US 12,403,251 B2Granted

Device and method for making aseptic connections

AssigneeAmgen Inc.

InventorsIan B. Hanson, Lawton Laurence, Antonio Ubach, Rajan Ramaswamy, Daniel S. Codd, Scott Beaver, Kevin L. Bokelman, Danielle Feldman, Matthew J. Clemente

Life of this patent

Estimating the term…

patentgrep

Loading patent…

Abstract

The present invention provides devices and methods for establishing aseptic connections between two or more components or subassemblies. The devices may be used in medical devices such as drug delivery pumps (10). In some embodiments, a connection is made between a drug container (50, 1050, 2050) and a fluid pathway connection assembly (300, 1300, 2300). The fluid pathway connection assembly may include a connection hub (312, 1312, 2312), a piercing member (316, 1316, 2316), and a piercing member retainer (314, 1314, 2314). The assembly may further include a first film (318, 1318, 2318) covering a cavity (312A, 1312A, 2312A), thereby maintaining the aseptic condition of the cavity. The drug container may hold a fluid drug and include a pierceable seal (326, 1326, 2326). A second film (322, 1322, 2322) may cover a recess (328, 1328, 2328) formed by the seal and thereby maintain the aseptic condition of the interior of the chamber. The piercing member may be caused to pierce the first and second film and the pierceable seal to open a fluid pathway for delivery of the fluid drug through the fluid pathway connection assembly.

Claims27

Dependent claims

A drug delivery device comprising:

a drug container having a longitudinal axis and a distal end with an opening covered by a pierceable seal;
a connection hub having a rigid wall, the rigid wall having a drug container facing surface and a radially inwardly facing surface, the radially inwardly facing surface being closer to the pierceable seal than the drug container facing surface, the radially inwardly facing surface at least partially defining an interior space, wherein the rigid wall and any component of the drug delivery device formed in one piece with the rigid wall is free from contact with a distalmost surface of the pierceable seal and any component of the drug delivery device contacting the distalmost surface of the pierceable seal;
and
a piercing member having an unactuated position wherein a tip of the piercing member is exterior to the drug container, and a delivery position wherein the tip of the piercing member pierces through the pierceable seal into the drug container,
wherein the tip of the piercing member is configured to move through the interior space of the connection hub in moving from the unactuated position to the delivery position, and the piercing member is free from contact with the pierceable seal and any member disposed at least partially within the pierceable seal when the piercing member is in the unactuated positioned.

2 more elements

A drug delivery device comprising:

a drug container comprising a longitudinal axis, a wall, and an opening;
a pierceable seal covering the opening and fixedly secured to an exterior surface of the wall of the drug container;
a connection hub disposed adjacent to the pierceable seal and having a rigid wall, the rigid wall having a drug container facing surface and a radially inwardly facing surface, the radially inwardly facing surface being closer to the pierceable seal than the drug container facing surface, the radially inwardly facing surface at least partially defining an interior space, and wherein the rigid wall and any component of the drug delivery device formed in one piece with the rigid wall is free from contact with a distalmost surface of the pierceable seal and any component of the drug delivery device contacting the distalmost surface of the pierceable seal;
and
a piercing member having an unactuated position wherein a tip of the piercing member is exterior to the drug container, and a delivery position wherein the tip of the piercing member pierces through the pierceable seal into the drug container,
wherein the tip of the piercing member is configured to move through the interior space of the connection hub in moving from the unactuated position to the delivery position, and the piercing member is free from contact with the pierceable seal and any member disposed at least partially within the pierceable seal when the piercing member is in the unactuated position.

3 more elements

Dependencies are inferred from the claim text.

Facts

Application: 16/752,075Filed 24 Jan 2020 · continuation
Priority: 2 Mar 2015
Published: US 2020/0155759 A121 May 2020
Granted: 2 Sep 2025
Term ends: Not estimatedThe source records don’t support an estimate.

Classification22 codes

A61M 5/162
Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor: needle sets, i.e. connections by puncture between reservoir and tube
A61J 1/201
Piercing means: having one piercing end
A61J 1/2051
Connecting means: having tap means, e.g. tap means activated by sliding
A61M 5/1413
Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor: modular systems comprising interconnecting elements

Family

Application62/127,021Us provisional application · filed 2 Mar 2015
Application62/148,082Us provisional application · filed 15 Apr 2015
PCT/US2016/020486Parent of this continuation · filed 2 Mar 2016
US 2020/0155759 A1Pre-grant publication · published 21 May 2020
Application15/552,828Parent of this continuation
US 10,569,014 B2Parent of this continuation
US 2018/0028747 A1Published application
US 12,403,251 B2This patent

From the US filing history. Foreign family members aren’t listed.