Granted Patent B2

US 12,630,318 · App. 18/893,817 · Granted May 19, 2026

Inventor: Daniel Py (New Milford, CT)

Assignee: Getinge Aseptic Solutions, LLC

B65B3/003A61J1/2096A61M5/32B65B39/004B65B39/12

Abstract

Claims (83)

1 . A transfer system comprising:

a device defining a chamber therein adapted to receive fluid therein and having an opening, and a pierceable septum in fluid communication with the chamber and sealing said opening; and

a needle comprising

a hollow shaft;

a septum-piercing tip formed at a distal end of the shaft;

at least one port in fluid communication with the interior of the hollow shaft; and

a closure;

wherein the needle is adapted to pierce the septum;

wherein one or more of the closure or the shaft is movable between (i) a first position wherein the closure closes the at least one port to prevent passage of fluid through the at least one port and hermetically seal the at least one port with respect to ambient atmosphere, and (ii) a second position opening the at least one port to permit passage of fluid through the at least one port;

wherein, along an entire length of the at least one port and in the first position, the needle defines a straight outermost surface thereof; and

wherein (a) the closure is biased in a direction from the second position toward the first position to normally close the at least one port, and (b) when the closure is located in its most distal position relative to the shaft, one or more of (i) at least a portion of the tip is exposed to ambient atmosphere or (ii) the closure does not enclose at least a portion of the tip.

2 . A system as defined in claim 1 , wherein the closure includes a flange or projection engageable with a biasing member for biasing the closure in a direction from the second position toward the first position.

3 . A system as defined in claim 2 , wherein an end of the closure is engageable with a stop surface to stop the closure in the first position.

4 . A system as defined in claim 1 adapted so that a portion of the closure extending along the at least one port in the first position is adapted to at least partially penetrate into or through the septum in the first position.

5 . A system as defined in claim 1 , wherein a portion of the closure radially adjacent to the port is adapted to at least partially penetrate into or through the septum in the first position.

6 . A system as defined in claim 5 , wherein a diameter of the closure at a distal end thereof is no greater than a maximum diameter of the tip.

7 . A system as defined in claim 1 , wherein the shaft defines a proximal end and a distal end, and the closure defines a surface located, in the first position, closer to the proximal end of the shaft than the portion of the port closest to the distal end of the shaft and adapted to engage the septum and thereby one or more of (a) cause relative movement of the closure and the shaft, or (b) prevent further movement of the closure relative to the septum.

8 . A system as defined in claim 7 , wherein the surface is axially spaced from a distal end of the at least one port a distance at least equal to a thickness of the septum to be pierced by the needle.

9 . A transfer system comprising:

a device defining a chamber therein adapted to receive fluid therein and having an opening, and a pierceable septum in fluid communication with the chamber and sealing said opening; and

a needle comprising

first means for providing a conduit for the passage of fluid therethrough;

second means formed at one end of the first means for piercing the septum;

third means in fluid communication with the conduit for passage of fluid therethrough;

fourth means for closing the third means, wherein one or more of the fourth means or the first means is movable between (i) a first position wherein the fourth means closes and hermetically seals the third means with respect to ambient atmosphere and prevents passage of fluid through the third means and (ii) a second position opening the third means to permit passage of fluid through the third means; and

fifth means for biasing the fourth means in a direction from the second position toward the first position to normally close the third means;

wherein the needle is adapted to pierce the septum;

wherein, along an entire length of the third means and in the first position, the needle defines a straight outermost surface thereof; and

wherein, when the fourth means is located in its most distal position relative to the first means, one or more of (i) at least a portion of the second means is exposed to ambient atmosphere or (ii) the fourth means does not enclose at least a portion of the second means.

10 . A method comprising the following steps:

transferring fluid between a device and a needle of a transfer system, wherein the device defines a chamber therein adapted to receive fluid therein and having an opening, and a pierceable septum in fluid communication with the chamber and sealing said opening, the transferring step including:

piercing the septum with a needle adapted to pierce the septum and placing the needle in fluid communication with the chamber, the needle comprising a hollow shaft; a septum-piercing tip formed at a distal end of the shaft; at least one port in fluid communication with the interior of the hollow shaft; and a closure; wherein one or more of the closure or the shaft is movable between (i) a first position wherein, along an entire length of the at least one port, the needle defines a straight outermost surface thereof, and the closure closes the at least one port to prevent passage of fluid through the at least one port and hermetically seal the at least one port with respect to ambient atmosphere, and (ii) a second position opening the at least one port to permit passage of fluid through the at least one port; and wherein (a) the closure is biased in a direction from the second position toward the first position to normally close the at least one port, and (b) when the closure is located in its most distal position relative to the shaft, one or more of (i) at least a portion of the tip is exposed to ambient atmosphere or (ii) the closure does not enclose at least a portion of the tip;

after or during the piercing step, moving one or more of the closure or the shaft of the needle from the first position to the second position; and

flowing fluid between the needle and the chamber.

11 . A method as defined in claim 10 , further comprising the following steps:

withdrawing the needle from the septum; and

before or during the withdrawing step, moving one or more of the closure or the shaft of the needle from the second position to the first position.

12 . A method as defined in claim 10 , further comprising, while the closure is in the first position, penetrating a portion of the closure extending along the at least one port in the first position at least partially into or through the septum.

13 . A transfer system comprising:

a device defining a chamber therein adapted to receive fluid therein and having an opening, and a pierceable septum in fluid communication with the chamber and sealing said opening; and

a needle comprising

a hollow shaft;

a septum-piercing tip formed at one end of the shaft;

at least one port in fluid communication with the interior of the hollow shaft;

a needle holder configured for attachment thereof to a filling line; and

a closure;

wherein the needle is adapted to pierce the septum;

wherein one or more of the closure or the shaft is movable between (i) a first position wherein the closure closes the at least one port to prevent passage of fluid through the at least one port and hermetically seal the at least one port with respect to ambient atmosphere, and (ii) a second position opening the at least one port to permit passage of fluid through the at least one port; and

wherein a portion of the closure radially adjacent to the port is adapted to at least partially penetrate into or through the septum in the first position.

14 . A system as defined in claim 13 adapted so that a portion of the closure extending along the at least one port in the first position is adapted to at least partially penetrate into or through the septum in the first position.

15 . A transfer system comprising:

a device defining a chamber therein adapted to receive fluid therein and having an opening, and a pierceable septum in fluid communication with the chamber and sealing said opening; and

a needle comprising

a hollow shaft defining a proximal end and a distal end;

a septum-piercing tip formed at the distal end of the shaft;

at least one port in fluid communication with the interior of the hollow shaft; and

a closure;

wherein the needle is adapted to pierce the septum;

wherein one or more of the closure or the shaft is movable between (i) a first position wherein the closure closes the at least one port to prevent passage of fluid through the at least one port and hermetically seal the at least one port with respect to ambient atmosphere, and (ii) a second position opening the at least one port to permit passage of fluid through the at least one port; and

wherein the closure defines a surface located, in the first position, closer to the proximal end of the shaft than the portion of the port closest to the distal end of the shaft and adapted to engage the septum and thereby one or more of (a) cause relative movement of the closure and the shaft, or (b) prevent further movement of the closure relative to the septum.

16 . A system as defined in claim 15 wherein the surface is spaced from a distal end of the at least one port a distance at least equal to a thickness of the septum to be pierced by the needle.

17 . An apparatus comprising:

a first device comprising

a hollow shaft;

at least one port in fluid communication with an interior of the hollow shaft; and

a closure;

wherein one or more of the closure or the shaft is movable between (i) a first position wherein the closure closes the at least one port to prevent passage of fluid through the at least one port and hermetically seal the at least one port with respect to ambient atmosphere, and (ii) a second position opening the at least one port to permit passage of fluid through the at least one port; and

a second device adapted to engage with the first device for fluid flow therebetween, and including a septum having an aperture therethrough configured to receive at least a portion of the shaft and the closure during engagement of the first device and the second device;

wherein the closure is adapted to at least partially penetrate into or through the aperture in the first position.

18 . An apparatus as defined in claim 17 adapted so that one or more of (i) a portion of the closure extending along the at least one port in the first position is adapted to at least partially penetrate into or through the aperture in the first position; (ii) during at least a portion of said at least partial penetration of the closure into or through the aperture, the at least one port is prevented from contacting the septum; or (iii) during at least a portion of said at least partial penetration of the closure into or through the aperture, the closure is interposed between the at least one port and the septum.

19 . A method comprising:

engaging a first device and a second device, the first device comprising

a hollow shaft;

at least one port in fluid communication with an interior of the hollow shaft; and

a closure;

wherein one or more of the closure or the shaft is movable between (i) a first position wherein the closure closes the at least one port to prevent passage of fluid through the at least one port and hermetically seal the at least one port with respect to ambient atmosphere, and (ii) a second position opening the at least one port to permit passage of fluid through the at least one port; and

the second device comprising a septum having an aperture therethrough configured to receive at least a portion of the shaft and the closure during said engaging of the first device and the second device;

wherein the closure is adapted to at least partially penetrate into or through the aperture in the first position;

penetrating the shaft and closure at least partially into or through the aperture;

during or after the penetrating step, moving one or more of the closure or the shaft from the first position to the second position; and

flowing fluid between the first device and the second device;

wherein the penetrating step includes at least partially penetrating the closure into or through the aperture with the closure in the first position.

20 . A method as defined in claim 19 , wherein the penetrating step includes one or more of (i) while the closure is in the first position, at least partially penetrating a portion of the closure extending along the at least one port in the first position into or through the aperture; (ii) substantially preventing any contact between the at least one port and the septum; or (iii) interposing the closure between the at least one port and septum.

Continuity (4)

References Cited (179)