CA1098873A - Suture package - Google Patents

Abstract

A B S T R A C T

A surgical suture label having a needle protection flap permits direct dispensing of the suture. An envelope having a tearing notch and a tear angle guideline across the face of the envelope is also disclosed. When the envelope is torn from the tear notch along the guideline, the needle pro-tection flap is exposed for direct dispensing of the suture.

Description

8~3 The invention relates to a suture label which permits direct dis-pensing of the suture and to a tearable suture envelope that can be torn from a tear notch across the face of the envelope so as to expose the label. A
suture is a strand of material suitable for suturing, with or without an attached needle or needles, used for ligating or other surgical procedures.
It is important to provide convenience to the user and limit the risk of accidentally enclosing foreign items in the patient by llmiting the n~ber of e~traneous packaging materials associated with use of the product in the operating theater. A count is often kept to ensure that each item is accounted for and removed from the operating field. Considering the ramifica-tions of enclosing such material in the patient accidentally during surgical procedures, it is obviously essential to minimize this hazard.
It is essential that a package containing a surgical needle or needles, protect the suture from contact with the sharp point or cutting edge of the needle which could partially cut the suture or the package. Also the armed needle edges and points need to be protected so as to maintain their sharpness.
Generally, the prior art discloses a surgical suture or sutures packaged in a plastic or foil strippable envelope. Contained in the stripp-able envelope is an inner evenlope or pouch, which is sterile. The suture strand has been formed into various configurations of coils and loops, con-tained in or on various retainers, labels, or reels, within the inner envel-ope. The suture is normally prepared for the surgeon by stripping the outer envelope and transferring the inner envelope by s~erile forceps, or by pro-jecting it across a sterile barrier, into the sterile areas of the operating roomO The inner envelope is opened at the time of use.
According to the present invention there is provided a direct dis-pensing surgical suture label comprising a back panel; a strand cover flap adjacent said back panel; two side flaps adjacent opposite sides of said back panel containing inner and outer score lines and a needle retention slit; a 38~'3 label cover flap having rounded corners adjacent said back panel and opposite said strand cover flap; a needle protection flap adjacent said back panel and said label cover flap having rounded corners and having a diagonal cut adjacent said label cover flap forming a notch between said needle protection flap and said label cover flap; whereby when said strand cover flap is folded over said back panel and said side flaps are folded over said strand cover flap and a surgical suture strand is contained between said back panel and said strand cover flap with the end of said surgical suture placed over and in said needle retention slit and said label co~er flap and said needle protection flap are folded over said side flaps such that when said needle protection flap is lifted, the end of said surgical suture in said needle retention slit is directly dispensed from said label.
The suture label may have locking slits on the outside edge of said label cover flap, and the adjacent edge of said back panel and said strand cover flap.
According to another aspect, the present invention provides a suture package consisting of a sealed envelope having a tearing notch and a tear angle guideline and enclosed therein a direct dispensing surgical suture label as set forth above, and in which said needle protection flap is adjacent to the tear angle guideline of said envelope such that when said envelope is opened, said flap is exposed.
According to a further aspect, the invention provides a double envelope suture package comprising a strippable outer envelope containing the sealed envelope described above.
The inner envelope and label of the present invention have advan-tages over the prior art. After tearing the inner envelope oE the present invention, the label is exposed. The label can then be used for direct dispensing without extracting i~ from the inner envelope. Access ~o the suture is provided from the label by a needle protection flap which is lifted after tearing the inner envelope.

3t73 Because the inner envelope and label remain together after opening, the proliferation of packaging materials within the immediate area of the operation or other surgical procedure is reduced. Further, besides direct access to the suture with or without needles, the suture is oriented within the label and inner envelope to allow immediate use when grasped by the needle holder or by hand. This is a desired operating room and surgical procedure technique, as it reduces the amount of time between extracting the suture from the label to its actual use as a suture. Still further, in most operations and surgical procedures, the materials used for the operation or surgical procedure are counted subsequent to the operation or surgical procedure. The label and inner envelope of the present invention provide a readily identifiable and countable package. Finally, the size of the needle and the type of suture strand can be printed on the inner envelopeO This provides ready identification in a surgical procedure where more than one size and type of suture is used. The possibility of a mix-up in the sizes and types is also reduced because the suture is directly dispensed from the label contained in the inner envelope.
Figure 1 shows a peelable outer envelope containing ~, :

l a tearable foil inner envelope7 Figure 2 show~ the tearable inner snvelopo ia po- :
sition for use;
Figure 3 shows the inner.envelope being torn expos-ing the needle protection flap of the label;
Figure 4 shows the fully torn inner envelope and the fully opened needle protection flap exposing a needle;
Figure S deacribes one embodiment of the u~e of the direct di~pen~ing package by removing the needle with needle holders;
Figure 6 is a ront view of the suture label; ~:
Figure 7 shows the strand cover flap folded over the back panel of Figure 6;
Figure 8 shows the insertion of the suture strand in~o the label and the side flap~ folded over the strand cover flap of Figure 7;
Figure 9 ~hows the po~itioning o the ~uture in the ~ide flap needle retention slit; .
Figure lO de~cribes the label cover ~lap and the needle protection flap folded over the ~ide flaps of Figure 9.
The present suture label isl and remains, as a single piece within the inner envelope. In the preferred embodiment, the inner envelope which encloses and protects the suture in its label is notched and its around the label so that it may be breached starting at the notch and torn open at the approp-riate angle in~icated, without ~earing the envelope into more than one piece. The needle protection flap of the label i8 exposed during the tearing operation. The needle protection flap may be lifted with the hand or with the needle holder, expoaing the needle in its correct orientation. The needle is 3~73 1 gxaeped with the hand or nesdle holder and pulled gently and evenly, dispensin~ the ~uture. The pre~0nt inventlon, and it~ advantages are al~o apparent from detailed de~criptions of certain embodiment~ thereof which follow.
The five or ~ix panel cover i~ designed to protect the strand and envelope from damage by the needle. A notch and ~lit~ are ~peci~ically located, between the label cover flap and the needle protection flap, an~ on the ~ide ~lap~, re~pectively. The ~ize and orientation of the notch and ~lits aa~ist to hold the needle in proper orientation, and to aid the gra~ping and the dispensing of the needle with needle hol~er~.
The label is preferably of a sterilizable paper, of about 90 lb. weight, capable of withstanding alcoholid solu-tions, heat~ steam, ~a~, or radiation sterili~ation withoutadverse effect~. The paper may be coated with about 1/2 mil polyethylene so it is heat ~ealable. Such paper i~ known in the trade and i~ readily available~ Sealin~, if desired, may be by heat dies, or heat may be internally generated by ultra-~onic mean~.
An important aspect of the pre~ent inventlon is hav-ing a tearabl~ foil envelope that can be torn from a tear no ch acros~ the face 80 as to expose the labal, wikh part of the label being li~ted to permit direct dispen~ing of the suture -- that i8, the suture, usually with a needle, may be pulled out of the label while the label remains in the envel-ope. Nots the tear notch i~ a~ Ruch a location that the label i~ retained in the foil envelope by an untorn aorner. Thls avoids clutter in the operating room, a~ the entire label, and package a~emblv, though torn, i8 in a ~ingle piece.

~L~9~ 73 1 The inner envelope and suture are both protected from armed ed~ee of the needle by the strand cover ~lap and the needle protection flap, re~pectively.
The prepared ~uture i9 ~hown in Figure lG. The eut~
ure i~ enclo~ed and sealed in a notched 21 inner envelope 25 which i~ shown in Figure 2. The inner envelope in turn i9 sealed in a ~trippabl~ outer envelope 31 shown in ~i~ure 1.
The inner envelope may conveniently be made of a moisture proof material such a~ a 25 lb., aalendered, bleach-ed, pouch paper laminated with about a 1/2 mil of polyethyleneto a metallic foil ~uch a~ about a 1 mil aluminum ~oil which is again laminated to 1 mil polyethylene as an inner sealabIe layer. Such material i~ esqentially moi~ture proof so that synthetic ab~orbable sutures such as tho~e of polyglycolic acid are protected from hydrolytic degradation. The same ma-terial may be used for the packaging o~ catgut ~uturee which are packaged with a desired quantity of alcohol solution to maintain pla~ticity. Some ~uture~, in which the moi~ture content iq immaterial may aleo be packaged in the ~ame material to maintain consi~tency of use and packaging tandarde.
Referring to Figure 1 r the outer envelope 31 is peeled off. Using the tearing notch 21 as a start the user may then open the inner envelope 25 by tearing the laminate longitudianlly along the dotted guideline 23 to ~top line 24 without detaching the torn portion 26. This action expo~e~
the needle protection flap 20 shown in Figure 3. Thi~ action ie enhanced by the size and shape o~ needle protection ~lap 20 in relation to the inner envelope. To aid the user in proper u~e of the package a tear arrow could be indicated on ~he dotted guideline 23.

..

1 Figure 2 3hows the inner envelope held in the po-sition for u~e with the peelable outer envelope discarded.
Figure 3 ~hows the availability to lift of the needle protec-tion flap 20 after the inner envelope 25 ha~ been torn. The torn portion 26 is not detached from the inner envelope.
Figure 4 ~how~ the needle protectio~ flap 20 folded back and the needle 30 being grasped by the needle holders 27 Figure 4 ~how~ part o~ tha label cover flap 1 with ~he needle protection flap 20 lifted expo~ing the needle 30.
The needle retention slit 15 in side flap 14 allow~ acces~
to the needle by the needle holder 27.
Figure 5 show~ the suture bei~g dispen~ed from the label package described in Figure 4. Due to the design char-acteristics, the suture label is securely locked within the opened portion of the envelop~ 25 and the entire package re-main~ intact. Thus no additional materials or articles other than the needle and ~trand are added to the operating area.
Related hazards are thu~ minimized and accountability is simp-lified.
Figure 6 shows a 3uture label cutout and scored from a sheet of sterilizable paper which may be coated with polyethylene for heat sealing.
As shown in Figure 6, the suture cover consists of a back panel 2 to which is attached respectively, by score lines 10, 11, a ~trand cOver flap 3, a label cover flap 1 and a needle protection flap 20. Side flaps 14 are attached by score lines 2~ to back panel 2. Needle protection 1ap 20 is separated from label cover flap 1 by notch 5 and attached by score line 11 to back panel 2. Needle protection flap 20 30 iB formed with rounded corners. Needle retention slit 15 38~73 1 anchors a needle of any size and shapa in th~ aorrect orien~
tatlon and po~ition b~tween th~ ~tr~n~ covax ~lap ~ and th~
~ide flap~ 14. Both ~ide flap~ contain a needle retentlon slit 15. The butt of the needle protrudes throu~h the needle retention slit 15 for direct dispen~ing by hand or by needle holder~.
Figure 7 ~how~ the preferred ~olding of the strand cover flap 3 over the back panel 2 and between the inner ~core lines 28.
Figure ~ ~hows side flaps 14 folded in position over strand cover flap 3 shown in Fi~ura 7. The end of straDd 29 iS al80 shown in the appropriate position after in~erting the strand into the label. The strand configuration can be any particular series of loops or coils that allow the strand to dispense freely withou~ tangling~ The relationsllip of the needled end of the strand to the rest of the coil is of no major ~ignificance.
Figure 9 show5 the proper positioning of the orien-tation of the butt of the needle 30 in one of ~heneedle reten-tion ~lits 15.
Figure 10 show~ the relationship of needle protec-- tion flap 20 to the label cover flap 1 and to the side flap 14. Further, Figure 10 shows the n~edle protection flap 20 folded over the needle thus pxotecting the inner envelope from damage by the butt end o~ the needle. The needle protection flap 20 also i~ an aid in keeping the needle properly oriented in the label durlng pro~essing or tran~it.

Claims (6)

1. A direct dispensing surgical suture label com-prising a back panel; a strand cover flap adjacent said back panel; two side flaps adjacent opposite sides of said back panel containing inner and outer score lines and a needle re-tention slit; a label cover flap having rounded corners adjac-ent said back panel and opposite said strand cover flap; a needle protection flap adjacent said back panel and said label cover flap having rounded corners and having a diagonal cut adjacent said label cover flap forming a notch between said needle protection flap and said label cover flap; where-by when said strand cover flap is folded over aid back panel and said side flaps are folded over said strand cover flap and a surgical suture strand is contained between said back panel and Raid strand cover flap with the end of said surgical suture placed over and in said needle retention slit and said label cover flap and said needle protection flap are folded over said side flaps such that when said needle protection flap is lifted, the end of said surgical suture in said needle retention slit is directly dispensed from said label.

2. A direct dispensing surgical suture label des-cribed in Claim 1 having a heat sealable coating.

3. A direct dispensing surgical suture label des-cribed in Claim 1 manufactured from stiff sterilizable stock.

4. A direct dispensing surgical suture label des-cribed in Claim 1 having locking slits on the outside edge of said label cover flap, and the adjacent edge of aid back panel and said strand cover flap.

5. A suture package consisting of a sealed envelope having a tearing notch and a tear angle guideline and enclosed therein a direct dispensing surgical suture label as set forth in Claim 1, and in which said needle protection flap is adjacent to the tear angle guideline of said envelope, such that when said envelope is opened, said flap is exposed.

6. A double envelope suture package comprising a strippable outer envelope containing a sealed envelope described in Claim 5.