U.S. patent application number 09/927686 was filed with the patent office on 2002-01-31 for medicinal dosing apparatus and method.
Invention is credited to Farris, Barry.
Application Number | 20020011497 09/927686 |
Document ID | / |
Family ID | 22979044 |
Filed Date | 2002-01-31 |
United States Patent
Application |
20020011497 |
Kind Code |
A1 |
Farris, Barry |
January 31, 2002 |
Medicinal dosing apparatus and method
Abstract
External manipulation of a prefilled vial to dispense its
contents by deforming the vial is disclosed.
Inventors: |
Farris, Barry; (Pollock
Pines, CA) |
Correspondence
Address: |
Bernhard Kreten, Esq.
Bernhard Kreten, Esq. & Associates
Suite 245
77 Cadillac Drive
Sacramento
CA
95825
US
|
Family ID: |
22979044 |
Appl. No.: |
09/927686 |
Filed: |
August 9, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09927686 |
Aug 9, 2001 |
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09258085 |
Feb 25, 1999 |
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6296150 |
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Current U.S.
Class: |
222/102 ;
222/103; 222/105 |
Current CPC
Class: |
A61M 5/148 20130101;
A61M 5/2425 20130101; A61M 1/83 20210501; B65D 35/285 20130101 |
Class at
Publication: |
222/102 ;
222/103; 222/105 |
International
Class: |
B65D 035/28 |
Claims
I claim:
1. A dose administering device, comprising, in combination: a
closed end wall, a flexible, collapsible sidewall circumscribing
said end wall, an outlet coupling at an end of said sidewall
opposite said closed end wall, fluid in said device, and plunger
means disposed on an exterior of said device's flexible sidewall to
eject fluid by constricting said sidewall.
2. The device of claim 1 wherein said plunger means includes means
to sequester substantially all liquid in the fluid adjacent said
outlet coupling.
3. The device of claim 2 wherein said plunger means includes a
handle which supports said sequestering means thereon.
4. The device of claim 3 wherein said plunger means is embodied as
a plurality of rollers straddling said device.
5. The device of claim 4 wherein two rollers are provided, said
rollers oriented in planar registry and having a common end which
permits arcuate movement of one roller with respect to another.
6. The device of claim 5 including an end of said rollers remote
from said common end provided with latching means.
7. The device of claim 6 wherein said rollers are mounted on
spindles, and said spindles are received in collars, said collars
interconnected by a pivot defining said common end and including
biasing means for urging said rollers into parallel registry.
8. The device of claim 7 wherein said remote end includes a
resiliently biased catch which holds said rollers in parallel
registry.
9. The device of claim 8 wherein said outlet coupling is formed as
a luer coupling.
10. The device of claim 8 wherein said outlet coupling is formed as
a spike.
11. The device of claim 8 wherein said outlet is configured as a
conical taper narrowing from said sidewalls towards an axial
centerline to frictionally overlie a luer coupling.
12. The device of claim 2 wherein said sequestering means includes
a pair of arcuately shaped anvils under and overlying said flexible
sidewalls, adapted with means to contact said sidewalls and cause
tangential registry between opposing sidewalls thereof, to squeeze
liquid from said outlet by translating parallel a long axis of said
sidewall.
13. The device of claim 2 wherein said sequestering means includes
an upper tine located above said sidewall and a pair of lower tines
on an opposite side of said sidewall spaced from said upper tine so
that, upon moving said upper tine and lower tines relatively closer
to each other, said upper tine is straddled between said lower
tines.
14. The device of claim 13 wherein said tines are constrained to
operate on a frame, and a vertical trackway located on said frame
constrains said upper tine to move between said lower tines.
15. The device of claim 14 wherein said tines are contoured as
rollers.
16. The device of claim 6 including a tab projecting from said end
wall of said device and retaining means located above and below
said tab for grasping said tab to facilitate motion of said rollers
with respect to said tab.
17. The device of claim 16 wherein said tab includes a narrowed
waist portion adjacent said end wall and said retaining means
includes upper and lower teeth dimensioned to grip within said
narrowed waist portion.
18. The device of claim 4 wherein said rollers are attached to a
first link mechanism connected by a pivot to a second link, said
second link constraining said device at said outlet.
19. The device of claim 18 wherein said links include independent
adjustment means including a slot on one said link through which
said pivot is allowed to move, said slot having a plurality of
undulations to fix said pivot in one of several spots.
20. The device of claim 19 wherein free ends of each said link,
adjacent said device are provided with pivots.
21. The device of claim 20 wherein one of said pivots on said link
operates in a trackway.
22. A method for medicinal dosing, the steps including:
sequestering gas from liquid in a vial, constricting the vial to
sequester the gas in one area, opening the vial at a liquid
containing other area and squeezing the liquid from the vial by
deforming the via.
23. An apparatus for dosing, comprising, in combination: a vial
formed from elastically deformable material and having a sealed
outlet, liquid contained within said vial, means exterior said vial
for distorting an interior of said vial into two zones, one zone
with liquid adjacent said outlet, another zone predominately with
gas, said exterior means including means for squeezing the liquid
from said vial upon unsealing said outlet.
Description
BACKGROUND OF THE INVENTION
[0001] Syringes are well known medicinal dosing devices. In
essence, they operate by having a substantially cylindrical bore
within which a piston reciprocates. One end of the cylindrical bore
admits and dispels fluid from the interior while another end of the
cylinder allows a piston plunger to be received for axial
translation in providing the propelling force for the introduction
and utilization of the liquid. While these devices perform the
avowed purpose of dispensing medicine, they have changed little
since their inception. Typically, the piston includes a peripheral
seal at an end thereof within the cylinder of the syringe and
remote from the plunger. This seal is frequently lubricated with
silicone to reduce the co-efficient of friction and may include
latex, both ingredients of which have been the subject matter of
ongoing scrutiny with respect to adverse patient reactions to these
two products. In addition, in order for the syringe to receive the
fluid, they either must be prefilled which provides an opportunity
for contamination during the prefilling process, or they must be
subsequently filled at the site of usage which requires that the
syringe cooperate with an ampoule or a vial for fluid
transferal.
[0002] In response to these problems, applicant has devised a
series of prefilled syringes which are formed ascepticly and are
filled concurrently in a blow-fill seal process. These prefilled,
blow-filled seal syringes have dispensed for the need of receiving
fluid from another source after the manufacture of the syringe,
since the syringe is filled concurrently at its site of
fabrication. While this product operates quite efficient and
admirably, applicant has developed other devices in order to
provide solutions to problems in related areas of this
industry.
[0003] For example, applicant has devised an ampoule which is
elastically deformable and prefilled using blow-fill seal
technology which can dock with existing, conventional, known
syringes in order to provide a more economical ampoule or vial
where preference still exists for a conventional syringe.
[0004] The following prior art reflects the state of the art of
which applicant is aware and is included herewith to discharge
applicant's avowed duty to disclose relevant prior art. It is
respectfully submitted, however, that none of the prior art when
considered singly or in any conceivable, permissible combination
teaches or renders obvious the instant invention set forth
hereinafter.
1 PATENT NO. ISSUE DATE INVENTOR 829,178 August 21, 1906 Stegmaier
1,643,531 September 27, 1927 Wolf 1,762,430 June 10, 1930 Tokita
2,486,321 October 25, 1949 O'Sullivan 2,667,165 January 26, 1954
Smith 2,667,872 February 2, 1954 Smith 2,744,527 May 8, 1956
Barrett, et al. 2,744,528 May 8, 1956 Barrett, et al. 2,748,770
June 5, 1956 Moeck 2,768,623 October 30, 1956 Marchand 2,881,953
April 14, 1959 Kuschel 2,911,972 November 10, 1959 Elinger
3,078,847 February 26, 1963 Wandell, et al. 3,089,489 May 14, 1963
Dunmire 3,187,966 June 8, 1965 Klygis 3,261,381 July 19, 1966 Roach
3,335,914 August 15, 1967 Strazdins, et al. 3,340,869 September 12,
1967 Bane 3,419,007 December 31, 1968 Love 3,557,788 January 26,
1971 Swartz 3,712,295 January 23, 1973 Kline 3,736,933 June 5, 1973
Szabo 3,938,514 February 17, 1976 Boucher 3,977,553 August 31, 1976
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4,046,145 September 6, 1977 Choksi, et al. D 246,321 November 8,
1977 Lofman 4,130,117 December 19, 1978 Van Eck 4,168,032 September
18, 1979 Sneider 4,213,456 July 22, 1980 Bottger 4,248,227 February
3, 1981 Thomas 4,282,986 August 11, 1981 af Ekenstam, et al.
4,357,937 November 9, 1982 Burrell, Jr., et al. 4,411,656 October
25, 1983 Cornett, III 4,465,472 August 14, 1984 Urbaniak 4,502,616
March 5, 1985 Meierhoefer 4,506,793 March 26, 1985 MacGregor, et
al. 4,548,601 October 22, 1985 Lary 4,610,670 September 9, 1986
Spencer 4,643,309 February 17, 1987 Evers 4,753,638 June 28, 1988
Peters 4,883,473 November 28, 1989 Thomas 4,944,736 July 31, 1990
Holtz 4,955,871 September 11, 1990 Thomas 4,966,312 October 30,
1990 Waring 4,994,039 February 19, 1991 Mattson 5,035,689 July 30,
1991 Schroeder 5,102,398 April 7, 1992 Farris 5,215,221 June 1,
1993 Dirksing 5,222,950 June 29, 1993 Eisenberg 5,242,422 September
7, 1993 Schneberger, et al. 5,334,173 August 2, 1994 Armstrong, Jr.
5,356,406 October 18, 1994 Schraga 5,370,626 December 6, 1994
Farris 5,374,263 December 20, 1994 Weiler 5,409,125 April 25, 1995
Kimber, et al. 5,478,322 December 26, 1995 Farris, et al. 5,509,906
April 23, 1996 Poynter 5,538,506 July 23, 1996 Farris, et al.
5,716,346 February 10, 1998 Farris FOREIGN PRIOR ART FR 470700
April 7, 1914 Viviez DE 446819 July 7, 1927 Gaertner DE 556491
August 10, 1932 Meyer GB 0386298 February 9, 1933 Charlier DE
0577611 June 2, 1933 Schuckertwerke GB 557400 November 18, 1943
Wirth CH 0279468 March 1, 1952 Burmester CH 0092396 October 15,
1959 Merck & Co., Inc. FR 1316596 December 26, 1962 Bouet FR
1330410 May 13, 1963 Modiano AU 278032 December 2, 1965 Calmic
Limited FR 2058585 May 3, 1971 Darbon WO 87/01944 April 9, 1987
Axipac Limited FR 2594687 August 28, 1987 Hosnedl EU 324257 July
19, 1989 Smith Industries EU 350772 January 17, 1990 Hansen DE
3827335 February 15, 1990 Pfeiffer E & Co. SU 1553135 March 30,
1990 Popov
SUMMARY OF THE INVENTION
[0005] The instant invention takes into account the fact that not
all syringe related deployments require the elaborate methodologies
and structure of the prior art in order to be effective. One common
scenario involves catheter flushing which occurs predominately in a
hospital environment and requires that a flush be applied in the
catheter prior to and subsequent to the utilization of the catheter
for the delivery of medicine. Flushes typically include hepheron or
saline in sufficient quantity to purge the catheter line free from
the tendency of blood at the site from clotting.
[0006] Other examples where it is not essential to deliver
extremely precise dosages include intermuscular and some vaccine
injections and situations where exigent circumstances (i.e., time
is of the essence) and the portability of the medicine far
outweighs the risks associated with time delay (eg., battle field
environments).
[0007] The instant invention displays a variety of techniques which
offer varying degrees of precision by taking an economical medicine
storage device expeditiously and immediately deploying it without
intervening manipulations.
[0008] At its broadest, the instant invention is directed to a
device configured as a vial, preformed with the medication
contained therewithin which can serve as the dosage administering
device immediately. Initially, the liquid within the vial is
sequestered from gas, commonly introduced during the manufacturing
process. Once this sequestration has occurred, and perhaps
sequestering some of the liquid with the gas, the vial can be
oriented to push a quantity of the liquid immediately to its
intended site. The outlet of the vial can have any of several
contours, some of which are standardized by convention. For
example, a luer coupling can be disposed at the outlet, a spike can
be deployed at the outlet, or an outlet which is complemental to a
luer can be found at the outlet end.
[0009] Various instrumentalities can be disposed on the exterior in
order to act as an external plunger operating on exterior sidewalls
of the vial to urge the liquid out from the vial while retaining
the gas therewithin. All instrumentalities act on sidewalls of the
vial.
OBJECTS OF THE INVENTION
[0010] Accordingly, it is a primary object of the present invention
to provide a new and improved elastically deformable vial including
means to provide external pressure thereto, collapsing the vial to
remove the liquid therefrom, thus acting as an external syringe
plunger.
[0011] A further object of the present invention is to provide a
device as characterized above which is economical in construction,
asceptic in fact and durable in use.
[0012] Viewed from a first vantage point, it is an object of the
present invention to provide a dose administering device,
comprising, in combination: a closed end wall, a flexible,
collapsible sidewall circumscribing the end wall, an outlet
coupling at an end of the sidewall opposite the closed end wall,
fluid in said device, and plunger means disposed on an exterior of
said device's flexible sidewall to eject fluid by constricting the
sidewall.
[0013] Viewed from a second vantage point, it is an object of the
present invention to provide a method for medicinal dosing, the
steps including: sequestering gas from liquid in a vial,
constricting the vial to sequester the gas in one area, opening the
vial at a liquid containing other area and squeezing the liquid
from the vial by deforming the vial.
[0014] Viewed from a third vantage point, it is an object of the
present invention to provide an apparatus for dosing, comprising,
in combination: a vial formed from elastically deformable material
and having a sealed outlet, liquid contained within the vial, means
exterior the vial for distorting an interior of the vial into two
zones, one zone with liquid adjacent the outlet, another zone
predominately with gas, the exterior means including means for
squeezing the liquid from the vial upon unsealing the outlet.
[0015] These and other objects will be made manifest when
considering the following detailed specification when taken in
conjunction with the appended drawing figures.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] FIG. 1 is a perspective view of the apparatus according to
one form of the present invention.
[0017] FIG. 2 shows the vial associated therewith.
[0018] FIG. 3 shows the vial of FIG. 2 deployed on the device of
FIG. 1.
[0019] FIG. 4 is a schematic depiction of the apparatus of FIG. 3
in use.
[0020] FIG. 5 shows a second stage of the apparatus of FIG. 3 in
use.
[0021] FIG. 6 is a detail of one enabling component of that which
is shown in FIG. 1.
[0022] FIG. 7 is another enabling component of that which is shown
in FIG. 1.
[0023] FIG. 8 shows a first possible outlet on the vial.
[0024] FIG. 9 shows a second alternative outlet on the vial.
[0025] FIG. 10 shows a third alternative outlet on the vial.
[0026] FIG. 11 is an alternative embodiment to FIGS. 1 through
7.
[0027] FIG. 12 is another embodiment compared to FIGS. 1 through
7.
[0028] FIG. 13 shows FIG. 12 in a second deployed state.
[0029] FIG. 14 is another embodiment.
[0030] FIG. 15 shows FIG. 14 in a deployed configuration.
[0031] FIG. 16 shows FIGS. 14 and 15 in use.
[0032] FIG. 17 is a schematic depiction of another variation.
[0033] FIG. 18 shows FIG. 17 in the deployed configuration.
[0034] FIG. 19 shows FIGS. 17 and 18 in another stage.
[0035] FIG. 20 shows an adjustment capability of the instrument in
FIGS. 17 through 19.
[0036] FIG. 21 shows an initial manipulative step in using the
vial.
[0037] FIG. 22 shows a stage in manipulating the vial.
[0038] FIG. 23 shows a further stage of FIG. 22.
DESCRIPTION OF PREFERRED EMBODIMENTS
[0039] Considering the drawings, wherein like reference numerals
denote like parts throughout the various drawing figures, reference
numeral 10 is directed to the apparatus according to one form of
the present invention.
[0040] In its essence, the apparatus includes a rectangular hand
grip 2 which transversely supports a pair of rollers 6, 12 at one
end thereof. The rollers 6, 12 can be oriented to gird a vial 50,
and remove the contents therefrom. Initially, the vial 50 is
oriented as shown in FIG. 21 so that the gas appears at a tab end
52 of the vial and the liquid L is adjacent an outlet 54. At this
stage, note the outlet 54 remains closed with a removable opener 56
integrally formed thereto. Once the gas has been sequestered
adjacent the tab 52, the pair of rollers 6 and 12 constrict the
vial 50 as shown in FIGS. 3 and 4. This constriction is
sufficiently effective to sequester substantially all of the liquid
L to the left of FIG. 4 and all of the gas G to the right of the
rollers.
[0041] FIGS. 6 and 7 show details of how the rollers cooperate
against the vial to facilitate constriction. The left hand side of
FIG. 1 is shown in FIG. 6 and includes upper and lower bearing
collars 24, 22 into which roller spindles 8, 4 are placed. The
roller spindles allow rotation of the rollers 12, 6 thereon. The
upper bearing collar 24 is hinged to the lower bearing collar 22 as
shown in FIG. 1 by means of a pivot hinge 26 which extends between
ears 27 reaching up from the lower bearing collar 22. A lower
portion of the upper bearing collar 24 is necked-down to nest in
between the ears 27. The converse could have also been used for
support where the ears are on the upper bearing collar and the
necked-down portion on the lower bearing collar. FIG. 6 shows a
torsion spring 28 wrapped around the pivot hinge 26 to provide
biasing and urge the rollers 6, 12 to naturally go from the open
position of FIG. 1 to the closed position of FIG. 4. Thus, work has
to be done along arrow "A" to separate the rollers.
[0042] FIG. 7 reflects details of the right hand side of the
rollers of FIG. 1, and shows a catch mechanism that tightly
captures the upper roller to the lower roller. The catch is in the
form of a slip hook 16 which when deployed as shown in FIG. 3
overlies the upper roller spindle 8. When the vial 50 is so
captured, minimal clearance exists between the opposite walls of
the vial as shown in FIG. 4. The rollers 6, 12 themselves may be
constructed from any suitable material and may have a durametric
value which assures that the opposite walls of the vial are in
relatively tight tangential registry. The force B exerted by the
hook 16 assures a positive locking between the upper and lower
rollers via their respective spindles and is enhanced by a torsion
spring 18 wound about the lower spindle 4 and having a free end
abutting against the handle 2. An opposite free end includes a pip
20 that locates on a complementally formed indent on the hook 16.
The spring 18 ensures positive engagement and urges the hook 16 to
the closed and latched position so that force is required opposite
arrow "B" to unlatch the hook. FIG. 3 shows the position where the
rollers are set on to the vial 50 and the vial opening 54 has been
exposed by removing the closure 56. The vial 50 can then be docked
onto a fluid receiving device 100 shown to the left of FIG. 4. This
device can be a syringe needle if the vial 50 has a luer coupling
as shown in FIG. 9 or may be a complementally formed luer receiver
as shown in FIG. 10 which as a dimension X, complemental to the
taper of the luer in FIG. 9 upstream from its opening to allow
frictional engagement thereover. The outlet 54 may also be
configured as shown in FIG. 8 which is termed a cannula spike.
[0043] Typically, when the vial 50 is used as a flushing device,
the need for a precise amount of liquid dispensed by the vial 50 is
not as critical as when one is dispensing certain pharmacological
substances. Flushing frequently entails the washing of a catheter
site with heparin or saline and is not critical with respect to the
precise amount used at the catheter site.
[0044] Various other instrumentalities for causing the liquid to be
urged from the vial 50 are shown in FIGS. 11 through 20. In FIG.
11, the rollers are replaced with upper and lower pressure
administering devices 70 which do not rotate, but slide from right
to left to remove the liquid. The pressure imposed and the
coefficient of friction of such an anvil-type device 70 is designed
to provide sure, positive motion. Each anvil has a curved smooth
bottom surface to encourage point contact where they address one
another. The curve also provides low stress on the vial. FIG. 12
shows a variation in which a triangular frame 80 supports tines or
two lower rollers 82 and an upper tine or roller 84 constrained to
operate within a trackway 86 which is vertically disposed when in
the FIG. 13 orientation. Roller 84, when moved from its highest
elevation to its lowest elevation through the trackway 86 provides
the constriction of the vial and allows the rollers to translate
from right to left of that drawing figure.
[0045] FIGS. 14 through 16 show the roller arrangement of FIG. 1,
and adds a retaining mechanism 90 located above and below the tab
52. The retaining mechanism 90 replaced the FIG. 4 finger pressure
and acts as jaws which allow the tab to remain relatively
stationary (compared to the rollers) and therefore the vial when
the rollers 6 and 12 are first constricted against the vial and
then relatively translated. The retaining mechanism 90 includes
teeth 92 which are dimensioned to grip within a narrowed-down waist
53 where the tab 52 affixes to the main body of the vial 50. FIGS.
15 and 16 show the retaining mechanism 90 engaged on the vial with
the rollers 6, 12 advancing towards the outlet 54.
[0046] FIGS. 17 through 20 show an operation similar to FIGS. 14
through 16 in which the hand tool operates oppositely from that
which is shown in FIGS. 14 through 16. In other words, the
retaining jaws 90 in FIGS. 14 and 16 are instead modified and
located at the outlet end 54 of the vial. These modified retaining
devices 190 are fixed to a first link 192 in a pliers-type of
arrangement. It should be appreciated that any link mechanism
associated with FIGS. 14 through 16 would operate similar to that
which is shown in FIGS. 17 through 20. In FIGS. 17 through 20 the
rollers are attached to a second link 194 of the mechanism and a
pivot 196 extends in between them. The pivot 196 is shown as being
located on the first link 192. The second link 194 includes a slot
198 having a plurality of stops 188 depicted as undulations for
adjustment of the two links with respect to one another by
orientation of the pivot 196 in any of the undulation stops 188
formed in the slot 198. The upper extremities of each of the links
may include hinges 201, 203 respectively on the first link 192 and
second link 194. These hinges allow articulation as the links move
from an open position to a closed position as shown in FIG. 19. In
addition, at least one link, preferably the second link 194
constrains its hinge 203 to operate in a trackway 205 to provide
further freedom of motion and prevent tool binding.
[0047] FIGS. 21 through 23 schematically depict the process of
removing liquid from the vial. First sequester the gas into the
vial adjacent the tab 52. Then crease the vial below the gas and
next remove the cap 56 from the opening. Squeeze out the
liquid.
[0048] Moreover, having thus described the invention, it should be
apparent that numerous structural modifications and adaptations may
be resorted to without departing from the scope and fair meaning of
the instant invention as set forth hereinabove and as described
hereinbelow by the claims.
* * * * *