U.S. patent application number 12/930136 was filed with the patent office on 2011-11-17 for fluid dispensing apparatus.
Invention is credited to Joshua W. Kriesel, Marshall S. Kriesel.
Application Number | 20110282284 12/930136 |
Document ID | / |
Family ID | 39759856 |
Filed Date | 2011-11-17 |
United States Patent
Application |
20110282284 |
Kind Code |
A1 |
Kriesel; Marshall S. ; et
al. |
November 17, 2011 |
Fluid dispensing apparatus
Abstract
A compact fluid dispenser for use in controllably dispensing
fluid medicaments, such as antibiotics, blood clotting agents,
analgesics, and like medicinal agents from collapsible containers
at a uniform rate. The dispenser includes a novel stored energy
source that is provided in the form of a compressible-expandable
member that functions to continuously and uniformly expel fluid
from the apparatus reservoir. The apparatus further includes a
novel fluid flow control assembly that precisely controls the flow
of the medicament solutions from the apparatus reservoir to the
patient.
Inventors: |
Kriesel; Marshall S.; (St.
Paul, MN) ; Kriesel; Joshua W.; (San Francisco,
CA) |
Family ID: |
39759856 |
Appl. No.: |
12/930136 |
Filed: |
December 29, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11725220 |
Mar 14, 2007 |
7993304 |
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12930136 |
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60783019 |
Mar 15, 2006 |
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Current U.S.
Class: |
604/134 ;
604/131 |
Current CPC
Class: |
A61M 5/1454 20130101;
A61M 5/148 20130101 |
Class at
Publication: |
604/134 ;
604/131 |
International
Class: |
A61M 37/00 20060101
A61M037/00 |
Claims
1. A dispensing device for dispensing medicaments to a patient
comprising: (a) a supporting structure; (b) a pre-filled
collapsible container having a continuous wall formed of a single
material carried by said supporting structure, said collapsible
container comprising an hermetically sealed reservoir having an
outlet port and including sealing means for sealing said outlet
port, said sealing means comprising a pierceable member; (c) stored
energy means carried by said supporting structure and operably
associated with said collapsible reservoir for collapsing said
collapsible reservoir to expel fluid therefrom; (d) an
administration set, including an administration line interconnected
with said outlet of said collapsible reservoir; and (e) fluid
control means carried by said supporting structure for controlling
fluid flow from said collapsible reservoir toward said
administration set.
2. A dispensing device for dispensing medicaments to a patient
comprising: (a) a supporting structure; (b) a pre-filled
collapsible container having a continuous wall formed of a single
material carried by said supporting structure, said collapsible
container comprising an hermetically sealed reservoir having an
outlet port and including sealing means for sealing said outlet
port; (c) stored energy means carried by said supporting structure
and operably associated with said collapsible reservoir for
collapsing said collapsible reservoir to expel fluid therefrom,
said stored energy means comprising an expandable sponge operably
interconnected with said collapsible reservoir; (d) an
administration set, including an administration line interconnected
with said outlet of said collapsible reservoir; and (e) fluid flow
control means carried by said supporting structure for controlling
fluid flow from said collapsible reservoir toward said
administration set.
3. A dispensing device for dispensing medicaments to a patient
comprising: (a) a supporting structure comprising a base assembly
and a generally cylindrically shaped outer housing interconnected
with said base assembly; (b) a carriage assembly interconnected
with said supporting structure for movement between a first
position and a second position, said carriage assembly comprising a
carriage having a carriage base provided with a plurality of
circumferentially spaced openings; (c) locking means carried by
said supporting structure for locking said carriage assembly in
said first position; (d) an aseptically filled collapsible
container carried by said carriage assembly, said collapsible
container being formed by a blow-fill-seal process and having a
continuous wall including a collapsible side wall, a pierceable top
wall connected to said collapsible side wall; (e) a stored energy
means operably associated with said carriage assembly for moving
said carriage assembly between said first and second positions,
said stored energy means comprising a coil spring having a first
end in engagement with said supporting structure and a second end
in engagement with said carriage; (f) an administration set,
including an administration line interconnected with said outlet
port of said collapsible reservoir; and (g) fluid flow control
means carried by said base assembly of said supporting structure
for controlling fluid flow from said collapsible reservoir toward
said administration set, said flow control means comprising: (i)
rate control means carried by said supporting structure for
controlling the rate of fluid flow from said collapsible reservoir
toward said administration set, said rate control means comprising
a rate control plate having a plurality of fluid flow channels
interconnected with said outlet of said collapsible reservoir; and
(ii) operating means carried by said supporting structure for
controlling fluid flow between said collapsible reservoir and said
rate control means.
4. A dispensing device as defined in claim 3 further including
guide means connected to said supporting structure for guiding
travel of said carriage assembly between said first position and
said second position, said guide means comprising a plurality of
circumferentially spaced guide members connected to said base
assembly and a guide rib connected to said housing of said
supporting structure, said spaced-apart guide members being
slidably received within said openings provided in said carriage
base.
5. The dispensing device as defined in claim 3 in which said
operating means comprises a penetrating member movable between
first position and a second position permitting fluid flow from
said collapsible reservoir toward said administration set.
6. The dispensing device as defined in claim 3 in which said
collapsible container comprises a bellows structure.
7. The dispensing device as defined in claim 3 in which said rate
control means further includes selector means for selecting the
rate of fluid flow between said collapsible reservoir and said
administration set, said selector means comprising a selector
housing carried by said supporting structure and a selector member
rotatably carried by said selector housing.
8. The dispensing device as defined in claim 3 further including a
pierceable septum connected to said collapsible container.
9. The dispensing device as defined in claim 8 in which said
pierceable septum comprises a slit septum.
10. A dispensing device for dispensing medicaments to a patient
comprising: (a) a supporting structure; (b) a hermetically sealed,
unitary collapsible container carried by said supporting structure,
said unitary collapsible container comprising a bellows structure
and being formed using aseptic blow-fill-seal manufacturing
techniques and having a pre-filled, sealed fluid reservoir filled
with the fluid to be delivered to the patient; (c) access means
connected to said collapsible container for accessing said
reservoir; (d) a stored energy means operably associated with said
supporting structure for collapsing said collapsible container; and
(e) an administration set, including an administration line
interconnected with said outlet port of said collapsible
reservoir.
11. A dispensing device for dispensing medicaments to a patient
comprising: (a) a supporting structure; (b) a hermetically sealed,
unitary collapsible container carried by said supporting structure,
said unitary collapsible container having a telescoping side wall
and being formed using aseptic blow-fill-seal manufacturing
techniques and having a pre-filled, sealed fluid reservoir filled
with the fluid to be delivered to the patient; (c) access means
connected to said collapsible container for accessing said
reservoir; (d) a stored energy means operably associated with said
supporting structure for collapsing said collapsible container; and
(e) an administration set, including an administration line
interconnected with said outlet port of said collapsible
reservoir.
12. A dispensing device for dispensing medicaments to a patient
comprising: (a) a supporting structure; (b) a hermetically sealed,
unitary collapsible container carried by said supporting structure,
said unitary collapsible container being formed using aseptic
blow-fill-seal manufacturing techniques and having a pre-filled,
sealed fluid reservoir filled with the fluid to be delivered to the
patient; (c) access means connected to said collapsible container
for accessing said reservoir; (d) a stored energy means operably
associated with said supporting structure for collapsing said
collapsible container, said stored energy means comprising a
compressible-expandable member operably interconnected with said
carriage assembly; and (e) an administration set, including an
administration line interconnected with said outlet port of said
collapsible reservoir.
13. A dispensing device for dispensing medicaments to a patient
comprising: (a) a supporting structure; (b) a hermetically sealed,
unitary collapsible container carried by said supporting structure,
said unitary collapsible container being formed using aseptic
blow-fill-seal manufacturing techniques and having a pre-filled,
sealed fluid reservoir filled with the fluid to be delivered to the
patient; (c) access means connected to said collapsible container
for accessing said reservoir, said access means comprising a neck
portion connected to said collapsible container, a pierceable
septum carried by said neck portion and a sealing wall integrally
formed with said unitary collapsible container; (d) a stored energy
means operably associated with said supporting structure for
collapsing said collapsible container; and (e) an administration
set, including an administration line interconnected with said
outlet port of said collapsible reservoir.
14. A dispensing device for dispensing medicaments to a patient
comprising: (a) a supporting structure; (b) a hermetically sealed,
unitary collapsible container carried by said supporting structure,
said unitary collapsible container being formed using aseptic
blow-fill-seal manufacturing techniques and having a pre-filled,
sealed fluid reservoir filled with the fluid to be delivered to the
patient; (c) access means connected to said collapsible container
for accessing said reservoir; (d) a stored energy means operably
associated with said supporting structure for collapsing said
collapsible container; (e) an administration set, including an
administration line interconnected with said outlet port of said
collapsible reservoir; and (f) fluid flow control means carried by
said supporting structure for controlling fluid flow from said
collapsible reservoir toward said administration set.
15. A fluid dispensing device comprising: (a) a supporting
structure; (b) a pre-filled sealed, collapsible container carried
by said supporting structure, said collapsible container including
a fluid reservoir and being integrally formed as a single unit at
time of manufacture; (c) stored energy means carried by said
supporting structure and operably associated with said collapsible
container for collapsing said collapsible container to controllably
expel fluid from said fluid reservoir; (d) an administration set,
including an administration line interconnected with said fluid
reservoir; and (e) fluid flow control means carried by said
supporting structure for controlling fluid flow from said fluid
reservoir toward said administration set, said flow control means
comprising: (i) rate control means for controlling the rate of
fluid flow from said fluid reservoir toward said administration
set, said rate control means comprising a rate control plate having
a plurality of micro-channels of varying length, width, depth and
geometry interconnected with said fluid reservoir; and (ii)
operating means for controlling fluid flow between said collapsible
reservoir and said rate control means.
16. The dispensing device as defined in claim 15 in which said rate
control means further includes selector means for selecting the
rate of fluid flow between said fluid reservoir and said
administration set, said selector means comprising a selector
housing carried by said supporting structure and a selector member
rotatably carried by said selector housing.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS: This is a
[0001] Divisional Application of co-pending U.S. Ser. No.
11/725,220 filed Mar. 14, 2007 which is a Non-Provisional
Application claiming the benefit of co-pending Provisional
Application No. 60/783,019 filed Mar. 15, 2005.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
[0002] Not Applicable
INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT
DISC
[0003] Not Applicable
BACKGROUND OF THE INVENTION
[0004] 1. Field of the Invention
[0005] The present invention relates generally to fluid dispensing
apparatus. More particularly, the invention concerns medicament
dispensers for dispensing medicinal fluids to ambulatory
patients.
[0006] 2. Description of Related Art Including Information
Disclosed Under 37 CFR 1.97 and 1.98
[0007] A number of different types of medicament dispensers for
dispensing medicaments to ambulatory patients have been suggested
in the past. Many of the devices or apparatus seek either to
improve or to replace the traditional gravity flow and hypodermic
syringe methods which have been the standard for delivery of liquid
medicaments for many years.
[0008] The prior art gravity flow methods typically involve the use
of intravenous administration sets and the familiar flexible
solution bag suspended above the patient. Such gravametric methods
are cumbersome, imprecise and require bed confinement of the
patient. Periodic monitoring of the apparatus by the nurse or
doctor is required to detect malfunctions of the infusion
apparatus. Accordingly, the prior art devices or apparatus are not
well suited for use in those instances where the patient must be
transported to a remote facility for treatment.
[0009] With regard to the prior art, one of the most versatile and
unique fluid delivery apparatus developed in recent years is that
developed by one of the present inventors and described in U.S.
Pat. No. 5,205,820. The components of this novel fluid delivery
apparatus generally include: a base assembly, an elastomeric
membrane serving as a stored energy means, fluid flow channels for
filling and delivery, flow control means, a cover, and an ullage
which comprises a part of the base assembly.
[0010] Another prior art patent issued to one of the present
applicants, namely U.S. Pat. No. 5,743,879, discloses an injectable
medicament dispenser for use in controllably dispensing fluid
medicaments such as insulin, anti-infectives, analgesics,
oncolylotics, cardiac drugs biopharmaceuticals, and the like from a
pre-filled container at a uniform rate. The dispenser, which is
quite dissimilar in construction and operation from that of the
present invention, includes a stored energy source in the form of a
compressively deformable, polymeric, elastomeric member that
provides the force necessary to controllably discharge the
medicament from a pre-filled container, which is housed within the
body of the apparatus. After having been deformed, the polymeric,
elastomeric member will return to its starting configuration in a
highly predictable manner.
BRIEF SUMMARY OF THE INVENTION
[0011] By way of brief summary, one form of the dispensing
apparatus of the present invention for dispensing medicaments to a
patient comprises a supporting structure; a carriage assembly
interconnected with the supporting structure for movement between a
first position and a second position; a pre-filled collapsible
container carried by the carriage assembly, the collapsible
container having accessing means for accessing the reservoir
comprising a frangible member in the form of a pierceable member or
shearable member. The apparatus also includes guide means connected
to the supporting structure for guiding travel of the carriage
assembly between the first position and said second positions; a
stored energy source operably associated with the carriage assembly
for moving the carriage assembly between the first and second
positions; and an administration set, including an administration
line interconnected with the outlet port of the collapsible
reservoir.
[0012] With the forgoing in mind, it is an object of the present
invention to provide a compact fluid dispenser for use in
controllably dispensing fluid medicaments to ambulatory patients,
such as, antibiotics, blood clotting agents, analgesics, KVO,
artificial blood substitutes, resuscitation fluids, internal
nutritional solutions, biologics, and like beneficial agents from
pre-filled or field-filled containers at a uniform rate.
[0013] Another object of the invention is to provide a small,
compact pre-filled fluid dispenser that is aseptically filled and
sealed at the time of manufacture.
[0014] Another object of the invention is to provide an apparatus
that is of simple construction that can be used in the field with a
minimum amount of training.
[0015] Another object of the invention is to provide a dispenser in
which a stored energy source is provided in the form of a
compressible, expandable or retractable member of novel
construction that provides the force necessary to continuously and
uniformly expel fluid from the apparatus reservoir.
[0016] Another object of the invention is to provide a dispenser of
the class described which includes a fluid flow control assembly
that precisely controls the flow of the medicament solution to the
patient. Uniquely, the container is formed as a unitary structure
that includes a collapsible side wall and a pierceable closure wall
that isolates the beneficial agents contained within the container
reservoir from external contaminants.
[0017] Another object of the invention is to provide a dispenser
that includes precise variable flow rate selection.
[0018] Another object of the invention is to provide a fluid
dispenser of simple construction, which embodies an integrally
formed, collapsible, pre-filled drug container that contains the
beneficial agents to be delivered to the patient.
[0019] Another object of the invention is to provide a fluid
dispenser of the class described which is compact, lightweight, is
easy for ambulatory patients to use, is fully disposable,
transportable and is extremely reliable in operation.
[0020] Another object of the invention is to provide a fluid
dispenser as described in the preceding paragraphs that is easy and
inexpensive to manufacture in large quantities.
BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS
[0021] FIG. 1 is a generally perspective, top view of one form of
the fluid dispensing apparatus of the present invention for
dispensing medicaments to a patient.
[0022] FIG. 2 is a generally perspective, exploded view of the
fluid dispensing apparatus shown in FIG. 1 as it appears with a top
cover of the apparatus removed.
[0023] FIG. 3 is an enlarged, longitudinal, cross-sectional view of
the fluid dispensing apparatus illustrated in FIG. 1.
[0024] FIG. 4A is an enlarged, fragmentary, longitudinal,
cross-sectional view of the left-hand portion of the apparatus
shown in FIG. 3.
[0025] FIG. 4B is a fragmentary, longitudinal, cross-sectional view
similar to FIG. 4A, but showing the various components of the
apparatus as they appear following delivery to the patient of the
fluid contained within the apparatus reservoir.
[0026] FIG. 5 is a top plan view of the fluid reservoir assembly of
the invention.
[0027] FIG. 6 is a cross-sectional view taken along lines 6-6 of
FIG. 5.
[0028] FIG. 7 is an enlarged, cross-sectional view of the area
designated in FIG. 6 by the numeral "7".
[0029] FIG. 8 is a cross-sectional view taken along lines 8-8 of
FIG. 3.
[0030] FIG. 9 is a cross-sectional view taken along lines 9-9 of
FIG. 8.
[0031] FIG. 10 is a view taken along lines 10-10 of FIG. 9.
[0032] FIG. 11 is a generally perspective, exploded view of the
fluid delivery apparatus illustrated in FIG. 1.
[0033] FIG. 12 is a generally perspective, exploded view of the
multiple flow rate control assembly of the apparatus of the
invention and a portion of the administration set.
[0034] FIG. 13 is a cross-sectional view of the rate control
assembly depicted in FIG. 12 as it appears in an assembled
configuration.
[0035] FIG. 14 is an exploded, cross-sectional view of the rate
control assembly illustrated in FIG. 13.
[0036] FIG. 15 is a view taken along lines 15-15 of FIG. 14.
[0037] FIG. 16 is a top plan view of the selector knob of the
present invention for rotating the selector member in a manner to
select the rate of fluid flow to the patient.
[0038] FIG. 17 is a cross-sectional view taken along lines 17-17 of
FIG. 16.
[0039] FIG. 18 is a bottom plan view of the selector knob shown in
FIG. 17.
[0040] FIG. 19 is a top plan view of the selector member of the
apparatus which is rotated by the selector knob.
[0041] FIG. 20 is a cross-sectional view taken along lines 20-20 of
FIG. 19.
[0042] FIG. 21 is a bottom plan view of the selector member shown
in FIG. 20.
[0043] FIG. 22 is front view of the selector element of the rate
control means of the invention.
[0044] FIG. 23 is a bottom plan view of the selector element.
[0045] FIG. 24 is a top plan view of the nipple portion of one of
the rate control covers of the rate control assembly.
[0046] FIG. 25 is a cross-sectional view taken along lines 25-25 of
FIG. 24.
[0047] FIG. 26 is a top plan view of the other of the rate control
covers.
[0048] FIG. 27 is a cross-sectional view taken along lines 27-27 of
FIG. 26.
[0049] FIG. 28 is a view taken along lines 28-28 of FIG. 27.
[0050] FIG. 29 is a side elevation view of the selector member
housing of the apparatus.
[0051] FIG. 30 is a cross-sectional view taken along lines 30-30 of
FIG.
[0052] FIG. 31 is a view taken along lines 31-31 of FIG. 29.
[0053] FIG. 32 is a bottom plan view of the rate control plate of
the rate control assembly.
[0054] FIG. 33 is a top plan view of the cover member 89 of the
rate control assembly.
[0055] FIG. 34 is a cross-sectional view taken along lines 34-34 of
FIG. 33.
[0056] FIG. 35 is a top plan view of a portion of the supporting
structure of the apparatus of the invention.
[0057] FIG. 36 is a cross-sectional view taken along lines 36-36 of
FIG. 35.
[0058] FIG. 37 is a view taken along lines 37-37 of FIG. 36.
[0059] FIG. 38 is a side-elevational view of one form of the
control shaft of the flow control means of the invention.
[0060] FIG. 39 is a view taken along lines 39-39 of FIG. 38.
[0061] FIG. 40 is a view taken along lines 40-40 of FIG. 38.
[0062] FIG. 41 is an enlarged, cross-sectional view taken along
lines 41-41 of FIG. 38.
[0063] FIG. 42 is an enlarged, side-elevational view of one form of
the spring knife of the invention that is carried within cavities
formed in the control shaft as shown in FIG. 41.
[0064] FIG. 43 is a view taken along lines 43-43 of FIG. 42.
[0065] FIG. 44 is an enlarged, cross-sectional view of a portion of
the support structure and of the control shaft of the apparatus
illustrating the appearance of the components in their starting
position.
[0066] FIG. 45 is a cross-sectional view similar to FIG. 44 but
showing the appearance of the components after the initial rotation
of the control shaft from a first position to a second
position.
[0067] FIG. 46 is a cross-sectional view similar to FIG. 45 but
showing the appearance of the components after further rotation of
the control shaft from the second position to a third, final
position.
[0068] FIG. 47 is a generally perspective, diagrammatic view
showing the operating handle of the apparatus in its starting
position.
[0069] FIG. 48 is a generally perspective, diagrammatic view
illustrating the gripping of the apparatus handle by the
operator.
[0070] FIG. 49 is a generally perspective, diagrammatic view
illustrating the movement of the operating handle by the operator
to open the fluid flow path between the reservoir and the rate
control means of the invention.
[0071] FIG. 50 is a generally perspective, diagrammatic view
illustrating the operation of the locking means of the apparatus in
a manner to lock the carriage to the base component of the
apparatus structural support.
[0072] FIG. 51 is a generally perspective, diagrammatic view
illustrating the operation of the locking means of the apparatus to
release the carriage so as to arm the system to permit delivery of
fluid to the patient via the administration set of the
apparatus.
[0073] FIG. 52 is a longitudinal, cross-sectional view of an
alternate form of the fluid dispensing apparatus of the invention
showing the reservoir in a pre-filled condition.
[0074] FIG. 53A is a fragmentary, longitudinal, cross-sectional
view of the left-hand portion of the apparatus shown in FIG.
52.
[0075] FIG. 53B is a fragmentary, longitudinal, cross-sectional
view similar to FIG. 53A, but showing the various components of the
apparatus as they appear with administration line installed and
following delivery to the patient of the fluid contained within the
apparatus reservoir.
[0076] FIG. 54 is a cross-sectional view of the fluid reservoir
assembly of this latest form of the invention.
[0077] FIG. 55 is a cross-sectional view showing the fluid
reservoir assembly as it appears in a substantially empty condition
following delivery to the patient of the fluid contained within the
reservoir.
[0078] FIG. 56 is a generally perspective, exploded view of a
portion of the administration set and of the single or fixed rate
control assembly of this latest embodiment of the invention.
[0079] FIG. 57 is an exploded, cross-sectional view of the upper
portion of the apparatus illustrated in FIG. 52.
[0080] FIG. 58 is a cross-sectional view taken along lines 58-58 of
FIG. 57.
[0081] FIG. 59 is a cross-sectional view taken along lines 59-59 of
FIG. 57.
[0082] FIG. 60 is a cross-sectional view taken along lines 60-60 of
FIG. 57.
[0083] FIG. 61 is a cross-sectional view taken along lines 61-61 of
FIG. 57.
[0084] FIG. 62 is a top plan view of the rate control plate of the
rate control apparatus of this latest form of the invention.
[0085] FIG. 63 is a cross-sectional view taken along lines 63-63 of
FIG. 62.
[0086] FIG. 64 is a view taken along lines 64-64 of FIG. 63.
[0087] FIG. 65 is a longitudinal, cross-sectional view of yet
another form of the dispensing apparatus of the invention showing
the reservoir in a pre-filled condition.
[0088] FIG. 66 is a longitudinal, cross-sectional view similar to
FIG. 65, but with the reservoir in a substantially empty condition
showing the configuration of the apparatus after the fluid
dispensing step.
[0089] FIG. 67 is a generally perspective, exploded view of the
apparatus shown in FIG. 65.
[0090] FIG. 67A is a longitudinal, cross-sectional view of yet
another form of the fluid dispensing apparatus of the
invention.
[0091] FIG. 67B is a view, similar to FIG. 67A, but showing the
configuration of the apparatus after the fluid dispensing step.
[0092] FIG. 68 is a longitudinal, cross-sectional view of still
another form of the fluid dispensing apparatus of the invention
showing the reservoir in a pre-filled condition.
[0093] FIG. 68A is a generally perspective view of the fluid
dispensing apparatus of the invention shown in FIG. 68 as it
appears following removal of the closure cap.
[0094] FIG. 68B is a fragmentary, generally perspective, exploded
view of the upper portion of the fluid dispensing apparatus of the
invention shown in FIG. 68 as it appears following removal of the
tear strip.
[0095] FIG. 69 is a longitudinal, cross-sectional view similar to
FIG. 68 but showing the various components of the apparatus as they
appear following delivery to the patient of the fluid contained
within the apparatus reservoir.
[0096] FIG. 69A is an enlarged, cross-sectional view of the
selector member housing of the fluid dispensing apparatus.
[0097] FIG. 69B is a cross-sectional view taken along lines 69B-69B
of FIG. 69A.
[0098] FIG. 69C is an enlarged, cross-sectional view of the
selector member of the fluid dispensing apparatus.
[0099] FIG. 69D is a view taken along lines 69D-69D of FIG. 68.
[0100] FIG. 69E is an enlarged, generally perspective, exploded
view of the rate control portion of the fluid dispensing apparatus
shown in FIGS. 68 and 69.
[0101] FIG. 70 is a foreshortened, longitudinal, cross-sectional
view of still another form of the fluid dispensing apparatus of the
invention showing the reservoir in a filled condition.
[0102] FIG. 71 is a foreshortened, longitudinal, cross-sectional
view similar to FIG. 70, but showing the various components of the
apparatus as they appear following delivery to the patient of the
fluid contained within the apparatus reservoir which is shown in a
substantially empty condition.
[0103] FIG. 72 is a foreshortened, longitudinal, cross-sectional
view of yet another alternate form of the fluid dispensing
apparatus of the invention showing the reservoir in a filled
condition.
[0104] FIG. 73 is a foreshortened, longitudinal, cross-sectional
view similar to FIG. 72, but showing the various components of the
apparatus as they appear following delivery to the patient of the
fluid contained within the apparatus reservoir which is
substantially empty.
[0105] FIG. 74 is a top plan view of the collapsible container of
this alternate embodiment of the invention.
[0106] FIG. 75 is a cross-sectional view taken along lines 75-75 of
FIG. 74.
[0107] FIG. 76 is an exploded, cross-sectional view of the
reservoir access assembly of this latest form of the invention.
[0108] FIG. 77 is a fragmentary, cross-sectional view of the
collapsible container as it appears in the collapsed substantially
empty condition.
[0109] FIG. 78 is a foreshortened, longitudinal, cross-sectional
view of an alternate form of the fluid dispensing apparatus of the
invention showing the reservoir in a pre-filled condition.
[0110] FIG. 79 is a foreshortened longitudinal, cross-sectional
view, similar to FIG. 78, but showing the various components of the
apparatus as they appear following delivery to the patient of the
fluid contained within the apparatus reservoir with the reservoir
substantially empty.
[0111] FIG. 80 is a top plan view of the collapsible container of
this alternate embodiment of the invention.
[0112] FIG. 81 is a cross-sectional view taken along lines 81-81 of
FIG. 80.
[0113] FIG. 82 is an exploded, cross-sectional view of the
reservoir access assembly of this latest form of the invention.
[0114] FIG. 82A is a foreshortened, longitudinal, cross-sectional
view of yet another alternate form of the fluid dispensing
apparatus of the invention showing the reservoir in a pre-filled
condition.
[0115] FIG. 82B is a foreshortened, longitudinal, cross-sectional
view, similar to FIG. 83A, but showing the various components of
the apparatus as they appear following delivery to the patient of
the fluid contained within the apparatus reservoir which is
substantially empty.
[0116] FIG. 82C is a fragmentary, exploded view of the accessing
neck assembly of the apparatus shown in FIG. 82A.
[0117] FIG. 82D is a fragmentary view similar to FIG. 82C but
showing the neck assembly in an assembled configuration.
[0118] FIG. 82E is a foreshortened, longitudinal, cross-sectional
view of still another alternate form of the fluid dispensing
apparatus of the invention showing the reservoir in a pre-filled
condition.
[0119] FIG. 82F is a foreshortened, longitudinal, cross-sectional
view, similar to FIG. 82E, but showing the various components of
the apparatus as they appear following delivery to the patient of
the fluid contained within the apparatus reservoir which is
substantially empty.
[0120] FIG. 83 is a cross-sectional view of still another form of
the dispensing apparatus of the invention.
[0121] FIG. 84 is a cross-sectional view similar to FIG. 83 but
showing the various components of the apparatus as they appear
following delivery to the patient of the fluid contained with the
fluid reservoir.
[0122] FIG. 85 is a top plan view of the collapsible container of
this alternate embodiment of the invention.
[0123] FIG. 86 is a cross-sectional view taken along lines 86-86 of
FIG. 85.
[0124] FIG. 87 is a cross-sectional view of the reservoir access
assembly of this latest form of the invention.
[0125] FIG. 88 is a fragmentary, cross-sectional view of the
collapsible container as it appears in the collapsed
configuration.
[0126] FIG. 89 is a foreshortened, longitudinal, cross-sectional
view of still another alternate form of the fluid dispensing
apparatus of the invention showing the reservoir in a pre-filled
condition.
[0127] FIG. 90 is a foreshortened, longitudinal, cross-sectional
view, similar to FIG. 89, but showing the various components of the
apparatus as they appear following delivery to the patient of the
fluid contained within the apparatus reservoir which is
substantially empty.
[0128] FIG. 91 is a top plan view of the collapsible container of
this alternate embodiment of the invention.
[0129] FIG. 92 is a cross-sectional view taken along lines 92-92 of
FIG. 91.
[0130] FIG. 93 is a cross-sectional view of the luer-like reservoir
access assembly of this latest form of the invention.
[0131] FIG. 94 is a fragmentary, cross-sectional view of the
collapsible container as it appears in the collapsed
configuration.
[0132] FIG. 95 is a foreshortened, longitudinal, cross-sectional
view of yet another alternate form of the fluid dispensing
apparatus of the invention showing the reservoir in a pre-filled
condition.
[0133] FIG. 96 is a foreshortened, longitudinal, cross-sectional
view, similar to FIG. 95, but showing the various components of the
apparatus as they appear following delivery to the patient of the
fluid contained within the apparatus reservoir with the reservoir
substantially empty.
[0134] FIG. 97 is a top plan view of the collapsible container of
this alternate embodiment of the invention.
[0135] FIG. 98 is a cross-sectional view taken along lines 98-98 of
FIG. 97.
[0136] FIG. 99 is a cross-sectional view of the luer-like reservoir
access assembly of this latest form of the invention.
[0137] FIG. 100 is a foreshortened, longitudinal, cross-sectional
view of yet another alternate form of the fluid dispensing
apparatus of the invention showing the reservoir in a pre-filled
condition.
[0138] FIG. 101 is a foreshortened, longitudinal, cross-sectional
view similar to FIG. 100 but showing the various components of the
apparatus as they appear following delivery to the patient of the
fluid contained within the apparatus reservoir which is shown
substantially empty.
[0139] FIG. 102 is a top plan view of the collapsible container of
this alternate embodiment of the invention.
[0140] FIG. 103 is a cross-sectional view taken along lines 103-103
of FIG. 102.
[0141] FIG. 104 is a cross-sectional view of the luer-like
reservoir access assembly of this latest form of the invention.
[0142] FIG. 105 is a fragmentary, cross-sectional view of the
collapsible container as it appears in the collapsed
configuration.
[0143] FIG. 106 is a foreshortened, longitudinal, cross-sectional
view of still another alternate form of the fluid dispensing
apparatus of the invention showing the reservoir in a pre-filled
condition.
[0144] FIG. 107 is a foreshortened, longitudinal, cross-sectional
view similar to FIG. 106 but showing the various components of the
apparatus as they appear following delivery to the patient of the
fluid contained within the apparatus reservoir which is shown
substantially empty.
[0145] FIG. 108 is a top plan view of the collapsible container of
this alternate embodiment of the invention.
[0146] FIG. 109 is a cross-sectional view taken along lines 109-109
of FIG. 108.
[0147] FIG. 110 is a cross-sectional view of the luer-like
reservoir access assembly of this latest form of the invention.
[0148] FIG. 111 is a foreshortened, longitudinal, cross-sectional
view of still another alternate form of the pre-filled reservoir
type fluid dispensing apparatus of the invention that includes a
sponge-like stored energy source.
[0149] FIG. 112 is a foreshortened, longitudinal, cross-sectional
view, similar to FIG. 111, but showing the various components of
the apparatus as they appear following delivery to the patient of
the fluid contained within the apparatus reservoir showing the
reservoir substantially empty.
[0150] FIG. 113 is a top plan view of the collapsible container of
this alternate embodiment of the invention.
[0151] FIG. 114 is a cross-sectional view taken along lines 114-114
of FIG. 113.
[0152] FIG. 115 is a cross-sectional, exploded view of the
luer-like reservoir access assembly of this latest form of the
invention.
[0153] FIG. 116 is a fragmentary, cross-sectional view of the
collapsible container as it appears in the collapsed
configuration.
[0154] FIG. 117 is a foreshortened, longitudinal, cross-sectional
view of still another alternate form of the pre-filled reservoir
type fluid dispensing apparatus of the invention that includes a
sponge-like stored energy source.
[0155] FIG. 118 is a foreshortened, longitudinal, cross-sectional
view, similar to FIG. 117, but showing the various components of
the apparatus as they appear following delivery to the patient of
the fluid contained within the apparatus reservoir which is shown
in a substantially empty condition.
[0156] FIG. 119 is a top plan view of the collapsible container of
this alternate embodiment of the invention.
[0157] FIG. 120 is a partial cross-sectional view taken along lines
120-120 of FIG. 119.
[0158] FIG. 121 is a cross-sectional, exploded view of the
luer-like reservoir access assembly of this latest form of the
invention.
[0159] FIG. 122 is a foreshortened, longitudinal, cross-sectional
view of yet another alternate form of the pre-filled reservoir type
fluid dispensing apparatus of the invention that includes a
sponge-like stored energy source.
[0160] FIG. 123 is a foreshortened, longitudinal, cross-sectional
view, similar to FIG. 122, but showing the various components of
the apparatus as they appear following delivery to the patient of
the fluid contained within the apparatus reservoir which appears in
a substantially empty condition.
[0161] FIG. 124 is a top plan view of the collapsible container of
this alternate embodiment of the invention.
[0162] FIG. 125 is a cross-sectional view taken along lines 125-125
of FIG. 124.
[0163] FIG. 126 is a fragmentary, cross-sectional view of the
collapsible container as it appears in the collapsed
configuration.
[0164] FIG. 127 is a foreshortened, longitudinal, cross-sectional
view of still another alternate form of the pre-filled reservoir
type fluid dispensing apparatus of the invention that includes a
sponge-like stored energy source.
[0165] FIG. 128 is a foreshortened, longitudinal, cross-sectional
view, similar to FIG. 127, but showing the various components of
the apparatus as they appear following delivery to the patient of
the fluid contained within the apparatus reservoir which appears in
a substantially empty condition.
[0166] FIG. 129 is a top plan view of the collapsible container of
this alternate embodiment of the invention.
[0167] FIG. 130 is a partial cross-sectional view taken along lines
130-130 of FIG. 129.
DETAILED DESCRIPTION OF THE INVENTION
Definitions
[0168] As used herein, the following terms have the following
meanings:
Unitary Container
[0169] A closed container formed from a single component.
Continuous/Uninterrupted Wall
[0170] A wall having no break in uniformity or continuity.
Patient
[0171] Individual seeking medical care.
Hermetically Sealed Container
[0172] A container that is designed and intended to be secure
against the entry of microorganisms and to maintain the safety and
quality of its contents after pressurizing.
Biologic
[0173] A virus, therapeutic serum, toxin, antitoxin, vaccine,
blood, blood component or derivative, allergenic product, or
analogous product applicable to the prevention, treatment or cure
of diseases or injuries of man.
Drug
[0174] As defined by the Food, Drug and Cosmetic Act, drugs are
"articles (other than food) intended for the use in the diagnosis,
cure, mitigation, treatment, or prevention of disease in man or
other animals, or to affect the structure or any function."
Drug Product
[0175] A finished dosage form (e.g. tablet, capsule, or solution)
that contains the active drug ingredient usually combined with
inactive ingredients.
Artificial Blood Substitutes
[0176] Blood Substitutes are used to fill fluid volume and/or carry
oxygen and other gases in the cardiovascular system. These include
volume expanders for inert products, and oxygen therapeutics for
oxygen-carrying products.
Resuscitation Fluids
[0177] Infusion of hyperosmotic-hyperoncotic solutions such as
hypertonic saline dextran (HSD) as used for resuscitation of
traumatic shock and perioperative volume support or as an adjunct
to other conventional isotonic crystalloid solutions. Where
hypotension is caused by myocardial depression, pathological
vasodilatation and extravascation of circulating volume due to
widespread capillary leak, a resuscitative effort is attempted to
correct the absolute and relative hypovolemia by refilling the
vascular tree. Here resuscitation with a small volume of
hypertonic-hyperoncotic solution allows systemic and splanchnic
hemodynamic and oxygen transport recovery, without an increase in
pulmonary artery pressure. Alternate types of normotonic,
hyperoncotic, hypertonic, and hypertonic-hyperoncotic solutions can
be used for systemic hemodynamic recovery.
KVO
[0178] KVO--keeping-the-vein-open in an IV set up, a phrase that
refers to the flow rate of a maintenance IV line established as a
prophylactic access.
Nutritionals
[0179] Dietary supplemental enteral nutrition support feeding
solutions used for nasoenteric application typically used in
nasogastric, nasoduodenal and nasojejunal or intravenous routes of
administration.
Beneficial Agent
[0180] The term beneficial agent can include any substance or
compound that is biologically active and includes any
physiologically or pharmacologically active substance that produces
a localized or systemic effect in humans or animals and that can be
delivered by the present invention to produce a beneficial and
useful result.
Diluent
[0181] A liquid that dilutes, as in an inert solution used to
dilute a medicament. An inert liquid carrier of a beneficial
agent.
Device
[0182] An instrument, apparatus, implement, machine, contrivance,
implant, in vitro reagent, or other similar or related article,
including any component, part or accessory, which is intended for
use in the diagnosis, cure, treatment or prevention of disease. A
device does not achieve its intended purpose through chemical
action in the body and is not dependent upon being metabolized to
achieve its purpose.
Apparatus
[0183] An appliance or device for a particular purpose: An
integrated group of materials or apparatus used for a particular
purpose. The totality of means by which a designated function is
performed or a specific task executed, a group of body parts that
work together to perform a given function.
Reservoir
[0184] A receptacle or chamber for storing a fluid. A part of a
machine, apparatus, where liquid is stored.
Liquid Container
[0185] A receptacle for holding a liquid. A fluid dispenser that is
carried or transported.
Collapsible
[0186] To cause to fold, break down, or fall down or inward or as
in bent-over or doubled-up so that one part lies on another.
Collapsible Container
[0187] A dispensing apparatus in which one or more walls of the
container are made of a material which will deform (collapse) when
pressure is applied thereto; or a dispensing apparatus having a
collapsible or telescoping wall structure.
Aseptic Processing
[0188] The term `aseptic processing` as it is applied in the
pharmaceutical industry refers to the assembly of sterilized
components and product in a specialized clean environment.
Sterile Product
[0189] A sterile product is one that is free from all living
organisms, whether in a vegetative or spore state.
[0190] Blow-Fill-Seal Process
[0191] The concept of aseptic blow-fill-seal (BFS) is that a
container is formed, filled, and sealed as a unitary container in a
continuous manner without human intervention in a sterile enclosed
area inside a machine. The process is multi-stepped, pharmaceutical
grade resin is extruded into a tube, which is then formed into a
container. A mandrel is inserted into the newly formed container
and filled. The container is then sealed, all inside a sterile
shrouded chamber. The product is then discharged to a non-sterile
area for packaging and distribution.
Integrally Formed
[0192] An article of one-piece construction, or several parts that
are rigidly secured together and is smoothly continuous in form and
that any such components making up the part have been then rendered
inseparable.
Septum
[0193] A word borrowed from the Latin "saeptum" meaning a dividing
wall or enclosure; thus, a thin partition or membrane that divides
two spaces.
Slit Septum
[0194] A septum that is partially slit to aid in cannula
penetration.
Penetrating
[0195] Tending to penetrate; having the power of entering or
piercing.
Cutting
[0196] Capable of or designed for incising, shearing, or severing
as to cut off from a main body.
Frangible
[0197] An article, item or object that is capable of being ruptured
or broken, but does not necessarily imply any inherent materials
weakness. A material object, under load that demonstrates a
mechanical strain rate deformation behavior, leading to
disintegration.
Luer-like Connector
[0198] A connector used to connect medical apparatus. Classically,
the Luer consists of a tapered barrel and a conical male part that
fits into it with or without a seal.
Surface Treatment
[0199] The processes of surface treatments, more formally surface
engineering, to tailor the surfaces of engineering materials to
change, alter or modify the physical surface characteristics and
improve the function of the materials properties for its intended
purpose.
Spring
[0200] A mechanical element that can be deformed by a mechanical
force such that the deformation is directly proportional to the
force or torque applied to it. An elastic machine component able to
deflect under load in a prescribed manner and to recover its
initial shape when unloaded. The combination of force and
displacement in a deflected spring is energy which may be stored
when moving loads are being arrested.
Constant Force Spring
[0201] Constant force springs are a special variety of extension
spring. They are tightly coiled wound bands of pre-hardened spring
steel or stainless steel strip with built-in curvature so that each
turn of the strip wraps tightly on its inner neighbor. When the
strip is extended (deflected) the inherent stress resists the
loading force; the same as a common extension spring, but at a
nearly constant (zero) rate. The constant-force spring is well
suited to long extensions with no load build-up. In use, the spring
is usually mounted with the ID tightly wrapped on a drum and the
free end attached to the loading force. Considerable flexibility is
possible with constant-force springs because the load capacity can
be multiplied by using two or more strips in tandem, or
back-to-back. Constant force springs are available in a wide
variety of sizes.
Apparatus of the Invention
[0202] Referring to the drawings and particularly to FIGS. 1
through 3, one form of the fluid dispensing apparatus of the
present invention for dispensing medicaments to a patient is there
shown and generally designated by the numeral 50. The dispensing
apparatus here comprises a supporting structure 52, which includes
a housing 54 having an upper portion 55 and a generally
cylindrically shaped skirt portion 56. Supporting structure 52 can
be constructed from metal, plastic or any suitable material.
Connected to portion 56 is a base segment 57, the details of
construction of which will presently be described.
[0203] Disposed within skirt portion 56 is a carriage assembly 58,
which is movable between a first position shown in FIGS. 3 and 4A
and a second position shown in FIG. 4B. As best seen by referring
to FIGS. 4A and 4B, carriage assembly 58 comprises a carriage 60
having a carriage flange 60a to which the novel stored energy means
of the present invention is operably interconnected. Carriage
assembly 58 is releasably locked in its first position by a novel
locking means the character of which will be described in the
paragraphs, which follow.
[0204] Carried by carriage assembly 58 is a reservoir defining
assembly 64 that defines a fluid reservoir 65. As illustrated in
FIGS. 3 and 6, reservoir defining assembly 64 includes a top wall
64a, an accordion-like side wall 64b that is connected to top wall
64a and a bottom wall 64c that is connected to side wall 64b. As
illustrated in FIG. 3, bottom wall 64c includes a cup-shaped
portion 64e. Reservoir 65 has a combination inlet/outlet 66 that is
formed in a reservoir nipple 68 showing a scoreline 69 that also
comprises a part of the reservoir assembly 64.
[0205] In the preferred form of the invention shown in FIG. 6,
nipple 68 is sealably interconnected with top wall 64a in
accordance with an aseptic blow-fill-seal technique of a character
well understood by those skilled in the art. This blow-fill-seal
technique comprises the continuous extrusion through an extruder
head of a length of a parison in the form of a hollow tube between
and through two co-acting first or main mold halves. The method
includes the step of cutting off the parison below the extruder
head and above the main mold halves to create an opening which
allows a blowing and filling nozzle assembly to be moved downwardly
into the opening in the parison for molding and thereafter filling
a molded container.
[0206] When the container portion of the container assembly is
filled with the desired amount of liquid, the blowing and filling
nozzle assembly is retracted from the opening in the parison. A
separate pair of co-acting second or upper sealing mold halves are
then moved together around the exposed length of parison to form
and seal the container upper portion. The finished container
assembly, completely formed, filled, and sealed as a unitary
structure is then conveyed out of the molding apparatus. Further
information concerning aseptic blow-fill and blow-fill-seal
techniques is available from Weiler Engineering of Elgin, Ill. and
from Rommelag of Waiblingen, Germany.
[0207] To controllably move the carriage assembly from its first
position to its second position and to thereby controllably expel
the fluid from the fluid reservoir 65, novel stored energy means
are provided. These novel stored energy means, which are operably
associated with carriage assembly 58, are here provided in the form
of three circumferentially spaced-apart, constant force springs 70
(FIGS. 3 and 8). It is to be understood that an alternate number of
springs can be used as may be desired. As illustrated in FIGS. 3, 8
and 9, constant force springs 70 are housed within spring retainers
72a which form a part of a spring housing 72 which includes a
cavity 73 having internal threads 73a. Housing 72, in turn, forms a
part of the supporting structure 52 of the apparatus. The details
of construction and operation of these important constant force
springs will presently be described.
[0208] As will be discussed more fully in the paragraphs which
follow during the fluid dispensing step, as the carriage assembly
58 is moved by the constant force springs 70 toward its deployed
position, the accordion-like sidewall 64b of the reservoir assembly
64 will be urged to move into the collapsed configuration shown in
FIG. 4B and in so doing will cause the fluid contained within the
container to be controllably and substantially expelled
therefrom.
[0209] To further control the flow of fluid from reservoir 65
toward the administration set 76 of the invention and then on to
the patient, novel fluid flow control means are provided. The fluid
flow control means, which is carried by the supporting structure
52, here comprises two cooperating components, namely a rate
control means for controlling the rate of fluid flow from the
collapsible reservoir toward the administration set and an
operating means for controlling fluid flow between the collapsible
reservoir and the rate control means.
[0210] Considering first the rate control means of the invention,
this important means comprises a rate control housing 82, which
includes a first cover member 84, that engages a selector element
86 which is received within a cavity 87 provided in selector member
88 and located therewithin by a flat "F" (FIG. 23). Selector member
88, which has an enlarged diameter portion 88a (See FIG. 14), forms
a part of the selector means of the invention for selecting the
desired rate of fluid flow from the fluid reservoir toward the
administration set. Cover member 84 also has a rate control plate
cavity 84b. As best seen in FIGS. 13 and 14, rate control housing
82 includes a second cover member 89 having an outwardly extending
attached nipple 92, the purpose of which will presently be
described.
[0211] Interconnected with rate control housing 82 is a selector
knob 94, that includes a central bore 96, the enlarged, threaded
diameter portion 96a of which sealably receives the connector hub
77 of the administration set 76 (FIG. 12). The enlarged diameter
portion 96b of bore 96, which includes a groove 96c, receives the
reduced diameter portion 88b of selector member 88 (FIGS. 13 and
14). A threaded cap 95 retains selector member 88 in position. As
shown in FIG. 14, selector member 88 includes an orientation spine
88s that is received in groove 96c. Selector knob 94 also includes
an outwardly extending flange 94c which carries circumferentially
spaced finger-gripping elements 100 which assist in rotating the
selector knob (FIG. 12). Flange 94c also carries an indicator arrow
101, which, upon rotation of the selector member, aligns with flow
rate indicia 104 imprinted on the rim portion 106a of a selector
member support 106 that supports selector knob 94 (FIGS. 2, 12 and
13). Selector member support 106 also includes a skirt portion 106b
that is interconnected with rate control housing 82 in the manner
shown in FIGS. 3 and 13. It is to be noted that the movable
components of the dispensing apparatus typically carry conventional
0-rings to provide appropriate sealing of the components within the
apparatus with their mating parts. Throughout the drawings these
0-rings are identified as "0".
[0212] As illustrated in FIGS. 4A and 4B, first cover member 84
cooperates with second cover 89 to sealably enclose the rate
control plate 110 of the invention (FIGS. 13 and 14) that is
disposed between covers 84 and 89 and is oriented therebetween by a
spline 84c on cover 84 and notches "N" formed on cover 89 and plate
110. Rate control plate 110 is provided with a plurality of fluid
flow channels of different lengths, widths, depths and geometry
(FIG. 32) that are in fluid communication with outlet 66 of
collapsible reservoir 65 via the operating means of the invention,
central passageway 92a of nipple 92, and central passageway 68a of
nipple 68. After operating the operating means of the invention in
a manner presently to be described to permit fluid to flow into the
passageway of the nipples 68 and 92 via the operating means, fluid
will flow through passageway 89a, through a conventional
particulate filter 111, into a well 89b and into inlet 110a of the
rate control plate. From inlet 110a, the fluid will flow into the
various circuitous fluid channels 112a, 112b, 112c, 112d, 112e and
112f formed in the rate control plate, each of which is of a
different length, width, depth and geometry (see FIGS. 12 and 32).
As each of the channels fills with the medicinal fluid to be
dispensed to the patient, the fluid will flow into outlet
passageways 114a, 114b, 114c, 114d, 114e and 114f respectively
formed in rate control cover 84 (FIG. 28). From these outlet
passageways, the fluid will flow into and fill circumferentially
spaced-apart fluid passageways 116a, 116b, 116c, 116d, 116e and
116f formed in cover member 84 (see FIGS. 26 and 27).
[0213] As best seen by referring to FIG. 21, selector member 88,
which controllably rotates with knob 94, is provided with an inlet
120, a radially extending inlet passageway 122 and an outlet 124
that is in communication with a central passageway 126 via an
orifice 86a of the selector element 86 (FIG. 23). When the
connector hub 77 of the administration set 76 is in position within
the cavity 96a formed in selector knob 94 in the manner shown in
FIG. 4B, the fluid will flow through the selector film 86 and
directly into the inlet 77a of the hub 77 of the administration set
76 (FIGS. 3, 20, 21, 22, and 23).
[0214] With the construction just described, by rotating the
selector knob 94, (See FIG. 4B) which, in turn, rotates selector
member 88, inlet 120 of the selector member can be selectively
brought into index with one of the axially extending passageways
formed in selector member 88, thereby providing fluid communication
with a selected one of the circuitous flow passageways formed in
rate control plate 110. Since outlet passageway 124 is in fluid
communication with the administration set 76 in the manner
previously described, the rate of fluid flow toward the patient can
be precisely controlled by selecting a rate control passageway of
appropriate length that is formed in rate control plate 110.
[0215] Considering now the previously identified operating means of
the invention, this important means, which controls fluid flow
between collapsible reservoir 65 and passageway 92a of nipple 92 of
the rate control means, here comprises an operating shaft 128
(FIGS. 4A, 4B and 38) that is sealably, rotatably mounted within a
generally cylindrical-shaped chamber 130 (FIGS. 4A, 4B and 36)
formed in housing 54 of supporting structure 52 (FIGS. 3, 4A and
36). Operating shaft 128 can be rotated within chamber 130, which
is closed by a closure cap 130a, by an "L"-shaped operating handle
134 (FIG. 2) between the position shown in FIG. 44, blocking fluid
flow from collapsible reservoir 65 toward administration set 76 and
the position shown in FIG. 46 permitting fluid flow from the
reservoir toward the administration set.
[0216] Turning particularly to FIGS. 38 through 41, operating shaft
128 can be seen to comprise a body portion 128a and a reduced
diameter neck portion 128b. Circumferentially spaced-apart,
generally arcuate-shaped cavities 131 and 132, which are formed in
body portion 128a, are strategically located to receive the end
portions of nipples 68 and 92 when the operating shaft is held in
position within chamber 130 by integral retainer clips 135 in the
manner shown in FIG. 36. Also formed within operating shaft 128 is
a transversely extending fluid passageway 136, which, upon rotation
of the operating shaft by handle 134, can be moved into alignment
with the fluid passageways 68a and 92a of nipples 68 and 92
respectively (see FIG. 46).
[0217] Mounted within each of the cavities 131 and 132 is a spring
knife 140, which, as indicated in FIGS. 41 and 42, includes a
cutting edge 140a formed proximate one extremity and a pair of
mounting clips 142 provided proximate the opposite extremity. Tabs
142a of the mounting clips are received within slots 144 formed in
body portion 128a so as to secure the spring knives within the
arcuate cavities in the manner illustrated in FIG. 44. With this
construction, as the operating shaft 128 is rotated by handle 134
from the position shown in FIG. 44 into the position shown in FIG.
45 the spring knives will cleanly sever the sealed tip portions 68b
and 92b of nipples 68 and 92 respectively. Continued rotation of
operating member 128 will move sealed tip portions 68b and 92b into
the cavities for rotation therewith (FIG. 45) and will move
transverse passageway 136 into alignment with passageways 68a and
92a in a manner shown in FIG. 46. With the operating member in this
position fluid can flow freely from reservoir 65 toward the rate
control means of the invention via passageways 68a and 92a of
nipples 68 and 92.
[0218] From passageway 68a, fluid will flow through passageway 136,
through passageway 92a, through conventional particulate filter
111, through well 89b, through outlet 89a, into inlet 110a of rate
control plate 110 of the rate control assembly and then into the
various circuitous fluid channels 112a, 112b, 112c, 112d, 112e and
112f formed in the rate control plate (see FIGS. 3, 13 and 32).
Rate control plate 110, which can be constructed from various
plastics, is oriented relative to members 84 and 89 by the
previously identified notches "N" and spines "S" and 84c. Filter
111 is maintained in position within cavity 92b of member 92 which
is received in a cavity 89b formed in plate 89. As each of the
channels fills with the medicinal fluid to be dispensed to the
patient, the fluid will flow next into outlet passageways 114a,
114b, 114c, 114d, 114e and 114f respectively formed in rate control
cover 84 (FIG. 28). From these outlet passageways, the fluid flows
into and fills circumferentially spaced-apart fluid passageways
116a, 116b, 116c, 116d, 116e and 116f formed in cover member 84
(see FIGS. 26 and 27). By controllably rotating knob 94 which in
turn rotates the selector member 88, inlet 120 thereof can be
selectively brought into index with one of the fluid passageways
formed in cover member 84 via element 86, thereby providing fluid
communication with a selected one of the circuitous flow
passageways formed in rate control plate 110. Since outlet
passageway 124 of the selector member 88 is in fluid communication
with the administration set 76 in the manner previously described
the fluid can be delivered to the patient at a selected controlled
rate of flow.
[0219] With the apparatus in the configuration shown in FIG. 1 and
with the fluid reservoir 65 filled with the medicament to be
dispensed to the patient, the dispensing operation can be commenced
by removing the top cover 150 which is snapped over a cover
connector 152 that protrudes from the rate control cover 84. With
the top cover removed, the administration line 76a of the
administration set 76 can be unwrapped from the sleeve 106b of the
selector knob support 106 about which it has been coiled (see FIG.
3). Removal of the top cover 150 also exposes the selector knob 94
so that the fluid flow rate can be selected by rotating the
selector knob to the desired flow rate indicated by the indicia 104
imprinted on the rim of the selector knob support 106 (FIG. 2). In
this regard, it is to be noted that selector knob 94 is provided
with a plurality of circumferentially spaced cavities 97c (FIG. 17)
that are engaged by a protuberance 106p formed on inwardly
extending flange 106d of support 106 (FIGS. 13 and 31). With the
desired flow rate thusly set, the operating shaft 128 is next
rotated through the use of the operating handle 134 from the
starting position shown in FIG. 47 to the fully rotated position
shown in FIG. 49. In this way, communication is opened between the
reservoir outlet 66 and passageway 92a of nipple 92 which, in turn,
is in communication with the rate control assembly of the
invention.
[0220] Following the controlled rotation of the operating shaft 128
in the manner shown in FIGS. 44 through 49, the carriage locking
means of the invention can now be manipulated in the manner
illustrated in FIG. 51 to release the carriage 60 from base segment
57 in order to permit the stored energy means, or constant force
springs 70 to move the carriage from the fully deployed or extended
starting position shown in FIG. 4A to the retracted position shown
in FIG. 4B. In this regard, as best seen in FIGS. 4A, 4B and 51,
the carriage locking means here comprises the previously identified
base segment 57 which includes a locking sleeve 57a that is
provided with a cam groove 155 that is adapted to mate with a male
thread 157 formed on the base 57 of container 64 (see FIGS. 4A and
6). With this construction, upon rotating base segment 57 so as to
release the carriage in the manner shown in FIGS. 4B and 51,
carriage 60 is then free to move in response to the urging of the
constant force springs 70 from the position shown in FIG. 4A to the
fluid delivery position shown in FIG. 4B. As the carriage moves
into the fluid delivery position the fluid contained within
reservoir 65 will be caused to controllably flow toward reservoir
outlet 66, into fluid passageway 68a of nipple 68, through
passageway 136 formed in control member 128 and into passageway 92a
of nipple 92. From passageway 92a, fluid will flow through
conventional particulate filter 111, into the well 89b, through
outlet 89a, and into inlet 110a of rate control plate 110 and then
into the various circuitous fluid channels 112a, 112b, 112c, 112d,
112e and 112f formed in the rate control plate (see FIG. 32). As
each of the channels fills with the medicinal fluid to be dispensed
to the patient, the fluid will flow into and fill circumferentially
spaced-apart fluid passageways 114a, 114b, 114c, 114d, 114e and
114f formed in cover member 84 (see FIG. 28). By controllably
rotating the selector knob 94, inlet 120 of selector member 88 can
be selectively brought into index with one of the fluid passageways
116a, 116b, 116c, 116d, 116e and 116f formed in cover member 84,
thereby providing fluid communication with a selected one of the
circuitous flow rate control passageways formed in rate control
plate 110 and in this way select the desired rate of fluid flow to
the administration set and then on to the patient.
[0221] In the present form of the invention, administration set 76,
which comprises a part of the dispensing means of the invention for
delivering medicinal fluids to the patient, includes, in addition
to administration line 76a, a conventional "Y"-site injection
septum or port 76b, a conventional gas vent and particulate filter
76c and a line clamp 76d. Provided at the distal end of the
administration line is a Luer connector 76e of conventional
construction (FIG. 2) which enables the apparatus to be
interconnected with the patient in a conventional manner.
[0222] The stored energy members or constant-force springs 70,
which are a special variety of extension spring, are readily
commercially available from several sources, including Barnes Group
Inc. of Bristol, Conn.; Stock Drive Products/Sterling Instrument of
Hyde Park, N.Y. and Walker Corporation of Ontario, Calif. Constant
force extension springs are basically high stress, long deflection
apparatus that offer great advantages when used in applications,
such as the present application, where very low or zero gradient is
desired, where space is a factor and where very high reliability,
accuracy, and linear force tolerance is required. Constant force
springs, such as springs 70, provide markedly superior constant
force loading when compared to conventional helical extension or
like conventional types of springs. A constant force spring is
typically a roll of pre-stressed metal strip that exerts a nearly
constant restraining force to resist uncoiling or recoiling. The
force is constant over time because the change in the radius of the
curvature is constant. Springs 70 can be of a laminate
construction, or alternatively spring 70 can comprise a single
spring element of the character shown in the drawings.
[0223] Turning now to FIGS. 52, 53A and 53B, an alternate form of
the dispensing apparatus of the present invention for dispensing
medicaments to a patient is there shown. This alternate form of
dispensing apparatus is similar in many respects to that shown in
FIGS. 1 through 51 and like numerals are used in FIGS. 52 through
64 to identify like components. As before, the dispensing apparatus
here includes a supporting structure which includes an upper
portion 154 and a generally cylindrically shaped skirt portion 156
that is interconnected with the upper portion in the manner best
seen in FIG. 52 of the drawings.
[0224] Disposed within skirt portion 156 is a carriage assembly 60
which is movable between a first position shown in FIGS. 52 and 53A
and a second position shown in FIG. 53B. Carriage assembly 60 is of
identical construction and operation to that previously described
and is releasably locked in its first position by locking means
also identical to the locking means previously described
herein.
[0225] The primary difference between this latest form of
dispensing apparatus of the invention and that previously described
resides in the provision of a single, rather than multiple, flow
rate control assembly 160 and a reservoir defining assembly 162 of
a totally different construction. Reservoir defining assembly 162
here comprises a collapsible container assembly 164 which is
carried by carriage assembly 60 in the manner illustrated in FIG.
52.
[0226] As best seen by referring to FIGS. 52 and 54, collapsible
container assembly 162 includes a collapsible container 164 having
a collapsible sidewall 164a, an interconnected bottom wall 164b and
an interconnected top wall 164c to which a sealed reservoir nipple
166 which is scored about its periphery is sealably interconnected.
Collapsible container assembly 164 defines a fluid reservoir 168
having an inlet/outlet that is generally identified by the numeral
170 (FIGS. 52 and 54).
[0227] In the preferred form of this alternate embodiment of the
invention, nipple 166 is sealably interconnected with member top
wall 164c in accordance with an aseptic blow-fill-seal technique of
the general character previously described to form a unitary
structure.
[0228] To controllably move the carriage assembly 60 from its first
position to its second position, novel stored energy means are
provided. This novel stored energy means, which is identical in
construction and operation to that previously described, comprises
three circumferentially spaced constant force springs 70.
[0229] As in the earlier described embodiment of the invention,
following operation of the operating means, when the locking means
of the invention is manipulated in a manner to unlock the carriage
assembly from base portion that is substantially similar to base
portion 57, springs 70 will move from their extended position shown
in FIGS. 52 and 53A to their retracted position shown in FIG. 53B
and in so doing will controllably move the carriage assembly from
its fully deployed or extended starting position shown in FIG. 52
to its fully retracted position shown in FIG. 53B. As the carriage
assembly moves toward its retracted position, the collapsible
sidewall 164a of the collapsible container 164 will move into the
collapsed configuration shown in FIG. 53B. As the collapsible
container collapses, the medicinal fluid or diluent contained
within the container will be substantially and controllably
expelled therefrom.
[0230] To further control the flow of medicinal fluid from
reservoir 168 toward the administration set 76 of the invention and
then on to the patient, flow control means are provided. As before
this novel fluid flow control means, comprises two cooperating
components, namely a rate control means for controlling the rate of
fluid flow from the collapsible reservoir to the patient and an
operating means for controlling fluid flow between the collapsible
reservoir and the rate control means. As previously mentioned, the
rate control means is different from that previously described.
However, the flow control means of this embodiment is identical in
construction and operation to that previously described. The
important alternate form of rate control means will be more fully
described in the succeeding paragraphs.
[0231] As in the earlier described embodiment of the invention, the
important flow control means, which controls fluid flow between
collapsible reservoir 164 and the rate control means, comprises an
operating shaft 128 that is rotatably mounted within a generally
cylindrically shaped chamber 130 formed in upper portion 154 of the
supporting structure. As before, operating shaft 128 can be rotated
within chamber 130 by an "L"-shaped operating handle between a
first position blocking fluid flow from collapsible reservoir 168
toward administration set 76 and a second position permitting fluid
flow from the reservoir toward the administration set.
[0232] Operating shaft 128 includes circumferentially spaced-apart
generally arcuate-shaped cavities 131 and 132 that are
strategically located to receive the end portion 166a of container
nipple 166 and also to receive the end portion 172a of the rate
control means nipple 172 when the operating shaft is held in
position within chamber 130 by the retainer clips 125. As best seen
in FIG. 57, nipple 172 is affixed to and extends from a cover 173,
which forms a part of the rate control assembly 177 of this latest
form of the invention. As in the earlier described embodiment, as
the operating shaft 128 is rotated by the operating handle from it
first position into its second position spring knives 140 will
cleanly sever the sealed tip portions 166a and 172a of nipples 166
and 172 respectively. Continued rotation of the operating member
will capture the tip portions within the cavities for rotation
therewith and will move transverse passageway 136 into alignment
with fluid passageways 166p and 172p of the respective nipples.
With the operating member in this position fluid can flow freely
from reservoir 168 toward the rate control means of the invention
via passageways 166p and 172p of nipples 166 and 172 and 136 of
control shaft 128.
[0233] From passageway 172p, fluid will flow through a conventional
particulate filter 111 and then into the inlet 179 of the rate
control plate 180 of the rate control assembly 160 (FIG. 64). The
fluid will then flow through channel 182 and outwardly of outlet
186. From outlet 186 the fluid will flow into inlet 188 of
circuitous flow channel 180a. Unlike the rate control plate of the
previously described embodiment of the invention, rate control
plate 180 has but a single micro-channel 180a. It is apparent that
by varying the geometry of the micro-channel, including its length,
depth, width and geometry, the rate of fluid flow from reservoir
168 toward the administration set of the apparatus can be precisely
controlled. After flowing through the rate control channel 180a,
fluid will flow through outlet 190 of the rate control plate and
into inlet 192a formed in the upper plate 192 of the rate control
assembly. After rate control cover 196 has been mated with upper
plate 192 in the manner shown in FIGS. 52 and 56, the
administration line 76a of the administration set 76 can be unwound
from the periphery of the upper plate 192 and the hub portion 77 of
the administration set can be inserted into the socket 196a formed
in cover 196. With the administration set thusly interconnected
with the rate control assembly, the fluid will flow from inlet 192a
into the inlet 76c of the administration set and onward toward the
patient at a precisely controlled rate.
[0234] Turning now to FIGS. 65, 66 and 67, an alternate form of the
dispensing apparatus of the present invention for dispensing
medicaments to a patient is there shown and generally designated by
the numeral 300. This alternate form of the dispensing apparatus is
similar in many respects to the previously described embodiments
and like numerals are used in FIGS. 65 through 67 to identify like
components. As before, the dispensing apparatus here includes a
supporting structure 302 which includes an upper portion 304 and a
generally cylindrically shaped skirt portion 306 that is
interconnected with the upper portion in the manner best seen in
FIG. 65 of the drawings.
[0235] Disposed within skirt portion 306 is a carriage assembly 309
which is movable between a first position shown in FIG. 65 and a
second position shown in FIG. 66. Carriage assembly 309 is of
similar construction and operation to that previously described and
is releasably locked in its first position by locking means also
similar to the locking means previously described herein. As
before, the locking means secures the carriage assembly and until
released prevents forced loading of the reservoir assembly.
[0236] The primary difference between this latest form of
dispensing apparatus of the invention and that previously described
resides in the provision of a novel stored energy source, which is
of a totally different construction. More particularly, rather than
being of a mechanical spring, the novel stored energy means of this
latest form of the invention comprises a compressible, expandable
sponge-like configuration, which is generally designated in the
drawings by 312. This unique stored energy source, which functions
to move the carriage 309 in the first compressed position shown in
FIG. 65 to the second expanded position shown in FIG. 66 can take
several forms. By way of non-limiting example, stored energy source
312 can comprise a microporous, mesoporous, macroporous, ordered
structure and can be constructed from Polypropylene (PP), Ultra
High Molecular Weight Polyethylene (UHMWPE), High Density
Polyethylene (HDPE), Polyvinylidene Fluoride (PVDF), Ethyle-vinyl
Acetate (EVA), Styrene Acrylonitrile (SAN), Polytetrafluroethylene
(PTFE), silicone and porous cellulose acetate. A suitable source of
certain of these materials is NUSIL Technology of Carpinteria,
Calif. However, practice has shown that any porous plastic material
including an open cell, porous foam or sponge-like material is
suitable for use in constructing the stored energy source. The
stored energy material employed may also be a cellular metal,
porous metal, a metal sponge or solid metal foam. The metal foams
may be derived from single element or alloys of two or more
elements. The metals or alloys comprising the foams may be
crystalline or amorphous. They may also have regions that display
semi-crystalline characteristics. General examples of these
materials include Al, Cu/Al, Sn, Au, Pb, brass, steel and negative
Poisson metal foams.
[0237] As in the last described embodiment of the invention,
reservoir defining assembly 162 here comprises a collapsible
container assembly 164, which is of identical construction to that
previously described in connection with FIGS. 52 and 54. Container
assembly 164 is carried by carriage assembly 309 in the manner
illustrated in FIG. 65. Collapsible container assembly 164, which
includes a nipple assembly 166, defines a fluid reservoir 168
having an inlet/outlet that is generally identified by the numeral
170.
[0238] To control the flow of fluid from reservoir 168 toward the
administration set 76 of the invention and then on to the patient,
novel fluid flow control means are provided. The fluid flow control
means, which is carried by the supporting structure 302 is
identical in construction and operation to that previously
described in connection with FIGS. 1 through 51. As before, this
fluid flow control means here comprises two supporting components,
namely a rate control means for controlling the rate of fluid flow
from the collapsible reservoir toward the administration set and an
operating means for controlling fluid flow between the collapsible
reservoir and the rate control means. Because the operating means
and the rate control means of this latest form of the invention are
substantially identical to those described in connection with the
embodiment of the invention shown in FIGS. 1 through 51, these
means will not be further described.
[0239] In operating the apparatus of this latest form of the
invention, with the apparatus in the configuration shown in FIG. 65
and with the fluid reservoir 168 filled with the medicament or
diluent to be dispensed to the patient, the dispensing operation
can be commenced by removing the top cover 150, which is snapped
over a cover connector 152 that protrudes from the rate control
cover 84. With a cover removed, the administration line of the
administration set 76 can be unwrapped from the sleeve 104b of the
selector knob support 104 about which it has been coiled. Removal
of the top cover 150 also exposes the selector knob 92 so that the
fluid flow rate can be selected by rotating the selector member to
the desired flow rate indicated by the indicia imprinted on the rim
of the selector knob support 104. With the desired flow rate
appropriately set, the operating shaft 128 is next rotated through
the use of the operating handle to open communication between the
reservoir outlet 170 and passageway 92a of nipple 92 via passageway
166p, which, in turn, is in communication with the rate control
assembly of the invention.
[0240] Following the controlled rotation of the operating shaft
128, which is interconnected with structural member 304, the
carriage locking means of the invention can now be manipulated in a
manner to release the carriage from base segment 214 in order to
permit the stored energy means, or sponge 312 to move the carriage
from the starting position shown in FIG. 65 to the extended
position shown in FIG. 66.
[0241] As the carriage moves toward its extended position fluid
will be controllably expelled from reservoir 168, through the flow
control means and on to the administration set in the manner
previously described.
[0242] Turning now to FIGS. 67A and 67B, yet another form of the
dispensing apparatus of the present invention for dispensing
medicaments to a patient is there shown and generally designated by
the numeral 315. This alternate form of the dispensing apparatus is
similar in many respects to the previously described embodiments
and like numerals are used in FIGS. 67A and 67B to identify like
components. As before, the dispensing apparatus here includes a
supporting structure 316 which includes an upper portion 316a and a
generally cylindrically shaped skirt portion 316b that is
interconnected with the upper portion in the manner best seen in
FIG. 67A of the drawings.
[0243] Disposed within skirt portion 316b is a carriage assembly
318 which is movable between a first position shown in FIG. 67A and
a second position shown in FIG. 67B. Carriage assembly 318 is of
similar construction and operation to that previously described and
is releasably locked in its first position by locking means
somewhat similar to the locking means previously described
herein.
[0244] The primary difference between this latest form of
dispensing apparatus of the invention and that described in
connection with FIGS. 65 through 67 resides in the provision of a
novel collapsible container 319 which has accordion-wall
construction similar to that shown in FIGS. 3 and 6 of the
drawings.
[0245] Container assembly 319 is carried by carriage assembly 318
in the manner illustrated in FIG. 67A. Collapsible container
assembly 319, which includes a nipple assembly 319a, defines a
fluid reservoir 320 having an inlet/outlet that is generally
identified by the numeral 320a.
[0246] To control the flow of fluid from reservoir 320 toward the
administration set 76 of the invention and then on to the patient,
novel fluid flow control means are provided which are identical in
construction and operation to that previously described in
connection with FIGS. 1 through 51.
[0247] In operating the apparatus of this latest form of the
invention, with the apparatus in the configuration shown in FIG.
67A and with the fluid reservoir 320 filled with the medicament or
diluent to be dispensed to the patient, the dispensing operation
can be commenced by removing the top cover 150, which is snapped
over a cover connector 152 that protrudes from the rate control
cover 84. With a cover removed, the administration line of the
administration set 76 can be unwrapped from the sleeve 104b of the
selector knob support 104 about which it has been coiled. Removal
of the top cover 150 also exposes the selector knob 92 so that the
fluid flow rate can be selected by rotating the selector member to
the desired flow rate indicated by the indicia imprinted on the rim
of the selector knob support 104. With the desired flow rate
appropriately set, the operating shaft 128 is next rotated through
the use of the operating handle to open communication between the
reservoir outlet 320a, through passageway 166p, passageway 136, and
passageway 92a of nipple 92, which, in turn, is in communication
with the rate control assembly of the invention.
[0248] Following the controlled rotation of the operating shaft
128, the carriage locking means of the invention can now be
manipulated in a manner to release the carriage from base segment
316c in order to permit the stored energy means, or sponge 312, to
move the carnage from the starting position shown in FIG. 67A to
the extended position shown in FIG. 67B.
[0249] In this latest form of the invention, the carriage release
means comprises a threaded connector boss 321 that is rotatably
carried by base segment 316c and is constructed and arranged to
threadably engage a threaded aperture 318d formed in the carriage
base 318a, with this construction rotation of the threaded boss
using pivotal handle 321a, will cause the boss to disengage the
base segment permitting the stored energy source to move the
carriage toward the position shown in FIG. 67B.
[0250] As the carriage moves toward its retracted position, fluid
will be controllably expelled from reservoir 320, through the flow
control means and on to the administration set in the manner
previously described.
[0251] Referring next to FIGS. 68, 68A, 68B and 69, still another
form of the dispensing apparatus of the present invention for
dispensing medicaments to a patient is there shown and generally
designated by the numeral 322. This alternate form of dispensing
apparatus is similar in some respects to the earlier described
embodiments and like numerals are used in FIGS. 68 and 69 to
identify like components. Because the flow control means of this
latest form of the invention is of different construction and
operates in a different way, the dispensing apparatus 322 includes
a supporting structure 324, which, is of necessity, somewhat
different in construction. More particularly, the supporting
structure 324 here comprises a connector assembly 326 and a
generally cylindrically shaped outer housing 328 that is
interconnected with the connector assembly in the manner best seen
in FIG. 68 of the drawings.
[0252] Disposed within outer housing 328 is the carriage assembly,
which is movable between a first position shown in FIG. 68 and a
second position shown in FIG. 69. Carriage assembly 329 comprises a
carriage 330 having a carriage base 330a that has proximate its
periphery a connector portion 330b. Carriage assembly 329 is
releasably locked to base 328a of outer housing 328 in its first
position by a novel locking means the character of which will
presently be described.
[0253] Carried by carriage assembly 329 is a reservoir defining
assembly 334 that defines a fluid reservoir 335. Reservoir defining
assembly 334 here includes a collapsible container 336 having a
sidewall 336a, an interconnected bottom wall 336b and an
interconnected top wall 336c having a thin wall portion 336d to
which a sealed reservoir septum assembly 338 is sealably
interconnected (see FIG. 68). In a manner presently to be
described, fluid reservoir 335 is accessible via a slit septum
338s, which comprises a part of reservoir septum assembly 338. As
best seen in FIG. 68, septum 338s is disposed within a generally
cylindrically shaped holding ring 342, which in turn is disposed
within septum assembly 338.
[0254] In the preferred form of this alternate embodiment of the
invention, reservoir assembly 334 is formed by the previously
described aseptic blow-fill-seal technique to form a hermetically
sealed container that contains the fluid to be dispensed.
[0255] The primary difference between this latest form of
dispensing apparatus of the invention and those previously
described herein resides in the provision of a totally different
operating means for controlling fluid flow between reservoir 335
and the rate control means of the invention. This important
operating means here comprises a septum-penetrating assembly
generally designated in FIG. 68 by the numeral 339. Assembly 339,
which is disposed within a skirt 340 formed on a selector member
housing 342 includes a pointed septum-penetrating member 344 having
an elastomeric overcoat 344e, which is received within a guide
passageway 346 formed on support member 326. Assembly 339 includes
an internally threaded counterbore 339c which threadably mates with
externally threaded portion 326a of connector assembly 326.
Assembly 339 also includes a cavity 339a, which closely receives a
portion of the somewhat differently configured rate control
assembly 350, the details of construction of which will presently
be described.
[0256] In this latest embodiment of the invention, selector member
housing 342 along with septum-penetrating assembly 339 is movable
within a guide sleeve 352 that extends outwardly from support
member 326, from the first position shown in FIG. 68 to the second
position shown in FIG. 69. In addition to guiding the travel of the
septum-penetrating assembly, guide sleeve 352 defines a cylindrical
space 352a about which the administration line 76a of the
administration set can be coiled in the manner best seen in FIG.
68.
[0257] Selector member housing 342 is retained in its first
position by a tear strip 354 that is removably receivable between a
circumferentially extending rib 342a formed on housing 342 and the
upper extremity 352b of guide sleeve 352. When the tear strip 354
is removed in the manner illustrated in FIG. 68B, a rotational
force exerted on selector member housing 342 will move the housing
along with the septum-penetrating assembly into the second position
shown in FIG. 69 and in so doing will cause the septum-penetrating
member 344 to pierce the septum 338s in the manner shown in FIG.
69. Piercing of the septum 338s and thin wall portion 336d opens a
fluid communication path from reservoir 335 to the rate control
assembly 350 via a central fluid passageway 344a formed in
septum-penetrating member 344. As will be described in greater
detail hereinafter, from passageway 344a fluid will flow through
conventional particulate filter 357, into inlet 360 of rate control
cover 362 of the rate control assembly 350, into inlet 364p of rate
control plate 364 and then into the various circuitous fluid
channels of the rate control plate (see FIG. 69E). The fluid will
then flow via the sealably connected rate control cover 366 into
the various circumferentially spaced-apart fluid passageways formed
in the selector housing 342 (see FIGS. 69A and 69B).
[0258] Considering in greater detail the rate control assembly 350
of this latest form of the invention, as shown in FIG. 69E rate
control plate 364 is provided with circuitous fluid channels 364a,
364b, 364c, 364d, 364e and 364f, each of which is of a different
geometry including channel length, depth, width and geometry. As
the fluid flows from reservoir 335 into the inlet 364p of rate
control plate 364 via the orifice of the rate control cover 362,
each of the circuitous fluid channels will fill with the medicinal
fluid to be dispensed to the patient. From the circuitous fluid
channels, the fluid will flow into outlet passageways 366a, 366b,
366c, 366d, 366e, 366f and 366p respectively formed in rate control
cover 366. From these outlet passageways, the fluid flows into and
fills circumferentially spaced-apart fluid passageways 374a, 374b,
374c, 374d, 374e and 374f formed in selector housing 342 (see FIG.
69B).
[0259] As best seen by referring to FIGS. 69C and 69E, selector
member 370 is provided with an inlet passageway 377 and an outlet
passageway 378 that is interconnected with inlet passageway 376 by
means of an axially extending stub passageway 380 which, in turn,
is connected to a circumferentially extending channel passageway
382 formed in selector member 370 (FIG. 69C). With this
construction, by rotating the selector member 370, inlet passageway
377 can be selectively brought into index with one of the radial
extensions 384 of the axially extending passageways formed in
selector member housing 342 thereby providing fluid communication
between outlet passageway 378 and the selected one of the
circuitous flow passageways formed in rate control plate 364 via
annular channel passageway 382 and the selected axially extending
passageway formed in the selector member housing 342. Since outlet
passageway 378 is in fluid communication with the administration
set 76 of the invention via passageway 386 (FIG. 69A), the rate of
fluid flow toward the patient can be precisely controlled by
selecting a rate control passageway of appropriate configuration
and length that is formed in rate control plate 364.
[0260] With the apparatus in the configuration shown in FIG. 68,
and with the fluid reservoir 335 filled with the medicament or
diluent to be dispensed to the patient, the dispensing operation
can be commenced by removing the top cover 390, which is snapped
over a cover connector 392 that is provided on connector member
326. With the cover removed, the administration line 76a of the
administration set 76 can be unwrapped from the selector member
housing about which it has been coiled. Removal of the top cover
390 also exposes the selector member 370, which is secured in
position by a selector member retainer component 395, so that the
fluid flow rate can be selected by rotating the selector member to
the desired flow rate indicated by the indicia 397 imprinted on the
selector member retainer component.
[0261] In the manner previously described, movement within guide
sleeve 352 of the selector member housing 342, along with
septum-penetrating assembly 339 from the first position shown in
FIG. 68 to the second position shown in FIG. 69 opens fluid
communication between reservoir 335 and the rate control assembly
350. This done, the carriage locking means of this latest form of
the invention can be manipulated in a manner to release the
carriage 330 from base member 328a in order to permit the stored
energy means, or springs 70, to move the carriage from the starting
position shown in FIG. 68 to the position shown in FIG. 69.
[0262] In this regard, as indicated in Figures and 68, 69 and 69D
the carriage locking means includes a locking member 400 having a
shank portion 400a which extends through a keyhole-shaped opening
402 provided in the carriage base 330a (see FIG. 69D). The carriage
locking means also includes a finger-engaging, operating member 406
that is connected to shank portion 400a. Operating member 406
functions to rotate locking member 400 from a transverse locking
position to a release position in alignment with keyhole opening
402 formed in carriage base 330a. As the operating member is
rotated from a locked position to a release position, the stored
energy means, or springs 70 (FIGS. 68 and 69) will move the
carriage from a position shown in FIG. 68 into the position shown
in FIG. 69 and in so doing will urge the fluid contained within
reservoir 335 to flow toward penetrating member 344, into
passageway 344a formed in the penetrating member and into the inlet
of rate control cover 362 via filter 357 of the rate of control
assembly 350. The fluid will then flow into the various circuitous
fluid channels formed in the rate control plate and then into the
various outlet passageways formed in rate control cover 364. From
the rate control cover, the fluid will flow into the various
circumferentially spaced-apart fluid passageways formed in the
selector housing 342 (see FIGS. 69A and 69B). By rotating the
selector member 370, inlet passageway 377 of selector member 370
can be selectively brought into index with one of the radial
extensions 384 formed in selector member housing 342 thereby
providing fluid communication between outlet passageway 378 and the
selected one of the circuitous flow passageways formed in the rate
control plate. From outlet passageway 378 the fluid will flow via
passageway 386 toward the patient via the administration set
76.
[0263] To recover any medicament that may remain in reservoir 335
following the fluid delivery step, a pierceable septum 410, which
is carried by selector member 370, can be conveniently pierced
using a conventional syringe, or like apparatus (not shown).
Piercing of septum 410 opens communication between reservoir 335
and the syringe via central passageway 376, via the rate control
assembly 350, via central passageway 364p and via passageway 344a
of penetrating member 344 so that any remaining medicament can be
readily extracted from reservoir 335.
[0264] Turning now to FIGS. 70 and 71, still another alternate form
of the dispensing apparatus of the present invention for dispensing
medicaments and diluents to a patient is there shown and generally
designated by the numeral 420. This alternate form of the
dispensing apparatus is similar in many respects to that shown in
FIGS. 68 through 69E and like numerals are used in FIGS. 70 and 71
to identify like components. As before, the dispensing apparatus
here includes a supporting structure 324 which includes a connector
assembly 326 and a generally cylindrically shaped outer housing 328
that is interconnected with the connector assembly in the manner
best seen in FIG. 70 of the drawings.
[0265] Disposed within wall portion 328 is a carriage assembly 329
which is movable between a first position shown in FIG. 70 and a
second position shown in FIG. 71. Carriage assembly 329 is of
identical construction and operation to that previously described
and is releasably locked in its first position by locking means
also identical to the locking means previously described
herein.
[0266] The primary difference between this latest form of
dispensing apparatus of the invention and that previously described
resides in the provision of a reservoir defining assembly 422 of a
totally different construction. Reservoir defining assembly 422
here comprises a collapsible container assembly 424, which is
carried by carriage assembly 329 in the manner illustrated in FIG.
70.
[0267] As best seen by referring to FIGS. 70 and 71, collapsible
container assembly 424 includes a collapsible, accordion, or
bellows-like sidewall 424a, an interconnected bottom wall 424b and
an interconnected top wall 424c having a thin wall portion 424t to
which a sealed reservoir septum assembly 424d is integrally formed
(see FIG. 68). Reservoir septum assembly 424d is substantially
identical to the reservoir septum assembly previously described and
includes a slit septum 424s, which provides access to the fluid
reservoir 425 of collapsible container assembly 424 of this latest
form of the invention. As before, septum assembly 424d is
preferably sealably interconnected with top wall 424c in accordance
with the previously described aseptic blow-fill-seal technique.
[0268] As in the earlier described embodiment, selector member
housing 342 is retained in its first position by a tear strip 354.
When the tear strip is removed, a rotary force exerted on selector
member housing 342 will move the internally threaded penetrating
assembly 339 into the second position shown in FIG. 71 and in so
doing will cause the penetrating member 344 to pierce the septum
424s. Movement within guide sleeve 352 of the selector member
housing 342, along with septum-penetrating assembly 339 from the
first position shown in FIG. 70 to the second position shown in
FIG. 71 opens fluid communication between reservoir 425 and the
rate control assembly 350, which is identical in construction and
operation to that previously described. This done, the carriage
locking means of this latest form of the invention, which is also
identical in construction and operation to that previously
described, can now be manipulated in a manner to release the
carriage 330 from base member 328a.
[0269] Once again, in order to controllably move the carriage
assembly from its first position to its second position, novel
stored energy means are provided. This novel stored energy means,
which is operably associated with carriage assembly 330, is here
provided in the form of three constant force springs 70 which are
of identical construction and operation to those previously
described. As the carriage assembly moves toward its deployed
position, the collapsible sidewall 424a of the collapsible
container assembly 424 will move into the collapsed configuration
shown in FIG. 71. As the collapsible container collapses, the
medicinal fluid contained within the container reservoir will be
substantially controllably expelled therefrom.
[0270] From reservoir 425, the fluid will flow through penetrating
member 344, through conventional particulate filter 357, through
the rate control assembly 350, through the selector member 370 and
toward the patient via the administration set 76.
[0271] Turning next to FIGS. 72 through 77, still another form of
the dispensing apparatus of the present invention for dispensing
medicaments to a patient is there shown and generally designated by
the numeral 432. This alternate form of dispensing apparatus is
similar in some respects to that shown in FIGS. 70 and 71 and like
numerals are used in FIGS. 72 through 77 to identify like
components. As best seen in FIGS. 72 and 73 the supporting
structure 434 is similar in many respects to the previously
described supporting structures and here comprises a connector
assembly 436 and a generally cylindrically shaped outer housing 438
that is interconnected with the connector assembly in the manner
best seen in FIG. 72 of the drawings.
[0272] Disposed within outer housing 438 is the carriage assembly
330, which is of identical construction and operation to that
previously described and is releasably locked in its first position
by locking means also identical in construction and operation to
the locking means previously described herein. Carried by carriage
assembly 330 is a reservoir defining assembly 440 which is of a
somewhat different construction. This important reservoir defining
assembly here includes a collapsible container assembly 442 having
a sidewall 442a, an interconnected bottom wall 442b, an
interconnected top wall 442c having a thin wall portion 444 and an
interconnected neck portion 442d which is sealed at the time of
manufacture by the previously discussed blow-fill-seal technique to
form a hermetically sealed liquid filled container. Neck portion
442d forms a part of the novel reservoir access means of the
invention. Collapsible container assembly 442 defines a fluid
reservoir 447 that, in a manner presently to be described, is
accessible via a penetrating member 344 that is adapted to pierce
closure wall 444 as well as a pierceable septum membrane 452 which
is positioned over closure wall 444 by means of a closure cap 454
which is affixed to the neck portion 442d of container assembly 442
(see FIGS. 72 and 73). Penetrating member 344, pierceable membrane
452 and threaded closure cap 454 also form a part of the novel
reservoir access means of the invention (FIG. 75).
[0273] In the preferred form of this latest alternate embodiment of
the invention, closure wall 444 is sealably interconnected with
neck portion 442d in accordance with the previously described
aseptic blow-fill-seal technique.
[0274] The primary difference between this latest form of
dispensing apparatus of the invention and those previously
described herein resides in the somewhat differently configured
container assembly 442. In constructing the container assembly 442,
the basic container is formed using the aseptic blow-fill-seal
technique earlier described herein and the reservoir portion of the
container is sealed by the thin closure wall portion 444. The
piercable membrane 452 is then positioned over the closure wall 444
and the cap 454 is positioned over the piercable membrane 452 and
secured to neck portion 442d by any suitable means such as adhesive
bonding or sonic welding. This done the container assembly 440 is
interconnected with connector member 436 by threading cap 454 into
threaded counterbore 436c.
[0275] Once again, in order to controllably move the carriage
assembly from its first position to its second position, novel
stored energy means are provided. This novel stored energy means,
which is operably associated with carriage assembly 330, is here
provided in the form of three constant force springs 70, which are
also identical construction and operation to that previously
described.
[0276] As in the earlier described embodiments of the invention,
when the locking means of the invention is manipulated in a manner
to unlock the carriage assembly from base portion 438a of the outer
housing 438 to arm the apparatus constant force springs 70 will
move from their extended position shown in FIG. 72 to their
retracted position shown in FIG. 73 and in so doing will
controllably apply a substantially constant force to the carriage
to move the carriage assembly from its fully deployed or extended
starting position shown in FIG. 72 to its fully retracted position
shown in FIG. 73. Following operation of the operating means the
carriage assembly can then move toward its retracted position at
which time the sidewall 442a of the collapsible container 442 will
be urged to move into the collapsed configuration shown in FIGS. 73
and 77. As the collapsible container collapses, the medicinal fluid
contained within the container will be substantially expelled in a
controlled manner therefrom.
[0277] To control the flow of medicinal fluid or diluent from
reservoir 447 toward the administration set 76 of the invention and
then on to the patient, flow control means are provided. Once
again, this novel fluid flow control means, comprises two
cooperating components, namely a rate control means for controlling
the rate of fluid flow from the collapsible reservoir and an
operating means for controlling fluid flow between the collapsible
reservoir and the rate control means. Both the operating means and
the rate control means of this latest form of the invention are
identical in construction and operation to those described in
connection with the embodiment of FIGS. 68 and 69.
[0278] As in the earlier described embodiment, selector member
housing 342 is retained in its first position by a tear strip 354.
When the tear strip is removed, a rotary force exerted on selector
member housing 342 will controllably move the housing along with
the penetrating assembly into the second position shown in FIG. 73
and in so doing will cause the penetrating member 344 to pierce the
membrane, shown here as an elastomeric septum 452 (FIGS. 75 and 76)
as well as the closure wall 444 in the manner shown in FIG. 73.
Piercing of the septum 452 and the closure wall 444 opens a fluid
communication path from reservoir 447 to the rate control assembly
350 via a central fluid passageway 344a formed in penetrating
member 344. From reservoir 447, the fluid will flow through central
fluid passageway 344a of penetrating member 344, through
conventional particulate filter 357, through the rate control
assembly 350, through the selector member 370 and toward the
patient via the administration set 76.
[0279] Referring next to FIGS. 78 through 81, yet another form of
the dispensing apparatus of the present invention for dispensing
medicaments to a patient is there shown and generally designated by
the numeral 452. This alternate form of dispensing apparatus is
similar in most respects to that shown in FIGS. 73 through 77 and
like numerals are used in FIGS. 78 through 81 to identify like
components. The major difference between this latest embodiment of
the invention and that shown in FIGS. 73 through 77 resides in the
differently configured reservoir defining container 454. As shown
in FIG. 78 container 454, rather than being in the nature of the
collapsible bottle, comprises a reservoir defining unitary
container having a continuous bellows-like sidewall 454a that is
movable from the expanded, starting configuration shown in FIG. 78
to the collapsed configuration shown in FIG. 79. This important
reservoir defining container here includes, in addition to sidewall
454a, an interconnected bottom wall 454b, an interconnected top
wall 454c and an interconnected neck portion 454d which is sealed
at the time of manufacture by a thin closure wall 455. Neck portion
454d forms a part of the novel reservoir access means of the
invention. Collapsible unitary container 454 defines a fluid
reservoir 457 that is accessible via a penetrating member 344 that
is identical to that previously described. Penetrating member 344
is adapted to pierce closure wall 455 as well as a pierceable
membrane 456 which is positioned over closure wall 455 by means of
a closure cap 459 which is affixed to the neck portion 454d of
container assembly 454 (see also FIGS. 82 and 83).
[0280] As best seen in FIGS. 78 and 79 the supporting structure 434
is substantially identical to the supporting structure of the last
described embodiment and here comprises a connector assembly 436
and a generally cylindrically shaped outer housing 438 that is
interconnected with the connector assembly in the manner best seen
in FIG. 78 of the drawings.
[0281] Disposed within outer housing 438 is the carriage assembly
429 which is of identical construction and operation to that
previously described and is releasably locked in its first position
by locking means also identical in construction and operation to
the locking means previously described herein. Carried by carriage
assembly is the previously described reservoir defining container
454.
[0282] As in the last described embodiment of the invention,
closure wall 455 is integrally formed with neck portion 454d in
accordance with the previously described 454 is formed using the
earlier described aseptic blow-fill-seal technique to form a
unitary container (FIG. 82).
[0283] As before, the basic unitary container and the hermetically
sealed reservoir portion of the container is closed by the thin
closure wall 455. The piercable septum membrane 456 is then
positioned over the closure wall 455 and the cap 459 is positioned
over the piercable septum and secured to neck portion 454d by any
suitable means such as adhesive bonding or sonic welding. It is to
be understood that septum 456 can also be constructed as a slit or
partially slit member. It is Important to note that closure wall
455 effectively prevents the medicament contained within the fluid
reservoir from coming in contact with external contaminants.
[0284] Once again, in order to controllably move the carriage
assembly from its first position to its second position, novel
stored energy means are provided. This novel stored energy means,
which is operably associated with carriage assembly 330, is here
provided in the form of three constant force springs 70, which are
also identical construction and operation to that previously
described.
[0285] As in the earlier described embodiments of the invention,
following operation at the operating means of the invention, when
the locking means of the invention is manipulated in a manner to
unlock the carriage assembly from base portion 438a of the outer
housing 438, springs 70 will move from their extended position
shown in FIG. 78 to their retracted position shown in FIG. 79 and
in so doing will controllably move the carriage assembly from its
starting position shown in FIG. 78 to its fully deployed, reservoir
substantially empty position shown in FIG. 79. As the carriage
assembly moves toward its deployed position, the sidewall 454a of
the collapsible container 454 will move into the collapsed
configuration shown in FIG. 79. As the collapsible container
collapses, the medicinal fluid contained within the container will
be controllably expelled therefrom.
[0286] To control the flow of medicinal fluid from reservoir 457
toward the administration set 76 of the invention and then on to
the patient, flow control means are provided. Once again, this
novel fluid flow control means, comprises two cooperating
components, namely a rate control means for controlling the rate of
fluid flow from the collapsible reservoir and an operating means
for controlling fluid flow between the collapsible reservoir and
the rate control means. Both the operating means and the rate
control means of this latest form of the invention are identical in
construction and operation to those described in connection with
the embodiment of FIGS. 68 and 69.
[0287] As in the earlier described embodiment, selector member
housing 342 is retained in its first position by a tear strip 354.
When the tear strip is removed, a rotary force exerted on threaded
selector member housing 342 will controllably move the housing
along with the penetrating assembly 344 into the second position
shown in FIG. 79 and in so doing will cause the penetrating member
344 to pierce the septum 456 as well as the closure wall 455 in the
manner shown in FIG. 79. Piercing of the membrane 456 and the
closure wall 455 opens a fluid communication path from reservoir
457 to the rate control assembly 350 via a central fluid passageway
344a formed in penetrating member 344. From reservoir 457, the
fluid will flow through central fluid passageway 344a of
penetrating member 344, through conventional particulate filter
357, through the rate control assembly 350, through the selector
member and toward the patient via the administration set 76.
[0288] Referring next to FIGS. 82A through 82D, yet another form of
the dispensing apparatus of the present invention for dispensing
medicaments to a patient is there shown. This alternate form of
dispensing apparatus is similar in most respects to that shown in
FIGS. 78 through 81 and like numerals are used in FIGS. 82A through
82D to identify like components. The major difference between this
latest embodiment of the invention and that shown in FIGS. 78
through 81 resides in the somewhat differently configured reservoir
defining container 458. More particularly, as shown in FIG. 82A
container 458 has a differently configured reservoir accessing neck
assembly 458a, which is interconnected with the container top wall
458b. In addition, to top wall 458b the container formed as a
unitary structure has a bellows-like sidewall 458c that is movable
from the expanded, starting configuration shown in FIG. 82A to the
collapsed configuration shown in FIG. 82B and an interconnected
bottom wall 458d. Collapsible container 458 defines a fluid
reservoir 459 that is accessible via a penetrating member 344 that
is identical to that previously described. Penetrating member 344
is adapted to pierce a closure wall 458e that forms an integral
part of the sealing portion 460 of the neck assembly. As shown In
FIG. 82D, insert component 459 of the neck assembly is
interconnected with the neck assembly base portion 460a by an
insert molding process or by a subsequent bonding step. With the
unique construction thus described, the container of this
embodiment need not be sealed at the time of manufacture. Rather,
base portion 460a of the neck assembly can be left open and then
later sealed by the interconnection therewith of the sealing
portion 460.
[0289] As best seen in FIG. 82A the supporting structure 434 is
substantially identical to the supporting structure of the last
described embodiment as is the carriage assembly 429. Carriage
assembly 429 is releasably locked in the first position shown in
FIG. 82A by locking means which is also identical in construction
and operation to the locking means previously described herein.
Carried by the carriage assembly is the previously described
reservoir defining container 458.
[0290] As previously mentioned, a unique feature of this latest
embodiment resides in the fact that the basic container 458 can be
formed using the earlier described aseptic blow-fill technique, but
left unsealed. The container can later be hermetically sealed by
mating the sealing portion 460 with the neck base portion 460a and
then sealably interconnecting the components by any suitable means
such as adhesive bonding or sonic welding. However, it is to be
understood that, if desired, the sealing portion 460 and the base
portion 460a can be sealably interconnected during a blow-fill
operation.
[0291] Once again, in order to controllably move the carriage
assembly from its first position to its second position, novel
stored energy means are provided. This novel stored energy means,
which is operably associated with carriage assembly 330, is here
provided in the form of three constant force springs 70, which are
also identical in construction and operation to that previously
described.
[0292] As in the earlier described embodiment, selector member
housing 342 is retained in its first position by a tear strip 354.
When the tear strip is removed, rotary force exerted on selector
member housing 342 will controllably move the housing, along with
the penetrating assembly 344 into the second position shown in FIG.
82B and in so doing will cause the penetrating member 344 to pierce
the closure wall 458e in the manner shown in FIG. 82B. Piercing of
the closure wall 458e opens a fluid communication path from
reservoir 459 to the rate control assembly 350 via a central fluid
passageway 344a formed in penetrating member 344. From reservoir
459, the fluid will flow through central fluid passageway 344a of
penetrating member 344, through conventional particulate filter
357, through the rate control assembly 350, through the selector
member 370 and toward the patient via the administration set 76. It
is to be noted that due to the novel construction of the reservoir
accessing means, or neck assembly 458a, following penetration of
closure wall 458e, the elastomeric-coated wall of the penetrating
member will sealably engage the inwardly protruding collar 460c
formed on sealing portion 460 of the neck assembly so as to
substantially prevent fluid leakage between the collar and the
penetrating member.
[0293] As in the earlier described embodiments of the invention,
following operation of the operating means of the invention, when
the locking means of the invention is manipulated in a manner to
unlock the carriage assembly from base portion 438a of the outer
housing 438, springs 70 will move from their extended position
shown in FIG. 82A to their retracted position shown in FIG. 82B and
in so doing will controllably move the carriage assembly from its
starting position to its fully deployed, reservoir substantially
empty position shown in FIG. 82B. As the carriage assembly moves
toward its deployed position, the sidewall 458c of the collapsible
container 458 will move into the collapsed configuration shown in
FIG. 82B. As the collapsible container collapses, the medicinal
fluid contained within the container will be controllably expelled
therefrom.
[0294] To control the flow of medicinal fluid from reservoir 459
toward the administration set 76 of the invention and then on to
the patient, flow control means are provided. This novel fluid flow
control means, is identical in construction and operation to the
control means described in connection with FIGS. 78 through 81.
[0295] Referring next to FIGS. 82E and 82F, still another form of
the dispensing apparatus of the present invention for dispensing
medicaments to a patient is there shown. This alternate form of
dispensing apparatus is similar in most respects to that shown in
FIGS. 82A through 82D and like numerals are used in FIGS. 82E and
82F to identify like components. The major difference between this
latest embodiment of the invention and that shown in FIGS. 82A
through 82D resides in the somewhat differently configured
reservoir defining container 461. As shown in FIG. 82E container
461, rather than being of a bellows-like construction, here
comprises a container having a collapsible bottle-like construction
as a unitary structure. This reservoir defining, bottle-like
container here includes a sidewall 461a, an interconnected bottom
wall 461b, an interconnected top wall 461c and an interconnected
neck portion 461d which is identical to the neck portion 458a of
the previously described embodiment and is of the construction
shown in FIGS. 82C and 82D. Collapsible container 461 defines a
fluid reservoir 463 that is accessible via a penetrating member 344
that is identical in construction and operation to that previously
described.
[0296] As illustrated in FIGS. 82E and 82F the supporting structure
434 is substantially identical to the supporting structure of the
last described embodiment as is the carriage assembly 429. Carriage
assembly 429 is releasably locked in its first position by locking
means also identical in construction and operation to the locking
means previously described herein. Carried by carriage assembly is
the previously described reservoir defining container 461.
[0297] Once again, in order to controllably move the carriage
assembly from its first position to its second position, novel
stored energy means are provided. This novel stored energy means,
which is operably associated with carriage assembly 330, is here
provided in the form of three constant force springs 70, which are
also identical construction and operation to that previously
described.
[0298] To control the flow of medicinal fluid from reservoir 463
toward the administration set 76 of the invention and then on to
the patient, flow control means are provided. Once again, this
novel fluid flow control means is identical in construction and
operation to those previously described.
[0299] Turning next to FIGS. 83 through 88, still another form of
the dispensing apparatus of the present invention for dispensing
medicaments to a patient is there shown and generally designated by
the numeral 462. This alternate form of dispensing apparatus is
similar in many respects to that shown in FIGS. 78 through 82 and
like numerals are used in FIGS. 83 through 88 to identify like
components. As best seen in FIGS. 83 and 84 the supporting
structure 464 is similar in many respects to supporting structure
434 and here comprises a connector assembly 466 and a generally
cylindrically shaped outer housing 468 that is interconnected with
the connector assembly in the manner best seen in FIG. 83 of the
drawings.
[0300] Disposed within outer housing 468 is the carriage assembly
430, which is of identical construction and operation to that
previously described and is releasably locked in its first position
by locking means also identical in construction and operation to
the locking means previously described herein. Carried by carriage
assembly is a reservoir defining assembly 470, which is of a
somewhat different construction. This important reservoir defining
assembly here includes a unitary collapsible container assembly 472
having a sidewall 472a, an interconnected bottom wall 472b and an
interconnected thin film top wall 472c. Connected to top wall 472c
and extending therefrom is a luer-like connector 474 having
external threads 474a and an integrally formed sealing wall 474b.
Connector 474, which is interconnected with top wall 472c at the
time of manufacture of the collapsible container assembly 472,
forms a part of the novel reservoir access means of this latest
form of the invention. Collapsible container assembly 472 defines a
fluid reservoir 477 that, in a manner presently to be described, is
accessible via a slightly differently configured penetrating member
480a that penetrates sealing wall 474b of top walls 472c.
[0301] In the preferred form of this latest alternate embodiment of
the invention, luer-like connector 474 is sealably interconnected
with top wall 472c in accordance with the previously described
aseptic blow-fill-seal technique. Connector 474 of container 470 is
threadably interconnected with connector member 464 and secured in
position by locking tabs 68e (FIG. 85).
[0302] The primary differences between this latest form of
dispensing apparatus of the invention and those previously
described herein resides in the somewhat differently configured
container assembly 470 and the somewhat differently configured
penetrating assembly 480. In constructing the container assembly,
the basic container is formed using the aseptic blow-fill-seal
technique earlier described herein and the reservoir portion of the
container is sealed by the interconnected walls of the
container.
[0303] In order to controllably move the carriage assembly from its
first position to its second position, novel stored energy means
are provided. This novel stored energy means, which is operably
associated with carriage assembly 430, is here provided in the form
of three constant force springs 70, which are also identical in
construction and operation to that previously described.
[0304] As in the earlier described embodiments of the invention,
following operation at the operating means of the invention, when
the locking means of the invention is manipulated in a manner to
unlock the carriage assembly from base portion 468a of the outer
housing 468, springs 70 will move from their extended position
shown in FIG. 83 to their retracted position shown in FIG. 84 and
in so doing will controllably move the carriage assembly from its
starting position shown in FIG. 83 to its fully deployed or
retracted position shown in FIG. 84. As the carriage assembly moves
toward its deployed position, the collapsible sidewall 472a of the
collapsible container 472 will move into the collapsed
configuration shown in FIG. 84. As the container collapses and
following operation of the operating means, the medicinal fluid
contained within the container will be controllably expelled
therefrom.
[0305] To further control the flow of medicinal fluid from
reservoir 477 toward the administration set 76 of the invention and
then on to the patient, flow control means are provided. These
important flow control means are identical to those previously
described in connection with the embodiment of FIGS. 68 and 69 and
will not here be further discussed.
[0306] As in the last described embodiment, selector member housing
342 is retained in its first position by a tear strip 354 that is
removably receivable between a circumferentially extending rib 342a
formed on housing 342 and the upper extremity 352b of guide sleeve
352. When the tear strip 354 is removed and rotary force exerted on
selector member housing 342 will move the housing along with the
penetrating assembly 480 into the second position shown in FIG. 84
and in so doing will cause the penetrating member 480a to penetrate
sealing wall 474b of top wall 472c of the container assembly.
[0307] Penetrating member 480a is of a slightly different
construction that is better suited for penetrating sealing wall
474b of the container assembly. More particularly, penetrating
member 480a has a generally cylindrically shaped body portion 481a,
an intermediate tapered portion 481b and a reduced diameter sharp
penetrating extremity 481c. To guide the travel of the penetrating
member 480a, the support member 466 here includes a guide
passageway 467, which guides the travel of the penetrating member
480a as selector member housing 342, along with penetrating
assembly 480 is moved from the first position shown in FIG. 83 to
the second position shown in FIG. 84. As the penetrating member
480a pierces wall 474b, tapered portion 481b sealably engages
tapered wall 474c of luer-like connector 474 thereby forming a
substantially fluid seal.
[0308] Piercing of wall 474b opens a fluid communication path from
reservoir 477 to the rate control assembly 350 via a central fluid
passageway 481d formed in penetrating member 480a. From passageway
481d, fluid will flow through conventional particulate filter 357,
into the inlet of the rate control assembly 350 and into the
circumferentially spaced-apart fluid passageways formed in the
selector housing 342. In operating the apparatus in the manner
previously described herein, by rotating the selector member 370,
which is carried by selector member housing 342 passageway 376 can
be selectively brought into index with one of the radial extensions
384 of the axially extending passageways formed in selector member
370, thereby providing fluid communication between outlet
passageway 378 and the selected one of the circuitous flow
passageways formed in rate control plate 364. Since outlet
passageway 378 is in fluid communication with the administration
set 76 of the invention via passageway 386, the rate of fluid flow
toward the patient can be precisely controlled by selecting a rate
control passageway of appropriate geometry, width and length that
is formed in rate control plate 364 (see FIG. 69E).
[0309] Turning next to FIGS. 89 through 94, still another form of
the dispensing apparatus of the present invention for dispensing
medicaments to a patient is there shown and generally designated by
the numeral 492.
[0310] This alternate form of dispensing apparatus is similar in
many respects to that shown in FIGS. 83 through 88 and like
numerals are used in FIGS. 89 through 94 to identify like
components.
[0311] The major difference between this latest embodiment of the
invention and that shown in FIGS. 83 through 88 resides in the
differently configured reservoir defining container assembly 494
and the somewhat differently configured penetrating assembly 495.
As before, in constructing the container assembly 494, the basic
container is formed using the aseptic blow-fill-seal technique
earlier described herein and the reservoir portion of the container
is sealed by the interconnected walls of the container.
[0312] As best seen in FIGS. 89 and 90 the supporting structure 498
is similar in many respects to supporting structure 464 and here
comprises a connector assembly 500 and a generally cylindrically
shaped outer housing 502 that is interconnected with the connector
assembly in the manner best seen in FIG. 89 of the drawings.
[0313] Disposed within outer housing 498 is the carriage assembly
430, which is of identical construction and operation to that
previously described and is releasably locked in its first position
by locking means also identical in construction and operation to
the locking means previously described herein. Carried by the
carriage assembly 430 is the previously identified reservoir
defining assembly 494.
[0314] Once again, in order to controllably move the carriage
assembly from its first position to its second position, novel
stored energy means are provided. This novel stored energy means,
which is operably associated with carriage assembly 430, is here
provided in the form of three constant force springs 70, which are
also identical construction and operation to that previously
described.
[0315] As in the earlier described embodiments of the invention,
following operation of the operating means at the invention, when
the locking means of the invention is manipulated in a manner to
unlock the carriage assembly from base portion 502a of the outer
housing 502, springs 70 will move from their extended position
shown in FIG. 89 to their retracted position shown in FIG. 90 and
in so doing will controllably move the carriage assembly from its
starting position shown in FIG. 89 to its fully deployed or
extended position shown in FIG. 90. As the carriage assembly moves
toward its contracted position, container 494a will be urged to
move into the collapsed configuration shown in FIGS. 90 and 94.
Following operation of the operating means, as the collapsible
container collapses, the medicinal fluid contained within the
container will be controllably expelled therefrom through fluid
passageway 496a formed in the penetrating member 496. As before,
penetrating member 496 is receivable within a luer-like connector
497 having internal threads 497a. Connector 497, which forms a part
of the novel reservoir access means of this latest form of the
invention, is interconnected with top wall 499 of the collapsible
container at the time of manufacture of the collapsible container
assembly 494.
[0316] To further control the flow of medicinal fluid from
reservoir 507 of the collapsible container 494a toward the
administration set 76 and then on to the patient, flow control
means are provided. Once again, this novel fluid flow control
means, comprises two cooperating components, namely a rate control
means for controlling the rate of fluid flow from the collapsible
reservoir and an operating means for controlling fluid flow between
the collapsible reservoir and the rate control means. These
components are, in this latest embodiment of the invention,
substantially identical in construction and operation to those
described in connection with Figure drawings 68 through 69A.
However, as previously mentioned, the penetrating member 496 is of
a slightly different construction that is better suited for
penetrating top thin sealing wall 509 of top wall 499 of the
container assembly. More particularly, penetrating member 496 has a
generally cylindrically shaped body portion 496b which, as before,
is coated with an elastomer, such as silicone, an intermediate
tapered portion 496c and a reduced diameter penetrating extremity
496d.
[0317] Support member 500 includes a guide passageway 500a, which
guides the travel of the penetrating member 496. Similarly, member
500 has a sealing wall which sealably engages the reduced diameter
penetrating extremity 496d following its penetration of thin
sealing wall 509 of the top wall 499 of the container assembly.
[0318] In this latest embodiment of the invention, selector member
housing 242, along with penetrating assembly 495 is rotatably
movable from the first position shown in FIG. 89 to the second
position shown in FIG. 90. In addition to guiding the travel of
member 242, guide sleeve 250 defines a cylindrical space 250a about
which the administration line 76a of the administration set can be
coiled in the manner best seen in FIG. 89.
[0319] As in the earlier described embodiment, selector member
housing 242 is retained in its first position by a tear strip 252
that is removably receivable between a circumferentially extending
rib 242a formed on housing 242 and the upper extremity 250b of
guide sleeve 250. When the tear strip 252 is removed, a rotational
force exerted on selector member housing 242 will move the housing
along with the penetrating assembly into the second sealed position
shown in FIG. 90 and in so doing will cause the penetrating member
496 to pierce thin sealing container wall 509 in the manner shown
in FIG. 90. Piercing of wall 509 opens a fluid communication path
from reservoir 507 to the rate control assembly 350 and then into
the circumferentially spaced-apart fluid passageways formed in the
selector housing 242. In operating the apparatus in the manner
previously described herein, by rotating the selector member 370,
which is carried by selector member housing 242, the rate of fluid
flow toward the patient can be precisely controlled.
[0320] Turning next to FIGS. 95 through 99, still another form of
the dispensing apparatus of the present invention for dispensing
medicaments to a patient is there shown and generally designated by
the numeral 512. This alternate form of dispensing apparatus is
similar in many respects to that shown in FIGS. 89 through 94 and
like numerals are used in FIGS. 95 through 99 to identify like
components.
[0321] The major difference between this latest embodiment of the
invention and that shown in FIGS. 88 through 91 resides in the
differently configured reservoir defining container 514. As shown
in FIGS. 95 and 98, container 514, rather than being in the nature
of the collapsible bottle, comprises a reservoir defining unitary
container having a bellows-like sidewall 514a that is movable from
the expanded, starting configuration shown in FIG. 95 to the
collapsed configuration shown in FIG. 96. This important reservoir
defining container here includes, in addition to sidewall 514a, an
interconnected bottom wall 514b and an interconnected top wall
514c.
[0322] Connected to top wall 514c and extending therefrom is a
luer-like connector 497 which is substantially identical to that
previously described. Collapsible unitary container 514 defines a
fluid reservoir 517 that is accessible via a penetrating member 496
that is identical to the penetrating member previously described in
connection with FIGS. 89 and 90 and is adapted to pierce a closure
wall 514d in the manner previously described.
[0323] As indicated in FIGS. 95 and 96 the supporting structure 498
is substantially identical to the supporting structure of the last
described embodiment. Similarly, the carriage assembly 430, which
is carried within cylindrically shaped outer housing 502, is of
identical construction and operation to that previously described
and is releasably locked in its first position by locking means
also identical in construction and operation to the locking means
previously described herein. Carried by carriage assembly 430 in
the manner illustrated in FIG. 95 is the previously described
reservoir defining container assembly 514.
[0324] As in the earlier described embodiments of the invention,
following the operation of the operating means when the locking
means of the invention is manipulated in a manner to unlock the
carriage assembly from base portion 502a of the outer housing 502,
springs 70 will move from their extended position shown in FIG. 95
to their retracted position shown in FIG. 96 and in so doing will
controllably move the carriage assembly from its starting position
shown in FIG. 95 to its fully contracted position shown in FIG. 96.
As the carriage assembly moves toward its deployed position, the
accordion-like, collapsible sidewall 514a of the collapsible
container assembly 514 will move into the collapsed configuration
shown in FIG. 96. As the container collapses, the medicinal fluid
contained within the container will be controllably expelled
therefrom.
[0325] To further control the flow of medicinal fluid from
reservoir 517 toward the administration set 76 of the invention and
then on to the patient, flow control means are provided. These
important flow control means are identical to those previously
described in connection with the embodiment of FIGS. 88 through 91
and will not here be further discussed.
[0326] As in the last described embodiment, selector member housing
242 is retained in its first position by a tear strip 252. When the
tear strip 252 is removed, a rotational force exerted on selector
member housing 242 will move the housing along with the penetrating
assembly into the second position shown in FIG. 96 and in so doing
will cause the penetrating member 496 to pierce the closure wall
514d and sealably engage sealing wall 497b of member 500.
[0327] Piercing of the closure wall 514d opens a fluid
communication path from reservoir 517 to the rate control assembly
250. The fluid will then flow into the circumferentially
spaced-apart fluid passageways formed in the selector housing 242.
In operating the apparatus in the manner previously described
herein, by rotating the selector member 370, which is carried by
selector member housing 242, the rate of fluid flow toward the
patient can be precisely controlled.
[0328] Turning next to FIGS. 100 through 105, still another form of
the dispensing apparatus of the present invention for dispensing
medicaments to a patient is there shown and generally designated by
the numeral 522. This alternate form of dispensing apparatus is
similar in many respects to that shown in FIGS. 95 through 99 and
like numerals are used in FIGS. 100 through 105 to identify like
components.
[0329] The difference between this latest embodiment of the
invention and that shown in FIGS. 95 through 99 resides in the
slightly differently configured reservoir defining unitary
container 524 and the slightly differently configured penetrating
assembly 526. As shown in FIG. 100 unitary container 524 is similar
in most respects to container 494 of FIG. 89 except that the
luer-like connector 527 is provided with a differently configured
sealing wall 537 for sealably engaging the slightly differently
configured penetrating member 526a of penetrating assembly 526.
[0330] Reservoir defining container 524 has a collapsible sidewall
524a that is movable from the expanded, starting configuration
shown in FIG. 100 to the collapsed configuration shown in FIG. 101.
This important reservoir defining container here includes, in
addition to sidewall 524a, an interconnected bottom wall 524b, an
interconnected top wall 524c to which luer-like connector 527 is
attached. Luer-like connector 527 here forms a part of the novel
reservoir access means of the invention.
[0331] Collapsible container assembly 524 defines a fluid reservoir
531 that is accessible via elastomer coated penetrating member
526a. Penetrating member 526a here comprises an elongated body
portion 533 that terminates in a substantially punch-like end 535
comprising a cutter means that is adapted to pierce closure wall
537 of luer-like connector 527 in the manner shown in FIGS. 100 and
101. After penetrating member 526a pierces closure wall 537, the
elongated body portion 533 of the penetrating member sealably
engages sealing wall 527a of luer-like connector 527 in the manner
shown in FIG. 101 to form a substantially perfect fluid seal.
[0332] As best seen in FIGS. 100 and 101 the supporting structure
538 is similar in many respects to supporting structure 498 and
here comprises a connector assembly 538a and a generally
cylindrically shaped outer housing 538b that is interconnected with
the connector assembly in the manner best seen in FIG. 100 of the
drawings. Connector assembly 538a includes a guide passageway 540
that guides the travel of penetrating member 526a.
[0333] Except for the differently configured collapsible container
524 and the differently configured penetrating member 526a, the
apparatus of this latest form of the invention, including the
carriage assembly 330, the locking means, the stored energy source
and a flow control means operate in the same manner to accomplish
the same result as the apparatus discussed in connection with FIGS.
95 through 99.
[0334] Turning next to FIGS. 106 through 110, still another form of
the dispensing apparatus of the present invention for dispensing
medicaments to a patient is there shown and generally designated by
the numeral 532.
[0335] This alternate form of dispensing apparatus is similar in
many respects to that shown in FIGS. 100 through 105 and like
numerals are used in FIGS. 106 through 110 to identify like
components.
[0336] The difference between this latest embodiment of the
invention and that shown in FIGS. 100 through 105 resides only in
the differently configured reservoir defining container unitary
assembly 534. As shown in FIG. 106, container 535 of reservoir
defining container assembly 534, rather than being in the nature of
the collapsible bottle, comprises a reservoir defining container
having a bellows-like sidewall 535a that is movable from the
expanded, starting configuration shown in FIG. 106 to the collapsed
configuration shown in FIG. 107. This important reservoir defining
container here includes, in addition to sidewall 535a, an
interconnected bottom wall 535b and an interconnected top wall
535c.
[0337] Connected to top wall 535c and extending therefrom is
luer-like connector 527, which is identical to that shown in FIG.
100. Collapsible container assembly 534 defines a fluid reservoir
537 that is accessible via penetrating member 526a that is
identical to the penetrating member previously described in
connection with FIGS. 100 and 101 and is adapted to pierce an
integrally formed thin film closure wall 539 in the manner
previously described.
[0338] Except for the differently configured collapsible unitary
container 535a, the apparatus of this latest form of the invention,
including the carriage assembly 330, the locking means, the stored
energy source and a flow control means operate in the same manner
to accomplish the same result as the apparatus discussed in
connection with FIGS. 100 through 105.
[0339] Referring next to FIGS. 111 through 116, still another form
of the dispensing apparatus of the present invention for dispensing
medicaments to a patient is there shown and generally designated by
the numeral 542. This alternate form of dispensing apparatus is
similar in some respects to the earlier described embodiments shown
in FIGS. 72 through 77 and like numerals are used in FIGS. 111
through 116 to identify like components.
[0340] The primary difference between this latest form of
dispensing apparatus and that previously described in connection
with FIGS. 72 through 77 resides in the provision of a novel stored
energy source, which is of a totally different construction. More
particularly, rather than being constant force springs, the novel
stored energy means of this latest form of the invention comprises
a compressible, expandable sponge-like configuration, which is
generally designated in the drawings by the numeral 544. This
unique stored energy source, which functions to move carriage 546
from the first compressed position shown in FIG. 111 to the second
expanded position shown in FIG. 112 can take several forms. By way
of non-limiting example, stored energy source 544 can comprise a
microporous, mesoporous, macroporous, ordered structure and can be
constructed from Polypropylene (PP), Ultra High Molecular Weight
Polyethylene (UHMWPE), High Density Polyethylene (HDPE),
Polyvinylidene Fluoride (PVDF), Ethyle-vinyl Acetate (EVA), Styrene
Acrylonitrile (SAN), Polytetrafluroethylene (PTFE) and porous
cellulose acetate. A suitable source of these materials is NUSIL
Technologies of Carpinteria, Calif. However, practice has shown
that any porous plastic material including an open cell, porous
sponge material is suitable for use in constructing the stored
energy source. The stored energy source can also comprise a
metallized foam as described in greater detail in connection with
the embodiments of FIGS. 65 through 67.
[0341] As in the embodiment of the invention shown in FIG. 72, the
reservoir defining assembly 440 here comprises a collapsible
container assembly 442, which is of identical construction that
previously described and is carried by carriage assembly 546 in the
manner illustrated in FIG. 111. Container assembly 442 can be
interconnected with the connector member either by threads, or as
shown here, by a snap-fit assembly.
[0342] As before, the carriage assembly 546 is releasably secured
to base portion 438a of the outer housing 438 by a novel locking
means. Following operation of the operating means when the locking
means of the invention is manipulated in a manner to unlock the
carriage assembly 546 from the base portion 438a, sponge 544 will
expand from the first compressed position shown in FIG. 111 to the
second expanded position shown in FIG. 112 and in so doing will
controllably move the carriage assembly from its starting position
shown in FIG. 111 to its fully deployed or extended position shown
in FIG. 112. As the carriage assembly moves toward its deployed
position, the sidewall 442a of the collapsible container 442 will
move into the collapsed configuration shown in FIG. 112. As the
collapsible container collapses, the medicinal fluid contained
within the container reservoir 447 will be controllably urged
outwardly thereof.
[0343] To control the flow of medicinal fluid from reservoir 447
toward the administration set 76 of the invention and then on to
the patient, flow control means are provided. Once again, this
novel fluid flow control means, comprises two cooperating
components, namely a rate control means for controlling the rate of
fluid flow from the collapsible reservoir and an operating means
for controlling fluid flow between the collapsible reservoir and
the rate control means. Both the operating means and the rate
control means of this latest form of the invention are identical in
construction and operation to those described in connection with
the embodiment of FIGS. 72 through 77.
[0344] As in the earlier described embodiment, the selector member
housing 342 is retained in its first position by a tear strip 354.
When the tear strip is removed, a rotational force exerted on
selector member housing 342 will move the housing along with the
penetrating assembly 338 into the second position shown in FIG. 112
and in so doing will cause the penetrating member 344 to pierce the
septal membrane 452 as well as the thin sealing closure wall 444 in
the manner shown in FIG. 112. Piercing of the membrane 452 and the
thin sealing closure wall 444 opens a fluid communication path from
reservoir 447 to the rate control assembly 350 via a central fluid
passageway 344a formed in penetrating member 344. From reservoir
447, the fluid will flow through central fluid passageway 344a of
penetrating member 344, through conventional particulate filter
357, through the rate control assembly 350, through the selector
member 370 and toward the patient via the administration set
76.
[0345] Referring next to FIGS. 117 through 121, yet another form of
the dispensing apparatus of the present invention for dispensing
medicaments to a patient is there shown and generally designated by
the numeral 552. This alternate form of dispensing apparatus is
similar in most respects to that shown in FIGS. 111 through 116 and
like numerals are used in FIGS. 117 through 121 to identify like
components. The major difference between this latest embodiment of
the invention and that shown in FIGS. 111 through 116 resides in
the differently configured reservoir defining container 554. As
shown in FIGS. 117 and 120, unitary container 554, rather than
being in the nature of the collapsible bottle, comprises a
reservoir defining container having a bellows-like sidewall 554a
that is movable from the expanded, starting configuration shown in
FIG. 117 to the collapsed configuration shown in FIG. 118. This
important reservoir defining container here includes, in addition
to sidewall 554a, an interconnected bottom wall 554b, an
interconnected top wall 554c and an interconnected neck portion
554d, which is sealed following filling at the time of manufacture
by a thin closure wall 555. Neck portion 554d forms a part of the
novel reservoir access means of the invention. Collapsible
container 554 defines a fluid reservoir 557 that is accessible via
a penetrating member 344 that is identical to that previously
described. Elastomer-coated penetrating member 344 is adapted to
pierce closure wall 555 as well as a pierceable membrane 452, which
is positioned over closure wall 555 by means of a closure cap 454,
which is affixed to the neck portion 554d of container assembly 554
(see also FIGS. 120 and 121).
[0346] As best seen in FIGS. 117 and 118 the supporting structure
is substantially identical to the supporting structure of the last
described embodiment and here comprises a connector assembly 436
and a generally cylindrically shaped outer housing 438 that is
interconnected with the connector assembly in the manner best seen
in FIG. 117 of the drawings.
[0347] Disposed within outer housing 438 is the carriage assembly
546, which is of identical construction and operation to that
previously described and is releasably locked in its first position
by locking means also identical in construction and operation to
the locking means previously described herein. Carried by the
carriage assembly is the previously described reservoir defining
container 554.
[0348] As in the last described embodiment of the invention, thin
sealing closure wall 555 is sealably interconnected with neck
portion 554d and top wall 554c in accordance with the previously
described aseptic blow-fill-seal technique previously
discussed.
[0349] As before, the basic unitary container 554 is formed using
the earlier described aseptic blow-fill-seal technique and after
filling the reservoir portion of the container is sealed by the
thin closure wall 555. The piercable membrane 452 is then
positioned over the closure wall 555 and the cap 454 is positioned
over the piercable membrane and secured to neck portion 554d by any
suitable means such as adhesive bonding or sonic welding. The
container along with neck portion 554d is then interconnected with
connector member 436 and retained in position by the previously
described snap-fit tabs.
[0350] Once again, in order to controllably move the carriage
assembly from its first position to its second position, novel
stored energy means are provided. This novel stored energy means,
which is operably associated with carriage assembly 546, is here
provided in the form of a compressible, expandable sponge-like
configuration 544, which is identical in construction and operation
to that previously described.
[0351] As in the earlier described embodiments of the invention
following operation of the operating means, when the locking means
of the invention is manipulated in a manner to unlock the carriage
assembly from base portion 438a of the outer housing 438, sponge
544 will expand and in so doing will controllably move the carriage
assembly from its starting position shown in FIG. 117 to its fully
deployed or extended position shown in FIG. 118. As the carriage
assembly moves toward its deployed position, the sidewall 554a of
the collapsible container 554 will be urged to move toward the
collapsed configuration shown in FIG. 118. As the collapsible
container collapses, the medicinal fluid contained within the
container will be controllably expelled therefrom.
[0352] To control the flow of medicinal fluid from reservoir 557
toward the administration set 76 of the invention and then on to
the patient, flow control means are provided. Once again, this
novel fluid flow control means, comprises two cooperating
components, namely a rate control means for controlling the rate of
fluid flow from the collapsible reservoir and an operating means
for controlling fluid flow between the collapsible reservoir and
the rate control means. Both the operating means and the rate
control means of this latest form of the invention are identical in
construction and operation to those described in connection with
the embodiment of FIGS. 111 and 112.
[0353] As in the earlier described embodiment, selector member
housing 342 is retained in its first position by a tear strip 354.
When the tear strip is removed, a rotational force exerted on
selector member housing 342 will move the housing along with the
penetrating assembly into the second position shown in FIG. 118 and
in so doing will cause the penetrating member 344 to pierce the
membrane 452 as well as the closure wall 555 in the manner shown in
FIG. 118. Piercing of the membrane 452 and the closure wall 555
opens a fluid communication path from reservoir 557 to the rate
control assembly 350 via a central fluid passageway 344a formed in
penetrating member 344. From reservoir 557, the fluid will flow
through central fluid passageway 344a of penetrating member 344,
through conventional particulate filter 357, through the rate
control assembly 350, through the selector member 370 and toward
the patient via the administration set 76.
[0354] Turning next to FIGS. 122 through 126, still another form of
the dispensing apparatus of the present invention for dispensing
medicaments to a patient is there shown and generally designated by
the numeral 562. This alternate form of dispensing apparatus is
similar in many respects to that shown in FIGS. 83 through 88 and
like numerals are used in FIGS. 122 through 126 to identify like
components. As best seen in FIGS. 122 and 123 the supporting
structure 564 is similar in many respects to supporting structure
436 of FIGS. 111 and 112 and here comprises a connector assembly
566 and a generally cylindrically shaped outer housing 568 that is
interconnected with the connector assembly in the manner best seen
in FIG. 122 of the drawings.
[0355] Disposed within outer housing 568 is the carriage assembly
546, which is of identical construction and operation to that
described in connection with the preceding embodiment and is
releasably locked in its first position by locking means also
identical in construction and operation to the locking means
previously described herein. Carried by carriage assembly 546 is a
reservoir defining assembly 570, which is of a somewhat different
construction. This important reservoir defining assembly here
includes a bottle-like collapsible, unitary container assembly 572
having a sidewall 572a, an interconnected bottom wall 572b and an
interconnected top wall 572c. Connected to top wall 572c and
extending therefrom is a luer-like connector 574 having external
threads 574a and a thin film sealing wall 574b. Connector 574,
which is interconnected with top wall 572c at the time of
manufacture of the collapsible container assembly, forms a part of
the novel reservoir access means of this latest form of the
invention. Collapsible container assembly 570 defines a fluid
reservoir 577 that is accessible via a penetrating member 344 that
is identical to that previously described and is adapted to pierce
top wall 574b and sealably engage a sealing wall 574c formed on
connector 574.
[0356] In the preferred form of this latest alternate embodiment of
the invention, following filling of the container the luer-like
connector 574 is sealably interconnected with top wall 572c in
accordance with the previously described aseptic blow-fill-seal
technique.
[0357] In order to controllably move the carriage assembly from its
first position to its second position, novel stored energy means
are provided. This novel stored energy means, which is operably
associated with carriage assembly 546, is here provided in the form
of a compressible, expandable sponge-like configuration 544, which
is identical in construction and operation to that previously
described.
[0358] As in the earlier described embodiments of the invention,
following operation of the operating means when the locking means
of the invention is manipulated in a manner to unlock the carriage
assembly from base portion 568a of the outer housing 568, sponge
544 will expand from its extended position shown in FIG. 122 to the
position shown in FIG. 123 and in so doing will controllably move
the carriage assembly from its starting position shown in FIG. 122
to its fully deployed or extended position shown in FIG. 123. As
the carriage assembly moves toward its deployed position, the
collapsible sidewall 572a of the collapsible container 572 will
move into the collapsed configuration shown in FIG. 123. As the
container collapses, the medicinal fluid contained within the
container will be controllably expelled therefrom.
[0359] To further control the flow of medicinal fluid from
reservoir 577 toward the administration set 76 of the invention and
then on to the patient, flow control means are provided. These
important flow control means are identical to those previously
described in connection with the previously described embodiments
and will not here be further discussed.
[0360] As in the last described embodiment, selector member housing
342 is retained in its first position by a tear strip 354. When the
tear strip 354 is removed, a rotational force exerted on selector
member housing 342 will move the housing along with the penetrating
assembly 344 into the second position shown in FIG. 123 and in so
doing will cause the penetrating member 344 to penetrate top wall
574b of the container assembly.
[0361] Piercing of wall 574b opens a fluid communication path from
reservoir 577 to the rate control assembly 350 via a central fluid
passageway 344a formed in penetrating member 344. From passageway
344a, fluid will flow through conventional particulate filter 357,
into the inlet of the rate control assembly 350 and into the
circumferentially spaced-apart fluid passageways formed in the
selector housing 342. In operating the apparatus in the manner
previously described herein, by rotating the selector member 370,
which is carried by selector member housing 342, the rate of fluid
flow toward the patient can be precisely controlled by selecting
the rate control passageway of appropriate geometry, width and
length that is formed in rate control plate 364.
[0362] Turning next to FIGS. 127 through 130, yet another form of
the dispensing apparatus of the present invention for dispensing
medicaments to a patient is there shown and generally designated by
the numeral 572. This alternate form of dispensing apparatus is
similar in many respects to that shown in FIGS. 122 through 126 and
like numerals are used in FIGS. 127 through 130 to identify like
components. As best seen in FIGS. 127 and 128 the supporting
structure 564 is similar in many respects to supporting structure
436 of FIGS. 111 and 112 and here comprises a connector assembly
566 and a generally cylindrically shaped outer housing 568 that is
interconnected with the connector assembly in the manner best seen
in FIG. 127 of the drawings.
[0363] Disposed within outer housing 568 is the carriage assembly
546, which is of identical construction and operation to that
described in connection with the preceding embodiment and is
releasably locked in its first position by locking means also
identical in construction and operation to the locking means
previously described herein. Carried by carriage assembly 546 is a
reservoir defining assembly 574, which is of a somewhat different
construction. This important reservoir defining assembly here
comprises a unitary collapsible container assembly 576 having an
accordion-like sidewall 576a, an interconnected bottom wall 576b
and an interconnected top wall 576c. Connected to top wall 572c and
extending therefrom is a Luer-like connector 578 having external
threads 578a and a sealing wall 578b. Connector 578, which is
interconnected with top wall 576c at the time of manufacture of the
collapsible container assembly, forms a part of the novel reservoir
access means of this latest form of the invention. Collapsible
container assembly 576 defines a fluid reservoir 579 that is
accessible via a penetrating member 344 that is identical to that
previously described and is adapted to pierce top wall 578b and
sealably engage sealing wall 578c formed on connector 578.
[0364] In the preferred form of this latest alternate embodiment of
the invention, following filling of the container the luer-like
connector 578 is sealably interconnected with top wall 576c in
accordance with the previously described aseptic blow-fill-seal
technique.
[0365] In order to controllably move the carriage assembly from its
first position to its second position, novel stored energy means
are provided. This novel stored energy means, which is operably
associated with carriage assembly 546, is here provided in the form
of a compressible, expandable sponge-like configuration 544, which
is identical in construction and operation to that previously
described.
[0366] As in the earlier described embodiments of the invention,
following operation of the operating means when the locking means
of the invention is manipulated in a manner to unlock the carriage
assembly from base portion 568a of the outer housing 568, sponge
544 will expand from its compressed position shown in FIG. 127 to
the expanded position shown in FIG. 128 and in so doing will
controllably move the carriage assembly from its starting position
shown in FIG. 127 to its fully deployed or extended position shown
in FIG. 128. As the carriage assembly moves toward its deployed
position, the collapsible sidewall 576a of the collapsible
container 576 will move into the collapsed configuration shown in
FIG. 128. As the container collapses, the medicinal fluid contained
within the container will be controllably expelled therefrom.
[0367] To further control the flow of medicinal fluid from
reservoir 579 toward the administration set 76 of the invention and
then on to the patient, flow control means are provided. These
important flow control means are identical to those previously
described in connection with the previously described embodiments
and will not here be further discussed.
[0368] As in the last described embodiment, selector member housing
342 is retained in its first position by a tear strip 354. When the
tear strip 354 is removed, a rotational force exerted on selector
member housing 342 will move the housing along with the penetrating
assembly 344 into the second position shown in FIG. 128 and in so
doing will cause the penetrating member 344 to penetrate top wall
578b of the container assembly.
[0369] Piercing of wall 578b opens a fluid communication path from
reservoir 579 to the rate control assembly 350 via a central fluid
passageway 344a formed in penetrating member 344. From passageway
344a, fluid will flow through conventional particulate filter 357,
into the inlet of the rate of control assembly 350 and into the
circumferentially spaced-apart fluid passageways formed in the
selector housing 342. In operating the apparatus in the manner
previously described herein, by rotating the selector member 370,
which is carried by selector member housing 342, the rate of fluid
flow toward the patient can be precisely controlled by selecting
the rate control passageway of appropriate geometry and length that
is formed in rate control plate 364.
[0370] Having now described the invention in detail in accordance
with the requirements of the patent statutes, those skilled in this
art will have no difficulty in making changes and modifications in
the individual parts or their relative assembly in order to meet
specific requirements or conditions. Such changes and modifications
may be made without departing from the scope and spirit of the
invention, as set forth in the following claims.
* * * * *