Catheter insertion device

Abstract

The catheter insertion device is provided as an external applicator attachable to the drug delivery device. The drug delivery device has an inner module therein that includes an insertion needle hub and needle, and a catheter hub and catheter. The external applicator includes a driver and a spring that drive the drive pin into the drug delivery device to force the needle hub and catheter hub downward until the catheter hub is locked in the downward position and the needle hub returns into the external applicator. When insertion is completed, the automatic release feature automatically disengages the external applicator from the drug delivery device.

Description

Technical Field

[0001] The present invention generally relates to medical infusion systems, such as insulin infusion sets or insertion sets, in which a simple, low profile and low parts count manual insertion set is equipped with a dual retraction spring configuration for automatically retracting an introducer needle. The dual retraction spring configuration is achieved using multiple barrel guides and bosses in the insertion set housing, which allows the use of a much smaller retraction spring than a single barrel configuration. Background Art

[0002] Diabetes is a group of diseases characterized by high levels of blood sugar, which is caused by the inability of diabetic patients to maintain adequate levels of insulin production when needed. People with diabetes will need some form of daily insulin treatment to maintain control of their glucose levels. If left untreated, diabetes can be dangerous for affected patients and may lead to serious health complications and premature death. However, such complications can be minimized by utilizing one or more treatment options to help control diabetes and reduce the risk of complications.

[0003] Treatment options for people with diabetes include special diets, oral medications, and / or insulin therapy. The main goal of diabetes treatment is to control glucose, or blood sugar, levels in people with diabetes. However, maintaining proper diabetes management can be complex because it must be balanced with the activities of the person with diabetes.

[0004] There are two main daily insulin treatment approaches for the treatment of type 1 diabetes. In the first approach, people with diabetes self-inject insulin when needed using a syringe or insulin pen. This approach requires a needle stick for each injection, and people with diabetes may need three to four injections per day. Syringes and insulin pens for injecting insulin are relatively simple to use and inexpensive.

[0005] Another effective method of insulin therapy and control of diabetes is infusion therapy or infusion pump therapy using an insulin pump. An insulin pump can provide a continuous infusion of insulin to a diabetic patient at varying rates in order to more closely match the function and behavior of a normally functioning pancreas in a non-diabetic patient to produce the required insulin, and can help a diabetic patient maintain his / her blood sugar levels within a target range based on the individual needs of the diabetic patient.

[0006] Infusion pump therapy requires an infusion cannula, usually in the form of an infusion needle or flexible catheter, which pierces the diabetic patient's skin and through which insulin is infused. Infusion pump therapy offers the advantages of continuous infusion of insulin, precise dosing, and a programmable delivery schedule.

[0007] In infusion therapy, insulin dosage is usually administered with a basal rate and a bolus dose. When insulin is administered with a basal rate, insulin is continuously delivered within 24 hours to maintain the blood sugar level of the diabetic patient within a consistent range between meals and rest (usually at night). Insulin pumps can also set the basal rate of insulin to change according to different times of day and night. In contrast, bolus doses are usually applied when the diabetic patient has a meal, and a single additional insulin injection is usually provided to balance the carbohydrates consumed. Insulin pumps can be configured to enable the diabetic patient to set the volume of the bolus dose according to the amount or type of the meal consumed by the diabetic patient. In addition, insulin pumps can also be configured to enable the diabetic patient to infuse insulin that corrects or supplements the bolus dose to compensate for the low blood sugar level when the diabetic patient calculates the bolus dose for the specific meal to be consumed.

[0008] Insulin pumps advantageously deliver insulin over a period of time rather than in a single injection, generally resulting in smaller variations in the recommended blood sugar range. In addition, insulin pumps can reduce the number of needle sticks that diabetic patients must endure and improve diabetes management to increase the quality of life of diabetic patients.

[0009] Typically, regardless of whether the diabetic patient uses multiple direct injections (MDIs) or a pump, the diabetic patient takes a fasting blood glucose medication (FBGM) upon waking from sleep and tests blood glucose during or after each meal to determine if a correction dose is needed. Additionally, the diabetic patient may test blood glucose before bed to determine if a correction dose is needed, for example, after a bedtime snack.

[0010] To facilitate infusion therapy, there are generally two types of insulin pumps, namely conventional pumps and patch pumps. Conventional pumps require the use of disposable components, commonly referred to as an infusion set, tube set or pump set, which delivers insulin from a reservoir within the pump to the user's skin. The infusion set consists of a pump connector, a section of tubing and a seat 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 the base on the skin surface during use. The cannula can be inserted into the skin manually or with the aid of a manual or automatic insertion device. The insertion device can be a separate unit as required by the user.

[0011] Another type of insulin pump is a patch pump. Different from the traditional infusion pump and infusion set combination, the patch pump is an integrated device, which combines most or all of the fluid components, including a fluid reservoir, a pumping mechanism and a mechanism for automatically inserting a cannula, in a single housing, which adheres to the infusion site on the patient's skin and does not require the use of a separate infusion set or tube set. The patch pump containing insulin adheres to the skin and delivers insulin over a period of time through an integrated subcutaneous cannula. Some patch pumps can communicate wirelessly with separate controller devices (such as a device sold by Insulet under the trade name OmniPod®), while other patch pumps are completely self-sufficient. When the insulin reservoir is exhausted or complications (such as being limited to the cannula or infusion site) may occur, this device is frequently replaced, for example, once every three days.

[0012] Since the patch pump is designed as a self-contained unit worn by a diabetic patient, it is best to be as small as possible so as not to interfere with the user's activities. Therefore, in order to minimize user discomfort, it is preferred to minimize the overall thickness of the patch pump. However, in order to minimize the thickness of the patch pump, its component parts should be reduced as much as possible. One such component is an insertion mechanism for automatically inserting the cannula into the user's skin.

[0013] In order to minimize the height of the insertion mechanism, some conventional insertion mechanisms are configured to insert the cannula at an acute angle (e.g., 30 to 45 degrees) to the skin surface. However, it may be preferred to insert the cannula perpendicularly or nearly perpendicularly from the skin surface because this will require a minimum length of cannula insertion. In other words, with a minimum length of cannula inserted into the user's skin, the user may experience greater comfort and fewer complications, such as premature kinking of the cannula. But 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 therefore increase the overall height of the patch pump itself.

[0014] Therefore, there is a need for an improved insertion mechanism for use in limited space environments such as patch pumps, which can insert a cannula vertically or nearly vertically into the user's skin surface in a cost-effective manner while minimizing or reducing its height to reduce the overall height of a device (such as a patch pump) in which the insertion mechanism is incorporated. Summary of the invention

[0015] An object of the present invention is to substantially solve the above-mentioned and other problems and to provide advanced, improved and novel components and elements of an insertion device which facilitates insertion of an indwelling catheter or soft catheter and retraction of an introducer needle while reducing the number of components required to construct and use the insertion device.

[0016] Another object of the present invention is to provide a manual insertion device that automatically retracts at least the introducer needle, thereby reducing the number of parts of the exemplary embodiment, which serves to keep the production cost of the parts low and simplify the assembly of the device. Automatic retraction also simplifies the user interface by minimizing the number of user activation steps. For the user, there is only one step: pressing a button.

[0017] Another object of the present invention is to provide a manual insertion device that uses a dual retraction spring configuration to automatically retract at least the introducer needle, which configuration is achieved using multiple cylindrical guides and bosses in the insertion device housing, which allows the use of a much smaller retraction spring, thereby making the device smaller and more compact.

[0018] Another object of the present invention is to provide a manual insertion device having at least the functions of automatic guide needle retraction and activation button lock to provide needle protection and maintain catheter insertion.

[0019] These and other objects are substantially achieved by providing an insertion device having a dual retraction spring configuration for automatically retracting an introducer needle. The dual retraction spring configuration is achieved using multiple cylindrical guides and bosses in the insertion device housing, which allows the use of a much smaller retraction spring than a single barrel configuration. A button of the insertion device is used to insert the introducer needle and catheter, and once the introducer needle and catheter have been fully inserted, a rotational engagement releases the dual retraction springs, causing the introducer needle to automatically retract, thereby leaving the catheter in the user's body. The end of the introducer needle remains in the inserted catheter or a wedge retaining the catheter and / or in the septum of the inserted catheter to provide an uninterrupted fluid path.

[0020] Additional and / or other aspects and advantages of the present invention will be set forth in the following description, or will be apparent from the description, or may be understood through practice of the present invention. The present invention may include a method or apparatus or system having one or more of the above aspects and / or one or more features and combinations thereof. The present invention may include, for example, one or more features and / or combinations of the above aspects as described in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The various objects, advantages and novel features of the exemplary embodiments of the present invention will be more readily understood by reading the following detailed description in conjunction with the accompanying drawings, in which:

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

[0023] Figure 2 is in a pre-activated state according to an embodiment of the present invention Figure 1 Another isometric view of the insertion device;

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

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

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

[0027] Figure 6 According to an embodiment of the present invention Figure 1 A view of a guide needle subassembly of an insertion device of the invention, the subassembly being viewed from the top with the plastic tube;

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

[0029] Figure 8 According to an embodiment of the present invention Figure 1 An assembly drawing of a button subassembly of an insertion device, which includes Figure 5 The catheter / diaphragm subassembly and Figure 6 a guide needle subassembly;

[0030] Fig. 9 According to an embodiment of the present invention Figure 1 A view of a complete button subassembly of an insertion device;

[0031] Fig.10 To assemble the button subassembly and spring into the Figure 1 A view of the insertion device housing illustrating the use of a temporary protective tube over the catheter;

[0032] Fig.11 To assemble the button subassembly and spring into the Figure 1 a partially completed view of a housing of an insertion device illustrating the use of a temporary protective tube over a catheter;

[0033] Fig.12 According to an embodiment of the present invention Figure 1 A fully assembled view of the insertion device of FIG. 1 , wherein the base is omitted for illustration purposes;

[0034] Fig.13 According to an embodiment of the present invention, the Figure 1A cross-sectional view of an insertion device;

[0035] Fig.14 is in a pre-activated state according to an embodiment of the present invention Figure 1 Another cross-sectional view of the insertion device;

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

[0037] Fig.16 According to an embodiment of the present invention Figure 1 A transparent view of the insertion device in an intermediate activated state showing the position of the radial operating pin within the helical path;

[0038] Fig.17 According to an embodiment of the present invention Figure 1 Bottom view of the top housing of the insertion device, showing the spiral path surface for Fig.16 The mating portion of the radial operating pin shown;

[0039] Fig.18 According to an embodiment of the present invention Figure 1 A view of the mechanism housing of the insertion device showing the helical path surface for Fig.16 The mating portion of the radial operating pin shown;

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

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

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

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

[0044] Fig.23 According to an embodiment of the present invention, the Figure 1 A cross-sectional view of an insertion device;

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

[0046] Fig.25 is a view of another embodiment of an insertion mechanism according to an embodiment of the present invention, the insertion mechanism being a subassembly separate from the top housing or the base;

[0047] Fig.26 is a view of another embodiment of an insertion mechanism created as a subassembly in a base according to an embodiment of the present invention;

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

[0049] Fig.28 According to an embodiment of the present invention Fig. 27 A cross-sectional view of the locking arm of the device in an intermediate activated state during insertion;

[0050] Fig.29 According to an embodiment of the present invention Fig. 27 A cross-sectional view of the locking arm in an activated state showing the device;

[0051] Fig.30 is a perspective view of a patch pump with a low-profile cannula inserter, with the cover not shown for clarity;

[0052] Fig.31 for Fig.30 An exploded view of the components of the patch pump shown with the cover;

[0053] Fig.32 A perspective view of an alternative design for a patch pump with a flexible reservoir, without the cover shown;

[0054] Fig.33 for Fig.32 Schematic diagram of the patch pump fluid structure and metering subsystem of the patch pump;

[0055] Fig.34 is an isometric view of an alternative embodiment of the present invention;

[0056] Fig.35 and Fig.36 An external applicator assembled to a drug delivery device according to an exemplary embodiment of the present invention is shown;

[0057] Fig.37 is an exploded view of an internal module subassembly and an external applicator subassembly;

[0058] Fig.38An assembly drawing of the internal module subassembly and the external applicator subassembly;

[0059] Fig.39 are cross-sectional views of opposite sides of an external applicator;

[0060] FIG. 40A to FIG. 40C The catheter insertion sequence is shown;

[0061] FIG. 41A to FIG. 41B shows a release sequence of an external applicator from a drug delivery device; and

[0062] Fig.42 Shown is how the flexure arms of the inner module lock the catheter adapter in the deployed position.

[0063] Throughout the drawings, like reference numerals will be understood to refer to like parts, components and structures. DETAILED DESCRIPTION

[0064] The exemplary embodiments of the present invention described below provide a novel component that provides one or more infusion set elements configured to insert a catheter up to 8 mm below the skin surface, but the embodiments are not limited thereto. The insertion device is configured to perform manual insertion of the catheter, which makes the insertion device smaller, simpler and cheaper than automatic or spring-assisted insertion devices.

[0065] The exemplary embodiment of the present invention described below utilizes a manual insertion device and includes a dual retraction spring configuration for automatically retracting the guide needle, which also allows the device to be very small in size. The dual retraction spring configuration is achieved using multiple cylindrical or barrel guides. In an exemplary embodiment, a barrel guides the button and the catheter, and the adjacent barrel contains the retraction spring, with one retraction spring on each side of the button and the catheter. Placing the spring in a separate barrel allows the use of a much smaller spring compared to a single barrel configuration in which the spring is coaxial with the catheter. Due to the restrictions of the spring design, the spring extends almost from the bottom of the housing to the top, so a single coaxial spring forms a passage to the button assembly. For features such as locking arms, passages are required, and if these features are implemented as inside the spring, the entire mechanism must grow to accommodate them, thereby increasing the footprint of the mechanism.

[0066] Figure 1 and Figure 2 shows the insertion device before use, Figure 3 The device is shown after the cannula is deployed. Figures 1 to 3 As shown, the insertion device includes a top housing 100 and a base 102. The top housing 100 is shown having an opening 104 through a top surface from which a user-accessible and user-actuatable button 200 slidably extends. Figure 4, the contents of the insert device are shown in more detail, including the mechanism housing 300. The top housing 100, the button 200, and the mechanism housing 300 may be made of ABS, and the base 102 may be made of PETG, but the embodiment is not limited thereto.

[0067] like Figure 4 As shown, the exemplary insertion device is assembled by stacking a plurality of subassemblies together, which are trapped between a top housing 100 and a mechanism housing 300 . Figure 4 According to an embodiment of the present invention Figure 1 A view of the insertion device. Figure 4 The subassemblies of the present invention and the subassemblies discussed in more detail below include a catheter / septum subassembly, a guide needle subassembly, and a button subassembly. For the sake of clarity, other features and functions of the insertion device known to those skilled in the art are omitted from the drawings and discussion.

[0068] An exemplary catheter / diaphragm subassembly is Figure 5 shown. Figure 5 According to an embodiment of the present invention Figure 1 A cross-sectional view of the catheter / septum subassembly of the insertion device of FIG. Figure 5 As shown, the catheter / septum subassembly is assembled by attaching the catheter 202 to the metal wedge 204, then inserting the septum 206 into the wedge and trapping it between the release collar 208 and the catheter wedge cap 210. The septum 206 is radially compressed by the wedge 204 and axially compressed by the release collar 208 to form a seal between the septum 206 and the wedge 204. The catheter 202 can be a 24G plastic catheter made using FEP, and the release collar 208 and the catheter wedge cap 210 can be made using PTEG, but the embodiment is not limited thereto. The wedge 204 can be made using 305 stainless steel and the septum 206 can be made using isoprene, but the embodiment is not limited thereto.

[0069] Figure 6 and Figure 7 An exemplary introducer needle subassembly is shown. Figure 6 According to an embodiment of the present invention Figure 1 A view of the guide needle subassembly of the insertion device of FIG. 1 , assembled from the top with the plastic tube, Figure 7 2 is a view of another introducer needle subassembly assembled from the side without the plastic tube. It is assembled by gluing or press fitting the tube 220 onto the non-patient end of the cannula or introducer needle 222, then placing the introducer needle through the introducer needle hub 224 and snapping it into place using any number of grooves, slots or detents 226 provided on the top surface of the introducer needle hub 224. Figure 6The guide needle subassembly is used in the following discussion. The guide needle 222 can be a hollow 24G needle or cannula made of 304 stainless steel, and the guide needle hub 224 can be made of PETG, but the embodiment is not limited thereto.

[0070] Figure 7 An alternative embodiment of the introducer needle subassembly is assembled using an introducer needle 232 having a long proximal end 234 that is directly connected to a pump or reservoir (not shown). Removing the flexible plastic tubing in this embodiment makes assembly of the insertion device easier and reduces the risks associated with attaching the two components, but a large loop is required on the proximal end 234 of the cannula to reduce the force required to bend the cannula during insertion and retraction.

[0071] Figure 8 An exemplary button subassembly is shown in FIG. Figure 8 yes Figure 1 An assembled view of the button subassembly of the insertion device, including the catheter / septum subassembly and the guide needle subassembly, Fig. 9 According to an embodiment of the present invention Figure 1 200. The button subassembly is formed by combining the catheter / septum subassembly and the introducer needle subassembly with the button 200. As described in more detail below, once assembled, the introducer needle subassembly cannot be rotated in the button 200. The catheter / septum subassembly can be rotated in the button 200, and in doing so, can be rotated from a position fixed to the introducer needle subassembly to a position separated from the introducer needle subassembly.

[0072] Specifically, the button subassembly is constructed by inserting the guide needle 222 of the guide needle subassembly through the septum 206 and the catheter 202 of the catheter / septum subassembly. The catheter / septum subassembly is then secured to the guide needle subassembly by rotating the catheter / septum subassembly 20 degrees or more to lock the pawl or tooth 238 on the release collar 208 into the groove or slot 240 on the top surface of the guide needle hub 224, which couples the guide needle hub 224 and the catheter / septum subassembly. In this position, the tooth 238 is locked above the top of the guide needle hub 224, so that when the button 200 is pressed, the guide needle hub 224 also moves downward. This causes the guide needle 222 and the catheter 202 to move simultaneously so as to be inserted into the user's skin surface (not shown).

[0073] The button subassembly is then completed by snapping the release collar 208 into the button 200 to secure the introducer needle subassembly and the catheter / septum subassembly in place. To this end, the button 200 may include a detent 212 on a deflectable arm 214 to deflect and then capture the lower edge of the release collar 208 therebetween (e.g., Fig. 9200 ). Between the deflectable arms 214, a slot 216 is provided in the button 200 to allow linear movement of the introducer needle hub 224 relative to the button 200, but inhibit rotational movement of the introducer needle hub relative to the button 200. The slot 216 in the button 200 also allows rotational movement of a radially operating pin 218 of the release collar 208 relative to the button 200, as described in more detail below. In the exemplary embodiment, the substantially cylindrical pin 218 is shown on the outer circumference of the release collar 208. However, in this or other embodiments of the invention, any detent or protrusion of the release collar that can operate with the spiral path can be provided as a radially operating pin.

[0074] The button subassembly may then be assembled with the housing top 100 and the mechanism housing 300 . Fig.10 The button subassembly and spring assembly are assembled to Figure 1 A view of the insertion device housing and illustrating the use of a temporary protective tube over the catheter, Fig.11 The button subassembly and spring assembly are assembled to Figure 1 A partially completed view of the housing of the insertion device. Fig.12 According to an embodiment of the present invention Figure 1 FIG. 2 is a view of a complete assembly of an insertion device, with the base omitted for illustrative purposes.

[0075] To complete the assembly, the button 200 and its components are slidably assembled with the protrusion 106 extending from the inner surface of the top housing 100, such as Fig.13 As shown in more detail. Fig.13 is in a pre-activated state according to an embodiment of the present invention Figure 1 The button locking arm 112 of the top housing 100 holds the button subassembly in place during the next assembly step, which is placing the mechanism housing 300 into the top housing 100, thereby trapping the other subassemblies therein.

[0076] During the placement of the mechanism housing 300 into the top housing 100, a temporary tube 228 is placed over the catheter 202 and the introducer needle 222 therein to protect the needle tip during assembly and to guide the catheter through the exit hole in the mechanism housing 300. The retraction spring 230 is press-fit onto the introducer needle hub 224, and the button subassembly is inserted through the hole 104 in the top housing 100, as shown. Fig.11 A tube or cannula 220 connected to a reservoir or pump (not shown) is sealed in a receiving feature of the top housing. The spring 230 may be made of stainless steel, but the embodiment is not limited thereto.

[0077] The mechanism housing 300 is preferably composed of three cylinders, guides or barrels, including a central barrel 302 that slidably receives and guides the button subassembly, and two barrels 304 that constrain the spring 230, one barrel 304 on each side of the central barrel 302. During assembly, the spring 230 is captured between the boss 242 of the guide needle seat 224 and the bottom of the barrel 304 of the mechanism housing 300. When doing so, the spring 230 applies an expansion force between the bottom of the guide needle seat 224 and the barrel 304 of the mechanism housing 300. In the exemplary embodiment, multiple springs 230 and adjacent barrels 304 are shown. However, in this or other embodiments of the present invention, a single spring and adjacent barrels can be provided in a substantially similar manner, wherein the unused adjacent barrels can be left empty or can be completely omitted. In addition, a single spring can be set on the top of the button and extend during the insertion process, and when completed, the spring retracts to its natural state, thereby retracting the guide needle from the catheter.

[0078] The diameter and length of the circular boss 242 can be set to center the spring 230 during operation. The spring 230 can be partially pre-loaded during assembly of the insertion device, and the mechanism housing 300 can be laser welded or glued to the top housing 100. Then, the bottom or base 102 can be added. When doing so, as the final assembly step, the complete 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 having all the parts captured between the top and bottom housings. In an exemplary production, the mechanism housing 300 is attached to the top housing 100 using snaps or adhesives (not shown) that hold the mechanism together. In the following description of Fig.25 and Fig.26 In two other exemplary embodiments described, similar subassembly concepts are used to make the assembly easier to manage, but the subassemblies are separate units in one embodiment and part of the base in another embodiment.

[0079] In each embodiment, after final assembly, the insertion device is sealed from the rest of the device. That is, the mechanism housing 300, into which water from showering or swimming freely enters through the conduit outlet hole or from the button hole on the top of the housing, is sealed by a laser welding or gluing step, thereby protecting the remaining contents of the device housing 100, such as the contents of the electronic compartment / pump compartment of the device.

[0080] Fig.13 for Figure 1 A cross-sectional view of a fully assembled insertion device, Fig.14 According to an embodiment of the present invention Figure 1 The fully assembled insertion device in the pre-activated state is perpendicular to Fig.13 Another sectional view of the view. Fig.13As shown, one or more breakable ribs 236 on the activation button 200 are captured by the stepped detents 110 in the top housing 100 to hold the button 200 in the pre-activated position. A safety tab (not shown) may also be positioned in the button slot to prevent accidental activation of the device during shipping and handling once the device is removed from the packaging. The safety tab will be removed just prior to insertion.

[0081] To activate the device, the user pushes the button 200 into the top housing 100. Once the ribs 236 break or the deformation force threshold is exceeded, the three ribs 236 yield and the button 200 suddenly moves downward to insert the guide needle 222 and the catheter 202 and load the retraction spring 230. During the assembly process of the insertion device, the spring 230 can be partially preloaded. The minimum breaking force of the breakable ribs 236 ensures that the user pushes hard enough to fully insert the catheter. Partial activation will result in the catheter not being fully inserted, the guide needle not being retracted, and the catheter not being locked in the post-activation position.

[0082] The release of the button 200 from the rib 236 is configured to occur once the desired amount of activation force has been applied to the button 200. Since the button 200 is releasably held in the upward and extended position by the engagement between the rib 236 and the stepped pawl 110, the force applied by the user to the button 200 steadily increases over a period of time before release. At the time of sudden release, the force on the button 200 has reached the desired value, and therefore, the button 200 accelerates downward due to the sudden freedom of movement and the desired force applied to the button at the time of release and maintained thereafter. This release ensures that the user has applied the desired amount of downward force, speed, smoothness, and angle. This activation substantially eliminates variations in the force, speed, smoothness, and angle applied by the user, and reduces insertion failures and / or user discomfort.

[0083] Upon release of the button 200 , the button subassembly and the components therein begin to travel through the mechanism housing 300 . Fig.15 A view of the insertion device at the beginning of such an insertion is shown. Fig.15 is in an intermediate activation state according to an embodiment of the present invention Figure 1 A cross-sectional view of a fully assembled insertion device.

[0084] Fig.15Also shown is one of the two teeth 238 on the release collar 208, which couples the guide needle hub 224 and the catheter / septum subassembly. In this position, the teeth 238 are locked to the top of the guide needle hub 224, so when the button 200 is pressed, the guide needle hub 224 also moves downward. When the button 200 is pressed, the guide needle hub 224 also moves downward, which causes the guide needle 222 and the catheter 202 to be inserted into the user's skin surface (not shown) at the same time, and also causes the guide needle hub 224 to compress the spring 230. In order to create an insertion device with a small footprint, each spring 230 has a small diameter relative to the compressed length, which will cause the spring to bend during compression if there is no support. During compression, the boss 242 on the guide needle hub 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 applies an expansion force to retract the guide needle hub and the guide needle. However, in this or other embodiments of the invention, one or more extension springs may be used and apply a retraction force to retract the introducer needle hub and introducer needle.

[0085] As mentioned above, Figure 5 The catheter / septum subassembly of the present invention is attached to the button 200 and the introducer needle hub 224, but is free to rotate up to 20 degrees about a major axis. In this case, the major 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 movement of the introducer needle hub 224 relative to the button 200, but prohibits rotational movement of the introducer needle hub 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 degree of this rotation is controlled by the radial operating pin 218 extending from the release collar 208. During the insertion process, i.e., during the downward movement of the button subassembly, the radial operating pin 218 moves in a spiral path 400 generated by the combined features in the top housing 100 and the mechanism housing 300. During this movement, the radial operating pin 218 of the release collar 208 rotates the release collar 208 to ultimately release the introducer needle subassembly from the catheter / septum subassembly. The surface 108 in the top housing 100 and the surface 308 in the mechanism housing 300 that forms the spiral path 400 are divided into two parts so that the two parts can be molded without a slide. That is, by using the connection of two separately molded parts to produce the spiral path 400, there is no need for a single part with a slide or the path molded therein, thereby significantly simplifying the manufacture of the insertion device. Fig.17 and Fig.18 Surface 108 in top housing 100 and surface 308 in mechanism housing 300 are shown forming a spiral path 400 when assembled.

[0086] Fig.17 for Figure 1 A bottom view of the top housing 100 of the insertion device showing a portion of the path surface, Fig.18 for Figure 1 FIG. 3 is a view of the mechanism housing 300 of the insertion device, showing the remaining portion of the path surface of the radial operating pin 218 according to an embodiment of the present invention. Fig.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 similarly curved, wavy, or other configured shape 108 that forms half, one side, or a portion of the spiral path 400 when assembled with the mechanism housing 300. Fig.18 As shown, the inner diameter or chamber surface of the mechanism housing 300 in which the button subassembly is slidably disposed may be provided with a curved, wavy, or otherwise configured shape 308 that also forms a half, side, or portion of the spiral path 400 when assembled with the top housing 100. When the top housing 100 and the mechanism housing 300 are assembled, the elements 108 and 308 form the spiral path 400. The path is spiral and causes rotational movement of the release collar 208 relative to the button 200 by guiding the radial operating pin 218 therein when the button 200 and the release collar 208 are moved in a linear direction.

[0087] As described above, the slot 216 provided in the button 200 allows the radial operating pin 218 of the release collar 208 to move. Figure 5 The catheter / septum subassembly is attached to the button 200 and the introducer needle hub 224, but is free to rotate up to 20 degrees about the main axis. This 20 degree rotation allows the radial operating pin 218 of the release collar 208 to move in the spiral path 400. When the button 200 is pressed, the release collar 208 and the radial operating pin 218 of the release collar 208 also move downward through the fixed top housing 100 and the mechanism housing 300. Therefore, the radial operating pin 218 of the release collar 208 slidably disposed in the spiral path 400 rotates the release collar as it moves downward through the fixed top housing 100 and the mechanism housing 300 through the button 200.

[0088] In the pre-activated state, the angle of the radial operating pin 218 is limited to an orientation in which the teeth 238 of the release collar 208 are fully engaged with the introducer needle hub 224. During the movement of the button 200 between the pre-activated state and the post-activated state, the radial operating pin 218 of the release collar 208 rotates the release collar 208 as it moves through the helical path 400 that secures the top housing 100 and the mechanism housing 300.

[0089] In the activated state, the radial operating pin 218 has been rotated up to 20 degrees, which disengages the introducer needle hub 224 from the teeth 238 of the release collar 208, causing the introducer needle hub 224 to disengage from the release collar 208 and retract under the action of the compression spring 230. The release collar 208 and other components of the catheter / septum subassembly remain in the down and inserted position.

[0090] Fig.19 The insertion device is shown during the insertion of the introducer needle 222 and the catheter 202, and at a point in time just before the introducer needle hub 224 is released to retract by the radial operating pin 218 of the release collar 208. The radial operating pin 218 and the release collar 208 are almost completely rotated by engagement with the spiral path 400, and at the end of the rotation of the spiral path 400, the teeth 238 on the release collar 208 will move out of the pawl 240 of the introducer needle hub 224 and release the introducer needle hub 224 so that it can be pushed upward and retracted by the spring 230. That is, when the radial operating pin 218 and the release collar 208 are rotated by engagement with the spiral path 400, the teeth 238 on the release collar 208 are rotated simultaneously until the pawl 240 of the introducer needle hub 224 is disengaged. At this point, the release collar 208 depressed by the button 200 is no longer secured to the introducer needle hub 224, and the spring 230 forces the introducer needle hub 224 and the introducer needle 222 upward into the retracted position, placing the catheter / septum subassembly in the downward insertion position. The button 200 is locked in the downward position, thereby maintaining the catheter / septum subassembly in the downward insertion position. Fig. 22 As shown, a locking arm 112 protruding from the top housing 100 holds the button subassembly in place during assembly, and the locking arm 112 can also be configured to snap into a detent 244 in the button 200 in an activated state, locking the button subassembly in place, thereby holding the catheter in the skin.

[0091] Fig. 20 The insertion device is shown just as the introducer needle 222 and catheter 202 are fully inserted. The retraction spring 230 is fully compressed, and the radial operating pin 218 and the release collar 208 have been rotated to the extent necessary to disengage the teeth 238 of the release collar 208 from the introducer needle hub 224 to release the introducer needle hub 224 for retraction, as shown in FIG. Fig.21 and Fig.23 shown. Fig.21 and Fig.23 The insertion device is shown in an activated state. At this point, the release collar 208 depressed by the button 200 is no longer fixed to the introducer needle hub 224, and the spring 230 forces the introducer needle hub 224 and the introducer needle 222 upward into the retracted position, placing the catheter / septum subassembly in the downward insertion position.

[0092] The introducer needle 222 is retracted deeper into the housing than its pre-activated state position to ensure needle stick protection and protect the catheter from damage. The tip of the introducer needle 222 remains sealed by the septum 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 introducer needle 222 remains within the catheter 202 and is sealed by the septum 206 to form an uninterrupted fluid path with the catheter 202.

[0093] In an exemplary embodiment, manual insertion of the introducer needle and catheter can make the insertion device smaller, simpler, and less expensive than insertion devices that employ spring-assisted insertion. Other patch pump plastic catheter insertion mechanisms use an insertion spring that is larger relative to the retraction spring because the insertion force is larger relative to the retraction force. Fully integrated spring-assisted insertion also requires an angled insertion of the low-profile device, which increases the stroke and significantly increases the wound and mechanism size. The insertion spring does not serve any purpose after insertion and simply takes up space in the device, where size is one of the most important user requirements for the product.

[0094] In an exemplary embodiment, the dual retraction spring configuration also allows for very small size. One barrel of the insertion device housing guides the button and catheter, and an adjacent barrel houses the two retraction springs. Having the springs in separate barrels and guided by a boss on the guide needle seat allows the springs to be much smaller than a single barrel configuration in which the springs are coaxial with the catheter. Since the constraints of the spring design require the spring to extend almost from the bottom to the top of the housing, a single coaxial spring forms a path to the button assembly. For features like locking arms, paths are required, and if these features are implemented inside the spring, the entire mechanism must grow to accommodate them, thereby increasing the footprint of the mechanism. Passively locking the catheter and retracting the guide needle creates the simplest possible manual insertion user interface for the manual insertion mechanism, which is a single button press.

[0095] As described above, the retraction spring 230 is minimally loaded before use to ensure that the introducer needle 222 is fully retracted into the device. The spring 230 is further loaded during the insertion process. Providing a minimally loaded spring and an incompletely loaded spring in the insertion device reduces the risks associated with sterilizing and storing loaded springs and simplifies the design.

[0096] To operate the insertion device, the user applies the insertion device to the skin surface using the adhesive on the base 102 of the device. The user then manually pushes the protruding button 200 until the rib 236 breaks or deforms. The button 200, now suddenly free to move, is quickly pushed into the top housing 100 and used to push and insert the plastic catheter 202 and the guide needle 222 into the user's skin surface. When the button 200 is pushed, the release collar 208 is rotated by the radial operating pin 218 of the spiral path 400 by the movement of the release collar 208. The release collar 208 rotates to the extent required to disengage the release collar 208 from the guide needle seat 224, and then the guide needle seat 224 and the guide needle 222 are retracted to the retracted position, beyond the original needle position, to ensure needle protection. Now, the plastic catheter 202 disengaged from the guide needle 222 remains in the downward insertion position. The button 200 automatically locks in the lower position, flush with the top of the housing, which also locks the catheter at the desired depth in the subcutaneous layer. A sensor (not shown) may be provided to sense the activated state and notify other electronic devices (not shown) that the catheter has been properly inserted, which allows the patient to infuse the drug. The pump or reservoir then infuses the drug through the introducer needle, into the catheter, out of the catheter and into the patient's subcutaneous layer.

[0097] In order to best achieve the desired depth, the base can include a skin interface geometry to achieve and maintain the desired insertion depth, avoid bulging of the skin surface, and / or strain the skin surface at the insertion site. Figures 48 to 50 show examples of such skin interface geometries when the catheter is deployed. In the perspective view of the device 502, the post 504 extending from the catheter 506 during placement protrudes into the skin surface (not shown), which helps prevent the catheter tip from being inserted shallowly when the skin is strained. The post 504 can extend from the base surface of the device 502 to any desired length and can be rounded and / or chamfered at the distal end that contacts the skin surface.

[0098] A well 508 may be provided around the post 504. The well 508 provides space for the skin to be displaced during insertion and helps the post 504 to protrude into the skin surface. A wall 510 surrounds and defines the well 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 that contacts the skin surface. The rounded counter-cylinder 512 in FIGS. 48 to 50 may be provided or excluded from the geometry as desired.

[0099] In the exemplary embodiment described above, the insert mechanism can be created as a subassembly in the top housing 100. This makes the insert mechanism easy to handle during the production process so that other subsystems can be assembled. Alternatively, the insert mechanism can be created as a subassembly separate from the top housing 100 or the base 102, such as Fig.25 As shown, or created as a subassembly in the base 102, such as Fig.26 shown.

[0100] exist Fig.25 , the complete button subassembly 250 (which is similar to the reference Fig. 9 The mechanism housing 350 is fixed by means of a snap or a pawl 252 (which is similar to the reference Figure 4 In this case, the insertion mechanism is created as a separate subassembly from the top housing 100 or the base 102. Once completed, Fig.25 The insertion mechanism can then be assembled with one or more of the top housing 100 and the base 102.

[0101] exist Fig.26 , the complete button subassembly 260 (which is similar to the reference Fig. 9 The same as described above) is fixed in the mechanism housing 360 (which is the same as the reference Figure 4 In this case, the insertion mechanism is created as a subassembly in the base 102. In addition, Fig.25 and Fig.26 In each embodiment, as mentioned above Fig.17 and Fig.18 The surface producing the spiral path as described may be provided in the button subassembly 250 and the mechanism housing 350, as well as in the button subassembly 260, the mechanism housing 360 and / or the base 102, so that the surface may again be split between the two parts so that both parts may be molded without a slide.

[0102] In the exemplary embodiment described above, the rib 236 determines the minimum insertion force to begin activating the device to ensure full activation. Alternatively, the locking arm 112 can be configured to also determine the minimum activation force. As described above, the locking arm 112 protrudes from the top housing and snaps into a detent in the button in the activated state, locking the button subassembly in place, thereby retaining the catheter in the skin. Fig. 27 Another embodiment of a locking arm 272 is shown, which includes a flange 274 on the locking arm that holds the button 270 in the pre-activated position. The wavy flange 274 of the locking arm 272 protrudes and captures the bottom edge of the button 270 in the pre-activated state, 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 out of the way of the inserted button 270. Fig.28 The device is shown in an intermediate state during insertion. The locking arms 272 will bend outwardly, rather than Fig.28 The minimal deflection force of the locking arm 272 and flange 274 ensures that the user pushes hard enough to fully insert the catheter. Fig.29 As shown, locking arm 272 and flange 274 snap into detent 276 in button 270 when the button reaches the lowermost position locking the button and catheter.

[0103] In the above embodiments, the patch pump may be equipped with one or more of the described features. Fig.30 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 with a transparent cover, and the various components assembled to form the patch pump 1 are shown. Fig.31 yes Fig.30 2, shown with a solid cover 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 an insertion needle with a catheter into the user's skin; control electronics 8 in the form of a circuit board with optional communication capabilities with external devices such as remote controls and computers, including smart phones; a dose button 6 on the cover 2 for actuating insulin doses, including bolus doses; and a base 9 to which the various components above can be attached by fasteners 91. The patch pump 1 also includes various fluid connector lines that deliver insulin pumped from the reservoir 4 to the infusion site.

[0104] As mentioned above, it should be understood that the insertion mechanism has a variety of configurations. In some embodiments, the insertion mechanism inserts the soft catheter into the skin. In these embodiments, the soft catheter is usually supported on a rigid insertion needle. The insertion needle is inserted into the skin together with the soft catheter, and then retracted from the skin, leaving the soft catheter in the skin. In other embodiments, the soft catheter is not provided, and the insertion needle remains in the skin and forms a part of the insulin flow path to deliver insulin until the infusion is completed. The insertion needle is usually hollow, and if they form a part of the insulin flow path, they need to be hollow. However, the insertion needle that supports the soft catheter and then retracts can be solid or hollow. If the insertion needle deploys the soft catheter, and retracts but is still a part of the insulin flow path, the insertion needle should be hollow. However, if the insertion needle deploys the soft catheter, then retracts but does not form a 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 in addition, it can also be made soft enough to provide comfort to the user.

[0105] Fig.32A perspective view of an alternative design of a patch pump 1A having a flexible reservoir 4A, shown without a cover. This arrangement can further reduce the external dimensions of the patch pump 1A, wherein the flexible reservoir 4A fills a void within the patch pump 1A. The patch pump 1A shown has a conventional cannula insertion device 7A, which typically inserts the cannula at an acute angle of less than 90 degrees at the user's skin surface. The patch pump 1A also includes: a power source 5A in the form of a battery; a metering subsystem 41 that monitors the volume of insulin and includes a low volume detection capability; control electronics 8A for controlling components of the device; and a reservoir fill port 43 for receiving a refill syringe 45 to fill the reservoir 4A.

[0106] Fig.33 for Fig.32 FIG. 1 is a diagram of a patch pump fluid structure and metering subsystem of a patch pump 1A. The energy storage subsystem for the patch pump 1A includes a battery 5A. The control electronics 8A of the patch pump 1A may include a microcontroller 81, a sensing electronics 82, a pump and valve controller 83, a sensing electronics 85, and a deployment electronics 87 that controls the actuation of the patch pump 1A. The patch pump 1A includes a fluid subsystem that may include a reservoir 4A, a volume sensor 48 for the reservoir 4A, and a reservoir fill port 43 for receiving a refill syringe 45 to refill the 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 an occlusion sensor, a deployment actuator, and a cannula 47 for insertion into an infusion site on the user's skin. Fig.30 and Fig.31 The structure of the patch pump Fig.33 Same or similar to those shown.

[0107] Fig.34 Another exemplary embodiment of an insertion mechanism is shown. This embodiment includes an external applicator 3400 attached to an IDD 3402. Also included is an internal module 3404 mounted inside the housing of the IDD 3402. As shown, and described in further detail below, the external applicator 3400 is attached to the IDD 3402 so as to interact with the internal module 3404 and automatically release from the IDD 3402 when cannula insertion is complete. Cannula insertion is initiated by the user pressing a release button 3406 of the external applicator 3400.

[0108] like Fig.35 As shown, prior to use, the outer applicator 3400 and the inner module 3404 subassembly are assembled. Fig.35 The passive release member 3406 of the external applicator 3400 includes a locking feature 3408, such as Fig.35When the external applicator 3400 is assembled to the IDD 3402, the passive release member rotates counterclockwise, as shown in FIG. Fig.36 As shown, the locking feature 3408 is locked to the cap 3410 of the internal module 3404. Fig.36 As shown by the arrows in , the rotation is preferably caused by the interaction of features on the passive release member and the cap 3410.

[0109] Fig.37 34 is an exploded view of the internal module 3404 subassembly and the external applicator 3400 subassembly. The components of each will now be briefly described. The internal module 3404 includes a cap 3410, a needle hub 3412 and a needle 3414, a catheter hub 3416 and a catheter 3418, a return spring 3420 and a base 3422. The external applicator 3400 includes a release button 3406, a drive disk 3424, a clock spring 3426, a yoke 3428, a drive pin 3430, an applicator housing 3432 and a passive release 3406.

[0110] Fig.38 3404 and the outer applicator 3400 are assembled isometric views. As shown, the base 3422 includes a flexure arm 3434 that allows the catheter adapter 3416 to pass through and then retain the catheter adapter 3416 in a deployed position, which will be described in further detail below. The base 3422 also includes a snap 3436, which engages a corresponding feature in the cap 3410 during assembly and locks the cap 3410 to the base 3422. In the outer applicator 3400, the drive wheel 3424 and the clock spring 3426 are supported on a support feature 3438 molded into the applicator housing 3432.

[0111] Fig.39 The assembled external applicator 3400 is shown in cross-section from a first side and an opposite side. As will be described in further detail below, the drive disk 3424 includes a drive post 3440 housed in a slot 3442 of a yoke 3428. These interactions translate the rotation of the drive disk 3424 into up and down reciprocating motion of the yoke 3428 and the drive pin 3430. The applicator housing 3432 is manufactured with support features to radially and axially support the clock spring 3426, as shown at 3431. The release button 3406 includes a release feature 3427 that holds the drive disk 3424 until the button is pressed, disengaging the drive disk 3424 from the release button 3406, and allowing the clock spring 3426 to rotate the drive disk 3424. The applicator housing 3432 also includes a ridge 3442 that supports the yoke 3428 and otherwise helps keep the assembled parts in place.

[0112] FIG. 40A to FIG. 40CThe needle insertion process is shown after the release button is pressed. Fig.40A The storage state is shown. The needle hub 3412, catheter hub 3416 and drive pin 3430 are in the upward position and the return spring 3420 is in the uncompressed state. As the drive disk 3424 rotates, the drive pin 3430 and yoke slot 3442 interact to drive the yoke 3428 and drive pin 3430 downward. When the drive disk 3424 has been rotated approximately 180 degrees, the fully inserted position is Fig.40B In Fig.40A Of note is the flexure arm 3434, which flexes and allows the catheter seat 3416 to pass and be captured in the downward position. The return spring 3420 is compressed by the needle seat 3412. As the drive disk 3424 continues to rotate, the yoke 3428 reciprocates upward and pulls the needle seat 3412 upward to Fig.40C In the upper position shown, as the drive disk 3424 continues to rotate, the yoke 3428 is driven by the return spring 3420 and allows the yoke 3428 to return to the upper position.

[0113] Fig.41A and Fig.41B 34 shows how the external applicator 3400 is automatically released from the IDD 3402. Fig.41A As shown, the passive release member 3406 includes a column 3444. The drive plate 3424 includes Fig.41B The cam surface 3446 is shown. Rotation of the drive disk 3424 causes the cam surface 3446 to push the post 3444, thereby rotating the passive release member in a clockwise direction and thereby disengaging the outer applicator 3400 from the IDD 3402. Fig.42 The flex arm 3434 is shown after the catheter adapter 3416 has been moved downwardly past the terminal end of the flex arm 3434, such that the catheter adapter 3416 is captured in a downward position.

[0114] Although only a few exemplary embodiments of the present invention have been described in detail above, those skilled in the art will readily appreciate that various modifications may be made to the exemplary embodiments without materially departing from the novel teachings and advantages of the present invention. Therefore, all such modifications are intended to be included within the scope of the appended claims and their equivalents.

Claims

1. A catheter insertion device, characterized in that The catheter insertion device comprises: an internal module subassembly and an external applicator subassembly, wherein the internal module subassembly is housed within a housing of a drug delivery device and the external applicator subassembly is removably attached to the drug delivery device; wherein the internal module subassembly includes a needle hub having an insertion needle fixed thereon, a cap having a hole therein, a base snapped to the cap, a return spring between the needle hub and the base, and a catheter hub having a catheter fixed thereon; The external applicator assembly includes a release button, a housing and a passive release member, wherein the passive release member is capable of rotating between a first orientation released from the drug delivery device and a second position fixed to the drug delivery device; the external applicator subassembly also includes a drive disk and a clock spring, and a yoke fixed to a drive pin, wherein when the release button releases the drive disk, the drive disk causes the yoke and the drive pin to reciprocate so that the drive pin drives the needle seat downward to insert the catheter, and then the drive pin returns to the external applicator housing.

2. The catheter insertion device according to claim 1, characterized in that The drive plate includes a cam surface that positions the passive release member in a second position after the release button is depressed.

3. The catheter insertion device according to claim 1, characterized in that The yoke includes a slot, and the drive plate has a drive pin inserted into the slot for converting the rotational motion of the drive plate into reciprocating linear motion of the yoke and the drive pin.

4. The catheter insertion device according to claim 1, characterized in that The inner module subassembly includes a flexure arm that allows the catheter adapter to reach a downward position of the catheter adapter through a distal end of the flexure arm and lock the catheter adapter in the downward position.

5. The catheter insertion device according to claim 1, characterized in that The release button includes a release feature that prevents the disk drive from rotating before the release button is pressed and releases the drive disk when the release button is pressed.

Images