US 3523530 A
Description (OCR text may contain errors)
United States Patent  Inventors John N. Pagones Sunland, California;
Elmer F. St. Amand, North Hollywood, California  Appl. No. 685,573
 Filed Nov. 24, 1967  Patented Aug. 11, 1970  Assignee American Hospital Supply Corporation Evanston, Illinois a Corp. of Illinois  NEEDLE ASSEMBLY FOR PARENTERAL LIQUID 2l4,2l4.2,215,2l6, 221,272
 References Cited UNITED STATES PATENTS 2,674,265 4/1954 Dennis l28/213X 2,866,457 12/1958 Moore 128/214 2,955,595 10/1960 Semple 128/214 20 I7 35 I6 l8 Primary Examiner Dalton L. Truluck Attorney- Larry N. Barger and Robert T. Merrick ABSTRACT: A blood bag with a donor tube having a needle assembly at its distal end. This needle assembly has a cannula with a sharpened forward end and an enlarged tubular adapter cemented to a rear end of the cannula. A soft thermoplastic housing that is not readily bendable to the adapter includes hub and protector sections that encase the adapter and cannula respectively. A pair of longitudinally spaced facing shoulders in the hub section abut ends of the adapter to mechanically lock the adapter against longitudinal movement relative to the hub section. When used to make a venipuncture, the protector section is broken off from the hub section of the housing at a frangible peripheral groove structure, located forward of both shoulders in the hub section. Thus, after the protector section is removed to expose the sharpened end of the cannula, the rear of the cannula and adapter are still firmly anchored in the hub section.
NEEDLE ASSEMBLY FOR PARENTERAL LIQUID CONTAINER This invention relates to an improvement in parenteral liquid containers commonly referred to as blood bags. These blood bags" normally include a flexible sac or bag with a donor tube for filling the bag with blood from a donor, and outlet ports for dispensing the blood to a patient. At an outer end of the doner tube is a needle assembly for making a venipuncture in the donors arm. It is to such a needle assembly that this invention relates.
It is of utmost importance to maintain the sterile integrity of a hypodermic cannula used to make the venipuncture. If the cannula is contaminated it could be dangerous to the blood donor and such contamination could also be washed into the blood bag and administered to the patient. To insure that the hypodermic needle is sterilely protected, this invention provides in the combination of a blood bag and a flexible donor tube, a cannula with a sharpened forward end, a tubular adapter connected to a rear end of the cannula, and a onepiece plastic housing encasing the cannula and adapter. The one-piece housing is not readily bondable to the adapter but has desired fiangible properties, and includes a hub section with longitudinally spaced shoulders abutting ends of the adapter to mechanically lock the adapter to the hub section. A frangible groove section in the housing, located forward of both shoulders of the hub section, provides a structure for breaking apart the hub end protector sections without destroying the mechanical lock between the hub section and the adapter. Immediately prior to use, the nurse checks to see if the protector section is still attached to the hub section of the housing. If the grooved section is broken, she has a visual indication that the donor needle is unsafe to use.
The donor needle assembly described above is intended to protect the cannula used to make the venipuncture in the donors arm. It has also been found that a second needle assembly of the same construction can be attached to the end of a branch tube joined to the donor tube between the blood bag and donor needle assembly. This second needle assembly, called a sampling needle assembly, is used for taking blood samples as blood is drawn from the donor. Such samples taken directly from the donor tube are necessary for certain tests requiring samples of blood which have not been mixed with the anticoagulant solution in the bag.
Perhaps the invention can be better understood with reference to the following drawings, in which:
FIGURE 1 is a front elevational view ofthe blood bag showing both the donor needle assembly and the sampling needle assembly attached to the flexible donor tube;
FIGURE 2 is an enlarged top plan view of the donor needle assembly;
FIGURE 3 is a sectional view taken along line 3-3 of FIGURE 2; and
FIGURE 4 is a sectional view taken along line 4-4 of FIGURE 2.
Referring in more specific detail to the drawings, FIGURE 1 shows the flexible blood bag 1 having at its top end a port structure 2 with donor (collection) tube 3 and dispensing spouts 4 and 5, which spouts have tear-off caps 6 and 7 protecting them from contamination. The bag has a hanging structure 8 at its bottom end for suspending the blood bag upside down when dispensing blood. On each side of the bag are loops 9, 10, 11 and 12 for retaining small test tubes used in collecting samples of blood from the donor tube.
The flexible donor tube 3 is integrally attached at one end to the bag and has a donor needle assembly 13 at its opposite end. The details of the donor needle assembly are best seen in FIGURES 2, 3 and 4. As shown in these FIGURES, the donor needle assembly includes a cannula l4 sharpened at its forward end. At its rearward end the cannula has a tubular adapter 15 of a rigid plastic such as Nylon cemented to the cannula. The tubular adapter has a narrowed tube-receiving section 16 at its rear which fits inside the flexible donor tube. Thus, the cannula's passage is directly connected through the tubular adapter to the donor tubes bore.
To sterilely protect the cannula and adapter is a one-piece thermoplastic housing 17 which has a hub section 18 and a protector section 19, respectively, fitting over the adapter and cannula. The hub and protector sections are joined together by a section with a peripheral groove 20 and the housing section can be between .010 inch and .050 inch thick at the groove but is preferably about .020 inch thick.
The tubular adapter supporting the cannula is rigidly held in the housings hub section. It is held against forward movement by a necked-down portion 21 inside the hub section near groove 20. The adapter is held against rearward movement by the donor tube abutting an external flange 22 on the adapter, because the donor tube is sealed to the inside of the hub section by a solvent seal or heat seal. Thus, the housing and donor tube, both of plasticized polyvinyl chloride, can be sealed together to amply lock in the adapter which, because it is of nylon, cannot be readily solvent or heat sealed to the hub section of the housing.
Inside the protector section 19 is another feature of the invention. As shown in FIGURE 3, the protector section has a chamber with a forward portion 23 that is approximately the same diameter as the cannulas outside diameter and fits tightly about the cannula. This forms an effective seal with the forward end of the cannula and keeps anticoagulant solution within the bag from leaking out of the cannula and filling the chamber encasing the cannula. This chamber in the protector section also has a rear portion 24 that is larger in diameter than the cannula to reduce frictional drag when the protector is pulled off the cannula preparatory to inserting the cannula in the donors arm.
When a nurse is ready to take blood from a donor, she grasps the hub section of the housing in the indented areas 25 and 26 with one hand, thus giving her firm control of the hub. With the other hand she grasps the protector section and twists it relative to the hub section. The longitudinal ribs 27 and 28 on the protector section keep her fingers from slipping on the protector section. After the protector has been broken apart at groove 20 and the protector removed, she then makes the venipuncture and begins withdrawal of the blood. Preferably, the hub section has its bottom surface 36 slanted so the hub fits closely to the donors arm when the cannula is in his vein. An indicator arrow 29 on top of the hub section shows the orientation of bevel 30 of the sharpened end of the cannula even when it is hidden from view in the donors arm. After blood begins to flow from the donor, the nurse can stop it at any time by closing clamp 31 on the donor tube.
The structure described above is sufficient for collecting blood. However, sometimes it is desirable to sample the blood from the donor before it gets into the bag and mixed with anticoagulant solution in the bag. Such sampling can be accomplished with the structure shown in FIGURE I. Here, a flexible branch tube 32 joins the donor tube at a Y-connector 33 positioned in the donor tube between the bag and donor needle assembly. On an outer end of the branch tube is a sampling needle assembly 34 which can have the same structure as the donor needle assembly. When an operator desires a sample, he shuts off clamp 31. Next, he breaks off the protector of the sampling needle assembly and inserts the cannula into a sample receiving test tube, usually through a puncturable rubber stopper in the test tubes mouth. When a sufficient sample has been collected, he can shut off the blood flow by closing off collar permanently secured to the cannula adjacent its rear end and a hollow housing fitting over the collar and cannula with a hub section and a protector section separable along a frangile circumferential groove, the improvement of: a pair of longitudinally spaced shoulders both of which are attached to the hub section and located rearwardly of the housings frangible circumferential groove, one of the shoulders being provided by an end surface of a tube bonded to the hub section of the housing, said retaining collar abutting said shoulders to firmly lock the collar and cannula from longitudinal movement, relative to the hub section after the protector has been removed by fracturing the housing at the circumferential groove.
2. The improvement in a hypodermic needle and protector combination as set forth in claim 1, wherein the retaining collar and hub section are of dissimilar materials that are not readily bondable together.
3. The improvement in a hypodermic needle and protector combination as set forth in claim 1, wherein said shoulder is formed by an end portion ofa flexible tube fitting within and bonded to the housings hub section, said flexible tube extending a substantial distance beyond the housing to conduct fluid to or from said cannula.
4. The improvement in a hypodermic needle and protector combination as set forth in claim 3, wherein the retaining collar and hub section are of dissimilar materials that are not readily bondable together.
5. A sterile needle assembly in combination with a flexible tube ofa blood bag donor assembly or the like comprising: an elongated, rigid cannula having a sharpened forward end;
i a rigid tubular adapter circumposed about and projecting rearwardly beyond the rear end of said cannula,
said adapter comprising a rigid plastic compatible to and being fixedly secured over the rear end of said cannula;
said adpater having an enlarged diameter intermediate portion defining forward and rear shoulders;
at flexible tube ofa relatively soft thermoplastic material incompatible to being sealingly connected to said adapter and being telescopically received on the rear end of said adapter and in abutting engagement with said adapter rear shoulder; and
a one-piece soft thermoplastic housing compatible to and being sealingly secured to said flexible tube and incompatible to being sealingly connected to said adapter,
said housing including a forward, closed sleeve portion sheathing said sharpened forward end of said cannula and integral with a rear portion circumjacent to and surrounding said flexible tube and adapter and sealingly connected to the tube of compatible plastic material,
said rear portion of said housing including a forward internal shoulder abuttingly engaging the forward shoulder of said adapter and mechanically interlocking the adapter and cannula against axial movement relative to the rear portion of said housing,
said housing including a reduced diameter, annular groove defining a frangible connection forwardly of the forward shoulder of said adapter and the mechanical interlock and being manually-severable to separate the forward and 5 rear housing portions without disturbing the mechanical interlock between the adapter and the rear portion of the housing,
said groove being substantially adjacent the forward end of said adapter whereby manual separation of the forward portion is facilitated,
said flexible tube projecting radially beyond the intermediate portion of said adapter and defining a shoulder there-at,
said housing rear portion having a rear, internal shoulder mechanically intergaging the rear shoulder defined by the edge of said flexible tube. 4
6. The structure as claimed in Claim 5 in which said adapter has an internal bore diverging rearwardly from the rear end of said cannula.
7. The structure as claimed in Claim 5 in which said housing forward portion includes an internal bore terminating rearwardly at said frangible connection and being sealingly circumposed about said cannula immediately to the rear of the sharpened forward end of the cannula, said internal bore diverging rearwardly from the seal to said frangible connection of said housing whereby manual twisting of the forward housing portion relative to the rear portion of the housing is facilitated and separation of the separated parts is promoted.
8. The structure as claimed in Claim 7 in which the rear portion of said housing includes opposed, laterally-indented finger grip portions to facilitate grasping during separation of the housing parts and positive positioning during introduction of the needle into a patients anatomy.
9. The structure as claimed in Claim 5 in which said adapter comprises nylon and said flexible tube and housing comprise plasticized polyvinyl chloride.