CA1235033A

CA1235033A - Dual mode i.v. infusion device

Info

Publication number: CA1235033A
Application number: CA000516747A
Authority: CA
Inventors: Raymond E. Cannon; Ted C. Bloomquist
Original assignee: Raymond E. Cannon; Ted C. Bloomquist; Fisher Scientific Group Inc.; Ivac Holdings, Inc.; Alaris Medical Systems, Inc.; Imed Corporation; Cardinal Health 303, Inc.
Current assignee: CareFusion 303 Inc
Priority date: 1985-11-26
Filing date: 1986-08-25
Publication date: 1988-04-12
Also published as: JPS62176457A; JPS62127058A; AU580184B2; JPH0528152B2; AU6154686A; US4617014A; JPH0442943B2

Abstract

DUAL MODE I.V. INFUSION DEVICE
ABSTRACT OF THE INVENTION

A dual mode peristaltic device is provided for infusing I.V. solutions to a patient through an I.V. tube. In a first mode of operation, the device functions as a peristaltic pump and in the second mode of operation it functions like a controller.
Included in the device and associated with the I.V. tube is a pressure sensing strain gauge assembly that monitors dimensional changes in the outer diameter of the I.V. tube as an indication of fluid pressure changes in the tube. The strain gauge assembly is positioned relative to the device's peristaltic means to alternately monitor fluid pressure in a patent I.V. tube upstream and downstream from the gauge assembly. In the first mode (pump mode), the device is programmed to alarm and cease operation when fluid pressure downstream from the gauge assembly reaches a pre-selected value. In the second mode (controller mode), the device is programmed to alarm and cease operation when there is no dif-ferential between fluid pressure upstream and downstream from the gauge assembly.

Description

1 DUAL MODE IVY. INFUSION DEVICE

2 BACKGROUND OF THE INVENTION

4 This invention relates generally to a device used for the infusion of medical solutions to a patient. More specific gaily, the present invention relates to a dual mode device which 7 can alternately function either as an infusion pump or as a con-8 troller. This invention is particularly, though not exclusively, (I useful for the intranveous infusion of medical solutions to a patient under conditions where the flexibility of a dual mode 11 capability is desired.

DESCRIPTION OF THE PRIOR ART

16 Many medical devices have been proposed to infuse medic 17 eel solutions to a patient. Indeed, in recent years the use of 18 such devices has gained wide acceptance. Consequently, a variety 19 of medical solution infusion devices have been suggested for use in numerous medical and surgical applications. Typically, these 21 devices can be grouped into either of two categories. The first I group it generically referred to a controllers and the second 23 group is referred to as pumps. Examples of medical devices in I each category are so numerous it is not deemed instructive to list them here.
I
27 It is instructive, however, to understand the basic 28 difference between a pump and a controller. Fundamentally, 23 controllers are medical devices which connect with a gravity feed IVY. administration line for the purpose of controlling the rate 1 of fluid flow through the line. In IVY. administration systems 2 where controllers are used, the fluid pressure for delivering

3 fluid to the patient is dependent solely on the system head

4 height. In other words, fluid pressure in the system depends on

5 the bottle height of the fluid source above the patient. In such G a system, the function of the controller is to constrict the 7 tubing of the administration set to regulate the rate of fluid 8 slow through the tubing. The controller does not contribute to the fluid pressure.

11 Several advantages are obtained by using controllers.

12 Firstly, as mentioned above, they provide a means for controlling 13 the rate of fluid flow through a gravity system. Secondly, con-14 trollers are generally perceived by hospital personnel as being safe since they operate at low fluid pressures and thus are not 16 apt to cause tissue damage to the patient at the injection site.

17 Further, they are easily understood and rather simple to use. An 18 example of a controller which is widely used throughout the 19 medical profession at the present time is disclosed in U.S.

Patent No. 4,300,552 to Cannon which is assigned to the same 21 assignee as the present invention.

I

I Unlike controllers, medical devices in the second I group, i.e. pumps, provide a mechanical action on fluid within I the system to establish an artificial fluid pressure for the 2G system. The medical devices properly grouped into this category 27 are of several types and include, but are not necessarily limited 28 to, cassette-type pumps, syringe pumps, diaphragm pumps and 29 peristaltic pumps. As should be expected, the use of pumps for 3Q the infusion of medical solutions provides certain advantages Al I

1 which are not attainable by a controller. Importantly these 2 advantages may be very necessary in a particular medical applique-3 lion. For example, an Ivy pump is better suited than is a con-troller to (a) overcome resistance to fluid flow caused by small gauge catheters and small gauge IVY. tubing; (b) infuse the

6 more viscous fluids; (c) overcome in viva resistance; (d) achieve

7 higher fluid flow rates; and (e) provide perceptively a higher

8 degree of volumetric accuracy. These advantages are due, in Jo large part, to the fact that pumps exert a mechanical pressure on the fluid prior to the infusion of the fluid into the patient 11 whereas controllers depend on gravity to move fluid through the 12 system. An example of an IVY. pump is disclosed in U.S. Patent 13 No. 3,985,133 to Jenkins which is assigned to the same assignee 14 as the preset invention.

16 Regardless of the type of IVY. infusion system used, it 17 is widely recognized that the ability to monitor fluid pressure 18 in the fluid line is a distinct advantage for the safe operation 19 of any IVY. administration system. Specifically, but regardless whether it be a pump or a controller, where electromechanical 21 medical devices are employed and fluid pressure within the line I can be determined, the medical device can be programmed to react 23 to changes in the fluid pressure. For example, in a pumping I system, if the detected fluid pressure of the line rises above Rome predetermined level, an occlusion in the system may be 2G indicated and it would be advantageous to have the medical device 27 cease operation. Likewise, with a controller, if the detected 28 fluid pressure rises above a predetermined level, an occlusion 29 may be indicated and the infusion should be stopped.

~35~33 1 The importance of knowing the fluid pressure in an IVY.
2 administration system is underscored by the fact that several 3 proposals have been made for devices which monitor physical 4 characteristics of the fluid flow line and correlate changes in these characteristics to changes in fluid pressure. In one such G system, as disclosed in U.S. Patent No 4,526,574 to Pekkarinen, 7 a differential occlusion sensing apparatus is disclosed which monitors the location of a portion of the IVY. tube and trays-(J fates variations of the location measurement from a base location I into a fluid pressure indication. In another system, as disk 11 closed in U.S. Patent No. RYE 31,315 to Jenkins et at . and assignee 12 to same assignee as for the present invention, the fluctuations 13 of a diaphragm in fluid communication with the fluid flow are 14 monitored as being indicative of the fluid pressure level.

16 It will be appreciated that in a hospital environment, 17 circumstances can dictate whether there is a need for a pump or a 18 controller. Presently, depending on the situation, hospital per-19 sonnet must obtain a pump for situations wherein a pump is required and obtain a controller for those situations requiring a 21 controller. Not only does this require the availability of two 22 separate medical devices, it also requires knowledge and skills 23 for their separate set up and operation. Until the present I invention, there has been no single unitary medical device or) capable of obtaining the desired advantage of either a pump or a 2G controller.

28 In light of the above, the present invention recognizes 2~J the separate and distinct advantages obtainable by using pumps or controllers and the benefits to be derived in IVY. administration ~.~3~3 septum which have fluid pressure monitoring capabili~ias.
Specifically, the present invention recognize the desirability of ob~aininy the combined advantages of a pump and a controller from a jingle universal device which, depending on the desires of the operator, can function either as an IVY. pump or like a controller and which thereby obtain the desired advantage of the particular mode owe operation. In accordance with the resent invention, they'll dual mode capability it made possible by providing the system with a fluid pressure Sonora which permit modal operation in compliance with detectable pressure limitation Also, with electronic controls to cease operation of the system whenever elevated fluid pressure indicate an occlusion, the dual mode medical device of the present invention can be sanely operated regardless of its selected mode of operation. Specifically, where a peristaltic pump it used, hi invention eecognlze~ that the necessary fluid pressure information for a dual mode device can be obtained by alternately monitoring fluid rouser in the patent IVY. tube upstream and downstream from the moving zone of occlusion.
Accordingly, the present invention provides a single medical device which can be witched to function either as a peristaltic pump or like a controller. The prevent invention can Allah provide a dual mode device which is directly operable on an IVY. tube for the infusion of medical solution to a patient and it thus non-invasive of the fluid line. The present invention alto can provide a cot effective, relatively accurate and easy to use medical device or the infusion of medical solutions to a patient.

1 SUMMERY OF TH~_INVENTION

3 The preferred embodiment of the present invention come 4 proses a medical device for infusing IVY. fluids to a patient through an IVY. tube in which the device is operatively engageabl~
with a portion of the IVY. tube. Upon engagement of the device 7 with the IVY. tube, a peristaltic means in the device is post-toned against a portion of the IVY. tube to sequentially squeeze the IVY. tube and produce a moving zone of occlusion along the tube for pumping fluid there through in accordance with the ports-11 tactic action. The device further includes a strain gauge 12 assembly which is positioned against the Ivy tube and operatic 13 very associated with the peristaltic pumping means so as to be 14 able to monitor fluid pressure downstream and upstream of the occlusion respectively before and after the occlusion has passed 16 the point at which the gauge assembly is operatively associated 17 with the IVY. tube. The present invention further includes means 18 to switch the device between one mode of operation wherein the 19 strain gauge assembly monitors only the fluid pressure downstream from the strain gauge assembly (the pumping mode) and another 21 mode wherein the strain gauge assembly it able to alternately I monitor the fluid pressure in the IVY. line upstream and down-I stream from the occlusion (the controller mode).
I
In the first or pumping mode, the device of the present 2G invention it provided with microprocessor programmed means to I alarm and cease operation of the pump whenever the strain gauge 28 assembly indicates that fluid pressure downstream from the occlu-I soon has reached a preselected value. In the controller mode of operation, the device is microprocessor programmed to alarm I
I

1 and/or cease operation when the differential between fluid 2 pressure downstream from the peristaltic occlusion and the fluid 3 pressure upstream from the peristaltic occlusion is a null.

The novel features of this invention, as well as the invention itself, will be best understood from the accompanying 7 drawings, taken together with the accompanying description, in 8 which similar reference characters refer to similar parts and in

9 which:

14 Fig. l shows the device in its environment for infusing medical solutions from a fluid source to a patient;

17 Fig. 2 is a cross-sectional view of the peristaltic 18 assembly as seen along the line 2~2 in Fig. l and rotated into 19 the position as shown for clarity;

21 Fig. 3 is a portion of the peristaltic assembly as 22 shown in Fig. 2 with the peristaltic action taking place at a 23 different location;
I
Fig. 4 is a cross-sectional view of a portion of the 2G peristaltic assembly as seen along the line 4-4 in Fig. 2;
~27 I Fig. 5 is a cross-sectional view of a portion of the I peristaltic assembly as seen along the line 5-5 in Fig. 2;

~235~33 1 Fig. 6 is a cross-sectional view of the strain gauge 2 assembly of the peristaltic assembly as seen along the line 6-6 3 in Fig. 2;

Fig. 7 is a graph showing periodic variation in fluid pressure as a function of the peristaltic action of the device;

8 Fig. 8 is a cross-sectional view of a portion of a peristaltic assembly of an alternate embodiment of the present invention; and 12 Fig. 9 is a block diagram of the electronic components 13 of the present invention.

18 Referring initially to Fig. l, a contxoller/pump 19 generally designated lo is shown in its intended environment.
The contxoller/pump lo is mounted on IVY. pole 12 in a manner 21 well known in the art. An IVY. fluid source 14 is hung from the 22 IVY. pole 12 as shown in Fig. 1, and an IVY. tube 16 is connected 23 in fluid communication with fluid source lo and operatively con-2~1 netted with controller/pump lo in a manner as generally shown in Fig. l. Downstream from its point of engagement with controller/
I pump lo, IVY. tube 16 is coupled with patient 20 for the infusion 27 of medical solutions to the patient 20.

29 Fig. 2 is a cross-sectional view of the peristaltic assembly, generally designated 22, which is shown here in icily-31 lion from controller/pump lo for purposes of clarity. As shown I

1 in Fig. 2, peristaltic assembly 22 includes a motor 24 which is 2 preferably a stepper motor but may be of any type well known in 3 the relevant art. A drive shaft 26 is rotated by the stepper 4 motor 24 and is secured to an attachment 28 by any means well known in the art in a manner which permits the rotation of attachment 28 to move a drive pulley 30. Drive pulley 30 is con-7 netted in operative engagement with an attachment 32 that is in 8 turn secured to cam shaft 34 by any means well known in the art.
(~) The cam shaft 34 is supported on peristaltic assembly 22 by a bushing 36 and a bushing 38. Fixed on cam shaft 34 at predator-11 mined locations along the axis of the cam shaft 34 is a series of 12 cam lobes 40. As will be appreciated by those skilled in the 13 pertinent art, cam lobes 40 are eccentrically mounted on cam 14 shaft 34 in a helical pattern along the axis of cam shaft 34 in a manner which will create a peristaltic action by the movement of 16 thy fingers 42. The movement of the individual fingers 42 will 17 be best appreciated by reference to Fig 4.

19 Referring to Fig. 4, it is seen that each of the India visual fingers 42 are formed with a aperture 58 to receive an 21 individual cam lobe 40 therein. Each finger 42 it mounted in 22 housing 48 of the peristaltic assembly 22 in a manner which pro-.3 vises for movement of the finger 42 in a direction substantially I perpendicular to the longitudinal axis of cam shaft 34. It will or) be appreciated with reference to Fig. 4 that the housing 48 come 2G proses a side aye and a side 50b which are formed with baffles 27 aye and 52b to create groves aye and 54b that maintain the align-28 mint of finger 42 relative to cam shaft 34. A cross-reference of 29 Fig. 4 with Fig. 5 shows that the rotation of cam shaft 34 causes a consequent rotation of the eccentrically mounted cam lobe 40 Lowe 1 which, in turn, urges against respective portions of the aperture 2 58 to cause a reciprocal vertical motion of finger 42 within the 3 housing 48. Referring back to Fig. 2 or Fig. 3, it can be apple-4 elated by the skilled artisan that cam lobes 40 can be sequent tidally located along cam shaft 34 in a helical manner. With cam 6 lobes 40 so located, rotation of cam shaft 14 causes fingers 42 7 to move in a direction substantially perpendicular to the axis of 8 cam shaft 34 and in a manner which will provide a peristaltic 9 action by the concerted movement of the various fingers 42.

11 Again referring to Fig. 2, it will be seen that the 12 IVY. tube 16 can be placed in operative contact with the ports-13 tactic assembly 22 by location of the respective figments 50 and 14 62 into the base 84 of peristaltic assembly 22. As shown in Fig.
2, a pumping section 18 of Ivy tube 16 can be defined between 16 figments 60 and 62. This particular pumping section 18 may be 17 made of the same material as IVY. tube 16. However, in the pro-18 furred embodiment, the pumping section 18 comprises a very flex-19 isle and compressible elastomeric material. Such elastomers may be a silicone rubber of the type identified as RX 50 and manufac-21 lured by Dow Corning. It will also be appreciated by reference I to Fig. 2 or Fly. 3 that once IVY. tube 16 and its associated I pumping section 18 have been mounted on peristaltic assembly 22, I a door 82 can be closed to provide a platen 46 that is positioned I against pumping section 18, as shown, and which provides nests-2G lance against the motion of the fingers 42 as they urge on 27 pumping section 18. Also shown in Fig. 2 and Fig. 3, a membrane 28 56 is located between the ends 94 of fingers 42 and pumping sea-29 lion 18 to separate fingers 42 from pumping section 18 and pro-vise for the isolation of IVY. tube 16 and pumping section 18 *rum - 10 -1;~35033 1 from the peristaltic assembly 22. Again, it will be appreciated 2 by the skilled artisan that depending upon can shaft rotation 3 and the helical orientation of cam lobes 40 along cam shaft 34, a 4 particular finger 42 can be caused to urge against pumping sea-lion 18. Further, it will be appreciated that each complete 6 revolution of cam shaft 34 causes a sequential progression ox the 7 fingers 42 to urge against pumping suction 18 and generate a 8 peristaltic action against pumping section 18. The specific 9 action of fingers 42 on pumping section 18 is best seen by cross-referencing Fig. 4 and Fig. 5. These figures respectively show 11 the action of a finger 42 that causes an occlusion on pumping 12 section 18 and a patently open) condition on pumping section 18. It 13 will be appreciated by thy skilled artisan that a moving zone of 14 occlusion is created as cam shaft 34 is rotated to cause a sequential urging of fingers 42 against pumping section 18.

17 The preferred embodiment of the present invention also 18 includes a gauge assembly 44 which is associated with peristaltic 19 assembly 22 and mounted with respect to the fingers 42 of ports-tactic assembly 22 as generally shown in Fig. 2 and Fig. JO A
21 more detailed description of 'eke gauge assembly 44 can be 22 obtained with reference to Fig. 6.
I
I In Fig. 6 the gauge assembly 44 is shown in cross-section and is seen to include a mounting block 70 on which is I fixedly mounted a cantilevered strain beam 68. On the surface ox 27 cantilevered strain beam 68, jut not shown in Fig. 6, is a strain 28 gauge. The entire assembly which comprises block 70, strain beam 29 68 and strain gauge 108 is of a type similar to model no. X1680 I manufactured by Transducers, Inc., 14030 Boise Lane, Sorts, CA
31 90701. Extending from mounting block 70, as shown in Fig. 6, is l 33 ,1 1 a travel limiter 72. Mounted on the opposite side of the keynote 2 levered strain beam 68 opposite from the travel limiter 72 is a 3 protective extension 74. Fixedly attached to cantilevered strain 4 beam 68 at the end opposite from its connection with mounting 5 block 70 is a pressure transmitting member 76 which is positioned 6 to physically connect the end of cantilevered strain beam 68 with 7 pumping section 18 upon engagement of the IVY. tube 16 with the 8 controller/ pump lo Also connected with cantilevered strain 9 beam 68 is an electrical junction block 78 that provides a con-section for the electrical circuitry from the strain gauge (not Al shown). Electrical wiring 8Q provides further connection between 12 the cantilevered strain beam 68 and the electronic components of 13 the present invention for a purpose to be subsequently discussed.

As will be appreciated by reference to Fig. 6, upon 16 engagement of IVY. tube 16 with controller/pump lo a portion of 17 pumping section 18 is positioned between platen 46 of door a and 18 the pressure transmitting member 76 which to directly and physic 19 gaily connected with the cantilevered strain beam 68. As also seen in Fig. 6 and previously discussed, a membrane 56 can be 21 placed between the pressure transmitting member 76 and pumping 22 section 18 for the purposes of isolating the peristaltic mechanist 23 from the functional IVY. administration sex being used in con-I junction with the controller/pump 10 and protecting the interior of controller/pump lo from tampering and contaminants.

27 Referring now to Fig. 9, the electronic componentry of 28 the controller/pump lo is jet forth in block diagram form. As 29 seen in Fig. 9, this componentry includes a microprocessor lo which may be of any type well known in the pertinent art. For .

Lo I

1 example, a microprocessor as manufactured by Intel Corporation, 2 model no. 8032, can be used for the purposes of the present 3 invention. Electrically connected to microprocessor 100 is an 4 EPROM 102 which provides code information for the operation of microprocessor 100. Also electrically connected to microprocessor G loo is a RAM 104 which has the capacity to store and preserve 7 various system parameters during a power off condition. It will 8 be appreciated by the skilled artisan that EPROM 102 and RAM 104 9 are of types well known in the pertinent art. Examples of these components which will satisfy the requirements of the present 11 invention are respectively a model no. D27512 manufactured by 12 Intel and a model no. HM6116 manufactured by Hitachi. Also 13 electrically connected to microprocessor 100 is a watchdog air-14 cult 106 which provides for system integrity More specifically, it watchdog circuitry 106 insures that stepper motor 24 and micro-16 processor 100 are functioning correctly. Additionally, watchdog 17 circuit 106 provides a reset capability for the system and pro-18 vises means for stopping the operation of the system.

Also shown in Fig. 9 is a strain gauge 108. It will be 21 recalled that strain gauge 108 was not shown in the earlier 22 description of gauge assembly 44. As can now be more easily 23 appreciated it is the strain gauge 108 which is electrically I attached to cantilevered strain beam 68. With this attachment the flexors of cantilevered strain beam ye which are caused by 2G the movement of pressure transmitting member 76 in response to 27 variations in the outer diameter of pumping section 18 will be 28 sensed by the strain gauge 108. Electronically, it can be apple-I elated that the analog voltage measurements obtained from strain gauge 108 represent a voltage which requires conversion by an A/D

1 converter 110 before it is electrically compatible with micro 2 processor 100. As shown in Fig. 9, the circuitry r this 3 electrical connection is provided.

Also shown in Fig. 9 is the electrical relationship of the stepper motor 24 with microprocessor 100. As seen in Fig. 9, 7 it is necessary for stepper motor 24 to be directly connected with motor controller 112. A motor sensor 114 (also generally 9 known as a shaft encoder is also directly connected with motor controller 112 and generates electronic signals which correlate 11 the running of motor controller 112 with the position of cam 12 shaft 34 as indicated by cam shaft rotational position a. A
13 keyboard/display 116 is provided to permit operator access to the .
14 electronic componentry of the controller/pump 10. Through keyboard/display 116 an operator is able to key in the various 16 system parameters which are necessary to operate the controller/
17 pump 10. It is through keyboard/display 116 that an operator 18 selects the mode of operation for controller/pump 10 and stab-19 fishes the preselected values for fluid pressure limitations in .

the selected mode of operation. Together with input from 21 keyboard/display 116, microprocessor 100 operates in accordance 22 with code from EPROM 102 and input from RAM 104. One result 23 obtained from this arrangement is that a reading on strain gauge 24 108 can be read by microprocessor 100 in accordance with a preset program.

27 As envisioned in the present invention, motor sensor 2.$ 114 monitors cam shaft position a . Based on cam shaft post-29 lion I, input from motor sensor 114, motor controller 112 pro-vises signals to microprocessor 100 which are compared and timed S~33 1 according to a prepared program. Microprocessor 100 also 2 receives signals from A/D converter 110 which have been generated 3 by strain gauge 108 in response to movements of cantilevered 4 strain beam assembly 68. Recall that readings from strain gauge assembly 54 are correlated to fluid pressure readings in IVY.
tube 16. Microprocessor 100 is preprogrammed to accept fluid 7 pressure reading from strain gauge 108 at selected times which X depend on cam shaft position as indicated by motor sensor 114.
(J Further, microprocessor 100 is preprogrammed to compare the fluid I pressure readings from strain gauge 108 with the modal fluid 11 pressure limitations established by the operator. Stepper motor 12 24 is then run in accordance with programmed signals from 13 microprocessor 100 to operate the structure of controller/pump 10 14 as discussed elsewhere in this disclosure.

16 Further in Fig. 9, it is shown that various peripheral 17 electrical components may be added to -the controller/pump 10 to 18 expand its capabilities. Examples of peripheral equipment that 19 could be included within a system for controller/pump 10 is shown in Fig. 9 and connections between these peripheral componentry 21 and microprocessor 100 is accomplished by way of an I/O expander 22 lob. As seen in Fig. 9, an air-in-line detector (AIL) 120, an 23 empty bottle detector (END) 122 and a door sensor 128 are 24 examples of peripheral equipment which could be incorporated into the controller/pump 10 system. Also shown in Fig. 9 and electric 2G gaily connected to I/O expander 118 is an alarm 124 and a power 27 owe switch 126. In all respects the electronic componentry of 28 the present invention are made from electronic elements which are 29 well known in the pertinent art and are commercially available.
It will be understood and appreciated that the electronic come 31 ponentry system as set forth in Fig 9 is merely illustrative and l 3 1 that its purpose is to provide a background which is electronic 2 gaily compatible with the structural integrity and the cooper-3 lion of structure of the controller/pump lo of the present 4 invention.

Fly. 8 shows an alternate embodiment of the present 7 invention which employs two gauge assemblies as opposed to the 8 single gauge assembly 44 disclosed for the preferred embodiment In the alternate embodiment, a gauge assembly 64 is positioned at the upstream end of the peristaltic fingers 42 and a second gauge 11 assembly 66 is positioned at the downstream end of the ports-12 tactic fingers I In all respects, gauge assemblies 64 and 66 13 are similar in structure to that as disclosed for gauge assembly 14 44 and incorporate all of the elements previously described for gauge assembly 44. It will be understood that electronic come 16 ponentry for the alternate embodiment need not include provision 17 for alternately reading gauge assemblies 64 and 66. Instead, 18 continuous readings may be taken and used in a logic sequence 19 similar to that for the preferred embodiment.

I

23 ..
I In its operation controller/pump lo is placed in opera-live engagement with an IVY. tube 16. This is done by positioning I IVY. tube 16 against base 84 of peristaltic assembly 22 as shown 27 in Fig. I. With tube 16 in this position, the figments 60 and 62 28 are operatively engaged with base 84. As discussed previously, I the portion of IVY. tube 16 that is placed against membrane 56 and in operative engagement with controller/pump lo is preferably 31 a flexible and compressible pumping section 18.

35i~33 1 Once IVY. tube 16 with its pumping section 18 have been 2 engaged with controller/pump 10, the door 82 is closed. The 3 closure of door 82 causes platen 46 to come in contact with 4 pumping section 18 and enclose pumping section 18 between platen 46 and membrane So.

7 activation of stepper motor 24 causes rotation of drive 8 shaft 26 in a manner that causes drive pulley 30 to rotate cam 9 shaft 34. The actual positioning of jam shaft 34 is represented by cam shaft rotation I. As will be appreciated by those skilled 11 in the art, a complete revolution of cam shaft 34 will cause cam 12 lobes 40 to reciprocate lingers 42 substantially perpendicular to 13 the axis of pumping section 18. Due to the helical configuration 14 of cam lobes 40 on cam shaft 34, fingers 42 urge against pumping 16 section 18 to create a moving zone of occlusion along the length 16 of pumping section 18 during each revolution of cam shaft 34.
17 For example, an occlusion, such as the one represented in Fig. 2 18 by the character A, is caused to move along the length of pumping 19 section 18 and create a peristaltic pumping action.

21 Turing operation of the peristaltic assembly 22, it 22 will be appreciated by reference to Fig. 6 that gauge assembly 44 23 can be positioned to determine dimensional differences in the I outer diameter of pumping section 18. As seen in Fig. 6, pumping section 18 is located directly between platen 46 and membrane 56.
2G During the pumping of fluid through pumping section 18, the outer 27 diameter of pumping section 18 will vary, dependent upon the I fluid pressure within pumping section 18. This variation in 29 pressure will cause a consequent variation in the distance between membrane 56 and platen 46 on respectively opposite sides '~35~3~

1 of the center portion of pumping section 18. It will be apple-2 elated by those skillet in the pertinent art that this change in 3 dimension can be correlated to changes in the fluid pressure 4 within the pumping section 18. As will be further appreciated by 5 those skilled in the art, a variation in the outer diameter of G pumping section 18 and the consequent change in distance between 7 membrane 56 and platen 46 will cause a motion of pressure trays-milting member 76 generally in an up and down direction as India acted by the arrow 96. Further, it will be appreciated that the movement of pressure -transmitting member 76 in a direction as 11 indicated by arrow 96 will be manifested as a fluctuation of the 12 cantilevered strain beam 68. With a strain gauge, or strain 13 gauges, (not shown in Fig. 6) mounted on cantilevered strain beam 14 68, the fluctuations of cantilevered strain beam 68 can be electronically measured and transmitted to a microprocessor 100.

17 It should be recognized that the motion of pressure 18 transmitting member 76 in the direction of arrow 96 is limited by I the travel limiter 72~ This is a safety feature for the controller/pump 10 since travel limiter 72 precludes a motion of I pressure transmitting member 76 through a distance that could 22 break or permanently bend the cantilevered strain beam 68u This 23 safety feature is particularly important because it prevents any I inadvertent manipulation of pressure transmitting member 76 that I could damage cantilevered strain beam 68.

27 As previously indicated, controller/pump 10 can be 28 operated in either one of two modes. Operation in the controller I simulation mode requires operation of the componerlts in a manner as now described. It has been recognized that the fluid pressure fly I in IVY. tube 16 will generally vary according to the periodic 2 cycles of graph 86 as presented in Fig. 7. As seen in Fig. 7, 3 the graph 86 depicts variations in fluid pressure P at a set 4 point within IVY tube 16 as a function of cam shaft rotation I.
Stated differently, for successive revolutions of cam shaft 34, the variation in fluid pressure P at a particular point will vary 7 in a manner depicted by the graph 86.

9 Referring back to the structure of controller/pump 10, it is seen that the peristaltic assembly 22 as shown in Fig. 2 11 has been activated to the point where cam shaft rotation 9 causes 12 a peristaltic finger 42 to occlude pumping section lo at location 13 A. It has been determined that during operation when peristaltic 14 assembly 22 is in this configuration, the fluid pressure in the section of pumping section 18 contacting gauge assembly 44 16 corresponds to points 88 on graph 86 in Fig. 7. Further, when 17 peristaltic assembly 22 has moved to cause an occlusion of 18 pumping section 18 at point B, as shown in Fig. I the fluid 19 pressure in the section of pumping section 18 contacting gauge assembly 44 corresponds with the points MU on staph 86 in Fig. 7.
21 The points 92 on graph 86 in Fig. 7 indicate the pressure in the 22 portion of pumping section 18 in contact with gauge assembly 44 23 during the transition of the occlusion from point A, as shown in I Fig. 2, to the point B, us shown in Fig. 3.
en) 2G It will be further appreciated by those skilled in the 27 relevant art that during normal operation of the controller/pump 28 10 in the simulated controller mode, the fluid pressure upstream 29 from the occlusion caused by peristaltic assembly 22 will be dependent upon the height of fluid source 14. The downstream ~23~3~3 1 pressure during such operation, because of the occlusion created 2 on pumping section 18 by peristaltic assembly 22, will be a value 3 less than the upstream fluid pressure. Specifically, an upstream 4 fluid pressure reading can be made by gauge assembly 44 when the occlusion is at point B as shown in Fig. 3, and a downstream 6 fluid pressure reading can be made by gauge assembly 44 when the 7 occlusion is at point A as shown in Fig. 2. Further, it has been 8 found what the differential, indicated by the character 98 on (3 graph 86 in Fig. 7, between the upstream pressure indicated at point 88 and the downstream pressure indicated at point 90 will 11 be relatively constant during normal operation of controller/pump 12 lo Under these conditions, controller/pump lo will be pro-13 trammed to rotate cam shaft 34 at an angular velocity which Wylie provide the fluid flow rate preselected by the operator.

lug Since fluid pressure in a controller is normally stab-17 fished by bottle height ire., the height of the fluid source 14 18 above the patient 20, controller/pump lo needs to be sensitive to 19 this parameter. Accordingly, for normal operation of controller/
pump lo in the simulated controller mode, any decrease in Defoe 21 ferential 98 would indicate that the upstream pressure (indicated 22 by point 88) should also be increased to maintain a differential I gay This can be accomplished very simply by the operator raising fluid source 14 to increase the hydrostatic pressure in IVY. tube 16 upstream frown the occlusion caused by peristaltic assembly 22.
2G It is recognized, however, that there is a limit on the height to 27 which an operator may be willing to raise the fluid source lo.
28 Consequently, when fluid source 14 has been raised as high as the 29 operator feels is safe and the differential 98 continues to dim-nigh or reaches a null, an alarm condition should be dictated.

~23~ 3 1 Accordingly, when switched into the controller mode, controller/
2 pump lo should be programmed through appropriate circuitry shown 3 in Fig. 9 to alarm and cease operation where there is no longer a differential 98.

6 When controller/pump lo is to be used in the pumping 7 mode, the upstream fluid pressure in IVY. tube 16 becomes of much less importance. In this mode of operation, cam shaft 34 is 9 caused to rotate with an angular velocity which will provide a peristaltic action by peristaltic assembly 22 in a manner that 11 provides the desired rate of fluid flow. The crucial consider-12 lion in this mode of operation will be the downstream fluid 13 pressure in IVY. tube 16 which may increase to a level that India 14 gates an occlusion downstream from controller/pump 10. Thus, by having the electronic components of controller/pump lo monitor 16 the downstream pressure in Ivy tube 16, a condition can be 17 detected wherein the downstream pressure exceeds some preselected 18 maximum. Such a preselected maximum can be established that 19 either indicates a possible occlusion or an otherwise harmful condition for the patent 20. Thus, when controller/pump 10 is I operating in the pumping mode, the downstream pressure in IVY.
22 tube 16 is monitored and upon reaching a preselected maximum, 23 electronic circuitry is programmed to alarm controller/pump lo and cease its operation.

I
2G While the particular controller/pump as herein shown 27 and disclosed in detail is fully capable of obtaining the objects 28 and providing the advantages herein before stated, it is to be I understood that it is merely illustrative of the presently pro-furred embodiment of the invention and that no limitations are 31 intended to the details of construction or design herein shown 32 other than as defined in the appended claims.

Claims

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. A device for infusing I.V. medical fluids from a fluid source to a patient through an I.V. tubing having a compressible pumping section, which device comprises:
a case;
means for holding a portion of said compressible pumping section on said case;
peristaltic means mounted on said case and operatively engaged with said tube to sequentially squeeze said pumping sec-tion and produce at least one moving zone of occlusion along said pumping section for infusing fluids to the patient;
a gauge fixedly mounted on said case and operatively coupled with said pumping section, at a predetermined location thereon, for sensing fluid pressure in said pumping section at said location at a first time when said I.V. tube downstream from said location is patent and at a second time when said I.V. tube upstream from said location is patent;
means to determine a pressure differential between said first time and said second time; and means to alarm and cease operation of said device when said pressure differential attains a predetermined value.

2. A device as cited in claim 1 wherein said peris-taltic means is a linear peristaltic pump having an upstream end and a downstream end.

3. A device as cited in claim 2 wherein said pumping section is made of an elastomeric material.

4. A device as cited in claim 3 wherein said gauge is a strain gauge associated with said peristaltic means and posi-tioned to engage said pumping section intermediate said upstream end and said downstream end of said peristaltic means.

5. A device as cited in claim 4 wherein said gauge is positioned substantially equidistant from said upstream end and said downstream end and intermediate therebetween.

6. A device as cited in claim 5 further comprising means to selectively cause said device to alarm and cease opera-tion when the differential attains a predetermined minimum value.

7. A device as cited in claim 5 further comprising:
means for selectively disregarding the fluid pressure in said pumping section at said second time; and means to alarm and cease operation of said device when the fluid pressure at said first time attains a predetermined value.
8. A device for infusing medical solutions to a patient which comprises:
a fluid source;
a compressible tube connecting said fluid source in fluid communication with the patient;

a case having means for engagingly receiving a portion of said tube therein;
means mounted on said case and engageable with said portion of said tube for generating a moving zone of occlusion thereon to pump fluid from said source to the patient;

Claim 8 (Continued) a gauge mounted on said case and operatively associated with said tube to alternately measure the outside diameter of said tube at a first time when said tube downstream from said gauge is patent and at a second time when said tube upstream from said gauge is patent;
means for comparing the measurement at the first time with the measurement at the second time to establish a differen-tial; and means to alarm said device and cease operation when said differential attains a predetermined value.

9. A device as cited in claim 8 wherein said portion of said tube is made of an elastomeric material.

10. A device as cited in claim 9 wherein said gauge is synchronized with said pumping means to establish the first time when said zone of occlusion is upstream from said gauge and to establish the second time when said zone of occlusion is down-stream from said gauge.

11. A device as cited in claim 10 wherein said gauge is a strain gauge.

12. A device as cited in claim 11 wherein said pumping means is a linear peristaltic pump having a first end and a second end.

13. A device as cited in claim 12 wherein said gauge is mounted for operative engagement with said portion of said tube intermediate the engagement of said portion of said tube with said first end and said second end of said pumping means.

14. A device as cited in claim 13 wherein said gauge is noninvasive of said tube.

15. A device as cited in claim 14 wherein said engaging means is formed having a peripheral portion that com-prises a flexible membrane separating said tube from said pumping means.

16. A device as cited in claim 14 wherein said tube further comprises a first fitment and a second fitment to define said portion of said tube, and said case further comprises a first attaching means and a second attaching means respectively engageable with said first and second fitments to engageably receive said tùbe.

17. A device as cited in claim 15 further comprising means to selectively cause said device to alarm and cease opera-tion when the differential has attained a predetermined minimum value.

18. A device as cited in claim 16 further comprising:
means for selectively disregarding the fluid pressure in said pumping section at said second time; and means to alarm and cease operation of said device when the fluid pressure at said first time attains a predetermined value.

19. A method for pumping fluid through a tube having a compressible pumping section which comprises the steps of:
A. Engaging said pumping section with a device comprising: a case; means for holding a portion of said compressible pumping section on said case; peristaltic means mounted on said case and operatively engaged with said tube to sequentially squeeze said pumping section and produce at least one moving zone of occlusion along said pumping section for infusing fluids;
B. Monitoring the fluid pressure at a fixed location of said pumping section with a gauge operatively coupled with said pumping section for sensing fluid pressure in said pumping section at said location at a first time when said I.V. tube downstream from said location is patent and at a second time when said I.V.
tube upstream from said location is patent;
C. Determining a pressure differential between said first time and said second time; and D. Discontinuing the infusion of fluids when said pressure differential attains a predetermined minimum value

20. The method as cited in claim 19 further comprising the steps of:
E. selectively disregarding the monitoring of fluid pressure at said second time and the determination of said pressure differential; and F. discontinuing infusion of fluids when said fluid pressure at said first time attains a predetermined value.