Patent Application
20100022953
Therapeutic treatments can sometimes involve parenteral delivery of a variety of medications according to protocols that require specific timing and dosages. Such complex protocols of medical infusions can cause confusion by healthcare workers and lead to treatment mistakes. Life-threatening medical emergencies, for example, can require complicated protocols involving the injection of multiple potent and potentially dangerous medications. An example of such a critical medication decision and action sequence is the ACLS (Advanced Cardiac Life Support) protocol set forth by the American Heart Association (AHA). This protocol is complicated, requiring even experienced emergency physicians to carry booklets with them in order that they can refer to them during cardiac emergencies. This is complemented by a “crash cart” that contains supplies that are used during an emergency and includes a drawer full of syringes and bottles of medications used during the ACLS protocol. The use of booklets and crash carts with the need to open boxes, prepare syringes and draw up specific doses of medications, while helpful, still offers opportunities for delay and error.
Access to the medications themselves can also cause delay and error during the administration of a complex treatment protocol. To administer medications to a patient, healthcare workers need to locate the various medications, remove them from their cardboard containers, assemble the syringes, uncap the needles, draw the proper dosage of medication into the syringe, and inject the dose into a patient fluid line while under sterile technique. The process wastes precious time, is prone to dosing errors, and increases the risk of needle sticks to the healthcare workers.
Disclosed herein is a medication delivery cartridge. The cartridge includes a casing having an internal cavity extending between a proximal end and a distal end of the casing. The cartridge also includes a plunger translatable within the internal cavity and having a penetrable fluid outlet. The cartridge also includes a volume of medicine contained within the internal cavity disposed between the plunger and the proximal end of the casing. The cartridge includes a first penetrable sterility barrier spanning the internal cavity proximate the distal end of the casing.
The first penetrable sterility barrier can include one or more scored features that aid in penetrating the first penetrable sterility barrier. The scored feature(s) can be biased toward a preferential tear pattern in the first penetrable sterility barrier upon penetration.
The cartridge can also include an outer housing surrounding at least a portion of the casing. The outer housing can include a closed distal end region and an open proximal end region. The casing can be translatable relative to the outer housing in a first direction. The outer housing can further include a dispensing element disposed between the proximal end region of the casing and the closed distal end region of the housing. The dispensing element can impart a force on the proximal end of the casing to translate the casing relative to the outer housing in the first direction. The dispensing element can be a compressed spring, a volume of compressed gas, or a push rod. Translation of the plunger within the internal cavity or translation of the casing relative to the plunger can each reduce a volume of the internal cavity.
The cartridge can further include one or more fluid port assemblies each having a connector. The connector can have an internal bore extending between an open proximal end and a distal end of the connector. The cartridge can also include a receiver surrounding the connector and including a second penetrable sterility barrier spanning the open proximal end of the bore and a sleeve surrounding the connector and disposed within the receiver. The distal end of the connector can fluidically couple to a medication-receiving fluid conduit having a fluid inlet at a first region and a fluid outlet conduit that can couple to a patient catheter line at a second region. The casing can be translatable within the receiver of the fluid port assembly. The receiver and second penetrable sterility barrier can maintain the connector in a sterile condition. The sleeve can abut the plunger when the connector penetrates the fluid outlet of the plunger and restrict movement of the plunger upon translation of the casing relative to the fluid port assembly. Translation of the casing and restriction of plunger movement can reduce a volume of the internal cavity and evacuate at least a portion of the volume of medication out the fluid outlet of the plunger into the open proximal end of the connector.
The outer housing of the cartridge can further include a first alignment feature. The receiver can include a second alignment feature having a shape complementary to the first alignment feature of the outer housing. The first alignment feature of the outer housing can engage the second alignment feature and fix the outer housing to the fluid port assembly.
The second penetrable sterility barrier can include one or more scored features that each aids in penetrating the second penetrable sterility barrier. The scored feature(s) can be biased toward a preferential tear pattern in the second penetrable sterility barrier upon penetration. The preferential tear pattern can prevent contamination of the open proximal end of the connector upon fluidically coupling the casing and the fluid port assembly. The casing can further include a disabling feature at the distal end region to contact the scored feature(s) of the second penetrable sterility barrier of the receiver. The sleeve surrounding the connector can disable the second penetrable sterility barrier.
Also disclosed herein is an interrelated medication delivery system. The system includes a medication-receiving fluid conduit having a fluid inlet at a first region and a fluid outlet conduit adapted to couple to a patient catheter line at a second region. The system also includes one or more fluid port assemblies. The fluid port assembly includes a connector having an internal bore extending between an open proximal end and a distal end of the connector and a first sterility barrier surrounding the connector and including a first penetrable member spanning the open proximal end of the bore. The distal end of the connector can fluidically couple to the fluid inlet of the medication-receiving fluid conduit when the first penetrable member is penetrated. The system also includes an outer housing surrounding at least a portion of the casing. The outer housing can include a closed distal end region and an open proximal end region. The system also includes a medication delivery cartridge. The cartridge includes a casing having an internal cavity extending between a proximal end and a distal end of the casing. The cartridge also includes a plunger translatable within the internal cavity, the plunger having a penetrable fluid outlet. The cartridge also includes a volume of medicine contained within the internal cavity disposed between the plunger and the proximal end of the casing. The cartridge also includes a second sterility barrier proximate the distal end of the casing. The second sterility barrier has a second penetrable member spanning the internal cavity. The cartridge can be translatable relative to the outer housing in a first direction.
The first member spanning the open proximal end of the bore can include one or more scored features that each aids in penetration of the first member. The second member can include one or more scored features that each aids in penetration of the second member. The scored features can be biased toward a preferential tear pattern upon penetration. The cartridge can further include a first disabling feature at the distal end region of the casing to contact the scored feature(s) of the first member of the first sterility barrier. The fluid port assembly can further include a second disabling feature to contact the scored feature(s) of the second member of the second sterility barrier.
The outer housing can further include a first alignment feature. The first sterility barrier can further include a second alignment feature having a shape complementary to the first alignment feature of the outer housing. The first alignment feature of the outer housing can engage the second alignment feature and fix the outer housing to the fluid port assembly.
Translation of the plunger within the internal cavity or translation of the casing relative to the plunger can reduce a volume of the internal cavity. The system can further include a sleeve surrounding the connector and disposed within the first sterility barrier. The sleeve can abut the plunger when the connector penetrates the fluid outlet of the plunger and restrict movement of the plunger upon translation of the cartridge relative to the fluid port assembly. Translation of the casing and restriction of plunger movement can reduce a volume of the internal cavity and evacuate at least a portion of the volume of medication out the fluid outlet of the plunger and into the open proximal end of the connector. The sleeve surrounding the connector can penetrate the second member of the cartridge.
The outer housing can farther include a dispensing element disposed between the proximal end of the casing and the closed distal end region of the housing. The dispensing element can impart a force on the proximal end of the cartridge to translate the cartridge relative to the outer housing in the first direction. The dispensing element can be a compressed spring, a volume of compressed gas, or a push rod. The system can further include an activation element that, when activated, causes the dispensing element to translate the cartridge in the first direction relative to the outer housing. The activation element can be a retaining pin, an energy source, a motor, or manual pressure by a user.
Also disclosed herein is an interrelated medication delivery device. The device includes a cartridge and a cartridge receiver. The cartridge includes an outer housing, a cartridge casing, a plunger, a volume of medicine and a first penetrable sterility barrier. The cartridge casing includes an internal cavity extending between a proximal end and a distal end of the cartridge casing. At least a portion of the cartridge casing is translatable within the outer housing. The plunger is translatable within the internal cavity and includes a penetrable fluid outlet. The volume of medication is contained within the internal cavity disposed between the plunger and the proximal end of the cartridge casing. The first penetrable sterility barrier is proximate to the distal end of the cartridge casing and spans the internal cavity. The cartridge receiving is reversibly coupled to the outer housing of the cartridge. The cartridge receiver includes a receiver casing having an open proximal end. The cartridge receiver includes a fluid conduit disposed within the receiver casing and extending between a fluid inlet and a fluid outlet. The cartridge receiver includes a second penetrable sterility barrier spanning the open proximal end of the receiver casing.
The subject matter described herein provides many advantages. For example, the current subject matter allows for the rapid delivery of medications, such as the ACLS protocol, with less delay and probability for error so that doctors and other medical specialists can quickly and safely focus on patient symptoms and responses rather than the details of administering the protocol. The current medication delivery system improves the reliability, speed, accuracy, and ease of administering, such as in emergency situations.
More details of the devices, systems and methods for delivering medications are set forth in the accompanying drawings and the description below. Other features and advantages will be apparent from the description and drawings, and from the claims.
These and other aspects will now be described in detail with reference to the following drawings. Generally speaking the figures are not to scale in absolute terms or comparatively but are intended to be illustrative of claimed features. Also, relative placement of features and elements may be modified for the purpose of illustrative clarity.
Described herein are devices, systems and methods for rapidly delivering medications, such as for the ACLS protocol, with less delay and probability for error so that doctors and other medical specialists can quickly and safely focus on patient symptoms and responses rather than the details of administering the protocol. Described herein are devices, systems and methods that deliver medication that improves reliability, speed, accuracy, and ease of administering such as in emergency situations. The medication delivery systems described herein are of a relatively small size such that they can be easily stored and readily transported, such as on a “crash cart.” The medication delivery systems described herein can be used in a hospital or another healthcare setting such as in an ambulance, skilled nursing facility, medical clinic, and the like. The medication delivery systems described herein can be used for adult or pediatric patients. The medication delivery systems can be used with a variety of routes of administration such as parenteral routes of administration including intravenous (IV) or intraosseous (IO).
A medication delivery system is depicted in block diagram form according to
The system 2 can also include a plurality of cartridge-receiving ports or cartridge interfaces 18 and a flush interface 19 that can selectively activate cartridges 6 as well as a fluid source 14 to enable medications to be selectively delivered from cartridges 6 to medication-receiving conduit 4 for the rapid delivery of bolus infusions. Each cartridge 6 at a cartridge interface 18 can be manual activated, electrically activated via controller 20 and selectively either manually or electronically activated. It should be appreciated that manual mode can be available or selected even when the system 2 is being used in an automatic mode. For example, the manual administration of a drug can be available as a back-up operating mode in the event of some kind of failure in the system. Cartridges and, if present, cartridges carried within one or more cassettes can remain in place during manual administration.
Each cartridge 6 can contain a predetermined, initial volume of medication sometimes referred hereafter as a “bolus” of medication. A cartridge 6 can inject the full bolus of medication into medication receiving conduit 4 in response to activation. The “bolus” can be equal to a maximum prescribed medication which would be given to an adult patient, for example. Delivery of the bolus can occur rapidly.
The system 2 can optionally include a “controlled bolus” dosage metering system 200 that can be internal or external to the system 2. The dosage metering system 200 can control fluid outflow in pulsed increments from the system such that aliquots of medication are delivered to the patient. Dosage metering system 200 can receive fluid from medication receiving conduit 4 and provide at least a portion of the full bolus to output conduit 16. Dosage metering system 200 can operate in at least two selectable modes: a “bolus” mode and a “controlled bolus” or metering mode. In the “bolus” mode the metering system 200 can deliver the full bolus of medication to output conduit 16. In the “controlled bolus” mode the metering system 200 can control the delivery amount of the full bolus. For example, the metering system 200 can control or meter a prescribed aliquot dosage of medication to output conduit 16. An aliquot dosage of medication can be less than the full bolus of medication contained within the cartridge 6.
Controller 20 can be coupled to I/O 22 and user interface 24 that includes display 26. I/O 22 allows external devices such as a computer to be coupled to system 2 enabling external control of system 2 and/or information to be received from or sent to system 2. User interface 24 can be used to control system 2 or to view a status of system 2 via display 26. Each cartridge interface 18 can include one or more sensors that provide status information to controller 20 indicative of a status of each cartridge 6. Such status information can be indicative of whether one or more cartridges 6 are present, whether a cartridge 6 is being activated, whether the proper cartridge is loaded, proper loading of cartridge, whether a cartridge 6 has already been activated and/or whether it has functioned properly, what drug is pre-loaded and into which cartridge, completion of medication dispense and the like. If a cartridge 6 is loaded into a cassette 8, the cassette 8 can also include one or more sensors and provide feedback information about cartridge status as well as cassette status.
Controller 20 can receive instructions that define a prescribed controlled bolus dosage of a medication from a cartridge 6 to be delivered to a patient such as over a period of time for medication delivery. The instructions can be received from user interface 24 or from I/O 22. Prescribed controlled bolus dosage can be equal to or less than the full bolus or a dosage equal to or less than the full bolus amount. In response to the instructions the controller 20 can select a “bolus” mode if the prescribed dosage desired equals the full bolus to be delivered immediately to output conduit 16. Alternatively, the controller 20 can select a “controlled bolus” metering mode if the prescribed dosage desired is less than the full bolus or if there is a need to meter an aliquot of medication over a controlled time period.
The metering system 200 can deliver the full bolus of medication from cartridge 6 if the “bolus” mode is selected. The metering system 200 can also meter a prescribed controlled bolus dosage if the “controlled bolus” metering mode is selected wherein the prescribed dosage may be less than the full bolus or it may be the full bolus that is metered over a controlled time period. The delivery rate can be selected to dispense medication over a period of time until the selected metered amount has been fully delivered to the outgoing conduit 16. Additionally, the rate for a specific medication can be non-linear in that the rate changes over a period of time.
The dosage metering system 200 can also be used as a safety mechanism. Should a cartridge 6 mistakenly release an unintended bolus of medication, controller 20 can block the dose by diverting the unintended medication to a waste container 203 contained within dosage metering system 200 (see
As mentioned previously, dosage metering system 200 can selectively operate in a “bolus” mode and a “controlled bolus” metering mode. In the “bolus” mode dosage metering system 200 can provide a bolus medication delivery by routing medication received from a cartridge 6 through a bypass conduit 201. During this mode, valve 205 can couple medication receiving conduits 4 to bypass conduit 201 which passes medicated fluid to output conduit 16. In the “bolus” mode the full dose of medication provided by cartridge 6 can be delivered to a patient. The bolus can be a maximum prescribed amount for a patient. If, however, the prescribed amount is less than this bolus amount then the metering mode can be used to set an aliquot of medication to be delivered as described below.
In the “controlled bolus” metering mode dosage metering system 200 uses dosage metering device 202 to meter a prescribed amount of medication received from cartridge 6 to output conduit 16. During this mode, valve 205 can couple the medication receiving conduits 4 to dosage metering device 202. Dosage metering device 202 can meter an aliquot of medication over a period of time or simply a rate of delivery from cartridge 6 according to the prescribed amount.
After the prescribed amount of medication has been metered by dosage metering device 202, valves 204 and 205 can operate cooperatively to discard any remaining medication from cartridge 6 and upstream fluid conduit to waste container 203. Valve 205 can close while valve 204 remains opens to allow medication to flow from cartridge 6 to waste container 203. A pump in dosage metering device 202 can transfer any remaining medication to waste container 203. The pump 14b can flush any remaining medication to waste container 203. In other words, the full bolus volume of the medication can be evacuated from the cartridge and the non-prescribed portion can be discarded into a waste container or other reservoir. As a safety feature, the fluid can also pass first to the container 203 to deliver an unwanted portion of the medication from cartridge 6 and then deliver the remaining prescribed dosage aliquot of medication to the patient.
As mentioned, the flush pump 14b can be used to flush remaining medication to waste container 203. The type of pump can vary. Pumps can include positive displacement pumps, peristaltic pumps, diaphragm pumps, syringe pumps, positive pressure bag squeezing pumps, pressurized gas pumps, or other type of parenteral mediation delivery pumps. The pump can be under control of controller 20.
The system 2 can also include a pump that controls flow of medication from the cartridge to the patient. In an example, the system 2 can include a reciprocating piston pump, or other pump as mentioned previously, that could be positioned downstream of the medication cartridge. The pump can be self-metering in that it pushes a known amount of fluid into the medication-receiving conduit 4 with each piston stroke. Each port position for each cartridge loaded into the system could include a separate pump and piston.
The system provides a plurality of single-dose medication packages that can be compactly housed in an array of cartridges that facilitate ease of proper loading within the system. Cartridges 6 can be carried in cassettes 8 (8a, 8b, and 8c). The cassette 8 can be a housing having multiple support features that position, support and align along one or more axes the plurality of cartridges 6 for loading together into the system 2. Cassettes 8 can facilitate proper organization and loading of cartridges 6 so that cartridges 6 do not need to be individually loaded in the system and connected to each corresponding medication-receiving conduit in the system. Cassettes 8a, 8b, and 8c can be individually associated with corresponding medication-receiving conduits 4a, 4b, and 4c, respectively. Upon being loaded into system 2, cassette 8a, 8b, and 8c can selectively inject medication from cartridges 6 into medication-receiving conduit 4a, 4b and 4c, respectively. The plurality of cartridges 6 loaded into one or more cassettes 8 facilitates the speed and ease of administering a large number of medications to a patient. The cassettes allow for a rapid and accurate association of each cartridge to a specific medication-receiving conduit and maintain an economical, compact design with respect to size of the overall system.
Each cassette 8 (one of 8a, 8b, 8c) can have a columnar dimension defined along a columnar axis C. Cartridges 6 within a cassette 8 can be generally arranged in a columnar group also along columnar axis C. A portion of medication-receiving conduit 4 that receives medication from cassette 8 can generally pass fluid from input conduit 10 to output conduit 16 along or parallel to columnar axis C according to the system depicted in
While three cassettes 8a-8c are shown in the figures, more than or less than three cassettes 8 are considered herein or to distribute or carry cartridges 6 among cassettes 8 differently. For example, more than one cassette 8 can hold cartridges 6 for a given medication-receiving conduit 4. As another example, cassettes 8 can be aligned generally perpendicular to the flow path of fluid through medication-receiving conduits 4 such that a single cassette delivers fluid to more than one medication-receiving conduit 4. In yet another example, cassettes can be aligned in a variety of axes to facilitate a compact and effective means for incorporating a multitude of cassettes to deliver fluid from multitude cartridges to more than one medication-receiving conduit 4.
When medication has been injected or dispensed by a cartridge 6 into a medication-receiving conduit 4, pressurized fluid solution source 14 can provide a pressurized fluid into input conduit 10 to deliver the medication to output conduit 16 and to a patient (not shown). Fluid source 14 can include a film bag reservoir 14a containing a fluid such as saline and a peristaltic pump 14b. A valve 28 can be used to prevent backflow of fluid when pump 14b is activated or when cartridge 6 is delivering medication. Valve 28 can be, for example, a one-way valve or check valve that allows forward fluid flow from external fluid source 12 and through conduit 10 toward medication-receiving conduits 4 but resists backflow. The configuration of valve 28 can vary, for example, the valve can be a one-way check valve such as a ball, diaphragm, duck bill, swing, clapper, stop-check, lift-check, double check, double ball, pressure differential valve and other valves known in the art. Valve 28 can also be a controllable valve. Each medication-receiving conduit 4 (4a, 4b, 4c) can have an associated valve 30 (30a, 30b, 30c respectively) that prevents backflow when medication is being injected into conduit 4 (when a cartridge 6 is delivering medication) and to selectively leave open only one conduit (that just received medication) when pump 14b is activated. The valves controlling the branched fluid conduits can provide for better flushing and also renders the system fluid-tight and ensures the rapid delivery of medication to a patient.
The three cassettes depicted can include a plurality of medications. The plurality of medications can be selected based on an ACLS (Advanced Cardiac Life Support) protocol. Medications can include, for example, (labeling of cartridges in figure indicated in parenthesis) epinephrine (EP), lidocaine (LI), amiodarone (AM), atropine (AT), magnesium sulfate (MS), naloxone (NX), adenosine (AD), sodium bicarbonate (SB), dextrose (DX), vasopressin (V), and calcium chloride (CC). More or less can be included in more or less than, for example, three cassettes. Variations of these or other medications for an ACLS protocol which may change from time to time in the clinical practice of emergency medicine are considered. Medications can also include emergency medications for purposes other than ACLS and/or cardiac-related emergencies. Other protocols could include protocols for use in anesthesia, procedural sedation, rapid intubation, and treatment of stroke. Table 1 below provides dosages and drug inventories of an ACLS protocol. It should be appreciated that the drug inventories and dosages are illustrative and are not meant to be limiting.
Cartridges 6 can be arranged in a columnar arrangement along columnar axis C within each cassette 8. Each cartridge 6 can have a longest dimension that is aligned with displacement axis D, which is the direction that a portion of a cartridge 6 is displaced in order to inject medication into medication-receiving conduit 4 as will be depicted with respect to
Cartridges 6 can also be individually installed into system 2 (without the use of cassettes). The cartridges 6 can be installed in columnar groups 8a, 8b, and 8c such that each columnar group of cartridges is aligned with columnar axis C. The columnar groups 8a, 8b, and 8c can be arranged along transverse axis T. Each cartridge can have a long axis that is parallel with displacement axis D.
Cartridge 6 can include an outer housing 64 surrounding a hollow cylindrical portion 44 that has an inner surface 45 defining an internal cylindrical cavity 46. A penetrable plunger 48 can be disposed within the internal cavity 46. The penetrable plunger 48 can include a feature 66 that facilitates penetration of plunger 48 by distal end 54. Contained within cavity 46 between plunger 48 and inner surface 45 can be a volume of medication 68. Feature 66 is a fluid outlet that allows fluid to flow out of the cartridge 6 and into the cartridge-receiving fluid conduit 50 before flowing into the medication-receiving fluid conduit 4. Cartridge 6 can also include a cap 76 that maintains sterility inside cartridge 6 before use. The cap 76 can be penetrable and removable. The sterility cap and sterility barriers will be described in more detail below.
Within housing 64 can be a dispensing element 70, such as a compressed spring, that can displace cylindrical portion 44 in displacement direction DS upon activation of a release mechanism 74. Release mechanism 74 is depicted in
The housing 64 can include other types of dispensing elements 70 or mechanisms to impart force on the cylindrical portion 44. For example the force can be automatically imparted by an electric motor, solenoid, air pressure, a compressed or expanding gas, magnetic or electromagnetic force, reciprocating piston pump, and the like. The housing 64 can include a dispensing element that can be manually depressed, or threaded etc. such that the medication within the internal cavity is evacuated from the cartridge.
According to
According to
Cartridge 6 has a leading end 34 and a trailing end 36 relative to a direction of displacement DS (or direction of insertion DI) that is the direction that casing 100 is displaced to fluidically couple cartridge 6 to a corresponding conduit assembly 60. The leading end 34 of cartridge 6 can be the same as the leading end 34 of casing 100 relative to DS. Casing 100 can include a conduit sterility cap disabling feature 101 that is proximate to the leading end 34 to be discussed below. Feature 101 can also define the leading end 34.
Disposed proximate to the leading end 34 is a cartridge sterility cap 76 that maintains the fluid outlet 66 in a sterile condition prior to the coupling of cartridge 6 to conduit assembly 60. Together the cartidge sterility cap 76 and cylindrical portion 44 (casing 100) provide a cartridge sterility barrier for fluid outlet 66. The configuration of the cartridge sterility cap 76 can vary. The cartridge sterility cap 76 can be disposed in a recessed position relative to the leading end 34. The cap 76 can be a plug-type device having a penetrable, central region spanning the plug. The cartridge sterility cap 76 can be integrated with the casing 100. Alternatively, the cap 76 can be a separate device, for example, one that can be removably coupled to or mounted in or on a portion of the casing 100. The cap 76 can include a center spanning region that includes a penetrable, membrane-type barrier. In this example, the cap 76 can include a penetrable material coupled to a support ring that fits on, in or around a portion of the casing 100 such that the penetrable material spans the cavity 46.
According to
Surrounding the cartridge-receiving conduit 50 can be a sleeve 62 that extends in the first direction 102 from a proximal end 62P to a distal end 62D. The distal end 62D of sleeve 62 can engage plunger 48 to align fluid outlet 66 to fluid inlet 54 when cartridge 6 is coupled to conduit assembly 60. Sleeve 62 can also include a cartridge sterility cap disabling feature 103 proximate to distal end 62D. Feature 103 can define the distal end 62D.
Surrounding sleeve 62 can be a conduit housing 106. Disposed upon conduit housing 106 can be a conduit sterility cap 104. Together conduit housing 106 and conduit sterility cap 104 form a sterility barrier that preserves the sterility of cartridge-receiving conduit 50. The configuration of the conduit sterility barrier 104 can vary. The conduit sterility cap 104 can be disposed in a recessed position of the housing 106. The cap 104 can be a plug-type device having a penetrable, central region spanning the plug. The conduit sterility cap 104 can be integrated with the housing 106. Alternatively, the cap 104 can be a separate device, for example, one that can be removably coupled to or mounted in or on a portion of the housing 106. The cap 104 can include a center spanning region that includes a penetrable, membrane-type barrier. In this example, the cap 104 can include a penetrable material coupled to a support ring that fits on, in or around a portion of the housing 106 such that the penetrable material spans the bore of the housing 106.
The sterility barriers and sterility caps described herein can be manufactured of a variety of materials. They can be sterilized such as by ethylene oxide, gamma radiation or autoclave and the like and avoids fracture and aging. As such the sterility barriers and sterility caps can have a relatively prolonged shelf-life. The sterility barrier of the cartridge can be manufactured of the same material or a different material as the sterility barrier of the receiver conduit. In a variation, one or more portions of the sterility barriers can be manufactured of silicone rubber (natural rubber and synthetic), polyethylene, HDPE (high-density polyethylene), polyester or similar medical disposable material.
Conduit housing 106 can also include a conduit assembly alignment feature 110. Cartridge alignment feature 108 and conduit alignment feature 110 can be complementary mechanical features with respect to each other and enable cartridge housing 64 to be fixedly mounted to conduit housing 106. Complementary alignment features 108 and 110 also provide mechanical alignment of cartridge housing 64 with respect to conduit housing 106. Optionally, feature 110 may be located as part of the housing of system 2 so as to provide mechanical alignment and fixation of cartridge housing 64 to conduit housing 106. The configuration of the mechanical alignment and fixation of cartridge housing 64 and conduit housing 106 can vary. Features 108, 110 can have complementary shapes such that they snap together or thread together or another mechanical engagement. Features 110 and 108 can also have a lead-in design to facilitate the ease of engagement.
Cartridge 6 is configured to enable casing 100 to move or slide relative to housing 64 in displacement direction DS. A force against casing 100 can be provided by a dispensing mechanism 70 or element, for example a spring that is disposed within housing 64 can urge casing 100 in the displacement direction DS. It should be appreciated that another dispensing mechanism 70 to impart force on the casing 100 is considered such as compressed gas, expanding gas, electric motor, solenoid and the like. Manual dispensing mechanisms 70 are considered as well, for example a push rod coupled to the plunger or casing. The motion of casing 100 relative to housing 64 occurs when a release mechanism 74 is triggered such as by an activation mechanism 75 allowing dispensing mechanism 70 to displace casing 100 in direction DS relative to housing 64. The release mechanism 74 as well as the activation mechanism 75 can vary as described above. As an example, the release mechanism 74 shown in
As stated before, casing 100 can be slideably mounted in cartridge housing 64 to enable casing 100 to be displaced in displacement direction DS relative to housing 64. Release mechanism 74 can be activated by an activation mechanism 75, allowing dispensing element 70 or other energy source or force to drive or displace casing 100 in the direction DS. According to
According to
According to
Referring again to
Installation of the cartridge 6 (singly or in combination when carried within a cassette 8) into the system 2 can involve one or more multi-part operations. For example, the cartridge 6 can dock with its corresponding port or conduit assembly 60 such that the cartridge 6 is installed or in a “docked” mode with the system 2. Docking can occur without a fluid connection being formed between cartridge 6 and the conduit assembly 60 and without breach of either of the penetrable sterility barriers, if used. The cartridge and conduit assembly in the docked mode can remain sterile and can be reused if further activation is not performed. The cartridge and conduit assembly in the docked mode can also be mechanically coupled together through the coupling of their respective alignment features, if present. The cartridge 6 once docked with the conduit assembly 60 in the system 2 can then be selectively displaced in the displacement direction DS such that a fluid connection between the cartridge and the conduit assembly 60 is created. Upon displacement, one or more of the penetrable sterility barriers, if present, can be breached and a fluid coupling between the cartridge and the conduit assembly is formed. The cartridge is in a “loaded” mode with the system. Once a cartridge is docked and loaded into the system, dispensing of the medication within the cartridge 6 can begin.
Cartridges 6 can also be inserted into the system 2 pre-coupled to the conduit assembly 60. In this example, a port or interface at the leading end of the cartridge/conduit assembly couples to a corresponding port or interface within the housing of the system 2. A multi-part operation of docking, loading and dispensing as described above can also be used in a pre-coupled cartridge/conduit assembly.
Various disabling portions 101 can be envisioned that will rupture and initiate tear patterns upon sterility cap 104 that prevents contamination of the coupling between needle tip 54 and plunger 48.
According to
According to
According to 86, valve 30a is then opened to selectively allow fluid to push the medication through medication receiving conduit 4a towards the patient (not shown). According to 92, pump 14b is activated while valve 30a is open and valves 30b and 30c remain closed. Pump 14b delivers fluid out of fluid source 14 and through conduit 4a until the medication reaches the patient. According to 94 valves 30b and 30c are then opened. Pump 14b is deactivated at about the same time valves 30b-c are opened according to 98.
According to 214, valves 30a-30c are all open and fluid is being delivered from external fluid source 12 (
According to 240, dosage metering device 202 meters fluid received from medication receiving conduits 4 to output conduit 16 pursuant to the prescribed amount of medication to be delivered from cartridge 6 to the patient. Controller 20 can determine the amount of medication to be delivered based on the type of patient (e.g. adult or pediatric) and the necessity for a time metered dosage determined by the medication selected by the user. According to 250, a decision is made whether any remaining medication is present; otherwise action is moved to 280. For remaining medication (e.g. the full bolus of medication minus the prescribed amount) to be disposed from cartridge 6, valve 204 is opened directing remaining medication through conduit 208 to waste container 203 according to 260. After the remaining medication has been transferred to waste container 203, valve 204 is closed according to 270.
According to 280, valve 30a is then opened to selectively allow fluid to push the epinephrine through medication receiving conduit 4a. According to 282, pump 14b is activated while valve 30a is open and valves 30b and 30c remain closed. Pump 14b delivers fluid out of fluid source 14 and through conduit 4a. According to 284, the metering device delivers fluid until the prescribed medication has reached the patient. According to 286 valves 30b and 30c are then opened. Pump 14b and metering device 202 are both deactivated at about the same time valves 30b-c are opened according to 288 and metering device 202 is deactivated according to 290. According to 292, metering device valve 205 is switched to fluid bypass.
According to 214, valves 30a-30c are all open and fluid is being delivered from external fluid source 12 (
According to 240, a metered dose of dispensed cartridge 6 or alternate reservoir 206, medication is delivered to patient. According to 250, a decision is made whether any remaining medication is present; otherwise action is moved to 280. For remaining medication (e.g. the fill bolus of medication minus the prescribed amount) to be disposed from cartridge 6 a decision is made according to 254, to open valve 204 or valve 207 to dispose remaining fluid through conduit 208 to waste 203 or through conduit 209 to alternate reservoir 206 for later use. If remaining fluid is sent to waste, then valve 204 is opened according to 260 or alternately valve 207 is opened to alternate reservoir 206 according to 264. Upon cartridge 6 being fully expelled or alternate reservoir being emptied to a metered amount, valve 204 or 207 is closed according to 270.
According to 280, valve 30a is then opened to selectively allow fluid to push the epinephrine through medication receiving conduit 4a. According to 282, pump 14b is activated while valve 30a is open and valves 30b and 30c remain closed. Pump 14b delivers fluid out of fluid source 14 and through conduit 4a. According to 284, the metering device delivers fluid until the prescribed medication has reached the patient. According to 286 valves 30b and 30c are then opened. Pump 14b and metering device 202 are both deactivated at about the same time valves 30b-c are opened according to 288 and 290. According to 292, metering device valve 205 is switched to fluid bypass. Many variations of the sequence of events can be considered to allow fluids to be partially dispensed with the balance going to an alternate reservoir for future use. It can also be envisioned that a plurality of alternate reservoirs could be configured to do the same.
It should be appreciated that variations of the medical delivery systems described herein can exist. For example, the branching configuration of medication-receiving conduits 4 can have more or less than three parallel conduits 4. Orientation of the cartridges can vary as can the arrangement of cartridges within the cassettes. Cartridges can also be used in the absence of a cassette. As another example, fluid supply 14 can incorporate a “bag squeezer,” or other type of pump rather than a peristaltic pump in order to pressurize the fluid solution. It should also be appreciated that a variety of elements described herein can be used individually or in a variety of combinations. For example, the sterility barrier assemblies described above with respect to the cartridges and cartridge-receiving ports can be optional features that are not necessarily integral to the medication delivery system as a whole. The sterility barriers can be used with fluid injection systems separate from the medication delivery system described herein. Features described herein in the context with or respect to one exemplary device or system can be implemented separately or in any suitable sub-combination with other exemplary devices or systems.
It should also be appreciated that the systems described herein can be used manually or via electronic automation. Although the medication delivery system is described herein in terms of emergency use such as during an ACLS protocol, the medication delivery system can be used for other medication delivery protocols. Also, the delivery system can be used with various routes of administration including intravenous as well as other routes of administration such as an intraosseous route of administration, for example, in the event of a venous access problem.
While this specification contains many specifics, these should not be construed as limitations on the scope of what is claimed or of what may be claimed, but rather as descriptions of features specific to particular embodiments. Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable sub-combination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a sub-combination or a variation of a sub-combination. Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. Only a few examples and implementations are disclosed. Variations, modifications and enhancements to the described examples and implementations and other implementations may be made based on what is disclosed.
This application claims priority of U.S. Provisional Patent Application Ser. No. 61/083,213, entitled “System for Emergency Medication Administration,” filed Jul. 24, 2008; and 61/088,768, entitled “System for Emergency Medication Administration,” filed Aug. 14, 2008; and 61/093,436, entitled “versatile System for Emergency Medication Administration,” filed Sep. 1, 2008. Priority of the filing dates of Jul. 24, 2008, Aug. 14, 2008, and Sep. 1, 2008, are hereby claimed, and the disclosures of the Provisional Patent Applications are hereby fully incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 61083213 | Jul 2008 | US | |
| 61088768 | Aug 2008 | US | |
| 61093436 | Sep 2008 | US |
