U.S. patent application number 10/882904 was filed with the patent office on 2004-11-25 for folded compact tampon applicator.
Invention is credited to Hull, Raymond J. JR..
Application Number | 20040236266 10/882904 |
Document ID | / |
Family ID | 25216977 |
Filed Date | 2004-11-25 |
United States Patent
Application |
20040236266 |
Kind Code |
A1 |
Hull, Raymond J. JR. |
November 25, 2004 |
Folded compact tampon applicator
Abstract
An applicator system for delivering an object into a mammalian
body cavity is disclosed. The applicator includes a tubular
insertion member arranged and configured to contain the object and
a linearly-biased expulsion member having a first end slideably
fitted within the tubular insertion member. The tubular insertion
member has an insertion end and a gripper end, opposite thereof.
The expulsion member extends out of the gripper end of the tubular
insertion member, and terminates in a second end. The applicator
also includes an expulsion member restraint capable of restraining
the second end of the expulsion member proximate an outer surface
of the insertion end of the tubular insertion. The expulsion member
is bent when so restrained. The invention also relates to a method
of delivering an object into a body cavity from an applicator. In
this method, the applicator is substantially as described above,
and the method includes the steps of: a) releasing the expulsion
member restraint to permit the expulsion member to spontaneously
attain a substantially linear configuration with the second end
extending rearwardly away from the gripper end of the tubular
insertion member; b) inserting the insertion end of the tubular
insertion member into the body cavity; c) applying force on the
second end of the expulsion member to move the first end thereof
toward the insertion end of the tubular insertion member; d)
expelling the object out of the insertion end of the tubular
insertion member and into the body cavity; and e) removing the
applicator from the body cavity.
Inventors: |
Hull, Raymond J. JR.;
(Hampton, NJ) |
Correspondence
Address: |
PHILIP S. JOHNSON
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK
NJ
08933-7003
US
|
Family ID: |
25216977 |
Appl. No.: |
10/882904 |
Filed: |
June 30, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10882904 |
Jun 30, 2004 |
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09815139 |
Mar 22, 2001 |
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6773422 |
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Current U.S.
Class: |
604/18 |
Current CPC
Class: |
A61F 13/263
20130101 |
Class at
Publication: |
604/018 |
International
Class: |
A61F 013/20 |
Claims
1. An applicator for delivering an object into a mammalian body
cavity comprising: a) a tubular insertion member having a
longitudinal axis and a perimeter measured in a plane perpendicular
to the longitudinal axis and arranged and configured to contain the
object and having an insertion end and a gripper end opposite
thereof; b) a linearly-biased expulsion member having a first end
slideably fitted within the tubular insertion member, extending out
of the gripper end of the tubular insertion member, and terminating
in a second end, the expulsion member having sufficient rigidity to
transmit linear forces without significant linear deformation when
delivering the object from the tubular insertion member; and c) an
expulsion member restraint capable of restraining the second end of
the expulsion member proximate an outer surface of the insertion
end of the tubular insertion member such that when the expulsion
member is bent and constrained, a perimeter of the resulting folded
applicator measured in the plane perpendicular to the longitudinal
axis and about both the tubular insertion member and the
constrained expulsion member is similar to the perimeter of the
insertion member.
2. The applicator of claim 1 wherein the expulsion member is
capable of being bent under an outside influence and of reverting
to a substantially linear configuration when the outside influence
is removed.
3. The applicator of claim 1 wherein the expulsion member has a
hinge portion intermediate the first end and the second end.
4. The applicator of claim 1 wherein the expulsion member comprises
a first portion arranged and configured to correspond to the
interior of the gripper end of the tubular insertion member in a
manner to permit the expulsion member to easily slide in the
tubular insertion member while maintaining a substantially uniform
orientation to the longitudinal axis of the tubular insertion
member and a second portion extending from the first portion to the
second end of the expulsion member.
5. The applicator of claim 4 wherein the second portion comprises a
hinge portion proximate the first portion.
6. The applicator of claim 5 wherein the second portion extends
about 75% of the length of the expulsion member or less.
7. The applicator of claim 1 wherein the expulsion member comprises
an enlarged portion proximate the first end and a beam, having a
reduced cross-sectional area in comparison to the enlarged portion,
extending toward the second end.
8. The applicator of claim 7 wherein the beam comprises a hinge
portion proximate the enlarged portion.
9-15. Canceled.
16. The applicator of claim 15 wherein the tubular insertion member
is substantially cylindrical and the expulsion member restraint
comprises a mechanical catch that is unitary with the second end
and has a cross-section corresponding to a circular segment with a
central angle of greater than about 180.degree..
17. The applicator of claim 1 wherein the expulsion member
comprises plastic.
18. The applicator of claim 17 wherein the expulsion member
consists essentially of plastic.
19. The applicator of claim 1 wherein the expulsion member
comprises paper.
20. The applicator of claim 19 wherein the expulsion member
consists essentially of paper.
21-26. Canceled.
27. A method of delivering a tampon into a body cavity from an
applicator, said applicator including a tubular insertion member
having a longitudinal axis and a perimeter measured in a plane
perpendicular to the longitudinal axis and arranged and configured
to contain the tampon and having an insertion end and a gripper end
opposite thereof, and a linearly-biased expulsion member having a
first end slideably fitted within the tubular insertion member,
extending out of the gripper end of the tubular insertion member,
and terminating in a second end, and an expulsion member restraint
which restrains the second end of the expulsion member proximate an
outer surface of the insertion end of the tubular insertion member,
such that a perimeter of the resulting folded applicator measured
in the plane perpendicular to the longitudinal axis and about both
the tubular insertion member and the constrained expulsion member
is similar to the perimeter of the insertion member, the method
comprising the steps of: a) releasing the expulsion member
restraint to permit the expulsion member to spontaneously attain a
substantially linear configuration with the second end extending
rearwardly away from the gripper end of the tubular insertion
member; b) inserting the insertion end of the tubular insertion
member into the body cavity; c) applying a force differential
between the expulsion member and the tubular insertion member
sufficient to cause relative movement of the first end of the
expulsion member toward the insertion end of the tubular insertion
member without significant linear deformation of the expulsion
member; d) expelling the tampon out of the insertion end of the
tubular insertion member and into the body cavity; and e) removing
the applicator from the body.
28-30. Canceled.
31. The method of claim 27 wherein the step of releasing the
expulsion member restraint comprises disengaging a mechanical catch
that is unitary with the expulsion member second end from the
tubular insertion member.
32-34. Canceled.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to applicator systems for
delivering materials into mammalian body cavities having a compact
format in which the expulsion member is manipulated to present a
shorter than normal length during storage. The applicator is
particularly useful for delivering intravaginal devices, such as
catamenial devices, into a vaginal canal.
BACKGROUND OF THE INVENTION
[0002] Applicators for delivering materials into a body cavity
typically comprise a tubular insertion member having an insertion
end and a gripper end opposite thereof, and an elongate expulsion
member slideably fitted within the tubular insertion member for
expelling the contained materials. A class of applicators is known
as compact applicators, because they present a shorter packaged
size, especially length, than required for use.
[0003] One type of compact applicator has an insertion member
adapted to contain the insertable device and an expulsion member
that is stored between the insertable device and the insertion
member, e.g., in an annular space between a cylindrical tampon and
a cylindrical, tubular insertion member. An example of this type of
compact applicator is shown in Ring, U.S. Pat. No. 4,291,696. This
type requires the user to prepare the applicator for use by first
partially withdrawing the expulsion member in a controlled manner
prior to pushing against the insertable device to expel it from the
insertion member. This step introduces significant complexity to
the applicator, as the insertable device must be prevented from
following the expulsion member as it is withdrawn. Additionally,
the expulsion member should also be somehow prevented from being
completely removed from the insertion member.
[0004] A second type of compact applicator stores substantial
portions, if not all, of the expulsion member outside of the
insertion member. One example of this approach is disclosed in
Buzot, U.S. Ser. No. 09/331907, filed Dec. 23, 1998, based upon WO
99/33429. This applicator includes an external pusher element that
is bent and inserted through an opening in the applicator to bear
on a rear surface of the tampon. While this is an interesting and
promising advance in the art, it requires several manipulations by
the user prior to expelling the tampon from the applicator.
[0005] Another approach is described in Sakurai et al. U.S. Pat.
No. 4,269,187. This approach incorporates a push-out top end
contained within an outer cylinder and at least one inserting
supporting piece connected to the push-out top end and folded
outwardly from the outer cylinder. A preferred embodiment of this
device incorporates a pair of such outwardly folded elements
supporting pieces that are locked together prior to use. Again,
this approach also appears to require the user to actively unfold
and manipulate the push-out elements prior to use.
[0006] Therefore, what is needed is a compact applicator that
requires little manipulation by a user prior to use and that is
robust to reliably and easily expels an insertable object contained
therein.
SUMMARY OF THE INVENTION
[0007] An applicator system for delivering an object into a
mammalian body cavity is disclosed. The applicator includes a
tubular insertion member arranged and configured to contain the
object and a linearly-biased expulsion member having a first end
slideably fitted within the tubular insertion member. The tubular
insertion member has an insertion end and a gripper end, opposite
thereof. The expulsion member extends out of the gripper end of the
tubular insertion member, and terminates in a second end. The
applicator also includes an expulsion member restraint capable of
restraining the second end of the expulsion member proximate an
outer surface of the insertion end of the tubular insertion. The
expulsion member is bent when so restrained.
[0008] The invention also relates to a method of delivering an
object into a body cavity from an applicator. In this method, the
applicator is substantially as described above, and the method
includes the steps of: a) releasing the expulsion member restraint
to permit the expulsion member to 5 spontaneously attain a
substantially linear configuration with the second end extending
rearwardly away from the gripper end of the tubular insertion
member; b) inserting the insertion end of the tubular insertion
member into the body cavity; c) applying force on the second end of
the expulsion member to move the first end thereof toward the
insertion end of the tubular insertion member; d) expelling the
object out of the insertion end of the tubular insertion member and
into the body cavity; and e) removing the applicator from the body
cavity.
BRIEF DESCRIPTION OF THE DRAWING
[0009] FIG. 1 is a side elevation of a compact tampon applicator
according to the present invention in its stored or packaged
configuration and, in phantom, locations of a portion of the
expulsion member as it moves into a ready-for-use
configuration.
[0010] FIG. 2 is a cross-section of the side elevation of FIG.
1.
[0011] FIG. 3 is a perspective view of an expulsion member useful
in the present invention.
[0012] FIGS. 4 and 5 are cross-sections taken along lines 4-4 and
5-5 of FIG. 3.
[0013] FIGS. 6A and 6B are end elevations of two embodiments of
applicators according to the present invention.
[0014] FIG. 7 is a detail of the insertion end of a tubular
insertion member and the second end of an expulsion member
according to an alternative embodiment of the present
invention.
[0015] FIG. 8 is a side elevation of an alternative embodiment of
the present invention in a ready-for-use configuration.
[0016] FIG. 9 is a side elevation of the alternative embodiment of
FIG. 8 in a stored or packaged configuration.
[0017] FIG. 10 is a cross-section of the hinge portion of the beam
in the alternative embodiment of FIG. 8, taken along line
10-10.
[0018] FIG. 11 is a detail of the-insertion end of a tubular
insertion member and the second end of an expulsion member
according to an alternative embodiment of the present
invention.
[0019] FIG. 12 is a side elevation of an alternative embodiment of
the present invention in a packaged configuration.
[0020] FIG. 13 is a side elevation of the alternative embodiment of
FIG. 12 in an unpackaged, ready-for-use configuration.
[0021] FIG. 14 is a side elevation of the embodiment of FIG. 1 in a
ready-for-use configuration.
[0022] FIG. 15 is a side elevation of the embodiment of FIG. 1, as
a contained tampon is being expelled.
DETAILED DESCRIPTION OF THE INVENTION
[0023] As used in herein the specification and the claims, an
element is "linearly-biased" if it tends to exhibit a substantially
linear configuration in the absence of significant outside forces.
For example, an element that is capable of being bent under an
outside influence, such as a restraint, and of spontaneously
reverting to a substantially linear configuration when the outside
influence is removed is a linearly-biased element.
[0024] The term "diameter" as used in herein the specification and
the claims relates to a chord passing through the center of a
figure or body, and it can be measured as the length of this
straight line (chord) through the center of the body in a given
plane. Unless otherwise noted, this plane is perpendicular to the
major longitudinal axis of the body. In a non-circular
cross-section, the body may have a maximum diameter and a minimum
diameter.
[0025] As used herein, a "unitary" device is one that has the
characteristic of being a unit or a whole. This includes both
devices that are created from a single element and those formed by
fixing together individual elements to form the whole.
[0026] As used herein the specification and the claims, the term
"intravaginal device" and related terms includes support devices,
obstructing devices useful to block the flow of and/or collect
bodily liquids, and the like. The term includes, without
limitation, incontinence devices and vaginal supports, such as
pessaries; and obstructing devices, such as menstrual collection
cups and inflatable or expandable vaginal blocking devices (devices
which do not, themselves, absorb the bodily liquids).
[0027] While the present invention generally relates to applicator
devices having a tubular insertion member, the following detailed
description will refer, specifically, to a tampon applicator for
ease of understanding. One of ordinary skill in the art will
recognize other uses for this invention.
[0028] Referring now to the drawings, wherein like reference
numerals designate like elements, FIGS. 1 and 2 depict an
applicator 10, comprising a tubular insertion member 12, having an
insertion end 14 and a gripper end 16 that is suitable to contain a
tampon 18 that can be delivered into the body cavity. The insertion
end may have a plurality of inwardly curved petals 20 that form a
substantially closed feature 22. The applicator 10 also includes a
linearly-biased expulsion member 24 having a first end 26 that is
insertable into the tubular insertion member 12 and is capable of
bearing against the tampon 18. The expulsion member 24 terminates
in a second end 28, opposite the first end 26, that may be
manipulated to move the first end 26 within the tubular insertion
member 12. The first end 26 of the expulsion member 24 is arranged
and configured to be slideably introduced into the tubular
insertion member 12 through its gripper end 16.
[0029] The applicators 10 or other tubular devices of the present
invention can have tube geometries or cross-sections that are
useful to contain the object to be inserted. Often, the shape of
the tampon 18 or other element contained suggests the shape of the
tubular insertion member 12, but departures from this general rule
may be made. Therefore, the tubular insertion member 12 may take on
numerous cross-sectional shapes including, without limitation,
circular, oval, polygonal (e.g., trapezoidal, rectangular,
triangular), and the like. For example, cylindrical tampons may be
contained within rectangular insertion members and trapezoidal
tampons (such as those disclosed in Van Iten et al., U.S. Pat. No.
5,350,371) and cup-shaped-tampons (such as those disclosed in
Bailey, U.S. Pat. No. 2,330,257) can be contained in a generally
cylindrical insertion member. In addition, the insertion member 12
can substantially elongated, curved, or flexible, or it can take on
other shapes that are apparent to one of ordinary skill in the art.
The specific geometry, itself, is not critical to the practice of
the present invention. In addition, the edge of the tubular device
(both finished and unfinished) may be a standard, planar edge
coincident with a plane perpendicular to the longitudinal axis of
the tubular device. However, the edge may also be coincident with a
plane oblique to the longitudinal axis, or it may be otherwise
contoured and/or recessed as described in the commonly assigned,
copending application of Buzot, U.S. Ser. No. 09/454,989 (herein
incorporated by reference).
[0030] The first end 26 of the linearly-biased expulsion member 24
is provided to bear against the rear end 19 of the tampon 18,
especially as it is use to expel the tampon 18. In order to expel
the tampon 18 effectively, it is useful to provide a first portion
30 of the expulsion member 24 located adjacent the first end 26. It
is preferred that the first portion 30 has a length that is
sufficient to provide some directional stability to the expulsion
member 24 in the tubular insertion member 12. In particular, it is
preferred that the enlarged portion 30 corresponds to the size and
shape of the interior of the gripper end 16 of the tubular
insertion member 12 proximate the first portion 30. This allows the
expulsion member 24 to more easily slide within the tubular
insertion member 12 without binding or becoming jammed.
[0031] The expulsion member 24 (shown alone in FIG. 3) also has a
second portion 32 extending from the first portion 30 to the second
end 28. Preferably, the second portion is formed of a beam 32
having a reduced cross-section in comparison to the first portion
30. As this beam 32 is used to transmit force exerted on the second
end 28 along the expulsion member 24 and through the first portion
30 to the tampon 18, the second portion should have sufficient
column strength and rigidity to transmit such linear forces without
significant deformation. While the linear forces encountered in use
of applicators may vary, it is preferred that the beam 32 be
capable of withstanding a linear force sufficient to expel the
tampon 18 into a user's vaginal canal without buckling. Generally,
this force is at least about 5 N (Newtons), more preferably, at
least about 10 N, and most preferably, at least about 15 N. This
column strength can be determined by securing the first portion of
the expulsion member into an appropriately sized receptacle placed
on the fixed jaw of a Instron Universal Testing Machine, available
from Instron Corporation, Canton, Mass., USA, to prevent the first
portion from twisting or bending. The moveable jaw is brought to
contact the second end of the expulsion member and is then set to
compress the expulsion member at a rate of about 5 cm/minute. The
force exerted on the expulsion member is measured continuously, and
the point at which this force begins to fall instead of rise is the
point at which the expulsion member buckles. The maximum force
achieved is the column strength of the expulsion member.
Notwithstanding the required column strength and rigidity necessary
to transmit the expulsion forces, the beam must also be
sufficiently flexible to be bent into a compact configuration,
again without permanent damage to itself, such as a permanently set
bent configuration.
[0032] The proportion of the expulsion member 24 provided by the
first portion 30 and by the second portion 32 can vary. However,
the first portion 30 preferably has sufficient length and other
external dimensions to help it to be predictably oriented in the
tubular insertion member 12. For example, it is helpful if the
first portion has dimensions to allow it to slide within the
tubular insertion member 12 while maintaining a substantially
uniform orientation to the longitudinal axis of the insertion
member 12. These dimensions may include a length that is
approximately equal to the maximum diameter of the first portion 30
or greater.
[0033] The second portion 32 preferably has sufficient length to be
wrapped back towards the insertion end of the tubular insertion
member 12. Thus, it preferably extends about 3/4 of the length of
the expulsion member or less. This provides a sufficient length to
dispense an object from the tubular insertion member 12. An
additional relationship can be the relationship of the packaged
length of the applicator 10 having a bent expulsion member 24.
Thus, it is preferred that the packaged length of the applicator
("L" as shown in FIG. 1) is less than about 70% of the length of
the applicator 10 having an extended expulsion member 24 ("L'" as
shown in FIG. 1), and more preferably, less than about 60%.
[0034] The second portion 32 is preferably a beam, and it can have
any cross-section that effectively transmits the linear forces
described above and permits the required bending. A representative,
non-limiting list of useful cross-sections include circular, oval,
and the like; polygonal including triangular, trapezoidal,
parallelograms such as rectangular, rhomboidal, and the like;
"I"-section; angle sections; "T"-sections; "Z"-sections;
"H"-sections; channel-section, including standard channel-sections
with substantially straight base and walls, "U"-sections, and
sections defined by circular segments; and other sections that
provide the appropriate balance of column strength and rigidity
under linear forces aligned with the longitudinal axis of the beam
and flexibility under forces directed at an angle to the
longitudinal axis of the beam. Preferred cross-sections of the beam
include channel sections, and especially preferred cross-sections
include channel-sections defined by circular segments. Such
circular segments may be further described by their central angle,
.theta..
[0035] In a preferred embodiment, the first portion is an enlarged
portion, and the second portion comprises a beam having a reduced
cross-sectional area in comparison to the enlarged portion. This
provides a good bearing surface against the tampon, corresponds to
the larger interior dimensions of the tubular insertion member, and
allows a less bulky beam to extend outwardly from the tubular
insertion member that can be bent around the insertion member for
more discrete packaging.
[0036] Preferably, expulsion member 24 has a hinge portion 34
intermediate the first end 26 and the second end 28. In a
particularly preferred embodiment, the hinge portion 34 is adjacent
the enlarged portion 30 of the expulsion member 24. The hinge
portion 34 provides a defined bending location for the expulsion
member 24. However, unlike unbiased hinges, the hinge portion 34
doesn't affect the linear bias of the expulsion member 24.
Therefore, the hinge portion 34, in addition to the usual
characteristic of providing a bending location, must be able to
transmit linear force from the second end 28 of the expulsion
member 24 to the first end 26 and to provide a mechanism to return
the expulsion member 24 to a substantially linear configuration
once an outside, bending influence is removed.
[0037] Useful hinge portions 34 can be provided by an unmodified
portion of the beam 32; by a modified portion of the beam 32; by an
added, biased hinge element such as a spring-biased hinge; and by
any other useful element that provides the properties and
characteristics described above.
[0038] Preferably, the hinge portion 34 is provided by an
unmodified portion of the beam 32, if the beam 32 is sufficiently
flexible to bending moments (or forces) by itself, or by a modified
portion of the beam 32, such as a localized reduction in wall
height of a channel-section beam. As used herein the specification
and the claims, the term "wall height" relates to a measure of 5
the distance from the uppermost edges of a channel wall or the ends
of a circular segment down to the base of a substantially
flat-bottomed channel or the midpoint of the circular segment.
These measurements can be seen in FIGS. 4 and 5. Other
modifications of beam sections can be used. For example, one or
more flanges may be locally reduced or removed from a hinge portion
of "I"-, "H"-, "Z"-, "T"-, or angle section beams. In the case of
the hinge portion 34 formed of either a modified or unmodified
portion of the beam 32, it is preferred that the hinge portion 34
provides a gradual bend of the beam in contrast to a localized
angle or crease. This gradual bend results in significantly less
material damage of the beam 32 and provides more spring-back upon
release.
[0039] Preferably, the hinge portion 34 provides sufficient
spring-back to provide an angle a upon release of less than
90.degree., more preferably, less than about 600, and most
preferably, about 0.degree.. As can be seen in FIG. 1, this angle a
is the amount by which the spring-back of the material fails to
provide a straight beam 32. This provides a more rigid structure to
transmit the expulsion force applied to the second end 28 through
the expulsion member 24 to the tampon.18.
[0040] The applicator 10 also includes an expulsion member
restraint capable of restraining the second end 28 of the expulsion
member 24 proximate an outer surface of the insertion end 14 of the
tubular insertion member 12 such that the expulsion member 24 is
bent when so restrained. The restraint may be unitary with the
applicator, or it may be external to the applicator. Unitary
restraints can be unitary with the tubular insertion member 12 or,
preferably, unitary with the expulsion member 24. In several
embodiments, illustrated in FIGS. 1-3 and 6-11, the restraint is
unitary with the second end 28 of the expulsion member 24. The
first of these embodiments, shown in FIGS. 1-3 and 6A and 6B, the
expulsion member 24 has a tubular enlarged portion 30 and a beam 32
having a cross-section substantially corresponding to a circular
segment having a first central angle providing a first wall height.
The second end 28 has a unitary mechanical catch 36 in the form of
a portion of the beam having a larger central angle, greater than
about 180.degree. providing a greater wall height. The increased
central angle provides a mechanical catch 36 that is capable of
engaging an outer surface of the tubular insertion member 12,
especially when the tubular insertion member 12 is cylindrical.
[0041] Another embodiment in which the restraint is a mechanical
catch that is unitary with the second end 28 of the expulsion
member 24 is shown in FIG. 7. In this embodiment, the mechanical
catch 36' is a hook 38. This hook 38 is oriented to engage with a
gap disposed between adjacent petals 20 at the insertion end 14 of
the tubular insertion member 12. The hook 38 is sufficiently
flexible to be released from this gap to allow the expulsion member
24 to reacquire its substantially linear orientation.
[0042] Yet another restraint that is unitary with the expulsion
member 24 is based upon an adhesive material 40 disposed on the
second end 28 of the expulsion member 24. An example of-this
embodiment is shown in FIGS. 8-10, which also illustrate a "T"
cross-section beam 32. Preferably, the adhesive material 40 is a
pressure sensitive adhesive that is substantially non-transferable
to the outer surface of the tubular insertion member 12.
[0043] In addition, the restraint may be unitary with the tubular
insertion member 12. An example of such a restraint is shown in
FIG. 11 in which the tubular insertion member 12 has an aperture 41
or a receptacle (not shown) provided therein to accept at least a
portion of the second end 28 of the expulsion member 24.
[0044] Alternatively, the restraint may be external to the
applicator as shown in FIGS. 12 and 13. Preferably, the external
restraint substantially surrounds the expulsion member second end
28 and the tubular insertion member 12. In a particularly preferred
embodiment, the external restraint is formed of packaging material
42. Of course alternatives may be employed, such as a band of
elastic material, plastic, or even paper.
[0045] Additional features may be incorporated into the tubular
insertion member 12 and/or expulsion member 24. For example, one or
both members may incorporate features to help keep them together
prior to and during use. The tubular insertion member 12 may
incorporate an internally directed stop 44 to help to contain the
tampon 18 and the first portion 30 of the expulsion member 24. In
addition, the expulsion member 24 may incorporate one or more
raised features, such as a raised ring 46. This raised feature 46
can interact with the internally directed stop 44 to improve the
ability of the tubular insertion member 12 and the expulsion member
24 to remain interlocked. The expulsion member 24 may also
incorporate a locking device to reinforce the hinge portion 34 to
prevent premature collapse or otherwise increase the column
strength of the extended expulsion member 24.
[0046] The applicator devices of the present invention can be made
of materials known to those of ordinary skill in the art.
Generally, the tubular insertion members are plastic or paper.
Plastic materials include, without limitation, polyolefins such as
polyethylene and polypropylene (including polyolefin copolymers);
polyesters such as polyethylene terephthalate; polyamides such as
nylon; polyurethanes; polystyrene; polycaprolactone; polyvinyl
alcohol; ethylene-vinyl acetate copolymers; elastomers such as
silicones, natural rubbers, and synthetic rubbers including block
copolymers; cellophane; PHBV such as those disclosed in Dabi et
al., U.S. Pat. No. 5,910,520 (herein incorporated by reference);
starch-based polymers including those disclosed in Dabi et al.,
U.S. Pat. No. 5,910,520; and the like.
[0047] Paper materials include, without limitation, paperboard,
cardboard, cup stock, paper, and the like. The paper may be a
single layer of material, or it can be a plurality of laminated
layers to provide multiple benefits relating to the various layers.
Laminated paper material may include a surface layer or coating of
plastic, wax, silicone, lubricants, and the like, which may be
useful to increase the comfort to the user during insertion and
withdrawal. The plastic coating may include, without limitation,
those plastic materials listed above. Laminated paper material may
also include additional layers such as adhesive layers, tie layers,
and the like.
[0048] An example of such a surface layer is disclosed in
Blanchard, U.S. Pat. No. 6,171,426. A representative, non-limiting
list of useful materials to be used as the surface layer includes,
waxes, cellophane, polyolefins, polyesters, epoxies, and the like.
The surface layers may also include thermal stabilizers, pigments,
fragrances, surfactants, antimicrobial agents, medicaments, and the
like.
[0049] The tubular insertion member 12 of the applicator 10
provided by the present invention is preferably substantially
closed prior to expulsion of the materials contained therein.
Alternatively, the insertion end of the applicator can be more or
less open, that is the diameter along the length of the tubular
insertion member is substantially equivalent to the diameter of the
insertion end. Procter & Gamble, of Cincinnati, Ohio, currently
offers for sale an open-ended tampon applicator under the trade
name TAMPAX flushable applicator tampons.
[0050] The expulsion member 24 of the applicator 10 provided by the
present invention can be made from the same materials as discussed
above for the tubular insertion member 12. However, although paper
is not as useful unless modified substantially to provide the
appropriate spring-back, and some metals such as superelastic metal
alloys such as Nitinol (Ni--Ti alloy) may also be used. However,
plastics are most preferred materials. The above, representative
list of plastics useful for the tubular insertion member are also
useful for the expulsion member. The expulsion member 24 having a
modified hinge portion 34 may also be optimized by determining a
minimum beam dimension for the hinge portion 34 to provide the
appropriate column strength to resist buckling failure during
expulsion. This minimum beam dimension-may also reduce the
likelihood that the beam would become irrecoverably damaged during
the bending of the hinge portion 34 to allow the desired
spring-back. Additionally, reinforcements to the remainder of the
beam 32 may provide benefits in use. This may be especially true in
providing appropriate column strength.
[0051] Typical dimensions for each of the tubular insertion and
expulsion members include a length of from about 50 to about 100
millimeters, a diameter of from about 8 to about 16 millimeters,
and a thickness of from about 0.4 to about 0.6 millimeters.
Preferably, the diameter of the expulsion member is less than the
diameter of the tubular insertion member to allow for a telescopic
arrangement of the two.
[0052] The applicator of the present invention can be made by
appropriate processes that will be recognized by those of ordinary
skill in the art. For example, paper tubular insertion members can
be constructed from a single layer of paper material, or from a
plurality of laminated layers to provide multiple benefits relating
to the various layers. The applicators can be made from sheets of
material using several processing including, without limitation:
spiral winding as disclosed in Campion et al., U.S. Pat. No.
5,346,468, convolute winding as disclosed in Whitehead, U.S. Pat.
No. 4,508,531, and forming a sheet around a mandrel and then
sealing an overlapped seam as disclosed in Hinzmann, U.S. Pat. No.
4,755,164.
[0053] If the applicator includes a surface layer, as described
above, it may be applied using any useful technique. Many
techniques are known for applying the surface layers. A
representative, non-limiting list of such techniques includes
spraying, extruding, slot-coating, brushing, transfer coating, and
the like. Additional processing steps may be required to cure the
surface treatments to a useable form other than simple air curing,
such as applying irradiation or other forms of energy.
[0054] Again, the tubular insertion member of the applicator
provided by the present invention is preferably substantially
closed prior to expulsion of the materials contained therein. One
technique for substantially closing the insertion end of the
applicator is by employing a plurality of inwardly curved petals.
The petals will flex and/or hinge to an open position upon
expelling materials contained by the applicator. The number of
petals generally ranges from about four to about six. An
alternative technique for substantially closing the insertion end
of an applicator is by pleating the insertion end. This technique
is disclosed in Neilsen et al., U.S. Pat. No. 5,782,793. When an
applicator is constructed with more than one layer of material, a
single layer may extend into the insertion end in an effort to
reduce the force required to expel the contained materials. An
example of this is disclosed in Fox et al., U.S. Pat. No.
5,827,214. These collective closures may be of spherical shape, or
alternatively tapered shape.
[0055] Plastic applicator members may be manufactured using any
useful technique, and many techniques are known for manufacturing
plastic applicators. A representative, non-limiting list of such
techniques includes injection-molding, blow-molding, extrusion,
formation from one or more sheets (as described above for paper),
and the like. Generally, the applicator members (for example, the
tubular insertion members) can be formed through an injection
molding process. This process may be used, because it allows the
manufacture to balance some key characteristics of the tubular
insertion member. Mold inserts and cores can be machined to form a
slightly tapered product. For example, the wall thickness around
the gripper end 16 is relatively thick to maintain structural
stability during the insertion and expulsion steps of use, while
the thickness in the insertion end 14 can be minimized to provide
flexibility and low expulsion force. Injection molding also enables
the manufacture to make uniquely shaped tubular insertion members
and expulsion members. As mentioned above, the less sophisticated
and/or less expensive techniques, such as extrusion and blow
molding can also be employed. For example, extruded tubes can be
further manipulated to form additional features, such as raised or
indented rings or other formations. They can also have portions
removed to form the hinge portion of the expulsion member. Extruded
plastic tubes provide further orientation of the polymer. This
orientation may be useful to increase the spring-back and column
strength of the expulsion member.
[0056] The applicator of the present invention can be used for the
delivery of an object into a mammalian body cavity. Such objects
may include suppositories, absorbent devices, and the like, and
they may be delivered into body cavities including the mouth, nose,
vagina, urethra, and rectum. These materials may be in the form of
solids, creams, foams, gels, and the like.
[0057] Preferably, the applicator is used to deliver intravaginal
devices, including catamenial devices, such as tampons,
intravaginal collection devices, and is interlabial pads; birth
control devices such as diaphragms or intrauterine devices (IUDs);
compositions in the form of suppositories, such as medicaments,
moisturizers, vitamins and minerals, spermicides, and odor
controlling agents; medical devices and incontinence devices and
vaginal supports such as pessaries; and obstructing devices.
Obstructing devices include menstrual collection cups and
inflatable or expandable blocking devices.
[0058] In use, the applicator 10 can be removed from its packaging
material, e.g., 42. If the packaging material 42 is used as an
external restraint (as in FIG. 12), the expulsion member 24 would
then automatically unfold to provide a substantially linear
expulsion member 24, as shown in FIG. 13. Alternatively, the user
may need to initiate separation of the second end 28 of the
expulsion member 24 from the tubular insertion member 12 by
releasing the mechanical catch 36 or adhesive material 40 to allow
the expulsion member 24 to unfold (as shown in FIGS. 1 and 14).
Next, a user may place insertion end 14 into the body cavity
orifice, delivering tampon 18 into the body cavity by pushing on
expulsion member 24 until tampon 18 is expelled from tubular
insertion member 12 (as shown in FIG. 15) and withdrawing
applicator 10 from the body, leaving tampon 18 within the body
cavity.
[0059] Alternately, a user could pull tubular insertion member 12
onto expulsion member 24 while maintaining expulsion member 24
steady relative the user's body. This substantially eliminates
friction between the tampon 18 and the user's body.
[0060] The specification and embodiments above are presented to aid
in the complete and non-limiting understanding of the invention
disclosed herein. Since many variations and embodiments of the
invention can be made without departing from its spirit and scope,
the invention resides in the claims hereinafter appended.
* * * * *