Rotationally actuated insertion mechanism for drug delivery pumps - Patents.com

Abstract

To provide insertion mechanisms for drug delivery pumps, drug delivery pumps with safety integrated insertion mechanisms, methods of operating such devices, and methods of assembling such devices.SOLUTION: An insertion mechanism for a drug pump includes an insertion mechanism, a housing 202, a sleeve 220, a rotational biasing member 210 initially held in an energized state, a retraction biasing member 216, and a hub 212 connected to a proximal end of a needle 214, wherein the retraction biasing member is held initially in an energized state between the hub and the sleeve. The needle is inserted into a target tissue by the rotational biasing member and interaction between the hub and housing. Retraction of the needle is caused by decompressing or de-energizing the retraction biasing member. A drug delivery pump includes an activation mechanism, a drive mechanism, a sterile access connection, and the insertion mechanism. Assembly and operation methods are provided.SELECTED DRAWING: Figure 8B

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Patent Application No. 62 / 114,200, filed February 10, 2015, U.S. Provisional Patent Application No. 62 / 133,690, filed March 16, 2015, and U.S. Provisional Patent Application No. 62 / 147,403, filed April 14, 2015, all of which are incorporated by reference in their entireties for all purposes.

[0002] The present invention relates to drug delivery pumps, more particularly to an insertion mechanism for a drug delivery pump, a drug delivery pump having a safety integrated insertion mechanism, a method of operating such a device, and a method of assembling such a device. [Background technology]

[0003] Parenteral delivery of various drugs, i.e., delivery by means other than through the digestive tract, has become a desirable method of drug delivery for many reasons. This form of drug delivery by injection may enhance the effect of the delivered substance and ensure that the unaltered drug reaches its intended site in significant concentrations. Similarly, undesirable side effects associated with other delivery routes, such as systemic toxicity, may possibly be avoided by parenteral delivery. Bypassing the digestive system of a mammalian patient avoids the degradation of the active ingredient caused by catalytic enzymes in the digestive tract and liver, and may ensure that the required amount of drug at the desired concentration reaches the target site.

[0004] Traditionally, manually operated syringes and injection pens have been used to deliver parenteral drugs to patients. More recently, parenteral delivery of liquid medicines into the body has been achieved by administering a bolus injection using a needle and a reservoir, continuously by a gravity-driven dispenser, or by transdermal patch technology. Bolus injections often do not fully meet the clinical needs of the patient and may require more individual doses than are desired at the particular time the bolus injection is given. Continuous delivery of medicines through gravity-fed systems reduces the patient's mobility and lifestyle, and limits treatment to simplified flow rates and profiles. Transdermal patches, another form of drug delivery, are similarly limited. Transdermal patches often require specific molecular drug structures to be effective, and control of drug administration through transdermal patches is greatly limited.

[0005] Ambulatory infusion pumps have been developed to deliver liquid medications to patients. These infusion devices have the ability to provide sophisticated fluid delivery profiles that achieve bolus requirements, continuous infusion, and variable flow rate delivery. These infusion capabilities usually result in better efficacy of drugs and treatments and less toxicity to the patient's body. Currently available portable infusion devices tend to be costly, difficult to program and prepare for infusion, bulky, heavy, and very fragile. Filling these devices can be difficult and require the patient to carry both the intended medication as well as the filling accessories. The devices often require specialized care, maintenance, and cleaning to ensure proper functionality and safety for their intended long-term use, which is not cost-effective for the patient or health care provider.

[0006] Compared to syringes and injection pens, pump-type delivery devices can be significantly more convenient for patients in that a dose of drug may be calculated and automatically delivered to the patient at any time during the day or night. Furthermore, when used in conjunction with a metabolic sensor or monitor, the pump may be automatically controlled to provide an appropriate dose of fluid medium at the appropriate time of need based on the detected or monitored metabolic level. As a result, pump-type delivery devices have become an important aspect of modern medical treatment of various types of medical conditions, such as diabetes, etc.

[0007] Although pump-type delivery systems have been utilized to solve many patient needs, manually operated syringes and injection pens often remain the preferred choice for drug delivery because they now offer integrated safety features and can be easily read to identify the status of drug delivery and end of dose delivery. However, manually operated syringes and injection pens are not universally applicable and are not preferred for the delivery of all drugs. There remains a need for an adjustable (and / or programmable) infusion system that is accurate and reliable and can provide clinicians and patients with a compact, low-cost, lightweight, and easy-to-use alternative for parenteral delivery of liquid medicines. Summary of the Invention

[0008] The present invention provides an insertion mechanism for a drug delivery pump, a drug delivery pump with an integrated safety insertion mechanism, a method of operating such a device, and a method of assembling such a device. Additionally, embodiments of the present invention provide a novel insertion mechanism and a sterile fluid pathway through the drug pump, which pathway is only engaged, connected, or opened by appropriate activation by the user. Thus, the novel device of the present invention alleviates one or more of the problems associated with the prior art devices as referenced above. The devices described herein may further include features that prevent delivery of medication in too large a volume or at too fast a rate. By providing such an automatic safety mechanism, patient safety may be ensured. Some medications, such as insulin, can be dangerous, and possibly even lethal, if not delivered according to prescribed parameters. The safety features described below may ensure that delivery of the medication is terminated if the delivery deviates from the specified parameters.

[0009] In a first embodiment, the present invention provides an insertion mechanism for a drug pump, the insertion mechanism including: an insertion mechanism housing having an internal chamber; a sleeve disposed within the housing; one or more rotational biasing members initially held in an energized state, at least a portion of the rotational biasing members engaging the housing; a retraction biasing member; a hub connected to a proximal end of the needle, the retraction biasing member initially held in an energized state between the hub and the sleeve; and a fluid conduit to enable fluid flow from the drug container to the needle.

[0010] The insertion mechanism may further include a base connected to the distal end of the insertion mechanism housing. A sterile boot may be securely connected to the hub at a first end and fastened between the sleeve and the base at the other end. The term "sterile boot" is used to describe a boot in which certain internal components may reside in a sterile state during one or more stages of operation. The boot need not be sterile throughout the entire operation of the mechanism or pump, and may in fact not be initially sterile until assembly and sterilization of certain components occurs. Furthermore, the term "boot" is not intended to imply any particular shape or configuration, but instead is utilized to describe a component that may provide an interior space in which other components may reside during one or more stages of operation.

[0011] In another embodiment, the present invention provides a drug delivery pump with integrated safety features including a housing and an assembly platform on which an activation mechanism, a drive mechanism, fluid pathway connections, a power and control system, and an insertion mechanism for the drug pump may be mounted, the insertion mechanism including an insertion mechanism housing having an internal chamber; a sleeve disposed within the housing; one or more rotational biasing members initially held in an energy stored state, at least a portion of the rotational biasing members engaging the housing; a retraction biasing member; a hub connected to a proximal end of the needle, the retraction biasing member initially held in an energy stored state between the hub and the sleeve; and a conduit to enable fluid flow from the drug container to the needle.

[0012] The insertion mechanism may further include a base connected to a distal end of the insertion mechanism housing. The sterile boot may be rigidly connected to the hub at a first end and clamped between the sleeve and the base at the other end. In a further embodiment, the invention provides a method of assembling the insertion mechanism, the method comprising the steps of: connecting a hub to a proximal end of the needle; connecting a conduit to the hub; connecting a sterile boot to the hub; inserting the hub, the conduit and the sterile boot into the sleeve; placing a housing around the sleeve; and connecting the base to the sleeve by engagement of a flex arm with a hole in the housing. The method may further include inserting a retraction biasing member into the sleeve or housing of the needle insertion mechanism at a position where the retraction biasing member is constrained between the hub at one end and the sleeve or housing at the other end. A rotational biasing member may be disposed about the housing such that a portion of the rotational biasing member engages a portion of the housing, thereby coupling energy release of the biasing member to rotation of the housing.

[0013] In yet another embodiment, the present invention provides a method of operating a drug delivery pump. The method of operating includes triggering an activation mechanism to disengage an anti-rotation feature from an insertion mechanism housing, which disengages to allow a rotational biasing member to release energy and effect rotation of the housing, which effect distal translation of a hub and needle disposed within the housing, which drives insertion of the needle and / or flexible cannula into a user's body; connecting a fluid passageway connection having a piercing member to a drug container having a pierceable seal; and activating a drive mechanism to force fluid through the fluid passageway connection, the conduit, and the needle and into the user's body. The method further includes causing and / or allowing further energy release of the rotational biasing member, thereby causing further rotation of the housing. This rotation allows a retraction biasing member to expand and effect proximal displacement of the hub and needle, which retracts the needle from the target tissue. In such embodiments, the flexible cannula may remain in the target tissue after needle retraction, thereby allowing delivery to continue.In a preferred embodiment, the method of operation may further include initially displacing one or more on-body sensors to allow for displacement of the activation mechanism.

[0014] According to a feature of the present disclosure, an insertion mechanism for a drug pump is provided. The insertion mechanism has an axis (A) and includes a rotatably disposed housing, at least one rotational biasing member, a sleeve, a needle, a hub, and a retraction biasing member. The at least one rotational biasing member is coupled to the housing and is initially held in an energy-stored state. The rotational biasing member is arranged to rotate the housing as the rotational biasing member is deenergized. The sleeve, needle, and hub are at least partially disposed within an internal chamber of the housing. The needle has a hollow interior, a proximal end, and a distal end. The hub is connected to the proximal end of the needle. The needle and hub are configured to translate axially between an initial position and an insertion position. The at least one retraction biasing member is disposed between the hub and at least one axially stationary element. The retraction biasing member is arranged to move the hub and the needle from the insertion position to an at least partially retracted position when the retraction biasing member is deenergized. Rotation of the housing caused by release of energy from the rotational biasing member causes axial translation of the hub and needle in the distal direction from the initial position to the insertion position, and release of energy from the retraction biasing member causes translation of the hub and needle in the proximal direction to an at least partially retracted position.

[0015] According to another feature of the present disclosure, such an insertion mechanism is provided that includes a cannula having a lumen. The cannula is at least partially disposed within an internal chamber of the housing, and a distal end of the needle is at least partially disposed within the lumen of the cannula. An initial rotation of the housing caused by de-energizing the rotational biasing member results in axial translation of the hub, needle, and cannula in a distal direction from an initial position to an insertion position. A further secondary rotation of the housing caused by de-energizing the rotational biasing member allows for de-energizing the retraction biasing member, which results in translation of the hub and needle in a proximal direction to an at least partially retracted position where the needle is at least partially disposed within the lumen of the cannula.

[0016] According to yet another feature of the present disclosure, at least one retraction biasing member is provided for further moving the hub to a fully retracted position where the needle is no longer disposed within the lumen of the cannula. In this embodiment, a tertiary rotation of the housing caused by de-energizing the rotational biasing member is further provided which allows de-energizing the retraction biasing member which causes translation of the hub and needle in a proximal direction to a fully retracted position to terminate the flow of medicament through the cannula. The tertiary rotation is initiated by a stop mechanism.

[0017] According to a further feature of the present disclosure, there is provided a drug pump including a drug pump housing, an activation mechanism, a drive mechanism, and an insertion mechanism having an axis (A). The insertion mechanism includes a housing having an interior chamber, at least one axial stationary element, a needle, a hub, and at least one retraction biasing member. The at least one axial stationary element includes a sleeve. The sleeve, needle, and hub are at least partially within the interior chamber of the housing. The needle has a hollow interior, a proximal end, and a distal end. The hub is connected to the proximal end of the needle. The needle and hub are configured to translate axially between an initial position, an insertion position, and a retracted position in which the distal end of the needle is disposed within at least one of the housing and the at least one axial stationary element. The at least one retraction biasing member is disposed between the hub and the at least one axial stationary element. The retraction biasing member is disposed to move the hub and the needle from the insertion position to the retracted position when the retraction biasing member is deenergized. The retraction biasing member is permitted to release energy to retract the hub and needle to the retracted position in response to a stop mechanism including at least one of a user input, a device operation error, and an end-of-dose signal.

[0018] According to yet another feature of the present disclosure, there is provided a method of operating a drug pump including one or more of the disclosed insertion mechanisms, the method including allowing at least one rotational biasing member to de-energize from an initial energy-stored state, such de-energization resulting in rotation of the needle housing, thereby resulting in translation of the needle and hub in a distal direction from an initial position to an insertion position, connecting a sterile access connection to the drug container, and activating a drive mechanism to force fluid through the sterile access connection, the conduit, the needle and into the target.

[0019] Throughout this specification, unless otherwise indicated, the terms "comprise," "comprises," "comprising," or related terms such as "includes" or "consists of" are used inclusively and not exclusively, such that a stated integer or group of integers may include one or more other unstated integers or groups of integers. As described further below, embodiments of the invention may include one or more additional components that may be considered standard components in the medical device industry. Components and embodiments including such components are understood to be within the contemplation and breadth and scope of the invention.

[0020] The following non-limiting embodiments of the present invention are described herein with reference to the following drawings. [Brief description of the drawings]

[0021] [Figure 1A] FIG. 1 is an isometric view of a drug delivery pump with an integrated safety insertion mechanism according to one embodiment of the present invention. [Figure 1B] FIG. 1B is an isometric view of the internal components of the drug delivery pump shown in FIG. 1A. [Figure 1C] FIG. 1B is a bottom isometric view of the drug delivery pump shown in FIG. 1A. [Figure 2A]FIG. 2 is an isometric view of the internal components of a second embodiment of a drug delivery pump. [Figure 2B] FIG. 2B is a second isometric view of the internal components of the drug delivery pump shown in FIG. 2A. [Figure 3A] FIG. 2 is an exploded view along axis "A" of an insertion mechanism in accordance with at least one embodiment of the present invention. [Figure 3B] FIG. 3B is a cross-sectional view of the disassembled insertion mechanism of FIG. 3A. [Figure 4A] FIG. 1 is an isometric view of an insertion mechanism housing in accordance with at least one embodiment of the present invention. [Figure 4B] FIG. 4B is a cross-sectional view of the insertion mechanism housing shown in FIG. 4A. [Diagram 5] FIG. 1 is an isometric view of a hub in accordance with at least one embodiment of the present invention. [Figure 6] FIG. 2 is an isometric view of a sleeve in accordance with at least one embodiment of the present invention. [Figure 7] 1A-1C illustrate an embodiment of a base of an insertion mechanism in accordance with at least one embodiment of the present invention. [Figure 8A] FIG. 2 illustrates an isometric view of an insertion mechanism according to at least one embodiment of the present invention in an initial configuration. [Figure 8B] FIG. 8B is a cross-sectional view of the insertion mechanism of FIG. 8A in an initial configuration. [Figure 9A] FIG. 8B is an isometric view of the insertion mechanism of FIG. 8A in a needle pre-inserted configuration. [Figure 9B] FIG. 9B is a cross-sectional view of the insertion mechanism of FIG. 9A in a needle pre-inserted configuration. [Figure 10A] FIG. 9B is an isometric view of the insertion mechanism of FIGS. 8A and 9A in a needle retraction configuration. [Figure 10B] FIG. 10B is a cross-sectional view of the insertion mechanism of FIG. 10A in a needle retracted configuration. [Figure 11] FIG. 1 is an isometric view of an insertion mechanism in accordance with at least one embodiment of the present invention. [Figure 12] FIG. 12 is a side cross-sectional view of the embodiment of FIG. [Figure 13] FIG. 12 is a front cross-sectional view of the embodiment of FIG. [Figure 14A]FIG. 2 illustrates a cross-sectional view of an insertion mechanism according to at least one embodiment of the present invention in an initial configuration. [Figure 14B] FIG. 14B is a cross-sectional view of the insertion mechanism of FIG. 14A in an inserted configuration. [Figure 14C] FIG. 14B is a cross-sectional view of the insertion mechanism of FIG. 14A in a delivery configuration. [Figure 15A] FIG. 1 is a side cross-sectional elevation view of an insertion mechanism housing in accordance with at least one embodiment of the present invention. [Figure 15B] FIG. 15B is an isometric cross-sectional view of the insertion mechanism housing of FIG. [Figure 16A] FIG. 14C is an enlarged, partial cross-sectional view of the insertion mechanism of FIGS. 14A-14C while in a delivery configuration. [Figure 16B] FIG. 14D is an enlarged, partial cross-sectional view of the insertion mechanism of FIGS. 14A-14C while in a retracted position. [Figure 17A] FIG. 2 illustrates a cross-sectional view of an insertion mechanism according to at least one embodiment of the present invention in an initial configuration. [Figure 17B] FIG. 17B is a cross-sectional view of the insertion mechanism of FIG. 17A in an inserted configuration. [Figure 17C] FIG. 17B is a cross-sectional view of the insertion mechanism of FIG. 17A with the needle hub in a partially retracted position. [Figure 17D] FIG. 17B is a cross-sectional view of the insertion mechanism of FIG. 17A with the needle hub in a fully retracted position. [Figure 18A] FIG. 17B is a cross-sectional view of the insertion mechanism of FIG. 17A in an initial configuration taken at a 45° rotation relative to the view of FIG. 17A. [Figure 18B] FIG. 18B is a cross-sectional view of the insertion mechanism of FIG. 18A in an inserted configuration. [Figure 18C] FIG. 18B is a cross-sectional view of the insertion mechanism of FIG. 18A with the needle hub in a retracted configuration. [Figure 19A] FIG. 18B is a cross-sectional view of the insertion mechanism of FIGS. 17A and 18A in an initial configuration taken at a 270° rotation relative to the view of FIG. 18A. [Figure 19B] FIG. 19B is a cross-sectional view of the insertion mechanism of FIG. 19A in an inserted configuration. [Figure 19C] FIG. 19B is a cross-sectional view of the insertion mechanism of FIG. 19A with the needle hub in a retracted configuration. [Figure 20] FIG. 17B is an isometric view of the clip shown in FIGS. 17A-19C. [Figure 21] FIG. 19 is an isometric view of the cannula holder shown in FIGS. 17A-19C. [Figure 22] FIG. 17B is an isometric view of the needle hub shown in FIGS. 17A-19C. [Diagram 23] FIG. 17C is an isometric cross-sectional view of the housing shown in FIGS. 17A-19C. [Figure 24A] FIG. 2 illustrates a cross-sectional view of a NIM activation mechanism according to at least one embodiment of the present invention in an initial configuration. [Figure 24B] FIG. 24B is a cross-sectional view of the NIM activation mechanism of FIG. 24A in an activated configuration. [Figure 25A] FIG. 2 illustrates a top view of a NIM retraction mechanism in accordance with at least one embodiment of the present invention in a delivery configuration. [Figure 25B] FIG. 25B is a top view of the NIM retraction mechanism of FIG. 25A in a retracted configuration. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0022] As used herein to describe any relative position of an insertion mechanism, a drug delivery pump, or a component of the invention, the term "axial" or "axially" generally refers to the longitudinal axis "A" about which the insertion mechanism is preferably positioned, but not necessarily symmetrically positioned. The term "radial" generally refers to a direction perpendicular to axis A. The terms "proximal," "rear," "rearward," "back," or "backward" generally refer to the axial direction in direction "P." The terms "distal," "front," "frontward," "depressed," or "forward" generally refer to the axial direction in direction "D."

[0023] As used herein, the term "glass" should be understood to include other similarly non-reactive materials suitable for use in pharmaceutical grade applications that would normally require glass, including, but not limited to, certain non-reactive polymers such as cyclic olefin copolymers (COC) and cyclic olefin polymers (COP).

[0024] The term "plastic" may include both thermoplastic and thermosetting polymers. Thermoplastic polymers can be resoftened to their original state by heat, whereas thermosetting polymers cannot. As used herein, the term "plastic" refers primarily to moldable thermoplastic polymers such as polyethylene and polypropylene, or acrylics, which also generally contain other ingredients such as hardeners, fillers, reinforcements, colorants, and / or plasticizers and can be formed or molded under heat and pressure. As used herein, the term "plastic" is not intended to include glass, non-reactive polymers, or elastomers that are approved for use in applications where the glass, non-reactive polymer, or elastomer is in direct contact with a treatment liquid that may interact with the plastic or may be degraded by substituents that may otherwise enter the liquid from the plastic. The terms "elastomer," "elastomeric," and "elastomeric material" refer primarily to crosslinkable thermoset rubbery polymers that are more readily deformable than plastics, but are approved for use with pharmaceutical grade fluids and do not readily undergo exudation or gas migration under ambient temperature and pressure.

[0025] "Fluid" refers primarily to liquids, but may include solid suspensions dispersed in the liquid, and gases dissolved or otherwise co-present within the liquid within the fluid-containing portion of the syringe.

[0026] As used herein, the term "pump" is intended to include any number of drug delivery systems capable of expelling a fluid to a user upon activation, including, for example, injection systems, infusion systems, bolus injectors, and the like.

[0027] According to various aspects and embodiments described herein, reference is made to a "biasing member," such as in the context of one or more biasing members for the insertion or retraction of a needle, trocar, and / or cannula. It will be appreciated that the biasing member may be any member capable of storing and releasing energy. Non-limiting examples include springs, such as coil springs, compression or tension springs, torsion springs, and leaf springs, elastic compressible or resilient bands, or any other member having a similar function. In at least one embodiment of the invention, the biasing member is a spring.

[0028] The novel devices of the present invention provide an insertion mechanism with integrated safety features, and a drug delivery pump incorporating such an insertion mechanism. Such devices are safe, easy to use, and aesthetically and ergonomically appealing for self-administering patients. The devices described herein incorporate features that make device activation, operation, and lockout simple, even for untrained users. The novel devices of the present invention provide these desirable features without any of the problems associated with known prior art devices. Certain non-limiting embodiments of the novel drug delivery pump, insertion mechanism, and their respective components are further described herein with reference to the accompanying drawings. The devices described herein may be configured for delivery of controlled substances and may further include features to prevent so-called "run-away" delivery of the drug. When delivering controlled substances, this may be an important safety feature to protect the patient. For example, some drugs, such as insulin, can be dangerous, and possibly even lethal, if administered in too large an amount and / or at too fast a rate. By providing such an automatic safety stop feature, patient safety may be ensured.

[0029] Drug delivery pump: 1A-1C illustrate an exemplary drug delivery device according to at least one embodiment of the present invention. The drug delivery device may be utilized to effect delivery of a drug treatment into the body of a user. As shown in FIGS. 1A-1C, drug pump 10 includes pump housing 12. Pump housing 12 may include one or more housing subcomponents that are securely engageable to facilitate easier manufacture, assembly, and operation of the drug pump. For example, drug pump 10 includes pump housing 12 including upper housing 12A and lower housing 12B. Drug pump may further include activation mechanism 14, status indicator (not shown), and window 18. Window 18 may be any translucent or transparent surface through which operation of the drug pump may be observed. 1B, the drug pump further includes an assembly platform 20, a drive mechanism 100 having a drug container 50, an insertion mechanism 200, a fluid path connection 300 for establishing a sterile fluid connection between the drug container 50 and a needle or trocar within the insertion mechanism 200, and a power and control system 400. One or more of these drug pump components may be modular in that they may be preassembled, for example, as separate components and configured to be in a predetermined position on the assembly platform 20 of the drug pump 10 during manufacture. The platform 20 may be a portion of the housing 12, such as a portion of the lower housing 12B, or alternatively, may be a separate component.

[0030] The pump housing 12 houses all of the device components and provides a means for removably attaching the device 10 to the skin of a user. The pump housing 12 also provides protection for the internal components of the device 10 against environmental influences. The pump housing 12 is ergonomically and aesthetically designed in size, shape, and associated features to facilitate easy packaging, storage, handling, and use by users who may be untrained and / or physically impaired. Additionally, the exterior surfaces of the pump housing 12 may be utilized to provide product labeling, safety instructions, and the like. Additionally, as discussed above, the housing 12 may include certain components, such as status indicators and windows 18, that may provide operational feedback to the user.

[0031] In at least one embodiment, the drug pump 10 provides an activation mechanism 14 that is displaced by a user to trigger a start command to the power and control system 400. In a preferred embodiment, the activation mechanism is a start button 14 that is positioned through the pump housing 12, such as through a hole between the upper housing 12A and the lower housing 12B, and contacts a control arm 40 of the power and control system 400. In at least one embodiment, the start button 14 may be a push button, and in other embodiments, may be an ON / OFF switch, a toggle, or any similar activation feature known in the art. The pump housing 12 also provides a status indicator and a window 18. In other embodiments, one or more of the activation mechanism 14, status indicator, window 18, and combinations thereof may be provided on the upper housing 12A or the lower housing 12B, such as on a side that is observable by the user when the drug pump 10 is placed on the target tissue. Housing 12 is described in further detail below with reference to other components and embodiments of the present invention.

[0032] The drug pump is configured such that activation by a user by depressing an activation mechanism initiates the drug pump to insert the fluid passage into the user; to enable, connect, or open the necessary connections between the drug container, the fluid passage connection, and the sterile fluid conduit; and to force the drug fluid stored in the drug container through the fluid passage and the fluid conduit for delivery into the user. For example, one or more optional safety mechanisms may be utilized to prevent premature activation of the drug pump. For example, an optional on-body sensor 24 (shown in FIG. 1C ) may be provided in one embodiment as a safety feature to ensure that the power and control system 400 or the activation mechanism cannot be engaged unless the drug pump 10 is in contact with the target tissue. In one such embodiment, the on-body sensor 24 is located on the bottom of the lower housing 12B that is in contact with the user's body. Displacement of the on-body sensor 24 allows depression of the activation mechanism. Thus, in at least one embodiment, the on-body sensor 24 is a mechanical safety mechanism, such as, for example, a mechanical lockout, that prevents the activation mechanism 14 from triggering the drug pump 10. In another embodiment, the on-body sensor may be an electromechanical sensor, such as, for example, a mechanical lockout, that sends a signal to the power and control system 400 to allow activation. In yet another embodiment, the on-body sensor may be an electrical-based sensor, such as, for example, an inductive-based, capacitive-based, or impedance-based sensor, that must detect tissue before allowing activation of the power and control system 400. In at least one embodiment, the housing 12 is configured to at least partially prevent harmful substances from entering the drug pump. For example, the housing may be configured to limit the passage of fluids into the drug pump. This may allow the device to be worn while showering, swimming, or during other activities.The use of an electrical-based skin sensor may eliminate a possible entry point into the drug pump. These concepts are not mutually exclusive, and one or more combinations may be utilized within the scope of the present invention, for example, to prevent premature activation of the drug pump. In a preferred embodiment, drug pump 10 utilizes one or more mechanical on-body sensors. Additional integrated safety mechanisms are described herein with reference to other components of the novel drug pump.

[0033] A second embodiment of a drug delivery pump 1300 is shown in FIGS. 2A-2B. As in the first embodiment, the drug container 1050 and the insertion mechanism 200 may be disposed on an assembly platform or housing 1012. In this embodiment, the insertion mechanism 200, the fluid path connections, and the drug delivery drive mechanism are controlled by the movement of an actuator 207, such as a motor or solenoid, and the rotation of one or more gears 209. Additionally or alternatively, a relief mechanism may be used to control the rotation rate of the one or more gears. One of the gears may engage teeth 208 of the insertion mechanism housing 202. Thus, the rotation of the one or more gears 209 of the gear train controls the rotation of the insertion mechanism housing and thereby the insertion of the needle into the target tissue. The operation of the insertion mechanism is further described herein.

[0034] Power and control systems: The power and control system 400 includes a power source that provides energy for various electrical components in the drug pump, one or more feedback mechanisms, a microcontroller, a circuit board, one or more conductive pads, and one or more interconnects. Other components commonly used in such electrical systems may be included as well, as would be recognized by one of ordinary skill in the art. The one or more feedback mechanisms may include, for example, an audible alarm, such as a piezoelectric alarm, and / or a light indicator, such as a light emitting diode (LED). The microcontroller may be, for example, a microprocessor. The power and control system 400 controls the interaction of several devices with the user and interfaces to the drive mechanism 100. In one embodiment, the power and control system 400 interfaces to a control arm to identify when the on-body sensor 24 and / or the activation mechanism 14 are activated. The power and control system 400 may also interface to a status indicator on the pump housing 12, which may include a transparent or translucent material that allows for light transmission, to provide visual feedback to the user. The power and control system 400 interfaces with the drive mechanism 100 through one or more interconnects to relay status indications, such as activation, drug delivery, and end of dose, to the user. Such status indications may be presented to the user by auditory tones, such as through an audible alarm, and / or by visual indicators, such as through an LED. In a preferred embodiment, the control interfaces between the power and control system and other components of the drug pump are not engaged or connected until activated by the user. This is a desirable safety feature to prevent accidental operation of the drug pump and may also preserve the energy contained in the power source during storage, transportation, etc.

[0035] The power and control system 400 may be configured to provide a number of different status indicators to the user. For example, the power and control system 400 may be configured such that if the device start checks do not provide an error after the on-body sensor and / or trigger mechanism are pressed, the power and control system 400 provides a ready-to-start status signal via the status indicator. After providing the ready-to-start status signal, and in embodiments using an optional on-body sensor, if the on-body sensor remains in contact with the target tissue, the power and control system 400 will power the drive mechanism 100 to begin delivery of the medical treatment through the fluid path connection 300 and the sterile fluid conduit 30 to the needle or cannula in the needle insertion mechanism 200. In a preferred embodiment of the present invention, the insertion mechanism 200 and the fluid path connection 300 may be activated directly by user manipulation of the activation mechanism 14.

[0036] During the drug delivery process, the power and control system 400 is configured to provide an ejection status signal via the status indicator. After the drug has been administered into the target tissue, and optionally after the expiration of any further dwell time, the power and control system 400 may provide a remove okay status signal via the status indicator to ensure that substantially the entire dose has been delivered to the user. This may be independently verified by the user by observing the drive mechanism and drug dose delivery through the window 18 of the pump housing 12. Additionally, the power and control system 400 may be configured to provide one or more alarm signals via the status indicator, such as, for example, an alarm indicating a fault or malfunction condition.

[0037] Other power and control system configurations may be utilized by the novel drug pump of the present invention. For example, an activation delay may be utilized during drug delivery. As previously mentioned, one such delay optionally included in the system configuration is a dwell time to ensure that substantially all of the drug dose has been delivered before signaling termination to the user. Similarly, activation of the device may require a delayed depression (i.e., press) of the activation mechanism 14 of the drug pump 10 prior to drug pump activation. Additionally, the system may include functionality that allows the user to deactivate or power down the drug pump in response to an end-of-dose signal. Such functionality may also require a delayed depression of the activation mechanism to prevent accidental deactivation of the device. Such functionality provides the drug pump with desired safety integration and ease of use parameters. Further safety features may be integrated into the activation mechanism to prevent partial depression and therefore partial activation of the drug pump. For example, the activation mechanism and / or the power and control system may be configured to turn the device fully OFF or fully ON to prevent partial activation. These features are described in further detail with respect to other aspects of the novel drug pump.

[0038] Fluid passage connections: The fluid path connection 300 includes a sterile fluid conduit 30, a piercing member, a connection hub, and a sterile sleeve. The fluid path connection may further include one or more flow restrictors. Upon proper activation of the device 10, the fluid path connection 300 is enabled to connect the sterile fluid conduit 30 to the drug container of the drive mechanism 100. Such connection may be facilitated by a piercing member, such as a needle, penetrating a pierceable seal of the drug container of the drive mechanism 100. Sterility of this connection may be maintained by performing the connection within a flexible sterile sleeve. Substantially simultaneous activation of the insertion mechanism completes the fluid path between the drug container and the insertion mechanism to enable drug delivery into the target tissue.

[0039] In at least one embodiment of the invention, the piercing member of the fluid path connection is caused to penetrate the pierceable seal of the drug container of the drive mechanism by a direct action of the user, such as by the user pressing an activation mechanism. For example, the activation mechanism itself may compress the fluid path connection such that displacement of the activation mechanism from its original position also results in displacement of the fluid path connection. In a preferred embodiment, this connection is made possible by the user pressing the activation mechanism, thereby forcing the piercing member through the pierceable seal, as this pierceable seal prevents fluid flow from the drug container until desired by the user. In such an embodiment, a compressible sterile sleeve may be securely attached between the cap of the drug container and the connection hub of the fluid path connection. The piercing member may be present in the sterile sleeve until a connection between the fluid path connection and the drug container is desired. The sterile sleeve may be sterilized to ensure sterility of the piercing member and the fluid path prior to activation.

[0040] Alternatively or additionally, sterility of the flow path may be maintained by one or more membranes or foils that define one or more sterile chambers of the fluid passage connection. The membranes or foils may be pierced during use of the drug pump by a piercing member or alternatively by an introducer member. In such embodiments, the piercing member may be at least partially disposed within the lumen of the introducer member to prevent the piercing member from coming into contact with foreign matter.

[0041] The drug pump is capable of delivering a range of drugs with different viscosities and volumes. The drug pump is capable of delivering a controlled flow rate and / or a specified volume of drug. In one embodiment, the drug delivery process is controlled by one or more flow restrictors in the fluid path connection and / or the sterile fluid conduit. In other embodiments, other flow rates may be provided by varying the geometry of the fluid flow path or delivery conduit, by varying the speed at which components of the drive mechanism advance into the drug container to expel the drug into the drug container, or a combination thereof. Still further details regarding the fluid path connection 300 and the sterile fluid conduit 30 are provided in later sections below with reference to other embodiments.

[0042] Drive: 1B, the drive mechanism 100 includes a drug container 50 having a cap 51, a pierceable seal, and a plunger seal. The drug container may contain a drug fluid in a barrel between the cap and the plunger seal for delivery through the insertion mechanism and the drug pump into a target tissue. The drive mechanism may include any suitable structure or mechanism for advancing the plunger seal within the barrel. For example, the drive mechanism may further include one or more drive biasing members, one or more release mechanisms, and one or more guides. The components of the drive mechanism function to force fluid out of the drug container, through the pierceable seal or preferably through a piercing member of the fluid pathway connection, for delivery through the fluid pathway connection, the sterile fluid conduit, and the insertion mechanism into the target tissue.

[0043] In one embodiment, the fluid stored in the medication container comprises insulin. The fluid may include any concentration of insulin, including U-100, U-300, and U-500.

[0044] The drive mechanism may further include one or more electrical contacts positioned on corresponding components that, upon contact between the electrical contacts, can sustain an energy pathway or otherwise relay a signal to and / or from the power and control system 400. Such signals may be transmitted across one or more interconnects. Such components may be utilized within the drive mechanism to measure and relay information related to the operating state of the drive mechanism, which information may be converted by the power and control system 400 into tactile, auditory, and / or visual feedback to the user.

[0045] In one particular embodiment, the drive mechanism 100 uses one or more compression springs as the biasing member(s). When the user activates the drug pump, a power and control system may be actuated to directly or indirectly release the compression spring(s) from an energy stored state. Upon release, the compression spring(s) may abut and act on the plunger seal to force the fluid drug out of the drug container. Translation of the plunger seal may be controlled, limited, or metered by features of the drive mechanism 100. A fluid path connection is connected through the pierceable seal prior to, simultaneously with, or after activation of the drive mechanism to allow fluid flow from the drug container through the fluid path connection, the sterile fluid conduit, and the insertion mechanism into the target tissue for drug delivery. In at least one embodiment, fluid flows only through the conduits, needles, and cannulas of the insertion mechanism, thereby maintaining sterility of the fluid paths before and during drug delivery. These components and their functions are described in more detail below.

[0046] Insertion Mechanism: An exemplary insertion mechanism 200 is shown in exploded form in FIGS. 3A and 3B, while individual components are shown in FIGS. 4A-4B and 5-7, and an assembled device and exemplary operation are shown in FIGS. 8A-10B. In this first embodiment, the insertion mechanism 200 includes an insertion mechanism housing 202 having one or more protrusions 202A, a base 252, and a sterile boot 250, as shown in FIGS. 3A and 3B. The base 252 may be connected to the assembly platform 20 to integrate the insertion mechanism into the drug pump 10 (as shown in FIG. 1B). The connection of the base 252 to the assembly platform 20 may be such that, for example, the bottom of the base is permitted to pass through a hole in the assembly platform 20 to allow direct contact of the base 252 against the target tissue. In such a configuration, the bottom of the base 252 may include a sealing membrane 254, which, in at least one embodiment, is removable prior to use of the drug pump 10. Alternatively, sealing membrane 254 may remain attached to the bottom of base 252 such that needle 214 pierces sealing membrane 254 during operation of drug pump 10 .

[0047] 3A and 3B, the insertion mechanism 200 may further include a needle assembly including a rotational biasing member 210, a needle hub 212, and a needle 214, a retraction biasing member 216, a sleeve 220, and a needle insertion mechanism (NIM) conduit 218. The NIM conduit 218 may be connected to a sterile fluid conduit 30 or a sterile access connection 300, as described in more detail herein, to allow fluid flow through the NIM conduit 218, the needle 214, and into the target tissue during drug delivery.

[0048] As used herein, "needle" refers to a variety of needles, including, but not limited to, conventional hollow needles, such as hard hollow steel needles. When assembled, the proximal end of needle 214 is maintained in fixed contact with hub 212, while the remainder of needle 214 is preferably positioned within sterile boot 250. Needle 214 may further pass through base opening 252E (see FIG. 7).

[0049] In the embodiment shown, the sterile boot 250 is a collapsible or compressible sterile membrane that is in fixed engagement with the hub 212 at a proximal end and with the sleeve 220 and / or base 252 at a distal end. In other words, the distal end of the sterile boot 250 is maintained in engagement with a fixed element, e.g., the sleeve 220 / base 252, while the proximal end of the sterile boot 250 is maintained in engagement with a fixed element, i.e., an element that is movable relative to the hub 212. In at least one embodiment, the sterile boot 250 is maintained in fixed engagement at the distal end between the base 252 and the sleeve 220. As will be appreciated by one of ordinary skill in the art, in other embodiments (not shown), the sterile boot 250 may be maintained in fixed engagement at the distal end between the base 252 and the insertion mechanism housing 202.

[0050] The base 252 includes a base opening 252E through which the needle 214 may pass during operation of the insertion mechanism, as described further below. Sterility of the needle 214 is maintained by its initial positioning within a sterile portion of the insertion mechanism. In particular, as described above, the needle 214 is maintained within the sterile environment of the sterile boot 250. The base opening 252E of the base 252 may be similarly closed off from a non-sterile environment, such as by a sealing membrane 254.

[0051] Figures 4A-4B and 5-7 show components of the insertion mechanism according to at least a first embodiment in further detail. As shown in Figures 4A-4B, the insertion mechanism housing 202 may be a substantially cylindrical component having an internal chamber within which the NIM conduit 218, hub 212, needle 214, sleeve 220, retraction biasing member 216, and sterility boot 250 are substantially disposed in an initial configuration (as shown in Figures 8A and 8B). A guide surface 204 (best seen in Figure 4B) is positioned on an inner surface of the housing 202 and is configured to interact with a corresponding follower, here extension arm 212A of the hub 212. Although two arms 212A are provided on the hub 212 and two guide surfaces 204 are provided on the housing 202, it will be appreciated that a greater or lesser number of corresponding extension arms 212 and guide surfaces 204 may be provided, so long as the extension arms 212A and guide surfaces 204 are provided in pairs and configured for engagement. The guide surfaces 204 are inclined circumferentially about the inner surface of the housing 202. That is, the guide surfaces 204 each present an at least partially radially disposed surface having components extending in both the axial and circumferential directions. As a result, as the housing 202 rotates relative to the hub 212, movement of the guide surfaces 204 contacting the extension arms 212A causes or allows the hub 212 to translate axially proximally or distally relative to an initial position. Thus, the guide surfaces 204 function as cam surfaces that translate the rotational motion of the housing 202 into axial translation of the hub 212. In other words, and as will be described in more detail below, rotation of the housing 202 is translated into axial movement of the hub 212 by interaction of the guide surfaces 204 with the extension arms 212 A of the hub 212 .

[0052] To provide rotational movement to the housing 202, the housing 202 may further include one or more engagement surfaces 202B arranged to interact with the rotational biasing member 210. In the embodiment shown, the housing 202 comprises one or more protrusions 202A configured to engage a proximal end of the rotational biasing member 210. The protrusions 202A may form the engagement surface 202B in the form of a recess in which the proximal end of the rotational biasing member 210 may be disposed. Thus, unwinding and / or deenergizing the rotational biasing member 210 results in rotation of the housing 202 about the axis A.

[0053] Although the illustrated embodiment shows the rotational biasing member engaging protrusion 202A, the rotation of housing 202 and rotational biasing member 210 may be coupled in any manner. For example, rotational biasing member 210 may engage a slot, hole, or bore in housing 202. As in the illustrated embodiment, rotational biasing member 210 may be positioned outside of housing 202 in a substantially concentric relationship. The distal end of the rotational biasing member may engage base 252 or another axially stationary feature of drug pump 10, thereby limiting movement of the distal end of rotational biasing member 210.

[0054] Additionally, the protrusion 202A or another feature of the housing 202 may further contact a portion of the sterile access connection during rotation of the housing 202. This contact may be used in conjunction with the rotation of the housing 202 to initiate piercing of the pierceable seal, thereby allowing the contents of the drug container to flow through the conduit.

[0055] The hub 212 includes the extension arms 212A described above extending from a central body portion 212C, as seen in Figure 5. The hub 212 further includes a bore 212B configured to receive a portion of the NIM conduit 218. The bore 212B allows the NIM conduit 218 to be in fluid communication with the needle 214 for delivery of a fluid medicament to the target tissue. The needle 214 is securely engaged to the hub 212 by bonding, press fit, or any other means known to one of skill in the art.

[0056] The central body portion 212C of the hub 212 is disposed for axial translation within the sleeve 220, which is shown in more detail in FIG. 6. To control the axial movement of the hub 212 relative to the sleeve 220, the hub 212 and the sleeve 220 include a protrusion 212D and a recess configured to engage with one another. In the illustrated embodiment, the protrusion 212D of the hub 212 is configured as part of the extension arm 212A, and the sleeve 220 includes a slot 220A into which the extension arm 212A of the hub 212 is at least partially disposed during operation of the insertion mechanism. This interaction limits the ability of the hub 212 to rotate relative to the sleeve 220.

[0057] The sleeve 220 may further include structure configured to engage the base 252 to limit movement of the sleeve relative to the base 252. In the illustrated embodiment, the sleeve 220 includes one or more holes 220B configured to interface with flex arms 252A of the base 252. During assembly, the flex arms 252A engage the holes 220B, thereby limiting movement of the sleeve 220 relative to the base 252. The base 252 may further include one or more lower alignment members 252C configured to engage one or more alignment notches 220C of the sleeve 220, as shown in FIG. 7. This engagement aligns the sleeve 220 to the base 252 and further limits rotation of the sleeve 220 relative to the base 252. The base 252 may also include one or more upper alignment members 252D configured to engage the surface 206 of the housing 202 during installation, thereby positioning the housing 202 relative to the base 252.

[0058] The operation of the insertion mechanism is described herein with reference to the above components in view of Figures 8-10. Figure 8A shows an isometric view of an insertion mechanism according to at least one embodiment of the present invention in a locked and ready stage, and Figure 8B shows a cross-sectional view. The proximal end of the rotational biasing member 210 is disposed on the engagement surface 202B of the housing 202, and the rotational biasing member 210 is in an energized state. In this initial position, the hub 212 is in a retracted proximal position such that the needle 214 does not extend through the opening 252E of the base 252. The sterilization boot 250 is in an extended configuration, with one end engaged with the hub 212 and the other end engaged with the sleeve 220 and the base 252. The extension arm 212A of the hub 212 is positioned within or substantially adjacent to the proximal portion 204A (see Figure 4B) of the guide surface 204. A coiled fluidic NIM conduit 218 may be positioned proximal to the hub 212. The fluidic NIM conduit 218 may be connected at one end to the hub 212 and allow fluid drug contents to pass from the drug reservoir 50 to the needle 214 for delivery to the target tissue.

[0059] In this embodiment, the retraction biasing member 216 is disposed in a relatively depressurized and / or de-energized state between the hub 212 and one or more axial stationary elements of the insertion mechanism, where the axial stationary elements are part of the sleeve 220. However, it will be appreciated that the axial stationary elements may include alternative components, such as, for example, a base 252 or a combination of two or more such axial stationary elements.

[0060] It will be further appreciated that the retraction biasing member may be alternatively disposed and may include any suitable type of retraction biasing member. For example, in alternative embodiments, the retraction biasing member may include a tension spring as opposed to a compression spring. In such embodiments, the retraction biasing member may be disposed proximal to the hub 212 and coupled to the hub and the axial stationary member in an unenergized state, such that axial translation of the hub 212 in a distal direction stores energy in the tension spring.

[0061] As will be appreciated by one of ordinary skill in the art, the insertion mechanism 200 may be held in this initial configuration by interaction with other components of the drug pump 10. For example, the drug pump 10 may include a NIM activation mechanism. The NIM activation mechanism may be triggered or activated by depression of the activation member 14. Alternatively, the NIM activation mechanism may include a separate member configured for activation by a user. By way of example, the activation member 14 may engage a slide that, in the initial configuration, prevents rotation of the housing 202 by interaction with the protrusion 202A. Depression of the trigger member 14 may displace the slide and disengage the slide or another component from the protrusion 202A of the housing 202, thereby allowing rotation of the housing 202.

[0062] One example of a NIM activation mechanism is shown in FIGS. 24A-24B. The NIM activation mechanism includes a throw arm 606, a NIM interlock 608, and a NIM retainer 610. Initially, as shown in FIG. 24A, the NIM retainer 610 is positioned such that the NIM retainer 610 is in contact with the protrusion 202A of the housing 202 to prevent the housing 202 from rotating about axis A, thereby preventing activation of the NIM 200. In the illustrated embodiment, the NIM retainer 610 is configured for rotational movement about axis B. The NIM retainer 610 may be mounted to the housing 12, for example, in a bore 610A. For example, a pin or shaft may be disposed within the bore 610A about which the NIM retainer 610 may rotate. The pin or shaft may be an integral part of the housing 12, or alternatively, may be a separate component. The NIM retainer 610 is initially prevented from rotating by contact between the arm 610B of the NIM retainer 610 and the NIM interlock 608. The NIM interlock 608 is initially in a first position in contact with or adjacent the lower surface 606B of the throw arm 606.

[0063] Depression of the activation mechanism 14 results in translation of the throw arm 606. The angled surface 606C of the throw arm 606 contacts the NIM interlock 608, causing the NIM interlock 608 to translate in a direction substantially perpendicular to the direction of translation of the throw arm 606 (i.e., in the direction of the shaded arrow in FIG. 24A). FIG. 24B shows the position of the throw arm 606 and the NIM interlock 608 after translation of the throw arm. As shown, in this configuration, the NIM interlock is positioned adjacent to or in contact with the upper surface 606D of the throw arm 606. The window 608A of the NIM retainer 608 aligns with the arm 610B of the NIM retainer 610. Thus, as shown in FIG. 24B, the NIM retainer 610 can rotate about axis B.

[0064] In at least one embodiment, the NIM retainer 610 is biased to rotate by a biasing member. The biasing member may be, for example, a torsion spring. Rotation of the NIM retainer 610 disengages the NIM retainer 610 from the protrusion 202A of the housing 202. Thus, the NIM 200 can be activated to insert a fluid path into the target tissue. Alternatively, a force applied to the NIM retainer 610 by the protrusion 202A results in rotation of the NIM retainer 610.

[0065] In other embodiments, the NIM interlock 608 may directly engage a portion of the NIM 200, such as protrusion 202A, to initially prevent activation of the NIM 200. Translation of the NIM interlock 608 in a direction perpendicular to the translation of the throw arm 606 may cause the NIM interlock 608 to disengage the NIM 200, allowing the NIM 200 to activate.

[0066] In another embodiment, the throw arm 606 directly engages a portion of the NIM such that translation of the throw arm 606 allows activation of the NIM 200.

[0067] In an alternative embodiment shown in FIGS. 2A-2B, a portion of the housing 202 may have gear teeth 208 configured to interact with a gear 209 that prevents rotation of the housing. In this configuration, the gear may be connected to a motor 207 that controls the rotation of the gear and therefore the rotation of the housing. The housing may be capable of being disengaged from the gear, thereby allowing free rotation of the housing in response to energy release of the rotational biasing member. The gear 209 may be connected to the motor 207 through a gear train that controls the relationship between the rotation of the motor 207 and the rotation of the gear 209. Additionally or alternatively, a relief mechanism may be used to control the rotation of the gear train.

[0068] FIG. 9A shows an isometric view of the insertion mechanism at the needle insertion stage, and FIG. 9B shows a cross-sectional view. As shown, unwinding and / or de-energizing of the rotational biasing member 210 rotates the housing 202 about axis A (see FIG. 3A). As the housing 202 rotates, contact between the guide surface 204 and the extension arm 212A of the needle hub 212 translates the hub 212 in a distal direction. The force applied by the rotational biasing member 216 may ensure that the extension arm 212A maintains contact with the guide surface 204. The hub 212 is prevented from rotating by the interaction between the extension arm 212A and the slot 220A of the sleeve 220. The sleeve 220 is coupled to the base 252 by the engagement of the flex arm 252A with the hole 220B. As shown in FIG. 9B, the sterile boot 250 is permitted to collapse as the housing 202 rotates and the hub 212 translates distally, inserting the needle 214 into the target tissue. At this stage, shown in FIG. 9B, the needle 214 is introduced into the target tissue for drug delivery and the extension arm 212A comes into contact with the distal portion 204B of the guide surface 204. The distal translation of the hub 212 causes the retraction biasing member 216 to be compressed or energized. The rotation of the housing 202 is preferably limited or stopped at a position where the guide surface 204 holds the hub 212 in a distal position. The rotation of the housing 202 may be stopped at this position by an interaction between the protrusion 202A and a stopping component of the drug pump 10. Alternatively, the stopping component may interact with another portion of the housing 202. Once the needle 214 is inserted, a fluid pathway is completed from the NIM conduit 218 through the needle 214 to the target tissue. When a fluid pathway connection is made to the drug container and the drive mechanism is activated, the fluid drug treatment is forced from the drug container through the fluid pathway connection and the sterile fluid conduit 218 and into the needle 214 for delivery into the target tissue.

[0069] 10A and 10B, once drug delivery is complete, the needle 214 is retracted (i.e., axially translated proximally) back into the insertion mechanism housing 202. As the housing 202 continues to rotate, e.g., under the force of the rotational biasing member 210, a secondary rotation of the housing 202 positions the housing 202 and the hub 212 relative to one another to allow the retraction biasing member 216 to at least partially de-energize. That is, further rotation of the housing 202 axially aligns the extension arm 212A of the hub 212 with the axial slot 208 of the housing 202 such that proximal translation of the hub 212 within the housing 202 is no longer restricted by the guide surface 204. In this position, the retraction biasing member 216, which was energized as the hub 212 translated distally relative to the housing 202, can be de-energized or de-energized. Extension of the retraction biasing member 216 causes the hub 212 and the needle 214 to which it is connected to translate axially in a proximal direction. Activation of the insertion mechanism thus inserts the needle 214 into the target tissue, which in turn retracts the needle 214 after drug delivery is completed or by some other retraction actuation mechanism.

[0070] 11-13 show another embodiment of the insertion mechanism. For ease of understanding, the structures of this embodiment are identified by the reference numerals utilized for similar structures in the first disclosed embodiment being prefaced with the numeral "1". That is, the structures are identified with "1XXX", where "XXX" refers to the similar structures in the first embodiment. Thus, in the absence of a specific explanation below regarding the reference numerals shown in FIGS. 11-13, one skilled in the art will understand that the structures identified with the reference numerals "1XXX" refer to the same or similar structures as discussed with respect to the first embodiment.

[0071] As shown in Figure 11, one end of the rotational biasing member 1210 is disposed along an engagement surface in the form of a recess 1202B formed in the housing 1202 of the insertion mechanism. By engaging the housing 1202 in this manner, the requirement for a protrusion extending outwardly from the housing is eliminated, thereby allowing the overall size of the insertion mechanism to be reduced. Additionally, as shown in Figure 12, the sterile boot 1250 may be configured in an "accordion" configuration, which may allow the diameter of the sterile boot 1250 to be smaller than the diameter of the sterile boot shown in the previous embodiment.

[0072] It is also seen in FIG. 12 that the base portion of the insertion mechanism may include a base 1252, through which a base opening 1252E extends, and a surrounding platform 1020. As seen in FIG. 12, the base 1252 and the platform 1020 may have engagement structures that maintain the relative positions of the base 1252 and the platform 1020. The platform 1020 may further have one or more positioning structures, such as an upwardly extending boss 1020A, that help position and hold the needle insertion mechanism. A rotational biasing member 1210 may be positioned around the outside of the boss 1020A and may engage one or more of the stationary structures, such as the base 1252, the platform 1020, or the sleeve 1220. Thus, as energy is released from the rotational biasing member 1210, the housing 1202 rotates as described above.

[0073] The needle insertion mechanism may also include a cap 1222. The cap may engage the sleeve 1220 and act to hold the components of the needle insertion mechanism in place. In particular, the cap may hold the conduit 1218, which is fluidly coupled to the needle 1214 by the hub 1212, in place within the sleeve 1220. Note that the retraction biasing member 1216 abuts the lower surface of the hub 1212. The cap 1222 may be coupled to the sleeve 1220 by any suitable mechanism. For example, the cap 1222 may include one or more circumferential flex arms 1222A, which may flex outwardly in response to contact with a protrusion of the sleeve 1220 during installation (see FIG. 13). The flex arms 1222A may then return to their natural position, as best seen in the cross-sectional view of FIG. 13, thereby returning to a predetermined location with respect to the sleeve. 13, one or more flex arms 1020B of the platform 1020 may engage with holes 1220B in the sleeve 1220. This engagement holds and positions the insertion mechanism relative to the platform 1020 and relative to the drug pump. The operational stages of this embodiment may be substantially similar to those described above (i.e., de-energizing the rotational biasing member results in insertion of the needle, and de-energizing the retraction biasing member results in retraction of the needle).

[0074] Further embodiments of needle insertion mechanisms are shown in Figures 14A-16B. In this embodiment, a flexible cannula 2260 is inserted into the target tissue to deliver the agent, utilizing a rigid needle 2214 to aid in placement. The rigid needle 2214 may be a hollow needle or a solid trocar. In the embodiment shown in Figures 14A-14C, a hollow needle is used to insert the cannula 2260. For ease of understanding, the structures of this embodiment are identified by prefixing the reference numerals utilized for similar structures in the first disclosed embodiment with the numeral "2", or by changing the reference numerals from "1XXX" to "2XXX" in the second disclosed embodiment. That is, the structures are identified with "2XXX" and "XXX" refers to the similar structures in the first embodiment, or similar structures in the second embodiment are identified with "1XXX". Thus, with respect to the reference numerals shown in Figures 14A-16B, unless otherwise specified below, those skilled in the art will understand that the structure identified with the reference numeral "2XXX" refers to the same or similar structure as discussed with respect to the first or second embodiment. For clarity, the platform is not shown in Figures 14A-14C. Those skilled in the art will understand that a platform similar to the platform shown in the previous embodiment may be used in this or subsequent embodiments.

[0075] 14A shows the insertion mechanism in an initial configuration prior to activation. In the initial configuration, the flexible cannula 2260 is disposed such that the rigid needle 2214 passes through the lumen of the flexible cannula. Additionally, the proximal end of the flexible cannula 2260 is in contact with or adjacent to the needle hub 2212. As shown, the cannula 2260 is initially disposed within the sterile boot 2250, with the septum 2270 disposed within the hole 2252E in the base 2252. Thus, the needle 2214 and the cannula 2260 are thereby maintained in a sterile condition. The cannula may be engaged to the needle by a press fit, bonding, or any other joining method. The needle may be further retained and / or positioned within the hub 2212 by a retainer 2290. Upon activation of the insertion mechanism, rotation of the housing 2202, effected by de-energization of the rotational biasing member 2210, causes the needle hub 2212 to translate distally. This translation may be guided by contact between the follower / arm 2212A of the hub 2212 and a guide surface 2204 on the interior of the housing 2202, as described above and shown in FIGS. 15A-15B. Translation of the needle hub 2212 causes the needle 2214 and cannula 2260 to similarly translate distally, piercing the septum 2270 and being inserted into the target tissue. FIG. 14B shows the insertion mechanism at the end of the insertion step.

[0076] As the housing 2202 continues to rotate, e.g., under the force of the rotational biasing member 2210, a second rotation of the housing 2202 positions the housing 2202 and the hub 2212 relative to one another to allow the retraction biasing member 2216 to at least partially de-energize. In other words, this further rotation of the housing 2202 aligns the extension arm 2212A of the hub 2212 with the axial slot 2208 of the housing 2202. In this position, the retraction biasing member 2216 can be de-energized or decompressed, causing the hub 2212 and needle 2214 to translate axially in a proximal direction. FIG. 14C illustrates the insertion mechanism at the end of this step. The cannula 2260 is maintained in the insertion position and within the target tissue, and the needle 2214 is at least partially disposed within the cannula. This creates a fluid pathway through the conduit 2218, needle 2214, and cannula 2260 for delivering the agent to the target tissue. Because only the flexible cannula 2260 is disposed within the target tissue, the cannula 2260 may flex in response to movement. This may provide advantages in patient comfort. The barb 2260A of the cannula 2260 may be configured to engage the septum 2270, thereby resisting retraction of the cannula 2260 into the insertion mechanism. Optionally, the needle 2214 may be partially disposed within the target tissue when in this position.

[0077] In addition to the advantages mentioned above, the insertion mechanisms described herein may also be capable of terminating the flow of medication to the target tissue by disconnecting the fluid path. This may be an important safety feature to protect the patient. For example, some medications, such as insulin, may be dangerous, and possibly even lethal, if administered in too large an amount and / or at too fast a rate. By providing such an automatic safety stop mechanism, so-called "runaway" delivery of medication may be prevented, thereby ensuring patient safety. Although the methods and associated structures for terminating flow may be discussed with respect to one or more particular insertion mechanisms disclosed herein, it will be recognized that the methods and associated structures may be utilized or adapted for any of the insertion mechanisms disclosed herein or within the spirit and scope of the present disclosure.

[0078] The interruption of delivery of the drug to the target tissue may be triggered, for example, by an error in the delivery of the drug or by input from the user. For example, the user may realize that they have already taken their drug dose and wish to pause or terminate drug delivery from the device. With such user input to the device, delivery of the drug may be stopped and / or fluid passage through the needle or cannula may be terminated by retraction of the needle to its fully retracted position, as described below.

[0079] Additionally or alternatively, the device may pause or abort drug delivery if an error alarm is received during operation. For example, if the drive mechanism is not functioning properly, the needle insertion mechanism may be triggered to fully retract and abort drug delivery to the target tissue to prevent over-delivery of agent to the target tissue. This capability of the needle insertion mechanism provides a valuable safety feature for drug delivery to the user.

[0080] In some embodiments, retraction is activated by removal of the drug pump from the target tissue. In other embodiments, retraction is activated when it is determined that an error has occurred in the delivery of the substance to the target tissue. For example, an obstruction in the drug delivery passageway that prevents the flow of the agent may be detected by a sensing function of the drug delivery pump. Once an obstruction is detected, an electrical or mechanical input may be used to initiate retraction of the needle.

[0081] Activating the retraction of the needle may be accomplished through a number of mechanisms. For example, a stop mechanism may be provided on the outside of the housing 12 that, when pressed or engaged by the user, activates the retraction of the needle from the user's body. For example, in one embodiment, pressing or engaging the stop mechanism may allow the housing 202 to rotate, thus allowing the retraction biasing member 216 to extend and retract the needle 214. Activation of the stop mechanism may be spring assisted such that the travel distance and / or force required to press the stop mechanism is reduced. Additionally or alternatively, an electrical or mechanical actuator may effect activation of the retraction when the drive mechanism 100 reaches end of dose. For example, an electrical connection may be made such that an electrical current is applied to the Nitinol component when end of dose is reached. When the electrical current is applied, the temperature of the Nitinol component increases. Due to the shape memory properties of Nitinol, the component may be configured to transform from a first configuration to a second configuration upon increasing temperature. In this second configuration, the Nitinol component may enable or effect actuation of needle retraction, for example, by allowing rotation of the housing 202.

[0082] Alternatively or additionally, a sensor such as on-body sensor 24 may cause or enable activation of needle retraction when drug pump 10 is removed from the target tissue. For example, the position of on-body sensor 24 may prevent rotation of housing 202 to a retracted position when pump 10 is placed on the target tissue. A change in configuration of on-body sensor 24 may enable rotation when removed from the target tissue. In another embodiment, a light sensor may be located on drug pump 10 near base opening 252. When drug pump 10 is in place on the user's body, light will be substantially blocked from entering the light sensor. Upon removal of drug pump 10 from the target tissue, light may be sensed by the light sensor, which may trigger an electromechanical actuator to enable or provide activation of retraction. In other embodiments, a pin-type press-fit interconnect is used to initiate needle retraction. The pin is biased to at least partially protrude from housing 12 and may be displaced by placement of pump 10 on the user. When displaced, the pin may engage a female hole on a PCB that may be part of the power and control system 400. Upon removal of the pump 10 from the user, the actuated pin disengages the female PCB hole, thereby causing a signal to activate retraction of the needle.

[0083] Retraction of the needle and / or cannula may also be initiated by a fault and / or failure of the drive mechanism 100. For example, the drive mechanism may include a tether that serves to meter or control the delivery rate of the contents of the drug container 50. Tension applied to or maintained by the tether may be monitored by one or more sensors. A decrease in tension in the tether may indicate that the tether is not properly metering or controlling the delivery of the drug. The sensor may be a mechanical component or linkage in contact with a portion of the tether, the contact at least in part controlling the position and / or configuration of the sensor. In response to a decrease in tension in the tether, the sensor deforms from a first position to a second position. This deformation may directly or indirectly result in retraction of the needle and / or cannula. Retraction may be caused by a purely mechanical action, or alternatively may involve an electrical signal received and / or generated by the power and control system 400.

[0084] In other embodiments, the sensor may be a strain gauge, load cell, force sensor, or other sensor configured to measure and / or monitor strain, load, or tension present in the tether. In these embodiments, the sensor is at least partially affixed to the tether and generates an electrical signal based on the tension in the tether. The electrical signal may vary in magnitude proportional to the amount of tension in the tether. Alternatively, the signal may be interrupted or initiated when the tension in the tether falls below or exceeds a specified magnitude. The signal may be monitored by a power and control system, which may effect or enable retraction of the needle and / or cannula based on the presence, absence, or magnitude of the signal.

[0085] In yet other embodiments, a mechanical failure of the tether may directly initiate or interrupt an electrical signal. For example, the tether may be at least partially constructed from an electrically conductive material. The tether may be in electrical communication with a power and control system. A mechanical failure of the tether may interrupt a current path through the tether, resulting in a change in current flow in one or more circuits. This change may initiate or allow retraction of the needle and / or cannula.

[0086] Additionally or alternatively, the position and / or velocity of one or more features of the drive system may be monitored by a sensor, such as an optical sensor, a potentiometer, or a transducer, such as an encoder. If the position and / or velocity of a monitored feature exceeds or falls below a specified threshold, the power and control system may initiate and / or enable retraction of the needle and / or cannula.

[0087] In one example, in the embodiment shown in Figures 14A-14C, the flow of agent to the target tissue can be terminated by retracting the needle 2214 from the cannula 2260. Figure 16A shows a detailed view of the needle 2214 in a delivery position. In this position, the needle 2214 is at least partially disposed within the cannula 2260, creating a fluid path through the conduit, the needle, and the cannula and into the target tissue. Figure 16B shows a detailed view of the needle 2214 in a retracted configuration such that the needle 2214 is no longer disposed within the cannula 2260. That is, as the housing 2200 continues to rotate, e.g., under the force of the rotational biasing member 2210, this third rotation of the housing 2200 aligns the follower 2212A with the retraction hole 2207 within the housing 2200, allowing the retraction biasing member 2216 to further de-energize and move the needle 2214 to a fully retracted position. Because the needle 2214 is no longer disposed within the cannula 2260, a fluid path does not exist for delivery of the agent to the target tissue. Any additional fluid passing through the conduit 2218 will be expelled through the needle 2214 into the interior of the drug pump, e.g., the sterile boot 2250. A barrier 2280 may be included to further prevent any agent from entering the cannula 2260 after withdrawal of the needle from the cannula. The barrier 2280 may be, for example, a septum that is pierced by the needle during assembly of the needle and cannula. Alternatively, the barrier 2280 may be a membrane or clip that is displaced by the needle during assembly, but that substantially covers the lumen of the cannula upon withdrawal of the needle from the cannula. A pressure differential within the cannula may also prevent flow of agent through the cannula after withdrawal of the needle, with or without the barrier 2280.

[0088] As shown in Figures 25A-25B, the second or third rotation of the housing may be controlled by a NIM retraction mechanism. In one example of a NIM retraction mechanism, with the needle and needle hub in the delivery position, the projection 202A may be in contact with the stop member 620, as shown in Figure 25A. In this position, the stop member 620 is prevented from rotating about the spindle 624 by contact with the slide member 622. Thus, further rotation of the housing 202 is prevented. For example, in an embodiment having a flexible cannula as shown in Figures 14A-14C and described above, or as shown in Figures 17A-22 and described below, this position may correspond to the positions shown in Figures 14C and 18C, respectively. In response to a trigger mechanism, the slide member 622 may be displaced to the position shown in Figure 25B to allow the stop member 620 to rotate about the spindle 624. Thus, the stop member 620 no longer limits the rotation of the housing 202, allowing the needle to be fully withdrawn to a position where drug is no longer delivered to the target tissue, as shown in Figures 16B and 17D. The trigger mechanism that causes the displacement of the slide member 622 may be caused, for example, by a user input, an interruption in the operation of the drug pump, or any other event described above. Furthermore, the displacement of the slide member 622 may be purely mechanical, or alternatively, may occur at least in part in response to a signal from the power and control system 400.

[0089] Another embodiment is shown in Figures 17A-22. As with the embodiment of Figures 14A-14C described above, this embodiment is configured to insert a flexible cannula into a target. For ease of understanding, the structures of this embodiment are identified by prefixing the reference numerals utilized for similar structures in the first disclosed embodiment with the numeral "3", or by changing the reference numerals from "2XXX" to "3XXX" in the embodiments of Figures 14A-14C. That is, the structures are identified with "3XXX", with "XXX" referring to the similar structures in the first embodiment, or similar structures in the embodiments of Figures 14A-14C identified with "2XXX". Thus, in the absence of a specific explanation below with respect to the reference numerals shown in Figures 17A-22, one skilled in the art will understand that the structures identified with the reference numerals "3XXX" refer to the same or similar structures discussed with respect to the first or second embodiment.

[0090] The operating stages are shown in three different cross sections in Figures 17-19, while the individual components clip 3286, cannula retainer 3282, needle hub 3212, and housing 3202 are shown in Figures 20-23, respectively. The first cross section, shown in Figures 17A-17D, shows the interaction of the follower 3212A of the needle hub 3212 with the guide surface 3204 of the housing 3202 at various operating stages. Initially, the hook arm 3212C engages with the notch 3202C of the housing 3202, as shown in Figure 17A. This allows for proper positioning and alignment of the needle hub 3212 relative to the housing 3202.

[0091] Rotation of the housing caused by the release of energy in the rotational biasing member 3210 disengages the hook arm 3212C from the notch 3202C. Further rotation of the housing 3202 and contact between the follower 3212A and the guide surface 3204 translates the needle hub 3212 distally until the needle 3214 and cannula 3260 are fully inserted into the target as shown in FIG.

[0092] After insertion of the needle 3214 and cannula 3260, continued, i.e., secondary, rotation of the housing 3202 aligns the axial slot 3208 of the housing 3202 with the follower 3212A. Thus, the retraction biasing member 3216 can be de-energized, which results in distal translation of the needle hub 3212 to an at least partially retracted position, as shown in FIG. 17C. In this position, the needle 3214 is disposed at least partially within the cannula 3260, through the septum 3284, and the follower 3212A is in contact with the proximal portion 3204A of the guide surface 3204. Thus, contents may be delivered through the needle 3214, the cannula 3260, and to the target tissue.

[0093] To terminate delivery of the agent to the target tissue, continued rotation of the housing 3202 may further retract the needle 3214 to the position shown in FIG. 17D. That is, as the housing 3200 continues to rotate, for example, under the force of the rotational biasing member 3210, this third rotation of the housing 3200 causes the follower 3212A to disengage the proximal portion 3204A and align with the retraction hole 3207, thereby allowing further proximal translation of the needle hub 3212 in response to the energy release of the retraction biasing member 3216. In this position, the needle 3214 is retracted from the septum 3284. Thus, contents flowing through the needle 3214 cannot enter the cannula 3260. Retraction of the needle may be effected by any of the safety mechanisms described, for example, the safety mechanisms shown in FIGS. 25A and 25B.

[0094] A second cross section, shown in Figures 18A-18C, illustrates the interaction of the connecting arm 3286A of the clip 3286 with the needle hub 3212. The clip 3286 and needle hub 3212 are shown in more detail in Figures 20 and 22, respectively. Initially, as seen in Figure 18A, the connecting arm 3286A engages the needle hub 3212, thereby coupling the axial translation of the clip 3286 and the needle hub 3212. As seen in Figure 18B, the connecting arm 3286A remains engaged to the needle hub 3212 as the needle 3214 and cannula 3260 are inserted into the target. As discussed below and best seen in Figures 19A-19C, the clip 3286 engages the flex arm 3220D of the sleeve 3220 as it translates distally. This engagement prevents the clip 3286 from translating in the proximal direction. Thus, when the follower 3212A aligns with the proximal portion 3204A of the guide surface 3204, the connecting arm 3286A disengages from the needle hub 3212 by flexing outward (i.e., in the direction of the hatched arrow in FIG. 18C ). As a result, when the follower 3212A aligns with the proximal portion 3204A of the guide surface 3204, the needle hub 3212 and needle 3214 translate in the proximal direction and the needle 3214 is at least partially withdrawn from the target. The cannula 3260 remains disposed within the target.

[0095] A third cross section is shown in Figures 19A-19C. The interaction between the flex arm 3220D of the sleeve 3220 and the clip 3286 may be seen in these figures. As the clip 3286 is translated distally during needle and cannula insertion, it comes into contact with the flex arm 3220D and displaces the flex arm 3220D outwardly (i.e., in the direction of the solid arrow shown in Figure 19A). As shown in Figure 19B, continued distal translation of the clip 3286 allows the flex arm 3220D to at least partially return to its initial position. As shown in Figure 19C, as the biasing member 3216 begins to extend, the translation of the clip 3286 is limited by contact with the flex arm 3220D. This limiting allows the cannula 3260 to remain disposed within the target. 20, the clip 3286 may include an angled surface 3286B configured to engage the flex arm 3320D. The angled surface may create an undercut that ensures that contact between the angled surface 3286B and the flex arm 3320D does not result in outward deflection of the flex arm 3320D.

[0096] 21, cannula retainer 3282 includes a bore 3282B and a pin 3282A. When assembled, the shoulder and septum 3284 of the cannula 3260 are disposed within the bore 3282B. They are held in this position by the position of the clip 3286. The pin 3282A is configured to engage a hole 3286D in the clip 3286. This engagement may be configured to be a press-fit engagement that maintains the relative positions of the cannula retainer 3282 and the clip 3286. A central hole 3286C in the clip 3286 is adapted to receive the needle 3214.

[0097] Certain optional standard components or variations of the insertion mechanism 200 or drug pump 10 are contemplated while remaining within the breadth and scope of the present invention. For example, the upper or lower housing may optionally include one or more transparent or semi-transparent windows 18, as shown in FIGS. 1A-1C, to allow a user to observe the operation of the drug pump 10 or to verify that a drug dose has been completed. Additionally, the drug pump 10 may include an adhesive patch (not shown) and a patch liner (not shown) on the bottom surface of the housing 12. The adhesive patch may be utilized to attach the drug pump 10 to a target tissue for delivery of a drug dose. As will be readily understood by one of ordinary skill in the art, the adhesive patch may have an adhesive surface for attaching the drug pump to the target tissue. The adhesive surface of the adhesive patch is first covered by a non-adhesive patch liner, which is removed from the adhesive patch prior to placing the drug pump 10 in contact with the target tissue. The adhesive patch may optionally include a protective shroud that prevents activation of optional on-body sensors and covers the base opening 252E. Removal of the patch liner may remove the protective shroud, or the protective shroud may be removed separately. Removal of the patch liner may also remove the sealing membrane 254 of the insertion system 200, opening the insertion system to the target tissue for drug delivery.

[0098] Similarly, one or more of the components of the insertion mechanism 200 and drug pump 10 may be modified while functionally remaining within the breadth and scope of the present invention. For example, as discussed above, the housing of the drug pump 10 is shown as two separate components, i.e., upper housing 12A and lower housing 12B, but these components may be a single, integral component. As previously discussed, adhesives, glues, or other known materials or methods may be utilized to secure one or more components of the insertion mechanism and / or drug pump to one another. Alternatively, one or more components of the insertion mechanism and / or drug pump may be integral components. For example, the upper and lower housings may be separate components secured together by adhesives or glues, threaded connections, interference fits, fusion bonding, welding, ultrasonic welding, etc., or the upper and lower housings may be a single, integral component. Such standard components and functional variations would be recognized by one of ordinary skill in the art and would therefore fall within the breadth and scope of the present invention.

[0099] It will be appreciated from the above that the insertion mechanism and drug pump disclosed herein provide an efficient and easy to operate system for automated drug delivery from a drug container. The novel embodiments described herein provide an integrated safety feature, allowing direct user activation of the insertion mechanism and configured to maintain sterility of the fluid pathway. As discussed above, the integrated safety feature includes optional on-body sensors, redundant lockouts, automated needle insertion and retraction by user activation, and multiple user feedback options, including visual and audio feedback options. The novel insertion mechanism of the present invention may be directly activated by the user. For example, in at least one embodiment, the anti-rotation feature that maintains the insertion mechanism in its locked and retracted state is directly displaced from its locked position by user depression of the activation mechanism, whether it be a stop component configured to engage the protrusion 202A or a gear engaged with teeth on the housing 202. Alternatively, one or more additional components, such as a spring mechanism, may be included that displace the anti-rotation feature by direct displacement of the activation mechanism by the user without any intervening steps. In at least one configuration, rotation of the motor causes or enables rotation of a gear, thereby enabling rotation of the housing of the insertion mechanism.

[0100] Additionally, the novel configuration of the insertion mechanism and drug pump of the present invention maintains the sterility of the fluid pathways during storage, shipping, and throughout operation of the device. Because the pathway along which the drug fluid travels within the device is maintained completely sterile, only these components need to be sterilized during the manufacturing process. These components include the drug container, the fluid pathway connections, the sterile fluid conduits, and the insertion mechanism of the drive mechanism. In at least one embodiment of the present invention, the power and control system, assembly platform, control arm, activation mechanism, housing, and other components of the drug pump do not need to be sterilized. This significantly improves the manufacturability of the device and reduces the associated assembly costs. Thus, the device of the present invention does not require terminal sterilization once assembly is complete. A further advantage of the present invention is that the components described herein are formed to be modular, such that, for example, the housing and other components of the drug pump may be easily configured to receive and operate the insertion mechanism 200 or numerous other variations of the insertion mechanism described herein.

[0101] The assembly and / or manufacture of any of the components of the insertion mechanism 200, drug pump 10, or individual components may utilize a number of materials and methods known in the art. For example, a number of known cleaning fluids, such as isopropyl alcohol, may be used to clean the components and / or devices. A number of known adhesives or glues may be used in the manufacturing process as well. Additionally, siliconization fluids and processes may be used during the manufacture of the new components and devices. Additionally, known siliconization processes may be used during one or more stages of the manufacturing or assembly stages to ensure sterility of the final product.

[0102] In a further embodiment, the present invention provides a method of assembling an insertion mechanism, the method comprising the steps of: connecting a hub to a proximal end of a needle; connecting a conduit to the hub; connecting a sterile boot to the hub; inserting a retraction biasing member into a sleeve of the needle insertion mechanism; inserting the hub, conduit and sterile boot into the sleeve (in this position the retraction biasing member is constrained between the hub on one end and the sleeve on the other end); placing a housing around the sleeve; and connecting a base to the sleeve by engagement of a flex arm with a hole in the housing. A rotational biasing member may be disposed around the housing such that a portion of the rotational biasing member engages a portion of the housing, thereby coupling energy release of the biasing member to rotation of the housing. Optionally, the method of assembling may further comprise disposing a flexible cannula around the needle and within the sterile boot.

[0103] The distal end of the sterile boot may be positioned and held in fixed engagement with the distal end of the insertion mechanism housing by the engagement of the housing with the base. In this position, the sterile boot is in an extended configuration around the needle and / or cannula, creating a tubular volume that may be sterile. A fluid conduit may be connected to the hub, such that the fluid passage, when open, passes directly from the fluid conduit through the hub and through the needle. A fluid passage connection may be attached to the opposing end of the fluid conduit. The fluid passage connection, particularly the sterile sleeve of the fluid passage connection, may be connected to the cap and pierceable seal of the drug container. A plunger seal and a drive mechanism may be connected to the drug container at the opposing end of the fluid passage connection. A sealing membrane may be attached to the bottom of the base to close the insertion mechanism from the environment. The components that constitute the passages for fluid flow are now assembled. These components may be sterilized by a number of known methods and may then be fixedly or removably mounted to the assembly platform or housing of the drug pump.

[0104] Manufacturing the drug pump includes attaching a base of the insertion mechanism to an assembly platform or housing of the drug pump. In at least one embodiment, the attachment passes through the assembly platform and / or housing such that the base of the insertion mechanism is in direct contact with the target tissue. The manufacturing method further includes attaching the fluid pathway connections, drug container, and drive mechanism to the assembly platform or housing. Additional components of the drug pump described above, including the power and control system, activation mechanism, and control arm, may be attached, preformed, or preassembled to the assembly platform or housing. Adhesive patches and patch liners may be attached to surfaces of the drug pump housing that contact the user during operation of the device.

[0105] A method of operating a drug pump may include activating an activation mechanism by a user, displacing a control arm to actuate an insertion mechanism, and operating a power and control system to activate a drive control mechanism to force a flow of the fluid drug through the drug pump. The method may further include engaging an optional on-body sensor prior to activating the activation mechanism. The method may also include establishing a connection between the fluid pathway connection and the drug container. Additionally, the operating method may include translating a plunger seal within the drive control mechanism and the drug container to force a flow of the fluid drug through the drug container, the fluid pathway connection, the sterile fluid conduit, and the insertion mechanism to deliver the fluid drug to the user's body.

[0106] Throughout the specification, the objective has been to describe preferred embodiments of the invention without limiting the invention to any one embodiment or particular collection of features. Various changes and modifications may be made to the described and illustrated embodiments without departing from the invention. The disclosures of each patent document and scientific text, computer programs and algorithms referenced in this specification are incorporated by reference in their entirety.

Claims

1. 1. A wearable drug delivery device comprising: An outer housing; a medication storage container positioned at least partially within the outer housing; a fluid conduit positioned at least partially within the outer housing; an insertion mechanism positioned at least partially within the outer housing; Including, The insertion mechanism is an insertion mechanism housing; a rotational biasing member configured to rotate at least a portion of the insertion mechanism housing, at least a portion of the rotational biasing member extending around at least a portion of the insertion mechanism housing; a delivery member connected or configured to be connected in fluid communication with the medication storage container via at least a fluid conduit; Including, the delivery member is movable between a first position and a second position, in the first position an insertion portion of the delivery member is positioned within the outer housing and in the second position an insertion portion of the delivery member is positioned exterior to the outer housing for insertion into the patient; the insertion mechanism housing is operatively coupled to the delivery member and configured to rotate relative to the delivery member such that an initial rotation of the insertion mechanism housing relative to the delivery member moves the delivery member distally from the first position to the second position; the insertion mechanism is configured to move the delivery member proximally from the second position to the first position; A wearable drug delivery device, wherein the fluid conduit is operably coupled to the delivery member such that at least a portion of the fluid conduit moves in a proximal direction when the delivery member moves from the second position to the first position.

2. The insertion mechanism housing includes a hub, the hub including: (i) facilitating a connection between the delivery member and the drug storage container such that a fluid flow path passes through at least a portion of the hub during operation of the wearable drug delivery device; and (ii) mechanically engages the insertion mechanism housing such that an initial rotation of the insertion mechanism housing relative to the hub moves the delivery member along or parallel to the axis from the first position to the second position; The wearable drug delivery device of claim 1 , configured as follows:

3. the insertion mechanism housing includes a first guide surface; The wearable drug delivery device of claim 1 , wherein the hub comprises an outwardly extending follower configured to slidably engage the first guide surface during rotation of the insertion mechanism housing.

4. The wearable drug delivery device of claim 3 , wherein at least a portion of the first guide surface extends axially and circumferentially.

5. The wearable drug delivery device of claim 1 , wherein the rotational biasing member is configured to rotate the insertion mechanism housing in only a single rotational direction.

6. The insertion mechanism housing is rotatable about an axis; The wearable drug delivery device of claim 1 , wherein the axis is at least substantially parallel to a longitudinal axis of the delivery member.

7. a radially outwardly extending protrusion configured to mechanically interact with the insertion mechanism housing such that an initial rotation of the insertion mechanism housing relative to the hub moves the delivery member axially from the first position to the second position; The wearable drug delivery device of claim 2 , wherein the radially outwardly extending protrusion is limited to one side of the hub.

8. a first abutment member having a first position and a second position; In the first position, the first abutment member engages the insertion mechanism housing to prevent the rotation biasing member from rotating the insertion mechanism housing; The wearable drug delivery device of claim 1 , wherein in the second position, the first abutment member is disengaged from the insertion mechanism housing to allow the rotation biasing member to rotate the insertion mechanism housing.

9. the insertion mechanism housing includes a cylindrical portion and a second abutment member extending outwardly from the cylindrical portion; The wearable drug delivery device of claim 8 , wherein the second abutment member engages with the first abutment member when the first abutment member is in the first position.

10. a drive mechanism positioned at least partially within the outer housing; The wearable drug delivery device of claim 1 , wherein the drive mechanism is configured to move the drug from the drug storage container through the delivery member and into the patient.

11. The wearable drug delivery device of claim 2, wherein the fluid conduit is coupled to the hub so as to connect the delivery member in fluid communication with the drug storage container during operation of the wearable drug delivery device and so that at least a portion of the fluid conduit and the hub translate together during insertion of the delivery member into a patient.

12. The wearable drug delivery device of claim 1 , wherein the rotational biasing member comprises a torsion spring.

13. The wearable drug delivery device of claim 1 , wherein the delivery member comprises a needle.

14. The wearable drug delivery device of claim 13 , wherein the needle has a hollow interior.

15. The wearable drug delivery device of claim 1 , wherein the delivery member is fluidly coupled to the drug storage container via at least a fluid conduit at least prior to rotation of the insertion mechanism housing.

16. The wearable drug delivery device of claim 15 , wherein the insertion mechanism does not have a cover surrounding the rotational biasing member.

17. 10. The wearable drug delivery device of claim 1, comprising an adhesive applied to a wall of the outer housing for attaching the outer housing to the patient's skin.

18. an opening formed in a wall of the outer housing; The wearable drug delivery device of claim 17 , wherein the insertion portion of the delivery member extends through the opening at the second position.

19. 1. A method for controlling operation of a wearable drug delivery device, comprising: The wearable drug delivery device comprises An outer housing; a fluid conduit positioned at least partially within the outer housing; a medication storage container positioned at least partially within the outer housing; an insertion mechanism positioned at least partially within the outer housing; The insertion mechanism includes: an insertion mechanism housing; A starting mechanism; a rotational biasing member configured to rotate at least a portion of the insertion mechanism housing, at least a portion of the rotational biasing member extending around at least a portion of the insertion mechanism housing; a delivery member connected or configured to be connected in fluid communication with the medication storage container via at least a fluid conduit; An initial rotation of the insertion mechanism housing relative to the delivery member; the insertion mechanism housing is operably coupled to the delivery member to axially move the delivery member from the first position to the second position; and configured to rotate relative to the delivery member; The method comprises: an actuation mechanism releasing a rotational biasing member; a rotational biasing member rotating the insertion mechanism housing to move the delivery member distally from a first position to a second position, where in the first position an insertion portion of the delivery member is positioned within the outer housing and in the second position the insertion portion of the delivery member is outside of the outer housing; an insertion mechanism moving the delivery member proximally from a second position to a first position, the fluid conduit being operably coupled to the delivery member such that at least a portion of the fluid conduit moves proximally as the delivery member moves from the second position to the first position; A method for controlling the operation of a wearable drug delivery device, comprising:

20. 20. The method of claim 19, wherein releasing the rotational biasing member comprises disengaging the first abutment member from a second abutment member extending outwardly from the cylindrical portion of the insertion mechanism housing.

21. A wearable drug delivery device comprising: An outer housing; a medication storage container positioned at least partially within the outer housing; a fluid conduit positioned at least partially within the outer housing; an insertion mechanism positioned at least partially within the outer housing; Including, The insertion mechanism is an insertion mechanism housing; a rotational biasing member configured to rotate at least a portion of the insertion mechanism housing, at least a portion of the rotational biasing member extending around at least a portion of the insertion mechanism housing; a delivery member connected or configured to be connected in fluid communication with the medication storage container via at least a fluid conduit; Including, the delivery member is movable between a first position and a second position, in the first position an insertion portion of the delivery member is positioned within the outer housing and in the second position an insertion portion of the delivery member is positioned exterior to the outer housing for insertion into the patient; the insertion mechanism housing is operatively coupled to the delivery member and configured to rotate relative to the delivery member such that an initial rotation of the insertion mechanism housing relative to the delivery member axially moves the delivery member from the first position to the second position; The insertion mechanism housing includes: (i) facilitating a connection between the delivery member and the drug storage container such that a fluid flow path passes through at least a portion of the hub during operation of the wearable drug delivery device; (ii) A wearable drug delivery device comprising a hub configured to mechanically engage with the insertion mechanism housing such that an initial rotation of the insertion mechanism housing relative to the hub moves the delivery member from a first position to a second position along or parallel to the axis.

Images