Pressure/force computer controlled drug delivery system and the like
17 claims: 3 independent, 14 dependent
- 1Patentkrav 1. Elektronisk anordning för att selektivt injicera eller extrahera vätska från en patients kropp, innefattande:en behållare för injicering eller uppsamling av nämnda vätska;en vätsketilldelningssektion försedd med en första ände vilken är kopplad till nämnda behållare och en andra ände som är anpassad för att föras in i nämnda kropp;en elektrisk drivmekanism som är anordnad och konstruerad för att anbringa en kraft inne i nämnda behållare som svar på kommandon i antingen en första riktning i vilken vätska injiceras från nämnda behållare genom nämnda vätsketilldelningssystem in i nämnda kropp och en andra riktning i vilken vätska extraheras från nämnda kropp genom nämnda vätsketilldelningssystem;en givare för detektering av en intern parameter som indikerar en kraft vilken alstras av nämnda drivmekanism och interna motstånd inne i nämnda behållare och nämnda vätsketilldelningssystem gentemot nämnda kraft;och en regulator som är kopplad till nämnda givare, varvid nämnda regulator innefattar en räknare för att beräkna ett ingångs-/utgångstryck vid nämnda andra ände som en funktion av nämnda interna parameter, varvid nämnda regulator avger nämnda kommandon för att garantera att nämnda utgångstryck inte överstiger en förutbestämd nivå.
- 2Anordning enligt patentkrav 1,kännetecknad av att nämnda regulator innefattar en jämförare som jämför nämnda ingångs-/utgångstryck med ett förutbestämt tröskelvärde.
- 3Anordning enligt patentkrav 2, kännetecknad av att nämnda förutbestämda tröskelvärde väljs så att det motsvarar en trycknivå i en patients vävnad, vilken nivå har fastställts för att minimera smärta och/eller vävnadsskador på nämnda patient.
- 4Anordning enligt patentkrav 1,kännetecknad av att den dessutom innefattar ett minne för lagring av fysiska karakteristika hos nämnda vätsketilldelningssystem 526 308 och nämnda behållare, varvid nämnda räknare är anpassad för att fastställa nämnda utgångs/ingångstryck, baserat på nämnda fysiska karakteristika.
- 5Anordning enligt patentkrav 4, kännetecknad av att nämnda minne dessutom är anpassat för att lagra vätskekarakteristika för nämnda vätska, varvid nämnda räknare är anpassad för att alstra nämnda ingångs-/utgångstiyck baserat på nämnda vätskekarakteristika.
- 6Anordning enligt patentkrav 1,kännetecknad av att nämnda behållare och nämnda vätsketilldelningssektion är av engångstyp.
- 7Injektionsanordning för injicering av vätskor i kroppsvävnader, innefattande:en vätskebehållare innehållande en vätska som skall injiceras;en vätsketilldelningssektion försedd med en första ände vilken är kopplad till nämnda vätskebehållare och en andra ände som är anpassad för att föras in i nämnda vävnader;en drivmekanism anpassad för att alstra ett internt tryck inne i nämnda vätskebehållare som svar på kommandon för att tvinga nämnda vätska att rinna genom nämnda vätsketilldelningssektion och ut genom nämnda andra ände, varvid nämnda vätska har ett utgångstryck vid nämnda andra ände;ett inmatningselement för inmatning av fysiska karakteristika för minst en av nämnd vätska, nämnd vätskebehållare eller nämnd vätsketilldelningsssektion;en givare som detekterar en intern parameter vilken indikerar nämnda interna tryck och systemmotstånd mot nämnda interna tryck;och en regulator som tar emot nämnda fysiska karakteristika och nämnda interna parameter, varvid nämnda regulator innefattar en räknare för att fastställa nämnda utgångstryck baserat på nämnda fysiska karakteristika och nämnda interna parameter, varvid nämnda regulator avger nämnda kommandon för att garantera att nämnda utgångstryck inte överstiger en säker nivå. I··· • ·· ··. :·· • · 526 308 det dessutom innefattar
- 8System enligt patentkrav 7, kännetecknat av att ett hus, varvid nämnda hus innefattar minst en del av nämnda drift.
- 9System enligt patentkrav 7, kännetecknat av att regulatorn innefattar en överordnad mikroprocessor som är anpassad for att hantera nämnda fysiska karakteristika och en underordnad mikroprocessor som styrs av nämnda överordnade mikroprocessor för att avge nämnda kommandon.
- 10System enligt patentkrav 9, kännetecknat av att nämnda drivsystem innefattar en motor som styrs av nämnda underordnade mikroprocessor och en koppling som förbinder nämnda motor med nämnda behållare.
- 11System enligt patentkrav 10, kännetecknat av att nämnda givare är placerad inne i nämnda koppling.
- 12System enligt patentkrav 10, kännetecknat av att nämnda motor och nämnda underordnade mikroprocessor är anordnade inne i nämnda hus.
- 13System enligt patentkrav 8, kännetecknat av att det dessutom innefattar en monteringssektion för montering av nämnda behållare på nämnda hus.
- 14System enligt patentkrav 13, kännetecknat av att det dessutom innefattar en behållargivare som detekterar när nämnda behållare är i läge, varvid nämnda regulator avger kommandon efter det att nämnda behållare har detekterats.
- 15System enligt patentkrav 8, kännetecknat av att nämnda behållare är en spruta försedd med en cylinder och en kolv som kan förflyttas fram och tillbaka inne i nämnda cylinder, varvid nämnda drivmekanism är kopplad till nämnda kolv.
- 16System enligt patentkrav 8, kännetecknat av att nämnda behållare är en ampull som har en sidovägg och en stoppanordning, varvid nämnda drivmekanism innefattar en adapter som är försedd med ett element som är kopplat till nämnda stoppelement.
- 17Medicinsk elektronisk injektionsanordning för att selektivt injicera vätska, innefattande:en vätskekälla anpassad för att rymma nämnda vätska;·· ·*·ί 526 308 ....... : ·' en vätskeutsprutningssektion försedd med en första ände vilken är kopplad till nämnda vätskekälla och en andra ände som är anpassad för att spruta ut nämnda vätska;en drivmekanism som är ansluten till nämnda vätskeutsprutningssektion och anordnad och konstruerad för att förorsaka att nämnda vätska sprutas ut som svar på en 5 kommandosignal;en givare som är kopplad till nämnda vätskeutsprutningssektion för detektering av ett internt tryck hos nämnda vätska i nämnda vätskeutsprutningssektion;och en regulator som är kopplad till nämnda givare och nämnda drivmekanism, varvid nämnda regulator är anpassad för att generera nämnda kommandosignal i beroende av 10 nämnda interna tryck. / 0 9 Ο 3η ο - U 17 (Τβί) Ρ-^ ο or XCÖ /^0 Cq ( Ο L X?' - Π/ QD 0 Ο* £· 526 303 ··· ··· 5/17 LO LL ! Q 7 η Ο Ο 0 U ύ if’::**: ·ι ·: ”?:**: a a a a · a * a a a · · · · ••a···· fc 4 «· · a » ·· ·· a·* aa· ·· a*
Independent claims17
417 paragraphs in 10 sections, as filed
SWEDEN (12) PATENT (13) C2 (nt 526 308)
2005-08-16
2000-11-30
2000-10-09
1999-03-05
1999-03-05 (19) SE <<sub>51</sub>)
International class <sup>7</sup>
A61M 5/145, 5/168
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PATENT AND REGISTRATION (45) (41) (22) (24) (62) (86) (86) (83)
Patent filed Application widely available The patent application was submitted on expiration date
Application number International filing date
Filing date for European patent application Deposit of microorganism (21) Patent application number (J003633-5
Application received as:
Swedish patent application completed international patent application with number PCT / US99 / 07446 converted European patent application with number (30)
1998-04-10 US 081388
1998-11-30
US 201464 (73) (72) (74) (54) (56) (57)
Assignee
INVENTOR
AGENT
NAME
Milestone Scientific Inc., 220 South Orange Avenue
Livingston NJ 07039 US
Angelo Ascione, Woodbridge NJ US Claudia Hochman, Greatneck NY US Hardie Johnson, Enola PA US Lawrence Brown, Enola PA US Mark Hochman, Greatneck NY US Michelle Lockwood, Mechansburg PA US
Zacco Sweden AB (publ)
Through pressure / force computer controlled system for the allocation of medicine and the like
CALLED PUBLICATIONS:
US A 5 425 716, US A 5 295 975, EP A2 0 319 272, US A 4 395 258
SUMMARY:
The electric infusion pump system (10) minimizes pain and tissue damage by monitoring and controlling hypodermic injection pressure. The infusion pump system consists of a mechanical unit and an electric regulator (18). The mechanical unit consists of a drive mechanism (12) comprising a housing (22), a motor (66), a holder for the liquid storage device, a load cell (78) for determining the liquid pressure, and a coupling (30) for moving the liquid storage device piston (94); a liquid storage device (90) comprising a reciprocating piston (94); and a liquid delivery device comprising a tube (14) and a needle (17). The electrical controller (18), which controls the entire operation of the system via control of the motor (66), consists of a parent microprocessor, a secondary microprocessor, a user input device, and a memory.
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The numbers in parentheses indicate the INID code.
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• · · ♦
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Summary
The electric infusion pump system (10) minimizes pain and tissue damage by monitoring and controlling hypodermic injection pressure. The infusion pump system consists of a mechanical unit and an electric regulator (18). The mechanical unit consists of a drive mechanism (12) comprising a housing (22), a motor (66), a holder for the liquid storage device, a load cell (78) for determining the fluid pressure, and a coupling (30) for moving the liquid storage device piston (94); a liquid storage device (90) comprising a reciprocating piston (94); and a liquid delivery device comprising a tube (14) and a needle (17). The electrical controller (18), which controls the entire operation of the system via control of the motor (66), consists of a parent microprocessor, a secondary microprocessor, a user input device, and a memory.
• ·
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Title: By pressure / force computer controlled system for the allocation of medicine and the like
Related Application: The present application invokes priority from the Provisional American Application with Serial No. 60 / 081,388 filed April 10, 1998.
The prior art
Field of the Invention
The present invention generally relates to improvements in drug delivery, especially subcutaneous injection / suction systems (syringes) for drug delivery which provide an intermittent, temporary or limited drug delivery (as opposed to continuous drug delivery by syringe pumps). In particular, the present invention relates to an improved means for subcutaneous injection and suction of drugs (fluids), wherein the invention provides a means and method for controlling and monitoring the interaction between a specific flow rate and pressure during fluid injection and suction with a subcutaneous needle with hollow core.
b. Description of prior art
Infusion pump devices and systems are relatively known in the medical arts for use in delivering or administering a prescribed medication to a patient. These can be compact pump housings or larger stationary pump housing units. The administration of prescribed drugs has been described in the literature as an assignment to a patient through an infusion tube and one associated with this catheter or the like, the medicament thus being. ... 20 inserted intravenously. These systems have been improved over time with regard to determining • · ·
J 'of the infusion line occlusion. A blockage in the pipe would increase the pressure in the syringe. Prior art systems have been developed to identify a predetermined threshold value or • to monitor pressure to determine means for selecting the areas of occlusion pressure to •. guarantee patient safety. In the patents US 5,295,967, US 4,731,058; and US 5,080,653 * · · j ·. ·. 25 described systems (with syringe pumps or the like) which are suitable for the intended use with intravenous drug administration and especially for monitoring the ··· occlusion during infusion. However, these systems do not provide a means for subcutaneous drug administration via a subcutaneous needle. In addition, these systems provide no means for ···· * 1
526 308 ΓΓ: '-J:.
suction during drug administration, which is a medical requirement for subcutaneous injection in an attempt to avoid intravascular movement of the subcutaneous needle.
Pain, tissue damage and post-operative complications have long been accepted as negative side effects from the use of existing subcutaneous injection systems for drug delivery. This is well documented in both dental and medical literature. The pain and tissue damage is a direct result of the uncontrolled flow rate in combination with excessive pressure created during the allocation of drug solutions within the tissue spaces. Subjective pain reactions in a patient have been shown to be minimal at specific flow rates during the administration of a medication. It has also been scientifically proven that specific pressures (in themselves too high without occlusion) for a specific tissue type can cause damage. It is therefore crucial that a specific flow rate in combination with a specified pressure range can be maintained during the administration of fluids (medications) when a subcutaneous injection is given to prevent subjective pain reactions as well as tissue damage. It is also necessary that this system allows for suction under controlled conditions of speed and pressure to avoid the same adverse side effects during fluid movement. In the patent US5 180371 of Spinello, which is incorporated herein by reference, an invention was presented which enabled the setting of a flow rate of the drug via a subcutaneous needle. However, this invention did not disclose any means for determining, detecting or monitoring the pressure during the administration of a medication.
At the beginning of the 1980s, several researchers clearly demonstrated (see, e.g., Rood, The Pressure Created by Inferior Alveolar Injections, British Dental J. 144: 280 - 282 (1978); Walton and Aboot, Periodontal Ligament Injection; a Clinical Evaluation J ADA (October 1981); Smith: and Walton, Periodontal Ligament Injection; Distribution of Injected Solution Oral Surg.
25: 55: 232: 238 (1983) and came to the conclusion that the pressure created by the ·· ·
Injected fluid is essential to prevent tissue damage and pain reactions.
Variability, different collagen types and densities of connective tissues result in different complications and extensibility of the tissues. These variations are found between different people and with one and the same person. In his article in 1978, Rood explains that the relationship ···<sup>A </sup>• · · · ······································ ability B. May.In the case between the injection rate and the increase in pressure that was evident at the smaller volumes • disappeared when 2.0 ml was injected. Several high pressures were recorded and some unexpectedly low.
• · ··· Many curves showed a pattern that indicated a tissue rupture and it is possible
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526 308 that said low pressure was due to the fluid no longer being retained within the pterygomandible space when the volume was injected similar to the previously estimated volume of the tissue space. From this it can be seen that the flow rate is not directly related to the pressure during an intermediate injection.
Smith and Walton described in their article above that they conducted a histological study on animals (dogs) using a technique for calibrating manual pressure. They concluded that the injection volume and needle placement were not always related to the allocation ... Injection under a moderate to strong back pressure gave a deeper and more scattered color penetration. This again confirms that pressure is the decisive variable when assigning the solution in tissues and that the volume is not always related to the pressure generated.
Pashley, Nelson & Pashley who in Pressures Created by Dental Injections (J Dent Res 1981) used a pressure transducer and a fixed flow rate created by a motor driven, traditional syringe clearly demonstrated that different tissues have different tissue compliances. The intermediate pressure variability was statistically and clinically significant even at a constant flow rate. Therefore, it can be concluded that they gave rise to large pressure variations using a measured flow rate.
In his article, Pertot and Dejou describe Effects of the force developed during periodontal ligament injections in dogs (Oral Surg. Oral Med, Oral Pathol. 1992) how to use a syringe that was connected to a miniature power converter and:. found a positive correlation between the number of osteoclasts and the force applied to the · · ··· ·: syringe plunger, which indicated the pressure generated in the room-promoted osteioclastic: *. ·. 25 PDL activity. This experiment again indicates that pressure is a critical factor for • · tissue damage and depends on the resistance encountered and not on the flow rate of the • ·: solution in the tissues.
• · · • · · · · · · · · ·. · · ·. One of the goals of dental care and medicine is to be able to provide patients with the most care • · • · ·. ···. humane and painless way. An absolute requirement for every treatment is to give it • · ·. ···. To the desired result without causing injury or pain to the individual. Therefore, in all surgical areas there is a great need for an injection system that can be used to administer
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526 303 ·· a fluid while not causing any major pain or tissue damage to the patient.
Summary of the Invention
The present invention aims to minimize the subjective pain reactions and any potential tissue damage to a patient that results from inappropriate pressures that occur during the delivery of a medication via a subcutaneous needle.
Another object of the invention is to achieve these advantages when using different, varied sources of medicine, ie. both standard syringes and anesthesia vials or the like.
Another purpose is to propose a system that can be easily used by a practitioner after minimal training.
A further object is to propose a system of the type discussed above having a portion which is essentially a disposable portion.
Another object is to propose a system that can provide not only injections but also actual suction and / or biopsy with the possibility of controlling both flow rate and pressure.
A further object is to propose a system that automatically determines and uses the output pressure (or input pressure) as a control parameter for any size or combination of syringe, tube or needle.
References in prior art are known in which attempts to use a pressure transducer to measure the pressure inside the syringe have been made (see, for example, US Patent 5,295,967). A major disadvantage of these systems is their inability to adjust the flow rate and / or pressure of the fluid to compensate for changes in resistances throughout the system, or to the output pressure.
• · · / “(The outlet pressure refers to the fluid pressure immediately downstream of the needle tip inside the • ·
'..IN. 25 patient's body). In addition, prior art technology has failed to suggest any means to • · • · ·. ···. determine this initial pressure. The present invention includes a microprocessor-based. systems that measure a pressure or force generated outside the tissues, and then use this measurement to accurately determine the corresponding output pressure. In other words
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monitors the system by using a specific software, the output pressure and generates and maintains a specific flow rate even when changes occur in the resistance within the system.
The invention also proposes a system that automatically compensates for the total resistance found within the system and which has been shown to have an influence on the flow rates and the measured pressure. We believe that this is the first system with the ability to give a precisely determined flow rate and pressure desired by taking into account the entire resistance of the system. Without this possibility, the flow rates and output pressures cannot be accurately derived for varying disposable units consisting of different syringe, tube and needle sizes and flow characteristics. A critical feature of the system is that it controls and monitors the pressure by using a converter that generates a feedback parameter.
Briefly, a system of this invention for delivering a fluid by injecting it into a patient comprises a mechanical unit and an electrical regulator. The mechanical unit consists of a drive mechanism and a disposable portion consisting of a liquid storage device such as a syringe, capsule or the like, and a liquid dispensing section comprising a tube connected to said liquid storage device and terminated in a needle adapted to be inserted into the person's tissue. The drive mechanism comprises a housing with an internal motor and a holder for mounting the liquid storage device on the housing. The liquid storage device comprises a reciprocating piston. A clutch is used to move the piston by means of said motor. An important fact is that a transducer is used to detect the force or pressure generated by the engine and applied by the piston within the liquid storage device. If a capsule is used as a liquid storage device, an adapter is also provided to enable the same holder to attach the capsule as well. The holder is arranged and constructed for fixed syringes and capsules of varying sizes. The motor, the coupling associated with the motor and the electrical controller discussed below are at least partially located within the housing to be protected.
The electrical controller is provided to control the entire operation of the system.
The controller comprises a parent microprocessor which may be arranged as a standalone standard personal computer or a portfolio computer, and an internal subordinate microprocessor which operates in response to commands from the parent microprocessor.
526 308 • · · • · · • « · • · ·
The parent microprocessor provides the interface to the clinician and collects data regarding the mechanical unit. The parent microprocessor is further associated with a memory containing multiple databases, each database being associated with one of the elements in the disposable portion as well as with other parameters.
The fluid storage device is replenished and a setting procedure is initiated during which various operating parameters are calculated, retrieved or received from the clinic. The clinic also specifies the flow rates of the fluid and peak output pressure and the total amount of fluid to be delivered. Then he maneuvers a pneumatic control such as a foot pedal and initiates the fluid flow. As an alternative, commands can be initiated by the clinician either electronically or by voice commands. During the dispensing, the output from the transducer is used to calculate the current outgoing fluid pressure. If this initial pressure approaches a certain threshold, the fluid flow rate is automatically reduced to prevent an excessively high initial pressure, thereby ensuring that the patient is not exposed to any unnecessary pain and that no tissues are damaged. Many optional properties are also offered such as suction, aeration or loading of the medium with or without air.
As an alternative, the system can be used for biopsy where the input pressure and flow rate of the outgoing or withdrawn fluid constitute the relevant control parameters.
Throughout the procedure, the clinician is provided with constantly up-to-date information on the ongoing procedure, both visually and via hearing, including the current flow rate, total extruded or aspirated volume, output or input pressure, and other parameters. The secondary microprocessor receives commands from the parent microprocessor and generates the drive signals required to operate the motor.
526 308 • ·· ·· • · · · · • · · · · • « · · · · • · · · · ·· ·· ···· ·· ··· • ·· • · • ·
Brief description of the figures
Figure 1 is a diagram illustrating the main components of the mechanical system of the present invention;
Figures 2 show an orthogonal view of the drive mechanism;
Figure 3 shows the most important elements of the drive mechanism;
Figure 4 shows how the elements of the drive mechanism of Figure 3 are located in the housing;
Figure 5A shows a top view of the housing without the holder;
Figure 5B shows a perspective view of the housing without the holder;
Figure 6 shows a side view of a clip for attaching a syringe to the housing;
Figure 7A is a top view of the platform 30 of Figure 2;
Figure 7B shows a side view of the platform 30 in Figures 2 and 6;
Figure 8 shows a side view in section of a prior art liquid ampoule;
Figure 9 shows a somewhat schematic side view of an adapter for use of the ampoule of Figure 8 together with the system of Figures 1-7;
Figure 10 is a block diagram of the electronic controller;
Figure 11 shows a general flow chart for the operation of the controller of Figure 10;
Figure 12A shows a typical display showing various possible choices for the elements in the disposable portion;
Figure 12B shows a typical display summarizing operational characteristics and parameters of the current method;
Figure 13 shows a typical monitor shown for the clinician during the setup procedure;
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Figure 14 graphically shows the control signals derived for a foot pedal;
Figures 15A and 15B show typical time-dependent curves for the liquid flow and initial pressure, respectively;
Figures 16A and 16B show time-dependent curves for the fluid flow and output pressure when said pressure exceeds a threshold level;
Figure 17 shows a suction flow diagram;
Figure 18 shows a flow chart for loading a syringe;
Figure 19 shows the syringe and associated equipment required for charging; and
Figure 20 shows a flow chart for determining a typical component contributing to the determination of the output pressure.
Detailed description of preferred embodiments
The present invention relates to a system for administering medication as, for example, an anesthetic, or for providing suction, for example, for a biopsy, in an effective manner that simultaneously ensures that the patient's pain is minimized. The system includes a mechanical unit which cooperates with an electronic controller.
The mechanical unit is illustrated in Figures 1-9 and the electronic controller 150 is shown in Figures 10-18.
A drug delivery system 10 constructed in accordance with the invention comprises a drive mechanism 12, a feeding tube 14 and a handle 16 which terminates with a needle 17. More specifically, one syringe is 90 (or another
:.: (liquid storage device) mounted on the drive mechanism with one end of the tube 14 connected to the syringe 90. The drive mechanism 12 actuates a piston 94 to selectively eject • ··
* ... · liquid through the tube 12, the handle 16, and the needle 17 or alternatively to withdraw the fluid.
···
· ... · 25 The drive mechanism 12 is associated with an external controller to select varying «··
· ... · operating parameters as discussed in more detail below. This external controller may be arranged on the housing of the drive mechanism or be arranged as a separate one
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control unit 18 which is connected to the drive mechanism 12 through a cable 20. The control unit 18 may for example be a personal computer or a portfolio computer. As an alternative, the control unit 18 may be built-in.
Details of the drive mechanism 12 are shown in Figures 2-5. Beginning in Figure 2, it is seen that the drive mechanism 12 comprises a housing 22 having an upper side 24 and an intermediate side 26 which is arranged lower than the upper side 24. On the intermediate side 26 a rail 28 is provided which extends along the longitudinal axis of the housing 14. A platform 30 provided on the rail 28 can be moved back and forth parallel to said longitudinal axis, as described in more detail below.
On the upper side 24 and as is more clearly shown in Figures 5A and 5B, two parallel elongate grooves 32 and 34 are provided and between these grooves a groove 36 is provided. The ends of each of the grooves have side extensions 38 which are opposite each other. The groove 36 terminates in the vicinity of a transverse groove 54.
A clamp 40 may be displaced in the notches 32, 34. As can be seen from Figure 6, the clamp 40 has a generally C-shaped body 42 terminating with legs 44 extending towards each other, and a rib 46. A screw 48 having a head 50 extends through a threaded hole (not shown in the figure) in bar 46 and terminates with a roundabout 52.
The clamp 40 is designed and arranged so that its legs 44 fit into the extensions 38 and allow the clamp to move horizontally in the slots 32, 34.
The platform 30 (which is shown in more detail in Figures 7A and 7B) is formed on its upper side 58 with a groove 56 arranged on one side with a graduated wedge groove 60.
• Inside the housing 22, an engine 66 (Figures 3 and 4) is provided which is firmly secured in the housing. A worm screw 72 is threaded through the motor 66. The worm screw 72 is arranged so ·· · • '. when the engine 66 is started, the worm screw 72 moves in one or the other direction, depending on its direction of rotation, parallel to the longitudinal axis of the housing 22. The one end of the worm screw 72 is without rotation fixed to a block 74, which is connected to a platform 76. Between the platform 76 and the block 74, a load cell 78 is provided for transmitting and measuring.
· ... · the force between block 74 and platform 76. The load cell 78 is bidirectional so that it can measure both pressure and elongation depending on whether the worm screw 72 moves left or right according to Figure 3. Two short bars 80 are used to connect block 74 to the platform
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76, to prevent transfer of rotational forces generated by the motor 66 to the platform 76.
Two pillars or rods 82, 84 extend between the platforms 30 and 76 and connect these two elements to each other. These bars 82, 84 can slide in two bushing pairs
68, 70 on the housing 22. In addition to these bushings, the platforms 76 and 30 are floating on the inside and outside of the housing 22. The rods 82, 84 extend through the wall 86 extending between the surfaces 24 and 26 via holes (not shown in the figures). . The rail is hollow and aligned with the tensioning screw 72 to allow the latter to move longitudinally along its axis through the housing 22.
Typically, the syringe 90 is provided with a cylinder 92 located in a groove 36 such that its finger tab 95A (seen in Figure 6) rests in the groove 54. The syringe 90 also includes a plunger 94 which can be reciprocated within the cylinder. 92 using a rod 93. The rod ends with a finger grip 96. When the syringe 90 is positioned in the groove 36, the finger grip 96 rests in the groove 58 of the platform 30. In this position, the syringe 90 is fixed to the housing 22 by inserting the legs 44 of the clamp 40 into the groove extensions 38 and by sliding the clamp 40 forward or sliding left over the syringe 90 until it is at the end of the syringe body 92 adjacent the groove 54.1 this position tightens the screw 50, forcing the pivot 52 forward so that it contacts the syringe 90 cylinder. The groove 36 assists in positioning the syringe 90. The syringe is terminated with a Luer lock 95 which is used to connect the syringe to the tube 14.
It should be noted here that the motor 66, the block 74, the load cell 80, the worm screw 72 and the platform 76 are all located inside the housing 22. The platform 30 is located outside the housing; 22. When the motor 66 is switched on, as described in more detail below, it forces * · · ··· ·: the worm screw 72 to move in one or the other direction. The worm screw in turn forces the platforms 30, 76 and the rods 82 and 84 to move together, thereby forcing
Ϊ '. ·. the piston 94 to be moved. The only elements moving in and out of the housing are the rods 82, 84.
• Thus, most crucial elements of the system are protected inside the housing from bumps or ···; * · *; spilled liquids. For now, the drive mechanism 12 is adapted to receive and operate syringes of varying diameters and lengths. Similarly, the feed tube 14, the handle of the **<sup>···</sup>: 16 and the needle 17 have any desired size.
··· ···
526 308 ·· «I
In the embodiment described heretofore, it is assumed that the liquid is dispensed from the syringe 90 and that it must therefore be preloaded with said fluid either by the manufacturer, or must be filled in by the clinician or an assistant before any surgery is started. However, in many methods, it is more desirable to deliver the liquid to be delivered in a vial such as vial 100 as shown in Figure 8. As can be seen from this figure, the ampoule 100 consists of a cylindrical container 102.1 at one end, the container 102 is provided with a piston 104 which is made of rubber or some other flexible material which can be moved back and forth through the container 102 to selectively expel the liquid contained in it. At the opposite end, the vial is provided with a seal in the form of a membrane 106 which must be pierced before the contents of the vial can be assigned.
Figure 9 shows an adapter 110 which allows the device of Figures 1-7 to dispense a liquid from the ampoule 100. The adapter 110 includes a holder 112 adapted to hold the ampoule 100. The holder 112 has a first end provided with a connector 114 (e.g., a Luer connector) for connecting adapter 110 to supply tube 14. Inside the holder 112, adjacent to the connector 114, is a tag 116 which is designed and positioned to punch holes on the membrane 106 as the ampoule 100 is inserted into the holder 112.1 at the opposite end, the holder 112 is provided with radially protruding protrusions 118 to secure the holder 112 on a drive mechanism 12. The ampoule holder 112 described so far is disclosed in the jointly assigned parallel patent application with Serial No. US 09/028 009 filed February 23, 1998, entitled Dental Anesthetic and Delivery Injection Unit, which is incorporated herein by reference. .
The adapter 110 further comprises a coupling element 118 formed by a bar 120 ··· · j which terminates at one end with a bar or hook 121 and the opposite end with a thumb plate 122. The bar 120 extends through a cap 124 which is adapted to be mounted on the holder 112 by protrusions 116 which cooperate with the corresponding recesses (not shown in the figure) in the cap 124. The capsule 124 is provided with a flap 126 extending radially and having approximately the same shape as a finger flap 95A on a standard syringe 90.
··· • · • · • ··; '30 To mount an ampoule 100 on the drive mechanism 12, the ampoule 100 is first inserted into the ··· · * ··. holder 112 from its rear end. Once the vial 100 is in place inside the holder 112 ···, the rod 120 is positioned so that it is aligned longitudinally along the axis of the holder 112
526 308 and thereafter its hook 121 is inserted into the piston 104 until it is firmly secured therewith. Thereafter, the vial 100 is moved forwardly toward the connector 114 so that the tag 116 penetrates the diaphragm 106 and thereby provides a discharge of the liquid contained in the vial. To ensure that liquid does not leak, the tube 14 can first be mounted on the connector 114, but this tube is not shown in Figure 9 to make the figure clearer.
Instead of a hook, a plunger 121A may be fixed to the rod 120 in such a way that when this plunger is inserted into the holder 112 a vacuum / pressure coupling is created between it and the plunger 104.
As a result, the displacement of the piston 121A in either direction causes the piston 104 to follow and thereby either pressurize liquid into the system or suck it out of the system.
Thereafter, the cap 124 is coupled to the holder 112 by sliding the projections 116 into the appropriate recesses of the cap 124 and thereby attaching it to the holder 112. In this configuration, the ampoule 100 and adapter 110 have a configuration similar to a syringe 90 and can be mounted on the driving device of Figures 1-7 in the same way as a syringe, the clamp 40 cooperating with the cap 124, the tab 126 extending into the groove 54 , and the thumb plate 122 cooperates with the notch 56 on the platform 30. When the adapter 110 is in this position, the motor 66 can be used to advance or pull out the rod 120 and the piston 104 into or out of the vial 100 or via the hook 121 or a piston thereby causing the liquid to be extruded or sucked in as desired. . The hook 121 (or piston) formed at the end of the bar 120 is arranged to provide good cooperation and a fixed mechanical connection of the bar 120 to the piston 104, thereby ensuring that the piston 104 follows the movement of the bar 120 and the platform 30 in both. directions.
. . Figure 10 shows a block diagram of the electronic controller 150. The controller 150 comprises two microprocessors: a master microprocessor 152 and a slave microprocessor 154. The secondary microprocessor 154. used
j. to derive the signals that actually drive the motor 66 and to collect information • ·. J. regarding the position of the platforms 30, 76.
• · · • · · • · · • · ·
The parent microprocessor 152 is used to collect information about the rest of the system, including the syringe 90, and its contents, the tube 14, the handle.
J "16, etc., and to generate control signals for the secondary microprocessor 154 required for operation of the motor 66 and for dispensing the contents of the syringe 90.
526 308
<img file="SE526308C2_D0010.tif" />
The secondary microprocessor 154 and its associated circuits are physically located within the housing 22. The parent microprocessor 152 is built into the controller 18 connected to the housing 22 through the cable 20 as shown in Figure 1.
As shown in Figure 10, microprocessor 152 is connected to a memory 5,160, input devices 162, visualization devices 164, and an interface 166.
Memory 160 is used to store programs and data for parent microprocessor 152. Specifically, memory 160 is used to store six or more databases, each of which is distributed for the following information: (a) syringes; (b) tubes; (c) needles; (d) liquids; (e) control parameters; and (f) profiles consisting of a plurality of parameters for a particular method to be performed. Each of these parameters is used to determine the control signals generated for the secondary microprocessor 154. Each of these databases contains suitable parameters for varying commercially available products, or, alternatively, parameter data derived using a specific algorithm. The information regarding the various elements of a particular configuration is fed through the input devices 102 and confirmed on the display device 164. These input devices may include a keyboard, a tactile screen, a mouse, but also a microphone. If a microphone is included, voice commands are interpreted by a voice identification unit 162A.
The display device 164 is further used to provide an indication as well as instructions for operating the system 10. The commands for operating the motor 66 are generated by the parent microprocessor 152 and transmitted to an interface 162. The microprocessor 152 is further provided with a speaker 165 which is used to deliver various oral messages, including pre-registered or synthesized words (generated by a. voice synthesized circuit 165A), etc., to provide instructions to the clinician and to provide other information about the current state of the entire system and its elements without the clinician's entire
•. '. 25 time needs to observe the displays.
The secondary microprocessor 154 receives these commands via cable 20 or another connection means and interface 170.
The secondary microprocessor 154 is also connected to one or more position transducers 172 and a chopper driver circuit 174. As previously mentioned, the power is measured. between
<img file="SE526308C2_D0011.tif" />
526 308 platform 76 and block 74 of a load cell 78. This load cell may, for example, be a Model S400 load cell manufactured by SMD, Inc. of Meridien, Connecticut.
The secondary microprocessor 154 is also connected to a foot switch or pedal 176. The foot pedal 176 preferably consists of an air chamber with a flexible side wall, said side wall being adapted to change the air volume and pressure inside the chamber in response to activation by a human operator. A pressure transducer (not shown in the figures) is included in the foot pedal and is arranged to provide information about said pressure to the secondary microprocessor 154 via a corresponding analog / digital converter 190. Foot pedals of this kind are well known in the art and are therefore not disclosed. in detail here.
The operating sequence of the system 10 is now described with reference to Figure 11. With the book at step 300, the system is first adjusted. Since this step involves the exchange of information with the clinician and the outside world, it is performed by the parent microprocessor 152.
Step 300 first involves the clinician entering the following information: type of syringe used, type (i.e., size and length) of tube 14, type of needle used, and name or other identification of the fluid in the syringe. This information can be entered manually by the clinician using an input device such as a keyboard or a tactile monitor provided in the monitor. As an alternative, several corresponding substances (e.g. syringes) can be found and displayed on screen from databases and then presented to the clinician. The clinician then uses a standard pointing device such as a mouse or a tactile screen to select the appropriate spray. As an alternative, a voice command can be used for this selection. Figure 12A shows a typical display for selecting or selecting a syringe. As can be seen from this monitor and when a syringe has been selected or selected, its physical characteristics such as length, nominal volume, stroke, injection power are found in the database and displayed on the monitor. After the needle and liquid have been selected, their characteristics are found and likewise displayed.
Some of the information such as the length of the tube 14 must be entered manually as it would be difficult for the system to determine it. However, other information, as well as different operating parameters, is automatically determined. For example, the identity of a syringe can be encoded on part of the syringe and read by the system. As described below is
526 308 is a necessary parameter of the cross-sectional area A. This is determined by dividing the volume by the stroke length or length of the syringe.
As soon as the information regarding the components of the system has been entered or otherwise selected, another monitor (Figure 12B) is displayed for the clinician. This monitor is used either to provide the clinician with information or to enable the clinician to enter some additional operational parameters required to complete the setting.
The screen of Figure 12B has four general areas with the designations 502, 504, 506, 508 and 510.1. The field 502 is given some general information or the information is selected by the clinician including a designation on the profile to be used for the current procedure, e.g. Periodic ligament injection). In the field surface 504, the parameters from the screen of Figure 12A are repeated in an abbreviated format, whereby the information regarding the syringe, needle, tube and fluid is indicated.
In field 506, the clinician selects the type of surgery required (e.g., injection), the high and low flow rates, and the optimum pressure limit. As previously mentioned, the latter parameter is particularly important because it controls the degree of pain and tissue damage that the patient may be exposed to during the procedure. Additional parameters can also be selected within this field, such as charge flow rates, suction volume and flow rate, aeration volume and flow rate, etc.
In field 508, the clinician specifies the total amount of fluid to be delivered and if (a) the syringe is charged, (b) if it is to be charged with air; or (c) if it is to be charged without air.
• · • * · <sup>:</sup>··: The clinician also chooses in this area whether or not to use suction.
.'<sup>:</sup> Finally, the field 510 is used to specify various parameters calculated from the previously received and selected information, including system volume, maximum flow rates, maximum pressure, and so on.
In one embodiment of the invention, the system uses and, more specifically, the ···
The parent microprocessor 152 has these parameters for retrieving from the profile database a profile that determines the sequence and programming characteristics needed to dispense the liquid through the needle as shown in FIG. as required, or an optimized speed. The profile
526 308 for each particular combination syringe needle is calculated and stored in memory in advance. These profiles have a unique characteristic for each type of surgical procedure. For example, a profile for a periodontal ligament (PDL) is different than a profile for a subcutaneous anesthesia assignment in a skull. Only one group or family of profiles associated with a specific procedure can be stored in the memory of the parent microprocessor as other such profiles are redundant.
As an alternative, the parent microprocessor 152 can be programmed to perform the calculations required to generate the profiles. However, it is expected that for most applications, the profiles will a priori be calculated and programmed or stored in the database as explained above.
After the set-up procedure is completed, at step 302, a test is performed to determine whether the clinician wishes to fill the syringe 90 using the present device or not. In many cases, expect the clinician to either preload the syringe manually or use a preloaded syringe or ampoule. If the syringe is loaded or removed from the device, at step 304, the parent microprocessor 152 then sends a command to the secondary microprocessor 154 to move the platform 30 to an initial position.
With reference to Figure 10, microprocessor 154 is connected to the charge cell 80 through an analog-to-digital converter 83, a RAM 182, an EEPROM memory 184, and a limit switch 172. By utilizing the information that can be derived from these elements, whose functions are described in more detail below, and in response to commands from the parent microprocessor 152 via interface 170, the secondary microprocessor 154 controls the operation of the motor 66. More specifically, the secondary microprocessor 154 operates a chopper driver circuit 188 which then generates step pulses to motor 66 to cause said motor to rotate in either direction through a discrete angular increment.
The frequency of these pulses is determined by the speed of the motor. Separate speeds can be used for high flow rate, low flow aeration, suction and charging. The clinics select the values for all of these speed parameters and the microprocessor then calculates the corresponding motor speed (e.g., step frequency) using the syringe dimensions and the fluid delivery system.
Microprocessor 154 monitors the position of the platforms 30, 76 by counting the steps performed by the motor 66. As an alternative or as an addition, other ···· • · · • «·
525 30£<sup>:</sup> sensor switches are provided for detecting and shaping the location of the platforms, such as the platform 76 at various points along its path of movement. In the preferred embodiment, at least one encoder switch 172 is provided which defines the output position of the platform 76. All other positions of the platform 76 are calculated from this starting position.
For example, the initial position may be the outer left position shown in Figure 4.
The motor 66 is preferably made of permanent magnets of rare earths so that it can be relatively compact and yet provide a high torque.
Now returning to Figure 11, at step 304, microprocessor 152 sends a command to instruct microprocessor 154 to move platform 76 to the initial position. A list of all commands of this type is stored in memory 160 as part of the control database. Microprocessor 154 starts the motor until the platform 76 reaches its initial position and this position is controlled by an output of sensor 172 and reported to microprocessor 152. Thereafter, at step 306, microprocessor 152 commands the platform 76 to move to an initial position. This initial position depends on the selected syringe and the amount of liquid contained in the syringe, and is defined by the profile stored in the profile database.
The system 10 is now ready to receive a filled syringe. Figure 13 shows a typical image on the screen 164 which can be shown to the clinician at this time. The display includes a plurality of soft or programmed buttons that can be activated by the clinician to initiate certain commands as well as several display fields in which information is provided to the clinician. At this particular moment, the displays display the following buttons 198 with the captions: Finish, Print, Pedal. For other occasions, other buttons may be displayed.
• · * · * t ·:: In addition, the display in Figure 13 includes the following information fields: a message field 200 where instructions are given for the next phase; or a message appears as ·· ·<sup>v</sup> • · ·
·. · * 25 informs the clinic of the step or procedures currently being performed; two graphs 202,204 where the liquid flow and the output pressure are shown as a function of time, a spray icon 206, a pressure gauge 208 showing the output pressure as a percentage of the maximum allowable pressure (a • · ·
*. another parameter developed as part of the profile), and another set of meters collectively marked with 210 indicating the following parameters: the location of the platform 76 • · • · in inches in the cylinder. relative to its initial site, the volume of fluid that has been injected (or collected in the case of biopsy), the current
526 308
<img file="SE526308C2_D0012.tif" />
the flow rate in cc / second, the current pressure (psi), the applied force and the force applied by the pedal switch 176.1 in the arc of step 306, the display fields 202,204,208 and 210 show no values for corresponding values and the icon 206 is provided with a sign 212 show that no syringe has been detected. Display 200 displays a message giving instructions to the clinician to charge syringe 90 and to press pedal 176.
The clinic can now take a filled syringe and place it in the groove 36 with the finger tab 95A extending into the groove 54 and the thumb tab 96 inserted into the groove 56 of the platform 30. As mentioned above, the motor 66 has moved the platforms 76, 30 to the original position. This initial position is defined as the position where the filled syringe 90 can be mounted with its thumb flap 96 which fits into the groove 56. It should be noted that the system does not accept syringes in any other position. In fact, the software is used to ensure that a correct syringe with the correct amount of fluid is loaded and that another syringe cannot be loaded by mistake.
The system waits for the syringe to be mounted in step 310. The clinician may indicate that the syringe is mounted either by physically activating the footswitch 176 momentarily or activating the pedal button 198 on the monitor. When the pedal signal is detected, the drug assignment can be performed. First, the red stop symbol 212 is turned off. At step 312, the system checks to see if the clinic has requested an aeration. If so, an aeration occurs at step 313 during which the drug delivery system is released from potential air bubbles.
The volume of the needle, handle and tube are known and therefore the volume of fluid to be aerated can easily be calculated.
. . As mentioned above, the footswitch 176 preferably comprises an air bellows and an air pressure sensor (not shown in the figures). The output of the air pressure transducer is applied to the analog-to-digital converter 190 and the digital equivalent to the output of the ·<sub>;</sub>· / Footswitch is supplied to microprocessor 154. Microprocessor 154 uses this sensor • · • ·. . ·. together with a table stored in EEPROM memory 184 to determine or generate a switching indication signal indicating the switch's position. It has been found that for the • · • ·. ···. best reaction and sensitivity, the switch's positions are transformed into four different modes or · «· · ···. Conditions using hysteresis. In other words, and as shown in Figure 14 ···, the switch is first in idle state. When the switch is pressed, the ··· internal pressure increases. When it reaches a first value ON 1, microprocessor 154 generates a command
<img file="SE526308C2_D0013.tif" />
596 308
LOW FLOW. If the pressure increases but does not exceed a level of ON2, the LOW FLOW command is maintained. If the pressure is reduced to below a level OFF1, the idle state is indicated. The pressure OFF1 is typically lower than ONI. If the pressure exceeds ON2, a HIGH FLOW command is generated. This HIGH FLOW command is not disconnected until the pressure has dropped below a pressure level OFF2 lower than ON2.
Referring to Figure 11, after a possible aeration, at step 314, the position or condition of the pedal 176 is determined. If a LOW FLOW command is received, the medicine is assigned at low speed. If a HIGH FLOW command has been received, the medicine is assigned at a high flow rate. The current HIGH and LOW FLOW values have been set in advance as mentioned above.
Once the pedal is pressed, the engine is initiated and run at a predetermined speed corresponding to the requested flow rate (step 316). A typical drug assignment is shown in Figures 15A and 15B in the manner in which they occur in fields 202 and 204. According to these figures, the flow rate is built up relatively quickly to a first value.
LOW at TO and stay at a constant level. The initial pressure waves rise in a somewhat irregular manner, which is determined by the tissue's resistance to fluid flow and other factors. At TI, the pedal is activated to a higher level HIGH and fluid flow rate rises to this new speed. The output pressure also continues to rise. At T2, the pedal can be released back to the lower LOW level. As this procedure continues, the microprocessor monitors
152 constantly different pressure parameters (step 318) and it accumulates the total allocated volume and compares this current volume with the total requested volume (step 320). If this is not achieved, at step 322, a check is made to determine if pedal 176 is still pressed. If so, repeat step 314. If not, it is assumed that a:. suction has been requested and consequently a suction routine is performed as described below ··· ·: 25 in connection with Figure 17.
·· · • · ·
At step 318, the current pressure indicated by the load cell is checked for a threshold value which is the peak pressure that is safe for the system. The pressure level depends on the • · · ··· components selected for the system. In addition, at step 318, the output pressure level is also monitored. As mentioned above, it has been found that the liquid pressure below ···. ···. 30 an injection plays a very important role in terms of the degree of pain and tissue damage ··· that a patient is exposed to during an injection. At low pressure levels, the pain is minimal, which ··· means that the patient feels almost no pain at all. However, if the pressure increases over a certain ···· ··
526 308
<img file="SE526308C2_D0014.tif" />
level, the injection becomes very painful. Therefore, an important factor in the present invention is the control of the flow rate so that a low level of the output pressure is guaranteed.
Specifically, if at step 318 the pressure (i.e. the pressure inside the system or the output pressure) is found to be too high, the flow rate is reduced at step 324. At step 326, the pressures are checked again. If any of the pressures are still too high, the flow rate is reduced again at step 320. If acceptable, the flow rate is resumed at step 328 and the procedure continues with step 320.
The flow rate and various other parameters are shown for the clinician on the screen in Figure 13 so that he can easily see what is happening. In all likelihood, a pressure increase such as that shown in Figures 16A and 16B is caused either by a blockage or by the needle encountering a leg. As soon as an abnormal pressure is detected, a visual as well as an audible alarm is triggered. Therefore, the clinician is expected to make a maneuver to stop the high pressure. However, if the blockage continues and the pressure continues to increase, the flow rate is gradually reduced as shown in Figure 16A until it ceases completely.
To now return to step 320, when the specified volume has been reached or a stop command has been issued by the clinician, a final subprogram is performed at step 330. During this subprogram, the forward movement of the syringe plunger is stopped and a message is displayed to the clinician to retract the needle. . The clinician may pull out the needle, disconnect tube 14 from syringe 90 and discard tube 14, handle 16, and needle 17. As an option, a suction sub-program, as set out below, can also be executed to ensure that fluid does not drip out of the needle 17.
• ·
ί.ί: In many cases, suction is desirable during a: medication infusion procedure. For example, when infusing an anesthetic agent, after insertion of the needle, a suction is needed to check if the needle end is placed in a blood vessel. At this moment • · ·<sup>:</sup> · * Causes the suction to draw out small blood from the blood vessel. This blood is visible in the handle 16 or • · * · * ··; ' needle 17 recesses.
• · · • · • · ···
· ... · As shown in Figure 11 and if at step 322 it is shown that the pedal is pressed ··· * ♦ ·. · An SUG program is initiated as shown in Figure 17.
526 308
<img file="SE526308C2_D0015.tif" />
Specifically, at step 400, a check is made to determine if piston 94 in syringe 90 has been stopped. If not, at step 402, a check is made to determine if the piston is moving at low speed. If so, a stop sub program is executed at step 404 for low speed to slow up and stop the engine. Otherwise, at step 406, a high speed stop subprogram is executed to reduce engine speed and stop the same.
At step 408, a check is performed to determine if there is enough space to perform a suction. Referring to Fig. 3 and the moment a suction command is received, the piston 94 could be in its position along the right, which means that if it is pulled even further from the syringe it could fall out. Of course, such an event is not desirable. Therefore, at step 408, a check is performed to determine from the position of the piston and the length of the syringe if it is without risk of performing a suction without the piston falling out. If not, the procedure is stopped and at step 410 an error message is displayed for the clinician to indicate that it is not risk-free to suck at this moment.
Otherwise, the engine is reversed at step 412 and goes in the opposite direction for a predetermined amount of time causing the piston 74 to retract. After the piston has moved with the predetermined distance, it is stopped (step 414). The piston is then moved forward (step 416) until it returns to its original position at step 408. The engine is then stopped (step 418).
Steps 416 and 418 may be excluded if suction occurs at the end of the procedure when the needle is pulled out of the tissue.
In this way, the present system is used to assign an anesthetic agent for a particular procedure. If, for example, the procedure is a periodontal ligature, the following parameters can
<td colspan="2">apply:</td>
<td>Type of syringe</td><td>Dental ampoule</td>
<td>Syringe Size</td><td>1.8 cc</td>
<td>Medicine:</td><td>local anesthetic agents (lidocaine HC12%, and epinephrine 1: 100000)</td>
526 308
<img file="SE526308C2_D0016.tif" />
<td>Specific weight of the medicine:</td><td> 0,0361</td>
<td>Tube inner diameter:</td><td>0.38 mm (0.015)</td>
<td>Pipe length:</td><td>1524 mm (60)</td>
<td>Needle type:</td><td>BD 30 G 1/2</td>
<td>needle length:</td><td>12.7 mm (0.5)</td>
<td>Needle inner diameter:</td><td>0.152 mm (0.006)</td>
<td>Low speed:</td><td>0.0059 cc / sec</td>
<td>High speed:</td><td>0.370 cc / sec</td>
<td>Top Press:</td><td>17.6 at (250 psi)</td>
When a normal syringe and needle of the dimensions described above are used to manually inject the same fluid, it has been found that an output pressure of up to 46.4 at (660 psi) or more is generated.
For other procedures, different syringes, medications, tubes and / or needles are used.
··· ·· ·
As stated above, a critical parameter monitored by the present system is the fluid outlet pressure at the end of the needle, i.e. pressure inside the tissue as the fluid comes out of the needle. This is the pressure indicated by the graphs in Figures 15A and 16A. However, it is very difficult to directly measure this pressure. In the present invention, therefore, an indirect measurement is performed rather than a direct measurement. More specifically, the desired initial or needle pressure Pn is derived from the force indicated by the cell 78 and physical characteristics of the system. More specifically, it has been found that the output pressure under a steady state (i.e., where the piston moves at a constant speed) can be expressed as follows:
<img file="SE526308C2_D0017.tif" />
Pn = Ps-dVhn + dVhl-d (Fl + Ft + Fn) there
<img file="SE526308C2_D0018.tif" />
• · · ·
526 308 ···· • · • · • ·
Ps is the pressure generated in the piston / liquid interface through the movement of the piston;
Vhn is the drop rate in the needle;
Vhl is the fall velocity of the syringe;
d is the specific weight of the liquid; and
F1, FT and Fn represent frictional losses due to the flow in the syringe, tube and needle respectively.
There are some other minor pressure losses in the system which have been found to be less than 1% and can therefore be neglected.
The friction losses have been determined empirically and stored as part of the profile for each of the system elements. Typical values for eg F1, FT and Fn have been found to be:
F1 = 0.1%; Ft = 89%; Fn = 11% of the total pressure loss.
The density of the liquid is known and is usually close to the density of the water.
Fall rates are calculated using the expression:
Vhl = A * Q<sup>2</sup> d / [(274)<sup>2</sup> D<sup>4</sup>(2g) j there
Δ is the kinetic energy factor that relates to Reynolds number and which has a value of 2 for laminar flow;
Q is the respective fluid flow, as indicated in Figures 15A and 16A;
·· · • · · \; g is the gravitational constant; and • · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · --------D syringe for Vhl and needle for Vhn.
• · · • · · • · • « • · · <sup>:</sup>. J 20 Another factor for acceleration must be added as the engine accelerates or • · ·
· ../ reduces speed. This factor is given by the following expression:
• · · • ·· ·· • · · · « · · · • · · · > · · · ·· ··
<img file="SE526308C2_D0019.tif" />
526 308
Ms * a / As + Mt * a / At + Mn * a / An where Ms, Mt and Mn are the liquid masses in the syringe, tube and needle respectively, and As, At and An are corresponding cross-sectional areas.
A program for determining the initial pressure (designated in the program list as needle pressure) is attached at the end of this description. As can be seen from this list, and from the flow chart in Figure 20, to calculate the output pressure, the frictional losses in each of the three components (syringe, tube and needle) are first determined as follows. At step 700, a Reynolds number is determined from the flow rate, component diameter and viscosity. If Reynolds number exceeds 2000 (indicating a turbulent flow), then (step 702) a Kinetic Energy Factor parameter such as 1 and Friction Loss are calculated using
Reynolds numbers (step 704).
At R <2000 (step 706), the Kinetic Energy Factor is set to 2 and a different expression is used to determine (step 706) the loss of friction (based on the viscosity of the liquid, the flow rate and the diameter of the component). If no flow exists, the Friction Loss and Kinetic Energy Factor are both stated as 0 (708). Then, the parameters from all components are calculated, the inertia loss for each component is calculated, the stopping power is calculated, and all of these parameters are used to obtain the output pressure or needle pressure (step 712).
Each time the microprocessor 152 checks the pressure (step 318 in Figure 11), it actually calculates the output or needle pressure Pn as indicated above. Figures 16B and 17B show a normal pressure curve and an abnormal pressure curve, respectively, using these expressions.
If we now go back to step 302 in Figure 11 and if the device is to be used to charge the syringe, a charging sub-program is initiated as indicated in Figure 18. At step 700 in this figure, platform 30 is moved to its original position. In step 602, a test is performed to determine whether the syringe should be charged with or without air. If a charge with air is to occur, the platform 30 is positioned at step 604 for the spray head when the syringe is fully full. At step 606, the system waits for the syringe to be inserted.
To charge a syringe, the system must be connected to a liquid source such as a vial or bottle. More specifically, and as shown in Figure 19, to achieve charging, syringe 90 is connected to tube 14 via a three-way valve 700. Valve 700 is used to
<img file="SE526308C2_D0020.tif" />
526 303 ·· ·· ···· ·· • · · • · · connect the system to the fluid source 702 through a tube 706. For charging the syringe, place the valve so that the fluid source 702 is connected to the syringe. In Figure 19, the liquid source 702 is shown upside down so as to be provided with an air space 706. For charging with air, the spray piston 94 is placed as if the syringe was full, ie. in the position shown in Figure 19. For charging without air, the syringe plunger is moved as close as possible to the opposite end as shown at 94 A. As soon as the connections shown in Figure 19 have been made, the clinician can place the syringe on the groove 38 and secure it with the clamp 40, the piston head being inserted into the platform 30.
Returning to Figure 18, the syringe is now detected at step 606. At 608, the syringe 10 is advanced to the empty position which forces the air from the syringe into the source 702, thereby putting it under pressure. At step 610, the position returns to an initial position corresponding to the fluid level to be injected as previously determined by the clinician. At step 612, the clinician is reminded to turn valve 700 to connect syringe 90 to tube 14. Now the system returns to step 308.
If, at step 602, it is determined that charging should occur without air, at step 604, platform 30 is moved to the empty position of the syringe. The system then waits for the syringe to be placed in its position at 616, after which the system proceeds with step 610 as shown in the figure.
The system has so far been described as a system that performs an injection procedure. However, it will be obvious to those skilled in the art that it may be used equally effectively to perform a biopsy, for example, to perform a spinal cord drain or other similar anaerobic procedure. Essentially the same parameters can be used for this procedure, with some minor changes. For example, instead of defining an initial pressure, the clinician now defines an • input pressure. Some of the subprograms such as aeration, loading and suction are not needed at all for biopsy.
• · · • · · • ·: ·. ·. A large number of changes can, of course, be made to this invention without the need for change. it would go beyond its scope as defined in the appended claims.
<img file="SE526308C2_D0021.tif" />
526 308
program List
<td>uses food., system tools;</td><td></td>
<td>type</td><td></td>
<td>T Press - Registration</td><td></td>
<td>Flow rate: simple;</td><td>// Cubic inch / other (input)</td>
<td>Mechanism Power: simple;</td><td>// Pound (DB)</td>
<td>JMachine Resistance ???</td><td></td>
<td>ChargeCellKraft: simple;</td><td>// Pounds (input)</td>
<td>Spray Power: Easy;</td><td>// Pound (DB)</td>
<td>Injection Diameter: simple;</td><td>// Thumb (input)</td>
<td>Spray Length: simple;</td><td>// Tum (DB)</td>
<td>Pipe Diameter: simple;</td><td>// Tum (DB)</td>
<td>Pipe Length: simple;</td><td>// Tum (DB)</td>
<td>Needle Diameter: simple;</td><td>// Tum (DB)</td>
<td>Needle Length: simple;</td><td>H Tum (DB)</td>
<td>Specific weight: simple</td><td>// Off / Cubic (DB)</td>
<td>Viscosity: simple</td><td>// No units (DB)</td>
The term DB indicates that the value of a parameter is found in one of the databases.
526 308
Input means that the parameter has been calculated earlier.
Estimated - Value calculated through this subprogram end;
The following variables are defined during the course of this procedure:
SpeedLast: simple;
TimeSist: double;
execution function Calculate Pressure (P: TTpressure): simple;
art.
KineticEnergyFactor = 2.0;
Gravity = 386.4;
where
KineticEnergyFactor Syringe: simple;
H ': 15 Kinetic Energy Factor Needle: simple;
Kinetic Energy Factor Tubes: simple;
• · ·· · • · · • ·. ... Syringe Friction Loss: Simple;
• · · • · · •« · • · ·
Syringe Flow Loss: Simple;
» · • · • >· ···
Syringe Fall Speed: Simple;
Needle Friction Loss: Simple;
526 308
Needle Flow Loss: Simple;
Needle Case Speed: Simple;
Pipe Friction Loss: simple;
Pipe Flow Loss: simple;
Speed constant: simple;
Stop Power: Simple;
Reynolds Sprayer: simple;
Reynolds Tubes: simple;
Reynolds Needle: simple;
Needle Print: simple; // Returned value
Volume, Accel: single;
SpeedNow: simple;
TimeNow: double;
start: 15 Speed constant: = P.Specific Weight / (Sqr (PI / 4.0) * 2.0 * Gravity);
• ·· · Attempts • · ·· · • «· 'J ReynoldsSprayer: = P.Flow rate / (PI * P.SprayDiameter * (P. Viscosity / 4));
• · · ·· · • · · • · ·
· ./* about ReynoldsSpruta τ 2000.0 when starting • · • · ··· • ··
KineticEnergyFactorSpray: = 1.0;
• · · • · • · • · ·
Syringe Friction Loss: = 0.25 / sqr (log10 (0.0000012 / (3.7 * P. Syringe Diameter)) + ··· '
526 308 + (5.74 / Power (Reynolds Syringe,
0,9))));
end otherwise start
KineticEnergyFactorSpray: = 2.0;
Syringe Friction Loss: - (16 * P Viscosity * PI * P.SprayerDiameter) /
P.Flow rate ended;
except
Syringe Friction Loss: = 0;
KineticEnergyFactorSpray: = 0;
final;
try
Reynolds Tube: = P. Flow Rate / (PI * P. Tube Diameter * (P. Viscosity / 4));
if ReynoldsPipe τ 2000.0 then start • J j 15 KineticEnergyFactorPipe: = 1.0;
··. Pipe Friction Loss: = 0.25 / sqr (log10 (0.0000012 / • · · · · · · · · · · (3.7 * P.RoseDiameter) + (5.74 / Power (ReynoldsPipe, • · · ·· · ·· ·
0,9))));
• · • · ··· ··· • · '· · ·' End otherwise start
Kinetic Energy Factor Tube: = 2, 0;
526 308 PkLJHH Γ • · · · ·· ·· ··· «
Pipe Friction Loss: (16 * P. Viscosity * PI * P. Pipe Diameter) /
P.Flow rate ended;
except
Tube Friction Loss: = 0;
KineticEnergyFactorPipe: = 0;
final;
try
Reynolds Needle: = P. Flow Rate / (PI * P. Needle Diameter * (P. Viscosity / 4));
if ReynoldsNål τ 2000.0 then start
Kinetic Energy Factor Needle: = 1.0;
Needle Friction Loss: = 0.25 / sqr (log10 (0.0000012 / (3.7 * P.Needle Diameter)) + (5.74 / Power (ReynoldsNeed, • · · · · · ···)
0,9))));
end otherwise start
Kinetic Energy Factor Needle: = 2.0;
Needle Friction Loss: (16 * P. Viscosity * PI * P. Needle Diameter) /
P.Flow rate ended;
• · • · ···
526 308
<img file="SE526308C2_D0022.tif" />
except
Needle Friction Loss: = 0;
KineticEnergyFactorNeed: = 0;
final;
Volume: = (PI / 4) * sqr (P.Spray Diameter) *
P.SprayLength + (PI / 4) * sqr (P.RoseDiameter) *
P.Pipe Length + (PI / 4) * sqr (P.New Diameter) *
P.NålLängd):
SpeedNow: = P.Flow Speed / ((PI / 4) *
Sqr (P.SprayDiameter));
TimeNow: now * 24 * 60 * 60;
if (TimeSist> 0) and (not P.TestSet) then start: ϊ ': 15 First time entered switch! ·. ·. Accel: = ((P.Specific Weight * Volume) / Gravity) * • · ·· · • · ♦<sup>:</sup> // ABS ???
• · · • «· ··· • · ((SpeedLast - SpeedNow) / (TimeNow • · • · ···
C? TidSist));
end otherwise start
526 3 08 r 'r · *<sup>:</sup>.J
Accel: = 0;
final;
SpeedLast: = SpeedNow: // Preserve to the next tme
TimeSist: = TimeNow
NeedleFall Speed: = (Speed Constant *
Kinetic Energy Energy Factor Needle) * (Sqr. P.Flow Speed) /
Power (P. Needle Diameter, 4.0));
SyringeFall Speed: = (Speed Constant *
KineticEnergyFactorSpray) * (Sqr. P.Flow Speed) /
Power (P.Spray Diameter, 4.0));
SyringeFlowout Loss: = (SyringeFrictionLoss * P.SprayLength *
Sqr (P.Flow Speed)) /: 15 (P.Spray Diameter * 2.0 * Gravity * t ·. ·. Sqr (PI * Sqr (P.SprayDiameter) 14.0));
• · ·· · • * * 'Pipe Flow Loss: = (Pipe Friction Loss * P.PipeLength * • · · • · · ·· «\ j' Sqr (P.Flowing Speed)) / • · • ·« · · • · ·
· ... '(P. Tube Diameter * 2.0 * Gravity *
Sqr (PI * Sqr (P. Tube Diameter) / 4.0));
b 2 6 308
<img file="SE526308C2_D0023.tif" />
Needle Flow Loss: - (Needle Friction Loss * P. Needle Length *
Sqr (P.Flow Speed)) / (P. Needle Diameter * 2.0 * Gravity *
Sqr (PI * Sqr (P. Needle Diameter) / 4.0)):
Stopping Power: - P. ChargingCellKraft - P.Spray Power P.Mechanism Power;
H Stopping Force: = P. ChargingCellKraft;
Needle pressure: = (Stopping Force / (PI * sqr (P.SprayDiameter / 2))) NeedleFall Speed + SprayerFall Speed (P.SpecificWeight * (SprayFlow Loss +
PipeFlow Loss + NeedleFlow Loss) (Accel / (PI * sqr (P.SprayDiameter /
2))));
final.
·· · • · ·
<img file="SE526308C2_D0024.tif" />
· · · · · · · ··· ··· · · ··· · · · ···
526 308 ••• ί
Contents10
41 sheets
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87 members in 29 offices
Priority claims12
| Document | Office | Kind | Date |
|---|---|---|---|
| 8138898 | United States of America | P | |
| 8138898 | United States of America | P | |
| 20146498 | United States of America | A | |
| 20146498 | United States of America | A | |
| 9907446 | United States of America | W | |
| 9907446 | United States of America | W | |
| 081388 | – | – | – |
| 201464 | – | – | – |
| PCTUS9907446 | – | – | – |
| US19980081388P | – | – | – |
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1 legal event, as the office reported them to INPADOC
Events
| Event | Code | |
|---|---|---|
| Patent has lapsedLapsedNUG | NUG |
Numbers
- Publication, DOCDB
- 526308
- Publication, EPODOC
- SE526308
- Application
- 3633
- Application, DOCDB
- 0003633
- Application, EPODOC
- SE20000003633
Titles2
- Swedish
- Genom tryck/kraft datorstyrt system för tilldelning av medicin och liknande
- English
- Through pressure / force computer controlled system for the allocation of medicine and the like
Classification
- CPC, 4
- A61M5/1456
- A61M1/00
- A61M5/16854
- Y10S128/12
- IPC, 6
- A61M1 00
- A61M5 145
- A61M5 00
- A61M5 168
- A61M31 00
- A61M37 00
