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EP-3679970-B1 - CRADLE FOR AN INFUSION PUMP UNIT

EP3679970B1EP 3679970 B1EP3679970 B1EP 3679970B1EP-3679970-B1

Inventors

  • DECK, FRANK

Dates

Publication Date
20260506
Application Date
20190111

Claims (12)

  1. Cradle (1) for an infusion pump unit, wherein the cradle (1) has a proximal side (23) and a distal side (21), wherein the distal side (21) has an infusion pump unit attachment structure (22) for attaching an initially separate infusion pump unit; wherein the cradle (1) comprises: a cradle base (2); a flow channel (3) for a liquid drug; and a pierceable septum (4), wherein the pierceable septum (4) covers an opening of the flow channel (3) and seals the flow channel (3), and wherein at least an inner piercing core of the pierceable septum (4) is movably mounted with respect to the cradle base (2), characterized in that the inner piercing core of the pierceable septum (4) is movable in a lateral direction of the cradle base (2) and tiltable with respect to a horizontal plane (H) of the cradle base (2).
  2. The cradle (1) according to claim 1, wherein the pierceable septum (4) is sealingly connected to the cradle base (2) by clamping or crimping.
  3. The cradle (1) according to any of the previous claims, wherein the pierceable septum (4) comprises a circumferential sealing ring (42), the inner piercing core (41) and a deformable ribbon (43), wherein the sealing ring (42) and the inner piercing core (41) are circumferentially connected by the deformable ribbon (43).
  4. The cradle (1) according to claim 3, wherein the cradle (1) comprises a stopper (5), wherein the stopper (5) is configured to delimit a movement of the inner piercing core (41) of the septum (4).
  5. The cradle (1) according to any of the previous claims, wherein the cradle (1) comprises a pivotable arm (6), wherein the pivotable arm (6) at least partially comprises the flow channel (3), and wherein the septum (4) is arranged on the pivotable arm (6), and wherein a piercing surface of the septum (4) is essentially parallel to at least a part of the pivotable arm (6).
  6. The cradle (1) according to claim 5, wherein the pivotable arm (6) is pivotable in a lateral direction of the cradle base (2) and/or pivotable out of a horizontal plane of the cradle base (2).
  7. Cradle (1) for an infusion pump unit (8) with a transfer cannula (81), wherein the cradle (1) and the infusion pump unit (8) are releasably connectable wherein the cradle (1) has a proximal side (23) and a distal side (21), the distal side (21) having an infusion pump unit attachment structure (22) for attaching an initially separate infusion pump unit; wherein the cradle (1) comprises: a cradle base (2); a flow channel (3) for a liquid drug; and a pierceable septum (4), wherein the pierceable septum (4) covers an opening of the flow channel (3) and seals the flow channel (3), the cradle (1) further comprising a guide (7) for providing a linear guiding path, wherein the guide (7) is arranged on the distal side (21) of the cradle (1), and wherein the guide (7) surrounds the flow channel (3) and the pierceable septum (4); and characterized in that the guide (7) is movable along a piercing axis (A) of the pierceable septum between an initial position and an operating position, wherein in the initial position the guide (7) prevents the transfer cannula (81) of the infusion pump unit (8) to pierce the septum (4) before the septum (4) and the transfer cannula (81) are aligned in a predefined state, and wherein in the operating position, the transfer cannula (81) can penetrate the septum substantially perpendicular to the piercing surface of the septum (4).
  8. The cradle (1) according to claim 7, wherein in the initial position the guide (7) protrudes from the flow channel (3) and the pierceable septum (4).
  9. The cradle (1) according to any of claims 7 or 8, wherein the guide (7) is tubular.
  10. The cradle (1) according to any of claims 7 to 9, wherein the guide (7) is sliding movable between the initial position and the operating position.
  11. The cradle (1) according to any of claims 7 or 10, wherein in the initial position, the piercing surface of the septum (4) and the transfer cannula (81) of the infusion pump unit (8) are arranged substantially perpendicular to each other and/or the transfer cannula (81) is arranged above a central area of the piercing surface of the septum (4).
  12. The cradle according to any of claims 7 to11, wherein the guide (7) is configured such that any lateral relative movement between the transfer cannula (81) and the septum (4) is prevented in the operating position.

Description

Field of disclosure The present invention lies in the field of cradles for infusion pump units and infusion systems including a cradle. Background, prior art Continuous Subcutaneous Insulin Infusion (CSII) is an established and therapeutically advantageous way of treating diabetes mellitus. Under CSII, a diabetic carries a miniaturized infusion device in form of an insulin pump substantially continuously, night and day. The insulin pump infuses minimal quantities of insulin in a substantially continuous way according to a person-specific, generally time-variable infusion schedule or regime, thus providing a so-called basal amount of insulin that is required by the diabetic's body for maintaining a normal or close-to-normal metabolism and in particular blood glucose concentration. Typically, the basal administration schedule follows a generally circadian cycle and is pre-set by a healthcare professional. In addition, insulin pumps are designed to administer larger insulin quantities, so-called boli, within a short period of time on demand. For a number of years, insulin pumps have virtually always been designed as battery-powered and self-contained devices with a footprint comparable to a credit card. This footprint allows them to be carried in a trousers' pocket, with a corresponding holster and a belt, as necklace, or the like. Via infusion tubing of typically 0.5m to 1.5m length, such devices are coupled to a subcutaneous infusion cannula. A typically syringe-like drug container that is received by a container compartment of the device as well as infusion tubing and the infusion cannula are designed as disposables and are replaced by the patient after a relatively short lifetime of typically a number of days. Over the last years, comparatively sophisticated devices have become available that may include wireless coupling to a remote controller, to a standard computer like a PC a smartphone, or to glucose measurement devices or continuous glucose monitors (CGMs). A typical, commercially available state-of-the-art system includes the ACCU-CHEK® Combo Spirit infusion device and the ACCU-CHEK® Combo Aviva remote controller and glucose measurement device, provided by Roche Diabetes Care. Mainly in order to increase application comfort and discreetness, alternative devices and systems have been developed and become available over the last years. Such devices, while operating according to the same technical principles, are designed as patch-devices that are adhesively attached directly to the infusion site. In addition, for eliminating the need of additional tubing between infusion device and infusion cannula, the infusion site - in most cases the abdomen region - is normally covered by cloths and therefore allows carrying the device in a particularly discrete way during most everyday life situations. These devices are fully integrated disposable devices that need to be discarded and replaced once the application time, which is mainly determined by the container volume and the permissible indwelling time of the infusion cannula, has passed. Replacement is also required if the device is removed from the infusion site for further reasons, such as required for many sportive activities or showering. For improving cost efficiency, modular patch-based systems have been designed that allow selective replacement of components. An example of such a system is disclosed in WO 2009/016635 A2, directed towards a system with a patch unit or liquid drug infusion device that is removable attachable to a cradle, with the cradle being removable attachable to a patient's skin. A subcutaneous infusion cannula is attached to the cradle and fluidic couples, in operation, to the patch unit. The patch unit may itself be two-parted and include a disposable drug container and a reusable dispensing mechanism and control circuitry. In addition to the general advantages associated with a modular design, the architecture allows temporary removing the comparatively sensitive patch unit, including the drug container, e.g. for sportive activity, with the less critical and rugged cradle remaining attached to the skin. WO 2010/041261A1 discloses elements for absorbing shock, pressure, impact and/or other external forces exerted upon a therapeutic fluid delivery device during use to protect the device from physical and internal damage and, thereby, according to some embodiments, maintain for example regulated and continuous administration of therapeutic fluid into the body. A disclosed arrangement may include a dispensing unit and a cradle unit that is securable to the patient's skin. The cradle unit may include a septum and provide for the insertion of a cannula. WO2014/029416A1 discloses a therapeutic system comprising a fluid delivery. The fluid delivery device comprises: a fluid reservoir for storing a fluid and an outlet port with a lumen for outputting the fluid. The outlet port is formed on an exterior surface of the fluid delivery device,