(19)
(11)EP 3 024 502 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
02.09.2020 Bulletin 2020/36

(21)Application number: 15831341.1

(22)Date of filing:  01.04.2015
(51)International Patent Classification (IPC): 
A61L 2/08(2006.01)
B23P 17/04(2006.01)
A61M 5/148(2006.01)
A61M 31/00(2006.01)
A61M 5/145(2006.01)
(86)International application number:
PCT/US2015/023747
(87)International publication number:
WO 2016/025035 (18.02.2016 Gazette  2016/07)

(54)

APPARATUS FOR DISPENSING MEDICINAL FLUIDS AND METHOD OF MAKING SAME

VORRICHTUNG ZUM VERTEILEN MEDIZINISCHER FLÜSSIGKEITEN UND VERFAHREN ZUR HERSTELLUNG DAVON

APPAREIL POUR DISTRIBUER DES FLUIDES MÉDICAUX ET SON PROCÉDÉ DE FABRICATION


(84)Designated Contracting States:
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

(30)Priority: 09.08.2014 US 201414455891

(43)Date of publication of application:
01.06.2016 Bulletin 2016/22

(73)Proprietor: Bioq Pharma Incorporated
San Francisco, CA 94107 (US)

(72)Inventors:
  • KRIESEL, Marshall, S.
    St. Paul, MN 55104 (US)
  • BILVIN, Donald, B.
    Oakland, CA 94618 (US)
  • KRIESEL, Joshua, W.
    San Francisco, CA 94107 (US)
  • WATTS, Richard, P.
    Morro Bay, CA 93442 (US)
  • TRENHOLME, Phillip, C.
    Santa Cruz, CA 95060 (US)

(74)Representative: Beattie, Alex Thomas Stewart 
Forresters IP LLP Skygarden Erika-Mann-Strasse 11
80636 München
80636 München (DE)


(56)References cited: : 
WO-A1-00/69492
WO-A1-2006/126902
US-A1- 2011 282 300
US-A1- 2012 209 195
US-A1- 2014 053 509
WO-A1-02/055140
WO-A1-2010/064074
US-A1- 2011 282 300
US-A1- 2014 053 509
  
      
    Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention).


    Description

    BACKGROUND OF THE INVENTION


    1. FIELD OF THE INVENTION



    [0001] The present invention relates generally to fluid dispensing devices. More particularly, the invention concerns a novel, compact fluid dispenser for dispensing medicinal fluids such as Bupivacaine to ambulatory patients. The fluid dispenser is specifically configured for use at the point-of-care and will allow drug or fluid infusion to be initiated during virtually any phase of care in any healthcare setting, and continue uninterrupted while en-route to other medical facilities or during rehabilitation.

    2. DESCRIPTION OF RELATED ART INCLUDING INFORMATION DISCLOSED UNDER 37 CFR 1.97 AND 1.98



    [0002] A number of different types of medicament dispensers for dispensing medicaments to ambulatory patients have been suggested in the past. Many of the devices seek either to improve or to replace the traditional gravity flow and hypodermic syringe methods which have been the standard for delivery of liquid medicaments for many years.

    [0003] With regard to the prior art, one of the most versatile and unique fluid delivery apparatus developed in recent years is that developed by Marshall Kriesel and described in U.S. Patent No. 5,205,820. The components of this novel fluid delivery apparatus generally include: a base assembly, an elastomeric membrane serving as a stored energy means, fluid flow channels for filling and delivery, flow control means, a cover, and an ullage which comprises a part of the base assembly.

    [0004] Another fluid dispensing device is disclosed in United States Publication No. 2005/0277884 that was published on December 15, 2005. This publication discloses a compact fluid dispenser for use in controllably dispensing fluid medicaments such as antibiotics, analgesics, and like medicinal agents from the device reservoir which is provided in the form of a novel bellows-type assembly. The fluid dispenser includes a unique stored energy mechanism which takes the form of a constant-force spring member of novel design that provides the force necessary to continuously and substantially uniformly expel fluid from the device reservoir. The device also includes novel adjustable flow rate control assembly that is disposed intermediate the fluid reservoir outlet and the outlet port of the device for precisely controlling the rate of fluid flow from the outlet port toward the patient.

    [0005] Still another fluid dispensing apparatus is disclosed in U.S. Patent No. 7,220,245. This apparatus comprises a compact fluid dispenser for use in controllably dispensing fluid medicaments such as, antibiotics, oncolylotics, hormones, steroids, blood clotting agents, analgesics, and like medicinal agents from prefilled containers at a uniform rate. The dispenser uniquely includes a stored energy source that is provided in the form of a substantially constant-force, compressible-expandable wave spring that provides the force necessary to continuously and uniformly expel fluid from the device reservoir. The device further includes a fluid flow control assembly that precisely controls the flow of medicament solution to the patient.

    [0006] US2011/0282300 A1 discloses a dispensing device and the method of making same for dispensing medicaments to a patient that includes a housing, a first assembly connected to the first end of the housing that includes a body portion, and a penetrating sub-assembly. The first assembly also includes a rate control chip of novel construction that is connected to the penetrating sub-assembly and functions to control the rate of flow of medicinal fluid to the patient. Disposed within the housing is a second assembly that includes a shuttle, a collapsible container carried by the shuttle and a plurality of variable force springs that function to thrust the collapsible container into penetrating engagement with the penetrating member of the penetrating assembly and then to collapse the collapsible container to deliver the medicinal fluid to the patient. Connected to the second end of the housing is a novel third assembly that includes an operating member that is threadably connected to the shuttle. The operating member functions to controllably move the shuttle forwardly of the housing. The apparatus also includes a novel locking mechanism that releasably locks the operating member against rotation relative to the shuttle.

    BRIEF SUMMARY OF THE INVENTION



    [0007] The invention is as set out in the appended set of claims.

    [0008] By way of brief summary, one form of the apparatus of the invention for dispensing fluids to a patient comprises housing and a first assembly connected to the first end of said housing that includes a body portion and a penetrating sub-assembly that is connected to the body portion. The first assembly also includes a rate control chip of novel construction that is connected to the penetrating sub-assembly and functions to control the rate of flow of medicinal fluid to the patient. Disposed within the housing is a second assembly that includes a shuttle, a collapsible container carried by the shuttle and a plurality of variable force springs that function to thrust the collapsible container into penetrating engagement with the penetrating member of the penetrating assembly and then to collapse the collapsible container to deliver the medicinal fluid to the patient. Connected to the second end of the housing is a novel third assembly that includes an operating member that is threadably connected to the shuttle. The operating member functions to controllably move the shuttle forwardly of the housing. The apparatus also includes a novel locking mechanism that releasably locks the operating member against rotation relative to the shuttle.

    [0009] With the forgoing in mind, it is an object of the invention to provide an apparatus of the character described that can be used for dispensing medicinal fluids in hospitals, surgery centers, home care, austere environments, and various other alternate sites of care. The fluid delivery apparatus is uniquely configured for use at the point-of-care and will allow drug or fluid infusion to be initiated during virtually any phase of care, in any healthcare setting, and continue uninterrupted, while en-route to other medical facilities or during rehabilitation.

    [0010] Additionally, the self-contained and therapy-specific nature of the fluid delivery apparatus functions to reduce the probability of costly and potentially life-threatening medication errors.

    [0011] Another object of the invention is to provide a fluid dispensing apparatus that can be used for controllably dispensing at a uniform rate a wide variety of fluid medicaments, such as Bupivacane, Ropivaciane, Propofol and like medicinals.

    [0012] Another object of the invention is to provide a fluid dispensing apparatus of the character described in the preceding paragraph in which the first assembly that includes the penetrating sub-assembly and the rate control chip and a portion of the second assembly that includes the collapsible container can be hermetically sealed and sterilized without adversely affecting the medicinal fluid contained within the collapsible container. Another object of the invention is to provide a fluid dispensing apparatus of the aforementioned character that is of simple compact construction and one that can be used by the military in the field and in the home care environment with a minimum amount of training.

    [0013] Another object of the invention is to allow infusion therapy to be initiated quickly at the point of care without the assistance of a medical professional.

    [0014] Another object of the invention is to provide a fluid dispensing apparatus of the character described in the preceding paragraphs in which the stored energy source is provided in the form of a variable force spring in which the force variation is achieved by modifying a constant force spring in a manner to controllably vary the cross-sectional mass of the spring along its length.

    [0015] Another object of the invention is to provide a fluid dispensing apparatus of the character described in the preceding paragraphs in which the stored energy source is provided in the form of a variable force spring in which the force variation is achieved by coiling the band portion of the spring about the spring drum in varying degrees of tightness.

    [0016] Another object of the invention is to provide a fluid dispensing apparatus of the class described which includes a fluid flow control assembly that precisely controls the flow of the medicament solution to the patient.

    [0017] Another object of the invention is to provide a fluid dispensing apparatus of the character described in the preceding paragraphs that embodies an integrally formed, aseptically filled, unitary semi-rigid collapsible container that includes a fluid reservoir that contains the beneficial agents to be delivered to the patient.

    [0018] Another object of the invention is to provide a fluid dispensing apparatus of the class described which is of a lightweight, small diameter construction and one that is reliable in operation.

    [0019] Another object of the invention is to provide a fluid dispensing apparatus that is easy and inexpensive to manufacture in large quantities.

    BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS



    [0020] 

    Figure 1 is a generally perspective view of one form of the apparatus of the invention for dispensing fluids to a patient.

    Figure 2 is a longitudinal cross-sectional view of the housing portion of the apparatus shown in Figure 1 of the drawings.

    Figure 2A is a cross-sectional view of the forward portion of the apparatus shown in Figure 2 of the drawings.

    Figure 2B is a generally diagrammatical view, similar to Figure 2A illustrating the step of E-Beam sterilization of the forward portion of the apparatus.

    Figure 3 is a generally perspective exploded view of the forward portion of the apparatus of the invention, including the administration set and illustrating the fluid flow path through the apparatus.

    Figure 3A is a generally perspective exploded view of the rear portion of the apparatus of the invention.

    Figure 4 is a cross-sectional view taken along lines 4-4 of Figure 2.

    Figure 5 is a cross-sectional view similar to Figure 2, but showing the locking assembly in an unlocked configuration to permit rotation of the operating assembly of the invention.

    Figure 6 is a fragmentary, cross-sectional view of the rear portion of the apparatus of the invention showing the locking assembly in a locked configuration to prevent rotation of the operating assembly of the invention.

    Figure 7 is a fragmentary, cross-sectional view similar to Figure 6, but showing the locking assembly in an unlocked configuration to permit rotation of the operating assembly of the invention relative to the shuttle assembly.

    Figure 8 is a cross-sectional view similar to Figure 5, but illustrating advancement of the shuttle assembly from the position shown in Figure 5 as a result of the rotation of the operating assembly relative to the shuttle assembly.

    Figure 9 is a cross-sectional view similar to Figure 8 illustrating the further advancement of the shuttle assembly from the position shown in Figure 8 as a result of the continued rotation of the operating assembly relative to the shuttle assembly.

    Figure 10 is a cross-sectional view similar to Figure 9 illustrating the further advancement of the shuttle assembly from the position shown in Figure 9 as a result of the variable force springs of the invention acting upon the shuttle assembly.

    Figure 11 is a top plan view of one form of the rate control chip assembly of the invention for controlling the rate of fluid flow toward the patient.

    Figure 12 is a cross-sectional view taken along lines 12-12 of Figure 11.

    Figure 13 is a side elevational of view of one of the variable force springs of the apparatus of the present invention illustrating the method of coiling the band portion of the spring about the spring drum in varying degrees of tightness.

    Figure 14 is a cross-sectional view taken along lines 14-14 of Figure 13.

    Figure 15 is a cross-sectional view similar to Figure 10, but showing the collapsible container of the invention in a collapsed condition following delivery of the medicinal fluid to the patient.

    Figure 16 is a cross-sectional view illustrating an alternate form of the apparatus of the invention for dispensing fluids to a patient.

    Figure 16A is an enlarged cross-sectional view illustrating the second assembly of the alternate form of the invention that includes the collapsible container and the stored energy source, shown here as a plurality of tapered springs.

    Figure 17 is a generally illustrative view of the configuration of a retractable spring that would deliver a force that decreases by a factor of w.sub.1/w.sub.2 as a spring returned from its fully extended configuration to its fully coiled configuration.

    Figure 18 is a generally graphical representation, plotting pressure versus the length of the reservoir container when a constant force spring is used to compress a bellows-like reservoir container.

    Figure 19 is a generally graphical representation, similar to Figure 13, plotting pressure versus the degree of compression for the reservoir container when the container is compressed by a constant force spring.

    Figure 20 is a generally perspective view of an alternate form of the apparatus of the invention for dispensing fluids to a patient.

    Figure 21 is a generally perspective, illustrative view showing the manner of removal of one form of the disabling assembly of the invention.

    Figure 22 is a longitudinal, cross-sectional view of the apparatus shown in Figure 20 of the drawings.

    Figure 22A is an exploded perspective view of the apparatus shown in Figure 20 of the drawings.

    Figure 23 is a side elevational view of the substantially transparent housing of the apparatus shown in Figure 20 of the drawings.

    Figure 24 is a view taken along lines 24-24 of Figure 23.

    Figure 25 is a view taken along lines 25-25 of Figure 23.

    Figure 26 is a generally perspective bottom view of one form of the rotatable end cap of the apparatus of this latest form of the invention.

    Figure 27 is a cross-sectional view similar to Figure 22, but showing the shuttle of the apparatus moved forward to a first advanced position.

    Figure 28 is a cross-sectional view similar to Figure 27, but showing the shuttle of the apparatus moved forward to a further advanced position.

    Figure 29 is a cross-sectional view similar to Figure 28, but showing the shuttle of the apparatus moved forward to still a further advanced final position.

    Figure 30 is a side view of one form of the shuttle of the apparatus.

    Figure 31A is an end view of one form of the alignment sleeve of the apparatus.

    Figure 31 is a cross-sectional view taken along lines 31-31 of figure 31A.

    Figure 32 is a side elevational view of one form of the fluidics assembly of the apparatus, including the fluidics hub and the fluidics manifold.

    Figure 33 is a view taken along lines 33-33 of Figure 32.

    Figure 34 is a cross-sectional view taken along lines 34-34 of Figure 33.

    Figure 35 is a top plan view of the rate control chip of this latest form of the apparatus.

    Figure 36 is a generally perspective, illustrative view of the sterilization apparatus of this latest form of the invention.


    DETAILED DESCRIPTION OF THE INVENTION


    Definitions - As used herein the following terms mean:


    Unitary Container:



    [0021] A unitary closed container blow molded from a plastic parison.

    Continuous/Uninterrupted Wall:



    [0022] A wall having no break in uniformity or continuity.

    Hermetically Sealed Container:



    [0023] A container that is designed and intended to be secure against the entry of microorganisms and to maintain the safety and quality of its contents after pressurizing.

    Aseptic Processing:



    [0024] The term aseptic processing' as it is applied in the pharmaceutical industry refers to the assembly of sterilized components and product in a specialized clean environment.

    Sterile Product:



    [0025] A sterile product is one that is free from all living organisms, whether in a vegetative or spore state.

    Blow-Fill-Seal Process:



    [0026] The concept of aseptic blow-fill-seal (BFS) is that a container is formed, filled, and sealed as a unitary container in a continuous manner without human intervention in a sterile enclosed area inside a machine. The process is multi-stepped; pharmaceutical grade resin is extruded into a tube, which is then formed into a container. A mandrel is inserted into the newly formed container and filled. The container is then sealed, all inside a sterile shrouded chamber. The product is then discharged to a non-sterile area for packaging and distribution.

    Collapsible Container:



    [0027] A dispensing apparatus in which one or more walls of the container are made of a material which will deform (collapse) when pressure is applied thereto; or a dispensing apparatus having a collapsible or telescoping wall structure.

    Constant-Force Spring:



    [0028] Constant-force springs are a special variety of extension spring. They are tightly coiled wound bands of pre-hardened spring steel or stainless steel strip with built-in curvature so that each turn of the strip wraps tightly on its inner neighbor. When the strip is extended (deflected), the inherent stress resists the loading force; the same as a common extension spring but at a nearly constant (zero) rate. The constant-force spring is well suited to long extensions with no load build-up. In use, the spring is usually mounted with the ID tightly wrapped on a drum and the free end attached to the loading force. Considerable flexibility is possible with constant-force springs because the load capacity can be multiplied by using two or more strips in tandem, or back-to-back. Constant-force springs are available in a wide variety of sizes.

    Modified Constant-Force Spring (Variable Force Spring):



    [0029] The modified constant-force spring or variable force spring of the present invention comprises a spring of highly novel configuration that includes an elongated, pre-stressed strip of spring material that may be metal, a polymer, a plastic, or a composite material with built-in curvature so that, like the conventional constant-force spring, each turn of the strip wraps tightly on its inner neighbor. Uniquely, in one form of the invention, the pre-stressed strip of spring material is coiled about the spring drum to predetermined varying degrees of tightness that produces highly specific and desirable linear and non-linear force-distention curves.

    Micro-channel



    [0030] As used herein, the term of micro-channel means a fluid flow passageway having a width of between about 0.25 in. and about 0.127 in. and a depth of between about 0.25 in. and about 0.127 in.

    Ullage



    [0031] The inwardly extending protuberance formed on the bottom wall of a collapsible container which when the collapsible container is collapsed, substantially fills the upper portion of the container so as to urge substantially all of the fluid from the container.

    APPARATUS OF THE INVENTION



    [0032] Referring now to the drawings and particularly to Figures 1 and 2, the operating components of one form of the apparatus of the present invention for dispensing fluids to a patient is there shown. This apparatus, which is generally designated in Figure 1 by the numeral 20, comprises a housing 22 having first and second ends 22a and 22b. Connected to the first end of housing 22 by conventional connectors 23 is a first assembly 24 that includes a front cover 26. Disposed within front cover 26 are a connector member, or hub 28 and a penetrating sub-assembly 30 that is connected to the connector member. As best seen in Figure 2 of the drawings, connector member 28 has a shoulder portion 28a and a central bore 28b, the purpose of which will presently be described. Penetrating sub-assembly 30 includes a body portion 30a and a penetrating member 32 that is connected to and extends outwardly from the body portion. Penetrating member 32 has a fluid passageway 32a which, in a manner presently to be described, is in communication with the fluid reservoir of the apparatus.

    [0033] Also forming a part of first assembly 24 is a novel rate control assembly 34 that is connected to penetrating sub-assembly by conventional connectors 35 in the manner shown in Figure 2 of the drawings. Rate control assembly 34 includes a rate control member, or chip 36, that is provided with a planar surface 36a having a circuitous micro-channel 40 formed therein. Rate control assembly 34 also includes a very thin, substantially transparent cover 36c that is adhesively bonded to the rate control member (Figure 12). Micro-channel 40, which for sake of clarity, is viewed in Figure 11 through the substantially transparent cover 36c, has an inlet 40a that is in communication with the fluid passageway 32a of the penetrating member 32 and an outlet 40b that is in communication with the administration set of the apparatus, the character of which will presently be described. While micro-channel 40 can be of various configurations, it preferably has a width of between about 0.250 mm and about 0.127 mm and a depth of between about 0.250 mm and about 0.127 mm.

    [0034] Disposed within the housing 22 is the important second assembly 42 of the invention (see Figure 3A). A unique feature of the present invention resides in the fact that the second assembly 42 is controllably, progressively movable within housing 32 between a first position shown in Figure 2 of the drawings, to a second position shown in Figure 5, to a third position shown in Figure 8, to a fourth position shown in Figure 9 and finally, into a fifth position shown in Figure 10.

    [0035] In the present form of the invention, the important second assembly 42 comprises a shuttle 44 and a unitary, hermetically sealed collapsible container 46 that is carried by the shuttle in the manner shown in Figure 2 of the drawings. In the preferred form of the invention, collapsible container 46 is formed in accordance with an aseptic blow-fill-seal manufacturing technique which is of a character well understood by those skilled in the art. This technique involves the continuous plastic extrusion through an extruder head of a length of parison in the form of a hollow tube between and through two co-acting first or main mold halves. The technique further includes the step of cutting off the parison below the extruder head and above the main mold halves to create an opening which allows a blowing and filling nozzle assembly to be moved downwardly into the opening in the parison for molding the molded container. Further details concerning the technique are available from Rommelag GMBH of Stuttgart, Germany and Weiler Engineering of Elgin, Illinois.

    [0036] In a manner presently to be described, collapsible container 46 is accessible via the previously identified penetrating member 32 that is adapted to pierce the closure wall 48 of the collapsible container, as well as a pierceable membrane 50 which is positioned over closure wall 48 by means of a retainer collar 52 which is affixed to the neck portion 54 of the collapsible container 46 and is also affixed to a container positioning collar 55 which circumscribes the neck portion of the container (Figure 2). Retaining collar 55 also includes a flange portion 55a that engages the upper portion of the accordion wall of the container and functions to retain the container in position.

    [0037] As previously discussed, an important object of the present invention is to provide an apparatus in which the first assembly 24, which includes the penetrating sub-assembly 30 and the rate control assembly 34 and which also includes a portion of the second assembly 42 which comprises the collapsible container 45, can be hermetically sealed and sterilized without adversely affecting the medicinal fluid contained within the collapsible container.

    [0038] To accomplish this important objective, a plurality of strategically placed O-rings is provided. As best seen in Figure 2A, a first O-ring 0-1 is provided on the upper portion of connector member, or hub 28, and is arranged to sealably engage the body portion 30a of penetrating sub-assembly 30. Similarly, a second O-ring O-2, which is provided on the retaining collar 55, is adapted to sealably engage the inner wall portion of the connector member 28. Additionally, a third O-ring O-3, which is carried by the neck portion 54 of the collapsible container 46, is disposed in sealing engagement with a reduced diameter portion 55a of the retaining collar 55. With this arrangement, the penetrating sub-assembly 30, the rate control chip 36, and a portion of the second assembly 42 which includes the collapsible container 45, can be effectively hermetically sealed.

    [0039] Referring next to Figure 2B of the drawings, the electron beam sterilization step of the present invention is there diagrammatically illustrated. With regard to sterilization, ethylene oxide (EO) and gamma radiation are among the most popular and well established processes for sterilizing polymer-based medical devices. However, these techniques can lead to significant alterations in the materials being treated. Accordingly, sterilization of polymer-based medical devices by electron beam has recently become quite popular and has been proven to be both fast and cost effective.

    [0040] In accordance with this technique, as electrons scan through polymer-based medical devices, they kill its microbial population by directly breaking microbial DNA chains and by creating secondary particles such as free radicals. These unpaired and highly reactive compounds or atoms further react with the microbes. The damaged DNA keeps microorganisms in the product from reproducing, rendering the product sterile. Further, recent experience has shown that a dose delivered rapidly by electron beam reduces the polymer's degradation and embrittlement. This advantage makes electron beam sterilization a clear choice over gamma sterilization for several polymers which, until now, were perceived as having marginal radiation stability.

    [0041] As depicted in Figure 2B and in accordance with the method of the present invention, when the electron beam source EBS is strategically positioned in the manner there illustrated, the critical portions of the apparatus can be effectively sterilized without adversely affecting the medicinal fluid contained within the collapsible container 46. More particularly, by directing the electron beam through a scanning angle of between about 15 and about 20 degrees, through a scanning width of between about 30 and 60 mm and by directing the beam along strategically selected trajectories, such as trajectories T-1, T-2 and T-3, the critical portions of the apparatus such as the penetrating member 32 and the neck 54 of the collapsible container can be effectively sterilized.

    [0042] As previously discussed, the basic container 46 of the invention is formed using the earlier described aseptic blow-fill-seal technique and the reservoir portion 56 of the container is sealed by the thin closure wall 48. The pierceable membrane 50 is then positioned over the closure wall and the retainer cap 52 is positioned over the pierceable septal membrane 50 and secured to neck portion 54 by any suitable means such as adhesive bonding, sonic or heat welding. As illustrated in Figure 2 of the drawings, the collapsible container 46 also includes an accordion shaped sidewall 58 that is integrally formed with said neck portion 54 and a bottom wall 60 that is integrally formed with the accordion shaped sidewall 58. To ensure that the maximum amount of medicinal fluid contained within the collapsible container is dispensed to the patient, bottom wall 60 is provided with an ullage, here provided as an inwardly extending, generally cup-shaped protuberance 60a. As illustrated in Figure 15 of the drawings, when the container is collapsed, protuberance 60a resides within and substantially fills the upper portion of the collapsible container that was previously filled with the medicinal fluid. In this way, substantially all of the medicinal fluid contained within the collapsible container is urged therefrom.

    [0043] Also forming a part of the important second assembly of the invention is a novel stored energy means that is operably associated with shuttle 44 for moving the shuttle 44 and the collapsible container 46 within the housing 22. More particularly, as will be discussed in greater detail hereinafter, the novel stored energy means of the invention uniquely functions to move the shuttle within the housing from the first advanced position shown in Figure 9 of the drawings to the second advanced position shown in Figure 10 wherein the piercing member pierces the septal membrane 50 and the pierceable top wall 48 of the collapsible container 46 to open communication between said fluid passageway 32a of said penetrating member and the reservoir 56 of said collapsible container. After communication is open between the fluid passageway of the penetrating member and the collapsible container, the stored energy means then moves the shuttle into the third advanced position shown in Figure 15 wherein the side wall 58 of the collapsible container is collapsed and the medicinal fluid has been delivered to the patient.

    [0044] In the present form of the invention, this important stored energy means comprises a plurality of circumferentially spaced apart variable force springs 62, each of which comprises a drum assembly 64 and an elongated band of material 66, a portion of which is wound about the drum assembly. Each of the drum assemblies 64, which includes a spindle 64a, is carried by the shuttle 44 in the manner illustrated in Figures 2 and 4 of the drawings so that the elongate bands 66 extend over the collapsible container and the end portions 66a thereof are fixedly connected to the connector member 28 by suitable connectors 67. It is this unique construction that enables the diameter of the housing 22 to be maintained at a minimum.

    [0045] Variable force springs 62 here comprise constant force springs that have been strategically modified in a manner presently to be described and as illustrated in Figures 13 and 14 of the drawings. Conventional constant-force springs of the character that are here strategically modified, which are typically referred to as Negator extension springs, are commercially available from several sources, including Barnes Group Inc. of Bristol, Connecticut, Stock Drive Products/Sterling Instrument of Hyde Park, New York and Walker Corporation of Ontario, California. The conventional constant-force extension spring is basically a high stress, long deflection device that offers great advantages for a variety of applications where very low or zero gradient is desired, where space is a factor and where very high reliability, accuracy, and forced tolerance is required. A constant-force spring is typically a roll of pre-stressed, strip of metal that exerts a nearly constant restraining force to resist uncoiling. In conventional constant-force springs, the force is constant because the change in the radius of the curvature is constant. The force delivered by a typical prior art constant force spring such as the Negator extension spring, depends on several structural and geometric factors. Structural factors include material composition and heat treatment. Geometric factors include the thickness of the spring, the change in radius of curvature of the spring as the spring is extended, and the width of the spring.

    [0046] Also forming a part of the apparatus of the present invention is a novel third, or operating assembly 70 that is connected to housing 22 at a location proximate the second end 22b thereof. Third assembly 70 here comprises an internally threaded operating member 72 that is threadably connected to the external threads 73 of the shuttle 44. In a manner presently to be described, controlled manual rotation of the operating member causes the controlled advancement of the second assembly of the invention from the initial position through the second and third, or first advanced position and then into the fourth, or second advanced position.

    [0047] In the present form of the invention, this important stored energy means comprises a plurality of circumferentially spaced apart variable force springs 62, each of which comprises a drum assembly 64 and an elongated band of material 66, a portion of which is wound about the drum assembly. Each of the drum assemblies 64, which includes a spindle 64a, is carried by the shuttle 44 in the manner illustrated in Figures 2 and 4 of the drawings so that the elongate bands 66 extend over the collapsible container and the end portions 66a thereof are fixedly connected to the connector member 28 by suitable connectors 67. It is this unique construction that enables the diameter of the housing 22 to be maintained at a minimum.

    [0048] Third assembly 70 here also comprises a novel manually operated locking assembly 76 that functions to releasably lock the operating member 72 in the first, or starting position shown in Figures 2 and 6. Locking assembly 76 here comprises a generally planar locking member 78 that includes a generally circular shaped central portion 80 having a central aperture 80a and a pair of circumferentially spaced, generally arcuate shaped grooves 82 that terminate at one end in semicircular shaped openings 82a. Locking member 78 also includes three circumferentially spaced apart, radially outwardly extending arms 78a.

    [0049] Operably associated with the locking member 78 is a pusher assembly that is generally designated in Figures 3A and 5 by the numeral 84. This important pusher assembly which is movable between a first extended position shown in Figure 6 and a second forward position shown in Figure 7, comprises a pusher member 86 having a centrally located, forwardly extending shaft 88 that is receivable within central aperture 80a of locking member 78. Pusher assembly 84 also includes a pair of forwardly extending shafts 90, each having an enlarged head portion 90a and a cylindrical shaped shaft portion that is receivable within a selected one of the plurality of arcuate shaped grooves 82. When the pusher assembly is in the locked position shown in Figure 6, the enlarged head portions 90a of the shafts 90 are locked within the semicircular openings 82a, thereby blocking rotation of the operating member 72. More particularly, as best seen in Figure 6 of the drawings, when the locking assembly is in the retracted position there shown, the extremity of the arm identified in Figure 6 as 85 is in engagement with a locking shoulder 72a formed internally of the operating member 72. With this construction, any attempt to rotate the operating member will be blocked by the enlarged head portions 90a of the shafts 90. However, when the locking assembly is manually moved into the forward release position shown in Figure 7, the enlarged head portions of the shafts are moved inwardly relative to locking member 78 and out of engagement with the semicircular openings 82a, thereby permitting rotation of the operating member 72. As the operating member is rotated, the second assembly 42 will be caused to move forwardly of the housing 22 from the position shown in Figure 2 of the drawings into the position shown in Figure 5 of the drawings. Continued rotation of the operating member will cause the second assembly to continue to move forwardly of the housing 22 from the position shown in Figure 2, into the position shown in Figure 5, and then into the position shown in Figure 9.

    [0050] As discussed in the previous paragraph, with the apparatus in the configuration shown in Figures 2 and 6, the operating member 72 is locked against rotation relative to the shuttle. Accordingly, in order to commence the fluid delivery process, it is necessary to manually urge the locking assembly inwardly into the release position shown in Figure 7. Rotation of the operating member will then cause the second assembly 42 to move progressively forward of the housing 22 from the first initial position shown in Figure 2 of the drawings, to a second position shown in Figure 5, to a third position shown in Figure 8 and to a fourth position shown in Figure 9. As the second assembly moves forwardly of the housing, a plurality of outwardly extending, circumferentially spaced protuberances 94 formed on the shuttle member will slide along within the circumferentially spaced grooves 96 formed in housing 22, thereby guiding its forward movement.

    [0051] It is to be noted that when the shuttle 44 reaches the first advanced position shown in Figure 9 wherein the pierceable top wall of said collapsible container is disposed proximate the piercing member, the threads of the shuttle become free of the threads on the operating member, thereby permitting the variable force springs to wind about their respective drums and in so doing to thrust the collapsible container forwardly of the housing from the first advanced position to a second advanced position wherein the penetrating member 32 will completely pierce the elastomeric septum 50 and the closure wall 48 of the collapsible container in the manner illustrated in Figure 10 of the drawings.

    [0052] Once communication is established between the penetrating member 32 and the reservoir 56 of the collapsible container, the variable force springs 62 will continue to wind about their respective drums and in so doing will cause the shuttle to move forwardly into a third advanced position shown in Figure 15 of the drawings wherein the side wall of said collapsible container is collapsed. As the container collapses, the protuberance 60a will move toward the neck of the container and into the position shown in Figure 15 wherein it fills a substantial portion of the reservoir of the collapsible container. As illustrated in Figure 3 of the drawings, as the container collapses, the medicinal fluid contained within the reservoir will controllably flow from the reservoir in the direction of the arrow "F-1" into the internal passageway 32a of the penetrating member 32.

    [0053] As previously mentioned, the stored energy means of the present invention which functions to collapse the collapsible container 46, here comprises a plurality of circumferentially spaced, variable force springs 62. Each of the variable force springs comprises a drum assembly 64 and a band of material 66 having a first portion wound about the drum assembly and a second end portion 66a connected to the body portion 28 of first assembly 24. Referring to Figures 13 and 14 of the drawings, one example of the coiling method of the variable force springs 62 is there illustrated. In accordance with this coiling method, the band portion of the spring is initially wound tightly about the drum 64 to produce a first segment 96 having a diameter "D-1". This done, the band portion is then coiled, or wound more loosely about the drum 64 to produce a second segment 98 having a diameter "D-2". Finally, the band portion is coiled, or wound even more loosely about the drum 64 to produce a third segment 100 having a diameter "D-3".

    [0054] By coiling the springs about their respective drums with a variation of coil tightness in the manner described in the preceding paragraph and as illustrated in Figures 13 and 14, springs having highly specific and desirable linear and non-linear force-distention curves can be produced which will meet the fluid delivery requirements of the invention.

    [0055] Spring assemblies, such as those depicted in Figures 13 and 14 of the drawings, that exhibit a variation of coil tightness that produce highly specific and desirable linear and non-linear force-distention curves to meet the fluid delivery requirements of the invention, are available by custom order from various sources, including Vulcan Mfg. & Spring Company of Telford, Pennsylvania.

    [0056] As previously discussed, with the construction described in the preceding paragraphs, as the accordion-like side wall 58 of the container 46 collapses in a controlled manner in the manner illustrated in Figure 15 of the drawings, fluid will flow from reservoir 56 into the flow passageway 32a of penetrating member 32 (see Figure 3). From the penetrating member, the fluid will flow in the direction of the arrow "F-2" into the inlet 40a of the micro-channel 40 of the rate control means of the invention which functions to precisely control the rate of fluid flow from the fluid reservoir 56 toward the patient. After flowing through the micro-channel 40 at a controlled rate, the fluid will flow in the direction of the arrows "F-3" into the connector block 31 (Figure 3) and then in the direction of the arrows "F-4" into the proximal end 106a of line 106 of the administration set 104 via conventional connectors 31a and 105. It is apparent that by varying the geometry, including the length, width and depth of the micro-channel 40, the rate of fluid flow to the administration set and to the patient can be readily varied.

    [0057] Disposed between the proximal end 106a and the distal end 106b of the administration line is a conventional clamp 108, a conventional gas vent and a conventional filter 110 and an injector site 112, shown here as a conventional "Y" site. Provided at the distal end 106b of the administration line is a luer connector 114 and luer cap 114a of conventional construction.

    [0058] As in the earlier described embodiment of the invention, critical portions of the device can be hermetically sealed and sterilized without adversely affecting the medicinal fluid contained within the collapsible container.

    [0059] Referring next to Figure 16 of the drawings, an alternate form of the apparatus of the invention for dispensing fluids to a patient is there shown. While the second assembly of the apparatus is somewhat different from that of the earlier described second assembly 42 of the earlier described embodiment, the balance of the apparatus is substantially identical in construction and operation to that previously described. Accordingly, like numerals are used in Figure 16 to identify like components.

    [0060] As in the earlier described embodiment and as illustrated in Figure 16 of the drawings, the somewhat differently configured second assembly 120 of this latest form of the invention is disposed within a housing 22 of the character previously described and cooperates with the first and third assemblies 24 and 70 in the manner previously described. During the operation of the apparatus that includes the alternate form of the second assembly 120, the second assembly is progressively movable within housing 22 between a first position, to a second position, to a third position, to a fourth position and, finally, into a fifth position.

    [0061] Referring particularly to Figure 16A of the drawings, it can be seen that second assembly 120 here comprises a shuttle 44 and a unitary, hermetically sealed collapsible container 46 that is carried by the shuttle. In the manner previously described, collapsible container 46 is accessible via the previously identified penetrating member 32 that is adapted to pierce the closure wall 48 of the collapsible container (see Figure 16), as well as a pierceable membrane 50 which is positioned over closure wall 48 by means of a retainer collar 52 which is affixed to the neck portion 54 of the collapsible container 46 and is also affixed to a container positioning collar 55 which circumscribes the neck portion of the container.

    [0062] As in the earlier described embodiment of the invention, critical portions of the device can be hermetically sealed and sterilized without adversely affecting the medicinal fluid contained within the collapsible container.

    [0063] Importantly, this latest form of the invention includes differently configured variable force springs 122. More particularly, the variable force characteristics of the springs of this latest form of the invention are uniquely achieved by varying the cross-sectional mass of the elongated band portion of the spring. Here, the variable cross-sectional mass of the spring is achieved by a constant force spring that has been modified to exhibit varying width along its length. More particularly, as illustrated in Figure 16A of the drawings, this latest form of the modified spring exhibits a tapered body, or an elongated band portion 122a.

    [0064] Springs 122 can be constructed from various materials, such as metal, plastic, ceramic, composite and alloys, that is, intermetallic phases, intermetallic compounds, solid solution, metal-semi metal solutions including but not limited to Al/Cu, Al/Mn, Al/Si, Al/Mg, Al/Mg/Si, Al/Zn, Pb/Sn/Sb, Sn/Sb/Cu, Al/Sb, Zn/Sb, In/Sb, Sb/Pb, Au/Cu, Ti/Al/Sn, Nb/Zr, Cr/Fe, non-ferrous alloys, Cu/Mn/Ni, Al/Ni/Co, Ni/Cu/Zn, Ni/Cr, Ni/Cu/Mn, Cu/Zn, Ni/Cu/Sn. These springs comprise a novel modification of the prior art constant force springs to provide variable springs suitable for use in many diverse applications.

    [0065] With the foregoing in mind, if one wanted to produce a spring that delivered a force that increased by a factor of two as the spring returned from its fully extended conformation to its equilibrium, or fully coiled conformation, one would require that, as illustrated in Figure 17 of the drawings, the width of the spring change by a factor of two along its length. In the example illustrated in Figure 18, the force will decrease by a factor of w.sub.1/w.sub.2 as the spring changes from a fully extended configuration to a fully retracted configuration.

    [0066] One form of the modified spring of this latest form of the invention can be described algebraically as follows: If x denotes the position of a point along a line that is parallel to the longitudinal axis of the spring and w(x) denotes the width of the spring at that point, then: w(x)=(constant)x. This describes the case wherein the width varies linearly with x as is shown in Figure 17 of the drawings.

    [0067] However, it is to be observed that the relationship between a position along the longitudinal axis of the spring and the width of the spring at that position need not be linear as shown in Figure 17. Further, the width of the spring could be any arbitrary function of x. Thus: w(x)=f(x) where (x) denotes an arbitrary function of x.

    [0068] Using this concept, a spring can be designed that can be used to controllably compress a bellows type reservoir such as reservoir 56, which when compressed by the modified springs 120, exhibits a pressure vs. degree of compression curve of the character shown in Figure 19. Stated another way, it is apparent that the concept can be employed to design a spring that generates a pressure that is independent of the degree of compression of the bellows-type reservoir.

    [0069] By way of example, suppose that the pressure vs. degree of compression curve for a bellows-like container when compressed by a constant force spring is exemplified by the curve P(x) and the force of the constant force spring is "FCFS". Further assume that the drop in pressure as the container is compressed is due to the force "BF(x)", which is the force required to compress the container. Then the net force producing the pressure in the container can then be written: F(x)=FCFS-BF(x). Assume for simplicity that the area on which the force F acts is constant and is represented by "A". Then the pressure in the bottle is: P(x)=(FCFS-BF(x))/A. This equation describes, in functional form, the curve labeled P(x) in Figure 18 and includes explicitly the contributions of the two forces generating the pressure within the reservoir 56 of the bellows-like container that is the force due to the spring and the force due to the bellows-like container.

    [0070] The foregoing analysis allows one to design a spring, the force of which changes in such a way that the sum of all forces generating the pressure in the container is independent of the degree of the compression of the container, i.e., independent of the variable x. The force delivered by such a spring can be stated as: F(x)=FCFS+AF(x). Where "FCFS" is the force delivered by the original constant force spring and AF(x) is an additional force whose functional form is to be determined. Thus, the modified spring can be thought of as being composed of two parts, one part delivers the force of the original constant force spring (a force independent of x) and the other delivers a force that depends on the variable x.

    [0071] For this system, the net force generating the pressure in the reservoir of the bellows-like collapsible container, such as container 46, is stated as:



    [0072] Assuming that: AF(x)=BF(x) for all x. Then the total force compressing the container is: FS(x)=FCFS+AF(x)-AF(x)=FCFS which force is independent of the degree of compression of the collapsible container, and wherein the pressure within the container is independent of the degree of compression of the container.

    [0073] P.sub.ms(x)=(FCFS+AF(x)-AF(x))/A=FCFS/A. Where P.sub.ms(x) denotes the pressure in the fluid reservoir when the modified spring of the invention is used.

    [0074] In designing the modified spring of this latest form of the invention, the information contained in the pressure vs. displacement curve when the container is compressed by a constant force spring can be used to determine how the cross-sectional mass, in this case the width of the spring, must vary as a function of x in order that the pressure in the container when compressed with the modified spring remains constant.

    [0075] The force delivered by the spring being linearly dependent on the width of the spring if all other things remain constant, thus:

    Substituting this into equation:

    then:



    [0076] However, it is to be observed that FCFS/A-P(x) is just the difference between the two curves shown in Figure 19, FCFS/A being the horizontal line. Thus, the modification to the width, denoted w(x), of the original constant force spring is proportional to the difference between the two curves shown in Figure 19. In other words, the shape of the change in the width of the spring as a function of x is similar to the difference between the two curves as a function of x. Furthermore, one can simply "read off" the shape of the curve w(x) from the pressure vs. displacement curve.

    [0077] The broader utility of a variable force spring whose width defines the specific force may be that the spring design can be appropriately constructed to deliver a non-linear and highly variable force to meet a specific requirement. In this way, a spring that has a width that simply decreases as it is unrolled could be used. Alternatively, the spring could have an increasing width, followed by a width that decreases again during its distention. The spring force provided is therefore highly tunable to meet a variety of applications and requirements, simply by constructing a spring of specific width at the desired distension.

    [0078] Once communication is established between the penetrating member and the reservoir 56 of the collapsible container in the manner previously described, the three circumferentially spaced, variable force springs 122 will continue to wind about their respective drums 122b and in so doing will cause the shuttle to move forwardly, causing the collapse of the collapsible container and the movement of the protuberance 60a into the position wherein it fills a substantial portion of the reservoir of the collapsible container. As the container collapses, the medicinal fluid contained within the reservoir will controllably flow into the internal passageway 32a of the penetrating member 32, through the rate control means of the invention and then to the administration set which is of the character previously described.

    [0079] Referring now to Figures 20 through 26, an alternate form of the apparatus of the invention for dispensing fluids to a patient is there shown. This apparatus, which is generally designated in Figure 20 by the numeral 130, is similar in many respects to the apparatus illustrated in Figures 1 through 19 and like numbers are used in Figures 20 through 26 to identify like components. Apparatus 130 here comprises a substantially transparent, generally cylindrically shaped hollow plastic housing 132 having first and second ends 132a and 132b, an intermediate concave portion 132c and a longitudinally extending center line 132d (see Figure 23). As shown in Figure 20, housing 132 is provided with a covering 133 that includes identifying indicia and a viewing window 133a, the purpose of which will presently be described.

    [0080] Connected to the first end of housing 132 is a first assembly 134 that includes a front cover 136. Disposed within front cover 136 are a connector member, or fluidics hub 138 and a penetrating sub-assembly 140 that is connected to the connector member (see Figure 22). As best seen in Figure 34 of the drawings, connector member 138 has a shoulder portion 138a and a central bore 138b. As illustrated in Figure 34, penetrating sub-assembly 140 includes a mounting plate 141 and a penetrating member 142 that is connected to the mounting plate and extends outwardly along the longitudinal center line of housing 132. Penetrating member 142 has a fluid passageway 142a which, in a manner presently to be described, is in communication with the fluid reservoir of the apparatus.

    [0081] Also forming a part of first assembly 134 is a novel rate control assembly 144 that is connected to penetrating sub-assembly in the manner shown in Figure 22 of the drawings. Rate control assembly 144 includes a rate control member, or chip 146, that is provided with a planar surface 146a having a circuitous micro-channel 150 formed therein (see Figure 35). Micro-channel 150 has an inlet 150a that is in communication with the fluid passageway 142a of the penetrating member 142 and an outlet 150b that is in communication with the administration set of the apparatus, the character of which will presently be described. While micro-channel 150 can be of various configurations, it preferably has a width of between about 0.250 mm and about 0.127 mm and a depth of between about 0.250 mm and about 0.127 mm.

    [0082] Disposed within the housing 132 is the important second assembly 152 of the invention (see Figure 22). A unique feature of the present invention resides in the fact that the second assembly 152 is controllably, progressively movable within housing 132 between a first position shown in Figure 22 of the drawings, to a second position shown in Figure 27 and finally, into a third position shown in Figure 29.

    [0083] In this latest form of the invention, the important second assembly 152 comprises a shuttle 154 having external threads 154a and a unitary, hermetically sealed collapsible container 156 that is carried by the shuttle in the manner shown in Figure 22 of the drawings. As before, collapsible container 156 is formed in accordance with an aseptic blow-fill-seal manufacturing technique which is of a character well understood by those skilled in the art and previously described herein. As illustrated in the drawings, collapsible container 156 has a longitudinal center line 156a that is aligned with the longitudinal center line of the housing. Collapsible container 156 includes a neck portion 156b having a closure wall 156c, an accordion like sidewall 156d, a base portion 156e having an inwardly extending protuberance or ullage 156f and a fluid reservoir 156g (see Figure 22).

    [0084] As illustrated in Figure 30 of the drawings, externally threaded shuttle 154 uniquely includes a plurality of circumferentially spaced alignment protuberances 154p that are closely receivable within the inwardly extending protuberance or ullage 156f of the collapsible container (see Figures 22 and 22A). As indicated in the drawings, alignment protuberances 154p function to precisely align the longitudinal axis of the collapsible container with the longitudinal axis of housing 132. When the collapsible container is in position on the threaded shuttle, it can be affixed to the protuberances 154p in any suitable manner, such as by a plurality of strips of adhesive tape 157. In a manner presently to be described, collapsible container 156 is accessible via the previously identified penetrating member 142 that is adapted to pierce the closure wall 156c of the collapsible container.

    [0085] Importantly, second assembly 152 also includes an alignment sleeve 160 that functions to actually align the collapsible container 156. As depicted in Figure 31 of the drawings, alignment sleeve 160 has a generally circular shaped flange 162 and a generally cylindrically shaped body portion 164 that extends forwardly from flange 162. Body portion 164 is provided with an axial bore 164a that telescopically receives the neck portion 156b of the collapsible container (see Figure 22). A yieldably deformable locking tab 165 provided on the alignment sleeve engages a circumferentially extending locking ring 167 provided on the neck portion of the collapsible container in a manner to securely hold the collapsible container in a centered position within the alignment sleeve (see Figures 22 and 31).

    [0086] Rotatably connected to and closing the second end 132b of housing 132 is a first operating member shown here as an end cap 168 having internal threads 168a. End cap 168 is provided with a plurality of circumferentially spaced apart locking fingers 169 that engage a shoulder 132s formed internally of housing 132(see Figure 22). As depicted in Figure 22 of the drawings, end cap 168 is threadably connected to threaded shuttle 154 for rotational movement relative thereto. With this construction, rotation of end cap 168 relative to the second end of housing 132 functions to controllably move the shuttle along the longitudinally extending center line of the housing from a first starting position shown in Figure 22 to a second advanced position shown in Figure 27. As illustrated in Figure 25 of the drawings, housing 132 is provided with a multiplicity of circumferentially spaced saw tooth like protrusions 132p. As the end cap is rotated, an outwardly protruding, yieldably deformable locking finger 168f provided on the end cap rides over the protrusions (see Figure 26). However, locking finger 168f is constructed and arranged to engage the saw tooth like protrusions 168p in a manner to prevent rotation of the end cap in the opposite direction. Accordingly, after the end cap has been fully rotated, it cannot be rotated in either direction.

    [0087] An important safety feature of the apparatus of this latest form of the invention resides in the provision of a disabling assembly 170 that is carried by housing 132. Disabling assembly 170 uniquely functions to prevent accidental rotation of the operating member or end cap 168 and in this way prevents any delivery of medicament to the patient. As illustrated in Figure 21 of the drawings in this latest form of the invention, this important disabling assembly comprises a thin-film 172 that encapsulates housing 132, covering 133 and a portion of the internally threaded end cap 168. Thin-film 172 can be constructed from a wide variety of films but preferably comprises a heat shrinkable polyolefin film. At time of use of the apparatus of the invention, the thin-film 172 can be removed in the manner illustrated in Figure 21 by pulling downwardly on a tear strip 172t, which forms a part of the disabling assembly 170. After removal of the tear strip, the thin-film 172 can be separated from the apparatus and discarded. Removal of the thin-film permits rotation of the end cap 168 in the manner described in the preceding paragraphs.

    [0088] To controllably advance the shuttle from the second advanced position shown in Figure 27 to the third advanced position shown in Figure 28 and to the fourth, or final position shown in Figure 29, novel stored energy means are provided. In this latest embodiment of the invention, the stored energy means comprise a plurality of circumferentially spaced, variable force springs 176 that are carried by the shuttle in the manner illustrated in the drawings. As in the earlier described embodiments of the invention, the stored energy means functions to controllably collapse the collapsible container 156 and expel the medicinal fluids there from to the patient via the rate control assembly of the invention. The variable force springs 176 are of similar construction and operation to those previously described herein and each comprises a drum assembly 178 and a band of material 180 having a first portion 180a wound about the drum assembly and a second end portion 180b connected to connector member, or fluidics hub 138 by a suitable connector, such as connector 181 (see Figure 22). Each of the drum assemblies 178, which includes a spindle 178s, is carried by the shuttle 154 in the manner illustrated in the drawings so that the elongate bands 180 extend over the collapsible container and the end portions 180b thereof are fixedly connected to the connector member 138.

    [0089] The variable force characteristics of the springs of this latest form of the invention are uniquely achieved by varying the cross-sectional mass of the elongated band portion of the spring. Here, the variable cross-sectional mass of the spring is achieved by a constant force spring that has been modified to exhibit varying width along its length. See for example, the modified spring illustrated in figure 16A. As before, springs 176 can be constructed from various materials, such as metal, plastic, ceramic, composites and alloys.

    [0090] It is important to note that prior to the advancement of the shuttle to the second advanced position shown in Figure 27, the springs 176 of the second operating assembly are locked against operation by the locking mechanism of the invention. This important locking mechanism, which here comprises a part of the first operating assembly, comprises the threads 168a of end cap 168 which engage the threads 154a of the shuttle. However, when the shuttle reaches the second advanced position, the threads 154a provided on the shuttle no longer engage the threads 168a of the end cap thereby releasing the springs 176 from their locked inoperative configuration.

    [0091] With the construction described in the preceding paragraphs, as the accordion-like side wall 156d of the container 156 collapses in the manner illustrated in Figures 28 and 29 of the drawings, fluid will flow from the container reservoir 156g into the flow passageway 142a of penetrating member 142 (see Figure 29). From the penetrating member, the fluid will flow into the inlet 150a of the micro-channel 150 of the rate control means of the invention which functions to precisely control the rate of fluid flow from the fluid reservoir 156g toward the patient.

    [0092] After flowing through the micro-channel 150 at a controlled rate, the fluid will flow into the proximal end of line 106 of the administration set 104 which is of identical construction and operation to that previously described in connection with the embodiment of Figure 1 of the drawings. It is apparent that by varying the geometry, including the length, width and depth of the micro-channel 150, the rate of fluid flow to the administration set and to the patient can be readily varied.

    [0093] Prior to encapsulating the generally cylindrically shaped, substantially transparent housing 132 and the covering 133 with the shrink wrap film 172, the viewing window 133a is strategically superimposed over shuttle 154 so that the controlled advancement of the shuttle within the housing by the stored energy means can be observed. By calibrating the viewing window, that is by marking the window with appropriate indices 133q of quantity, the volume of medicament being delivered to the patient can be constantly monitored by the caregiver.

    [0094] As in the earlier described embodiment of the invention, critical portions of the device can be hermetically sealed and sterilized without adversely affecting the medicinal fluid contained within the collapsible container. Referring to Figure 36 of the drawings, the electron beam sterilization apparatus of this latest form of the invention is there diagrammatically illustrated. As depicted in Figure 36, in accordance with the method of this latest form of the invention, a plurality of the fully assembled, protectively boxed units 190 are strategically positioned within in a vertical orientation within the forward holding chamber 192a of a shielded sterilization container 192. A stainless steel shielding panel 194 that extends along the front of the sterilization container is of a critical predetermined height "H" so that it effectively shields all but the upper portions of the boxed units from radiation emanating from the electron beam source EBS. With this arrangement, with the electron beam source EBS strategically positioned relative to the sterilization container in the manner illustrated, the critical portions of the boxed units can be effectively sterilized without adversely affecting the medicinal fluid contained within the collapsible container 156. More particularly, the critical portions of the units that are to be sterilized, namely the penetrating member 142 and the neck portion of the collapsible container 156, will be exposed to the radiation while the medicinal fluid contained within the collapsible container is effectively shielded from the radiation by the steel shielding panel 194. Sterilization container 192 also includes a rearward portion 192b within which a plurality of layers of protective foam 198 are positioned.

    [0095] Having now described the invention in detail in accordance with the requirements of the patent statutes, those skilled in this art will have no difficulty in making changes and modifications in the individual parts or their relative assembly in order to meet specific requirements or conditions.


    Claims

    1. An apparatus for dispensing medicinal fluids to a patient comprising:

    (a) a generally cylindrically shaped housing (132) having first and second ends (132a, 132b) and a longitudinally extending center line;

    (b) a first assembly (134) connected to said first end of said housing, said first assembly comprising:

    (i) a front cover (136);

    (ii) a fluidics hub (138) disposed within said front cover, said fluidics hub having a generally cylindrical bore;

    (iii) a penetrating sub-assembly (140) connected to said fluidics hub, said penetrating sub-assembly comprising a mounting plate (141) and a penetrating member (142) connected to said mounting plate and extending along said longitudinal center line of said housing, said penetrating member having a fluid passageway (142a); and

    (iv) a rate control assembly (144) connected to said penetrating sub-assembly, said rate control assembly including a rate control member (146) having a micro-channel (150) formed therein in communication with said fluid passageway of said penetrating member;

    (c) a second assembly (152) carried by said housing (132) for movement relative thereto between a first position and a second advanced position, said second assembly comprising:

    (i) an externally threaded shuttle (154); and

    (ii) a collapsible container (156) carried by said externally threaded shuttle (154), said collapsible container (156) having a longitudinal center line aligned with said longitudinal center line of said housing (132) and including a neck portion (54) having a closure wall (156c) and a base portion (156e) having an inwardly extending ullage (156f); and

    (iii) an alignment sleeve (160) having an axial bore (164a), said neck portion (54) of said collapsible container (156) being telescopically receivable within said axial bore (164a) of said alignment sleeve (160);

    (d) an internally threaded end cap (168) threadably connected to said shuttle (154) for rotational movement relative thereto between a first position and a second position to move said shuttle (154) of said second assembly (152) within said housing (132) along said longitudinally extending center line from said first position to said second advanced position, wherein said internally threaded end cap (168) includes an outwardly protruding locking finger (169) and said second end of said generally cylindrically shaped housing (132) is provided with a multiplicity of circumferentially spaced, saw tooth like protrusions (132p) engageable by said locking finger (169);

    (e) stored energy means operably associated with said shuttle (154) for moving said shuttle (154) along said longitudinally extending center line from said second advanced position to a further advanced position; and

    (f) a disabling assembly (170) carried by said generally cylindrically shaped housing for preventing rotation of said internally threaded end cap (168) of said first operating assembly (70), said disabling assembly comprising a thin-film (172) encapsulating said generally cylindrically shaped housing (132) and a portion of said internally threaded end cap (168).


     
    2. The apparatus as defined in claim 1, wherein said stored energy means comprises a plurality of circumferentially spaced, variable force springs (122, 176) carried by said shuttle.
     
    3. The apparatus as defined in claim 1 in which said thin-film of said disabling assembly comprises a heat shrinkable polyolefin film.
     
    4. The apparatus as defined in claim 1, in which said generally cylindrically shaped housing is substantially transparent and in which said apparatus further includes a cover (133) circumscribing said housing and having a window (133a) superimposed over said shuttle (154).
     
    5. The apparatus as defined in claim 1, further including an administration line connected to said rate control assembly.
     
    6. The apparatus as defined in claim 5, wherein the apparatus further comprises a shielded enclosure (192) for containing the housing and a source of radiation for directing radiation at said shielded enclosure.
     
    7. The apparatus as defined in claim 6 in which said source of radiation comprises an electron beam.
     
    8. The apparatus as defined in claim 1 in which said threaded shuttle (154) includes a plurality of circumferentially spaced alignment protuberances (154p) receivable within said ullage (156f) of said base portion (156e) of said collapsible container (156).
     


    Ansprüche

    1. Vorrichtung zum Verteilen medizinischer Flüssigkeiten an einen Patienten, umfassend:

    (a) ein generell zylindrisch geformtes Gehäuse (132) mit ersten und zweiten Enden (132a, 132b) und einer sich longitudinal erstreckenden Mittellinie;

    (b) eine erste Baugruppe (134), die mit dem ersten Ende des Gehäuses verbunden ist, wobei die erste Baugruppe umfasst:

    (i) eine vordere Abdeckung (136);

    (ii) einen Fluidik-Hub (138), der innerhalb der vorderen Abdeckung angeordnet ist, wobei der Fluidik-Hub eine generell zylindrische Bohrung aufweist;

    (iii) eine penetrierende untergeordnete Baugruppe (140), die mit dem Fluidik-Hub verbunden ist, wobei die penetrierende untergeordnete Baugruppe eine Montageplatte (141) und ein penetrierendes Element (142) umfasst, das mit der Montageplatte verbunden ist und sich entlang der longitudinalen Mittellinie des Gehäuses erstreckt, wobei das penetrierende Element einen Flüssigkeitsdurchgang (142a) aufweist; und

    (iv) eine Mengensteuerungsbaugruppe (144), die mit der penetrierenden untergeordneten Baugruppe verbunden ist, wobei, die Mengensteuerungsbaugruppe ein Mengensteuerungselement (146) mit einem darin geformten Mikrokanal (150) in Kommunikation mit dem Flüssigkeitsdurchgang des penetrierenden Elements aufweist;

    (c) eine zweite Baugruppe (152), die vom Gehäuse (132) getragen wird für Bewegung relativ dazu zwischen einer ersten Position und einer zweiten vorgerückten Position, wobei die zweite Baugruppe umfasst:

    (i) ein Shuttle (154) mit Außengewinde; und

    (ii) einen faltbaren Behälter (156), der vom Shuttle (154) mit Außengewinde getragen wird, wobei der faltbare Behälter (156) eine longitudinale Mittellinie aufweist, die mit der longitudinalen Mittellinie des Gehäuses (132) ausgerichtet ist und einen Halsabschnitt (54) einschließt, der eine Verschlusswand (156c) und einen Basisabschnitt (156e) aufweist, der einen sich nach innen erstreckenden füllungsfreien Raum (156f) aufweist; und

    (iii) eine Ausrichtungshülse (160), die eine axiale Bohrung (164a) aufweist, wobei der Halsabschnitt (54) des faltbaren Behälters (156) teleskopisch innerhalb der axialen Bohrung (164a) der Ausrichtungshülse (160) aufnehmbar ist;

    (d) eine Endkappe (168) mit Innengewinde, die schraubbar mit dem Shuttle (154) verbunden ist für Drehbewegung relativ dazu zwischen einer ersten Position und einer zweiten Position, um das Shuttle (154) der zweiten Baugruppe (152) innerhalb des Gehäuses (132) entlang der sich longitudinal erstreckenden Mittellinie aus der ersten Position in die zweite vorgerückte Position zu bewegen, wobei die Endkappe 168) mit Innengewinde einen nach außen hervorstehenden Finger (169) einschließt und das zweite Ende des generell zylindrisch geformten Gehäuses (132) mit einer Vielheit von zirkumferenziell beabstandeten sägezahnartigen Überständen (132p) versehen ist, in die der Verriegelungsfinger (169) eingreift;

    (e) gespeichertes, funktionsfähig mit dem Shuttle (154) verbundenes Energiemittel zur Bewegung des Shuttles (154) entlang der sich longitudinal erstreckenden Mittellinie aus der zweiten vorgerückten Position in eine weiter vorgerückte Position; und

    (f) eine deaktivierende Baugruppe (170), die vom generell zylindrisch geformten Gehäuse getragen wird, um Drehung der Endkappe (168) mit Innengewinde der ersten Betriebsbaugruppe (70) zu verhindern, wobei die deaktivierende Baugruppe eine Dünnschicht (172) umfasst, die das generell zylindrisch geformte Gehäuse (132) und einen Abschnitt der Endkappe (168) mit Innengewinde kapselt.


     
    2. Vorrichtung wie in Anspruch 1 definiert, wobei das gespeicherte Energiemittel eine Vielzahl von zirkumferenziell beabstandeten Federn (122, 176) variierbarer Kraft umfasst, die vom Shuttle getragen werden.
     
    3. Vorrichtung wie in Anspruch 1 definiert, in welcher die Dünnschicht der deaktivierenden Baugruppe eine Schrumpffolie aus Polyolefin umfasst.
     
    4. Vorrichtung wie in Anspruch 1 definiert, in welcher das generell zylindrisch geformte Gehäuse im Wesentlichen transparent ist und in welchem die Vorrichtung ferner eine Abdeckung (133) einschließt, die das Gehäuse umschreibt und ein Fenster (133a) aufweist, welches das Shuttle (154) überlagert.
     
    5. Vorrichtung wie in Anspruch 1 definiert, die ferner eine Verwaltungslinie einschließt, die mit der Mengensteuerungsbaugruppe verbunden ist.
     
    6. Vorrichtung wie in Anspruch 5 definiert, wobei die Vorrichtung ferner einen abgeschirmten Verschluss (192) zum Beinhalten des Gehäuses und einer Strahlungsquelle zur Richtung von Strahlung zum abgeschirmten Verschluss umfasst.
     
    7. Vorrichtung wie in Anspruch 6 definiert, in welcher die Strahlungsquelle einen Elektronenstrahl umfasst.
     
    8. Vorrichtung wie in Anspruch 1 definiert, in welcher das mit Gewinde versehene Shuttle (154) eine Vielzahl von zirkumferenziell beabstandeten Ausrichtungsvorsprüngen (154p) einschließt, die innerhalb des füllungsfreien Raumes (156f) des Basisabschnitts (156e) des faltbaren Behälters (156) aufnehmbar sind.
     


    Revendications

    1. Appareil de distribution de fluides médicaux à un patient comprenant :

    (a) un boîtier de forme généralement cylindrique (132) ayant des première et deuxième extrémités (132a, 132b) et un conduit central s'étendant longitudinalement ;

    (b) un premier ensemble (134) relié à ladite première extrémité dudit boîtier, ledit premier ensemble comprenant :

    (i) un couvercle avant (136) ;

    (ii) une partie centrale fluidique (138) disposée dans ledit couvercle avant, ladite partie centrale fluidique ayant un alésage généralement cylindrique ;

    (iii) un sous-ensemble de pénétration (140) relié à ladite partie centrale fluidique, ledit sous-ensemble de pénétration comprenant une plaque de montage (141) et un élément de pénétration (142) relié à ladite plaque de montage et s'étendant le long dudit conduit central longitudinal dudit boîtier, ledit élément de pénétration ayant un passage de fluide (142a) ; et

    (iv) un ensemble de commande du débit (144) relié audit sous-ensemble de pénétration, ledit ensemble de commande du débit incluant un élément de commande du débit (146) ayant un micro-canal (150) formé dedans en communication avec ledit passage de fluide dudit élément de pénétration ;

    (c) un deuxième ensemble (152) porté par ledit boîtier (132) pour un déplacement par rapport à celui-ci entre une première position et une deuxième position avancée, ledit deuxième ensemble comprenant :

    (i) une navette filetée extérieurement (154) ; et

    (ii) un récipient démontable (156) porté par ladite navette filetée extérieurement (154), ledit récipient démontable (156) ayant un conduit central longitudinal aligné avec ledit conduit central longitudinal dudit boîtier (132) et incluant une partie col (54) ayant une paroi de fermeture (156c) et une partie base (156e) ayant un creux s'étendant vers l'intérieur (156f) ; et

    (iii) un manchon d'alignement (160) ayant un alésage axial (164a), ladite partie col (54) dudit récipient démontable (156) pouvant être reçue de manière télescopique dans ledit alésage axial (164a) dudit manchon d'alignement (160) ;

    (d) un capuchon d'extrémité fileté intérieurement (168) relié de manière filetée à ladite navette (154) pour un déplacement rotatif par rapport à celle-ci entre une première position et une deuxième position pour déplacer ladite navette (154) dudit deuxième ensemble (152) dans ledit boîtier (132) le long dudit conduit central s'étendant longitudinalement de ladite première position vers ladite deuxième position avancée, où ledit capuchon d'extrémité fileté intérieurement (168) inclut un doigt de verrouillage saillant vers l'extérieur (169) et ladite deuxième extrémité dudit boîtier de forme généralement cylindrique (132) est munie d'une multiplicité de saillies en forme de dents de scie espacés sur la circonférence (132p) pouvant être mises en prise par ledit doigt de verrouillage (169) ;

    (e) un moyen de stockage d'énergie associé de manière fonctionnelle à ladite navette (154) pour déplacer ladite navette (154) le long dudit conduit central s'étendant longitudinalement de ladite deuxième position avancée vers une autre position avancée ; et

    (f) un ensemble de désactivation (170) porté par ledit boîtier de forme généralement cylindrique pour empêcher la rotation dudit capuchon d'extrémité fileté intérieurement (168) dudit premier ensemble d'actionnement (70), ledit ensemble de désactivation comprenant un film mince (172) encapsulant ledit boîtier de forme généralement cylindrique (132) et une partie dudit capuchon d'extrémité fileté intérieurement (168).


     
    2. Appareil défini selon la revendication 1, où ledit moyen de stockage d'énergie comprend une pluralité de ressorts à force variable, espacés sur la circonférence (122, 176), portés par ladite navette.
     
    3. Appareil défini selon la revendication 1 dans lequel ledit film mince dudit ensemble de désactivation comprend un film de polyoléfine thermorétractable.
     
    4. Appareil défini selon la revendication 1, dans lequel ledit boîtier de forme généralement cylindrique est sensiblement transparent et dans lequel ledit appareil inclut en outre une enveloppe (133) entourant ledit boîtier et ayant une fenêtre (133a) superposée sur ladite navette (154).
     
    5. Appareil défini selon la revendication 1, incluant en outre un conduit d'administration relié audit ensemble de commande du débit.
     
    6. Appareil défini selon la revendication 5, où l'appareil comprend en outre une enceinte protégée (192) pour contenir le boîtier et une source de rayonnement pour diriger un rayonnement vers ladite enceinte protégée.
     
    7. Appareil défini selon la revendication 6, dans lequel ladite source de rayonnement comprend un faisceau d'électrons.
     
    8. Appareil défini selon la revendication 1, dans lequel ladite navette filetée (154) inclut une pluralité de saillies d'alignement espacées sur la circonférence (154p) pouvant être reçus dans ledit creux (156f) de ladite partie base (156e) dudit récipient démontable (156).
     




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    Cited references

    REFERENCES CITED IN THE DESCRIPTION



    This list of references cited by the applicant is for the reader's convenience only. It does not form part of the European patent document. Even though great care has been taken in compiling the references, errors or omissions cannot be excluded and the EPO disclaims all liability in this regard.

    Patent documents cited in the description