CA2213534C - Electronic syringe - Google Patents
Electronic syringe Download PDFInfo
- Publication number
- CA2213534C CA2213534C CA002213534A CA2213534A CA2213534C CA 2213534 C CA2213534 C CA 2213534C CA 002213534 A CA002213534 A CA 002213534A CA 2213534 A CA2213534 A CA 2213534A CA 2213534 C CA2213534 C CA 2213534C
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- CA
- Canada
- Prior art keywords
- electronic
- syringe
- disposed
- switch
- housing
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31525—Dosing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/3129—Syringe barrels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31533—Dosing mechanisms, i.e. setting a dose
- A61M5/31545—Setting modes for dosing
- A61M5/31546—Electrically operated dose setting, e.g. input via touch screen or plus/minus buttons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
- A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
- A61M2005/31588—Constructional features or modes of drive mechanisms for piston rods electrically driven
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/59—Aesthetic features, e.g. distraction means to prevent fears of child patients
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/82—Internal energy supply devices
- A61M2205/8237—Charging means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2209/00—Ancillary equipment
- A61M2209/08—Supports for equipment
- A61M2209/084—Supporting bases, stands for equipment
- A61M2209/086—Docking stations
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S128/00—Surgery
- Y10S128/01—Motorized syringe
Abstract
An electronic syringe for use in administering anaesthetic andthe like injections or for aspirating fluids. The electronic syringe is particularly well suited in dental applications where a precise level of han d control is required. The syringe housing is a compact, pen-style arrangement that may be gripped between the middle and index fingers of the practitioner's hand which allows for thumb-free operation. Motorized, optionally cordless, operation with speed control and data collection is also provided such that an injection can be preformed on a patient in a steady, painless, non-intimidating manner. When connected to a processing device, the data collection feature is capable of updating a patient database with the amount of anaesthetic and the like injected for record keeping purposes.
Description
CA 02213~34 1997-08-22 W 096/25965 PCT/CA~6/00099 ELECIRONIC SYRINGE
TECHNICAL FIELD
The present invention relates to an elec:tronic syringe, and more 5 particularly to a compact, pen-style grip, electronic syringe that allows a practitioner to ~lmini~ter injections or aspirations at a controlled rate and with a precise degree of hand contro] thereby minirni7ing or elimin~ting patient fear and discomfort.
Electronic syringes are known in the art. Typical uses for such devices include injecting biocompatiible material, specifically anaesthetic such as block, conduction and para-apical anaesthesia, thraugh bone tissue. Electronic syringes are also used in a~lmini~tering insulin and 15 other pharmaceuticals.
In most dental applications, practitioners are required ta regularly ~tlmini~ter anaesthetic injections in confined spaces using comventional manual syringes.
Conventional manual syringes, as used in dentistry applications, 20 usually comprise a hollow cylindrical housing, having one en,d adapted to receive a needle and the other end adapted to receive a piston assembly. The outer surface of the housing iis provided withl a pair of finger grips such that the device can be held i~rmly between the middle and index fingers of the practitioner's hand. ~n~t-.stlleti,c is commonly 25 supplied in premeasured ampoules which are ~lesignP~l to fit into the housing. The ampoule has one end pravided with a pierceable membrane that receives the needle in sealinçr engagement and another end fitted with a slidable plunger which engages the piston assembly.
The piston assembly incll~es a shaft, one end of which is filted with a 30 pl~lng~.r, and an opposing end provided with a thumbrest. In operation, CA 02213~34 1997-08-22 the anaesthetic injection is ~flmini~tered by depressing the plunger with the practitioner's thumb which causes the piston to engage the plunger, thereby forcing anaesthetic from the ampoule via the needle.
There are several disadvantages associated with conventional , manual syringes used in dentistry applications. For example, due to the potential for uneven thumb pressure applied on the thumbrest, the practitioner has very little control over the flow rate of anaesthetic exiting the needle. As a result, it is virtually impossible to achieve a subet~nti~lly constant flow rate with a m~nll~l syringe. Further, many practitioners often complain that, due to the m~nner by which a conventional m~nll~l syringe is grasped, such a syringe offers poor control of the needle tip when ~lmini~tering the injection. As a result, unsteady injections generally lead to unnecessary pain and discomfort to the patient. Still further, it is generally uncontested that the majority of patients dislike the thought of receiving an injection, especially a dental injection. Tn~1ee-1, this aversion is usually due to the fact that many m~nll~l syringes are highly intimi(l~tin~ in appearance.
The prior art has aLI~-I.pl~d to address various of these disadv~nt~t s, with little or no noticeable success.
United States patent 4,617,016 (Blomberg) t~ches an insulin injection device adapted to accommodate conventional disposable syringes. Through the use of a motor in communication with a tr~n.~mi~ion and lead screw, the device is capable of being used to load an empty ~,ylinge with a predetermined amount of insulin from an external ampoule prior to injecting. Ul~ol lullately, the device is cumbersome and somewhat intimi~ting to the patient. Another disadvantage is that, using a conventional hypodermic ~yl;l~ which must be replaced between injections adds to the ~elalillg cost of the unit. Yet another disadvantage is that there is no means for tracking the amount of insulin injected.
CA 02213~34 1997-08-22 W 096/25965 PCT/CA~G/00~9 United States patent 5,269,762 (Armbruster et al.) teaches a portable hand-held power assister device for injecting a liquicl, such as X-ray contrast media, into the vascular system of a m7~mm~1 at a single constant rate. The assister device is a pistol type arrangement that 5 externa]Lly receives a conventiona]L syringe onto the front of the unit. A
connector, coupled to one end of a lead screw/transmission drive engages the thumbrest on the syringe. A forward-reverse switch is provided which is used to load and dispense the syringe. Clearly, this device is not suited for lSnely controlled variable rate injections (e.g. for 10 dental applications) and is intended to be used ~remotely of the patient via a bull~;lnLy needle. Thus, in a denta]L application (and other applications), the device cannot provide the delicate and preciise hand control necessary to ~lmini~ter an injection without the patient éxperiencing discomfort.
It would be desirable to have an electronic device capable of 15 dispensing a fluid at a constant and precise rate. It would also be advantageous if such a device could be operated in a "thumb-less"
m~nn~.r and was configured to a]Llow the practitioner to halve precise control of the amount of fluid being ~imini~t~red. It would a]Lso be further advantageous if the device was configured to be less intimitl~ting 20 in appearance than the prior art devices.
DISCLOSURE OF THE INVENTION
It is an objective of the present invention to provide an electronic syringe which obviates or miti~tes at least one of the above-mentioned 25 disadv~nt~ s of the prior art.
Accordingly, in one of its aspects, the present invention provides an electronic syringe coll.pl;sing:
a genera]Lly elongate housing comprising a needle and electronic control means at opposite ends thereof;
CA 02213~34 1997-08-22 W O 96/25965 PCT/CA~G~ 9 an ampoule receiving first portion disposed in the housing adjacent the needle;
drive means in electrical communication with the electronic control means;
a plunger disposed between the first portion and the drive means, the drive means actuating the plunger through the first portion; and switch means located on the housing for actuating the drive means.
In another of its aspects, the present invention an electronic 10 syringe comprising:
a generally elongate housing comprising needle attachment means and electronic control means at opposite ends thereof;
an ampoule receiving first portion disposed in the housing adjacent the needle attachment means;
drive means in electrical communication with the electronic control means;
a plunger disposed between the first portion and the drive means, the drive means ~ctu~tinP the plunger through the first portion; and switch means located on the housing for actuating the drive means.
Thus, the present invention relates to an electronic syringe. As used throughout this spe.cifi~tion the term "electronic syringe" has a broad m~ ning and is intended to encompass a device used for injection or aspiration, as warranted by the intended application.
Further, as used throughout this specification, the term "electronic", when used in the context of describing an injection syringe, is intended to have a broad me~ning which encompasses an injection O
syringe wherein at least a portion of the energy requirement to actuate the plllnger in the syringe is achieved electrically.
W 096/2~965 ]?CT/CA9GJ~D~5 BRIEF DESCRIPTION OF THE DRAWINC;S
Embodiments of the present invention will be described with reference to the accompanying drawings, in which:
Figure l illustrates a perspective view of an electronic syringe in 5 accordance with an embodiment of the present invention;
Figure 2a illustrates a sectional view taken along line II-II of Figure l, wherein the syringe illustrated in Figure l has been further adapted to include a battery power supply;
Figure 2b illustrates a sectional view taken along line II-II of l0 Figure l, wherein the syringe illustrated in Figure l has been further adapted to include an umbilical cord;
Figure 3a illustrates a sectional view of an electronic syringe in accordance with another embodiment of lhe present invention and adapted to include a battery power supply;
lS Figure 3b illustrates a sectional view of a syringe sirnilar to the one illustrated in Figure 3a and adapted to include a ba1tery power supply;
Figure 3c illustrates a sectional view of a syringe similar to the one illu~ d in Figure 3a and adapted to inc~ de an umb)ilical cord;
20 and Figure 4 illustrates a block diagram of an electranic control circuit in accordance with an embodiment of the present imrention.
In the Figures, like reference numera]s are used to de!si~n~te like elements.
BEST MODE FOR CARRYING OUT l~ INVENTION
Wlth lcr~ ce to Figure l, there is illu~llal~d an electronic syringe l0 in accordance with an embodiment of the present invention.
As can be seen in the Figure, syringe l0 inc11~1Ps a elongate housing 14 30 of varying circular cross-section, having a paLir of ends 15, l 6 and control CA 02213~34 1997-08-22 W 096/25965 PCT/CA9"~--99 switches 18,22. A needle 26 is provided with a collar 30 and is removably received by end 15. Housing 14 assumes the appearance and feel similar to that of a pen which provides the practitioner with an enh~nced comfort level, thereby providing confident, steady and a 5 precise degree of hand control. To the patient, the pen-like appearance is much less intimidating when co~ ,d to conventional electronic syringe devices.
Housing 14 is preferably moulded from a medical grade plastic material such as a liquid crystal polymer commercially available from 10 Hoechst Celanese under the tradename Vectra LCPTM . Another possible alternate material is medical grade LexanTM commercially available from General Electric Plastics. The type of material used to mould the housing would depend on the exact method of sterilization to be used and the type of application in which syringe 10 will be subjected 15 or the environment in which it will be used.
In an alternative embodiment, a portion A of housing 14 may be configured to be detachable from the rem~in-ler of housing 14. In this embodiment, it is ~l~f~ d that portion A be constructed of a m~t~rial (e.g. stainless steel and the like) capable of will.~ 1ing the rigors of 20 high lt;n.~el~t~lre sterilization (e.g. by autoclaving). Portion A can be readily designed to by detachable from the rem~inrler of housing 14 using a conventional "quick connect" system which allows for rapid attachment and detachment between portion A and the rem~in~ler of housing 14. In this embodiment it is ~ler~;rlcd that collar 30 is 25 removably connected to end 1~ of portion A. While the longitlldin~l length of portion A is not particularly restricted, it is pl~f~ cd that it corresponds sub~t~nti~lly to the portion of housing 14 which encases the fluid cont~ininP ampoule described hereinbelow.
A base member 34 inrlll-les a cradle 36 and an interface socket 38.~ase member 34 is used to store and recharge syringe 10 when not W 096/25965 PCT/CA~ C95 in use and is also used to collect data via soc~-.et 38 when syringe 10 is placed in the base. The operation of collecting data and n~charging syringe 10 will be described in greater detail hereinbelow.
Needle 26 comprises a collar 30 through which is passecl a hollow S shaft 62. Shaft 62 acts as a p~s~ .way for fluid p~in~ bet~1veen a tip 66 in needle 26, adapted for piercing tissue, and an inward end 70 adapted for piercing an ampoule cont~inin~ a fluid. Needle 26 is typically available in three common sizes, narnely 25, 27 and 30 gauge.
The gauge sizes correspond to the outside diameter of hollow shaft 62.
As illustra~ed in Figure 2a, the internals of syringe 10 comprise a removable ampoule 40, a drive system 42, an electronic conbrol system 46, a battery 50 and a fluid rate switch 54.
Ampoule 40 is a conventional, genera]ly cylindrical, <lisposable container used to p~c.k~ge ~ ~cd fluids such as medicants, ~n~esthetics 15 and the like. Ampoule 40 is provided with a pair of ends, one end having a pierceable membrane 74 which receives inward end 70 of needle 26 in sealing engagement. The opposi"g end of ampoule 40 is fitted with an internally slidable plunger 78.
Switches 18,22 are cl~m~he.ll, on/off, finger pressure sensitive 20 switches that encircle housing 14 and are used to stop ancl start the operation of syringe 10. The use of this type of switch enables operation of syringe 10 through 360~ about t~he longitu~lin~l axis of the unit without having to rotate the device to access either of switches 18,22. Switch 18 is mounted in close proxirnity to end 15 to f~cilit~t~
25 injections requiring the practitioner's hand to be positioned near needle 26 for finer control. Switch 22 is mounted towards the middle of housing 14 and provides opera(ing control when the practitioner requires a longer reach.
Fluid rate switch 54 is a rotary, three position selector which 30 allows the practitioner to select from three speed settings namely, slow, CA 02213~34 1997-08-22 medium and fast and are selected depending on the size of needle 26 selected.
Battery S0 is preferably a conventional rechargeable AA type unit. External connections to a conventional battery charger power 5 supply (not shown) and the data communication circuit (not shown) are accomplished via metal contact strips 114 moulded into end 16 of housing 14. Contact strips 114 engage complementary contact strips provided in socket 38 of base member 34.
Drive system 42 comprises a lead screw 90, a lead nut 94, a motor 82, a thin walled tube 98 and a piston 102. Lead screw 90 has a proximal end directly coupled to the shaft of motor 82, and a free distal end. Lead nut 94 engages lead screw 90 in a complementary manner and is movable along lead screw 90 between a fully retracted and a fully extended position. I~be 98 freely surrounds lead screw 90 and has one end fixedly attached to lead nut 94. The opposing end of tube 98 is fitted to piston 102 and is long enough such that piston 102 does not i.l-wr~;,e with the distal end of lead screw 90 when lead nut 94 is in the fully retracted position. As illustrated in Figure 2a, the fully retracted position is such that lead nut 94 is near the ,~r~i.--al end of lead screw 90 and piston 102 is in close coupling ~ illlily with plunger 78 when ampoule 40 is full. The fully retracted position is the normal resting position when syringe 10 is not in use. In the fully extended position, the proximal end of lead screw 90 is near lead nut 94. It is ~lcrelled that lead screw 90 has a stroke length such that, at the fully extended position, piston 102 and plunger 78 have tr~n~l~t~d to fully dispense the contents of ampoule 40.
The engagement of lead nut 94 with lead screw 90 is such that there exists a small amount of backlash or "play" to allow for momentary "self aspilalion" caused by back pressure in the tissue when first pierced by needle 26. Typically, upon piercing, a small amount of W O 96/25965 PCT/CA~G/00_99 _9_ blood will enter ampoule 40 as the back pressure in the tissue equalizes that in ampoule 40. As the pressure eql-~li7~s, a force is tr~n~mittc-~l to lead screw 90 via lead nut 94 as plunger 78 presses against piston 102.
A certaiin amount of backlash is required to absorb the force created by 5 pressure eqn~li7~tion. This self aspiration assists the practitioner in determinin~ whether a blood vessel has been pierced. As would be a~a,cllL to one of skiill in the art, other methods of introducing "play"
into drive system 42 exist. For example, "pl~ly" may be introduced into drive system 42 by employing a flexible coupling, spring or having plunger 78 and piston 102 sit in a spaced relationship initially upon insertion of ampoule 40 into syringe 10.
Preferably, motor 82 is a Series lCl16, mini~ re DC motor manufactured by MicroMo Electronics Inc. and includes a 64:1 10/1 gearhead and a Series HE encoder (not shown). Lead screw 90 is a conventional stainless steel lead screw such as that m~mllF~t.tured by Kerk Motion Products Inc. and may includc- a TeflonTM coatiing which serves to extend the liife thereof. Lead nut 94 is a conventianal off-the-shelf component also rn~n~lf~ctured by Kerk Motion Produc,ts Inc. and is preferably forrned from AcetalTM which is a self-lubricating plastiic having long life characteristics. As is knawn in the art, AcetalTM is commercially available E.I. Du Pont de Nernours and Company.
A feedback sensor 106 which comprises a high resolution potentiometer strip 110 mounted to the outer surface of tube 98. A
wiper contact (not shown), fixedly ~tt~-~.he~l to the inner surface of housing 14, contacts potentiometer strip 110 as lead nut 94 moves tube 98 along lead screw 90. The motion of potentiometer strip 1 :l0 along the - wiper contact which causes a variation in electrical re~i~t~nce through potentiometer strip 110 which is co~ d into positional information by electronic control system 46. A non~ , e~mple of a suitable CA 02213~34 1997-08-22 feedback sensor 106 is manufactured by Data Instruments Inc. and is commercially available under model name MystR~M.
With reference to Figure 4, electronic control system 46 comprises a battery charge interface (not shown), a voltage converter 5 122, a counter 126, a motor control circuit 130, a feedback control circuit 134 and a col~,pul~r interface 138. Fluid rate switch 54 determines the desired flow rate by providing voltage converter 122 with an input voltage proportional to the desired flow rate. This causes voltage converter 122 to output a frequency pulse proportional to injection flow rate. The frequency output pulse from voltage converter 122 is input to counter 126 which counts one incremental step for each input pulse from a predetermined maximum value, representing a full ampoule, to zero, representing an empty ampoule. Each incremental step of the counter is passed to a high ~;ullel~t driver portion of the 1~ motor control circuit 130 which rotates motor 82 in micro-step increments. In this regard, the feedback control circuit, connected to feedback sensor 106, provides a precise voltage that is directly proportional to the position of piston 102 and the volume amount of injected material.
Computer interface 138 enables creation and/or mainlellal.ce of a record of the amount of anaesthetic ~(lmini~tered during an operating cycle of syringe 10. Feedback control circuit 134 provides the proportional voltage that is scaled and held by colll~ulel interface 138 until syringe 10 is placed in base 34. As would be apparent to one of skill in the art, base member 34 further incl~ e~ components of electronic control system 46, sufflcient to f~rilit~t~ co~ n.ication with a proces~in~ device. Specifically, the communication Cil~iuiLIy comprises a analog to digital converter, memory, a microcontroller, a conventional asynchronous serial communication means and complementary electrical contacts disposed in socket 38. The proces~ing W 096/25965 F'CT/CA9G~'~ A 099 device can be any one of a number of deviees including D3MTM and compatible personal co~ , AppleTM ICol"pul~l~, RISC based systems, or larger type systems and the like.
When syringe 10 is placed in base 34, the microcontroller senses 5 a voltage at the complementary electrical contacts and activates the communication circuitry. The stored vollage representing volume information is passed to the analog to digital converter where the signal is converted into a digital volume representation and sto~red in the memory unit. The digital value is then transmitted to the processing 10 device via a suitable communication means such as a RS232 asynchronous communication adaptor and the like, such that patient databases may be updated.
In the event that dat~ collection and record updating is not a requirement for the specific application, the data collection cill;uilly can 15 be tlimin~t~d from syringe 10 which will result in a smaller, more compact housing. In such a case, components required for data transmission, disposed in base member 34, could also be eli.min~t~
As illustrated in Pigure 2b, it is possible to replace electronic control system 46 and battery 50 with a power/data umbilical cable 118.
20 Rlimin~ting these components from syringe 10 allows for a ~rn~ller more compact housing 14. In many applications, a more compact model may be desired over the cordless, but bulkier, f ature of syringe 10. The previously mentioned battery cha~ components would be replaced with a conventional DC power supply in e]ectronic control system 46 25 and housed in base member 34.
In development of the present electronic syringe, it has been d~ mil~ed that patients suffer the most discomfort when in jection fluid enters the tissue. The patient will also experience pain if the flow rate of ~n~t-sthetic entering the tissue is too fast. It has been de~;rl~lil,ed that 30 typical injections take from 15 seconds to 45 seconds to ~tlmini~t~r CA 02213~34 1997-08-22 W O 96/25965 PCT/CA~6/00099 ap~ mately 1.8 mL of anaesthetic depending on the size of needle diameter employed. As discussed above, dental practitioners typically employ three sizes of needle, namely: 25, 27 and 30 gauge. In order to facilitate an anaesthetic injection with minim~l discomfort to the patient, 5 flow properties of a typical anaesthetic injection should be as expressed in Table 1.
Dispensing Needle Flow Needle Exit Ampoule Time Gauge Rate Velocity Fluid (sec) (mL/s) (cm/s) Velocity (cm/s) 0.04 200 0.113 27 0.06 175 0.170 0.12 225 0.340 It has also been determined that, based on the smallest needle diameter (30 gauge), the maximum constant force required to successfully ~mini~ter the anaesthetic injection, without having the patient experience discomfort, is a~loximately 1.5 lbs.
VVlth this in mind, the operation of ~lmini~tering an injection, in accordance with the present invention, will now be described with ,~,r~ ;nce to Figure 2a. Ampoule 40 is pushed into housing 14 via end 15 until fully seated in the position shown in the Figure. Needle 26 is then placed into end lS forcing inward end 70 to pierce membrane 74 in se~linP engagement with ampoule 40. Fluid rate switch 54 is then used to select the desired injection rate as del~ ed by the selected size of needle 26 and as indicated in Table 1. Syringe 10 is gripped between the thumb and index finger of the practitioner's hand in a CA 022l3~34 l997-08-22 W 096/25965 l'CTlCA~6100A99 manner similar to that of holding a pen or pencil as previously described. The practitioner's index finger extends to activabe either of switches 18,22. Providing syringe 10 with a pen style housing 14 enables the practitioner to exercise superior hand control and provide 5 steady injections while substantially decreasing patient discomfort. The pen style housing is also subst~nti~lly less intiimidating to the patient and allows for thumb-free operation of the device.
Lead nut 94, coupled to tube 98 and piston 102 is in the fully retracted position. When switch 18 (or 22) is depressed, electronic control system 46 activates motor 82 effecting rotation of leald screw 90 which advances lead nut 94, tube 98 and piston 102 in the r~ ud direction. Piston 102 abuts plunger 78 and forces plunger 78 through ampoule 40 dispensing fluid through hollow shaft 62, out tip 66 thereby accompli~hing the injection. When switch 18 is released, motor 82 stops 15 and the injection is halted. Once switch 18 or 22 is depressed again, operation resumes and the injection continl~es.
Electrically, electronic control system 46 operates motor 82 in the following manner. When the practitioner activates either of switches 18 or 22, voltage converter 122 is activated and outputs pulses at a 20 frequency proportional to the injection rate, as selected by ~uid rate switch. As previously mentioned, the OUtplUt pulses pass c:ounter 126 and through motor control circuit 130 effecting motor 82 to advance in micro-step increments. Each micro-step corresponds to a specific amount of fluid volume dispensed. In order to track the amount of fluid 25 dispensed, the counter counts pulses down from a maximum value, corresponding to a full ampoule 40, to zero, corresponding ltO an empty ampoule 40. Feedback sensor 106 via feedback control circuit 134 provides a voltage which is proportional to the amount of volume dispensed and is stored in colllp~ r interface 138 until syringe 10 is 30 returned to base 34.
CA 022l3~34 l997-08-22 W 096/25965 PCT/CAgGJ'~C99 Once the timer has reached zero, and a check with the volume dispensed as determined by feedback sensor 106 indicates that ampoule 40 is empty, by lead nut 94 being in the fully extended position, motor 82 is automatically reversed. The reversing motion tr~n~lat~s lead nut 94, tube 98 and piston 102 back to the fully retracted position. Once feedback sensor 106 indicates the fully retracted position has been reached, motor 82 is turned off and the operation cycle is complete. At this point, needle assembly 26 and ampoule 40 may be removed from the unit and discarded.
When the unit has been returned to base member 34, data representing the amount of anaesthetic injected is tr~ d via contact strips 114 and socket 38 to the processing device operating the patient database. By retrieving this information from syringe 10, an accurate patient record can be obtained by providing automatic up-l~tinp Once 15 the data has been retrieved from electronic control means 46, the memory is cleared and syringe 10 is reset and ready for another operating cycle.
An alternative embodiment in accordance with the present invention is shown in Figures 3a, 3b, and 3c and, in these Figures, like 20 elements to those of the above described embodiment of Figures 1, 2a and 2b are indicated with like reference numerals. Further, portion A
discusse-l above with respect to the embo-liment illustrated in Figures 1 and 2a is similar in function and operation to portion B illustrated in Figure 3a.
Thus, with reference to Figure 3a, an electronic syringe 200 is provided with an elongate housing 204 of varying circular cross-section.
In this embodiment, a drive system is used which differs from the one employed in the embo~iimPnt~ illu~LIdled in Figures 1, 2a and 2b. A
drive system 242 comprises a combination lead screw 290 and a motor 282, a piston 202 and lead nut 294. Lead nut 294 is fi,~cedly ~tt~checl W 09612~965 l?CTICA~ G~9 with the rotor of motor 282, which, as it rotates, drives lead screw 290 axially through motor 282. Combined lead ,screw 290 and ~motor 282 may be obtained from Haydon Switch and Instrument Inc.
Lead screw 290 has a free proximal end, which allows axial 5 translation between a fully retracted and a fully extended po~iition, and a distal end directly coupled to piston 202. ~s shown in Figures 3a, 3b and 3c, the fully retracted position is such tha,t the proximal end of lead screw 290 is fully retracted into housing 204 and piston 202 is in close proximity with plunger 78 when ampoule 4Q is full. Again, the fully retracted position is the normal resting position when syringe 200 is not in use. The fully extended position is such th~t the proximal e nd of lead screw 290 is near lead nut 294. It is ~nvrrvlled that lead screw 290 has a stroke length such that, at the fully extended position, piston 202 and plunger 78 have tr~n~l~t~rl to fully dispense the colllrv~ of ampoule 40.
Drive system 242 further includes feedback sensor .L06 having high resolution potentiometer strip 110 mounted to the inner surface of housing 204, along the length of the stroke of lead screw 290. The wiper contact (not shown), fixedly attached to the proximal e nd of lead screw 290, contacts potentiometer strip 110 .lS the lead screvv tr~n~l~tes through motor 282 and lead nut 294. The function of feedback sensor 110 is similar to that previously described.
As illustrated in Figure 3b, in the event that data collection and record updating is not a requirement for the s]pecific application, the data collection Cil'CUilly can be elimin~t.-~l from syringe 200 which will result in a smaller, more compact housing. Components requinvd for data L,allsll.ission, disposed in base member 34, will also be elimin~t~d.
As illustrated in Figure 3c, and similar to Figun 2b, it is Col~lrv~ ated that electronic control system 46 and battery 50 may be replaced with a power/data umbilical cable 118. Fli",i~ these components from syringe 200 allows for a smaller mo:re compact CA 02213~34 1997-08-22 W 096/2~965 PCT/CA~6/OC~g9 housing 204. In many applications, a more compact model may be desired over the cordless, yet bulkier, feature of syringe 200. The previously mentioned battery charger components would be replaced with a conventional DC power supply in electronic control system 46 5 and housed in base member 34.
Functionally, the operation of syringe 200 is substantially the same as that of the previously-described embodiment. Mechanically, the major operating difference with respect to the previously-dlescribed embodiment is that lead screw 290 tr~nel~t~s through motor 282 and lead nut 294 elimin~ting the requirement of the previously described tube 98.
It is co~ ;lllplated that communications between syringe 10 and the processing device may be further enhanced by provided the ability to load data to syringe 10 in addition to presently transferring data from the syringe. For example, a practitioner using a personal (or other) 15 computer and ~l~aling to ~lmini~ter an injection, would retrieve the patient record from the patient database. The practitioner then selects from a menu, or enters directly, the type of anaesthetic about to be mini~tered. The computer could verify, based on information available, whether the patient is sensitive to the anaesthetic selected and 20 offer alternatives. Should the patient record in~iç~te any other special requirements for example, patient history with respect to pain thresholds, the computer would then load syringe 10 with data representing a predetermined operating sequence. Such an operating sequence may include acceleration/deceleration patterns, flow rate data and amount of 25 ~nzl~sthetic to ~t1mini~ter.
The practitioner then merely sets needle 26, presses switches 18 or 22 and syringe 10 takes care of the entire injection operation. Once syringe 10 is returned to base member 34, actual volume dispensed data is l~ e~l to the co~ . Ier and the preloaded volume data is verified 30 with the actual volume dispensed.
CA 02213~34 1997-08-22 W 096/25965 ]~CT/CA~Gf~R3 The present electronic syringe is suitable for injection of biocompatible materials such as pharmaceutical (e.g. anaesthetics, insulin, etc.), vit~min~, minerals, im~ging dyes and the like.
It is colllen~labed that the materials and means described above 5 may be substituted without departing from the spirit and scope of the invention. For example, although the above-described drive system employed an electric lead screw device, it is collLenll)lated that pneumatic cylinders, solenoid, electromagne~tic or hydraulic actuators could also be employed. Also, the electronic control means Imay be any 10 suitable device including an application specific integrated circuit (ASIC) or a micro controller. It is zllso contemplated that a reset switch would be provided on syringe 10 to enable the practitioner to reverse the injection procedure at any time. It is furlher co.llelll~lab d that the present electronic syringe is also suitable for aspiration of various body 15 fluids such as bone marrow, blood, excess joint fluids and the like. In this case drive sysbem 42 could be provided with a sliding feature and a plunger engagement means which would allow an empty ampoule to be filled with any of the above-iden~ified fluids.
TECHNICAL FIELD
The present invention relates to an elec:tronic syringe, and more 5 particularly to a compact, pen-style grip, electronic syringe that allows a practitioner to ~lmini~ter injections or aspirations at a controlled rate and with a precise degree of hand contro] thereby minirni7ing or elimin~ting patient fear and discomfort.
Electronic syringes are known in the art. Typical uses for such devices include injecting biocompatiible material, specifically anaesthetic such as block, conduction and para-apical anaesthesia, thraugh bone tissue. Electronic syringes are also used in a~lmini~tering insulin and 15 other pharmaceuticals.
In most dental applications, practitioners are required ta regularly ~tlmini~ter anaesthetic injections in confined spaces using comventional manual syringes.
Conventional manual syringes, as used in dentistry applications, 20 usually comprise a hollow cylindrical housing, having one en,d adapted to receive a needle and the other end adapted to receive a piston assembly. The outer surface of the housing iis provided withl a pair of finger grips such that the device can be held i~rmly between the middle and index fingers of the practitioner's hand. ~n~t-.stlleti,c is commonly 25 supplied in premeasured ampoules which are ~lesignP~l to fit into the housing. The ampoule has one end pravided with a pierceable membrane that receives the needle in sealinçr engagement and another end fitted with a slidable plunger which engages the piston assembly.
The piston assembly incll~es a shaft, one end of which is filted with a 30 pl~lng~.r, and an opposing end provided with a thumbrest. In operation, CA 02213~34 1997-08-22 the anaesthetic injection is ~flmini~tered by depressing the plunger with the practitioner's thumb which causes the piston to engage the plunger, thereby forcing anaesthetic from the ampoule via the needle.
There are several disadvantages associated with conventional , manual syringes used in dentistry applications. For example, due to the potential for uneven thumb pressure applied on the thumbrest, the practitioner has very little control over the flow rate of anaesthetic exiting the needle. As a result, it is virtually impossible to achieve a subet~nti~lly constant flow rate with a m~nll~l syringe. Further, many practitioners often complain that, due to the m~nner by which a conventional m~nll~l syringe is grasped, such a syringe offers poor control of the needle tip when ~lmini~tering the injection. As a result, unsteady injections generally lead to unnecessary pain and discomfort to the patient. Still further, it is generally uncontested that the majority of patients dislike the thought of receiving an injection, especially a dental injection. Tn~1ee-1, this aversion is usually due to the fact that many m~nll~l syringes are highly intimi(l~tin~ in appearance.
The prior art has aLI~-I.pl~d to address various of these disadv~nt~t s, with little or no noticeable success.
United States patent 4,617,016 (Blomberg) t~ches an insulin injection device adapted to accommodate conventional disposable syringes. Through the use of a motor in communication with a tr~n.~mi~ion and lead screw, the device is capable of being used to load an empty ~,ylinge with a predetermined amount of insulin from an external ampoule prior to injecting. Ul~ol lullately, the device is cumbersome and somewhat intimi~ting to the patient. Another disadvantage is that, using a conventional hypodermic ~yl;l~ which must be replaced between injections adds to the ~elalillg cost of the unit. Yet another disadvantage is that there is no means for tracking the amount of insulin injected.
CA 02213~34 1997-08-22 W 096/25965 PCT/CA~G/00~9 United States patent 5,269,762 (Armbruster et al.) teaches a portable hand-held power assister device for injecting a liquicl, such as X-ray contrast media, into the vascular system of a m7~mm~1 at a single constant rate. The assister device is a pistol type arrangement that 5 externa]Lly receives a conventiona]L syringe onto the front of the unit. A
connector, coupled to one end of a lead screw/transmission drive engages the thumbrest on the syringe. A forward-reverse switch is provided which is used to load and dispense the syringe. Clearly, this device is not suited for lSnely controlled variable rate injections (e.g. for 10 dental applications) and is intended to be used ~remotely of the patient via a bull~;lnLy needle. Thus, in a denta]L application (and other applications), the device cannot provide the delicate and preciise hand control necessary to ~lmini~ter an injection without the patient éxperiencing discomfort.
It would be desirable to have an electronic device capable of 15 dispensing a fluid at a constant and precise rate. It would also be advantageous if such a device could be operated in a "thumb-less"
m~nn~.r and was configured to a]Llow the practitioner to halve precise control of the amount of fluid being ~imini~t~red. It would a]Lso be further advantageous if the device was configured to be less intimitl~ting 20 in appearance than the prior art devices.
DISCLOSURE OF THE INVENTION
It is an objective of the present invention to provide an electronic syringe which obviates or miti~tes at least one of the above-mentioned 25 disadv~nt~ s of the prior art.
Accordingly, in one of its aspects, the present invention provides an electronic syringe coll.pl;sing:
a genera]Lly elongate housing comprising a needle and electronic control means at opposite ends thereof;
CA 02213~34 1997-08-22 W O 96/25965 PCT/CA~G~ 9 an ampoule receiving first portion disposed in the housing adjacent the needle;
drive means in electrical communication with the electronic control means;
a plunger disposed between the first portion and the drive means, the drive means actuating the plunger through the first portion; and switch means located on the housing for actuating the drive means.
In another of its aspects, the present invention an electronic 10 syringe comprising:
a generally elongate housing comprising needle attachment means and electronic control means at opposite ends thereof;
an ampoule receiving first portion disposed in the housing adjacent the needle attachment means;
drive means in electrical communication with the electronic control means;
a plunger disposed between the first portion and the drive means, the drive means ~ctu~tinP the plunger through the first portion; and switch means located on the housing for actuating the drive means.
Thus, the present invention relates to an electronic syringe. As used throughout this spe.cifi~tion the term "electronic syringe" has a broad m~ ning and is intended to encompass a device used for injection or aspiration, as warranted by the intended application.
Further, as used throughout this specification, the term "electronic", when used in the context of describing an injection syringe, is intended to have a broad me~ning which encompasses an injection O
syringe wherein at least a portion of the energy requirement to actuate the plllnger in the syringe is achieved electrically.
W 096/2~965 ]?CT/CA9GJ~D~5 BRIEF DESCRIPTION OF THE DRAWINC;S
Embodiments of the present invention will be described with reference to the accompanying drawings, in which:
Figure l illustrates a perspective view of an electronic syringe in 5 accordance with an embodiment of the present invention;
Figure 2a illustrates a sectional view taken along line II-II of Figure l, wherein the syringe illustrated in Figure l has been further adapted to include a battery power supply;
Figure 2b illustrates a sectional view taken along line II-II of l0 Figure l, wherein the syringe illustrated in Figure l has been further adapted to include an umbilical cord;
Figure 3a illustrates a sectional view of an electronic syringe in accordance with another embodiment of lhe present invention and adapted to include a battery power supply;
lS Figure 3b illustrates a sectional view of a syringe sirnilar to the one illustrated in Figure 3a and adapted to include a ba1tery power supply;
Figure 3c illustrates a sectional view of a syringe similar to the one illu~ d in Figure 3a and adapted to inc~ de an umb)ilical cord;
20 and Figure 4 illustrates a block diagram of an electranic control circuit in accordance with an embodiment of the present imrention.
In the Figures, like reference numera]s are used to de!si~n~te like elements.
BEST MODE FOR CARRYING OUT l~ INVENTION
Wlth lcr~ ce to Figure l, there is illu~llal~d an electronic syringe l0 in accordance with an embodiment of the present invention.
As can be seen in the Figure, syringe l0 inc11~1Ps a elongate housing 14 30 of varying circular cross-section, having a paLir of ends 15, l 6 and control CA 02213~34 1997-08-22 W 096/25965 PCT/CA9"~--99 switches 18,22. A needle 26 is provided with a collar 30 and is removably received by end 15. Housing 14 assumes the appearance and feel similar to that of a pen which provides the practitioner with an enh~nced comfort level, thereby providing confident, steady and a 5 precise degree of hand control. To the patient, the pen-like appearance is much less intimidating when co~ ,d to conventional electronic syringe devices.
Housing 14 is preferably moulded from a medical grade plastic material such as a liquid crystal polymer commercially available from 10 Hoechst Celanese under the tradename Vectra LCPTM . Another possible alternate material is medical grade LexanTM commercially available from General Electric Plastics. The type of material used to mould the housing would depend on the exact method of sterilization to be used and the type of application in which syringe 10 will be subjected 15 or the environment in which it will be used.
In an alternative embodiment, a portion A of housing 14 may be configured to be detachable from the rem~in-ler of housing 14. In this embodiment, it is ~l~f~ d that portion A be constructed of a m~t~rial (e.g. stainless steel and the like) capable of will.~ 1ing the rigors of 20 high lt;n.~el~t~lre sterilization (e.g. by autoclaving). Portion A can be readily designed to by detachable from the rem~inrler of housing 14 using a conventional "quick connect" system which allows for rapid attachment and detachment between portion A and the rem~in~ler of housing 14. In this embodiment it is ~ler~;rlcd that collar 30 is 25 removably connected to end 1~ of portion A. While the longitlldin~l length of portion A is not particularly restricted, it is pl~f~ cd that it corresponds sub~t~nti~lly to the portion of housing 14 which encases the fluid cont~ininP ampoule described hereinbelow.
A base member 34 inrlll-les a cradle 36 and an interface socket 38.~ase member 34 is used to store and recharge syringe 10 when not W 096/25965 PCT/CA~ C95 in use and is also used to collect data via soc~-.et 38 when syringe 10 is placed in the base. The operation of collecting data and n~charging syringe 10 will be described in greater detail hereinbelow.
Needle 26 comprises a collar 30 through which is passecl a hollow S shaft 62. Shaft 62 acts as a p~s~ .way for fluid p~in~ bet~1veen a tip 66 in needle 26, adapted for piercing tissue, and an inward end 70 adapted for piercing an ampoule cont~inin~ a fluid. Needle 26 is typically available in three common sizes, narnely 25, 27 and 30 gauge.
The gauge sizes correspond to the outside diameter of hollow shaft 62.
As illustra~ed in Figure 2a, the internals of syringe 10 comprise a removable ampoule 40, a drive system 42, an electronic conbrol system 46, a battery 50 and a fluid rate switch 54.
Ampoule 40 is a conventional, genera]ly cylindrical, <lisposable container used to p~c.k~ge ~ ~cd fluids such as medicants, ~n~esthetics 15 and the like. Ampoule 40 is provided with a pair of ends, one end having a pierceable membrane 74 which receives inward end 70 of needle 26 in sealing engagement. The opposi"g end of ampoule 40 is fitted with an internally slidable plunger 78.
Switches 18,22 are cl~m~he.ll, on/off, finger pressure sensitive 20 switches that encircle housing 14 and are used to stop ancl start the operation of syringe 10. The use of this type of switch enables operation of syringe 10 through 360~ about t~he longitu~lin~l axis of the unit without having to rotate the device to access either of switches 18,22. Switch 18 is mounted in close proxirnity to end 15 to f~cilit~t~
25 injections requiring the practitioner's hand to be positioned near needle 26 for finer control. Switch 22 is mounted towards the middle of housing 14 and provides opera(ing control when the practitioner requires a longer reach.
Fluid rate switch 54 is a rotary, three position selector which 30 allows the practitioner to select from three speed settings namely, slow, CA 02213~34 1997-08-22 medium and fast and are selected depending on the size of needle 26 selected.
Battery S0 is preferably a conventional rechargeable AA type unit. External connections to a conventional battery charger power 5 supply (not shown) and the data communication circuit (not shown) are accomplished via metal contact strips 114 moulded into end 16 of housing 14. Contact strips 114 engage complementary contact strips provided in socket 38 of base member 34.
Drive system 42 comprises a lead screw 90, a lead nut 94, a motor 82, a thin walled tube 98 and a piston 102. Lead screw 90 has a proximal end directly coupled to the shaft of motor 82, and a free distal end. Lead nut 94 engages lead screw 90 in a complementary manner and is movable along lead screw 90 between a fully retracted and a fully extended position. I~be 98 freely surrounds lead screw 90 and has one end fixedly attached to lead nut 94. The opposing end of tube 98 is fitted to piston 102 and is long enough such that piston 102 does not i.l-wr~;,e with the distal end of lead screw 90 when lead nut 94 is in the fully retracted position. As illustrated in Figure 2a, the fully retracted position is such that lead nut 94 is near the ,~r~i.--al end of lead screw 90 and piston 102 is in close coupling ~ illlily with plunger 78 when ampoule 40 is full. The fully retracted position is the normal resting position when syringe 10 is not in use. In the fully extended position, the proximal end of lead screw 90 is near lead nut 94. It is ~lcrelled that lead screw 90 has a stroke length such that, at the fully extended position, piston 102 and plunger 78 have tr~n~l~t~d to fully dispense the contents of ampoule 40.
The engagement of lead nut 94 with lead screw 90 is such that there exists a small amount of backlash or "play" to allow for momentary "self aspilalion" caused by back pressure in the tissue when first pierced by needle 26. Typically, upon piercing, a small amount of W O 96/25965 PCT/CA~G/00_99 _9_ blood will enter ampoule 40 as the back pressure in the tissue equalizes that in ampoule 40. As the pressure eql-~li7~s, a force is tr~n~mittc-~l to lead screw 90 via lead nut 94 as plunger 78 presses against piston 102.
A certaiin amount of backlash is required to absorb the force created by 5 pressure eqn~li7~tion. This self aspiration assists the practitioner in determinin~ whether a blood vessel has been pierced. As would be a~a,cllL to one of skiill in the art, other methods of introducing "play"
into drive system 42 exist. For example, "pl~ly" may be introduced into drive system 42 by employing a flexible coupling, spring or having plunger 78 and piston 102 sit in a spaced relationship initially upon insertion of ampoule 40 into syringe 10.
Preferably, motor 82 is a Series lCl16, mini~ re DC motor manufactured by MicroMo Electronics Inc. and includes a 64:1 10/1 gearhead and a Series HE encoder (not shown). Lead screw 90 is a conventional stainless steel lead screw such as that m~mllF~t.tured by Kerk Motion Products Inc. and may includc- a TeflonTM coatiing which serves to extend the liife thereof. Lead nut 94 is a conventianal off-the-shelf component also rn~n~lf~ctured by Kerk Motion Produc,ts Inc. and is preferably forrned from AcetalTM which is a self-lubricating plastiic having long life characteristics. As is knawn in the art, AcetalTM is commercially available E.I. Du Pont de Nernours and Company.
A feedback sensor 106 which comprises a high resolution potentiometer strip 110 mounted to the outer surface of tube 98. A
wiper contact (not shown), fixedly ~tt~-~.he~l to the inner surface of housing 14, contacts potentiometer strip 110 as lead nut 94 moves tube 98 along lead screw 90. The motion of potentiometer strip 1 :l0 along the - wiper contact which causes a variation in electrical re~i~t~nce through potentiometer strip 110 which is co~ d into positional information by electronic control system 46. A non~ , e~mple of a suitable CA 02213~34 1997-08-22 feedback sensor 106 is manufactured by Data Instruments Inc. and is commercially available under model name MystR~M.
With reference to Figure 4, electronic control system 46 comprises a battery charge interface (not shown), a voltage converter 5 122, a counter 126, a motor control circuit 130, a feedback control circuit 134 and a col~,pul~r interface 138. Fluid rate switch 54 determines the desired flow rate by providing voltage converter 122 with an input voltage proportional to the desired flow rate. This causes voltage converter 122 to output a frequency pulse proportional to injection flow rate. The frequency output pulse from voltage converter 122 is input to counter 126 which counts one incremental step for each input pulse from a predetermined maximum value, representing a full ampoule, to zero, representing an empty ampoule. Each incremental step of the counter is passed to a high ~;ullel~t driver portion of the 1~ motor control circuit 130 which rotates motor 82 in micro-step increments. In this regard, the feedback control circuit, connected to feedback sensor 106, provides a precise voltage that is directly proportional to the position of piston 102 and the volume amount of injected material.
Computer interface 138 enables creation and/or mainlellal.ce of a record of the amount of anaesthetic ~(lmini~tered during an operating cycle of syringe 10. Feedback control circuit 134 provides the proportional voltage that is scaled and held by colll~ulel interface 138 until syringe 10 is placed in base 34. As would be apparent to one of skill in the art, base member 34 further incl~ e~ components of electronic control system 46, sufflcient to f~rilit~t~ co~ n.ication with a proces~in~ device. Specifically, the communication Cil~iuiLIy comprises a analog to digital converter, memory, a microcontroller, a conventional asynchronous serial communication means and complementary electrical contacts disposed in socket 38. The proces~ing W 096/25965 F'CT/CA9G~'~ A 099 device can be any one of a number of deviees including D3MTM and compatible personal co~ , AppleTM ICol"pul~l~, RISC based systems, or larger type systems and the like.
When syringe 10 is placed in base 34, the microcontroller senses 5 a voltage at the complementary electrical contacts and activates the communication circuitry. The stored vollage representing volume information is passed to the analog to digital converter where the signal is converted into a digital volume representation and sto~red in the memory unit. The digital value is then transmitted to the processing 10 device via a suitable communication means such as a RS232 asynchronous communication adaptor and the like, such that patient databases may be updated.
In the event that dat~ collection and record updating is not a requirement for the specific application, the data collection cill;uilly can 15 be tlimin~t~d from syringe 10 which will result in a smaller, more compact housing. In such a case, components required for data transmission, disposed in base member 34, could also be eli.min~t~
As illustrated in Pigure 2b, it is possible to replace electronic control system 46 and battery 50 with a power/data umbilical cable 118.
20 Rlimin~ting these components from syringe 10 allows for a ~rn~ller more compact housing 14. In many applications, a more compact model may be desired over the cordless, but bulkier, f ature of syringe 10. The previously mentioned battery cha~ components would be replaced with a conventional DC power supply in e]ectronic control system 46 25 and housed in base member 34.
In development of the present electronic syringe, it has been d~ mil~ed that patients suffer the most discomfort when in jection fluid enters the tissue. The patient will also experience pain if the flow rate of ~n~t-sthetic entering the tissue is too fast. It has been de~;rl~lil,ed that 30 typical injections take from 15 seconds to 45 seconds to ~tlmini~t~r CA 02213~34 1997-08-22 W O 96/25965 PCT/CA~6/00099 ap~ mately 1.8 mL of anaesthetic depending on the size of needle diameter employed. As discussed above, dental practitioners typically employ three sizes of needle, namely: 25, 27 and 30 gauge. In order to facilitate an anaesthetic injection with minim~l discomfort to the patient, 5 flow properties of a typical anaesthetic injection should be as expressed in Table 1.
Dispensing Needle Flow Needle Exit Ampoule Time Gauge Rate Velocity Fluid (sec) (mL/s) (cm/s) Velocity (cm/s) 0.04 200 0.113 27 0.06 175 0.170 0.12 225 0.340 It has also been determined that, based on the smallest needle diameter (30 gauge), the maximum constant force required to successfully ~mini~ter the anaesthetic injection, without having the patient experience discomfort, is a~loximately 1.5 lbs.
VVlth this in mind, the operation of ~lmini~tering an injection, in accordance with the present invention, will now be described with ,~,r~ ;nce to Figure 2a. Ampoule 40 is pushed into housing 14 via end 15 until fully seated in the position shown in the Figure. Needle 26 is then placed into end lS forcing inward end 70 to pierce membrane 74 in se~linP engagement with ampoule 40. Fluid rate switch 54 is then used to select the desired injection rate as del~ ed by the selected size of needle 26 and as indicated in Table 1. Syringe 10 is gripped between the thumb and index finger of the practitioner's hand in a CA 022l3~34 l997-08-22 W 096/25965 l'CTlCA~6100A99 manner similar to that of holding a pen or pencil as previously described. The practitioner's index finger extends to activabe either of switches 18,22. Providing syringe 10 with a pen style housing 14 enables the practitioner to exercise superior hand control and provide 5 steady injections while substantially decreasing patient discomfort. The pen style housing is also subst~nti~lly less intiimidating to the patient and allows for thumb-free operation of the device.
Lead nut 94, coupled to tube 98 and piston 102 is in the fully retracted position. When switch 18 (or 22) is depressed, electronic control system 46 activates motor 82 effecting rotation of leald screw 90 which advances lead nut 94, tube 98 and piston 102 in the r~ ud direction. Piston 102 abuts plunger 78 and forces plunger 78 through ampoule 40 dispensing fluid through hollow shaft 62, out tip 66 thereby accompli~hing the injection. When switch 18 is released, motor 82 stops 15 and the injection is halted. Once switch 18 or 22 is depressed again, operation resumes and the injection continl~es.
Electrically, electronic control system 46 operates motor 82 in the following manner. When the practitioner activates either of switches 18 or 22, voltage converter 122 is activated and outputs pulses at a 20 frequency proportional to the injection rate, as selected by ~uid rate switch. As previously mentioned, the OUtplUt pulses pass c:ounter 126 and through motor control circuit 130 effecting motor 82 to advance in micro-step increments. Each micro-step corresponds to a specific amount of fluid volume dispensed. In order to track the amount of fluid 25 dispensed, the counter counts pulses down from a maximum value, corresponding to a full ampoule 40, to zero, corresponding ltO an empty ampoule 40. Feedback sensor 106 via feedback control circuit 134 provides a voltage which is proportional to the amount of volume dispensed and is stored in colllp~ r interface 138 until syringe 10 is 30 returned to base 34.
CA 022l3~34 l997-08-22 W 096/25965 PCT/CAgGJ'~C99 Once the timer has reached zero, and a check with the volume dispensed as determined by feedback sensor 106 indicates that ampoule 40 is empty, by lead nut 94 being in the fully extended position, motor 82 is automatically reversed. The reversing motion tr~n~lat~s lead nut 94, tube 98 and piston 102 back to the fully retracted position. Once feedback sensor 106 indicates the fully retracted position has been reached, motor 82 is turned off and the operation cycle is complete. At this point, needle assembly 26 and ampoule 40 may be removed from the unit and discarded.
When the unit has been returned to base member 34, data representing the amount of anaesthetic injected is tr~ d via contact strips 114 and socket 38 to the processing device operating the patient database. By retrieving this information from syringe 10, an accurate patient record can be obtained by providing automatic up-l~tinp Once 15 the data has been retrieved from electronic control means 46, the memory is cleared and syringe 10 is reset and ready for another operating cycle.
An alternative embodiment in accordance with the present invention is shown in Figures 3a, 3b, and 3c and, in these Figures, like 20 elements to those of the above described embodiment of Figures 1, 2a and 2b are indicated with like reference numerals. Further, portion A
discusse-l above with respect to the embo-liment illustrated in Figures 1 and 2a is similar in function and operation to portion B illustrated in Figure 3a.
Thus, with reference to Figure 3a, an electronic syringe 200 is provided with an elongate housing 204 of varying circular cross-section.
In this embodiment, a drive system is used which differs from the one employed in the embo~iimPnt~ illu~LIdled in Figures 1, 2a and 2b. A
drive system 242 comprises a combination lead screw 290 and a motor 282, a piston 202 and lead nut 294. Lead nut 294 is fi,~cedly ~tt~checl W 09612~965 l?CTICA~ G~9 with the rotor of motor 282, which, as it rotates, drives lead screw 290 axially through motor 282. Combined lead ,screw 290 and ~motor 282 may be obtained from Haydon Switch and Instrument Inc.
Lead screw 290 has a free proximal end, which allows axial 5 translation between a fully retracted and a fully extended po~iition, and a distal end directly coupled to piston 202. ~s shown in Figures 3a, 3b and 3c, the fully retracted position is such tha,t the proximal end of lead screw 290 is fully retracted into housing 204 and piston 202 is in close proximity with plunger 78 when ampoule 4Q is full. Again, the fully retracted position is the normal resting position when syringe 200 is not in use. The fully extended position is such th~t the proximal e nd of lead screw 290 is near lead nut 294. It is ~nvrrvlled that lead screw 290 has a stroke length such that, at the fully extended position, piston 202 and plunger 78 have tr~n~l~t~rl to fully dispense the colllrv~ of ampoule 40.
Drive system 242 further includes feedback sensor .L06 having high resolution potentiometer strip 110 mounted to the inner surface of housing 204, along the length of the stroke of lead screw 290. The wiper contact (not shown), fixedly attached to the proximal e nd of lead screw 290, contacts potentiometer strip 110 .lS the lead screvv tr~n~l~tes through motor 282 and lead nut 294. The function of feedback sensor 110 is similar to that previously described.
As illustrated in Figure 3b, in the event that data collection and record updating is not a requirement for the s]pecific application, the data collection Cil'CUilly can be elimin~t.-~l from syringe 200 which will result in a smaller, more compact housing. Components requinvd for data L,allsll.ission, disposed in base member 34, will also be elimin~t~d.
As illustrated in Figure 3c, and similar to Figun 2b, it is Col~lrv~ ated that electronic control system 46 and battery 50 may be replaced with a power/data umbilical cable 118. Fli",i~ these components from syringe 200 allows for a smaller mo:re compact CA 02213~34 1997-08-22 W 096/2~965 PCT/CA~6/OC~g9 housing 204. In many applications, a more compact model may be desired over the cordless, yet bulkier, feature of syringe 200. The previously mentioned battery charger components would be replaced with a conventional DC power supply in electronic control system 46 5 and housed in base member 34.
Functionally, the operation of syringe 200 is substantially the same as that of the previously-described embodiment. Mechanically, the major operating difference with respect to the previously-dlescribed embodiment is that lead screw 290 tr~nel~t~s through motor 282 and lead nut 294 elimin~ting the requirement of the previously described tube 98.
It is co~ ;lllplated that communications between syringe 10 and the processing device may be further enhanced by provided the ability to load data to syringe 10 in addition to presently transferring data from the syringe. For example, a practitioner using a personal (or other) 15 computer and ~l~aling to ~lmini~ter an injection, would retrieve the patient record from the patient database. The practitioner then selects from a menu, or enters directly, the type of anaesthetic about to be mini~tered. The computer could verify, based on information available, whether the patient is sensitive to the anaesthetic selected and 20 offer alternatives. Should the patient record in~iç~te any other special requirements for example, patient history with respect to pain thresholds, the computer would then load syringe 10 with data representing a predetermined operating sequence. Such an operating sequence may include acceleration/deceleration patterns, flow rate data and amount of 25 ~nzl~sthetic to ~t1mini~ter.
The practitioner then merely sets needle 26, presses switches 18 or 22 and syringe 10 takes care of the entire injection operation. Once syringe 10 is returned to base member 34, actual volume dispensed data is l~ e~l to the co~ . Ier and the preloaded volume data is verified 30 with the actual volume dispensed.
CA 02213~34 1997-08-22 W 096/25965 ]~CT/CA~Gf~R3 The present electronic syringe is suitable for injection of biocompatible materials such as pharmaceutical (e.g. anaesthetics, insulin, etc.), vit~min~, minerals, im~ging dyes and the like.
It is colllen~labed that the materials and means described above 5 may be substituted without departing from the spirit and scope of the invention. For example, although the above-described drive system employed an electric lead screw device, it is collLenll)lated that pneumatic cylinders, solenoid, electromagne~tic or hydraulic actuators could also be employed. Also, the electronic control means Imay be any 10 suitable device including an application specific integrated circuit (ASIC) or a micro controller. It is zllso contemplated that a reset switch would be provided on syringe 10 to enable the practitioner to reverse the injection procedure at any time. It is furlher co.llelll~lab d that the present electronic syringe is also suitable for aspiration of various body 15 fluids such as bone marrow, blood, excess joint fluids and the like. In this case drive sysbem 42 could be provided with a sliding feature and a plunger engagement means which would allow an empty ampoule to be filled with any of the above-iden~ified fluids.
Claims (31)
1. An electronic syringe comprising:
a pen-style elongate housing comprising a needle and electronic control means at opposite ends thereof;
an ampoule receiving first portion disposed in the housing adjacent the needle;
drive means in electrical communication with the electronic control means;
a plunger disposed between the first portion and the drive means, the drive means actuating the plunger through the first portion; and switch means located on the pen-style elongate housing between said opposite ends for actuating the drive means.
a pen-style elongate housing comprising a needle and electronic control means at opposite ends thereof;
an ampoule receiving first portion disposed in the housing adjacent the needle;
drive means in electrical communication with the electronic control means;
a plunger disposed between the first portion and the drive means, the drive means actuating the plunger through the first portion; and switch means located on the pen-style elongate housing between said opposite ends for actuating the drive means.
2. An electronic syringe defined in claim 1, further comprising a power means coupleable to said electronic control means.
3. An electronic syringe defined in claim 2, wherein said electronic control means comprises a rechargeable battery disposed within said electronic syringe, and wherein said power means comprises a battery charger detachably coupleable to said battery.
4. An electronic syringe defined in claim 2, wherein said power means communicates with said electronic syringe via an umbilical cord.
5. An electronic syringe defined in any one of claims 1-4, further comprising abase member upon which said syringe may be mounted.
6. An electronic syringe defined in any one of claims 1-5, wherein said drive means comprises an electric motor.
7. An electronic syringe defined in claim 6, wherein said electric motor comprises a DC stepper motor.
8. An electronic syringe defined in any one of claims 1-7, wherein said drive means further comprises a lead screw and a lead nut.
9. An electronic syringe defined in claim 8, wherein said lead screw and said lead nut in combination provide a backlash, said backlash providing self aspiration of said ampoule.
10. An electronic device defined in any one of claims 1-9, said electronic control means further comprises a flow rate selector switch.
11. An electronic syringe defined in any one of claims 1-10, wherein said electronic control means further comprises a reset switch.
12. An electronic syringe defined in any one of claims 1-10, wherein said electronic control means further comprises a reverse switch.
13. A syringe defined in any one of claims 1-10, wherein said switch means is disposed on said housing adjacent the ampoule receiving portion.
14. An electronic syringe comprising:
a generally elongate housing comprising a needle and electronic control means at opposite ends thereof;
an ampoule receiving first portion disposed in the housing adjacent the needle;
drive means in electrical communication with the electronic control means;
a plunger disposed between the first portion and the drive means, the drive means actuating the plunger through the first portion; and switch means located on the housing between said opposite ends for actuating the drive means, wherein said electronic control means further comprises a feedback sensor mounted to said drive means which provides a signal representative of a measurement of volume injected and aspirated.
a generally elongate housing comprising a needle and electronic control means at opposite ends thereof;
an ampoule receiving first portion disposed in the housing adjacent the needle;
drive means in electrical communication with the electronic control means;
a plunger disposed between the first portion and the drive means, the drive means actuating the plunger through the first portion; and switch means located on the housing between said opposite ends for actuating the drive means, wherein said electronic control means further comprises a feedback sensor mounted to said drive means which provides a signal representative of a measurement of volume injected and aspirated.
15. An electronic syringe defined in claim 14, wherein said feedback sensor comprises a potentiometer strip and a wiper contact.
16. An electronic syringe defined in any one of claims 14-15, wherein said signal representative of said measurement is stored in said electronic control means.
17. An electronic syringe defined in claim 16, wherein said electronic control means converts said signal representative of said measurement of volume injected and aspirated, to a digital signal.
18. An electronic syringe defined in claim 17, wherein said electronic control means further comprises a communication means for communicating said digital signal to a processing device.
19. An electronic syringe defined in claim 18, wherein said communication means comprises an asynchronous communications adapter.
20. A syringe defined in any one of claims 18-19, further comprising the processing device.
21. An electronic syringe defined in claim 20, wherein said processing device maintains a patient database and updates said database with said digital signal representing volume injected and aspirated.
22. An electronic syringe defined in claim 20 wherein said processing device comprises a computer.
23. An electronic syringe comprising:
an elongate tubular housing having a first end adapted to hold a needle and a second end disposed opposite said first end along a longitudinal axis of said elongate tubular housing;
an electrical drive unit disposed at said second end, said electrical drive unit comprising a a motor disposed along the longitudinal axis of said elongate tubular housing;
an ampoule receiving portion disposed in said housing between said first end and said electrical drive unit; and a switch disposed on said elongate tubular housing, for activating said electrical drive unit.
an elongate tubular housing having a first end adapted to hold a needle and a second end disposed opposite said first end along a longitudinal axis of said elongate tubular housing;
an electrical drive unit disposed at said second end, said electrical drive unit comprising a a motor disposed along the longitudinal axis of said elongate tubular housing;
an ampoule receiving portion disposed in said housing between said first end and said electrical drive unit; and a switch disposed on said elongate tubular housing, for activating said electrical drive unit.
24. A syringe defined in claim 23 wherein said electrical drive unit includes an electrical control unit disposed on said longitudinal axis and in electrical communication with said switch and said motor.
25. A syringe defined in any one of claims 23-24 wherein said switch comprises a first on/off finger pressure switch disposed adjacent said first end.
26. A syringe defined in claim 25, wherein said first switch is activated by finger pressure applied in a direction toward said longitudinal axis.
27. A syringe defined in any one of claims 25-26, further comprising another on/off finger pressure switch spaced apart from said first switch in a direction toward said second end.
28. A syringe defined in any one of claims 23-27 wherein said electrical drive unit comprises a battery compartment disposed adjacent said second end, an electrical control unit disposed adjacent said battery compartment, and a motor disposed between said electrical control unit and ampoule receiving portion.
29. A syringe defined in any one of claims 23-28, wherein said switch is disposed on said housing adjacent the ampoule receiving portion.
30. An electronic syringe defined in any one of claims 23-29, wherein said electrical drive unit includes a battery compartment disposed along the longitudinal axis of said tubular housing.
31. An electronic syringe defined in any one of claims 23-30, wherein said electrical drive unit includes an electrical cable disposed along the longitudinal axis of said tubular housing.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/392,225 US5690618A (en) | 1995-02-22 | 1995-02-22 | Electronic syringe |
| US08/392,225 | 1995-02-22 | ||
| PCT/CA1996/000099 WO1996025965A1 (en) | 1995-02-22 | 1996-02-22 | Electronic syringe |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2213534A1 CA2213534A1 (en) | 1996-08-29 |
| CA2213534C true CA2213534C (en) | 2002-04-30 |
Family
ID=23549791
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002213534A Expired - Fee Related CA2213534C (en) | 1995-02-22 | 1996-02-22 | Electronic syringe |
Country Status (9)
| Country | Link |
|---|---|
| US (1) | US5690618A (en) |
| EP (1) | EP0810890B1 (en) |
| JP (1) | JPH11500038A (en) |
| AT (1) | ATE227142T1 (en) |
| AU (1) | AU4660896A (en) |
| CA (1) | CA2213534C (en) |
| DE (1) | DE69624687T2 (en) |
| DK (1) | DK0810890T3 (en) |
| WO (1) | WO1996025965A1 (en) |
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-
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- 1995-02-22 US US08/392,225 patent/US5690618A/en not_active Expired - Lifetime
-
1996
- 1996-02-22 AU AU46608/96A patent/AU4660896A/en not_active Abandoned
- 1996-02-22 CA CA002213534A patent/CA2213534C/en not_active Expired - Fee Related
- 1996-02-22 AT AT96902193T patent/ATE227142T1/en not_active IP Right Cessation
- 1996-02-22 EP EP96902193A patent/EP0810890B1/en not_active Expired - Lifetime
- 1996-02-22 DE DE69624687T patent/DE69624687T2/en not_active Expired - Lifetime
- 1996-02-22 DK DK96902193T patent/DK0810890T3/en active
- 1996-02-22 WO PCT/CA1996/000099 patent/WO1996025965A1/en active IP Right Grant
- 1996-02-22 JP JP8525261A patent/JPH11500038A/en active Pending
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| DE69624687T2 (en) | 2003-09-18 |
| WO1996025965A1 (en) | 1996-08-29 |
| AU4660896A (en) | 1996-09-11 |
| EP0810890A1 (en) | 1997-12-10 |
| ATE227142T1 (en) | 2002-11-15 |
| DE69624687D1 (en) | 2002-12-12 |
| US5690618A (en) | 1997-11-25 |
| DK0810890T3 (en) | 2003-03-03 |
| CA2213534A1 (en) | 1996-08-29 |
| JPH11500038A (en) | 1999-01-06 |
| EP0810890B1 (en) | 2002-11-06 |
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| EEER | Examination request | ||
| MKLA | Lapsed |