Injection port for single-use syringe

• US 5,222,948 A
• Filed: 09/09/1991
• Issued: 06/29/1993
• Est. Priority Date: 09/09/1991
• Status: Expired due to Term

• Current Assignee: Path
• Original Assignee: Path
• Inventors: Austin, Glenn, Thomas, Ronny D., Nelson, Carib
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): Polutta, Mark O.
• Application Number:
  US07/756,889
• Time in Patent Office: 659 Days
• Field of Search: 604/200, 604/201, 604/212, 604/213, 604/215-217, 604/240, 604/243, 604/244, 604/246, 604/247, 604/905, 137/855
• US Class Current: 604/213
• CPC Class Codes: A61M 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• CPC Class Codes: A61M 5/50 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile retractable needles or needle protectors with means for preventing re-use A61M5/321
• CPC Class Codes: Y10S 604/905 Aseptic connectors or couplings, e.g. frangible, piercable
• CPC Class Codes: Y10T 137/7891 Flap or reed

Abstract

An improved injection port (1) for a single-use syringe is described. One embodiment of the injection port has a one-way valve system for making it more difficult to reuse the syringe (2). The one-way valve system has a flap or diaphragm valve (6) housed in a valve chamber (11) at the proximal end of port cylinder (45). When the valve (6) is seated against valve seat (51) on valve cap (5), refilling of the syringe is blocked. During injection, the valve (6) unseats and moves toward radial ribs (7), allowing flow of medicament into the proximal end of a needle (2). Another embodiment of the injection port (1) includes longitudinal grooves (8) on the interior surface of the chamber (12) at the distal end of cylinder (45). The grooves (8) vent pressure from a Luer syringe inserted in the distal end of the cylinder (45).

Claims

1. An injection port assembly insertable at a distal end of a prefilled medicament reservoir of a medical syringe in order to make the syringe substantially non-reusable by permitting substantial fluid flow out of the distal end of the syringe medicament reservoir and preventing substantial fluid flow into said distal end of the syringe medicament reservoir, said injection port assembly comprising:

a tubular wall having a proximal wall portion and a distal wall portion;

a valve chamber in the proximal wall portion for forming a fluid-tight seal with the syringe, said valve chamber having a proximal chamber end and a distal chamber end, said distal chamber end having a central aperture for communicating with a hypodermic needle;

a plurality of radial ribs surrounding the central aperture and extending from the central aperture to the tubular wall and defining both a central cavity extending in a proximal direction and a series of passages between the ribs, the passages communicating with the central cavity, a valve seat closing the proximal chamber end and having a valve seat surface surrounding a central opening for connecting the valve chamber with said medicament reservoir;

a valve flap disposed in the valve chamber between the valve seat and the ribs, said valve flap being free to move between the valve seat and the ribs as pressure is applied to the valve flap by fluid entering the valve chamber, the valve flap having a diameter smaller than the inner diameter of the chamber and large enough to sealingly cover the central opening when in contact with the tubular wall of the chamber and also large enough to cover the central cavity but not all of the passages between the ribs; and

means for positioning the injection port assembly in a syringe between a medicament reservoir and a hypodermic needle.

2. A syringe device associated with a syringe and comprising an injection port associated with an outlet of a fluid reservoir of said syringe, said injection port comprising;

a port cylinder having a central axis, said port cylinder including a tubular wall having a proximal cylinder end, a distal cylinder end, an interior wall surface and an exterior wall surface;

an elongated chamber defined within a distal portion of the interior wall surface, said elongated chamber having a proximal chamber end between said proximal cylinder end and said distal cylinder end;

a valve chamber within a proximal portion of the interior wall surface for axially communicating with the proximal chamber end, said valve chamber having a proximal valve chamber portion and a distal valve chamber portion;

a circular membrane connected to the interior wall surface and extending between said valve chamber and said elongated chamber;

a plurality of radial ribs extending between said membrane and said valve chamber, said radial ribs defining a central cavity extending along the central axis and a radial passage between each of the ribs;

a valve seat connected to the proximal cylinder end, said valve seat including a valve neck portion having an exterior neck surface fitting within the interior wall surface and having a distal neck end and a proximal neck end, said valve neck portion including an interior neck surface defining a central neck opening axially communicating with said valve chamber, and a valve seat surface at the distal neck end having an inner diameter defining said central neck opening, said valve seat surface having an outer diameter smaller than the diameter of the interior wall surface, said valve seat further including a valve flange portion having a distal flange end and a proximal flange end, said distal flange end connected to the proximal neck end, said valve flange portion having a central flange opening therethrough axially communicating with said central neck opening; and

a valve flap disposed in said valve chamber, said valve flap having a diameter greater than the diameter of the central cavity between the radial ribs and greater than the diameter of said central neck opening, said valve flap being operable when a needle is inserted through the membrane for allowing substantial fluid flow from the valve chamber into the needle and through the needle in a direction along the central axis toward the distal end of the tubular wall, and for preventing substantial fluid flow opposite to said direction.

3. A syringe device as recited in claim 2, wherein said valve flap is made of plastic.

4. A syringe device as recited in claim 2, wherein said valve flap is made of metal.

5. A syringe device as recited in claim 2, wherein said radial ribs include six ribs each having a side connected to the interior wall surface and a rib base connected to said membrane.

6. A syringe device as recited in claim 2, wherein said interior wall surface has a circumferential bead groove near the proximal wall end, and the exterior neck surface of the valve seat has a circumferential bead thereon which fits within said circumferential bead groove.

7. A syringe device as recited in claim 2, wherein said port cylinder further includes a flange on the exterior wall surface at an axial location between said distal cylinder end and said proximal cylinder end.

8. A syringe device as recited in claim 2, wherein the interior wall surface around said elongated chamber has a pair of circumferential ribs axially spaced apart for positioning a needle hub therebetween.

9. A syringe device as recited in claim 2, wherein said port cylinder further includes vent means for venting said elongated chamber.

10. A syringe device as recited in claim 9, wherein said vent means include at least one longitudinal groove on the interior wall surface extending from said distal cylinder end toward said proximal chamber end.

11. A syringe device as recited in claim 9, further comprising a needle axially supported in a needle hub held in said elongated chamber, said needle hub having an outer diameter slightly less than the diameter of the interior wall surface.

12. A syringe device as recited in claim 2, further comprising a needle axially supported in a needle hub held in said elongated chamber, said needle hub having an outer diameter slightly less than the diameter of the interior wall surface.

13. A syringe device as recited in claim 12, further comprising said reservoir connected to the proximal end of said port cylinder and fluidly communicating with said central neck opening.

14. A syringe device as recited in claim 13, further comprising a protector cap connected to the distal cylinder end.

15. A syringe device as recited in claim 13, wherein said reservoir includes a compressible oil-can type reservoir.

16. A syringe device as recited in claim 15, wherein the reservoir is heat-sealed to said injection port.

17. A syringe device operatively associatable with a syringe and comprising an injection port operatively associatable with an outlet of a fluid reservoir of said syringe, said injection port comprising:

a port cylinder having a central axis, said port cylinder including a tubular wall having a proximal wall end surrounding a proximal cylinder opening, a distal wall end surrounding a distal cylinder opening, an interior wall surface and an exterior wall surface;

an elongated chamber defined within a distal portion of the interior wall surface;

a circular membrane circumferentially connected to the interior wall surface between said distal wall end and said proximal wall end; and

vent means for venting pressure introduced into said elongated chamber from a distal end of said port cylinder during attempts to refill a reservoir from said distal end when said reservoir is operatively attached to a proximal end of said port cylinder; and

one-way valve means operatively associated with said injection port and operable when a needle is inserted through the membrane for allowing substantial fluid flow from the proximal cylinder opening into the needle and through the needle in a direction along the central axis toward the distal wall end, and for preventing substantial fluid flow opposite to said direction.

18. A syringe device operatively associatable with a syringe and comprising an injection port operatively associatable with an outlet of a fluid reservoir of said syringe, said injection port comprising:

a port cylinder having a central axis, said port cylinder including a tubular wall having a proximal wall end surrounding a proximal cylinder opening, a distal wall end surrounding a distal cylinder opening, an interior wall surface and an exterior wall surface;

an elongated chamber defined within a distal portion of the interior wall surface;

a circular membrane circumferentially connected to the interior wall surface between said distal wall end and said proximal wall end; and

vent means for venting pressure introduced into said elongated chamber from a distal end of said port cylinder during attempts to refill a reservoir from said distal end when said reservoir is operatively attached to a proximal end of said port cylinder, said vent means comprising one or more pairs of diametrically opposed longitudinal grooves running lengthwise along the interior wall surface of said elongated chamber;

a valve chamber within a proximal portion of the interior wall surface between said proximal wall end and said membrane and axially communicating with the proximal cylinder opening;

a plurality of radial ribs extending between said membrane and said valve chamber, said radial ribs defining a central cavity extending along the central axis and a radial passage between each adjacent rib;

a valve seat connected to the proximal cylinder end, said valve seat including a valve neck portion having an exterior neck surface fitting within the interior wall surface and having a distal neck end and a proximal neck end, said valve neck portion including an interior neck surface defining a central neck opening axially communicating with said valve chamber, and a valve seat surface at the distal neck end having an inner diameter defining said central neck opening, said valve seat surface having an outer diameter smaller than the diameter of the interior wall surface, said valve seat further including a valve flange portion having a distal flange end and a proximal flange end, said distal flange end connected to the proximal neck end, said valve flange portion having a central flange opening therethrough axially communicating with said central neck opening; and

a valve flap disposed in said valve chamber, said valve flap having a diameter greater than the diameter of the central cavity between the radial ribs and greater than the diameter of said central neck opening, said valve flap being operable when a needle is inserted through the membrane for allowing substantial fluid flow from the valve chamber into the needle and through the needle in a direction along the central axis toward the distal wall end, and for preventing substantial fluid flow opposite to said direction, said valve flap being movable in said valve chamber.