Method And Apparatus For The Manufacture Of Surgical Pouches

Abstract

A disposable surgical pouch having a corrugated, chevron, rip open seal is disclosed comprising polyethylene front and backer pieces and a paper header, such pouches being made in a continuous strip from rolls of sheet polyethylene and paper.

Description

BACKGROUND OF THE INVENTION

This invention relates to surgical packages or pouches and apparatus for the manufacture thereof. More particularly, this invention relates to an improved seal for surgical pouches and a method for manufacturing pouches having that improved seal.

It has been found desirable in the past to pack surgical instruments in packages or pouches which may be easily opened during the course of an operation and from which the instrument may be removed without contamination. Specifically, at a central instrument supply station a pouch is provided in which a surgical instrument is placed and the pouch sealed. The instrument is sterilized while it is in the pouch so that the interior of the pouch is sterilized simultaneously. The pouch and instrument are then transported to the operating room. When it is desired to use the instrument during the course of an operation, the pouch is opened and the instrument removed. Preferably, the pouch should be capable of being opened in such a way that the instrument may be removed without contacting any exterior, perhaps nonsterile, surface of the pouch.

Various surgical pouches and methods of manufacture thereof have heretofore been proposed but they have had many weaknesses associated therewith. The pouches were often either relatively difficult to open or had seals which did not adequately protect the contained instruments from contamination. They were often of complex design or made of expensive material. Further, the apparatus for making such pouches was often crude and expensive.

SUMMARY OF THE INVENTION

A surgical pouch of polyethylene and paper is provided by this invention. A polyethylene front piece and a paper header are first heat-sealed together and the front piece is then heat-sealed to a polyethylene backer piece. The header and backer are then secured together using a tortuous, corrugated chevron-shaped seal. The pouches are made in a continuous strip from rolls of polyethylene sheeting and paper.

Accordingly, it is an object of this invention to provide a surgical bag having a seal which keeps the contents of the pouch sterile under normal conditions but which may be easily opened.

It is an object of this invention to provide a surgical pouch having a tortuous, chevron-shaped seal which will be easy to open at the desired time yet will maintain the sterility of its contents.

It is an object of this invention to provide a disposable package which is of simple design and construction.

It is an object of this invention to provide an apparatus for making a surgical pouch including machinery for forming a tortuous, chevron-shaped seal.

It is an object of this invention to provide a surgical bag which is of simple design and construction and can be made from inexpensive materials.

It is an object of this invention to provide a relatively simple and economical method for manufacturing surgical pouches.

Further and additional objects will appear from the description, accompanying drawings and appended claims.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a partial top plan view of a surgical pouch of one embodiment of this invention;

FIG. 2 is a partial side view of the surgical pouch of FIG. 1;

FIG. 3 is a partial cross section of the surgical pouch of FIG. 1 taken along the line 3--3 of FIG. 1;

FIG. 4 is a perspective view of an apparatus for making the surgical pouch of FIG. 1 in accordance with one embodiment of this invention; and

FIG. 5 is a detailed, partial perspective view of the chevron seal bar of the apparatus of FIG. 3.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to the drawings, and more particularly to FIGS. 1, 2 and 3, a surgical pouch or package 10 of the preferred embodiment of the present invention is there shown. The pouch 10 is comprised generally of a front 12, a header 14, and a backer 16, and has an insertion opening 18 at one end and a removal opening 20 at the other end. In a finished pouch, the removal opening area 20 is closed by a chevron seal 22, which will be described in detail later. The instrument to be packaged may be inserted into the pouch through insertion opening 18 which would then be heat-sealed shut. When it is desired to use the instrument, the pouch is opened at removal opening 20 and the instrument removed. Front 12 and backer 16 are preferably of polyethylene sheet and in one application a thickness of 0.004 inch has been found to be desirable. Header 14 is preferably made of paper and in one application forty-two pound surgical kraft has been found useful. The desired overall dimensions of the illustrated pouch are 7 inches wide by 13 inches long.

Backer 16 underlies the entire area of the pouch. Front 12 partially overlies backer 16 and is coextensive therewith and heat-sealed thereto by two side seals 24 and 26. Front 12 is preferably disposed on backer 16 so that the back extends beyond the front a short distance, perhaps one-half inch, at one end of the pouch to form a lip 28 and a greater distance, perhaps 4 inches, at the other end of the pouch to expose a header mating area 30 where the header 14 and backer 16 may be sealed at removal opening 20. Header 14 partially overlies both front 12 and backer 16. It is coextensive with front 12 and backer 16 along the sides of the pouch.

Header 14 is heat-sealed to front 12 at seal 32 along their area of overlap leaving a loose flap of header 34. Header 14 is additionally sealed to backer 16 at chevron seal 22 and side seals 36 and 38.

Chevron seal 22 forms an important part of this invention. It must be such that the pouch is sufficiently sealed to maintain required sterility, yet still be capable of being easily opened for removal of the enclosed sterilized instrument. In the preferred embodiment shown, the chevron seal 22 consists of four parallel V-shaped seal strips 40, 42, 44 and 46, separated by three parallel nonseal strips or ridges 48, 50 and 52. The header 14 and backer 16 are heat-sealed together at the V-shaped strips, but are not sealed at the ridges. As may best be seen in FIG. 3, header 14 may separate from backer 16 in the area of ridges 48, 50 and 52.

It has been found that the angle included within the chevron, indicated at 53, is critical and should be within a certain range in order to insure both proper sealing and the desired ease of opening. In the described embodiment, angle 53 should be in the range of 110.degree.-120.degree. and is preferably 114.degree.. The chevron-shaped seal additionally provides two triangular-shaped gripping portions 54 and 55. At these portions, header 14 and backer 16 are separately exposed so that they may be gripped and torn apart to open the pouch. Once the chevron seal 22 is broken, the bag is normally disposed of.

An apparatus 56 for making the above-described surgical pouches in accordance with the teachings of the present invention is disclosed in FIG. 4. It comprises generally two vertical end frames 58 and 60, a horizontal mounting frame 62 connecting the upper ends of end frames 58 and 60, and a control panel 64 affixed to a work table 66 which is suitably connected to end frames 58 and 60. Work table 66 additionally is supported by legs 68.

In end frame 60 various rolls are conventionally mounted on spools. Included are a roll 70 of backer polyethylene sheeting 72, a roll 74 of front polyethylene sheeting 76, and a roll 78 of header paper 80. Roll 70 has a width equal to the length of the finished pouch, while rolls 74 and 78 have widths equal to the lengthwise dimension of the front and header, respectively, of the finished pouch. The rolls are positioned on the spools so that sheets 72 and 76 and paper 80 will be properly aligned on work table 66. In a normal sequence, backer polyethylene sheeting 72 comes off roll 70, passes around a dancer roller 82, over a guide roller 84, underneath a subplate 86 and then down the surface of work table 66. Front polyethylene sheeting 76 comes off roll 74, over a dancer roller 87, over subplate 86, and then down the surface of work table 66 partially overlying back polyethylene sheeting 72. The header paper 80 comes off roll 78, passes under a roller 88 and over subplate 86 partially overlying front polyethylene sheeting 76, and finally down the surface of work table 66 further partially overlying back polyethylene sheeting 72. Subplate 86 is suspended above work table 66 so that sheeting 72 may pass between it and the work table. As back sheeting 72, front sheeting 76, and header paper 80 progress down work table 66 and through end frame 58, they are formed into a series of surgical pouches in a manner that will be hereinafter described.

The horizontal mounting frame 62 is comprised of rails 90 and 92 to which are attached a header-front sealing apparatus 94, a front-back sealing apparatus 96, and a chevron sealing apparatus 98. Electric eye apparatus 100 is attached to end frame 58. Apparatus 96 includes a pneumatic cylinder 102 mounted on crossbars 103, a piston rod 104 extending from the cylinder and connected to a piston (not shown) within the cylinder, and an H-shaped seal die 106 attached to one end of piston rod 104. Also connected to each side of seal die 106 is a guide tube 108 which extends around a guide rod 110 for reciprocal movement thereabout. Guide rods 110 are, in turn, firmly affixed to guide rod holders 112 attached to crossbars 103. Pneumatic and regulator lines 113 are connected to pneumatic cylinder 102. Die 114 of sealing apparatus 94 is in the shape of a straight bar while die 116 of sealing apparatus 98 is in the shape of a V. Each sealing apparatus is such that when the correct pneumatic pressure is applied through lines 113, the sealing die will move down toward work table 66, remain there for a predetermined time at a predetermined temperature and pressure to effect the desired seal, and then move back away from the product on work table 66. The sealing apparatus are all similar and function in substantially the same manner.

A drive apparatus, generally indicated at 118, is disposed within end frame 58. The drive apparatus includes a conventional electric motor having a variable speed V-belt drive 120 which is connected to a mechanism 122. Mechanism 122 is such that each time it is actuated a fixed length of polyethylene sheeting and header paper is drawn off rolls 70, 74 and 78 and down onto work table 66. A cutter 124 may also be included to separate the individual pouches from one another after they are formed.

Electric eye apparatus 100 controls the operation of the sealing apparatus 94, 96 and 98 and motor 120. When motor 120 is actuated, it draws the polyethylene and paper down the work table in predetermined lengths at discrete intervals. A small electric light source, not shown, is mounted in work table 66 so that it shines through polyethylene sheeting 72 and 76 and falls on the electric eye. The above-described heat sealing operations reduce the transparency of the polyethylene. Each time a sealed area passes over the light source, the amount of light falling on the electric eye is reduced. The electric eye 100, electric motor 120, and pneumatic lines 113 are interconnected at control panel 64 so that every time this occurs, the sealing apparatus 94, 96 and 98 and motor 120 are sequentially actuated in turn.

In alternative embodiments of this invention, either mechanism 122 or the electric eye apparatus 100 might be omitted. In the first instance, the electric motor 120 drawing the product down the work table would be stopped by the electric eye when the seal portions passed under the eye, the sealing assemblies actuated, and the motor restarted. In the second instance, mechanism 122 would draw off a predetermined length of product, the sealing assemblies actuated, and the process repeated.

The sequence of operation will now be described. As backer polyethylene sheeting 72, front polyethylene sheeting 76, and paper header 80 advance down work table 66, seal 32 is first formed by the action of die 114 on the header paper 80 and front polyethylene sheeting 76. Backer polyethylene sheeting 72 passes beneath subplate 86 and is not subjected to the action of seal bar 114. The front and backer sheeting then come together and die 106 forms side seals 24, 26, 36 and 38. Die 116 then forms chevron seal 22 between header paper 80 and backer sheeting 72 to complete the formation of the surgical pouches. In the operation of the machine, all die assemblies are actuated simultaneously, but the seals of an individual pouch are formed sequentially. The finished pouches then pass under photoelectric eye 100 and through drawing mechanism 122 and cutter 124. In some applications of this invention, it may be desirable to wind the integral surgical pouches onto a roll; in that case, cutter 124 may be omitted.

FIG. 4 shows a partial detailed view of die 116 used for forming the chevron seal. It includes a die surface 126 composed of four parallel bars 128 of equal width separated by three recessed areas 130, also of equal width. In one application of this invention, it was found useful to make the recesses 130, 0.006 inch deep and 0.0625 inch wide. The die was kept at a temperature of 380.degree. centigrade by running current through an electrical resistance wire included within the die (not shown). To form the chevron seal, the die was forced against the header paper with a pressure of 200 pounds per square inch for 0.6 second.

It is to be understood that the various component parts of apparatus 56 are conventional; invention is claimed to lie in their combination only. All the component parts are readily available and they have, therefore, been represented somewhat schematically.

It will be obvious that certain modifications of the specific embodiment shown may be made without departing from the spirit and scope of this invention. For example, different grades of polyethylene or other thermoplastic materials might be used for the front and back pieces, different configurations for the pouch might be desired, and various constructions for the apparatus could be used. It will be seen, however, that a surgical pouch and apparatus for the manufacture thereof has been provided which fully satisfy the above-named objects.

While a particular embodiment of this invention is disclosed above, it will be understood, of course, that the invention is not to be limited thereto, since many modifications may be made. It is contemplated, therefore, by the appended claims, to cover any such modifications as fall within the true spirit and scope of this invention.

Claims

I claim:

1. An apparatus for the manufacture of a disposable surgical pouch from a paper web and a plurality of webs of thermoplastic material comprising an elongate frame, a work surface associated with said frame, means at one end of said frame for supplying said paper and thermoplastic webs, means for drawing said webs from said supply means along said work surface, first sealing means for sealing said paper web to a first of said thermoplastic webs with a portion of said paper web extending beyond said first thermoplastic web, second sealing means for sealing said paper web portion to a second of said thermoplastic webs, third sealing means for sealing said first thermoplastic web to said second thermoplastic web, and means for controlling the operation of said sealing assemblies and said drawing means.

2. The apparatus of claim 1 additionally comprising a subplate disposed between said work surface and said first sealing means.

3. The apparatus of claim 2 wherein said control means is operative to alternately actuate said drawing means and said sealing assemblies.