Closed drug transfer system

• US 9,510,997 B2
• Filed: 02/03/2014
• Issued: 12/06/2016
• Est. Priority Date: 02/07/2013
• Status: Active Grant

• Current Assignee: Equashield Medical Ltd.
• Original Assignee: Equashield Medical Ltd.
• Inventors: Tavor, Raanan, Kriheli, Marino
• Primary Examiner(s): Deak, Leslie
• Application Number:
  US14/762,225
• Publication Number:
  US 20150359709A1
• Time in Patent Office: 1,037 Days
• US Class Current: 1/1
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61J 1/2048 Connecting means
• CPC Class Codes: A61J 1/2051 having tap means, e.g. tap means activated by sliding
• CPC Class Codes: A61J 1/2072 for internal venting
• CPC Class Codes: A61J 1/2082 for gas filtration
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61J 1/22 with means for metering the amount of fluid
• CPC Class Codes: A61M 5/162 Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14

Abstract

The application describes innovative designs for components of a drug transfer apparatus that overcome problems encountered in daily use of prior art apparatuses. Specifically described are components configured to prevent liquid from entering the air chamber of syringes coupled to the apparatus and to prevent tearing of the rubber stopper of drug vials when they are attached to the apparatus.

Claims

1. A fluid transfer apparatus comprising:

(a) a syringe-like proximal section comprising;

(i) a cylindrical body;

(ii) a piston that is displaceable within said cylindrical body, said piston defining a distal liquid chamber and a proximal air chamber, both of variable volume;

(b) a connector section fixedly attached to the distal end of said proximal section, wherein the distal end of said connector section is adapted to be connectable to a fluid transfer component, said connector section comprising;

(i) a needle holder;

(ii) a liquid conduit that passes through and is rigidly attached to said needle holder, wherein the distal end of said liquid conduit begins in said connector section and the proximal end of said liquid conduit terminates in said distal liquid chamber;

(iii) an air conduit that passes through and is rigidly attached to said needle holder, wherein the distal end of said air conduit begins in said connector section and the proximal end of said air conduit terminates in said proximal air chamber; and

(iv) a membrane located at the distal end of said connector section, wherein said membrane encloses the distal ends of said liquid conduit and said air conduit isolating them from the surroundings;

wherein, said connector section is configured to allow a head portion of said fluid transfer component to enter the interior of said connector section and to allow said membrane in said connector section to be pushed proximally when it is contacted by a membrane located in said head portion of said fluid transfer component;

whereupon further pushing of said membranes together causes said distal ends of said liquid conduit and said air conduit to penetrate said membrane in said connector section and to penetrate said membrane in said head portion, thereby establishing a liquid channel via said liquid conduit between the interior of said distal liquid chamber and the interior of said fluid transfer component and a separate air channel via said air conduit between the interior of said proximal air chamber and the interior of said fluid transfer component;

said fluid transfer apparatus characterized in that a hydrophobic filter is inserted in said air channel in at least one location between said proximal air chamber in said syringe-like proximal section of said fluid transfer apparatus and said fluid transfer component.

2. The apparatus of claim 1, wherein a section of the air channel is located outside of said apparatus.

3. The apparatus of claim 1, wherein the connector section comprises a hollow cylindrical outer body having:

(a) a distal shoulder portion radially protruding from said outer body and terminating with an opening through which the proximal end of a fluid transfer component can be inserted for coupling;

(b) a closed proximal cap having a central portion comprising connection means protruding proximally from it to connect to the syringe-like proximal portion of said apparatus;

(c) a needle holder protruding into the interior of said outer body from a central portion of said closed proximal cap for retaining therein two conduits comprising sharp pointed ends and further provided with apertures through which liquid and air respectively are transferred during a fluid transfer operation; and

(d) a double membrane seal actuator reciprocably displaceable within the hollow interior of said outer body;

wherein said double membrane seal actuator comprises;

(i) a cylindrical actuator casing;

(ii) a proximal membrane that seals the proximal end of said casing

(iii) a distal membrane that seals the distal end of said casing, wherein a part of said distal membrane protrudes distally from said casing; and

(iv) at least one resilient arm which is connected at a proximal end thereof to an intermediate portion of the exterior of said casing and comprises an enlarged locking element at its distal end;

said enlarged locking element having specifically shaped surface areas which interact with the inner wall of said hollow cylindrical outer body of said connector section to enable a four step procedure for connecting or separating said connector section to a fluid transfer component.

4. The apparatus of claim 3, comprising a sleeve made of an elastic material, said sleeve surrounding the tip and the distal opening of the needle of the air conduit inside the double membrane seal actuator.

5. The apparatus of claim 1, wherein the connector section comprises a hollow cylindrical outer body having:

(a) a distal shoulder portion radially protruding from said outer body and terminating with an opening through which the proximal end of a fluid transfer component can be inserted for coupling;

(b) a closed proximal cap having a central portion comprising connection means protruding proximally from it to connect to the throat of the syringe-like proximal portion of said apparatus;

(c) an elongated cylindrical needle holder protruding into the interior of said outer body from a central portion of said closed proximal cap for retaining therein two conduits comprising sharp pointed ends and further provided with apertures through which liquid and air respectively are transferred during a fluid transfer operation; and

(d) a single membrane seal actuator reciprocably displaceable within the hollow interior of said outer body;

wherein said single membrane seal actuator comprises;

(i) a cylindrical actuator casing;

(ii) a proximal O-ring that seals the proximal end of said casing to the outer surface of said elongated cylindrical needle holder;

(iii) a distal membrane that seals the distal end of said casing, wherein a part of said distal membrane protrudes distally from said casing; and

(iv) at least one resilient arm which is connected at a proximal end thereof to an intermediate portion of the exterior of said casing and comprises enlarged locking elements at its distal end;

said enlarged locking element having specifically shaped surface areas which interact with the inner wall of said hollow cylindrical outer body of said connector section to enable a four step procedure for connecting or separating said connector section to a fluid transfer component.

6. The apparatus of claim 5, comprising a sleeve made of an elastic material, said sleeve surrounding the tip and the distal opening of the needle of the air conduit inside the single membrane seal actuator.

7. The apparatus of claim 1, wherein the fluid transfer component is a vial adaptor, wherein said vial adaptor comprises an air channel and a separate liquid channel, thereby providing a closed transfer system that does not vent to or communicate with the environment.

8. The apparatus of claim 7, wherein the vial adaptor comprises:

(a) a distal collar portion comprised of a disk shaped central piece with a plurality of segments adapted for facilitating securement of said vial adaptor to a head portion of a medical vial or any type of vessel or device that has a head section similar to that of the head portion of a standard medicine vial, said segments attached to the circumference of said disk shaped central piece and projecting distally away from it;

(b) a longitudinal extension projecting proximally from said disk shaped central piece said longitudinal extension adapted to be coupled to a fluid transfer device;

(c) a membrane that seals the proximal end of said longitudinal extension;

(d) a spike element which protrudes distally from the center of said disk shaped central piece;

(e) an air channel and a liquid channel both of which are internally formed within said longitudinal extension and said spike element, said channels adapted to allow fluid communication through said vial adapter from said proximally located membrane to openings at the tip of said spike;

wherein an annular shaped flat hydrophobic filter is located in said disk shaped central piece, said vial adaptor and said filter adapted to allow fluid flowing in said liquid channel to pass through said vial adapter without passing through said filter and to force fluid flowing through said air channel to pass through said filter.

9. The apparatus of claim 8, wherein one or both of the outer and inner circumferential edges of the annular shaped flat hydrophobic filter are welded, glued, or mechanically pressed to the vial adaptor.

10. The apparatus of claim 8, wherein the annular shaped flat hydrophobic filter is supported by and lays on plurality of closely spaced supporting ribs from one or both of above and below.

11. The apparatus of claim 8, comprising a by-pass comprising a one-way valve placed in parallel to the filter in the air channel.

12. The apparatus of claim 11, wherein the one-way valve is comprised of an elastic cap, which is tightly fit over an end of a rigid tube.

13. The apparatus of claim 7, wherein the vial adaptor comprises:

(a) a bottom part adapted to be attached to the head section of a medical vial or any type of vessel or device that has a head section similar to that of the head of a standard medicine vial;

(b) a top part comprising;

(i) a disk shaped central piece and a plurality of wings adapted for facilitating securement of said top part to said bottom part, said wings attached to the circumference of said disk shaped central piece and projecting distally away from it;

(ii) a longitudinal extension projecting proximally from said disk shaped central piece, said longitudinal extension adapted to be coupled to a fluid transfer device;

(iii) a membrane that seals the proximal end of said longitudinal extension;

(iv) a spike element which protrudes distally from the center of said disk shaped central piece;

(v) an air channel and a liquid channel both of which are internally formed within said longitudinal extension and said spike element, said channels adapted to allow fluid communication through said vial adapter from said proximally located membrane to openings at the tip of said spike;

(c) a first locking mechanism; and

(d) a second locking mechanism;

wherein, said first locking mechanism is adapted to lock said top part to said bottom part such that the tip of said spike cannot contact a stopper in said head section when said head section is being attached to said bottom part and to release said top part from said bottom part after said bottom part has been attached to said head section; and

said second locking mechanism is adapted to allow, after said bottom part has been attached to said head section, said spike to penetrate said stopper in said head section and to irremovably lock said top part to said bottom part.

14. The apparatus of claim 13, wherein an annular shaped flat hydrophobic filter is located in said disk shaped element, said vial adaptor and said filter adapted to allow fluid flowing in said liquid channel to pass through said vial adapter without passing through said filter and to force fluid flowing through said air channel to pass through said filter.

15. The apparatus of claim 1, comprising a selective valve in the air path located between the filter and the fluid transfer component to which or from which liquid is being transferred.

16. The apparatus of claim 15, wherein said selective valve is activated by one of:

electricity, pressure, or gravity.

17. The apparatus of claim 16, wherein the selective valve is a gravity activated valve comprising a housing having a first opening on its side and a second opening on its end, a heavy weight inside of said housing, and an elastic layer connected to the end of said weight that faces said second opening;

wherein the dimensions of said weight and said elastic layer are such that said weight can move freely inside housing a short distance in a direction parallel to a longitudinal axis of housing;

wherein in a first vertical orientation gravity pulls said weight downwards pressing said elastic layer onto said second opening, thereby preventing fluid from entering said housing through said second opening; and

wherein an inverted vertical orientation gravity pulls said weight and attached elastic layer away from said second housing, thereby allowing fluid to enter said housing through said second opening.