U.S. patent number 3,749,238 [Application Number 05/183,115] was granted by the patent office on 1973-07-31 for suture dispenser package and method of making.
This patent grant is currently assigned to Cenco Medical Health Supply Corporation. Invention is credited to Stanley E. Taylor.
United States Patent |
3,749,238 |
Taylor |
July 31, 1973 |
SUTURE DISPENSER PACKAGE AND METHOD OF MAKING
Abstract
A suture dispenser package for directly dispensing sterile
sutures including a molded in depth tray having a circular cavity
for receiving a reel means on which an elongated suture is wound, a
cavity for receiving a clip means retaining the unwound end of the
elongated suture or a needle attached to it, and a narrow
passageway between the two cavities which acts to straighten the
suture as it is pulled through it. A lid means which is sealable
about the periphery of the tray encloses and maintains the suture
containing reel and the clip means within their cavities in the
tray forming a primary suture pack which may be further enclosed by
a secondary package. A method of making a sterile suture dispenser
package including, winding an elongated suture about a suture reel,
placing the unwound end or suture needle of the suture in a clip
means and positioning the reel and clip means in cavities formed in
a molded in depth tray, sterilizing the tray and its contents, and
sealing a lid to a flange disposed about the upper periphery of the
tray, enclosing the tray and its contents. This entire primary
suture pack is then enclosed by and sealed within a secondary
suture package and externally sterilized through the permeable
material forming the secondary suture package.
Inventors: |
Taylor; Stanley E. (Chesterton,
EN) |
Assignee: |
Cenco Medical Health Supply
Corporation (Chicago, IL)
|
Family
ID: |
22671507 |
Appl.
No.: |
05/183,115 |
Filed: |
September 23, 1971 |
Current U.S.
Class: |
206/227;
206/63.3; 206/471; 206/484 |
Current CPC
Class: |
A61B
17/06133 (20130101); A61B 17/06123 (20130101) |
Current International
Class: |
A61B
17/06 (20060101); A61i 017/02 (); B65d
081/18 () |
Field of
Search: |
;206/63.3 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Dixson, Jr.; William T.
Claims
I claim:
1. In a suture dispenser package particularly adapted for the
direct dispensing of sterile sutures, and including suture
containing means, reel means having an elongated suture wound
thereabout and disposed for rotation within said suture containing
means to allow said suture to be unwound and dispensed therefrom,
extraction ramp means formed in said suture containing means to
assist in straightening said suture as said suture is unwound from
said reel means, and lid means formed to cover said suture
containing means in sealed relationship thereto to form a sterile
primary suture pack, a portion of said lid means being removable
from said suture containing means at any desired time to permit
access to an unwound end of said suture, a remaining portion of
said lid means maintaining said reel means within said suture
containing means during rotation of said reel means to dispense
said suture, the improvement comprising, clip means disposed in
said suture containing means to retain, in a fixed position for
easy access prior to the dispensing of said suture, the unwound end
of said suture, said clip means having a retention portion having a
top flap and a bottom flap hingedly mounted thereon, said top flap
being positionable adjacent a portion of said bottom flap by
insertion under tab means disposed on said bottom flap, said top
flap and said bottom flap when so disposed retaining the unwound
end of said suture in fixed position between them prior to use,
said clip means also having a mounting portion disposed adjacent
said reel means effective to maintain said clip means properly
positioned within said suture containing means.
2. The improvement set forth in claim 1 wherein the unwound end of
said suture retained by said retention portion of said clip means
is attached to a suture needle, said suture needle being similarly
retained between said top flap and said bottom flap of said
retention portion of said clip means in position for gripping by a
needle clamp prior to use.
3. The improvement set forth in claim 1 wherein the said suture
containing means includes a tray formed in depth having a flange
disposed about its periphery to provide a sealing area for sealing
said lid means thereto, said tray having a reel containing cavity
formed in the configuration of said reel means and including an
upwardly projecting axle means disposed at its center, said axle
means receiving said mounting portion of said clip means thereover,
said reel containing cavity receiving said reel means over said
axle means for rotation therearound, said tray also having a clip
means containing cavity receiving said retention portion of said
clip means therein, said reel containing cavity and said clip means
containing cavity having extraction ramp means disposed between
them including a convex shoulder defining one wall of a passageway
open at its opposite ends to said reel containing cavity and said
clip means containing cavity, respectively, and being effective to
bend said suture being extracted from said reel containing cavity
in the reverse direction of its winding as it travels along the
passageway toward said clip means containing cavity.
4. The improvement set forth in claim 1 wherein said primary suture
pack is completely enshrouded and enclosed within a secondary
package means, said secondary package means being constructed of a
transparent, permeable material allowing inspection and
sterilization of said primary package therethrough.
5. A process for manufacturing a suture dispenser package
particularly adapted for the direct dispensing of sterile sutures
characterized by the steps of:
winding an elongated suture about a suture reel means leaving one
end of said suture unwound;
positioning clip means having a retention portion with a top flap
and a bottom flap adjacent the unwound end of said suture and a
suture needle attached thereto in such a manner that said unwound
end and said needle are received between said top flap and said
bottom flap of said retention portion of said clip means, said top
flap then being moved adjacent said bottom flap to retain said
suture and said needle therebetween;
forming suture containing means for receiving said reel means
containing said suture in position for rotation therein, and for
supporting said clip means, and having extraction ramp means
disposed therein to assist in straightening said suture as it is
unwound from said reel means;
inserting said clip means retaining the unwound end of said suture
and attached needle and said reel means containing said suture into
said suture containing means, said retention portion of said clip
means being disposed on the opposite side of said extraction ramp
means from said reel means, said suture being directed across said
extraction ramp means from said reel means to said retention
portion of said clip means during dispensing;
applying tubing solution to soak said suture contained on said reel
means, and retained in said clip means;
sterilizing said reel means, said suture, said clip means and said
suture containing means;
sealing a lid means about the periphery of said suture containing
means thereby enclosing said reel means, said suture, said clip
means, and said extracting ramp means to form a primary suture
pack;
enshrouding said primary suture pack within a secondary package
means having at least a portion thereof formed of permeable
material;
sealing said secondary package means to thereby enclose said
primary suture pack; and,
sterilizing the exterior of said primary suture pack and the
interior of said secondary package means by sterilization means
permeating said secondary package means.
6. The process of claim 5 wherein said suture containing means
includes a multi-cavity tray formed in depth having a flange
disposed about its periphery to provide a sealing area for sealing
said lid means thereto, said tray having a reel containing cavity
formed therein in the configuration of said reel means including an
upwardly projecting axle means formed at its center, said axle
means receiving a mounting portion of said clip means thereover,
said reel containing cavity receiving said reel means over said
axle means for rotation therearound; said tray also having a clip
means containing cavity formed therein receiving said retention
portion of said clip means therein said extraction ramp means being
formed in said tray between said reel containing cavity and said
clip means containing cavity and including a convex shoulder
defining one wall of a passageway therebetween upon which said
suture is moved as it is unwound from said reel means and extracted
from said reel containing cavity in such a manner that said suture
is bent in the reverse direction of its winding to straighten it
for use.
7. The process of claim 5 wherein said sterilization means used to
sterilize both said primary suture pack and said secondary package
means includes one hundred percent ethylene oxide gas.
Description
BACKGROUND OF THE INVENTION
This invention relates to suture dispensers, and in particular, to
a suture dispenser package for directly dispensing sterile sutures
for use in medical and surgical procedures and to a method of
making such a package.
The use of sutures is necessary in almost every area of medical and
surgical practice. As the techniques and procedures used in these
various areas requiring sutures have become more sophisticated and
timewise more efficient, the demand for a type of suture which is
readily available in a sterile condition has greatly increased.
In order to meet this demand, sutures have been made available over
the past few years in small, often hand-held packages which are
constructed of disposable materials and which are formed in such a
manner that they contain the sutures in ready to use sterile
condition. These suture packages are illustrated by U. S. Pat. Nos.
3,338,401 and 3,280,971 issued to P. E. Regan, Jr. All of these new
suture packages have attempted to provide a readily accessible
suture while maintaining the paramount requirement of complete
sterility of the suture at all times. They have also recognized the
need for packaging the sutures in a condition which will allow them
to be used at a date several months subsequent to their manufacture
without their becoming brittle and flaking or breaking during
use.
The patents of Regan teach the packaging of sutures within a
coiled, sterilized sleeve enclosable within an outer pack ('971) or
in a channel having a plurality of convolutions, molded from the
suture package itself, receiving a plurality of of elongated
sutures and allowing for the introduction of a liquid to surround
the sutures within the pack to prevent brittleness and dryness
while permitting easy access to one end of the suture through a
peelable lid on the pack. ('401)
Despite the advances in suture packaging art illustrated by these
patents and by the commercially available types of suture dispenser
packs, there remain several significant problems in the development
of adequate suture packaging. Considering that sutures are so
universally required in medical and surgical work and that the
ability to have immediate access to completely sterile non-brittle
sutures with a minimum of handling, time consuming package opening
operations or inadvertent spillage of liquid is absolutely
essential, these problems are extremely important. Among the major
problems which have not been solved by the presently available
types of suture packs is the coil set taken by sutures from their
configuration during storage, no matter what suture winding system
is used. This type of set is not only a hindrance to tight
stitching and rapid and easy workability of the suture, but also
requires that the user manually straighten the sterile suture after
extraction from the card or other receptacle containing the suture.
Such manual straightening is bothersome, difficult, and increases
the chances of contamination of the suture before use.
A further problem is that once the actual suture is obtained from
the protective sterile packaging, the operator is often left with
various pieces of superfluous packaging which not only have a
nuisance value, but also pose a sterility hazard. For example,
there may be a torn off end of a primary package, a cardboard
retainer or sleeve for the suture, winding holders, caps, spilled
solution from the package, or fiber particles which flake out
because of the dryness of the package.
A third problem has been that, with available suture packages, the
user has a number of manipulations to perform in order to open the
protective or secondary and primary packages before the suture is
available for use. Each of these manipulations presents an
additional sterility hazard as well as being wasteful of valuable
time. Some of the manipulations the user must go through after
opening the outer pack and depositing the primary pack on a sterile
field area; (1) opening the primary package, (2) withdrawing the
suture from the primary package enclosed or held by a card reel,
plastic holder or winding stem, (3) opening the card reel and/or
holder while using a clamp to hold the needle, (4) extracting a
suture from the card reel and/or holder, and, (5) straightening the
suture after removal by tugging at both ends. Again, all of the
above manipulations must be completed under sterile conditions.
Another drawback to the present forms of packaging and dispensing
is that once the sterile primary pack containing the suture has
been opened, the construction of the packages is such that the
solution soaking the suture to keept it moist either quickly
evaporates or spills. In addition, presently available packages are
usually constructed of opaque material or in such a manner or
labeled so that neither suture or needle are visible before
opening. It is apparent that it would be a distinct advantage to
the suture user and other medical personnel to be able to not only
distinguish the type of suture being used, but also the position of
the holder before opening.
An obvious disadvantage with the Regan patents described above is
that having a plurality of sutures in a narrow passageway presents
the danger of entangling the sutures or extracting more than one
suture when only one is required or desired. Such suture packs, in
addition to providing little control over the dispensing of an
individual suture, also provide no means by which the suture,
stored in coiled position, can be easily straightened. Furthermore,
from the manufacturing standpoint, the diposition of a suture or
plurality of sutures in narrow passageways may present significant
mass production problems.
DESCRIPTION OF THE INVENTION
This sterile suture dispenser package and method of making solves
the major problems of presently available suture packages and
dispensers by providing a completely sterile pack-age containing a
reel held suture which is unwound as desired and straightened as it
is unwound. This invention solves the problems described above by a
molded in depth tray having a reel containing cavity with a boss or
axle extending upward at its center and a suture needle clip
containing cavity with a narrow passageway therebetween, which is
constructed of a clear, lightweight, easily formed material so that
the suture and its orientation are easily visible to the user prior
to use. The suture is wound about a conventional suture reel in an
easy manufacturing step, leaving one end of the suture unwound for
attachment to a suture needle. This needle is then placed in
position between a clip means having overlapping tabs retaining the
needle between them and having an opposite end of similar
configuration to the suture reel with a hole formed at its center
to receive the axle formed in the tray. The reel and the clip means
are then inserted into their respective cavities in the formed
tray. When nested properly in these cavities, they are sterilized,
and then enclosed within the tray by a lidding material which is
sealed around the periphery of the side walls of the tray. This
lidding material is provided with a tab over extending the end of
the tray near the clip means so that the lidding material and tray
may be separated for easy access to the suture needle.
This entire primary pack is then placed inside a sleeve or shroud
which is sealed around its perimeter. The outside portion of the
primary pack is then sterilized through the secondary package by a
media which permeates the material forming a secondary package.
The unique construction of this package overcomes the problem of
the coil set the sutures take from the winding system of the reel
because it provides an extraction ramp or shoulder configuration
formed in the passageway between the reel containing cavity and the
suture needle clip containing cavity. As the suture is unwound from
the reel and travels through this passageway, it moves along a
convex shoulder which tends to bend the suture in the opposite
direction from which it is wound. The user, by placing his thumb on
one side of the reel and his finger or fingers on the opposite
side, may exert a pressure on the central axis of the reel which
will cause the suture to be extracted under tension. This
combination of tension and the unique formation of extraction ramp
or shoulder cause the suture to be straightened automatically as it
is extracted for use.
The suture dispenser package of this invention also eliminates any
superfluous packaging since, once the protective secondary package
is removed, the remainder of the pack remains an integral unit.
Thus, the user is not left with a tab or a clip which separates
from the primary suture package itself. There is only one piece of
material to deal with and that contains the suture itself. When the
suture is cimpletely extracted from the package, the entire package
may be thrown away. This invention eliminates the nuisance of many
disposable pieces and their hazard to sterility.
Moreover, the elimination of excess packaging also tends to
eliminate the necessity of excess manipulation in order to arrive
at a sterile suture. The operations required by the unique
construction of this invention after the secondary package has been
opened and the suture primary package disposed on a sterile field
are simply; (1) opening the completely sterile primary package by
pulling a tab at one end, (2) sliding the suture needle clip means
open with a needle clamp, and, (3) pulling on the needle to unwind
the desired amount of suture from the reel while exerting a
pressure on the center of the reel whenever a braking or tensile
force is required. No removal of a suture card or holder or the
extra steps of separately opening the needle clamp and
straightening the suture are required with the apparatus of this
invention.
Furthermore, the construction of this invention is such that the
reel containing cavity acts as a container to hold the solution for
soaking the suture to prevent dryness. The construction of the
narrow passageway between the suture cavity and the clip means
cavity as well as the difference in elevation between the two
cavities when the suture is held in position, bottom down for
extraction, prevents any unwanted spillage of soaking solution.
Accordingly, it is an object of this invention to provide a suture
dispenser package and method of making permitting the direct
dispensing of sterile sutures from a sterile package.
It is a further object of this invention to provide a suture
dispenser package and method of making such an apparatus allowing
the suture user to exert tension on the suture as it is being
unwound to control its dispensing.
It is also an object of this invention to provide a suture
dispenser package which will straighten the suture as it is
dispensed from the sterile package.
It is a still further object of this invention to provide a suture
dispenser package and method of making allowing retention of the
soaking solution within the sterile suture package and eliminating
spillage.
It is another object of this invention to provide a suture
dispenser package and method of making which will eliminate the
superfluous pieces of packing material previously necessary in
packaging sterile sutures for direct dispensation.
It is one more object of this invention to provide a suture
dispenser package and method of making for direct dispensing of
sterile sutures which eliminates the excessive manipulation
necessary to gain access to the suture.
It is still another object of this invention to provide a suture
dispenser package and method of making permitting observation of
the suture contained therein before and during use.
It is an additional object of this invention to provide a suture
dispenser package having a means for holding a suture needle in
fixed position after the top of the sterile suture package is
removed.
It is also an object of this invention to provide a suture
dispenser package and method of making using a secondary package to
contain the primary suture pack and maintain its sterility prior to
use.
It is further object of this invention to provide a sterile suture
dispenser package which may be sterilized inside and out.
These and other important objects of the invention will become
apparent from the following description taken in conjunction with
the drawings illustrating a preferred embodiment wherein:
FIG. 1 is a perspective view of a complete sterile suture dispenser
package;
FIG. 2 is an exploded view of the primary suture containing and
dispensing pack shown in FIG. 1;
FIG. 3 is a bottom perspective view of the primary suture package
shown in FIG. 2 as assembled;
FIG. 4 is a top perspective view of the primary suture dispenser
pack having the portion of lidding material covering the suture
needle clip means peeled back, the clip means opened and a needle
forceps removing the suture needle; and,
FIG. 5 is an enlarged cross sectional side view of the primary
sterile suture dispenser pack of this invention.
Referring now to the drawings and more particularly FIG. 1, the
sterile suture dispenser package of this invention is shown at
10.
This suture dispenser 10 includes a secondary package 12, which
completely encloses and enshrouds the primary suture pack 14. This
secondary suture package 12 is constructed of a foil-paper-adhesive
base which is covered by a transparent film cover. The base and
cover are sealed about a peripheral seal area 18 by the chevron
type seal shown to define the secondary package 12, and thereby
enclose primary suture pack 14. The secondary package 12 is opened
by pulling the secondary pack peel tabs 16 in opposite directions
thereby peeling the transparent film cover from the
foil-paper-adhesive base.
The elements of the primary suture pack 14 are shown more clearly
in an exploded view in FIG. 2. These include a suture containing
means or molded in depth tray 20 which functions as a base for the
primary suture pack 14. This suture containing means 20 includes an
upwardly protruding axle or boss 24 molded in its bottom which is
disposed at the center of a suture reel cavity 30. The suture
containing means 20 also includes, at its opposite end, and molded
to a lesser depth than the suture reel cavity 30, a clip means
cavity 32. Between the reel cavity 24 and the clip means cavity 32,
is disposed an extraction ramp means or shoulder 26 which, with the
side wall of the molded in depth tray 20, defines a suture
passageway 27 between cavities 24 and 32.
Insertable within the suture containing means 20 is a suture
retention clip means 22 which includes a portion having a
configuration similar to that of the suture reel cavity 30 with an
opening 34 at its center for insertion over the axle or boss 24 of
the reel cavity 30. The suture retention clip means 22 has, at its
opposite end, a clip means top flap 36 and a clip means bottom flap
38 which are hingedly attached so that the top flap 36 may be swung
downwardly over bottom flap 38 and inserted under a flap securing
or tab means 40 to maintain top flap 36 adjacent bottom flap 38 to
retain suture needle 48 between flaps 36 and 38. This portion of
suture retention clip means 22 is likewise disposed within suture
containing means 20 in the clip means cavity 32, the bottom flap 38
being adjacent to the inside floor of suture containing means 20.
This portion of clip means 22 is also provided with a perforated
opening pull tab 42 which enables the user to raise top flap 36 to
gain access to the suture needle 48.
Reel means 44 may be a conventional spool-type reel having a boss
aperature 45 disposed through its center which may be inserted over
the axle or boss 24 in suture reel cavity 30 of suture containing
means 20, for rotation therearound, after a length of elongated
suture 46 is wound on it, as shown in FIG. 2. Normally the suture
46 will not be completely wound about reel 44, but will have one
free end on which is disposed a suture needle 48.
The final element in the primary suture pack 14 is the tray lidding
material or lid means 50 which is sealed about a suture tray
sealing flange 28 disposed at the uppermost portion of the walls of
the molded in depth tray 20. This lid means 50 acts to completely
cover the interior portion of the suture tray 20 and maintain in
position within the tray 20 the suture retention clip means 22 and
the reel means 44 containing the elongated suture 46 and attached
suture needle 48. The lid means 50 is preferrably provided with a
peelable portion 54 which may be unsealed and peeled back to afford
access to the suture needle 48 held by the top flap 36 and the
bottom flap 38 of the clip means 22 in clip means cavity 32. The
peel portion 54 is easily pulled back, as shown in FIG. 4, by a lid
means peel tab 52.
FIG. 3 illustrates the primary suture pack 14 of this invention in
its assembled condition with the lid means 50 sealed in place over
the suture tray 20. The molded in depth tray 20 is fabricated of a
transparent material such as polyvinyl chloride to permit the
suture user to determine the disposition of the suture needle 48,
and the type of suture 46 before opening, and the amount of suture
46 remaining during actual use of the suture pack 14. Such
visibility also prevents accidental spillage of suture moisturizing
fluid because the user is able to determine in what portion of the
package the fluid resides.
FIG. 3 also illustrates the configuration of the extraction ramp
means or shoulder 26 and the suture passageway 27. The suture 46,
as it is unwound or extracted from the reel 44, is pulled through
the passageway 27 and across the surface of shoulder 26 before
exiting through clip means cavity 32, in such a manner that it is
given a reverse bend from that it acquired on the suture reel 44.
This reverse bend, plus the tension exerted on the suture needle 48
and suture 46, and the braking pressure applied to suture reel 44
through the primary package 14 causes the suture 46 to be
automatically straightened, eliminating coil set, as it is unwound
and before it is used.
In the manufacture of the sterile suture dispensing package 10, the
suture containing means or tray 20 is initially molded in depth in
the general configuration shown in FIG. 2. As mentioned, this tray
20 will have, subsequent to the molding process, a reel cavity 20
and a clip means cavity 32. Though the bottoms of both cavities
will be substantially flat, the bottom of the clip means cavity 32
will be elevated somewhat above the suture reel cavity bottom to
prevent passage of moisturizing fluid or tubing solution from one
cavity to the other during use, and thereby eliminate accidental
spillage of the fluid. The suture reel cavity 30 will also have an
upwardly protruding boss 24, acting as an axle for reel means 44 to
rotate about, molded in its bottom substantially at the center of
the cavity 30. The two cavities 30 and 32 are separated by the
extraction ramp means or shoulder 26 which partially forms the
suture passageway 27 between the cavities.
An elongated suture 46 of any type desired is then wound onto the
suture reel 44, a needle 48 being attached, if desired, to the
remaining free end of the suture 46. The suture needle 48 is then
placed in the needle retention portion of the suture retention clip
means 22 between the top flap 36 and bottom flap 38. The top flap
36 is then moved downward over the needle 48 and inserted under
flap securing or tab means 40, thereby maintaining needle 48 and
suture 46 in a fixed position with respect to the clip means
22.
The sub-assembly of the suture containing reel 44 and attached clip
means 22 is then inserted into the tray 20 so that the boss opening
34 of the clip means 22 and the axle opening 45 of the reel means
44 are inserted over the boss 24 molded in the tray 20. When the
passageway portion of the clip means 22 and the needle retention
portion of this clip means are also in their respective positions
within the tray 20, a predetermined amount of tubing solution is
applied to the tray to help maintain the proper moisture of the
wound suture 46. Likewise, a suitable amount of 100 percent liquid
ethylene oxide solution may be applied at the same time as the
tubing solution to sterilize the suture 46 and entire contents of
the tray 20. Although this method of moisturization and
sterilization is preferred, it is obvious that other methods could
be successfully used.
The final step is preparing the primary pack 14 shown in FIG. 2 is
heat sealing the tray lid means 50 in proper position onto the tray
20 about the suture tray sealing flange 28. This pre-sterilized
lidding means 50, when sealed, encloses a suture pack which is
completely sterile on its interior.
The assembled primary pack 14 is then enclosed by the secondary
package 12 shown in FIG. 1, and the secondary package 12 sealed
about its periphery 18. The secondary package 12 is preferrably
fabricated of permeable material to permit sterilization of the
exterior of the primary pack and the interior of the secondary pack
after sealing of the secondary package 12. While 100 percent liquid
ethylene oxide is preferred for this sterilization, sterilization
could also be accomplished before the sealing of either the primary
14 and secondary 12 packages through the non-opening ends of both
packs.
The use of the sterile suture dispensing apparatus 10 of this
invention is both simple and easy to accomplish. Since the
secondary package 12 is constructed of a foil-paper-adhesive base
and a transparent film cover, the type and length of the suture 46
can easily be determined by reading the identifying copy on the
lidding material 50 of the primary suture pack 14 which is visible
through the transparent cover of the secondary pack 12. When the
proper suture has been selected, the secondary pack peel tabs 16
are pulled apart in opposite directions to expose the primary pack
14. This package, which is sterile on its outer surface, is then
removed from the secondary package 12 and the type and position of
the suture 46 contained in the primary package 14 can again be
checked by viewing the position of the suture 46 and needle 48 and
the color of the color coded suture reel 44 through the transparent
bottom of the suture tray 20.
When the suture 46 is to be used, the lid means peel tab 52, shown
in FIG. 2, a portion of the lidding material 50 which extends
beyond the flange 28 of the tray 20 and is not sealed thereto, is
grasped and pulled backwardly along the lid means peel portion 54
to the line indicated in FIG. 2.
As shown in FIG. 4, this action exposes the free or needle
containing end of the suture 46 which has been retained by the clip
means 22. The needle 48 is easily accessible by grasping the
perforated opening pull tab 42 with a needle clamp or forceps 56 as
shown in FIG. 4, and pulling in an upwardly and outwardly direction
to move the top flap 36 away from the bottom flap 38 and expose the
needle 48. The forceps 56 may be then used to grasp and extract the
needle 48 and attached suture 46 from the package. By positioning
the thumb and index finger of one hand on opposite sides of the
package 14 over the central axis of the reel means 44, the user may
control the speed at which the suture 46 is extracted from the
primary pack 14. In addition, such a braking action on the reel
means 44 will provide sufficient tension on the suture to
straighten it as it passes through the passageway 27 and over the
shoulder 26 formed in the tray 20.
In FIG. 5 is shown a cross-sectional view of the primary pack 14 as
completely assembled. This view gives a more detailed view of the
suture 46 wound about the reel 44 and also shows the relationship
of the tray 20, the clip means 22 and the reel 44.
The suture reel 44 may be formed of any suitable material which is
light in weight, subject to sterilization and easily formed, such
as plastic which has been used and found acceptable in injection
molding of these reels. Such material should also be adaptable to
color coding.
The suture tray 20 may be formed of any suitable material which is
again light in weight, transparent, durable and easily molded,
preferrably by an injection molding process, to form a multi-cavity
unit, such as plastic.
The tray lid material 50 may be formed of any suitable material
which is easily sealable to a plastic type material impervious to
microorganisms and opaque on at least its outer surface so that
coding, artwork, and suture information may be printed on this
surface. Such a surface will thereby permit identification of the
manufacturer up to the point of use of the suture, a practice which
is not possible with the suture dispensers now available. The
material used should be easily peelable and sealable with respect
to the suture tray but have suitable sealing capability for the
retention of the alcohol base tubing solution.
The clip means 22 may be formed of lightweight, pliable material
which is also transparent and easily cut or shaped to fit within
the molded suture tray, such as plastic.
The secondary package may be formed from a suitable material which
is permeable for purposes of sterilization but which will prevent
the entry of microorganisms and the escape of tubing solution from
within, and is preferrably formed of a foil-paper-adhesive base and
a transparent film cover which may be heat sealed together about
their periphery by a chevron type seal to form a package.
Alternatively, the secondary package could consist of a formed
pouch which would require only an end sealing after filling.
While the invention has been described in relation to a preferred
embodiment, it will be apparent to those skilled in the art that
the structural details of the apparatus and sequential steps in its
method of making are capable of wide variation without departing
from the principles of the invention.
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