US-12623026-B2 - Injection monitoring module

US12623026B2US 12623026 B2US12623026 B2US 12623026B2US-12623026-B2

Abstract

An injection monitoring module for mounting onto the body of an injection pen system comprising a rotatable dose setting wheel, and an injection activator, and having a central longitudinal axis, the injection monitoring module comprising: a hollow main body comprising a central longitudinal bore; a magnetic field production means, located on the hollow main body, at the proximal extremity of the bore; an injection monitoring system comprising at least one magnetic sensor; an inner sleeve located within the bore, engaging with the outer surface of the dose wheel, and co-rotating therewith during dose setting, without axial translation; the inner sleeve being connected to the monitoring system to enable co-rotation of both the sleeve and monitoring system about the axis during dose setting, and translation of the monitoring system along the axis, without rotation, during injection of a drug from the pen.

Inventors

Alain MARCOZ

Assignees

BIOCORP PRODUCTION S.A.S.

Dates

Publication Date: 20260512
Application Date: 20200623

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 and fixed against rotation during injection, wherein the injection monitoring module comprises: a hollow main body adapted and configured to be coaxially mounted around the body of the pen injection 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 the bore of the hollow main body; the hollow main body further comprising an inner sleeve rotationally located within the central longitudinal bore, and configured to frictionally engage with an outer surface of the dose setting wheel to co-rotate around the central longitudinal axis with respect to said hollow main body, without axial translation along said central longitudinal axis, with the dose setting wheel during dose setting; wherein the inner sleeve is rotationally locked to the injection monitoring system such that rotation of said injection monitoring system causes rotation of said inner sleeve with respect to said hollow main body; and wherein the injection monitoring system is configured for translational movement with respect to said inner sleeve along the central longitudinal axis, during injection and/or ejection of a drug from the pen injection system.
2 . 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 body of the injection pen system at a location distal to the dose setting wheel.
3 . Injection monitoring module according to claim 2 , wherein the hollow main body further comprises translational abutment means adapted and configured to prevent axial translational movement of the inner sleeve along the central longitudinal axis, when the injection monitoring module is in the mounted position on the injection pen system.
4 . Injection monitoring module according to claim 3 , wherein the translational abutment means of the hollow main body are formed as an annular groove or annular slot provided on an inside surface of the hollow main body.
5 . Injection monitoring module according to claim 4 , wherein the translational abutment means are formed from a distally oriented surface provided on the hollow main body, and a respectively proximally oriented surface of the distal body portion, said distally oriented surface and said proximally oriented surface forming together a cooperating translational abutment surface for said inner sleeve.
6 . Injection monitoring module according to claim 1 , wherein the inner sleeve further comprises surface engagement means located adjacent to, or substantially at, a distal extremity of said inner sleeve, wherein said surface engagement means are configured to engage with at least an inner surface of a distal body portion of the hollow main body and thereby prevent translational movement of the inner sleeve in a distal and/or proximal direction, when the injection monitoring module is in the mounted position on the injection pen system.
7 . Injection monitoring module according to claim 6 , wherein where the surface engagement means comprise at least one continuous projection, or a plurality of separate projections, extending radially outwardly from an outer surface of said inner sleeve.
8 . Injection monitoring module according to claim 6 , wherein the surface engagement means comprise at least one distally oriented surface, and said distally oriented surface of the surface engagement means engages with a respectively proximally oriented surface of a translational abutment means provided on an inside surface of the hollow main body.
9 . Injection monitoring module according to claim 6 , wherein the surface engagement means comprise at least one continuous projection, or a plurality of separate projections, extending radially outwardly from an outer surface of said inner sleeve and the translational abutment means of the hollow main body are formed as an annular groove or annular slot provided on an inside surface of the hollow main body, wherein said annular groove or annular slot is adapted and dimensioned to receive said at least one continuous projection, or a plurality of separate projections, extending radially outwardly from an outer surface of said inner sleeve.
10 . Injection monitoring module according to claim 1 , wherein the inner sleeve further comprises at least one, or a plurality, of elastically deformable surfaces extending inwardly towards the central longitudinal axis from said inner sleeve, forming at least one, or a plurality, of frictionally engaging surfaces to frictionally engage with an outer surface of the dose setting wheel.
11 . Injection monitoring module according to claim 10 , wherein the at least one, or plurality, of elastically deformable surfaces extending inwardly towards the central longitudinal axis from said inner sleeve is a ring of elastically deformable material comprising a plurality of coaxially aligned, radially spaced apart teeth, extending in a same direction from said ring, and said ring is seated at a proximal extremity of the inner sleeve, with the teeth oriented to extend in a distal direction, along an outer and/or inner surface of said sleeve.
12 . Injection monitoring module according to claim 10 , wherein the inner sleeve further comprises a plurality of coaxially aligned, radially spaced apart, openings traversing the inner sleeve from an outer surface to an inner surface.
13 . Injection monitoring module according to claim 12 , wherein the at least one, or plurality, of elastically deformable surfaces extends through the radially spaced apart openings traversing the inner sleeve.
14 . Injection monitoring module according to claim 1 , wherein the inner sleeve further comprises at least one injection monitoring system connection surface extending from an inner surface of the inner sleeve and projecting inwardly towards the central longitudinal axis of the bore.
15 . Injection monitoring module according to claim 14 , wherein the at least one injection monitoring system connection surface extending from the inner surface of the inner sleeve and projecting inwardly towards the central longitudinal axis of the bore comprises at least one, or a plurality of, recesses provided in said connecting surface.
16 . Injection monitoring module according to claim 15 , wherein the injection monitoring system comprises a housing, and said injection monitoring system housing comprises at least one connection surface extending from said housing in a distal direction.
17 . Injection monitoring module according to claim 16 , wherein the at least one injection monitoring system connection surface and the at least one injection system housing connection surface are adapted and configured to engage mutually with each other in a first position in which rotation of the injection monitoring system housing causes co-rotation of the inner sleeve, and to engage with each other in a second position in which the injection monitoring system only translates along the central longitudinal axis in a distal or proximal direction, without rotation of the injection monitoring system housing around said central longitudinal axis.
18 . Injection monitoring module according to claim 17 , wherein the at least one connection surface extending from said injection monitoring system housing comprises at least one, or a plurality of, distally extending projections, extending from a distal extremity of the housing and aligned coaxially with the central longitudinal axis.
19 . Injection monitoring module according to claim 18 , wherein, in the first position, the at least one, or plurality of, distally extending projections of the injection monitoring housing each comprise an outwardly facing connection surface which frictionally engages with a corresponding inwardly facing surface of the at least one, or plurality, of recesses provided in said inwardly projecting connecting surface.
20 . Injection monitoring module according to claim 18 , wherein, in the second position, the at least one, or plurality of, distally extending projections extending from said injection monitoring system housing further comprise at least one distally oriented contact surface which is in contact with the injection activator.

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 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 other manufacturers. Furthermore, in order to overcome the issues with bulkiness and unwieldiness of the modified pen injection systems, there has 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 arr