CROSS-REFERENCE TO RELATED APPLICATIONSThis application is a divisional of U.S. patent application Ser. No. 13/953,725, filed on Jul. 29, 2013, which is a continuation of U.S. patent application Ser. No. 13/160,279, filed Jun. 14, 2011 and issued as U.S. Pat. No. 8,517,989 on Aug. 27, 2013, which claims the benefit underTitle 35, United States Code §119(e) of U.S. Provisional Patent Application No. 61/397,642 filed Jun. 14, 2010, which is incorporated by reference in its entirety and made part of this specification.
FIELD OF THE INVENTIONThe present invention relates generally to the field of medicine and therapeutic medication delivery, and more particularly to self-contained parenteral infusion kits.
BACKGROUND OF THE INVENTIONThe current practice of intravenous medication infusion often involves a relatively complicated process of assembling several sterile parts and performing appropriate dosing calculations. Further, where more refined dosing is required or desired, expensive electronic infusion pumps are often utilized. Infusion pumps offer certain advantages, but drawbacks include cost, the need for a power source, maintenance requirements, susceptibility to adverse environmental conditions, and perhaps most importantly, require requisite knowledge to use safely and effectively. There are several circumstances where less expensive yet automated intravenous infusion systems are ideal.
Intravenous infusions are now more commonly performed in prehospital settings where smaller, lighter, and self-powered systems enjoy a distinct advantage. In the prehospital setting, equipment storage space is minimal, power may be nonexistent, and equipment must be portable and able to withstand the elements. Yet, emerging data suggests that early prehospital use of certain medications may improve outcome. For example, the early administration of Progestins may improve patient clinical outcome following traumatic brain injury and stroke. Progestins, however, must be infused over a significant duration and should be started early. This ideal window exists at a time when a single paramedic is responsible for performing multiple tasks to stabilize the patient, limiting the time available to manage an intravenous medication system.
Furthermore, administering intravenous medication in other prehospital settings, such as military environments, produces still greater challenges. In addition to the difficulties encountered above, personnel may be scarce, and patients can suddenly and frequently outnumber trained clinical staff. In some locations, the highest level of immediate care is quite commonly a field medic. Further, calamitous events such as natural disasters, war, and insurrection may displace a vast number of people and commonly degrade, destroy, and overwhelm the local hospital system, making medication infusion using standard pumps impossible.
Yet, developing a viable portable intravenous system poses challenges. Infusion pumps are typically too complicated and expensive to dedicate for use with a single medication or make disposable. Traditional pre-packaged and sealed medical and surgical kits have limitations. For example, medications are commonly required in kits, and when a medication's shelf life expires, a typical kit is no longer useful for patient care and frequently must be destroyed. This practice is expensive, wasteful, and presents logistical burden of accounting for and managing medical waste.
Therefore, what is needed is a relatively small, portable, self-contained, and self-powered system which can reliably deliver an intravenous infusion safely and effectively. What is further needed is a kit which contains medications permitting more rapid setup and delivery of an intravenous system, while allowing medications to be inspected and replaced without exposing the remainder of the kit.
SUMMARY OF THE INVENTIONAspects of the present invention disclose a sterile or non-sterile sealed infusion kit which may be recyclable or disposable, and which may be operated without an AC electric power source. Embodiments of the present invention include a prepackaged infusion kit which may be utilized with or without prepackaged medicaments. Other embodiments describe prepackaged medications contained with the infusion system. Further still, other aspects of the invention disclose a prepackaged system containing specific medication dosages allowing for a more rapid, efficient, and safe infusion. Other aspects of the invention disclose a variety of self-powered force applicators to drive medication from the inventive infuser into the patient's system. Other aspects of the invention describe a kit containing perishable medications or adjunctive solutions wherein a portion of the kit may be opened to expose the perishable substances so they may be changed without opening the remainder of the kit.
OBJECTS OF THE INVENTIONAccordingly, a primary object of the present invention is to provide
Other further objects of the present invention will become apparent from a careful reading of the included drawing figures, the claims and detailed description of the invention.
BRIEF DESCRIPTION OF THE DRAWINGSFIG. 1 is a partially exploded perspective view of an embodiment vacuum drive infuser with an embodiment packaging.
FIG. 2 is a partially exploded perspective view of an embodiment spring-drive infuser with an embodiment packaging.
FIG. 3 is a partially exploded perspective view of an embodiment coaxial vacuum powered syringe with an embodiment packaging.
FIG. 4 is a partially exploded perspective view of an embodiment spring-driven infuser, with embodiment packaging.
FIG. 5 is a partially exploded perspective view of an embodiment gas-driven infuser, with embodiment packaging.
FIG. 6 is a partially exploded perspective view of an embodiment gas-driven infuser, with embodiment packaging.
FIG. 7 is a partially exploded perspective view of an embodiment elastomeric balloon, with embodiment packaging.
FIG. 8 is a partially exploded perspective view of an embodiment motor driven infuser with a portion of threaded tube removed to expose worm screw, with embodiment packaging.
FIG. 9 is a perspective view of an embodiment packaging.
DESCRIPTION OF THE PREFERRED EMBODIMENTTurning now toFIG. 1,infuser5 may be comprised of a medication holding vessel, such as a syringe10 coupled tochamber15 byclamp20.Driver25 is attached to or integrally formed with a portion ofhandle30 disposed withinchamber15 and an airtight seal is formed between sliding sealedpiston35, mounted on the end ofdriver25, and the inner surface ofchamber15. Whenhandle30 is drawn back,piston35 increases a vacuum force within that portion ofchamber15 distal topiston35. In an alternative embodiment,handle30 is shaped to define aplatform33 which makes contact with the most proximal surface ofplunger40. In an alternative embodiment, a portion ofhandle30 is shaped to formplunger40 which is in a fluid tight disposition within syringe10.Clamp20 holds syringe10 andchamber15 tightly together in place to prevent movement of syringe10 relative tochamber15.
Functionally, the user places medication vial92 into standardvial adapter60, during which sharp center spike65 penetrates the membrane ofvial92. A standardmedical stopcock50 is then oriented to allow the medicament invial92 to flow into syringe10 during standard aspiration ofplunger40, after first rotatinghandle30 so thatplatform33 andplunger40 are no longer in contact. After the desired amount of medicament has been aspirated into syringe10,stopcock50 is then adjusted to eventually permit the flow of medicament in syringe10 out of syringe opening45 and preferably intoinfusion tubing70. It should be noted thatstopcock50 may be a two-way, three-way, four-way, or six-way stopcock.
The practitioner then withdrawsinfuser handle30 whereinpiston35 is drawn back to produce or increase a vacuum inchamber15. Next,handle30 may be rotated to allowdriving platform33 to make contact with and push downwardly onsyringe plunger40.Handle30 is then released and the force generated bypiston35 sliding forwardly to fill the vacuum causesdriver25 and handle30 to likewise move forwardly and in so doing, drivesplatform33 to depressplunger40. Asplunger40 moves forwardly within syringe10, a flowable medicament may flow from syringe opening45 and out of syringe10 into any attachedintravenous tubing70 or other route of intravenous administration.
In a preferred embodiment,stopcock50 andvial adapter55 may be assistive in controlling flow in and out of syringe10 by permitting syringe10 to be filled with medication. For example,stopcock50, having a first port, second port, and a third port, or more, may be coupled to syringe via luer lock (or other coupling) and opened to provide flow between syringe10 andvial adapter55.Vial adapter55 has anouter housing60 andinner spike65 capable of piercing the membrane on a standard medication vial. A vial may be inserted alongadapter55 whereinspike65 pierces the membrane surface of the vial. The user may then actuatestopcock50 to permit flow from syringe10 throughtubing70 which is connected by luer lock or other connector. As syringe10'splunger40 moves forwardly medication is forced from syringe10 throughstopcock50 and throughtubing70 and thereafter into a patient's circulatory system.
In a preferred embodiment,infuser5, or any embodiment infuser described hereinafter, may be disposed within asealable packaging75.Packaging75 is comprised of atray80 which is shaped to define at least one indentation, recess or well to accommodate kit items, andremovable covering85 that sealstray80'stop surface90.Infuser5 may be disposed withinfirst well95. One ormore vials92 may be disposed in one ormore medicament wells94 which may be identically or differently shaped and correspond to the size and shape of theappropriate vials92 or other medicament containers to be stored within.Stopcock50,vial adapter55 andtubing70 may be stored in thefirst well95 or in an alternative embodiment, wells shaped to provide adequate individual storage. In one embodiment, medicaments such asvials92 are independently sealed byfoldable flap cover42 which folds alongseam82 and may be locked into place by a fitable engagement ofprojections86 and recesses84.Medication cover42 may be opened and closed independently ofcover85, whereincover85 may remain sealed asmedication cover42 is opened and closed.Medication cover42 may be transparent or partially transparent to permit ready medication viewing while medication cover42 is in the closed position withprojections86 fitably engaged withinrecesses84. In this way, written packaging materials and indicia appearing on the surface of vial92 (or other medicaments disposed within medication recess94) may be inspected. Information such as medication expiration dates, lot number, and the like may be inspected without opening the packaging. Should it become necessary to change the medicament,medication cover42 may be opened—removingprojections86 fromrecesses84 andmedication cover42 is folded outwardly and reflected to exposemedication wells94. After medication has been replaced, cover42 may be folded inwardly and closed bysnap fitting projections86 withinrecesses84.
In an alternative embodiment, thefirst well95 is covered with afirst cover85, and one ormore medicament wells94 are covered with a second cover. One or more of the covers covering any wells may be re-sealable. Alternatively, each well may have its own cover which may be re-sealable.
Turning now toFIG. 2, an alternative embodiment spring-driveninfuser200, may be comprised of asyringe210 coupled tochamber215 byclamp220.Handle30 is shaped to define aplatform233 which makes contact with the most proximal surface of aplunger240 found in a typical syringe. In an alternative embodiment, a portion ofhandle230 is shaped to formplunger240. Driver225 is attached to a portion ofhandle230 disposed withinchamber215 and terminates inpiston235.Spring237 is disposed around driver225 and has a first end affixed to clamp220 and second end affixed to the proximal portion ofpiston235.
In a preferred embodiment,infuser200 may be disposed within asealable packaging275. Packaging275 is comprised of atray280 which is shaped to define at least one indentation, recess or well to accommodate kit items, such as well295, andremovable covering285seals tray280'stop surface290. Cover242 may be folded alongseam282 and closed as described above.
Functionally, the user withdraws handle230 whereinpiston235 is drawn back to produce compression inspring237. Compression inspring237 acting on the proximal side ofpiston235,biases piston235, driver225, and handle230 forwardly. A portion ofhandle230 is shaped to formdriver platform233 which makes contact with and depressplunger240, which is driven forwardly. In an alternative, a portion ofhandle230 is shaped to define an integrally formed plunger. Asplunger240 moves forwardly, a flowable medicament may flow fromsyringe opening245 and out ofsyringe210.
Turning now toFIG. 3, coaxial vacuum poweredsyringe infuser300 may be comprised ofchamber315 segmented intodriver housing317 andplunger housing319 by a portion ofchamber315 shaped to definedivider323.Shaft325 is coupled topiston335 disposed withindriver housing317 andplunger340 withinplunger housing319.Shaft325 is disposed and moves withinairtight shaft seal342;shaft seal342 itself being disposed withinaperture344 ofdivider323. The circumferential surface ofpiston335 andplunger340 may be rubberized to provide an airtight seal indriver housing317 and at least a fluidtight seal inplunger housing319.Chamber315 is formed with vacuum V existing between the surface ofpiston335 and the surface ofdivider323 tending to drivepiston335 anddivider323 into contact. It should be noted that in a preferred embodiment,piston335,shaft325, andplunger340 are integrally formed as a single coaxial driver.
Functionally, the user may fillplunger housing319 with a flowable medicament. This is accomplished a variety of ways, for example, by attaching a standard syringe to opening345 and forcing medication out of the standard syringe intoplunger housing319 or by attaching a syringe tostopcock350 and actuating it to provide flow betweenstopcock350 andplunger housing319. The force of vacuum V is overcome by the force driving medication intoplunger housing319, andplunger340,shaft325, andpiston335 together move backwardly plungerhousing315 is filled distally toplunger340. When vacuum force V is greater than the opposing resistance, medicament may flow fromhousing319 throughopening345 andstopcock350 andtubing370 when attached.
In a preferred embodiment,infuser300 may be disposed within asealable packaging375. Packaging375 is comprised of atray380 which is shaped to define at least one indentation, recess, or well to accommodate kit items, such as well395, andremovable covering385seals tray380'stop surface390.Infuser300 and optionally stopcock350,vial adapter355 andtubing370 may be stored in first well395 or in an alternative embodiment, wells shaped to provide adequate individual storage.
Now,FIG. 4 demonstratesinfuser400 which may be comprised of asyringe410 coupled tochamber415 byclamp420.Driver425 is attached to or integrally formed with a portion ofhandle430 disposed withinchamber415.Spring axle435 is disposed within a relatively distal aspect ofchamber415 and freely rotatable therein. Flat torsioncoil power spring438 is affixed toaxle435 under tension to bias rotation.Wire441 is affixed toaxle435 at one end andcoupling443 at the other end. Coupling443 is affixed to the terminal aspect ofdriver425. Whencoil spring438 rotatesaxle435,wire441 is wound ontoaxle435 andwire441 applies a traction force to drivedriver425, handle430, and handleplatform433 forwardly withinchamber415.
Functionally, the user withdraws handle430 whereinpiston435 is drawn back to increase tension inspring438, asdriver425 andwire441 affect rotation ofaxle435.Syringe410 may be filled with a flowable medicament by the standard means of aspiration. When the desired volume of medicament has been collected withinsyringe410, handle430 is energized by pullinghandle430 back, following which, handle430 is rotated sufficiently to engagedriver platform433 andplunger440. When handle430 is released, the force generated bydriver425 moving forwardly drives handle430,platform433, and depressesplunger440 forwardly causing medication to flow from withinsyringe410 throughopening445.
Turning now toFIG. 5,infuser500 may be comprised of asyringe510 coupled tochamber515, the chamber having a top and bottom, byclamp520.Driver525 is attached to a portion ofhandle530 and disposed withinchamber515. Sliding sealedpiston535 is mounted on the end ofdriver525, and a seal is formed between sliding sealedpiston535 and the inner surface ofchamber515 and cap537 seals the top ofchamber515.Driver525 passes through aperture539 incap537 withdriver525 and cap forming an airtight seal. Gas, such as CO2, nitrogen, or air, pressurizes thechamber515 such that gas pressure G exerts positive pressure betweencap537 andpiston535 to drivedriver525 forwardly. The terminal aspect ofchamber515 has opening536 to provide air to move in and expelled fromchamber515 distal topiston535. A portion ofhandle530 is shaped to defineplatform533 which makes contact with the most proximal surface of aplunger540 found in a typical syringe. In the alternative, aportion handle530 is shaped to define an integrally formed plunger disposed forming a syringe.
Functionally, the user withdraws handle530 whereinpiston535 is drawn back to further compress the gas G inchamber515, raising the pressure and energizing the apparatus. Thesyringe510 may be filled with a flowable medicament in the usual way frommedicament vial592, by aspirating the medicament throughstopcock550 into the syringe when themedicament vial592 is spiked ontovial adapter555. Whensyringe510 has been filled with the desired amount of medication, handle530 is rotated to placeplatform533 into alignment withplunger540 and released. The force generated bypiston535 sliding forwardly, driven by the force of compressed gas G, causesdriver525 and handle530 to likewise move forwardly and in so doing, driveplunger540 withinsyringe510. Asplunger540 moves forwardly, a flowable medicament may flow from syringe opening545 and out ofsyringe510.
FIG. 6 illustratesinfuser600 which may be comprised of adriver625 coupled topiston635 disposed withchamber615. A seal, such as one or more O-rings633 are located on the circumferential surface ofpiston635 to provide a seal.Driver625 is attached to a portion ofhandle630 shaped to defineplatform633 that makes contact with a standard syringe.Driver625 passes throughaperture639 sealed with O-ring641 such seal being airtight. Gas, such as CO2, nitrogen, or air, is stored withincylinder643 flows throughregulator646 intopressurize chamber615; gas pressure G exerts positive pressure to drivedriver625 forwardly. A portion ofhandle630 is shaped to define aplatform633 which makes contact with the most proximal surface of aplunger640 of a typical syringe.
Functionally, gas G flows fromcylinder643 throughregulator646 intochamber615, raising pressure. When the force of gas pressure G exceeds the force of the piston's static resistance (i.e. between ofpiston635 and chamber615) and the forces acting onplatform633,piston635 will move forwardly to driveplatform633 and anystandard syringe plunger640 in contact therewith.Regulator646 maintains a constant pressure inchamber615 so that the pressure force remains the same throughout the infusion cycle.
Turning now toFIG. 7,infuser700 consists of a single or double walledelastomeric balloon710 having aninternal reservoir715 capable of holding medication.Balloon710 terminates in acoupling720 capable of reversibly attaching tostopcock750,intravenous tubing770, or a standard syringe. Filledelastomeric balloon710 has sufficient resiliency to generate an effective amount of force to drive a medicament throughtubing770. A medicament may be prepackaged withinreservoir715 orreservoir715 may be filled by a standard syringe.
In a preferred embodiment,infuser700 may be disposed within asealable packaging775. Packaging775 is comprised of atray780 which is shaped to define at least one indentation, recess or well to accommodate kit items, such as well795, and aremovable covering785seals tray780'stop surface790.Infuser700 and optionally stopcock750,vial adapter755 andtubing770 may be stored in first well795 or in an alternative embodiment, disposed within wells shaped to provide adequate individual storage.
FIG. 8 illustrates anembodiment infuser800 having an integrated circuit and attachedbattery802 electrically coupled to reversibleservo gearhead motor804.Worm screw820 is coupled tomotor804 by coupling805 at screw's first end.FIG. 8 illustrates threadedtube815 which forms part ofdriver housing arm830 and threadedtube815 is disposed withinhousing816.Worm screw820 is disposed within threadedtube815.FIG. 8 illustrates a portion of threadedtube815, with a portion oftube815 omitted (for illustrative purposes) to showworm screw820 disposed therein. The second end ofscrew820 is disposed withindriver arm830.Platform833 may make contact withplunger840 ofsyringe810.
Functionally, when circuit is closed,motor804 actuates to rotatably driveworm screw820.Worm screw820 threadably engages threadedtube815 resulting inworm screw820 being driven axially forwardly drivingarm830 andplatform833 downwardly to depressplunger840 and force a flowable medicament fromsyringe810.Motor804 may be reversed to drive worm screw axially backwardly.
In a preferred embodiment,infuser800 may be disposed within asealable packaging875. Packaging875 is comprised of atray880 which is shaped to define at least one indentation, recess or well to accommodate kit items, such as well895, and aremovable covering885seals tray880'stop surface790.Infuser800 and optionally stopcock850,vial adapter855 andtubing870 may be stored in first well895 or in an alternative embodiment, disposed within wells shaped to provide adequate individual storage.
With regard to the kit covering, in an alternative embodiment, illustrated byFIG. 9,seam82, recesses84, andprojections84 are omitted, and the top surface is uniform. In one embodiment, the top surface may be covered with aremovable covering925. In one embodiment, covering925 is a single use cover; in an alternative embodiment,cover925 is a single reusable cover which may be replaced over the top surface to re-seal all contents within tray950. It should be realized thattray packaging900 may be used with medical apparatus and medicaments of all types.
Several example embodiments are described above. The general inventive concepts include use of a force applicator acting on a flowable therapeutic substance or medicament within a vessel. In several of present embodiments described above, the containing vessel is a syringe coupled to several embodiments of a force applicator in a side-by-side or coaxial arrangement. It should be immediately recognized that the location, arrangement, and relative size of the vessel, force applicator, and/or handle may be changed without departing from the spirit and scope of the invention. Further, in several embodiments, an example component of a force applicator includes a handle which forms or engages a portion of a standard syringe.
As is customary, ultimately, the infusion and patient clinical response is monitored by the professional administering the medicament. In some therapeutic settings, the apparatus may be utilized with limited clinician involvement (e.g. infusion of antibiotics). In other settings, the apparatus is utilized with active bedside clinician involvement (e.g. anesthetics or potent analgesics) where patient response is actively monitored, and the infusion may be interrupted when a desirable clinical effect is achieved. As is also customary, the infusion may be interrupted where an undesirable or adverse clinical effect is encountered. It should be recognized that a force applicator may take a variety of shapes and sizes to impart force on a flowable therapeutic substance without departing from the scope and spirit of the present invention.
The term medicament, as used herein, refers to any flowable substance which may have therapeutic benefit. Further, the apparatus described herein may be utilized without regard to intravenous line placement, and may be utilized to provide an infusion through central and peripheral venous access locations. It should be recognized that the system described herein may be utilized to provide infusion through any therapeutically acceptable location, including but not limited to intraosseous, epidural, intrathecal, or intraperitoneal routes.
It should be further recognized, that the present invention may be utilized to facilitate mixture, admixture, or reconstitution of medication, and the embodiment vial housing can be used to facilitate reconstitution of powered medicaments. For example, a dilutent vial may be puncturingly engaged on an embodiment vial adapter and stopcock engaged to permit flow between a syringe and vial and permit dilutent aspiration into the syringe. The stopcock may be aligned to close flow between the syringe and vial, and a second vial containing the medicament to be reconstituted puncturingly engaged on the vial adapter whereupon, stopcock may be aligned to permit flow between the syringe and vial to allow dilutent to be instilled into vial where it can be agitated and mixed according to manufacturer's instructions and accepted clinical practices. Further, the number, size, shape, and contents of medication vials may be variable. For example, several vials containing the same substance may be provided where repeat dosing is foreseeable.
Further, the present invention describes, in part, a kit containing medical apparatus to facilitate the infusion of therapeutic substances and medications or adjunctive solutions contained within that kit where the apparatus and medications are separately contained and where the medications may be inspected and accessed without opening that portion of the kit containing apparatus. It should be immediately recognized that the inventive kit herein described may be utilized with any type of medical apparatus capable of being separately sealed.
The syringe and/or force applicator may or may not be have indicia printed or etched thereupon. Examples of such indicia include such information to facilitate accurate medication administration such as cubic centimeters (cc), milliliters (ml), age, weight, and dosing information.
The present invention may be practiced with several medication classes, including, but not limited to: opiates, opioids, sedatives, benzodiazepines, propofol, vasopressors, anesthetics, vasodilators, anticoagulants, antibiotics, antiarrhythmics, antiepileptics, antirheumatic drugs, steroids, chemotherapeutic agents, and progestins. It should be noted that the term medicament, as used herein, refers to any substance which may have a potential health benefit or therapeutic use.
References are made herein to the spatial orientation of the inventive apparatus. Distal and distally are used to refer to points relatively closer to the subject patient (e.g. furthest from handle225); whereas proximal and proximally referring to points relatively further from the patient (e.g. closest to handle225). Forwardly and backwardly are used to describe the movement of certain embodiments and forward and forwardly refer to movement in the direction of opening230 whereas backward or backwardly refer to movement away from opening230. The inventive infuser embodiments described herein may be practiced with or without the use of the example packaging, and the apparatus described herein may be packaged according to any acceptable custom. Stopcocks, vials, and tubing are described as optional embodiments and may or may not be included used with the inventive infuser/medicament containing vessel.
Although the present invention has been described with reference to the preferred embodiments, it should be understood that various modifications and variations can be easily made by those skilled in the art without departing from the scope and spirit of the invention. Accordingly, the foregoing disclosure should be interpreted as illustrative only and is not to be interpreted in a limiting sense. It is further intended that any other embodiments of the present invention that result from any changes in application or method of use or operation, method of manufacture, shape, size, or material which are not specified within the detailed written description or illustrations contained herein yet are considered apparent or obvious to one skilled in the art are within the scope of the present invention.