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Publication Number

US-10322227-B2

Patent

Publication Date

2019-06-18

Expiration Date


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.

Core Innovation

The invention provides an apparatus with a housing having a dispensing end, an upper side, a lower side, and a grip, where the housing is sized and configured to hold at least a flange of a syringe body and a plunger of the syringe. The syringe is oriented with the plunger away from the dispensing end of the housing. A shuttle is mounted in the housing for reciprocal translational motion relative to the housing and engages a proximal flange of the plunger so translational movement of the shuttle toward the dispensing end causes corresponding translational movement of the plunger toward the dispensing end, and translational movement away from the dispensing end causes corresponding translational movement of the plunger away from the dispensing end. The shuttle includes a pin.

An actuation lever is rotationally coupled to the housing at a pivot and includes an upwardly extending cam that defines a non-linear cam path having an upper end and a lower end, with the pin of the shuttle disposed within the cam path. A trigger is coupled to the lever and extends downward relative to the pivot and the lower side of the housing, and is movable between a first position spaced from the grip and a second position adjacent to the grip. In further configurations, the actuation lever includes a first segment extending below the pivot point and a second segment extending above the pivot point, where the first segment includes a trigger for manual actuation from an extended position to a retracted position and the second segment includes the upwardly extending cam.

The disclosed system further includes sterile, ready-to-use medical infusion kits/system combining a syringe and large-bore tubing with an axially extending dual check valve having an inlet tube and an exit port, packaged to connect to infusion devices. The infusion delivery device includes a housing with a manual/electronic trigger and a lever/cam mechanism driving a shuttle that translates the syringe plunger via pin/track engagement, and includes a return spring and a lid with latching/locking. Volume infused and/or pressure can be estimated using optional tracking/display features such as mechanical dial, electronic display, or encoder, and pressure monitoring and safety can be provided using a pressure relief valve and/or pressure monitoring using load cells with alarms/lockout. Tubing configurations, connectors, adapters, spikes, thumb clamps, filters, and Y connectors are described, including configurations for pain-medication syringe use and intraosseous infusion.

Claims Coverage

The partial content includes two independent claims (clm-00001 and clm-00016). Each independent claim is directed to a housing-operated syringe apparatus that converts lever and trigger actuation into reciprocal shuttle motion using a non-linear cam path, with safety/limiting concepts described in the claim families via dependent claims.

Reciprocal shuttle translating syringe plunger via proximal flange engagement

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 such that translational movement of the shuttle toward the dispensing end causes corresponding translational movement of the plunger toward the dispensing end, and translational movement of the shuttle away from the dispensing end causes corresponding translational movement of the plunger away from the dispensing end, the shuttle including a pin.

Non-linear cam path coupling lever motion to shuttle pin

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

Trigger movable between extended and grip-adjacent positions

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

Actuation lever segments with trigger and non-linear cam

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

Force-threshold driven pressure-limiting configuration

A lever including a first configuration and a second configuration responsive to force on the trigger toward the grip exceeding a predetermined threshold, such that preventing a lever from applying force to a shuttle that would make the fluid dispensed from a syringe exceed a predetermined maximum pressure.

Predetermined maximum pressure limitation range

The apparatus configured so that the predetermined maximum pressure falls between about 100 PSI and about 200 PSI.

Across the two independent claims, the core inventive structure is a housing-held syringe actuated by a reciprocal shuttle whose motion is coupled to an actuation lever through a non-linear cam path with a shuttle pin, with a trigger movable relative to the grip. The claim families further describe safety/limiting by switching lever configuration based on a predetermined force threshold to prevent exceeding a predetermined maximum dispensed-fluid pressure, including quantitative ranges for the threshold and maximum pressure in dependent claims.

Stated Advantages

Prevents the fluid dispensed from exceeding a predetermined maximum pressure.

Enables estimated volume infused and/or pressure monitoring using optional tracking/display features and pressure monitoring/relief mechanisms.

Provides safety via pressure relief valve and/or pressure monitoring with alarms/lockout.

Documented Applications

Medical infusion delivery using sterile, ready-to-use infusion kits/system with syringe and tubing connected to infusion devices.

Intraosseous infusion.

Pain-medication syringe configurations using luer engagement.

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