MXPA99003825A - Fluid flow control system incorporating a disposable pump cartridge - Google Patents

Abstract

A fluid flow control system includes a disposable cartridge (52) which is receivable in a shifting carrier body portion (281) of a control module (277). The disposable cartridge (52) houses a disposable pump (36, 211) and a pressure transducer element (20, 244) which are fluidly interconnected by an internal fluid flow circuit (2, 102, 103, 183, 185, 187, 191, 195, 196, 261, 262, 263) formed in part by an elastomeric separating sheet (177) within the cartridge (52). Following loading of the cartridge (52), shifting of the carrierbody portion (281) automatically results in a drive connection to the pump (36, 211), the positioning of various flow control valves (389) within the cartridge (52) and the seating of the pressure transducer element (20, 244) to the control module (277). External flow lines are readily placed in fluid communication with the internal fluid flow circuit (2, 102, 103, 183, 185, 187, 191, 195, 196, 261, 262, 263) through exterior connection ports (66-69) provided on the cartridge (52).

Description

SYSTEM, OF FLUID FLOW CONTROL THAT INCORPORATES A DISPOSABLE PUMP CARTRIDGE BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention pertains to the technique of fluid pumping and, more specifically to a fluid flow system incorporating a control module to which a cartridge is removably attached. Disposable pump that defines an internal fluid flow circuit. The system is particularly applicable for use in a surgical procedure that requires a controlled pressure and / or flow rate of a fluid either released to or withdrawn from a patient, thereby exposing the fluid flow circuit to possible contaminants. * 2. Discussion of the Prior Art In some environments, pumping devices are required which need only produce instead of slow flow rates but which can not be reused without being perfectly cleaned between uses. For example, during a surgical or other medical procedure, it may be necessary to release various body fluids to and remove them from a patient. A pumping device used for this purpose will obviously be exposed to REF. 29945 these fluids. Following the procedure, the pumping device and other exposed system components will have to be discarded or, in some way, sanitized before being used again. Although the associated pump speeds for these systems are more than slow since pumping devices can be made very small, the cost associated with the manufacture of those pumping devices and the other exposed system components is still very high and therefore Discarding those components after a single use would be expensive. Of course, cleaning and sterilizing those components to be used later can also be expensive, as well as consuming time. Some fluid flow control systems must also be provided for the flow of numerous fluids. For example, during an eye surgery, it is common to provide an irrigation fluid to the surgical site while extracting or aspirating the material suspended in the additional fluid from the site. During such a procedure, it is imperative to properly control the flow of the fluids to maintain an appropriate intraocular environment. Larger fluctuations in intraocular pressure may occur if an appropriate fluid balance is not maintained during irrigation and aspiration, either alone or during a phacoemulsification procedure. Perhaps it is more important to "control aspiration since it is responsible for maintaining the shape of the anterior chamber during surgery." Several pumping systems, including peristaltic and venturi systems, are commonly used in the art to perform such ocular operations. In any case, controlling the flow velocity and / or pressure of the surgical site is a critical issue.Although the surgeon generally controls the system, typically through a pedal unit, it is becoming increasingly common to provide additional sensitive equipment for regulate the flow velocities and / or pressures of the system, Of course, this sensitive equipment is added to the costs of such systems and potentially the number of components that must be cleaned between uses is added, although some control systems have been proposed. of fluid flow for use in medical environments where systems incorporate pumping devices that e are designed to be discarded after a single use, such known systems do not satisfy all the needs of the technique. For example, such known systems lack disposable portions that efficiently provide the flow of multiple fluids therethrough, do not present designs designed to minimize the costs associated with the production and use of the system to present an economically viable system, do not define versatile arrangements that "can accurately and selectively control both flow rates and pressures, and they are not simple construction and operation, yet reliable, to gain wide acceptance in the market." Therefore, there is a need in the art for a improved fluid flow control system that overcomes those and other problems known in the art.

BRIEF DESCRIPTION OF THE INVENTION A versatile and inexpensive flow control system is provided which is particularly adapted for use in environments requiring more than slow flow rates (generally less than 60 ml / min) and having portions that are exposed to potential contaminants. The fluid flow control system includes a disposable cartridge defined by a housing within which is mounted a pump and a pressure transducer element. The cartridge housing has numerous external connection gates for joining the tubes of a fluid supply source, an outlet fluid conduit, a feed line and a contaminated fluid reservoir. A separating member in the form of an elastomeric sheet is placed in the housing of the cartridge and defines, together with the open channels on an internal surface of a section of the cartridge housing, a plurality of flow passages which collectively define a circuit of fluid flow that is in fluid communication with each of the external connection gates, as well as the inlet and outlet gates of each pump and pressure transducer element. The fluid flow control system also includes a control module for supporting the disposable cartridge during the operation of the system and for regulating the flow of fluid through the fluid flow circuit. The control module includes a control housing having a main body portion and a carrier body portion that is displaceable, through a mechanism carried by the main body portion, relative to the main body portion between a position of loading / unloading the cartridge and a position of use of the system. The control module incorporates a plurality of linearly moving valve members, a reusable transducer element and a pump motor shaft that automatically engage with disposable cartridge portions after loading and displacement of the carrier body portion. According to the invention, the disposable cartridge contains, or has fluidly connected to it, all system components that may be contaminated "during use." A user of the system only needs to place a new cartridge in the carrier body portion. to cause the cartridge to be operatively interconnected to the control module and then connect the required pipes or ducts to the external connecting gates.The flow in and through the cartridge will be regulated by the extension and retraction of the valve members that can coupling the elastomeric sheet and, in combination with the cartridge housing, puncturing the sheet to produce flow regulation at selected points in the fluid flow circuit In the preferred embodiment, the flow through the system can be selectively controlled based on the data fed by the operator and the selected parameters of the pressure of the stema, flow velocity or both. ~ The additional features and advantages of the invention will become more readily apparent from the following detailed description of a preferred embodiment thereof when taken in conjunction with the drawings wherein the like reference number refers to corresponding parts in the different views.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a total schematic view of a fluid flow circuit established by a "preferred embodiment of the invention; Figure 2 is a perspective view of "a disposable cartridge constructed in accordance with the invention, Figure 3 is a rear plan view of the cartridge of Figure 2, Figure 4 is a front plan view of the cartridge of Figure 2: Figure 5 is an exploded view of the cartridge of Figure 2 taken in a first direction; Figure 6 is an exploded view of the cartridge ^ of Figure 2, similar to that shown in Figure 5 but taken in an opposite direction; Figure 7 is a schematic of a fluid flow circuit formed within the cartridge of Figure 2; Figure 8 is an exploded view of a control module incorporated in the present invention; Figure 9 is a perspective view of the right side of the control module in a position ^ of loading / unloading the cartridge; Figure 10 is a perspective view of the right side, similar to that of Figure 9 but describing the control module in a position in use; Figure 11 is a perspective view of the left rear side of the control module of the invention; Figure 12 is a partial full-section cross-sectional view of the fluid flow control system of the invention in a loaded and in use condition; and Figure 13 is a schematic of an electronic control circuit incorporated in the preferred embodiment of the invention.

DETAILED DESCRIPTION OF THE PREFERRED MODALITY For the purposes of this invention, the fluid flow control system of the invention will be described% in particular in connection with a fluid circuit designed to both irrigate and aspirate a surgical site. With initial reference to Figure 1, the total fluid flow circuit that can be used in connection with surgical procedures of the eye is generally indicated at 2. The fluid flow circuit 2 includes a first tubular passage A which is adapted to receive a supply of irrigation fluid, such as a saline solution, which is received within the first tubular passage 4 through an input zone of the supply 6. The first tubular passage 4 terminates in a discharge nozzle 8, the position which is controlled by a surgeon or other operating assistant for irrigation purposes. Between the input zone of the supply 6 and the discharge nozzle 8, a first control point of the valve 10 is defined. As will be described more fully below, the first control point of the valve 10 establishes a predetermined location within the first tubular passage 4 wherein the flow of fluid through it can be controlled. The fluid flow circuit 2 also includes a second tubular passage 13 including an intake nozzle 16 and one end thereof. In a flow circuit 2, the intake nozzle 16 and the second tubular passage 13 are used for suction purposes. Away from the intake nozzle 16, the second tubular passage 13 is connected to an inlet gate 18 of a pressure transducer 20. Along the second tubular passage 13 a second valve control point 24 is defined. The second passage tubular 13 can be interconnected through a ventilation line 27 to a first tubular passage 4. As shown in this Figure, the ventilation line 27, if provided, could associate therewith a third valve control point 29. The pressure transducer 20 has an outlet 32 which is connected to an inlet port 34 of a pump 36. As will be described more fully below, the pump 36 may be constituted by numerous types of known pump units, however, in the preferred embodiment, the pump 36 is constituted by a "miniature spiral fluid" device having an output flow rate that ranges from the order of 1 ml / min to 60 ml / min, to a maximum vacuum pressure of approximately 550 mm Hg. More specifically, the preferred embodiment incorporates a spiral fluid device as set forth in a copending US Patent Application, entitled "Compact Spiral Fluid Device" ', filed on the same date as this on behalf of Ronald J. Forni . In a similar manner, the pressure transducer 20 may take various forms in accordance with the present invention although it is preferably constructed in the manner set forth in the co-pending US Patent Application entitled "Fluid Pressure Detection Unit" filed on the same date. that I present it in the name of Reed and Franzosa. Although the particular configuration of the pressure transducer 20 and the pump 32 are not considered part of the present invention, the descriptions in the two copending applications cited are incorporated herein by reference for the purpose of making a more complete reference. The pump 36 has associated with it a discharge gate 38 which is in fluid communication with a reservoir 41. The output 32 of the pressure transducer 20 is also connected to a first end 43 of a calibration conduit 45. The calibration conductor 45 includes a second end 47 that also discharges into the reservoir "41. Located within the calibration conduit 45, between the first and second ends 43 and 47, is a normally closed pressure calibration valve indicated at 49. The conduit calibration 45 and its associated valve 49 are included simply for the purpose of making a more complete description and can be used to calibrate the pressure transducer 20, however, since it is not considered an essential feature of the present invention as the pressure transducer 20 may not require such calibration. A main aspect of the present invention relates to an integration of the structural components of the fluid flow circuit 2 towards an assembly that can be made in a compact and economically viable way. Since the components of the fluid flow circuit 2 represent the entire structure that will be subjected to potentially contaminated fluids during the surgical operation, the incorporation of those components in an integrated assembly will not only allow the components to be easily isolated from the other components of the fluid. system that do not need to be directly exposed to the different fluids flowing through circuit 2, but can be provided for the efficient replacement of a used assembly and discard it after a single use as it will be more completely evident later.

Reference will now be made to Figures 2-6 in which the structure of a disposable cartridge 52 designed to integrate the components of the fluid flow circuit 2 is described. The disposable cartridge 52 includes a first housing section 54 and a second section of housing 56 which are adapted to be joined together along a circumferential seal 58. In the preferred embodiment, the first and second housing sections 54 and 56 are molded from plastic and are joined at joint 58 through a welding operation. Of course, other connection arrangements, including mechanical fasteners or adhesives, could be used. As best shown in Figures 4 and 6, the first housing section 54 includes an external surface 60 which is generally rectangular in shape but which is provided with a semicircular lower extension 62. Separated from the lower semicircular extension 62, the outer surface 60 of the first housing section 54 is formed with a hole 64 and, formed in an upper section of the first housing 54 are first, second, third and fourth external connection gates 66-69. In the preferred embodiment, each external connecting gate 66-69 is defined by a respective generally cylindrical, straight, member 71-75 having a central "bore" 76-79.The external connecting gates 66-69 are adapted to be interconnected to tubes or other fluid conduits (not shown) that are interconnected to the disposable cartridge 52 to complete the fluid flow circuit 2. To ensure proper connections preventing potential human error upon completion of the circuit, in the preferred embodiment, the external connection gates 66-69 have different sizes, which correspond to the sizes of the respective conduits to be connected thereto. The second external connection gate 67 is actually defined by the cylindrical member 72, which constitutes a member internal cylindrical and an outer cylindrical member 82 which are separated by an annular space 85 as shown clearly in the Figure 4. Each of the external connecting gates 66, 68 and 69 are adapted to have tubular conduits positioned around their respective cylindrical members 71, 73 and 74 while a conduit is adapted to be inserted into the annular space 85 and around the internal cylindrical member 72 of the second external connecting gate 67 to be placed in fluid communication with the central hole 77. Finally, the external surface 60 is also formed with a pair of separate suspension members 88 and 89 which, as shown in FIG. discussed more fully below, are provided to suspend a bag or other container (not shown) defining the reservoir 41 of the disposable cartridge 52. In the preferred embodiment, the suspension members 88 and 89 each include a portion that outwardly projecting 91 and a vertical tongue portion 93. When a tubular bag is used for reservoir 41, the bag is preferred. It is provided with separate openings to be used for hanging the bag of the suspension members 88 and 89. The first housing section 54 has an internal surface 95 as best shown in Figure 5. The inner surface 95 is formed with a pair of box-shaped openings 96 in the suspension members 88 and 89, an inner annular edge 99 which extends around the entire inner periphery of the first housing section 54 and a plurality of open channels generally indicated at 102 and 103. The channels 102 and 103 are actually defined by raised wall portions 104 of the inner surface 95. As shown, the open channel 102 includes a first end 106 that extends along an upper wall portion 108 of the first accommodation section 54, downwardly along the portion of the side wall 110 and then end at a second end 112 adjacent the orifice 64. The open channel 103 has a first end 114 arranged adjacent to the hole "64 and subsequently divided into sub-channels 116 and 117 having respective end ends 118 and 119. As clearly shown in this figure, the open channel 102 is formed with first, second and third holes 121-123 in the portion of the upper wall 108 and the open channel 103 is formed with a fourth hole 124 at the terminal end 119. The holes 121-124 are actually defined by central holes 76-79 of the external connecting gates 66-69 and therefore the channels 102 and 103 open to the outside to place the cartridge 52. Finally, the inner surface 95 of this first housing section 54 is preferably provided with a plurality of reinforcing edges, one of which is indicated at 126. With ref Particular reference to Figures 2, 3 and 5, the second housing section 56 includes an outer surface 129 having a recessed upper section 132 defined by the annular, inwardly inclined wall 134 leading to a base 136. Radially inwardly of the base 136 is an upwardly sloping and inwardly sloping wall 138 which leads to a central annular rim 139 which is provided with an opening 140. The lower recessed section 132, second housing 56 is provided with a lower opening 143 which defines an internal, annular seating surface 145. The outer surface 129 is further provided with several separate openings 147-150 extending fully through the second housing section 56. As shown in Figure 6, the second section of housing 56 has an internal surface 152 from which numerous straight inner wall members 154-160 project. The straight inner wall members 154-156 improve the structural integrity and guide functions of the valve member as will become more clearly apparent when considered in connection with the type of valve incorporated in the preferred embodiment. At this point, however, it should be understood that the openings 147 and 148 are located between an upper wall 161 of the second housing section 56 and the wall member 154, the opening 149 is arranged between a side wall (not marked) of the second housing section 56 and the wall member 155, and the opening 150 is positioned between an opposite (unmarked) side wall of the second housing section 56 and the wall member 159. The straight inner wall member 154 is preferably formed with a dependent stopping member 162 which, as will be described more fully below, provides an alignment and mounting aid for the pump 36. Within the second housing section 56, the base 136 of the recessed section 132 defines an elevated surface 164 from which extends an "annular wall 167 having an upper projection 168 which is formed with a slot 169. The slot 169 is adapted for to receive a U-shaped ring (not shown) to be used to seal against a portion of the pump 36. Mounted between the first and second housing sections 54 and 56 is an elastomeric sheet 177 which is shown to be larger. in Figures 5 and 6. The elastomeric sheet 177 is extremely flexible and foldable and includes a first ladle 179 formed with numerous straight sealing walls which are adapted to be hermetically coupled to the raised wall portions 104 of the channels 102. and 103 to define a plurality of fluid flow passages. More specifically, the straight sealing walls 181 of the elastomeric sheet 177 define an upper channel 183 that leads to a side channel 185 and a lower channel portion 187. The lower channel portion 187 terminates in a wall 181 formed around a opening 190. Adenás, the straight sealing walls 181 define a further lower channel portion 191 that bifurcates by means of a straight wall 191 towards the subchannel portions 195 and 196. The elastomeric sheet 177 is also provided with a plurality of through holes 197-200. More specifically, a first through hole 197 is provided in the lower channel portion 187 adjacent the terminal wall 189, a second through hole 198 is provided in the lower channel portion 191 adjacent the wall 189, and are provided a third and fourth through holes 199 and 200 at the terminal ends of the sub-channel portions 195 and 196 respectively On the second side 201 of the elastomeric sheet 177, each of the through-holes 197-200 have associated with them straight sealing rings 204-207 respectively As indicated above, the pump 36 is preferably constituted by a spiral fluid device which is generally indicated in those figures at 211. Although the particular construction of the spiral fluid device 211 is not considered part of other known types of pumps could also be used in the present invention, in general, the spiral fluid device 211 includes a pair of fluted spiral elements 214 and 216. Although not shown, the first and second spiral elements 214 and 216 have spirally intricately convoluted internally striated members defining at least one fluid chamber that moves radially from an inlet region of the pump to an exit zone of the pump when one of the enclosing members rotates along a circular path around an orbit center relative to the other of the enclosing members. In accordance with the preferred construction of the spiral fluid device 211 which pertains "to the disposable cartridge assembly 52, the first spiral member 214 includes an exposed side 217 that is formed with a central bulb 218 provided with a hole 220. In addition, the side exposed 217 is formed with an annular groove 222 that is adapted to receive an O-shaped ring or other known type of seal (not shown) used to fluidly seal the first spiral member 214 to the first housing section 54 as shown in FIG. will see in more detail later The second spiral member 216 includes a flange 226 extending radially towards <; -_ outside the first spiral element 214. The rim 226 includes a peripheral edge 228 that is formed with a straight edge 230 having a central slot 232. As best shown in Figure 6, the second spiral member 216 has an exposed side 235 which is formed with a pair of spaced annular cavities 236 and 238 defining central straight connectors 240 and 241. Straight connectors 240 and 241 actually define the outlet and inlet gates for the spiral fluid device 211. Also placed inside the disposable cartridge 52 there is a pressure transducer element 244 that actually constitutes part of a total pressure transducer assembly preferably constructed in the manner set forth in accordance with that identified above and by reference to the co-pending "incorporated" US Patent Application. , the pressure transducer element 244 includes an outer sleeve 247 preferably - formed of plastic or to which a hinged diaphragm 249 is sealed which is preferably formed of stainless steel. The bushing 247 is formed with a projection that is located at the center 252, as well as a pair of diametrically opposed fluid flow connectors 255 and 256 which constitute the inlet and outlet gates for the pressure transducer 244 to allow flow of the system fluid through it. ^ _ - As shown in Figures 2-6, the first and second housing sections 54 and 56 of the disposable cartridge 52 are adapted to be interconnected with the elastomeric sheet 177, the spiral fluid device 211 and the pressure transducer element. 244 placed on it. More specifically, the elastomeric sheet 177 is preferably adhesively secured to the inner surface 95 of the first housing section 54 so that the elastomeric sheet 177 extends as a seal through open channels 102 and 103 of such channels define sealed fluid flow passages open only to holes 121-124 and through holes 197-200. More specifically, the straight sealing walls 181 of the elastomeric sheet 177 are actually received within a continuous groove 260 formed around the open channels 102 and 103. The spiral fluid device 211 is positioned within the second housing section. 56 inside the annular groove 222 which is seated on the raised surface 164 and 'the central core 218 projecting into the opening 140. The central core 218 has a diameter smaller than the opening 140 to allow orbital movement without obstruction of the first spiral member 214 during the operation of the spiral fluid device 211. The second spiral member 216 is also seated within the second housing section 56 with the rim 226 being sealed thereto by means of the 0-shaped ring placed within the groove 169 and the straight edge generally in contact with the straight inner wall member 154. In addition. The slot 232 provided on the second spiral member 216 receives the retainer member 162 to assist alignment and assembly of the spiral fluid device 211. The pressure transducer 244 is positioned in the lower aperture 143 with the diaphragm 249 being exposed to the outer surface 129 of second housing section 56. In addition, connectors 255 and 256 of pressure transducer member 244 are coupled with straight seal rings 204 and 205 of elastomeric sheet 177 while projection 252 that is located in the center extends through the opening 190 and into the hole 64. Also, the straight sealing rings 206 and 207 of elastomeric sheet 177 are interconnected with central straight connectors 240 and 241 of the spiral fluid device 211. From the above description it should be readily apparent that the spiral fluid device 211 is mounted as a seal within the disposable cartridge 52 and tie and a gate (an inlet gate in the described preferred embodiment) fluidly connected to the flow passage defined by the combination of the open channel 118 and the elastomeric sheet 177 through the use of the straight obturator ring 207. Similarly, the connector 240 defining an outlet for the spiral fluid device 211 is connected through the straight seal ring 206 to the sub-channel 117 in the fourth orifice 124. Again, the fourth orifice 124 leads to the connecting gate 69. As indicated above, a reservoir 41 in the form of a bag is adapted to be suspended from the suspension members 88 and is connected to the gate 69 so that the outlet of the spiral fluid device 211 leads to the reservoir 41. The entry and exit of the element Pressure transducer 244 are also in fluid communication with the fluid passages defined by the open channels 102 and 103 and the elastomeric sheet 177 through the connectors 255 and 256 and the first and second through holes 197 and 198. The sealing rings straight 204 and 205 provide a 'complete seal in this fluid communication.

Therefore, once assembled, the disposable cartridge establishes the total fluid flow circuit indicated generally at 2 in Figure 1. This is best represented schematically in Figure 7, where at least the passages were established. of fluid 261-263 with the fluid passage 261 receiving a fluid supply (for irrigation purposes in the described manner) at point 264; an outlet supply of irrigation fluids are provided at 265; an inlet inflow flow (perhaps with particles suspended therein) is placed in fluid communication with flow passage 261 in reference number 266; the fluid is allowed to flow to the pressure transducer element 244 from the fluid passage 261 at the location 267; the flow leaves the pressure transducer element 244 in place 268; the fluid inlet to the spiral fluid device 211 occurs at point 269 and the point 270 represents an outlet to the reservoir 41. The first, second and third control points of the valve 10, 24, and 29, as well as a point of valve for calibration valve 49, is also indicated. As will be discussed more fully below, those locations of the valve points represent areas where the elastomeric sheet 177 is punctured so as to extend within a respective portion of the fluid flow passages 261 and 263 to selectively control the fluid flow through those passages. Since the elastomeric sheet 177 is formed of a flexible and collapsible material, the sheet material itself is actually used to effect the valving operation, in combination with the valve elements used to bend the sheet as will be described in FIG. most complete way later. In any case, at this point, it should be readily apparent that the disposable cartridge 52 provides a mounting of integrated components, as well as an internal fluid flow circuit to which only a few fluid flow connections in connection with the gates need to be made. 66-69 to complete the total circuit. It should also be evident that those external connection gates 66-69 correspond directly to the tube connection locations discussed above with reference to numbers 264, 265, 266 and 270 respectively. Reference will now be made to Figures 8-12 which describe a control module 277 which cooperates with the disposable pump cartridge 52 to define the total fluid flow control system of the present invention. As shown, the control module 277 includes a main body portion 279 and a carrier body portion 281. The carrier body portion 281 includes a front panel 284, side panels 286 and 287, and bottom panel 289, a panel central 291, a top panel portion 293 and a back plate 295 as best shown in Figures 8 and 12. In the preferred embodiment, the carrier body portion 281 is made of metal with the back plate 295 being made of aluminum and the rest of the carrier body portion 281 is formed of sheet metal. Between the front panel 284 and the center panel 291, the carrier body portion 281 defines a receiving area or slot of the cartridge 298 which, as will be discussed in more detail below, is adapted to receive the disposable cartridge 52. In In the preferred embodiment, the front panel 284 includes a lower opening 300 through which a spring member 301 having at least one diverting finger 303 is placed (not shown in Figure 8, for clarity, but is observed in the Figures 9, 10 and 12) having an arcuate end end 305. The center panel 291 and the back plate 295 include a pair of aligned and spaced top openings 307 and 308. In reality, the center panel 291 and the back plate 295 are provided with four such openings, two others of which are arranged below the central panel 291. The location and purpose of each of these additional openings will become readily apparent hereinafter. The central panel 291 is also formed by a central opening 312 around which a plurality of arcuate grooves 314-317 are separated. The central panel 291 and the back plate 295 further define a lower rear opening 319 formed in the portion of the carrier body 281. Cantilevered from the rear plate 295, generally adjacent to the four corners thereof, are the respective guide rails 322-325. As will become more clearly evident subsequently, the rails 322-325 are slidably supported by the main body portion 279 and function to guide the cer body portion 281 during the movement of the relative displacement between the cer body portion 281 and the main body portion 279. In the pre-assigned embodiment shown, a main body portion 279 includes a base plate 327, a front plate 328, a rear plate 329, an upper plate 330 and at least one side plate 331. In In the preferred embodiment, plates 327-331 are formed of aluminum and are interconnected together with conventional mechanical fasteners (not shown). Adjacent to each of the corners from the rear end plates 328 and 329 are respective defined front and rear aligned holes 334 and 335 having a respective sleeve 337 preferably formed of plastic thereon. A respective guide rail 322-325 extends within each sleeve 337. As is clearly shown at least in Figures 10-12, the guide rails 322-325 each include a respective end portion 340 extending outwardly beyond the back plate 329. With this ngement, the cer body portion 281 is slidably supported by the main body portion 279 through the guide rails 322-325 with the cer body portion 281 moving toward and away from the faceplate 328 at least a distance defined by the length of the end portions 340. As will be discussed more fully below, the movement of the cer body portion 281 relative to the main body portion 279 allows the cer body portion 281 to assume and extend the cartridge loading / unloading position. as shown in Figure 9 in the position of use as shown in Figures 10 and 12. The deviation of the cer body portion 281 in relation to the portion of c Main body 279 is made in accordance with the present invention by means of a mechanism generally indicated at 342. Mechanism 342 is preferably constituted by a linear-bidirectional electric motor, 343 having a longitudinally associated deflectable shaft 345 extending through an opening 347 provided in the rear plate 329 and a sleeve 349 provided in the hole 350 provided "in the faceplate 328. The front end 352 of the shaft 345 is attached, for relative rotation, to the rear plate 395 of the cer body portion 281. With this ngement, the activation of the linear motor 343 causes the shaft 345 to rotate, such as through the helical drive or track gear, so that the axis 345 deviates linearly in relation to the main body portion 279. Since the shaft 345 is allowed to rotate in relation to the rear plate 295, only the movement of displacement l The axis 345 will be moved to the cer body portion 281. Since the linear motor 343 can be operated bidirectionally, the cer body portion 281 can be positively driven between the load / unload position of the position in use. At this point, it should be readily understood that, although the mechanism 342 constitutes a linear motor and mechanical drive in the preferred embodiment, several other types of linear drive systems, including solenoid, pneumatic and hydraulic actuators, could be used without departing from the spirit of the invention. The main body portion 279 also has mounted on it the pump drive motor 355 which includes an encapsulated housing 356 having an output motor shaft 357. As best shown in FIG. 12, the output drive shaft 357 has connected in a controlled manner to this a connector 359 having an internal connector element 359 and an external connector element 360. The external connector element 360 includes a encapsulated portion 361. In the preferred embodiment, the actuator connector 358 actually constitutes an eccentric sleeve used to transmit movement to the spiral fluid device 211. More specifically, the external connector element 360 is adapted to be received within the central core 218 of the first spiral member 214 to drive the spiral fluid device 211 after loading the disposable cartridge 52 in the manner that will be described in detail below. The pump drive motor 355 actually includes a front housing portion 362 that is mounted to a center section 262 of an alignment sleeve 364. The center section of the alignment sleeve 364 actually includes a first diametrical portion 365 and a second portion. of reduced diameter 367 and a front end 362 of the pump drive motor 255 in contact with the second reduced diameter portion 367 and is fixed to the first diametrical portion 365 as shown clearly in Figure 12. The alignment sleeve 364 by itself it is fixed in an opening 368 and provided in the faceplate 328. The alignment sleeve 364 has an internally projecting cylindrical sleeve 369 and an outer cylindrical sleeve 371 having several cut sections, circumferentially spaced, 372- 275 The internal cylindrical sleeve 369 is aligned with the central opening 312 and the different sections of the outer cylindrical sleeve 371 are respectively aligned with the arcuate grooves 314-317. With this arrangement, when the carrier body portion 281 is diverted to its position in use directly adjacent to the main body portion 279, the inner and outer cylindrical sleeves 369 and 371 project toward the cartridge receiving area 298. For reasons which will be discussed more fully "subsequently, the outer cylindrical sleeve 371 has a tapered front edge 336 as best shown in Figure 12. The main body portion 279 also supports a fixed pressure transducer element 377. As best illustrated in Figures 8 and 12, the fixed pressure transducer element 377 includes a vacuum tube portion 378 having an elongated diametrical head 380 and an annular rim 382. The fixed pressure transducer element 377 is fixedly secured to the faceplate 328 through the annular rim 328 and has a front end seat 384 having a 0 386-shaped ring against which the t-element sits pressure transducer 244 when the disposable cartridge 52 is placed within the carrier body portion 281 and the carrier body portion 281 is moved to its position in use as shown in Figure 12.

The fixed pressure transducer element 377 further includes a protective unit indicated at 387 which is adapted to be placed juxtaposed with the diaphragm 249 to detect deviations of the diaphragm 249 based on its exposure to fluid system pressures. Although not shown in those drawings for clarity, the pressure transducer element 377 also incorporates electronic control components within the tube 378 to receive signals from the sensor unit 387 for use in determining the oppression of the fluid system in the flow circuit. fluid flow 2 based on the detected movement of diaphragm 249. As indicated above, various different types of known transducer assemblies may be used to carry out the desired detection function in accordance with the present invention although the pressure transducer arrangement Preferred is described in the copending US Patent Application referenced above which has been incorporated herein by reference. The main body portion 279 of the control module 277 also supports several valve units one of which is indicated generally at 389. In accordance with the preferred embodiment, the valve unit 389 constitutes a solenoid valve and therefore includes a "solenoid housing 391 which is fixed within the main body portion 279 such as through the use of a generally U-shaped clamp 393 having a base 395 secured to the faceplate 328 and the leg portions. 397 and 398 that are attached to the housing of the solenoid 391 by means of a plurality of fasteners 399. Each valve unit 389 includes a linearly moving valve member 401 in the form of a rod having a tapered tip 405. Each member valve 401 is slidably mounted within a guide sleeve 407 which extends through a respective hole 4009 formed in the faceplate 328. Actually, in In the preferred embodiment, four such solenoid valve units 389 are provided, each of which has an associated valve member 401 which extends through the faceplate 328 and which can displace or deflect it linearly. The tapered tip 405 of each valve member 401 is adapted to extend through one of the respective openings discussed above with reference to the openings 307 and 308 formed in the carrier body portion 281 and then to the disposable cartridge 52 in the openings 147-150 respectively. When the carrier body portion 281 is in the position in use, the tapered tips 405 can couple the elastomeric sheet 177 in a first, second, third and fourth "valve control" points 10, 24, and 49 respectively. related to the operation of each valve unit 389 will be discussed describing the manner in which the fluid flow control system of the present invention operates.When preparing for a surgical procedure, the control module 277 would initially assume the position of loading / unloading illustrated in Figure 9. Of course, the main body portion 279 would have some type of external cover which does not show in detail the internal structure of the control module 277. In any case, in this position, the portion of Carrier body 281 is separated from the main body portion 279 to a support through the guide rails 322-325. 364 and the valve member 104 of each valve unit 389 is clear of the cartridge receiving area 298. As mentioned above, the carrier body portion 281 can be moved to this loading / unloading position by means of a linear motor 343 and the connection of the shaft 345 to the back plate 295. As clearly shown, the drive connector 358 is also separate from the cartridge receiving area 298. At this point, a new disposable cartridge 52 can be easily placed within the cartridge receiving area 298 with the projection located at the center 252 of the pressure transducer element 244 being positioned against the finger 303 of the spring member 301 and the external connecting gates 66 -69 extending above the front panel 284 of the carrier body portion 281. In the preferred installation sequence, a reservoir bag would be attached to the disposable cartridge 52 in the suspension members 88 and 89, as well as the fourth gate connection 69, prior to insertion of the disposable cartridge 52 into the cartridge receiving area 298. However, the reservoir assembly could likewise be attached at any time prior to the start-up of the system. - ^ Once the disposable cartridge 52 is in place, an operator presses a button (not shown) which drives the linear motor 343 and causes the carrier body portion 281 to be pulled toward the main body portion 279 of so that the control module 277 assumes the position in use (shown in Figures 10 and 11 without the cartridge 52 and in Figure 12 with the cartridge 52 in place). Alternatively, the cartridge 52 could couple a switch when it is inserted into the cartridge receiving area 298 to automatically produce a displacement of the carrier body portion 281. When the carrier body portion 281 is pulled toward the main body portion 279, the pressure transducer element 244 is automatically seated with the O-shaped ring 386 of the fixed pressure transducer element 277, the drive connector 358 is automatically positioned within the central core 218, the internal cylindrical sleeve 369 of the alignment sleeve 364 is arranged in the central opening 312, the outer cylindrical sleeve 371 of the alignment sleeve 364 extends through the arcuate grooves 314-317 until the tapered front edge 376 is placed against the inwardly tapered wall that extends upwards. formed in a second section of the housing 56 of the disposable cartridge 52 and each of the The valve members 401 extend through the back plate 295 and the front panel 284 of the carrier body portion 281 and toward the disposable cartridge 52 through a respective opening 147-150. Therefore, external connections can be made to the external connection gates 66-68 as discussed above. At this point, the flow control system of the present invention operates. During the procedure, the pump drive motor 355 can be controlled to operate the spiral fluid device 211 to create suction at a third connection point 68 through the flow passage 262, the pressure transducer element 244 and the passage of fluid 261. Of course, the fluid withdrawn in the operation of the spiral fluid device 211 is released directly into the reservoir 41 when the output of the spiral fluid device 211 is in "direct-flow communication with the external connection gate 69 by means of of the through hole 199 in the elastomeric sheet 177. The calibration valve 49 is normally closed which, in the described embodiment, occurs by extending a respective valve member 401 so that the tapered tip 405 punctures this elastomeric sheet 177 and it causes the same to obstruct the flow through the passage of fluid 263. This type of valve control can also be provided in the first, second and third valve control points 10, 24 and 29. When irrigation is desired, flow is readily allowed within the flow passage 261 whereby the first and second external connection gates 66 and 67 are placed in fluid communication with each other (ie, allowing the fluid to flow freely between points 264 and 265 as shown in Figure 7). Since the ventilation line 27 is normally closed, the valve member 401 associated with the third valve control point 29 is normally, fully extended. Operation of the pump drive motor 355 and the valve unit 389 during the use of the fluid flow control system of the present invention is actually electronically controlled in accordance with the preferred embodiment. More specifically, as shown in Figure 13, there is provided an electronic control unit 417, which receives inputs from an operator control member (such as a pedal) indicated at 420, a mode switch operating manual 422 and signals from the detection unit 387. The electronic control unit 417 uses those signals to produce control signals for each drive motor of the valve 355, the linear motor 343 and the valve units 389. The foot controller 420 is constructed according to that known in the prior art and allows a surgeon to control irrigation and aspiration as needed.The control switch of mode of operation 422 can be used to select whether control module 277 should provide a suction flow rate set, a suction vacuum pressure controlled or both, if a system based on the flow rate is desired, the switch The operating mode control 422 will be appropriately set and the pump drive motor 355 would accordingly be controlled in a manner similar to known peristaltic systems. On the other hand, the operation mode control switch 422 can be placed in a vacuum-based operation mode wherein the electronic control unit 417 would operate via the pump drive motor 355 based on signals not only received of the pedal 420 but also of the sensor unit 387 associated with the fixed pressure transducer element 377. In this mode, the control module 277 would operate in a manner analogous to the known venturi type systems. When operating in a pressure-based mode, the electronic control unit 417 would be set to shut off if an obstruction in the suction line would occur which would increase the system pressure beyond the threshold value. In addition, when operating in a flow velocity mode, the electronic control unit would also be sensitive to increases in the higher RPM which result in a possible obstruction in the suction line since such an increase higher than the RPM could drive the increase in suction after removing the blockage. In this way, the electronic control unit 417 would therefore still be sensitive to the pressure signals to avoid this potential problematic situation. Although described with respect to a preferred embodiment of the invention, it should be readily understood that various changes and / or modifications to the invention may be made without departing from the spirit thereof. For example, although the fluid flow control system of the present invention has been described with particular reference to the establishment of a total irrigation / suction flow control circuit, it should be readily understood that the principles of the present invention can be applied to other fields as well. For example, the system could be used to supply, remove or recirculate other body fluids, or even the field outside of the medical environment. In general, it is intended that the invention be limited only by the scope of the following claims.

It is noted that in relation to this date, the best method known to the applicant to carry out the aforementioned invention, is that which is clear from the present description of the invention.

Claims (46)

CLAIMS The invention being described as above, it is claimed as property contained in the following claims:

1. A fluid flow control system, characterized in that it comprises: a disposable cartridge including: a cartridge housing formed of at least two housing sections which are joined together, the housing sections are provided with at least two gates fluid connection and an opening that exposes an interior of the cartridge housing; a pump having associated inlet and outlet flaps and at least one movable pump element provided with a connecting member adapted to be interconnected with a drive element for operating the pump, the pump is positioned within the cartridge housing with the connecting member being located in the opening; and a spacer member positioned within the housing of the cartridge, the spacer member defines, at least in part, a plurality of flow passages interconnected fluidly, respectively, to at least two fluid connection gates and the inlet and shut-off gates. pump output; and a control module including: a control housing having a main body portion and a carrier body portion, the carrier body portion defining the cartridge receiving area that is adapted to receive the disposable cartridge; a drive unit including a drive element adapted to be operably connected to the pump connection member after insertion of the disposable cartridge into the cartridge receiving area; and means for controlling the operation of the drive unit to regulate an operation of the pump.

2. The fluid flow control system according to claim 1, characterized in that the separating member is constituted by a flexible sheet.

3. The fluid flow control system according to claim 2, characterized in that the flexible sheet is formed of an elastomeric material.

The fluid flow control system according to claim 1, characterized in that at least one of the two receiving sections are formed with a plurality of open channels which are covered by the separating member to define the plurality of passages. flow.

5. The fluid flow control system according to claim 4, characterized in that the separating member is formed with several raised walls which are coupled in a seal manner around the open channels.

The fluid flow control system according to claim 1, characterized in that it further comprises a pressure transducer including a disposable transducer element located in the cartridge housing and a reusable transducer element provided in the control housing, the Disposable transducer element is juxtaposed to the reusable transducer element after the insertion of the disposable cartridge in the cartridge receiving area.

The fluid flow control system according to claim 6, characterized in that the disposable transducer element includes a fluid inlet that is in fluid communication with at least a plurality of flow passages through the spacer member.

8. The fluid flow control system "according to claim 1, characterized in that one of the plurality of flow passages interconnects at least two fluid connection gates to provide fluid flow through the disposable cartridge that is independent of the operation of the pump

9. The fluid flow control system according to claim 1, characterized in that the pump constitutes a device of the spiral fluid of plastic

10. The fluid flow control system of ^ according to claim 1, characterized in that it further comprises a plurality of separate openings formed in the housing of the cartridge and a plurality of valve members movably mounted on the control housing, each of the valve members is adapted to extend into one of the separate openings and to obstruct flow through a predetermined section of the flow passage.

11. The fluid flow control system according to claim 10, characterized in that the valve members constitute linear solenoid valve units.

The fluid flow control system according to claim 10, characterized in that the spacer member is made of an elastomeric material and "each of the valve members is adapted to cause a respective portion of the elastomeric material to project towards a predetermined section of the flow passages to thereby obstruct flow within the flow passages

13. The fluid flow control system according to claim 1, characterized in that it further comprises a mechanism for deflecting or displacing the carrying body portion of the control housing between a loading / unloading position of the cartridge wherein the carrying body portion is separated from the main body portion and in a position in use where the carrying body portion is displaced towards the main body portion

14. The fluid flow control system in accordance with the claim 13, characterized in that it comprises a plurality of rail members connected to the carrier body portion and slidably received in the main body portion of the control housing, the rail members guide the carrier body portion to move between the positions of loading / unloading and in use.

15. The fluid flow control system according to claim 1, characterized in that the cartridge housing includes a front wall provided with "suspension elements adapted to support a reservoir unit", one of at least two connection gates. of fluid allow the reservoir unit to be fluidly connected to the flow passages

16. A disposable cartridge for use in a fluid flow control system, characterized in that it comprises: a cartridge housing formed of at least two sections of fluid housing which are joined together, the housing sections are provided with the two fluid connection flaps and an opening that exposes an interior of the cartridge housing; a pump having associated inlet and outlet gates and at least one movable pump element provided with a connecting member adapted to be interconnected with a drive element for operating the pump, the pump is positioned within the cartridge housing with the member of connection being located in the opening; and a spacer member positioned within the cartridge housing, the spacer member defines, at least in part, a plurality of flow passages fluidly interconnected, respectively, to at least two fluid connection gates and the inlet and outlet gates. of the bomb.

17. The disposable cartridge according to claim 16, characterized in that the separating member is constituted by a flexible sheet.

18. The disposable cartridge according to claim 17, characterized in that the flexible sheet is formed of an elastomeric material.

19. The disposable cartridge according to claim 16, characterized in that at least two receiving sections are formed with a plurality of open channels ^ which are covered by the separating member to define the plurality of flow passages.

20. The disposable cartridge according to claim 19, characterized in that the separating member is formed with several raised walls which are coupled in a seal manner around the open channels.

The disposable cartridge according to claim 16, characterized in that it further comprises a disposable pressure transducer element located in the cartridge housing.

The disposable cartridge according to claim 21, characterized in that the disposable transducer element includes a fluid inlet that is in fluid communication with at least a plurality of flow passages through the separator member.

23. The disposable cartridge according to claim 16, characterized in that one of the plurality of flow passages interconnects at least two fluid connection gates to provide fluid flow through the disposable cartridge that is independent of the operation of the pump.

24. The disposable cartridge according to claim 16, characterized in that the pump constitutes a device of the spiral plastic fluid.

The disposable cartridge according to claim 16, characterized in that it further comprises a plurality of separate openings formed in the cartridge housing, each of the separate openings being adapted to receive a respective valve member to obstruct a flow to through a predetermined section of the flow passages.

26. The disposable cartridge according to claim 16, characterized in that the cartridge housing includes a front wall provided with suspension elements adapted to support a reservoir unit, one of at least two fluid connection gates allows the reservoir unit to be connected fluidly to the flow passages.

27. A fluid flow control system, characterized in that it comprises: a disposable cartridge including: a cartridge housing formed of at least two housing sections which are joined together, the housing sections are provided with at least two gates fluid connection, an internal fluid flow passage circuit connected fluidly to the connection gates and an opening that exposes an interior of the cartridge housing; and a miniature spiral fluid device formed of plastic, the spiral fluid device has associated inlet and outlet gates in fluid communication with the internal fluid flow passage circuit and at least one mobile work element provided with a connecting member adapted to be interconnected with a drive element for operating the spiral fluid device, the spiral fluid device is positioned within the cartridge housing with the connecting member being located in the opening; and a control module including: a control housing having a main body portion and a carrier body portion, the carrier body portion defining the cartridge receiving area that is adapted to receive the disposable cartridge; a drive unit including a drive element adapted to be operably connected to the connecting member of the spiral fluid device after insertion of the disposable cartridge into the cartridge receiving area; and means for controlling the operation of the drive unit for regulating the operation of the spiral fluid device.

28. The fluid flow control system according to claim 27, characterized in that it further comprises a spacer member positioned within the housing of the cartridge, the spacer member defines, at least in part, the flow passage circuit of internal fluid

29. The fluid flow control system according to claim 28, characterized in that the separating member comprises an elastomeric sheet.

30. The fluid flow control system according to claim 29, characterized in that at least two housing sections are formed with a plurality of open channels which are covered by the separating member to define the circuit of the flow passage of internal fluid

31. The fluid flow control system according to claim 27, characterized in that it further comprises a plurality of separate openings formed in the cartridge housing and a plurality of valve members movably mounted on the control housing, each one of the valve members is adapted to extend towards one of the respective separate openings and to selectively obstruct a flow through a predetermined section of the circuit of the internal fluid flow passage.

32. The fluid flow control system according to claim 27, characterized in that the internal fluid flow passage circuit interconnects at least two fluid connection gates to provide fluid flow through the disposable cartridge that it is independent of the operation of the spiral fluid device.

33. The fluid flow control system according to claim 27, characterized in that it further comprises a pressure transducer that includes a disposable transducer element located in the cartridge housing in fluid communication with the internal fluid flow passage circuit and a reusable transducer element provided in the control housing, the disposable transducer element is juxtaposed to the reusable transducer element after insertion of the disposable cartridge into the cartridge receiving area.

34. The fluid flow control system according to claim 27, characterized in that it comprises a mechanism for moving the carrying body portion of the control housing between a loading / unloading position of the cartridge wherein the carrying body is separated from the portion of main body and in a position in use wherein the carrier body portion moves towards the main body portion.

35. The fluid flow control system according to claim 27, characterized in that the cartridge housing includes a front wall provided with suspension elements adapted to support a reservoir unit, one of at least two connection gates of fluid allow the reservoir unit to be fluidly connected to the internal fluid flow passage circuit.

36. A disposable cartridge for use in a fluid flow control system, characterized in that it comprises: a cartridge housing formed of at least two housing sections which are joined together, the housing sections are provided with at least two gates fluid connection, an internal fluid flow passage circuit connected fluidly to the connection gates and an opening that exposes an interior of the cartridge housing; and a miniature spiral fluid device formed of plastic, the spiral fluid device has associated inlet and outlet ports in fluid communication with the internal fluid flow passage circuit and at least one mobile work element provided with a member connection adapted to be interconnected with a drive element for the operation of the spiral fluid device-d, the spiral fluid device is positioned within the cartridge housing with the connecting member being located in the opening.

37. The disposable cartridge according to claim 36, characterized in that it further comprises a spacer member positioned within the housing of the cartridge, the spacer member defines, at least in part, the circuit of the internal fluid flow passage.

38. The disposable cartridge according to claim 37, characterized in that the separating member comprises an elastomeric sheet.

39. The disposable cartridge according to claim 38, characterized in that at least two receiving sections are formed with a plurality of open channels which are covered by the separating member to define the circuit of the internal fluid flow passage.

40. The disposable cartridge according to claim 36, characterized in that it further comprises a plurality of separate openings formed in the housing of the cartridge and a plurality of valve members movably mounted on the control housing, each of the members of The valve is adapted to extend into one of the respective separate openings and to selectively exclude a flow through a predetermined section of the internal fluid flow passage circuit.

41. The disposable cartridge according to claim 36, characterized in that the internal fluid flow passage circuit interconnects at least two fluid connection gates to provide fluid flow through the disposable cartridge that is independent of the operation of the spiral fluid device.

42. The disposable cartridge according to claim 36, characterized in that it further comprises a disposable transducer element located in the cartridge housing in fluid communication with the circuit of the internal fluid flow passage.

43. The disposable cartridge according to claim 36, characterized in that the cartridge housing includes a front wall provided with suspension elements adapted to support a reservoir unit, one of at least two fluid connection gates allow the reservoir unit to be connected from fluid way to the internal fluid flow passage circuit.

44. A method for establishing a fluid flow control system, characterized in that it comprises: - inserting a cartridge, containing a pump and defining a plurality of fluid flow passages therein, a carrier body portion of a control module; and moving the carrier body portion to a main body portion of the control module to allow a drive shaft, supported by the main body portion, to be operably connected to the pump

45. The method according to claim 44 , characterized in that it further comprises: linearly extending a valve member, supported by the main body portion of the control module, within the cartridge to a position controlling the flow of fluid with respect to one of the fluid flow passages.

46. The method according to claim 44, characterized in that it further comprises: detecting a fluid pressure within the fluid flow control system; and selectively fixing an operating mode for the fluid flow system so that the pump is operated based on the desired fluid flow rate and a desired system pressure.