U.S. patent application number 14/258766 was filed with the patent office on 2015-04-30 for surgical adhesive applicator.
This patent application is currently assigned to Advanced Medical Solutions (Plymouth) Limited. The applicant listed for this patent is Advanced Medical Solutions (Plymouth) Limited. Invention is credited to Richard J. Stenton.
Application Number | 20150119824 14/258766 |
Document ID | / |
Family ID | 38752501 |
Filed Date | 2015-04-30 |
United States Patent
Application |
20150119824 |
Kind Code |
A1 |
Stenton; Richard J. |
April 30, 2015 |
SURGICAL ADHESIVE APPLICATOR
Abstract
An adhesive applicator for applying medical adhesives,
particularly cyanoacrylates, to incisions such as those made during
minimally invasive surgery. The applicator employs a pipette tip or
similar narrow flow restrictor tip to close the incision and a body
of foam to seal the incision. Methods of using the applicator are
also disclosed.
Inventors: |
Stenton; Richard J.;
(Horrabridge, GB) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Advanced Medical Solutions (Plymouth) Limited |
Plymouth |
|
GB |
|
|
Assignee: |
Advanced Medical Solutions
(Plymouth) Limited
Plymouth
GB
|
Family ID: |
38752501 |
Appl. No.: |
14/258766 |
Filed: |
April 22, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11767229 |
Jun 22, 2007 |
8702751 |
|
|
14258766 |
|
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60817762 |
Jun 30, 2006 |
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Current U.S.
Class: |
604/290 ;
604/310; 606/214 |
Current CPC
Class: |
A61B 2017/00371
20130101; A61M 35/003 20130101; A61B 17/00491 20130101; A61B
2017/00862 20130101; A61B 2017/00889 20130101 |
Class at
Publication: |
604/290 ;
606/214; 604/310 |
International
Class: |
A61B 17/00 20060101
A61B017/00; A61M 35/00 20060101 A61M035/00 |
Claims
1. An applicator for controllably releasing and applying a surgical
adhesive to an incision comprising a receiver having a deformable
cylindrical body, the body having a deformable cylindrical wall and
a cylinder-closing first end and an open second end, the internal
dimensions of the receiver being set to accommodate and receive a
sealed ampoule of surgical adhesive, the ampoule being formed of a
frangible material which when fractured releases the surgical
adhesive, the second open end being cylindrical with a series of
circumferential sealing ribs present on the outer surface of the
second open end, a blunt cylindrical body of a surgical
adhesive-permeable foam material inserted into the open second end
of the receiver to absorb and transmit adhesive released from the
ampoule, a cylindrical collar having an open first end and an open
second end, the first end of the collar having an internal diameter
selected to sealably engage the circumferential sealing ribs, the
collar enclosing the body of foam material, and the second end of
the collar having an internal diameter selected to provide a
narrowed pathway for the released adhesive to pass when the collar
is sealed to the second end of the receiver.
2. The applicator of claim 1 further comprising a latching slot in
the outer surface of the second end of the receiver, the latching
slot located adjacent to the circumferential sealing ribs but being
between the circumferential sealing ribs and the first end, and the
collar having an internally-projecting locking key which fits into
the locking slot and locks the collar onto the receiver when the
collar is rotated on a common axis between the collar and the
receiver.
3. The applicator of claim 1 further comprising a flow restrictor
frictionally attached to the second end of the collar through which
surgical adhesive can pass.
4. The applicator of claim 3 wherein the flow restrictor is a
pipette tip
5. The applicator of claim 1 further comprising at least one
pressure barb positioned to apply an ampoule-fracturing force to
the sealed ampoule.
6. The applicator of claim 5 further comprising at least one
pressure pad positioned to apply an adhesive-expressing pressure to
the fractured ampoule.
7. The applicator of claim 1 further comprising a pair of wings,
each having an inside and an outside end with the inside end
affixed to the receiver at a position adjacent to the open end with
the two wings being positioned diametrically across the cylindrical
body, with the outside end of the wings being splayed out away from
the cylindrical wall but being movable toward the cylindrical wall
when a user applies opposing-finger pressure to the outside ends,
each of the wings having a pressure barb facing toward the
cylindrical wall, the pressure barb bearing upon the cylindrical
wall and capable of applying a compressing force to the cylindrical
wall, which compressing force distorts the cylindrical wall of the
cylindrical body and applies a fracturing force to an ampoule
accommodated and received within the receiver, the fracturing force
releasing surgical adhesive contained within the ampoule.
8. The applicator of claim 7 wherein each of the wings additionally
comprises a pressure pad facing toward the cylindrical wall, the
pressure pad bearing upon the cylindrical wall and capable of
applying an adhesive-expressing compressing force to the
cylindrical wall, which adhesive-expressing compressing force
distorts the cylindrical wall of the cylindrical body and applies
an adhesive expressing force to the ampoule, the
adhesive-expressing force expressing surgical adhesive contained
within the ampoule out of the applicator.
9. An applicator for controllably releasing and applying a surgical
adhesive to an incision comprising a receiver having a deformable
cylindrical body, the body having a deformable cylindrical wall and
a cylinder-closing first end and an open second end, the internal
dimensions of the receiver being set to accommodate and receive a
sealed ampoule of surgical adhesive, the ampoule being formed of a
frangible material, the second open end being cylindrical with a
series of circumferential sealing ribs present on the outer surface
of the second open end and a latching slot in the outer surface of
the second end, the latching slot located adjacent to the
circumferential sealing ribs but being between the circumferential
sealing ribs and the first end, a pair of wings, each having an
inside and an outside end with the inside end affixed to the
receiver at a position adjacent to the open end with the two wings
being positioned diametrically across the cylindrical body, with
the outside end of the wings being splayed out away from the
cylindrical wall but being movable toward the cylindrical wall when
a user applies opposing finger pressure to the outside ends, each
of the wings having a pressure barb facing toward the cylindrical
wall, the pressure barb bearing upon the cylindrical wall and
capable of applying a compressing force to the cylindrical wall,
which compressing force distorts the cylindrical wall of the
cylindrical body and applies a fracturing force to an ampoule
accommodated and received within the receiver, the fracturing force
releasing surgical adhesive contained within the ampoule, a blunt
cylindrical body of surgical adhesive-permeable foam inserted into
the open second end of the receiver to absorb and transmit adhesive
released from the ampoule, a cylindrical collar having an open
first end and an open second end, the first end having an internal
diameter selected to sealably engage the circumferential sealing
ribs and having an internally-projecting locking key which fits
into the locking slot and locks the collar onto the receiver when
the collar is rotated on a common axis between the collar and the
receiver, the collar enclosing the body of foam, and the second end
having an internal diameter selected to provide a narrowed pathway
for the adhesive to pass when the collar is sealed to the second
end of the receiver, and the second end of the collar having a
slightly tapered cylindrical shape sized to frictionally and
sealably engage a pipette tip the pipette tip, when sealed to the
collar providing a sealed narrow pathway for surgical adhesive to
pass from the receiver through the pipette tip and the collar, when
removed, providing a broader pathway for the adhesive to pass as a
sealing layer from the receiver through the body of foam to the
incision.
10. The applicator according to claim 1, wherein the surgical
adhesive comprises a cyanoacrylate ester, in monomeric form,
represented formula I: ##STR00003## where R is selected from the
group consisting of: alkyl of 1 to 10 carbon atoms, alkenyl of 2 to
10 carbon atoms, cycloalkyl groups of from 5 to 8 carbon atoms,
phenyl, 2-ethoxyethyl, 3-methoxybutyl, and a substituent of the
formula: ##STR00004## wherein each R' is independently selected
from the group consisting of: hydrogen and methyl, and R'' is
selected from the group consisting of: alkyl of from 1 to 6 carbon
atoms, alkenyl of from 2 to 6 carbon atoms, alkynyl of from 2 to 6
carbon atoms, cycloalkyl of from 3 to 8 carbon atoms, aralkyl
selected from the group consisting of benzyl, methylbenzyl and
phenylethyl, phenyl, and phenyl substituted with 1 to 3
substituents selected from the group consisting of hydroxy, chloro,
bromo, nitro, of alkyl 1 to 4 carbon atoms, and alkoxy of from 1 to
4 carbon atoms.
11. The applicator of claim 10, wherein the surgical adhesive
further comprises an antimicrobial agent.
12. A method of closing and sealing an incision with an adhesive
applicator comprising obtaining the applicator of claim 9 with the
sealed ampoule of surgical adhesive contained in the receiver,
applying a squeezing-together pressure to the wings to produce a
compressing force to the cylindrical wall, which compressing force
distorts the cylindrical wall of the cylindrical body and applies a
fracturing force to the ampoule, the fracturing force releasing the
surgical adhesive contained within the ampoule, the adhesive
passing through the adhesive-permeable foam through the cylindrical
collar and through the pipette tip to form the small drops of
adhesive, closing the incision by applying the small drops of
adhesive from the applicator to the incision; removing the pipette
tip to provide a tip-free applicator, sealing the incision by
applying a line of adhesive from the tip-free applicator to the
incision through the body of adhesive-permeable foam.
13. The method of claim 12, wherein the incision is a incision made
during laparoscopic surgery.
14. The method of claim 12, wherein the surgical adhesive comprises
a cyanoacrylate ester, in monomeric form, represented formula I:
##STR00005## where R is selected from the group consisting of:
alkyl of 1 to 10 carbon atoms, alkenyl of 2 to 10 carbon atoms,
cycloalkyl groups of from 5 to 8 carbon atoms, phenyl,
2-ethoxyethyl, 3-methoxybutyl, and a substituent of the formula:
##STR00006## wherein each R' is independently selected from the
group consisting of: hydrogen and methyl, and R'' is selected from
the group consisting of: alkyl of from 1 to 6 carbon atoms, alkenyl
of from 2 to 6 carbon atoms, alkynyl of from 2 to 6 carbon atoms,
cycloalkyl of from 3 to 8 carbon atoms, aralkyl selected from the
group consisting of benzyl, methylbenzyl and phenylethyl, phenyl,
and phenyl substituted with 1 to 3 substituents selected from the
group consisting of hydroxy, chloro, bromo, nitro, of alkyl 1 to 4
carbon atoms, and alkoxy of from 1 to 4 carbon atoms.
15. The applicator of claim 12, wherein the surgical adhesive
further comprises an antimicrobial agent.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims benefit under 35 U.S.C. .sctn.119
(e) of U.S. Provisional Application Ser. No. 60/817,762, filed 30
Jun. 2006, which is hereby incorporated by reference in its
entirety.
TECHNICAL FIELD
[0002] The present invention relates to applicators for surgical
adhesives.
BACKGROUND OF THE INVENTION
[0003] Minimally invasive surgery, such as laparoscopic surgery,
has become the surgical technique of choice in many situations. In
general, minimally invasive surgery is accomplished using small
incisions. Minimally invasive surgery often involves the use of
specialized equipment and techniques, such as miniature cameras
with microscopes, tiny fiber-optic flashlights and high definition
monitors. Benefits observed from the use of minimally invasive
surgery include minimized pain, faster recovery, and elimination of
potential complications associated with traditional surgical
techniques.
[0004] Minimally invasive surgical procedures can be used in a
number of situations including cardiovascular surgery, colon and
rectal surgery, gastroenterologic, gynecological surgery,
neurosurgery, orthopedic surgery, otorhinolaryngology (ear, nose
and throat) surgery, thoracic surgery, urological surgery, and
vascular surgery.
[0005] A particular type of minimally invasive surgery is
laparoscopic surgery. Laparoscopic surgery involves the performance
of surgical procedures with the assistance of a video camera and
several thin instruments. The use of the camera allows the surgeon
to sees images of the patient's body during surgery. During the
surgical procedure, small incisions of up to half an inch are made
and plastic tubes called ports are placed through these incisions.
The camera and the instruments are then introduced through the
ports which allow access to the inside of the patient. Laparoscopic
surgery is used to perform numerous surgeries such as
adrenalectomies, appendectomies, treatment for bowel tumors, lymph
node biopsys, gallbladder surgery, hernia repair, treatment for
stomach tumors, splenectomies, bariatric surgery, removal of
fibroids, removal of benign ovarian cysts, treatment of pelvic
endometriosis, fundoplication for gastroesophageal reflux disease
(GERD), myotomy for achalasia, nephrectomies, partial
nephrectomies, donor nephrectomies, pyeloplasties, and opening of
cysts.
[0006] The small incisions made during the minimally invasive
surgeries can be closed by traditional techniques, such as the
introduction of sutures or staples to close the incision wounds.
More recently, the use of surgical adhesives has gained favor in
closing the incisions. These adhesives are liquid in nature and,
upon contact with surface skin proteins and moisture, will
polymerize and the resulting polymer bonds strongly to the skin.
When applied over apposed skin sections of a wound, the adhesives
polymerize and join these apposed skin sections to result in
closure of the wound. The adhesives can be formulated to include
antimicrobial agents to aid in healing of the wound. The adhesive
need not be removed from the wound because it will naturally fall
away from the wound as the skin renews itself.
[0007] Many different applicators for adhesives have been
developed. However, the majority of these applicators do not
address the need for a versatile applicator capable of effectively
closing and sealing a wound. U.S. Pat. No. 7,094,250, commonly
assigned to the assignee of the instant application and
incorporated herein by reference, describes an applicator capable
of effectively closing, sealing, and dressing a wound using medical
adhesive. The present application describes an improvement to the
applicator described in this publication.
SUMMARY OF THE INVENTION
[0008] This invention provides for applicators suitable for use in
application of medical adhesive to incisions and methods of using
the applicators.
[0009] One aspect of the invention provides for an applicator for
controllably releasing and applying a surgical adhesive to an
incision. In a preferred embodiment, the applicator comprises a
receiver having a deformable cylindrical body. The body has a
deformable cylindrical wall and a cylinder-closing first end and an
open second end. The internal dimensions of the receiver are set to
accommodate and receive a sealed ampoule of surgical adhesive. The
ampoule is formed of a frangible material, which when fractured,
releases the surgical adhesive. The receiver's second open end is
cylindrical with a series of circumferential sealing ribs present
on the outer surface of the second open end. The applicator further
comprises a blunt cylindrical body of a surgical adhesive-permeable
foam inserted into the open second end of the receiver. The body of
foam serves to absorb and transmit adhesive released from the
ampoule. The applicator further comprises a cylindrical collar
having an open first end and an open second end. The first end of
the collar has an internal diameter selected to sealably engage the
circumferential sealing ribs and the collar encloses the body of
foam material. The second end of the collar has an internal
diameter selected to provide a narrowed pathway for the released
adhesive to pass when the collar is sealed to the second end of the
receiver.
[0010] In a preferred embodiment, the applicator additionally
comprises a latching slot in the outer surface of the second end of
the receiver. The latching slot is located adjacent to the
circumferential sealing ribs but is between the circumferential
sealing ribs and the first end. The collar has an
internally-projecting locking key which fits into the locking slot
and locks the collar onto the receiver when the collar is rotated
on a common axis between the collar and the receiver. In other
preferred embodiments, the applicator additionally comprises a flow
restrictor, such as a pipette tip, frictionally attached to the
second end of the collar through which surgical adhesive can
pass.
[0011] In some embodiments, the applicator additionally comprises
at least one pressure barb positioned to apply an
ampoule-fracturing force to the sealed ampoule. In some
embodiments, the applicator comprises at least one pressure pad
positioned to apply an adhesive-expressing pressure to the
fractured ampoule.
[0012] In further preferred embodiments, the applicator
additionally comprises a pair of wings, each having an inside and
an outside end with the inside end affixed to the receiver at a
position adjacent to the open end with the two wings being
positioned diametrically across the cylindrical body, with the
outside end of the wings being splayed out away from the
cylindrical wall but being movable toward the cylindrical wall when
a user applies opposing-finger pressure to the outside ends. Each
of the wings has a pressure barb facing toward the cylindrical
wall. The pressure barb bears upon the cylindrical wall and is
capable of applying a compressing force to the cylindrical wall
which distorts the cylindrical wall of the cylindrical body. When
so distorted, the cylindrical wall applies a fracturing force to an
ampoule accommodated and received within the receiver. The
fracturing force releases surgical adhesive contained within the
ampoule. Preferably, each of the wings additionally comprises a
pressure pad facing toward the cylindrical wall. The pressure pad
bears upon the cylindrical wall and is capable of applying an
adhesive-expressing compressing force to the cylindrical wall. This
compressing force distorts the cylindrical wall of the cylindrical
body and thus applies an adhesive expressing force to the ampoule.
The adhesive-expressing force expressing force expresses the
surgical adhesive contained within the ampoule out of the
applicator.
[0013] In yet another preferred embodiment, the applicator
comprises a receiver having a deformable cylindrical body. The body
has a deformable cylindrical wall and a cylinder-closing first end
and an open second end. The internal dimensions of the receiver are
set to accommodate and receive a sealed ampoule of surgical
adhesive. The ampoule is formed of a frangible material. The second
open end is cylindrical with a series of circumferential sealing
ribs present on the outer surface of the second open end and a
latching slot in the outer surface of the second end. The latching
slot is located adjacent to the circumferential sealing ribs but is
between the circumferential sealing ribs and the first end.
[0014] In one embodiment, the first end of the cylindrical collar
as defined above, has an internal diameter selected to sealably
engage the circumferential sealing ribs and has an
internally-projecting locking key which fits into the locking slot
and locks the collar onto the receiver when the collar is rotated
on a common axis between the collar and the receiver. The collar
encloses the body of foam. The second end has an internal diameter
selected to provide a narrowed pathway for the adhesive to pass
when the collar is sealed to the second end of the receiver. The
second end of the collar has a slightly tapered cylindrical shape
sized to frictionally and sealably engage a pipette tip or similar
flow-focusing nozzle. The pipette tip, when sealed to the collar
provides a sealed narrow pathway for surgical adhesive to pass from
the receiver through the pipette tip and the collar. When the
pipette is removed, there is a broader pathway for the adhesive to
pass as a sealing layer from the receiver through the body of foam
to the incision.
[0015] Another aspect of the invention provides for a method of
closing and sealing an incision with an adhesive applicator as
described above with a sealed ampoule of surgical adhesive
contained in the receiver and the collar and pipette tip in place.
A squeezing-together pressure is applied to the wings to produce a
compressing force to the cylindrical wall. The compressing force
distorts the cylindrical wall of the cylindrical body and applies a
fracturing force to the ampoule. The fracturing force releases the
surgical adhesive contained within the ampoule. Further pressure
can be applied to the wings to cause the pressure pads to supply an
adhesive-expressing force to the wall of the fractured ampoule. The
expressed adhesive passes through the adhesive-permeable body of
foam through the cylindrical collar and through the pipette tip to
form the small drops of adhesive. These small drops are applied to
the incision to "spot weld" or "suture" it closed. Next, the
pipette tip is removed to provide a tip-free applicator. The
incision is then sealed by applying a line of adhesive from the
tip-free applicator to the incision through the body of
adhesive-permeable foam.
[0016] In a preferred embodiment, the incision to be closed and
sealed is a incision made during laparoscopic surgery.
[0017] Preferably, the surgical adhesive to be applied by the
applicator comprises a cyanoacrylate ester. Even more preferably,
the surgical adhesive to be applied by the applicator comprises a
cyanoacrylate ester and an antimicrobial agent.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] This invention will be further described with reference
being made to the drawings in which:
[0019] FIG. 1 is a top plan view of an ampoule-fracturing receiver
employed in the applicator of this invention.
[0020] FIG. 2 is a side elevational view of the ampoule-fracturing
receiver depicted in FIG. 1.
[0021] FIG. 3 is a side cross-sectional view of the
ampoule-fracturing receiver depicted in FIGS. 1 and 2.
[0022] FIG. 4 is an expanded scale top plan view of the open end
portion of the ampoule-fracturing receiver employed in the
applicator of this invention taken within the area 4-4' shown in
FIG. 1 and showing the circumferential sealing ribs and locking key
employed when this receiver is incorporated into the application of
this invention.
[0023] FIG. 5 is a further expanded scale top plan view of a
portion of the ampoule-fracturing receiver employed in the
applicator of this invention taken within the area 5-5' shown in
FIG. 4 and showing the circumferential sealing ribs employed when
this receiver is incorporated into the application of this
invention.
[0024] FIG. 6 is an expanded scale side cross-sectional view of the
open end portion of the ampoule-fracturing receiver employed in the
applicator of this invention taken with in the area 6-6' shown in
FIG. 3 showing the circumferential sealing ribs employed when this
receiver is incorporated into the application of this
invention.
[0025] FIG. 7 is an exploded top plan view of the components of the
applicator of this invention showing their relationship to the
ampoule from which the liquid (adhesive) is released and applied by
the applicator.
[0026] FIGS. 8A-8C are a series of three perspective views showing
A. the applicator of this invention being used to apply small
bonding drops of adhesive to a surgical incision, B. the applicator
being partially disassembled to reveal a smoothing-strengthening
layer applicator and C. the applicator, in its partially
disassemble state, being used to apply the strengthening layer to
the incision.
DESCRIPTION OF PREFERRED EMBODIMENTS
[0027] With reference to the figures, FIG. 7 shows in blown up form
an applicator 100 for controllably releasing and applying a
surgical adhesive to an incision. The use of such an applicator in
this application is illustrated in FIG. 8 where in FIG. 8A the
applicator 100 can be seen delivering a series of small drops 10 of
adhesive to an incision 12 while being squeezed by fingers 14 and
16. In FIG. 8B, fingers 18 and 20 can be seen partially
disassembling the applicator to convert it to a form suitable for
delivering a broader strengthening layer 22 of adhesive to the
incision 12 as shown in FIG. 8C.
[0028] As shown in FIG. 7 and in detailed FIGS. 1 through 6,
applicator 100 includes a receiver 24 which a has a deformable
cylindrical body 26. Body 26 has a deformable cylindrical wall 28,
a cylinder-closing first end 30 and an open second end 32. As shown
most clearly in FIG. 7 the internal dimensions of the receiver are
selected to accommodate and receive a sealed ampoule 34 of surgical
adhesive. Ampoule 34 is formed of a material which can contain the
medical adhesive but which is also frangible, that is breakable, in
response to pressure applied to it.
[0029] The open second end 32 of body 26 is cylindrical. A series
of circumferential sealing ribs 36, having a diameter Dr are
present on the outer surface 38 of body 26 adjacent to the second
open end 32. These ribs provide a sealing surface to which a
liquid-tight seal with collar 62 can be formed. These ribs 36 are
cast into the body 26 of receiver 24 when it is being formed and
thus are made of the same deformable material as body 26.
Polypropylene resins, such as Basell Moplen EP548T give good
results but, of course, other similar adhesive-compatible resilient
plastics may be used. Body 26 carries a latching slot 40 in the
outer surface 38. Latching slot 40 is located near the second end
32 of body 26 adjacent to the circumferential sealing ribs 36. This
slot is located between the circumferential sealing ribs 36 and the
first end 30. It is also to be seen in FIG. 4 that it is located on
a portion of the body 26 having a larger diameter than the diameter
Dr of the circumferential sealing ribs 36. In this position, the
slot can play a part in attaching collar 62 to body 26 without
interfering with the sealing action of circumferential sealing ribs
36. This is important because of the nature of surgical adhesives.
They are selected because of their ability to adhere to skin. Any
inadvertent application of such materials around a surgical site,
which could be brought about by interference with the sealing
effects of the sealing ribs and subsequent leakage would thus be
highly undesirable.
[0030] The receiver 26 additionally includes a pair of wings 42 and
44. These wings each have an inside end 46 and an outside end 48.
The two inside ends 46 are affixed to the receiver 24 at a position
50 adjacent to the open end 32 with the two wings 42 and 44 being
diametrically opposed across the cylindrical body 26 as best
illustrated in FIG. 1. The outside ends 48 of the wings 42 and 44
are splayed out away from the cylindrical wall 28 but are movable
toward the cylindrical wall 28 when a user applies opposing finger
pressure to the outside ends 48 as shown in FIG. 8A.
[0031] Each of the wings 42 and 44 has a pressure barb 52 and 54,
respectively, projecting "inwards" toward the cylindrical wall 28
of receiver 26. The pressure barbs 52 and 54 bear upon the
cylindrical wall 28 in an area close to the second end 32. The
distance of pressure barbs 52 and 54 should be no less than 2 mm
and no greater than 8 mm from the end of sealed ampoule 34. If less
than 2 mm the ampoule is very difficult to break, more than 8 mm
and the dome end remains intact and blocks of the exit hole even
though the rest of the ampoule has fractured. When the user applies
a squeezing-together pressure to the two wings as shown in FIG. 8A
these barbs focus this pressure as a compressing force to the
cylindrical wall 28, which compressing force distorts the
cylindrical wall 28 of the cylindrical body 26 and causes this
pressure to be applied as an ampoule-fracturing/fracturing force
upon an ampoule 34 accommodated and received within receiver 24.
This fracturing force releases surgical adhesive contained within
ampoule 34. The wings 42 and 44 additionally include pressure pads
56 and 58. These pads also apply a wall-distorting force to wall 28
when the wings 42 and 44 are squeezed together and thus apply
pressure on the now-fractured ampoule to express adhesive out of
the ampoule through the fracture as shown in FIG. 8.
[0032] The released surgical adhesive comes into contact with a
blunt cylindrical body 60 of a surgical adhesive-permeable foam
inserted into the open second end 32 of receiver 24. The term
"foam" is used expansively here and is defined to include any
material, such as a sponge or fibrous material, that is permeable
to the surgical adhesive and acts as a "wick" absorbing and
transmitting the adhesive released from the ampoule. The blunt
cylindrical body of foam 60 is held in place in receiver 24 within
open end 32 by cylindrical collar 62. This collar has an open first
end 64 and an open second end 66. The first end 64 has an internal
diameter, Dc, which is selected to sealably engage the
circumferential sealing ribs (of diameter Dr) on the receiver 24 in
a surgical adhesive-impermeable seal. First end 64 also carries an
internally-projecting locking key (not shown) which is sized and
positioned to fit into the locking slot 40. This key and locking
slot lock the collar 62 onto the receiver 24 when the collar 62 is
rotated relative to the receiver 24 on the common axis between the
collar 62 and the receiver 24. As shown in FIG. 8B, when the collar
and receiver are rotated in the reverse direction relative to one
another, the two parts can be separated. Flats or grips 68 and 70
on collar 62 facilitate the user's rotation (and thus locking and
unlocking) of the collar 62 relative to receiver 24. The collar 62,
when attached to receiver 24, encloses the blunt cylindrical body
of foam 60. Second end 66 of collar 62 has a slightly tapered
cylindrical outer surface 72 shaped and sized with an average
external diameter Dc2 which frictionally and sealably fits into and
engages the inside diameter Dt of first end 74 of a flow restrictor
such as shown as pipette tip 76. The slightly tapered cylindrical
outer surface 72 can be used to apply a line of adhesive that is
smaller in width than the line of adhesive that is applied using
the blunt cylindrical body of foam 60.
[0033] Pipette tip 76, when its first end 74 is sealably-engaged to
second end 66 of collar 62, provides a sealed pathway for surgical
adhesive to pass from the original ampoule 34 through receiver 24,
through the blunt cylindrical body of foam 60 and collar 62
receiver and thence through the flow-restricting pipette tip 76 and
outward through end 78 to the surgical incision as a series of fine
"spot weld dots" or a fine line of adhesive or the like. When the
collar 62 (with pipette tip 76 attached) is removed, as shown in
FIG. 8B it exposes the blunt cylindrical body of foam 60. The blunt
cylindrical body of foam 60 is saturated with surgical adhesive and
when exposed provides a broader pathway for the adhesive to pass
from the receiver 24 to the incision 12, now as a
sealing-strengthening coating as shown in FIG. 8C.
Applications and Adhesives
[0034] An applicator configured as described herein can be used to
close and seal any incision or small wound. The preferred
application is the use of the applicator to close and seal
incisions made during minimally invasive surgery, such as
laparoscopic surgery.
[0035] The applicator can be supplied as a preassembled unit
comprising the applicator preloaded with a sealed ampoule of
surgical adhesive. Alternatively, the applicator can be supplied as
an applicator that does not contain a sealed ampoule of surgical
adhesive. In this situation, the user, such as a physician, nurse,
physician's aid, or clinician, assembles the applicator prior to
use so that it contains an ampoule of surgical adhesive.
[0036] The applicator is configured for use with liquid surgical
adhesive materials. The preferable liquid surgical adhesive
materials to be used with the application are liquids containing
cyanoacrylate prepolymers.
[0037] In situ polymerization of such cyanoacrylate compositions
provides for an adherent polymeric film which acts to close and
seal the incision. An antimicrobially-effective amount of an
antimicrobial iodophore or the like in the cyanoacrylate
composition may provide significant enhancements in the
effectiveness of the composition as well.
[0038] Since the polymeric film is naturally shed from the skin
surface two to four days following application, there is no need to
effect removal adhesive following surgery, therefore avoiding the
skin trauma such as that associated with removal of surgical
sutures or staples. Moreover, the addition of antimicrobial agents
to the cyanoacrylate composition results in the gradual release of
the antimicrobial from the polymerized cyanoacrylate composition,
providing antimicrobial at a level that provides protection for
post-surgical infection.
[0039] Accordingly, the applicator can be used to close and seal an
incision in the skin, such as an incision made during laparoscopic
surgery, as follows. An applicator, as described herein, with the
sealed ampoule of surgical adhesive contained in the receiver of
the applicator, is first used to close the incision by applying
small drops of adhesive from the applicator to the incision. The
small drops of adhesive are produced from the applicator when the
user squeezes the wings of the applicator to produce a compressing
force to the cylindrical wall. The compressing force distorts the
cylindrical wall of the cylindrical body and applies a fracturing
force to the ampoule. The fracturing force releases the surgical
adhesive contained within the ampoule and the adhesive passes
through the adhesive-permeable foam through the cylindrical collar
and through the flow restrictor, such as a pipette tip, to form the
small drops of adhesive. After the incision is closed using the
small drops of adhesive released from the applicator, the user
removes the collar from the body of the applicator, thus removing
the flow restrictor from the applicator. The removal of the collar
and the flow restrictor exposes the surgical adhesive-permeable
body of foam. The user then places the body of foam contained at
the end of the applicator on the closed incision and applies a line
of adhesive to seal and protect the incision.
[0040] It may be desirable in some applications to apply an
additional layer of adhesive after closing the incision but prior
to sealing the incision with adhesive applied through the body of
foam. This can be achieved by removing the pipette tip from the
applicator and applying the adhesive through the open end of the
collar. The resulting band of adhesive is narrower than the band
that is applied using the body of foam. After applying this
narrower band of adhesive through the open end of the collar, the
collar is removed to expose the body of foam and an additional line
of adhesive can thus be applied.
[0041] The adhesives which are applied by the applicator of the
present invention may preferably comprise a wide variety of
cyanoacrylate adhesive formulations. It is to be understood,
however, that the present invention is not so limited. Instead, any
suitable medical (or non-medical) adhesive can be used.
[0042] In accordance with an optional preferred aspect of the
present invention, a cyanoacrylate adhesive formulation is used.
Preferably, the cyanoacrylate composition used comprises a
cyanoacrylate prepolymer composition that can be applied as a
liquid to the skin surface. Optionally, the cyanoacrylate
prepolymer can include therapeutic agents such as analgesics,
anti-inflammatory agents, antimicrobial agents, and the like.
[0043] The cyanoacrylate composition which finds preferred
application using the applicator of this invention comprises a
cyanoacrylate ester, which, in monomeric form, is represented by
formula I:
##STR00001##
[0044] wherein R is selected from the group consisting of:
[0045] alkyl of 1 to 10 carbon atoms,
[0046] alkenyl of 2 to 10 carbon atoms,
[0047] cycloalkyl groups of from 5 to 8 carbon atoms,
[0048] phenyl,
[0049] 2-ethoxyethyl,
[0050] 3-methoxybutyl,
[0051] and a substituent of the formula:
##STR00002##
[0052] wherein each R' is independently selected from the group
consisting of: hydrogen and methyl, and R'' is selected from the
group consisting of:
[0053] alkyl of from 1 to 6 carbon atoms,
[0054] alkenyl of from 2 to 6 carbon atoms,
[0055] alkynyl of from 2 to 6 carbon atoms,
[0056] cycloalkyl of from 3 to 8 carbon atoms,
[0057] aralkyl selected from the group consisting of benzyl,
methylbenzyl and phenylethyl,
[0058] phenyl, and
[0059] phenyl substituted with 1 to 3 substituents selected from
the group consisting of hydroxy, chloro, bromo, nitro, alkyl of 1
to 4 carbon atoms, and alkoxy of from 1 to 4 carbon atoms.
[0060] Preferably, in the cyanoacrylate esters of formula I, R is
alkyl of from 2 to 10 carbon atoms and more preferably alkyl of
from 2 to 8 carbon atoms. Even more preferably, R is butyl, pentyl
or octyl or a mixture of butyl and octyl (e.g., 2-ethylhexyl) and
most preferably R is n-butyl.
[0061] It is to be understood that the term "polymerizable
cyanoacrylate esters" refers to polymerizable formulations
comprising cyanoacrylate monomers or polymerizable oligomers which,
in their monomeric form, are preferably compounds represented by
formula I as described above.
[0062] More preferably, in formula I, R is an alkyl group of from 2
to 10 carbon atoms including ethyl, n-propyl, iso-propyl, n-butyl,
iso-butyl, sec-butyl, n-pentyl, iso-pentyl, n-hexyl, iso-hexyl,
2-ethylhexyl, n-heptyl, octyl, nonyl, and decyl. More preferably, R
is butyl, pentyl or octyl and most preferably, R is n-butyl.
Mixtures of such compounds can also be employed as disclosed by
Berger, et al., U.S. Pat. No. 5,998,472 which is incorporated
herein by reference in its entirety.
[0063] A preferred cyanoacrylate ester for use in the invention is
n-butyl-2-cyanoacrylate.
[0064] The polymerizable cyanoacrylate esters described herein
rapidly polymerize in the presence of water vapor or tissue
protein, and the n-butyl-cyanoacrylate bonds to mammalian skin
tissue without causing histotoxicity or cytotoxicity.
Polymerization occurs at ambient skin temperature while maintaining
the skin surface under suitable conditions to allow polymerization
to proceed. In general, the length of time required for
polymerization will vary depending on factors such as the amount of
adhesive composition applied, the temperature of the skin, the
moisture content of the skin, the surface area of skin to which the
adhesive was applied, and the like. However, polymerization is
typically complete within about 10 to about 60 seconds, while the
skin is maintained at ambient conditions.
[0065] Such polymerizable cyanoacrylate esters are sometimes
referred to herein as prepolymers and compositions comprising such
esters are sometimes referred to herein as prepolymer
compositions.
[0066] Polymerizable cyanoacrylate esters are known in the art and
are described in, for example, U.S. Pat. Nos. 3,527,224; 3,591,676;
3,667,472; 3,995,641; 4,035,334; and 4,650,826 the disclosures of
each are incorporated herein by reference in their entirety.
[0067] In preferred embodiments, the sealing-strengthening layer of
liquid cyanoacrylate laid down by the applicator has a thickness of
no more that about 1 millimeter and yields a polymerized
cyanoacrylate composition layer that has a thickness of no more
than about 1 millimeter. More preferably, the polymer layer and the
liquid layer have a uniform thickness of from about 2 to about 500
.mu.m. Still more preferably, the layers have a thickness of from
about 20 to about 100 .mu.m.
[0068] Optionally, the cyanoacrylate composition applied by the
present applicator can include a "biocompatible plasticizer." As
used herein, the term "biocompatible plasticizer" refers to any
material which is soluble or dispersible in the cyanoacrylate
composition, which increases the flexibility of the resulting
polymeric film coating on the skin surface, and which, in the
amounts employed, is compatible with the skin as measured by the
lack of moderate to severe skin irritation. Suitable plasticizers
are well known in the art and include those disclosed in U.S. Pat.
Nos. 2,784,127 and 4,444,933 the disclosures of both of which are
incorporated herein by reference in their entirety. Specific
plasticizers include, by way of example only, acetyl tri-n-butyl
citrate, acetyl trihexyl citrate butyl benzyl phthalate, dibutyl
phthalate, dioctylphthalate, n-butyryl tri-n-hexyl citrate,
diethylene glycol dibenzoate and the like. The particular
biocompatible plasticizer employed is not critical and preferred
plasticizers include dioctylphthalate and C.sub.2-C.sub.4-acyl
tri-n-hexyl citrates.
[0069] Optionally as well, the cyanoacrylate composition applied by
the present applicator can include an "antimicrobial agent". As
used herein, the term "antimicrobial agent" refers to agents which
destroy microbes (i.e., bacteria, fungi, yeasts, prions and
viruses) thereby preventing their development and their pathogenic
action. In preferred embodiments, the cyanoacrylate composition may
contain from about 0.01 to about 5 weight-percent
antimicrobial.
[0070] Preferred cyanoacrylate compositions useful in the practice
of this invention are also disclosed in U.S. Pat. No. 5,480,935,
which application is incorporated herein by reference in its
entirety. In a particularly preferred embodiment, the cyanoacrylate
adhesive composition further comprises an antimicrobially effective
amount of a compatible antimicrobial agent. Such compositions
preferably comprise from about 0.1 to about 40 and preferably 1 to
30, or more preferably 5 to 20 weight percent of the compatible
antimicrobial agent either as a solution or as a suspension based
on the total weight of the composition. Compatible antimicrobial
agents are those which are either soluble or suspendable in the
cyanoacrylate composition, which do not cause premature
polymerization of the cyanoacrylate composition, which do not
prevent polymerization of the cyanoacrylate composition when
applied to mammalian skin, and which are compatible with the
intended use including biocompatibility with the patient's skin.
Suitable such compositions are disclosed in U.S. Pat. No. 5,762,919
which is incorporated herein by reference in its entirety.
[0071] In a particularly preferred embodiment, the compatible
antimicrobial agent comprises a complex of iodine molecules with a
biocompatible polymer. Such complexes are well known in the art and
the resulting complex typically comprises both available iodine and
iodide anions. These complexes, on contact with mammalian skin,
provide for a source of antimicrobial iodine. In any event, such
complexes are employed only as starting materials herein and, by
themselves, do not form a part of this invention. Suitable
biocompatible polymers include, by way of example only,
polyvinylpyrrolidone polymer which, when complexed with iodine, is
also referred to under the common name of povidone-iodine available
from BASF, Mt. Olive, N.J., USA. When povidone-iodine is employed
in the cyanoacrylate composition, it is preferably from about 5 to
about 40 weight percent and more preferably from about 10 to about
25 weight percent is added to the cyanoacrylate composition based
on the total weight of the composition.
[0072] Other suitable antimicrobial agents include complexes of
iodine molecules with copolymers of vinylpyrrolidone and vinyl
acetate, copolymers of vinylpyrrolidone and vinyl acetate
cross-linked with polyisocyanates, copolymers of vinylpyrrolidone
and vinyl functionalities, polymers of pyrrolidone and the
like.
[0073] The use of a compatible antimicrobial agent in the
composition permits the agent to be released from the polymeric
film thereby reducing microbial growth under the film.
[0074] Other medicaments suitable for use in conjunction with the
cyanoacrylate composition include corticoid steroids such as
described by Greff, et al. in U.S. Pat. No. 5,962,010 which is
incorporated herein by reference in its entirety and analgesic
compounds such as lidocaine. The former reduces inflammation at the
site of the application whereas the latter reduces pain.
Combinations of a steroid with an analgesic are also covered.
[0075] Although only preferred embodiments of the invention are
specifically disclosed and described above, it will be appreciated
that many modifications and variations of the present invention are
possible in light of the above teachings and within the purview of
the appended claims without departing from the spirit and intended
scope of the invention.
* * * * *