Surgical suture abstract
An improved surgical suture package has a back panel and a cover
flap foldably connected to one side of the back panel. The back
panel and cover flap each have a coordinating surface. The improvement
comprises a plurality of embossed patterns on the coordinating surfaces
of the back panel and cover flap.
Surgical suture claims
I claim:
1. An article of manufacture comprising a first part consisting
essentially of an outer sealed envelope having at least one edge
and means adjacent the at least one edge for opening the outer sealed
envelope, and contained therein a second part having a sterile,
surgical suture package, the surgical suture package having a back
panel and a cover flap foldably connected to one edge of the back
panel, said back panel and the cover flap each having a facing side
when said surgical suture package is folded on the one edge, the
improvement consisting of in combination, said surgical suture package
manufactured from a chemically sterilizable material and a plurality
of embossed patterns being equally spaced on each of the facing
sides of said back panel and cover flap, at least two surgical suture
strands contained on said back panel, and said cover flap laid onto
the at least two surgical suture strands and said back panel with
at least an end of each of said strands external to said back panel
and cover flap, such that when said outer sealed envelope is opened,
a single suture can be grasped and directly dispensed from said
package.
2. An article of manufacture comprising a first part consisting
essentially of an outer sealed envelope having at least one edge
and means adjacent the at least one edge for opening the outer sealed
envelope, and contained therein a second part having a sterile,
surgical suture package, the surgical suture package having a back
panel and a cover flap foldably connected to one edge of the back
panel, said back panel and the cover flap each having a facing side
when said surgical suture package is folded on the one edge, the
improvement consisting of in combination, said surgical suture package
manufactured from a chemically sterilizable paper and a plurality
of embossed circular patterns being equally spaced on each of the
facing sides of said back panel and cover flap, the plurality of
embossed circular patterns being in columns, the number of columns
on said panel being less than the number of columns on said flap,
at least two surgical suture strands contained on said back panel,
and said cover flap laid onto the at least two surgical suture strands
and said back panel with at least an end of each of said strands
external to said back panel and cover flap, such that when said
outer sealed envelope is opened, a single suture can be grasped
and directly dispensed from said package.
3. An article of manufacture comprising a first part consisting
essentially of an outer sealed envelope having at least one edge
and means adjacent the at least one edge for opening the outer sealed
envelope, and contained therein a second part having a sterile,
wound closure device package, the wound closure device package having
a back panel and a cover flap foldably connected to one edge of
the back panel, said back panel and cover flap each having a facing
side when said wound closure device package is folded on the one
edge, the improvement consisting of a plurality of embossed patterns
in columns on the facing sides of said back panel and cover flap,
and the number of columns on said panel being less than the number
of columns on said flap, at least two surgical suture strands contained
on said back panel, and said cover flap laid onto the at least two
surgical suture strands and said back panel with at least an end
of each of said strands external to said back panel and cover flap,
such that when said outer sealed envelope is opened, a single suture
can be grasped and directly dispensed from said package.
4. An article of manufacture comprising a first part consisting
essentially of an outer sealed envelope having at least one edge
and means adjacent the at least one edge for opening the outer sealed
envelope, and contained therein a second part having a sterile,
wound closure device package, the wound closure device package having
a back panel and a cover flap foldably connected to one edge of
the back panel such that said back panel and cover flap each having
a facing side when said wound closure device package is folded on
the one edge, the improvement consisting of a plurality of embossed
patterns in rows on each of the facing sides of said back panel
and cover flap, and the plurality of embossed patterns in rows on
said back panel being between the plurality of embossed patterns
in rows on said cover flap, at least two surgical suture strands
contained on said back panel, and said cover flap laid onto the
at least two surgical suture strands and said back panel with at
least an end of each of said strands external to said back panel
and cover flap, such that when said outer sealed envelope is opened,
a single suture can be grasped and directly dispensed from said
package.
5. An article of manufacture comprising a first part consisting
essentially of an outer sealed envelope having at least one edge
and means adjacent the at least one edge for opening the outer sealed
envelope, and contained therein a second part having a sterile,
surgical suture package, the surgical suture package having a back
panel and a cover flap foldably connected to one edge of the back
panel, said back panel and cover flap each having a facing side
when said surgical suture package is folded on the one edge, the
improvement consisting of said surgical suture package manufactured
from an irradiation sterilizable material selected from the group
consisting of polyolefin film and polyester film, and a plurality
of embossed patterns being equally spaced on each of the facing
sides of said back panel and cover flap, at least two surgical suture
strands contained on said back panel, and said cover flap laid onto
the at least two surgical suture strands and said back panel with
at least an end of each of said strands external to said back panel
and cover flap, such that when said outer sealed envelope is opened,
a single suture can be grasped and directly dispensed from said
package.
6. An article of manufacture comprising a first part consisting
essentially of an outer sealed envelope having at least one edge
and means adjacent the at least one edge for opening the outer sealed
envelope, and contained therein a second part having a sterile,
surgical suture package, the surgical suture package having a back
panel and a cover flap foldably connected to one edge of the back
panel, said back panel and cover flap each having a facing side
when said surgical suture package is folded on the one edge, the
improvement consisting of said surgical suture package manufactured
from metallic foil, and a plurality of embossed patterns being equally
spaced on each of the facing sides of said back panel and cover
flap, at least two surgical suture strands contained on said back
panel, and said cover flap laid onto the at least two surgical suture
strands and said back panel with at least an end of each of said
strands external to said back panel and cover flap, such that when
said outer sealed envelope is opened, a single suture can be grasped
and directly dispensed from said package.
7. The article of claim 1 wherein each of the embossed patterns
is circular.
8. The article of claim 1 wherein each of the embossed patterns
is linear.
9. The article of claim 8 wherein the plurality of embossed patterns
are parallel to each other.
10. The article of claim 1 wherein each of the embossed patterns
is curvilinear.
11. The article of claim 10 wherein each of the embossed patterns
is sinusoidal.
Surgical suture description
BACKGROUND AND SUMMARY OF THE INVENTION
This invention relates to an improved wound closure device package.
The improvement comprises a plurality of embossed patterns. The
wound closure device package can be a surgical suture package.
In one embodiment, the improved wound closure device package is
a surgical suture package. The surgical suture package has a panel.
The improvement is the surgical suture package manufactured from
an irradiation sterilizable paper, and a plurality of embossed patterns
on the panel. In a specific embodiment, the irradiation sterilizable
paper is kraft paper.
In another embodiment, the wound closure device package has a back
panel and a cover flap. The cover flap is foldably connected to
one side of the back panel. The back panel and cover flap each have
a coordinating surface. The improvement is a plurality of embossed
patterns in columns on the coordinating surfaces of the back panel
and cover flap. The number of columns on the back panel are less
than the number of columns on the cover flap. In another improvement,
the invention is a plurality of embossed patterns in rows on the
coordinating surfaces of the back panel and cover flap, and as shown
in FIG. 2 the rows of phantom embossed portions 4A on the back panel
1 are between the rows of embossed portions 5 on the cover flap
2.
In yet another embodiment, the improved wound closure device package
is a surgical suture package having a back panel and a cover flap.
The cover flap is foldably connected to one side of the back panel.
The back panel and cover flap each have a coordinating surface.
The improvement is the surgical suture package manufactured from
an irradiation sterilizable paper and a plurality of embossed patterns.
The embossed patterns are equally spaced on each of the coordinating
surfaces of the back panel and cover flap. In a specific embodiment,
the irradiation sterilizable paper is kraft paper.
In still another embodiment, the improved wound closure package
is a surgical suture package having a back panel and a cover flap.
The cover flap is foldably connected to one side of the back panel.
The back panel and cover flap each have a coordinating surface.
The improvement is the surgical suture package manufactured from
an irradiation sterilizable material. The material is selected from
metallic foil, polyolefin film and polyester film. The improvement
also is a plurality of embossed patterns being equally spaced on
each of the coordinating surfaces of the back panel and cover flap.
In a specific embodiment, the irradiation sterilizable material
is a laminated metallic foil.
In other specific embodiments, each of the embossed patterns is
circular, linear, curvilinear or sinusoidal. In a more specific
embodiment, the plurality of embossed linear patterns are parallel
to each other.
In still yet another embodiment, the improved wound closure device
package is a surgical suture package having a back panel and a cover
flap. The cover flap is foldably connected to one side of the back
panel by at least one score line. The back panel and the cover flap
each have a coordinating surface. The improvement is the surgical
suture package manufactured from an irradiation sterilizable paper
and a plurality of embossed circular patterns. The embossed circular
patterns are equally spaced on each of the coordinating surfaces
of the back panel and cover flap. Also, the plurality of embossed
circular patterns are in columns. The number of columns on the panel
are less than the number of columns on the flap. In a specific embodiment,
the irradiation sterilizable paper is kraft paper. In another specific
embodiment, the plurality of embossed patterns on the back panel
and cover flap are in rows. The rows on the back panel are between
the rows on the cover flap.
In a still further embodiment, this improved wound closure device
package is a surgical suture package having a back panel and a cover
flap. The cover flap is foldably connected to one side of the back
panel. The back panel and the cover flap each have a coordinating
surface. The improvement comprises in combination, the surgical
suture package manufactured from a chemically sterilizable material
and a plurality of embossed patterns. The embossed patterns are
equally spaced on each of the coordinating surfaces of the back
panel and cover flap.
In a final embodiment, the improved wound closure device package
is a surgical suture package having a back panel and a cover flap.
The cover flap is foldably connected to one side of the back panel.
The back panel and the cover flap each have a coordinating surface.
The improvement comprises in combination, the surgical suture package
manufactured from a chemically sterilizable paper and a plurality
of embossed circular patterns. The embossed circular patterns are
equally spaced on each of the coordinating surfaces of the back
panel and cover flap. The plurality of embossed circular patterns
are in columns. The number of columns on the back panel are less
than the number of columns on the cover flap.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a front view of the suture package;
FIG. 2 is an expanded front view of the circled portion 2 of FIG.
1;
FIG. 3 is a section view along the line 3--3 of FIG. 2;
FIG. 4 is a right side view of a folded package of FIG. 1 showing
the flap 2 folded onto the panel 1;
FIG. 5 is a cut away and perspective view of a partially folded
package of FIG. 1 showing a plurality of surgical filaments;
FIGS. 6 8 10 and 12 are alternative front views of the suture
package of FIG. 1; and
FIGS. 7 9 11 and 13 are section views along the respective lines
7--7 9--9 11--11 and 13--13 of FIGS. 6 8 10 and 12.
DESCRIPTION OF THE INVENTION
FIG. 1 describes the best mode of carrying out the invention at
the time this application was filed. The intended use of the embodiment
shown in FIG. 1 is as an interior card in a two part package. However,
the embodiment shown in FIG. 1 can also be used as a component in
a multicomponent package. The additional part or components of the
package can be for a variety of purposes, e.g. visibility of the
ends of the needled or non-needled surgical filaments, ease of bonding
to make a sterile enclosure, and ease of dispensing the surgical
filaments.
As an example of a two part package, please see U.S. Pat. No. 4284194
FIGS. 1 to 4d and the improvements thereof in U.S. Pat. Nos. 4406363
FIGS. 1 to 12; 4413727 FIGS. 1 to 5 and 8 to 13; and 4708241
FIGS. 1 to 7. The disclosure in U.S. Pat. No. 4284194 at column
4 lines 34 to 37 is material to the patentability of the inventions
disclosed in this application. All of the above patents are incorporated
herein by reference.
In this application, it is to be understood that the terms "suture
package", "wound closure device package", or "surgical
suture package" include the inventions as shown and described,
either as an interior card, for example as described in U.S. Pat.
No. 4284194 FIG. 1 or as a substitute for a foam member, for
example as shown in U.S. Pat. No. 4413727 FIGS. 1 and 3 element
24 as one part of a two part package. These terms also include the
inventions as shown and described as one component in a multicomponent
package. Where designated and for contrast, a prior art two part
or multicomponent package may also be described by these terms.
The package of this invention is useful in singly dispensing a
braided wound closure device from a plurality of braided wound closure
devices. The braided wound closure device is preferably a needled
or non-needled suture, or ligature. Other wound closure devices,
such as ligament or tendon prosthetic devices, may be singly dispensed
from the package of this invention. This invention is also useful
in dispensing a surgical suture or ligature from a suture package
only containing a single suture or ligature. The single suture or
ligature can be in the form of a monofilament or braid.
The package can be cutout and embossed from a sheet of irradiation
and/or chemically sterilizable stock, for example surgical grade
kraft paper. Chemical sterilization can be by using a fluid, e.g.
ethylene oxide gas, which is sometimes abbreviated EtO. Various
EtO sterilization processes are described in the prior art. For
a background of the development of irradiation sterilization for
medical devices generally and surgical sutures specifically, please
see the monograph entitled "Radiosterilization of Medical Products
1974", International Atomic Energy Agency, Vienna, Austria,
1975 pages 431 to 435 which is incorporated herein by reference.
The package can also be cutout and embossed from an irradiation
and/or chemically sterilizable metallic foil, such as aluminum.
A stainless steel foil may also be useful. The metallic foil can
be of a laminated construction for increased strength, rigidity
and/or puncture resistance, or for other reasons. It is to be understood
that the materials used to manufacture the metallic foil laminate,
e.g. an adhesive, and a paper and/or a polymeric material are also
to be irradiation and/or chemically sterilizable. A metallic foil
laminated material is disclosed in U.S. Pat. No. 4135622 which
issued Jan. 23 1979. This patent is incorporated herein by reference.
Further, the package of this invention can be cutout and embossed
from an irradiation and/or chemically sterilizable sheet or film
of a polymeric material. The polymeric material may be natural,
such as cellophane, or synthetic, such as a polyolefin. polyester
or nylon. For a disclosure of a polyolefin suture package, please
see "Two-Piece Tray Delivers Sutures, Speeds Surgery"
by H. Forcinio in Food Drug Packaging vol. 48 no. 3 1984 pages
5 and 46 which is incorporated herein by reference. The polyester
can be polybutylene terephthalate or polyethylene terephthalate.
A polyether-ester, such as polybutester, may also be useful. The
polybutester can be a Hytrel.TM. polymer (Du Pont, Del., USA).
The apparatus and methods for making an embossed pattern on a foil,
sheet or film are described in the prior art. How to make and how
to use a two part or multicomponent suture package is also described
in the prior art. Please see, e.g., U.S. Pat. No. 4284194. Therefore,
a drawing of the improved suture package of this application beyond
that described in the FIGS. 1 to 5 is not necessary for the understanding
of how to make and/or how to use the subject matter sought to be
patented.
The package as shown in FIG. 1 comprises a back panel 1 and a strand
cover flap 2. The flap 2 is connected to the panel 1 by a score,
perforation or similar line 3. The utility of the suture package
is based on the embossed pattern, which is shown as circular portions
4 and 5. The function of the embossing is to provide a rough and/or
irregular surface that will hold the one or more sutures in position
within the package.
The function of the embossing also allows a single suture from
a plurality of sutures to be dispensed from the package. The following
theory, although not a part of this invention, is disclosed as one
explanation for the single suture dispensing package. Static friction
is greater than sliding (moving) friction. The force initially introduced
to a single suture for dispensing, e.g., by pulling the suture with
the thumb and index finger, is large enough to overcome the static
friction of that one suture against the retainer and the other sutures.
However, that one suture's sliding friction is not large enough
to overcome the static friction of the other sutures against the
retainer and against each other. Thus multiple surgical suture strands
can be packaged together and directly dispensed singly without tangling.
In this function, the embossing eliminates a foam layer or other
dispensing member, both of which are known prior art means of singly
dispensing a suture from a plurality of sutures. For example, please
see respectively U.S. Pat. No. 4284194 FIG. 1a, element 2a and
4533041 FIG. 5 element 26. The U.S. Pat. No. 4533041 is incorporated
herein by reference. The simplicity of the embossing in combination
with a reduction of packaging materials and/or of complex manufacturing
processes is an indicia of patentability of the inventions described
in this application. The circular portions 4 and 5 describe the
best mode of carrying out the inventions at the time this application
was filed.
In one embodiment, the size, shape and volume of each circular
portion 4 and 5 respectively on panel 1 and flap 2 is identical.
The total number of circular portions 4 can be and preferably is
different from the total number of circular portions 5.
In the embodiment shown in FIG. 1 the number of columns of circular
portions 5 on flap 2 are one more in number than the number of columns
of portions 4 on panel 1. With the proper spacing of each column
and row of circular portions 4 and 5 on the respective panel 1 and
flap 2 the circular portions 4 are located at the interstices of
the circular portions 5 when the panel 1 and flap 2 are folded onto
each other along the score or perforated line 3. As an example of
proper spacing, please see FIG. 2. The phantom circular portions
4A describe the location of the circular portions 4 of label 1 after
the panel 2 and label 1 are folded onto each other.
Although the portions 4 and 5 shown in FIGS. 1 2 and 5 are circular,
it is to be understood that other patterns are within the scope
of this invention. Such embossed patterns include, but are not limited
to, elliptical, egg shaped, square and rectangular. The embossed
patterns can also include a plurality of grooves having parallel
and/or intercepting axes. The intercepting axes can be oblique or
perpendicular to the parallel axes. The patterns can also be partial,
e.g. semicircular, or curvilinear, e.g. sinusoidal. Further, it
is to be understood that the embossed patterns can be concentric,
including coaxial. Finally, a drawing of all of these other above-discussed
patterns is not necessary for the understanding of the subject matter
sought to be patented in this application.
FIG. 3 is a section view of a circular portion 4 shown in FIG.
2. FIG. 4 is a right side view of a folded package of FIG. 1 showing
the flap 2 folded onto the panel 1. As shown in FIG. 5 the surgical
filaments 6 tend to flatten out both during and after being loaded
into the package. In subsequent packaging or storing, the surgical
filaments tend to further flatten out.
Referring again to FIGS. 1 2 and 5 the distance between two adjacent
columns of embossed patterns on the panel 1 and flap 2 is not critical
to the practice of this invention. In many embodimnents, the phantom
circular portions 4A (shown in FIG. 2) fit within the interstices
of the circular portions 5 of flap 2 when the package is folded
onto itself. It is also to be understood that in other embodiments
the circular portions 4 on panel 1 can touch or overlap the portions
5 on flap 2 when the package is folded onto itself.
Referring to FIGS. 1 and 5 in one embodiment the number of columns
of embossed patterns on panel 1 (there are six columns shown in
FIG. 1) is equal to or greater than the number of passes of surgical
filaments 6 loaded into the package (there are four passes shown
in FIG. 5). In another embodiment, the number of rows on the panel
1 and flap 2 (there are ten rows shown for each in FIG. 1) be at
least equal to the number of passes for the plurality of filaments
in the package. As used in this application, the term "column"
means a single line of circular portions 4 and/or 5 that are parallel
to the score line 3; the term "row" means a single line
of concentric portions 4 and/or 5 that are parallel to the top and
bottom of the package shown in FIG. 1.
As shown in FIGS. 1 and 5 the rows and columns of the circular
portions 4 and 5 are equally spaced in the respective panel 1 and
flap 2. However, unequal spacing may also be useful in practicing
this invention, which any person skilled in the surgical filament
art can conclude without undue experimentation.
It is to be understood that a prior art suture package can be improved
by a plurality of embossed patterns on a single card, for example
the circular portions 4 on back panel 1 in FIG. 1 being inserted
adjacent to a single suture. This improvement can be especially
useful in ophthalmic suture packages because an ophthalmic suture
is usually of a fine denier and may "drift" in the package.
The improved embodiment of this invention can stabilize the ophthalmic
suture and therefore make it easier to be located and dispensed.
As an example of this improved embodiment, the plurality of embossed
patterns on a single card can be placed on center panel 17 in FIG.
2 of U.S. Pat. No. 4412613. The flap 17a can then be folded onto
the single card as shown in FIG. 4 of this patent, which is incorporated
herein by reference.
It is also to be understood that the peripheral edges of either
or both of the panel 1 and flap 2 in this application can contain
additional flaps, panels or tabs, and/or the panel 1 and flap 2
can be of a different configuration than that shown in FIG. 1. Other
modes are embodied in the invention described in this application.
For example, referring to FIGS. 1 and 5 the suture package can
comprise a plurality of embossed patterns on either the back panel
1 or strand cover flap 2. |