US-12616796-B2 - Injection monitoring module with magnetic rotation sensing

US12616796B2US 12616796 B2US12616796 B2US 12616796B2US-12616796-B2

Abstract

Injection monitoring module removably mountable to a proximal extremity of an injection pen comprising a pen body, a proximally located dose setting wheel, and an injection activator, the dose setting wheel rotating about a central longitudinal axis of the pen during dose setting, the injection monitoring module comprising a hollow main body coaxially mounted on, and engaging in co-rotation with the dose setting wheel, the main body comprising a longitudinal bore having a proximal and distal extremities, and a central longitudinal axis; one or more magnets located on or within the main body; an injection monitoring system comprising at least one magnetic sensor movable in translation along the central axis within the bore, from a first monitoring position, to a second monitoring position; the injection monitoring module further comprising a rotational stop means preventing rotational movement of the monitoring system about the central axis during dose selection.

Inventors

Alain MARCOZ

Assignees

BIOCORP PRODUCTION S.A.S.

Dates

Publication Date: 20260505
Application Date: 20201013

Claims (20)

1 . Injection monitoring module adapted and configured to be removably mounted to a proximal extremity of an injection pen system for delivery of a drug, the injection pen system having a pen body, a proximally located dose setting wheel connected to said body, and an injection activator, the dose setting wheel being rotatable about a central longitudinal axis of the pen injection system during dose setting, wherein the injection monitoring module comprises: a hollow main body adapted and configured to be coaxially mounted on, and engage in corotation with, the dose setting wheel at the proximal extremity of the injection pen system, the hollow main body comprising a central longitudinal bore having a proximal extremity and a distal extremity, and a central longitudinal axis; a magnetic field production means, located on or within the hollow main body, at the proximal extremity of the central longitudinal bore; an injection monitoring system comprising at least one or a plurality of magnetic sensors, the injection monitoring system being located at the proximal extremity of, and movable in translation along said central longitudinal axis within the bore of the hollow main body, from a first monitoring position in which the injection monitoring system is not in abutting contact with a proximal surface of the injection activator, to a second monitoring position in which the injection monitoring system is in abutting contact with a proximal surface of the injection activator; the injection monitoring module further comprising a rotational stop means configured and adapted to prevent rotational movement of the injection monitoring system about said central longitudinal axis during dose selection.
2 . Injection monitoring module according to claim 1 , wherein the rotational stop means comprises a rotationally fixed coupling disposed in parallel to the central longitudinal axis, the rotationally fixed coupling connecting the injection monitoring system to the body of the pen injection system.
3 . Injection monitoring module according to claim 1 , wherein the rotational stop means is further configured and adapted to permit translational movement of the injection monitoring system from the first injection monitoring position to the second injection monitoring position during injection, and vice-versa, from the second injection monitoring position to the first injection monitoring position, after completion of injection.
4 . Injection monitoring module according to claim 2 , wherein the rotationally fixed coupling comprises: at least one elongate rod member, or a plurality of elongate rod members, extending from the injection monitoring system in a distal direction in parallel to the longitudinal axis and bypassing an outside surface of the hollow main body; and a sheath member, mounted on the body of the injection pen system, adapted and configured to receive the at least one, or plurality of, elongate rod members in sliding engagement with said sheath member during translational movement of the injection monitoring system from the first monitoring position to the second monitoring position.
5 . Injection monitoring module according to claim 4 , wherein the at least one, or plurality of, elongate rod member(s), of the rotationally fixed coupling of the rotational stop means is/are integrally formed with an injection monitoring system holder.
6 . Injection monitoring module according to claim 4 , wherein the at least one, or plurality of, elongate rod member(s), is/are integrally formed with a cap of the injection monitoring system holder.
7 . Injection monitoring module according to claim 4 , wherein the at least one, or plurality of, elongate rod member(s) comprises at least one portion of the elongate rod member which defines an elliptical spline, extending in a distal direction from said injection monitoring system in parallel to the central longitudinal axis.
8 . Injection monitoring module according to claim 4 , wherein the sheath member comprises at least one runnel, or a plurality of runnels, configured and adapted to respectively receive the at least one, or the plurality of, elongate rod members, in sliding engagement.
9 . Injection monitoring module according to claim 8 , wherein the at least one, or plurality of runnel(s) extend(s) in parallel to the central longitudinal axis.
10 . Injection monitoring module according to claim 4 , wherein the sheath member further comprises a body mount portion, configured and adapted to enable removable mounting of the sheath member to the body of the pen injection system.
11 . Injection monitoring module according to claim 4 , wherein the sheath member further comprises a retaining bridge including at least one, or plurality of, runnel(s) each of which being configured to retain one of said at least one, or plurality of elongate rod member(s).
12 . Injection monitoring module according to claim 4 , wherein the rotationally fixed coupling further comprises a removable link configured and adapted to temporarily position the sheath member and the at least one, or plurality of, elongate rod members, in a predetermined, spaced apart relationship, along an axis parallel to central longitudinal axis during mounting of the injection monitoring module on the body of the injection pen system.
13 . Injection monitoring module according to claim 4 , wherein the sheath member and the injection monitoring system each further comprise a recess configured to receive and engage in a temporary positioning relationship with a portion of the removable link.
14 . Injection monitoring module according to claim 1 , wherein the hollow main body further comprises translational abutment means adapted and configured to prevent axial translational movement of the hollow main body along the central longitudinal axis, when the injection monitoring module is in the mounted position on the injection pen system.
15 . Injection monitoring module according to claim 14 , wherein the translational abutment means of the hollow main body comprises an annular flange extending inwardly into the bore toward the central longitudinal axis from an inside surface of the hollow main body.
16 . Injection monitoring module according to claim 1 , wherein the hollow main body further comprises a distal body portion which extends around and frictionally engages with an outer surface of the dose setting wheel.
17 . Injection monitoring module according to claim 1 , wherein the injection monitoring module further comprises injection begin determination means or injection end determination means and the injection begin and/or end determination means comprise an optical sensor and a corresponding reflecting surface.
18 . Injection monitoring module according to claim 4 , wherein an optical sensor is located on the injection monitoring system adjacent the at least one, or plurality of, elongate rod member(s) and the reflecting surface for the optical sensor is located on the sheath member facing opposite to, and in optical axial alignment with, the optical sensor on the injection monitoring module.
19 . Injection monitoring module according to claim 18 , wherein the injection monitoring system further comprises an electronic component board, and at least one micro-controller, in electrical connection with the one or plurality of magnetic field sensors and the at least one micro-controller is in electrical connection with the optical sensor.
20 . Injection monitoring module according to claim 19 , wherein the electronic component board comprises a communications unit in electrical connection with the at least one microcontroller.

Description

The present invention relates generally to monitoring systems for injectable drug delivery devices, and in particular to injection monitoring for injection pen systems. Injection monitoring is a well known field associated with injectable drug delivery devices, especially with regard to infusion systems, for example. Over time, such monitoring systems have been transferred more recently to injection pen systems for delivery of a drug, enabling users of such pen injection systems, and health care professionals involved in the treatment and follow-up of such patients, to monitor more closely their own injection regimes, and in many cases, the doses actually administered, in an attempt to lead to better healthcare outcomes. These developments have been accompanied by the increased associated use of software and portable communications devices such as tablets or smartphones, which have been programmed to receive information from, and interact with, the monitoring systems in order to provide information to the user or healthcare professional on-the-fly, or at regular intervals via appropriate communications units included in the monitoring systems. In regard to pen injection systems in particular, for example, one of the challenges has been to provide easy to use, reliable and fairly failsafe monitoring systems that can be adapted to the various different variants of such commercially available pen injection systems, of which there are many. Previous attempts at providing such monitoring systems have usually involved adapting the body of the pen injection system by including electronic components therein along with one or more sensors. One of the major disadvantages of such systems however, is that they tend to make the end product, once all of the electronic components have been integrated, into fairly bulky and unwieldy objects, and thus more difficult to use from a user perspective. Additionally, such modified systems tend to be very specific to a given brand or a manufacturer, and thus of little or no use with pen injection devices of other manufacturers. There has furthermore been a tendency to attempt to reduce the overall volume of the injection pen bodies as much of possible through miniaturisation of the complex electronic components, which in turn has brought about its own problems, in particular with regard to electromagnetic interference between the various components due to the close proximities of the circuits providing the required or desired integrated functionality. Moving the sensors in such monitoring systems further away from the source of electromagnetic interference only further complicates matters, potentially leading to erroneous readings, or requiring further systems to compensate for the physical separation of the sensors from the other electronic components, such as a micro-controller designed to control and command the various components and manage their interactions. The injection pen systems in question are well known per se and are commonly equipped with a proximally located dose setting wheel and injection activator, the dose setting wheel being rotatable about a central longitudinal axis of the pen injection system. The wheel is rotated by the user to select the dose of drug to be administered. The pen is generally configured, either mechanically or electro-mechanically to effect an injection upon activation of an injection activator. Such injection activators are quite commonly a simple press or push-button, in mechanical or electrical contact with the dispensing mechanism located within the pen injection system, the pressing of which causes the injection mechanism to fire and inject the drug contained within the pen injection system. In some pen injector systems, the dose setting wheel is configured to rotate not only during dose setting, but also during injection. This is generally achieved through the inclusion of one or more metallic components, such as a helically wound drive spring located within a housing body of the injection pen system and physically coupled to the dose setting wheel. As such metallic elements are relatively large objects in comparison to the electronic component systems that are included in many pen injection systems today, these large metallic objects can further perturb signals that the sensors in such electronic component systems are designed to capture or pick up, rendering the systems potentially less accurate, and/or requiring that complex correction mechanisms be put in place to avoid calculation errors. Some attempts at overcoming the difficulties of electronic component integration have already been described in the patent literature. For example, published PCT patent application WO2014128156A1 relates to a sensor assembly having a first rotary sensor part with a plurality of individual electrically conducting sensor areas arranged in a pattern, a second rotary sensor part arranged rotationally relative to the first part, and comprising a plur