US 3485352 A
Description (OCR text may contain errors)
Dec. 23, 1969 N. J. PILGER PACKAGE FOR STERILE MEDICAL CATHETEH 5 Sheets-Sheet 1 Filed Aug. l2, 1968 A TTOR/VEY Dec. 23, 1969 N. J. PILGER 3,485,352
PACKAGE FOR STERILE MEDICAL CATHETER Filed Aug. l2, 1968 3 Sheets-Sheet 2 A TTOR/VEY Dec. 23, 1969 Filed Aug. l2, 1968 N. J. PILGER 3,485,352
PACKAGE FOR STERILE MEDICAL CATHETER 3 Sheets-Sheet 3 Y els i 27 F/G. 8. 3,0 )s3/25 WIW Il l l 2 7 INI) y WW Il' lli' In j? wl lI '1| H I 25 nvvE/vron A TTR/VEY nited States Patent O 3,485,352 PACKAGE FOR STERILE MEDICAL CA'IHETER Nicholas J. Pilger, Thousand Oaks, Calif., assignor to American Hospital Supply Corporation, Evanston, Ill., a corporation of Illinois Filed Aug. 12, 1968, Ser. No. 751,827 Int. Cl. B65d 75/36, 79/00 US. Cl. 206-63.2 12 Claims ABSTRACT F THE DISCLOSURE A blister package for a flexible medical catheter, hypodermic syringe `and lubricant packet. The package has a plastic film member with a generally circular dish portion surrounded by a flange portion. The catheter is held in a large diameter coil by a series of posts near but spaced from the dish portion wall. A cover sheet pervious to sterilizing gases is sealed to the flange and to top surfaces of the posts. The circular dish portion, posts `and cover sheet keep the catheter from forming kinks or short radius bends regardless of how the package is stored or handled. In one version of the package, the flange portion provides legs whereby the package can be stored vertically on its end.
This invention relates to a package for an elongated flexible catheter used for draining urine from a patient, and particularly to a bubble or blister-type package for such catheter.
There have been problems in the past in packaging medical catheters. A catheter is long, about 16 inches, and must be kept sterile until the package is opened to remove the catheter. One previous method of packaging a catheter involved securing the catheter to a stiff cardboard strip and then sealing the catheter and cardboard strip between two elongated panels, one 'a transparent plastic and the other a paper with adhesive or coating. Just prior to use, these panels were peeled apart to gain access to the catheter, This package worked well for keeping the catheter sterile because sterilizing gases such as ethylene oxide could pass through the paper panel but bacteria could not.
This previous package, however, had disadvantages because it was so long (about inches long and 5 inches wide), and was thus diflicult to stack and store. Opening this package was tedious because the two panels had to be peeled apart over a long distance to release the catheter.
It was undesirable to shorten the package by bending the catheter about `a sharp radius at its middle. Even if this did not cause a kink in the tube, the catheter could take a set in this bent position when stored over long periods of time. Stresses set up in sharp bends could weaken a rubber or plastic catheter over a period of time. Also, just prior to insertion a forward end of a catheter is rolled in a bed of lubricant. A catheter with a kink or sharp bend is difficult to lubricate because the forward end flops about when the catheter is grasped at its other end and rolled. Therefore, any bend in the catheter should be kept at the largest possible radius to minimize these effects.
The package of this invention avoids sharp bends in the catheter and still considerably reduces the package length. The package has a transparent thermoplastic film member with a generally circular dish portion surrounded by a flange. The catheter is fitted next to the wall of the dish portion and is held in a generally circular coil by a series of posts spaced from but near the wall. This keeps the catheter from forming any sharp bends. Confining the catheter in this area is a sterilizing gas-pervious cover ice sheet which spans the dish portion, and is sealed to upper surfaces of the posts and flange.
This package which holds the catheter in a generally circular coil also has a place within the catheter coil for a packet of lubricant to aid in insertion of the catheter and a hypodermic syringe for inflating an elastic balloon on the catheter. All of these components are confined in a compact, easy-to-store package. In a modified version of the package, the flange has a construction whereby the package can stand upright on an end for vertical storage. Regardless of the position in which the package is stored or carried, the catheter is always confined in its large diameter coil by the dish portion Wall, the posts and the cover sheet.
The specific details of this invention will become more apparent with reference to the attached drawings, in which:
FIGURE 1 is a top plan view of a first embodiment of the invention showing the package with its cover sheet removed;
FIGURE 2 is an end elevational view of the first embodiment, showing the package lwith its cover sheet;
FIGURE 3 is a sectional view taken along line 3-3 of FIGURE 1;
FIGURE 4 is a sectional view taken along line 4-.4 of FIGURE l;
FIGURE 5 is a top plan view of a second embodiment of the invention, showing the package standing on its end and with its cover sheet removed;
FIGURE 6 is a side elevational View of the second embodiment showing the package standing on its end;
FIGURE 7 is an enlarged sectional view taken along line 7-7 of FIGURE 5; and
FIGURE 8 is an end elevational View of the second embodiment.
Referring to these drawings in detail, the first embodiment of the invention is shown in FIGURES 1-4. Here the package includes a transparent thermoplastic film member 1 of polyvinyl chloride or polypropylene which has a dish portion with a bottom 2 and a generally circular upstanding wall 3. An upper edge of this wall is integrally joined to a flange 4. Extending upwardly from bottom 2 are a series of posts 5, 6 and 7 which are near but spaced from the side wall 3. As illustrated in FIG- URE l, a flexible catheter 8 is held in a generally circular coil between the posts and the upstanding wall. This prevents kinks from forming in the catheter and still reduces the size of the package over packages where the catheter remains straight.
When a catheter is used on a patient, it is lubricated to reduce friction and pain as it is inserted into a urethra. The present package also provides a lubricant packet 9 which is confined to an inclined portion 31 of the dish portions bottom by a series of posts 5, 11 and 12. Thus, the lubricant packet -has an understanding edge 13 that can be readily grasped without contaminating other cornponents of the package.
Once the catheter is lubricated and inserted into the urethra, a balloon 14 on the catheter is inflated inside the patients bladder to insure the catheter stays in the urethra. This balloon is inflated by a hypodermic syringe 15 which is shown in the dish portion of the film member within a coil formed by the catheter. The syringe which is filled with sterile liquid is confined between posts 6, 11, 12 and 16 in the dish portion. A ledge section 17 abuts a plunger -18 of the hypodermic syringe and keeps it from working its way out of syringe barrel 19 during sterilization or shipping. Also, within the dish portion is a control card 20 to keep a record of the catheterized patient.
All of these contentsthe catheter, syringe, lubricant packet and control cardare confined within the dish portion by a cover sheet 21 sealed by an adhesive to flange 4. Preferably, the cover sheet is also sealed to top surfaces of the posts which are approximately level with the flange. This keeps the catheter from forming kinks regardless of how the package is stored-on its bottom, on its end, hung from hole 22 or upside down on its cover sheet. The cover sheet 21 is of a material pervious to sterilizing gases but impervious to bacteria such as du Ponts spun bonded polyolefin marketed under the trademark Tyvek. The combined film member 1 and cover sheet 21 keep the contents sterile until a nurse o1 physician grasps a portion of the cover sheet overlying notch 23 in the flange 4 and peels back the cover sheet to open the package.
' Turning now to a second embodiment of the invention shown in FIGURES -8, the dish portion 24 of the catheter package and its contents are identical to the embodiment of FIGURES l4. The flange structure, however, has been changed considerably over the first embodiment to permit the package to stand on its end as in FIGURES 5, 6 and 7. With certain storage shelves, this provides a saving in space.
In this embodiment there are two flanges, both of which are generally hexagonal in shape. A first flange 25 is integrally connected with an upper edge of the dish portions generally circular wall as in the first embodiment. A second flange 26 is spaced below the first flange and both flanges are connected together by a skirt 27. To give added strength to the package, the flanges 25 and 26 are farther apart at first end 28 than at second end 32, with the flanges converging toward each other as they approach second end 32, as shown in FIGURE 6.
At this first end 28, first flange 25 has a concave configuration where it joins to the skirt and hence provides two spaced apart feet 29 and 30, upon which the package can stand. As shown in FIGURES 6-8, the package with all its contents contained by cover sheet 33 can stand on its end while supported by the two feet 29 and 30 and the second flange 26. If desired, the package can also be hung in an upright position from a hanging hole 34.
In the foregoing specification, I have used specific embodiments to illustrate my invention. However, it is understood that persons skilled in the art can make certain modifications to these embodiments without departing from the spirit and scope of the invention.
1. A packaged medical catheter comprising: a thermoplastic film member including a dish portion with a bottom and a generally circular upstanding wall which has an upper edge, an external flange integral with the walls upper edge, and a plurality of posts in the dish portion, said posts being near but spaced from the generally circular wall; an elongated flexible catheter fitting between the generally circular wall and the posts; and a cover sheet sealed to an upper surface of the flange and extending across the dish portion to confine the catheter between the posts and wall, said cover sheet being manually peelable from the flange to gain access to the catheter.
2. A packaged medical catheter as set forth in claim 1 wherein the posts each has an upper surface approximately even with the flange and the cover sheet is peelably sealed to upper surfaces of both the flange and the posts.
3. A packaged medical catheter as set forth in claim 1 wherein the cover sheet is a porous member which is pervious to sterilizing gases but impervious to bacteria.
4. A packaged medical catheter as set forth in claim 1 which also includes a hypodermic syringe fitted within the dish portion, and the film member has means to limit axial extension of a plunger from a barrel of the hypodermic syringe.
5. A packaged medical catheter as set forth in claim 1 wherein the dish portion has an inclined portion in its bottom, and a lubricant packet is confined to this inclined 4 portion by a plurality of posts whereby an edge of the packet can be easily grasped.
6. A packaged medical catheter as set forth in claim 1 wherein the flange has a notch overlaid by the cover sheet to provide a place to' initiate peeling the cover sheet from the flange.
7. A packaged medical catheter as set forth in claim 1 wherein the' film member is of a transparent thermoplastic.
8. A packaged medical catheter comprising: a transparent thermoplastic film member including a dish portion with a generally circular upstanding wall having an upper edge and with a bottom having an inclined portion, an external flange integral with the walls upper edge, and a plurality of posts in the dish portion, said posts being near but spaced inwardly from the generally circular wall and having upper surfaces approximately level with the flanges upper surface; an elongated flexible catheter fitting between the generally circular wall and the posts; a lubricant packet on the inclined portion of the bottom; a hypodermic syringe in the dish portion within a coil formed by the catheter, said film member having means to limit axial extension of a plunger from a barrel of the hypodermic syringe; and a cover sheet pervious to sterilizing gases and impervious to bacteria spanning the dish portion and sealed to upper surfaces of the posts and flange to confine the catheter between the posts and generally circular wall, said cover sheet being manually peelable from the flange and posts to gain access to the catheter.
9. A packaged medical instrument comprising: a thermoplastic film member including a dish portion with a bottom and a surrounding wall having an upper edge, a first flange connected to the walls upper edge, a second flange spaced below said first flange, and a skirt integrally connecting the rst and second flanges together, said first flange having a concaved edge at one end of the film member where the first flange joins to the skirt, thus providing a pair of spaced apart feet at one end of the film member so the film member can stand on end supported by said feet and said second flange; a medical instrument within the dish portion; and a cover sheet spanning the dish portion and sealed to the first flange to confine the medical instrument wtihin the dish portion.
10. A packaged medical instrument as set forth in claim 9 wherein the surrounding wall is generally circular, the film member has a plurality of posts near but spaced inwardly from the surrounding wall, and the medical instrument is an elongated catheter which fits between the surrounding wall and posts.
11. A packaged medical instrument as set forth in claim 9 wherein the first and second flanges are spaced substantially farther apart at an end of the film member having said feet than they are at an opposite end of the film member.
12. A packaged medical instrument as set forth in claim 9 wherein outer edges of the first and second flanges are generally hexagonal.
References Cited UNITED STATES PATENTS 3,115,245 12/1963 Schechtel.
3,141,671 7/1964 Eyer 248-163 X FOREIGN PATENTS 1,400,304 4/ 1965 France.
JOSEPH R. LECLAIR, Primary Examiner I. M. CASKIE, Assistant Examiner