Apparatus and methods for administration of reconstituted medicament

• US 8,317,741 B2
• Filed: 05/26/2009
• Issued: 11/27/2012
• Est. Priority Date: 05/26/2009
• Status: Active Grant

• Current Assignee: Timothy Y. Kraushaar
• Original Assignee: Timothy Y. Kraushaar
• Inventors: Kraushaar, Timothy Y.
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Bosques, Edelmira
• Application Number:
  US12/471,749
• Publication Number:
  US 20100305548A1
• Time in Patent Office: 1,281 Days
• Field of Search: 604/82, 604/158, 604/6.1, 604/99.03, 604/167.04, 604/518
• US Class Current: 604/82
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/1475 Inlet or outlet ports
• CPC Class Codes: A61J 1/2058 having multiple connecting ports
• CPC Class Codes: A61J 1/2062 with directional valves
• CPC Class Codes: A61J 1/2072 for internal venting
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents

Abstract

A body portion of the apparatus comprises an interior cavity and a plurality of fluid lumens extending from the cavity to a periphery of the body portion. The apparatus further comprises a first fluid port in fluid communication with a first one of the fluid lumens. The first fluid port is configured to receive a syringe for injecting a liquid diluent and withdrawing a reconstituted liquid medicament. The apparatus further comprises a second fluid port in fluid communication with a second one of the fluid lumens. The second fluid port is configured to receive a medicament vial. The apparatus further comprises a third fluid port at an end of a third one of the fluid lumens for expelling the reconstituted liquid medicament. The apparatus further comprises a stopcock received within the body portion interior cavity and configured to regulate fluid communication between the fluid lumens. The stopcock has a first position in which fluid communication between the fluid lumens is blocked, a second position in which fluid communication is open between the first and second fluid lumens and a third position in which fluid communication is open between the first and third fluid lumens.

Claims

1. Apparatus for reconstituting a medicament in a vial with a liquid from a syringe, the apparatus comprising:

a body portion defining an interior cavity and having first, second, and third fluid ports communicating with the interior cavity, the body portion further defining a body lumen extending through the body portion without intersecting the interior cavity, and fourth and fifth fluid ports communicating with each other bidirectionally through the body lumen;

a fitting on the first fluid port configured to receive a syringe;

a fluid regulating element located within the interior cavity and configured to be selectively movable among (a) a first position in which fluid communication through the interior cavity is blocked, (b) a second position in which fluid communication is open through the interior cavity between the first and second fluid ports, and (c) a third position in which fluid communication is open through the interior cavity between the first and third fluid ports;

an adapter assembly fixed to the body portion and configured for removable attachment of a medicament vial so that the vial is in fluid communication with the second fluid port and the fourth fluid port; and

an expansible air chamber operatively connected to the fifth fluid port so as to allow the bidirectional passage of air through the body lumen between the air chamber and the fourth fluid port.

2. The apparatus of claim 1, wherein the first fluid port comprises a Luer fitting.

3. The apparatus of claim 1, wherein the body portion includes a spike configured to puncture an intravenous fluid bag, and wherein the spike includes the third fluid port.

4. The apparatus of claim 1, wherein the adapter assembly includes a first spacer lumen communicating with the second fluid port and a second spacer lumen communicating with the fourth fluid port.

5. The apparatus of claim 4, wherein the adapter assembly is configured to receive a medicament vial having a stopper, wherein the adapter assembly includes an adapter spike element configured to breach the stopper when a vial is attached to the body portion, and wherein the first and second spacer lumens extend through the adapter spike element.

6. The apparatus of claim 1, further comprising a check valve that allows free bidirectional airflow past the valve and through the body lumen.

7. The apparatus of claim 6, wherein the check valve prevents liquid flow past the valve and through the body lumen when the apparatus is oriented in a first orientation.

8. A method for reconstituting a medicament contained in a vial with a liquid from a syringe, the method comprising:

(a) using a medicament reconstituting apparatus, comprising;

a device body defining an interior cavity;

first, second, and third fluid ports communicating with the interior cavity;

a body lumen extending through the body without intersecting the interior cavity; and

fourth and fifth fluid ports communicating with each other through the body lumen;

a fluid regulating element located within the interior cavity and configured to be selectively movable among (i) a first position in which fluid communication through the interior cavity is blocked, (ii) a second position in which fluid communication is open through the interior cavity between the first and second fluid ports, and (iii) a third position in which fluid communication is open through the interior cavity between the first and third fluid ports; and

an expansible air chamber operatively connected to the fifth fluid port so as to allow the bidirectional passage of air through the body lumen between the air chamber and fourth fluid port;

(b) with the fluid regulating element in the first position, engaging the syringe containing the liquid with the device body so as to be in fluid communication with the first fluid port, and engaging the vial with the device body so as to be in fluid communication with the second and fourth fluid ports;

(c) moving the fluid regulating element to the second position;

(d) injecting the liquid from the syringe into the vial through the first fluid port, the interior cavity, and the second fluid port to create a reconstituted medicament;

(e) withdrawing the reconstituted medicament from the vial into the syringe through the second fluid port, the interior cavity, and the first fluid port;

(f) moving the fluid regulating element to the third position; and

(g) expelling the reconstituted medicament from the syringe out of the device body through the first fluid port, the interior cavity, and the third fluid port.

9. The method of claim 8, wherein the vial contains a volume of air, and wherein air is displaced from the vial into the expansible air chamber through the fourth fluid port, the body lumen, and the fifth fluid port during the step of injecting the liquid from the syringe into the vial.

10. The method of claim 9, wherein air is transferred from the expansible air chamber into the vial through the fifth fluid port, the body lumen, and the fourth fluid port during the step of withdrawing the reconstituted medicament from the vial into the syringe.

11. The method of claim 8, wherein, prior to the step of withdrawing the reconstituted medicament from the vial into the syringe, the apparatus is inverted.

12. The method of claim 8, wherein the vial has a stopper, wherein the device body includes an adapter assembly through which the second and fourth fluid ports communicate with the interior cavity, and wherein the step of engaging the vial with the device body includes the step of breaching the stopper to establish fluid communication between the interior of the vial and the interior cavity through the second and fourth fluid ports.

13. The method of claim 8, wherein the device body is configured for attachment of an IV line thereto so as to be in fluid communication with the third fluid port, and wherein the step of expelling includes the introduction of the reconstituted medicament into the IV line through the third fluid port.

14. Apparatus for reconstituting a medicament in a vial with a liquid from a syringe, the apparatus comprising:

a body portion defining an interior cavity and having first, second, and third fluid ports communicating with the interior cavity, the body portion further defining a body lumen extending through the body portion so as to be fluidly isolated from the interior cavity, and fourth and fifth fluid ports communicating with each other bidirectionally through the body lumen, wherein the first, second, third and fourth fluid ports all lie in the same plane;

a fitting on the first fluid port configured to receive a syringe;

a fluid regulating element located within the interior cavity and configured to be selectively movable among (a) a first position in which fluid communication through the interior cavity is blocked, (b) a second position in which fluid communication is open through the interior cavity between the first and second fluid ports, and (c) a third position in which fluid communication is open through the interior cavity between the first and third fluid ports;

an adapter assembly fixed to the body portion and configured for removable attachment of a medicament vial so that the vial is in fluid communication with the second fluid port and the fourth fluid port; and

an expansible air chamber operatively connected to the fifth fluid port so as to allow the bidirectional passage of air through the body lumen between the air chamber and the fourth fluid port.

15. The apparatus of claim 14, wherein the body portion includes a spike configured to puncture an intravenous fluid bag, and wherein the spike includes the third fluid port.

16. The apparatus of claim 14, wherein the adapter assembly includes a first spacer lumen communicating with the second fluid port and a second spacer lumen communicating with the fourth fluid port.

17. The apparatus of claim 16, wherein the adapter assembly is configured to receive a medicament vial having a stopper, wherein the adapter assembly includes an adapter spike element configured to breach the stopper when a vial is attached to the body portion, and wherein the first and second spacer lumens extend through the adapter spike element.

18. The apparatus of claim 14, further comprising a check valve that allows free bidirectional airflow past the valve and through the body lumen.

19. The apparatus of claim 18, wherein the check valve prevents liquid flow past the valve and through the body lumen when the apparatus is oriented in a first orientation.

20. A method for reconstituting a medicament contained in a vial with a liquid from a syringe, the method comprising:

(a) using a medicament reconstituting apparatus, comprising;

a device body defining an interior cavity;

first, second, and third fluid ports communicating with the interior cavity;

a body lumen extending through the body so as to be isolated from the interior cavity; and

fourth and fifth fluid ports communicating with each other through the body lumen;

wherein the first, second, third and fourth fluid ports all lie in the same plane;

a fluid regulating element located within the interior cavity and configured to be selectively movable among (i) a first position in which fluid communication through the interior cavity is blocked, (ii) a second position in which fluid communication is open through the interior cavity between the first and second fluid ports, and (iii) a third position in which fluid communication is open through the interior cavity between the first and third fluid ports; and

an expansible air chamber operatively connected to the fifth fluid port so as to allow the bidirectional passage of air through the body lumen between the air chamber and fourth fluid port;

(b) with the fluid regulating element in the first position, engaging the syringe containing the liquid with the device body so as to be in fluid communication with the first fluid port, and engaging the vial with the device body so as to be in fluid communication with the second and fourth fluid ports;

(c) moving the fluid regulating element to the second position;

(d) injecting the liquid from the syringe into the vial through the first fluid port, the interior cavity, and the second fluid port to create a reconstituted medicament;

(e) withdrawing the reconstituted medicament from the vial into the syringe through the second fluid port, the interior cavity, and the first fluid port;

(f) moving the fluid regulating element to the third position; and

(g) expelling the reconstituted medicament from the syringe out of the device body through the first fluid port, the interior cavity, and the third fluid port.

21. The method of claim 20, wherein the vial contains a volume of air, and wherein air is displaced from the vial into the expansible air chamber through the fourth fluid port, the body lumen, and the fifth fluid port during the step of injecting the liquid from the syringe into the vial.

22. The method of claim 21, wherein air is transferred from the expansible air chamber into the vial through the fifth fluid port, the body lumen, and the fourth fluid port during the step of withdrawing the reconstituted medicament from the vial into the syringe.

23. The method of claim 20, wherein the device body is configured for attachment of an IV line thereto so as to be in fluid communication with the third fluid port, and wherein the step of expelling includes the introduction of the reconstituted medicament into the IV line through the third fluid port.