U.S. patent number 3,876,068 [Application Number 05/386,672] was granted by the patent office on 1975-04-08 for suture reel-label package.
This patent grant is currently assigned to American Cyanamid Company. Invention is credited to Mario Sonnino.
United States Patent |
3,876,068 |
Sonnino |
April 8, 1975 |
Suture reel-label package
Abstract
Surgical sutures, including ligatures, are wound from a needled
or free end on a printed reel-label. The reel-label is made from
sealed together thicknesses of stiff inert sterilizable label
stock, with means, such as an aperture or grommet, to act as a
rotable axis to permit holding between a finger and thumb for
unwinding. A needle, if attached, is held in a pocket between the
thicknesses with the armed portions of the needle protected. The
friction between the thicknesses and the suture permits retention
of the suture during storage and unwinding from either end. The
suture reel assembly is stored in a sterile envelope which may be
completely dry. The thus formed package protects the suture from
kinks during storage, it protects the suture from the needle and
the package from the needle. It permits unwinding from either end
without tangling and it is capable of being rewound.
Inventors: |
Sonnino; Mario (New Canaan,
CT) |
Assignee: |
American Cyanamid Company
(Stamford, CT)
|
Family
ID: |
23526567 |
Appl.
No.: |
05/386,672 |
Filed: |
August 8, 1973 |
Current U.S.
Class: |
206/227;
206/63.3; 242/159 |
Current CPC
Class: |
A61B
17/06138 (20130101); A61B 17/06123 (20130101); A61B
2017/06142 (20130101) |
Current International
Class: |
A61B
17/06 (20060101); A61b 017/06 (); A61l
017/02 () |
Field of
Search: |
;206/63.3,227 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Summer; Leonard
Attorney, Agent or Firm: Walker; Samuel Branch
Claims
I claim:
1. A reel-label surgical suture combination comprising
two superimposed panels of stiff sterilizable label stock having a
heat sealable facing on one side;
said panels being rectangular, with rounded corners, with the
superimposed rounded corners having different radii;
accordion pleat folds joining the two panels on two parallel
edges;
an infolded panel ear strengthening the top and bottom of each said
panel;
cut-out tabs near the top and bottom of each panel, said tabs being
heat sealed to tabs from the opposing panel, to hold said panels
together;
said panels each having therein a hole, said holes being in
registration, and forming a spin axis substantially at the center
of said panels;
said tabs and said accordion pleat folds forming a suture holding
groove, to frictionally hold a suture therein;
said groove being effectively continuous and operatively centered
towards said spin axis;
at least one of said panels having therein at least one needle
retaining cut-out adapted to hold the sharp end of at least one
needle between panels in protective relationship;
a suture wound thereon, and at least in part in, said suture
holding groove;
said suture having thereon an eyeless surgical needle, the point of
said needle being inserted in one of said needle retaining
cut-outs;
and a needle protective cover adjacent to one of said panels on the
side opposite the other of said panels, covering and protecting
said needle;
whereby the sharp portion of said needle is protected from dulling
during shipment and the suture and the package are protected from
being damaged by the needle during packaging and shipment.
2. The reel-label surgical suture combination of claim 1 in which
the two superimposed panels and the accordion pleat folds are
formed from a single flat piece of label stock.
3. The reel-label surgical suture combination of claim 1 in which
the surgical needle has sharp edges at the sides of the needle,
which edges are protected by said needle protective cover.
4. A suture package consisting of a sealed envelope and enclosed
therein at least one reel-label surgical suture combination as set
forth in claim 1, and in which said needle protective cover
protects the envelope from the sharp edges of the needle.
5. A double envelope suture package comprising a strippable outer
envelope having therein at least one suture package as set forth in
claim 4, and in which the said suture package is both interiorly
and exteriorly sterile.
6. The reel-label of claim 1 in which at least a part of the
reel-label is of an X-ray opaque material to provide for X-ray
detection in a patient.
Description
BACKGROUND OF THE INVENTION
In this modern day of convenience packaging, more and more effort
is being put into attempting to package in a form which is
convenient and economical and which meets requirements for the
particular item being packaged.
In the packaging of surgical sutures, it is necessary that the
sutures be released in sterile condition, ready for use by the
surgeon with the economic requirement that the packaging be as
economical as consistent with the qualities required and to the
extent possible that a minimum of number pieces and minimum
quantity of packaging materials result from releasing the suture
for use. A count is often kept to insure that each needle and each
reel and envelope is removed from the operating field.
An acceptable package needs to be inexpensive and completely
reliable. The package must release a sterile suture for the
surgeon's use with his positive knowledge that the suture is, in
fact, sterile and none of its design characteristics have been
compromised during storage prior to use. Sutures may be stored in
hospitals for several years before use, although the usual storage
time is much shorter.
There are many sizes of sutures, and many materials of
construction, such as catgut, or polyglycolic acid for absorables,
and non-absorbables of silk, cotton, nylon, dacron, polyethylene,
polypropylene, stainless steel, insulated stainless steel, and
other materials of construction. There are several different needle
types in common use, including pointed straight, pointed curved,
three cornered straight, three cornered curved, both regular and
reverse, and needles with side cutting edges of various types. The
variations and combinations of each of these to meet the
preferences of many surgeons for different operative procedures
means that a suture manufacturer needs to supply different suture
combinations running into the thousands. Some of these are fast
moving items, others meet only with occasional demand. For purposes
of convenience and storage in the hospital as well as economy of
manufacture, it is highly desirable that as many suture
combinations as feasible be packaged in a minimum number of
different package styles and shapes and storage units. It is quite
common to package three dozen identical sutures in a box. It is
convenient to have most of the boxes about the same size and shape,
so that the hospital may store them most conveniently. It is also
convenient from the manufacturer's standpoint to be able to reduce
his inventory of box sizes and to be able to use the same
components for the maximum number of suture combinations in the
product line.
It is essential that a package for a side cutting needle; that is,
a needle which has a sharp edge on the side, protect the suture
from contact with the sharp side, or armed edge, of the needle
which could partially cut the suture and to avoid having the sharp
edges cut the package. Also, the armed needle edges need to be
protected so as to maintain their sharpness.
Additionally, it is highly desirable that the needles and sutures
be oriented in a consistent relationship within packages so that
the using surgeon, directly, or the nurse who passes the sutures to
the surgeon, will be able to rapidly and reliably grip the needle
without having to take time to orient the needle with respect to
the needle forceps at the time of use.
These requirements are so rigorous and of such importance that many
different package designs have been tried, some have been used, and
many have been found wanting in one or more particulars.
Most of the suture packages today are strippable, double envelope
packages of the type first disclosed in U.S. Pat. No. 3,043,067,
Rynkiewicz and Ayres, "Suture Package", July 10, 1962.
The outer envelope and certain details are disclosed in U.S. Pat.
No. 2,949,181, Buccino, "Suture Package And Process Of Making
Same", Aug. 16, 1960.
U.S. Pat. No. 3,357,550, Holmes and Murphy, "Combination Reel And
Label For Surgical Sutures", Dec. 12, 1967, shows a system in which
the reel also serves as a label with the reel being torn apart to
release the suture wound on the label.
U.S. Pat. No. 3,376,973, Granowitz and Buccino, "Package For
Surgical Sutures", Apr. 9, 1968, shows a molded plastic reel
fitting in a hub for surgical sutures with the assembled reel, hub
and suture being packaged in outer envelopes.
U.S. Pat. No. 3,038,475, Orcutt, "Surgical Needles And Manufacture
Of Same", June 12, 1962, shows certain forms of surgical needles,
including curved, triangular shaped needles with the edges being
sharp or round and which sharp side edges can damage sutures or
packages.
U.S. Pat. No. 2,841,150, Riall, "Cutting Edge Suture Needle", July
1, 1958, shows another type of side cutting needle, the sharp edges
of which can damage sutures or packages.
SUMMARY OF THE INVENTION
It has now been found that a suture package meeting the
requirements set forth above is advantageously formed from sheet
label stock one side of which is coated with a thermoplastic
adhesive, such as polyethylene, with either a single sheet of such
a material being doubled on itself to provide two thicknesses, or
two separate sheets of material being sealed together and
appropriately folded, so that the suture is wrapped between at
least two thicknesses of the label stock which are sealed together.
The suture is retained between the two sheets of material sealed
together, whereby the suture is held in position until time for use
and the suture is readily unreeled from either end from between the
two thicknesses of label stock. Conveniently, the needled end is
placed first and the free end is wound around the reel-label. At
the time of use, the needle is pulled free and the suture is
unwound from the needled end with the various turns of the suture
passing each other in the V-groove between the label stock
thicknesses, without tangling and without compromise of suture
quality.
In preferred embodiments of the invention, an additional thickness
of label stock which may be transparent covers and protects the
needle from contact with either the turns of the suture or the
envelope. The needle is inserted in retaining means in the
reel-label. The additional thickness of label stock covers the
needle in such fashion that the covering portion can be turned back
to release the needle in oriented relationship so that it may be
picked up by the user in consistent orientation. Any of the usual
types of needle forceps may be used.
The reel-lable having the suture wound thereon may be packaged dry
or in a selected tubing fluid in an interiorly and exteriorly
sterile inner envelope, which inner envelope is packaged in a
strippable outer envelope.
As is conventional in the art, the suture is served to a surgeon by
stripping the outer envelope, and either with forceps, or by
manually projecting, the inner envelope is passed across the
sterile barrier, into the sterile areas of the operating room.
The inner envelope is opened at time of use.
As used herein, the term sutures includes ligatures. Ligatures
technically are used without a needle for tying, whereas sutures
are used with a needle for penetration of tissues as well as tying.
The same material can be used for both purposes and frequently
parts of the same strand are actually used as both a suture and a
ligature depending upon the requirements of the surgeon at a
particular time during a surgical procedure.
The sutures may have a needle on one or both ends. Frequently a
needle is placed on each end so that the suture is cut and each
needle used separately, and sometimes each needle is used for
penetration for particular tissues at a particular time.
Conveniently, the needles are of the eyeless type that is
permanently attached to the end of the suture and designed for but
a single use. Such needles cause less trauma to tissues in which
they are used and are becoming surgically preferred.
The present invention is particularly adapted for the packaging of
polyglycolic acid sutures. These are a new class of synthetic
absorbable suture which is to be packed and stored dry. The
requirement for dryness is disclosed in U.S. Pat. No. 3,728,839,
Glick, "Storage Stable Surgically Absorbable Polyglycolic Acid
Products", Apr. 24, 1973.
The sutures may be collagen, either natural catgut or regenerated
catgut, which sutures are usually packaed in a conditioning fluid
such as a mixture of one or more alcohols in water so that the
collagen will have a preferred flexibility. Non-absorbable sutures
may be packed on the present reel-label and include such materials
as silk, silicone or wax coated, or cotton or linen, or one of the
newer synthetic materials such as nylon, polyester, isotactic
polypropylene, or linear polyethylene, stainless steel wire or
other wire, either insulated or bare, or the suture may be of such
other composition as preferred by the surgeon for the surgical
procedure in progress.
The reel-label is preferably of a label paper which is manufactured
for suture labels and is a sterilizable paper designed for either
letter press or offset printing. A paper with a 90 lb. weight basis
and designed to withstand heat, steam, or gas sterilization without
discoloration, and which accepts alcohol and water insoluble ink is
satisfactory. It is preferred that such paper be coated with about
one-half mil of polyethylene so that it becomes heat sealable. Such
paper is known in the trade and readily available. The sealing may
be by heated dies, or heat may be internally generated by
ultrasonic means.
The present reel-label is and remains as a single piece, so that
there is only one piece for disposal. In a preferred embodiment,
the inner envelope which encloses and protects the suture on its
reel-label is notched and fits around the reel-label so that it may
be breached starting at the notch and torn open without tearing the
envelope into more than one piece so that the inner envelope is a
single piece for discarding.
It is important that the various pieces be identifiable so that
after an operation, the surgical team can reliably find and count
all components of packaging as well as surgical needles to be
certain that undesired foreign elements are not sewn into the
patient at the time of use.
Time and motion studies show that the serving of a suture using the
present reel-label is faster and more efficient than with
conventional reels. Saving time reduces the time a patient is in
surgery, and, hence, the duration of risk, risks, saves time of the
medical operating team, and reduces time charges for the
operating-theater, all of which are conducive to better and more
economical patient care.
The present reel-label can have size and type designations for the
suture and needle. The reel itself as well as the envelopes and
boxes used may be color coded to designate the type of suture
material, and/or other useful information.
The present invention, and its advantages are also apparent from
the detailed description of certain embodiments thereof which
follow.
THE DRAWINGS
In the drawings:
FIG. 1 shows a flat scored cut-out for a rectangular
reel-label;
FIG. 2 is a pictorial view of the cut-out of FIG. 1 partially
folded;
FIG. 3 is the cut-out of FIG. 1 folded, and sealed to itself as a
reel-label;
FIG. 4 is a needle protective cover for the reel-label of FIG.
3;
FIG. 5 shows a rectangular reel-label with needle protective
cover;
FIG. 6 is a cross-section of FIG. 5 at 6--6;
FIG. 7 shows the cover turned back to expose a curved needle and
suture wound on the reel-label;
FIG. 8 is a cross-section of FIG. 7 at 8--8, but with the cover
shown flat;
FIG. 9 shows a rectangular reel-label in a notched tearable inner
envelope in a strippable outer envelope;
FIG. 10 shows the inner envelope of FIG. 9 torn open, and the reel
label being removed;
FIG. 11 shows a round reel-label in a double strippable
envelope;
FIG. 12 shows three rectangular reel-labels in a single package of
double envelopes;
FIG. 13 shows a rectangular reel label;
FIG. 14 shows a cross-section of FIG. 13 at 14--14;
FIG. 15 shows a round reel-label;
FIG. 16 shows a cross-section of FIG. 15 at 16--16, and shows a
X-ray opaque grommet;
As shown in FIG. 1, a reel-label is cut out and scored from a sheet
of stiff material such as 90 pound, sterilizable offset printing
paper which has thereon a coating of one-half mil polyethylene so
that it is heat sealable. The label is conveniently, but not
necessarily, die cut from rolls of paper stock and conveniently may
be cut out and printed in continuous rolls, except for a final cut
which is made at the time the label is folded and sealed.
As shown in FIG. 1, with the printed side up and the polyethylene
coated side down, face panel 21 has attached thereto along score
lines a first and a second accordion pleat panels 22 and 23, to the
second of which is attached the back panel 24. On the other side of
the rectangular panel are the third and fourth accordion pleat
panels 25 and 26. Conveniently, but not necessarily, the third
accordion pleat panel 25 is just slightly wider than the fourth
accordion pleat panel 26 so that, in folding, when adhesively
united to the back panel, the edge of the fourth accordion pleat
panel is just slightly back of the edge of the back panel to insure
that no edges stick out which can snag a suture being wound on the
reel-label. Conveniently, when the reel-label is being cut, score
lines are formed where the panels are to bend to insure that the
bending occurs at a designed fold line.
To the top and bottom of the face panel and the back panel are
attached ears, respectively, the top face panel ear 27, the bottom
face panel ear 28, top back panel ear 29, and the bottom back panel
ear 30. These ears are attached to the respective panels with score
lines 31 being stamped into the label stock at the time of cut-out.
These score lines permit accurately positioned folds to be readily
made between the panels. A tab notch 32 is formed in each of the
four ears. A tab 33 is cut on three sides near the top and bottom
of each of the face and back panels pointing towards the center of
the panels.
As shown in FIG. 2, the four ears are folded inwardly against the
face and back panels with the adhesive coated sides coming into the
contact and similarly the accordion pleat panels are folded
inwardly from each panel so that the face and back panels can then
be folded towards each other, as shown in FIG. 3, with the adhesive
of the face and back panels being sealed to each other at the tabs,
through the tab notches 32, in the upper tab seal zone 34 and the
lower tab seal zone 35. This holds the face and back panels
together in resilient spring-like configuration. The face and back
panels and united with side seal zones 36 on each side which
adhesively unite the accordion pleat panels to the face and back
panels for the length of the accordion pleat panels and adhesively
unite the panel ears to the respective panels. The seals may be
formed consecutively or concurrently.
The ears are advantageously fractionally smaller than the face and
back panel to which they are adhesively united. Conveniently, they
may be about a sixty-fourth of an inch narrower, so that allowing
for manufacturing tolerances in cutting and folding the ears, the
ears are necessarily slightly back from the face and back panels so
that no corners protrude on which the suture can be snagged. The
corners may be slightly rounded to reduce the chance of
snagging.
The back panel has four intermediate radius rounded corners 37. The
face panel has diagonally oriented two smaller radius rounded
corners 38 and two diagonal larger radius rounded corners 39. By
having the larger and smaller radii on the front face, as the
reel-label is assembled, two corners have the face panel protruding
slightly beyond the back panel so that they may be lifted easily
with the finger and the other two corners with a larger radius and,
hence, are slightly back of the back panel so that on each of the
corners, one of the panels may be conveniently manipulated to open
up the winding notch 49 between the panels.
Near the center of the face panel is a face panel rotating hole 40
and near the center of the back panel is a back panel rotating hole
41. These holes extend through the panel so that in unwrapping the
suture, the surgeon may hold the reel-label with the thumb and a
finger on each side and touching throuch the hole to permit the
reel-lable to rotate during release of the suture. Preferably, the
rotating hole is of a rounded polygon configuration. As shown, it
is conveniently a diamond shaped hole with rounded corners. By
having the hole other than round, the suture reel-labels may be
mounted on a spindle and positively driven by a non-round spindle
which is shaped to match the rotating hole. Conveniently, a diamond
shaped hole with rounded corners is used but a hexagonal,
triangular, or other shaped hole may be used for the purpose if
desired.
A separate needle protective cover 42 is cut from similar stiff
label paper of s size and shape to nearly cover the face of the
assembled panels with a cover seal flap 43. The needle protective
cover is sealed along one edge to position the cover seal flap
close to the face panel of the reel-label assembly, as shown in
FIG. 5. One corner of the needle protective cover is a lifting
corner 44 which extends slightly beyond the face panel so that it
may be lifted by the thumb of the user.
Identifying indicia 45 may be printed on the needle protective
cover. Conveniently, but not necessarily, a cover rotating hole 46
is formed in the needle protective cover so that the cover may be
either in the closed position or in the open position as the
reel-label is rotated to unwind a suture.
The needle protective cover may also be of a transparent material,
for example, a mylar polyethylene laminate which permits inspection
of the needle and suture while protecting the needle and suture. If
transparent, the identifying indicia may either be printed on the
needle protective cover or on the face panel of the reel-label.
In FIG. 7 is shown a curved needle 47 which is inserted through the
cut-out notch of the tab 33 so that the needles extend between the
tab and the panel ear. This keeps the needle away from the suture
and holds it in a positively oriented position until time of use.
The suture 48 extends from the curved needle 47 and is wound up and
into the winding notch 49 which winding notch is formed by the tabs
sealed together in the tab seal zones at the top and bottom and the
accordion pleated panels on the edges. The suture may be wound in
this winding notch by wrapping the suture in either direction with
the free end being wound down into the notch or left free. At the
time of use, the needle may be removed from its pocket and unwound
with the turns of the suture passing each other in the winding
notch.
By having the suture fit in the winding notch 49 in such fashion
that turns can pass each other, the suture may be wound or unwound
from either end at any time. This permits placing the needle 47
first, and winding the suture in the winding notch without slack
and yet without tension. The needle pocket 50, which is formed by
the cut-out for the tab 33 and the panel ear, permits a needle to
be placed between two thicknesses of the panel stock and out of
contact with the suture independently of whether the needle is
curved, straight, triangular in cross-section, or duck-billed with
sharp sides, the needle pocket provides a receptacle in which the
point may be placed and the diagonal from the pocket is long enough
for the entire needle to be placed between the face panel and the
needle protective cover 42.
If the tabs 33 are narrower than the tab notches, the reel-label is
easier to assemble and has more resiliency. If the tab is slightly
wider, the needle is necessarily more certainly diverted from
passing into the winding notch rather than being retained between
the face panel and the face panel ear.
For those packages in which the suture is double-armed, that is,
has a needle on each end, a pocket at the top and a pocket at the
bottom can be used, one for each needle. Alternatively, both
needles may be placed in the same pocket.
In FIG. 8 is shown the suture wound between the accordion pleat
panels. In this, as in other figures, the thickness of the panel
stock is exaggerated for clarity.
The niceties of having the radii of curvature on the face panel and
the back panel different in each corner and having all corners
slightly rounded, and slightly smaller so that even with
manufacturing tolerances, none of the ears or accordion panels
stick out enough to snag the suture are features which are
preferred for the best practice of the invention. For many
purposes, a less refined reel-label may be adequate.
The cover 42, as well as the paper stock from which the panels are
formed, may be colored in order that the color of the reel-label
give a clue as to the type of suture material wound around.
Similarly, the suture size, the suture material, and the type of
needle may be printed on the needle protective cover on the face
panel or the back panel. Usually, to avoid confusion, a minimum of
printing is desirable in order that the user may very rapidly
identify the data which is needed and not be too confused with
extraneous information.
The size of the reel-label is, of course, commensurate with the
size of the suture and its needle. Conveniently, a face panel which
is 2 7/16 inches long and 11/4inches wide gives good results. The
radii of carvature of the back panel can conveniently be about a
quarter of an inch whereas the smaller radius can be one-sixteenth
inch and the larger radius three-eighths inch on the face panel
with the ears one-sixty-fourth inch less on each corner. The
accordion folds are conveniently a quarter of an inch for the first
and second accordion pleat and a sixty-fourth of an inch more for
the third accordion pleat panel and a sixty-fourth of an inch less
for the fourth accordion pleat panel. Such a size permits sutures
normally in use in a hospital to be conveniently packaged. For
metric countries or where desired, panels may be varied
considerably in size to accommodate sutures of selected sizes and
appropriate needles.
In FIG. 9 is shown the reel-label with the needle protective cover
attached in a notched tearable inner envelope 51 in a strippable
outer envelope 55. The inner envelope may conveniently be made of a
moisture proof material such as a 25 pound, calendered, bleached,
pouch paper laminated with about a half a mil of polyethylene to a
metallic foil such as about a one mil aluminum foil which is again
laminated to one mil polyethylene as an inner sealable layer. Such
a material is disclosed in U.S. Pat. No. 3,728,839, supra. Such
material is essentially moisture proof so that synthetic absorbable
sutures such as those of polyglycolic acid are protected from
hyrolytic degradation. The same material may be used for the
packaging of catgut sutures which are packaged with a desired
quantity of water to maintain plasticity. Some sutures in which the
moisture content is immaterial may be also packaged in the same
material to maintain consistency of packaging standards.
By having a peaked seal 53 and a tearing notch 52 therein, when the
inner envelope is to be opened, the user can use the tearing notch
as a start, and tear the laminate longitudinally along the face of
the reel-label as shown in FIG. 10 so that without detaching the
torn portion, the suture on the reel-label can be removed with
forceps 54 or with the gloved fingers to release the reel-label
having the suture thereon for use.
The notched tearable inner envelope 51 is packaged in a strippable
outer envelope 55 of the type disclosed in U.S. Pat. No. 2,949,181,
supra.
A modification of this invention is shown in FIG. 11. As shown in
FIGS. 15 and 16, a round reel 56 is formed from sealing together a
round face panel 57 and a round back panel 58 with an annular seal
59. The annular seal is inside the periphery of the face and back
panels. As shown in FIG. 16, this leaves an external notch in which
the suture is wound. As shown in FIG. 15, a threading notch 60 is
formed in at least one of the panels in order that one or more
needles 61 may be placed in an internal slit 62 with the suture 63
being wound into the winding notch formed between the round face
panel and the round back panel.
From the constructional standpoint, the panels may be sealed
together before the round face panel and the round back panel are
cut out from larger stock.
As shown in FIG. 16, conveniently, an X-ray opaque grommet 64 may
be inserted to hold the panels together and also serve as a turning
axis for unreeling the suture. The metal grommet gives positive
indication by X-ray if a package is accidentally dropped into an
incision during an operation.
In FIG. 13 is shown a similar type of reel except that the face
panels are rectangular and long enough so that a straight needle 65
can be inserted into the retaining slit 66 with the rear end being
held in a positioning slit 67. In this modification, an annular
seal 68 is used to hold the panels together and a square hold 69 is
used for a rotatable axis. The square hole has the advantage that
it may be used on a square drive shaft in winding the suture onto
the reel assembly.
In FIG. 12 is shown an assembly with three rectangular reels of the
type shown in 13 packaged into a sterile envelope 70 in a
strippable envelope 71.
Many incidental advantages accrue from the use of the present
reel-label. For instance, it takes from 8 to 16 turns, depending on
length, to wind a suture onto the present reel-labels. It is
convenient to have one or more suture reel-labels ganged on a
single spindle with the needles being inserted into the needle
pockets. All of the sutures are wound on the reels by mechanically
turned spindles simultaneously. Gang winding permits saving of time
and effort, even though winding eight turns by hands is
comparatively quick.
The use of rectangular reels gives a larger printing surface for
identification of the suture type, size, and needle. Additionally,
it provides a longer diagonal so that long straight needles can be
inserted in the pocket and protected for their entire length. A
rectangular reel permits the use of a rectangular envelope which
maintains the orientation so that the user can expect to find a
needle in the same relative position with respect to the envelope
each time the sterile inner envelope is opened. This permits more
raipd seizing of the needle with needle forceps with positive
knowledge that orientation is as planned.
By having no sharp corners around which the suture is wound, even
sutures which tend to attain a permanent set are curved minimally
when unreeled for use.
By using the cover and having the needle point between the face
panel and a face panel ear, the needle is positively positioned and
is protected during winding so that the needle neither harms the
suture nor the envelope nor has its sharpness compromised during
the assembly and storage prior to actual use. The light frictional
crimp from the sealed together panels permits as many as three
sutures to be wound on a single reel and yet each one can be
positively unwound without tangling. It also permits a longer
length material to be wound for use as ligatures.
A radio opaque or magnetic grommet or ink permits detection of the
package should it be inadvertently dropped into an incision.
By only having one part to the reel, the number of extraneous
pieces in the operating theater are reduced. It permits more
positive counting in and out of the operating room of each of the
elements of packaging to insure that all needles and extraneous
items are accounted for before an incision is closed. The paper
stock from which the panels are made, as well as the envelope, are
free from traps which would pick up and retain contaminants and are
readily sterilized by conventional sterilizing procedures. The
package is such that any sterilizing cycle which is adaptable to
the suture may be used. The package, for instance, will stand heat,
dry or wet, ethylene oxide, radiation, ultrasonic vibration, or
other sterilizing agents or combinations of these. The reel-label
and package are sufficiently sturdy that only the characteristics
of the suture material need to be considered as controlling
parameters during packaging, sterilization, and storage.
Whereas, it is usually most convenient to cut the reel-label blank
of FIG. 1 from strip material and fold on score lines to form the
finished reel-label, the face and back panels and accordion pleats
as well as ears may be cut from separate strips or cut out as
separate panels and adhered together. For constructions such as
shown in FIGS. 13 and 15 where the edges of the panels extend
beyond the annular seals, it is essentially necessary that separate
panels be used. The feasibility of using folded panels is an
alternative that must be placed in its proper economic context
with, of course, the cost of each method of operation being
considered before the final decision is made.
The reel-label may be made of plastic, or a plastic laminate, or
foam, or paper of unique characteristics as well as conventional
label stock.
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