US 20070088267A1

(19) United States (12) Patent Application Publication (10) Pub. No.: US 2007/0088267 A1 Shekalim (54)

(43) Pub. Date:

DRUG DELIVERY DEVICE AND METHOD

Apr. 19, 2007

Publication Classi?cation

(76) Inventor: Avraham Shekalim, Nesher (IL)

(51) Int. Cl. A61M 5/20

Correspondence Address:

(52)

(2006.01)

US. Cl. ............................................................ .. 604/134

Mark M Friedman

c/o Polkinghorn 9003 Florin Way (21) AP p1~ NO‘:

10/558,409

(57) ABSTRACT A drug delivery device (10) includes a pressurized reservoir (14) in communication With a How path to an outlet (12). The How path includes tWo normally-closed valves (16, 18)

(22)

PCT Filed:

May 30, 2004

and a How restriction (18). Apressure measurement arrange ment (22) measures a diiTerential ?uid pressure between tWo

(86)

PCT NO;

pCT/IL04/00460

of the How restriction (18), one of the points being between

Nov. 28, 2005

the valves (16, 18). A controller (28) selectively opens the valves (16, 18) to deliver a de?ned quantity of the liquid medicament to the outlet (12).

Upper Marlboro’ MD 20772 (Us)

points (24, 26) along the How path Which span at least part § 371(c)(1), (2), (4) Date:

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Patent Application Publication Apr. 19, 2007 Sheet 1 0f 18

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(/0 Controller

Reservoir, spring loaded

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Pressure seiasor

Tem perature

First valve

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Second Valve

sensor

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Patent Application Publication Apr. 19, 2007 Sheet 2 0f 18

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Check for occlusion

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Patent Application Publication Apr. 19, 2007 Sheet 10 0f 18

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Patent Application Publication Apr. 19, 2007 Sheet 13 0f 18

US 2007/0088267 A1

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Patent Application Publication Apr. 19, 2007 Sheet 14 0f 18

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Patent Application Publication Apr. 19, 2007 Sheet 15 0f 18

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DRUG DELIVERY DEVICE AND METHOD FIELD AND BACKGROUND OF THE INVENTION

having a diaphragm Which separates the drug from propel lant, normally freon, maintained at negative pressure. A solenoid is activated driving an armature and a belloWs

pumping element. This displacement of the armature opens a check valve Which draWs drug from the storage chamber

[0001] The present invention relates to drug delivery

into a doWnstream pumping chamber. A restriction Will

devices and, in particular, it concerns a drug delivery device and corresponding methods Which employ a pressurized reservoir of liquid medicament With controlled release via a How restriction and multiple valves.

prevent back?oW in the outlet during this short period. When

[0002] LoW-dosage infusion pumps, both external and implantable, have been developed to the point of commer

through a restrictor and into the patient.

cial and medical acceptance. For certain applications, a simple “constant ?oW” device is su?icient. In many cases,

hoWever, Where patients require adjustments in the dosage as a function of time, constant ?oW pumps are inadequate.

A typical example is diabetes Where the quantity of medi

the pump chamber is full, the check valve closes and the

solenoid is then de-energized. A spring force typically displaces the belloWs into the chamber pumping the drug

[0005] Negative pressure systems, While o?cering advan tages of safety, sulfer from major disadvantages. First, the

negative pressure requirements require special precautions and equipment for ?lling and handling of the devices. Furthermore, since all of the drug must be positively dis placed by a pump Working against a pressure gradient, the

cation, such as insulin, to be infused varies due to require

devices have high poWer consumption, requiring bulky

ments of the patient. Fluctuations can occur on a daily basis or more randomly as a function of the ingestion of food.

poWer sources and/or frequent battery replacement.

Consequently, to address the shortcomings of constant ?oW

devices and obtain signi?cant ?exibility in dosage rates, various “implantable programmable” pumps have been developed. In the de?nition of system requirements dealing With such implantable programmable pumps, a device Which Will provide programmable bolus and basal ?oW rates over a Wide dynamic range is a standing system requirement. This requirement can be set forth in a practical sense by reference to the treatment of diabetes. It is known that the amount of

medication, typically insulin, to be infused per unit of time, should be adjusted at certain time intervals. A patient’s requirements may ?uctuate either at set, knoWn rates or may

vary abnormally, for example, by the ingestion of food or by other transitory conditions. Those conditions Will call for the administration of a bolus dose of infusate. In the daily

administration of insulin, hoWever, the patient may require

[0006] A second approach exempli?ed by U.S. Pat. Nos. 4,299,220 and 4,447,224 employs a positive pressure stor age chamber in combination With an accumulator pump. The

positive pressure of the storage chamber eliminates the

handling problems of negative pressure devices. Where suf?ciently high pressure is used to drive drug delivery Without additional pumping, at least part of the poWer

consumption is reduced, although many valve actuation elements are also consume a lot of poWer.

[0007] Despite the advantages of simplicity of implemen tation and energy e?iciency, safety remains a major concern for positive pressure devices. Given the fact that drug chamber pressure is above body pressure, there remains a remote possibility for an overdose of drug should all valves in line With the output fail open at the same time. An

a basal dose that is supplanted by bolus doses at, for example, meal times. The di?‘erence in How rates betWeen basal and bolus doses may be quite large, in the orders of

improved degree of safety can be achieved in such systems by providing redundant valves. HoWever, even With redun dant valves, there remains some risk of multiple component failure Which could result in overdosing. Depending upon

several times. Thus, a device to achieve proper ?oW rates over the spectrum of desired rates must have the ability to

the type of drug being administered, such overdosing could potentially be fatal.

continuously infuse, at very loW ?oW rates, yet provide, periodically, a substantially increased ?oW rate. Thus, the design criteria can be summarized as requiring, in the ?rst

instance, the ability for continuous basal drug delivery Which is adjustable to varying choices of How rate, including the ability to deliver a bolus dose at relatively high ?oW rates.

[0008] A further problem associated With all types of programmable drug delivery devices is that of repeat usage. Throughout the ?eld of medicine, there is a strong trend toWards use of disposable components for infusion sets and

the like. In the case of programmable drug delivery devices, the cost of the device is such that it is not presently feasible

to produce single-use disposable devices. Furthermore, the

[0003] The requirements of programmability, Wide range of How rates, and failsafe operation greatly complicate the economic viability limit the feasibility of many of the theoretical solutions that have been proposed to-date.

subdivision of components betWeen disposable “Wet” com ponents and reusable electronic and control components Which is common in hospital infusion control systems such as the IVACTM system is typically considered impractical here because of the extremely loW ?oW rates and precision control required from such devices.

[0004]

[0009]

design of programmable drug delivery devices. Secondary issues such as poWer consumption, overall system life and

In an attempt to ensure failsafe operation, many

programmable drug delivery devices employ a negative pressure storage chamber, e?‘ectively precluding the possi

There is therefore a need for a programmable drug

delivery device and corresponding methods of delivering

bility of drug leakage in the case of device malfunction. Examples of such devices, referred to as “negative pressure pumps”, may be found in Us. Pat. Nos. 4,482,346 and

drugs based upon a pressurized reservoir and Which Would reliably identify and appropriately address a range of mal function conditions to avoid risk of drug overdosing. It Would also be highly advantageous to provide a program

4,486,190. Both of these prior art devices are solenoid

mable drug delivery device and corresponding method

activated negative pressure pumps. A diaphragm storage

facilitating subdivision of the device into reusable electronic and control components, and disposable components Which

chamber maintains the drug to be infused in a chamber

262$ ?gs

Apr 19, 2007 - tation and energy e?iciency, safety remains a major concern for positive pressure ... Which is common in hospital infusion control systems such.

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