U.S. patent application number 12/837329 was filed with the patent office on 2010-11-04 for device with penetrable and resealable portion.
Invention is credited to Daniel Py.
Application Number | 20100276035 12/837329 |
Document ID | / |
Family ID | 23275266 |
Filed Date | 2010-11-04 |
United States Patent
Application |
20100276035 |
Kind Code |
A1 |
Py; Daniel |
November 4, 2010 |
Device with penetrable and resealable portion
Abstract
A syringe and a reconstitution syringe are provided for the
delivery of controlled doses of any of numerous different sterile
substances, such as vaccines, medicaments, pharmaceutical
preparations, cosmetics, and food products. A plunger of the
syringe defines a resealable stopper frictionally and slidably
received within a hollow syringe body for dispensing the medicament
or other substance through a dispensing tip of the syringe upon
movement of the plunger. The resealable stopper defines a
heat-sealable portion to allow the stopper to be penetrated by a
needle or other filling device to fill the syringe with a
medicament or other substance, and in turn allow the hole remaining
upon withdrawal of the needle to be heat sealed by transmission of
laser energy thereon. A reconstitution syringe defines within a
syringe body plural compartments, wherein each compartment stores a
respective component of a multi-component medicament or other
preparation.
Inventors: |
Py; Daniel; (Stamford,
CT) |
Correspondence
Address: |
MCCARTER & ENGLISH, LLP HARTFORD;CITYPLACE I
185 ASYLUM STREET
HARTFORD
CT
06103
US
|
Family ID: |
23275266 |
Appl. No.: |
12/837329 |
Filed: |
July 15, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11714004 |
Mar 5, 2007 |
7779609 |
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12837329 |
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10265075 |
Oct 3, 2002 |
7186241 |
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11714004 |
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60327128 |
Oct 3, 2001 |
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Current U.S.
Class: |
141/98 |
Current CPC
Class: |
A61M 5/1782 20130101;
A61M 2005/3123 20130101; A61J 1/2044 20150501; A61M 5/284 20130101;
A61M 5/3129 20130101; A61J 1/2093 20130101; A61J 1/2041 20150501;
A61J 1/2055 20150501 |
Class at
Publication: |
141/98 |
International
Class: |
B65B 3/04 20060101
B65B003/04 |
Claims
1-20. (canceled)
21. A device including a body defining a sealed empty chamber, and
a penetrable and thermally resealable portion in fluid
communication with the chamber, wherein the penetrable and
thermally resealable portion defines a penetrable region that is
penetrable by a filling member for introducing a sterile substance
through the penetrable and thermally resealable portion and into
the chamber, and is resealable in response to the application of
laser radiation thereto at a predetermined wavelength and power for
hermetically sealing the penetrable region and the sterile
substance within the chamber after removing the filling member from
the penetrable region, wherein the penetrable and thermally
resealable portion defines (i) a predetermined wall thickness, (ii)
a predetermined color and opacity that substantially absorbs the
laser radiation at the predetermined wavelength and substantially
prevents the passage of the radiation through the predetermined
wall thickness thereof, and (iii) a predetermined color and opacity
that causes the laser radiation at the predetermined wavelength and
power to hermetically seal a filling member aperture formed in the
penetrable region within a predetermined time period and
substantially without burning the penetrable region.
22. A device as defined in claim 21, further comprising a device
that exerts pressure on sterile substance in the device in order to
dispense the substance from the device.
23. A device as defined in claim 22, wherein the device is manually
engageable to exert pressure on the sterile substance.
24. A device as defined in claim 23, wherein the manually
engageable device exerts pressure on the sterile substance
contained within the chamber in order to dispense the substance
therefrom.
25. A device as defined in claim 21, further comprising a sterile
food hermetically sealed within the chamber.
26. A device as defined in claim 21, further comprising a manually
engageable device for dispensing substantially metered amounts of
substance therefrom.
27. A device as defined in claim 21, further comprising a first
body portion defining a first compartment forming a first sealed,
empty storage chamber; a second body portion defining a second
compartment forming a second sealed storage chamber; wherein the
penetrable and thermally resealable portion is in fluid
communication with the first storage chamber, and the first and
second compartments define a storage state in which the first and
second compartments are hermetically sealed relative to each other,
and a dispensing state in which the first and second compartments
are in fluid communication with each other.
28. A device as defined in claim 27, wherein at least one of the
first and second body portions is movable relative to the other
from the storage state to the dispensing state.
29. A device as defined in claim 27, wherein the penetrable and
thermally resealable portion is penetrable by a needle for
aseptically filling a respective chamber through the needle and is
laser resealable for resealing a resulting needle hole therein upon
removing the needle therefrom.
30. A device as defined in claim 21, wherein the penetrable and
thermally resealable portion thermally insulates the sterile
substance in the chamber from the laser energy applied by the laser
source to avoid thermal damage to the sterile substance in the
chamber.
31. A device as defined in claim 21, wherein the penetrable and
thermally resealable portion includes an overlying portion formed
of a first material, and an underlying portion formed of a second
material.
32. A device as defined in claim 31, wherein the overlying portion
is formed of a fusible material, and the underlying portion is
formed of an infusible material.
33. A device as defined in claim 21, wherein the predetermined time
period is approximately 2 seconds.
34. A device as defined in claim 33, wherein the predetermined time
period is less than or equal to about 1.5 seconds.
35. A device as defined in claim 34, wherein the predetermined time
period is less than or equal to about 1 second.
36. A device as defined in claim 21, wherein the predetermined
wavelength is about 980 nm.
37. A device as defined in claim 21, wherein the predetermined
power is less than about 30 watts.
38. A device as defined in claim 37, wherein the predetermined
power is less than or equal to about 10 watts.
39. A device as defined in claim 21, wherein the predetermined
opacity is defined by a colorant in an amount within the range of
about 0.3% to about 0.6% by weight.
40. A device as defined in claim 39, wherein the colorant is
gray.
41. A device as defined in claim 21, wherein the penetrable and
thermally resealable portion includes a styrene block copolymer and
an olefin.
42. A device as defined in claim 41, wherein the ratio of the
styrene block copolymer to the olefin is within the range of about
50:50 by weight to about 95:5 by weight.
43. A device as defined in claim 21, wherein the predetermined
color is gray.
44. A device for storing a sterile substance including a body
defining a sealed empty chamber, and means in fluid communication
with the chamber and defining a predetermined wall thickness for
penetration by a filling member, for introducing the sterile
substance therethrough and into the chamber, for substantially
absorbing laser radiation at a predetermined wavelength and power,
for substantially preventing the passage of the radiation through
the predetermined wall thickness thereof, and for causing the laser
radiation at the predetermined wavelength and power to hermetically
seal a filling member aperture formed therein within a
predetermined time period and substantially without burning the
penetrable region for hermetically sealing the sterile substance
within the chamber.
45. A device as defined in claim 44, wherein the means is a
thermoplastic portion defining a penetrable region that is
resealable to hermetically seal a filling member aperture by
applying laser radiation at a predetermined wavelength and power
thereto, wherein the penetrable and thermally resealable portion
comprises a thermoplastic body defining (i) a predetermined wall
thickness, (ii) a predetermined color and opacity that
substantially absorbs the laser radiation at the predetermined
wavelength and substantially prevents the passage of the radiation
through the predetermined wall thickness thereof, and (iii) a
predetermined color and opacity that causes the laser radiation at
the predetermined wavelength and power to hermetically seal a
needle aperture formed in the needle penetration region thereof in
a predetermined time period and substantially without burning the
penetrable region.
46. A device as defined in claim 44, wherein the predetermined
wavelength is about 980 nm, the predetermined power is less than
about 30 watts, and the predetermined time period is approximately
2 seconds.
47. A device used to store and deliver a sterile food product
including a body defining a sterile chamber, and a penetrable and
thermally resealable portion in fluid communication with the
chamber, wherein the penetrable and thermally resealable portion
defines a penetrable region that is penetrable by a filling member
for introducing the sterile food product through the penetrable and
thermally resealable portion and into the chamber, and is
resealable in response to the application of laser radiation
thereto at a predetermined wavelength and power for hermetically
sealing the penetrable region and the sterile food product within
the chamber after removing the filling member from the penetrable
region, wherein the penetrable and thermally resealable portion
defines (i) a predetermined wall thickness, (ii) a predetermined
color and opacity that substantially absorbs the laser radiation at
the predetermined wavelength and substantially prevents the passage
of the radiation through the predetermined wall thickness thereof,
and (iii) a predetermined color and opacity that causes the laser
radiation at the predetermined wavelength and power to hermetically
seal a filling member aperture formed in the penetrable region in a
predetermined time period.
48. A device including a first body portion defining a first
compartment forming a first sealed, empty storage chamber; a second
body portion defining a second compartment forming a second sealed
storage chamber; and a penetrable and thermally resealable portion
in fluid communication with the first storage chamber; wherein the
first and second compartments define a storage state in which the
first and second compartments are hermetically sealed relative to
each other, and a dispensing state in which the first and second
compartments are in fluid communication with each other, the
penetrable and thermally resealable portion is penetrable by a
filling member coupled in fluid communication with a source of a
first component for introducing the first component through the
filling member and into the first sealed, empty storage chamber,
and is resealable after withdrawing the filling member from the
penetrable and thermally resealable portion by applying radiation
thereto to reseal the penetrated region and form a substantially
gas-tight seal between the penetrated region and the first
compartment.
49. A device as defined in claim 48, wherein the first compartment
contains the first component, and the second compartment contains a
second component, and at least one of the first and second
compartments is movable from (i) a storage state in which the first
and second compartments are hermetically sealed relative to each
other to prevent intermixing of the first and second components, to
(ii) a dispensing state in which the first and second compartments
are in fluid communication with each other to allow intermixing the
first and second components into a multi-component preparation and
dispensing the preparation.
50. A device as defined in claim 49, wherein the multi-component
preparation is a vaccine, medicament, cosmetic or food product.
51. A device used to store and deliver a sterile substance
including a body defining a sealed empty chamber, and a penetrable
and resealable portion in fluid communication with the chamber,
wherein the penetrable and resealable portion defines a penetrable
region that is penetrable by a filling member for introducing the
sterile substance through the penetrable and resealable portion and
into the chamber, and is resealable in response to the application
of radiation thereto for sealing the penetrable region after
removing the filling member therefrom, wherein the penetrable and
resealable portion defines a predetermined wall thickness for
penetration by the filling member to fill the sterile substance
therethrough and into the chamber, and substantially absorbs the
radiation at the predetermined wavelength and substantially
prevents the passage of the radiation therethrough to hermetically
seal a filling member aperture formed in the penetrable region
thereof in a predetermined time period and substantially without
burning the penetrable region.
52. A device as defined in claim 50, wherein the radiation is laser
radiation.
53. A device as defined in claim 50, wherein the penetrable and
resealable portion includes an overlying portion formed of a first
material, and an underlying portion formed of a second material.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This patent application claims the benefit of U.S.
application Ser. No. 10/265,075, filed Oct. 3, 2002, which claims
the benefit of U.S. Provisional Application Ser. No. 60/327,128,
filed Oct. 3, 2001, entitled "Syringe And Reconstitution Syringe",
the contents of which are hereby expressly incorporated by
reference as part of the present disclosure.
BACKGROUND
[0002] The present invention relates to syringes for delivering
controlled, metered doses of any of numerous different substances
to humans or animals, such as vaccines, medicaments and
pharmaceutical preparations. The syringes of the present invention
may include means for controlling the travel of the plungers in the
syringes for delivering precise amounts of the substances contained
within the syringes. The syringes of the present invention also may
include fusible or heat sealable stoppers connected to, or
otherwise forming the plungers, for hermetically sealing the
interfaces between the plungers and the interiors of the syringes,
and thereby preventing ingress of air or contaminants through the
plungers and into contact with the medicaments or other substances
contained within the syringes.
[0003] A typical prior art syringe includes a hollow syringe body,
a plunger slidably received within one end of the hollow body, and
a needle connected to the other end of the hollow body. The plunger
is moved through the syringe body to, in turn, eject through the
needle the medicament or other substance contained within the
syringe. The syringe body typically defines a transparent,
graduated cylinder, and the user visually aligns the plunger tip
with the appropriate graduation to dispense a desired amount of
medicament or other substance from the syringe. One of the
drawbacks associated with this type of syringe is that physicians,
practitioners and other users may become tired, have difficulty
focusing on the graduations, and/or may shake or otherwise have
difficulty precisely aligning the plunger with the correct
graduation (s) on the syringe body. As a result, human error or
physical impairment can easily cause a user to dispense the
incorrect amount of medicament or other substance from the syringe,
and similarly prevent a user from precisely metering a constant
dosage from one application to the next. When dispensing
medicaments, accurate and controlled delivery is critical,
particularly for avoiding overmedication. Overmedication can
especially occur when the medicament is in the form of a liquid or
other type of fluid.
[0004] Several devices described in the prior art permit controlled
doses of medicaments to be delivered. These devices can be
complicated to manufacture, assemble and fill with medicaments. As
a result, these devices can be expensive to manufacture and may not
be useful for vaccines, over the counter ("OTC") medicaments, and
other types of pharmaceutical preparations. Another disadvantage of
these prior art devices is that air can enter the device during
filling and/or storage after the device is filled. Air entering the
device during filling or storage can cause degradation of the
medicament or other substance contained therein, reducing the
efficacy of the medicament or other substance, and/or causing
spoilage which may require that the medicament or other substance
be discarded.
[0005] For some medicaments, preservatives are added to prevent
degradation or spoilage of the medicament before use due to ingress
of air or other contaminants. The preservatives can react with the
medicament, however, reducing its efficacy. Also, some users can
have undesirable adverse reactions to the preservatives in the
medicaments.
[0006] Accordingly, it is an object of a currently preferred
embodiment the present invention to provide a syringe that can be
filled with a sterile substance, such as a vaccine, medicament or
other pharmaceutical preparation, while maintaining the sterility
of the syringe and substance during filling and storage thereafter.
It is yet another object of a currently preferred embodiment of the
present invention to provide a syringe with a heat sealable and/or
fusible stopper on the plunger that prevents ingress of air or
other contaminants through the plunger and into the substance
contained within the syringe.
[0007] It is also an object of a currently preferred embodiment of
the present invention to provide a syringe including means for
providing a metered dose of a substance contained within the
syringe, such as a vaccine, medicament or pharmaceutical
preparation. It is another object of a currently preferred
embodiment of the present invention to provide a syringe that can
be relatively inexpensive to manufacture, easy-to-use and that
provides a metered dose of a vaccine or other medicament,
pharmaceutical preparation or other substance.
[0008] It is an object of another currently preferred embodiment of
the present invention to provide a reconstitution syringe including
multiple chambers for storing multi-component substances, such as
vaccines, and other medicaments and pharmaceutical preparations,
whereby the components can be mixed immediately prior to use and
metered doses of such substances can be dispensed from the
syringe.
SUMMARY OF THE INVENTION
[0009] One aspect of the present invention is directed to a syringe
that may be used for the delivery of any of numerous different
sterile substances, such as vaccines, medicaments, pharmaceutical
preparations, cosmetics, and food products. In accordance with one
aspect of the present invention, the syringe comprises a syringe
body defining therein a chamber for receiving a predetermined
substance to be dispensed from the syringe. A plunger of the
syringe is slidably received within the syringe body for dispensing
the substance upon movement therein. The plunger includes a
resealable stopper penetrable by a needle or like filling member
for introducing the predetermined substance through the stopper and
into the chamber of the syringe body. The penetrable region of the
resealable stopper is fusible in response to the application of
thermal energy thereto for hermetically sealing the penetrable
region upon removing the needle or like filling member
therefrom.
[0010] In one embodiment of the present invention, the resealable
stopper includes a base portion formed of a first material
compatible with the predetermined substance contained within the
syringe. The base portion defines a peripheral surface for slidably
contacting an inner wall of the syringe body and a
substance-exposed surface defining the portion of the stopper
exposed to the predetermined substance contained within the
syringe. A resealable portion overlies the base portion, and both
the resealable portion and base portion are penetrable by the
needle or like filling member for introducing the predetermined
substance through the stopper and into the syringe body. The
penetrable region of the base portion is substantially infusible in
response to the application of thermal energy thereto, and the
penetrable region of the resealable portion is fusible in response
to the application of thermal energy thereto for hermetically
sealing the penetrable region upon removing the needle or like
filling member therefrom.
[0011] In another embodiment of the present invention, the
penetrable region of the resealable stopper is heat resealable to
hermetically seal the needle aperture by applying laser radiation
at a predetermined wavelength and power thereto. The resealable
stopper comprises a thermoplastic body defining (i) a predetermined
wall thickness in an axial direction thereof, (ii) a predetermined
color and opacity that substantially absorbs the laser radiation at
the predetermined wavelength and substantially prevents the passage
of the radiation through the predetermined wall thickness thereof,
and (iii) a predetermined color and opacity that causes the laser
radiation at the predetermined wavelength and power to hermetically
seal a needle aperture formed in the needle penetration region
thereof in a predetermined time period of less than approximately 2
seconds and substantially without burning the needle penetration
region. In a currently preferred embodiment of the present
invention, the needle penetration region is formed of a
thermoplastic blend of a first material consisting essentially of a
styrene block copolymer and a second material consisting
essentially of an olefin. Preferably, the first and second
materials are blended within a range of about 50:50 to about 95:5
by weight.
[0012] In one embodiment of the present invention, the syringe
includes means for controlling the travel of the plunger assembly
to deliver a pre-determined dose of the substance contained within
the syringe. The means for controlling the travel of the plunger
assembly may include, for example, cam-like members formed on the
upper guide portion of the plunger assembly which engage and
cooperate with steps formed on the inner wall of the upper chamber
of the syringe body. As the plunger assembly is rotated, the
cam-like members travel along the steps to create step-wise
movement of the plunger assembly into the syringe. The step-wise
movement results in delivery of a precise, pre-determined quantity
of the substance contained in the syringe with each step-wise or
incremental movement of the plunger.
[0013] Another aspect of the present invention is directed to a
syringe provided in the form of a reconstitution syringe that
includes multiple compartments for storage of any of numerous
different multi-component substances for forming vaccines,
medicaments, or other pharmaceutical preparations. In a currently
preferred embodiment of the present invention, the syringe body
includes an upper chamber, a transition portion, and a lower
chamber that contains the compartments for storage of the
multi-component substances. The plunger assembly preferably
includes an outer frame which extends to a point within the lower
chamber of the syringe body. At the end of the outer frame within
the lower chamber of the syringe body, an elastomeric plug is held
in an opening in the outer frame. A closure member is contained
within the outer frame of the plunger assembly and extends from the
top of the syringe body to approximately the top of the lower
chamber of the syringe body. The closure member includes a base
that seals the lower portion of the outer frame. In a currently
preferred embodiment of the reconstitution syringe of the present
invention, the top of the closure member includes a plurality of
cam-like members which engage steps on the inner wall of the
syringe body, or like means for providing step-wise movement of the
plunger assembly.
[0014] Also in a currently preferred embodiment of the present
invention, the reconstitution syringe includes two compartments for
storing the multiple components of the substance to be contained
within the syringe body. The first compartment is defined by the
walls of the outer frame, the base of the closure member, and the
inner surface of the end of the outer frame, including the
elastomeric plug. The second compartment is formed in the lower
portion of the syringe body and is defined by the dispensing tip
and the outer surface of the end of the outer frame, including the
elastomeric plug.
[0015] In use, the first compartment of the syringe contains a
first component of a multi-component vaccine, medicament or other
preparation, which is typically a fluid, such as a saline solution
or a solvent. The second compartment contains a second component of
the preparation, which may be a powder, a liquid, or another fluid
or lyophilized product. To mix the two components, the closure
member is held in place and the outer frame is withdrawn from the
syringe body until a snap engagement on the upper portion of the
closure is engaged by the outer frame. As the outer frame is
withdrawn, the fluid in the first compartment exerts pressure on
the elastomeric plug, causing the plug to be released and thereby
placing the first and second compartments in fluid communication
with each other and allowing the first and second components to
intermix. The elastomeric plug acts as a mixing ball to thereby
provide means for facilitating mixing of the two components and, in
turn, provide a multi-component mixture. The outer frame and
closure cooperate to form the plunger mechanism for delivery of the
preparation.
[0016] To create a hermetically-sealed compartment for storage of
the preparation in the syringe, the currently preferred embodiments
of the present invention include a fusible or heat sealable stopper
at the base of the plunger. The compartment(s) for storage of the
preparation is (are) filled by inserting a needle, such as a
non-coring, double lumen needle, through the fusible stopper into
the storage compartment. As the storage compartment is filled, the
air in the storage compartment is allowed to escape through an
annular one-way valve formed on the outer periphery of the fusible
stopper. After the storage compartment is filled, the heat sealable
insert on the fusible stopper is heated, such as by laser
transmission, to fuse the hole created by the needle, and the
one-way valve on the outer periphery of the fusible stopper returns
to its normal position to hermetically seal the interface between
the plunger and the interior of the syringe.
[0017] One advantage of the currently preferred embodiments of the
present invention is that the fusible or heat sealable stopper on
the plunger provides a hermetically sealable interface between the
plunger and the interior of the syringe, thus preventing
contamination of the interior of the syringe during filling and
storage of the syringe. In addition, the resealable stoppers enable
the syringes of the present invention to be filled with a sterile
substance, such as a vaccine, medicament or other pharmaceutical
preparation, while maintaining the sterility of the syringe and
substance during filling and storage thereafter. In addition, the
currently preferred embodiments of the present invention may be
relatively inexpensively manufactured, thereby allowing the
syringes to be used with a wide variety of substances, including
liquids, cremes and ointments.
[0018] Another advantage of the currently preferred embodiments of
the present invention is that they provide means for delivering
controlled doses of vaccines, medicaments and other pharmaceutical
preparations.
[0019] Yet another advantage of the currently preferred embodiments
of the reconstitution syringe of the present invention is that the
separable components of the vaccine, medicament or other
preparation can be stored separately until immediately prior to
use, which is especially advantageous for multi-component
substances that have a relatively short shelf life when mixed.
[0020] Other advantages of the syringes of the present invention
will become more readily apparent in view of the following detailed
description of the preferred embodiments, claims and accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] FIG. 1 is a partial, cross-sectional view of a syringe
embodying the present invention.
[0022] FIG. 2 is a partial, cross-sectional view of the fusible or
heat sealable stopper of the syringe of FIG. 1.
[0023] FIG. 3 is a cross-sectional view of the heat sealable
stopper and syringe body of FIG. 2.
[0024] FIGS. 4A through 4C are somewhat schematic, partial
cross-sectional views of a second syringe embodying the present
invention including means for effecting step-wise movement of the
plunger within the syringe body, and illustrating the progressive
movement of the plunger within the syringe body.
[0025] FIG. 5 is a perspective view of a first half of the syringe
body of FIG. 4.
[0026] FIG. 6 is a perspective view of a second half of the syringe
body of FIG. 4.
[0027] FIG. 7 is a perspective view of the plunger of the syringe
of FIG. 4.
[0028] FIG. 8 is another perspective view of the plunger of the
syringe of FIG. 4.
[0029] FIG. 9 is a somewhat schematic, cross-sectional view of a
reconstitution syringe embodying the present invention.
[0030] FIGS. 10 through 13 are somewhat schematic, cross-sectional
views of the reconstitution syringe of FIG. 9 illustrating
progressively the movement of the outer frame of the plunger
relative to the closure member to intermix the multi-component
preparation, the mixing of the preparation, and the dispensing of
the mixed preparation.
DETAILED DESCRIPTION OF THE INVENTION
[0031] As shown in FIGS. 1 and 2, the present invention relates to
an improved syringe 10 for delivery of controlled doses of sterile
substances, such as vaccines, medicaments and other pharmaceutical
preparations. The syringe 10 comprises a syringe body 12 and a
plunger assembly 14. A fusible or heat sealable stopper 16 is
provided at the base of the plunger 14 to hermetically seal a
chamber 18 of the syringe and thereby prevent ingress of air or
contaminants into contact with the sterile substance contained
therein. As described further below, the currently preferred
embodiments of the present invention preferably include means for
controlling the travel of the plunger in the syringe which results
in the delivery of a relatively precise amount of the sterile
substance in the syringe. In addition, as shown in FIGS. 9-13, the
syringe of the present invention may take the form of a
reconstitution syringe including multiple compartments to allow
separate storage of the components of a multi-component substance,
such as a vaccine, medicament or pharmaceutical preparation, prior
to use. This can be especially advantageous where the medicament
has a relatively short shelf life.
[0032] As used herein, the term "syringe" means a device used to
inject or deliver a substance such as a liquid, creme, ointment or
other fluid into a body or onto the skin. In addition, the term
"plunger" is used herein to mean a device used to exert pressure on
a substance such as a liquid, creme, ointment or other fluid
contained within a chamber of a syringe.
[0033] Hermetically Sealed Syringe Assembly
[0034] In a preferred embodiment of the present invention
illustrated in FIGS. 1-3, the syringe 10 comprises a syringe body
12 and a plunger assembly 14. In accordance with the present
invention, the plunger assembly 14 includes a heat sealable or
fusible stopper 16 allowing the syringe to be filled in a sterile
filling machine of the type disclosed in commonly-assigned U.S.
patent application Ser. No. 09/781,846, filed in the name of Dr.
Daniel Py, which is hereby expressly incorporated by reference as
part of the present disclosure. The syringe body 12 is generally
cylindrical; however, as shown typically in FIG. 3, the outer
surface of the syringe body 12 may define a rectangular or other
non-cylindrical shape to facilitate gripping, mounting within
another device, or otherwise as may be required. A flange 15 (FIG.
4) or other means for gripping the syringe may be provided at the
top of the syringe opposite a dispensing end 17 of the syringe used
for dispensing the medicament or other substance contained within
the syringe.
[0035] At the dispensing end 17 of the syringe, means 19 are
provided to connect a hypodermic needle to the syringe body (not
shown) to dispense the contents of the syringe. The means 19 for
connection of a needle to the syringe body may take the form of any
of numerous different devices or methods that are currently, or
later become known for performing this function. For example, a
conventional connection means marketed under the trademark LUER-LOK
may be included at the end of the syringe to allow connection of a
hypodermic needle. Other needle connection means, such as threaded
fittings, elastomeric plugs, or fitted end caps equally may be used
to attach a needle to the end of the syringe. The lower end 17 of
the syringe body may be shaped or threaded as required in a manner
known to those of ordinary skill in the pertinent art to
accommodate the selected needle connection means 19. A cap or other
means for hermetically sealing the dispensing end of the syringe
(not shown) may be secured to the dispensing end 17 of the syringe
until the hypodermic needle is connected to the syringe to dispense
the medicament or other substance therefrom.
[0036] As shown best in FIG. 2, the plunger assembly 14 comprises a
drive portion 20 fixedly attached to the fusible stopper 16. The
drive portion 20 of the plunger is preferably in the form of a rod
or other appropriate shape, and generally defines an outer diameter
less than the inner diameter of the syringe body 12. As shown in
FIG. 4, at the end of the drive portion 20 opposite the fusible
stopper 16, a flange, knob or other gripping portion 15 is
preferably provided for allowing a user to grip and, in turn, force
the plunger into the syringe to deliver the medicament or other
substance therefrom.
[0037] The fusible stopper 16 is provided at the base of the
plunger 14 to hermetically seal the lower chamber 18 of the
syringe. As shown in FIG. 2, the fusible stopper 16 is formed at
the end of the plunger 14 and includes a resilient base 24 made of
vulcanized rubber or like material which is known to those of
ordinary skill in the pertinent art, and acceptable for use in the
manufacture of stoppers or like elements placed in contact with or
otherwise exposed to the sterile substance to be contained within
the syringe. The lower portion 26 of the base 24 of the fusible
stopper 16 defines a peripheral sealing surface 32 that is shaped
and dimensioned to slidably and frictionally engage the inner wall
of the syringe body 12. The base 24 of the fusible stopper further
defines a peripheral wall 28 extending upwardly from the lower
portion 26 of the base 24. The peripheral wall 28 defines an outer
diameter slightly less than that of the sealing surface 32 and the
inner diameter of the syringe body 12 to reduce the friction
between the fusible stopper and the syringe body upon movement of
the plunger therein.
[0038] At the upper end of the peripheral wall 28, an annular
raised portion or protuberance 34 dimensioned to be frictionally
received within the chamber 18 of the syringe body 12 further seals
the plunger assembly 14 and prevents air from contacting the
medicament contained within the syringe. At the top of the
peripheral wall 28, a one-way valve is formed by a wedge-shaped,
flexible annular flap 36, which is shaped and dimensioned to be
flexible and to contact the inside of the syringe body 12 to form
the annular one-way valve. The tip 38 of the flexible flap 36 makes
contact with the inside of the syringe body 12 when the plunger is
in its fully-retracted position. As shown in FIG. 2, in the
illustrated embodiment of the present invention, the inside
diameter of the syringe body 12 in the area of the one-way valve 36
may be slightly larger than the inside diameter of the syringe at
the base 24 of the fusible stopper 16 when the plunger is in the
illustrated retracted position. As the plunger 14 is advanced into
the syringe body 12, the inside diameter of the syringe body
decreases slightly, causing the flexible flap 36 to make increased
contact with the syringe body, thereby sealing the lower portion of
the syringe from ingress of air.
[0039] As shown in FIGS. 2 and 3, the inner wall of the chamber 18
of the syringe body 12 is provided with a plurality of
axially-elongated grooves 40 angularly spaced relative to each
other about the axis of the syringe. The grooves 40 are formed in
the inner wall of the chamber 18 and extend in the axial direction
from below the base 24 of the fusible stopper 16 when in the
fully-retracted position and upwardly beyond the annular
protuberance 34. As described below, the grooves 40 allow air
contained in the syringe to escape as the syringe is filled with a
medicament or other substance.
[0040] A resealable member 42 is contained within an upper recess
44 of the base 24 defined by the peripheral wall 28. The resealable
member 42 is received within a recess 44 formed in the peripheral
wall 28 of the base 24, and is secured in place by the end of the
drive portion 20 of the plunger. The interior surface of the
peripheral wall 28 of the fusible stopper is shaped with an annular
groove 46. An annular flange 48 is formed at the end of the drive
portion 20 and is dimensioned and shaped complementary to the
annular groove 46 on the interior surface of the peripheral wall
28. Accordingly, the annular flange 48 is pressed, snapped or
otherwise received within the annular groove 46 to fixedly secure
the resealable stopper 16 to the drive portion 20. A second flange
50 is axially spaced relative to the first flange 48 to capture and
retain the base 24 and the resealable stopper on the drive portion.
In the embodiment of the invention shown in FIGS. 1 and 2, the
drive portion 20 is in the form of a hollow tube to allow insertion
of a filling needle to fill the chamber 18, and allow re-sealing of
the needle hole after filling, as described in the above-mentioned
co-pending patent application.
[0041] The resealable member 42 is preferably made of a resilient
polymeric material, such as a blend of the polymeric material sold
by Shell Oil Co. under the registered trademark KRATON.RTM. and a
low-density polyethylene, such as the polyethylene sold by Dow
Chemical Co. under the trademarks ENGAGE.TM. or EXACT.TM.. However,
as may be recognized by those skilled in the pertinent art based on
teachings herein, other appropriate materials that are currently or
later become known for performing the function of the heat sealable
stopper equally may be used. An important feature of the resealable
member 42 is that it be resealable to form a gas tight seal after
inserting a needle or like injection member through the resealable
member. Preferably, the resealable member 42 can be sealed by
heating the area punctured by the needle with laser or other
radiation transmission as described, for example, in the
above-mentioned co-pending patent application.
[0042] To fill the chamber 18 of the syringe with the desired
medicament, a hypodermic needle, a non-coring, double lumen needle,
or other type of injection member is inserted through the
resealable member 42 and the resilient base 24 of the fusible
stopper 16 in order to dispense the medicament or other sterile
substance into the chamber 18 of the syringe. As the medicament is
injected into the chamber of the syringe, the air within the
chamber is displaced by the medicament and forced out. The air
escapes through the plurality of grooves 40 formed in the inner
wall of the syringe body 12. At the top of the peripheral wall 28,
the force of the escaping air causes the flexible flap 36 of the
one-way valve to move away from the inner wall of the syringe body,
allowing the air to pass out of the syringe body. When the syringe
has been filled with the medicament or other substance, the
flexible flap 36 returns to its normal position in contact with the
syringe body 12, thereby forming a hermetic seal to prevent air
from entering the syringe and contacting the medicament or other
substance therein. As the plunger is inserted into the chamber 18
of the syringe, the grooves 40 terminate, and the chamber is
further sealed by the peripheral sealing surface 32 and the annular
protuberance 34 on the resealable stopper 16.
[0043] After the syringe 10 is filled with the medicament or other
substance, the resealable member 42 is heated to fuse the hole
formed by the needle or other filling member. If necessary, a laser
(not shown) may be used to sterilize the surface of the resealable
member prior to needle filling. In addition, the same laser or a
different laser may be used to seal the hole remaining after
filling. Preferably, the syringe is filled in a sterile filling
machine, and in accordance with a method of the types disclosed in
the above-mentioned co-pending patent application. The laser allows
sufficient energy to be directed to the resealable member in the
fusible stopper while avoiding heating of the medicament or other
substance in the syringe. Other methods of heating the resealable
member known to those skilled in the art may be used depending on
the heat sensitivity of the medicament contained in the syringe
and/or other factors.
[0044] Because the syringe is hermetically sealed after it is
filled with the medicament or other preparation, the syringe may be
stored for extended periods of time without spoilage due to ingress
of air and without the addition of preservatives to prevent such
spoilage.
[0045] In the currently preferred embodiments of the present
invention, at least a portion of the resealable stopper is formed
of a thermoplastic material defining a needle penetration region
that is pierceable with a needle to form a needle aperture
therethrough, and is heat resealable to hermetically seal the
needle aperture by applying laser radiation at a predetermined
wavelength and power thereto. In an alternative embodiment of the
present invention, the entire body of the stopper is formed of the
thermoplastic material. In another embodiment of the invention as
described above, an overlying portion of the stopper if formed of
the fusible thermoplastic material, and an underlying portion of
the stopper is formed of an infusible material, such as vulcanized
rubber. Preferably, each thermoplastic portion or body defines (i)
a predetermined wall thickness in an axial direction thereof, (ii)
a predetermined color and opacity that substantially absorbs the
laser radiation at the predetermined wavelength and substantially
prevents the passage of the radiation through the predetermined
wall thickness thereof, and (iii) a predetermined color and opacity
that causes the laser radiation at the predetermined wavelength and
power to hermetically seal the needle aperture formed in the needle
penetration region thereof in a predetermined time period and
substantially without burning the needle penetration region (i.e.,
without creating an irreversible change in molecular structure or
chemical properties of the material). In a currently preferred
embodiment, the predetermined time period is approximately 2
seconds, is preferably less than or equal to about 1.5 seconds, and
most preferably is less than or equal to about 1 second. Also in a
currently preferred embodiment, the predetermined wavelength of the
laser radiation is about 980 nm, and the predetermined power of
each laser is preferably less than about 30 Watts, and most
preferably less than or equal to about 10 Watts, or within the
range of about 8 to about 10 Watts. Also in a currently preferred
embodiment, the predetermined color of the material is gray, and
the predetermined opacity is defined by a dark gray colorant added
to the stopper material in an amount within the range of about 0.3%
to about 0.6% by weight.
[0046] In addition, the thermoplastic material may be a blend of a
first material that is preferably a styrene block copolymer, such
as the materials sold under either the trademarks KRATON or
DYNAFLEX, and a second material that is preferably an olefin, such
as the materials sold under either the trademarks ENGAGE or EXACT.
In a currently preferred embodiment of the invention, the first and
second materials are blended within the range of about 50:50 by
weight to about 95:5 by weight (i.e., first material: second
material). In one exemplary embodiment of the present invention,
the blend of first and second materials is about 50:50 by weight.
The benefits of such blends over the first material by itself are
improved water or vapor barrier properties, and thus improved
product shelf life; improved heat sealability; a reduced
coefficient of friction; improved moldability or mold flow rates;
and a reduction in hystereses losses. As may be recognized by those
skilled in the pertinent art, these numbers and materials are only
exemplary, however, and may be changed if desired or otherwise
required in a particular system.
[0047] Hermetically Sealed Syringe With Step-Wise Movement
[0048] In FIGS. 4-8, another syringe embodying the present
invention is indicated generally by the reference numeral 110. The
syringe 110 is substantially similar to the syringe 10 described
above with reference to FIGS. 1-3, and therefore like reference
numerals preceded by the numeral 1 are used to indicate like
elements. The primary difference of the syringe 110 in comparison
to the syringe 10 is that the syringe 110 includes means for
controlling the travel of the plunger 114 and effecting step-wise
movement of the plunger to, in turn, dispense predetermined doses
of the medicament or other substance contained within the
syringe.
[0049] As shown in FIGS. 4-6, the inner walls of the syringe body
12 define a cylindrical cavity. The inner wall of the upper portion
of the syringe body includes a plurality of steps 152 defining an
approximately helical path. As shown in FIGS. 5 and 6, the inner
wall of the upper portion of the syringe body 12 defines two
helical sets of steps 152 formed on opposite sides of the inner
wall of the upper chamber 154 of the syringe body relative to each
other. Each set of steps 152 defines an approximately helical path.
As shown in FIG. 5, one set of steps 152 is oriented to allow
travel along the steps in the direction from the top of the upper
chamber 154 toward a tapered portion 156 of the syringe body 112.
As shown in FIG. 6, one set of steps 152 is oriented in the
opposite direction relative to the other set of steps to prevent
rearward movement of the plunger 114, as described further
below.
[0050] As shown in FIGS. 4A-4C, the inner wall 158 of the lower
chamber 118 of the syringe body 112 defines a smooth cylindrical
cavity and has an approximately constant inner diameter over the
axial length of the lower chamber. The lower chamber 118 of the
syringe is used to contain the medicament or other substance, and
is dimensioned to frictionally engage the resealable stopper 116 of
the plunger 114 as described further below. The inner diameter of
the lower chamber 118 is preferably constant to ensure that a
specific quantity of the medicament or other substance contained
therein is dispensed from the syringe for a pre-determined distance
of travel by the plunger 114.
[0051] Referring now to FIGS. 7 and 8, the plunger 114 comprises of
a lower drive portion 160 and an upper guide portion 162. A fusible
stopper 116, as described in further detail above with reference to
FIGS. 1 and 2, is fixedly attached to the end portion 162 of the
plunger. The fusible stopper 116 contacts the medicament or other
substance in the lower chamber 118 of the syringe during use. As
described in detail above, the fusible stopper 116 is shaped and
dimensioned to fit frictionally into the lower chamber 118 of the
syringe body 112 to hermetically seal the lower chamber of the
syringe. The drive portion 160 of the plunger 114 is shaped and
dimensioned to fit within the lower chamber 118 of the syringe
body. The outside diameter of the drive portion 160 is preferably
at least slightly less than the inside diameter of the lower
chamber 118 of the syringe body to reduce the frictional force
generated by movement of the plunger within the syringe body. The
lower drive portion 160 should be sufficiently long to be fully
inserted into the lower chamber 118 of the syringe body.
[0052] The upper guide portion 162 of the plunger 114 defines two
diametrically-opposed, cam-like members 164 that extend
perpendicularly from the outside surface of the upper guide portion
of the plunger. The cam-like members 164 cooperate with the steps
152 formed on the inner wall of the upper chamber 154 of the
syringe body to provide means for controlling the travel of the
plunger through the syringe in a stepwise manner. The cam-like
members 164 are preferably located on the upper guide portion 162
such that the fusible stopper 116 is in contact with the medicament
or other substance contained in the lower chamber 118 when the
cam-like members 164 engage the top step 152 formed on the inner
wall of the upper chamber 154 of the syringe body 112. The outside
surface of the upper guide portion 162 of the plunger 114
preferably includes a plurality of vanes 166 or other support means
to provide additional rigidity and/or strength to the plunger
during use. A knob or other gripping portion 115 is formed at the
upper end of the plunger 114 to provide means for the user to grip
the plunger during use.
[0053] At the end of the lower chamber 118 of the syringe, means
119 are provided to connect a hypodermic needle to the syringe to
dispense the contents of the syringe. The means 119 for connection
of a hypodermic needle to the syringe body may be any one of
several devices or methods that are currently, or later become
known to those skilled in the art for performing this function. For
example, a conventional connection means marketed under the
trademark LUER-LOK may be included at the end of the syringe to
allow connection of a hypodermic needle. Other needle connection
means, such as threaded fittings, elastomeric plugs, or fitted end
caps may be used to attach a needle to the end of the syringe
instead. The lower end of the syringe body may be shaped or
threaded as required to accommodate the selected needle connection
means. A cap or other means for hermetically sealing the dispensing
end of the syringe may be used until the hypodermic needle is
connected to the syringe to dispense the medicament or other
substance therefrom.
[0054] To deliver a dose of medicament or other substance contained
within the syringe 110, the plunger 114 is rotated and depressed
until the cam-like members 164 on the upper guide portion each
travel down one step 152 along the inner wall of the upper chamber
154 of the syringe. The distance that the base 124 of the plunger
travels is thereby precisely controlled, and a precise volume of
the medicament or other substance can be delivered. The volume of
substance delivered is a function of the height of the step 152 and
the inside diameter of the lower chamber 118. By setting these two
parameters, the volume of medicament delivered as a result of
travel by the plunger along a single step may be precisely
controlled. For example, if the inside diameter of the lower
chamber of the syringe is 6 mm, and it is desired to have movement
of the plunger assembly by one step result in the delivery of 100
microliters of the substance contained in the syringe, then the
step height would be set at approximately 3.54 mm. Where the
medicament includes an active ingredient and a carrier, the dose of
active ingredient delivered also may be a function of the
concentration of active ingredient in the carrier. Delivery of a
higher dose can be achieved by instructing the user to move the
plunger by the number of steps required to deliver the desired
amount of the medicament. In the example provided above, movement
by two steps would result in delivery of 200 microliters, etc.
[0055] As may be recognized by those skilled in the pertinent art
based on the teachings herein, the structure for performing the
function of controlling the travel of the plunger to effect
step-wise movement of the plunger and dispense predetermined doses,
can take any of numerous different configurations that are
currently or later become known for performing this function. For
example, this structure may take the form of any of the different
thread configurations disclosed in commonly assigned U.S. Patent
Application Ser. No. 60/403,484, filed Aug. 13, 2002 and entitled
"Dispenser With Sealed Chamber And One-Way Valve For Providing
Metered Amounts Of Substances", which is hereby expressly
incorporated by reference as part of the present disclosure.
[0056] In one such exemplary embodiment, the means for controlling
the travel of the plunger includes threads formed on the upper
portion of the plunger assembly 14 that engage partial threads
formed on the inner wall of the upper portion of the syringe body
12. The threads on the upper portion of the plunger define a
plurality of regions in which the thread diameter gradually
increases, beginning from a diameter that corresponds to the
diameter of the partial threads on the inner wall of the upper
portion of the syringe, to a diameter that is greater than the
diameter of the partial threads. The largest diameter threads on
the plunger have a smaller diameter than the diameter of the
syringe body between the partial threads.
[0057] As the plunger is rotated, the larger diameter threads on
the plunger are progressively engaged by the partial threads on the
inner wall of the upper portion of the syringe body. This causes
the upper portion of the syringe body to expand slightly. As the
largest diameter threads on the plunger disengage from the partial
threads on the syringe body and enter the area between the partial
threads, the syringe body returns to its original diameter. When
the larger diameter threads are located in the area between the
partial threads, the plunger assembly is locked in position until
sufficient force is applied to the plunger assembly to cause the
larger diameter threads to engage the partial threads on the inner
wall of the syringe. By establishing the thread pitch as desired,
the distance of travel of the plunger for each rotation of the
plunger through the threaded portions can be precisely controlled,
resulting in delivery of a pre-determined amount of the substances
for each incremental rotation (or step-wise movement) of the
plunger.
[0058] Syringe with Multiple Compartments for Storage of Components
of Medicament
[0059] Turning to FIGS. 9-13, a reconstitution syringe 210 of the
present invention permits individual components of a
multi-component medicament or other preparation to be stored in
separate compartments within the lower chamber of the syringe. The
components of the multi-component preparation may be mixed within
the syringe when desired for use. Many of the components of the
reconstitution syringe 210 are the same as those in the syringes 10
and 110 described above, and therefore like reference numerals
preceded by the numeral "2", or preceded by the "2" instead of the
numeral "1", are used to indicate like elements.
[0060] As shown in FIG. 10, in this embodiment of the invention,
the syringe body 212 defines an upper chamber 254, a transition
portion 256 and a lower chamber 218. As shown in FIG. 9, the inside
wall of the upper chamber 254 defines two sets of steps 252 formed
on opposite sides of the inner wall of the upper chamber relative
to each other. Each set of steps 252 defines an approximately
helical path. One set of steps 252 is oriented to allow travel
along the steps in the direction from the top of the upper chamber
254 toward the lower chamber 218 of the syringe body. The second
set of steps 252 is oriented in the opposite direction to prevent
movement of the plunger in that direction.
[0061] Referring to FIG. 9, the plunger 214 comprises an outer
frame 268, a closure member 270, and an elastomeric plug 272. The
outer frame 268 of the plunger fits slidingly within the outer body
212 of the syringe. Preferably, the outer frame 268 defines an
upper portion 274, a transition portion 276, and a lower portion
278, with each section having a diameter slightly less than the
diameter of the corresponding portion of the body 112 of the
syringe. As shown in FIG. 9, in the storage mode, the outer frame
268 of the plunger extends from the top of the syringe body 212 to
a point within the lower chamber 218 of the syringe body. The
extent to which the outer frame 268 of the plunger assembly extends
within the inner chambers of the syringe body can be varied
depending upon the relative amounts of the components to be
contained within the syringe during storage.
[0062] As shown typically in FIG. 9, on the inside wall of the
upper portion 274 of the outer frame 268, an axial slot 280 is
provided which, as described below, corresponds in position to a
snap engagement 282 and one of the two cam-like members 264 on the
closure member 270 of the plunger. A second axial slot 284 is
provided in the inside wall of the upper portion 274 of the outer
frame 268 for receiving a second cam-like member 264 formed on the
closure member 270. As described below, the axial slots 280, 284
allow the outer frame 268 to be withdrawn from the syringe during
use with the closure member 270 held stationary. A flange 286 is
provided at the top of the outer frame 268 for the user to grip the
outer frame in use.
[0063] The distal end 288 of the lower portion 278 of the outer
frame 268 defines a generally frustoconical portion 290 defining
therein a central opening 292. During storage, an elastomeric plug
272 is secured within the opening 292 to seal the end of the outer
frame. The distal end 288 of the outer frame is shaped to fit into
a complementary shaped annular groove 294 formed on the elastomeric
plug 272 to hold the elastomeric plug in place and form a seal
between the distal end of the outer frame and the plug. The
elastomeric plug 272 may be made of any appropriate material known
to those skilled in the art for use in storage of medicaments or
other substances to be contained within the syringe, such as, for
example, vulcanized rubber or any of numerous different types of
polymeric materials.
[0064] An annular protuberance 296 is provided on the outer frame
268 at the base of the frustoconical portion 290. The annular
protuberance 296 fits frictionally within the lower chamber 218 of
the syringe body 212 to form a seal between the outer frame of the
plunger and the syringe body. As can be seen in FIG. 9, the
frustoconical portion 290 of the distal end 288, the elastomeric
plug 272, and the annular protuberance 296 define a boundary within
the lower chamber of the syringe body and divide the lower chamber
of the syringe body into two compartments 298 and 300.
[0065] The closure member 270 is slidingly received within the
outer frame 268 of the plunger. As can be seen, the closure member
is generally cylindrical, and extends from the top of the upper
chamber 254 of the syringe body to a pre-determined location within
the lower portion of the outer frame 268. The predetermined point
is at a point corresponding to the top of the lower chamber 218 of
the syringe body. At the end of the closure member 270 within the
lower chamber 218 of the syringe is a resealable stopper 216, which
hermetically seals the top of the first compartment 298 of the
syringe. In this embodiment of the invention, the resealable
stopper 216 forms a hermetic seal with the inner surface of the
outer frame 268 of the plunger assembly 214.
[0066] At the end of the closure member 268 opposite the fusible
stopper 216, the closure member defines two opposed cam-like
members 264 that extend perpendicularly from the axial wall of the
closure member. The cam-like members 264 cooperate with the steps
252 formed on the inner wall of the upper chamber 254 of the
syringe body to provide step-wise movement of the plunger assembly
during dispensing of the multi-component medicament or other
preparation. In the illustrated storage mode of the reconstitution
syringe, one cam-like member 264 is engaged with the uppermost step
252 formed on the inner wall of the syringe body. On at least one
of the cam-like members, an arm 302 extends perpendicularly from
the cam-like member within the inner wall of the outer frame 268 of
the plunger. At the end of the arm 302, a snap engagement 282 is
provided. The snap engagement 282 fits within the corresponding
axial slot 280 on the outer frame.
[0067] As shown in FIG. 9, in the storage mode, the syringe body
212, the outer frame 268 of the plunger, the elastomeric plug 272
and the closure member 270 define two compartments 298, 300 which
are used to contain the two components of the medicament or other
multi-component preparation. The first compartment 298 is located
within the outer frame 268 of the plunger and is bounded by the
fusible stopper 216 of the closure member 270 of the plunger, the
frustoconical portion 288 of the outer frame of the plunger, and
the elastomeric plug 272. The first compartment 298 is used to
contain a first component of a medicament or other multi-component
preparation, such as, for example, a saline solution or a solvent.
The first compartment 298 may be filled by inserting a needle or
other injection device through the fusible stopper 216 as described
above and filling the first compartment with the first component of
the preparation. After the filling step is complete, the resealable
member of the fusible stopper is heated to seal the needle puncture
and preventingress of air. As described above, the resealable
member may be heated using a laser as described above.
[0068] The second compartment 300 is located within the lower
chamber 218 of the syringe body 212 and is bounded by the
frustoconical portion 288 of the outer frame of the plunger, the
elastomeric plug 272 and the dispensing tip 217 described in
further detail below. The second compartment 300 is used to contain
a second component of the medicament or other multi-component
preparation, such as, for example, a lyophilized product, a powder
or a second fluid.
[0069] At the dispensing end 217 of the syringe, a dispensing
mechanism is provided. In the embodiment of the invention
illustrated in FIG. 9, the dispensing mechanism comprises a central
post 304 defining therein at least one channel that communicates
with the second compartment 300 inside the lower chamber 218 of the
syringe. At the end of the syringe body 212, the syringe body
defines an annular retention shoulder 306. Any appropriate
dispensing tip mechanism known to one skilled in the art can be
fixedly attached to the syringe body. For example, the conventional
connection device marketed under the trade name LUER-LOK can be
used at the dispensing tip of the syringe to allow attachment of
disposable needles. In this embodiment of the invention, as the
closure member 270 of the plunger assembly advances into the
syringe, the medicament is dispensed through a channel in the post
304 and through the disposable needle (not shown). Other needle
connection means, such as threaded fittings, elastomeric plugs, or
fitted end caps equally may be used to attach a needle to the end
of the syringe. The lower end of the syringe body may be shaped or
threaded as required to accommodate the selected needle connection
means. A cap or other means (not shown) to hermetically seal the
dispensing end of the syringe may be used until the hypodermic or
other needle is connected to the syringe to dispense the medicament
or other substance therein.
[0070] In use, the reconstitution syringe operates in the following
manner. As indicated by the arrows in FIG. 10, the outer frame 268
of the plunger 214 is withdrawn from the syringe body 212. As the
outer frame 268 is initially withdrawn, the closure member 270 is
held stationary by a retention shoulder 308 formed on the top of
the syringe body 212 that interacts with the cam-like member 264 to
prevent outward axial movement of the closure member. The axial
slots 280, 284 in the upper portion of the outer frame 268 allow
the outer frame to be withdrawn past the cam-like members 264 and
the snap engagement 282.
[0071] As the outer frame 268 is withdrawn, the volume of the first
compartment 298 is reduced, causing the fluid pressure in the first
compartment 298 to increase. When the pressure in the first
compartment 298 is sufficiently high, the elastomeric plug 272 is
released from the frustoconical portion 290 formed on the distal
end 288 of the outer frame. The release of the elastomeric plug 272
results in a fluid communication path being formed between the
first compartment 298 and the second compartment 300, allowing the
component in the first compartment to flow through the central
opening 294 and mix with the component in the second compartment
300.
[0072] As shown in FIG. 11, the outer frame 268 of the plunger is
withdrawn from the syringe until the snap engagement 282 engages a
corresponding engagement portion 308 formed at the base of the
axial slot 280 in the outer frame 268. When the outer frame 268 is
fully withdrawn, the fusible stopper 272 of the closure member 270
is typically positioned adjacent to the opening 292. As shown in
FIG. 11, when the outer frame 268 is fully withdrawn, a single
compartment is formed for the medicament or other multi-component
substance, bounded by the inner walls of the lower chamber 218 of
the syringe body, the fusible stopper 216 of the plunger, the
distal end 288 of the outer frame, and the dispensing end 217 of
the syringe.
[0073] After the outer frame 268 has been fully withdrawn, the
syringe may be shaken to mix the two components of the medicament
or other preparation within the chamber 218. The elastomeric plug
272 acts like a mixing ball and provides a mechanism to obtain
complete mixing of the components. This provides the advantage of
assuring that the medicament or other multi-component preparation
contained in the syringe after mixing provides the desired dose of
the medicament for each predetermined movement of the plunger.
[0074] The snap engagement 282 and the engagement portion 308 act
together to capture the closure member 270 in the outer frame 268
and thereby fixedly secure the two parts together. The cam-like
members 264 are maintained within the axial slots 280, 284 in the
side of the outer frame 268. As a result, the outer frame 268 and
closure member 270 move together and act as a plunger assembly to
dispense the mixed medicament from the syringe. As shown in FIGS.
12 and 13, as the outer frame 268 is rotated in the direction that
causes the plunger mechanism to travel in the direction toward the
dispensing tip of the syringe (typically clockwise), the cam-like
members 264 on the closure member 270 cooperate with the steps 252
on the inner wall of the upper chamber of the syringe to provide
step-wise movement of the upper frame and closure member into the
syringe. As described above, as the closure member travels one step
into the syringe, the base of the closure member travels a precise
distance, and a precise volume of the medicament or other
multi-component substance contained therein can be delivered.
[0075] In another embodiment of the invention, the inner walls of
the upper chamber of the syringe body are smooth, and the cam-like
members on the closure member fit within the upper chamber of the
syringe. This allows the entire contents of the syringe to be
delivered in a single dose without step-wise movement of the
plunger mechanism.
[0076] As described above, those skilled in the pertinent art may
recognize based on the teachings herein that the structure for
performing the function of controlling the travel of the plunger
can take any of numerous different configurations that are
currently or later become known for performing this function, such
as any of the structures disclosed in the above-mentioned
co-pending patent application.
[0077] The preferred embodiments disclosed herein are to be
considered exemplary of the principles of the present invention and
are not intended to limit the invention to the embodiments
described. In addition, various modifications will be apparent to
those skilled in the pertinent art based on the teachings herein
without departing from the spirit or scope of the invention
disclosed herein and defined in the claims. Accordingly, this
detailed description of the preferred embodiments is to be taken in
an illustrative, as opposed to a limiting sense.
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