Drive mechanism for drug delivery pumps with integrated status indication.

(54) Title: DRIVE MECHANISM FOR PUMPS FOR THE SUPPLY OF DRUGS WITH INTEGRATED STATE INDICATION.

(54) Title: DRIVE MECHANISM FOR DRUG DELIVERY PUMPS WITH INTEGRATED STATUS INDICATION.

(57) Summary

A drive mechanism 2100, 3100 includes a housing 2130, a piston 2110 adapted to impart movement to a plunger seal 2060 within a drug container 2050, a plurality of parallel diverter members 2106, 2122, and a retainer. 2115. Deflection members 2106, 2122 are positioned to release energy to cause movement of piston 2110 from a first retracted position to a second extended position, piston 2110 rests against piston seal 2060 to distribute the medicine. Retainer 2115 is positioned to hold bypass members 2106, 2122 in the energized position, and to release bypass members 2106, 2122 to allow piston 2110 to distribute the medicine. The drive mechanism 2100, 3100 may also include an end of dose indicator 2133, 3133, to identify at least one of when the sleeve mount 2120, 3120 is positioned underlying the window 2131, 3131 in housing 2130, 3130. , the relative movement of the sleeve assembly 2120, 3120 with reference to the window 2131, 3131 or other reference component, the stopping of such movement, and the speed or change of speed of the movement.

(57) Abstract

A drive mechanism 2100, 3100 includes a housing 2130, a pistón 2110 adapted to impart movement to a plunger seal 2060 within a drug container 2050, a plurality of biasing members 2106, 2122 disposed in parallel, and a retainer 2115. The biasing members 2106 , 2122 are disposed to release energy to cause movement of the piston 2110 from a retracted first position to the extended second position, the piston 2110 bearing against the plunger seal 2060 to dispense medicine. The retainer 2115 is disposed to maintain the biasing members 2106, 2122 in the energized position and to release the biasing members 2106, 2122 to permit the pistón 2110 to dispense the medicine. The drive mechanism 2100, 3100 may also inelude an end-of-dose indicator 2133, 3133 to identify at least one of when the sleeve assembly 2120, 3120 is disposed subjacent to window 2131, 3131 in the housing 2130, 3130 the relative motion of the sleeve assembly 2120, 3120 with reference to the window 2131.3131 or another reference component, the stoppage of such motion, and the rated or change of rate of motion.

DRIVE MECHANISM FOR PUMPS FOR THE SUPPLY OF

DRUGS WITH INTEGRATED STATE INDICATION

CROSS REFERENCE WITH RELATED REQUESTS

This application claims the priority of PCT Application PCT / US2014 / 013005 and United States Application 14 / 163,690, both filed on January 24, 2014, and United States Provisional Application 61 / 912,642, filed on December 6, 2013, each of which is incorporated by reference in this document in its entirety for all purposes.

COUNTRYSIDE

This invention relates to pumps for drug delivery. More particularly, this invention relates to integrated state indication actuation mechanisms, drug delivery pumps with integrated state actuation mechanisms, methods of operating such devices, and methods of mounting such devices.

BACKGROUND

Parenteral delivery of various drugs, that is, delivery by means other than through the digestive tract, has become a desired method of

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Similarly, drugs for various reasons. This form of injection drugs can improve substance being delivered and unchanged medicine reaches its site of significant concentration. Thus unwanted side effects associated with other routes of delivery, such as systemic toxicity, can potentially be avoided through parenteral delivery. By bypassing the digestive system of a mammalian patient, degradation of the active ingredients, caused by catalytic enzymes in the digestive tract and liver, can be avoided, and ensure that a required amount of the drug, at a desired concentration, reaches the site selected.

Traditionally, manually operated syringes and injection pens have been used to deliver parenteral drugs to a patient. More recently, parenteral delivery of liquid medicines into the body has been accomplished by administering bolus injections using a needle and reservoir, continuously, via gravity powered dispensers, or via transdermal patch technologies. Bolus injections often correspond imperfectly to the patient's clinical needs, and usually require larger individual doses than desired at the specific time they are provided. Continuous supply of medicine through gravity fed systems compromises patient mobility and lifestyle, and limits therapy to simplified flow rates and profiles. Another form of drug delivery, transdermal patches, similarly, have their restrictions. Transdermal patches often require drug-specific molecular structures for efficacy, and control of drug delivery through a transdermal patch is severely limited.

Ambulatory infusion pumps have been developed to deliver liquid medications to a patient. These infusion devices have the ability to deliver sophisticated fluid delivery profiles, meeting bolus requirements, continuous infusion, and variable flow rate delivery. These infusion capabilities usually result in better drug and therapy efficacy, and less toxicity to the patient's system. Currently available ambulatory infusion devices are expensive, difficult to program and prepare for infusion, and tend to be bulky, heavy, and very fragile. Filling these devices can be difficult and require the patient to carry both the intended medication and accessories for filling. The devices often require specialized care, maintenance, and cleaning to ensure proper functionality and safety for their intended long-term use, and are not cost effective for patients or medical professionals.

Compared to injection syringes and pens, pump-type delivery devices can be significantly more convenient for a patient, in that drug doses can be automatically calculated and delivered to a patient at any time during the day or the day. night. Furthermore, when used in conjunction with metabolic sensors or monitors, pumps can be automatically controlled to provide appropriate doses of a fluid medium at appropriate times of need, based on detected or controlled metabolic levels. As a result, pump-type delivery devices have become an important aspect of modern medical treatments for various types of medical conditions, such as diabetes, and the like.

Although pump-type delivery systems have been used to address various patient needs, frequently operated manually operated syringes and injection pens remain a preferred choice for drug delivery as they now provide integrated safety features and can Read easily to identify drug delivery status and end of dose distribution. However, manually operated syringes and pens are not universally applicable and are not preferred for the delivery of all drugs. There is a need for an adjustable (and / or programmable) infusion system that is accurate and reliable and that can offer clinicians and patients a small, low-cost, lightweight, easy-to-use alternative for parenteral delivery. of liquid medicines.

SUMMARY

The present invention provides drive mechanisms with integrated status indication, drug delivery pumps incorporating such drive mechanisms, methods for operating such devices, and methods for mounting such devices. The actuation mechanisms of the present invention provide integrated status indication features, which provide feedback to the user before, during, and after drug delivery. For example, an initial feedback can be provided to the user to identify that the system is operational and ready for drug delivery. Upon activation, the system may provide one or more indications of the status of drug delivery to the user. Upon termination of drug delivery, the drive mechanism and drug pump can provide an indication of end of dose. Since the indication of the end of the dose is related to the piston reaching the end of its axial translation, the actuation mechanism and the drug pump provide a true indication of the end of the dose to the user. In addition, the embodiments of the present invention provide for the end of dose compliance, to ensure that substantially all of the drug dose has been delivered to the user and that the status indication features have been appropriately contacted to provide a Exact feedback to the user. Through these mechanisms, accurate confirmation of drug dose delivery can be provided to the user or administrator. Accordingly, the novel devices of the present invention alleviate one or more of the problems associated with prior art devices, such as those referred to above.

In a first embodiment, the present invention provides a drive mechanism having an integrated status indication, including: an actuator housing, a status switch interconnect, an actuator bypass member, a piston, and a container for the drug that has a cap, a pierceable seal, a cylinder, and a plunger seal.

The actuator bypass member can be configured to rest on a surface of the piston interface.

The drug container may preferably contain a drug fluid for delivery to the user. The drive mechanism may further include a connection assembly

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provide a more even distribution of the force of the deflection member to the piston. A contact sleeve can be slidably mounted to the actuator housing through an axial opening in the actuator housing, such that the sleeve hooks at a distal end of the contact sleeve are brought into contact with the piston between the surface of the the interface and a contact protrusion near the proximal end of the piston. The piston may also include a securing groove, between the contact boss and the proximal end of the piston. The contact sleeve may have a radially extending ring at its proximal end, in which one or more flexible pins reside.

The drive mechanism may further include one or more contact surfaces located on the corresponding components. Such contact surfaces may be electrical contact surfaces, mechanical contact surfaces, or electromechanical contact surfaces. Such surfaces may initially be in contact and cause them to disengage or initially be disconnected and cause them to engage, to allow a signal to be sent to, and / or the power control system. In at least one embodiment, as further described herein, the contact surfaces may be electrical contact surfaces that are initially disconnected and cause them to engage, whereby, upon such engagement, the contact surfaces are capable of continue an energy path or otherwise transmit a signal to the energy and control system. In another embodiment of the present invention, the contact surfaces are mechanical contact surfaces that are initially in contact and are caused to disengage, whereby, upon such decoupling, such decoupling is communicated to the power and control system. Such signals can be transferred through one or more interconnections to the power and control system or by mechanical action to the power and control system. Such components can be used within the drive mechanism to measure and transfer information related to the operating state of the drive mechanism, which can be converted by the power and control system into tactile, auditory and / or visual feedback to the user. Regardless of the electrical or mechanical nature of the contact surfaces, the movement of the components that allows the transmission of a signal to the energy control system is enabled by a deflection member that axially translates a contact sleeve in the axial direction. during device operation.

The drive mechanism may include a slidably mounted piston extension at a distal end and within an axial opening of the piston; a piston extension deflection member, which is mounted within the axial opening of the piston and is initially compressed between the piston extension and the piston; and optionally, a support for the piston deflection member between the piston extension deflection member and the piston extension. The piston extension is retained within the piston by the interaction between one or more piston extension extension arms and one or more corresponding piston connection slots. The piston extension can be used to perform a compliance push of the drug fluid from the drug container. Additionally or alternately, the actuation mechanism may utilize a compressible plunger seal, where such compressibility or distance allows for push of drug fluid compliance from the drug container. Other characteristics of

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piston, an incremental state stem having a stem interconnect mounted, fixed, printed, or otherwise attached thereto, and a drug container having a cap, pierceable seal, cylinder, and plunger seal , wherein the stem of the incremental state resides within the axial openings of the actuator and piston housing. The incremental state stem may have one or more interconnects, which contact one or more contacts on the piston to provide incremental state feedback to the user. The incremental state mode can similarly utilize the electrical, mechanical, electromechanical interconnects and contacts, and / or one or more of the compliance features, described above.

In a further embodiment, the present invention provides a drug delivery pump with an integrated status indication. The drug pump includes a housing and mounting platform, on which an activation mechanism, an insertion mechanism, a fluid path connection, a power and control system, and a drive mechanism can be mounted. that has a container for the drug. The actuator bypass member can be configured to rest on a surface of the piston interface. The drug container may preferably contain a drug fluid for delivery to the user. The drive mechanism may further include a connection assembly attached to the pierceable seal. A cover sleeve can be used between the actuator bypass member and the surface of the piston interface to, for example, provide a more even distribution of force from the bypass member to the piston. A contact sleeve can be slidably mounted to the actuator housing through an axial opening in the actuator housing, such that the sleeve hooks at a distal end of the contact sleeve are brought into contact with the piston between the surface of the the interface and a contact protrusion near the proximal end of the piston. The piston may also include a securing groove, between the contact boss and the proximal end of the piston. The contact sleeve may have a radially extending ring at its proximal end, in which one or more flexible pins reside. The drive mechanism may further include one or more contact surfaces located on the corresponding components. Such contact surfaces can be electrical contact surfaces, mechanical contact surfaces, or electromechanical contact surfaces. Such surfaces may initially be in contact and cause them to disengage, or initially be disconnected and cause them to engage, to allow a signal to be sent to, and / or from the energy control system. In at least one embodiment, as further described herein, the contact surfaces may be electrical contact surfaces, which are initially disconnected and cause them to engage, whereby upon such engagement, the contact surfaces are capable of continue an energy path or otherwise transmit a signal to the energy and control system. In another embodiment of the present invention, the contact surfaces are mechanical contact surfaces that are initially in contact, and are made to decouple, whereby upon decoupling, such decoupling is communicated to the power and control system. Regardless of the electrical or mechanical nature of the contact surfaces, the movement of the components that enables the transmission of a signal to the energy control system is enabled by a deflection member that axially translates a contact sleeve in the direction axial during device operation.

In yet another embodiment, the present invention provides a drug delivery pump with an indication of incremental status. The drug pump includes a housing and mounting platform, on which an activation mechanism, an insertion mechanism, a fluid path connection, a power and control system, and a drive mechanism can be mounted. having a drug container, and further including an incremental state stem having a stem interconnect mounted, fixed, printed, or otherwise attached thereto, where the incremental state stem resides within the axial openings of the actuator and piston housing, and where the incremental state stem has one or more interconnects that contact one or more contacts on the piston to terminate a transmission to the power and control system to provide incremental feedback to the user. The drug delivery pump with an incremental status indication can similarly utilize electrical, mechanical or electromechanical interconnections and contacts, and / or one or more of the compliance features, described above.

The present invention further provides a mounting method. The drug container can be mounted first and filled with a drug fluid. The drug container includes a lid, a pierceable seal, a cylinder, and a plunger seal. The pierceable seal can be fixedly attached between the cap and the cylinder, at a distal end of the cylinder. The cylinder can be filled with a drug fluid through the open proximal end prior to insertion of the plunger seal from the proximal end of cylinder 58. An optional connection mount can be mounted on a distal end of the pierceable seal. The connection assembly is for guiding the insertion of the pierceable member of the fluid path connection into the cylinder of the drug container. The drug container can then be mounted at a distal end of the actuator housing.

Before mounting the drug container to the housing, a status switch interconnect can be mounted at a proximal end of the actuator housing. A contact sleeve, which has one or more sleeve hooks at a distal end and a ring at a proximal end that has an electrical contact thereon, can be mounted to the actuator housing through an axial opening from the proximal end of the actuator housing. An actuator bypass member can be inserted into a distal end of the actuator housing. Optionally, a cover sleeve can be inserted into a distal end of the actuator housing to substantially cover the deflection member. A piston can be inserted into the distal end of the actuator housing and through an axial opening of the contact sleeve, such that a piston contact boss is proximal to the hooks of the contact sleeve sleeve. The piston and actuator bypass member, and an optional cover sleeve, can be compressed into the actuator housing. Such an assembly places the actuator diverter member in an initial, energized compressed state, and preferably places a surface of the piston interface in contact with the proximal surface of the piston seal within the proximal end of the cylinder. When a piston extension is employed, the piston extension and the piston extension deflection member, and an optional piston deflection member holder, can be compressed into an axial opening of the piston prior to compression of the components. Before or after installing these components in the drive mechanism housing, the primary container can be attached.

When one or more interconnects or contacts are used for status indication, such components may be mounted, connected, printed, or otherwise attached to their corresponding components prior to mounting such components on the drive mechanism. When a separate incremental state stem and a corresponding stem interconnect are used for such an indication of the incremental state, the stem interconnect may be mounted, affixed, printed, or otherwise attached to the incremental state stem prior to mounting the incremental state stem to the proximal end of the contact sleeve and / or to the proximal end of the actuator housing, in such a manner, that the stem of the incremental state resides within an axial opening of the contact sleeve and the actuator housing. The stem of the incremental state is further mounted to reside within an axial opening of the piston.

The disclosure discloses, in one aspect, a drug pump drive mechanism, for use in cooperation with a drug container that includes a plunger seal. The drive mechanism has a shaft and includes an actuator housing, a piston adapted to impart movement to the plunger seal within the drug container, a plurality of parallel positioned diverter members, and a retainer. The piston is positioned for movement from a first retracted position along the axis to a second extended position. The deflection members are adapted to move from a first energized position to a second non-energized position, as a result of the release of energy. The deflection members are positioned to cause movement of the piston from the first retracted position to the second extended position, as the deflection members move from the first energized position to the second non-energized position. The retainer is positioned to hold the deviation members in the first energized position, when the retainer is in a first detent position, and to release the deviation members from the first energized position, when the retainer is moved to a second position. of release.

In at least one embodiment, the plurality of deflection members includes at least one of a tension spring or a compression spring. In at least one embodiment, the plurality of deflection members includes a pair of springs, in at least one embodiment of which the springs are compression springs. In at least one embodiment, the compression springs are concentrically positioned, and positioned around at least a portion of the piston. In at least one embodiment, the retainer engages at least a portion of the piston to retain the piston in its retracted position when the retainer is in its first retention position. At least one embodiment further includes a sleeve mount positioned around at least one of the plurality of deflection members. In at least one embodiment, the sleeve assembly includes a plurality of telescopic sleeves, and the sleeve assembly is positioned to move axially with the piston. At least one embodiment further includes at least one window and at least a portion of the sleeve assembly is visible through the window with at least a portion of the sleeve assembly being visible through the window, until the piston is in the second extended position. At least one embodiment further includes an end of dose indicator positioned substantially adjacent the window, the end of dose indicator is adapted to identify at least one of when the sleeve assembly is positioned underlying the window and when the sleeve assembly is not positioned underlying the window, the relative movement of the sleeve assembly with reference to the window or other component of the reference, stopping such movement, and the speed or change of speed of the movement. In at least one embodiment, the end-of-dose indicator includes a sensor in place to detect at least one of when the sleeve assembly is positioned underlying the window and when the sleeve assembly is not positioned underlying the window. In at least one embodiment, the sensor is a mechanical sensor, an electrical sensor, an ultrasonic sensor, a capacitive sensor, a magnetic sensor, or an optical sensor. In at least one embodiment, the sensor is a mechanical sensor positioned to abut against the sleeve mount, when the sleeve mount is positioned underlying the window.

In another aspect of the disclosure, a drug pump drive mechanism is provided for use in cooperation with a drug container including a plunger seal; the drive mechanism has a shaft and includes an actuator housing, a piston adapted to impart movement to the plunger seal within the drug container, at least one deflection member, a retainer, a sleeve mount, and a pressure gauge. end of dose. The piston is positioned for movement from at least a first retracted position to a second position extended along the axis. At least one deflection member is positioned and adapted to move from a first energized position to a second non-energized position, as a result of the release of energy. The deflection member is positioned to cause movement of the piston from the first retracted position to the second extended position, as the deflection member moves from the first energized position to the second non-energized position. The retainer is positioned to hold the deviation member in the first energized position when the retainer is in a first detent position, and to release the deviation member from the first energized position when the retainer is moved to a second release position. The sleeve mount is adapted to move along the axis with the piston. The sleeve assembly is placed at least partially within the actuator housing, and at least a portion of the sleeve assembly is visible through a window in the housing, when the piston is in one of the first retracted or second position extended. The sleeve assembly is not visible through the window when the piston is in another position than the first retracted or second extended position. The end of dose indicator is positioned substantially adjacent to the window. The end-of-dose indicator is adapted to identify at least one of when the sleeve assembly is positioned underlying the window, and when the sleeve assembly is not positioned underlying the window.

In at least one embodiment, the sleeve assembly is positioned around at least one deflection member and includes a plurality of telescopic sleeves. In one embodiment, the sleeve assembly is placed around the deflection members. In at least one embodiment, the at least one deflection member includes a plurality of deflection members. A particular embodiment includes at least two compression springs placed in parallel. In at least one embodiment, the end-of-dose indicator includes a sensor in place to detect at least one of when the sleeve assembly is positioned underlying the window and when the sleeve assembly is not positioned underlying the window. In at least one embodiment, the sensor is at least one of a mechanical sensor, a mechanical sensor, an electrical sensor, an ultrasonic sensor, a capacitive sensor, a magnetic sensor, or an optical sensor. In a particular embodiment, the sensor is a mechanical sensor positioned to abut against the sleeve mount, when the sleeve mount is positioned underlying the window. In some embodiments, at least a portion of a distal end of the piston is adapted to be placed within the drug container when the piston is in the first retracted position and the drive mechanism of a drug pump is positioned to be used in cooperation with the container for the drug.

At least some embodiments of the present invention provide the driving force necessary to push a plunger seal and a drug fluid into the drug container, while reducing or minimizing the space occupied by the drive mechanism and device. total. Accordingly, the present invention can provide a drive mechanism that can be used within a more compact drug delivery pump device. Some embodiments of the present invention can be used similarly, to provide additional strength, as may be required for highly viscous drug fluids or for larger volume drug containers.

In accordance with another aspect of the description, a drug pump drive mechanism is provided for use in cooperation with a drug container, including a plunger seal and a power and control system. The drive mechanism includes an actuator housing, a piston, at least one deflection member, a retainer, a sleeve mount, and an end of dose indicator. The actuator housing includes a shaft, the housing further includes at least one window. The piston is positioned for movement from at least a first retracted position to a second position extended along the axis. The piston is also adapted to impart movement to the plunger seal within the drug container. At least one deflection member is positioned and adapted to move from a first energized position to a second non-energized position as a result of energy release. The deflection member is also positioned to cause movement of the piston from the first retracted position to the second extended position, as the deflection member moves from the first energized position to the second non-energized position. The retainer is movable between a first retention position and a second release position. The retainer is positioned to hold the deviation member in the first energized position when the retainer is in the first detent position, and to release the deviation member from the first energized position when the retainer is moved to the second release position. The sleeve assembly is placed at least partially within the actuator housing. At least a portion of the sleeve assembly is adapted to move along the axis with the piston. At least a portion of the sleeve assembly is visible through the window, when the piston is in one of the first retracted or second extended position, the sleeve assembly is not visible through the window when the piston is in another position of the first position retracted or the second position extended. The end of dose indicator includes at least one switch interconnect, at least a portion of which is positioned substantially adjacent to the window and is adapted to identify at least one of when the sleeve assembly is positioned underlying the window and when the sleeve mount is not positioned underneath the window. The switch interconnect includes a mechanical trigger adapted to engage the sleeve mount through the window. The switch interconnect is further adapted to selectively couple the power and control system as a result of the end of trigger engagement or disengagement.

The novel embodiments of the present invention provide actuation mechanisms with an integrated status indication, which are capable of providing the incremental status of drug delivery before, during, and after operation of the device, and provide means to ensure compliance with the drug dose, i.e., ensuring substantially that the entire drug dose is delivered to the user. Throughout this specification, unless otherwise indicated, comprise, understand, and comprise or related terms such as include or consist of, are used inclusive rather than exclusive, such that an indicated integer or group of integers it can include one or more of other integers or groups of unspecified integers. As will be further described below, the embodiments of the present invention may include one or more additional components that can be considered standard components in the medical device industry. Components and modalities containing such components are contemplated within the present invention, and are understood to fall within the scope and scope of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The following non-limiting embodiments of the invention are described herein with reference to the following drawings, wherein:

Figure 1A shows an isometric view of a drug delivery pump having integrated safety insertion mechanisms, in accordance with an embodiment of the present invention;

<td>The figure</td><td>IB</td><td>shows a</td><td>view</td><td>isometric</td><td>of</td><td>the</td>

<td colspan="2">interior components</td><td>of the bomb</td><td>for him</td><td>supply</td><td>of</td><td>the</td>

<td>drugs shown in</td><td>the</td><td>Figure 1A;</td><td></td><td></td><td></td><td></td>

<td>The figure</td><td>1 C</td><td colspan="2">shows a view</td><td>isometric</td><td>of</td><td>the</td>

bottom of the drug delivery pump shown in Figure 1A;

<td></td><td>The</td><td>Figure 2 shows a</td><td>view</td><td>isometric of</td><td>a</td>

<td>mechanism</td><td>of</td><td colspan="2">drive, okay</td><td>with at least</td><td>a</td>

<td>modality</td><td>of</td><td>the present invention;</td><td></td><td></td><td></td>

<td></td><td>The</td><td>Figure 3 shows a</td><td>view</td><td>exploded, to</td><td>the</td>

along axis A, of the drive mechanism shown in Figure 2,

<td></td><td colspan="2">The</td><td>Figure</td><td>4A</td><td>shows a</td><td>view</td><td>in</td><td>section</td>

<td colspan="3">cross</td><td colspan="2">of the mechanism</td><td colspan="3">drive shown</td><td>in the</td>

<td>Figure</td><td> 2</td><td>in</td><td>A state</td><td colspan="2">initial idle;</td><td></td><td></td><td></td>

<td></td><td></td><td>The</td><td>Figure</td><td>4B</td><td>shows a</td><td>view</td><td>in</td><td>section</td>

<td colspan="3">cross</td><td colspan="2">of the mechanism</td><td colspan="3">drive shown</td><td>in the</td>

<td>Figure</td><td> 2</td><td>in</td><td>A state</td><td colspan="2">actuated;</td><td></td><td></td><td></td>

<td></td><td></td><td>The</td><td>Figure</td><td>4C</td><td>shows a</td><td>view</td><td>in</td><td>section</td>

cross section of the actuation mechanism shown in Figure 2, in a further actuated state as drug delivery from the mechanism continues;

Figure 4D shows a cross-sectional view of the actuation mechanism shown in Figure 2, as the mechanism is near completion of drug delivery;

Figure 4E shows a cross-sectional view of the actuation mechanism shown in Figure 2, as the mechanism pushes compliance to ensure termination of drug delivery;

Figure 5 shows an isometric view of a drive mechanism, according to a second embodiment of the present invention;

Figure 6 shows an exploded view, along an axis A, of the drive mechanism shown in Figure 5;

Figure 7 shows a cross-sectional view of the drive mechanism shown in Figure 5, in an actuated state;

Figure 8 shows an isometric view of the drive mechanism according to a further embodiment of the present invention;

Figure 9A shows a cross-sectional view of the drive mechanism shown in Figure 8, in an initial idle state;

Figure 9B shows a cross-sectional view of the actuation mechanism shown in Figure 8, in an actuated state and as the mechanism approaches completion of drug delivery;

Figure 9C shows a cross-sectional view of the actuation mechanism shown in Figure 8, as the mechanism ends drug delivery and activates an end-of-dose signal.

Figure 10A is an isometric view of yet another embodiment of a drug delivery pump, having integrated safety insertion mechanisms, in accordance with the teachings of the present invention;

Figure 10B is an isometric view of the interior components of the drug delivery pump shown in Figure 10A;

Figure 10C is an isometric view of the bottom of the drug delivery pump shown in Figure 10A;

Figure 11 is an isometric view of a drive mechanism, in accordance with the embodiment of Figures 10A-10C;

Figure 12 is an exploded view, along an axis A, of the drive mechanism shown in Figure 11,

Figure 13A is a cross sectional view of the drive mechanism shown in Figure 11, in an initial idle state;

Figure 13B is a cross sectional view of the drive mechanism shown in Figure 11, in an actuated state;

Figure 13C is a cross-sectional view of the actuation mechanism shown in Figure 11, at the termination of drug delivery;

Figure 14A is a cross-sectional view of the drive mechanism, taken along line 14-14 in Figure 11;

Figure 14B is a cross-sectional view of the drive mechanism similar to Figure 14A, but after sensor activation;

Figure 15 is an isometric view of a drive mechanism, in accordance with yet another embodiment of the present invention;

Figure 16A is a cross sectional view of the drive mechanism, taken along line 15-15 in Figure 15; and

Figure 16B is a cross-sectional view of the drive mechanism similar to Figure 16A, but after activation of the sensor.

DETAILED DESCRIPTION

As used herein to describe drive mechanisms, drug delivery pumps, or any of the relative positions of the components of the present invention, the terms "axially or axially" generally refer to a longitudinal axis A , around which the drive mechanisms are preferably placed, although not necessarily symmetrically around it. The term radial generally refers to a direction normal to the A axis. The terms proximal, posterior, posterior, rear, or rearward generally refer to an axial direction in the P direction. The terms distal, frontal, frontally, depressed or forward, generally refer to an axial direction in the D direction. As used herein, the term includes other materials not suitable for pharmaceutical use, which normally non-exclusively, certain glass should be understood to be similarly reactive, in a grade application requiring glass, including, non-reactive polymers such as copolymers of cyclic olefins (COC) and polymers of cyclic definas (COP). The term plastic can include both thermoplastic and thermoset polymers. Thermoplastic polymers can be re-softened to their original condition by heat; thermoset polymers cannot. As used herein, the term "plastic" refers primarily to moldable thermoplastic polymers such as, for example, polyethylene and polypropylene, or an acrylic resin, which typically also contains other ingredients such as curing agents, fillers, bonding agents, reinforcement, colorants, and / or plasticizers, etc., and which 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 they are in direct contact with therapeutic liquids that can interact with the plastic, or that can deqradarse by substituents that could otherwise enter the liquid in the plastic. The term elastomer, elastomeric, or elastomeric material, primarily refers to crosslinked, thermo-fixed rubbery polymers that are more easily deformable than plastics, but are not approved for use with pharmaceutical grade fluids, and are not readily susceptible to leaching or migration of gas under ambient temperature and pressure. Fluid refers primarily to liquids, but may also include suspensions of solids dispersed in liquids, and gases dissolved in, or otherwise present along with the liquids within the fluid-containing portions of the syringes. In accordance with various aspects and modalities described herein, reference is made to a diversion member, such as in the context of one or more diversion members for insertion or retraction of the needle, trocar, and / or cannula. It will be appreciated that the deflection member can be any member that is capable of storing and releasing energy. Non-limiting examples include a spring, such as, for example, a coil spring, a compression or extension spring, a torsion spring, and a leaf spring, a compressible or resistant elastic band, or any other member with similar functions. In at least one embodiment of the present invention, the deflection member is a spring, preferably a compression spring.

The novel devices of the present invention provide actuation mechanisms with integrated status indication, and drug delivery pumps incorporating such actuation mechanisms. Such devices are safe and easy to use, and are aesthetically and ergonomically appealing to self-administered patients. The devices described in this document incorporate features that make device activation, operation and assurance 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 pumps, actuation mechanisms, and their respective components are further described herein, with reference to the accompanying Figures.

As used herein, the term pump is intended to include any number of drug delivery systems that are capable of delivering a fluid to a user upon activation. Such drug delivery systems include, for example, injection systems, infusion pumps, bolus injectors, and the like. Figures 1A-1C show an exemplary drug delivery device, in accordance with at least one embodiment of the present invention. The drug delivery device can be used to administer the delivery of a drug treatment into a user's body. As shown in Figures 1A-1C, the drug pump 10 includes a pump housing 12. The pump housing 12 may include one or more subcomponents of the housing, which are fixedly engageable to facilitate manufacturing , easier mounting and operation of the drug pump. For example, the drug pump 10 includes a pump housing 12 that includes an upper housing 12A and a lower housing 12B. The drug pump may further include an activation mechanism 14, a status indicator 16, and a window 18. Window 18 can be any translucent or transmitting surface, through which the operation of the drug pump can be observed. As shown in Figure IB, the drug pump further includes mounting platform 20, sterile fluid conduit 30, actuation mechanism 100 having a drug container 50, insertion mechanism 200, the fluid path connection 300, and a power and control system 400. One or more of the components of such drug pumps may be may, for example, be preassembled separately and configured in position in modular as the mounting platform 20 of the drug pump 10 as components during manufacturing.

Pump housing 12 contains all components of the device, and provides a means for removably attaching device 10 to the user's skin. The pump housing 12 also provides protection to the interior components of the device 10 against environmental influences. The pump housing 12 is ergonomically and aesthetically designed in size, shape, and related features to facilitate easy packaging, storage, handling, and use by users, who may be untrained and / or physically disabled. Furthermore, the external surface of the pump housing 12 can be used to provide product labeling, safety instructions, and the like. Furthermore, as described above, housing 12 may include certain components, such as a status indicator 16 and a window 18, that can provide feedback of the operation to the user.

In at least one embodiment, the drug pump 10 provides an activation mechanism 14 that is moved by the user to activate the start command to the power and control system 400. In a preferred embodiment, the activation mechanism is a start button 14, which is located through the pump housing 12, such as through an opening between the upper housing 12A and the lower housing 12B, and which enters contact with 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, it may be an on / off switch, a toggle switch, or any similar activation feature known in the art. The pump housing 12 also provides a status indicator 16 and a window 18. In other embodiments, one or more of trigger mechanism 14, status indicator 16, window 18, and combinations thereof, may be provided in upper housing 12A or lower housing 12B, such as, for example, on one side Visible to the user, when the drug pump 10 is placed on the user's body. Housing 12 is described in greater detail hereinafter, with reference to other components and embodiments of the present invention.

The drug pump is configured such that upon activation by a user by depressing the activation mechanism, the drug pump is started to: insert a fluid path into the user; enable, connect, or open the necessary connections between a drug container, a fluid path, and a sterile fluid line; and propelling the drug fluid stored in the drug container through the fluid path and the fluid line for delivery to a user. One or more optional safety mechanisms can be used, for example, to prevent premature activation of the drug pump. For example, an optional body sensor 24 (shown in Figure 1C), may be provided in one embodiment as a safety feature, to ensure that the power and control system 400, or the trigger mechanism, cannot be coupled to unless the drug pump 10 is in contact with the user's body. In such an embodiment, the sensor in the body 24 is located in the lower part of the lower housing 12B, where it can enter

<td>in touch with him</td><td>Body</td><td>of the</td><td colspan="2">user.</td><td>After</td><td>the</td>

<td colspan="2">sensor displacement in the</td><td colspan="2">Body</td><td>24, it</td><td>It allows</td><td>the</td>

<td>mechanism tightness</td><td colspan="2">activation.</td><td>In</td><td colspan="2">consequence in</td><td>to the</td>

<td>minus one modality,</td><td>the sensor</td><td>in</td><td>the</td><td>Body</td><td>24 is</td><td>a</td>

<td>safety mechanism</td><td>mechanic,</td><td>such</td><td colspan="2">like for</td><td>example,</td><td>a</td>

mechanical lock that prevents activation of the drug pump 10 by the trigger mechanism 14. In another embodiment, the sensor in the body may be an electromechanical sensor, such as a mechanical lock, that sends a signal to the power system and control 400, to allow activation. In still other embodiments, the sensor in the body may be electrically based such as, for example, a capacitance or impedance based sensor that must detect tissue before allowing activation of the power and control system 400. These concepts are not mutually mutually exclusive. exclusive, and one or more combinations may be used within the scope of the present invention to prevent, for example, premature activation of the drug pump. In a preferred embodiment, the drug pump 10 uses one or more mechanical sensors in the body. Additional integrated safety mechanisms are described herein, with reference to other components of the novel drug pumps.

Power and control system:

The power and control system 400 includes a power source, which provides the power for various electrical components within the drug pump, one or more feedback mechanisms, a microcontroller, a circuit board, one or more conductive pads, and one or more interconnections. Other components commonly used in such electrical systems may also be included, as will be appreciated by someone of ordinary skill in the art. One or more feedback mechanisms can include, for example, audible alarms, such as piezo-alarms and / or light indicators such as light-emitting diodes (LEDs).

The microcontroller can be, for example, a microprocessor. The power and control system 400 controls various interactions of the device with the user and interfaces with the drive mechanism 100. In one embodiment, the power and control system 400 interfaces with the control arm 40, to identify when the sensor in body 24 and / or activation mechanism 14 have been activated. The power and control system 400 can also be interconnected with the status indicator 16 of the pump housing 12, which can be a transmitting or translucent material, allowing light transfer, to provide visual feedback to the user. Power and control system 400 interfaces with drive mechanism 100 through one or more interfaces to transmit status indication, such as activation, drug delivery, and end of dose, to the user. Such status indication can be presented to the user via audible tones, such as through audible alarms, and / or via visual indicators, such as through LEDs. In a preferred embodiment, the control interconnects between the power and control system and the other components of the drug pump are not coupled or connected until user activation. This is a desirable safety feature that prevents accidental operation of the drug pump, and can further maintain the energy contained in the energy source during storage, transportation, and the like.

The power and control system 400 can be configured to provide various different status indicators to the user. For example, the power and control system 400 can be configured such that after the sensor in the body and / or the trigger mechanism has been depressed, the power and control system 400 provides a ready-to-start status signal via status indicator 16, if device startup checks do not provide errors. After providing the ready-to-start status signal, and, in an optional body-sensor mode, if the body-sensor remains in contact with the user's body, the power and control system 400 will energize the drive mechanism. 100 to begin delivery of the drug treatment through the fluid path 300 connection and the sterile fluid line 30. In a preferred embodiment of the present invention, insertion mechanism 200 and fluid path connection 300 can be activated directly by user operation of activation mechanism 14. During the drug delivery process, the energy system and Control 400 is configured to provide a distribution status signal via status indicator 16. After the drug has been administered into the user's body and after the end of any additional residence time, to ensure that substantially all of the dose has been delivered to the user, the Power and Control System 400 can provide a status signal of acceptable to withdraw via status indicator 16. This can be independently verified by a user, by observing the drive mechanism and drug dose delivery through window 18 of pump housing 12. In addition, power and control system 400 can be configured to provide a or more alert signals via status indicator 16, such as, for example, failure indicator alerts or operational failure situations.

Furthermore, the power and control system 400 can be configured to be easily removed from the pump housing 12. In at least one embodiment, the power and control system 400, or certain portions thereof, can be removed from the pump housing 12, by opening a window in the pump housing 12, disconnecting or detaching the power and control system 400 or portions thereof, and removing the power and control system 400 or portions thereof from the drug pump 10. This may be a desired feature for drug pumps 10, which require compliance with regulations related to the manufacture, transportation, use, and disposal of medical devices that contain electronic components. In such configurations of power and control system 400 and pump housing 12, certain or all electronic components such as, for example, the PCB board and batteries, can be easily removed from the drug pump 10, and placed by appropriate methods separate from the other components of the drug pump 10. The drug pumps 10 of the present invention contemplate a window in the upper housing 12A of the pump housing 12 for that purpose, but various other configurations could easily be employed, as will be readily appreciated by someone having ordinary experience in the technique.

Other configurations of the power and control system can be used with the novel drug pumps of the present invention. For example, certain activation delays can be used during drug delivery. As mentioned above, one such delay optionally included within the system configuration is a residence time that ensures that substantially all of the drug dose has been delivered before signaling completion to the user. Similarly, activation of the device may require delayed oppression (i.e., push) of drug pump 10 activation mechanism 14, prior to drug pump activation. Additionally, the system may include a feature that allows the user to respond to end-of-dose signals and to turn the pump for the drug on or off. Such a feature may similarly require delayed oppression of the activation mechanism to avoid accidental deactivation of the device. Such features provide desirable safety and user-friendly integration parameters to drug pumps. An additional safety feature can be integrated into the activation mechanism to avoid partial oppression, and therefore partial activation, of the drug pumps. For example, the activation mechanism and / or the power and control system can be configured, so that the device is completely off or completely on, to avoid partial activation. Such

<td>characteristics</td><td>are described with</td><td>higher</td><td>detail</td><td>here</td>

<td>later,</td><td>with respect to others</td><td>aspects</td><td>of the</td><td>bombs</td>

<td>for the drug</td><td>innovative.</td><td></td><td></td><td></td>

Fluid Path Connection:

Fluid path connection 300 includes a sterile fluid conduit 30, a pierceable member, a connection point, and a sterile sleeve. The fluid path connection may further include one or more flow restrictors. Upon proper activation of device 10, fluid path connection 300 is enabled to connect sterile fluid line 30 to drug container of drive mechanism 100. Such a connection can be facilitated by a piercing member, such as a needle, which penetrates a pierceable seal of the drug container of the drive mechanism 100. The sterility of this connection can be maintained by making the connection within a flexible sterile cuff. Upon substantially simultaneous activation of the insertion mechanism, the fluid path between the drug container and the insertion mechanism is terminated to allow delivery of the drug to the user's body.

In at least one embodiment of the present invention, the piercing member of the fluid path connection is penetrated into the pierceable seal of the drug container of the drive mechanism by direct action of the user, such as by the oppression of the activation mechanism by the user. For example, the activation mechanism itself can be supported at the fluid path connection, such that such displacement of the activation mechanism from its original position also causes displacement of the fluid path connection. In a preferred embodiment, this connection is enabled by the user who depresses the trigger mechanism and thus directs the piercing member through the pierceable seal, as this prevents fluid from flowing from the drug container to desired by the user. In such an embodiment, a sterile compressible sleeve can be fixedly attached between the lid of the drug container and the connection point of the fluid path connection. The piercing member may reside within the sterile sleeve until a connection is desired between the fluid connection path and the drug container. The sterile sleeve can be sterilized to ensure sterility of the piercing member and fluid path prior to activation.

The drug pump is capable of delivering a range of drugs with different viscosities and volumes. The drug pump is capable of delivering a drug at a controlled flow rate (rapidity) and / or a specified volume. In one embodiment, the drug delivery process is controlled by one or more flow restrictors within the fluid path connection and / or the sterile fluid line. In other embodiments, other flow rates may be provided by varying the geometry of the fluid flow path or delivery line, varying the speed at which a component of the drive mechanism advances into the drug container to distribute the drug in the same, or combinations thereof. Still other details about the connection of the fluid path 300 and the sterile fluid line 30 are provided hereinafter in later sections with reference to other embodiments.

Insertion Mechanism:

Various insertion mechanisms can be used within the pumps for the drug of the present invention.

In at least one embodiment, the insertion mechanism

200 includes an insert mechanism housing that has one or more lock windows, and a base for connection to the mounting platform and / or pump housing (as shown in

Figure IB and the

The connection of the base to the mounting platform 20 can be, for example, such that the bottom of the base is allowed to pass through a hole in the mounting platform to allow direct contact of the base with the body. of the user. In such configurations, the bottom of the base may include a sealing membrane that is removable prior to use of the drug pump 10. The insertion mechanism may further include one or more insertion deflection members, a needle, a retraction deviation member, a cannula, and a dispenser. The dispenser can be connected to the sterile fluid conduit 30, to allow fluid flow through the dispenser, the cannula, and into the user's body during drug delivery.

As used herein, needle is intended to refer to a variety of needles, including, but not limited to, conventional hollow needles, such as rigid steel hollow needles, and solid center needles more commonly referred to as trocars. In a preferred embodiment, the needle is a 27 gauge solid center trocar, and in other embodiments, the needle may be a needle of any size suitable for inserting the cannula for the type of drug and drug delivery (eg, subcutaneous , intramuscular, intradermal, etc.) intended. A sterile sleeve can be used within the needle insertion mechanism. The sterile sleeve is a collapsible sterile membrane that is in fixed engagement at a proximal end with the dispenser and at a distal end with the base. In at least one embodiment, the sterile sleeve is held in fixed engagement at a distal end between the base and the insert mechanism housing. The base includes an opening in the base through which the needle and cannula can pass during operation of the insertion mechanism, as will be further described below. The sterility of the cannula and needle is maintained by their initial positioning within the sterile portions of the insertion mechanism. Specifically, as described above, the needle and cannula are held in the sterile medium of the dispenser and the sterile sleeve. The opening in the base of the base can be closed from the non-sterile means as well, such as for example by a sealing membrane 254 (shown in Figure 1C).

In accordance with at least one embodiment of the present invention, the insertion mechanism is initially secured in a ready-to-use stage by locking pins that are initially placed within the locking windows of the insertion mechanism housing. In this initial configuration, the insert deflection member and the retraction deflection member are each retained in their compressed, energized states. As shown in Figure IB, the locking pins 208 can be moved directly by the depressing of the actuating mechanism 14 by the user. As the user uncouples any safety mechanisms, such as an optional body sensor 24 (shown in Figure 1C), the trigger mechanism 14 can be depressed to start the drug pump. Oppression of actuating mechanism 14 can directly cause translation or displacement of control arm 40, and directly or indirectly cause displacement of locking pins 208 from their initial position within locking windows 202Ά of the mechanism housing Insertion 202. The displacement of the locking pins 208 allows the insertion bypass member to decompress from the compressed, energized home state. This decompression of

<td>member of</td><td>deviation</td><td>of</td><td>insertion</td><td colspan="2">directs the needle and the</td>

<td colspan="2">cannula towards the body</td><td>of the</td><td>user.</td><td>At the end of the</td><td>stage of</td>

<td>insertion,</td><td>the member</td><td>of</td><td>deviation</td><td>retraction</td><td>is left</td>

<td>expand</td><td colspan="4">in the proximal direction from their</td><td>state</td>

<td>energized</td><td>initial.</td><td>This</td><td>expansion</td><td colspan="2">axial in direction</td>

proximal of the retraction deviation member, retracts the needle, while maintaining the cannula in fluid communication with the user's body. Accordingly, the insertion mechanism can be used to insert a needle and cannula into the user and subsequently retract the needle while retaining the cannula in position for delivery of the drug to the user's body.

Drive Mechanism:

With reference to the modalities shown in the

Figures 2 and 3, the drive mechanism 100 includes an actuator housing 130, a status switch interconnect 132, and a drug container 50 having a cap 52, a pierceable seal 56, a cylinder 58, and a seal piston 60. The drug container may contain a drug fluid, within the cylinder between the pierceable seal and the plunger seal, for delivery through the insertion mechanism and the drug pump into the user's body. The seals described herein can be comprised of various materials, but in a preferred embodiment, are comprised of one or more elastomers or rubbers.

The drive mechanism may further include a connection assembly to guide the insertion of the piercing member of the fluid path connection into the cylinder 58 of the drug container 50. The drive mechanism 100 may further contain one or more actuator bypass members, one or more release mechanisms, and one or more guides, as further described herein. The drive mechanism components operate to propel fluid from the drug container through the pierceable seal, or preferably, through the piercing member of the fluid path connection, for delivery through the fluid path connection, sterile fluid passage, and insertion mechanism in the user's body.

The drive mechanism may further include one or more contact surfaces located on the corresponding components. Such contact surfaces can be electrical contact surfaces, mechanical contact surfaces, or electromechanical contact surfaces. Such surfaces may initially be in contact and cause to be decoupled, or initially be disconnected and cause to be coupled, to allow a signal to be sent to and / or from the energy control system 400. In at least one embodiment, as further described herein, the contact surfaces may be electrical contact surfaces, which are initially disconnected and caused to engage, whereby upon such engagement, the contact surfaces are capable to continue an energy path or otherwise transmit a signal to the energy and control system 400. In another embodiment of the present invention, the contact surfaces are mechanical contact surfaces that are initially in contact, and are made to decouple, whereby upon such decoupling, such decoupling is communicated to the power and control system 400. Such signals can be transferred through one or more interconnections 132 to the power and control system 400, or by mechanical action to the power and control system

400. Such components can be used within the drive mechanism to measure and transmit information related to the operating state of the drive mechanism, which can be converted by the power and control system 400 into tactile, auditory and / or visual feedback to the user. Such modalities are further described herein. Regardless of the electrical or mechanical nature of the contact surfaces, the movement of the components that enables the transmission of a signal to the energy control system 400 is enabled by a deflection member 122 that axially translates a contact sleeve 140 in the axial direction during the operation of the device.

<td>In a</td><td>particular modality the mechanism of</td>

<td>drive 100</td><td>employs one or more compression springs</td>

<td>like the members</td><td>deviation. After activation of the</td>

pump for the drug by the user, the power and control system can be actuated to directly or indirectly release the compression springs from an energized state. Upon release, the compression springs can be positioned against, and act on the plunger seal to push the drug out of the fluid out of the drug container. The fluid path connection can be connected through the pierceable seal prior to, concurrently with, or after activation of the drive mechanism to allow fluid flow from the drug container through the fluid connection. fluid path, sterile fluid passageway, and insertion mechanism, and to the user's body for drug delivery. In at least one embodiment, fluid flows through only a dispenser and insertion mechanism cannula, thereby maintaining sterility of the fluid path before and during drug delivery. Such components and their functions are described in more detail hereinafter.

Referring now to the embodiment of the drive mechanism shown in Figure 3, the drive mechanism 100 includes a drug container 50 having a lid 52, a pierceable seal 56, a cylinder 58, and a plunger seal 60, and optionally a connection assembly 54. Drug container 50 is mounted at a distal end of an actuator housing 130. Tablet within actuator housing 130, between drug container 50 and proximal end of actuator surface describes

122 and a piston

122 accommodation 130,

<td>this</td><td>a</td><td>member</td><td>deviation</td><td>of the</td><td colspan="2">actuator</td>

<td> 110,</td><td>in</td><td>where</td><td>the member of</td><td colspan="2">deviation</td><td>of the</td>

<td>I know</td><td colspan="2">configure</td><td colspan="2">to stand</td><td>on</td><td>a</td>

I know

110C of the piston 110, as well as the interface additionally herein.

Optionally, a cover sleeve 120 can be used between actuator deflection member 122 and the interface surface 110C of piston 110 to, for example, promote more uniform distribution of force from actuator deflection member 122 to piston 110, avoid deformation of the deviation member of the actuator 122, and / or hide the deviation member from the user view. The surface of the piston interface 110C

<td>110 se</td><td>make</td><td>rest</td><td>substantially</td><td>adjacent to or in</td>

<td>Contact</td><td>with</td><td>an extreme</td><td colspan="2">proximal seal 60.</td>

<td></td><td>The</td><td>mechanism</td><td>drive</td><td>100 further includes,</td>

<td>mounted</td><td>in</td><td colspan="2">a distal end, a</td><td>interconnection of</td>

state switch 132. A contact sleeve 140 is slidably mounted to the actuator housing 130 through an axial opening in the housing 130, such that the hooks of the sleeve 140B at a distal end of the contact sleeve 140 are brought into contact with piston 110 between the surface of interface 110 and a contact boss 110B near the proximal end of piston 110. The piston 110 also includes a securing groove 110A, between the contact boss 110B and the proximal end of the piston 110. The contact sleeve 140 has a radially extending ring 140C at its proximal end, in which one or more reside. flexible pins 140A. An electrical contact 134 can be connected, mounted, printed, or otherwise mounted to the ring

140C, which during operation of the drive mechanism, may come into contact with the corresponding state switch interconnect 132, to close an electrical circuit or otherwise allow transmission to the power and control system to provide feedback to the user.

The components of the drive mechanism 100, upon activation, can be used to direct axial translation in the axial direction of the plunger seal 60 of the drug container 50. Optionally, the drive mechanism 100 may include one or more compliance features, which allow for additional axial translation of the plunger seal 60 to, for example, ensure that substantially all of the drug dose is delivered to the user, and ensure that the mechanisms Contact feedback have been connected. For example, in one embodiment of the present invention, the hooks of the sleeve 140B are flexible arms that can allow, after sufficient application of force by the actuator deflection member 122 to the piston 110, that the surface of the interface 110C axially translate beyond the sleeve hooks 140B to direct additional axial translation of the plunger seal 60 for the fluid fluid compliance push from the drug container. Additionally or alternately, the plunger seal 60 itself may have some compressibility, allowing the fluid compliance of the drug to be pushed from the drug container.

In at least one embodiment of the present invention, a push of drug fluid compliance from the drug container is enabled by a piston extension 102. In such embodiments, the drive mechanism 100 further includes a piston extension 102 slidably mounted at a distal end and within an axial opening of piston 110. The extension of the piston 102 can be retained within the piston 110 by the interaction between the extension arms 102B of the piston extension 102 and the connecting grooves 110D of the piston 110, as shown in Figures 4A-4E. The piston extension may be actuated by a piston extension deviation member 106, which is mounted within the axial opening of piston 110, and initially compressed between piston extension 102 and piston 110. An optional piston deflection member bracket 104 can be used between piston extension deflection member 106 and piston extension 102 to, for example, promote more even distribution of force from the piston deflection member. extension of the piston 106 to the extension of the piston 102. The function of the optional piston extension is described in more detail hereinafter.

The novel drive mechanism of the present invention integrates an indication of the status of the drug dose delivery. Through the use of one or more status switch interconnects and one or more corresponding electrical contacts, the status of the drive mechanism before, during, and after operation can be transmitted to the power and control system to provide feedback to the user. Such feedback may be tactile, visual, and / or auditory, as described above, and may be redundant, such that more than one signal or types of feedback are provided to the user during use of the device. For example, an initial feedback can be provided to the user to identify that the system is operational and ready for drug delivery. Upon activation, the system may then provide one or more indications of the status of drug delivery to the user. With the termination of drug delivery, the drive mechanism and the drug pump can provide an indication of the end of the dose. Since the indication of the end of the dose is related to the piston reaching the end of its axial translation, the actuation mechanism and the drug pump provide an indication of the end of the true dose to the user.

In at least one embodiment, as shown in Figure 2 and Figure 3, an end-of-dose status indication can be provided to the user once the status switch interconnect 132 contacts the electrical contact 134 at the end of axial displacement of piston 110 and plunger 60 into cylinder 58 of drug container 50. In a further embodiment, the indication of the incremental state conveyed by various stages of drug delivery can be communicated to the user during operation. In one such embodiment, the hooks on sleeve 140B of cover sleeve 120 may have one or more interconnects that contact one or more electrical contacts on the outer surface of piston 110 during operation. As piston 110 translates axially in the distal direction to push plunger seal 60 distally, thereby pushing fluid out of the drug container through the end of the pierceable seal, the electrical contacts of piston 110 can contact sequentially with the interconnection on the hooks of the sleeve 140B to transmit the incremental state of the operation. Depending on the number of electrical contacts located on the outer surface of the piston 110, the frequency of the incremental state indication can be varied as desired. The location of the contacts and interconnects can be interchanged in several other configurations, allowing the closure of an electrical circuit, and otherwise allowing for transmission between components.

In another embodiment of the drive mechanism 500, shown in Figures 5 and 6, the incremental state indication can be measured and transmitted by a separate incremental state stem 650 and a corresponding stem interconnect 652. The stem interconnect 652 may be mounted, affixed, printed, or otherwise attached to the incremental state stem 650. Incremental state stem 650 may be a static, i.e. non-moving or moving component, which is mounted to the distal end of contact sleeve 640 and / or the distal end of actuator housing 630, such that the stem Incremental state 650 resides within an axial opening of contact sleeve 640 and actuator housing 630. Incremental state stem 650 further resides within an axial opening of piston 610. In such embodiments of the present invention, one or more contacts can be located on an internal surface of the piston 610, so that they are sequentially interconnected with one or more corresponding interconnections on the stem of the incremental state 650. As piston 610 translates axially in the axial direction to push plunger seal 60 distally, thereby pushing fluid out of the drug container through the end of the perforable seal, the electrical contacts of piston 610 can contact sequentially with the interconnect in the stem of the incremental state 650, to transmit the incremental state of the operation. Depending on the number of electrical contacts, the frequency of the incremental status indication can be varied as desired. The location of the contacts and interconnects can be interchanged in several other configurations, allowing the closure of an electrical circuit or otherwise allowing transmission between components.

Figure 7 shows a cross-sectional view of the embodiment of the drive mechanism shown in Figure 5 during operation of the drive mechanism. As shown, the incremental state stem 650 may be a static component that is mounted to the distal end of contact sleeve 640 and / or the distal end of actuator housing 630, such that the incremental state stem 650 resides within an axial opening of contact sleeve 640 and actuator housing 630. As piston 610 is translated axially in the distal direction (i.e., in the direction of the solid arrow) to push the plunger seal 60 distally, the electrical contacts of piston 610 can sequentially contact the interconnect on the stem of the Incremental state 650 to transmit the incremental state of operation through the interconnect of stem 652. Accordingly, the incremental state of the drive mechanism, and therefore, the state of drug delivery, can be communicated to the user during use of the device.

Returning now to the embodiment shown in Figures 2-3, additional aspects of the novel drive mechanism will be described with reference to Figures 4A-4E. One or more of these aspects can be used in a similar way in the modality shown in Figure 5, or any other variation captured by the modalities described herein. Figure 4A shows a cross-sectional view of the drive mechanism, according to at least a first embodiment, during its initial secured stage. A fluid, such as a drug fluid, can be contained within cylinder 58, between plunger seal 60 and pierceable seal 56, for delivery to a user. Upon activation by the user, a fluid path connection can be connected to the drug container through pierceable seal 56. As described above, this fluid connection can be facilitated by a fluid path connection piercing member, which pierces the pierceable seal and terminates the fluid path from the drug container through the fluid connection. fluid path, fluid passage, insertion mechanism, and cannula for delivery of the drug fluid to the user's body. Initially, one or more locking mechanisms (not shown) may reside within the locking grooves 110A of the piston 110. Directly or indirectly, upon activation of the device by the user, the locking mechanism may be removed from the grooves of assurance 110A of the

<td>piston 110 p</td><td>plow</td><td>allow</td><td>the operation of the</td><td colspan="2">mechanism</td><td>of</td>

<td>drive.</td><td></td><td></td><td></td><td></td><td></td><td></td>

<td>How</td><td>I know</td><td>shows</td><td>in Figure 4A,</td><td>the</td><td>member</td><td>of</td>

<td>deviation from</td><td>the</td><td>extension</td><td>piston 106 and</td><td>the</td><td>member</td><td>of</td>

Bypass of actuator 122, both are initially in a compressed, energized state. Actuator deflection member 122 may be maintained in this state until device activation between the internal features of actuator housing 130 and interface surface 110C of piston 110. As the locking mechanism is withdrawn from the locking groove 110A of the piston 110, the actuator deflection member 122 is allowed to expand (i.e. decompress) axially in the distal direction (i.e. in the direction of the solid arrow). . Such expansion causes actuator bypass member 122 to act on, and distally translate, the interface surface 110C and piston 110, thereby distally moving plunger 60 to push drug fluid out of cylinder 58. Translation Distal piston 110 causes distal translation of piston extension deviation member 106 and piston extension 102, when such optional features are incorporated into the device. As shown in Figure 4B, such distal translation of piston 110 and plunger seal 60 continues to drive fluid flow out of cylinder 58 through pierceable seal 56. The interconnect of state switch 132 is prevented from entering in premature contact with electrical contact 134 via one or more flexible pins 140A, as shown in Figure 4C. Alternately, low force springs or other resistance mechanisms may be used in addition to, or alternately with, the flexible pins 140A to achieve the same functions. During the distal translation of the piston 110, the hooks of the sleeve 140B can slidably contact the external surface of the piston 110. As described above, interconnects and electrical contacts can be located in these components to provide an indication of the incremental state during operation of the drive mechanism.

As the actuation mechanism 100 approaches or reaches the end of the dose, the flexible pins 140Ά can flex outward (i.e., in the direction of the hollow arrows) by the decompression force of the deflection member of the actuator 122. Such flexing of the flexible pins 140A can allow the state switch interconnect 132 to contact the electrical contact 134, closing a circuit or otherwise allowing a transmission to the power and control system to provide feedback to the user. At this stage, one or more delivery compliance mechanisms can be used to ensure that the state switch interconnect 132 has contacted electrical contact 134 and / or that substantially all of the drug dose has been delivered. For example, in one embodiment of the present invention, the hooks of the sleeve 140B are flexible arms that can allow, after sufficient application of force by the actuator deflection member 122 to the piston 110, allowing the interface surface 110C to axially translate past the sleeve hooks 140B to direct additional axial translation of the plunger seal 60 for a push of drug fluid compliance from the drug container. Additionally or alternately, the plunger seal 60 itself may have some compressibility, allowing a push of drug fluid compliance from the drug container. For example, when a popping plunger seal is employed, i.e., a plunger seal that is deformable from an initial state, the plunger seal may deform or pop to provide a push of drug fluid compliance from the container to the drug.

In at least one embodiment of the present invention, a push of drug fluid compliance from the drug container is enabled by a piston extension 102. In such embodiments, the drive mechanism 100 further includes a piston extension 102, slidably mounted at a distal end and within an axial opening of piston 110. The extension of the piston 102 can be retained within the piston 110 by the interaction between the extension arms 102B of the piston extension 102 and the connecting grooves 110D of the piston 110, as shown in Figure 4D. The

<td>extension</td><td>of the</td><td>piston</td><td>can</td><td>act</td><td>by</td><td>a member of</td>

<td>deviation</td><td>of</td><td colspan="2">the extension</td><td>piston</td><td> 106,</td><td>which is mounted</td>

<td>within</td><td>the</td><td>opening</td><td>axial</td><td>piston</td><td> 110</td><td>and it compresses</td>

initially between piston 102 extension and piston

110. An optional piston deflection member bracket 104 can be used between piston extension deflection member 106 and piston extension 102 to, for example, promote more even distribution of force from the extension deflection member. piston 106 to piston 102 extension.

As the piston 110 reaches the end of its displacement within the cylinder 58, the extension of the piston 102 can be allowed to move axially in the distal direction by the force exerted by the deflection member of the extension of the piston 106. At this stage, the piston extension deflection member 106 is allowed to expand (i.e. decompress) axially in the distal direction, so that the extension arms 102B of the piston extension 102 can be moved distally (i.e. in the direction of the solid arrow), within the connecting grooves 110D of the piston 110, as shown in Figure 4D. As shown in Figure 4E, such distal translation (i.e., in the direction of the shaded arrow) of the extension of the piston 102, allows a compliance thrust (shown by dimension C in Figure 4E) of the drug fluid from the drug container. The extension of the piston 102 can be configured so that the extension arms 102B can contact and apply a force on a distal end of the connection grooves 110D to distally move the piston 110 additionally (i.e. in the direction of the arrow Shaded) . This additional distal translation of piston 110 can be used to ensure that the state switch interconnect 132 has engaged contact 134.

As described above, the novel drive mechanisms of the present invention integrate an indication of the status of drug dose delivery. Through the integration of the end-of-dose status indication mechanisms to the axial translation of the piston, and thus the plunger seal, a true and accurate end-of-dose indication can be provided to the user. By using one or more contact surfaces on the corresponding components, the state of the drive mechanism before, during, and after operation can be transmitted to the power and control system to provide feedback to the user. Such feedback can be tactile, visual, and / or auditory, as described above, and can be redundant, such that more than one signal or types of feedback are provided to the user during use of the device. Figures 4A-4E above show an arrangement that provides an end of dose status indication to the user, once the status switch interconnect 132 contacts electrical contact 134 at the end of axial displacement of piston 110 and plunger 60 within cylinder 58 of drug container 50. As described above, the novel devices described herein can further provide an incremental status indication to transmit various stages of drug delivery to the user during operation. In one such embodiment, the hooks of sleeve 140B of cover sleeve 120 may have one or more interconnects that contact one or more electrical contacts on the outer surface of piston 110 during operation. A redundant end-of-dose indication may be used after contact between sleeve hooks 140B of contact sleeve 140 and contact protrusion 110B of piston 110. Electrical contacts or interconnections along piston 110 may come into contact sequentially with the corresponding interconnections or contacts on the hooks of the sleeve 140B, to transmit the incremental state of the operation. Depending on the number of electrical contacts located on the outer surface of the piston 110, the frequency of the incremental state indication can be varied as desired. The location of the contacts and interconnects can be interchanged in various other configurations, allowing the closure of an electrical circuit, or otherwise allowing for transmission between components.

In another embodiment of the drive mechanism 500, shown in Figures 5-7, the incremental state indication can be measured and transmitted by a separate incremental state stem 650 and a corresponding stem interconnect 652. As shown in Figure 7, the incremental state stem 650 may be a static component that mounts to the distal end of contact sleeve 640 and / or the distal end of actuator housing 630, such that the state stem Incremental 650 resides within an axial opening of contact sleeve 640 and actuator housing 630. As the piston 610 is translated axially in the distal direction (i.e., in the direction of the solid arrow) to push the piston seal 60 distally, the electrical contacts of the piston 610 can sequentially contact the interconnect on the stem of the incremental state 650, to transmit the incremental state of operation through stem interconnect 652.

Depending on the number of electrical contacts, the frequency of the incremental status indication can be varied as desired.

The location of the contacts and interconnects can be interchanged in various other configurations, allowing the closure of an electrical circuit, or otherwise allowing for transmission between components. Accordingly, the incremental state of the drive mechanism, and therefore, the state of drug delivery, can be communicated to the user during use of the device.

In a further embodiment of the drive mechanism, shown in

Figures and 9A-9C, the drive mechanism

1000 can be similar to the components mechanism

100 but uses additional mechanism surfaces show or to the mechanism functions contact surfaces

500, and incorporating the respective of such modalities, mechanical rather than electrical, as described shows an isometric view of the actuator 1000 in accordance with the present invention.

views in cross section initial drive, about how an active one modalities,

Those of the one modality

Figures 9A-9C mechanism shown in Figure 8, in an inactive state, the state of completion of the mechanism, ends the signal of the end, and according to the mechanism, drug delivery, dose delivery.

the drug switch interconnect

In such a state it is an 1150 mechanical trigger and the contact surface is 1140P bolt. As shown in Figure 9A, the optional piston extension deviation member 1106 and one of the actuator deviation member 1122 are both initially in a deviation state to the compressed, energized state. Actuator member 1122 can be maintained in that activation of the device between the internal features of actuator housing 1130 and the interface surface 1110C of piston 1110. As the locking mechanism is removed from the locking groove 1110A of piston 1110, the member actuator deflection 1122 is allowed to expand (ie, decompress) axially in the distal direction (ie, in the direction of the solid arrow). Such expansion causes actuator deflection member 1122 to act on, and distally translate, the interface surface 1110C and piston 1110, thereby distally moving plunger 1060 to push drug fluid out of cylinder 1058. The distal translation The piston 1110 causes distal translation of the piston extension deflection member 1106 and piston extension 1102, when such optional features are incorporated into the device.

As the picture shows

9B, such distal translation of piston 1110 and plunger seal 1060 continues to drive fluid flow out of cylinder 1058 through pierceable seal 1056.

As described above, electrical interconnects and contacts can be located in these components to provide indication of incremental status during operation of the drive mechanism. As shown in Figure 9C, as actuator 1000 reaches the end of dose, bolt 1140P disengages from mechanical trigger

1150 to allow transmission to the power and control system 400 to provide feedback to the user. In such an embodiment, disengagement of bolt 1140P from mechanical trigger 1150 allows the trigger to rotate as it is deflected by a deflection member, such as a constant force spring 1170. Initially, constant force spring 1170 deflects the mechanical trigger. 1150 against the 1140P bolt. Following axial translation of bolt 1140P, as described above, bolt 1140P disengages from mechanical trigger 1150, which is then rotated or otherwise displaced to allow transmission of feedback to the user. At this stage, one or more delivery compliance mechanisms, as described above, can be used to ensure that bolt 1140P has disengaged mechanical trigger 1150 and / or that substantially the entire drug dose has been delivered.

The assembly and / or fabrication of the drive mechanism 100, the drug delivery pump 10, or any of the individual components can utilize various materials and methodologies known in the art. For example, various known cleaning fluids such as isopropyl alcohol and hexane can be used to clean components and / or devices.

Various known adhesives or glues can similarly be used in the manufacturing process. In addition, lubrication fluids can be employed during novel devices, sterilization processes, manufacturing or final product stages.

The mechanism various methodologies.

for the drug 50 can fluid for delivery to the drug 50 includes a cylinder cap 58, and a seal of the can be coupled in a cylinder 58 way, at one end cylinder 58 can be filled with and processes for the manufacture of the In addition, they can in a mounting to ensure drive can

In a mounting method, mount first user. The

52, a silicone plunger seal and / or components and employing the or more of sterility mounted on the container and filled with a container for the perforable 56, a

60. The pierceable seal secures between the cap 52 and the distal of cylinder 58. Fluid of the drug through the open proximal end prior to insertion of the plunger seal 60 from the proximal end of cylinder 58. An optional connection assembly 54, may be mounted on a distal end of pierceable seal 56. Connection assembly 54 is to guide insertion of the piercing member from the fluid path connection into cylinder 58 of drug container 50. Drug container 50 can then be mounted to a distal end of actuator housing 130.

One or more switch state interconnects 132 may be mounted at a proximal end of actuator housing 130. A contact sleeve 140, having one or more sleeve hooks 140B at a distal end and a ring 140C at a proximal end having An electrical contact 134 therein can be mounted to the actuator housing 130 through an axial opening from the proximal end of the actuator housing 130. An actuator bypass member 122 can be inserted into a distal end of the actuator housing 130. Optionally, a cover sleeve 120 can be inserted into a distal end of the actuator housing 130 to substantially cover the bypass member 122. A piston can be inserted into the distal end of the actuator housing 130 and through an axial opening of the contact sleeve 140, such that a contact boss 110B of the piston 110 is proximal to the hooks of the sleeve 140B of the contact sleeve 140 Piston 110 and actuator bypass member 122, and optional cover sleeve 120, can be compressed into actuator housing 130. Such an assembly places actuator bypass member 122 in a compressed, energized initial state, and preferably places a surface of the piston interface 110C in contact with the proximal surface of piston seal 60 within the proximal end of cylinder 58. When a piston extension 102 is employed, the piston extension 102 and the piston extension deviation member 106, and an optional piston deviation member holder, can be compressed into an axial opening of the piston 110. The piston, piston deflection member, contact sleeve, and optional components can be compressed and secured in the ready-to-operate state within actuator housing 130 prior to attachment or mounting of the drug container 50.

When one or more interconnects or contacts are used for status indication, such components may be mounted, connected, printed, or otherwise attached to their corresponding components prior to mounting such components on drive mechanism 100. When a separate incremental state stem 650 and a corresponding stem interface 652 are used for such an indication of the incremental state, the stem interconnect 652 may be mounted, attached, printed, or otherwise attached to the incremental state stem 650. Incremental state stem 650 and stem interconnect 652 at the proximal end of contact sleeve 640 and / or the proximal end of actuator housing 630, are mounted such that the incremental state stem 650 resides within a Axial opening of contact sleeve 640 and actuator housing 630.

Incremental state stem 650 is further mounted to reside within an axial opening of piston 610.

It will be appreciated that the end-of-dose indicator or interconnections / contact can include any appropriate arrangement, including, for example, mechanical, electrical, electromechanical, ultrasonic, capacitive, or magnetic arrangements. Similarly, the drive mechanism can be of any suitable design.

Alternate arrangements for both the drive mechanism and the end-of-dose indicator or interconnections / contact are illustrated, for example, in Figures 10A-14B. For clarity, the reference numbers used in Figures 10A-14B are similar to those in the embodiments of Figures 1A-4C, only preceded by the number "2 or 20 as appropriate, to provide a reference number having four digits, i.e. 2XXX. For example, the drug pump and drive mechanism of Figures 10A-14B will be designated by the numbers 2010 and 2100, respectively, as opposed to the drug pump 10 and drive mechanism 100 of Figures 1A- 4E. However, this correlation should not be taken as an indication that the components of Figures 10A-14B with reference numbers similar to those of the embodiments of Figures 1A-4E, are exactly the same as the respective components of Figures 1A-4E.

As shown in Figures 10A-10C, the 2010 drug pump includes a drive mechanism 2100 for receiving a drug container 2050, an insertion mechanism 2200, a fluid path connection 2300 that includes a supply line fluid 2030, and a power and control system 2400, all residing within a 2012 housing, and a 2014 activation mechanism that is operated by a user from outside the 2012 housing. The 2012 enclosure can take any of several configurations and is provided by any of several components, such as a single-body or multi-component 2012 enclosure. Certain other components, such as power and signal electronics, trigger buttons and safety sensors, are also omitted for clarity, but are understood to be standard components within such drug pump devices. Although the 2012 housing, insertion mechanism 2200, fluid path connection 2300, and power and control system 2500, as well as activation mechanism 2014 are not discussed in detail, those skilled in the art will appreciate that they may be the same or similar to the components and systems discussed in detail, with respect to the other modalities described herein.

The drive mechanism 2100, the primary drug container 2050, and a portion of the fluid path connection 2300 are shown isometric in Figure 11 and exploded in Figure 12. Figures 13A- 13C illustrate drive mechanism 2100 in cross section as it progresses through various stages of operation. Figures 14A-14B illustrate a lateral cross section of the drive mechanism 2100 in various stages of operation.

The container for the primary drug 2050 retains the drug treatment to be injected or infused into the patient, and can be a vial or similar container from which a drug treatment can be dosed. To provide a sterile means for drug treatment, the drug container 2050 may include a cylinder 2058 with a pierceable seal 2056 positioned at a distal end and a plunger seal 2060 positioned within a proximal end. Pierceable seal 2056 and plunger seal 2060 can be formed of various materials, such as one or more elastomeric materials, and are dimensioned and formulated to maintain a seal within cylinder 2058.

The fluid path connection portion 2300 illustrated in Figures 11-13C includes a connection assembly 2054, a sterile sleeve 2310, and a perforation assembly 2320. Drill assembly 2320 includes a drill member 2322 that extends from a center 2324 that supports drill member 2322, and provides a fluid connection 2326 (see Figure 11), to which fluid conduit 2030 or other connector The fluid can be fluidly coupled to fluidly couple drug container 2050 to insertion mechanism 2200. Connection assembly 2054 is positioned adjacent to pierceable seal 2056, and includes an opening adapted to guide insertion of the piercing member

2322 Fluid Path Connection to Drug Container 2056 Pierceable Seal

2050.

The 2310 sterile sleeve is placed around the drill mount

2320, and provides a sterile means for terminating the fluid coupling of the fluid path connection 2300.

A collar

2052 it can be provided in order to secure a rim of the sterile sleeve 2310, connection assembly 2054, pierceable seal, and cylinder 2058 in a fixed relationship with each other.

Referring to Figures 1A and IB, in operation, when a user activates trigger mechanism 2014, such as by pressing the illustrated start button, an arm 2015 coupled to trigger mechanism 2014, exerts an axial force on drill assembly 2320. to move piercing member 2322 axially, to pierce pierceable seal 2056.

The

2100 is drive mechanism

<td>adapted</td><td>for</td><td>be used in</td><td>cooperation</td><td>with</td><td>the extreme</td>

<td>proximal</td><td>of the</td><td>container for</td><td>the drug</td><td> 2050,</td><td>to make</td>

<td>move along</td><td colspan="2">axially seal</td><td>plunger</td><td> 2060</td><td>inside of the</td>

<td>cylinder</td><td> 2058,</td><td>for delivery</td><td colspan="3">pharmacological treatment to</td>

one through the fluid path connection 2300, once pierceable seal 2056 has been pierced by piercing member 2322.

The 2100 drive mechanism includes an actuator housing

2130 having an axis that is coincident with axis A of drive mechanism 2100 (see

Figure 11).

Axis A can be placed in coincidence with the axes in container 2050 and piston seal 2060.

A piston 2110 is placed at least partially inside the actuator housing

2130 for longitudinal movement along the axis of the drive mechanism

2100. It will be appreciated that the term shaft when used in relation to the actuator housing

2130, is not intended to require that the shaft be in a central location of the 2130 actuator housing, or that the actuator housing

2130 be round.

Piston 2110 is mounted to move between a first retracted position (illustrated in Figure 13A), where piston 2110 is at least partially positioned within actuator housing 2130, and a second extended position (illustrated in Figures 13B and 13C ), wherein the piston 2110 extends axially outward from the actuator housing 2130. Piston 2110 includes an interface surface 2110C that is positioned to directly face plunger seal 2060 when mounted with a 2050 drug container, or to otherwise transmit actuating force to plunger seal 2060. In other words, the piston 2110 of the drive mechanism 2100 of Figures 10A-14B, is adapted to exert a distributing force on the plunger seal 2060 of the drug container 2050, and to travel outward from a distal end of a housing 2012 to advance the plunger seal 2060 into the drug container 2050 to distribute the drug. Although the initial position shown in Figure 13A illustrates the interface surface 2110C of piston 2110 as positioned substantially adjacent to the distal end of housing 2012, it will be appreciated that in alternate embodiments, the piston may initially be placed in a position extending out of actuator housing 2130. In such an arrangement, at the initial mounting of the drive mechanism 2100 with a 2050 drug container, the piston 2110 may initially be positioned at least partially within the proximal end of the 2050 drug container.

In order to impart axial movement to piston 2010, drive mechanism 2100 further includes a plurality of piston deflection members 2106, 2122, positioned to move from a first energized position when piston 2110 is in the first retracted position. to a second non-energized position when piston 2110 is in a second extended position. It will be appreciated that for purposes of this description and the accompanying claims, the term non-energized second position is a relative term. That is, the piston deflection members 2106, 2122 in the second non-energized position have less energy than the piston deflection members 2106, 2122 in the first energized position. This does not mean, however, that the piston deflection members 2106, 2122 in the second non-energized position are either completely non-energized or do not store energy.

As long as the piston 2110 is held in the first retracted position, the deflection members 2106, 2122 are held in their first energized position (see Figure 13A). The piston 2110 is held in the first retracted position by a retaining element or hook 2115. Although any appropriate arrangement can be used to retain piston 2110 in the first retracted position, hook 2115 can be placed against an external surface of the 2012 drug pump housing, and received in a locking groove 2110A of piston 2110. FIG. 13A illustrates hook 2115 placed in such a first holding position. It will thus be appreciated, by those skilled in the art, that engagement of the retaining element or hook 2115 to hold the piston 2110 in its first retracted position with the deflection members 2106, 2122 in their first energized position, allows the mechanism Actuator 2100 is handled as a self-contained unit so that it can be mounted on the 2010 drug pump or in cooperation with a 2050 drug container. In operation, however, once hook 2115 is withdrawn or moved to a second release position (see Figures 13B and 13C), piston deflection members 2106, 2122 exert an axial distributional force on piston 2110. as they move to a second non-energized position, and the piston moves to its second extended position. In at least one embodiment, hook 2115 can be removed through an action caused, directly or indirectly, by movement of trigger mechanism 2014. The action of removing hook 2115 can be accomplished in several ways. For example, referring to Figure 12, the action of removing the hook

2114 it is a linear movement, perpendicular, with respect to the axis A of the container for drug 2050.

In accordance with one aspect of the invention, as illustrated in the embodiment of Figures 10A-13C, the drive mechanism 2100 is small in size and / or space, although capable of providing the necessary distribution force to push a Drug fluid from a 2050 drug container through a 2030 fluid conduit for drug delivery via an insertion mechanism 2200. In this embodiment of the drive mechanism 2100, the piston deflection members 2106, 2122 are placed in parallel, in contrast to the series arrangement of the embodiments of Figures 1A-9C. It will thus be appreciated, by those skilled in the art, that the drive mechanism 2100 of Figures 10A-14B provides a significantly smaller space than the prior art devices, or even drive mechanisms 100, 500, 1000 of the other modalities in this document.

For the purpose of this description and its claims, when used in relation to the deviation members, either in a specific embodiment of the deviation members, such as springs, or the general use of the term deviation members, the parallel terms They should be interpreted as they would be by those experienced in the art. That is, the terms serial, series, or placed in series are to be interpreted as springs placed and operating as they would connect end-to-end, and the terms parallel, parallel, or placed in parallel, are to be interpreted as springs placed and operating as it would be in a side by side relationship.

Those skilled in the art will appreciate that for series-placed deflection members, the inverse of the equivalent spring constant is equal to the sum of the respective inverses of the spring constants of the individual deflection members. In contrast, the equivalent spring constant of the deflection members 2106, 2122 in a parallel relationship will be the sum of the spring constants of the individual deflection members. Similarly, the distribution force exerted by deflection members 2106, 2122 in a parallel relationship will be the sum of the forces exerted by deflection members 2106, 2122 individually. As a result, the use of deflection members 2106, 2122 placed in parallel provide the desired distribution force in a substantially more compact package, allowing the drive mechanism 2100 to be more compact than the embodiments of Figures 1Ά9C. By extension, the use of deviant members

2106, 2122 placed in parallel, can allow the entire 2010 drug pump to be substantially more compact than an arrangement where the diverter members are placed in series.

In this embodiment, deflection members 2106, 2122 are in the form of a pair of compression springs placed concentrically. However, alternate arrangements are considered. For example, one or more of the deflection members could alternatively, for example, be tension springs, depending on the structure of the drive mechanism components. Furthermore, in the illustrated drive mechanism 2100, the deflection members 2106, 2122 are positioned concentric with respect to each other and the piston 2100. In an alternate embodiment, however, the deflection members may be alternately positioned, by way of example only, in a side-by-side arrangement or on opposite sides of the piston. In still other embodiments, three or more deflection members could be provided and placed in parallel in any appropriate configuration. It will be further appreciated that an additional deflection member may be provided and placed in series with one or more of the deflection members placed in parallel. For example, in an embodiment where the piston includes an extension, similar to the extension of the piston 102 in the

Figures 1A-4E, for example, an additional deflection member can be provided to engage the piston extension.

Returning now to the embodiment of Figures 10A14B, actuation mechanism 2100 includes an end of dose indicator 2133. End of dose indicator 2133 includes an interconnect of switch 2132 and a contact sleeve assembly 2120, adapted to movement with piston 2110. Piston 2110 has an interface surface 2112 that is capable of contacting or otherwise abutting on plunger seal 2060 to push drug fluid out of cylinder 2058 through fluid path connection 2300 to supplying to a patient. In order to provide access of the end of dose indicator 2133 to the interior of the actuator housing 2130, an access window 2131 is included, the importance of which will be further described below.

The mounting contact sleeve 2120 in the embodiment illustrated in Figures 11-13C, includes a pair of telescopic sleeves 2124, 2126. The first sleeve 2124 is adapted for movement with the piston 2110 according to the piston deflection members 2106, 2122 de-energize. A distal flange, generally radially extending 2124A of the first sleeve 2124, is positioned underlying the head 2111 of the piston 2110. In this way, one or both of the deflection members 2106, 2122 abut against the flange 2124A, which abuts against the head of the piston 2111 to impart axial movement to the piston 2110. The second sleeve 2126 is slidably coupled to the first sleeve 2124, the first sleeve 2124 slides distally outward from the second sleeve 2126. In order to allow the second sleeve 2126 to move with the first sleeve 2124 when the first sleeve 2124 is fully extended from the second sleeve 2126, a coupling structure is provided. In the illustrated embodiment, sleeves 2124, 2126 include respective flanges 2124B, 2126A, which engage as the proximal end of first sleeve 2124 approaches the distal end of second sleeve 2126 (see Figure 13A), to make the second Sleeve 2126 moves in the same way in an axial direction with piston 2110 (see Figure 13C).

It will be appreciated, however, that alternative arrangements are considered. By way of example only, the first sleeve 2124 could alternatively be formed integrally with the piston 2110. In this way, the first sleeve 2124 formed with the piston 2110 would move outwardly from a second sleeve 2126, in a similar to that described above. Furthermore, although the sleeve assembly 2120 has been described as including a pair of telescopic sleeves, alternate numbers of sleeves can be used, such as three or more telescopic sleeves. The number of sleeves can depend on cooperative structures, however, such as the relative dimensions of the actuator housing 2130, and the displacement of the piston 2110. For example, in an embodiment using a smaller actuator housing, but having a similar piston displacement, three or more telescopic sleeves may be desirable. In some embodiments where multiple sleeves are provided around the deflection members 2106, 2122, and the deflection members 2106, 2122 are in the form of compression springs, as shown in the illustrated embodiment, the springs in a state compressed, energized, may have a length equal to undeployed sleeves 2124, 2126, although they have an uncompressed, non-powered length that is equal to the length of deployed sleeves. Furthermore, although the end of dose indicator 2133 is described in relation to a drive mechanism 2100 that includes a plurality of deviation members placed in parallel, those skilled in the art will appreciate that the end of dose 2133 could also used in relation to a drive mechanism that includes a single deflection device or a plurality of deflection members placed in series and / or parallel.

As the sleeve assembly 2120 moves axially outward, the proximal end 2126B of the sleeve assembly 2120 passes into the window 2131 of the actuator housing 2130. In the particularly illustrated embodiment, as the second sleeve 2126 moves axially outward, proximal end 2126B of second sleeve 2126 passes window 2131 of actuator housing 2130.

Switch 2132 interconnect includes a 2134 sensor and 2136 electronic coupling to the

<td>2400 power and control.</td><td>To the</td><td>minus a portion of the</td><td>sensor</td><td> 2134</td>

<td>is placed adjacent to</td><td>the</td><td>window 2131, and it</td><td>adapts</td><td>for</td>

<td>identify a change</td><td>in</td><td>the presence of the</td><td>montage</td><td>of the</td>

contact sleeve 2120 proximal to window 2131 within actuator housing 2130. For example, in the illustrated embodiment, sensor 2134 can read that sleeve assembly 2120 is no longer present proximal to window 2131.

In order to better illustrate the relationship of sensor 2134 and sleeve assembly 2120 during movement of sleeve assembly 2120, portions of sleeve assembly 2120 are spaced apart in Figures 13A-13B; in Figures 14A-14B, housing 2130, sleeve 2126, deflection members 2106, 2122, and end of dose indicator 2133 are shown in the cross section taken along line 14-14 in Figure 11. In the illustrated embodiment, sleeve assembly 1120 is positioned adjacent window 2131, when piston 2110 is in the first retracted position (see Figure 13A), and sleeve assembly 1120 begins to move outward with piston 2110. (see Figures 13B and 14A). Conversely, sleeve assembly 1120 is not positioned adjacent window 2131 when piston 2110 is in the second fully extended position (see Figures 13C and 14B). As the proximal end 2126B of the second sleeve 2126 passes to the window, the interconnect of switch 2132 identifies that the sleeve assembly has passed window 2131, and that the end of dose has occurred, and provides that information to the power system and 2400 control. The 2136 electronic coupling can be of any appropriate design. In the illustrated embodiment, for example, sensor 2134 connects directly to a PCB board 2138.

The illustrated switch interface 2132 includes a mechanical sensor 2134 in the form of a rotatably mounted trigger 2135, essentially a mechanical on / off switch. Trigger 2135 is placed in a first position in contact with the sleeve mount

2120, when piston 2110 is in a first retracted position. As the piston 2110 moves out of the actuator housing 2130, the trigger 2135 slides along the telescopic sleeve 2120 assembly until the proximal end 2126B of the second sleeve 2126 passes the window 2131, that is, the Trigger 2135. As the second sleeve 2126 passes to Trigger 2135, Trigger 2135 moves to a second position. Movement of trigger 2135 to the second position results in electronic coupling 2135, which provides a signal indicating the end of the dose to the 2400 power and control system.

The interconnect of switch 2132 can be of any appropriate design, however. For example, the interconnect of switch 2132 may include a sensor of an electromechanical nature, such as that illustrated in Figures 10A-14B, or a sensor of an electrical nature, such as, for example, a reader or optical sensor. Additionally or alternately, the interconnect of switch 2132 may use an ultrasonic sensor, a capacitive sensor, a magnetic sensor, or various other types of sensors. Consequently, the sensor may not require physical contact with the corresponding reference component. In an embodiment that includes an optical sensor, the sensor can read the presence or absence of the sleeve assembly 2120, for example, by reading the interior of the actuator housing actuator 2130 opposite window 2131. The sensor can be configured to additionally or alternately identify, at least one of when the sleeve mount is positioned underlying the window, and when the sleeve mount is not positioned underlying the window, the relative movement of the sleeve mount with reference to the window or other reference component, the stop of such movement, and the speed or change of speed of the movement.

As described above, the interconnects of the switch and the end-of-dose indicator sensors can be configured in a myriad of ways, to function within the drive mechanisms of the present invention. The interconnects of the switch and the sensors can initially be connected (for example, a closed or complete circuit) or disconnected (for example, an open or separate circuit) from a PCB board. Additionally, the sensor can use a trigger that is coupled directly or indirectly to a PCB board to allow transmission of a signal to the power control system. In addition, the actuation mechanism may include more than one interconnect of the switch, sensor, and / or trigger, for example, for functional redundancy or operational robustness.

Figures 15 and 16A-16B show another embodiment of the drive mechanism 3100, including an end of dose indicator 3133. End of dose indicator 3133 includes a switch 3132 interconnect and contact sleeve 3120 assembly. , adapted for movement with the piston. As described above with reference to the modalities shown in Figures 10A-14B, the piston has an interface surface that is capable of contacting or otherwise abutting on the plunger seal to propel drug fluid out of the cylinder through the fluid path connection for delivery to a patient. In order to provide access to the end of dose indicator 3133 into the actuator housing 3130, the actuator housing 3130 includes an access window 3131. In at least one embodiment, the actuator housing 3130 includes more than one window 3131, to allow the passage of more than one interconnect of the switch, sensor and / or trigger to, for example, interconnect with the 3120 sleeve assembly. In order to better illustrate the relationship of the end of dose indicator 3133 and sleeve assembly 3120 during movement of sleeve assembly 3120, Figures 16A and 16B show housing 3130, sleeve 3126, deflection members 3106 , 3122, and the end of dose indicator 3133 in a cross section taken along line 15-15 in Figure 15, before and after actuation, respectively. The 3138 PCB board is included in this view of the 3100 drive mechanism to show the interaction between the 3133 Dose End Indicator and the 3138 PCB board.

The illustrated 3133 Dose Indicator includes a 3134 sensor that includes a mechanical trigger, rotatably mounted 3135, essentially a mechanical on / off switch. In at least one embodiment, the end of dose indicator 3133 has more than one trigger 3135 mounted through more than a corresponding window 3131 of actuation mechanism 3100, for functional redundancy and / or operational robustness. Each of the triggers 3135 is placed in a first position in contact with the sleeve assembly 3120, particularly, the sleeve 3126 thereof, when the piston 3110 is in a first retracted position, illustrated in Figure 16A. As the piston 3110 moves out of the actuator housing 3130, the triggers 3135 slide along the telescopic sleeve 3120 assembly, until such time as the proximal end of the second sleeve 3126 passes the windows 3131, that is, triggers 3135. As second sleeve 3126 passes at least one of triggers 3135, trigger 3135 moves to a second position, illustrated in Figure 16B. Movement of trigger 3135 to the second position results in the transmission of a signal indicating the end of the dose to the power and control system. In this configuration, movement of at least one 3135 trigger will cause signal transmission to occur.

Those skilled in the art will appreciate that in some configurations, there is a possibility that the arrangement of spring 3122 underlying window 3131 after axial movement of sleeve 3126, may inhibit actuation of sensor 3134 from switch interconnect 3132, for example. , inhibiting the movement of trigger 3135 to an actuated position. Although sensor 3134, or trigger 3135, can be prevented from being actuated only temporarily, such delay may result in a corresponding delay in indication of end of dose. Consequently, the inclusion of two or more sensors 3134 or triggers 3135, can provide desirable redundancy. Furthermore, windows 3131 and sensors 3134 can be positioned to maximize the opportunity for actuation of at least one of triggers 3135, concurrently for the purpose of dose delivery. Because more than one 3135 trigger is used in this configuration, the 3133 end-of-dose indicator provides functional redundancy to ensure that an accurate signal is transmitted to the power and control system.

For the purposes of this description and the appended claims, transmission of a signal means the provision of an indication that the end of the dose has occurred. That transmission may be associated with a mechanical movement, for example, coupling or decoupling, or an electrical signal, for example, the provision of an electrical signal or provision, or the suspension of an electrical signal or connection, or a combination of such transmissions. .

In at least one embodiment of the configuration shown in Figures 15-16B, the interconnections of switch 3132 are directly coupled to a PCB board 3138 to allow transmission of a signal to the power control system. Switch 3132 interconnects can be further configured to initially connect (eg, a closed or full circuit) or disconnect (eg, an open or separate circuit) from a 3138 PCB, although the mode shown in Figures 16A-16B shows switch 3132 interconnects initially connected to PCB 3138, that is, prior to dose fil. As the second sleeve 3126 passes at least one of the triggers 3135, as shown in the transition from Figure 16A to Figure 16B, the trigger 3135 moves to a second position, namely, a distance shown as 'DI' in Figure 16B. Movement of trigger 3135 to the second position results, in at least one embodiment, in a disconnection of the interconnection of switch 3132 from PCB board 3138, and the resulting transmission of a * signal indicating the end of dose to the power system And control. Although the illustrated design shows switch 3132 interconnect directly coupled to 3138 PCB board, it will be appreciated that switch 3132 interconnect could alternatively or additionally be coupled to one or more conductive or non-conductive intermediate structures.

The 3133 End-of-Dose Indicator, 3135 Triggers, and 3138 PCB Board, can be alternately configured, as will be readily appreciated by someone with ordinary experience, to cause a connection between them, upon triggering the 3135 trigger to the second position. By way of example only, a trigger may be activated such that the switch interconnect is not in communication with the PCB board prior to the end of the dose, the movement of the trigger at the end of the dose provides a connection directly to, or transmitted to, the PCB board.

In addition, as described below, the connection and disconnection (or vice versa) between the switch 3132 interconnects and the PCB board can be used to provide an indication of incremental status.

The end of dose indicator 3133 may be of any appropriate design and formed of any appropriate material or materials, and by any appropriate manufacturing method. The illustrated switch interconnect 3132 may be formed in whole or in part of a conductive material, for example. In an arrangement where an electrical connection occurs when trigger 3135 is in the position illustrated in Figure 16A and an electrical connection is suspended when trigger 3135 is in the position illustrated in Figure 16B, for example, at least a portion of switch interface 3132 positioned to mate with PCB 3138 can be formed or coated with a conductive material. Conversely, in an arrangement where an electrical connection does not occur when trigger 3135 is in the position illustrated in Figure 16A and an electrical connection occurs when trigger 3135 is in the position illustrated in Figure 16B, for example, at minus a portion of the switch interconnect 3132 positioned to mate with the 3138 PCB, may be formed or coated with an insulating material.

Although illustrated as an electromechanical arrangement that reads the position of a telescopic sleeve, any appropriate arrangement can be provided to read the relative position of any appropriate component, the end-of-dose indicator provides a signal to the power and control system to indicate that all the drug has been administered. In addition, the switch interconnections and corresponding contacts and / or the reference component can be used to provide an indication of the incremental status, in addition to an indication of the end of dose. For example, in the switch interconnect arrangement described above with reference to Figures 10A-14B or Figures 15-16B, the switch interconnect 2132, 3132 may be an electromechanical sensor configured to recognize various bumps, flanges, or grooves, on the corresponding sleeve 2126, 3126, or any other reference component, the contact with which allows the switch interconnect to signal an indication of the incremental state (for example, start of delivery, number of volumes delivered, duration of piston displacement, etc.), and a final indication of end of dose. As described herein, a similar incremental status indication can be provided in this configuration, using a different type of sensor arrangement. For example, the switch interface 2132, 3132 may be an optical sensor configured to recognize various markings on the corresponding sleeve 2126, 3126, or any other reference component. As the optical sensor recognizes several of the markings, it allows the switch interconnect to signal an indication of the incremental status (eg, start of delivery, number of volumes delivered, duration of piston displacement, etc.), and a final indication of end of dose. Any arrangement can be provided

100 appropriate to read the relative position of various marks, flanges, grooves or respective indicators on any appropriate reference component, and the recognition of such indicators by the interconnection of the switch, allows you to provide a signal to the power and control system, to indicate the Incremental state of drug delivery, including the final state that the entire dose has been administered. As will be appreciated by someone with ordinary experience in the relevant art, indicators may not necessarily be defined aspects in a reference component, and switch interconnects can be configured to recognize the actual displacement of the reference component itself. The switch interconnects can be configured as such, to recognize the rate of change, the distance of the displacement or other related measurements in the actual displacement of the reference components and allow a signal to the power and control system to provide the user with such information or feedback. .

It will be appreciated by those skilled in the art, that the embodiments of the present invention provide the driving force necessary to push a plunger seal and a drug fluid into a drug container, while reducing or minimizing the drive space and the

101 total device. Accordingly, the present invention provides a drive mechanism that can be used with a more compact drug delivery pump device. The embodiments of the present invention can be similarly used to provide additional strength, as may be required for highly viscous drug fluids or for larger volume drug containers.

The embodiments shown and detailed herein, describe only a few possible variations of the present invention; Other similar variations are contemplated and incorporated within the scope of this description.

The drive mechanism may further include one or more contact surfaces located on the corresponding components. Such contact surfaces can be electrical contact surfaces, mechanical contact surfaces, or electromechanical contact surfaces. Such surfaces may initially be in contact and cause them to disengage, or initially be

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102 fluid path, can be connected to the cap and / or perforable seal of the drug container. A fluid passage can be connected to the other end of the fluid path connection, which itself is connected to the insertion mechanism, so that the fluid path, when opened, connected or otherwise enabled, is It directly moves from the drug container, the fluid path connection, the fluid passage, the insertion mechanism, and through the drug delivery cannula into a user's body. The components that make up the path for fluid flow are now assembled. These components can be sterilized, by various known methods, and then mounted either fixedly or removably to a mounting platform or drug pump housing, as shown in Figure IB.

Certain optional standard components or variations of the drive mechanism 100 or the drug pump 10 are contemplated, so long as they remain within the scope and scope of the present invention. For example, the upper and lower housings may optionally contain one or more transparent or translucent windows 18, as shown in Figure 1A, to allow the user to view the operation of the drug pump 10 or verify that the drug dose It has been

103 finished. In addition, the drug pump 10 may contain an adhesive patch 26 and a patch liner 28 on the underside of housing 12. Adhesive patch 26 can be used to adhere the drug pump 10 to the user's body for delivery of the dose of the drug. As will be readily understood by someone having ordinary skill in the art, the adhesive patch 26 may have an adhesive surface for adhesion of the drug pump to the user's body. The adhesive surface of the adhesive patch 26 may initially be covered with a coating of the non-adhesive patch 28, which is removed from the adhesive patch 26 prior to placement of the drug pump 10, in contact with the user's body. Removal of the coating from patch 28 can further remove the sealing membrane 254 from insertion mechanism 200, opening the insertion mechanism to the user's body for drug delivery (as shown in Figure 1C).

Similarly, one or more of the components of the drive mechanism 100 and the drug pump 10 can be modified as long as they remain functionally within the scope and scope of the present invention. For example, as described above, although the drug pump housing 10 is shown as two separate components, the upper housing 12A and the

104 bottom housing 12B, these components may be a single unified component. Similarly, although electrical contact 134 is shown as a separate component of contact sleeve 140, it may be a unified component printed on the surface of the ring of contact sleeve 140. As discussed above, a glue, adhesive, or other known materials or methods can be used to secure one or more components of the drive mechanism and / or the drug pump to one another. Alternatively, one or more components of the drive mechanism and / or the drug pump may be a unified component. For example, the upper housing and the lower housing may be separate components fixed together by an adhesive or glue, a screw connection, an interference fit, fusion bonding, soldering, ultrasonic welding, and the like; or the upper housing and the lower housing can be a single unified component. Such standard components and functional variations will be appreciated by one of ordinary skill in the art and, accordingly, are within the scope and scope of the present invention.

It will be appreciated from the foregoing description that the drive mechanisms and drug pumps described herein provide an efficient and easily operated system for delivery of the drugs.

105 Automated drugs from a drug container. The novel modalities described herein provide an integrated status indication to provide feedback to the user. The novel drive mechanisms of the present invention can be activated directly or indirectly by the user. For example, in at least one embodiment, the locking pins that hold the drive mechanism in its energized, locked state move directly from the corresponding locking grooves in piston 110 by user oppression of the trigger mechanism. Furthermore, the novel configurations of the drive mechanism and the drug pumps of the present invention maintain sterility of the fluid path during storage, transportation, and the entire operation of the device. Because the path in which the drug fluid travels within the device is completely maintained in a sterile condition, only these components need to be sterilized during the manufacturing process. Such components include the drug container of the drive mechanism, the fluid path connection, the sterile fluid passage, and the insertion mechanism. In at least one embodiment of the present invention, the power and control system, the mounting platform, the control arm, the

106 Activation, housing, and other components of the drug pump do not need to be sterilized. This greatly improves the manufacturing of the device and reduces the associated mounting costs. Accordingly, the devices of the present invention do not require terminal sterilization upon completion of assembly.

additional benefit of the present invention is that

The components described herein are designed to be modular so that, for example, the housing and other components of the drug pump can be easily configured to accept and operate the drive mechanism 100, the drive mechanism 500, or other variations of the drive mechanism described herein.

The manufacture of a drug pump includes the step of attaching both the drive mechanism and the drug container, either separately or as a combined component, to a drug pump mounting or housing platform. The manufacturing method further includes attaching the fluid path connection, the drug container, and the insertion mechanism to the mounting platform or housing. Additional components of the drug pump, as described above, including the power and control system, the trigger mechanism, and

107 The control arm can be attached, pre-formed, or pre-mounted to the mounting or housing platform. An adhesive patch and a patch liner can be attached to the surface of the drug pump housing, which comes into contact with the user during operation of the device.

One method of operating the drug pump includes the steps of: activating, by the user, the activation mechanism; move a control arm to operate an insertion mechanism; and actuating a power and control system to activate an actuator control mechanism to direct the flow of the fluid drug through the drug pump. The method may further include the step of: attaching a sensor to the optional body prior to activating the trigger mechanism. The method may similarly include the step of: establishing a connection between a fluid path connection to a drug container. In addition, the method of operation may include moving a plunger seal into the actuator control mechanism and the drug container, to drive the flow of the fluid drug through the drug container, connecting the fluid path, a sterile fluid conduit, and the insertion mechanism for delivery of the fluid drug to a user's body. The method of operation of the insertion mechanism and the drug pump can be better appreciated with reference to the

108

Figures 4A-4E, as described above.

Throughout the specification, the object has been to describe the preferred embodiments of the invention, without limiting the invention to any one embodiment or collection of specific features. Various changes and modifications can be made to the described and illustrated embodiments, without departing from the present invention. The description of each patent and scientific document, computer program and algorithm referred to in this specification is incorporated by reference in its entirety.

109