CN-116322839-B - Injection monitoring module with magnetic rotation induction

Abstract

An injection monitoring module detachably mountable to a proximal end of an injection pen includes a pen body, a dose setting wheel at the proximal end, and an injection activator. The dose setting wheel rotates around the central longitudinal axis of the pen during dose setting. The injection monitoring module comprises a hollow body coaxially mounted on and co-rotatably engaged with the dose setting wheel. The body includes a longitudinal bore having a proximal end, a distal end, and a central longitudinal axis, and one or more magnets located on or within the body. The injection monitoring system includes at least one magnetic field sensor that moves along a central axis within the bore from a first monitoring position to a second monitoring position. The injection monitoring module further comprises rotation stopping means for preventing rotational movement of the monitoring system around the central axis during dose selection.

Inventors

• A. Malkoz

Assignees

• 生物合作制造公司

Dates

Publication Date

20260512

Application Date

20201013

Claims (20)

1. 1. An injection monitoring module adapted to be configured to be detachably mounted to a proximal end of an injection pen system for delivering a medicament, the injection pen system having a pen body, a proximally located dose setting wheel connected to the pen body, the dose setting wheel rotating about a central longitudinal axis of the injection pen system during dose setting, and an injection activator, wherein the injection monitoring module comprises: a hollow body adapted to be coaxially mounted on the dose setting wheel of the proximal end of the injection pen system and configured for co-rotating engagement with the dose setting wheel of the proximal end of the injection pen system, the hollow body comprising a central longitudinal bore having a proximal end, a distal end and a central longitudinal axis; A magnetic field generating device located on or within the hollow body, the magnetic field generating device being at the proximal end of the central longitudinal bore; An injection monitoring system comprising at least one or more magnetic field sensors, the injection monitoring system being located at the proximal end of the hollow body and the injection monitoring system moving along the central longitudinal axis within the bore of the hollow body from a first monitoring position to a second monitoring position, the injection monitoring system being out of adjacent contact with a proximal surface of the injection activator in the first monitoring position, the injection monitoring system being in adjacent contact with a proximal surface of the injection activator in the second monitoring position; The injection monitoring module further comprises a rotational stop device configured and adapted to prevent rotational movement of the injection monitoring system about the central longitudinal axis during dose selection; Wherein the rotational stop device comprises a rotational stationary connector arranged parallel to the central longitudinal axis, the rotational stationary connector connecting the injection monitoring system to the pen body of the injection pen system; the rotationally fixed connector includes: At least one elongate rod member or a plurality of elongate rod members extending in a distal direction from the injection monitoring system and beyond an outer surface of the hollow body parallel to the longitudinal axis, and A sheath member mounted on the pen body of the injection pen system, the sheath member adapted to be configured to receive the at least one or more elongate rod members in sliding engagement during translational movement of the injection monitoring system from the first monitoring position to the second monitoring position.
2. 2. The injection monitoring module of claim 1, wherein the rotational stop device is further configured and adapted to allow the injection monitoring system to move from the first monitoring position to the second monitoring position and vice versa during an injection, and from the second monitoring position to the first monitoring position after an injection is completed.
3. 3. The injection monitoring module of claim 1, wherein the at least one or more elongate rod members are integrally formed with a bracket of the injection monitoring system.
4. 4. The injection monitoring module of claim 3, wherein the at least one or more elongate rod members are integrally formed with a cover of the injection monitoring system holder.
5. 5. The injection monitoring module of any of claims 3-4, wherein the at least one or more elongate rod members comprise at least a portion of the elongate rod members defining an elliptical spline extending distally from the injection monitoring system parallel to the central longitudinal axis.
6. 6. The injection monitoring module of any of claims 3-4, wherein the sheath member comprises at least one or more flow channels configured to receive the at least one or more elongate rod members, respectively, in sliding engagement.
7. 7. The injection monitoring module of claim 6, wherein the at least one or more flow channels extend parallel to the central longitudinal axis.
8. 8. The injection monitoring module of claim 6, wherein the sheath member further comprises a pen body mounting portion configured to be adapted to removably mount the sheath member to the pen body of the injection pen system.
9. 9. The injection monitoring module of claim 6, wherein the sheath member further comprises a securing bridge configured and adapted to secure the respective at least one or more elongate rod members in the respective at least one or more flow channels, respectively.
10. 10. The injection monitoring module of claim 1, wherein the rotationally fixed connector further comprises a detachable link configured to temporarily position the sheath member and the at least one or more elongate rod members in a predetermined spaced relationship along an axis parallel to the central longitudinal axis during installation of the injection monitoring module on a pen body of the injection pen system.
11. 11. The injection monitoring module of claim 10, wherein the sheath member and the injection monitoring system each further comprise a recess configured to receive and engage a portion of the detachable link in a temporary positioning relationship.
12. 12. The injection monitoring module of claim 1, wherein the hollow body further comprises a translation stop configured to prevent axial translational movement of the hollow body along the central longitudinal axis when the injection monitoring module is in a mounted position on the injection pen system.
13. 13. The injection monitoring module of claim 12, wherein the translational stop of the hollow body comprises an annular flange extending inwardly into the bore from an inner surface of the hollow body toward the central longitudinal axis.
14. 14. The injection monitoring module of claim 13, wherein the hollow body further comprises a distal body portion extending around an outer surface of the dose setting wheel and frictionally engaging the dose setting wheel.
15. 15. The injection monitoring module of claim 1, wherein the injection monitoring module further comprises an injection start determining means.
16. 16. The injection monitoring module of claim 1, wherein the injection monitoring module further comprises end of injection determination means.
17. 17. The injection monitoring module of claim 15, wherein the injection start determining means comprises an optical sensor and a corresponding reflective surface.
18. 18. The injection monitoring module of claim 16, wherein the end of injection determining means comprises an optical sensor and a corresponding reflective surface.
19. 19. The injection monitoring module of claim 17 or 18, wherein an optical sensor is located on the injection monitoring system adjacent to the at least one or more elongate rod members.
20. 20. An injection monitoring module according to claim 17 or 18, wherein the reflective surface for the optical sensor is located on the sheath member opposite and in optical axial alignment with the optical sensor on the injection monitoring module.

Description

Injection monitoring module with magnetic rotation induction Technical Field The present invention relates generally to monitoring systems for injectable drug delivery devices, and in particular to injection monitoring for injection pen systems. Background The field of injection monitoring is well known in connection with injection drug delivery devices, for example in particular in connection with infusion systems. Over time, such monitoring systems have recently moved to injection pen systems for delivering drugs, enabling users of such injection pen systems and healthcare professionals involved in the treatment and follow-up of such patients to more closely monitor their own injection methods, in many cases the actual doses administered, in an attempt to obtain better healthcare results. These developments have been accompanied by an increase in the relative use of software and portable communication devices (such as tablet computers or smartphones) that have been programmed to receive information from and interact with the monitoring system in order to provide information to users or healthcare professionals in real time or periodically through appropriate communication units contained in the monitoring system. For example, with respect to injection pen systems, one of the challenges is to provide an easy-to-use, reliable and reasonably safe monitoring system that can accommodate the various variations of such commercially available injection pen systems, many of which are available. Previous attempts to provide such monitoring systems have generally involved adjusting the body of the injection pen system, including the electronics and one or more sensors. However, one of the main drawbacks of such systems is that once all electronic components are integrated together, they tend to make the final product a rather bulky and heavy object, and thus more difficult to use from a user's point of view. In addition, such improved systems tend to be largely specific to a particular brand or manufacturer, and therefore little or no injection pen equipment is used by other manufacturers. In addition, there is a trend to try to reduce the overall volume of the injection pen body as much as possible through miniaturization of complex electronic components, which in turn presents its own problems, particularly electromagnetic interference between the various components due to the close proximity between the circuits providing the required or desired integrated functions. Moving the sensor in the monitoring system away from the electromagnetic interference source simply complicates the problem, may lead to erroneous readings, or requires a further system to compensate for the physical separation between the sensor and other electronic components, such as a microcontroller designed to control and command the various components and manage interactions between them. Injection pen systems are well known per se and are typically equipped with a dose setting wheel and an injection activator in a proximal position, the dose setting wheel being rotatable about a central longitudinal axis of the injection pen system. The user selects the dose to be administered by rotating the wheel. The pen is typically mechanically or electromechanically configured to produce an injection effect upon actuation of the injection activator. Such an injection activator is typically a simple push or push button that is in mechanical or electrical contact with a dispensing mechanism located within the injection pen system, the depression of which causes the injection mechanism to fire and expel the medicament within the injection pen system. In some injection pen systems, the dose setting wheel rotates not only during dose setting, but also during injection. This is typically accomplished by incorporating one or more metal components, such as a helically wound drive spring located within the injection pen system housing and physically connected to the dose setting wheel. Since these metallic components are relatively large objects compared to the electronic component systems that are currently included in many injection pen systems, these large metallic objects may further interfere with sensors in these electronic component systems that are designed to capture or receive signals, making the system potentially less accurate and/or requiring complex corrective mechanisms to avoid calculation errors. Several attempts to overcome the difficulties of electronic component integration have been described in the patent literature. For example, published PCT patent application WO2014128156A1 relates to a sensor assembly having a first rotary sensor portion with a plurality of individually conductive sensor areas arranged in a pattern, and a second rotary sensor portion rotatably arranged relative to the first portion and including a plurality of contact structures adapted to contact the conductive sensor areas on the first sensor rotary portion. The conta