U.S. patent application number 13/585999 was filed with the patent office on 2012-12-06 for device for administering a fluid product.
This patent application is currently assigned to TecPharma Licensing AG.. Invention is credited to Fritz Kirchhofer.
Application Number | 20120310208 13/585999 |
Document ID | / |
Family ID | 35427285 |
Filed Date | 2012-12-06 |
United States Patent
Application |
20120310208 |
Kind Code |
A1 |
Kirchhofer; Fritz |
December 6, 2012 |
DEVICE FOR ADMINISTERING A FLUID PRODUCT
Abstract
An administering device for a fluid product includes a product
receptacle that accommodates the product to be administered, a
fluid reservoir for a driving fluid, a driving means, a product
chamber, and a fluid connection. The product receptacle includes an
opening at a forward end and a product stopper at a rear end. The
driving means acts upon the fluid reservoir, the pressure chamber
adjoins the product stopper while the fluid connection is located
between the fluid reservoir and the pressure chamber, and the
driving means acts upon the fluid reservoir in such a way that the
pressure chamber is impinged upon by pressure which affects the
product stopper and the product is discharged from the product
receptacle.
Inventors: |
Kirchhofer; Fritz;
(Sumiswald, CH) |
Assignee: |
TecPharma Licensing AG.
|
Family ID: |
35427285 |
Appl. No.: |
13/585999 |
Filed: |
August 15, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12846103 |
Jul 29, 2010 |
8277413 |
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13585999 |
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11923339 |
Oct 24, 2007 |
7789858 |
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12846103 |
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PCT/CH2006/000221 |
Apr 24, 2006 |
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11923339 |
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Current U.S.
Class: |
604/506 ;
604/134 |
Current CPC
Class: |
A61M 2005/14506
20130101; A61M 5/14566 20130101; A61M 2005/14513 20130101; A61M
5/14526 20130101 |
Class at
Publication: |
604/506 ;
604/134 |
International
Class: |
A61M 5/20 20060101
A61M005/20 |
Foreign Application Data
Date |
Code |
Application Number |
Apr 25, 2005 |
CH |
724/05 |
Claims
1. A device for administering a fluid product, comprising: a
product container configured to accommodate the fluid product to be
administered, said product container comprising an opening at a
front end and a product stopper movable relative to the product
container at a rear end; a fluid reservoir for accommodating a
drive fluid; a drive means operatively coupled to the fluid
reservoir; a pressure chamber operatively coupled to the product
stopper; and a fluid connection between the fluid reservoir and the
pressure chamber; wherein the drive means acts on the fluid
reservoir in such a way that the pressure chamber is charged with
pressure which acts on the product stopper, and the product is
discharged from the product container.
2. The administering device according to claim 1, wherein the drive
means is biased and/or held in a biased position.
3. The administering device according to claim 1, further
comprising a connecting means for forming the fluid connection,
said connecting means comprising first state and a second state,
wherein the fluid connection is closed in the first state, and a
the fluid connection is opened in the second state such that the
fluid connection is open to the drive fluid.
4. The administering device according to claim 3, wherein the
product container or the connecting means triggers the drive
means.
5. The administering device according to claim 3, wherein when the
product container is inserted into the casing, the connecting means
is activated in such a way that the fluid connection is moved to
the second, open state.
6. The administering device according to claim 3, wherein the
connecting means forms a part of the fluid connection.
7. The administering device according to claim 3, wherein when the
product container is inserted into the casing, the connecting means
is activated by the product stopper.
8. The administering device according to claim 7, wherein the
connecting means advances the product stopper by a distance that
allows the product container to be vented.
9. The administering device according to claim 3, wherein the
connecting means forms a flow section of the fluid connection which
exhibits a maximum flow resistance in the fluid connection.
10. The administering device according to claim 3, wherein
connecting means forms the fluid connection.
11. The administering device according to claim 3, wherein the
connecting means comprises a tube-like hollow element with which a
sealing membrane for sealing the fluid connection can be
pierced.
12. The administering device according to claim 3, wherein the
pressure chamber is formed by one or more walls of the product
container and the product stopper together with the connecting
means.
13. The administering device according to claim 1, wherein the
fluid connection to the pressure chamber comprises a dimension,
said dimension of the fluid connection defining the pressure in the
pressure chamber.
14. The administering device according to claim 1, further
comprising a casing, said casing configured as the pressure
chamber, fluid connection, product container and fluid reservoir,
and wherein the casing is configured to accommodate the drive
means.
15. The administering device according to claim 1, further
comprising a casing, said casing accommodating the drive means and
each of the pressure chamber, the fluid connection, the product
container and the fluid reservoir.
16. The administering device according to claim 15, further
comprising: a sealing means, which seals the fluid connection; and
a connecting means, which is accommodated in the casing in such a
way that it can be moved from an initial position towards an
activating position; wherein the connecting means is arranged such
that the product stopper can be coupled to the connecting means by
inserting the product container, in order to move the connecting
means to the activating position; and wherein the sealing means and
the connecting means are arranged such that the connecting means is
brought to bear on the sealing means by the movement into the
activating position, in order to open the fluid connection.
17. The administering device according to claim 16, wherein the
connecting means comprises a bearing structure which is guided
movably in the casing and a hollow element, preferably an elongated
hollow element, which protrudes from the bearing structure and
forms a section of the fluid connection in the activating
position.
18. The administering device according to claim 15, wherein: the
casing forms a compartment comprising an opening; and the product
container can be inserted into the compartment through the opening,
preferably in the proximal direction; wherein inserting the product
container opens the fluid connection which is sealed before the
product container is inserted.
19. The administering device according to claim 15, further
comprising: a compartment formed by the casing, said compartment
comprising an opening through which the product container can be
inserted into the compartment; and a sealing element arranged in
the compartment, said sealing arrangement configured to abut with
the product container when it is inserted; wherein the sealing
element seals off a proximal end section of the inserted product
container from the compartment.
20. The administering device according to claim 15, wherein the
pressure chamber is formed by one or more walls of the product
container and the product stopper together with the casing.
21. The administering device according to claim 1, wherein the
drive means is a spring element.
22. The administering device according to claim 1, wherein the
fluid connection is formed by a capillary having a diameter of 0.5
to 3 mm.
23. The administering device according to claim 1, wherein the
fluid connection is formed in a meandering or looped shape.
24. A method for continuously administering a fluid product, using
an administering device, the method comprising the steps of:
providing an administering device comprising: a product container
configured to accommodate the fluid product to be administered,
said product container comprising an opening at a front end and a
product stopper movable relative to the product container at a rear
end; a fluid reservoir for accommodating a drive fluid; a drive
means operatively coupled to the fluid reservoir; a pressure
chamber operatively coupled to the product stopper; and a fluid
connection between the fluid reservoir and the pressure chamber;
and actuating the administering device, wherein, when the
administering device is actuated, the drive means acts on the fluid
reservoir in such a way that the pressure chamber is charged with
pressure which acts on the product stopper, and the product is
discharged from the product container.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. Ser. No.
12/846,103 filed Jul. 29, 2010, which is a continuation of U.S.
Ser. No. 11/923,339 filed Oct. 24, 2007, issued as U.S. Pat. No.
7,789,858, which is a continuation of International Application No.
PCT/CH2006/000221, filed 24 Apr. 2006, which claims the benefit of
priority from Swiss Application No. 724/05, filed 25 Apr. 2005, the
subject matter of both are hereby incorporated by reference in
their entirety.
BACKGROUND
[0002] The present invention relates to devices for injecting,
infusing, administering, delivering or dispensing substances, and
to methods of making and using such devices. More particularly, the
invention relates to a device for administering a fluid product, in
particular a device for administering a fluid product at a
continuous delivery rate.
[0003] For various diseases, such as for example diabetes, it can
be necessary to continuously administer a particular amount of a
fluid medicine to a patient. Various systems for this purpose are
known, which enable the medicine to be supplied continuously over
an extended period of time. The period of time of administration,
the amount of the product administered within the period of time,
the repetition rate of a number of consecutive administrations and
possible extra deliveries can usually be set in such systems.
Administering devices are known which can be connected to an
external product container for a fluid medicine and, as soon as
said container is empty, can be connected to the next container.
Accordingly, such administering systems can be reused. Furthermore,
implantable devices are also known which can be inserted into a
patient's body tissue and are coupled to an external product
container by means of a connector. Various possibilities exist for
driving such systems, such as for example using gravity, various
drive systems in the form of mechanical springs or hydraulic
drives. In order to regulate the flow rate, the flow amount from
the product container for the fluid medicine is usually limited at
the outlet. Simple valves, clamps or programmable electronic
devices can be used for this.
[0004] U.S. Pat. No. 5,788,673 discloses an infusion system in
which a drive unit is combined with a conventional syringe. The
syringe includes a product container that accommodates the fluid
product, and a drive piston rod by which a product stopper within
the product container can be advanced. The fluid product can be
discharged from the syringe through an outlet opposite the product
stopper. At the opening, the syringe also includes a valve for
regulating the fluid flow. The drive unit comprises a chamber for a
liquid medium, a second chamber which communicates with the first
chamber, a piston and a valve system. A spring force can be exerted
on the piston that conveys the liquid medium from the first chamber
to the second chamber and back. The valve system controls the
movement of the piston in the forward or backward direction and
thus the discharge of the fluid product from the syringe.
[0005] The known systems for administering fluid medicines are
generally designed to be reused. They therefore exhibit a complex
construction comprising a large number of components and are
therefore costly to manufacture. Furthermore, the patient or an
assistant has to learn how to change the administering device from
an empty product container to a new, full product container. If
handled incorrectly, it is for example possible for an incorrect
dosage to be administered to a patient.
SUMMARY
[0006] The present invention to provides a device for administering
a fluid medicine, which is easy to handle, can be initiated in a
few operating steps, ensures reliable functioning and ensures a
continuous discharge at a constant medicine rate.
[0007] In addition, according to the invention, an administering
device for continuously administering a fluid medicine, which is
suitable for being used once, is provided.
[0008] The administering device of the present invention, according
to certain embodiments, is configured to administer a fluid
product, primarily a therapeutic medicine such as for example
insulin. However, the administering device may also be used for
administering other fluid products, which are to be administered
into a body tissue. The administering device comprises a product
container which accommodates the product to be administered and
comprises an opening for discharging the product from the product
container at its front, distal end, and a product stopper at its
rear, proximal end. A typical ampoule, such as is used for
injection syringes or pens for quickly administering small dosages
and/or injection shots, may be used as the product container. The
product stopper may be moved relative to the product container and
seals the proximal end of the container in a fluid-proof seal.
[0009] According to various embodiments, the administering device
also comprises a fluid reservoir for a drive fluid and a drive
means that acts on the fluid reservoir. The drive fluid may be a
non-compressible liquid. At least one of the fluid reservoir and
the product container should be a non-compressible chamber; and in
some implementations, the fluid reservoir and the product container
are each formed by a non-compressible chamber. A non-compressible
chamber may include solid, stable walls in a suitable geometric
shape. The fluid reservoir includes a drive stopper, which
transfers the action of the drive means onto the drive fluid within
the fluid reservoir and charges the fluid reservoir with pressure.
Various systems, including known systems, can be used as the drive
means, such as for example mechanical springs, hydraulic drives or
gas drives. A mechanical spring, for example a mechanical pressure
spring, may be used as the drive means in the present
invention.
[0010] A pressure chamber may be connected to the product stopper
of the product container, according to some implementations. The
pressure chamber may be formed by one or more walls of the product
container, the product stopper and a closed end of the container.
The closed end of the pressure chamber may be formed by a casing
wall, such as by means of a seal. Accordingly, the pressure chamber
may be at least partially or completely arranged within the product
container. According to certain embodiments, the product container
may be subdivided by the product stopper into a chamber for the
product and the pressure chamber. A fluid connection is provided
between the fluid reservoir and the pressure chamber, and the drive
fluid may be conveyed out of the fluid reservoir, through the fluid
connection, into the pressure chamber.
[0011] In accordance with the present invention, the drive means
acts on the fluid reservoir in such a way that the pressure chamber
is charged with pressure via the fluid connection, said pressure
acting on the product stopper and thus discharging the product from
the product container. Although for certain embodiments, a casing
of the device forms a compartment for a product container, which is
or can be accommodated in it, the casing, in other embodiments, may
accommodate one or more or all of the components of the
administering device in order to directly form the product
container.
[0012] According to one embodiment of the present invention, the
fluid connection exhibits a first, resting state in which it is
closed, i.e. in which no drive fluid can flow from the fluid
reservoir to the pressure chamber. A connecting means is provided
in the administering device and moves the fluid connection from the
first, closed, resting state to a second, open, administering state
in which the fluid connection is open to the drive fluid. The
connecting means therefore serves to connect the fluid reservoir
containing the drive fluid to the pressure chamber connected to the
product stopper of the product container. If, in the second, open
state, the drive means then acts on the fluid reservoir or drive
stopper of the fluid reservoir, the drive fluid is conveyed through
the fluid connection.
[0013] According to certain embodiments, the drive means is biased
in the administering device in the resting state, i.e. the drive
means constantly acts on the fluid reservoir or drive stopper. The
drive means may be held in the biased position by a holding and/or
securing device. The holding device may include known locking
systems in which, for example, the drive stopper of the drive means
is held in place by a movable latch or stopper, for example, which
may be removed or released by a push button or slider in order to
release the locking system. In another embodiment, the holding
device may be formed by the seal of the fluid connection, for
example by means of the sealing membrane. The bias on the drive
means may then be released by opening the fluid connection. In
alternative embodiments, the drive means may only be tensed when
the fluid connection is opened or after the fluid connection has
been opened.
[0014] According to one embodiment, a casing is provided which
accommodates the product container, the fluid reservoir, the
pressure chamber and the fluid connection. In some implementations,
a pre-assembled unit may be provided that includes the casing, the
fluid reservoir, the pressure chamber and the fluid connection, and
comprises a compartment into which the product container can be
inserted when necessary, for example shortly before the required
administration. Accordingly, in order to use the administering
device in accordance with the invention, only the product container
need be inserted into the casing compartment. When the product
container is inserted into the casing, the connecting means may be
activated, such that the fluid connection is moved from the resting
state to the administrating state. If the drive means is already
biased within the casing, the drive means may be triggered with the
aid of the product container and the pressure chamber consequently
charged with pressure. The pressure force begins to act on the
drive stopper in such a way that the stopper is shifted relative to
the fluid reservoir, and drive fluid flows from the fluid reservoir
into the pressure chamber, wherein a pressure is built up in the
pressure chamber which acts on the product stopper, and the fluid
product is therefore discharged through the opening in the product
container.
[0015] According to certain embodiments, the fluid connection
comprises a sealing membrane for sealing it. The fluid connection
may be moved from the closed state to the open state by penetrating
the sealing membrane, and connecting means then exhibits a flow
cross-section through which product can flow. For example, a
tube-like hollow element, such as a hollow needle, conduit,
capillary, or passage may serve as a connecting means and penetrate
and/or pierce the sealing membrane of the fluid connection.
Accordingly, the connecting means can form a part of the fluid
connection. It is for example possible on the one hand for the
fluid connection to be formed by a narrow capillary which feeds
from the fluid reservoir, is conveyed within the casing towards the
product container compartment, and is sealed with the sealing
membrane at the end, which feeds into the compartment, and on the
other for the fluid connection to be formed from the hollow needle
of the connecting element. The pressure in the pressure chamber may
be defined by dimensioning the fluid connection. The pressure in
the pressure chamber is dependent on the size of the outlet area
and/or the diameter of the fluid connection and on the length of
the capillary. It is independent of the pressure of the drive
element on the fluid reservoir or drive stopper. This
implementation enables pressure fluctuations in the drive means to
be equalized. In some implementations, the fluid connection may
have a diameter of about 0.5 to about 3 mm. It is also possible to
arrange the fluid connection within the casing in a looping,
spiralling, meandering or labyrinthine manner. This enables the
fluid connection path between the fluid space and the pressure
chamber to be lengthened and the pressure in the pressure chamber
to be regulated by selecting a particular fluid connection
length.
[0016] In a particular embodiment, the connecting means forms a
partial section of the fluid connection in the state in which the
fluid reservoir is connected to the product reservoir. In another
embodiment, the connecting means alone forms the fluid connection
in the connected state. Alternatively, the hollow element, which
penetrates the sealing membrane, may form the fluid connection. For
example, the sealing membrane may form a wall of the fluid
reservoir thus allowing the hollow element to form a fluid
connection with the fluid in the reservoir once the hollow element
penetrates the membrane.
[0017] The administering device of the present invention may be
configured to be a single-use device. A user inserts the product
container into the casing comprising the other components of the
device, which in some embodiments, connects the pressure chamber to
the fluid reservoir. Inserting may also simultaneously trigger
administration. No further hand operations are necessary in order
to initiate the device or regulate the administering amount. Once
administration is complete, i.e. as soon as the product container
is empty, the connection to the patient can be interrupted and the
whole administering apparatus disposed of.
[0018] In alternative embodiments, the administering device may be
reusable. If, for example, the drive means is only tensed or
charged when the product container is inserted or after the product
container has been inserted or by inserting the product container,
the administering device may be repeatedly charged and used by
again inserting a product container. The drive means can also be
biased before a new product container is inserted.
[0019] According to some implementations, the connecting means is
activated by the product stopper when the product container is
inserted into the casing. As described, this can move the fluid
connection from a closed state to an open state. It is, however,
also simultaneously possible to form the connecting means in such a
way that the product stopper within the product container is
shifted in the distal direction of the product container when the
container is inserted into the casing. The connecting means may
advance the product stopper by a distance which allows the product
container to be vented. This only requires a small movement by the
product stopper within the product container, which may remove
possible air pockets within the product container through the front
opening of the product container, and the administering device may
be directly connected to an administering conduit, which leads to
the patient. The frictional force to overcome the snug fit of the
product stopper in the product container is preferably greater than
the force required to move the fluid connection from the closed
state to the open state, i.e. to pierce the sealing membrane. When
the product container is inserted, the membrane is then pierced
first and the fluid connection between the fluid reservoir and the
pressure chamber thus opened, and then the product stopper is
distally shifted by a venting distance. The pressure building up in
the pressure chamber immediately begins to advance the product
stopper and thus administer the product.
[0020] In accordance with another aspect of the invention, a method
is claimed, according to which, in a device for administering, and
in some instances, for continuously administering, a fluid product,
inserting a product container triggers the administration and/or a
venting process for venting a product container.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] FIG. 1 depicts a first embodiment of an administering
apparatus in accordance with the present invention, in a resting
state;
[0022] FIG. 2 depicts the administering device according to FIG. 1,
in an administering state;
[0023] FIG. 3 depicts the administering device during
administration; and
[0024] FIG. 4 depicts a second embodiment of an administering
device in accordance with the present invention.
DETAILED DESCRIPTION
[0025] FIG. 1 shows a first embodiment of an administering device
in accordance with the present invention. The administering device
comprises a casing (1) in which a product container in the form of
an ampoule (2), a fluid reservoir (3), a drive means in the form of
a spring (4), a fluid connection (5) and a connecting means (6) are
accommodated. Water may be used as the drive fluid, the physical
parameters of which are well known. However, it is also possible to
use other fluids that differ in viscosity. The ampoule (2) is
filled with the fluid product (7). Ampoule (2) comprises an opening
(8) at its front, distal end and a product stopper (9) at its rear,
proximal end. In FIG. 1, the ampoule (2) has not yet been
completely inserted into the casing (1) and the administering
device is in its resting state.
[0026] In the embodiment in accordance with FIGS. 1 to 3, the
ampoule (2) and the fluid reservoir (3) together with the spring
(4) are arranged next to each other, offset in parallel, within the
casing. The fluid connection (5) forms a transverse connection
within the casing (1). This arrangement enables the overall length
of the administering device to be kept small. The fluid connection
(5) is spread over the area of the casing (1) in a number of loops
(not shown).
[0027] The connecting means (6) is provided within the casing (1)
as a movable element. The connecting means (6) can be moved along
the longitudinal axis of the ampoule and is arranged between the
ampoule (2) and the fluid connection (5) and comprises a hollow
needle (10). The fluid connection (5) is permanently connected to
the fluid reservoir (3) at one end and sealed by a sealing membrane
(13) at the other end. The hollow needle (10) of the connecting
element (6) is arranged opposite the sealing membrane (13) at an
axially small distance. In addition, the connecting means (6) is
provided centrally relative to the product stopper (9).
[0028] The system consisting of the spring (4), the fluid reservoir
(3), the fluid connection (5) and the sealing membrane (13) forms a
sealed fluid system in the resting state. In this embodiment, the
spring (4) is already biased within the system. Even in the resting
state, it therefore exerts a pressure on the fluid reservoir
comprising the drive fluid. The sealing membrane (13) is therefore
embodied such that it withstands this pressure.
[0029] In FIG. 2, the ampoule (2) has been completely inserted into
the casing (1) of the administering device. When the ampoule (2) is
completely inserted into the casing (1), the product stopper (9)
comes to rest on the connecting means (6). If the ampoule (2) is
inserted further, the product stopper (9) initially presses the
connecting element (6) towards the sealing membrane (13) until the
hollow needle (10) pierces the membrane and the connecting element
(6) abuts a shift stopper (14), which may be formed by the casing
or may be affixed to the casing. The connecting means (6) cannot
then be shifted further in the direction of the longitudinal axis
of the ampoule, relative to the casing. The ampoule (2) can,
however, still be inserted further in the insertion direction, into
the casing (1), wherein the product stopper (9), which abuts the
connecting means (6), is shifted relative to the wall of the
ampoule (2). This shift path of the product stopper (9) reduces the
volume within the ampoule (2) for the fluid product, and the
ampoule is vented and/or a small amount of the fluid product is
discharged from the ampoule (2) through the opening (8). A small
shift path of a few millimetres is sufficient for the venting
process. The ampoule (2) is inserted into the casing (1) until it
also abuts a shift stopper (14) within the casing, wherein the
circumference of the proximal end of the ampoule (2) abuts a seal
(11). In order to secure the ampoule (2) within the casing (1), a
latching or locking mechanism can advantageously be provided.
[0030] The administering device is then in an administering state
in which a fluid connection (5) is provided by piercing the sealing
membrane (13) in the open state.
[0031] FIG. 3 shows the administering device in the administering
state, after a certain product amount has been administered. The
pressure chamber (12), which is formed by the wall of the ampoule
(2), the product stopper (9), the connecting means (6) and the seal
(11), can be seen in FIG. 3. Since the spring (4) is mounted,
already biased, within the casing, opening the fluid connection (5)
causes the drive fluid to flow from the fluid reservoir (3),
through the fluid connection (5) through the hollow needle (10),
into the pressure chamber (12). The flow amount through the fluid
connection (5) depends on the diameter and length of the fluid
connection (5). The pressure exerted on the product stopper (9) is
therefore independent of variants in the pressure of the drive
element, i.e. the spring (4). The discharge rate of the
administering device can be defined by selecting the diameter and
length of the fluid connection (5) and then remains constant
throughout the administration of the fluid product (7) from the
ampoule (2).
[0032] As soon as the product stopper (9) has reached the front,
distal end of the ampoule (2), the ampoule is completely empty and
the administering device can be disposed of.
[0033] FIG. 4 shows another embodiment of the present invention, in
which the ampoule (2), the fluid reservoir (3) and the drive spring
(4) are arranged along the same axis within the casing (1). In this
embodiment, the administering device exhibits a slim, elongated
shape. Its mode of operation corresponds to the functioning of the
embodiment from FIGS. 1 to 3.
[0034] In this second example embodiment, the connecting means (6),
i.e. its hollow needle (10), alone forms the entire fluid
connection (5) between the fluid reservoir (3) and the pressure
chamber on the proximal side of the product stopper (9).
[0035] Embodiments of the present invention, including preferred
embodiments, have been presented for the purpose of illustration
and description. They are not intended to be exhaustive or to limit
the invention to the precise forms and steps disclosed. The
embodiments were chosen and described to provide the best
illustration of the principles of the invention and the practical
application thereof, and to enable one of ordinary skill in the art
to utilize the invention in various embodiments and with various
modifications as are suited to the particular use contemplated. All
such modifications and variations are within the scope of the
invention as determined by the appended claims when interpreted in
accordance with the breadth they are fairly, legally, and equitably
entitled.
* * * * *