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:
Needle
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112.
Patent Application Publication Apr. 19, 2007 Sheet 1 0f 18
PM. I
US 2007/0088267 A1
(/0 Controller
Reservoir, spring loaded
-@+
22
Pressure seiasor
Tem perature
First valve
' Restrimd path
Second Valve
sensor
2.0
I30‘ One way inlet valve
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Patent Application Publication Apr. 19, 2007 Sheet 2 0f 18
US 2007/0088267 A1
F142
K 3%
Get pressure reading 3
3% ’\,[ Calculate ?uidremaining |—> mmaniniépmgilgsriluser when low
Check for occlusion
é Check for Catheter seneration
Calculate how long to open both valves
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Close ?rst valve a?erlsmall time delay
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Get pressure reading‘Pl
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second valve leak -
First valve leak —
alarm user
alarm user
Cycle ?nished
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62
Patent Application Publication Apr. 19, 2007 Sheet 3 0f 18
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Patent Application Publication Apr. 19, 2007 Sheet 5 0f 18
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Patent Application Publication Apr. 19, 2007 Sheet 6 0f 18
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Patent Application Publication Apr. 19, 2007 Sheet 7 0f 18
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Patent Application Publication Apr. 19, 2007 Sheet 9 0f 18
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Patent Application Publication Apr. 19, 2007 Sheet 10 0f 18
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US 2007/0088267 A1
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Patent Application Publication Apr. 19, 2007 Sheet 11 0f 18
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Patent Application Publication Apr. 19, 2007 Sheet 12 0f 18
US 2007/0088267 A1
FM. 14D 3. Af'ter izappilar-y passage Fluid goes port and to second valve Inlet
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Patent Application Publication Apr. 19, 2007 Sheet 13 0f 18
US 2007/0088267 A1
F14 :5 / Controller Reservoir, spring loaded
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Pressure sensor
Temperature
I 2-
First valve - Variable restriction
One way inlet valve
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2””
Patent Application Publication Apr. 19, 2007 Sheet 14 0f 18
US 2007/0088267 A1
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inlet valve
elatomeric seal
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‘ Second Valve
k,
Patent Application Publication Apr. 19, 2007 Sheet 15 0f 18
US 2007/0088267 A1
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Patent Application Publication Apr. 19, 2007 Sheet 16 0f 18
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Patent Application Publication Apr. 19, 2007 Sheet 17 0f 18
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Patent Application Publication Apr. 19, 2007 Sheet 18 0f 18 '
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Apr. 19, 2007
US 2007/0088267 A1
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