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EP-3592405-B1 - RECONSTITUTION DEVICE, SYSTEM AND METHOD

EP3592405B1EP 3592405 B1EP3592405 B1EP 3592405B1EP-3592405-B1

Inventors

  • BOURELLE, Dylan
  • HUDDLESTON, MATTHEW
  • PALMER, JOETTA, RENEE
  • STEFANCHIK, DAVID

Dates

Publication Date
20260506
Application Date
20180309

Claims (8)

  1. A device for reconstituting a lyophilized product comprising: a. a housing (316) including a vial receptacle (306); b. a vial holder (302) configured to be connected to the vial receptacle (306) of the housing and to hold a first vial containing a lyophilized product and a second vial containing a diluent; c. a pressurized fluid supply system configured to transfer diluent from the second vial to the first vial; d. a motor (325) configured to be connected to the vial holder (302) when the vial holder (302) is connected to the vial receptacle (306) and to vibrate the first vial so that the lyophilized product in the first vial is reconstituted with diluent transferred from the second vial to the first vial; e. a trigger mechanism (342) and an electronic controller (348), wherein the electronic controller (348) is configured to control the motor (325) and the trigger mechanism (342) is connected to the vial receptacle (306) and the electronic controller (348); and f. a vial holder carriage (318) configured to receive the vial holder (302) and to activate the trigger mechanism (342) when the vial holder (302) is connected to the vial holder carriage (318) and wherein the motor (325) is configured to vibrate the vial holder carriage (318).
  2. The device of claim 1 wherein the lyophilized product includes a drug.
  3. The device of claim 1 further comprising a vial retainer (328) configured to lock the vial holder (302) within the vial holder carriage (318) after the vial holder (302) is inserted into the vial holder carriage (318).
  4. The device of claim 1 wherein the motor (325) is an eccentric rotating mass motor.
  5. The device of claim 1 wherein the housing (316) further comprises an injection device receptacle (314), said injection device receptacle (314) configured to receive an injection device (315) and wherein the pressurized fluid supply system is further configured to transfer reconstituted product from the first vial to an injection device connected to the injection device receptacle.
  6. The device of claim 1 wherein the motor (325) is configured to vibrate the first vial at a frequency below 500 Hz.
  7. The device of claim 1 further comprising a vibration dampener (320) configured to be connected to the vial holder (302) when the vial holder (302) is connected to the vial receptacle (306) of the housing (316).
  8. The device of claim 1 wherein the vial holder (302) is configured to hold the first and second vials in inverted positions.

Description

FIELD OF THE INVENTION The present application claims priority to and the benefit of United States Provisional Patent Application Serial No. 62/469,870, filed March 10, 2017, and United States Provisional Patent Application Serial No. 62/520,335, filed June 15, 2017. The present subject matter relates generally to transfer devices for mixing, diluting or reconstituting a medication and transferring the resulting liquid medication into an injection device. BACKGROUND Injection devices that are worn by a patient temporarily or for extended period are well known in the medical field. The subject matter of this application relates to a transfer device for use particularly but not exclusively with the injection device described in PCT Published Application No. WO 2014/204894, published December 24, 2014. That injection device includes an internal resilient bladder that may be filled with any suitable injectable medicament, whether drug, antibiotic, biologic or other injectable, for subcutaneous injection, typically a bolus injection, into a patient while the device is being worn by the patient. This injection device must be filled (wholly or partially) with the desired injectable before injection into the patient. In some situations, the injectable must be diluted or reconstituted. There has been an increase in the use of such injection devices due to an increase in the number of therapeutic biologics administered subcutaneously (SC) rather than intravenously (IV). The injections allow for more flexibility for patients/caregivers and increase the overall quality of life of the patients/caregivers. The formulations of injectables, however, are typically unstable over long periods of time at room temperatures. For example, high protein freeze drying or lyophilizing the formulations have become attractive. Such an approach, however, requires manual reconstitution of the product prior to administration. The process for reconstitution of a lyophilized drug includes a number of steps required by the user. For example, the process is typically carried out using two separate vials (one filled with diluent, the other with the lyophilized medication). The user must use syringe to retract diluent from the first vial and transfer it to the second/lyophilized vial. Then the user must manually shake/roll the second vial for an extended period of time after which he or she must visually inspect the vial and determine if the medication is sufficiently reconstituted. The overall complexity and time consumption of the process leads to issues regarding compliance, safety, and ease of administration for the patients/caregivers. US2013/274656 and WO2014/204894 describes different devices for reconstituting a lyophilized product. SUMMARY There are several aspects of the present subject matter which may be embodied separately or together in the devices and systems described and claimed below. These aspects may be employed alone or in combination with other aspects of the subject matter described herein, and the description of these aspects together is not intended to preclude the use of these aspects separately or the claiming of such aspects separately or in different combinations as set forth in the claims appended hereto. The invention is defined in the independent claim 1. Preferable embodiments are further defined in dependent claims 2-8. In one aspect, a disposable fluid transfer device includes an injector support surface configured to receive an injection device thereon. A fluid transfer port extends upwardly from the support surface for transfer of liquid into an injection device when received on the support surface. A lyophilized drug vial adapter is configured to receive a vial containing a lyophilized drug, while a diluent vial adapter is configured to receive a vial containing a diluent. A syringe adapter is configured to receive a syringe. A fluid flow path may be placed in communication between the lyophilized drug vial adapter and syringe adapter, between the diluent vial adapter and the syringe adapter and between the syringe adapter and the fluid transfer port. A manual valve in the fluid flow path selectively places the diluent vial adapter in communication with the syringe adapter, the lyophilized drug vial adapter in communication with the syringe adapter or the syringe adapter in communication with fluid transfer port. In another aspect, a device for reconstituting a lyophilized product features a housing including a vial receptacle. A vial holder is configured to be connected to the vial receptacle of the housing and to hold a first vial containing a lyophilized product and a second vial containing a diluent. A pressurized fluid supply system is configured to transfer diluent from the second vial to the first vial. A motor is configured to be connected to the vial holder when the vial holder is connected to the vial receptacle. The motor vibrates the first vial so that the lyophilized product in the first vial i