US 3030955 A
Description (OCR text may contain errors)
April 24, 1962 F. c. GossETT ETAL. 3,030,955
PLASTIC CONTAINER Filed 0G17. 8, 1956 76 5 85 77 INVENTORS ,C250 C. 6055577; EQOA/,0L A #AM/L 7' O/V, wfg @IgA/ys Uited States Pater 3,030,955 PLASTIC CONTAINER Fred C. Gossett, Glendale, and Donald A. Hamilton,
Burbank, Calif., assignors to Don Baxter, Inc., Glendale, Calif., a corporation of Nevada Filed Oct. 8, 1956, Ser. No. 614,561 14 Claims. (Cl.,128-272) This invention relates to a flexible plastic container for sterile, injectable fluids. The invention is particularly concerned with providing a resealable, leakproof, sterile entrance through which fluids can be easily added to or Withdrawn from the container.
Flexible plastic containers have numerous advantages over the glass containers now in use. There are serious probl-ems, however, in providing a means for withdrawing fluids from the containers. It has been suggested that the iiuid be removed by puncturing the wall of the container with the pointed connector of the administration set. Such a device may be dislodged from its place in the container, and it cannot be removed without leaving a large hole in the wall of the container. Moreover when the pointed connector is pushed through the wall of the container it may extend completely through the container and puncture the wall on the far side. Various entry devices have been suggested, but none of these are entirely satisfactory. Devices can be attached inside the container, or a neck can be built on the container so that a rubber stopper may be used, but such designs make it difficult to manufacture the containers economically, in large quantities, on standard filling machines. Entry devices, heretofore suggested for attachment to the outside of the container, require a rather large force to push the pointed connector through them. This becomes particularly disadvantageous when setups for intravenous injections are made by women, who sometimes do not have the strength to force the connector through the entry device.
It is the general object of this invention to provide a plastic container with an entry device which may be easily entered for the addition or withdrawal of lluids.
Another object of the invention is to provide a sterile, resealable, inexpensive entry device for a plastic container. A further object of the invention is to provide a plastic container entry device having visible indication that the unit has been sterilized.
A still further object of the invention is to provide an entry device which prevents puncture of the opposite container wall when a cannula is inserted through the .entry device.
Plastic containers of the present invention will be more fully understood from the description of the preferred form of the invention given with the accompanying drawings, in which:
FIGURE 1 is a plan view of the invention ready for use;
FIGURE 2 is a cross section of a portion of the invention with the administration set connector in place;
FIGURE 3 is a sectional View of the complete entry pad;
FIGURE 4 is a sectional view, partly in elevation, of the entry pad cap;
FIGURE 5 is a sectional view of a modification of the invention;
FIGURE 6 is a sectional view of a second modification of the invention;
FIGURE 7 is a sectional view of a third modification of the invention.
Referring now to FIGURES 1 to 4, the plastic container is generally indicated as 10. The container body 11, containing solution, may be made from an extruded, lay-iiat tubing which is heatsealed transverselyalong the lines 13 and 14. The heat-sealed end 14 is provided with a hole 15 which may be used to suspend the container on a hanger 16. An entry pad 17 is attached to the body .11. An administration set, generally indicated as 18, is attached to the entry pad 17 by the connector 19. The connector 19 is provided with a tapered spike 20, a piercing point 21, louvered openings 22 and a drip tube 23. The drip tube 23 extends into the drip housing 24 to which a ilexible tube 25 is attached. The tube 25 is provided with a clamp 26, a needle adapter 27, and a needle 28.
The entry pad 17 may be cemented to the wall 29 of the plastic container body 11. Alternatively, the flange 30 of the entry pad may be heat-sealed to the container wall 29. The pad 17 is provided with a tubular passage 31 having an annular ledge 32. A relatively thin section 33 of the pad is recessed to provide an index 33a to mark the area through which medication may be injected into the container by a needle. The ange 3'5 aids in holding the cap 36 iirmly in place on the pad 17. The pad 17 is made of an elastic material which is compatible with the container wall 29 so it can be cemented irmly to the wall. For example, the pad may be molded of a polyvinyl chloride plastisol.
The cap 36 is provided with a handle 37 to facilitate removing the cap from the pad without contaminating the passage 31 or stem 4t). The cap 36 has a relatively thin top 38 and shoulder 39 adapted to tit over the flange 35 of the entry pad. A stem 411 extends from the top 38 and is provided with a tapered boss 41 and a shoulder 42. The length of the stem 41B is slightly less than the passage 31 so that a space is left between the end 45 of the plug and the container wall 29. During sterilization, steam apparently displaces air from this space. On cooling, the steam condenses, forming a vacuum in the space and drawing the container wall 29 in to form a dimple 46 in the wall 29. The stem 40 supports the Walls of the passageway 31 thus preventing their collapse. Likewise, this vacuum pulls the plug 40 farther into the passageway 31 to form a cap dimple 47. The plastic of the container wall 29 and the cap top 38 apparently deforms sutliciently while warm so that the dimple remains after cooling. Since the formation of these dimples is due to the sterilization process, the dimples give visible indication that the unit has been sterilized.
The cap 36 is preferably formed of a exible material. The material, however, must be sufliciently incompatible with the material of the pad 17 to prevent the two parts from welding together during sterilization. The cap may be made of rigid material but in this case, the cap dimple 47 would not be stormed.
In use, the container is inspected for the presence of the dimple 46 or 47. Then the container wall 29 is grasped firmly around the base of the pad 17. The cap 36 is pulled off by the handle 37, carefully avoiding contamination of either the cap or the passage 31. The connector 19 of the administration set is forced into the passageway 311 and through the container wall at the dimple 46. The drip housing 24, which is preferably made of flexible material, is `filled by squeezing it to expel air into the container 10, then releasing it to draw iluid 12 into the drip housing. Clamp 26 is then opened to allow solution to iill the set 1S. A needle 2S is inserted into the vein of the patient and the administration started. When needed, sodium thiopental or other medication may be injected into the container through the thin portion 33 of the pad or it may be injected more directly into the patient through the rubber gland 43. If the drip housing 24 of the administration set becomes llooded with uid so that the rate of flow -from the drip tube 23 cannot be seen, the set and container are invetted `and the drip housing 24 squeezed to force solution 3 into the container and released to draw air back into the set.
In the modification of the invention shown in FIGURE 5 a cylindrical, plastic tube 48 is attached to the con# tainer wall 29 by the annular flange 49. A pressure proof cap 50 is provided with a handle 51 and a plug 52. The plug 52 has a central bore 53, so that pressure in the tube 48 forces the sides of the plug against the tube 48, and the annular groove 55 of the plug 52 firmly holds the annular boss 54 of the tube 48. This provides a pressure-proof cap which will not be blown off during sterilization and prevents collapse of the tube 48 by the vacuum of condensing steam after sterilization. During sterilization, the container dimple 46 forms, to provide a visible indication that the container has been sterilized. Alternatively, the tube 48 can be provided with a cotton plug or breather (not shown) to allow steam and air to pass freely in and out of the tube 4S. In this way, a pressure-proof cap is not needed, but the container dimple 46 would not be formed. Since steam and air can pass freely through the cotton plug, no vacuum would `form in the tube 48 thus preventing collapse of the tube 43.
In the modification shown in FIGURE 6, the entry pad generally indicated as 59 is attached to the container wall 60. The body 61, preferably made of a flexible material, is encased in a rigid outer collar 62. The rigid inner collar 63 is provided with a shoulder 64 in which a resilient self-sealing pad 65 is placed. The body 61 is provided with a neck 66 having a lip 67 over which the cap 36 (FIGURE 4) may be placed. The tapered passage 68, having a ledge 69, passes through the neck 66 and the upper part of the body 61, terminating at the upper surface of the pad 65. A passage 70 is provided in the inner collar 63 below the rubber pad 65. After sterilization, the container wall 60` is drawn into the passage 76 to form the indentation 71.
To assemble, the rubber pad 65 is forced into the inner collar 63 compressing the pad, and the body 61 slipped over the inner collar. The outer collar 62 is then forced over the body 61 compressing it against the inner collar 63. A cap 36 (FIGURE 4) is snapped over the lip 67. The assembled pad 59 is then cemented to the wall 60 of the solution container. The container is I-led and sterilized in an autoclave by steam under pressure. During sterilization the indentation 71 forms in the same manner as the dimple 46 (FIGURE 3).
In use, the cap 36 is removed and the needle 72 of an administration set (not shown) is forced through the self-sealing pad 65 and the indentation 71 into the passage 70. The cannula 73 is shorter than the distance from the top of the lip 67 to the container wall 60. When the' needle is removed, the resilient pad 65, which is compressed by the inner collar 63, seals around the needle hole. This type of entry pad is particularly useful for a blood container which must be filled with blood and then resealed. Such containers usually contain only the anticoagulant solution when marketed. The container is lled by blood through a donor set having a needle 72 for piercing the pad 65. Since the container has only a small amount of iliquid in it when the donor set needle is forced through the entry device, there is a danger of puncturing the opposite wall of the container. By use of the entry device shown in FIGURE 6i, this danger is avoided because the needle extends only into the area 70 and does not reach beyond this area into the container. Moreover, pressure on the container holds the opposite wall away from the indentation 71 and also holds the indentation 71 in place so it can be pierced by the point of the cannula 73.
In the modification shown in FIGURE 7, the entry pad 74 has a body 75 obliquely attached to the container wall 76 along the annular area 77. The body 75 is provided with a passage 78 closed by a rubber pad 79. The pad 79 is compressed by a rigid ring 80 and is held in 4 place by a ledge 81. The rigid ring 80 is held in the plastisol body 75 by an annular boss 82.. A second rigid cylindrical ring 83 compresses the body 75 against the inner ring 80. The body 75 is provided with an indentation 84 into which is drawn the portion S5 of the container wall.
In this design, a needile(not shown) passed through the pad 79, the passage 78 and wall 85 will not pierce the opposite container even if too long a needle is used.
1. A plastic container `for injectable fluids comprising: a layflat plastic body; an entry device heat-sealed to said body by a flange; a tubular passage through said entry device terminated by a portion of the body; a dimple in said portion of the body indicating sterilization of the container; a relatively thin portion of the entry device indexed for injection of medication; a lip on said entry `device adapted to hold a cap in position; a cap on said entry device; a handle on said cap; a plug extending from said cap into the passage, the length of said plug being slightly less than the length of said passage; and a cap dimple formed in the top of said cap indicating sterilization of the container.
2. A plastic container for injectable fluids comprising: a layat plastic body; an entry device on said body; a tubular passage through said entry device; a dimple in said body; a thin portion in the flexible entry device suitable for injection of medication into the container; a lip on said entry device; a cap on said entry device; a handle on said cap; and a plug extending from said cap into the plug passage, the length of said plug being slightly less than the length of said passage; and a dimple in said cap indicating sterilization of the container.
3. A plastic container for injectable fluid comprising: a layat plastic body; a cylindrical tube attached to the outside of said body; means for preventing collapse of said tube after sterilization; said means comprising a plug slightly shorter than said tube; and a portion of the lbody drawn into the base of said' tube to form a dimple; a thin exterior top on said plug; and a dimple on .said top formed by drawing the plug down into said passage.
4. A plastic container for injectable uids comprising: a layflat plastic body; a cylindrical tube attached to the outside of said body; means for preventing collapse of said tube after sterilization; said means comprising a plug shorter than said tube; and a portion of the body drawn into the base of said tube to form a dimple.
5. A plastic container for injectable uid comprising: a layat plastic body; an entry device on said body; a tubular passage through said entry device; a rubber pad between the ends of said passage closing same; a rigid member compressing said rubber pad; an enlarged area in said passage adjacent the'ibody; and a portion of the body drawn into said enlarged passage portion.
6. A plastic container for injectable fluids comprising: a layflat plastic body; sterile `solution in said body; an entry device on said body; a tubular passage partially through said entry device; a cap on said entry device; an enlarged'` portion of said passage adjacent the body; a portion of the body drawn into said enlarged passage portion and a hole through said portion of the body.
7. A plastic container for injectable fluids comprising: a layat plastic body; an entry device on said body; a tubular passage through said entry device at an oblique angle to the' body; an enlarged passage portion adjacent said body; and a portion of the body drawn into said enlarged passage portion.
8. A plastic container for injectable iluid comprising: a flexible plastic body; a cylindrical tube attached to the outside of said body; a plug slightly shorter than said tube inserted therein; a portion of the container body drawn into the base of said tube to form a dimple; a thin exterior top on said plug, and a dimple on said top formed by drawing the plug down into said tube.
9. A plastic container for injectable uids comprising: a flexible plastic body; a cylindrical tube attached to the outside of said body; a plug closing the passage of said tube; a space between said plug and the plastic body; and a portion of said body drawn at least partially into said space.
l0. A plastic container for injectable fluids comprising: a flexible plastic body; an entry device attached to said body; relatively rigid Walls on the entry device; an inner surface on said walls defining a passage; a rubber pad extending transversely across a portion of the passage and compressed by the rigid walls thereof; and the body extending continuously and imperforately across said passage and extending into a portion of said passage adjacent the plug.
ll. A plastic container for injectable fluids comprising: a flexible plastic body; an entry device attached to said body, the walls of said entry device defining a passage therethrough; a plug closing said passage; and the `body extending continuously and imperforately across the passage and extending into a portion of the passage adjacent the plug.
l2. A plastic container for injectable fluids as set forth in claim 1l wherein the entry device has relatively rigid walls and the body extending into a portion of the passage contacts the inner surface of said walls and the bottom surface of the plug.
13. A plastic container for injectable uids comprising: a iiexible plastic body having a wall; an entry device attached to said wall; a tubular passage through said entry device; means hermetically sealing said passage; a space between said means and the area at which the entry device is attached to the body wall; and the body walfl extending continuously and imperforately across said space and extending at least partially into said space.
14. A plastic container as set forth in claim 13 wherein the means sealing the passage is a thin diaphragm.
References Cited in the ile of this patent UNITED STATES PATENTS 2,072,853 Baxter Mar. 9, 1937 2,442,983 Nesset June 8, 1948 2,642,866 Smith June 23, 1953 2,702,034 Walter Feb. 15, 1955 2,838,046 Butler June 10, 1958 2,894,510 Bellamy July 14, 1959