Closed drug transfer system

• US 9,610,222 B2
• Filed: 07/27/2016
• Issued: 04/04/2017
• Est. Priority Date: 02/07/2013
• Status: Active Grant

• Current Assignee: Equashield Medical Ltd.
• Original Assignee: Equashield Medical Ltd.
• Inventors: Kriheli, Marino, Tavor, Raanan
• Primary Examiner(s): DEAK, LESLIE R
• Application Number:
  US15/220,953
• Publication Number:
  US 20160331639A1
• Time in Patent Office: 251 Days
• 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

A vial adaptor having 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. The top part has numerous components. The apparatus also has a first locking mechanism; and a second locking mechanism. The first locking mechanism is adapted to lock a top part to the bottom part such that a tip of a spike cannot contact a stopper in the head section when the head section is being attached to the bottom part and to release the top part from the bottom part after the bottom part has been attached to the head section. The second locking mechanism is adapted to allow, after the bottom part has been attached to the head section, the spike to penetrate the stopper in the head section and to irremovably lock the top part to the bottom part.

Claims

1. A vial adaptor comprising:

(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, thereby providing a closed transfer device that does not vent to or communicate with the environment;

(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.

2. The vial adaptor of claim 1, 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.

3. The vial adaptor of claim 2, 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.

4. The vial adaptor of claim 2, wherein the annular shaped flat hydrophobic filter is supported by and lays on a plurality of closely spaced supporting ribs from one or both of above and below.

5. The vial adaptor of claim 2, comprising a by-pass comprising a one-way valve placed in parallel to the filter in the air channel.

6. The vial adaptor of claim 5, wherein the one-way valve is comprised of an elastic cap, which is tightly fit over an end of a rigid tube.

7. The vial adaptor of claim 2, 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.

8. The vial adaptor of claim 7, wherein the selective valve is activated by one of:

electricity, pressure, or gravity.

9. The vial adaptor of claim 8, 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.

10. A vial adaptor comprising:

(a) a distal collar portion comprised of a disk shaped central piece and a plurality of segments adapted for facilitating securement of said vial adaptor to a head portion of a 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;

(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, thereby providing a closed transfer device that does not vent to or communicate with the environment;

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 prevent liquid flowing through said air channel from passing through said filter and to allow air flowing through said air channel to pass through said filter.

11. The vial adaptor of claim 10, 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.

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

13. The vial adaptor of claim 10, comprising a by-pass comprising a one-way valve placed in parallel to the filter in the air channel.

14. The vial adaptor of claim 13, wherein the one-way valve is comprised of an elastic cap, which is tightly fit over an end of a rigid tube.

15. The vial adaptor of claim 10, 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 vial adaptor of claim 15, wherein the selective valve is activated by one of:

electricity, pressure, or gravity.

17. The vial adaptor 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.