Apparatus and kits for fluid infusion

• US 10,391,257 B2
• Filed: 06/02/2017
• Issued: 08/27/2019
• Est. Priority Date: 02/24/2015
• Status: Active Grant

• Current Assignee: 410 Medical, Inc., Studio Hagler LLC
• Original Assignee: 410 Medical, Inc.
• Inventors: Piehl, Mark D., Robertson, Galen C., Hagler, John Tyler Willis, Titkemeyer, Robert W., Feiler, Jr., Frederic C.
• Primary Examiner(s): Hayman, Imani N
• Assistant Examiner(s): Swanson, Leah J
• Application Number:
  US15/612,668
• Publication Number:
  US 20170319783A1
• Time in Patent Office: 816 Days
• Field of Search: 604 9301
• CPC Class Codes: A61M 2005/202 cocking means, e.g. to bias the main drive spring of an injector
• CPC Class Codes: A61M 2005/2026 Semi-automatic, e.g. user activated piston is assisted by additional source of energy
• CPC Class Codes: A61M 2005/2073 preventing premature release, e.g. by making use of a safety lock
• CPC Class Codes: A61M 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• CPC Class Codes: A61M 2005/31588 electrically driven
• CPC Class Codes: A61M 2039/2493 Check valve with complex design, e.g. several inlets and outlets and several check valves in one body
• CPC Class Codes: A61M 2205/332 Force measuring means
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3379 Masses, volumes, levels of fluids in reservoirs, flow rates
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 39/10 Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014
• CPC Class Codes: A61M 39/105 Multi-channel connectors or couplings, e.g. for connecting multi-lumen tubes multi-channel connectors in general F16L37/56
• CPC Class Codes: A61M 39/24 Check- or non-return valves
• CPC Class Codes: A61M 39/28 Clamping means for squeezing flexible tubes, e.g. roller clamps tube strippers A61M1/83
• 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 5/007 for contrast media
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/1456 with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir
• 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 5/19 : having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491
• CPC Class Codes: A61M 5/2033 : Spring-loaded one-shot injectors with or without automatic needle insertion multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287
• CPC Class Codes: A61M 5/3146 : Priming, e.g. purging, reducing backlash or clearance
• CPC Class Codes: A61M 5/3158 : performed by axially moving actuator operated by user, e.g. an injection button
• CPC Class Codes: A61M 5/31581 : performed by rotationally moving or pivoting actuator operated by user, e.g. an injection lever or handle
• CPC Class Codes: A61M 5/31586 : performed by rotationally moving or pivoted actuator, e.g. an injection lever or handle
• CPC Class Codes: A61M 5/486 : Indicating injection pressure
• CPC Class Codes: A61M 5/488 : Limiting injection pressure
• CPC Class Codes: A61P 23/02 : Local anaesthetics
• CPC Class Codes: A61P 25/02 : for peripheral neuropathies
• CPC Class Codes: A61P 25/04 : Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 29/00 : Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Abstract

An infusion device includes a housing with an interior chamber sized and configured to hold at least a flange and plunger of a syringe, a trigger held by the housing, and a lever in communication with the trigger and including an upwardly extending cam with a cam path having an upper end. The cam is in communication with the flange of the syringe. In response to actuation of the trigger to dispense fluid from the syringe, the upper end of the cam travels upward above the syringe and longitudinally toward a dispensing end of the syringe to linearly translate the plunger of the syringe in a first direction to dispense fluid from the syringe. To refill fluid into the syringe, the upper end of the cam travels downward and longitudinally away from the dispensing end of the syringe to linearly translate the plunger in a second direction to intake fluid.

Claims

1. An infusion device, comprising:

a tubing set including;

a valve body having a first end, a second end opposite to and axially aligned with the first end and in selective fluid communication with the first end, and an inlet projecting laterally from the valve body between the first end and the second end and in selective fluid communication with the second end,

a syringe having an axially extending syringe body with a first end and an opposite second end, and a plunger disposed in the syringe body and extending from the second end, the first end of the syringe coupled to the second end of the valve body with the syringe body axially aligned with the first end and the second end of the valve body, and

inlet tubing having a first end coupled to the inlet of the valve and a second end coupleable to a source of liquid; and

a housing sized and configured to receive the syringe and the valve body, the housing having an upper surface defining a first receiving aperture and a second receiving aperture, the first receiving aperture configured to receive at least one of the inlet of the valve body or the inlet tubing such that the inlet is at least partially disposed within the first receiving aperture and such that the inlet extends laterally from the housing, the second receiving aperture configured to receive the first end of the valve body such that the first end extends axially from the housing; and

a lid defining a first receiving aperture and a second receiving aperture, the lid coupled to the housing and configured to transition relative to the housing between an open position and a closed position, the first receiving aperture of the lid configured to cooperate with the first receiving aperture of the housing to retain the at least one of the inlet tubing or the inlet of the valve body between the lid and the housing and the second receiving aperture of the lid configured to cooperate with the second receiving aperture of the housing to retain the first end of the valve body between the lid and the housing when the lid is in the closed position.

2. The infusion device of claim 1, wherein the syringe has a neck portion adjacent the first end of the syringe body and the lid includes an internal wall, the internal wall disposed proximal of the first receiving aperture and the second receiving aperture of the lid and projecting into an interior region of the lid, the internal wall defining a third receiving aperture and configured to engage the neck portion of the syringe such that at least a portion of the neck portion of the syringe is disposed within the third receiving aperture defined by the internal wall.

3. The infusion device of claim 1, wherein the syringe body includes visual indicia of volume and the orientation in which the valve body and the syringe can be secured relative to the housing is such that the visual indicia of volume are facing away from the housing and visible to a user of the infusion device during use.

4. The infusion device of claim 1, wherein the lid and the housing are configured to collectively enclose the syringe and a portion of the valve body when the lid is in the closed position.

5. The infusion device of claim 1, wherein the lid and the housing are configured to collectively enclose the second end of the syringe body and a portion of the plunger extending from the second end of the syringe body when the lid is in the closed position.

6. The infusion device of claim 1, wherein the first receiving aperture of the housing is disposed on a sidewall of the housing and the second receiving aperture of the housing is disposed on a distal end of the housing.

7. The infusion device of claim 1, wherein a central axis of the first receiving aperture of the housing and a central axis of the second receiving aperture of the housing are perpendicular.

8. The infusion device of claim 1, wherein the syringe body includes a flange extending laterally from the second end thereof, the housing includes a slot configured to receive the flange of the syringe body, the housing configured to receive the flange in the slot via movement of the valve body and the syringe towards the housing laterally relative to the axis of the syringe body.

9. An infusion device, comprising:

a housing with an interior chamber that is sized and configured to simultaneously receive a syringe having a distal end and a valve having a first end, a second end, and a side inlet disposed between the first end and the second end, the second end of the valve coupled to the distal end of the syringe, the housing defining a first aperture and a second aperture, the first aperture configured to receive the first end of the valve and the second aperture configured to receive the side inlet of the valve such that the first end of the valve is partially disposed within the first aperture of the housing and the side inlet of the valve is partially disposed within the second aperture of the housing, and

a lid rotationally coupled to the housing for movement between an open position in which the syringe and valve can be moved laterally into engagement with the housing and a closed position in which the lid, the housing, and the valve can collectively form an enclosure around the syringe, the lid defining a first aperture and a second aperture, the first aperture of the lid configured to receive the first end of the valve such that the first end of the valve is at least partially disposed within the first aperture of the lid and the second aperture of the lid configured to receive the side inlet of the valve such that the side inlet of the valve can be at least partially disposed within the second aperture of the lid, the lid configured to retain the valve between the housing and the lid via engagement of the housing and the lid with the side inlet of the valve such that the side inlet of the valve is retained between the housing and the lid and the orientation of the valve and the syringe can be maintained relative to the housing and the lid.

10. The infusion device of claim 9, wherein the lid includes a first latching element and the housing includes a corresponding second latching element, the first latching element configured to releasably engage with the second latching element when the lid is in the closed position.

11. The infusion device of claim 9, wherein the lid is visually transmissive such that the syringe can be viewed through the lid when the syringe is disposed in the housing and the lid is in the closed position.

12. The infusion device of claim 11, wherein the syringe includes visual indicia of volume, and the lid is visually transmissive such that the visual indicia of volume can be viewed through the lid when the syringe is disposed in the housing and the lid is in the closed position.

13. The infusion device of claim 9, wherein the lid is rotationally coupled to the housing via a fixed pivot, the fixed pivot disposed proximal of the second aperture of the lid when the lid is in the closed position.

14. A method of infusing fluid to a subject, comprising:

engaging a pre-assembled tubing set with an infusion delivery device, the pre-assembled tubing set including;

a valve having a first end, a second end opposite to the first end and in selective fluid communication with the first end and an inlet projecting laterally from the valve between the first end and the second end and in selective fluid communication with the first end,

a syringe having an axially extending syringe body, a first end and an opposite second end, and a plunger movably received in the syringe body, the first end of the syringe body coupled to the first end of the valve, and

inlet tubing having a first end coupled to the inlet of the valve and a second end, the inlet tubing coupled to the inlet such that a portion of the inlet tubing adjacent the valve extends laterally outward relative to an axis of the syringe body,

the pre-assembled tubing set engaged with the infusion delivery device by displacement of the syringe and valve laterally relative to the infusion delivery device such that at least a portion of the inlet of the valve is disposed within a first valve receiving aperture of a housing of the infusion delivery device and at least a portion of the second end of the valve is disposed within a second valve receiving aperture of the housing of the infusion delivery device;

fluidically coupling the second end of the inlet tubing to a source of fluid;

enclosing at least a portion of the syringe and a portion of the valve by closing a lid of the infusion delivery device such that a first aperture of the lid cooperates with the first receiving aperture of the housing to retain the inlet of the valve between the lid and the housing and a second aperture of the lid cooperates with the second receiving aperture of the housing to retain the second end of the valve between the lid and the housing;

then repetitively, serially;

actuating a trigger of the infusion delivery device to move the plunger of the syringe in a first direction to draw fluid from the source of fluid, through the inlet tubing, through the inlet and first end of the valve, and into the syringe body; and

then

actuating the trigger to move the plunger of the syringe in a second opposing direction to dispense fluid from the syringe, through the first end of the valve, and out of the second end of the valve.

15. The method of claim 14, wherein the syringe includes visual indicia of the volume of the syringe, the visual indicia of the volume of the syringe facing away from the infusion delivery device when the pre-assembled tubing set is engaged with the infusion delivery device.

16. The method of claim 14, wherein the enclosing includes enclosing the entire syringe.

17. The method of claim 14, wherein the second end of the inlet tubing includes a spike and fluidically coupling the second end of the inlet tubing to a source of fluid includes coupling the spike with the source of fluid.

18. The method of claim 14, further comprising coupling outlet tubing to the second end of the valve such that, when the trigger is actuated to dispense fluid from the syringe, through the first end of the valve, and out of the second end of the valve, the fluid travels through the outlet tubing.

19. The method of claim 18, wherein the outlet tubing has a first end and a second end, the second end of the outlet tubing is coupled to one of an intravenous needle or an intraosseous needle, the coupling of the outlet tubing to the second end of the valve includes coupling the first end of the outlet tubing to the second end of the valve, and further comprising inserting the one of the intravenous needle or the intraosseous needle into the subject.

20. The method of claim 14, wherein the syringe body includes a flange extending laterally from the second end thereof and the infusion delivery device includes a slot configured to receive the flange of the syringe body, and engaging the preassembled tubing with the infusion delivery device includes engaging the flange with the slot.

21. An infusion device, comprising:

a valve having a first end, a second end in selective fluid communication with the first end, and an inlet projecting laterally from the valve between the first end and the second end and in selective fluid communication with the first end;

a syringe engaged with the first end of the valve, the inlet of the valve projecting laterally from a centerline of the syringe;

large bore tubing having an inner diameter greater than 3 mm and less than or equal to 6 mm, the large bore tubing having a first end coupled to the inlet of the valve and a second end coupleable to a source of fluid, such that the fluid can be drawn from the source of fluid through the large bore tubing, the inlet of the valve and the first end of the valve and into a reservoir of the syringe and dispensed from the reservoir of the syringe, through the first end of the valve, and through the second end of the valve;

a housing defining a first receiving aperture, a second receiving aperture, and an interior chamber, the first receiving aperture and the second receiving aperture configured to receive the second end of the valve and the inlet of the valve, respectively, with the first end of the large bore tubing coupled to the inlet of the valve, such that the second end of the valve is at least partially disposed within the first receiving aperture and the inlet of the valve is at least partially disposed within the second receiving aperture, and

a lid defining a first receiving aperture and a second receiving aperture, the lid coupled to the housing and configured to transition relative to the housing between an open position and a closed position, the first receiving aperture of the lid configured to cooperate with the second receiving aperture of the housing to retain the at least one of the large bore tubing or the inlet of the valve between the lid and the housing and the second receiving aperture of the lid configured to cooperate with the first receiving aperture of the housing to retain the second end of the valve between the lid and the housing when the lid is in the closed position.

22. The infusion device of claim 21, wherein the second end of the large bore tubing includes a spike configured to couple the large bore tubing to the source of fluid.

23. The infusion device of claim 21, further comprising outlet tubing coupled to the second end of the valve.

24. The infusion device of claim 23, wherein the outlet tubing has a smaller inner diameter than the inner diameter of the large bore tubing.

25. The infusion device of claim 21, wherein the fluid is saline.

26. The infusion device of claim 21, wherein the fluid is at least one of blood or blood products.

27. The infusion device of claim 21, wherein the valve includes a first check valve and a second check valve,

the first check valve configured to selectively allow fluid flow through the inlet of the valve such that fluid can flow from the large bore tubing, through the inlet, through the first end, and into the syringe, and such that fluid is prevented from flowing from the syringe, through the first end, and out of the inlet, and

the second check valve configured to selectively allow fluid flow through the second end of the valve such that fluid can flow from the syringe, through the first end, and out of the second end of the valve, and fluid is prevented from flowing into the valve and into the syringe via the second end of the valve.