This invention relates to removable apparatus for controlling the flow of intravenous fluid from a source to a patient. The invention particularly relates to apparatus for providing for precise controls over the rate of fluid flow to a patient during the operation of the apparatus under normal circumstances such as in the room assigned to the patient and for controls over the rate of fluid flow in accordance with manual adjustments during such abnormal conditions as the transport of a patient from one room to another. More particularly, the invention relates to apparatus for providing for a manual control over the rate of fluid flow to a patient when removed from a system, for a setting of rate in a system upon insertion of the apparatus into the system and an overriding of the manual control by the system setting under such circumstances and for the reassertion of the manual control upon a removal of such apparatus from the system.
As the practice of medicine becomes increasingly complex and increasingly refined, the equipment and techniques used to provide care for a patient have become increasingly sensitive in order to assure that the patient receives optimum care. For example, after an operation has been performed on a patient and the patient is in the recuperative state, intravenous fluid often has to be introduced to the patient. The rate of introduction of fluid to the patient is dependent upon a number of different factors including the weight, age, sex and physical state of the patient. As the patient recovers from his illness, the rate of introduction of the intravenous fluid to the patient is preferably adjusted to assure that the patient receives an optimum benefit from the fluid.
A considerable effort has been devoted over a substantial period of time to provide a satisfactory system for controlling the rate at which fluid such as intravenous fluid is introduced to a patient. Considerable progress has been made in developing a satisfactory system for certain types of operations. For example, a system providing for the pumping of fluid on a precise volumetric basis to a patient has been disclosed and claimed in Pat. No. 3,985,133 issued on Oct. 12, 1976, and assigned of record to the assignee of record of this application.
A number of fundamental problems have remained until fairly recently in systems providing for the flow of fluid on a gravitational basis to a patient. Such problems have existed until recently even though a considerable effort has been devoted to the solution of such problems. For example, a satisfactory system has not existed until recently for providing for the introduction of fluid to a patient on a gravitational basis at a precise and predetermined rate. Furthermore, a system has not existed until recently which could be used on a sterile and hygienic basis for different patients such that any contamination from the use of the system for one patient would not affect the health or safety of subsequent patients.
Applications have been recently filed which disclose and claim systems for overcoming the above difficulties. For example, application Ser. No. 913,294 has been recently filed by Jon A. Jenkins on June 7, 1978, and has been assigned of record to the assignee of record of this application. This application discloses and claims a system for providing for the flow of intravenous fluid to patient on a gravitational basis at a precise and predetermined rate and for providing a sterile and hygienic operation for individual patients.
Application Ser. No. 913,282 has also been filed by me on June 7, 1978, for a "Cassette for Intravenous Controller" and has been assigned by me of record to the assignee of record of this application. This application discloses and claims a casette which is disposed in the system to provide for the flow of fluid on the controlled basis to the patient and which is easily removable from the system so that a sterile cassette can be replaced in the system for a previously used cassette every time that the system is to be used for a different patient.
Although the system and cassette disclosed and claimed in the application specified in the previous paragraph provide for the flow of fluid on a gravitational basis to a patient at precise rates under sterile conditions, improvements would be still desirable to enhance the scope of operation of the system. For example, it would be desirable to provide a system which could be coupled to a patient even during movement of the patient and which would provide for a flow of fluid to the patient at controlled rates during such movement. In this way, intravenous fluid could be introduced to the patient at such controlled rates even during the movement of the patient from an operating room to a recovery room or from the recovery room to a room of permanent assignment in a hospital. It would also be desirable to provide such a system with instantaneous capabilities of controlling precisely and automatically the flow of fluid on a gravitational basis to the patient after the movement of the patient to a room of permanent assignment. As will be seen, a system of such capabilities would have a considerable flexibility in operation since it would provide for a controllable flow of fluid to a patient under all conditions which may be encountered in a hospital.
This application provides a system with the capabilities discussed in the previous paragraph. The system includes apparatus which is free-standing and which is manually adjustable at such times to vary the rate at which intravenous fluid flows to a patient. Such manual adjustments may be operative to control the rate of fluid flow during the time that a patient is being moved from an operating room to a recovery room or from the recovery room to his assigned room.
The apparatus may also be inserted easily and conveniently into a system when the patient is recuperating in his assigned room. At such times, desired rates of fluid flow may be set in such system, which then overrides any previous manual adjustment of such apparatus and adjusts the rate of fluid flow in accordance with any such setting. This provides for a precise control of the flow of fluid in accordance with such settings during the time that the patient is in his assigned room.
In this way, the precise controls can become operative when the patient has been moved to his assigned room and the system is operative on a semipermanent basis in the assigned room. When a desired rate of fluid flow has been preset into the system, the system then operates in a servo loop to adjust the rate of fluid flow on an instantaneous basis so that the desired rate of fluid flow is precisely maintained.
The apparatus is removably disposed in the system for controlling the flow of fluid to the patient. As a result, the manual adjustment may be provided when the apparatus is removed from the system and the system control of the rate of fluid flow may be provided when the apparatus has been coupled into the system. The removal of the apparatus from the system or the coupling of the apparatus into the system may be provided easily on an instantaneous basis.
The apparatus includes a plug member defining a passage which communicates at a first position with an input or inlet line and, at a displaced position in a particular direction, with an output or outlet line. A resilient member such as a diaphragm may be disposed in the particular direction in the passage and may be displaced in a transverse direction from the inlet and outlet lines. A rod may extend into the passage to constrain the diaphragm in the transverse direction. A button may be disposed between the inlet and outlet lines to cooperate with the diaphragm in providing a barrier against the flow of fluid through the passage between the inlet and outlet lines in accordance with the stretching of the diaphragm in the transverse direction. A knob may be adjustably threaded on the plug member to press the rod against the diaphragm.
One of the button, the diaphragm or the rod may have a channel to facilitate the flow of fluid through the passage at the desired rate. In a preferred embodiment, the buttom may be disposed laterally across the passage at a position between the inlet and outlet lines and at least two channels may be disposed in the button. Each of the channels may be provided with a different cross-sectional area than the other channels. Individual ones of the channels are progressively closed as the knob is progressively rotated in a direction to increase the force of the rod on the diaphragm.
The knob may be manually adjusted, during the movement of the patient from the operating room to the recovery room or from the recovery room to his assigned room, to control the rate at which fluid flows to the patient. The knob may be coupled to a driving member when the apparatus is inserted into the system. At such times, a motor drives the driving member through an angle dependent upon a rate which is preset into the system. In this way, the diaphragm is constrained, such as by compression, in the transverse direction in accordance with the operation of the motor. The motor may be servo-controlled to adjust the constraint of the diaphragm at each instant in the transverse direction in accordance with the rate at which drops of the fluid are actually flowing to the patient. This servo-control insures that the actual rate of flow of fluid to the patient corresponds to the rate preset into the system when the apparatus is inserted into the system.
In another embodiment, the button may be in the form of a closed loop enveloping one of the inlet and outlet lines. A channel or notch may be provided in the button at a position between the inlet and outlet lines. In still other embodiments, the channel may be provided in the diaphragm, preferably at the surface facing the notch. In other embodiments, the channel may be provided in the rod, preferably at the surface facing the diaphragm.
The apparatus included in this invention is adapted to be used in the system disclosed and claimed in copending application Ser. No. 913,294. It is also adapted to be included in the cassette disclosed and claimed in application Ser. No. 913,282 or to be used as a separate item in the system without including the casette in the system.
In the Drawings:
FIG. 1 is a schematic diagram, partly in block form, of a system for controlling the flow of intravenous fluid to a patient on a gravitational basis;
FIG. 2 is a sectional view of control apparatus, including a cassette, capable of being included in the system of FIG. 1 and shows the positioning relative to such control apparatus of a drop sensor included in the system shown in FIG. 1;
FIG. 3 is a sectional view of the apparatus, including the cassette, shown in FIG. 2 when the apparatus is removed from the system shown in FIG. 1 and is in a position to provide for the flow of fluid at a very low rate;
FIG. 4 is an enlarged fragmentary sectional view of certain elements of the cassette shown in FIGS. 2 and 3;
FIG. 5 is an exploded perspective view of the system shown in FIG. 1 and of the apparatus of FIGS. 2 and 3 in a position removed from the system;
FIG. 6 is a schematic view of a cassette which may be constructed to include the apparatus of FIGS. 2 and 3;
FIG. 7 is a perspective view of a preferred embodiment of a cassette for use in the apparatus shown in FIGS. 1, 5 and 6;
FIG. 8 is a fragmentary sectional view of the cassette shown in FIG. 6 and is taken substantially on the line 8--8 of FIG. 7;
FIG. 9 is a fragmentary sectional view of the cassette shown in FIGS. 7 and 8 and is taken substantially on the line 9--9 of FIG. 7;
FIG. 10 is a fragmentary sectional view of another embodiment of a cassette for use in the apparatus in FIGS. 1, 5 and 6;
FIG. 11 is a fragmentary sectional view of another embodiment of a cassette for use in the apparatus of FIGS. 1, 5 and 6;
FIG. 12 is an enlarged fragmentary sectional view of certain elements of the cassette shown in FIG. 11 and is taken substantially on the line 12--12 of FIG. 11;
FIG. 13 is a fragmentary sectional view of a further embodiment of a cassette for use in the apparatus of FIGS. 1, 5 and 6;
FIG. 14 is an enlarged fragmentary sectional view of certain elements of the cassette shown in FIG. 13 and is taken substantially on the line 14--14 of FIG. 13;
FIG. 15 is a fragmentary sectional view of a still further embodiment of a cassette for use in the apparatus shown in FIGS. 1, 5 and 6;
FIG. 16 is an enlarged fragmentary sectional view of certain elements of the cassette shown in FIG. 15 and is taken substantially on the line 16--16 of FIG. 15;
FIG. 17 is a fragmentary sectional view of still another embodiment of a cassette for use in the apparatus shown in FIGS. 1, 5 and 6; and
FIG. 18 is an enlarged fragmentary sectional view of certain elements of the cassette shown in FIG. 17 and is taken substantially on the line 18--18 of FIG. 17.
FIG. 3 illustrates equipment which forms a part of this invention and which provides for a flow of intravenous fluid to a patient at a rate dependent upon a manual adjustment of such apparatus. The equipment includes a source 10 of intravenous fluid and a conduit 12 extending from such source to apparatus generally indicated at 14 and forming a part of this invention and constituting a cassette. An output conduit 16 extends from the apparatus 14 to a patient schematically illustrated at 20.
The apparatus 14 includes a plug member 22 formed from a suitable material such as a plastic material. The plug member 22 is provided with an input line 24 constructed to receive the input conduit 12 and with an output line 26 constructed to receive the output conduit 16. A cavity or passage 28 is disposed between, and in communication with, the input line 24 and the output line 26. Button 30 is disposed in the passage 28 in a closed loop around one of the lines such as the output line 26 and is preferably provided with an annular configuration. The button 30 is preferably provided with a channel or notch at one position as at 31 (FIG. 4) to facilitate the flow of fluid on a controlled basis. The notch 31 may be V-shaped to provide a progressive control over the rate of fluid flow.
A resilient member such as a diaphragm 32 is disposed in the cavity or passage 28. The ends of the diaphragm 32 are provided with a bulbous construction and the bulbous ends are disposed in sockets 34 in the plug member 22 to maintain the diaphragm in a taut relationship. The diaphragm 32 is disposed so that it extends in the same direction as the distance between the input line 24 and the output line 26 at the positions at which these lines communicate with the passage 22.
A pusher rod 36 is disposed in a socket 38 in the plug member 22. The pusher rod 36 is disposed against the diaphragm 32 at a position intermediate the sockets 34 to stretch the diaphragm in a direction transverse to the disposition of the diaphragm in the passage 22. A knob 40 is internally threaded on a threaded protuberance 42 extending from the plug member 22. The knob 40 presses against the pusher rod 36. The knob 40 may be provided with a frusto-concial external surface which may be knurled or otherwise deformed to facilitate gripping.
The knob 40 may be rotatably adjusted on the protuberance 42 to adjust the pressure exerted against the pusher rod 36. This in turn provides for an adjustment of the force exerted by the pusher rod 36 against the diaphragm 32. In this way, the position of the diaphragm 32 adjacent the button 30 may be adjusted in accordance with adjustments in the positioning of the knob 40 so as to control the rate at which fluid flows through the passage 28 from the input line 24 to the output line 26. The manual adjustment of the knob 40 accordingly provides for a control of the rate at which fluid flows from the source 10 to the patient 20.
The channel or notch 31 is provided in the button 30 to obtain a flow of fluid to the patient at low rates in accordance with the adjustment of the knob 40. This may be seen on a schematic basis in FIG. 4. At such low rates, the diaphragm 32 tends to be drawn into the notch 31. The positioning of the diaphragm 32 in the notch 31 is dependent upon the adjustment of the knob 40. As a result, for low settings of the knob 40, fluid can flow through the passage to the output line only in the space between the diaphragm 32 and the bottom of the V-shaped notch 31.
The apparatus disclosed above is adapted to be used when the patient is being moved from an operating room to a recovery room or from a recovery room to an assigned room. Since the apparatus 14 is relatively small and can even be held in the palm of a hand, it can be held by a nurse or even can be disposed in the palm of a patient as the patient is being moved from one room to another. During such movement, the rate of flow of fluid to the patient can be controlled by the adjustment of the knob 40 on the protuberance 42.
FIG. 1 illustrates a system for providing an automatic control over the rate of flow of fluid on a gravitational basis to a patient. The system includes the apparatus 14 shown in FIGS. 2 and 3 and described in detail above. The apparatus 14 is adapted to be supported in fixed position relative to such system by a housing generally indicated at 50 in FIG. 5. The holder includes a drive member 52 (FIG. 5) which is provided with a socket 64. The socket 54 is knurled or otherwise deformed in a manner similar to the external surface of the knob 40 so as to engage the knob and rotate the knob as it rotates. The drive member 52 may be spring loaded to facilitate the driving relationship between it and the knob 40. The drive member 52 is adapted to be driven by a stepper motor 56.
The stepper motor 56 is included in an electrical system which is shown on a schematic basis in FIG. 1. The system includes settings 58 (FIG. 5) which are disposed on the front panel of the housing 50 and which are preferably provided with digital capabilities of a plurality of digits of progressive value. For example, three digits may be provided to register the values of units, tens and hundreds to provide capabilities of selecting rates of digital flow between values of "1" and "999".
The selections in the settings 58 are introduced to a comparator 60 (FIG. 1) which compares such desired values with the actual values of flow provided by a drop sensor 62. The drop sensor may be of a conventional construction and is operative to sense the number of drops of fluid flowing through the output line 12 in a particular period of time such as one second. The comparator 60 compares the signals from the settings 58 and the drop sensor 62 and produces an error signal representing any differences between the characteristics of the signals being sensed. The error signal is then introduced to the stepper motor 56 to operate the stepper motor in a direction for reducing the error signal. The stepper motor drives the drive member 52, which in turn drives the knob 50, in a direction to control the flow of fluid through the passage 28. In this way, the stepper motor 56 is controlled on an instantaneous basis to obtain a flow of fluid through the output line 16 at a rate directly related to the values provided in the settings 58.
As will be seen from FIG. 5, the apparatus 14 is adapted to be removably disposed in the housing 50. The housing 50 may include the drive member 52 and the stepper motor 56. In this way, the apparatus 14 may be easily coupled into the housing 50 when the system shown in FIG. 5 is to be operative in an assigned room of a patient to provide a flow of fluid to the patient at a precise rate in a closed-loop.
The apparatus 14 may be easily decoupled from the housing 50 to operate independently of the system when the patient is being moved from an operating room to a recovery room or from a recovery room to an assigned room. Under such circumstances, the manual adjustment of the knob 40 is sufficient to regulate the flow of fluid at a desired rate with sufficient accuracy in an open-loop servo so that the patient is receiving good medical attention.
The embodiment shown in FIGS. 1 through 5 and described above is practical and has been successfully tested and operates within the principles of the invention. However, this embodiment has occasionally experienced problems of hysteresis. Such hysteresis results from the failure of the diaphragm 32 to respond properly when the knob 40 is moved in a direction to relieve the force on the diaphragm. In other words, the diaphragm occasionally tends to remain in the notch 31 even though it should move from the notch as the force exerted by the rod 36 on the diaphragm is relieved. This causes fluid to flow through the passage 28 between the inlet line 24 and the outlet line 26 at a rate less than that desired. It will be appreciated that this occurs only when the knob 40 is manually adjusted since the rate of fluid flow is automatically adjusted when the rate of fluid flow is under the control of the system shown in FIGS. 1 and 5.
FIGS. 7, 8 and 9 illustrate a preferred embodiment of a disposable cassette since this embodiment overcomes any problems of hysteresis. The embodiment shown in FIGS. 7, 8 and 9 is substantially identical to the embodiment shown in FIGS. 2 and 3 except for the construction and disposition of the button. In the embodiment shown in FIGS. 7, 8 and 9, a button 110 is disposed laterally across a passage 112 at a position between an inlet line 114 and an outlet line 116 to provide a barrier against the flow of fluid through the passage between the inlet and outlet lines.
Channels such as channels 120, 122, 124 and 126 are provided in the button 110 at laterally spaced positions along the button. Although four channels are shown, any number of channels or notches equal to or greater than two may be provided. Each of the channels may be provided with an individual cross-sectional area. Preferably, each of the channels 120, 122, 124 and 126 is provided with a V-shaped cut having a different cross-sectional area than the cross-sectional area of the other channels. For example, the channels 122, 124 and 126 may respectively have a greater cross-sectional area than the channels 120, 122 and 124.
By providing a plurality of channels of individual cross-sectional areas, the different channels become sequentially closed as the force exerted on a diaphragm 130 is progressively increased. Thus, fluid tends to flow through at least the channel 126, and possibly one or more of the other channels, provided that a rod 132 has not been manually positioned to the position where the flow of fluid has been completely interrupeted. Since the fluid tends to flow through at least one of the channels and since the channels are laterally displaced, any tendency for the diaphragm 130 to remain in the compressed position across the lateral dimension represented by the different channels is minimized when the force for constraining, such as by compression, the diaphragm is relieved.
FIGS. 11 and 12 illustrate another embodiment of the invention. In this embodiment, a button 150 is disposed in a closed loop around one of an inlet line 152 and an outlet line 154. Channels or notches 156 and 158 are disposed in the button 150. The notches 156 and 158 are preferably V-shaped in cross section. A diaphragm 160 cooperates with the notches to control the flow of fluid in the notches. This cooperation is facilitated by providing a relieved portion 162 in the diaphragm at a position between the notches 156 and 158. The relieved portion 162 defines thickened portions 164 and 166 in the diaphragm 160 at positions respectively contiguous to the notches 156 and 158. The thickened portions 164 and 166, and the relieved portion between such thickened portion, cooperate with the notches in controlling the flow of fluid at the desired rate. Although the relieved portion 162 is shown and described as being included in the embodiment of FIGS. 11 and 12, it will be appreciated that the diaphragm 160 can be provided with a substantially uniform thickness.
FIGS. 13 and 14 illustrate another embodiment of the invention. In this embodiment, a button 170 is disposed between an inlet line 172 and an outlet line 174. The button is provided with a relieved portion 176 at an intermediate position along its length. A channel or notch 178 is provided along the length of the relieved portion. A diaphragm 180 is provided with a thickened portion 182 at a position corresponding to the position of the relieved portion 176. The thickened portion 182 has a configuration substantially matching that of the relieved portion 176. In this way, the thickened portion 182 cooperates with the channel 178 in controlling the rate at which fluid flows through the channel between the inlet line 172 and the outlet line 174.
In the embodiment shown in FIGS. 15 and 16, an inlet line 190 is provided at the periphery of a button 192 and an outlet line 194 is extended through the button. A plurality of channels 195 may be disposed in the button 192 in a configuration corresponding to the radial spokes of a wheel so as to communicate with the outlet line 194 at their inner end. A diaphragm 196 may be provided with a thickened portion 198 at positions adjacent the button 192.
In all of the embodiments described above, one or more channels have been provided in a button. It will be appreciated, however, that the channel may be provided in the diaphragm or in the rod without departing from the scope of the invention. For example, in the embodiment shown in FIG. 10, a button 210 may be provided without any channel and a channel 212 may be provided in a diaphragm 214 at a position adjacent the button. Furthermore, FIGS. 17 and 18 illustrate an embodiment in which a channel 220 is provided in a rod 222 at a position adjacent that in which a diaphragm 224 cooperates with a button 226.
The apparatus 14 may also be included in a cassette which is generally indicated at 70 in FIG. 6 and which is disclosed and claimed in application Ser. No. 913,282. As disclosed in such application, the cassette 70 may be included in a system, such as that shown in FIG. 1, for controlling the rate of flow of intravenous fluid to a patient on a gravitational basis. When the apparatus 14 is included in the cassette 70, it may be permanently disposed in the cassette rather than being removable as in the embodiment described above. However, even when the apparatus 14 is included in the cassette, it has the flexibility of being manually adjustable to control the rate of flow of intravenous fluid to a patient or of being controlled by the system in accordance with adjustments in the setting 58 shown in FIG. 5.
When the apparatus 14 is included in the cassette 70, it may be disposed at any convenient position in the hydraulic circuit provided by the cassette. This hydraulic circuit is shown on a schematic basis in FIG. 6. For example, the apparatus 14 may be disposed at a position 71 designated as "X" in an output line 72 in the cassette. The position "X" is provided in the output line 72 at a position effluent any branching of the fluid into auxiliary lines in the cassette. In this way, all of the fluid flowing through the cassette passes through the apparatus 14.
The hydraulic circuit shown in FIG. 6 includes a pair of auxiliary lines 74 and 76 extending from the input line 70 to opposite ends of a chamber generally indicated at 78. Valves 80 and 82 are respectively disposed in the auxiliary lines 74 and 76. A resilient member such as a diaphragm 84 is disposed in the chamber 78 to divide the chamber into a pair of compartments 86 and 88. Auxiliary lines 90 and 92 respectively extend from the compartments 86 and 88 to an output line 94. Valves 96 and 98 are respectively disposed in the auxiliary lines 90 and 92. The apparatus 14 is preferably disposed in the output line 94 as illustrated in FIG. 6.
The diaphragm 84 is constrainable, such as by compression, in the chamber 78 to increase the volume of one of the compartments and correspondingly reduce the volume of the other compartment. A transducer generally indicated at 100 is movable with the movement of the diaphragm to indicate the disposition of the diaphragm at each instant. The transducer 100 produces at each instant a signal which controls the direction in which fluid flows into and out of the chamber. For example, the valves 80 and 98 may be initially open and the valves 82 and 96 may be initially closed. In this relationship, fluid flows into the compartment 86 and out of the compartment 88 and accordingly constrains, such as by compression, the diaphragm 84 into the compartment 88. When the diaphragm has been constrained to a particular limit, the transducer 100 produces a signal which causes the valves 80 and 98 to close and the valves 82 and 96 to open. In this relationship, fluid flows into the compartment 88 and out of the compartment 86 and accordingly causes the transducer 100 to stretch into the compartment 86.
In this way, fluid flows at alternate times into the compartment 86 and out of the compartment 88 and at the other times into the compartment 88 and out of the compartment 86. The rate of fluid flow into and out of the compartments 86 and 88 is dependent upon the setting of the knob 40 in the apparatus 14. The setting of the knob 40 may be manually adjusted or the knob 40 may be automatically set by the system of FIGS. 1 and 5 in accordance with values inserted into the settings 58.
The apparatus and system described above has certain important advantages. It provides for the introduction of fluid on a gravitational basis to a patient at preset rates even when the patient is being moved from an operating room to a recovery room or from a recovery room to an assigned room. This rate of fluid flow may be manually preset to any desired value.
The apparatus and the system including the apparatus also provide for the flow of intravenous fluid on a gravitational basis to a patient at precisely controlled rates when the patient has been moved to his assigned room. Such precisely controlled rates may be inserted by a physician or nurse into the system by the operation of the setting 58. The system then operates in a closed-loop servo to insure at each instant that the rate of fluid flow to the patient is precisely regulated at the desired rate inserted by the physician or nurse.
The apparatus and system are also advantageous because they can be easily converted between manual control of the rate of fluid flow or system control of the rate of fluid flow. The apparatus and system are further advantageous because the apparatus 14 is relatively small and light and can be easily moved with the patient as the patient is transported from the operating room to the recovery room or from the recovery room to the assigned room.
Although this application has been disclosed and illustrated with reference to particular applications, the principles involved are susceptible of numerous other applications which will be apparent to persons skilled in the art. The invention is, therefore, to be limited only as indicated by the scope of the appended claims.