Apparatus, kits and related methods for fluid infusion

• US 10,322,227 B2
• Filed: 02/23/2016
• Issued: 06/18/2019
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: 410 Medical, Inc.
• 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): Sirmons, Kevin C
• Assistant Examiner(s): Swanson, Leah J
• Application Number:
  US15/051,456
• Publication Number:
  US 20160166761A1
• Time in Patent Office: 1,211 Days
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 17/3498 Valves therefor, e.g. flapper valves, slide valves haemostasis valves A61M39/06; check valves A61M39/24
• CPC Class Codes: A61M 1/024 Means for controlling the quantity of transfused blood, e.g. by weighing the container and automatic stopping of the transfusion after reaching a determined amount
• CPC Class Codes: A61M 2005/2026 Semi-automatic, e.g. user activated piston is assisted by additional source of energy
• CPC Class Codes: A61M 2005/3126 Specific display means related to dosing
• CPC Class Codes: A61M 2005/3152 including gearings to multiply or attenuate the piston displacing force
• CPC Class Codes: A61M 2202/10 Bone-marrow
• CPC Class Codes: A61M 2205/75 with filters
• CPC Class Codes: A61M 39/223 Multiway valves
• CPC Class Codes: A61M 39/24 Check- 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 5/007 for contrast media
• CPC Class Codes: A61M 5/1408 in parallel, e.g. manifolds, sequencing valves access sites A61M39/02; tube connectors A61M39/10
• 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 5/2033 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 5/31581 performed by rotationally moving or pivoting actuator operated by user, e.g. an injection lever or handle

Abstract

A kit of components for a medical infusion includes a syringe having a syringe body with a liquid chamber having a volumetric capacity in a range of 5 ml to 30 ml, large bore tubing having an inner diameter greater than 3 mm and less than or equal to 6 mm and a length in a range of 4 feet to 10 feet, a valve with an axially extending valve body with opposing first and second ends, and a package holding the syringe pre-attached to the valve body and the large bore tubing in a sterile condition to thereby provide components in a ready-to-use configuration for insertion of the syringe and valve into an infusion device. The valve body includes an inlet tube residing between the first and second ends of the valve body and an exit port on the first end of the valve body.

Claims

1. An apparatus, comprising:

a housing having a dispensing end, an upper side, a lower side, a grip extending from the lower side, and sized and configured to hold at least a flange of a body of a syringe and a plunger of the syringe with the syringe oriented with the plunger away from the dispensing end of the housing;

a shuttle mounted in the housing for reciprocal translational motion relative to the housing and configured to receive and engage a proximal flange of the plunger of the syringe such that translational movement of the shuttle toward the dispensing end of the housing causes corresponding translational movement of the plunger toward the dispensing end of the housing and translational movement of the shuttle away from the dispensing end of the housing causes corresponding translational movement of the plunger away from the dispensing end of the housing, the shuttle including a pin;

a lever rotationally coupled to the housing at a pivot and extending upwardly from the pivot, the lever including an upwardly extending cam defining a non-linear cam path having an upper end and a lower end, the pin of the shuttle disposed within the cam path; and

a trigger coupled to the lever and extending downwardly relative to the pivot and the lower side of the housing, the trigger movable between a first position spaced from the grip and a second position adjacent to the grip.

2. The apparatus of claim 1, wherein the lever includes a lower portion extending downwardly from the pivot and coupled to the trigger, the lower portion having a first configuration and a second configuration, the lower portion configured to transition from the first configuration to the second configuration in response to an application of force on the trigger toward the grip that exceeds a predetermined force threshold such that the lever is prevented from applying a force to the shuttle that causes the pressure of the fluid dispensed from the syringe to exceed a predetermined maximum pressure.

3. The apparatus of claim 2, wherein the lower portion of the lever includes a first segment and a second segment, the second segment coupled to the trigger, the second segment having a first orientation relative to the first segment in the first configuration and a second orientation relative to the first segment in the second configuration.

4. The apparatus of claim 3, wherein the lower portion of the lever includes a separable segment forming a portion of an outer surface of the lever, the separable segment, the first segment, and the second segment collectively defining an aperture such that the separable segment bounds the aperture when the lower portion is in the first configuration, the separable segment configured to separate into a first separated portion and a second separated portion during the transition of the lower portion from the first configuration to the second configuration such that, when the lower portion is in the second configuration, the separable segment no longer bounds the aperture.

5. The apparatus of claim 4, wherein the separable segment has a thickness when the lower portion is in the first configuration, the thickness corresponding to the predetermined force threshold.

6. The apparatus of claim 5, wherein the thickness is between about 0.01 and about 0.1 inches.

7. The apparatus of claim 4, wherein, when the lower portion is in the first configuration, the first segment, the second segment, and the separable segment are monolithically formed.

8. The apparatus of claim 4, wherein, when the lower portion is in the second configuration, the first separated portion is coupled to the first segment and the second separated portion is coupled to the second segment.

9. The apparatus of claim 4, wherein the trigger includes a connector, the connector disposed in the aperture when the lower portion is in the first configuration.

10. The apparatus of claim 2, wherein the predetermined force threshold is about 100 lbf.

11. The apparatus of claim 2, wherein the predetermined force threshold is between about 70 lbf and about 100 lbf.

12. The apparatus of claim 2, wherein the predetermined force threshold is about 50 lbf.

13. The apparatus of claim 2, wherein the predetermined maximum pressure is between about 100 PSI and about 200 PSI.

14. The apparatus of claim 2, wherein the predetermined maximum pressure is about 100 PSI.

15. The apparatus of claim 1, wherein the shuttle defines a slot, the slot configured to receive at least a portion of the proximal flange of the plunger such that the at least a portion of the proximal flange of the plunger is disposed within the slot.

16. An apparatus, comprising:

a housing having a dispensing end and sized and configured to hold at least a flange of a body of a syringe and a plunger of the syringe with the syringe oriented with the plunger away from the dispensing end of the housing;

a shuttle mounted in the housing for reciprocal translational motion relative to the housing and configured to receive and engage a proximal flange of the plunger of the syringe such that translational movement of the shuttle toward the dispensing end of the housing causes corresponding translational movement of the plunger toward the dispensing end of the housing and translational movement of the shuttle away from the dispensing end of the housing causes corresponding translational movement of the plunger away from the dispensing end of the housing, the shuttle including a pin; and

an actuation lever rotationally coupled to the housing at a pivot point, the actuation lever including a first segment extending below the pivot point and a second segment extending above the pivot point, the first segment of the actuation lever including a trigger for manual actuation by a user from an extended position to a retracted position, the second segment of the actuation lever including an upwardly extending cam defining a non-linear cam path having an upper end, the pin of the shuttle disposed within the cam path.

17. The apparatus of claim 16, wherein the first segment has a first configuration and a second configuration, the first segment configured to transition from the first configuration to the second configuration in response to an application of force on the trigger toward the grip that exceeds a predetermined force threshold such that the lever is prevented from applying a force to the shuttle that causes the pressure of the fluid dispensed from the syringe to exceed a predetermined maximum pressure.

18. The apparatus of claim 17, wherein the first segment includes a first portion and a second portion, the second portion coupled to the trigger, the second portion having a first orientation relative to the first portion in the first configuration and a second orientation relative to the first portion in the second configuration.

19. The apparatus of claim 18, wherein the first segment includes a separable segment forming a portion of an outer surface of the actuation lever, the separable segment, the first portion, and the second portion collectively defining an aperture such that the separable segment bounds the aperture when the first segment is in the first configuration, the separable segment configured to separate into a first separated portion and a second separated portion during the transition of the first segment from the first configuration to the second configuration such that, when the first segment is in the second configuration, the separable segment no longer bounds the aperture.

20. The apparatus of claim 19, wherein the separable segment has a thickness when the first segment is in the first configuration, the thickness corresponding to the predetermined force threshold.

21. The apparatus of claim 20, wherein the thickness is between about 0.01 and about 0.1 inches.

22. The apparatus of claim 19, wherein, when the first segment is in the first configuration, the first portion, the second portion, and the separable segment are monolithically formed.

23. The apparatus of claim 19, wherein, when the first segment is in the second configuration, the first separated portion is coupled to the first portion and the second separated portion is coupled to the second portion.

24. The apparatus of claim 19, wherein the trigger includes a connector, the connector disposed in the aperture when the first segment is in the first configuration.

25. The apparatus of claim 17, wherein the predetermined force threshold is about 100 lbf.

26. The apparatus of claim 17, wherein the predetermined force threshold is between about 70 lbf and about 100 lbf.

27. The apparatus of claim 17, wherein the predetermined force threshold is about 50 lbf.

28. The apparatus of claim 17, wherein the predetermined maximum pressure is between about 100 PSI and about 200 PSI.

29. The apparatus of claim 17, wherein the predetermined maximum pressure is about 100 PSI.

30. The apparatus of claim 16, wherein the shuttle defines a slot, the slot configured to receive at least a portion of the proximal flange of the plunger such that the at least a portion of the proximal flange of the plunger is disposed within the slot.