WO1993017729A1 - System and apparatus for controlling fluid flow from a surgical handpiece - Google Patents

System and apparatus for controlling fluid flow from a surgical handpiece Download PDF

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Publication number
WO1993017729A1
WO1993017729A1 PCT/US1993/000944 US9300944W WO9317729A1 WO 1993017729 A1 WO1993017729 A1 WO 1993017729A1 US 9300944 W US9300944 W US 9300944W WO 9317729 A1 WO9317729 A1 WO 9317729A1
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WO
WIPO (PCT)
Prior art keywords
body
reservoir
system
console
pump
Prior art date
Application number
PCT/US1993/000944
Other languages
French (fr)
Inventor
Charles E. Beuchat
Original Assignee
Alcon Surgical, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to US84530492A priority Critical
Priority to US07/845,304 priority
Application filed by Alcon Surgical, Inc. filed Critical Alcon Surgical, Inc.
Priority claimed from AU36071/93A external-priority patent/AU3607193A/en
Publication of WO1993017729A1 publication Critical patent/WO1993017729A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/0058Suction-irrigation systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/12General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit

Abstract

A system for controlling fluid flow in a microsurgical handpiece containing a control console (16), a cassette (14) having a body (30) with an open channel (60) integrally formed in the top and a gasket (36) adhered to the top to seal channel (60) fluid-tight and forming a small reservoir (26). A container (28) forming a large reservoir is mounted to body (30). Cassette (14) is retained on console (16). A passage (50) formed in body (30) and having a valve (50a) connects small reservoir (26) with large reservoir (28). A peristaltic pump (46) located in console (16) communicates with small reservoir (26) through a plurality of passages (74, 76, 78) in console (16) and cassette body (30). A venturi or diaphragm pump (44) located in console (16) communicates with large reservoir (28) through a conduit (58, 60) having another valve (58a). A flexible tubing (75) connects handpiece (12) to small reservoir (26) through a passage (76) in body (30). A microprocessor (49) in console (16) controls the operation of valves (50a, 56, 66a, 66a) and pumps (44, 46).

Description

SYSTEM AND APPARATUS FOR CONTROLLING FLUID FLOW FROM A SURGICAL HANDPIECE

Background of the Invention

The present invention relates to microsurgical equipment and, in particular, to ultrasonic microsurgical handpieces, irrigation/aspiration handpieces and control systems.

A typical ultrasonic surgical device consists of an ultrasonically driven handpiece with attached cutting tip and irrigating sleeve and an electronic control console. The handpiece assembly or probe is attached to the control console by an electric cable and flexible tubings. Through the electric cable, the console varies the power level transmitted by the handpiece to the attached cutting tip and the flexible tubings supply irrigation fluid to and draw aspiration fluid from the eye through the handpiece assembly.

The operative part of the handpiece is a centrally located, hollow resonating bar or horn directly attached to a set of piezo-electric crystals. The crystals supply the required ultrasonic vibrations needed to drive both the horn and the attached cutting tip during surgery and are controlled by the console. The crystal/horn assembly is suspended within the hollow body or shell of the handpiece by flexible mountings. The handpiece body terminates in a reduced-diameter portion or nosecone at the body's distal end. The nosecone is externally threaded to accept the irrigation sleeve. The horn has a bore that is internally threaded at its distal end to receive the cutting tip. The irrigation sleeve also has an internally threaded bore that is screwed onto the external thread of the nosecone. The cutting tip and sleeve are sized so that the tip projects only a predetermined amount past the open end of the irrigating sleeve. Ultrasonic surgical instruments, cutting tips and irrigating sleeves are more fully described in U.S. Patents Nos. 3,589,363, 3,693,613, 4,180,074, 4,223,676, 4,515,583, 4,573,979, 4,578,059, 4,609,368, 4,634,420, 4,643,717, 4,652,255, 4,681,561, 4,705,500, 4,787,889, 4,808,154, 4,816,017, 4,816,018, 4,869,715, 4,922,902 and 4,983,160, the entire contents of which are incorporated herein by reference.

In use, the cutting tip and irrigating sleeve ends are inserted into a small incision of predetermined width in the cornea, or other surgical site. The cutting tip is ultrasonically vibrated within the irrigating sleeve by the crystal-driven ultrasonic horn, thereby emulsifying the selected tissue in situ. The hollow bore of the cutting tip communicates with the bore in the horn that in turn communicates with the aspiration line from the handpiece to the console. A reduced pressure or vacuum pump in the console draws (aspirates) the emulsified tissue from the surgical site through the open end of the cutting tip, the cutting tip and horn bores and the aspiration line and into a collection container on the console. The aspiration of emulsified tissue is aided by a saline flushing solution or irrigant that is injected into the surgical site through the small annular gap between the inside surface of the irrigating sleeve and the cutting tip and by ports at the distal end of the sleeve. The multiple connections for power, aspiration and irrigation between the handpiece and the console in such microsurgical instruments have made complex the preparation and interconnection of the equipment preparatory to the surgical procedure, with consequent concerns about maintaining sterility and assuring error-free connection. Accordingly, in modern versions of typical microsurgical instruments, the fluid handling connections have come to be centralized in a "cassette" which contains in one unit connections for the aspiration and irrigation lines, internal conduits for directing the flow of fluids and a collection container for aspirated fluid and tissue. The cassette typically is supplied in a sterile package with the connecting tubing already attached. Thus, setting up the equipment requires only connecting the cassette tubing to the surgical handpiece and inserting the cassette into a receptacle on the console. The receptacle contains a device or devices to exercise control over the flow of fluids through the fluid conduits within the cassette. The cassette usually is discarded after a single use but also may be reusable if made from autoclavable materials.

Such a cassette is disclosed, for example in Steppe, et al., U.S. Patent No. 4,713,051. The Steppe, et al. cassette is intended to cooperate with a control console that has the roller head element of a peristaltic pump as well as protruding occluder bars that can occlude the flexible tubular conduits that carry fluids through the cassette. The cassette also is connected to a controlled vent valve within the console that quickly relieves the vacuum created within the aspiration conduit of the cassette when the aspiration function is discontinued by the surgeon. When the cassette is installed in the console, an arcuate cutout on the cassette containing a tubular, compressible conduit that forms the lumen of a peristaltic pump engages the roller head to supply a source of reduced pressure for the handpiece. The output of the peristaltic pump is collected in a flexible bag suspended from the cassette. The Steppe, et al., cassette, however, is limited to use with a peristaltic pump and contains flexible tubings as internal fluid conduits. The use of flexible tubings increases the complexity and manufacturing cost of the cassette. Another microsurgical cassette intended to avoid some of the 5 disadvantages associated with the use of standard or even special tubes for conducting fluid through the body of the cassette is disclosed in Sundblom, et al., U.S. Patent No. 4,758,238. The Sundblom, et al. cassette uses channels molded into the body of the cassette and a covering gasket held tightly against the molded body by a cover plate as internal fluid lo conduits. The gasket is flexible and stretchable and at certain points along the conduit, enlarged chambers are formed in the conduits. The chambers allow enough room for the gasket to be blocked by the action of a valve stem stretching the gasket into the chamber to seal the conduit inlet. While this cassette addresses some of the disadvantages associated is with the use of flexible tubings as internal conduits, the Sundblom, et al., cassette is limited to use with a diaphragm or venturi pump.

De eo, et al., U.S. Patent No. 4,798,580, discloses a microsurgical cassette having a peristaltic pump tube within the cassette that cooperates with a roller drive on the console to provide a source of reduced pressure

20 for the aspiration function of the microsurgical handpiece. The DeMeo, et al. cassette has a vent for venting the suction conduit to the atmosphere when the peristaltic pump is stopped. This vent consists of a flexible tube that is compressed and thereby occluded by an occluder bar in the console. The occluder bar occludes the vent whenever the peristaltic pump

25 is operating and is withdrawn when the peristaltic pump is stopped to vent atmospheric air into the suction line.

The DeMeo, et al . cassette also has an irrigation fluid conduit consisting of an inlet port for connection to a source of irrigation fluid, an outlet port for connection to the tubing supplying irrigation fluid to

30 the microsurgical handpiece and a flexible tube within the cassette connecting the inlet port and the outlet port. A portion of the tube can be occluded to prevent or permit the flow of irrigation fluid by pressure from a console-mounted actuator. This cassette has many of the -disadvantages associated with the Steppe, et al., cassette discussed above.

'*. 35 Ophthalmic surgeons generally prefer to use the type of vacuum pump on which they were trained. Many cataract surgeons are trained on peristaltic pumps and, accordingly, they tend to prefer these pumps. On the other hand, a significant number of posterior segment surgeons are trained on venturi or diaphragm pumps and, of course, such systems tend to be preferred. However, pump preferences are based not only on these training factors, but equally significantly to pump selection are the different performance characteristics for each type of pump. For example, when performing anterior segment surgery (e.g. cataract surgery), most surgeons prefer the flow characteristics of a peristaltic pump that help to prevent chamber collapse upon the break-up of any occluding tissue. The peristaltic pump is also used in situations favoring pumping systems having smaller size and weight, and less noise. Also, peristaltic pumps provide a greater degree of pumping control and have the further advantage that the fluid does not contact the pump components. On the other hand, during posterior segment surgery (e.g. vitrectomy surgery), surgeons prefer the high, pulseless flow of a diaphragm or venturi pumping system. Diaphragm or venturi pumps also have an inherently quick vacuum response or rise time at the operative site. However, diaphragm and venturi type pumps cannot be used to sense occlusions at the handpiece, whereas peristaltic pump systems can sense these occlusions.

The prior art has, in general, provided separate pump control consoles for each of the different types of pumps, increasing the amount of acquisition, operating and maintenance expenses that must be paid by the surgeon. Another drawback of using different pump systems is the requirement that different aspiration fluid collection containers be used with each type of system. Specifically, the type of aspiration collection container generally differs with the type of system used. For example, peristaltic systems tend to use flexible containers for tissue and fluid collection, while diaphragm and venturi systems tend to use rigid containers. These different containers affect the rate at which tissue is aspirated because the aspiration rate is primarily a function of the pressure level provided by the pump and the volume of the collection container. If the pressure level is too high or the container size too large, then the tissue removal rate can be too slow for surgery.

Consequently, smaller containers that provide faster vacuum rise time generally are preferred. However, smaller containers fill more quickly and sometimes must be emptied prior to conclusion of the operation, thereby - prolonging the operation - an undesirable result. A solution to this latter problem is to use a smaller container for quick rise time in combination with a larger storage container. Such a combination is disclosed in Sundblom, et al., U.S. Patent No. 4,758,238.

Another approach for obviating the necessity of purchasing different systems for anterior and posterior segment surgery is disclosed generally £ in U.S. Patent No. 4,428,748. Specifically, a dual mode handpiece is disclosed that can be used for performing phacoe ulsification and for performing posterior segment operations, such as in vitrectomy. Nonetheless, the versatile handpiece is limited by the control console that contains only a peristaltic pump. As a result, this system fails to provide the desired quick response time and has the same limitations as other peristaltic systems.

Until the present invention, prior art surgical aspiration and irrigation systems were not operable in different modes for allowing a surgeon to alternate selectively between different individual pumps for use with different surgical handpieces and operable selectively in another mode for combining the operation of the different pumps. Moreover, the prior art lacks a multi-mode system compatible with a single multi-functional surgical cassette. Despite the many achievements to date, there is ongoing interest in overcoming the above limitations and improving state of the art.

Brief Summary of the Invention

The present invention improves upon prior art systems by providing an aspiration fluid flow controlling system and apparatus for use in controlling aspiration of tissue and fluid from a surgical site having both a peristaltic pump and a venturi or diaphragm pump. Essentially, the system comprises a control console, a surgical handpiece having a cutting tip with an aspiration passage for allowing the aspiration of body fluids and tissue and a cassette. The cassette releasably cooperates with the control console for controlling the system. The cassette has a housing with a passage that will connect to different reduced pressure sources (pumps). In this manner, body fluid and tissue from a surgical site are aspirated into a container that is connected to and supported by the housing. The passage includes a valve for occluding the aspiration flow from the surgical site through the passage and the handpiece tip to control aspiration at the surgical site. A second passage in the housing has a second valve and is connected on one side to the handpiece and on the other side to a source of irrigation fluid. The second passage and valve allow the system to control the flow of irrigation fluid to the surgical site.

In a first embodiment, the housing has a small reservoir that is connected to a peristaltic pump in the console. A rigid container is suspended from the housing and forms a second, larger reservoir that is connected to a venturi or diaphragm pump. Valves having diaphragms integrally formed in the housing and operated by valve stems actuated by solenoids in the console allow the control console to connect, either independently or consecutively, the peristaltic and venturi/diaphragm pumps to the small and large reservoirs, whereby the pumps can be operated either independently or together through either the small or large reservoirs. The control console may use a microprocessor for controlling the pumps and valves and to allow different modes of operation.

In a second embodiment, the system uses only a venturi or diaphragm pump as the source of reduced pressure.

In a third embodiment, the system contains a fluidic block assembly in combination with both a venturi or diaphragm pump and a peristaltic pump.

The present invention further contemplates a system and apparatus for selectively controlling the aspiration of tissue and fluid from a surgical site into a single ulti-function cassette through both the independent and collective use of different types of pumps.

Accordingly, one objective of the present invention is to provide a system and apparatus for selectively controlling the aspiration of tissue and fluid from a surgical site having both a positive displacement type pump and a vacuum type pump.

Another objective of the present invention is to provide a system and apparatus for selectively controlling the aspiration of tissue and fluid from a surgical site having both a peristaltic pump and a diaphragm pump. Still another objective of the present invention is to provide a system and apparatus for selectively controlling the aspiration of tissue and fluid from a surgical site having both a peristaltic pump and a venturi pump.

Still another objective of the present invention is to provide a system and apparatus for controlling the aspiration of fluids from a surgical site having both a fast response time and a relatively large aspiration fluid storage capacity.

Still another objective of the present invention is to provide, in a single unit, a microsurgical cassette containing all the necessary passages and connections for providing fluid flow between a control console and a microsurgical handpiece.

Another objective of the present invention is to provide a microsurgical cassette that is simple and inexpensive to manufacture.

Another objective of the present invention is to provide a simple microsurgical cassette containing an integral waste container.

Another objective of the invention is to provide a microsurgical cassette having a simple and efficient valve for allowing the console to control the fluid to or from the handpiece. Still another objective of the present invention is to provide a microsurgical cassette having valves that are simple to manufacture and operate, yet provide an effective, reliable occlusion of fluid flow.

Still another objective of the present invention is to provide a microsurgical cassette having valves that exhibit fast response and are operable by light load solenoids in the console.

A further objective of the present invention is to provide a microsurgical cassette having valves with improved reliability.

These and other objectives and advantages of the present invention will be apparent from the detailed description, drawings and claims that follow.

Brief Description of the Drawings

FIG. 1 is a schematic view of a surgical, aspirating control and collection system according to the first embodiment of the present invention.

FIG. 2 is an exploded perspective view of the multi-function cassette of the present invention.

FIG. 3 is top plan view of the cassette illustrated in FIG, 2. FIGS. 4A and 4B are enlarged cross sectional views of one preferred valve used in the cassette of the present invention shown in open and closed conditions.

FIGS. 4C and 4D are enlarged cross sectional views of a second preferred valve used in the cassette of the present invention shown in open and closed conditions.

FIG. 5 is a longitudinal cross-sectional view of the cassette illustrated in FIGS. 2 and 3 taken along line 5-5 in FIG. 3.

FIG. 6 is a schematic view of a surgical aspirating control and collection system according to the second embodiment of the present invention.

FIG. 7 is a schematic view of a surgical aspirating control and collection system according to the third embodiment of the present invention shown in peristaltic pump mode.

FIG. 8 is a schematic view of a surgical aspirating control and $ collection system according to the third embodiment of the present invention similar to FIG. 7 but shown in venturi pump mode.

Detailed Description of the Invention Referring generally to FIGS. 1-5, one embodiment of the surgical aspirating control and collecting system 10 of the present invention includes surgical handpiece 12, multi-function cassette 14, control console 16 and irrigation fluid source 18. Handpiece 12 can be one of a variety used in the field such as those available from Alcon Surgical, Inc., Fort Worth, Texas. Irrigation fluid source 18 is preferably a gravity-fed glass or plastic bottle and is well-known in the art and available from sources such Alcon Surgical, Inc., Fort Worth, Texas under the tradename BSS® or BSS® PLUS. As illustrated in FIG. 1, handpiece 12 is an ultrasonic surgical aspiration/irrigation handpiece having cutting tip assembly 12a for delivering irrigation fluid to the surgical site (not shown) and for allowing aspiration of body fluids and fragmented tissue debris from the site. Vitrectomy handpieces may also be used. Handpiece 12 is connected through cassette 14 to console 16 by flexible fluid tubings 20 and 75 that are preferably polyvinyl chloride (PVC) or si-licone rubber. As can best be seen in FIGS. 2, 3 and 5, cassette includes body 30, main collecting chamber or reservoir 24 and gasket 36. Large reservoir 24 is defined by a large, detachable collection vessel 28 mounted on body 30. Body 30 preferably is one-piece and molded from J-VON, silicone rubber or other suitably flexible material and may be made from multiple piece adhered together by suitable adhesive or hermetic or ultrasonic welded. Vessel 28 preferably is made from a clear rigid plastic such as rigid ABS and has a volume of approximately 750 cm3, although other materials and volumes may also be used. Body 30 is shaped to receive annular locking lip 34 of rim 37 at open end 35 of collection vessel 28 in annular locking recess 39 formed in bottom surface 32 of body 30. Small reservoir 26 is integrally molded into top surface 31 of body 30 and preferably has a volume of approximately 20-30 cm3. Top surface 31 of body 30 also contains integrally formed fluid passage 60. Passage 60 connects large reservoir 24 with pump 44 in console 16 through connector 61 and passage 58 in console 16. Reservoir 26 and passage 60 are sealed by gasket 36 that can be made of a thin, impermeable sheet material, for example, a polyester film such as that sold under the tradename MYLAR® or a similar material, that is bonded by any suitable adhesive to body 30. Alternatively, gasket 36 can be of construction similar to body 30 and hermetically or ultrasonically <? sealed to body 30.

Body 30 also contains integrally molded fluid passages 50, 66, 74 and 76. Passage 50 connects small reservoir 26 with large reservoir 24. Passage 62 connects on one end to small reservoir 26 and on the other end to vent valve 64 and vacuum transducer 65 within console 16 through connector 59 and passage 63 in console 16. Passage 66 controls the flow of irrigation fluid between source 18 and handpiece 12. Passage 74 intersects passage 76 and connects passage 76 with vent valve 82 and vacuum transducer 84 in console 16. Passage 76 connects small reservoir 26 with handpiece 12 through tubing 75. The integral construction of passages 50, 60, 66, 74 and 76 in body 30 reduces the production costs associated with the manufacture of cassette 14 and thus, enables the production of low-cost cassettes 14. Fluid flows within passages 50, 66, 74 and 76 are controlled by pinch valves 50a, 66a and 76a, respectively, that are defined by thin, flexible portion 38 of passages 50, 66 and 76 and a valve stem 50b, 66b and 76b, respectively. As can be seen in FIGS. 4A-4B, valves 50a, 66a and 76a operate by valve stems 50b, 66b and 76b pushing against wall portion 38 of each respective passage so that the passage is pinched shut and fluid flow through the passage is prevented. Valves stems 50b, 66b and 76b are caused to be pushed against wall portions 38 by solenoids (not shown) within console 16. The thickness of wall portions 38 used to achieve the desired valving will vary depending on the materials used, for example, between approximately 0.06 inches and 0.187 inches. Alternatively, as best seen in FIGS. 4C-4D, valves 50a, 66a and 76a can be formed of valve stems 50b, 66b and 76b and flexible plugs 38' instead of walls portion 38. Plugs 38' are preferably silicone rubber and fit within wall recess 39 in an associated pair of passageways 50d, 66d or 76d that are to be blocked by plug 38' and operate in a manner similar to wall portion 38 described above. Wall portion 38 or plugs 38' permit the use of light load solenoids in console 16 and are preferred structures for valves 50a, 66a and 76a, however, alternative valving structures may also be used.

Control console 16, as illustrated schematically in FIGS. 1 and 6, includes controller 48, pump 44 and peristaltic pump 46. Any suitable control console 16 can be used so long as it structurally and releasably supports cassette 14 in such a fashion that allows the functional cooperation described herein. Pump 44 is preferably a venturi, diaphragm or other type of self-priming pump. Pumps 44 and 46 are independently controlled but can be operated to function collectively and so. that their outputs are blended. Controller 48 is controlled by microprocessor unit to

(MPU) 49 that receives input from vacuum transducers 54, 65 and 84, and controls vent valves 64 and 82, both pumps 44 and 46, the solenoids that operate valves 50a, 66a and 76a and valve 56 within passage 58 in console 16. In use, cassette 14 is retained on console 16 by any suitable means (not shown) so that the solenoids are in operative association with valve stems 50b, 66b and 76b, passage 60 is in fluid communication with pump 44 and vacuum transducer 54 through console passage 58, passage 62 is in fluid communication with vent valve 64 and vacuum transducer 65 through passage 63 and passage 74 is in fluid communication with vent valve 82 and vacuum transducer 84. Irrigation source 18 is connected to handpiece 12 through irrigation line 20, passage 66 in body 30 and tubing 20'. Handpiece 12 is connected to small reservoir 26 through aspiration line 75 and passage 76 in body 30. Tube portion 78 of peristaltic pump 46 is connected on one end 78a to passage 76 upstream of valve 76a, looped over roller head 46a and is connected at the other end 78b to passage 76 downstream of valve 76a.

A pressure level to be maintained within reservoirs 24 and 26 is selected by a suitable control (not shown) on console 16. MPU 49 activates pump 44, thereby drawing down the pressure in reservoirs 24 and 26 through passage 58 in console 16, passage 60 in body 30 and passage 50 in body 30 between large reservoir 24 and small reservoir 26. When the desired pressure level in small reservoir 26 is reached, MPU 49 signals the appropriate solenoid to push on valve stem 50b, thereby closing valve 50a and sealing off passage 50. MPU 49 activates valve 56 within console 16, sealing off passage 58 and preventing the pressure within large reservoir 24 from being reduced further. When the pressure within large reservoir 24 rises above the preselected pressure, the pressure rise is detected by vacuum transducer 54 and MPU 49 opens valve 56, thereby reducing the pressure in reservoir 24. The pressure within small reservoir 26 is monitored by vacuum transducer 65 that signals MPU 49 to open valve 50a to lower the pressure within small reservoir 26 or to open vent valve 64 to raise the pressure in small reservoir 26. In this manner, small reservoir 26 maintains the preselected pressure level of large reservoir 24 and, because of the small volume in small reservoir 26, there will be a quick rise time at handpiece assembly 12. Irrigation fluid flow is controlled by valve 66a in passage 66. Valve stem 66b is pushed in and out upon command of MPU 49 by a solenoid in the manner described above to alternatively allow and prevent irrigation fluid flow to handpiece 12.

Small reservoir 26 communicates with handpiece 12 through aspiration passage 76 that is connected to tubing 75. Aspiration passage 76 is intersected internally of body 30 at two points spaced apart from each other by both ends 78a and 78b of peristaltic tube 78. Valve 76a is positioned within passage 76 between upstream end 78a and downstream end

5 78b of tube 78. For pump 46 to operate, valve 76a is closed so that handpiece assembly 12 is subject to the reduced pressure from peristaltic pump 46. If valve 76a is opened, only pump 44 can draw from pressure reservoirs 24 and 26. Operation of peristaltic pump 46 is achieved in a conventional fashion when pump head assembly 46a rotates and sequentially

ID occludes tubing 78. When pump head assembly 46a no longer rotates and is placed in proper orientation by controller 48, it occludes tubing 78. This prevents leakage of ambient air into cassette reservoir 26 and does not inhibit the pumping action of pump 44. Passage 74 intersects passage 76 upstream of valve 76a and is in communication with vent valve 82 and vacuum is transducer 84 so that, upon command of MPU 49, passage 74 and hence, tubing 75, can be vented to ambient air when required.

In use, a surgeon operates control console 16, through, for example, footswitch 80 so as to open val es 50a, 56 and 76a and control pumps 44 and 46. Also, pinch valve 66a, which is initially shut, is opened by new

20 footswitch 80 position so as to allow irrigation fluid flow to handpiece 12. Opening valves 50a, 56 and 76a, of course, opens respective passageways 50, 58, 60 and 76. This allows the reduced pressure of pump 46 to be applied to reservoirs 24 and 26 and ultimately to handpiece 12. Aspiration at the surgical site can be controlled by the surgeon up to the

25 preset value through normal operation of footswitch 80. To maintain the desired pressure level, transducers 54 and 65 monitor the pressure level in reservoirs 24 and 26, respectively. Vent valve 64 and transducer 65 combine in a known fashion to balance the pressure level in reservoir 26 while transducer 54 controls pump 44 for achieving the desired pressure

30 level. For example, if the pressure in reservoir 26 is too low, the pressure is increased by bleeding ambient air into reservoir 26 through vent valve 64. If the pressure is too high in reservoirs 24 and 26 then pump 44 is operated at a higher rate. When stasis is reached and maintained, aspiration from the surgical site continues in the desired

35 manner. As noted, large reservoir 24 acts as a pressure reservoir for small reservoir 26 and as the main debris retaining reservoir for pulling the aspirated body tissue and fluid from small reservoir 26. It will be noted that there is a continuous transfer of fluid from small reservoir 26 to large reservoir 24 because valve 50a generally is kept open. Reservoir .

26 exhibits a quick rise time because of its relatively small volume. Of course, when aspirant is in small reservoir 26, the combination of vent valve 64, transducers 54 and 65 and pump 44 keep the pressure level in reservoirs 24 and 26 maintained at the desired value for pulling the aspirant into reservoir 24. The foregoing describes the system 10 under the influence of pump 44.

The surgeon can cease operation of the aspiration flow of system 10 by moving footswitch 80 to a position where pinch valve 76a closes passageway 76, thereby stopping the aspiration flow. Also, quick stoppage of the aspiration at handpiece 12 can be accomplished by opening vent valve 82 that communicates with the handpiece 12 through passage 74 and tubing 75. The aspiration flow and the irrigation flow can be controlled independently.

If peristaltic pump 46 is operated exclusively, footswitch 80 can be moved to another suitable position, whereby valves 76a and 56 are closed. However, transducer 54 remains operable for monitoring the pressure level in reservoir 24 while transducer 65 monitors the pressure level in reservoir 26. Accordingly, the pressure level in both reservoirs 24 and 26 can be controlled at the desired values. If there is an occlusion at handpiece 12, transducer 84 senses the drop in pressure in passage 76 and transmits this information to MPU 49 which directs valve 76a and vent valve 82 to open and places handpiece 12 in communication with ambient conditions. As noted, transducer 84 and valve 82 monitor the operation of pump 46 as it would under a standard peristaltic system. Pump 44 is not operated while pump 46 is being operated. Hence, the foregoing description relates exclusively to use of pump 46.

As noted earlier, hybrid modes are contemplated that permit the collective use of both pumps 44 and 46. MPU 49 preferably includes a buffer device (not shown) for storing and feeding the previously noted inputs, in appropriately encoded form, so that they interact with a read only memories (ROMs) 86. ROMs 86 each serve to store a program defining MPU 49 operating instructions which will manipulate the inputs and control operation of system 10 as described. Controller 48 allows the surgeon to actuate either one of pumps 44 and 46 independently or, if desired, to operate them sequentially to thereby effect the hybrid pumping action. For example, in the hybrid mode, it is possible to have one of the ROMs 86 contain instructions so that the initial phase of the operating procedure will be governed through the exclusive use of pump 44 so as to take a advantage of the quick response time and relatively pulseless flow of this type of pump. The program can then cease operation of pump 44 and commence operation of pump 46 to complete the air withdrawal from reservoirs 24 and 26 to the desired preset pressure level established by the surgeon. For example, the switching can automatically occur when 85% of the desired pressure level is achieved by the pump 44. By switching to pump 46, occlusion breaks at handpiece 12 can be sensed and, thereby vent handpiece 12 when needed as noted above. Also, system 10 can be manually operated to switch between pumps 44 and 46. Thus, controller 48 permits a more rapid evacuation of the body fluids and debris from the surgical site while also allowing system 10 to detect occlusion breaks.

It will also be appreciated that control console 16 includes mode selection switch 88. Switch 88 is selectively operable between a plurality of positions to access different ROMs 86 to provide different programs for providing different operating characteristics. It will be appreciated that one of ROMs 86 can be programmed to operate both pumps 44 and 46 in a different sequence and even simultaneously; however, the latter would be inefficient. In this latter connection, valve 76a would remain closed while both pumps 44 and 46 are operated. Controller 48 would act to regulate the pressure levels in reservoirs 24 and 26 through the use of the transducers 54, 65 and 84 and vent valves 64 and 82. The foregoing also permits the rapid, withdrawal of aspirant from the surgical site. Accordingly, the surgeon needs only one machine for performing different surgical procedures. In a second embodiment of the present invention, illustrated schematically in FIG. 6, system 10 contains only vacuum pump 44 and does not contain a peristaltic pump. Cassette 14 is essentially the same as the first embodiment and operates in the same manner as the previous embodiments functions as they relate to use of pump 44. Reference is made to FIGS. 7 and 8 for illustrating a third embodiment of the present invention. As depicted, a dual aspiration control system 100 is disclosed which uses peristaltic pump 102 and/or vacuum pump 104 in conjunction with fluidic block assembly 106. Fluidic block assembly 106 is of the type disclosed in U.S. Patent No. 5,041,096, that is incorporated herein by reference in its entirety. Assembly 106 includes fluidic block 108 that cooperates with pumps 102 and/or 104 and collection vessel or bag 110 that receives the aspirated contents from handpiece assembly 12. The detailed features of assembly 106 and its manner of mechanical connection to control console 16 are fully disclosed in U.S. Patent No. 5,041,096 and, hence, will not be discussed. While this invention discusses a pair of different pumps 102 and 104 used in conjunction with fluidic block 108 and the noted U.S. Patent discusses a console with a single pump, the manner of mechanical connection of block 108 to the console is the same. Hence, only those features necessary to understand this invention will be discussed.

Fluidic block 108 is made of a rigid, low-cost, and molded plastic such as rigid ABS. Fluidic block 108 has an elongated shape and is formed with upper and lower aspiration passages 114, 116; respectively, as well as transducer passage 118. Lower aspiration passage 116 defines the fluid discharge passages in the lower extremity of fluid block 108 and terminates at discharge port 120. Fluidic block 108 has a projection so that collection vessel 110 may be removably suspended therefrom for receiving aspirant. Fluidic block 108 has fluid fittings 122, 124, 126 and 128. Fluid fitting 122 is removably secured to one open end of aspiration tubing 130, while the other end of the tubing 130 is removably secured to fluid fitting 124. Fluid fitting 126 communicates by way of passageway 131 with transducer 132 and vent valve 134 in control console 16. Fluid fitting 128 communicates with reservoir 138 through flexible aspiration tubing line 136. Reservoir 138 has a volume of about 20-30 cm3 for effecting a quick rise, which will.be discussed hereinafter.

Reference is made to peristaltic pump 102 which includes a plurality of pumping rollers 140 on a hub roller assembly 142 which are rotatably driven by a suitable motor (not shown) in console 16. Operation of the motor drives roller assembly 142 so that rollers 140 compress occludable tubing 130 for effecting the desired pressure levels in the manner discussed above.

Control console 16 includes passage 144 fluidly coupled to reservoir 138. Reservoir 138 is also connected to handpiece 12 through tubing 75. Control passage 144 leads to vacuum transducer 146 which monitors the pressure level in reservoir 138. Also in fluid communication with passage 144 is vent valve 148 and venturi or diaphragm pump 104 for creating the reduced pressure in the system. Valve 152 opens to reservoir 138 in response to a suitable command signal from controller 48 in control console 16. Reservoir 138 is connected to filter assembly 154 which is fluidly connected to and between console passage 144 and inlet 156 of reservoir 138. Filter assembly 154 is typically used with a venturi and/or diaphragm pump and is preferably a hydrophobic filter. Inlet 156 has a swivel-type connector to filter assembly 154 so as to allow swiveling of the reservoir 138 between the position shown in FIG. 7 and the position shown in FIG. 8. Suitable latching means (not shown) assist in retaining reservoir 138 in the desired positions. Microswitch 158 on console 16 is arranged so as to be contacted by reservoir 138. When switch 158 is energized, such as when reservoir 138 is in the upper position shown in FIG. 8, valve 152 is opened and pump 104 is operated under control of controller 48 to aspirate body fluid and tissue from handpiece 12.

In the peristaltic mode of operation, pump 104 is, of course, inoperable and thus valve 152 is closed. Reservoir 138 is in the orientation shown in FIG. 7 and pump 102 is operable. Specifically, rollers 140 sequentially occlude aspiration tubing 130 so as to aspirate body fluid and tissue from handpiece 12 through reservoir 138, through fluid block 108 and into collection vessel or bag 110. Vacuum transducer 132 and vent valve 134 operate in known fashion to control the pressure level within reservoir 138.

Whenever it is desired to have the system function in a venturi or diaphragm mode, reservoir 138 is pivoted or swiveled upwardly to the position indicated in FIG. 8. When held in this position by, for example, the latching means, microswitch 158 is actuated so as to open vent valve 152 and activate pump 104. Simultaneously, peristaltic pump 102 is deactivated along with its associated transducer 132 and vent valve 134. In this particular mode, pump 104 will aspirate body fluid and tissue from handpiece 12 through reservoir 138. Transducers 146 and 148 operate in conventional fashion to ensure that the pressure level in reservoir 138 is at the desired level. In this particular embodiment, pump 102 is inoperable, but is positioned so that rollers 140 do not occlude aspiration tubing 130, thereby allowing the aspirant to be drawn through reservoir 138, fluidic block 108 and tubing 130 and into collection bag 110. Another particular embodiment envisions that the peristaltic pump 102 can operate in conjunction with pump 104 as described in the previous embodiment, namely, consecutively or simultaneously. In the consecutive mode ROM 68 associated with controller 49 and MPU 49 can be used to initially operate pump 104 followed by peristaltic pump 102. In the simultaneous mode both pumps 102 and 104 would operate to pump aspirant quickly. The foregoing system, while not providing as much versatility, nevertheless allows fluidic block 108 to be used in a dual pressure mode and in an inexpensive yet highly reliable manner.

This description is given for purposes of illustration and explanation. It will be apparent to those skilled in the relevant art that modifications can be made to the invention as described above without departing from its scope or spirit.

Claims

I claim:
1. A system for controlling fluid flow in a microsurgical handpiece, comprising:
5 a) a control console; b) a cassette adapted to be retained within an interface area on the control console having a body with an integrally formed small reservoir and a container mounted to the body and forming a large reservoir;
ID c) a transfer passage formed in the body having a first valve for connecting the small reservoir with the large reservoir; d) a first pump located in the console in fluid communication with the small reservoir through a plurality of passages in the control console and the body; is e) a second pump located in the console in fluid communication with the large reservoir through a conduit having a second valve and communicating with the small reservoir through the large reservoir and the transfer passage; f) a means for fluidly connecting the handpiece to the cassette 20 through an aspiration passage in the body that communicates with the small reservoir; and g) a means within the control console for controlling the operation of the first and second valves and the first and second pumps.
25
2. The system of claim 1 wherein the small reservoir comprises an open channel formed in a top of the body and a gasket adhered to the top to seal the channel fluid-tight.
30 3. The system of claim 1 wherein the first pump is a peristaltic pump operated by a roller head in the interface area.
4. The system of claim 1 wherein the second pump is a venturi pump.
35
5. The system of claim 1 wherein the second pump is a diaphragm pump. I
6. The system of claim 1 wherein the controlling means comprises a microprocessor located in the console.
7. The system of claim 1 further comprising a means for controlling a flow of irrigation fluid to the handpiece through an irrigation passage in the body.
8. The system of claim 7 wherein the irrigation fluid flow controlling means comprises a third valve in the irrigation passage.
9. The system claim 1 further comprising a means contained within the control console for monitoring a pressure level in the small and large reservoirs so as to provide a signal for the operation of the first and second valve and first and second pump controlling means.
10. The system of claim 1 wherein the handpiece connecting means comprises flexible tubings.
11. A system for controlling fluid flow in a microsurgical handpiece, comprising: a) a control console; b) a cassette adapted to be retained within an interface area on the control console having, i) a body with an open channel integrally formed in a top of the body and a gasket adhered to the top to seal the channel fluid-tight forming a small reservoir and ii) a container forming a large reservoir mounted on the body; c) a transfer passage formed in the body having a first valve for connecting the small reservoir with the large reservoir; d) a peristaltic pump located in the console in fluid communication with the small reservoir through a plurality of passages in the control console and the body and in fluid communication with the large reservoir through the transfer passage; e) a venturi pump located in the console in fluid communication with the large reservoir through a conduit having a second valve and in fluid communication with the small reservoir through the transfer passage; f) a flexible tubing for fluidly connecting the handpiece to the cassette through an aspiration passage in the body that communicates with the small reservoir; and g) a microprocessor located in the control console for controlling the operation of the first and second valves, the peristaltic pump and the venturi pump.
12. The system of claim 11 further comprising a means for controlling a flow of irrigation fluid to the handpiece through an irrigation passage in the body.
13. The system of claim 12 wherein the irrigation fluid flow controlling means comprises a third valve in the irrigation passage controlled by the microprocessor.
14. The system claim 11 further comprising a means contained within the control console for monitoring a pressure level in the small and large reservoirs so as to provide a signal for the operation of the microprocessor.
15. A system for controlling fluid flow in a microsurgical handpiece, comprising: a) a control console; b) a cassette adapted to be retained within an interface area on the control console having, i) a body with an open channel integrally formed in a top of the body and a gasket adhered to the top to seal the channel fluid-tight forming a small reservoir and ii) a container mounted to the body and forming a large reservoir; c) a transfer passage formed in the body having a first valve for connecting the small reservoir with the large reservoir; d) a peristaltic pump located in the console in fluid communication with the small reservoir through a plurality of passages in the control console and the body; e) a diaphragm pump located in the console in fluid communication with the large reservoir through a conduit having a second valve and communicating with the small reservoir through the large reservoir and the transfer passage; f) a flexible tubing for fluidly connecting the handpiece to the cassette through an aspiration passage in the body that communicates with the small reservoir; and g) a microprocessor located in the control console for controlling the operation of the first and second valves, the peristaltic pump and the diaphragm pump.
16. The system of claim 15 further comprising a means for controlling a flow of irrigation fluid to the handpiece through an irrigation passage in the body.
17. The system of claim 16 wherein the irrigation fluid flow controlling means comprises a third valve in the irrigation passage controlled by the microprocessor.
18. The system claim 15 further comprising a means contained within the control console for monitoring a pressure level in the small and large reservoirs so as to provide a signal for the operation of the microprocessor.
PCT/US1993/000944 1992-03-03 1993-02-04 System and apparatus for controlling fluid flow from a surgical handpiece WO1993017729A1 (en)

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US84530492A true 1992-03-03 1992-03-03
US07/845,304 1992-03-03

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AU36071/93A AU3607193A (en) 1992-03-03 1993-02-04 System and apparatus for controlling fluid flow from a surgical handpiece

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