U.S. patent application number 11/467205 was filed with the patent office on 2006-12-14 for components and methods for patient infusion device.
This patent application is currently assigned to Insulet Corporation. Invention is credited to Matthew D. Abelson, John R. Bussiere, David P. Chastain, J. Christopher Flaherty, John T. Garibotto, William Gorman.
Application Number | 20060282290 11/467205 |
Document ID | / |
Family ID | 32029629 |
Filed Date | 2006-12-14 |
United States Patent
Application |
20060282290 |
Kind Code |
A1 |
Flaherty; J. Christopher ;
et al. |
December 14, 2006 |
Components and Methods For Patient Infusion Device
Abstract
A fluid delivery device including a housing, a reservoir
positioned within the housing, and a transcutaneous access tool
positioned within the housing and including, a cannula in fluid
communication with the reservoir and linearly moveable along an
axis of the transcutaneous access tool through a port in a wall of
the housing, a deployment member secured to the cannula and movable
along the axis of the transcutaneous access tool against the wall
of the housing defining the port, and an annular seal coaxially
positioned about the cannula and positioned between the deployment
member and the wall of the housing defining the port, so that the
seal provides a substantially fluid-tight seal between the
deployment member and the wall of the housing when the deployment
member is moved against the wall of the housing.
Inventors: |
Flaherty; J. Christopher;
(Topsfield, MA) ; Gorman; William; (South
Hamilton, MA) ; Garibotto; John T.; (Marblehead,
MA) ; Bussiere; John R.; (Littleton, MA) ;
Abelson; Matthew D.; (Somerville, MA) ; Chastain;
David P.; (Acton, MA) |
Correspondence
Address: |
INSULET CORPORATION
9 Oak Park Drive
Bedford
MA
01730
US
|
Assignee: |
Insulet Corporation
Bedford
MA
|
Family ID: |
32029629 |
Appl. No.: |
11/467205 |
Filed: |
August 25, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10260192 |
Sep 30, 2002 |
7128727 |
|
|
11467205 |
Aug 25, 2006 |
|
|
|
Current U.S.
Class: |
705/2 |
Current CPC
Class: |
A61M 2205/0266 20130101;
A61M 2005/14252 20130101; G16H 20/17 20180101; A61M 2005/1583
20130101; A61M 5/1454 20130101; A61M 2005/1585 20130101; A61M 5/158
20130101; A61M 5/14248 20130101 |
Class at
Publication: |
705/002 |
International
Class: |
G06Q 10/00 20060101
G06Q010/00; G06Q 50/00 20060101 G06Q050/00 |
Claims
1. A fluid delivery device comprising: a housing; a reservoir
positioned within the housing; and a transcutaneous access tool
positioned within the housing and including, a cannula in fluid
communication with the reservoir and linearly moveable along an
axis of the transcutaneous access tool through a port in a wall of
the housing, a deployment member secured to the cannula and movable
along the axis of the transcutaneous access tool against the wall
of the housing defining the port, and an annular seal coaxially
positioned about the cannula and positioned between the deployment
member and the wall of the housing defining the port, so that the
seal provides a substantially fluid-tight seal between the
deployment member and the wall of the housing when the deployment
member is moved against the wall of the housing.
2. A device according to claim 1, wherein the annular seal is
secured to the deployment member.
3. A device according to claim 1, wherein the annular seal
comprises at least one of an elastomer and rubber.
4. A device according to claim 1, wherein the cannula comprises a
flexible cannula.
5. A device according to claim 1, wherein the transcutaneous access
tool further comprises a deployment spring biasing the deployment
member towards the port in the wall of the housing.
6. A device according to claim 5, wherein the transcutaneous access
tool further includes a deployment latch mechanism maintaining the
deployment member against the bias force of the deployment
spring.
7. A device according to claim 6, wherein the deployment latch
mechanism comprises: a movable latch positioned in the path of the
deployment member to maintain the deployment member against the
bias force of the deployment spring; and an elongated shape memory
element having a changeable length decreasing from an uncharged
length to a charged length when at least one charge is applied to
the shape memory element, the shape memory element connected
between the latch and a fixed portion of the device such that the
changeable length of the shape memory element decreasing from an
uncharged length to a charged length causes the latch to be moved
out of the path of the deployment member.
8. A device according to claim 1, wherein the cannula of the
transcutaneous access tool comprises a first cannula and the
transcutaneous access tool further includes: a second cannula
disposed within the lumen of the first cannula; and a retraction
member secured to the second cannula and movable along the axis of
the transcutaneous access tool with respect to the deployment
member.
9. A device according to claim 8, wherein the transcutaneous access
tool further comprises a retraction spring biasing the retraction
member away from the deployment member.
10. A device according to claim 8, wherein the first cannula is
flexible and the second cannula is rigid.
11. A device according to claim 1, further comprising an outlet
plug removably connected to a distal end of the cannula.
12. A device according to claim 11, wherein the outlet plug
includes an air removal filter allowing air to exit the
cannula.
13. A device according to claim 11, wherein the port in the wall of
the housing comprises an internal exit port and the housing further
includes an external exit port for the flexible cannula and a
sterilization access port adjacent the external exit port.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a divisional of U.S. patent
application Ser. No. 10/260,192, which is related to U.S. Pat. No.
6,740,059 entitled DEVICES, SYSTEMS AND METHODS FOR PATIENT
INFUSION, which is assigned to the assignee of the present
application and incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The present invention relates generally to medical devices,
systems and methods, and more particularly to small, low cost,
portable infusion devices and methods that are useable to achieve
precise, sophisticated, and programmable flow patterns for the
delivery of therapeutic liquids such as insulin to a mammalian
patient. Even more particularly, the present invention is directed
to various new and improved components and methods for an infusion
device.
BACKGROUND OF THE INVENTION
[0003] Today, there are numerous diseases and other physical
ailments that are treated by various medicines including
pharmaceuticals, nutritional formulas, biologically derived or
active agents, hormonal and gene based material and other
substances in both solid or liquid form. In the delivery of these
medicines, it is often desirable to bypass the digestive system of
a mammalian patient to avoid degradation of the active ingredients
caused by the catalytic enzymes in the digestive tract and liver.
Delivery of a medicine other than by way of the intestines is known
as parenteral delivery. Parenteral delivery of various drugs in
liquid form is often desired to enhance the effect of the substance
being delivered, insuring that the unaltered medicine reaches its
intended site at a significant concentration. Also, undesired side
effects associated with other routes of delivery, such as systemic
toxicity, can potentially be avoided.
[0004] Often, a medicine may only be available in a liquid form, or
the liquid version may have desirable characteristics that cannot
be achieved with solid or pill form. Delivery of liquid medicines
may best be accomplished by infusing directly into the
cardiovascular system via veins or arteries, into the subcutaneous
tissue or directly into organs, tumors, cavities, bones or other
site specific locations within the body.
[0005] Parenteral delivery of liquid medicines into the body is
often accomplished by administering bolus injections using a needle
and reservoir, or continuously by gravity driven dispensers or
transdermal patch technologies. Bolus injections often imperfectly
match the clinical needs of the patient, and usually require larger
individual doses than are desired at the specific time they are
given. Continuous delivery of medicine through gravity feed systems
compromise the patient's mobility and lifestyle, and limit the
therapy to simplistic flow rates and profiles. Transdermal patches
have special requirements of the medicine being delivered,
particularly as it relates to the molecular structure, and similar
to gravity feed systems, the control of the drug administration is
severely limited.
[0006] Ambulatory infusion pumps have been developed for delivering
liquid medicaments to a patient. These infusion devices have the
ability to offer sophisticated fluid delivery profiles
accomplishing bolus requirements, continuous infusion and variable
flow rate delivery. These infusion capabilities usually result in
better efficacy of the drug and therapy and less toxicity to the
patient's system. An example of a use of an ambulatory infusion
pump is for the delivery of insulin for the treatment of diabetes
mellitus. These pumps can deliver insulin on a continuous basal
basis as well as a bolus basis as is disclosed in U.S. Pat. No.
4,498,843 to Schneider et al.
[0007] The ambulatory pumps often work with a reservoir to contain
the liquid medicine, such as a cartridge, a syringe or an IV bag,
and use electromechanical pumping or metering technology to deliver
the medication to the patient via tubing from the infusion device
to a needle that is inserted transcutaneously, or through the skin
of the patient. The devices allow control and programming via
electromechanical buttons or switches located on the housing of the
device, and accessed by the patient or clinician. The devices
include visual feedback via text or graphic screens, such as liquid
crystal displays known as LCD's, and may include alert or warning
lights and audio or vibration signals and alarms. The device can be
worn in a harness or pocket or strapped to the body of the
patient.
[0008] Currently available ambulatory infusion devices are
expensive, difficult to program and prepare for infusion, and tend
to be bulky, heavy and very fragile. Filling these devices can be
difficult and require the patient to carry both the intended
medication as well as filling accessories. The devices require
specialized care, maintenance, and cleaning to assure proper
functionality and safety for their intended long term use. Due to
the high cost of existing devices, healthcare providers limit the
patient populations approved to use the devices and therapies for
which the devices can be used.
[0009] Clearly, therefore, there was a need for a programmable and
adjustable infusion system that is precise and reliable and can
offer clinicians and patients a small, low cost, light-weight,
easy-to-use alternative for parenteral delivery of liquid
medicines.
[0010] In response, the applicant of the present application
provided a small, low cost, light-weight, easy-to-use device for
delivering liquid medicines to a patient. The device, which is
described in detail in co-pending U.S. application Ser. No.
09/943,992, filed on Aug. 31, 2001, includes an exit port, a
dispenser for causing fluid from a reservoir to flow to the exit
port, a local processor programmed to cause a flow of fluid to the
exit port based on flow instructions from a separate, remote
control device, and a wireless receiver connected to the local
processor for receiving the flow instructions. To reduce the size,
complexity and costs of the device, the device is provided with a
housing that is free of user input components, such as a keypad,
for providing flow instructions to the local processor. What is
still desired, however, are additional new and improved components
and methods for devices for delivering fluid to a patient.
SUMMARY OF THE INVENTION
[0011] The present invention provides a transcutaneous access tool
for use as part of device for delivering fluid, such as insulin for
example, to a patient. The transcutaneous access tool includes a
first cannula moveable along an axis of the transcutaneous access
tool, a fixed member including an elongated prong extending
parallel with the axis, and a deployment member secured to the
first cannula. The deployment member is movable along the axis away
from the fixed member and includes spaced-apart, resiliently
flexible fingers extending parallel with the axis and slidingly
received on the prong of the fixed member. The fingers having
distal ends that are laterally enlarged with respect to the
axis.
[0012] The transcutaneous access tool also includes a second
cannula disposed within the lumen of the first cannula, and a
retraction member secured to the second cannula and movable along
the axis between the fixed member and the deployment member. The
retraction member includes at least one catch extending laterally
inwardly with respect to the axis. The catch catches on the
laterally enlarged distal ends of the fingers of the deployment
element, and prevents the retraction member from being moved away
from the deployment member, when the fingers are laterally held
apart by the prong of the fixed member.
[0013] According to one aspect of the present invention, the
transcutaneous access tool further includes a deployment spring
biasing the deployment member away from the fixed member, and a
retraction spring biasing the retraction member away from the
deployment member and towards the fixed member. According to
another aspect, the first cannula is flexible and the second
cannula is rigid.
[0014] The present invention also provides a fluid delivery device
including a housing, a reservoir positioned within the housing, and
a transcutaneous access tool positioned within the housing. The
transcutaneous access tool includes a cannula in fluid
communication with the reservoir and linearly moveable along an
axis of the transcutaneous access tool through a port in a wall of
the housing, a deployment member secured to the cannula and movable
along the axis of the transcutaneous access tool against the wall
of the housing defining the port, and an annular seal coaxially
positioned about the cannula and positioned between the deployment
member and the wall of the housing defining the port, so that the
seal provides a substantially fluid-tight seal between the
deployment member and the wall of the housing when the deployment
member is moved against the wall of the housing. The seal allows a
fluid or gas, such as a sterilization medium, to enter the exit
port from outside the housing prior to deployment of the cannula,
but seals the housing in a fluid-tight manner upon deployment of
the cannula.
[0015] According to one aspect of the present invention, the device
also includes an outlet plug removably connected to a distal end of
the cannula extending out of the housing, and the port in the wall
of the housing comprises an internal exit port and the housing
further includes an external exit port for the flexible cannula and
a sterilization access port adjacent the external exit port.
[0016] The present invention additionally provides a fluid delivery
device including a housing having a port providing communication
with an interior of the device, an adhesive layer provided on an
exterior surface of the housing surrounding the port of the housing
and including resilient flaps normally sealing the port in a
substantially fluid-tight manner, and a protective layer removably
covering the adhesive layer and including a sterilization access
tube extending through the flaps of the adhesive layer and into the
housing. The sterilization access tube allows a fluid or gas, such
as a sterilization medium, to enter the port from outside the
housing prior to removal of the protective layer, and the flaps
seal the port in a fluid-tight manner after removal of the
protective layer.
[0017] The present invention also provides a flow path assembly
including a base layer having opposing first and second surfaces.
The base layer defines a fill chamber outlet port extending through
the base layer and between the opposing first and second surfaces,
an auxiliary chamber inlet port extending through the base layer
and between the opposing first and second surfaces, and a first
groove on the second surface of the base layer connecting the fill
chamber outlet port to the auxiliary chamber inlet port. The base
layer also defines an auxiliary chamber outlet port extending
through the base layer and between the opposing first and second
surfaces, a reservoir inlet port extending through the base layer
and between the opposing first and second surfaces, and a second
groove on the second surface of the base layer connecting the
auxiliary chamber outlet port to the reservoir inlet port. The base
layer further defines a reservoir outlet port extending through the
base layer and between the opposing first and second surfaces, a
cannula inlet port extending through the base layer and between the
opposing first and second surfaces, and a third groove on the
second surface of the base layer connecting the reservoir outlet
port to the cannula inlet port. The flow path assembly also
includes a cover layer substantially covering the second surface of
the base layer in a substantially fluid-tight manner.
[0018] According to one aspect of the present invention, the base
layer is relatively rigid and the cover layer is relatively
flexible. According to another aspect, the flow path assembly
includes a cannula connector member secured to the first surface of
the base layer in a substantially fluid-tight manner and defining a
cannula connector chamber in fluid communication with the cannula
inlet port of the base layer. According to an additional aspect,
the flow path assembly includes a fill port member secured to the
first surface of the base layer in a substantially fluid-tight
manner and defining a fill port chamber in fluid communication with
the fill chamber outlet port of the base layer.
[0019] According to another aspect of the present invention, the
first surface of the base layer defines an auxiliary recess
connecting the auxiliary chamber inlet port and the auxiliary
chamber outlet port. According to a further aspect, the assembly
includes a sensor assembly secured to the auxiliary chamber recess
of the first surface of the base layer in a substantially
fluid-tight manner, and the sensor assembly has a sensor chamber in
fluid communication with the auxiliary chamber inlet port and the
auxiliary chamber outlet port of the base layer.
[0020] According to an additional aspect, the first surface of the
base layer defines a reservoir shelf connecting the reservoir inlet
port and the reservoir outlet port. According to another aspect,
the assembly further includes a reservoir secured to the reservoir
shelf of the first surface of the base layer in a substantially
fluid-tight manner and the reservoir has a reservoir chamber in
fluid communication with the reservoir inlet port and the reservoir
outlet port. According to yet another aspect, the reservoir
includes an end cap closing the open first end of cylindrical side
wall in a substantially fluid-tight manner and defining a reservoir
port providing fluid communication between the reservoir chamber
and the reservoir inlet port and the reservoir outlet port.
[0021] The present invention provides another flow path assembly
including a cylindrical side wall having opposing first and second
open ends and defining a reservoir chamber, an end cap closing the
second open end of the side wall and defining a port providing
fluid communication with the reservoir chamber, a plunger received
in the reservoir chamber and slidingly moveable along the side wall
and between the opposing first and second open ends, and a lead
screw extending into the first open end of the side wall and having
a distal end secured to the plunger.
[0022] According to one aspect of the present invention, the flow
path assembly further includes a base layer having opposing first
and second surfaces, a fill chamber outlet port extending through
the base layer and between the opposing first and second surfaces,
a reservoir inlet port extending through the base layer and between
the opposing first and second surfaces, a reservoir outlet port
extending through the base layer and between the opposing first and
second surfaces, and a cannula inlet port extending through the
base layer and between the opposing first and second surfaces. The
second surface of the base layer defines a first groove connecting
the fill chamber outlet port to the reservoir inlet port, and a
second groove connecting the reservoir outlet port to the cannula
inlet port. The first surface of the base layer defines a reservoir
recess connecting the reservoir inlet port and the reservoir outlet
port and receiving the end cap of the reservoir in a substantially
fluid-tight manner. The port of the end cap provides fluid
communication between the reservoir chamber and the reservoir inlet
port and the reservoir outlet port.
[0023] The present invention provides an additional flow path
assembly including a first portion and a second portion of a
housing of a fluid delivery device assembled together to form an
end wall of the housing. The end wall includes a fill port, a
reservoir connection port, a cannula connection port, and at least
one flow path connecting the fill port, the reservoir connection
port and the cannula connection port.
[0024] According to one aspect of the present invention, the first
portion of the housing includes a first portion of the end wall and
the second portion of the housing includes a second portion of the
end wall. The first and the second portions of the end wall have
mating surfaces defining corresponding grooves which together
define the flow path of the end wall when the first and the second
portions of the housing are assembled together.
[0025] These aspects of the invention together with additional
features and advantages thereof may best be understood by reference
to the following detailed descriptions and examples taken in
connection with the accompanying illustrated drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] FIG. 1 is a perspective view of a first exemplary embodiment
of a fluid delivery device constructed in accordance with the
present invention shown secured on a patient, and a remote control
device for use with the fluid delivery device (the remote control
device being enlarged with respect to the patient and the fluid
delivery device for purposes of illustration);
[0027] FIGS. 2a and 2b are enlarged top and bottom perspective
views, respectively, of the fluid delivery device of FIG. 1;
[0028] FIG. 3 is a further enlarged top perspective view of the
fluid delivery device of FIG. 1, shown with a top housing portion
removed to reveal interior portions of the fluid delivery device,
including an exemplary embodiment of a transcutaneous access tool
constructed in accordance with the present invention and an
exemplary embodiment of a laminated flow path constructed in
accordance with the present invention;
[0029] FIGS. 4a-4c are simplified schematic views of the
transcutaneous access tool of the fluid delivery device of FIG. 3
illustrating deployment of a needle of the tool;
[0030] FIG. 5 is a further enlarged end perspective view of the
transcutaneous access tool of FIG. 3 showing an exemplary
embodiment of an exit port seal constructed in accordance with the
present invention for sealing the exit port of the device housing
upon deployment of the needle of the deployment of a needle of the
tool;
[0031] FIG. 6 is a sectional view of a fluid delivery device
including an exemplary embodiment of a exit port seal assembly
constructed in accordance with the present invention;
[0032] FIG. 7 is an enlarged sectional view of a portion of the
exemplary embodiment of the exit port seal assembly contained in
circle 7 of FIG. 6, illustrating how the assembly allows an
interior of the device to be sterilized prior to use of the
device;
[0033] FIG. 8 is a sectional view of the fluid delivery device of
FIG. 6 showing a protective bottom layer of the exit port seal
assembly removed;
[0034] FIG. 9 is an enlarged sectional view of a portion of the
exemplary embodiment of the exit port seal assembly contained in
circle 9 of FIG. 8, illustrating how the assembly seals the
interior of the device upon removal of the protective bottom layer
and prior to use of the device;
[0035] FIG. 10 is an enlarged sectional view of an exemplary
embodiment of an outlet plug constructed in accordance with the
present invention shown positioned within an outlet port of a
housing a fluid delivery device, and wherein the housing includes a
sterilization access port adjacent the outlet port;
[0036] FIG. 11 is an enlarged end perspective view of a portion of
the laminated flow path assembly of the fluid delivery device of
FIG. 3;
[0037] FIG. 12 is an enlarged sectional view of an exemplary
embodiment of a fluid reservoir and a reservoir end wall
constructed in accordance with the present invention, and an
exemplary embodiment of a plunger and a lead screw constructed in
accordance with the present invention and received in the reservoir
for forcing fluid towards the end wall;
[0038] FIG. 13 is a first end view of the plunger of FIG. 12;
[0039] FIG. 14 is a second end view of a portion of an exemplary
embodiment of a laminated flow path constructed in accordance with
the present invention for attachment to the end wall of the
reservoir of FIG. 12;
[0040] FIG. 15 is a sectional view of an exemplary embodiment of a
fluid reservoir constructed in accordance with the present
invention, and an exemplary embodiment of a device housing
including a laminated flow path constructed in accordance with the
present invention; and
[0041] FIG. 16 is a sectional view taken along line 16-16 of FIG.
15 of the device housing showing the laminated flow path connected
to the reservoir.
[0042] Like reference characters designate identical or
corresponding components and units throughout the several
views.
DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS
[0043] Referring to FIGS. 1 through 3, there is illustrated an
exemplary embodiment of a fluid delivery device 10 constructed in
accordance with the present inventions. Referring to FIG. 3, the
fluid delivery device 10 includes exemplary embodiments of a
reservoir 12 for receiving and holding fluid to be delivered by the
device 10, a transcutaneous access tool 14 for providing fluid
communication between the reservoir 12 and a patient, and a
laminated flow path assembly 16 connecting a fill port 18 to the
reservoir 12 and the reservoir to the transcutaneous access tool
14, all constructed in accordance with the present inventions.
[0044] The fluid delivery device 10 can be used for the delivery of
fluids to a person or animal. The types of liquids that can be
delivered by the fluid delivery device 10 include, but are not
limited to, insulin, antibiotics, nutritional fluids, total
parenteral nutrition or TPN, analgesics, morphine, hormones or
hormonal drugs, gene therapy drugs, anticoagulants, analgesics,
cardiovascular medications, AZT or chemotherapeutics. The types of
medical conditions that the fluid delivery device 10 might be used
to treat include, but are not limited to, diabetes, cardiovascular
disease, pain, chronic pain, cancer, AIDS, neurological diseases,
Alzheimer's Disease, ALS, Hepatitis, Parkinson's Disease or
spasticity. The volume of the reservoir 12 is chosen to best suit
the therapeutic application of the fluid delivery device 10
impacted by such factors as available concentrations of medicinal
fluids to be delivered, acceptable times between refills or
disposal of the fluid delivery device 10, size constraints and
other factors.
[0045] The fluid delivery device 10 also includes a dispenser 20
for causing fluid from the reservoir 12 to flow to the
transcutaneous access tool 14. A processor or electronic
microcontroller (hereinafter referred to as the "local" processor)
22 is connected to the dispenser 20, and is programmed to cause a
flow of fluid to the transcutaneous access tool 14 based on flow
instructions from a separate, remote control device 1000, an
example of which is shown in FIG. 1. A wireless receiver 24 is
connected to the local processor 22 for receiving flow instructions
from the remote control device 1000 and delivering the flow
instructions to the local processor 22. The device 10 also includes
a housing 26 containing the flow path assembly 16, the
transcutaneous access tool 14, the reservoir 12, the dispenser 20,
the local processor 22, and the wireless receiver 24.
[0046] As shown best in FIGS. 2a and 2b, the housing 26 of the
fluid delivery device 10 is free of user input components for
providing flow instructions to the local processor, such as
electromechanical switches or buttons on an outer surface of the
housing 26, or interfaces otherwise accessible to a user to adjust
the programmed flow rate through the local processor. The lack of
user input components allows the size, complexity and costs of the
device 10 to be substantially reduced so that the device 10 lends
itself to being small and disposable in nature. Examples of such
devices are disclosed in co-pending U.S. patent application Ser.
No. 09/943,992, filed on Aug. 31, 2001 (Atty. Docket No. INSL-110),
and entitled DEVICES, SYSTEMS AND METHODS FOR PATIENT INFUSION,
which is assigned to the assignee of the present application and
has previously been incorporated herein by reference.
[0047] In order to program, adjust the programming of, or otherwise
communicate user inputs to the local processor, the fluid delivery
device 10 includes the wireless communication element, or receiver
24, as shown in FIG. 3, for receiving the user inputs from the
separate, remote control device 1000 of FIG. 1. Signals can be sent
via a communication element (not shown) of the remote control
device 1000, which can include or be connected to an antenna 1300,
shown in FIG. 1 as being external to the device 1000.
[0048] The remote control device 1000 has user input components,
including an array of electromechanical switches, such as the
membrane keypad 1200 shown. The remote control device 1000 also
includes user output components, including a visual display, such
as a liquid crystal display (LCD) 1100. Alternatively, the control
device 1000 can be provided with a touch screen for both user input
and output. Although not shown in FIG. 1, the remote control device
1000 has its own processor (hereinafter referred to as the "remote"
processor) connected to the membrane keypad 1200 and the LCD 1100.
The remote processor receives the user inputs from the membrane
keypad 1200 and provides "flow" instructions for transmission to
the fluid delivery device 10, and provides information to the LCD
1100. Since the remote control device 1000 also includes a visual
display 1100, the fluid delivery device 10 can be void of an
information screen, further reducing the size, complexity and costs
of the device 10.
[0049] The communication element 24 of the device 10 preferably
receives electronic communication from the remote control device
1000 using radio frequency or other wireless communication
standards and protocols. In a preferred embodiment, the
communication element 24 is a two-way communication element,
including a receiver and a transmitter, for allowing the fluid
delivery device 10 to send information back to the remote control
device 1000. In such an embodiment, the remote control device 1000
also includes an integral communication element comprising a
receiver and a transmitter, for allowing the remote control device
1000 to receive the information sent by the fluid delivery device
10.
[0050] The local processor 22 of the device 10 contains all the
computer programs and electronic circuitry needed to allow a user
to program the desired flow patterns and adjust the program as
necessary. Such circuitry can include one or more microprocessors,
digital and analog integrated circuits, resistors, capacitors,
transistors and other semiconductors and other electronic
components known to those skilled in the art. The local processor
22 also includes programming, electronic circuitry and memory to
properly activate the dispenser 20 at the needed time
intervals.
[0051] In the exemplary embodiment of FIG. 3, the device 10 also
includes a power supply 28, such as a battery or capacitor, for
supplying power to the local processor 22. The power supply is
preferably integrated into the fluid delivery device 10, but can be
provided as replaceable, e.g., a replaceable battery. The device 10
can also include sensors or transducers such as a flow condition
sensor assembly 30 or dispenser position monitors 32, for
transmitting information to the local processor 22 to indicate how
and when to activate the dispenser 20, or to indicate other
parameters determining fluid flow, as well as conditions such as
the reservoir being empty or leaking, or the dispensing of too much
or too little fluid from the reservoir 12, etc.
[0052] As shown in FIG. 2b, the device 10 can also be provided with
an adhesive layer 34 on the outer surface of the housing 26 for
securing the device 10 directly to the skin of a patient, as
illustrated in FIG. 1. The adhesive layer 34 is provided on an
external "bottom" surface of the housing 26. The adhesive layer 34
is also preferably provided in a continuous ring encircling an
external exit port 36 of the housing 26 in order to provide a
protective seal around the penetrated patient's skin to prevent the
penetrated skin from becoming contaminated when a cannula 38 of the
transcutaneous access tool 14 extends through the skin. It is
preferable that the fill port 18 extend through the bottom surface
of the housing 26 to discourage and prevent filling and re-filling
of the fluid delivery device 10 when the device 10 is attached to a
patient's skin. The housing 26 can be made from flexible material,
or can be provided with flexible hinged sections that allow the
fluid delivery device 10 to flex during patient movement to prevent
detachment and aid in patient comfort.
[0053] As shown in FIGS. 2b and 3, an outlet plug 40 is secured to
the distal end of the cannula 38 of the transcutaneous access tool
14 prior to use of the device 10. The outlet plug 40 has an air
removal filter that allows air but not fluid to exit the cannula
38, and acts as a flow restriction system that operates to
substantially prime (i.e., purge of air) the flow path of the fluid
delivery device 10 prior to operation of the device 10, to ensure
that a desired volume of fluid is accurately delivered by the
device 10 during operation.
[0054] In the exemplary embodiment of FIG. 3, the reservoir 12 is
not pressurized, and the dispenser 20 is adapted to control flow
from the reservoir 12 by driving or pumping the fluid from the
reservoir to the transcutaneous access tool 14. Examples of such
"driving or pumping" dispensers are shown in co-pending U.S. patent
application Ser. No. 09/955,623, filed on Sep. 19, 2001 (Atty.
Docket No. INSL-117), and entitled PLUNGER FOR PATIENT INFUSION
DEVICE, which is assigned to the assignee of the present
application and incorporated herein by reference. Other examples of
dispensers are shown in co-pending U.S. patent application Ser. No.
10/128,205, filed on Apr. 23, 2002 (Atty. Docket No. INSL-122), and
entitled DISPENSER FOR PATIENT INFUSION DEVICE, which is assigned
to the assignee of the present application and incorporated herein
by reference, and co-pending U.S. patent application Ser. No.
10/128,203, filed on Apr. 23, 2002 (Atty. Docket No. INSL-123), and
entitled DISPENSER FOR PATIENT INFUSION DEVICE, which is assigned
to the assignee of the present application and incorporated herein
by reference. Further examples of dispensers are shown in
co-pending U.S. patent application Ser. No. 10/163,688, filed on
Jun. 9, 2002 (Atty. Docket No. INSL-124), and entitled PLUNGER FOR
PATIENT INFUSION DEVICE, which is assigned to the assignee of the
present application and incorporated herein by reference, and in
co-pending U.S. patent application Ser. No. 10/163,690, filed on
Jun. 9, 2002 (Atty. Docket No. INSL-125), and entitled PLUNGER FOR
PATIENT INFUSION DEVICE, which is also assigned to the assignee of
the present application and incorporated herein by reference.
[0055] In the embodiment shown in FIGS. 4 and 5, the reservoir 12
includes a cylindrical side wall 42 extending towards an outlet 44
connected to the transcutaneous access tool 14. A threaded lead
screw 46 is received in the reservoir 12 and extends towards the
outlet 44 of the reservoir 12 generally parallel with the side wall
42 of the reservoir 12, and a plunger 48 is secured to an end of
the lead screw 46. The lead screw 46, the plunger 48 and the
reservoir 12 are adapted (e.g., provided with o-rings) such that a
fluid-tight seal is formed between the plunger 48 and the lead
screw 46 and a fluid-tight seal is formed between the plunger 48
and the side wall of the reservoir 12, so that movement of the
plunger 48 towards the outlet 44 of the reservoir 12 forces fluid
through the outlet 44 to the transcutaneous access tool 14.
[0056] The dispenser 20 causes fluid flow by causing linear
movement of the lead screw 46 and the plunger 48 towards the outlet
44 of the reservoir 12. Although not shown in FIG. 3, the dispenser
20 includes an elongated shape memory element connected to the
local processor 22 and having a changeable length decreasing from
an uncharged length to a charged length when at least one charge is
applied to the shape memory element. The shape memory element is
operatively connected to the plunger 48 such that the changeable
length of the shape memory element causes the plunger 48 to move
along the side wall 42 of the reservoir 12.
[0057] In the exemplary embodiment shown in FIG. 3, the dispenser
20 includes a rotatable gear 50 linearly fixed with respect to the
reservoir 12. The gear 50 is coaxially fixed to an exterior surface
of a slotted tube 52 such that rotation of the gear 50 causes
rotation of the slotted tube 52 about a common longitudinal axis
"A". The lead screw 46 is coaxially positioned within the slotted
tube 52 and includes a radially extending pin 54 slidingly received
in longitudinal slots of the slotted tube 52 such that rotation of
the slotted tube 52 causes rotation of the lead screw 46. The lead
screw 46 is also threadedly engaged with a fixed nut assembly 56,
such that rotation of the gear 50 causes linear movement of the
lead screw 46 through the fixed nut assembly 56 and linear movement
of the plunger 48 towards the outlet 44 of the reservoir 12. In one
exemplary embodiment, the fixed nut assembly 56 is configured to be
disengaged from the lead screw 46 prior to use of the device to
allow the lead screw 46 and the plunger 48 to be linearly moved
away from an inlet 58 of the reservoir 12 during filling of the
reservoir 12 through the fill port 18.
[0058] The dispenser 20 further includes a ratchet member 60 for
engaging radially extending teeth of the gear 50, wherein the
ratchet member 60 and the gear 50 are adapted such that linear
movement of the ratchet member 60 in a first direction adjacent the
gear 50 causes rotation of the gear 50, while linear movement of
the ratchet member 60 in a second direction adjacent the gear 50
causes no rotation of the gear 50. The elongated shape memory
element (not viewable) is connected to the ratchet member 60 such
that the changeable length of the shape memory element decreasing
from an uncharged length to a charged length causes linear movement
of the ratchet member 60 in one of the first and the second
directions. The dispenser 20 can also include a return element,
such as a hinge spring (not viewable), connected to the ratchet
member 60 for causing linear movement of the ratchet member 60 in
the first direction.
[0059] It should be understood, however, that other types of
dispensers can also be used with a device incorporating the
reservoir 12, the transcutaneous access tool 14, or the laminated
flow path assembly 16 of the present inventions. For example, the
reservoir 12 can be pressurized and a dispenser that does not
create a driving or pumping force, but rather acts as a metering
device, allowing pulses of fluid to pass from the pressurized
reservoir 12, through the dispenser, to the transcutaneous access
tool 14. Examples of such "metering" dispensers are shown in
co-pending U.S. patent application Ser. No. 09/977,434, filed Oct.
12, 2001 (Atty. Docket No. INSL-116), and entitled LAMINATED
PATIENT INFUSION DEVICE, which is assigned to the assignee of the
present application and incorporated herein by reference. In any
event, in the exemplary embodiment shown the dispenser is
controlled by the local processor 22, which includes electronic
programming, controls, and circuitry to allow sophisticated fluid
delivery programming and control of the dispenser.
[0060] Referring now to FIGS. 3 through 5, the exemplary embodiment
of the transcutaneous access tool 14 constructed in accordance with
the present invention includes the first cannula 38, which is
preferably flexible, and a rigid second cannula 62 disposed within
the lumen of the flexible first cannula 38. The transcutaneous
access tool 14 also includes a movable deployment member 64 secured
to the first cannula 38, a movable retraction member 66 secured to
the second cannula 62, and a stationary fixed member 68 secured to
the housing 26.
[0061] The transcutaneous access tool 14 further includes a latch
72 that normally maintains the deployment member 64 and the first
cannula 38 in a pre-deployment position against the bias force of a
compressed helical deployment spring 70. A shape memory element 74
activated upon the application of an electrical charge removes the
latch 72 from the travel path of the deployment member 64, thereby
allowing the deployment spring 70 to drive the deployment member 64
and the retraction member 66 away from the fixed member 68 and
toward an internal exit port 76 of a wall 78 of the housing 26, and
force the distal tips of both the first cannula 38 and the second
cannula 62 through the external exit port 36 and into the skin of
the patient. FIG. 4a shows the transcutaneous access tool 14 prior
to deployment, while FIG. 4b shows the transcutaneous access tool
14 after deployment with the deployment member 64 and the
retraction member 66 moved fully away from the fixed member 68 by
the deployment spring 70.
[0062] The transcutaneous access tool 14 is in fluid communication
with the reservoir 12 of the device 10 at all times before and
after injection of the first cannula 38 into the skin of the
patient. The housing 26 includes a cannula guide portion 80 which
deflects the cannula (e.g., by approximately 40.degree.) as the
cannula 38 passes between the internal exit port 76 and the
external exit port 36. However, the cannula 38 does not have a bent
distal end (e.g., bent approximately 90.degree.).
[0063] A compressed helical retraction spring 82 biases the
retraction member 66 away from the deployment member 64. After the
second cannula 62 has injected the distal tip of the first cannula
38 into the skin of the patient, the retraction spring 82 is
allowed to force the retraction member 66 away from the deployment
member 64 and towards the fixed member 68, and withdraw the second
cannula 62 from the skin of the patient, as shown in FIG. 4c. The
deployment member 64, however, maintains the first cannula 38 in
the skin of the patient such that a relatively comfortable flow
path is created between the reservoir 12 and the patient.
[0064] In the exemplary embodiment of FIGS. 3 through 5, the
transcutaneous access tool 14 includes an elongated prong 84
extending from the fixed member 68 parallel with an axis "B" of the
transcutaneous access tool 14, spaced-apart, resiliently flexible
fingers 86 extending from the deployment member 64 parallel with
the axis "B" and slidingly received on the prong 84 of the fixed
member 68, and a catch 88 of the retraction member 66 extending
laterally inwardly with respect to the axis "B". The catch 88
catches on laterally enlarged distal ends 90 of the fingers 86 of
the deployment member 64, and prevents the retraction member 66
from being moved away from the deployment member 64 when the
fingers 86 are laterally held apart by the prong 84 of the fixed
member 68, as shown in FIGS. 4a and 4b.
[0065] The prong 84 and the fingers 86, however, are sized so that
the fingers 86 slide off a distal end of the prong 84 when the
deployment member 64 is fully deployed by the deployment spring 70,
as shown in FIG. 4c. The force of the retraction spring 82 causes
the catch 88 of the retraction member 66 to force the laterally
enlarged distal ends 90 of the fingers 86 laterally together (i.e.,
squeeze the fingers 86 together) and be released from the laterally
enlarged distal ends 90. The retraction spring 82 then forces the
retraction member 66 away from the deployment member 64 and towards
the fixed member 68, and withdraws the second cannula 62 from the
skin of the patient, as shown in FIG. 4c.
[0066] Referring to FIGS. 3 through 5, the trancutaneous access
tool 14 also includes an seal 92 that is moved between the
deployment member 64 and the wall 78 of the housing 26 defining the
internal exit port 76 upon deployment of the cannula 38. The seal
92 provides a substantially fluid-tight seal between the deployment
member 64 and the wall 78 of the housing 26 when the deployment
member 64 is moved against the wall 78, as shown in FIG. 4c. The
seal 92 allows a fluid or gas, such as a sterilization medium
(e.g., ethylene oxide), to enter the internal exit port 76 from
outside the housing 26 prior to deployment of the cannula 38, but
seals the housing 26 in a fluid-tight manner upon deployment of the
cannula 38.
[0067] In the exemplary embodiment shown, the seal 92 is annular in
shape, is coaxially positioned about the first cannula 38, and is
secured to the deployment member 64. The seal 92 is made from a
resiliently flexible material such as an elastomer or rubber. The
seal 92 can also be bonded to an outer surface of the first cannula
38.
[0068] Referring to FIG. 10, if the outlet plug 40, which includes
a side collar portion 94 and a central air filter portion 96, is
connected to the distal end of the cannula 38 prior to use of the
fluid delivery device 10, the housing 26 can further be provided
with a sterilization access port 98 adjacent the external exit port
36. As its name implies, the sterilization access port 98 allows a
sterilization medium to enter the housing 26 when the outlet plug
40 is blocking the external exit port 36. Alternatively, the outlet
plug 40 can be provided with its own sterilization access port,
which would be formed in the side collar portion 94 of the outlet
plug.
[0069] Referring now to FIGS. 3 and 11, the exemplary embodiment of
the flow path assembly 16 includes a base layer 100 having opposing
first and second surfaces 102, 104. The base layer 100 defines a
fill chamber outlet port 106 extending through the base layer 100
and between the opposing first and second surfaces 102, 104, an
auxiliary chamber inlet port 108 extending through the base layer
100 and between the opposing first and second surfaces 102, 104,
and a first groove 110 on the second surface 104 of the base layer
100 connecting the fill chamber outlet port 106 to the auxiliary
chamber inlet port 108. The base layer 100 also defines an
auxiliary chamber outlet port 112 extending through the base layer
100 and between the opposing first and second surfaces, the
reservoir inlet port 58 extending through the base layer 100 and
between the opposing first and second surfaces, and a second groove
114 on the second surface 104 of the base layer 100 connecting the
auxiliary chamber outlet port 112 to the reservoir inlet port 58.
The base layer 100 further defines the reservoir outlet port 44
extending through the base layer 100 and between the opposing first
and second surfaces, a cannula inlet port 116 extending through the
base layer 100 and between the opposing first and second surfaces,
and a third groove 118 on the second surface 104 of the base layer
100 connecting the reservoir outlet port 44 to the cannula inlet
port 116.
[0070] As shown in FIG. 3, the flow path assembly 16 also includes
a cover layer 118 substantially covering the second surface 104 of
the base layer 100 in a substantially fluid-tight manner, such that
the grooves 110, 114, 118 in the second surface 104 of the base
layer 100 are formed into fluid passageways. Preferably, the base
layer 100 is relatively rigid and the cover layer 118 is relatively
flexible. The base layer 100 is preferably comprised of a
relatively rigid plastic that is formed through injection molding,
for example, while the cover layer 118 is made from a relatively
flexible fluid-tight plastic, such as an elastomer, rubber or
thermoplastic. The base layer 100 and the cover layer 118 are
secured together in a suitable manner through bonding or by using
an adhesive, for example, in order to seal the grooves 110, 114,
118 of the base layer 100 in a fluid-tight manner. Among other
benefits and features, the laminated construction of the flow path
assembly 16 simplifies manufacturing (and thus the cost) of the
resulting fluid delivery device 10.
[0071] Referring to FIGS. 3 and 11, the flow path assembly 16 also
includes a cannula connector member 120 secured to the first
surface 102 of the base layer 100 in a substantially fluid-tight
manner and defining a cannula connector chamber (not viewable) in
fluid communication with the cannula inlet port 116 of the base
layer 100. The connector member 120 includes a needle septum 122
fitted in an opening of the connector chamber. The second cannula
62 of the transcutaneous access tool 14 extends through the needle
septum 122 to provide fluid communication between the reservoir 12
and the first cannula 38. Preferably, the connector member 120 is
unitarily formed as a single piece with the base layer 100, by
injection molding for example.
[0072] Still referring to FIGS. 3 and 11, the flow path assembly 16
also includes the fill port 18 secured to the first surface 102 of
the base layer 100 in a substantially fluid-tight manner and
defining a fill port chamber (not viewable) in fluid communication
with the fill chamber outlet port 106 of the base layer 100. The
fill port 18 includes a needle septum 124 (as shown in FIG. 2b)
fitted in an opening of the fill port chamber. Preferably, the fill
port 18 is unitarily formed as a single piece with the base layer
100, by injection molding for example.
[0073] Although not viewable, the first surface 102 of the base
layer 100 defines an auxiliary recess connecting the auxiliary
chamber inlet port 108 and the auxiliary chamber outlet port 112.
The flow sensor assembly 30 is secured to the auxiliary recess of
the first surface 102 of the base layer 100 in a substantially
fluid-tight manner, and the flow sensor assembly 30 has a flow
sensor chamber (not viewable) in fluid communication with the
auxiliary chamber inlet port 108 and the auxiliary chamber outlet
port 112 of the base layer 100. The flow sensor assembly provides
an indication of fluid pressure within the flow path assembly 16,
so that conditions within the flow path assembly can be determined.
Examples of flow sensor assemblies are shown in co-pending U.S.
patent application Ser. No. 10/087,507, filed on Mar. 1, 2002
(Atty. Docket No. INSL-118), and entitled FLOW CONDITION SENSOR
ASSEMBLY FOR PATIENT INFUSION DEVICE, which is assigned to the
assignee of the present application and incorporated herein by
reference.
[0074] While the exemplary embodiment of the flow path assembly 16
of FIGS. 3 and 11 includes the flow sensor assembly 30 in fluid
communication with the auxiliary chamber inlet port 108 and the
auxiliary chamber outlet port 112 of the base layer 100, the
auxiliary chamber inlet port 108 and the auxiliary chamber outlet
port 112 can be used to attach other types of "auxiliary" sensors
or devices to the flow path assembly 16. For example, an auxiliary
sensor connected to the auxiliary chamber inlet port 108 and the
auxiliary chamber outlet port 112 can be provided to not only
detect flow conditions but other parameters such as detection of
air, temperature monitoring, drug parameter monitoring
(concentration, pH, etc.) and other parameters important to
infusion of liquid therapeutics, in addition to flow rate. An
auxiliary device can include an air removal filter, a fluid
sterilization filter, a pressure release valve, and other types of
devices as desired.
[0075] Referring to FIG. 3, the first surface 102 of the base layer
100 defines a reservoir shelf 126 connecting the reservoir 58 inlet
port and the reservoir outlet port 44. The reservoir 12 includes
the cylindrical side wall 42 having opposing open ends, and one of
the open ends is received in a fluid-tight manner on the shelf 126
of the base layer 100 so that a interior chamber of the reservoir
12 is in fluid communication with the reservoir inlet port 58 and
the reservoir outlet port 44 of the base layer 100. The side wall
42 of the reservoir 12 can be made of any suitably strong and rigid
material that is compatible with the fluid to be held by the
reservoir 12 and that can be sterilized. In one exemplary
embodiment, the side wall 42 is comprised of stainless steel (in
FIG. 3 the side wall 42 is shown as being transparent only for
purposes of illustration). It is also contemplated that the side
wall 42 can be formed unitarily as a single piece with the base
layer 100, if desired.
[0076] Referring now to FIGS. 6 through 9, another fluid delivery
device 130 constructed in accordance with the present invention is
shown. The fluid delivery device 130 includes a housing 132 having
a port 134, an adhesive layer 136 provided on an exterior surface
of the housing 132 surrounding the port 134 and including
resiliently flexible flaps 138 normally sealing the port 134 in a
substantially fluid-tight manner. The adhesive layer 136 is for
securing the device 130 to a patient during use.
[0077] A protective layer 140 removably covers the adhesive layer
136 and includes a sterilization access tube 142 extending through
the flaps 138 of the adhesive layer 136 and into the housing 132.
Among other benefits and features, the sterilization access tube
142 allows a fluid or gas, such as a sterilization medium (e.g.,
ethylene oxide), to enter the port 134 from outside the housing 132
prior to removal of the protective layer 140. The flaps 138 then
seal the port 134 in a fluid-tight manner after removal of the
protective layer 140, to reduce the risks of contamination of the
fluid delivery device 130 during use. FIGS. 6 and 7 shown the
device 130 prior to removal of the protective layer 140, while
FIGS. 8 and 9 show the device 130 after removal of the protective
layer 140. The port 134 may also be used for passage of a
deployable cannula or other transcutaneous access tool (not shown),
or may be provided just to allow access of a sterilization medium
through the sterilization access tube 142 prior to use.
[0078] Referring to FIG. 12, another exemplary embodiment of a
reservoir 150 constructed in accordance with the present invention
is shown. The reservoir 150 includes a cylindrical side wall 152
having opposing first and second open ends 154, 156 and defining a
reservoir chamber, an end cap 158 closing the second open end 156
of the side wall 152 and defining a port 160 providing fluid
communication with the reservoir chamber, a plunger 162 received in
the reservoir chamber and slidingly moveable along the side wall
152 and between the opposing first and second open ends 154, 156,
and a lead screw 164 extending into the first open end 154 of the
side wall 152 and having a distal end secured to the plunger
162.
[0079] In the exemplary embodiment of FIGS. 12 and 13, a
resiliently flexible o-ring 166 is provided in a circumferential
groove of the plunger 162 to maintain a fluid-tight seal between
the plunger 162 and the side wall 152 of the reservoir 150. The
distal end of the lead screw 164 is preferably rotatably secured
within a socket 168 of the plunger 162 so that the lead screw 164
can be rotated independently of the plunger 162. In addition, the
distal end of the lead screw 164 is preferably snap-fit into the
socket 168 for ease of assembly. The end cap 158 is made of a
suitably rigid and strong material that is compliant with the fluid
to be held in the reservoir 150 and that can be easily sterilized,
such as stainless steel. The end cap 158 can be secured to the side
wall 152 by welding for example.
[0080] An exemplary embodiment of a flow path assembly constructed
in accordance with the present invention includes the reservoir 150
of FIGS. 12 and 13 assembled to a base layer 170 of FIG. 14. The
base layer 170 has opposing first and second surfaces 172 (only the
second surface is viewable in FIG. 14), a fill chamber outlet port
174 extending through the base layer 170 and between the opposing
first and second surfaces, a reservoir inlet port 176 extending
through the base layer 170 and between the opposing first and
second surfaces, a reservoir outlet port 178 extending through the
base layer 170 and between the opposing first and second surfaces,
and a cannula inlet port 180 extending through the base layer 170
and between the opposing first and second surfaces. The second
surface 172 of the base layer 170 defines a first groove 182
connecting the fill chamber outlet port 174 to the reservoir inlet
port 176, and a second groove 184 connecting the reservoir outlet
port 178 to the cannula inlet port 180.
[0081] The first surface of the base layer 170 defines a reservoir
recess 186 connecting the reservoir inlet port 176 and the
reservoir outlet port 178 and for receiving the end cap 158 of the
reservoir 150 of FIG. 12 in a substantially fluid-tight manner. The
port 160 of the end cap 158 provides fluid communication between
the reservoir 150 and the reservoir inlet port 176 and the
reservoir outlet port 178. During assembly, the end cap 158 of the
reservoir 150 is snap-fit into the reservoir recess 186 of the base
layer 170.
[0082] Referring to FIG. 14, the first surface of the base layer
170 also defines a fill port recess 188 over the fill chamber
outlet port 174 and a cannula connector recess 190 over the cannula
inlet port 180. The base layer 170 is made of a suitable strong and
rigid material, such as injection molded plastic or stainless
steel. Although not shown, the flow path assembly further includes
a cover layer secure over the second surface 172 of the base layer
170 in a fluid-tight manner such that the grooves 182, 184 are
formed into fluid passageways. Among other benefits and features,
the mating construction of the reservoir 150 and the base layer 170
of FIGS. 12 through 14 simplifies assembly (and thus the cost) of
the resulting fluid delivery device.
[0083] Referring to FIGS. 15 and 16, an additional flow path
assembly 200 constructed in accordance with the present invention
is shown. In general, the flow path assembly 200 of FIGS. 15 and 16
is unitarily formed as part of an end wall 202 of a housing 204 of
a fluid delivery device. Among other benefits and features, the
flow path assembly 200 of FIGS. 15 and 16 simplifies assembly (and
thus the cost) of the fluid delivery device by incorporating the
flow path into the end wall 202 of the housing 204, which can be
two injection molded pieces 206, 208 assembly together.
[0084] In the exemplary embodiment shown, the flow path assembly
200 includes a first portion 206 and a second portion 208 of the
housing 204 assembled together to form the end wall 202 of the
housing. The end wall 202 includes a fill port 210, a reservoir
connection port 212, a cannula connection port 214, and at least
one flow path 216 connecting the fill port, the reservoir
connection port and the cannula connection port.
[0085] In the exemplary embodiment shown, the first portion 206 of
the housing 204 includes a first portion of the end wall 202 and
the second portion 208 of the housing 204 includes a second portion
of the end wall 202. The first and the second portions of the end
wall 202 have mating surfaces defining corresponding grooves which
together define the flow path 216 of the end wall when the first
and the second portions 206, 208 of the housing 204 are assembled
together.
[0086] The end wall 202 of the housing 204 further includes an
interior surface defining a reservoir recess 218 in fluid
communication with the reservoir connection port 212, and a
reservoir side wall 220 is received in the recess 218. A
circumferential o-ring groove is provided in the reservoir recess
218, and a resiliently flexible o-ring 222 is positioned in the
groove to provide a fluid-tight seal between the side wall 220 of
the reservoir and the end wall 202 of the housing 204. The fill
port 210 extends between the mating surface of the second portion
of the end wall 202 and an exterior surface of the second portion
208 of the housing 204, and contains a needle septum 224.
[0087] As illustrated by the above described exemplary embodiments,
the present invention generally provides new and improved
components for a device for delivering fluid, such as insulin for
example, to a patient. It should be understood that the embodiments
described herein are merely exemplary and that a person skilled in
the art may make variations and modifications to the embodiments
described without departing from the spirit and scope of the
present invention. All such equivalent variations and modifications
are intended to be included within the scope of this invention as
defined by the appended claims.
* * * * *