U.S. patent application number 10/359699 was filed with the patent office on 2004-09-30 for applicators, dispensers and methods for dispensing and applying adhesive material.
This patent application is currently assigned to Closure Medical Corporation. Invention is credited to Cotter, William M., Goodman, Jack.
Application Number | 20040190975 10/359699 |
Document ID | / |
Family ID | 32987202 |
Filed Date | 2004-09-30 |
United States Patent
Application |
20040190975 |
Kind Code |
A1 |
Goodman, Jack ; et
al. |
September 30, 2004 |
Applicators, dispensers and methods for dispensing and applying
adhesive material
Abstract
An applicator/dispenser assembly for dispensing and/or applying
an adhesive material comprises: a first body portion and a second
body portion, at least one of the first and second body portions
being movable relative to the other of the first and second body
portions; a cavity in at least one of the first and second body
portions; and a piercing or breaking member arranged on one of the
first and second body portions. Movement of one of the first and
second body portions relative to the other of the first and second
body portions moves the piercing or breaking member into the
cavity. When a container of adhesive material is at least partially
disposed within the cavity, movement of one of the first and second
body portions relative to the other moves the piercing or breaking
member to rupture the container for dispensing and/or applying the
adhesive material.
Inventors: |
Goodman, Jack; (Ann Arbor,
MI) ; Cotter, William M.; (Raleigh, NC) |
Correspondence
Address: |
OLIFF & BERRIDGE, PLC
P.O. BOX 19928
ALEXANDRIA
VA
22320
US
|
Assignee: |
Closure Medical Corporation
Raleigh
NC
|
Family ID: |
32987202 |
Appl. No.: |
10/359699 |
Filed: |
February 7, 2003 |
Current U.S.
Class: |
401/134 |
Current CPC
Class: |
A61B 17/00491 20130101;
B05C 17/0116 20130101; B05C 17/00586 20130101; B05C 17/002
20130101; B05C 17/00583 20130101 |
Class at
Publication: |
401/134 |
International
Class: |
B43K 005/14 |
Claims
What is claimed is:
1. An applicator/dispenser assembly for dispensing and/or applying
a polymerizable monomeric adhesive material, comprising: a first
body portion and a second body portion, at least one of the first
and second body portions being movable relative to the other of the
first and second body portions; a cavity in at least one of the
first and second body portions; and a piercing or breaking member
arranged on one of the first and second body portions, wherein
movement of one of the first and second body portions relative to
the other of the first and second body portions moves the piercing
or breaking member into the cavity.
2. The applicator/dispenser according to claim 1, further
comprising a container of adhesive material at least partially
disposed within the cavity, wherein movement of one of the first
and second body portions relative to the other of the first and
second body portions moves the piercing or breaking member to
rupture the container.
3. The applicator/dispenser according to claim 2, further
comprising a second container having at least one opening, the
second container surrounding the container of adhesive, wherein
movement of one of the first and second body portions relative to
the other of the first and second body portions moves the piercing
or breaking member to rupture the container containing the adhesive
without breaking the second container.
4. The applicator/dispenser according to claim 2, wherein the
adhesive material comprises a polymerizable monomer adhesive
material.
5. The applicator/dispenser according to claim 2, wherein the
adhesive material comprises a polymerizable 1,1-disubstituted
ethylene monomer formulation.
6. The applicator/dispenser according to claim 2, wherein the
adhesive material comprises a cyanoacrylate formulation.
7. The applicator/dispenser according to claim 3, wherein the
container is formed from a material that stabilizes the
polymerizable monomeric adhesive material.
8. The applicator/dispenser according to claim 1, wherein at least
a part of the at least one of the first and second body portions
defining the cavity is formed from a material that stabilizes a
polymerizable monomeric adhesive material.
9. The applicator/dispenser according to claim 8, wherein at least
a part of the at least one of the first and second body portions
defining the cavity is formed from a material that stabilizes a
polymerizable monomeric adhesive material in the absence of a
stabilizer being added to the adhesive material.
10. The applicator/dispenser according to claim 8, wherein the
material that stabilizes a polymerizable monomeric adhesive
material is a halogenated polymeric material.
11. The applicator/dispenser according to claim 8, wherein the
halogenated polymeric material is selected from the group
consisting of polyolefins, halogenated hydrocarbons, and engineered
resins.
12. The applicator/dispenser according to claim 10, wherein the
halogenated polymeric material is a fluorinated polymeric
material.
13. The applicator/dispenser according to claim 1, wherein at least
an inner surface of the cavity is coated with a material that
stabilizes a polymerizable monomeric adhesive material.
14. The applicator/dispenser according to claim 1, wherein at least
an inner surface of the cavity is impregnated with a material that
stabilizes a polymerizable monomeric adhesive material.
15. The applicator/dispenser according to claim 1, further
comprising a pivoting connection that movably connects the first
and second body portions.
16. The applicator/dispenser according to claim 15, wherein the
first and second body portions comprise a handle portion of the
applicator/dispenser.
17. The applicator/dispenser according to claim 1, wherein the
second body portion is rotatable relative to the first body
portion.
18. The applicator/dispenser according to claim 17, further
comprising: a camming surface arranged on one of the first and
second body portions other than the one of the first and second
body portions on which the piercing or breaking member is arranged,
wherein rotation of the second body portion relative to the first
body portion the moves the piercing or breaking member into the
cavity by contacting the camming surface and the piercing or
breaking member.
19. The applicator/dispenser according to claim 1, further
comprising: a bladder disposed at least partially within the
cavity, at least a portion of the bladder being flexible; and a
container of adhesive material disposed within the bladder and at
least partially located in the cavity, wherein movement of one of
the first and second body portions relative to the other of the
first and second body portions moves the piercing or breaking
member to rupture the container.
20. The applicator/dispenser according to claim 19, further
comprising a plug member at least partially disposed in an opening
of the bladder, the plug member being made of a material that is at
least one of porous, absorbent and adsorbent in nature.
21. The applicator/dispenser according to claim 20, wherein the
plug member comprises an applicator tip.
22. The applicator/dispenser according to claim 20, wherein at
least one of a medicament, a polymerization initiator, a
polymerization rate modifier and a stabilizer for a polymerizable
monomer is in or on the plug member.
23. The applicator/dispenser according to claim 20, further
comprising an applicator/dispenser tip that is attached to at least
one of the plug member, the first body portion and the second body
portion.
24. The applicator/dispenser according to claim 23, wherein the
applicator/dispenser tip comprises one of a nozzle, a spatula, a
rolling ball, a brush, and a swab.
25. The applicator/dispenser according to claim 23, wherein the
applicator/dispenser tip is removable.
26. The applicator/dispenser according to claim 1, further
comprising: a slide assembly having a plunger portion that is at
least partially disposed in the cavity and a slide portion that is
at least partially disposed outside the cavity, the slide assembly
being slidably movable to move the plunder portion toward an
dispensing opening of the cavity; and an opening in at least one of
the first and second body portions through which the slide portion
of the slide assembly extends.
27. The applicator/dispenser according to claim 26, further
comprising: a container of adhesive material disposed in the cavity
between the dispensing opening of the cavity and the plunger
portion of the slide assembly, wherein movement of one of the first
and second body portions relative to the other of the first and
second body portions moves the piercing or breaking member to
rupture the container and movement of the slide member moves the
plunger portion to dispense the adhesive material from the cavity
once the container is ruptured.
28. The applicator/dispenser according to claim 27, further
comprising a plug member at least partially disposed in the
dispensing opening of the cavity, the plug member being made of a
material that is at least one of porous, absorbent and adsorbent in
nature.
29. The applicator/dispenser according to claim 28, wherein the
plug member comprises an applicator tip.
30. The applicator/dispenser according to claim 28, wherein at
least one of a medicament, a polymerization initiator, a
polymerization rate modifier and a stabilizer for a polymerizable
monomer is in or on the plug member.
31. The applicator/dispenser according to claim 28, further
comprising an applicator/dispenser tip that is attached to at least
one of the plug member, the first body portion and the second body
portion.
32. The applicator/dispenser according to claim 31, wherein the
applicator/dispenser tip comprises one of a nozzle, a spatula, a
rolling ball, a brush, and a swab.
33. The applicator/dispenser according to claim 31, wherein the
applicator/dispenser tip is removable.
34. A kit comprising: at least one applicator/dispenser of claim 1;
and a plurality of containers of adhesive material arranged to be
placed at least partially in the cavity of the at least one
applicator/dispenser, wherein movement of one of the first and
second body portions relative to the other of the first and second
body portions moves the piercing or breaking member to rupture one
of the containers that is placed at least partially in the
cavity.
35. The kit according to claim 34, further comprising a plurality
of removable applicator tips.
36. The kit according to claim 34, further comprising a
polymerization initiator or rate modifier for the adhesive
material.
37. The kit according to claim 34, wherein the adhesive material
comprises a polymerizable monomer adhesive material.
38. The kit according to claim 34, wherein the adhesive material
comprises a polymerizable 1,1-disubstituted ethylene monomer
formulation.
39. The kit according to claim 34, wherein the adhesive material
comprises a cyanoacrylate formulation.
40. The kit according to claim 34, wherein at least two of the
plurality of containers contain different amounts of adhesive
material.
41. The kit according to claim 34, wherein at least two of the
plurality of containers contain a different adhesive material.
42. A method of applying/dispensing an adhesive material,
comprising: placing a container of adhesive material at least
partially into the cavity of an applicator/dispenser according to
claim 1; moving one of the first and second body portions relative
to the other of the first and second body portions to move the
piercing or breaking member to rupture the container; and
dispensing the adhesive material from the cavity.
43. The method of claim 42, further comprising applying the
dispensed adhesive material to a substrate to be bonded.
44. The method of claim 43, wherein the substrate to be bonded is
tissue.
45. The method of claim 42, wherein moving one of the first and
second body portions relative to the other of the first and second
body portions comprises rotating one of the first and second body
portions relative to the other of the first and second body
portions.
46. The method of claim 42, wherein moving one of the first and
second body portions relative to the other of the first and second
body portions comprises pivoting one of the first and second body
portions relative to the other of the first and second body
portions.
Description
BACKGROUND OF THE INVENTION
[0001] This invention relates to applicators and/or dispensers for
dispensing and/or applying an adhesive material, for example, a
polymerizable monomer compound such as a cyanoacrylate adhesive,
particularly for medical use.
[0002] Numerous swabs, applicators, dispensers and kits for
dispensing and applying various materials, including adhesive
materials, are known. However, these known arrangements possess
various shortcomings that make them undesirable in many
applications.
[0003] Monomer and polymer adhesives are used in both industrial
(including household) and medical applications. Included among
these adhesives are the 1,1-disubstituted ethylene monomers and
polymers, such as the .alpha.-cyanoacrylates. Since the discovery
of the adhesive properties of such monomers and polymers, they have
found wide use due to the speed with which they cure, the strength
of the resulting bond formed, and their relative ease of use. These
characteristics have made the .alpha.-cyanoacrylate adhesives the
primary choice for numerous applications such as bonding plastics,
rubbers, glass, metals, wood, and, more recently, biological
tissues.
[0004] Medical applications of 1,1-disubstituted ethylene monomer
adhesive compositions include use as an alternate or an adjunct to
surgical sutures and staples in wound closure as well as for
covering and protecting tissue wounds such as lacerations,
abrasions, burns, stomatitis, sores, and other open surface wounds.
When such an adhesive is applied, it is usually applied in its
monomeric form, and the resultant polymerization gives rise to the
desired adhesive bond.
[0005] Applicators for dispensing a polymerizable and/or
cross-linkable material, such as a 1,1-disubstituted ethylene
formulation, are disclosed in U.S. Pat. No. 5,928,611 to Leung and
copending U.S. patent application Ser. No. 09/430,177, filed Oct.
29, 1999. In general, many different 1,1-disubstituted ethylene
formulations are known for various applications, for example,
cyanoacrylate formulations used as fast-acting surgical adhesives,
sealants, bioactive agent release matrixes and implants utilized in
medical, surgical and other in vivo applications. Such formulations
include those disclosed by Leung and the references cited
therein.
[0006] However, due to the need to apply the adhesive in its
monomeric form, and due to the rapid polymerization rate of the
monomers, it has been very difficult to design effective and
commercially viable applicators and/or dispensers. Such applicators
and/or dispensers must counterbalance the competing requirements
that the monomer not prematurely polymerize, that the monomer be
easily applied, that the monomer polymerize at a desired rate upon
application, and that the sanitary and/or sterile properties of the
monomer and applicator--whether real or perceived--be maintained.
This latter requirement, that the actual or perceived sanitary and
sterile condition of the monomer and applicator be maintained, is
particularly important in medical applications, where the user
and/or the patient desires a clean product so as not to introduce
further bacteria or foreign matter into a wound site.
[0007] A further problem in addressing the above requirements of
adhesive applicators and/or dispensers is the need to provide a
stable monomer product. Particularly in small quantities,
cyanoacrylate monomers are prone to premature polymerization, which
would render the product useless. Thus, industrial production of
monomeric adhesive compositions has had to balance rapid cure rates
and high bond strengths with shelf-life. The shelf-life of these
adhesives is primarily related to stability (i.e., constancy of
compositional nature), uncured physical properties, rate of cure of
the adhesive, as well as final cured properties of the composition.
For example, the shelf-life of a monomeric .alpha.-cyanoacrylate
composition may be measured as a function of the amount of time the
composition can be stored before unacceptable levels of
polymerization, such as measured by viscosity increase, occur.
Unacceptable levels are indicated by a level of polymerization
product that reduces the usefulness of the composition in the
application for which it is produced.
[0008] Known devices fail to provide an applicator and/or dispenser
that is optimized for convenient dispensing and application of
adhesive materials on a variety of surfaces and structures. The
known applicators are generally either optimized for delivery of
other compositions or are inconvenient for use in conjunction with
adhesives. Furthermore, such conventional devices generally do not
address the competing needs of ease of use and adhesive stability
prior to application.
SUMMARY OF THE INVENTION
[0009] This invention addresses the above needs by providing
applicators and dispensers that permit economical and efficient use
of adhesive compositions. In embodiments of this invention,
applicators and/or dispensers are provided that are more user
friendly. In embodiments of this invention, applicators and/or
dispensers are provided that are more ergonomic. In embodiments of
this invention, applicators and/or dispensers are provided whereby
an amount of adhesive material may be conveniently applied. The
applicators and/or dispensers can be either disposable or reusable,
depending on the desired application.
[0010] In embodiments, an applicator and/or dispenser is designed
to facilitate manipulation by hand for dispensing and/or applying
an adhesive. For example, in embodiments of this invention,
applicators and/or dispensers are provided that are pen-like,
providing a familiar feel to the user. In embodiments, an
applicator and/or dispenser is designed to be more comfortable to
the user, easier to grip and/or easier to operate.
[0011] In embodiments, an applicator and/or dispenser is designed
to provide acceptable stability and shelf-life to the adhesive
composition without the need to add separate stabilizer materials
to the polymerizable monomer. Thus, in these embodiments, because
the shelf-life is provided by the applicator and/or dispenser
itself, the cure rate of the adhesive composition is not adversely
affected, as in the case where one or more stabilizers are added.
Accordingly, the need to apply separate polymerization initiators
or rate modifiers can be reduced or even eliminated.
[0012] In other embodiments, an applicator and/or dispenser
includes a polymerization initiator or accelerator for the adhesive
material. The polymerization initiator or accelerator may be
disposed in or on a tip or other part of the applicator. The
polymerization initiator or accelerator may be absorbed or adsorbed
into a porous portion of the applicator, may be coated on a surface
of the applicator, or otherwise incorporated into a portion of the
applicator. The applicator and/or dispenser may also include a
frangible barrier separating first and second compartments, for
example, to keep the polymerization initiator or accelerator
separated from the adhesive material prior to use.
[0013] In particular, this invention is directed to an
applicator/dispenser for dispensing and/or applying an adhesive
material, comprising: a first body portion and a second body
portion, at least one of the first and second body portions being
movable relative to the other of the first and second body
portions; a cavity in at least one of the first and second body
portions; and a piercing or breaking member arranged on one of the
first and second body portions, wherein movement of one of the
first and second body portions relative to the other of the first
and second body portions moves the piercing or breaking member into
the cavity. In various embodiments, the applicator/dispenser
further comprises a container of adhesive material at least
partially disposed within the cavity, wherein movement of one of
the first and second body portions relative to the other of the
first and second body portions moves the piercing or breaking
member to rupture the container.
[0014] In embodiments, the adhesive material comprises a
polymerizable monomer adhesive material. In embodiments, the
adhesive material comprises a polymerizable 1,1-disubstituted
ethylene monomer formulation. In still other embodiments, the
adhesive material comprises a cyanoacrylate formulation.
[0015] In embodiments, an applicator/dispenser for a polymerizable
monomeric adhesive material includes a material that provides
acceptable stability and shelf-life to the adhesive composition
without the need to add separate stabilizer materials to the
polymerizable monomer. As noted above, because the shelf-life is
provided by the material of the applicator and/or dispenser, the
cure rate of the adhesive composition is not adversely affected.
Thus, the need to apply separate polymerization initiators or rate
modifiers can be reduced or even eliminated.
[0016] In other embodiments, the applicator/dispenser includes a
polymerization initiator or accelerator for the adhesive
material.
[0017] In embodiments, the applicator/dispenser further comprises a
pivoting connection that movably connects the first and second body
portions. In embodiments, the first and second body portions may
comprise a handle portion of the applicator/dispenser.
[0018] In other embodiments, the second body portion is rotatable
relative to the first body portion. In embodiments, the
applicator/dispenser further comprises a camming surface arranged
on one of the first and second body portions other than the one of
the first and second body portions on which the piercing or
breaking member is arranged, wherein rotation of the second body
portion relative to the first body portion moves the piercing or
breaking member into the cavity by contacting the camming surface
and the piercing or breaking member.
[0019] In embodiments, the applicator/dispenser further comprises:
a bladder disposed at least partially within the cavity, at least a
portion of the bladder being flexible; and a container of adhesive
material disposed within the bladder and at least partially located
in the cavity, wherein movement of one of the first and second body
portions relative to the other of the first and second body
portions moves the piercing or breaking member to rupture the
container. In embodiments, the applicator/dispenser further
comprises a plug member at least partially disposed in an opening
of the bladder, the plug member being made of a material that is at
least one of porous, absorbent and adsorbent in nature. In
embodiments, the plug member comprises an applicator tip.
[0020] In embodiments, the applicator/dispenser further comprises:
a slide assembly having a plunger portion that is at least
partially disposed in the cavity and a slide portion that is at
least partially disposed outside the cavity, the slide assembly
being slidably movable to move the plunger portion toward a
dispensing opening of the cavity; and an opening in at least one of
the first and second body portions through which the slide portion
of the slide assembly extends. In embodiments, the
applicator/dispenser further comprises: a container of adhesive
material disposed in the cavity between the dispensing opening of
the cavity and the plunger portion of the slide assembly, wherein
movement of one of the first and second body portions relative to
the other of the first and second body portions moves the piercing
or breaking member to rupture the container and movement of the
slide member moves the plunger portion to dispense the adhesive
material from the cavity once the container is ruptured.
[0021] In other embodiments, this invention is directed to a kit
comprising: at least one applicator/dispenser; and a plurality of
containers of adhesive material arranged to be placed at least
partially in the cavity of the at least one applicator/dispenser,
wherein movement of one of the first and second body portions
relative to the other of the first and second body portions moves
the piercing or breaking member to rupture one of the containers
that is placed at least partially in the cavity. In embodiments,
the kit further comprises a plurality of removable applicator tips.
In embodiments, the kit further comprises a polymerization
initiator or rate modifier for the adhesive material. In
embodiments, at least two of the plurality of containers contain
different amounts of adhesive material. In other embodiments, at
least two of the plurality of containers contain a different
adhesive material.
[0022] In other embodiments, this invention is directed to a method
of applying/dispensing an adhesive material comprising: placing a
container of adhesive material at least partially into the cavity
of an applicator/dispenser; moving one of the first and second body
portions relative to the other of the first and second body
portions to move the piercing or breaking member to rupture the
container; and dispensing the adhesive material from the cavity. In
embodiments, the method further comprises applying the dispensed
adhesive to a substrate to be bonded.
[0023] Various other features and advantages of this invention will
be apparent from the following detailed description of exemplary
embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] Exemplary embodiments of this invention are described in
detail below, with reference to the attached drawing figures, in
which:
[0025] FIG. 1 is a perspective view of a first exemplary embodiment
of this invention;
[0026] FIG. 2 is a perspective view of the exemplary embodiment of
FIG. 1 illustrating activation of the applicator/dispenser;
[0027] FIG. 3 is a perspective view of a bladder portion and an
ampoule of the exemplary embodiment of FIG. 1;
[0028] FIG. 4 is a partial cross-sectional view of the exemplary
embodiment of FIG. 1;
[0029] FIG. 5 is a perspective view of a second exemplary
embodiment of this invention;
[0030] FIG. 6 is a perspective view of the exemplary embodiment of
FIG. 5 illustrating activation of the applicator/dispenser;
[0031] FIG. 7 is a cross-sectional view of the exemplary embodiment
of FIG. 5;
[0032] FIG. 8 is a perspective view of a slider assembly of the
exemplary embodiment of FIG. 5;
[0033] FIG. 9 is a partial cross-sectional view of the exemplary
embodiment of FIG. 5;
[0034] FIG. 10 is a perspective view of a third exemplary
embodiment of this invention;
[0035] FIG. 11 is an exploded view of the exemplary embodiment of
FIG. 10; and
[0036] FIG. 12 is an enlarged, partial view of the exemplary
embodiment of FIG. 10.
DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
[0037] In embodiments of this invention, an applicator/dispenser is
provided that facilitates easy application of a desired quantity of
polymerizable adhesive material. In embodiments, an amount of
polymerizable adhesive material is prepackaged in the applicator
dispenser in a frangible ampoule that is broken upon activation of
the applicator/dispenser. The frangible ampoule may provide
stability and/or shelf-life for the amount of polymerizable
adhesive material.
[0038] FIGS. 1-4 illustrate a first embodiment of this invention,
although this invention is in no way limited to the specific design
depicted therein. As shown in FIGS. 1 and 2, an
applicator/dispenser 100 is formed by a first body portion 110 and
a second body portion 120 that are movable relative to one another.
For example, in the embodiment shown, a pivoting connection 130 is
provided that allows the first body portion 110 and the second body
portion 120 to be moved from an open, spaced apart relative
position, illustrated in FIG. 1, to a substantially closed,
adjacent position, illustrated in FIG. 2. The relative position
illustrated in FIG. 1 may be a "cocked" position in embodiments
that have an amount of polymerizable adhesive material prepackaged
in the applicator/dispenser 100.
[0039] The first body portion 110 and the second body portion 120
define a space therebetween into which a bladder 140 may be fitted.
As shown in FIGS. 1 and 2, the first body portion 110 has an
opening 112 through which a push button portion 142 of the bladder
140 may extend. As explained below, the push button portion 142 may
be depressed by a user to dispense a desired quantity of
polymerizable adhesive material from the applicator/dispenser 100,
for example, through a detachable or replaceable tip 150. A user's
thumb or finger may be used to depress the push button portion 142
while the applicator/dispenser 100 is held by the first and second
body portions 110, 120 as a handle. For example, a user may hold
the applicator/dispenser 100 as a pen and press the push button
portion 142 with an index finger.
[0040] It should be understood that the detachable or replaceable
tip 150 is optional and may have any desired configuration. If the
detachable or replaceable tip 150 is not provided or used, a porous
plug 170, described below, may form the tip of the
dispenser/applicator 100. The tip 150 may be selected for a
particular application, and is not limited to the tapered nozzle
design shown. For example, the applicator tip may be a fibrous
swab, a sponge swab, a foam swab, a brush, a spatula or the like.
Any suitable tip, either known or hereafter developed, may be used
with the applicators/dispensers according to this invention.
[0041] The tip 150 may be designed to friction fit over an end
portion 160 of the applicator/dispenser 100. Alternatively, the tip
150 may fit directly on the porous plug 170 that is situated in an
open end of the bladder 140, as described below.
[0042] The first body portion 110, the second body portion 120, the
bladder 140 and/or the tip 150 may be made of any suitable
material, preferably a material that promotes stability of the
polymerizable adhesive material to be dispensed so as to avoid
premature polymerization.
[0043] The porous plug 170 may include a polymerization initiator
or rate modifier for the polymerizable adhesive material to be
dispensed. The porous plug 170 may be impregnated with the
polymerization initiator or rate modifier, or may have the
polymerization initiator or rate modifier coated on a surface
thereof.
[0044] FIG. 3 shows an exemplary embodiment of the bladder 140
removed from the applicator/dispenser 100. As described above, the
bladder 140 has an open end 144 into which the porous plug 170 is
fitted. At least the push button portion 142 of the bladder 140 is
made of a flexible material. The bladder 140 may be blow molded of
a suitable rubber, silicone or plastic material, such as, for
example, polyvinyl chloride, polyethylene, polyurethane, natural or
nitril rubber, or any combination thereof.
[0045] A frangible ampoule 146 containing an amount of
polymerizable adhesive 148 is disposed in the bladder 140. The
frangible ampoule 146 may be made of any suitable material,
preferably a material that promotes stability and shelf-life of the
polymerizable adhesive material 148. For example, the frangible
ampoule 146 may be made of glass. Other materials, such as, a
plastic material or pierceable metal, such as aluminum, may be used
for the frangible ampoule 146. An example of a suitable ampoule
that can be used in the dispenser/applicators of the present
invention is disclosed in, for example, U.S. Pat. No. 5,928,611,
the entire disclosure of which is incorporated herein by reference.
In fact, where such an ampoule is used in the present invention,
the entire ampoule/applicator device may be used, which would
thereby constitute not only the ampoule 144, but also the porous
plug 170. In such embodiments, the dispensers/applicators of the
present invention are particularly suitable for dispensing or
applying the adhesive contained in the DERMABOND.RTM. topical skin
adhesive product, available from Ethicon (Somerville, N.J.).
[0046] FIG. 4 illustrates the bladder 140, the push button portion
142, the frangible ampoule 146 and the porous plug 170 assembled
and inserted into the space between the first body portion 110 and
the second body portion 120, with the porous plug 170 extending
through an opening in the end portion 160 of the
applicator/dispenser 100. As shown in FIG. 4, the second body
portion 120 includes a piercing or breaking member 122 that extends
inwardly from an inner surface thereof. The breaking member 122 is
located so that the frangible ampoule 146 is broken by the breaking
member 122 when the first and second body portions 110, 120 are
moved from the open position shown in FIG. 1 to the closed position
shown in FIG. 2. The first and second body portions 110, 120 act as
levers on the pivoting connection 130, thus providing a mechanical
advantage to facilitate breakage of the frangible ampoule 146.
[0047] Once the first and second body portions 110, 120 are moved
to the closed position shown in FIG. 2 and the frangible ampoule
146 is broken, the first and second body portions 110, 120 may be
prevented from accidentally returning to the open position shown in
FIG. 1. For example, a detent or other suitable latching mechanism
may be used to engage the first and second body portions 110, 120.
In embodiments where the applicator/dispenser 100 is only to be
used with the amount of polymerizable adhesive material 148
initially supplied, the latching mechanism may be irreversible.
[0048] In the embodiment shown, the breaking member 122 is situated
remote from the push button portion 142 and near the open end 144
of the bladder 140. This location causes the frangible ampoule 146
to be broken near the open end 144 of the bladder 140 to help
ensure that the polymerizable adhesive 148 will flow from the
bladder 140 and that the flow is not impeded by larger fragments of
the broken ampoule 146. Further, breaking the frangible ampoule 146
remote from the push button portion 142 may help to avoid fragments
that could accidentally pierce the push button portion 142 and cut
a user's thumb or finger. Although not shown, the bladder 140 may
be thicker or reinforced at the push button 142 to prevent such an
occurrence. Alternatively, the ampoule 146 may be placed within a
separate tube-like structure, such as a standard butyrate tube,
having a section removed, such as a partially opened end. Fragments
of the broken ampoule 146 can be contained by the tube while
allowing the polymerizable adhesive 148 to flow from the tube and
from the bladder 140.
[0049] The bladder 140 is designed to contain the polymerizable
adhesive 148 once the frangible ampoule 146 is broken. The
polymerizable adhesive 148 may be forced from the bladder 140 by
depressing the push button portion 142, displacing the
polymerizable adhesive 148 and causing it to flow through the
porous plug 170. The polymerizable adhesive 148 flowing through the
porous plug 170 may be applied directly to a desired site using the
porous plug 170 as an applicator tip. Alternatively, the detachable
or replaceable tip 150 may receive the polymerizable adhesive 148
flowing through the porous plug 170 for application.
[0050] A controlled flow of the polymerizable adhesive 148 may be
obtained by providing a slow, but steady pressure on the bladder
140, for example, by depressing the push button portion 142 to a
desired extent and/or a desired number of times. In embodiments,
the volume displaced by depressing the push button portion 142 may
correspond to a desired amount of the polymerizable adhesive 148
that is to be dispensed.
[0051] As noted above, the amount of polymerizable adhesive
material 148 may be prepackaged in the applicator/dispenser 100.
The applicator/dispenser 100 may be disposable and discarded after
the amount of polymerizable adhesive material 148 in the frangible
ampoule 146 has been dispensed or otherwise been used (i.e.,
polymerized). Alternatively, the amount of polymerizable adhesive
material 148 may be separate from the applicator/dispenser 100 and
supplied to the applicator/dispenser 100 prior to use.
[0052] In embodiments, a user may be able to select from a variety
of adhesive materials and/or amounts by selecting a frangible
ampoule and/or bladder assembly (bladder, ampoule and plug) to be
installed in the applicator/dispenser 100. For example, a kit may
be provided that includes at least one applicator/dispenser 100 and
a plurality of frangible ampoules 146 (or bladder assemblies). A
plurality of detachable or replaceable tips 150 may also be
included in the kit. The kit may also include a cleaning agent,
such as isopropyl alcohol or other chemical sterilants, such as
gluteraldehyde. Parts of the kit, such as the frangible ampoules
146 (or bladder assemblies) may be packaged separately, for
example, in a blister pouch, and may be unpackaged and combined
with the applicator/dispenser 100 as needed.
[0053] FIGS. 5-9 illustrate a second embodiment of this invention,
although this invention is in no way limited to the specific design
depicted therein. As shown in FIGS. 5 and 6, an
applicator/dispenser 200 is formed by a first body portion 210 and
a second body portion 220 that are movable relative to one another.
For example, in the embodiment shown, a pivoting connection 230 is
provided that allows the first body portion 210 and the second body
portion 220 to be moved from an open position, illustrated in FIG.
5, to a substantially closed position, illustrated in FIG. 6. The
open position illustrated in FIG. 5 may be a "cocked" position in
embodiments that have an amount of polymerizable adhesive material
prepackaged in the applicator/dispenser 200.
[0054] As shown in FIGS. 5 and 6, the first body portion 210 has an
opening through which a slide button portion 242 of a slider
assembly 240 may extend. As explained below, the slide button
portion 242 may be moved by a user to dispense a desired quantity
of polymerizable adhesive material from the applicator/dispenser
200, for example, through a porous plug 270 or other suitable tip.
A user's thumb or finger may be used to move the slide button 242
while the applicator/dispenser 200 is held by the first and second
body portions 210, 220 as a handle. For example, a user may hold
the applicator/dispenser 200 as a pen and push or slide forward the
slide button 242 with an index finger. The first body portion 210
may include one or more contours 212 for a user's thumb or
finger.
[0055] The slide button 242 is not limited to the specific
embodiment shown FIGS. 5-9. The slide button 242 may be formed by a
lever or other suitable mechanism, such as a syringe shaft, that is
arranged to move the plunger portion 244 forward.
[0056] FIG. 7 shows a cross-sectional view of the
applicator/dispenser 200 with the first and second body portions
210, 220 in the open position. As shown, the first and second body
portions 210, 220 define a chamber 260 into which a frangible
ampoule 280 containing an amount of polymerizable adhesive material
282 may be placed. As shown in FIG. 7, the first body portion 210
has an opening 214 through which the slide button portion 242 of
the slide assembly 240 may extend. In the embodiment shown, the
opening 214 is an elongated slot that allows the slide assembly to
move in an axial direction of the applicator/dispenser 200. Thus,
as explained below, the slide button portion 242 may be moved by a
user to move a plunger portion 244 of the slide assembly 240. Once
the frangible ampoule 280 is broken by a piercing or breaking
member 222 provided, for example, on the second body portion 220,
movement of the plunger portion 244 toward the porous plug 270 will
cause the polymerizable adhesive material 282 to be dispensed from
the applicator/dispenser 200.
[0057] Although not shown, it should be understood that the second
embodiment may also include a detachable or replaceable tip as
described above with respect to the first embodiment.
[0058] FIG. 8 shows an exemplary embodiment of the slide assembly
240 removed from the applicator/dispenser 200. The slide button
portion 242 and the plunger portion 244 are connected by an
intermediate portion 246 of the slide assembly 240. The
intermediate portion 246 should be sufficiently rigid to carry the
plunger portion 244 against any resistance caused by the
polymerizable adhesive material 282, contact between the plunger
portion 244 and the chamber 260, and/or the broken ampoule 280. On
the other hand, the slide button portion 242 may be made of a
rubber material or a plastic material that is comfortable and/or
provides a suitable grip for a user's finger or thumb. The plunger
portion 244 may be made of a rubber material or a plastic material
that will slide within the chamber 260 while providing a sufficient
seal against the inner surface of the chamber 260 to prevent
substantial leakage of the polymerizable adhesive material 282
during use. Alternatively, the plunger portion 244 may be provided
with one or more seal rings 248 of a suitable material. The slide
button portion 242 and the intermediate portion 246 may be made of
any variety of thermoplastics, such as ABS, polycarbonate,
ULTEM.TM. and the like. The plunger portion 244 and/or the seal
rings 248 may be made of any variety of rubbers, such as natural,
nitril, polyisoprene and the like. A suitable lubricant may be
provided to allow the plunger portion 244 and/or the seal rings 248
to slide while maintaining contact with the inside surface of the
chamber 260. Preferably, the lubricant and the materials selected
do not react with or cause premature polymerization of the adhesive
material.
[0059] FIG. 9 illustrates the slide assembly 240, the slide button
242, the plunger portion 244 and the frangible ampoule 280 inserted
into the chamber 260. As shown in FIG. 9, the piercing or breaking
member 222 extends inwardly from an inner surface of the second
body portion 220. The breaking member 222 is located so that the
frangible ampoule 280 is broken by the breaking member 222 when the
first and second body portions 210, 220 are moved from the open
position shown in FIG. 5 to the closed position shown in FIG. 6.
The first and second body portions 210, 220 act as levers on the
pivoting connection 230, thus providing a mechanical advantage to
facilitate breakage of the frangible ampoule 280.
[0060] As described above with respect to the first embodiment,
once the first and second body portions 210, 220 are moved to the
closed position shown in FIG. 6 and the frangible ampoule 280 is
broken, the first and second body portions 210, 220 may be
prevented from accidentally returning to the open position shown in
FIG. 5.
[0061] Although the breaking member 222 is situated near an end of
the frangible ampoule 280 remote from the porous plug 270 in the
embodiment shown, the breaking member 222 and frangible ampoule may
be located so that the frangible ampoule 280 will be broken near an
end closer to the porous plug 270 to help ensure that the
polymerizable adhesive 282 will not impeded by larger fragments of
the broken ampoule 280. Further, while the breaking member 222 is
shown as single localized member, it should be understood that the
breaking member 222 may extend along a portion of or the entire
ampoule 280 and/or may comprise a plurality of breaking members.
Further, while the ampoule 280 is shown as a single ampoule, it
should be understood that a plurality of ampoules may be provided.
For example, one ampoule may contain the adhesive material while
another ampoule contains a bioactive material, such as a
medicament, or other material.
[0062] The chamber 260 is designed to contain the polymerizable
adhesive 282 once the frangible ampoule 280 is broken. The
polymerizable adhesive 282 may be forced from the chamber 260 by
moving the slide button portion 242 so that the plunger portion 244
of the slide assembly 240 displaces the polymerizable adhesive 282
and causes it to flow through the porous plug 270. The
polymerizable adhesive 282 flowing through the porous plug 270 may
be applied directly to a desired site using the porous plug 270 as
an applicator tip. Alternatively, a detachable or replaceable tip
may receive the polymerizable adhesive 282 flowing through the
porous plug 270 for application.
[0063] A controlled flow of the polymerizable adhesive 282 may be
obtained by moving the slide button portion 242 to a desired
extent. In embodiments, movement of the slide assembly 240 may
create a pressure within the dispenser/applicator 200 to force the
polymerizable adhesive 282 to flow.
[0064] As noted above, the amount of polymerizable adhesive
material 282 may be prepackaged in the applicator/dispenser 200.
The applicator/dispenser 200 may be disposable and discarded after
the amount of polymerizable adhesive material 282 in the frangible
ampoule 280 has been dispensed or otherwise been used (i.e.,
polymerized). Alternatively, the amount of polymerizable adhesive
material 282 may be separate from the applicator/dispenser 200 and
supplied to the applicator/dispenser 200 prior to use.
[0065] In embodiments, a user may be able to select from a variety
of adhesive materials and/or amounts by selecting a frangible
ampoule to be installed in the applicator/dispenser 200. For
example, a kit may be provided that includes at least one
applicator/dispenser 200 and a plurality of frangible ampoules 280.
A plurality of detachable or replaceable tips may also be included
in the kit.
[0066] FIGS. 10-12 illustrate a third embodiment of this invention,
although this invention is in no way limited to the specific design
depicted therein. As shown in FIGS. 10 and 11, an
applicator/dispenser 300 is formed by a first body portion 310 and
a second body portion 320 that are movable relative to one another.
For example, in the embodiment shown, the first body portion 310
may be formed by two pieces that fit together to provide an open
end 314, as shown in FIG. 11. The second body portion 320 is
rotatably situated on the end 314 of the first body portion
310.
[0067] As shown in FIGS. 10 and 11, the first body portion 310 has
an opening 312 through which a push button portion 342 of the
bladder 340 may extend. As explained below, the push button portion
342 may be depressed by a user to dispense a desired quantity of
polymerizable adhesive material from the applicator/dispenser 300,
for example, through a detachable or replaceable tip 350. A user's
thumb or finger may be used to depress the push button portion 342
while the applicator/dispenser 300 is held by the first body
portion 310 as a handle. For example, a user may hold the
applicator/dispenser 300 as a pen and press the push button portion
342 with an index finger.
[0068] It should be understood that the detachable or replaceable
tip 350 may have any desired configuration. The tip 350 may be
selected for a particular application, and is not limited to the
tapered nozzle design shown. For example, the applicator tip may be
a fibrous swab, a sponge swab, a foam swab, a brush, a spatula or
the like. Any suitable tip, either known or hereafter developed,
may be used with the applicators/dispensers according to this
invention.
[0069] The tip 350 maybe designed to friction fit with the end 314
of the first body portion 310 of the applicator/dispenser 300.
Alternatively, the tip 350 may fit directly on a porous plug 370
that is situated in an open end of the bladder 340, as described
below. Further, the tip 350 may be non-detachable once the
applicator/dispenser 300 has been assembled, for example, by
connecting to the end 314 of the first body portion 310.
[0070] The first body portion 310, the second body portion 320, the
bladder 340 and/or the tip 350 may be made of any suitable
material, preferably a material that promotes stability of the
polymerizable adhesive material to be dispensed so as to avoid
premature polymerization.
[0071] The porous plug 370 may include a polymerization initiator
or rate modifier for the polymerizable adhesive material to be
dispensed. The porous plug 370 may be impregnated with the
polymerization initiator or rate modifier, or may have the
polymerization initiator or rate modifier coated on a surface
thereof.
[0072] FIG. 11 shows an exploded view of the third exemplary
embodiment. As described above with respect to the first
embodiment, the bladder 340 has an open end 344 into which the
porous plug 370 is fitted. At least the push button portion 342 of
the bladder 340 is made of a flexible material. The bladder 340 may
be blow molded of a suitable rubber or plastic material, such as,
for example, polyvinyl chloride, polyethylene, polyurethane,
natural rubber, nitril rubber, and the like.
[0073] A frangible ampoule 346 containing an amount of
polymerizable adhesive 348 is disposed in the bladder 340. The
frangible ampoule 346 may be made of any suitable material,
preferably a material that promotes stability and shelf-life of the
polymerizable adhesive material 348. For example, the frangible
ampoule 346 may be made of glass. Other materials, such as, a
plastic material or a pierceable metal material, such as aluminum,
may be used for the frangible ampoule 346. Similar to the
embodiment of FIGS. 1-4, discussed above, an example of a suitable
ampoule that can be used in the dispenser/applicators of the
present invention is disclosed in, for example, U.S. Pat. No.
5,928,611, the entire disclosure of which is incorporated herein by
reference. In fact, where such an ampoule is used in the present
invention, the entire ampoule/applicator device may be used, which
would thereby constitute not only the ampoule 346, but also the
porous plug 370. In such embodiments, the dispensers/applicators of
the present invention are particularly suitable for dispensing or
applying the adhesive contained in the DERMABOND.RTM. topical skin
adhesive product, available from Ethicon (Somerville, N.J.).
[0074] The bladder 340, the push button portion 342, the frangible
ampoule 346 and the porous plug 370 may be assembled and inserted
into the space between the two pieces of the first body portion
310, with the porous plug 370 extending through the open end 314 of
the first body portion 310 and the second body portion 320
rotatably situated on the end 314 of the first body portion
310.
[0075] As shown in FIGS. 11 and 12, the end 314 of the first body
portion 310 includes a piercing or breaking member 316 that extends
inwardly. The breaking member 316 is located so that the frangible
ampoule 346 is broken by the breaking member 316 when the first and
second body portions 310, 320 are rotated relative to one another
so that a camming surface or inclined ramp located on an inner
surface of the second body portion 320 presses the breaking member
316 into the frangible ampoule 346. Upon relative rotation, the
camming surface or ramp contacts a portion of the breaking member
316 that extends beyond the outer surface of the end 314 and
presses the breaking member 316 inwardly against the frangible
ampoule 346. The camming surface or ramp provides a mechanical
advantage to facilitate breakage of the frangible ampoule 346.
[0076] The bladder 340 is designed to contain the polymerizable
adhesive 348 once the frangible ampoule 346 is broken. The
polymerizable adhesive 348 may be forced from the bladder 340 by
depressing the push button portion 342, displacing the
polymerizable adhesive 348 and causing it to flow through the
porous plug 370. The polymerizable adhesive 348 flowing through the
porous plug 370 may be applied to a desired site using the tip
350.
[0077] A controlled flow of the polymerizable adhesive 348 may be
obtained by depressing the push button portion 342 to a desired
extent and/or a desired number of times. In embodiments, the volume
displaced by depressing the push button portion 342 may correspond
to a desired metered amount of the polymerizable adhesive 348 that
is to be dispensed.
[0078] As noted above, the amount of polymerizable adhesive
material 348 may be prepackaged in the applicator/dispenser 300.
The applicator/dispenser 300 may be disposable and discarded after
the amount of polymerizable adhesive material 348 in the frangible
ampoule 346 has been dispensed or otherwise been used (i.e.,
polymerized). Alternatively, the amount of polymerizable adhesive
material 348 may be separate from the applicator/dispenser 300 and
supplied to the applicator/dispenser 300 prior to use.
[0079] In embodiments, a user may be able to select from a variety
of adhesive materials and/or amounts by selecting a frangible
ampoule and/or bladder assembly (bladder, ampoule and plug) to be
installed in the applicator/dispenser 300. For example, a kit may
be provided that includes at least one applicator/dispenser 300 and
a plurality of frangible ampoules 346 (or bladder assemblies). A
plurality of detachable or replaceable tips 350 may also be
included in the kit.
[0080] By making portions of the applicators/dispensers of this
invention of a material that tends to stabilize the adhesive
monomer composition, it is possible and preferred in embodiments of
this invention that the adhesive composition does not include, or
is substantially free of, one or more stabilizer components such as
are known and used in the art as additives to the adhesive monomer
composition. This may reduce, or even eliminate, the need for a
polymerization initiator or accelerator. For example, suitable
materials include those disclosed in copending U.S. patent
application Ser. No. 09/874,039, filed Jun. 6, 2001, which is
hereby incorporated herein by reference in its entirety. For
example, suitable materials may include halogenated and/or
fluorinated materials.
[0081] Suitable applicator tips, either the replaceable tip or the
porous plug as described above, for the applicators/dispensers of
this invention include swabs, brushes, spatulas, droppers,
syringes, and the like. Any suitable applicator tip can be used
that allows for application of the adhesive composition to the
desired site, and thus different applicator tips may be appropriate
for different application methods. The applicator tip can have a
variety of suitable shapes, including, but not limited to, conical,
cylindrical, chisel or polygonal shapes such as rectangular or
trapezoidal. The length and size of the tip can be varied depending
on various application parameters. The tip may be detachable from
the applicator body, or may be an integral part of the
applicator.
[0082] The replaceable tip can be composed of any of a variety of
materials including polymerized materials such as plastics, foams,
rubber, thermosets, films, or membranes. Additionally, the
replaceable tip may be composed of materials such as metal, glass,
paper, ceramics, cardboard, and the like. The replaceable tip
material may be porous, absorbent, or adsorbent in nature to
enhance and facilitate application of the adhesive composition. In
general, the only limitation on the materials used to fabricate the
tip is that the tip must be sufficiently compatible with the
composition to be dispensed that undesirable effects on the
composition do not prevail during contact of the composition with
the tip. Thus, for example, according to embodiments of this
invention where the adhesive composition is packaged as already
being absorbed or adsorbed into the tip, or in direct contact with
the tip, the tip is preferably made from a material that tends to
stabilize, or at least does not prematurely polymerize, the
adhesive monomer composition. Where the tip is made from polymer
materials, the polymer material can be the same as or different
from those specified above. Suitable designs for tips that may be
used according to this invention are disclosed in, for example,
U.S. patent application Ser. No. 08/488,411, filed Jun. 7, 1995,
Ser. No. 09/069,979, filed Apr. 30, 1998, Ser. No. 09/069,875,
filed Apr. 30, 1998, and Ser. No. 09/385,030, filed Aug. 30, 1999,
the entire disclosures of which are incorporated herein by
reference.
[0083] Furthermore, the tips of the dispensers/applicators of this
invention can be provided in any of various sizes, depending on the
desired use of the product. For example, a standard preferred swab
size can be a rectangular shape having a size of about 1.3
cm.times.1.0 cm.times.0.64 cm. However, larger or smaller sizes can
be used, where the sizes are tailored to the shape of the tip
and/or the amount of adhesive material to be applied for a given
application. Thus, for example, where the dispenser/applicator is
intended for applications requiring a large amount of adhesive
material, a larger (and/or more absorbent) tip can be used; whereas
where the dispenser/applicator is intended for applications
requiring only a small amount of adhesive material, a smaller
(and/or less absorbent) tip can be used. Tailoring the size or
absorbency/adsorbency of the tip to the amount of adhesive required
can help prevent waste of adhesive material. For example, where a
large tip (and large amount of adhesive) is used for a small
adhesive application, the remaining adhesive in the tip is
generally wasted due to premature polymerization of the adhesive in
the tip.
[0084] In addition to a polymerization initiator or rate modifier,
the tip may include a medicament, an anesthetic and/or other
material to be applied.
[0085] The applicators/dispensers of this invention may be used to
apply the polymerizable adhesive composition to a variety of
substrates for the purposes of protecting, sealing, and bonding
surfaces together. Suitable substrates include, but are not limited
to, metals, plastics, rubbers, wood, ceramics, fabrics, cement,
paper, living tissue and the like. For example, the polymerizable
and/or cross-linkable material may be useful as tissue adhesives,
sealants for preventing bleeding or for covering open wounds,
systems for delivery of therapeutic or other bioactive agents, and
other biomedical applications. They find uses in, for example,
closing surgically incised or traumatically lacerated tissues;
setting fractured bone structures; retarding blood flow from
wounds; aiding repair and regrowth of living tissues; providing
implantable matrixes for delivering bioactive agents; dressing
burns; dressing skin or other superficial or surface wounds (such
as abrasions, chaffed or raw skin, and/or stomatitis); protecting
tissues prone to damage (e.g., as artificial calluses); and
providing structural implants.
[0086] The adhesive material, in embodiments, is preferably a
monomeric (including prepolymeric) adhesive composition. In
embodiments, the monomer is a 1,1-disubstituted ethylene monomer,
e.g., an .alpha.-cyanoacrylate. Preferred monomer compositions of
this invention, and polymers formed therefrom, are useful as tissue
adhesives, sealants for preventing bleeding or for covering open
wounds, and in other absorbable and non-absorbable biomedical
applications. They find uses in, for example, apposing surgically
incised or traumatically lacerated tissues; retarding blood flow
from wounds; drug delivery; dressing burns; dressing skin or other
superficial or surface wounds (such as abrasions, chaffed or raw
skin, and/or stomatitis); hernia repair; meniscus repair; and
aiding repair and regrowth of living tissue. Other preferred
monomer compositions of this invention, and polymers formed
therefrom, are useful in industrial and home applications, for
example in bonding rubbers, plastics, wood, composites, fabrics,
and other natural and synthetic materials.
[0087] The monomer (including prepolymeric) adhesive composition
may include one or more polymerizable monomers. Preferred monomers
that may be used in this invention are readily polymerizable, e.g.
anionically polymerizable or free radical polymerizable, or
polymerizable by zwitterions or ion pairs to form polymers. Such
monomers include those that form polymers, that may, but do not
need to, biodegrade. Such monomers are disclosed in, for example,
U.S. Pat. Nos. 5,328,687 and 5,928,611 to Leung et al., U.S. patent
application Ser. No. 09/430,177, filed on Oct. 29, 1999, and U.S.
Pat. No. 6,183,593, which are hereby incorporated in their entirety
by reference herein. Preferred monomers include 1,1-disubstituted
ethylene monomers, such as .alpha.-cyanoacrylates including, but
not limited to, alkyl .alpha.-cyanoacrylates having an alkyl chain
length of from about 1 to about 20 carbon atoms or more, preferably
from about 2 to about 12 or more preferably from about 3 to about 8
carbon atoms. Other suitable monomers include, but are not limited
to, alkyl ester cyanoacrylate monomers, such as those disclosed in,
for example, U.S. patent application Ser. No. 09/630,437, filed
Aug. 2, 2000, and Ser. No. 09/919,877, filed Aug. 2, 2001, the
entire disclosures of which are incorporated herein by
reference.
[0088] The .alpha.-cyanoacrylates of this invention can be prepared
according to several methods known in the art. U.S. Pat. Nos.
2,721,858, 3,254,111, 3,995,641, and 4,364,876, each of which is
hereby incorporated in its entirety by reference herein, disclose
methods for preparing .alpha.-cyanoacrylates.
[0089] As desired, the application according to this invention can
include any of a wide variety of additional materials, either mixed
into the polymerizable composition, or in a separate compartment
from the polymerizable composition. Examples of suitable additional
materials include, but are not limited to, plasticizing agents,
thixotropic agents, thickeners, natural or synthetic rubbers,
stabilizers, pH modifiers, bioactive agents, cross-linking agents,
chain transfer agents, fibrous reinforcements, colorants,
preservatives, formaldehyde reducing or scavenging agents,
flavorants, perfumes, mixtures thereof, and the like.
[0090] The adhesive material may optionally also include at least
one other plasticizing agent that assists in imparting flexibility
to the polymer formed from the monomer. The plasticizing agent
preferably contains little or no moisture and should not
significantly affect the stability or polymerization of the
monomer. Examples of suitable plasticizers include but are not
limited to tributyl citrate, acetyl tri-n-butyl citrate (ATBC),
polymethylmethacrylate, polydimethylsiloxane, hexadimethylsilazane,
isopropyl myristate, isopropyl palmitate, and others as listed in
U.S. patent application Ser. No. 09/471,392 filed Dec. 23, 1999,
the disclosure of which is incorporated in its entirety by
reference herein.
[0091] The adhesive material may also optionally include at least
one thixotropic agent. Suitable thixotropic agents are known to the
skilled artisan and include, but are not limited to, silica gels
such as those treated with a silyl isocyanate, and optionally
surface treated titanium dioxide. Examples of suitable thixotropic
agents and thickeners are disclosed in, for example, U.S. Pat. No.
4,720,513, and U.S. patent application Ser. No. 09/374,207 filed
Aug. 12, 1999, the disclosures of which are hereby incorporated in
their entireties by reference herein.
[0092] The adhesive material may optionally also include
thickeners. Suitable thickeners may include poly (2-ethylhexyl
methacrylate), poly(2-ethylhexyl acrylate) and others as listed in
U.S. patent application Ser. No. 09/471,392 filed Dec. 23, 1999,
and Ser. No. 09/374,207, filed Aug. 12, 1999, the disclosures of
which are incorporated by reference herein in their entirety.
[0093] The adhesive material may also optionally include at least
one natural or synthetic rubber to impart impact resistance.
Suitable rubbers are known to the skilled artisan. Such rubbers
include, but are not limited to, dienes, styrenes, acrylonitriles,
and mixtures thereof Examples of suitable rubbers are disclosed in,
for example, U.S. Pat. Nos. 4,313,865 and 4,560,723, the
disclosures of which are hereby incorporated in their entireties by
reference herein.
[0094] The adhesive material may optionally also include one or
more stabilizers, preferably both at least one anionic vapor phase
stabilizer and at least one anionic liquid phase stabilizer. The
composition may optionally also include, in addition to or in place
of the anionic stabilizers, at least one free radical stabilizer.
These stabilizing agents may inhibit premature polymerization.
Suitable anionic and free radical stabilizers may include those
listed in U.S. patent application Ser. No. 09/471,392 filed on Dec.
23, 1999, and Ser. No. 09/099,457, filed Jun. 18, 1998, the
disclosures of which are incorporated by reference herein in their
entirety.
[0095] However, as described above, a particular advantage of this
invention, such as in embodiments where stabilizing materials are
used, is that separate stabilizers can be omitted from the
composition. Thus, in embodiments, the polymerizable composition
preferably does not include any, or at least substantially none,
additional stabilizer.
[0096] The adhesive material may also include pH modifiers to
control the rate of degradation of the resulting polymer, as
disclosed in U.S. patent application Ser. No. 08/714,288, filed
Sep. 18, 1996, the entire disclosure of which is hereby
incorporated by reference herein in its entirety.
[0097] Adhesive materials of this invention may also include at
least one biocompatible agent effective to reduce active
formaldehyde concentration levels produced during in vivo
biodegradation of the polymer (also referred to herein as
"formaldehyde concentration reducing agents"). Preferably, this
component is a formaldehyde scavenger compound. Examples of
formaldehyde scavenger compounds useful in this invention include
sulfites; bisulfites; mixtures of sulfites and bisulfites, etc.
Additional examples of formaldehyde scavenger compounds useful in
this invention and methods for their implementation can be found in
U.S. Pat. Nos. 5,328,687, 5,514,371, 5,514,372, 5,575,997,
5,582,834 and 5,624,669, all to Leung et al., which are hereby
incorporated herein by reference in their entireties.
[0098] To improve the cohesive strength of adhesives formed from
the adhesive materials of this invention, difunctional monomeric
cross-linking agents may be added to the monomer compositions of
this invention. Such crosslinking agents are known. U.S. Pat. No.
3,940,362 to Overhults, which is hereby incorporated herein in its
entirety by reference, discloses exemplary cross-linking
agents.
[0099] The adhesive materials of this invention may further contain
fibrous reinforcement and colorants such as dyes, pigments, and
pigment dyes. Examples of suitable fibrous reinforcement include
PGA microfibrils, collagen microfibrils, and others as described in
U.S. patent application Ser. No. 09/471,392 filed on Dec. 23, 1999,
the disclosure of which is incorporated by reference herein in its
entirety.
[0100] The polymerizable adhesive materials useful in this
invention may also further contain one or more preservatives, for
prolonging the storage life of the composition. Suitable
preservatives, and methods for selecting them and incorporating
them into adhesive compositions, are disclosed in U.S. patent
application Ser. No. 09/430,180, the entire disclosure of which is
incorporated herein by reference.
[0101] In embodiments of this invention, the adhesive material
and/or parts of the applicator/dispenser may contain additional
materials such as a polymerization initiator, accelerator,
rate-modifier, and/or cross-linking agent for initiating
polymerization and/or cross-linking of the polymerizable monomer
material. Such initiators, accelerators, rate-modifiers, and/or
cross-linking agents can be included in the applicator tip, in the
adhesive material, and/or elsewhere, as appropriate.
[0102] In embodiments of this invention, particularly where the
adhesive material is not in contact with the applicator tip prior
to use, it is possible to incorporate into the applicator tip
additional components, such as polymerization initiators and/or
accelerators, anesthetic, medicament or the like, or even any of
the various additives described above with respect to the
polymerizable adhesive. This is advantageous, for example, where
additional initiator or accelerator may be necessary to provide the
desired cure rate of the adhesive once it is applied or where
additional treatment is desired. Furthermore, this is advantageous
in embodiments where additional stabilizers or polymerization
inhibitors must be added to the adhesive composition in the
assembly, so as to overcome the "cure speed loss" that often occurs
when such stabilizing agents are added.
[0103] In embodiments, the initiator or accelerator material is an
initiator and/or a rate modifier for polymerization and/or
cross-linking of a polymerizable monomer. As used herein, a
polymerization initiator is any material that causes a monomer
composition applied to a substantially dry tissue (i.e.,
substantially in the absence of plasma or like tissue fluids) to
polymerize in less than 300 seconds at ambient temperature, for
example, at approximately 21-25.degree. C. Preferably, the
initiator causes the monomer composition to polymerize in less than
150 seconds at ambient temperature, more preferably within 60, 90
or 130 seconds. As used herein, a polymerization rate modifier is
any material that changes the rate at which a polymerizable monomer
would polymerize in the absence of that material. Preferably, the
rate modifier accelerates the rate of the polymerization reaction,
although for particularly fast-acting monomers it may decelerate
that rate.
[0104] The material may be applied to the applicator tip, for
example, by spraying, dipping, injecting, or brushing the
applicator tip with a liquid medium containing the polymerization
initiator or accelerator. It is preferably applied to the tip by
dipping or injecting. For example, it may be applied to the tip by
pumping of the liquid medium, for example, through a syringe, onto
the tip. Methods of applying the polymerization initiator or
accelerator to an applicator tip are described in more detail in
U.S. Pat. No. 5,928,611 to Leung and U.S. patent application Ser.
No. 09/069,979, filed Apr. 30, 1998, Ser. No. 08/920,876, filed
Aug. 29, 1997, and Ser. No. 09/430,177, filed Oct. 29, 1999, the
entire disclosures of which is incorporated herein by
reference.
[0105] Particular initiators and accelerators for particular
monomers may be readily selected by one of skill in the art without
undue experimentation. Control of the molecular weight distribution
of the applied adhesive can be enhanced by selection of the
concentration and functionality of the initiator or accelerator
vis-a-vis the selected monomer. Suitable polymerization initiators
and accelerators for cyanoacrylate compositions include, but are
not limited to, detergent compositions; surfactants, including
nonionic surfactants such as polysorbate 20 (e.g., Tween 20.TM.;
ICI Americas), polysorbate 80 (e.g., Tween 80.TM.; ICI Americas),
and poloxamers; cationic surfactants such as tetrabutylammonium
bromide; anionic surfactants, including quaternary ammonium halides
such as benzalkonium chloride or its pure components, and
benzethonium chloride; stannous octoate (tin (II)
2-ethylhexanoate), and sodium tetradecyl sulfate; and amphoteric or
zwitterionic surfactants such as dodecyldimethyl(3-sulfopropyl)
ammonium hydroxide, inner salt; amines, imines, and amides, such as
imidazole, tryptamine, urea, arginine and povidine; phosphines,
phosphites and phosphonium salts, such as triphenylphosphine and
triethyl phosphite; alcohols such as ethylene glycol; methyl
gallate; inorganic bases and salts, such as sodium bisulfite,
magnesium hydroxide, calcium sulfate and sodium silicate; sulfur
compounds such as thiourea and polysulfides; polymeric cyclic
ethers such as monensin, nonactin, crown ethers, calixarenes and
polymeric epoxides; cyclic and acyclic carbonates, such as diethyl
carbonate; phase transfer catalysts such as Aliquat.TM. 336
(General Mills, Inc., Minneapolis, Minn.); organometallics;
manganese acetylacetonate; radical initiators and radicals, such as
di-t-butyl peroxide and azobisisobutyronitrile; and bioactive
compounds or agents.
[0106] In preferred embodiments, the initiator may be a bioactive
material, including quaternary ammonium halides such as
alkylbenzyldimethylammonium chloride (benzalkonium chloride; BAC)
its pure components, or mixtures thereof, especially those with an
alkyl containing 6-18 carbon atoms; benzethonium chloride; and
salts of sulfadiazine. Cobalt napthenate can be used as an
accelerator for peroxide. Other suitable bioactive materials are
disclosed in U.S. Pat. No. 5,928,611 to Leung and U.S. patent
application Ser. No. 08/920,876, filed Aug. 29, 1997, Ser. No.
09/430,176 filed Oct. 29, 1999, and Ser. No. 09/430,177, filed Oct.
29, 1999, the entire disclosures of which is incorporated herein by
reference.
[0107] The adhesive materials in this invention can also comprise a
medicament. Inclusion of a medicament is often desirable in
compositions intended for medical applications. The medicament can
either be added to the monomer-containing adhesive composition
prior to packaging, or, alternatively, to the applicator tip or
other part. Thus, the medicament may be applied to a tissue prior
to or simultaneously with application of the monomer-containing
adhesive composition. In addition to serving its medicinal
function, the medicament may be selected so that it functions in
conjunction with the co-packaged polymerizable monomer composition
to initiate polymerization of the monomer or modify (e.g.,
accelerate) the rate of polymerization for the monomer to form a
polymeric adhesive. The proper combination of medicament and
polymerizable monomer can be determined easily by one of skill in
the art. The medicament is supplied in an amount that will be
pharmaceutically effective when applied topically (i.e., directly
to tissue).
[0108] Examples of such medicaments include, but are not limited to
antibiotics, antimicrobials, antiseptics, bacteriocins,
bacteriostats, disinfectants, steroids, anesthetics, fungicides,
anti-inflammatory agents, antibacterial agents, antiviral agents,
antitumor agents, growth promoters, and mixtures thereof.
[0109] Exemplary medicaments include, but are not limited to,
quaternary ammonium halides such as benzalkonium chloride and
benzethonium chloride; chlorhexidine sulfate; gentamicin sulfate;
hydrogen peroxide; quinolone thioureas; silver salts, including,
but not limited to, silver acetate, silver benzoate, silver
carbonate, silver chloride, silver citrate, silver iodide, silver
nitrate, and silver sulfate; sodium hypochlorite; salts of
sulfadiazine, including, but not limited to silver, sodium, and
zinc salts; and mixtures thereof.
[0110] Preferable medicaments are those that are anions or help in
radical generation or that are ion pairs or are themselves
radicals.
[0111] In embodiments, the medicament is preferably a quaternary
ammonium halide such as alkylbenzyldimethylammonium chloride
(benzalkonium chloride; BAC) with an alkyl containing 6-18 carbon
atoms, its pure components, or mixtures thereof, or benzethonium
chloride; or a salt of sulfadiazine, such as a silver, sodium, or
zinc salt.
[0112] The medicament can have a pharmaceutical effect only at the
site of application (i.e., limited to the tissue on/in which it is
applied), or it can have a systemic effect (by systemic, it is not
only meant that the medicament has an effect throughout the
patient's body, but also at a specific site other than the site of
application). In embodiments where the medicament is applied in an
amount sufficient to show a systemic pharmaceutical activity, it
can be absorbed, transported, or otherwise distributed to the site
or sites within the patient where the pharmaceutical activity is
desired, e.g., through the cardiovascular or lymph systems. The
medicament may be in the form of a solid, such as a powder or a
solid film, or in the form of a liquid, such as a watery, viscous,
or paste-like material. The medicament may also be compounded with
a variety of additives, such as surfactants or emulsifiers, and
vehicles.
[0113] The polymerizable and/or cross-linkable material may be neat
(no additional compounds added) or in a solvent, emulsion or
suspension. Suitable solvents according to this invention include
alcohol, ether alcohol, hydrocarbons, halogenated hydrocarbons,
ethers, acetals, ketones, esters, acids, sulfur- or
nitrogen-containing organic compounds, mixtures thereof and the
like. Other suitable solvents are disclosed in U.S. Pat. No.
5,130,369 to Hughes et al. and U.S. Pat. No. 5,216,096 to Hattori
et al., the entire disclosures of which are incorporated herein by
reference. These solvents may be used either independently or in
combination of two or more. They may also be used in conjunction
with water to the extent that the polymerizable and/or
cross-linkable material is dissolved or suspended in such a
mixture. The total amount of solvent that may be incorporated into
the polymerizable and/or cross-linkable material may be 0 to 99,
preferably 1 to 50, and more preferably 3 to 25 percent by weight.
Selection of the amount will, of course, depend on the desired
monomer and process conditions, and amounts outside these ranges
may be acceptable.
[0114] In embodiments, the monomer composition and/or its packaging
are preferably sterilized. Sterilization of the monomer composition
and/or its packaging can be accomplished by techniques known to one
of ordinary skill in the art, and is preferably accomplished by
methods including, but not limited to, chemical, physical, and/or
irradiation methods. Examples of chemical methods include, but are
not limited to, exposure to ethylene oxide or hydrogen peroxide
vapor. Examples of physical methods include, but are not limited
to, sterilization by heat (dry or moist) or retort canning.
Examples of irradiation methods include, but are not limited to,
gamma irradiation, electron beam irradiation, and microwave
irradiation. A preferred method is electron beam irradiation, as
described in U.S. patent application Ser. No. 09/025,472, filed on
Feb. 18, 1998, the entire disclosure of which is incorporated
herein by reference. The composition must show low levels of
toxicity to living tissue during its useful life. In preferred
embodiments of this invention, the composition is sterilized to
provide a Sterility Assurance Level (SAL) of at least 10.sup.-3. In
embodiments, the Sterility Assurance Level may be at least
10.sup.-4, or may be at least 10.sup.-5, or may be at least
10.sup.-6. Further details of sterilization are disclosed in
incorporated U.S. patent application Ser. No. 09/874,039.
[0115] It should be understood that the individual features of the
various exemplary embodiments may be included or excluded as
desired for a given application. As such, all possible combinations
of the described features are considered to be encompassed by this
invention.
[0116] Thus, while this invention has been described in terms of
exemplary embodiments, it is to be understood that this invention
is not to be limited to the particular configuration of these
embodiments. One skilled in the art will recognize that various
modifications and/or alterations of these embodiments may be made
while remaining within the scope of this invention.
* * * * *