Medical infusion device with a source of controlled compliance

Surgery – Controlled release therapeutic device or system – Implanted dynamic device or system

Reexamination Certificate

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C604S093010

Reexamination Certificate

active

06537268

ABSTRACT:

FIELD OF THE INVENTION
This invention relates to medical infusion devices that are intended to deliver, in a controlled manner, desired quantities of a fluid to a patient, more particularly this invention relates to the utilization of compliant structures within such medical devices.
BACKGROUND
Both external and internally implanted infusion pumps are generally known in the art for use in delivering a selected fluid to the body of a patient (i.e. body of a person or animal being treated or benefited by the fluid) in a scheduled or preprogrammed manner. Such fluids include drugs, medications, proteins, e.g. insulin, or the like. Programmable medication infusion pumps offer significant potential advantages to patients who are required to comply with a long-term medication treatment regimen. Such pumps can operate automatically, with little or no patient intervention, to administer an important medication such as insulin to a diabetic patient on a regular basis.
Implantable infusion pumps typically include an internal fluid chamber or reservoir for receiving and storing a supply of the selected fluid (e.g. drug, medication, protein such as insulin) a miniature pump mechanism, programmable control means (e.g. electrical circuit possibly including telemetry elements for communication with an external programming device) for operating the pump mechanism to deliver discrete doses of the fluid from the internal reservoir to a desired region within the body. These pumps typically deliver medication to the body through a catheter connected to an output port of the pump mechanism. A refill port is typically provided on the pump to permit transcutaneous needle access for purpose of periodically refilling the pump reservoir with a fresh supply of fluid. Some implantable infusion pumps include a side port that is connected to the output port of the pump mechanism and to a first end of the catheter. The side port may be used in a process of flushing residue from the catheter, flushing the pump, and or to determine pump stroke volume.
Various infusion pumps, associated components and processes, for example, are described in the various patent publications listed in Table 1, the disclosures of which are hereby incorporated herein by reference. The brief description of each publication is provided in Table 1 to aid the reader in finding specific types of teachings. It is not intended that the incorporation of subject matter be limited to those topics specifically indicated, but instead the incorporation is to include all subject matter found in these publications. The teachings in these incorporated publications may be combined with the teachings herein in many ways.
TABLE 1
Pat. Pub. No.
(US if not indicated
other wise)
Issue Date
Inventor(s)
Brief Description of Subject Matter Disclosed in Each Publication
4,373,525
A change in the internal pressure of the fluid-infusion tube of a peristaltic fluid-
Feb. 15, 1983
infusion pump due to occlusion in the fluid-infusion tube is detected through a
Fischell
change in the diameter of the fluid-infusion tube. The occlusion is detected by
detection of the change in the distance between the opposite wall portions of the
tube.
4,482,346
An integral valve and pumping unit is provided for infusing medication into the
Nov. 13, 1984
body which employs only one moving part. This pumping unit is connected to the
Reinicke
medication supply reservoir through a first flow restriction device which has no
moving parts but has directional flow characteristics so that liquid medication can
flow readily from the reservoir to the pumping unit but flow from the pumping
unit to the reservoir encounters a relatively high resistance. A second flow
restriction device is connected between the pumping unit and the outlet catheter
which is employed to infuse medication into the body, this second flow restriction
device likewise having no moving parts and offering relatively little resistance to
liquid flow from the pumping unit to the catheter while having relatively high
resistance to flow in the opposite direction. The valve portion of the integral
valve-pump unit ensures that no liquid can flow either from the reservoir to the
catheter or vice versa, when the pumping unit is inoperative or when the reservoir
is being filled.
4,486,190
The implantable device includes a medication reservoir, a pulsatile pump and an
Dec. 4, 1984
absolute pressure transducer. The pumping pressure wave developed in the
Reinicke
pumping chamber is measured by the absolute pressure transducer whose output
is used to adjust the pulsing rate of the solenoid operated pump so that the
programmed time averaged rate of infusion of medication into the body is
precisely maintained throughout all operating temperature and pressure
conditions.
4,525,165
An apparatus for fluid handling and delivery in a medication infusion system is
Jun. 25, 1985
disclosed. The apparatus generally contains a pulsatile pump in combination with
Fischell
at least an accumulation flow restrictor. The pulsatile pump is economical in
electrical consumption by virtue of the use of a spring force pumping action. The
accumulator flow restrictor smooths the output from the pulsatile pump so that
medication is delivered in a manner compatible with human or animal body
needs. As an example, for infusion of medication such as insulin, the medication
infusion system can provide an infusion flow profile which mimics that of insulin
production in a normal person.
4,561,443
A two-way coherent inductive communications link between an external
Dec. 31, 1985
transceiver and an internal transceiver located in a biologically implanted
Hogrefe et al.
programmable medical device. Digitally formatted command data and
programming data is transmitted to the implanted medical device by frequency
shift keying the inductive communications link. Internal transceiver is powered by
the inductive field between internal and external transceivers. Digitally formatted
data is transmitted to external transceiver by internal transceiver amplitude
modulating inductive field. Immediate verification of the establishment of a
reliable communications link is provided by determining existence of frequency
lock and bit phase lock between internal and external transceivers.
4,573,994
Apparatus and method for filling, or refilling, the internal reservoir of a
Mar. 4, 1986
medication infusion system, wherein filling or refilling is permitted only when a
Fischell et al.
means for injecting medication is properly positioned relative to the reservoir.
Prior to filling or refilling, a pressure integrity check can be made to help assure
that injected medication enters the reservoir without leakage. Additionally,
flushing of a portion or all of the medication reservoir can be accomplished if
desired. Medication is introduced to and is stored in the reservoir at a pressure
below ambient body pressure.
4,604,090
An implantable medication infusion device wherein a generally cylindrical
Aug. 5, 1986
manifold is employed having a shallow recess on one face thereof. A flexible
Reinicke
diaphragm is positioned to form with the face of said manifold a medication
reservoir. A circular cover member is positioned over the diaphragm to form with
said diaphragm a pressure stabilizing chamber within which is positioned a two-
phase fluid for maintaining a constant pressure on said diaphragm. A permanent
magnet is positioned at the center of said diaphragm and is movable therewith. A
Hall effect transducer positioned on said manifold opposite said permanent
magnet is employed continuously to measure the position of said diaphragm and
provide an indication of the amount of medication in said reservoir. A method of
filling and sealing the pressure stabilizing chamber which insures that a small
bubble of two-phase fluid is present in said chamber at all times. An inlet filter is
positioned between the medication reservoir and an inlet check valve to act as a
bubble trap during the intake stroke of a pulsatile pumping unit also mounted in
the manifold.
4,619,653
A medication infusion system provi

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