally, diabetic patients may test their blood glucose before bedtime to determine if dose adjustments are required, for example, after eating a snack before bed.

[0012] For ease of injection therapy, there are generally two types of insulin pumps: conventional pumps and patch pumps. Conventional pumps require disposable components, often called infusion devices, tubing devices, or pump units, which deliver insulin from a reservoir within the pump to the user's skin. The infusion device consists of a pump connector, a section of tubing, and a sleeve or base 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 automatic insertion device. The insertion device can be a separate unit required by the user.

[0013] Another type of insulin pump is the patch pump. Unlike the combination of a traditional infusion pump and infusion device, a patch pump is an integrated device that combines most or all of the fluid components—including a fluid reservoir, a pumping mechanism, and a mechanism for automatically inserting a cannula—into a single housing that adheres adhesively to the infusion site on the patient's skin, eliminating the need for a separate infusion or tubing device. The patch pump, containing insulin, adheres to the skin and delivers insulin over a period of time via an integrated subcutaneous cannula. Some patch pumps can communicate wirelessly with a separate controller device (such as in one sold by Insulet under the trademark OmniPod), while others are completely self-contained. These devices are frequently replaced, for example, every three days, when the insulin reservoir is depleted or complications may arise, such as cannula or infusion site restriction.

[0014] Since the patch pump is designed as a standalone unit worn by diabetic patients, it is preferable that the patch pump 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. However, to minimize the thickness of the patch pump, its components should be minimized as much as possible. One such component is an insertion mechanism for automatically inserting the cannula into the user's skin.

[0015] To minimize the height of the insertion mechanism, some conventional insertion mechanisms are configured to insert the cannula at an acute angle to the skin surface, such as 30-45 degrees. However, it is preferable to insert the cannula perpendicular or nearly perpendicular to the skin surface, as this requires minimizing the length of the cannula inserted. In other words, with a minimized length of the cannula inserted into the user's skin, the user experiences greater comfort and fewer complications, such as premature kinking of the cannula. However, one problem with configuring the insertion mechanism to insert the cannula perpendicular to the skin surface is that this may increase the overall height of the insertion mechanism, and thus the overall height of the patch pump itself.

[0016] Therefore, there is a need for an improved insertion mechanism for use in confined space environments (e.g., in patch pumps) that can cost-effectively insert the cannula vertically or nearly vertically into the surface of the user's skin while minimizing or reducing its height in order to reduce the overall height of the device to which the insertion mechanism is attached (e.g., a patch pump). Summary of the Invention

[0017] One object of the present invention is to substantially solve the above and other problems and to provide advanced, improved and novel components and elements of the insertion device that facilitate the insertion of indwelling or soft catheters and the retraction of guide needles, while reducing the number of components required for the construction and use of the insertion device.

[0018] Another object of the present invention is to provide a manual insertion device with at least automatic guide pin retraction, which reduces the number of parts in the exemplary embodiments and helps to keep component manufacturing costs low and simplify device assembly. Automatic retraction also simplifies the user interface by minimizing the number of user steps required for activation. For the user, there is only one step: pressing a button.

[0019] These and other objectives are essentially achieved by providing an insertion device having a housing, a flexible firing arm, a button, a guide seat, a needle seat, an engagement and release clip, and a return spring. The housing includes at least one release window located in a distal portion of the housing. The button is slidable within the housing from an initial proximal position to an insertion distal position. The guide seat is secured to a guide tube, and the needle seat is secured to an insertion needle inserted into the guide tube in the initial configuration. The engagement and release clip, in a relaxed state, is larger than the interior of the housing and is compressed within the housing, engaging the guide seat to the needle seat in the compressed state. The return spring biases the needle seat in the proximal direction and is compressed as the button moves distally. The firing arm interferes with the distal movement of the button until a predetermined force is applied to the button, causing the firing arm to deflect and release the button. When the button is pressed distally, the engagement and release clip expands toward its relaxed configuration and becomes aligned with the release window. As the engagement and release clip expands, the return spring moves the needle seat to a final proximal position, thereby releasing the needle seat from the guide seat.

[0020] Additional and / or other aspects and advantages of the invention will be set forth in the following description, or will become apparent from the description, or may be learned by practice of the invention. The invention may include a method, apparatus, or system having one or more of the foregoing aspects and / or one or more features, or combinations thereof. The invention may include one or more features and / or combinations of the foregoing aspects, such as those described in the appended claims. Attached Figure Description

[0021] The various objects, advantages, and novel features of exemplary embodiments of the invention will become more readily apparent from the following detailed description, taken in conjunction with the accompanying drawings, in which:

[0022] Figure 1 This is an isometric view of an exemplary insertion device in a pre-start state according to an embodiment of the present invention;

[0023] Figure 2 According to an embodiment of the present invention Figure 1 Another isometric view of the insertion device in its pre-start state;

[0024] Figure 3 According to an embodiment of the present invention Figure 1A view of the insertion device in the activated state;

[0025] Figure 4 According to an embodiment of the present invention Figure 1 Exploded view of the insertion device;

[0026] Figure 5 According to an embodiment of the present invention Figure 1 A cross-sectional view of the catheter / diaphragm subassembly of the insertion device;

[0027] Figure 6 According to an embodiment of the present invention Figure 1 A view of the guide pin subassembly of the insertion device, which is assembled with the plastic tube from the top;

[0028] Figure 7 According to an embodiment of the present invention Figure 1 A view of another guide needle subassembly of the insertion device, which is assembled from the side without the plastic tube;

[0029] Figure 8 According to an embodiment of the present invention Figure 1 A view of the button sub-component of the insertion device, including Figure 5 The conduit / diaphragm subassembly and Figure 6 The guide pin assembly;

[0030] Figure 9 According to an embodiment of the present invention Figure 1 A view of the completed button sub-component of the insertion device;

[0031] Figure 10 The button sub-assembly and the spring are assembled together according to an embodiment of the present invention. Figure 1 A view inside the housing of the insertion device, showing the use of a temporary protective tube on the conduit;

[0032] Figure 11 The button sub-assembly and spring are partially assembled according to an embodiment of the present invention. Figure 1 A view inside the housing of the insertion device, showing the use of a temporary protective tube on the conduit;

[0033] Figure 12 According to an embodiment of the present invention Figure 1 A view of the completed components of the insertion device, wherein the base is omitted for illustrative purposes;

[0034] Figure 13 According to an embodiment of the present invention Figure 1 A cross-sectional view of the insertion device in its pre-start state;

[0035] Figure 14 According to an embodiment of the present invention Figure 1 Another cross-sectional view of the insertion device in the pre-start state;

[0036] Figure 15 According to an embodiment of the present invention Figure 1 A cross-sectional view of the insertion device in the intermediate start-up state;

[0037] Figure 16 According to an embodiment of the present invention Figure 1 A perspective view of the insertion device in the intermediate start-up state, showing the position of the radial operating pin within the helical path;

[0038] Figure 17 yes Figure 1 A bottom view of the top housing of the insertion device, showing an embodiment of the invention. Figure 16 The matching portion of the helical path surface of the radial operating pin;

[0039] Figure 18 yes Figure 1 A view of the housing of the insertion device, showing an embodiment of the invention. Figure 16 The matching portion of the helical path surface of the radial operating pin;

[0040] Figure 19 yes Figure 1 A transparent view of the insertion device in an intermediate activation state, showing the position of the radial operating pin according to an embodiment of the present invention;

[0041] Figure 20 yes Figure 1 A perspective view of the insertion device in the activated state, showing the position of the radial operating pin when fully inserted according to an embodiment of the present invention;

[0042] Figure 21 According to an embodiment of the present invention Figure 1 A perspective view of the insertion device in the activated state, showing the position of the radial operating pin when fully retracted;

[0043] Figure 22 yes Figure 1 A cross-sectional view of the insertion device, showing the locking arm of the top housing in the activated state according to an embodiment of the present invention;

[0044] Figure 23 According to an embodiment of the present invention Figure 1 A cross-sectional view of the insertion device in the activated state;

[0045] Figure 24 According to an embodiment of the present invention Figure 1 Another exploded view of the insertion device;

[0046] Figure 25This is a view of another embodiment of the insertion mechanism according to an embodiment of the present invention, which is formed as a sub-assembly separate from the top housing or base;

[0047] Figure 26 This is a view of another embodiment of an insertion mechanism formed as a sub-component in a base according to an embodiment of the present invention;

[0048] Figure 27 This is a cross-sectional view of another embodiment of the locking arm in the pre-activation state according to an embodiment of the present invention;

[0049] Figure 28 This is according to an embodiment of the present invention. Figure 27 A cross-sectional view of the locking arm, which is in the intermediate activation state during insertion, and the device is shown.

[0050] Figure 29 This is according to an embodiment of the present invention. Figure 27 A cross-sectional view of the locking arm in the activated state, showing the device;

[0051] Figure 30 This is a perspective view of a patch pump that incorporates a low-profile sleeve insertion device; the cover is not shown for clarity.

[0052] Figure 31 yes Figure 30 An exploded view of the various components of the patch pump, shown with a cover;

[0053] Figure 32 This is a perspective view of an alternative design for a patch pump with a flexible reservoir, shown without a cover;

[0054] Figure 33 yes Figure 32 Diagram of the surface mount pump fluid architecture and metering subsystem;

[0055] Figure 34 This is a perspective view of another embodiment of the cannula insertion device;

[0056] Figure 35 yes Figure 34 Exploded view of the sleeve insertion device;

[0057] Figure 36A This is a perspective view of the sleeve insertion device, showing the double-click firing arm according to this embodiment;

[0058] Figure 36B This is a cross-sectional view of the cannula insertion device, showing the double-click firing arm according to this embodiment;

[0059] Figure 37 This is a force diagram illustrating the user force required to operate the cannula insertion device according to an embodiment;

[0060] Figure 38 This is a perspective cross-sectional view of the engagement and release clip according to this embodiment;

[0061] Figure 39A It is a cross-sectional view of the engagement and release of the clip before the button is pressed;

[0062] Figure 39B It is a cross-sectional view of the engagement and release of the clip after the button is pressed;

[0063] Figure 40A and 40B The engagement and release clips are shown in the relaxed and engaged states, respectively.

[0064] Figure 41A Alternative embodiments of engaging and releasing clips are shown;

[0065] Figure 41B This is a side view, showing Figure 41A The loosening and mounting configuration of the engagement and release clips is shown.

[0066] Figure 41C and 41D An alternative clamp arm configuration for an exemplary engagement and release clamp is shown;

[0067] Figure 42 This is a side sectional view of the engagement and release clips in the engaged state;

[0068] Figure 43 This is a side view of the engagement and release of the clip, highlighting the contact points between the clip and the insertion device housing and socket;

[0069] Figure 44 The engagement and release clips are shown with the release window relative to the housing in the released state;

[0070] Figure 45 yes Figure 43 A three-dimensional diagram of the engagement and release clamps;

[0071] Figure 46 This is a perspective view of the button window after insertion, according to an exemplary embodiment of the insertion device.

[0072] In all the accompanying drawings, the same reference numerals will be understood to refer to the same parts, components and structures. Detailed Implementation

[0073] The novel apparatus provided by the exemplary embodiments of the present invention described below provides one or more infusion device elements configured to insert a catheter up to 8 mm into the skin surface, but the embodiments are not limited thereto. The insertion device is configured to perform manual insertion of the catheter, which allows the insertion device to be smaller, simpler, and cheaper than automatic or spring-assisted insertion devices.

[0074] The exemplary embodiments of the invention described below utilize a manual insertion device and include a double retraction spring configuration for automatic guide pin retraction, which also allows for a very small device size. The double retraction spring configuration is implemented using multiple cylindrical or barrel-shaped guides. In one exemplary embodiment, a barrel guides the button and guide tube, and adjacent barrels house the retraction springs, one on each side of the button and guide tube. Having springs in separate barrels allows for springs that are much smaller than in a single-barrel configuration where the spring is coaxial with the guide tube. A single coaxial spring forms a pathway to the button subassembly because spring design constraints require the spring to extend almost from the bottom to the top of the housing. Access pathways are needed for features such as locking arms, and if these features were implemented inside the springs, the entire mechanism would have to be enlarged to accommodate them, thus increasing the mechanism's footprint.

[0075] Figure 1 and 2 The insertion device before use is shown. Figure 3 The device after the casing is deployed is shown. (Example) Figure 1-3 As shown, the insertion device includes a top housing 100 and a base 102. The top housing 100 is shown with an opening 104 through its top surface, from which a user-accessible and user-activated button 200 extends slidably. The contents of the insertion device, including the mechanism housing 300, are... Figure 4 As shown in more detail, the top housing 100, button 200, and mechanism housing 300 may be made of ABS, and the base 102 may be made of PETG, but the embodiments are not limited thereto.

[0076] like Figure 4 As shown, the exemplary insertion device is assembled by stacking multiple sub-components together, which are confined between the top housing 100 and the mechanism housing 300. Figure 4 According to an embodiment of the present invention Figure 1 A view of the insertion device. Figure 4 The sub-assemblies, and those discussed in more detail below, include the catheter / septum sub-assembly, the guide needle assembly, and the button sub-assembly. For clarity, other features and functions of the insertion device well-known to those skilled in the art are omitted from the figures and discussion.

[0077] Figure 5 An exemplary catheter / diaphragm subassembly is shown. Figure 5According to an embodiment of the present invention Figure 1 A cross-sectional view of the catheter / diaphragm subassembly of the insertion device. (See image.) Figure 5 As shown, a catheter / diaphragm subassembly is assembled by attaching a conduit 202 to a metal wedge 204, then inserting a diaphragm 206 into the wedge and confining it between a release collar 208 and a catheter wedge cap 210. The diaphragm 206 is radially compressed by the wedge 204 and axially compressed by the release collar 208 to form a seal between the diaphragm 206 and the wedge 204. The conduit 202 may be a 24G plastic conduit manufactured using FEP, and the release collar 208 and the catheter wedge cap 210 may be manufactured using PTEG, but the embodiment is not limited thereto. The wedge 204 may be manufactured using 305 stainless steel, and the diaphragm 206 may be manufactured using isoprene, but the embodiment is not limited thereto.

[0078] Figure 6 and 7 An exemplary guide pin sub-assembly is shown. Figure 6 This is a view of the guide needle subassembly assembled from the top using plastic tubing. Figure 7 This is according to an embodiment of the present invention. Figure 1 A view of another guide needle assembly of the insertion device, which is assembled from the side without the plastic tube. Figure 6 The guide needle subassemblies used in the discussion below are assembled by gluing or press-fitting the tube 220 to the non-patient end of the cannula or guide needle 222, then placing the guide needle through the guide needle seat 224 and engaging it in place using any number of slots, slits, or stops 226 provided on the top surface of the guide needle seat 224. The guide needle 222 may be a hollow 24G needle or cannula made of 304 stainless steel, and the guide needle seat 224 may be made of PETG, but the embodiments are not limited thereto.

[0079] Figure 7 An alternative embodiment of the guide pin subassembly uses a guide pin 232 for assembly, which has a long proximal end 234 that is directly connected to a pump or container (not shown). In this embodiment, removing the flexible plastic tubing makes the assembly of the insertion device easier and reduces the risks associated with connecting the two components, but requires a large loop on the proximal end 234 of the tubing to reduce the force required to bend the tubing during insertion and retraction.

[0080] Figures 34-46 Other alternative embodiments of the guide pin assembly are shown, which make the assembly of the component easier in high-speed manufacturing. Figure 34 and 35Two guide seat subassemblies are illustrated. As described above, the guide seat pushes the guide pin during insertion, loads a compression spring during insertion, and retracts the guide pin after the plastic catheter is inserted. Figure 34 yes Figure 1 A view of the guide needle assembly 402 of the insertion device, wherein the needle 404 is assembled from the top with the plastic tube 406, and Figure 35 yes Figure 1 A view of the guide needle assembly 412 of the insertion device, wherein the needle 414 is assembled from the side without the plastic tube.

[0081] exist Figure 34 and 35 In this embodiment, to keep the insertion mechanism small, the guide seats 402, 412 are small, which presents challenges in molding the parts and assembling the guide pins 404, 414. Due to size constraints, standard straight needle sleeves and bonding processes are not feasible, so the pins 404, 414 must include bends and be attached to the guide seats 402, 412 by some method. Furthermore, handling and assembling such small pins 404, 414 can be difficult, and the following components are provided to simplify the manufacture of such sub-assemblies.

[0082] Figures 36-38 illustrate an embodiment of a unidirectional component guide seat, which is similar to... Figure 35 In one embodiment, the needle 424 is assembled into the guide seat from the side. Figure 35 The embodiment of the component requires multiple complex movements of the guide pin 414; the 90° bent portion of the pin 414 is inserted into the receiving groove 416 of the guide seat 412, and then the short arm 418 rotates, simultaneously bending it away from the distal end and snapping it into place. The unidirectional component guide seat of Figure 36 below is assembled by translating the guide pin 424 into the groove 426 in the guide seat. This single movement facilitates automated assembly. For example, the long, straight distal portion of the guide pin 424 is held between plates (not shown) to translate the pin 424 during assembly and prevent rotation. The guide seat can be molded using, for example, an AB mold. The engagement 428 in the guide seat holding the guide pin 424 is molded by cutting. Figure 37 and 38 As shown, the front or left structure 420 corresponds to one side of the mold, and the rear or right structure 425 corresponds to the other side of the mold.

[0083] Figures 39-43 show a bent, insert-molded guide pin seat 432 with a post-processed guide pin 434. As shown in Figure 40, the straight guide pin 434 is embedded into the guide seat 432, and as shown in Figure 41, a post-processed clamp with a steel pin 436 is located on the upper surface of the guide seat 432. Figure 42As shown, the guide pin 434 is then bent over the pin 436 and engaged with the guide seat 432 using a snap 438 to prevent the guide pin 434 from springing back. The exemplary snap-fit ​​geometry is for illustrative purposes only, and the invention is not limited thereto. The material, position, and diameter (if desired) of the pin 436 are sufficient to keep the bent portion of the pin 434 open and to prevent curling after the bending process to allow for fluid flow. Then, as... Figure 43 As shown, remove the pin retainer or rod 436, and sub-assembly 432 is ready for pipe assembly.

[0084] Figures 44-46 A tubular straight needle guide seat 442 is shown, featuring an adhesive guide needle 444 that bends after processing. (See diagram.) Figure 45 As shown, a straight guide pin 444 is inserted using standard procedures by inserting the blunt end of the pin 444 into the chamfered hole 446 passing through the guide seat 442. The distance from the seat to the tip can be set using, for example, a vision system and a camera or other suitable measuring system. Figure 46 As shown, the blunt side of the needle 444 is then bent onto the circular feature or shoulder 448 on the guide seat 442 and fastened into the guide seat 442 using the snap 450 to prevent the needle 444 from springing back.

[0085] The radius of the round feature or shoulder 448 is large enough to avoid curling or otherwise reducing the inner diameter of the needle 444 and to ensure fluid flow through the bend in the needle 444. The gap in the guide seat through-hole 446 required for assembly and the springback during the bending process prevent the needle from meeting the 90° bending angle tolerance after the first bend, thus requiring a second distal bend to correct the angle without providing the round feature or shoulder 448. However, this second bend would release the spring force exerted by the guide needle on the guide needle seat restraint latch, caused by the springback from the first bend. Alternatively, the through-hole 446 can be molded at an angle to the insertion direction, such that the needle will meet the 90° bending tolerance after the first bending process, eliminating the need for a second bend. However, this solution would require a more complex die, as the die pull direction for the through-hole 446 would differ from the primary die pull direction.

[0086] Therefore, the exemplary embodiment provides a circular feature or shoulder 448 such that the blunt side of the needle 444 then bends over the circular feature or shoulder 448 on the guide seat 442, and is secured to the guide seat 442 using a snap fastener 450 to prevent the needle 444 from springing back. In the final assembly step, glue is then dispensed into the glue pool 452, which will fix the needle 444 in place, preventing it from moving relative to the guide seat 442 and the catheter during insertion.

[0087] Figure 8 An exemplary button sub-component is shown. Figure 8 yes Figure 1 An assembly view of the button subassembly of the insertion device, including the catheter / diaphragm subassembly and the guide needle assembly. Figure 9 This is an embodiment of the present invention. Figure 1 The image shows a completed button subassembly of the insertion device. The button subassembly is constructed by combining the catheter / septum subassembly and the guide needle subassembly with button 200. As described in more detail below, once assembled, the guide needle assembly cannot be rotated within button 200. The catheter / septum subassembly can be rotated within button 200, and in doing so, can be rotated from a position fixed to the guide needle assembly to a position disengaged from the guide needle assembly.

[0088] Specifically, the button subassembly is constructed by inserting the guide pin 222 of the guide pin subassembly into the diaphragm 206 and conduit 202 of the conduit / diaphragm subassembly. Then, by rotating the conduit / diaphragm subassembly by 20 degrees or more, locking the stop or tooth 238 on the release collar 208 into a groove or slot 240 on the top surface of the guide pin seat 224, the conduit / diaphragm subassembly is secured to the guide pin assembly, and the guide pin seat 224 and the conduit / diaphragm assembly are connected. In this position, the tooth 238 is locked on the top of the guide pin seat 224, so that when the button 200 is pressed down, the guide pin seat 224 also moves downward. This causes the guide pin 222 and the conduit 202 to move simultaneously for insertion into the user's skin surface (not shown).

[0089] The button subassembly is then completed by snapping the release collar 208 into the button 200 to secure the guide needle subassembly and the catheter / diaphragm subassembly in place. For this purpose, the button 200 may include a stop 212 on a deflectable arm 214 to deflect the lower edge of the release collar 208 and then restrain it therebetween. Figure 9 As shown. Between the deflectable arms 214, a slot 216 is provided in the button 200 to allow linear travel of the guide pin seat 224 relative to the button 200, but to prevent rotational movement of the guide pin seat relative to the button 200. The slot 216 in the button 200 also allows rotational movement of the radially operating pin 218 of the release collar 208 relative to the button 200, as described in more detail below. In the exemplary embodiment, a generally cylindrical pin 218 is shown on the outer periphery of the release collar 208. However, in this or other embodiments of the invention, any stop or protrusion of the release collar operable with a helical path may be provided as a radially operating pin.

[0090] The button sub-assembly can then be assembled with the housing top 100 and the mechanism housing 300. Figure 10 It is the button sub-assembly and spring assembly. Figure 1 A view inside the housing of the insertion device, and shows the use of a temporary protective tube on the catheter. Figure 11The button sub-assembly and spring part are assembled into Figure 1 A view inside the housing of the insertion device. Figure 12 yes Figure 1 A view of the completed assembly of the insertion device, wherein, according to an embodiment of the invention, the base is omitted for illustrative purposes.

[0091] To complete the assembly, the button 200 and its components are slidably assembled with a protrusion 106 extending from the inner surface of the top housing 100, as shown below. Figure 13 As shown in more detail in the text, Figure 13 It is in the pre-start state according to an embodiment of the present invention. Figure 1 A cross-sectional view of the fully assembled insertion device. During the next assembly step, in which the mechanism housing 300 is placed into the top housing 100, the button locking arm 112 of the top housing 100 holds the button sub-assembly in place, thereby restraining other sub-assemblies therein.

[0092] During the placement of the mechanism housing 300 into the top housing 100, a temporary tube 228 is placed on the guide pin 222 therein and the guide tube 202 to protect the pin tip and guide the guide tube through the outlet port in the mechanism housing 300 during assembly. A retraction spring 230 presses against the guide pin seat 224, and the button sub-assembly is inserted through the hole 104 in the top housing 100, as... Figure 11 As shown, the tube or sleeve 220 connected to the reservoir or pump (not shown) is sealed in a receiving component within the top housing. The spring 230 may be made of stainless steel, but the embodiment is not limited thereto.

[0093] The mechanism housing 300 preferably includes three cylinders, guides, or tubes, including a central tube 302 that slidably receives and guides the button subassembly, and two tubes 304, one on each side of the central tube 302, which restrains the spring 230. During assembly, the spring 230 is restrained between the boss 242 of the guide pin seat 224 and the bottom of the tube 304 of the mechanism housing 300. In doing so, the spring 230 applies an expansion force between the guide pin seat 224 and the bottom of the tube 304 of the mechanism housing 300. In an exemplary embodiment, multiple springs 230 and adjacent tubes 304 are shown. However, in this or other embodiments of the invention, a single spring and adjacent tube can be provided in substantially the same manner, wherein unused adjacent tubes can remain empty or can be omitted entirely. Furthermore, a single spring can be disposed within the button top and extend during insertion, retracting to its natural state once completed, thereby retracting the guide pin from the guide tube.

[0094] The circular boss 242 has a specific diameter and length to center and align the spring 230 during operation. The spring 230 can be partially preloaded during assembly of the insertion device, and the mechanism housing 300 can be laser-welded or glued to the top housing 100. The bottom or base 102 can then be added. In doing so, as a final assembly step, the complete and fully assembled insertion mechanism subassembly can be placed on the base 102 along with all other components. Having a complete insertion mechanism subassembly allows for easy operation in production, rather than confining all components between the top and bottom housings. In exemplary production, the mechanism housing 300 will be attached to the top housing 100 using snaps or adhesives (not shown) to hold the mechanism together. See the following references... Figure 25 and 26 In the other two exemplary embodiments, a similar sub-component concept is used to make the assembly manageable, but in one embodiment the sub-component is an independent unit, while in another embodiment it is part of the base.

[0095] In each embodiment, after final assembly, the insertion device is hermetically sealed to the rest of the device. That is, the housing 300, into which water from a shower or swim can freely enter through a conduit outlet or a button hole on the top of the housing, is hermetically sealed by laser welding or adhesive bonding steps, thereby protecting the remaining contents of the device housing 100, such as the contents of the device's electronics / pump compartment.

[0096] Figure 13 It is a complete assembly according to an embodiment of the present invention. Figure 1 A cross-sectional view of the insertion device. Figure 14 It is a complete assembly according to an embodiment of the present invention. Figure 1 The insertion device is perpendicular to Figure 13 Another cross-sectional view of the view shows the insertion device in the pre-activation state. (See image below.) Figure 13 As shown, one or more breakable ribs 236 on the start button 200 are restrained by a stepper positioner 110 in the top housing 100 to hold the button 200 in the pre-start position. A safety tab (not shown) may also be positioned in the button slot to prevent accidental actuation of the device when it is removed from the packaging during transport and handling. The safety tab will be removed before insertion.

[0097] To activate the device, the user pushes button 200 into the top housing 100. Once rib 236 breaks or exceeds the deformation force threshold, all three ribs 236 yield, button 200 moves downward abruptly, inserting guide pin 222 and conduit 202, and loading retraction spring 230. Spring 230 can be partially preloaded during assembly of the insertion device. The minimum breaking force of the breakable rib 236 ensures that the user pushes hard enough to fully insert the conduit. Partial actuation will result in incomplete insertion of the conduit, failure of the guide pin to retract, and failure of the conduit to lock in the activated position.

[0098] Release of button 200 from rib 236 is configured to occur once the desired amount of actuation force has been applied to button 200. Since button 200 is releasably held in the upward and extended position via engagement between rib 236 and stepper positioner 110, the force applied to button 200 by the user steadily increases for a period of time before release. At the moment of sudden release, the force on button 200 has reached the desired value; therefore, due to the sudden free travel and the desired force applied to the button at release, button 200 is accelerated downwards and subsequently held. This release ensures that the user has applied the desired amount of downward force, velocity, smoothness, and angle. This actuation essentially eliminates variations in the force, velocity, smoothness, and angle applied by the user and reduces insertion failures and / or user discomfort.

[0099] After the release button 200, the button sub-assembly and its components begin to pass through the mechanism housing 300. Figure 15 A view of the insertion device is shown at the start of this insertion. Figure 15 It is in the intermediate startup state according to the embodiment of the present invention. Figure 1 A cross-sectional view of the fully assembled insertion device.

[0100] Figure 15One of the two teeth 238 on the release collar 208, which connects the guide needle seat 224 and the catheter / diaphragm subassembly, is also shown. In this position, the tooth 238 locks onto the top of the guide needle seat 224, so that when the button 200 is pressed, the guide needle seat 224 also moves downward. When the button 200 is pressed, the guide needle seat 224 also moves downward, which causes the guide needle 222 and the catheter 202 to be simultaneously inserted into the user's skin surface (not shown), and also causes the guide needle seat 224 to compress the spring 230. In order to produce an insertion device with a small footprint, each spring 230 has a small diameter relative to the compressed length, which would cause the spring to bend during compression if not supported. During compression, a boss 242 on the guide needle seat 224 translates through the middle of the spring 230 to prevent the spring 230 from bending. In an exemplary embodiment, the spring 230 is compressed and an expansion force is applied to retract the guide needle seat and the guide needle. However, in this embodiment or other embodiments of the invention, one or more tension springs may be used, and a retraction force may be applied to retract the guide pin seat and the guide pin.

[0101] As mentioned above, Figure 5 The conduit / diaphragm subassembly is connected to the button 200 and the guide needle seat 224, but can rotate freely about a main axis of up to 20 degrees. In this case, the main axis is defined as an axis extending along the geometric center of the insertion needle 222. A slot 216 is provided in the button 200 to allow linear travel of the guide needle seat 224 relative to the button 200, but to prevent rotational movement of the guide needle seat relative to the button 200. The slot 216 in the button 200 also allows rotational movement of the radial operating pin 218 of the release collar 208 relative to the button 200. The angle of this rotation is controlled by the radial operating pin 218 extending from the release collar 208. During insertion, i.e., during the downward travel of the button subassembly, the radial operating pin 218 travels in a helical path 400 created by the combined features in the top housing 100 and the mechanism housing 300. During this travel, the radial operating pin 218 of the release collar 208 causes the release collar 208 to rotate, ultimately releasing the guide needle subassembly from the conduit / diaphragm subassembly. Surface 108 in the top housing 100 forming the spiral path 400 and surface 308 in the mechanism housing 300 are divided into two parts, allowing these two parts to be molded without sliding. In other words, the spiral path 400 is generated by connecting two separately molded parts, eliminating the need for a single part with a slider or path molded therein, thus significantly simplifying the manufacture of the insertion device. Figure 17 and 18 Surface 108 in the top housing 100 and surface 308 in the mechanism housing 300 are shown, which form a helical path 400 when assembled.

[0102] Figure 17 yes Figure 1A bottom view of the top housing 100 of the insertion device, showing a portion of the path surface. Figure 18 yes Figure 1 A view of the mechanism housing 300 of the insertion device, showing the remainder of the path surface of the radial operating pin 218 according to an embodiment of the invention. Figure 17 As shown, the protrusion 106 of the top housing 100 in which the button subassembly is slidably disposed includes an edge that may be provided with a similar curved, wavy, or otherwise constructed shape 108, which forms half, one side, or a portion of the helical path 400 when assembled with the mechanism housing 300. Figure 18 As shown, the inner diameter or cavity surface of the mechanism housing 300, in which the button subassembly is slidably disposed, may be provided with a curved, wavy, or otherwise constructed shape 308, which, when assembled with the top housing 100, also forms half, one side, or a portion of the helical path 400. When the top housing 100 and the mechanism housing 300 are assembled, elements 108 and 308 form the helical path 400. This path is helical so that, as the button 200 and the release collar 208 travel in a straight direction, it causes rotational movement of the release collar 208 relative to the button 200 by guiding the radial operating pin 218 therein.

[0103] As described above, the slot 216 provided in the button 200 allows for the release of movement of the radial operating pin 218 of the collar 208. Furthermore, Figure 5 The conduit / diaphragm subassembly is attached to button 200 and guide pin seat 224, but rotates freely about the main axis by up to 20 degrees. This 20-degree rotation allows the radial operating pin 218 of release collar 208 to travel in the helical path 400. When button 200 is pressed, release collar 208 and its radial operating pin 218 also move downward through the stationary top housing 100 and mechanism housing 300. Thus, as the radial operating pin 218 of release collar 208 moves downward through the stationary top housing 100 and mechanism housing 300 via button 200, it is slidably positioned in the helical path 400, causing the release collar to rotate.

[0104] In the pre-start state, the angle of the radial operating pin 218 is restricted to the position where the teeth 238 of the release collar 208 are fully engaged with the guide pin seat 224. During the movement of the button 200 between the pre-start and post-start states, as the movement passes through the helical path 400 of the stationary top housing 100 and the mechanism housing 300, the radial operating pin 218 of the release collar 208 causes the release collar 208 to rotate.

[0105] In the initial state, the radial operating pin 218 has rotated up to 20 degrees, which disengages the guide pin seat 224 from the teeth 238 of the release collar 208, releasing the guide pin seat 224 from the release collar 208 for retraction by compression spring 230. The release collar 208 and other components of the catheter / diaphragm subassembly remain in the lower insertion position.

[0106] Figure 19 The diagram illustrates the insertion device during the insertion of the guide pin 222 and the catheter 202, and at a point before the guide pin seat 224 is released by the radial operating pin 218 of the release collar 208 for retraction. The radial operating pin 218 and the release collar 208 rotate almost completely through engagement with the helical channel 400, and at the end of rotation by the helical channel 400, the teeth 238 on the release collar 208 disengage from the positioning groove 240 of the guide pin seat 224, releasing the guide pin seat 224, which can then be pushed upwards and retracted by the spring 230. That is, as the radial operating pin 218 and the release collar 208 rotate through engagement with the helical channel 400, the teeth 238 on the release collar 208 rotate simultaneously until they disengage from the stop 240 of the guide pin seat 224. At this point, the release collar 208, held downward by button 200, is no longer secured to the guide needle seat 224, and spring 230 forces the guide needle seat 224 and guide needle 222 upward and into the retracted position, leaving the catheter / diaphragm subassembly in the downward and inserted position. Button 200 is locked in the downward position, thereby holding the catheter / diaphragm subassembly in the downward and inserted position. The locking arm 112, which holds the button subassembly in place during assembly and protrudes from the top housing 100, can also be configured to snap into the stop 244 in button 200 in the activated state of locking the button subassembly in place, thereby holding the catheter in the skin, as... Figure 22 As shown.

[0107] Figure 20 The insertion device is shown just as the guide pin 222 and catheter 202 are fully inserted. The retraction spring 230 is fully compressed, and the radial operating pin 218 and release collar 208 have been rotated to the extent required for the teeth 238 of the release collar 208 to disengage from the guide pin seat 224, releasing the guide pin seat 224 for retraction. Figure 21 and 23 As shown. Figure 21 and 23 The insertion device is shown in the activated state. At this time, the release collar 208, which is held downward by the button 200, is no longer fixed to the guide pin seat 224, and the spring 230 forces the guide pin seat 224 and the guide pin 222 upward and into the retracted position, leaving the catheter / diaphragm subassembly in the downward and inserted position.

[0108] The guide needle 222 is further retracted into the housing from its pre-activation position to ensure needle shielding and protect the catheter from damage. The tip of the guide needle 222 remains sealed by the diaphragm 206 in the fluid path to form an uninterrupted fluid path with the catheter 202. In this or other embodiments, the tip or distal portion of the guide needle 222 remains within the catheter 202 and is sealed by the diaphragm 206 to form an uninterrupted fluid path with the catheter 202.

[0109] In an exemplary embodiment, manual insertion of the guide needle and catheter allows for a smaller, simpler, and less expensive insertion device compared to those employing spring-assisted insertion. Other patch pump plastic catheter insertion mechanisms use insertion springs that are larger relative to the retraction spring because the insertion force is greater than the retraction force. Fully integrated spring-assisted insertion also requires angled insertion for low-profile devices, which increases travel and significantly increases wound and mechanism size. The insertion spring does not function after insertion and merely occupies space in the device, where size is one of the most important user requirements for the product.

[0110] In an exemplary embodiment, the double-retraction-spring configuration also allows for a very small size. A cylindrical guide button and conduit are inserted into the housing, and adjacent cylinders house two retraction springs. The springs are located in separate cylinders and guided by bosses on the guide pin seat, allowing for springs much smaller than in a single-cylinder structure where the spring is coaxial with the conduit. A single coaxial spring forms the pathway to the button subassembly because spring design constraints require the spring to extend almost from the bottom to the top of the housing. Features such as locking arms are required, and if these features were implemented inside the springs, the entire mechanism would have to be enlarged to accommodate them, thus increasing the mechanism's footprint. Passively locking the conduit downwards and retracting the guide pin creates the simplest possible manual insertion user interface for a manual insertion mechanism, which is a single-button press.

[0111] As described above, the retraction spring 230 is minimally loaded before use to ensure that the guide pin 222 is fully retracted into the device. The spring 230 is further loaded during insertion. Providing a minimally loaded and partially loaded spring in the insertion device reduces the risks associated with sterilizing and storing loaded springs and simplifies the design.

[0112] To operate the insertion device, the user applies the device to the skin surface using adhesive on the base 102. The user then manually pushes the protruding button 200 until the rib 236 breaks or deforms. The button 200, now suddenly free-moving, is quickly pushed into the top housing 100 and used to push and insert the plastic catheter 202 and guide needle 222 into the user's skin surface. When the button 200 is pushed, the release collar 208 rotates by moving its radial operating pin 218 along the helical path 400. The release collar 208 rotates to the desired degree of separation from the guide needle seat 224, and then the guide needle seat 224 and guide needle 222 retract to a retracted position beyond the original needle position to ensure needle shielding. The plastic catheter 202, now separated from the guide needle 222, remains in the downward and inserted position. The button 200 automatically locks in a lower position flush with the top of the housing, which also locks the catheter to the desired depth in the subcutaneous layer. A sensor (not shown) can be provided to detect the status after activation and notify other electronic devices (not shown) that the catheter has been correctly inserted, allowing the patient to receive medication. The pump or reservoir then injects the medication into the catheter via a guide needle and delivers it to the patient's subcutaneous layer.

[0113] To optimally aim at the desired depth, the base may include a skin interface geometry to achieve and maintain the desired insertion depth, avoid skin surface bulging, and / or tension on the skin surface at the insertion site. Examples of such skin interface geometries with deployed catheters are also disclosed. In a perspective view of device 502, during placement, catheter 506 protrudes from its extending post 504 into the skin surface (not shown), which helps prevent shallow catheter tip insertion in the event of skin bulging. Post 504 may extend from the base surface of device 502 to any desired length and may be rounded and / or chamfered at the distal end contacting the skin surface.

[0114] A well-shaped portion 508 may be provided surrounding the post 504. The well 508 provides space for skin that has shifted during insertion and helps the post 504 protrude into the skin surface. A wall 510 surrounds and defines the well-shaped portion 508 and may extend from the base surface of the device 502 to any desired length, and may be rounded and / or chamfered at the distal end in contact with the skin surface. The circular relative to the post 512 may be incorporated into or excluded from the geometry as needed.

[0115] In the exemplary embodiments described above, the insertion mechanism can be formed as a sub-assembly within the top housing 100. This allows for easy manipulation of the insertion mechanism during production, enabling the assembly of other subsystems. Alternatively, the insertion mechanism can be formed as a sub-assembly separate from the top housing 100 or the base 102, such as... Figure 25 As shown, or formed as a sub-component in base 102, such as Figure 26 As shown.

[0116] exist Figure 25 In, basically related to Figure 9 The same completed button subassembly 250 is secured to the main body of the button by means of, for example, a snap or stop 252. Figure 4 Within the same housing 350. In this case, the insertion mechanism is formed as a sub-assembly separate from the top housing 100 or the base 102. Upon completion, Figure 25 The insertion mechanism can then be assembled with one or more of the top housing 100 and the base 102.

[0117] exist Figure 26 In, with Figure 9 The substantially identical completed button sub-assembly 260 is fixed to the same position as... Figure 4 Within the substantially identical housing 360, in this case, the insertion mechanism is formed as a component in the base 102. Furthermore, in Figure 25 and 26 In each embodiment, the button subassembly 250 and mechanism housing 350, as well as in the button assembly 260, mechanism housing 360, and / or base 102, may be provided as described above. Figure 17 and 18 The surface that generates the spiral path allows the surface to be separated again between two parts, allowing the two parts to be molded without a slider.

[0118] In the exemplary embodiment described above, rib 236 determines the minimum insertion force required to initiate activation of the device, ensuring full activation. Alternatively, locking arm 112 may be configured to also determine the minimum activation force. As described above, locking arm 112 protrudes from the top housing and snaps into a stop in the button in the activated state, locking the button subassembly in place and thus retaining the catheter in the skin. Figure 27 Another embodiment of the locking arm 272 is shown, which includes a flange 274 on the locking arm that holds the button 270 in a pre-activation position. The shaped flange 274 of the locking arm 272 protrudes and confines the bottom edge of the button 270 in the pre-activation state, thereby holding the button subassembly in place until sufficient force is applied to the button. Once sufficient force is applied to the button 270, the flange 274 deflects away from the button 270. When sufficient force is applied, the locking arm 272 bends away from the path of the inserted button 270. Figure 28 The device is shown in an intermediate state during insertion. The locking arm 272 will bend outwards instead of... Figure 28 The interference is shown. The minimum deflection force of the locking arm 272 and flange 274 ensures that the user can push hard enough to fully insert the catheter. Then, when the button reaches the position shown... Figure 29When the locking button and the conduit are in the lowest position, the locking arm 272 and the flange 274 engage with the stop portion 276 in the button 270.

[0119] In the above embodiments, the patch pump may be provided with one or more of the aforementioned features. Figure 30 This is a perspective view of an exemplary embodiment of a patch pump 1 according to an exemplary embodiment of the present invention. For clarity, the patch pump 1 is shown having a transparent cover and various components assembled to form the patch pump 1 are shown. Figure 31 yes Figure 30 A view of various components of a patch pump 1, shown with a solid cap 2. The various components of the patch pump 1 may include: a reservoir 4 for storing insulin; a pump 3 for pumping insulin out of the reservoir 4; a power source 5 in the form of one or more batteries; an insertion mechanism 7 for inserting a guide needle with a catheter into the user's skin; control electronics 8 in the form of a circuit board, having optional communication capabilities with external devices such as remote controls and computers (including smartphones); a dose button 6 on the cap 2 for actuating insulin dosage, including bolus doses; and a base 9 to which the aforementioned various components can be connected via fasteners 91. The patch pump 1 also includes various fluid connector lines that deliver the insulin pumped from the reservoir 4 to the infusion site.

[0120] As described above, it should be understood that the insertion mechanism can have various structures. In some embodiments, the inserter mechanism inserts a soft catheter into the skin. In these embodiments, typically, the soft catheter is supported on a rigid insertion needle. The insertion needle is inserted into the skin along with the soft catheter and then retracts from the skin, leaving the soft catheter in place. In other embodiments, no soft catheter is provided, and the insertion needle remains in the skin and forms part of the insulin flow path to deliver insulin until the infusion is complete. Insertion needles are typically hollow, and need to be hollow if they form part of the insulin flow path. However, insertion needles that support the soft catheter and then retract can be solid or hollow. If the insertion needle deploys the soft catheter and retracts but remains part of the insulin flow path, the insertion needle should be hollow. However, if the insertion needle deploys the soft catheter and then retracts but does not form part of the insulin flow path, the insertion needle can be solid or hollow. In either case, the insertion needle is preferably rigid enough to reliably penetrate the skin, but can also be made flexible enough to provide comfort to the user.

[0121] Figure 32This is a perspective view of an alternative design for the patch pump 1A with a flexible reservoir 4A, shown without a cap. This arrangement further reduces the external dimensions of the patch pump 1A, where the flexible reservoir 4A fills the voids within the patch pump 1A. The patch pump 1A is shown with a conventional cannula insertion device 7A, which typically inserts the cannula at an acute angle of less than 90 degrees onto the surface of the user's skin. The patch pump 1A also includes: a power supply 5A in the form of a battery; a metering subsystem 41 that monitors insulin volume and includes low-volume detection capability; control electronics 8A for components controlling the device; and a reservoir filling port 43 for receiving a refill syringe 45 to fill the reservoir 4A.

[0122] Figure 33 yes Figure 32 The diagram shows the patch pump fluid structure and metering subsystem of patch pump 1A. The energy storage subsystem for patch pump 1A includes battery 5A. The control electronics 8A of patch pump 1A may include a microcontroller 81 for controlling the actuation of patch pump 1A, sensing electronics 82, a pump and valve controller 83, sensing electronics 85, and deployment electronics 87. Patch pump 1A includes a fluid subsystem that may include a reservoir 4A, a volume sensor 48 for reservoir 4A, and a reservoir filling port 43 for receiving a refill syringe 45 to refill reservoir 4A. The fluid subsystem may include a metering system that includes a pump and valve actuator 411 and an integrated pump and valve mechanism 413. The fluid subsystem may also include a blockage sensor 49, a deployment actuator 7, and a cannula 47 for insertion into an infusion site on the user's skin. Figure 30 and 31 The structure of the patch pump and Figure 33 The structures shown are the same or similar.

[0123] Another exemplary embodiment of the cannula insertion device is in Figure 34 As shown in the image. Figure 34 This is a perspective view of this embodiment of the cannula insertion device. Figure 35 It is shown Figure 34 An exploded view of the components of the illustrated embodiment. The components of the cannula insertion device shown herein include a housing 3401, a return spring 3402, a catheter seat 3403, a cannula 3404, an engagement and release clip 3405, a diaphragm and wedge 3406, a needle seat 3407, and a button 3408. As illustrated, the needle seat 3407 preferably surrounds the housing 3401 and includes an opening to allow the button 3408 to slide relative to the needle seat 3407.

[0124] The needle holder 3407 engages with the rigid insertion needle 3409 and is biased upward by the return spring 3402. Figure 36A and 36BA firing arm 3410 is shown attached to a housing 3401. The housing 3401 preferably includes at least one, and more preferably two, firing arms 3410 located on opposite sides of the housing 3401. Figure 36B As shown, the firing arm 3410 is substantially rigid but capable of flexing and, in its initial configuration, prevents the button 3408 from moving downwards until sufficient force is applied to the button to overcome the rigidity of the firing arm 3410. Therefore, once sufficient force is applied to the button 3408, the firing arm 3410 flexes and disengages, allowing the button to slide into the housing 3401. The housing material, the shape and length of the firing arm 3410, and the shape of the distal surface of the button 3408 are configured such that the force required to overcome the resistance of the firing arm 3410 is sufficient to allow the insertion pin to be fully inserted by a person pressing the button 3408.

[0125] Figure 37 The force distribution relative to button 3408 is shown. As illustrated, the force applied to the button increases sharply until it reaches the quick-action peak. This occurs when the button overcomes the resistance of the firing arm. Next, the force rapidly decreases from the quick-action peak towards zero force, then gradually increases with the energy applied to the return spring 3402. Finally, when the button is fully inserted, the engagement and release clip releases the pin seat 3407, thereby releasing the return spring and reducing the force on button 3408 to near zero.

[0126] Figure 38 This is a cross-sectional view showing the engagement and release clip 3405 in its initial configuration. The engagement and release clip 3405 is housed within a housing and engages the guide seat 3403 with the needle seat 3407. Figure 39A and 39B The functions of engaging and disengaging clip 3405 are shown in more detail. Figure 39A The engagement and release of clip 3405 before button 3408 is pushed is shown. Figure 39A As shown, the engagement and release clip 3405 prevents the needle hub 3407 from separating from the catheter seat 3403. Once the button 3408 has been pressed sufficiently, the engagement and release clip 3405 reaches the distal portion of the housing 3401, and a pair of release windows 3411 allow the engagement and release clip 3405 to return to its relaxed position, thereby releasing the needle hub 3407 from the catheter seat 3403. In the relaxed position, the engagement of the arms of the clip 3405 in the release windows 3411 prevents the engagement and release clip 3405 from moving in the proximal direction. Therefore, the engagement and release clip 3405 serves the dual purpose of releasing the needle hub and simultaneously holding the catheter seat in the insertion position.

[0127] Figure 40A The engagement and release clip 3405 in a relaxed state is shown. Figure 40BThe engagement and release clip 3405 is shown in a tensioned state, which is the configuration of the clip 3415 when it is installed within the housing 3401 and before it moves toward the release window 3411. In this configuration, the arms 3412 of the engagement and release clip 3405 press outward against the inner surface of the housing 3401. The engagement and release clip 3405 also preferably includes a connecting member 3413 connecting the arms 3412 to each other, and also includes an opening 3414 to allow the insertion pin 3409 to move relative to the clip and within the opening 3414.

[0128] Figures 41A-41D An alternative embodiment of the engagement and release clip 3405 is shown. Figure 41A The engagement and release clip 3405 in its released state is shown. Figure 41B The relative contours of one arm of the engagement and release clamp 3405 are shown, comparing the relaxed state configuration with the compressed state. Figure 41C and 41D An optional configuration of the arm for engaging and disengaging the clamp 3405 is shown, as well as the relative stresses applied to different portions of the clamp 3405 when it is in a tensioned state.

[0129] Figure 42 It is a cross-sectional view showing the relative positions of the needle seat 3407 and guide seat 3403, as well as the diaphragm and wedge 3406 and the engagement and release clip 3405 in the mounting configuration before the button 3408 is pressed.

[0130] Figure 43 The side profile of one arm 3412 of the engagement and release clamp 3405 is shown. The view also shows the position of the catheter seat and inner housing contact clamp 3405, as well as the tension and opening component of the force applied by the clamp arm 3412 at the contact position relative to the needle seat 3407.

[0131] Figure 44 This is a perspective view taken from the outside of housing 3401, showing the engagement and release positions of clip 3405 when the button is fully depressed and clip 3405 reaches window 3411. Window 3411 allows clip 3405 to return to its relaxed state, thereby releasing pin seat 3407. Figure 45 This is another perspective view showing the engagement and release of the clip 3405, pin seat 3407, and window 3411 at the point exactly when the clip 3405 first reaches the window 3411.

[0132] Figure 46 Another aspect of this embodiment of the insertion mechanism is shown. In some versions, button 3408 includes a semi-transparent or transparent window 3414 that allows the needle holder 3407 to be visible to the user to confirm that the insertion needle 3409 has been properly retracted.

[0133] Although only a few exemplary embodiments of the invention have been described in detail above, those skilled in the art will readily understand that many modifications can be made to the exemplary embodiments without departing from the novel teachings and advantages of the invention in essence. Therefore, all such modifications are intended to be included within the scope of the appended claims and their equivalents.

Claims

1. An insertion mechanism, characterized in that, The insertion mechanism includes: A housing, the housing including at least one release window at a distal portion of the housing; Flexible firing arm; A button that can slide within the housing from an initial proximal position to an inserted distal position; The catheter hub is used to secure the catheter. A needle hub, which is fixed to an insertion needle, which is inserted into the catheter in an initial configuration; Engagement and release clips, which in a relaxed state are larger than the interior of the housing and are compressed inside the housing, and in the compressed state engage the catheter seat to the needle seat; A return spring that biases the pin seat in the proximal direction and is compressed when the button is moved distally; The firing arm interferes with the movement of the button in the distal direction until a predetermined force is applied to the button, causing the firing arm to deflect and release the button; Wherein, when the button is pressed distally and the engagement and release clip is aligned with the release window, the engagement and release clip expands toward its relaxed state; and wherein, when the engagement and release clip expands and subsequently releases the needle hub from the catheter hub, the return spring moves the needle hub to a final proximal position, wherein the engagement and release clip is configured to hold the catheter hub in the insertion position while releasing the needle hub in the relaxed state.

2. The insertion mechanism according to claim 1, characterized in that, The pin header essentially surrounds the button and the housing.

3. The insertion mechanism according to claim 1, characterized in that, The needle holder includes at least one opening through which the button can move.

4. The insertion mechanism according to claim 1, characterized in that, The housing includes two firing arms on opposite sides of the housing.

5. The insertion mechanism according to claim 3, characterized in that, The needle holder includes two openings through which the button can move.

6. The insertion mechanism according to claim 1, characterized in that, The engagement and release clip includes two arms engaged by a connecting member.

7. The insertion mechanism according to claim 6, characterized in that, The connecting member includes an opening for receiving the insertion needle and the catheter.

8. The insertion mechanism according to claim 1, characterized in that, The insertion mechanism further includes a diaphragm and a wedge connected to the catheter, the insertion needle piercing the diaphragm.

9. The insertion mechanism according to claim 1, characterized in that, The button includes a semi-transparent button surface, through which the needle holder is visible when the insertion mechanism has been successfully deployed.

10. The insertion mechanism according to claim 1, characterized in that, When the engagement and release clip is in the relaxed state and aligned with the release window, the engagement and release clip prevents the catheter seat from moving in the proximal direction.

11. A drug infusion device, characterized in that, The drug infusion device includes: Device housing, which includes a drug reservoir connected to a catheter; A button housing, the button housing including at least one release window at a distal portion of the housing; Flexible firing arm; A button that can slide within the housing from an initial proximal position to an inserted distal position; The catheter hub, which is fixed to the catheter; A needle hub, which is fixed to an insertion needle, which is inserted into the catheter in an initial configuration; Engagement and release clips, which in a relaxed state are larger than the interior of the housing and are compressed inside the housing, and in the compressed state engage the catheter seat to the needle seat; A return spring that biases the pin seat in the proximal direction and is compressed when the button is moved distally; The firing arm interferes with the movement of the button in the distal direction until a predetermined force is applied to the button, causing the firing arm to deflect and release the button; Wherein, when the button is pressed distally and the engagement and release clip is aligned with the release window, the engagement and release clip expands toward its relaxed state; and wherein, when the engagement and release clip expands and subsequently releases the needle hub from the catheter hub, the return spring moves the needle hub to a final proximal position, wherein the engagement and release clip is configured to hold the catheter hub in the insertion position while releasing the needle hub in the relaxed state.

12. The drug infusion device according to claim 11, characterized in that, The pin header essentially surrounds the button and the housing.

13. The drug infusion device according to claim 11, characterized in that, The needle holder includes at least one opening through which the button can move.

14. The drug infusion device according to claim 11, characterized in that, The housing includes two firing arms located on opposite sides of the housing.

15. The drug infusion device according to claim 13, characterized in that, The needle holder includes two openings through which the button can move.

Images