This invention relates to apparatus for controlling the pressure at which fluid is pumped from a source to a receiver such as a patient. More particularly, the invention relates to apparatus for limiting within safe limits the pressure at which fluid, such as intravenous fluid, if transferred from a source to a receiver such as a patient.
As medical technology becomes advanced, it becomes increasingly apparent that the care of patients after surgery or in advanced stages of illnesses is quite sensitive and requires the imposition of different parameters for each individual patient. For example, after surgery, each individual patient requires the introduction of different amounts of fluid at preselected rates in accordance with a number of parameters unique to each patient. These parameters include the sex, age, weight and physical condition of the patient. Furthermore, such parameters as the age and physical condition of the patient affect the maximum fluid pressure to which the patient can be safely subjected.
While the patient is quite ill, the fluid is introduced intravenously to the patient. In one mode, a pump is provided to introduce the intravenous fluid at positive pressures from the source to the patient. The use of a pump offers advantages because the pump provides a pressure which assures that the fluid will be introduced intraveneously to the patient. However, it is often difficult to control the pressures of the fluid in the pump so that the pressures are maintained within safe limits. This is particularly true when fluid is introduced intravenously to infants or to persons of advanced age. When the fluid introduced intravenously to infants and to persons of advanced age becomes excessive, the delicate condition of the veins in such patients may prevent the veins of such patient from withstanding such excessive pressures so that the veins may become ruptured. This may be sometimes quite injurious and may be even fatal.
A considerable effort has been made to include in the pumps apparatus for limiting the pressures of the fluid from the pumps to safe limits. In spite of the considerable effort which has been provided for a number of decades to accomplish this, such efforts have not been successful. As on this date, fluid is often pumped intravenously from a source to a patient without sufficient controls to assure that the fluid introduced to the patient will be within safe limits.
This invention provides apparatus which overcomes the above difficulties. The apparatus of this invention is adapted to be used with any pump for controlling, within safe limits, the pressure of fluid, such as intravenous fluid, introduced from a source to a receiver such as a patient. When the pressure of the fluid from the pump exceeds such safe limits, the apparatus of this invention detects such excessive pressure of the fluid and is instrumental in obtaining a discontinuance of the operation of the pump. The apparatus of this invention can be adjusted to any desired pressure limit so that the pressure limit of the fluid introduced to the patient can be varied in accordance with such parameters as the age, sex and physical condition of the patient. The apparatus of this invention is also advantageous because it can be removably coupled to the pump to maintain the operation of the pump within safe pressure limits.
When the apparatus of this invention is coupled to the pump, a knob on the face of the pump may be adjusted to control the pressure limits established by the apparatus of this invention. However, when the apparatus of this invention is not coupled to the pump, the pump operates in its normal fashion to provide an introduction of the fluid to the receiver such as the patient at pressures which are dependent upon the operation of the pump and which sometimes may vary from the pressures expected from the pump.
The apparatus of this invention includes a disposable unit having an inlet for receiving fluid from a source, an outlet for transferring the fluid to a receiver such as the patient and a chamber communicating between the inlet and the outlet. A diaphragm across the chamber is constrained in accordance with the fluid in the chamber. The diaphragm transmits the constraint to a stiffener.
The disposable unit is removably attached to the pump casing. A knob is externally disposed on the pump casing and is adjustable to control the maximum pressure of the fluid in the disposable unit. The knob controls the force exerted on biasing means in a first direction. A force is also exerted against the biasing means in a second direction opposite to the first direction. This force is exerted by the fluid in the chamber and is dependent upon the force exerted on the stiffener by the fluid in the chamber.
The biasing means may include a spring. The force on the biasing means in the first direction is provided by a backup member which is pivotable at one end and is disposed against the spring at an intermediate position and is provided with an adjustable lever arm dependent upon the adjustment of the knob. The force in the opposite direction is transmitted by the stiffener to a diaphragm in the pump casing. This diaphragm in turn transmits the force to a vane which is pivotable at one end and is disposed against the spring at an intermediate position. Sensor means are coupled to the vane to provide an output indication after the vane has overcome the bias provided on the spring in the first direction. When the sensor means provides an output indication, the operation of the pump may be discontinued because the pressure of the fluid introduced intravenously to the patient exceeds a particular maximum limit.
The apparatus of this invention may be used with a pump disclosed and claimed in U.S. Pat. No. 3,985,133 issued on Oct. 12, 1976, for an "IV Pump" and assigned of record to the assignee of record of this application. One of the features of the pump of U.S. Pat. No. 3,985,133 is that a disposable cassette is removably coupled to the pump and is operative to provide a transfer of fluid from a source to a patient. The pump and the cassette are operably associated so that the fluid flows only through the cassette and not through the pump.
The apparatus of this invention is adapted to be removably coupled to the pump so that the fluid flows through the cassette and through the disposable unit of this invention from the source to the patient without flowing through the pump. In this way, the cassette disclosed in patient 3,985,133 and the disposable unit of this invention can be coupled to the pump for a particular patient and can be easily removed from the pump after the introduction of fluid to the patient. The pump can then be used for another patient without any requirement of sterilizing the pump. This can be accomplished by coupling another unit of the cassette and another unit of the disposable unit of this invention to the pump.
In the Drawings
FIG. 1 is a schematic perspective view of a pump, a disposable cassette removably coupled to the pump and a disposable unit removably coupled to the pump for maintaining the flow of fluid from a source to a receiver such as a patient within adjustable limits of pressure;
FIG. 2 is an enlarged sectional view of the pump and the disposable unit removably coupled to the pump for maintaining within adjustable limits the pressure of the fluid flowing through the disposable unit from the source to the patient;
FIG. 3 is an enlarged fragmentary top plan view of the pump and the disposable unit shown in FIG. 2;
FIG. 4 is an enlarged fragmentary bottom plan view of the pump and the disposable unit shown in FIG. 2;
FIG. 5 is a sectional view of the pump and the disposable unit and is taken substantially on the line 5--5 of FIG. 2;
FIG. 6 is a perspective view of the apparatus constituting this invention and illustrates the apparatus from a position above the apparatus; and
FIG. 7 is a sectional view of the pump and the disposable unit with the disposable unit separated from the pump but positioned to be coupled to the pump.
The apparatus of this invention is adapted to be operated with any pump for maintaining within adjustable limits the pressure of the fluid passing through the pump. However, for the purposes of explanation, the apparatus of this invention is described as being operated with a pump generally indicated at 10 in FIG. 1. This pump may be constructed in a manner similar to that disclosed and claimed in U.S. Pat. No. 3,985,133 assigned of record to the assignee of record of this application.
The pump 10 is adapted to be operated in conjunction with a cassette, generally indicated at 12, removably coupled to the pump. The cassette is provided with an input line 14 extending from a source 16 and with an output line 18 extending to a patient. The cassette 12 is also disclosed and claimed in U.S. Pat. No. 3,985,133.
A disposable unit is included in this invention and is generally indicated at 20. The disposable unit 20 is adapted to be removably disposed in a socket 22 in the front panel 23 of the pump 10. The disposable unit 20 is provided with an input line 24 which actually may constitute an extension of the output line 18 from the cassette. The disposable unit 20 is also provided with an output line 26 which extends to the patient. When the disposable unit 20 is properly inserted into the socket 22, fluid flows from the source 16 through the line 14, the cassette 12, the line 18, the disposable unit 20 and the output line 26 to the patient.
When the pressure of the fluid reaches a particular limit dependent upon the positioning of an adjustable knob 30 on the face of the pump 10, an output indication is provided in the pump. This output indication may be instrumental in discontinuing the operation of the pump to prevent the patient from being injured by excessive pressures of the fluid being introduced to the patient.
The disposable unit of this invention includes a housing 31 made from a suitable material such as a plastic. The housing 31 is in the form of a hollow button defining an inlet 32 for receiving the line 24 and an output 34 for receiving the line 26. A chamber 36 communicates with the lines 24 and 26.
The chamber 36 is closed at one end by a diaphragm 38 made from a resilient material such as rubber. The diaphragm 38 is provided at each end with rounded eyes 40 which are disposed in sockets in the housing 30 to retain the ends of the diaphragm in a fixed relationship with the housing. The diaphragm 38 is provided with a reinforcement 42 at an intermediate position between the eyes 40. The reinforcement 42 is disposed in an opening 44 in the housing.
The opening 44 communicates with a narrowed passage 46 which extends through the housing 31. A stiffener 48 is provided with a flat portion 50 which is disposed in flush relationship with the diaphragm 38 in the opening 44 in the housing. A tubular portion 52 extends through the passage 46 in integral relationship with the flat portion 50.
The housing 31 is provided with a detent portion such as a shoulder portion 56. When the housing 31 is inserted into the socket 22 in the front panel 23 of the pump 10, it engages detent members 62 defined by leaf springs. These detent members 62 are attached to the front panel 23 of the pump 10. Since the detent members 62 constitute leaf springs, the housing 31 can be easily inserted into the socket 22 in coupled relationship with the detent members 62 or the housing 31 can be easily removed from the socket.
When the housing 31 is inserted into the socket 22 in coupled relationship with the detent members 62, the stiffener 48 engages a diaphragm 64 made from a suitable material such as rubber. The diaphragm 64 is retained within the pump by the disposition of rounded eyes 66 in appropriate sockets in the pump. The diaphragm 64 is provided with a reinforcing portion 68 at an intermediate position between the rounded eyes 66.
The reinforcing portion 68 is disposed in coupled relationship with a hollow barrel portion 70 of a vane 72. The hollow barrel portion 70 of the vane 72 extends through an opening 74 in a support member 76 which is attached to the casing 23 and which defines at least a portion of the support for the diaphragm 64. The vane has protrusions 78 which rest on the support member 76 and which define fulcrums for the pivotal movement of the vane relative to the support member. The vane 72 has a projection 80 at the end opposite the protrusions 78.
A backup member 82 is disposed in spaced relationship to the vane 72 by screws 84 which extend through the member 82 to the support member 76. Springs 86 are disposed around the screws 84 to maintain the back-up member 82 in proper relationship to the support member 76. A spring 88 is also disposed between the vane 72 and the back-up member 82 at an intermediate position along the vane and the back-up member to provide a biasing force against the vane.
A cam 90 is shaped to define a tooth 92 which is disposed against the back-up member 82 at one end of the back-up member. The cam 90 is mounted on a shaft 94 for rotation with the shaft. The shaft 94 is in turn mounted on the housing 60 for rotation relative to the housing. The knob 30 is disposed on the shaft 94 and is manually operable to rotate the shaft 94 and the cam 90. The knob 30 is provided with a pointer 98 to provide for a visual indication of the setting of the knob relative to indications 100 on the face of the pump 10. The indications 100 represent different limits of pressure which can be applied to the fluid passing through the chamber 36 from the source 16 to the patient.
A pair of spaced extensions 102 are provided on the back-up member and are disposed in a direction facing the projection 80 in the vane 72. The extensions 102 are spaced to receive the projection 80 between them. A source of energy such as a light source 104 is disposed on one of the extensions 102, and a sensor such as a photocell 106 is disposed on the other extension. The sensor 106 is connected in an electrical circuit 108 to control the operation of the pump 10. For example, during the time that the sensor 106 is energized, the switch 108 is closed to obtain the operation of the pump 10.
When the knob 30 is rotated, it controls the positioning against the back-up member of the tooth 92 on the cam 90. For example, as the cam 90 is rotated in one direction, the tooth 92 is positioned at progressive positions toward the spring 88. This causes the pivotable arm between the spring 88 and the fulcrum represented by the position of contact of the tooth on the back-up member 82 to become shortened. This reduction in the length of the lever arm causes the force applied by the spring 88 against the vane 72 to become reduced.
In like manner, rotation of the knob 30 in the opposite direction causes the positioning of the tooth 92 to become rotated in a direction to displace the tooth away from the spring 88. This causes the distance of the lever arm between the spring 88 and the tooth 92 to become increased so that the force exerted by the spring on the vane 72 becomes increased.
The pressure of the fluid flowing through the line 24, the inlet 32, the chamber 36, the outlet 34 and the line 26 controls the force exerted on the vane 72 in a direction opposite to the direction of the force exerted on the vane by the spring 88. The pressure of such fluid is transmitted as a force to the diaphragm 38, which in turn applies such force against the diaphragm 64 by transmittal through the stiffener 48. The diaphragm 64 in turn applies such force against the vane 72.
As the pressure of the fluid in the chamber 36 progressively increases, the force applied by the diaphragm 64 against the vane 72 increases in a like manner. At a particular pressure of the fluid in the chamber 36, the force applied against the vane 72 by the diaphragm 64 will become greater than the force applied in an opposite direction against the vane 72 by the spring 88. This particular pressure is dependent upon the setting of the knob 30.
When the force applied against the vane 72 by the diaphragm 64 exceeds the force applied against the vane by the spring 88, the vane 72 is pivoted upwardly in FIG. 2 about the protruberances 78 as fulcrums. This causes the projection 80 to move into the space between the extensions 102. The pivotal movement of the vane 72 is represented by the broken lines shown in FIG. 2.
Upon a movement of the projection 80 into the space between the projections 102 for a sufficient distance to block the passage of light from the light source 104 to the photocell 106, the signal produced in the photocell is interrupted. This causes the circuit 108 to become opened and the operation of the pump 10 to become discontinued. The passage of fluid from the source 16 to the patient accordingly becomes interrupted when the pressure of the fluid in the chamber 36 exceeds a particular limit dependent upon the adjustable setting of the knob 30.
The apparatus constituting this invention has certain important advantages. It operates in conjunction with a pump such as the pump 10 to control within particular limits the pressure of the fluid introduced by the pump from a source to a receiver such as a patient. The apparatus is particularly advantageous when it is used with a pump for limiting the maximum pressure of the fluid applied by the pump from the source to the patient.
The apparatus of this invention also has other important advantages. This results from the fact that the apparatus is responsive to the difference between two counterbalancing forces, the first dependent upon the adjustable setting of a knob such as the knob 30 and the second dependent upon the pressure of the fluid introduced to the patient. Because of these two counterbalancing forces, an output indication is not produced until the force resulting from the pressure of the fluid exceeds the oppositely imposed force. However, when the force resulting from the pressure of the fluid exceeds the oppositely imposed force, the apparatus of this invention operates in a positive and reliable manner to indicate that the pressure limits in the fluid introduced to the patient have been exceeded.
Until the force imposed upon the vane 72 by the diaphragm 64 exceeds the force imposed upon the vane by the spring 88, there is no significant change in the positioning of any member including the diaphragms 38 and 64. This results from the fact that the vane 64 remains fixed in position until the force imposed upon the vane 72 from the diaphragm 38 exceeds the force imposed upon the vane by the spring 88. Since the diaphragm 38 remains in fixed position until an excessive pressure of the fluid in the chamber is produced, no variables are introduced which will alter the pressure of the fluid in the chamber. In this way, no variables affecting the output indication are provided until the apparatus of this invention is determining whether the pressure of the fluid in the chamber has reached a particular limit.
There are also other important advantages to the apparatus of this invention. For example, the apparatus of this invention includes a disposable unit which passes fluid to the receiver such as the patient without any passage of the fluid through the pump. Since the pump does not receive the fluid, it can be operated for successive patients without any necessity that the pump be sterilized after each such use. Furthermore, the disposable unit is relatively simple in construction and is also relatively inexpensive so that it can be discarded after the operation of the pump with a particular patient has been completed. Even though the disposable unit is discarded after each such use, the cost to the patient is minimized because the pump does not have to be sterilized after each such use.
The apparatus of this invention also offers other advantages of some importance. For example, the disposable unit is easily inserted into a socket in the pump to operate in conjunction with the pump in providing a control over the maximum pressure of the fluid introduced to the patient. The disposable unit is also easily removed from the pump after each such use.
Even when the disposable unit is not disposed in the socket 22 in the pump 10, the pump operates efficiently to introduce fluid from a source to a patient. Upon the insertion of the disposable unit into the socket 22 in the pump 10, the disposable unit becomes coupled on a positive basis to the pump and co-operates with the pump in controlling the pressure of the fluid flowing from the source to the patient.
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.