US 3542345 A
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Description (OCR text may contain errors)
United States Patent 2,646,261 7/1953 Poirot  Inventor Arthur Kurls 259/128 Riverdale, New York 3,331,589 7/1967 Hammitt 259/116  Appl. No. 736,797 3,445,092 /1969 Fierle 259/114X  Filed June 1968 Primary Examiner-Robert W. Jenkins Patented Nov. 24, 1970 A" L d w S ff  Assignee Ultrasonic Systems, Inc. 0mey eonar um Plainview, New York a corporation of Delaware ABSTRACT: The invention relates to receptacles, both of the  3 2 SAME reusable and disposable type, that are constructed in a man- 49 Cl i 8 D ner to obtain a dispersion or mixture of liquid or liquids and rawmg solids, contained therein, to form suspensions. emulsions.  U.S.Cl. 259/114 and the like, under the influence of ultrasonic vibrations.  Int. Cl B0ll'll/02 The receptacle may be in the form ofa vial forming part ofa Field of Search 259/114, syringe ith associated interrelated arts whereby the con- Vibratol' S0niC,Vibrat0l' E163 tents of both syringe and vial, or vial alone, may be ultra- 123/215, 216, sonically mixed in the vial and then the vial contents aspirated 213, 219 into the syringe for administration of the syringe contents to a patient. The invention also discloses both the method and  References cued apparatus for transmitting to the vial the ultrasonic mechani- UNITED STATES PATENTS cal vibrations and the construction of the vial to properly 2,578,673 12/1951 Cushman 259/113X transmit same tothe materials contained therein.
ll/ 69 f2 1 45 /5\ 68 80 7/ /0 (r-\- 76 75 I \l a E iv A i 46 ci ema" 3 He :L 72 J/ 7 i 55 36 32 Z Lzl Patented Nov. 24, 1970 Sheet ATTORNEY .5 23 I v Q on wm w m m, mw Tlm- Q k QR mm A w fi m m 72% 5 W a R\ H; 7 NR 1 m BE WW Q. M Iii: if X H 1.. ll l A w r l'i Tall \i 5 A JLH |H||III I HIIH; \N m\ &\ nu d ETWQ QM NWE /\Qm W mm ,A "i k. m N\ @w W G Patented Nov. 24, 1970 Sheet 3 INVENTOR.
ARTHUR KURIS ATTORNEY ULTRASONIC vIALs AND METHOD A D APPARATUS FOR MIX NG MATERIALS IN SAME BACKGROUND OF THE INVENTION The present invention relates generally to improvements in mixing of materials whereby ultrasonic energy is utilized and more particularly to the construction of receptacles designed to transmit mechanical elastic vibrations from an exterior source to the interior thereof, as well as the method and apparatus for supporting the receptacle and transmitting the energy thereto.
The invention is useful in connection with a variety of shaped receptacles, whether or not of the disposable nature, and has particular useful application with respect to vials that may be used to contain amedication and test tubes for use in laboratory equipment and therefore will be primarily described in connection with such uses for purposes of illustration of the invention.
Heretofore, ultrasonic energy hasbeen proposed for use in mixing of liquid or liquids and solids to form suspensions, emulsions, and the like. The energy has been transmitted to the material to be mixed by either, passing the materials through a vibrating system, as for example, illustrated in US. Pat. No. 3,328,610, or immersing the vibratory transmission member within a beaker containing the materials to be mixed.
However, in spite of the apparent advantages of ultrasonic mixing, several drawbacks are present which until now have limited their use for certain applications. The principle objection has been the inability to properly mix materials in a sterilized condition, or once a medicament has been packaged in a vial no convenient method of ultrasonically mixing prior to use being available. Moreover, ordinary manual or mechanical mixing methods for vials now available are unable to produce the total dispersion necessary to provide a product approaching the original consistency 'and quality prior to injection into a human.
Another obstacle presented in the use of ultrasonic dispensing apparatus involves sanitation or contamination. Materials being mixed for laboratory and medical applications must be maintained sterile, but even when the greatest care is taken, as long as a common mixing member is used the material will remain on portions of the mixing member and will be subject to the effects of harmful bacteria. At the present time it is necessary to have the ultrasonic equipment manually cleaned at frequent intervals to maintain them in sanitary condition since the same equipment may be used for mixing a variety of materials.
OBJECTIVES OF THE INVENTION An object of the present invention is to provide an improved method and apparatus for ultrasonically mixing materials.
Another object of the present invention is to provide a novel ultrasonically actuated receptacle for rapidly producing an intimate mixture of a plurality of materials contained therein.
Another object of the present invention is to provide a syringe package containing one ormore medicaments that may be readily mixed with ultrasonic energy while contained in the Syringe package.
Another object of the present invention is to provide a disposable vial, the contents thereof may be ultrasonically mixed with'cavitational energy while the vial remains sealed prior to its use. t
Other objects and advantages of this invention will become apparent as the disclosure proceeds.
SUMMARY OF'THE INVENTION What I have conceived of is the ability to utilize ultrasonic ene gy, while maintaining the ingredients to be mixed in a sterilized condition, as by providing a receptacle in the form of a vial, for example, that is disposable such that once it is used it may be disposed ofin the m anner which is common practice today inmany disposable medical items especially those dealing with syringes. The ability to ultrasonically mix ingredients after being packaged immediately broadens the spectrum of medications that have the tendency of settling out after storage for prolonged period of time. By using the present invention it is possible'by either the doctor or his associate to apply ultrasonic energy to the vial such that, prior to its use, it is mixed and any settling out of theme materials is avoided. The equipment associated with the invention may be of the handheld type such that it is easily used, and may even be battery. powered such that the doctor may carry same in his bag at all times and have it available irrespective of the location where the medication is applied.
One embodiment of the invention includes a receptacle in the-form of a vial, which is commercially packaged and contains therein one or more ingredients that are normally stored for a given period of time prior to being dispensed therefrom. If the ingredient is in the form of a medicament the vial will generally have a closure at one end thereof which may be in the form of a rubber stopper, such that the seal therebetween is airtight. The vial has coupled thereto a mixing or transmission member which extends through a wall portion thereof, generally the bottom of the vial, and which is adapted to have high frequency vibratory energy coupled thereto and transmitted through the mixing member such that the portion of the mixing member extending within the vial is in contact with the ingredient and affects an ultrasonic mixture thereof.
Preferably the mixing member may be resiliently mounted with respect to the vial such that a liquid tight seal is obtained therebetween, as by providing an O-ring mounted along the length of the mixing member. To obtain maximum transmission of vibratory energy with a minimal of energy loss the resilient means may be positioned at a node of longitudinal motion of the frequency which the mixing member is vibrated.
In accordance with a preferred aspect of the invention the front section of the mixing member that extends within the vial chamber may contain a surface configuration adapted to engender a greater degree of vibratory motion to the ingredients therein. This is accomplished in part by increasing the surface area of the front section as by providing a series of radially extending rings in longitudinally spaced apart position i so as 'to provide an increased surface area. The mixing member may also be in the form of an acoustical impedance transformer that is designed to increase the amplitude of vibration from the input section, which is positioned exteriorally of the vial, to the front section which is contained therein.
ln-accordance with another embodiment of the invention a vial adapted to be ultrasonically vibrated in accordance with the teachings herein is provided in combination with a syringe package, that may also contain a medicament, such that one or more ingredients maybe mixed together while all remain in the sterilized condition. In this manner a vial in combination with a hypodermic needle and a container containing a medication are assembled together and while in this assembled relationship the ingredients may be mixed together in a vial and the ultrasonic energy applied to themixing member associated therewith.
BRIEF DESCRIPTION OF THE DRAWINGS Although the characteristic features of this invention will be particularly pointed out in the claims, the invention itself, and the manner in which it may be made and used, may be better understood by referring to the following description taken in connection with the accompanying drawings forming a part hereof, wherein like reference numerals refer to like parts throughout the several views and in which:
FIG.'] is a side elevational view, of an ultrasonic system and vial in accordance with-the present invention;
FIG. 2, is a side elevational view, partly in cross section, taken along line 2-2 of FIG. 1;
FIG. 3 is an end view, partly in cross section, taken along line 3-3 of FIG. 2; I
PREFERRED EMBODIMENT OF THE INVENTION The high frequency transducer means may be either in the sonic or ultrasonic frequency range but for purposes of the present invention the word ultrasonic will be used to denote vibrations in the range of approximately 5,000 to 1,000,000 cycles per second. In addition the term fvial" as used herein is intended to include any receptacle capable of retaining a quantity of material therein.
Referring to the drawings, and particularly with respect to FIGS. 1, 2 and 3 thereof, we have apparatus generally indicated by the reference numeral 10, for coupling and transmitting to the receptacle vial l5 mechanical vibratory energy in the ultrasonic frequency range. The necessary high frequency vibrations is produced by an ultrasonic motor 11, and as illustrated may be in the form of a driving member adapted for being handheld as by an operator 12, and generally comprising a tubular housing or casing 14 into which an insert unit 17 supporting the coupling member 13 may be partially telescoped. The ultrasonic motor 11 is energized by an oscillation generator 18, with a power cable 19,.connecting the two together. The generator is an oscillator adapted to produce electrical energy having an ultrasonic frequency.
The vial or receptacle includes a body portion 20, with energy transmission means 24 in the form of a mixing member 25 capable of supporting ultrasonic vibrations connected thereto by coupling means 27 to rigidly couple the mixing member 25 to the body portion 20 and transmit the high frequency vibrations to the contents or material 30 contained in the chamber 29 of' the vial and which may consist ofa liquid 31 and powder 32, or one or more liquids or powders. The body portion 20 includes a bottom wall'34 integrally formed with the mixing member 25 and a side wall 35 extending upwardly therefrom and terminating in a neck portion 36 forming a rim 37 which forms the opening 38 of the vial. A closure 40 is provided including a body section 41 extending into the opening 38 in tightly fitting engagementtherewith with a top portion 42 engaging the end surface 39 of the vial. An overseal 45 affords protection against accidentally dislodging the closure 40 when withdrawing the material 30 from the vial 15 by inserting a syringe through the overseal opening 46 provided therefore. The body portion 20 may be made of a plastic, paper, glass or metallic material, depending on the coupling means 27 used.
The mixing member 25 is comprised of an input or rear section 50 terminating in an end surface 51, and a generally smaller output or front section 52 terminating in a front surface 53, both of which sections may have the same or different cross-sectional areas and formed from a solid piece of material capable of supporting ultrasonic vibrations. The juncture of the two sections is provided with a rear radius 55 and a front radius 56 to permit the proper transmission 'of the high frequency vibrations without endangering the strength of the bottom wall 34 of the vial 15 as by creating critical stress concentrations.
The mixing member 14 may be in the form of an acoustic impedance transformer and may be a solid block of plastic, glass, or metal such as aluminum alloy or Monel, and made a half wavelength (or an integral number thereof) long at the frequency of vibration. The rear section 50 thereofcoupled to the coupling member 13, is of relatively greater mass than the from section 52, although it does not have to be unless an in crease in the amplitude of vibration is required. The transition region between the two sections of differing mass is generally located at approximately the nodal or quarter wave point along its length with each section being equal to a quarter wavelength. The difference in mass between the two halves of the mixing member 25 effect an acoustic impedance transformation which increases the amplitude of vibration at the front end 53 relative to the driven or rear end 51 in inverse ratio to their masses.
A more complete discussion of several forms of acoustic impedance transformer, that may be used with the present invention, may be found in U.S. Pat. No. Re. 25,033. and which acoustic impedance transformers are generally formed of a single piece of vibration transmitting material having a Iongitudinal length .L substantially corresponding to one-half wavelength of sound traveling longitudinally through the material of the mixing member 25 at the frequency of the vibrations which are to be magnified, and the transformer is composed of two parts, having substantially different crosssectional areas which are substantially uniform throughout the major lengths thereof, with the juncture between the two parts being constituted by a portion of variable cross section confined within a proportion of the total length of the transformer, and with the modal plane N, of longitudinal vibration of the transformerbeing the division between the input or rear section 50 and the output or front section 52 of substantially different mass so that the transformer is operative to modify the amplitude of longitudinal vibrations transmitted therethrough by virtue, at least in part, of a mass effect.
In a particular acoustic impedance transformer constructed in accordance with the above requirements for modifying the amplitude of vibrations transmitted longitudinally therethrough, the rear and front sections of substantially different mass may be defined by cylindrical portions having suitably different diameters, or by prismatic portions having different cross-sectional dimensions.
For the purposes of the present inventi n, it is sufficient to note that the application of a relatively small longitudinal vibration to the end 51 of the mixing member 25 will produce an amplified longitudinal vibration at its outer or free end 53, in the direction indicated by the arrow 60.
In accordance with the embodiment of the vial i5 illustrated in FIGS. 1, 2 and 3, the coupling means 27 is integrally formed with the bottom 34 of the vial and the mixing member 25 extends therethrough with the rear section 50 extending exteriorly of the body portion 20 and the front section 52 therein for engagement with the materials 31 and 32. As indicated above for ideal coupling of energy the junction between the sections is located at approximately a node N, of longitudinal vibration at the bottom 34 of the vial, but this is not essential since the mixing time is relatively short. It is appreciated that the mixing member 25 may extend through any wall of the body member 20 and that the bottom has been illustrated for matter of convenience. Since the mixing means 24 is coupled to the vial 15 during the manufacturing process, and may be disposable, it is sterilized at assembly and remains such even as the energy is transmitted thereto. The ultrasonic energy, at the proper level and intensity, can also kill bacteria and further insure the sterility of the contents thereof.
Once the vial 15 is ready for use it is coupled to the ultrasonic motor 11 and by a static force or physical securement the energy is transmitted thereto. If desired a tapped axially extending hole 61 may be provided in the rear section 50 to receive a threaded stud 62 from the coupling member I3.
The ultrasonic motor 11 may be one of a variety of electromechanical types, such as electrodynamic, piesoelectric and magnetostrictive, and designed for effecting mixing through hand directed tools of suitable configuration, which are readily replaceable or interchangeable with other work performing tools in acoustically vibrated material treating devices, may be of the type disclosed in U.S. Pat. Nos. Re. 25,033, 3,075,288, 3,076,904 and 3,213,537, and wherein each coupling or tool member is rigidly joined, in end-to-end .and in engagement with relationship to a. connecting body or acoustic impedance transformer and to a transducer which may form an insert unit or assembly which is removably supported in a housing containing a coil in surrounding relationship to the transducer and receiving alternating current for producing an alternating electromagnetic field.
The transducer in the ultrasonic motor 11 is longitudinally dimensioned so as to have lengths which are whole multiples of half wavelengths of the compressional waves established a therein at the frequency of the biased alternating current supplied so that longitudinal loops of motion occur at the end of the output surface 16 of the couplingmember 13. Thus, the optimum amplitude of longitudinal vibration and hyperaccclerations of coupling member 13 is achieved, and such amplitude is determined by the relationship of the masses of the coupling member 13 and insert unit 17 which maybe made effective to either magnify or reduce the amplitude of the vibrations received from the transducer. The coupling member 13 may be permanentlyattached to the end of insert unit 17, for example, by brazing, solder or the like, or the coupling member may be provided with a threaded stud adapted to be screwed into a tapped hole in the end of insert unit 17 for effecting the rigid connection of the tool to the stem.
Support means-65 may be provided to act as an anvil or clamp so that the vial may be compressed between the vibratory working surface and a support surface to assure a proper coupling of the energy thereto. The support means 65 includes a pair of legs 66 and 67 respectively, secured together at their lower end by' bands 68 and provided with gripping means in the form of individual lugs 69 that extend outwardly from the upper end of the legs for engagement by the fingers of the surgeon or operator 12 in a manner hereinafter described. The leg 65 has a lower extension 70 that may have a configuration as that of the vial 15 to provide a seat 71 (FIG. 3) therefore and which extension 70 terminates in a support arm 72 at substantially right angle to the extension 70 which has a support surface 73 in spaced relation to the working surface 16 of the coupling member 13 for engagement with the front end of the overseal 45. The support arm 72 may have a slot 75 as seen in FIG. 3, to permit the insertion of a syringe through the opening 46 in the'overseal 45.
The legs 66 and 67 are in spaced relation to each other and may be contoured to conform to the cylindrical configuration of the ultrasonic transducer housing 14. The generator 18 is connected to the transducer 11 by means ofcable 19 in a conventional manner. As seen in FIG. 2 the cable 19 may enter the ultrasonic motor 11 from the side so as to leave the rear end 76 free for engagement by the thumb or any other finger of the surgeon to permit manual control of the relative displacement between the overlapping working and support sur faces.
The support means 65 is mounted for relative movement, with respect to the ultrasonic motor 11 by providing a pair of slots 77 on each of the legs 66 and 67, and which slots accept headed fasteners 78 which extend from the casing 14 through the slots 77 to permit free relative movement between the ultrasonic motor 11 and support means 65. The lower end of the casing 14 is provided with an annular shoulder 79 which is adapted to receive spring means in the form of a spring 80 which is contained within the shoulder 79 at one end thereof the bands 68 at the opposite end thereof. The spring 80 applies a static force in the direction of arrow 81, so that the working surfaces of the support means and ultrasonic motor means are biased towards each other whereby a force applied by the surgeon is required to bring the overlapping working and support surfaces away from each other for the insertion of the vial 15 therebetween.
Thus, the spring'is coupled to the support and ultrasonic motor means so as to forcethem together with a predetermined static force which might be varied in a conventional manner not shown. In this manner once the static force is determined forthe particular length of vial 15 the resultant coupling force may be obtained. Accordingly, the spring means may yieldably urge the support means 65 and transducer means 11 relative to each other to a position wherein the working surface 16 is in engagement with the rear surface 51 of the mixing member 25 of the vial 15 under a predetermined static force, so that the support and transducer means are first separated for the placement of the vial 15 in position therebetween. In contrast to this the spring means may be ad justed such that the working and support surfaces are normally maintained in spacially fixed relation to each other, so that the vial 15 is first positioned between the surfaces which are brought together by the operation of the handheld instrument.
The working surface of the coupling member 13 is vibrated at an ultrasonic rate, as for example, in the frequency range of from 10 kc./s. to 200 kc./s, and preferably in the range of 20 kc./s. to 60 kc./s.. so as to apply an additional recurring force to mixing member 25 and produce a continuous transmission of ultrasonic vibrations to the contents thereof. The vibrational force has a substantial component of vibration parallel to the axis of the mixing member 25, as indicated by the arrow 60. The frequency of the ultrasonic rate of vibration is selected in the above frequency range so as to preferably also produce an optimum flow and mixture of the materials 31 and 32 in the vial 15. The energy is then continually applied until a complete dispersion of the material occur.
In operation the vial 15 is placed in coupling relation to the ultrasonic motor 11 for a selected period oftir'ne and the energy transmitted thereto. During the mixing operatiomthe contents 30, which is illustrated as a powder 32 and liquid 31 are engaged by the front section 52 of the mixing member 25 and the vibratory energy imparted thereto by the vibration of the transmission means 24, engenders cavitation in the liquid and consequent violent agitation thereof. In addition to the mixing effect, any gases entrapped in the materials are liberated and removed from the mixture. The reconstituted and degassed mixture then exits through a needle which is inserted through the closure 40 or the overseal 45 and c osure may be removed. The entire process is continued until a sufficient admixture of the materials is obtained which might be anywhere from several seconds to several minutes. The intense, concentrated energy imparted to the contents 30 permits the length of the front section 52 to be kept relatively short, while providing a suitably mixed product. The time for mixing is cor respondingly brief, and enables the device to be readily adapted to medical and other uses.
ADDITIONAL EMBODIMENTS OF THE INVENTION For certain applications, as illustrated by the vial assembly 15a in FIG. 4, the coupling means 27a is adapted to mount the mixing member 25a by acoustical mounting means 850 so that the vibratory motion transmitted through the mixing member 15a remains substantially isolated therein and is transmitted to the body portion 20. The acoustical mounting means a may include a resilient support member 86a which may be made out of rubber and due to its poor sonic transmission qualities there is negligible sonic coupling to the body portion 20a. The support member 86a is generally situated near the axial nodal point of the mixing member 25a, which is provided with an axial flange 87a which extends into a seat 880 in the form of an annular groove,'at the junction of the front section 520 and rear section 50a. The support member 86a may be moulded on the radial flange 8741 or placed thereover since it is of a rubber material, in addition it may be formed in two sections. The body member 20a may be provided with a neck portion 36a at each end thereof, integrally formed with the side wall 35a with an overseal 45a engaging the rim 37a and maintaining the closure 40a at one end and the support member 86a at the other end within the openings 38a to provide a fluid tight seal. The bore 89a through the support member 86a is selected to generally provide a clearance with the mixing member 25a.
The front section 52a of the mixing member 25a may be provided with means 90a for increasing the mixing surface area, and which may include a plurality of longitudinally mating portion of the coupling member if a threaded stud is not used. The vials or receptacles may take many shapes and range in size from less than an ounce to a gallon or moredepending on the end use thereof.
Thus, the front section 52a of the mixing member 25a may be provided with means 90a for increasing the ability of the mixing member totransmit the vibrations to the material 30a therein may include a plurality of spaced toothlike projections 91a disposed crosswise along the axial length of the front section to form annular shoulders spaced longitudinally apart to increase the surface area of the front section. This permits increase in the cavitational surface for obtaining a mixture of the materials 31a and 32a.
FIG. illustrates a vial 15b is similar in construction to that in FIG. 4, except that the front section 52b of the mixing member 25b is provided with a threaded portion 96b as the surface increasing means 9% to assist the mixing. The rear section 50b is shown as the same diameter as the front section 5212 such that no amplitude increase is relied upon, the radial flange 87b and the portion adjacent thereto may also be in contact with the support member 86b.
In accordance with another feature c of the present invention, a syringe'package 1000 for packaging, mixing and dispensing medicaments for use with an ultrasonic driving member is disclosed and has incorporated therein the vial 150 of the present invention such that the nurse or other medically trained person might subject the material 300 therein to ultrasonic energy without in any way affecting the sterile condition of the syringe package. Disposable syringe packages are well known in the art, as for example as illustrated in US. Pat. No. 3,336,924.
The entire syringe assembly 100s is supported by the support means 65c such that the rear section 50c of the mixing member 250 engages the coupling member 13c and the vial 150 forms the first container and is supported by the lower extension 700 terminating in the support arm 720 with the support surface 730 engaging a portion of the syringe assembly so that the static coupling force may be applied. The mixing member 25c may be integrally formed with the bottom wall 340 of the vial, or resiliently mounted as illustrated in respect to FlG. 4. The front section 520 may be of reduced mass, if desired, to increase the amplitude of vibration. By providing an axial bore 101a extending substantially the length of the front section 52c, this not only increases the mixing surface area but permits the needle to enter the vial without engaging the front section 520 and extending into the bore 101C to remove the material 30: contained therein.
The syringe assembly, as indicated in said US. Pat. No. 3,336,924, may include an assembly ofa hypodermic injection device or syringe 102c which forms the second container for containing a liquid or medicament 103a in any liquid, soluble powder or soluble solid forms. The syringe 102C comprises an outer cylindrical cover 105e, provided with a finger engageable flange 106e, telescopingly receiving the liquid container here designated as a barrel 107e, this barrel being provided with an outwardly directed flange 1080 and containing the liquid medicament or solvent 1030, a plunger 1106 having a thumb engaged button lllc thereon and a piston 1120 within the barrel, and a hollow needle 113c affixed for movement with the barrel and communicating with the contents thereof. In this manner the vial c is frictionally telescopically associated with the second container. The glass vial 150 is embraced by a protective cover 1150 and provided with a long neck 36c accommodating a rubber stopper 400, the rubber stopper having a shoulder 42c butting against the adjacent end of the neck. The vial cover is long enough to extend beyond while pressing down with the thumb onbut t'oril l 1c. The vial cover is held with the other hand asa matter ofprecaution although the frictional or other engagement o f thecover 115a with the syringe cover 1050 may be relied on to hold parts" together during initial operation of the syringe package, Initial pressure of the thumb causes the entire assembly within the syringe cover to move to the right, as viewed in FIG. 6, since the needle now is blocked against flow of material therethrough. As a result, the needle penetrates the stopper. Further pressure on the button results in expulsion of the bar rel contents through the needle and into admixture with the contents of the vial.
At the time one or both materials 30c and 1013c are in the vial 150 the vibratory energy is turned on and the ultrasonic mixing takes place for the period of time as required. Then tlie contents of the vial is aspirated into the barrel by withdrawing the plunger while holding the barrel against movement, as by proper manipulation of flange 1030 and button 1110. The vial cover 1150 may now be manually detached from the syringe cover 1050, and the hypodermic syringe then be used in a normal manner. Alternatively, the covers need not be disengaged from one another and the barrel 107C with the solution therein and plunger 1110c may be withdrawn from the syringe cover 1050 and utilized as a hypodermic syringe, the contents of the barrel being expelled through the needle by reasons of finger and thumb engagement of the flange I08" and button 1110 and pressure applied between the two.
FIG. 7 illustrates a receptacle 10d in accordance with the invention, which may be in the form of a test tube and include an elongated body portion 20d forming a chamber 29d therein with an opening 38d at one end thereof and an opening 12M at the opposite end of the side wall 35d.
The mixing member 25d has its rear section 50d extending exteriorally of the body portion 20d, and may be equal to a quarter wavelength, with the front section 52d being a multiple of quarter wavelengths and in communication with the chamber. The coupling means 27d may include a radial flange 87d on the'mixing member 25d with acoustical mounting means d in the form of a resilient O-ring support member 86d contained in (l-ring seats 118d and 119d provided respectively on the flange 87d and body portion 20d so that the vibratory energy remains substantially isolated therein and is not transmitted to the body portion 200'. The means d for increasing the vibratory mixing area of the front section 52d may include a plurality of outwardly extending spaced apart toothlike members 91d disposed crosswise along the front section.
FIG. 8, illustrates a receptacle 15e similar to the receptacle in FIG. 7, except that the mixing member 25:: has coupling means 27e associated therewith and designed to facilitate easy removal of the mixing member from the body portion 20e. The support member 86e engages the radial flange 87a which is provided at the junction of the rear section 50c and front section 52e and has an exterior thread 1212 which mates with corresponding threaded portion in the body portion 20c. A cap l22e having a threaded portion l23e engages a threaded portion on the bottom end of the body portion 20e such that when it is secured in place the support member 86s abuts the body flange 124a and is compressed thereagainst to form a liquid tight seal to seal off the opening 120e at the bottom of the test tube l5e. A closure 40e may be provided at the open end 38e of the test tube so that the contents thereof may be mixed while either in the vertical or horizontal position.
The front portion 52e of the mixing member 25e, which is essentially a treating member for the material it contacts, may
tion and provide a noncontamination surface. Since the receptacle might be stored for a prolonged period of time it is important that the mixing member positioned therein is not subject to erosion and possible contamination of the materials to be treated. In addition, if the receptacle assembly is used for prolonged periods of time the problem of cavitational erosion of the mixing member 25e must be considered since particles of the eroded member might be harmful if injected into a human and also spoil the purity of the material. Accordingly a very fine flash coating 1252 may be applied to the entire mixing member 25e, or only the front section 52c, of a thickness in the range of .0001 to .060. The coating may be of a noble metal such as gold, or silver, or a plastic coating such as teflon to provide uoncontamination.
CONCLUSION From the above disclosure, it is evident that the method and apparatus of this invention embraces an interrelated series of devices and instruments which can be advantageously employed for treating materials in various receptacles, both as to size and shape. ln-accordance with the invention we have a receptacle assembly that may be used once and disposed of used any number of t'imesflhe mixing member for certain applications may be integrally formed with the vial such that the vibratory energy may even be transmitted to the walls thereof to act as a means for increasing the vibratory surface. If desired the mixing member'may be acoustically mounted such that a minimum of vibratory energy is transmitted to the walls ofthe receptacle.
Although illustrative embodiments of the present invention have been described in detail herein with reference to the accompanyingdrawings, it is to be understood that the invention is not limited to those precise embodiments, and that various changes and modifications may be effected therein without departing from the scope or spirit of the invention, except as defined in the appended claims.
l. A receptacle, for use with an ultrasonic driving member in mixing a material, comprising:
A. a body portion including a chamber for containing the material;
B. a mixing member capable of supporting ultrasonic vibrations and adapted to be set into vibration in a given direction at ultrasonic frequencies by the driving member, said mixing member being provided with a from section for contacting the material in said chamber and a rear section for engagement with the ultrasonic driving member;
means for coupling said mixing member to said body portion such that said front section is in communication with said chamber arid-said rear section is engageable exteriorly of said body portion, wherein ultrasonic vibratory motion imparted to said rear section is transmitted to the material by said front section for obtaining a mixing thereof; and
D. means for acoustically mounting said mixing member such that the vibratory motion transmitted through said mixing member remains substantially isolated therein and is not transmitted to said body portion.
2. A receptacle as in claim 1, wherein said means for acoustically mounting said mixing member includes a resilient member mounted between a wall of said body portion and'said mixing member to support said mixing member without acoustically loading same.
3. A receptacle as in claim 2, further including means for retaining said resilient member in afixed position relative to said mixing member, said means including a member adapted to be threadably engaged with said body portion and simultaneously support said resilient member.
4. A receptacle as in claim 2, wherein said resilient member is in the form ofan -ring.
5. A receptacle as in claim 4, wherein said mixing member is provided with O-ring seating means about the periphery thereof for receiving said O-ring.
6. A receptacle, for use with an ultrasonic driving member in mixing a material, comprising:
A. a body portion including a chamber for containingthe material;
B. a mixing membercapable of supporting ultrasonic vibrations and adapted to be set into vibration in a given direction at ultrasonic frequencies by the driving member, said mixing member being provided with a front section for contacting the material in said chamber and a rear section for engagement with the ultrasonic driving member;
C. means for coupling said mixing member to said body portion such thatsaid front section is in communication with said chamber and said rear section is engageable exteriorly of said body portion, wherein ultrasonic vibratory motion imparted to said rear section is transmitted to the material by said front section for obtaining a mixing thereof; and
D. means for increasing the vibratory mixing area of said from section which includes an axially extending bore in said front section terminating at its front end.
7. A receptacle, for use with an ultrasonic driving member in mixing a material, comprising:
A. a body portion including a chamber for containing the material;
B. an opening in said body portion communicating with said chamber, and through which the material may be placed therein;
C. closure means sealing off said opening to the atmosphere;
D. a mixing membercapable of supporting ultrasonic vibrations and adapted to be set into vibration in a given direction at ultrasonic frequencies by the driving member, said mixing member being provided with a front section for contacting the material'in said chamber and a rear section for engagement with the ultrasonic driving member; and
E. means for coupling said mixing member to said body portion such that said front section is in communication with said chamber and said rear section is engageable exteriorly of said body portion, wherein ultrasonic vibratory motion imparted to said rear section is transmitted to the material by said front section for obtaining a mixing thereof.
8. A receptacle as in claim 7, further including means for increasing the vibratory mixing area of said front section.
9. A receptacle as in claim 8, wherein said means for increasing the vibratory mixing area includes a plurality of outwardly extending spaced apart toothlike members disposed crosswise along said front section contained within said body portion.
10. A receptacle as in claim 8, wherein said means for increasing the vibratory mixing area includes a threaded portion extending along the'ax'ial length of said front section.
11. A receptacle as in claim 7, further comprising means for securing said rear section to the ultrasonic driving member.
12. A receptacle as in claim 11, wherein said securing means includes a'threadably engageable portion in said rear section adapted to mate with a complementary threadably engageable portion of the ultrasonic driving member.
13. A receptacle as in claim 11, wherein said securing means includes a recessed engageable portion in said rear section adapted to matewith a complementary engageable portion of the driving member.
14. A receptacle as in claim 7, wherein said coupling means integrally joins said mixing member to said body portion.
15. A receptacle as in claim 7, wherein said coupling means is removably secured to said body portion to permit disengagement of said mixing member therefrom.
16. A receptacle as in claim 7, wherein said coupling means provides a liquid impervious seal between said mixing member and said body member.
17. A receptacle as in claim 7, wherein said mixing member is constructed ofa metallic material.
18. A receptacle as in claim 7, wherein said mixing member is constructed of a plastic material.
19. A receptacle as in claim.7, wherein said mixing member is coated to provide a noncontamination surface.
20. A receptacle as in claim 7, wherein the length of said mixing member is substantially equal to an even number of quarter wavelengths of the frequency of vibration imparted thereto.
21. A receptacle as in claim 7, wherein said mixing member is coupled to said receptacle at substantially a node of longitudinal vibration of the frequency of vibration imparted thereto.
22. A receptacle as in claim 7, wherein said mixing member is an acoustical impedance transformer designed to increase the amplitude of vibration from its rear section to its front sec tion.
23. A receptacle as in claim 7, wherein said closure means is adapted to have a needle extend therethrough and remove the material from within the chamber after the material has been ultrasonically treated.
24. A vial assembly, for use with an ultrasonic driving member, comprising:
A. a receptacle including a bottom wall, a side wall integrally formed therewith and terminating in a rim portion forming a first opening at one end of said receptacle and containing therein a material to be mixed, said receptacle including a second opening extending through said bottom wall; B. a closure sealing off said first opening of said receptacle; C. a mixing member extending through said second opening capable of supporting ultrasonic vibrations and adapted to be set into vibration in a given direction at ultrasonic frequencies by the driving member, said mixing member, 1. being of a length substantially equal to an even number of quarter wavelengths of the frequency of vibration imparted thereto, and
2. being provided with a front section for contacting the material in said receptacle and a rear section for engagement with the ultrasonic driving member;
D. means for coupling'said mixing member to said body portion at said second opening to provide a liquid impervious seal therebetween such that,
I. said front section extends within said receptacle and said rear section extends exteriorly of said receptacle, and
2. said coupling means is located substantially at a node i of longitudinal vibration at the frequency of'ultrasonic vibratory motion imparted to said rear section and transmitted to the material by said front section for obtaining a mixing thereof; and
E. said coupling means including means for acoustically mounting said mixing member such. that the vibratory motion transmitted through said mixing member remains substantially isolated therein and is not transmitted to said body portion, said acoustically mounting means includes a resilient member mounted between the bottom wall of said second opening and said mixing member withoutacoustically loading same.
25. A vial assembly as in claim 24, further comprising meansfor increasing the vibratory mixing area of said from section by providing an axially extending bore therein terminating at its front end, said bore being in axial alinement with said first opening to permit a needle inserted through said closure to extend within said bore to aspirate the material therefrom.
26. A vial assembly as in claim 24, further comprising means for securing said rear section to the ultrasonic driving member which includes a thread ably engageable portion in said rear section adapted to mate with a complementary llZ threadably engageable portion of the ultrasonic driving member.
27. An apparatus for packaging, mixing and dispensing medicaments, for use with an ultrasonic driving member, comprising:
A. a vial forming a first container and containing a medicament;
B. a stopper closing of the vial;
C. a second container containing a medicament and a hollow needle carried thereby to communicate with its contents;
D. means frictionally separately telescopically associating the vial and second container such that. upon telescopic movement, the hollow needle will penetrate wholly through the stopper;
E. means connected with the second container to engage the contents thereof to be expelled into the vial and to aspirate the contents thereof into the second container; and
F. said vial including energy transmission means coupled thereto and'extending within said first container capable of supporting ultrasonic vibration and adapted to be set into vibration in a given direction at ultrasonic frequencies by the driving member such that the medicaments contained in said first container may be ultrasonically mixed together prior to being aspirated therefrom.
28. An apparatus as in claim 27, further including means for acoustically mounting said energy transmission means such that the vibratory motion transmitted therethrough is not transmitted to the remainder of said vial.
29. An apparatus as in claim 27, further including means for increasing the vibratory mixing area of said energy transmission means contained within said vial.
30. An apparatus as in claim 29, wherein said means for increasing the vibratory mixing area includes a plurality of outwardly extending spaced apart toothlike members disposed crosswise along said energy transmiss on means contained within said vial.
31. An apparatus as in claim 29, wherein said means for increasing the vibratory mixing area includes an axially extending bore in said energy transmission means within said vial in axial alinement with said hollow needle, such that when said hollow needle penetrates the stopper it enters the bore.
32. An apparatus as in claim 27, further comprising means for securing said energy transmission means to the ultrasonic driving member.
33. An apparatus as in claim 27, wherein said energy transmission means is an acoustical impedance transformer designed to increase the amplitude of vibration imparted thereto by the ultrasonic driving member.
34. A method of mixing a material in the form of a medicament in a sterile condition contained in a receptacle having an opening with closure means sealing it off to the atmosphere and an energy transmission mixing member capable of supporting ultrasonic vibrations coupled thereto and partially ex tending within the receptacle to contact the material, comprising the steps of:
60 A. supporting the receptacle;
B. applying the output surface of a transducer member against the transmission mixing member of the receptacle to apply a compressive force thereto;
C. vibrating the output surface of said transducer in a direction and at an ultrasonic rate to transmit mechanical vibrations to the transmission member;
D. continuing the application of said compressive force and mechanical vibrations until a mixture of the material in the receptacle in its sterile condition is obtained;
E. inserting the needle of a syringe through the closure means; and
F. aspirating the mixture from the receptacle into the syringe for application thereof.
35. A method of mixing a material as in claim 34, wherein 75 said transmission member is an acoustical impedance transformer designed to increase the amplitude of vibration imparted to it by said transducer member.
36. A method of mixing a material as in claim 34, wherein said mixing member is constructed of a metallic material.
37. A method of mixing a material as in claim 34, wherein said mixing member is constructed of a plastic material.
38. A method of mixing a material as in claim 34, wherein the length of the mixing member is substantially equal to an even number of quarter wavelengths of the frequency of vibration imparted thereto.
39. A method of mixing as in claim 34, further including the step of increasing the vibratory mixing area of said mixing member contained in the receptacle.
40. A method of mixing as in claim 39, wherein said mixing area is increased by providing a plurality of outwardly extending spaced aparttoothlike members disposed crosswise along said mixing member.
41. A method of mixing as in claim 34. wherein the transducer member is secured in energy transmission relation to the mixing member by compressing them against each other.
42. A method of mixing as in claim 34, wherein said mixing member is vibrated in the range of 1,000 to 100,000 cycles per second.
43. A hand held instrument, for mixing a material contained in a receptacle having a mixing member capable of supporting ultrasonic vibration coupled thereto, with a front section extending within the receptacle to engage the material and a rear section engageable exteriorly of the receptacle, comprising:
A. a coupling member having an output surface thereof for contact with the rear section of the mixing member;
B. transducer means operative to vibrate said output surface of the coupling member at a high frequency of at least 5,000 cycles per second and low amplitude, having a component of motion in a direction substantially perpendicular to said output surface;
C. support means for retaining the receptacle in place during the transmission of the vibratory energy thereto, said support means having a support surface for contact with the receptacle; and
D. means for mounting said support means with respect to said transducer means in a manner to permit relative displacement of said output and support surfaces towards and away from each other for engagement of said output surface with therear section and said support surface of the receptacle for applying a compressive force thereto. so as to obtain a proper coupling therewith and transmis sion of the vibratory energy through the mixing member to the material contained in the receptacle. 44. A hand held instrument as in claim 43, further including spring means yieldably urging said support means and transducer means for relative movement with respect to each other to apply a static force to the receptacle.
45. A hand held instrument as in claim 44. wherein said relative movement is to a position wherein said output and support surfaces are normally in engagement with each other under a predetermined static force. whereby said support and transducer means are first separated for the placement of the receptacle therebetween.
46. A hand held instrument as in claim 44. wherein said relative movement is to a position wherein said output and support surfaces are normally maintained in spacially fixed relation to each other, whereby the receptacle is positioned between said surfaces and then brought together by the operation of the hand held instrument to transmit the vibratory energy thereto.
47. A hand held instrument as in claim 43. wherein said support means includes means for gripping the instrument by the hand of the user to permit manual control of the relative displacement between said opposed output and support surfaces.
48. A hand held instrument as in claim 47, wherein:
A. said transducer means is contained in a housing; and
B. said support means further includes a pair of spaced gpart legs on opposite sides of said transducer housing in ixed spaced re atton to each other wlth said gripping means extending from one end of said legs, and one of said legs at its opposite end terminating in a support arm containing said support surface. 49. A hand held instrument as in claim 43, wherein said coupling member is integrally formed with said transducer means.