MEDICATION DELIVERY DEVICES HAVING PENETRABLE STERILITY BARRIERS AND ALIGNMENT FEATURES

• US 20100022953A1
• Filed: 07/24/2009
• Published: 01/28/2010
• Est. Priority Date: 07/24/2008
• Status: Abandoned Application

• Current Assignee: CRISI Medical Systems, Inc. (Becton, Dickinson & Co), Regents of the University of California (University of California)
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Palmer, Douglas Arthur, Vilke, Gary Michael, Killeen, James Patrick, Sohmer, Michael J., Chan, Theodore Craig, Bochenko, Walter John, DeKalb, Shawn Wayne
• Application Number:
  US12/509,308
• Publication Number:
  US 20100022953A1
• Time in Patent Office: Days
• US Class Current: 604/134
• CPC Class Codes: A61M 5/1454 spring-actuated, e.g. by a clockwork
• CPC Class Codes: A61M 5/14566 with a replaceable reservoir for receiving a piston rod of the pump
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/2429 by telescoping of ampoules or carpules with the syringe body
• CPC Class Codes: A61M 5/2466 by piercing without internal pressure increase A61M5/2429 takes precedence

Abstract

A medication delivery cartridge is described that includes a casing having an internal cavity extending between a proximal end and a distal end of the casing, a plunger translatable within the internal cavity that includes a penetrable fluid outlet, a volume of medicine contained within the internal cavity disposed between the plunger and the proximal end of the casing, and a first penetrable sterility barrier spanning the internal cavity proximate the distal end of the casing. Related apparatus, systems, and methods are also disclosed.

Claims

1. A medication delivery cartridge comprising:

a casing including an internal cavity extending between a proximal end and a distal end of the casing;

a plunger translatable within the internal cavity, the plunger comprising a penetrable fluid outlet;

a volume of medicine contained within the internal cavity disposed between the plunger and the proximal end of the casing; and

a first penetrable sterility barrier spanning the internal cavity proximate the distal end of the casing.

2. The cartridge of claim 1, wherein the first penetrable sterility barrier comprises at least one scored feature that aids in penetrating the first penetrable sterility barrier wherein the at least one scored feature is biased toward a preferential tear pattern in the first penetrable sterility barrier upon penetration.

3. The cartridge of claim 1, further comprising an outer housing surrounding at least a portion of the casing, the outer housing comprising a closed distal end region and an open proximal end region, wherein the casing is translatable relative to the outer housing in a first direction.

4. The cartridge of claim 3, wherein the outer housing further comprises a dispensing element disposed between the proximal end region of the casing and the closed distal end region of the housing, wherein the dispensing element imparts a force on the proximal end of the casing to translate the casing relative to the outer housing in the first direction.

5. The cartridge of claim 4, wherein the dispensing element comprises a compressed spring, a volume of compressed gas, or a push rod.

6. The cartridge of claim 1, wherein translation of the plunger within the internal cavity reduces a volume of the internal cavity.

7. The cartridge of claim 1, wherein translation of the casing relative to the plunger reduces a volume of the internal cavity.

8. The cartridge of claim 3, further comprising:

at least one fluid port assembly comprising a connector having an internal bore extending between an open proximal end and a distal end of the connector; and

a receiver surrounding the connector and including a second penetrable sterility barrier spanning the open proximal end of the bore and a sleeve surrounding the connector and disposed within the receiver,

wherein the distal end of the connector fluidically couples to a medication-receiving fluid conduit comprising a fluid inlet at a first region and a fluid outlet conduit adapted to couple to a patient catheter line at a second region.

9. The cartridge of claim 8, wherein the casing is translatable within the receiver of the fluid port assembly.

10. The cartridge of claim 8, wherein the receiver and second penetrable sterility barrier maintain the connector in a sterile condition.

11. The cartridge of claim 8, wherein the sleeve abuts the plunger when the connector penetrates the fluid outlet of the plunger and restricts movement of the plunger upon translation of the casing relative to the fluid port assembly.

12. The cartridge of claim 11, wherein translation of the casing and restriction of plunger movement reduces a volume of the internal cavity and evacuates at least a portion of the volume of medication out the fluid outlet of the plunger into the open proximal end of the connector.

13. The cartridge of claim 8, wherein the outer housing further comprises a first alignment feature and wherein the receiver further comprises a second alignment feature having a shape complementary to the first alignment feature of the outer housing.

14. The cartridge of claim 13, wherein the first alignment feature of the outer housing engages the second alignment feature and fixes the outer housing to the fluid port assembly.

15. The cartridge of claim 8, wherein the second penetrable sterility barrier comprises at least one scored feature that aids in penetrating the second penetrable sterility barrier wherein the at least one scored feature is biased toward a preferential tear pattern in the second penetrable sterility barrier upon penetration.

16. The cartridge of claim 15, wherein the preferential tear pattern prevents contamination of the open proximal end of the connector upon fluidically coupling the casing and the fluid port assembly.

17. The cartridge of claim 15, wherein the casing further comprises a disabling feature at the distal end region to contact the at least one scored feature of the second penetrable sterility barrier of the receiver.

18. The cartridge of claim 8, wherein the sleeve surrounding the connector disables the second penetrable sterility barrier.

19. A medication delivery system comprising:

a medication-receiving fluid conduit comprising a fluid inlet at a first region and a fluid outlet conduit adapted to couple to a patient catheter line at a second region;

at least one fluid port assembly comprising a connector having an internal bore extending between an open proximal end and a distal end of the connector; and

a first sterility barrier surrounding the connector and including a first penetrable member spanning the open proximal end of the bore, wherein the distal end of the connector fluidically couples to the fluid inlet of the medication-receiving fluid conduit when the first penetrable member is penetrated;

a medication delivery cartridge comprising;

a casing including an internal cavity extending between a proximal end and a distal end of the casing;

a plunger translatable within the internal cavity, the plunger comprising a penetrable fluid outlet;

a volume of medicine contained within the internal cavity disposed between the plunger and the proximal end of the casing;

a second sterility barrier proximate the distal end of the casing, the second sterility barrier comprising a second penetrable member spanning the internal cavity; and

an outer housing surrounding at least a portion of the casing, the outer housing comprising a closed distal end region and an open proximal end region, wherein the cartridge is translatable relative to the outer housing in a first direction.

20. The system of claim 19, wherein the first member spanning the open proximal end of the bore comprises at least one scored feature that aids in penetration of the first member, wherein the at least one scored feature is biased toward a preferential tear pattern in the first member upon penetration.

21. The system of claim 19, wherein the second member comprises at least one scored feature that aids in penetration of the second member, wherein the at least one scored feature is biased toward a preferential tear pattern in the second member upon penetration.

22. The system of claim 20, wherein the cartridge further comprises a first disabling feature at the distal end region of the casing to contact the at least one scored feature of the first member of the first sterility barrier.

23. The system of claim 22, wherein the fluid port assembly further comprises a second disabling feature to contact the at least one scored feature of the second member of the second sterility barrier.

24. The system of claim 19, wherein the outer housing further comprises a first alignment feature and, wherein the first sterility barrier further comprises a second alignment feature having a shape complementary to the first alignment feature of the outer housing.

25. The system of claim 24, wherein the first alignment feature of the outer housing engages the second alignment feature and fixes the outer housing to the fluid port assembly.

26. The system of claim 19, wherein translation of the plunger within the internal cavity reduces a volume of the internal cavity.

27. The system of claim 19, wherein translation of the casing relative to the plunger reduces a volume of the internal cavity.

28. The system of claim 19, further comprising a sleeve surrounding the connector and disposed within the first sterility barrier, wherein the sleeve abuts the plunger when the connector penetrates the fluid outlet of the plunger and restricts movement of the plunger upon translation of the cartridge relative to the fluid port assembly.

29. The system of claim 28, wherein translation of the casing and restriction of plunger movement reduces a volume of the internal cavity and evacuates at least a portion of the volume of medication out the fluid outlet of the plunger and into the open proximal end of the connector.

30. The system of claim 28, wherein the sleeve surrounding the connector penetrates the second member of the cartridge.

31. The system of claim 19, wherein the outer housing further comprises a dispensing element disposed between the proximal end of the casing and the closed distal end region of the housing, wherein the dispensing element imparts a force on the proximal end of the cartridge to translate the cartridge relative to the outer housing in the first direction.

32. The system of claim 31, wherein the dispensing element comprises a compressed spring, a volume of compressed gas, or a push rod.

33. The system of claim 31, further comprising an activation element that, when activated, causes the dispensing element to translate the cartridge in the first direction relative to the outer housing.

34. The system of claim 33, wherein the activation element comprises a retaining pin, an energy source, a motor, or manual pressure by a user.

35. A medication delivery device comprising:

a cartridge comprising;

an outer housing;

a cartridge casing including an internal cavity extending between a proximal end and a distal end of the cartridge casing, wherein at least a portion of the cartridge casing is translatable within the outer housing;

a plunger translatable within the internal cavity, the plunger comprising a penetrable fluid outlet;

a volume of medicine contained within the internal cavity disposed between the plunger and the proximal end of the cartridge casing; and

a first penetrable sterility barrier proximate the distal end of the cartridge casing, the first barrier spanning the internal cavity; and

a cartridge receiver reversibly coupled to the outer housing of the cartridge, the cartridge receiver comprising;

a receiver casing having an open proximal end;

a fluid conduit disposed within the receiver casing, the fluid conduit extending between a fluid inlet and a fluid outlet; and

a second penetrable sterility barrier spanning the open proximal end of the receiver casing.