US 3340869 A
Description (OCR text may contain errors)
Sept. 12,1967 A, BANE 3,340,869
COLLAPS IBLE AMPOULES Filed July 20. 1964 United States Patent 3,340,869 COLLAPSIBLE AMPOULES Arthur Bane, 25 Thurloe Court, Fulham Road, London S.W. 3, England Filed July 20, 1964, Ser. No. 383,777 Claims priority, application Great Britain, Aug. 8, 1963, 31,426/63; Dec. 16, 1963, 49,677/63 7 Claims. (Cl. 1282) The present invention relates to an ampoule in the form of a transparent, or translucent concertina-type collapsible bellows and which is provided or adapted to be provided at one end with a hypodermic needle so as to form a surgical hypodermic syringe and is also concerned with surgical hypodermic syringes embodying ampoules of this character.
One object of this invention is to provide an inexpensive, expendable ampoule which, having been pre-filled with a predetermined quantity of a medium to be injected and embodied in a hypodermic syringe, can be operated, after insertion of the hypodermic needle into a patient but prior to injection of its contents, to indicate whether the needle has punctured a blood vessel and should therefore be withdrawn and reinserted in a different position and/ or direction.
A further object is to provide an ampoule which is particularly well adapted for use in conjunction with a hypodermic needle for taking samples of body fluids.
With these objects in view, the concertina-type bellows of the ampoule according to this invention has two parts. One of these parts, which consists of one or more sections of the bellows, is designed to contain a predetermined quantity of a liquid medicament which will eventually be injected into the patient. The other part, which consists of at least one further bellows section, is designed to be used primarily for testing, after the hypo dermic needle has been inserted into the patients body but prior to injection of the liquid medicament, whether the hypodermic needle has been correctly inserted, i.e. whether it has or has not penetrated into a blood vessel to enable such testing to be carried out reliably and safely, one wall of the or each further bellows section is const-r-ucted so that firstly it has less structural stiffness against deformation under axial compression than the other end wall of the same bellows section, secondly it is collapsible under a predetermined axial compression force into an inverted fully collapsed position in which it lies close against the inner surface of the other end wall of the same bellows section and thirdly it has an inherent over-center bias which provides yielding resistance to initial displacement thereof out of the said inverted fully collapsed position in the direction to expand the bellows section of which it forms part.
In use, the said other part of the bellows is collapsed before the hypodermic needle is inserted into the patients body. During insertion of the needle, it remains in a stable collapsed condition due to its said inherent over-center bias. Next, in order to test whether the needle has been correctly inserted, the said one wall of the or each further bellows section constituting the said other part of the bellows is pulled out away from the other end wall thereof so as to apply suction through the hypodermic needle. If the needle has penetrated into a blood vessel, blood will be drawn by this suction into the ampoule and will be visible to the user through the translucent material thereof. If the needle has not penetrated into a blood vessel,
the user will observe that no blood has been drawn in. If this test shows that the needle has been incorrectly inserted, the needle must be withdrawn and reinserted at a different injection site where the test is again carried out. This procedure is repeated, if necessary, until the needle is shown to have been correctly inserted, whereupon the user applies sufiicient compression force to the ampoule to collapse all the bellows section, so that the liquid medicament will be discharged through the needle into the patients body.
The invention will now be described by way of example with reference to the accompanying drawings, in which:
FIG. 1 is a partly sectioned side view of a surgical hypodermic syringe embodying an ampoule which is shown in the fully expanded condition,
FIG. 2 is a fragmentary view of the ampoule of the same syringe with one bellows section collapsed,
FIG. 3 is a view corresponding to FIG. 1 of an alternative form of syringe ampoule, and
FIG. 4 is a partly sectioned side view of a sealed ampoule.
In FIG. 1 of the drawings, a needle unit, consisting of a hollow needle 1 fixed in a needle carrier 2, is shown engaged as a friction fit over the tapered end of a nozzle 3 on one end of a bellows-type ampoule 4. Integrally formed on the other end of the ampoule 4 is a stud 5 having a. neck 7 and a head 8.
The end section 9, 10 of the ampoule bellows is of larger diameter than the remaining bellows sections 11 and consequently is independently collapsible by applying against the end surface 12 of the stud 5 an axial force which is smaller than that required to collapse the said remaining bellows sections. Furthermore, the end section 9, 10 is so constructed and arranged that, under this smaller axial force, the wall 9 of the end section is resiliently deformed from the position shown in FIG. 1, past a dead-center position (not shown) into the collapsed position shown in FIG. 2 in which it lies in close contact against the inner surface of the wall 10. The wall 10 is structurally stiffer than the wall 9 and undergoes relatively little deformation during the collapse of the end section 9, 10.
To restore the end section to the expanded condition shown in FIG. 1, the user must pull the stud 5 in the direction away from the needle 1 until the wall 9 is deformed outwardly past its dead-center position.
The relatively greater deformability of the wall 9 as compared with the wall 10 may be achieved in various ways. For example, the wall thickness of the former may be made slightly less than that of the latter; or the wall 9 may be provided with one or more annular corrugations (not shown). When the wall 9 is invaginated, i.e. in the collapsed condition shown in FIG. 2, the base of the neck 7 together with the adjoining part of the wall 9 form, in effect, a plug which closes the orifice between the bellows section 9, 10 and the adjoining bellows section 11.
The end surface 12 of the stud 5 is slightly concave to receive the users thumb and the size and shape of the head 8 of the stud 5 are generally such as to provide a stable base for the syringe when stood needle upward upon a table or the like.
Suitable plastics materials for the ampoule 4 and stud 5 include nylon polymers, polyethylene, polypropylene and surgical grades of polyvinyl chloride. In some cases, anti-oxidants and/ or stabilizing agents selected in known manner according to the nature of the fluid to be injected may be incorporated in these materials.
In an alternative embodiment shown in FIG. 3, the end section 9', 10" of the ampoule bellows which is nearest to the stud 5 is of the same overall diameter as the remaining bellows sections 12, but is more easily collapsible than the latter by virtue of its smaller wall thickness. While in FIG. 3, both walls 9' and 10' of the end section are shown of reduced thickness, in a variant (not illustrated) the wall corresponding to the wall 10' is of the same thickness as the walls of the sections 12 and only the wall 9' is made thinner than the latter.
FIG. 4 illustrates a prefilled ampoule similar to that embodied in the syringe illustrated in FIG. 1, but having a removable sealing cap 14 fitted over the end of its nozzle 3.
The ampoule, when it is to be used for injection purposes, is preferably pre-filled with a predetermined quantity of the fluid to be injected. The pre-filled ampoules may be packed and supplied separately from the standard needle, in which case the nozzle 3 must be effectively sealed, for example by dip-sealing in a suitable material or by applying over it a press-fit sealing cap 14 (FIG. 4) which is subsequently removed and replaced by the needleunit 1, 2 immediately prior to use. Alternatively, the needle may be permanently affixed to the ampoule and packed as such, in which case the needle must be effectively sealed at least at its extremity by, for example, dip-sealing in a suitable material. This seal 15 (FIG. 1) is removed immediately prior to use.
In use as a hypodermic syringe, the unit is held by the needle carrier 2 and the stud is pressed in with the thumb to the position shown in FIG. 2, to exclude all air from the ampoule. The needle 1 is then inserted into the patent, after which the stud 5 is withdrawn.
This withdrawal movement will enable the user to observe whether a blood vessel has been punctured in a manner similar to that in the case of a conventional hypodermic syringe when the plunger is slightly withdrawn after the needle has been inserted. If blood is drawn into the syringe, it will be visible through the transparent or translucent wall of the ampoule 4. In that case, if intramuscular injection is required, the needle should be withdrawn and reinserted and the procedure repeated at a different injection site. Finally, after making sure in this manner that the needle has been correctly inserted, the user squeezes the ampoule 4 into the fully collapsed condition by thumb pressure against the plug 5 so that the required dose is discharged through the needle 1 into the patients body.
The syringe may be supplied to the user prefilled and with the section 9, collapsed.
While it is generally advantageous to arrange for only one section of the ampoule bellows to be collapsible independently of the others and for this section to be located at the end remote from the nozzle, two or more sections may be made independently collapsible and the independently collapsible section or sections may be located at the nozzle end or in an intermediate position along the length of the bellows.
The syringe according to this invention may be used for blood sampling. For this purpose, it is preferable for more than one bellows section to be independently collapsible and for the nozzle on the needle-supporting end of the ampoule to be located eccentrically. Furthermore, either the syringe may be supplied with the independently collapsible sections already collapsed, or these sections could be collapsed immediately before use. Then, to take a blood sample, the needle 1, from which the seal 15, if provided, has previously been removed, is inserted in a vein in the patients body. Next, the collapsed sections are pulled out creating a negative pressure within the ampoule so that blood is drawn into the ampoule. The needle is then removed and the ampoule is finally sealed, e.g., by fittting a plastics cap such as 14 (FIG. 4) over the nozzle 3 or heat-sealing its end. The sealed ampoule containing a sterile specimen of blood can now be sent to the laboratory.
The instrument can of course be similarly used for taking and storing specimens of other body liquids under sterile conditions.
1. An ampoule in the form of a translucent collapsible concertina-ty-pe bellows closed at one end and provided at the other end with a delivery and suction duct, said bellows comprising a plurality of bellows sections, each bellows section being defined by a pair of resilient end walls foldably joined together along a circumferential ridge and being foldably joined by at least one of its two end walls to an adjoining end wall of another bellows section along a circumferential valley and one end wall of at least one of said bellows sections having less structural stiffness to resist axial compression than the other end wall of the same bellows section and being collapsible under a predetermined axial compression force from an expanded position into an inverted collapsed position in which it lies close against said other end wall, and having an inherent over-center bias providing yielding resistance to initial displacement both out of said expanded position in the direction to collapse the bellows section of which it forms part and out of said inverted collapsed position in the direction to expand the said bellows section and push pull operating means on said closed end of said bellows.
2. An ampoule according to claim 1, wherein said one end wall also has less structural stiffness against axial deformation towards a collapsed position than the end walls of all the-other bellows sections.
3. An ampoule according to claim 2, wherein the said one bellows section is of larger diameter than the other bellows sections.
4. An ampoule according to claim 2, wherein the said one end wall is thinner than any other end wall of the bellows.
5. An ampoule according to claim 3, wherein the walls of all the bellows sections are frusto-conical and wherein said operating means comprises a stud.
6. An ampoule in the form of a translucent collapsible concertina-type bellows provided at one end with a mounting for a hypodermic needle, said mounting being formed with an interior duct for connecting the interior of said bellows to the interior of said needle, and at the other end with an operating stud, said bellows including a container portion located adjacent said ducted mounting and adapted to contain a predetermined quantity of a liquid medicament and a suction-producing portion located between said container portion and said operating stud and said suction-producing portion being collapsible under an axial compression force which is less than that required to collapse said container portion and having an inherent resilient bias yield-ingly opposing expansion thereof after being collapsed and collapse thereof after being expanded.
7. A sypringe ampoule comprising a translucent, accordian-pleated bellows, a push-pull operating stud provided on one end of said bellows, a mounting for a hypodermic needle provided on the other end of said bellows and formed with a duct for the passage of fluid between said bellows and said hypodermic needle, said bellows comprising a series of pairs of frusto-conical walls, the walls of each pair being foldably joined together at their bases to form a circumferential ridge and the adjoining walls of each two successive pairs being connected at their truncated open ends by a foldable joint forming a circumferential valley the wall adjoining the operating stud having less structural stiffness to resist axial compression than any other wall of the bellows and being deformable with an over-dead-center action between an expanded position and an inverted collapsed position in which it lies close against the inner surface of the other wall of the same pair.
References Cited UNITED STATES PATENTS 2,688,963 9/1914 Smith 128216 2,673,561 3/1954 Peterson 12 82l6 2,717,598 9/1955 Krasno l28--216 2,911,972 11/1959 Elinger 128216,
RICHARD A. GAUDET, Primary Examiner.
ROBERT E. MORGAN, Examiner.