Methods and appratus for monitoring rotation of an infusion pump driving mechanism

Abstract

An infusion system, method and device for delivering therapeutic fluid to the body of a patient are disclosed. The device includes a dispensing unit having a peristaltic pump for dispensing therapeutic fluid to the body of the patient. The peristaltic pump includes a driving mechanism. The device further includes a monitoring mechanism (112, 114) for monitoring operation of the driving mechanism and dispensing of therapeutic fluid to the body of the patient.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]The present application claims priority to U.S. Provisional Patent Application No. 60 / 928,751, filed May 11, 2007 and incorporates disclosure of this application herein by reference in its entirety.[0002]The present application also claims priority to U.S. Provisional Patent Application No. 60 / 928,815, filed on May 11, 2007, and entitled “A Positive Displacement Pump”, and U.S. Provisional Patent Application No. 60 / 928,750, filed on May 11, 2007, and entitled “Fluid Delivery Device”. This application incorporates disclosures of each of these applications herein by reference in their entireties.[0003]The present application also relates to the co-owned / co-pending U.S. patent application Ser. No. ______, and International Patent Application No. PCT / IL08 / ______, both filed on the even date herewith, and both entitled “A Positive Displacement Pump”, and U.S. patent application Ser. No. ______, and International Patent Application No. PCT / IL08...

AI Technical Summary

Benefits of technology

[0015]To overcome the deficiencies of the above conventional devices, some embodiments of the present invention are directed to an improved method and device for monitoring the rotation of a driving mechanism (i.e., motor, gears, shafts, etc.) capable of detecting occurrences of electro-mechanical disassociation. In some embodiments, the present invention is directed to an appropriate size (e.g., miniature) device for monitoring the rotation of a driving mechanism. The present invention also provides an efficient and cost-effective device for monitoring the rotation of a driving mechanism.

[0017]In some embodiments, the present invention is directed to an appropriately-sized device for monitoring the rotation of a rotary wheel of a positive displacement peristaltic pump and for providing a solution to the problem of having a no-flow or backflow of fluid as well as minimizing its effects on fluid delivery to the patient.

[0022]In some embodiments, the present invention relates to a method for preventing or at least minimizing the occurrence(s) of no-flow or backflow in a positive displacement peristaltic pump and minimizing its effects on fluid delivery to the patient.

[0027]Some embodiments of the present invention provide a solution for monitoring the rotation of different components of the infusion pump's driving mechanism so that it is possible to detect occurrences of electro-mechanical disassociation as well as motor malfunction.

[0028]Some embodiments of the present invention relate to systems and methods for preventing or at least minimizing the occurrence(s) of backflow in positive displacement peristaltic pumps, and minimizing its effects on fluid delivery to the patient.

Problems solved by technology

Both basal and bolus volumes must be delivered in precise doses, according to individual prescription, since an overdose or under-dose of insulin could be fatal.

These devices represent an improvement over multiple daily injections, but nevertheless, they all suffer from several drawbacks, one of the main drawbacks is its large size and weight of the device, caused by the configuration and the relatively large size of the driving mechanism of the syringe and the piston.

This relatively bulky device has to be carried in a patient's pocket or attached to the belt.

These uncomfortable bulky devices with a long tube are rejected by the majority of diabetic insulin users, since they disturb regular activities, such as sleeping and swimming.

Furthermore, the effect of the image projected on a body of a teenager is unacceptable.

These devices also have several limitations: they are bulky and expensive, their high selling price is due to the high production and accessory costs, and the user must discard the entire device every 2-3 days, including relatively expensive components, such as driving mechanism and other electronics.

e.g., i.e., i.e., i.e., e.g., As mentioned above, the volume of fluid infused to the patient must be delivered in precise doses, according to individual prescription, since an overdose or underdose of insulin could be fatal.

These encoders occupy a large space and hence are not suitable for a miniature infusion pump.

Furthermore, when the encoder is located on the motor shaft it monitors only the rotation of the motor itself, and cannot directly monitor rotations of shafts and gears.

Moreover, it does not detect occurrences of electro-mechanical disassociation due to breakage of gears, dust, etc.

Another problem which exists in rotary peristaltic pumps is that the resulting delivery of fluid occurs in a series of pulses or surges, the frequency of which is equal to the frequency of the passage of successive rollers in contact with the delivery tube.

The effect is that fluid is delivered at a widely varying rate during a pump cycle and this can be unacceptable in infusion procedures in which uniformity of delivery rate is a requirement (e.g., insulin pumps).

Moreover, the continuous change in flow rate can cause instability in sensitive feedback control systems which are designed to ensure that fluid is delivered at a constant rate.

Having frequent periods in which there is no fluid flowing downstream, i.e., towards the patient's body, is extremely hazardous when dealing with therapeutic fluid such as insulin.

When an insulin pump is set to its minimal flow rate, it is likely that the patient will not receive any insulin at all.

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