# US 2019/0167895 A1 · Drug Delivery Device And Method For Connecting A Fluid Flowpath > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2019/0167895 A1 - Document ID: US20190167895A1 - Status: Published application - Kind: A1 - Application number: 16/323,711 - Filed: 2017-08-08 - Published: 2019-06-06 - Earliest claimed: 2016-08-08 - Assignees: UNL Holdings LLC - Applicants: UNL Holdings LLC - Inventors: Alexis Marie Adolphe Dechelette; Robert S. Russo; Lawton Laurence; Shaun R. Devitt - Web page: https://patentgrep.com/patent/US20190167895A1 ## CPC - A61M 5/14248: {of the skin patch type} - A61M 5/142: Pressure infusion, e.g. using pumps - A61M 5/1452: {pressurised by means of pistons} - A61M 5/1454: {spring-actuated, e.g. by a clockwork} - A61M 5/14566: {with a replaceable reservoir for receiving a piston rod of the pump} - A61M 5/158: Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body} - A61M 5/162: Needle sets, i.e. connections by puncture between reservoir and tube - A61M 39/00: Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use (for respiratory devices, e.g. tracheal tubes, A61M16/00; artificial heart valves A61F2/24) - A61M 2005/14252: {with needle insertion means} - A61M 2005/1426: {with means for preventing access to the needle after use} - A61M 2005/1581: {Right-angle needle-type devices} - A61M 2039/0036: {characterised by a septum having particular features, e.g. having venting channels or being made from antimicrobial or self-lubricating elastomer} - A61M 2039/0081: {Means for facilitating introduction of a needle in the septum, e.g. guides, special construction of septum} - A61M 2039/205: {comprising air venting means} - A61M 2205/13: with means for the detection of operative contact with patient, e.g. lip sensor - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## Abstract Provided herein is a fluid pathway connection assembly, e.g., for connecting a fluid flowpath within a drug delivery device for delivery of a medicament to a target site. The fluid pathway connection assembly comprises 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. Upon, 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. 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 pierceable seal. Upon incorporation of the assembly into a sealed fluid flowpath, the volume is isolated from the environment and maintains the sterile condition of the portion of the piercing member disposed therein. Also provided herein are drug delivery pumps and methods of operating and assembling the assemblies and pumps described herein. ## Claims ### Claim 1 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, 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; 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 pierceable seal; and upon incorporation of the assembly into a sealed fluid flowpath, the volume is isolated from the environment and maintains the sterile condition of the portion of the piercing member disposed therein. ### Claim 2 (depends on 1) The assembly of claim 1, wherein the hollow needle piercing member is a rigid, hollow needle. ### Claim 3 (depends on 1) The assembly of claim 1, wherein the hollow needle piercing member is bent. ### Claim 4 (depends on 1) The assembly of claim 1, wherein the sleeve comprises a flange. ### Claim 5 (depends on 4) The assembly of claim 4, wherein the hollow needle piercing member is bent and at least a portion of the bent hollow needle piercing member is disposed within the flange. ### Claim 6 (depends on 1) The assembly of claim 1, wherein the sleeve includes side channels to facilitate sterilization. ### Claim 7 (depends on 1) The assembly of claim 1, wherein the pierceable seal is configured to sealingly engage the sleeve and, in sealing engagement, the sleeve and the pierceable seal form a volume within which a portion of the piercing member is disposed. ### Claim 8 (depends on 1) The assembly of claim 1, wherein the pierceable seal includes one or more sealing ribs for sealingly engaging the piercing member or the sleeve. ### Claim 9 (depends on 1) The assembly of claim 1, wherein the pierceable seal includes a recess and a tip of the piercing member is disposed within the recess upon establishment of the fluid flowpath through the pierceable seal. ### Claim 10 (depends on 19) The assembly of claim 19, further comprising a retainer that restricts deformation of the pierceable seal or prevents inadvertent relative movement between the piercing member and the pierceable seal. ### Claim 11 (depends on 1) The assembly of claim 1, wherein one or more of the piercing member, the sleeve and the pierceable seal includes a vent which allows for evacuation of the volume. ### Claim 12 (depends on 1) The assembly of claim 1, further comprising a crimp cap for securing the pierceable seal to a drug container. ### Claim 13 (depends on 1) The assembly of claim 1, wherein the pierceable seal is configured to sealingly engage a drug container. ### Claim 14 (depends on 1) A drug delivery pump, comprising an assembly of claim 1. ### Claim 15 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. ### Claim 16 (depends on 15) The drug delivery pump of claim 15, further comprising an on-body sensor. ### Claim 17 (depends on 15) The drug delivery pump of claim 15, wherein the drug container contains drug fluid. ### Claim 18 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. ### Claim 19 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.