Vial transfer and injection apparatus and method

• US 9,925,333 B2
• Filed: 06/17/2014
• Issued: 03/27/2018
• Est. Priority Date: 06/18/2013
• Status: Active Grant

• Current Assignee: Enable Injections, Inc.
• Original Assignee: Enable Injections, Inc.
• Inventors: Hooven, Michael D., Huddleston, Matthew J., Palmer, Joetta Renee, Stefanchik, David
• Primary Examiner(s): Hayman, Imani
• Assistant Examiner(s): Watts, Tezita
• Application Number:
  US14/888,303
• Publication Number:
  US 20160144105A1
• Time in Patent Office: 1,379 Days
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/206 With automatic needle insertion
• CPC Class Codes: A61M 2005/2414 from the side
• CPC Class Codes: A61M 2005/3123 having air entrapping or venting means, e.g. purging channels in pistons
• CPC Class Codes: A61M 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• CPC Class Codes: A61M 5/152 pressurised by contraction of elastic reservoirs containers for dispensing contents by contraction of an elastic bag provided therein, in general B65D83/0061
• CPC Class Codes: A61M 5/1782 Devices aiding filling of syringes in situ combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/3157 Means providing feedback signals when administration is completed A61M5/20 takes precedence
• CPC Class Codes: A61M 5/31591 Single dose, i.e. individually set dose administered only once from the same medicament reservoir, e.g. including single stroke limiting means

Abstract

Drug delivery system, injection device, transfer apparatus, vial holder and method of administering and transferring are disclosed. The system may include transfer apparatus and an injection device. The transfer apparatus may have receiving stations for a drug source, such as a vial or vial holder, and for an injection device, and fluid flow pathways for transferring drugs from the source into the injection device. The injection device may include an expandable elastic bladder and an injection cannula that is movable between a plurality of positions.

Claims

1. An injection device comprising:

a housing;

an arcuately expandable bladder made of elastomeric material and positioned within the housing, the bladder including a proximal end, a distal end and a wall extending between the proximal end and the distal end;

an injection cannula moveable within a central portion of the housing between a pre-dispense position and a dispense position, the injection cannula not being in fluid flow communication with the bladder in the pre-dispense position and being in fluid flow communication with the bladder in the dispense position;

a manifold within the housing attached to the proximal end of the bladder, the manifold having a fluid inlet port and a fluid pathway communicating between the fluid inlet port and the bladder for introduction of liquid under pressure into the bladder;

the distal end of the bladder being moveable within the housing, wherein the bladder elongates between the proximal end and the distal end and the distal end of the bladder moves along an arcuate path away from the proximal end of the bladder and at least partially around the central portion of the housing as liquid is introduced under pressure to expand the bladder; and

wherein an elastic force in the bladder wall when the bladder is arcuately expanded provides the pressure to expel liquid from the bladder and through the injection cannula, whereby the distal end of the bladder moves along the arcuate path and toward the proximal end due to the elastic force in the bladder wall as liquid flows from the bladder through the injection cannula.

2. The injection device of claim 1 including adhesive configured to attach the injection device to a patient'"'"'s skin.

3. The injection device of claim 1 further comprising a cannula actuator which is configured so that the injection cannula is moveable from the pre-dispense position to a first depth into a patient'"'"'s skin and then to a second depth less than the first depth, where the injection cannula is retained at the second depth.

4. The injection device of claim 3 wherein the injection cannula includes a side hole configured so that when the injection cannula is in the pre-dispense position and the first depth position, the side hole is not in fluid flow communication with the bladder and when the injection cannula is in the second depth position, the side hole is in fluid flow communication with the bladder.

5. The injection device of claim 4 further comprising a septum positioned within the housing and configured to seal around a periphery of the side hole of the injection cannula when the injection cannula is in the pre-dispense position and the first depth position.

6. The injection device of claim 1 further comprising a cannula actuator that includes a viewing window and a cavity in fluid communication with a proximal end of the injection cannula so that blood accumulates in the cavity and is visible through the viewing window after the injection cannula is inserted into a blood vessel of a patient.

7. The injection device of claim 1 in which the injection cannula is selectively moveable from the dispense position to another position in which the injection cannula is not in communication with the bladder to pause the flow of a drug to the patient.

8. The injection device of claim 1 wherein the housing is circular and includes a spiral recess within which the distal end of the bladder is positioned and moves along as liquid is introduced into and expelled from the bladder.

9. The injection device of claim 1 wherein the distal end of the bladder is provided with an indicator.

10. The injection device of claim 1 further comprising a mandrel connected to the distal end of the bladder and configured so that the bladder is prestressed to an expanded condition even after all liquid has been expelled from the bladder.

11. The injection device of claim 1 wherein the bladder wall includes an area of increased thickness along a side of the bladder wall, where the area of increased thickness deflects less than a remaining portion of the bladder wall so that the distal end moves along the arcuate path when a volume of liquid under pressure is introduced into the bladder.

12. The injection device of claim 1 wherein the bladder is C-shaped.

13. The injection device of claim 1 wherein the bladder is arranged in a planar helical configuration.

14. The injection device of claim 1 wherein the bladder is arranged in a spiral configuration.

15. The injection device of claim 1 wherein the bladder expands along a planar partial circular path.

16. The injection device of claim 1 wherein the bladder expands along a circular path.

17. The injection device of claim 1 wherein the bladder expands along a spiral path.

18. The injection device of claim 17 further comprising a mandrel connected to the distal end of the bladder and configured so that the bladder is prestressed to an expanded condition even after all liquid has been expelled from the bladder.

19. An injection device comprising:

a housing;

an arcuately expandable bladder made of elastomeric material and positioned within the housing, the bladder including a proximal end, a distal end and a wall extending between the proximal end and the distal end;

an injection cannula moveable within a central portion of the housing between a pre-dispense position and a dispense position, the injection cannula not being in fluid flow communication with the bladder in the pre-dispense position and being in fluid flow communication with the bladder in the dispense position;

a manifold within the housing attached to the proximal end of the bladder, the manifold having a fluid inlet port and a fluid pathway communicating between the fluid inlet port and the bladder for the introduction of liquid under pressure into the bladder;

the distal end of the bladder being moveable within the housing;

wherein the bladder elongates between the proximal end and the distal end and the distal end of the bladder moves along an arcuate path away from the proximal end of the bladder and at least partially around the central portion of the housing as liquid is introduced under pressure to expand the bladder;

the bladder wall including a radially inner wall portion and a radially outer wall portion relative to the central portion of the housing;

the radially inner wall portion being thicker than the radially outer wall portion along a length of the elongated wall substantially parallel to the arcuate path between the proximal end and the distal end of the bladder to induce the bladder to extend in the arcuate path at least partially around the central portion of the housing as it expands; and

wherein an elastic force in the bladder wall when the bladder is arcuately expanded provides pressure to expel liquid from the bladder and through the injection cannula, whereby the distal end of the bladder moves along the arcuate path and toward the proximal end due to the elastic force in the bladder wall as liquid flows from the bladder through the injection cannula.

20. The injection device of claim 19 wherein the thicker radially inner wall portion is molded into the bladder wall.

21. The injection device of claim 19 wherein the thicker radially inner wall portion includes a strip of material bonded to the radially inner wall portion.

22. An injection device comprising:

a housing;

an arcuately expandable bladder made of elastomeric material and positioned within the housing, the bladder including a proximal end, a distal end and a wall extending between the proximal end and the distal end;

an injection cannula moveable within a central portion of the housing between a pre-dispense position and a dispense position, the injection cannula not being in fluid flow communication with the bladder in the pre-dispense position and being in fluid flow communication with the bladder in the dispense position;

a manifold within the housing attached to the proximal end of the bladder;

the manifold having a fluid inlet port and a fluid pathway communicating between the fluid inlet port and the bladder for the introduction of liquid under pressure into the bladder;

the distal end of the bladder being moveable within the housing, wherein the bladder elongates between the proximal end and the distal end and the distal end of the bladder moves along an arcuate path away from the proximal end of the bladder and at least partially around the central portion of the housing as liquid is introduced under pressure to expand the bladder;

the bladder wall including a radially inner wall portion and a radially outer wall portion relative to the central portion of the housing, the radially inner wall portion being thicker than the radially outer wall portion along a length of the elongated wall substantially parallel to the arcuate path between the proximal end and the distal end of the bladder to induce the bladder to extend in the arcuate path at least partially around the central portion of the housing as it expands;

a guide extending at least partially around the central portion of the housing and slidably constraining the thicker radially inner wall portion to move along the arcuate path during bladder contraction and expansion; and

wherein an elastic force in the bladder wall when the bladder is arcuately expanded provides pressure to expel liquid from the bladder and through the injection cannula, whereby the distal end of the bladder moves along the arcuate path and toward the proximal end due to the elastic force in the bladder wall as liquid flows from the bladder through the injection cannula.

23. The injection device of claim 22 wherein the central portion of the housing includes a cylindrical wall and the guide includes a groove extending at least partially around the cylindrical wall and wherein a portion of the thicker radially inner wall portion of the bladder is slidably received in the groove.