WO2024059039A1

WO2024059039A1 - Cartridge for dispensing medical material

Info

Publication number: WO2024059039A1
Application number: PCT/US2023/032487
Authority: WO
Inventors: Michael B. SCALISE; Thomas Shilling
Original assignee: ODSS Holdings, LLC
Priority date: 2022-09-12
Filing date: 2023-09-12
Publication date: 2024-03-21

Abstract

A cartridge for delivering a metered amount of a liquid medical substance may include, for example, a housing including walls defining an interior volume, wherein a first port and a second port are defined through at least one of the walls. A structure within the interior volume of the housing defines an interior volume holding the liquid medical substance to be metered, the interior volume of the structure being separated from the interior volume of the housing via the structure, the interior volume of the structure communicable with the second port to meter the liquid medical substance, wherein a pressure applied to the interior volume of the housing via the first port urges the liquid medical substance out of the housing via the second port.

Description

CARTRIDGE FOR DISPENSING MEDICAL MATERIAL

TECHNICAL FIELD

[0001] The present disclosure is related generally to cartridges for dispensing medical materials for intravenous infusion, as well as devices, methods, and kits, using such cartridges.

BACKGROUND

[0002] Intravenous (IV) infusion of fluids into a patient's bloodstream is a common medical procedure. Fluids that are typically administered intravenously include “normal” saline solutions, hypertonic saline solutions, balanced (crystalloid) solutions, colloid solutions, glucose solutions, blood-based products, blood substitutes, plasma solutions, and others. Often while an infusion is administered other medical fluids such as drugs may be introduced into the infusion.

[0003] Some common IV systems include a reservoir, and an infusion kit with a dripper, a tube, and a catheter with an IV needle. The reservoir, also sometimes called an IV bag, holds a quantity of the fluid to be infused. The reservoir is held above the patient so that the liquid is fed via gravity. The IV fluid passes from the reservoir to the dripper to the tube and into the patient via the catheter. The rate of flow of the fluid (called a drip rate) may be controlled by the dripper.

[0004] US Patent No. 10,556,061 B2 discloses a device, kit, and method for producing medically-deliverable intravenous solutions using liquid or solid concentrates and other liquids such as water and/or solvents. In this patent, containers are connected to a housing for metering out concentrates into liquid in a flow path within the housing, ultimately for immediate IV infusion into a patient from the housing outlet.

[0005] Further refinements in such containers, and related devices, kits, and methods of use, addressing one or more needs of existing devices or other needs, would always be welcome.

SUMMARY

[0006] According to certain aspects of the disclosure, a cartridge for delivering a metered amount of a liquid medical substance may include, for example, a housing including walls defining an interior volume; a first port extending though one of the walls; a second port extending though one of the walls; a flexible enclosure within the interior volume of the housing, the flexible enclosure defining an interior volume holding the liquid medical substance to be metered and further defining an opening in communication with the second port; and a check valve in the second port in communication with the interior area of the flexible enclosure, the check valve and second port being configured to meter the liquid medical substance though the second port when a liquid is introduced into the interior volume of the housing external to the flexible enclosure via the first port. Various options and modifications are possible.

[0007] For example, the liquid medical substance is may be a concentrated medical solution, for example, at least one of a medicine or a saline solution. The flexible enclosure may substantially fill the interior volume of the housing when the flexible enclosure is filled with the liquid medical substance. Liquid introduced through the first port may create a fluid pressure within the interior volume of the housing that urges the liquid medical substance through the second port. The housing may be configured with features on an exterior of at least one of the walls to at least one of guide and secure the cartridge into a device into which the liquid medical substance is dispensable.

[0008] The flexible enclosure may include an inner compartment holding particles, and the second port may be openable to allow introduction of a first liquid into the interior volume of the flexible enclosure via the inner compartment, the first liquid and the particles creating the liquid medical substance in the interior of volume of the flexible enclosure. If so, the inner compartment may define a plurality of openings spaced circumferentially around the inner compartment configured to spray the liquid and the particles in different directions within the interior volume of the flexible enclosure to thereby promote mixing of the particles and the first liquid.

[0009] The cartridge may include a digital identification device attached to the housing, the digital identification device storing electronically readable identifying information regarding the cartridge and the liquid medical substance. The digital identification device may include at least one of a barcode, a QR code, an RFID transceiver, or a semiconductor chip.

[0010] The housing may define a container portion and a lid attached to the container portion in a fluid-tight configuration so as to define the interior volume of the housing therein. The lid may be removably attachable to the container portion and the flexible enclosure may be removably attachable to the second port. After dispensing of the liquid medical substance from the flexible enclosure, the flexible enclosure may be considered a used flexible enclosure, the lid portion may be removed from the container portion, the used flexible enclosure may be thereafter removed from the second port, a replacement flexible enclosure holding a liquid medical substance may be thereafter attached to the second port, and the lid may be thereafter reattached to the container portion. The first port and the second port may be defined in the lid portion.

[0011] The flexible enclosure may be bag-shaped and attached to the housing only at the second port. The second port includes may include structure for retaining the flexible enclosure thereon. An exterior of the housing may define structures for aligning the housing with mating structures in an opening in a device into which the cartridge may be inserted. An exterior of the housing may define a shaped protrusion within a family of shaped protrusions, the shaped protrusion for identifying the cartridge and contents of the cartridge, the shaped protrusion for insertion into a mating structure in a device into which the cartridge may be inserted.

[0012] According to other aspects of the disclosure, a cartridge for delivering a metered amount of a liquid medical substance may include, for example, a housing including walls defining an interior volume, wherein a first port and a second port are defined through at least one of the walls; and a structure within the interior volume of the housing, the structure defining an interior volume holding the liquid medical substance to be metered, the interior volume of the structure being separated from the interior volume of the housing via the structure, the interior volume of the structure communicable with the second port to meter the liquid medical substance; wherein a pressure applied to the interior volume of the housing via the first port urges the liquid medical substance out of the housing via the second port. As above, various options and modifications are possible.

[0013] For example, the cartridge may further include a valve in the second port. The valve may be configured as a one-way valve allowing selective flow out of the housing, or as a two-way valve allowing selective flow into or out of the housing. The structure may include a flexible membrane, and the flexible membrane may be in the form of a bag with an opening seal ingly surrounding the second port. The first port may be configured for receiving therethrough a liquid to provide a hydraulic pressure within the interior volume of the housing. The interior volume defined by the structure may hold particles, and the second port may include a two-way valve for selectively allowing flow of a liquid into the interior volume defined by the structure to liquify the particles to thereby create the liquid medical substance. The two-way valve may selectively allow flow of the liquid medical substance out of the interior volume defined by the structure. The housing may define a container portion and a lid attached to the container portion in a fluid-tight configuration so as to define the interior volume of the housing therein.

[0014] According to other aspects of the disclosure, a device for dispensing IV solution includes a cartridge as described above inserted into a device as described herein for creation of a medically-deliverable IV liquid including liquid medical substance metered from the cartridge. Such a device includes at least one pump for pumping liquid into the first port of the cartridge to expel the liquid medical substance from the second port.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Fig. 1 is an isometric view of one version of a device for producing a medically-deliverable intravenous solution according to certain aspects of the disclosure using one or more cartridges as disclosed herein, with front covers of the device in a closed position.

[0016] Fig. 2 is an isometric view of the device of Fig. 1 , with the front covers in an opened position showing a number of removable/replaceable cartridges in place in the housing.

[0017] Fig. 3 is a schematic view illustrating the functions, connections, and possible uses of different types of devices for producing a medically-deliverable intravenous solution in different environments, using one or more cartridges as disclosed herein.

[0018] Fig. 4 is a schematic sectional view of a cartridge according to certain aspects of the disclosure with a flexible enclosure in a filled configuration.

[0019] Fig. 5 is a side view of a case portion of a cartridge as in Fig. 4.

[0020] Fig. 6 is a bottom view of the case portion of Fig. 5.

[0021] Fig. 7 is a side view of a cover portion of a cartridge as in Fig. 4, having a square key in a first orientation.

[0022] Fig. 8 is a top view of the cover portion of Fig. 7.

[0023] Fig. 9 is a bottom view of the cover portion of Fig. 7. [0024] Fig. 10 is a side view of an alternate cover portion of a cartridge having a square key in a second orientation 45 degrees rotated relative to the key of Fig. 7.

[0025] Fig. 11 is a schematic sectional view of the flexible enclosure portion of a cartridge as in Fig. 4 in a filled configuration.

[0026] Fig. 12 is a schematic sectional view of the cartridge as in Fig. 4, with the flexible enclosure in an emptied configuration.

[0027] Fig. 13 is a side view of an alternative cover with a flexible enclosure that holds solid particles therein.

[0028] Fig. 14 is a top schematic view of the cover and flexible enclosure of Fig. 13.

[0029] Fig. 15 is a schematic view of components and functions of a device, similar to those in Figs. 1-3, that could be used with cartridges as described herein.

DETAILED DESCRIPTION

[0030] Detailed reference will now be made to the drawings in which examples embodying the present disclosure are shown. The detailed description uses numeral and letter designations to refer to features in the drawings. Like or similar designations in the drawings and description have been used to refer to like or similar parts of the disclosure.

[0031] The drawings and detailed description provide a full and enabling description of the disclosure and the manner and process of making and using it. Each embodiment is provided by way of explanation of the subject matter not limitation thereof. In fact, it will be apparent to those skilled in the art that various modifications and variations may be made to the disclosed subject matter without departing from the scope or spirit of the disclosure. For instance, features illustrated or described as part of one embodiment may be used with another embodiment to yield a still further embodiment.

[0032] Generally speaking, the present disclosure is directed to aspects of dispensing cartridges for metering medical materials, and to devices, kits, and methods using such cartridges. The materials may be liquid or solid, and may be mixed with a liquid such as water and/or a solvent.

[0033] Figs. 1-3 show aspects of one possible device for creating a medically- deliverable IV solution using one or more cartridges. It should be understood that the device of Figs. 1 and 2 is but one example of many, portable or non-portable, that could be used with the cartridges disclosed herein. The disclosure of Figs. 1 and 2 should therefore be considered only an explanatory embodiment and not a limitation of the disclosure.

[0034] With reference to the figures, a device 20 includes a housing 22 having an openable lid 24. Much of lid 24 includes a display 26, which may be an inputoutput device having a touch screen, buttons, knobs, etc. A liquid inlet 28 and a liquid outlet 30 are provided on housing 22. Liquid inlet 28 may employ any suitable connection or adapter such as a snap fit, luer lock, threading, “camelback” type connector, etc., for connection to one or more types of sources of liquid, such as a transportable container of liquid S1 , a municipal or other regional source of liquid with a fixed outlet S2, or an environmental source of liquid S3. Liquid outlet 30 may employ various connectors, and may be configured to connect to a conventional IV infusion kit 32, one or more of which may be supplied in a compartment 34 beneath a lid 36 within housing 22. Outlet 30 may function as a drip infusion IV source and/or an infusion pump IV source. The created liquids may be infused into a patient P or stored in a container C for later use.

[0035] A flow path through housing 22 between inlet 28 and outlet 30 can be considered a conduit through housing 22. A number of elements within housing 22 act on, modify, or add to fluid flowing through the conduit, as noted below, to create a medically-deliverable intravenous solution from a source of liquid supplied to inlet 28 and one or more concentrated substances added within housing 22. For example, one or more removable containers 38 may be provided for supplying a concentrate into the liquid flowing between inlet 28 and outlet 30. To achieve such flow, elements set forth in the devices disclosed in US Patent No. 10,556,061 , incorporated by reference herein, may be employed.

[0036] Fig. 3 shows a highly schematic view of the flow path through and components within the housing. Housing 22 may include a mixing channel 40 for receiving metered materials from one or more containers 38 into a liquid flow and/or a mixing chamber 42 where the metered materials and liquids may be further mixed and/or stored prior to IV infusion. The housing 22 may also include many features for creating and providing the IV infusible liquid, including for example, elements such as one or more pumps 44, valves 46, purification devices (such as filters and/or radiation sources) 48, power sources 50, a controller (e.g., a conventional integrated circuit, processor, memory holding data and a control program, etc., mounted for example on one or more printed circuit boards) 52, one or more sensors (e.g., flow rate, temperature, pressure, liquid type, liquid concentration, liquid fullness), a heating device 54, and other features.

[0037] Figs. 4-12 show aspects of one example of a container 60 that could be employed to meter a concentrated liquid or solid into a flow path within a device, such as housing 22. As illustrated, container 60 includes a housing 62 defining an interior volume 64 therein. Housing 62 includes a plurality of walls, which may be executed as a case 66 and a cover (lid) 68 that define within them the interior volume. First opening 70 and second opening 72 are ports defined through cover 68 so as to provide access to the interior volume 64 from outside of housing 62. First and/or second opening 70,72 may be an aseptic port that is activated by docking with the appropriate matching engagement structure in the device 20.

[0038] Case 66 is shown as generally cup-shaped and cover 68 is shown as generally planar, but alternative assembled configurations are possible, using two or more parts for creating housing 62. For example, both case 66 and cover 68 could be matingly cup-shaped. Also, one or both of openings 70,72 need not be defined in cover 68, as they could alternatively be located in case 66.

[0039] Case 66 and cover 68 are permanently or removably joined together via an attachment, such as a receiving groove 74 on cover 68 configured for receiving an edge 76 of case 66. The positions of such structures could be reversed, if desired. Case 66 and cover 68 may be made of a plastic, and may accordingly be joined by welding, adhesive, snap fit, or any other method providing an airtight and watertight seal. Alternatively, a sealing member such as an O-ring may be included to form or enhance the seal between parts. Other materials, and other joining and sealing methods and structures are also possible.

[0040] A digital data device 78 may be provided. Device 78 may be, for example, a one-or two way communicable wired or wireless device that provides identifying or status information regarding the cartridge and/or its contents. Device 78 may include, for example, an RFID transceiver, memory, and related circuitry for wireless communication; or it may include wired connectors for data and/or power connection to housing 22. Device 78 could also be external and include a readable barcode, QR code or the like. Device 78 may be mounted within or on a housing portion 80 that registers conventional connectors (not shown) of container 60 and housing 22 when container 60 is inserted into a corresponding slot 82 (Fig. 2) in housing 22.

[0041] Housing 62 may include ridges (84 on case 66 and 86 on cover 68) to ensure the container is properly registered and aligned with housing 22 during insertion and use. An optional protrusion 88 on cover 68 (whether located around a port or otherwise) may be one of a family of differently-shaped or differently oriented-protrusions, configured to function as a key to fit correspondingly shaped or aligned sockets in housing 22, and/or to provide tactile identification to a user. Protrusion 88 as illustrated is square, and alternate shapes could be round, triangular, hexagonal, etc., with each shape corresponding to the contents of its container 60 and a corresponding socket shape in a given slot 82 in the housing 22. Case 66a in Fig. 10 shows an alternate protrusion 88a, which is rotated 45 degrees relative to the position of protrusion 88 in Figs. 7-9, although protrusion 88a could also be round, triangular, etc., as noted above. The key and socket system is an optional safety mechanism to prevent installing an incorrect container in a given spot in the housing 22, and also allows a user to identify by feel a cartridge in a low light or dark environment. Use of the data device 78 also acts as safety/identification device, so that housing 22 and its controller 52 can determined by communication what is in a given container, and so that controls can be activated accordingly based on the container and its contents.

[0042] Fig. 4 shows flow into first opening/port 70 (arrow A) and flow out of second opening/port 72 (arrow B) (see also Figs. 11 and 12). Flexible enclosure (bag, pouch, etc.) 90 holds a concentrated medical solution to be metered into a flow within housing 22, for example via a downstream pump. Enclosure 90 is secured around an inner end of second opening/port 72 in an airtight and watertight fashion by seal or collar 92 (see Fig. 11). A flange 94 can secure seal 92 in place and therefore secure enclosure 90 to cover 68.

[0043] Flow A is liquid pumped by a pump within housing 22 into interior volume 64 of container 60 to pressure liquid within the interior of enclosure 90 out of the enclosure via second opening/port 72 (Flow B). It is thought that a pressure differential on the order of about 0.5 psi is sufficient to purge the liquid contents out of enclosure 90. If desired, a valve 96 may be employed in second opening/port 72, either activated (opened) when the cartridge is inserted into the housing, or activated by the pressure of the fluid pumped into the cartridge (i.e., acting as a one-way check valve) or downstream pumping to draw fluid in that direction. When liquid pumped into cartridge 60 has forced all liquid possible out of flexible enclosure 90, the flexible enclosure will be substantially compressed in the form shown in Fig. 12.

[0044] Figs. 13 and 14 show an alternate cover and flexible enclosure design, in which flow can be directed first into the flexible enclosure to dilute, dissolve, and/or mix certain contents in the container while filling the enclosure. After such filling, the structure of Figs. 13 and 14 operates similar to the previous embodiments, wherein fluid pumped into the container to urge the liquid out of the enclosure. As illustrated, cover 168 includes first opening/port 170, second opening/port 172, and protrusion 188. Flexible enclosure 190 may be pleated or folded for spatial efficiency and ensuring it unfolds to be fully filled with liquid. Flow A into second opening disperses a substance in inner housing 198, within flexible enclosure 190. The substance may be a powdered, particulate, dehydrated or other solid to be diluted by liquid, water, saline, a solvent, etc., following flow A. Inner housing 198 may be for example cylindrical, and may have a number of openings 200 defined therethrough to disperse the liquid and entrained substance into the interior of flexible enclosure, thereby mixing and/or dissolving the substance as needed. Alternatively, the substance could be a concentrated liquid having one or more components that are mixed, treated, or diluted by flow A of a particular complimentary liquid.

[0045] When flow B increases pressure within container 160, the liquid within flexible enclosure 190 is forced out of second opening/port 172 along arrows C. If desired, valve 196 in this embodiment may be a two-way check valve. It should be understood that valves 96/196 may simply protectively close port 72/172 when the cartridges are not in use, but be forced open (e.g., via contact with housing, overcoming a spring force, etc.) when inserted, with other valving or pumps upstream and downstream controlling or limiting flow, in combination with flow into port 70/170, any valves located therein, and/or the pressure differential caused by pumping within housing 22.

[0046] Thus, in using housing 22 (Figs. 1-3), one or more containers may be provided, connectable to housing and each holding a concentrated medical liquid and/or particulate solid. As shown, five containers 38 are inserted into openings 56 in housing 22. Each container 38 may (but need not) hold a different concentrated substance in a flexible enclosure. For example, containers may hold a concentrated saline solution, a blood plasma volume expander such as Hextend®, a drug such as morphine, a liquid such as potassium chloride, and a pH adjustment liquid. However, containers 38 may include any desired substance deliverable via intravenous infusion.

[0047] Each container may be in the form of an insertable and if desired, disposable or refillable, cartridge similar in concept to a printer cartridge. Cartridges may be used to form a saline solution such as what is conventionally called a “Normal Saline” (NS), a solution of 0.9% w/v of NaCI, about 300 mOsm/L. Less commonly, this solution is (perhaps inaccurately) referred to as physiological saline or isotonic saline. NS is used frequently in intravenous drips (IVs) for patients who cannot take fluids orally and have developed or are in danger of developing dehydration or hypovolemia. NS is typically the first fluid used when hypovolemia is severe enough to threaten the adequacy of blood circulation and has long been believed to be the safest fluid to give quickly in large volumes. Cartridges may also dispense “Half Normal Saline,” which is a similar product but with a 0.45% w/v of NaCI, or a “Hypertonic Saline.” Hypertonic Saline (HTS) refers to any saline solution with a concentration of NaCI higher than physiologic (0.9%). Commonly used preparations include 2%, 3%, 5%, 7%, and 23% NaCI. Cartridges can also dispense a Lactated Ringer Solution, which is a mixture of sodium chloride, sodium lactate, potassium chloride, and calcium chloride in water.

[0048] Device 20 as depicted can be sized and configured to be portable and mobile, and therefore can be placed in a typical first responder kit, emergency vehicle, medical facility, supply closet, military or hunting kit or facility, first aid kit, school, remote location, or carried by a hiker or in a vehicle, etc. If the device is instead being used to create a stockpile of medically-deliverable intravenous solution, it can be made larger, and could still be mobile (such as on a wheeled cart) or could be fixed in place in a building, for example near a source of power and liquid. The created solution could simply be saline solution or equivalents or substitutes with no additional medication, or the created solution can be combinations of such. The stockpiled solution could be used onsite, or could be shipped to alternate sites, as desired. Amounts can be made on-site periodically during down time to stock an emergency vehicle, medical facility, military vehicle, etc. [0049] Fig. 15 shows a schematic view of the organization of parts of a device that could be employed according to the present disclosure, with cartridges as discussed above. As shown, metering pumps and valves may be employed to transfer water, saline, medications, pH buffering solution, etc., through the depicted device. Inflow of liquid into the cartridges via their first openings purges the contents out of the cartridges and their internal pouches or the like via their second openings, although inflow into the powdered pharmaceutical cartridge occurs before such purging so that he powered material may be dissolved. Various filtration and purification steps may occur along the way, as shown. As shown, sensors can be provided to sense identity or quality of liquids, temperatures, pressures, etc., along the way as well.

[0050] In summary, for medical needs the cartridge approach to processing of inputs of water to produce medical grade injectable saline may include use of pH buffering as well as saline concentrates and medications. Interchangeable cartridges can provide the small, lightweight, and portable means to achieve these immediate in-situ processing goals. Liquid medications, other than saline, can also be stored and delivered in like manner.

[0051] Another great benefit of the cartridge approach to pharmaceutical medications is that they are available to an ever-greater extent in powdered form. This means that cartridges must be able to reconstitute powdered medications, as noted above. The mixing of sterile saline created within the device with powdered medication within a cartridge allows for immediate availability of such treatments as blood volume replacement from powdered plasma. The advantages of portability, long shelf life and light weight, along with immediate availability of injectable reconstituted dry plasma can save lives, if made available for use with portable pharmaceutical delivery devices.

[0052] The cartridge approach to other liquids or dissolvable materials is unlimited in scope and is intended to be explicitly applicable to these materials, other than but including medical, without constraining the scope of this disclosure

[0053] A cartridge has certain useful attributes where urgent medical care or other applications require. Portability while providing sterile containment that is secure, aseptically connectable, and able to carry documentation/identification through updatable electronic or physical means are beneficial. [0054] The preferred embodiments noted above provide a cartridge of a volume allowing for containment of a meaningful and appropriate amount of liquid or powdered content to be packaged at a pharmaceutical or other appropriate supplier. The cartridge is embodied so as to do this by use of a housing, optionally inclusive of internal collapsible bladder or pouch, and a base that can be assembled securely but inexpensively. This may be done by manual means, such as using adhesives for low volume production or ultrasonic or thermal welding as in the case of semiautomated or automated production.

[0055] For UV protection, the cartridge may be of a UV blocking plastic or other appropriate material. In the case of photo-reactive pharmaceuticals or other material, the case may be opaque. For powdered pharmaceuticals, the case may be all or partly transparent for visual verification of reconstitution being complete. (“Reconstitution” meaning the conversion of powdered cartridge content being liquified by the introduction of a solvent, such as water, saline or other, so as to render the powder as a useable liquid medication or otherwise.)

[0056] The access for dispensing of the liquid from the cartridge is by means of an aseptic port that is activated by docking with the appropriate matching engagement structure in the device housing to allow for the exiting of the liquid contained therein. This, and any other access orifice to the contents of the cartridge may be sealed with a removable film to ensure preservation of sterility of the contents during handling, transportation, or storage.

[0057] Within the case, according to the above embodiments, there is a bladder or flexible collapsible pouch that is internally in intimate contact with the liquid. The liquid is within this bladder or pouch, which may be elastomeric or non- elastomeric, depending upon the functional characteristics of the processing device to which the cartridge is attached.

[0058] The use of an internally enclosed elastomeric pouch allows the propulsion/dispensing of the contents of the cartridge to be induced by means of a supply of a second, non-interacting fluid into the cartridge but outside of the pouch. Inflow of the non-interacting fluid surrounds the pouch and exerting an expulsive force by means of increasing volume within the fixed volume of the cartridge. This water source provides a raised pressure for the delivery of the liquid contained within the bladder or pouch into the aseptic dispensing port that is integral to the cartridge bottom base part. [0059] The base of the cartridge may have an added mechanical feature, as may be required for providing a docking key, so that the cartridge is formed so as to allow only access to its aseptic port if the shape of the feature matches the receiving shape of the docking station of any functional device that may require the specified cartridge type and or contained substance as required by this matching shape arrangement. This feature is intended to prevent wrong docking placement of the cartridge during circumstances of darkness or other impairment of determining correct docking location(s). The packaging of the cartridge should be sterile as the cartridge is provided as able to be sterilized prior to packaging and use of any type of sterilization method is accounted for in the selection of the materials of the cartridge embodiment and its contents as appropriate.

[0060] The cartridge case also has along its perimeter, at any appropriate location, a containment volume for housing a digital data chip, or other wired or wireless identifier. The chip is so presented as to engage the communication device, such as a standard receiving socket, which is available at any compatible docking site, or to be reactive when signaled via RFID means. Optionally, the chip may be hermetically sealed within the case and only exposed reference contacts are made available to matching contactors at the docking site. Bidirectionally, the information about the contents may be made available as required for any purpose required by the functional processing device regarding the cartridge and its contents. The digital chip may also be of the read-write type where in the tracking of content utilization and available content status may be recorded as well as remaining liquid content volume available at any given moment. Other records such as expiration dates, use and volume used dates, and any such like required records, may be maintained and kept in the chip, even in circumstances of intermittent docking.

[0061] The case of the cartridge may have a special placement area for physical labeling regarding identification of contents and other information. The case may have additional features that are tactile identifiers for manual manipulation of the cartridge without visual assistance.

[0062] While preferred embodiments of the invention have been described above, it is to be understood that any and all equivalent realizations of the present invention are included within the scope and spirit thereof. Thus, the embodiments depicted are presented by way of example only and are not intended as limitations upon the present invention. Thus, while particular embodiments of the invention have been described and shown, it will be understood by those of ordinary skill in this art that the present invention is not limited thereto since many modifications can be made. Therefore, it is contemplated that any and all such embodiments are included in the present invention as may fall within the literal or equivalent scope of the appended claims.

Claims

1 . A cartridge for delivering a metered amount of a liquid medical substance, the cartridge comprising: a housing including walls defining an interior volume; a first port extending though one of the walls; a second port extending though one of the walls; a flexible enclosure within the interior volume of the housing, the flexible enclosure defining an interior volume holding the liquid medical substance to be metered and further defining an opening in communication with the second port; and a check valve in the second port in communication with the interior area of the flexible enclosure, the check valve and second port being configured to meter the liquid medical substance though the second port when a liquid is introduced into the interior volume of the housing external to the flexible enclosure via the first port.

2. The cartridge of claim 1 , wherein the liquid medical substance is a concentrated medical solution.

3. The cartridge of claim 1 or 2, wherein the liquid medical substance includes at least one of a medicine or a saline solution.

4. The cartridge of one of claims 1 to 3, wherein the flexible enclosure substantially fills the interior volume of the housing when the flexible enclosure is filled with the liquid medical substance.

5. The cartridge of one of claims 1 to 4, wherein the liquid introduced through the first port creates a fluid pressure within the interior volume of the housing that urges the liquid medical substance through the second port.

6. The cartridge of one of claims 1 to 5, wherein housing is configured with features on an exterior of at least one of the walls to at least one of guide and secure the cartridge into a device into which the liquid medical substance is dispensable.

7. The cartridge of one of claims 1 to 6, wherein the flexible enclosure includes an inner compartment holding particles, and the second port is openable to allow introduction of a first liquid into the interior volume of the flexible enclosure via the inner compartment, the first liquid and the particles creating the liquid medical substance in the interior of volume of the flexible enclosure.

8. The cartridge of claim 7, wherein the inner compartment defines a plurality of openings spaced circumferentially around the inner compartment configured to spray the liquid and the particles in different directions within the interior volume of the flexible enclosure to thereby promote mixing of the particles and the first liquid.

9. The cartridge of one of claims 1 to 8, further including a digital identification device attached to the housing, the digital identification device storing electronically readable identifying information regarding the cartridge and the liquid medical substance.

10. The cartridge of claim 9, wherein the digital identification device includes at least one of a barcode, a QR code, an RFID transceiver, or a chip.

11 . The cartridge of one of claims 1 to 10, wherein the housing defines a container portion and a lid attached to the container portion in a fluid-tight configuration so as to define the interior volume of the housing therein.

12. The cartridge of claim 11 , wherein the lid is removably attachable to the container portion and the flexible enclosure is removably attachable to the second port.

13. The cartridge of claim 12, wherein after dispensing of the liquid medical substance from the flexible enclosure the flexible enclosure is a used flexible enclosure, the lid portion may be removed from the container portion, the used flexible enclosure may be thereafter removed from the second port, a replacement flexible enclosure holding a liquid medical substance may be thereafter attached to the second port, and the lid may be thereafter reattached to the container portion.

13. The cartridge of claim 12, wherein the first port and the second port are defined in the lid portion.

14. The cartridge of one of claims 1 to 13, wherein the flexible enclosure is bag-shaped and is attached to the housing only at the second port.

15. The cartridge of claim 14, wherein the second port includes structure for retaining the flexible enclosure thereon.

16. the cartridge of one of claims 1 to 15, wherein an exterior of the housing defines structures for aligning the housing with mating structures in an opening in a device into which the cartridge may be inserted.

17. The cartridge of one of claims 1 to 16, wherein an exterior of the housing defines a shaped protrusion within a family of shaped protrusions, the shaped protrusion for identifying the cartridge and contents of the cartridge, the shaped protrusion for insertion into a mating structure in a device into which the cartridge may be inserted.

18. A cartridge for delivering a metered amount of a liquid medical substance, the cartridge comprising: a housing including walls defining an interior volume, wherein a first port and a second port are defined through at least one of the walls; and a structure within the interior volume of the housing, the structure defining an interior volume holding the liquid medical substance to be metered, the interior volume of the structure being separated from the interior volume of the housing via the structure, the interior volume of the structure communicable with the second port to meter the liquid medical substance; wherein a pressure applied to the interior volume of the housing via the first port urges the liquid medical substance out of the housing via the second port.

19. The cartridge of claim 18, further including a valve in the second port.

20. The cartridge of claim 19 or 20, wherein the valve is configured as a oneway valve allow selective flow out of the housing.

21 . The cartridge of claim 19 or 20, wherein the valve is configured as a two- way valve allow selective flow into or out of the housing.

22. The cartridge of one of claims 18 to 21 , wherein the structure includes a flexible membrane.

23. The cartridge of claim 22, wherein the flexible membrane is in the form of a bag with an opening sealingly surrounding the second port.

24. The cartridge of one of claims 18 to 23, wherein the first port is configured for receiving therethrough a liquid to provide a hydraulic pressure within the interior volume of the housing.

25. The cartridge of one of claims 18 to 24, wherein the interior volume defined by the structure holds particles, and wherein the second port includes a two- way valve for selectively allowing flow of a liquid into the interior volume defined by the structure to liquify the particles to thereby create the liquid medical substance.

26. The cartridge of claim 25, wherein the two-way valve selectively allows flow of the liquid medical substance out of the interior volume defined by the structure.

27. The cartridge of claim 26, wherein the housing defines a container portion and a lid attached to the container portion in a fluid-tight configuration so as to define the interior volume of the housing therein.

28. A device including a cartridge of any of claims 1-27 inserted into a device as described herein for creation of a medically-deliverable IV liquid including liquid medical substance metered from the cartridge.

29. The device of claim 28, the device including at least one pump for pumping liquid into the first port of the cartridge to expel the liquid medical substance from the second port.