Surgical needle abstract
A retainer for a combined surgical needle-suture device possesses
a needle shield featuring a stop element which prevents the tip
of the needle from puncturing the package in which the retainer
is held.
Surgical needle claims
What is claimed is:
1. A method for packaging a combined surgical needle-suture device
upon a retainer base panel which comprises:
a) slidably mounting a needle shield possessing a needle tip stop
and parallel flanged sides upon the obverse side of a flat retainer
base panel possessing parallel lateral sides such that the flanged
parallel lateral sides of the needle shield make gripping contact
with the parallel sides of the base panel; and,
b) placing the needle component of the combined surgical needle-suture
device in contact with the needle shield such that the point of
the needle is proximate to, or abuts, the stop.
2. The method of claim 1 wherein before or after step (b), the
free end of the suture component of the combined surgical suture-needle
device is passed through an aperture on the base panel and the suture
component is attached to the obverse side of the base panel.
3. The method of claim 2 wherein the suture component is placed
within a coiled passageway in contact with the obverse side of the
base panel.
4. The method of claim 3 wherein the suture component is drawn
into the passageway by a vacuum applied thereto.
Surgical needle description
SUMMARY OF THE INVENTION
By way of meeting the foregoing criteria, there is provided in
accordance with this invention a retainer for a combined surgical
needle-suture device, the retainer comprising:
a) a base panel for retaining at least one surgical needle of a
combined surgical needle-suture device; and,
b) a needle shield mounted upon the base panel, the needle shield
possessing a stop for retaining the tip of the needle.
The stop feature of the needle shield effectively prevents accidental
puncture by a stored needle and permits rapid access and removal
of an armed suture when desired.
BRIEF DESCRIPTION OF THE DRAWINGS
FIGS. 1 and 2 are perspective views of embodiments of a needle
shield in accordance with the present invention;
FIGS. 3 and 4 are perspective views of the obverse and reverse
sides, respectively, of an armed suture retainer card with the needle
shield of FIG. 1 mounted thereon;
FIG. 5 is a top plan view of a suture package, including its outer
breather package, suitable for packaging the armed suture retainer
of FIGS. 3 and 4; and,
FIG. 6 is a top plan view of the suture package of FIG. 5 removed
from the breather package and opened for partially exposure of its
armed suture contents.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
As shown in FIGS. 1 and 2 needle shields 10 and 10' are each fabricated
from a suitably stiff material, preferably a transparent thermoplastic
resin such as polyethylene terephthalate. The needle shields are
conveniently manufactured from sheets of thermoplastic resin by
such known and conventional processes as thermoforming.
Needle shield 10 possesses top and bottom edges 11 and 12 respectively,
and flanged parallel lateral edges 13 and 14 respectively, by which
the needle shield grips side edges 31 and 32 of retainer base panel
30 as shown in FIGS. 3 and 4. An arcuate stop, or wall, 16 projecting
upwardly from surface 15 of needle shield 10 retains the sharp tips
of needle components 18 (as shown in FIG. 3) preventing the tip
from causing accidental puncture of front panel 43 of peel-open
suture package 40 (shown in FIGS. 5 and 6). Advantageously, stop
16 continues a short distance up lateral edge 13 to provide additional
security against accidental puncture. By way of maintaining needle
components 18 in a neat array upon surface 15 of needle shield 10
the surface is provided with a series of cuts defining tabs 17 which,
when displaced upwardly from surface 15 provide elements for securing
individual needles 18 in place. Needle securing means other than
tabs 17 can, of course, be utilized, e.g., a series of approximately
parallel "bumps: with a needle snap-fitted therebetween (not
shown).
Needle shield 10', like needle shield 10 possesses flanged lateral
edges 13' and 14' by which the needle shield grips the side edges
of an armed suture retainer panel. Stop 16' is an integral element
of pocket 19 and like stop 16 of needle shield 10 retains the tip
of a needle thereby preventing accidental puncture of the armed
suture package. However, unlike needle shield 10 in which the needles
lie upon surface 15 of the shield, in needle shield 10' the stored
needles are retained within pocket 19 i.e., beneath surface 15'
of the shield.
As shown in FIGS. 3 and 4 and in dotted outline in FIG. 6 the
general appearance of retainer base panel 30 is that of a flat,
relatively stiff panel whose longest sides 31 and 32 are parallel
to each other to permit needle shield 10 or 10' to be slid onto
the retainer during the packaging operation. Retainer 30 can be
constructed from any of several different types of materials including
various kinds of plastics, paper-foil laminate, etc. Retainer base
panel 30 is more fully described, together with peel-open foil package
40 of FIGS. 5 and 6 for accommodating the loaded retainer, U.S.
Pat. No. 5154283 the contents of which are incorporated by reference
herein. A similar retainer base panel which is also suitable for
use herein is described in U.S. Pat. No. 5129511 the contents
of which are incorporated by reference herein.
As shown in FIGS. 3 and 4 needle shield 10 has been mounted in
place by being slid onto retainer base panel 30 in the direction
indicated by the arrow. A number of armed sutures are secured in
place upon retainer base panel 30 their curved needle components
18 lying flat upon a portion of obverse side 33 of the base panel
and a portion of surface 15 of needle shield 10 with their suture
components 20 extending through triangular shaped aperture 34 to
reverse side 35 of the base panel where they occupy coiled passageway
36. The sutures can be drawn into coiled passageway 36 by applying
a vacuum through orifice 37 positioned at the far end of the passageway.
Under the influence of the vacuum, the sutures quickly occupy the
passageway.
The fully loaded armed suture retainer of FIGS. 3 and 4 is conveniently
packaged in peel-open metal foil suture package 40 of FIG. 5 shown
in its outer breather package 50 following sterilization and sealing.
Suture package 40 comprises an envelope 41 made up of front panel
42 joined to a rear panel (not shown) along common edges 44 employing
any known and conventional adhesive. Peelable closure flap 45 completes
package 40 and is advantageously provided with a knurled or embossed
trapezoidally configured edge 46 to facilitate gripping. The material
of construction of the front and rear panels and the closure flap
is one which prevents or greatly impedes the transmission of moisture
therethrough. In the embodiment shown, the walls and the closure
flap are of laminate construction of a known type in which an aluminum
foil is faced on its interior side with a polyolefin film such as
polyethylene film. The laminate can vary in thickness from about
3 to about 5 mils and preferably from about 3.5 to about 4.5 mils.
Retainer base panel 30 is provided with an extension panel 38 which
is adhesively secured to the undersurface of closure flap 45 such
that when the closure flap is pulled open, it will not readily completely
separate from package 40 where it might otherwise litter the operating
area. To remove an armed suture from opened suture package 30 the
shank of a needle is grasped by a needle gripper and pulled away
from the package, usually in a direction which is more or less in
the plane of the package.
Outer breather package 50 (FIG. 5) can be of known and conventional
structure in which a gas-impermeable clear plastic sheet is heat
sealed around its top and bottom edges 51 and 52 and its longitudinal
edges 53 and 54 to a gas-permeable but sterile-secure backing sheet
such as a web of spun-bonded polyolefin fiber, e.g., DuPont's Tyvek.
In an improvement in this type of breather pouch which is especially
suitable for use with the present invention, the fibrous backing
sheet is provided with a strip of release agent, e.g., of a water-based
adhesive which dries to a non-tacky finish, along its longitudinal
edges which effectively eliminates the possibility of fiber-pull
in the sheet when the clear plastic sheet is stripped away. Thus,
as the top seal is peeled apart, the release agent along the longitudinal
edges facilitates opening of the package and substantially eliminates
the possibility of fiber-pull along the longitudinal edges by providing
a pull-force which is substantially less than the force required
to separate the fibers in the backing sheet from themselves. Also,
as a result of the application of the release agent to the longitudinal
edges, the pull force at the top and bottom seals required to separate
the plastic layer from the fibrous backing sheet is slightly greater
than the pull force required to separate the two layers at the side
edges. Thus, after the initial pull separates the sheets at the
top seal, it is easier to open the rest of the package by pulling
the sheets apart since the force required to separate the sheets
at the longitudinal edges is less than the force required to separate
the initial top heat seal.
The improved breather pouch can be manufactured on an apparatus
which feeds a web of fibrous backing material, e.g., Tyvek, having
at least two continuous longitudinally directed strips of release
agent material applied thereon at regular intervals starting at
the first edge of the web and terminating at the second longitudinal
edge. The apparatus feeds the web of Tyvek material and a web of
plastic material, preferably polyethylene, to a position to enclose
suture packages placed in rows between the plastic and Tyvek layers.
This assembly is then fed to a heat seal device which simultaneously
provides transverse and longitudinal heat seals to seal the suture
packages between the two layers. Preferably, the plastic web is
vacuum formed to provide recesses or pockets to accept the suture
packages thereon. The Tyvek then overlays the plastic and suture
packages and the heat seal device seals about the recesses. Alternately,
the release agent material may be positioned in longitudinal strips
between the tyvek and plastic layers prior to the heat sealing step,
so that the heat seal is through the release agent between the two
layers of material. It is preferred, however, that the release agent
material be applied directly to the Tyvek layer.
A heat seal platen is applied to the webs to form the seals for
adjacent packages. The assembly is then advanced to a cutter mechanism
which cuts the pouches just below the transverse seal to form the
bottom of one package and along the longitudinal seals, while ensuring
that the top edge seals of the individual packages include the gripping
tab formed for each package which facilitates separation of the
plastic layer from the Tyvek layer to open the pouch.
It will be thus seen that the objects set forth above, among those
made apparent from the preceding description, are efficiently attained,
and since certain changes can be made in the above construction
and different embodiments of the invention could be made without
departing from the scope thereof, it is intended that all matter
contained in the above description or shown in the accompanying
drawing shall be interpreted as illustrative and not in a limiting
sense. |