JPS58216056A - Volumetric injection apparatus and method - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to an infusion pump device and method, and more particularly to a positive displacement infusion pump device and method.

It is often necessary to inject fluids into a patient's body.

For many years, the substance was delivered to the patient only by gravity, which required that the container containing the liquid delivered to the patient be placed at a significant height above the patient.

The device was not completely satisfactory in terms of height requirements and the difficulty of accurately regulating the flow rate of the material. Adjustment is only guaranteed with a tube grip that is set by hand, and control is performed after counting the drops of fluid within a predetermined time.
Regular checks by the nurse to ensure that the desired delivery rate is maintained will ensure that the desired delivery rate is maintained, as changes in the enlargement of the veins will vary the resistance to the flow of intravenous fluid into the body, which will change the rate of delivery. It was done. Gravity flow made it very difficult to maintain a regulated flow rate for extended periods of time.

In recent years, significant interest has been paid to intravenous delivery pumps for infusing saline solutions etc. into patients, which allow for precise delivery of the intravenous fluid medium to the patient, are easily adjustable, and are capable of reducing the distance above the patient. There is a trend toward the development of positive-acting pumps that do not require the installation of a bottle and whose operation is reliable.

However, most pumps proposed so far are quite expensive and therefore cannot be disposed of after one use.

The pump has proven difficult to assemble after disassembly and sterilization, and therefore difficult to sterilize and maintain sterility.

Additionally, known pumping devices require air to be drawn into the IV fluid system to replace the amount of fluid drawn from the IV container and forced into the body, which may be due to airborne substances and This can result in either contamination of the fluid with microorganisms or actual forcing of air into the patient's venous system (air embolization) when the pump is not stopped when the IV fluid container is empty.

Also, existing methods of allowing air to displace fluid drawn from an intravenous fluid container system produce a volume delivery that is highly susceptible to pressure fluctuations, resulting in volume delivery fluctuations. Extremes in volume delivery caused by fluctuations in pressure may undesirably result in repeated extractions and reinfusions of the patient's blood, or excessively rapid delivery of fluid to the patient. These extreme cases can result in damage to the patient's blood or toxicity due to excessive amounts of intravenous fluid, respectively.

Furthermore, pumps of this nature can be installed in such a way that the action is reversed under certain circumstances, thereby reducing the possibility of errors (
Pump blood from the patient until detected and corrected (if any). Known pumps operate in an open system and thus pump air or fluid continuously, which can lead to air embolism or draining of the patient's blood supply if not stopped at the appropriate time. either of the following occurs. Known pumps rely on detection devices to detect failure modes P of the pump, such as pumping of air and blockage (pressure build-up) at the needle, and due to their specific construction, these does not eliminate the problem. Such detection devices are known to fail from time to time.

Prior art devices have previously been proposed for controlled liquid distribution of drip bath fluids (eg, U.S. Pat.
No. 967,620), and the device has heretofore been proposed and/or used for the dispensing of liquids by the use of a container having a compartment containing a fluid that is collapsed so that the fluid is expelled. For example, U.S. Patent No. 3,838,794
No. 5.506,005, No. 3,731.681, No. 5.797,492, No. 5.894,538,
(See No. 3.756,459, No. 3,938,539, No. 3.955,557, No. 3.974.825)
.

Additionally, devices for dispensing fluids using mechanical devices and/or vacuum devices have been proposed and/or used in the past (e.g., U.S. Pat. Nos. 3,884,228; 3,965,946). (see issue).

The present invention relates to a positive displacement infusion pump device and a method comprising introducing an incompressible material into a rigid container of infusion fluid, thereby forcing the fluid from the container and injecting it into a blood vessel of a patient in a predetermined manner. I will provide a.

Accordingly, it is an object of the present invention to provide a positive displacement infusion pump device and method.

It is another object of the present invention to provide a positive displacement drip pump device and method for introducing incompressible fluid into a container such as displacing drip fluid.

Yet another object of the present invention is to provide a positive displacement infusion pump device and method that accurately controls both volume and flow rate of fluid to a patient.

Still another object of the present invention is to provide a positive displacement drip pump device and method that allows the delivery flow rate to be easily adjusted as needed or desired.

Yet another object of the present invention is an improvement that provides a simple device for detecting infiltration while providing inherent protection for the patient from air emboli, back-up, contamination, and removal of undesirable volumes of blood. It is an object of the present invention to provide an apparatus and a method for a small-capacity type 11 drip pump.

Yet another object of the present invention is to provide a single-capacity drip pump device and method that is simple, inexpensive, and reliable in operation, as will become clear to those skilled in the art as the description progresses. In view of these and other objects, the invention resides in a novel construction, combination and arrangement of parts, and method, as hereinafter described and particularly as claimed. ,
Modifications in the very embodiments of the invention disclosed herein are intended to be covered as they fall within the scope of the claims.

The invention will be explained in detail below with reference to embodiments thereof and with reference to cooling drawings.

Infusion fluids are typically available from manufacturers in one of two distinct storage and distribution packages. One group of these packages are rigid bottles made of materials such as glass or resin;
The group consists of containers made of soft, collapsible materials such as flexible resin films in the form of bags.

The pump device 7 achieves advantageous results due to the separation of the drip system from the air, the incompressibility of the system and the finite delivery capacity, all of which are combined with the This is accomplished by active displacement of the drip fluid by a compressible substance.

As shown in FIG. 1, the pump device 7 includes a rigid fluid container 9 (usually provided by the provider of the intravenous fluid) that contains the intravenous fluid material. As will be appreciated, the amount of the particular intravenous fluid and the amount of incompressible material required to replace it will be selected as necessary for the particular intravenous delivery required by the patient.

A bag or other inflatable device 11 is placed within the container 9 and an inlet 13 (through the collar 14) is inserted into the bag 1.
1. The inlet 13 is connected to a storage container 15 of incompressible material via an alternating metering device 17 and a conduit 19.21. A programmable control device 23 controls the operation of the metering device 17 and thus the introduction of incompressible material into the bag 11 within the container 9. The incompressible substance may be a fluid, e.g. water, or a solid, and the programmable control device controls the opening and closing of the valve (
(including partial opening and closing), for example a mechanical drive with a cam and a cam follower or a control device such as an electronic programmer.

Furthermore, the programmable controller 23 may be any device, mechanical or electronic, that controls either the rate of the metering device 17 or the mechanical primary delivery device 15, or both.

Outlet 25 passes through stopper 14 and provides a discharge opening that communicates with the interior of container 9. The outlet 25 is coupled to an injection device 27, such as a needle, for fluid communication through the delivery control device 29 and conventional tubing, drip chambers, drug injection sites, etc. that constitute the delivery control device 29 and the dedicated tubes 31,33. Ru. The delivery control device 29 may be used to detect the flow rate of fluid to the patient, and when the flow rate is above a predetermined value or has nearly stopped flowing, such as indicating a device failure. It may be coupled to the tube layer device 35 so as to display whether it is below a predetermined value (just as the control device 17 may be coupled)
.

Although the mechanical ratio of the feed rate of the primary delivery device 15 can be varied as required to control the flow rate of injecting the incompressible substance into the bag 11 within the solution container 9, the metering device 17 may be used as a primary method of controlling the flow rate of injecting a non-compressible substance into an infusion container (as shown in FIG. 1 in phantom).

When the metering device 17 is used in this way, a change in the mechanical ratio of the feed rate of the second delivery device 15 is eliminated or a parallel device for the one provided by the metering device 17 is eliminated. This increases the certainty of obtaining the desired flow rate of delivery of the incompressible material.

Conventional equipment can be used for drip containers, conduits, delivery devices, and injection devices. Furthermore, the bag 11 is of such a nature that the incompressible material used to extrude the intravenous solution is immiscible with the intravenous solution and cannot enter the outlet 25 and ultimately be directed to the patient via the delivery device 29. If it is a liquid or solid,
May be removed from the device.

A second embodiment 47 of the invention is shown in FIG.

As shown, container 49 has a bag 51 therein, in which the nucleic acid is in the form of a flexible or collapsible bag of an infusion solution container, and the remaining volume of container 49 is non-compressible. is filled with a substance and then sealed with a stopper 52, which results in a positive extrusion device (inlet 5
4), the device otherwise operates exactly as the device shown in FIG. . Therefore, as shown in FIGS. 1 and 2,
The difference between the devices and methods of operation is that one uses an expandable cleft or an immiscible, incompressible material to extrude the intravenous solution (Figure 1), whereas the other The solution is extruded (Figure 2).

A simplified ponsiff 7 that may be useful in the present invention is:
It is shown in FIG. As shown, cylinder 79 is filled with incompressible material. The piston 81 is moved forward by a rotating screw 83 rotating in a threaded base 82 of the piston. Rotating screw 83 has threads that are interrupted intermittently to allow spring 84 to retract piston 81 a sufficient distance to ensure that no seepage occurs. Nut 85 is far enough away from the threaded base of nail 81 to ensure that spring 86 builds up enough tension to eventually offset the tension in spring 84. Spring 84 is sufficiently overcome such that screw 83 re-engages the threaded base of piston 81 to force continued forward movement of piston 81. The screw 83 is connected to the gear 88 which is rotatably driven by a conventional friction cone drive 89.
7°88, thereby providing continuous variability in the speed of forward movement of the piston 81. As shown, the friction cone drive 89 is driven by a motor 90. The exact amount of incompressible material delivered or extruded can be directly read from the position of the piston 81 observed in relation to a scale 92 inscribed in the transparent part of the cylinder 79.

In operation, an incompressible substance is controlledly introduced into a container having intravenous fluid therein such that the fluid within the container is precisely metered from the container into the patient's blood vessel.

The fluid may be metered at a constant flow rate or at different flow rates, as desired, and both volume and flow rate are carefully controlled. Furthermore, by periodically extracting the incompressible material from the container, this draws a small amount of blood from the vessel into the transparent tubing above the needle site, thus preventing the continuation of the needle in the vessel. gives assurance of proper positioning. The appearance of blood can be confirmed visually and/or electronically.

Accordingly, the present invention provides a precision metered bonding device and method specifically configured to force fluid from intravenous fluid containers (including currently available containers) through the use of incompressible materials.

The apparatus and method differ from currently known apparatus and methods that involve pumping fluid from a fluid container.

In the apparatus and method of the present invention, an incompressible substance is forced into a fluid container, thereby displacing the intravenous fluid within the container, providing the following advantages.

1) Air is completely excluded from the device, so there is no risk of air embolism, and contamination by air filtering through the drip fluid as replacement for fluid extracted from the container is eliminated; 2) pump backtracking is eliminated because the device is incompressible and fluid cannot re-enter the infusion device due to uncontrolled pressure fluctuations and/or pump failure; 6) if the device is incompressible , the amount of fluid forced out is independent of the back pressure introduced with changes in the patient's degree of vasodilation (dilatation of the luminal blood vessels), and 4) the volume displacement is 5) by reversing the pumping action, the fluid is
If the fluid being extracted is not blood, which is extracted from the patient in a suitable and regular manner, this means that the needle used to direct the IV fluid into the patient will move out of the blood vessel and the fluid will enter the tissue. 6) very precise control as incompressible fluid is prevented from filling the IV solution container and entering the delivery device; is maintained over the entire amount of substance delivered; 7) The nature of the actual Ponzo mechanism of action has been made very simple and an example device (a seemingly simple example is shown in Figure 6) can be used. , which reduces the cost and increases the reliability of the devices and methods disclosed herein over VC.

8) Since the incompressible material and the infusion solution are separated in the infusion solution container and the infusion solution container is constant in volume, any failure of the device that causes the pump to work in reverse will cause the infusion solution to be extracted from the patient. 9) The volume of incompressible material is equal to the volume of fluid in the IV solution container to completely force almost all of the IV solution out of the IV solution container. be done.

In view of the foregoing, it will be appreciated that the apparatus and method of the present invention provide a novel positive displacement infusion pump apparatus and method.

[Brief explanation of drawings]

FIG. 1 is a combined block and schematic diagram of one embodiment of the pump of the invention; FIG. 2 is a combined block and diagrammatic representation of another embodiment of the pump of the invention; FIG.
The figure shows a combined simplified block and schematic diagram of an extrusion-subdelivery device usable with the present invention. 7... Pump device 9.49... Container 11.51... Bag 13... Inlet 15...-Next delivery device (storage container) 17... Control device 19.21... Conduit 23...Programmable control device 29...Delivery control device 35...Alarm device 77...Pump 79...Cylinder 81...Piston 82...Base 83...Rotating screw 84 .86... Hane attorney Akira Asamura FIG, 2 FIG, 3. Procedural amendment (1st illusion, Z month 1982) 2nd, Mr. Commissioner of the Japan Patent Office ■, Minor case indication, Patent Application No. 92960 of 1982 3. Relationship with the case of the person making the amendment Special RR applicant address name Staodynamics Inc. (Name) 4. Agent 5. Date of amendment order 6. Increased due to amendment Engraving of the specification of the invention (no change in content) 311-

Claims (9)

[Claims] (1) In a positive displacement infusion device that injects a solution from a container into a patient through a discharge device. introducing incompressible material into the container such that a solution stored in the container is forced out of the container via the ejection device in an amount proportional to the amount of incompressible material introduced into the container; a delivery device, the delivery device having a control device for controlling the introduction of the incompressible substance into the container, so that solution exits the container via the evacuation device in a predetermined manner. Injection device discharged. (2) The delivery device includes a storage device for storing the incompressible substance, an inlet device surface communicating with the interior of the container, and a conveying device for conveying the incompressible substance from the storage device to the inlet device. An injection device according to claim 1. (3) The injection device 0 according to claim 1 or 2, wherein the control device includes a device for controlling extraction of the incompressible substance from the storage device. 4. The injection device of claim 6, wherein the extraction control device includes a programmable control device for controlling the release of incompressible material from the storage device. (5) The control device includes a metering device coupled between the storage device and the container, the metering device controlling the release of the incompressible material from the storage device to the container. 5. An injection device according to claim 4, wherein the injection device is controlled by said programmable control device to control the injection device. (6) The control device includes the control device and the storage device;
6. Infusion device according to claim 5, comprising an alarm device coupled to a zologrammable control device. 7. The injection device of claim 6, wherein the extraction control device includes a drive device for controlling the release of incompressible material from the storage device. (8) The delivery device includes a device for periodically extracting incompressible material from the container so as to ensure proper operation of the injection device. The injection device according to any one of Item 7. (9) In a method of actively forcing the solution from the container into the patient. An incompressible substance' such that the solution in the container is forced out of the container and injected into the patient? A method comprising the steps of: introducing the incompressible substance into the container and controlling the introduction of the incompressible substance into the container so that the fluid is accurately injected into the patient in a predetermined manner. 10. The method of claim 9, comprising the step of maintaining the container air-free. 10. The method of claim 9, wherein the incompressible material is introduced into a bag within the container and is thus maintained free from contact with the fluid within the container. Claims in which the solution is in a bag within the container, and the incompressible material is introduced into the container outside the nucleic acids and is thus maintained free from contact with the solution in the bag. The method according to item 9. a3 Claim 9, wherein controlling the introduction of non-compressible material into said container includes periodically extracting non-compressible material from said container so as to ensure proper operation of the drip delivery. The method described in any one of paragraphs 1 to 12.