Drug Delivery Device And Method For Connecting A Fluid Flowpath

A drug delivery pump comprising a pump housing including:

• an activation mechanism;
• a power and control system;
• a drive mechanism including a drug container;
• an insertion mechanism for delivering drug fluid to a target;
• a fluid pathway connection assembly, comprising:
• a hollow needle piercing member;
• a sleeve fixedly engaged with the piercing member;
• and
• a pierceable seal configured to sealingly engage the piercing member or the sleeve and the drug container;
• and
• a fluid conduit that fluidly connects the fluid pathway connection assembly to the insertion mechanism,
• wherein:
• in sealing engagement, the piercing member or the sleeve and the pierceable seal form a volume within which a portion of the piercing member is disposed;
• actuation of the activation mechanism initiates the power and control system, which activates the fluid pathway connection assembly, thereby establishing a fluid flowpath from the drug container through the fluid pathway connection assembly and the fluid conduit to the insertion mechanism, and the drive mechanism, thereby driving drug fluid through the fluid flowpath;
• the fluid pathway connection assembly is activated by relative movement between the piercing member and the pierceable seal and activation causes the piercing member to pierce the pierceable seal, thereby establishing a fluid flowpath through the fluid pathway connection assembly;
• and
• the volume is isolated from the environment and maintains the sterile condition of the portion of the piercing member disposed therein.

A method of operating a drug delivery pump, the drug delivery pump comprising:

• an activation mechanism;
• a power and control system;
• a drive mechanism including a drug container;
• an insertion mechanism for delivering drug fluid to a target;
• a fluid pathway connection assembly including a hollow needle piercing member, a sleeve fixedly engaged with the piercing member and a pierceable seal configured to sealingly engage the piercing member or the sleeve and the drug container, wherein, in sealing engagement, the piercing member or the sleeve and the pierceable seal form a volume within which a portion of the piercing member is disposed and which, upon incorporation of the assembly into a sealed fluid pathway, is isolated from the environment and maintains the sterile condition of the portion of the piercing member disposed therein;
• and
• a fluid conduit that fluidly connects the fluid pathway connection assembly to the insertion mechanism,
• the method comprising:
• activating the activation mechanism;
• actuating the insertion mechanism;
• actuating the fluid pathway connection assembly;
• and
• initiating the power and control system to activate the drive mechanism to drive fluid drug through the drug delivery pump, wherein:
• actuating the fluid pathway connection assembly causes the piercing member to pierce the pierceable seal, thereby establishing a fluid flowpath from the drug container through the fluid pathway connection assembly and the fluid conduit to the insertion mechanism, thereby delivering fluid drug to the target.

A method of assembling a fluid pathway connection assembly and a drug container, comprising:

• providing a fluid pathway connection assembly including a hollow needle piercing member, a sleeve and a pierceable seal configured to sealingly engage the piercing member or the sleeve, the pierceable seal having a cavity;
• inserting, at least partially, the pierceable seal into an end of a drug container;
• securely constraining the pierceable seal to the drug container;
• disposing, as least partially, the piercing member in the cavity of the pierceable seal;
• fixedly securing the piercing member and the sleeve to one another;
• and
• sealingly engaging the pierceable seal and the piercing member or the sleeve, thereby forming a volume, wherein:
• a portion of the piercing member is disposed within the volume, which, upon incorporation of the fluid pathway connection assembly into a sealed fluid flowpath, is isolated from the environment and maintains the sterile condition of the portion of the piercing member disposed therein;
• and
• the fluid pathway connection assembly is activated by relative movement between the piercing member and the pierceable seal and activation causes the piercing member to pierce the pierceable seal,
• thereby assembling the fluid connection pathway and the drug container.