Patent Description:
The use of ultrasonic surgical instruments for various surgical procedures, including cataract removal, is well known. For example, the phacoemulsification procedure, first disclosed in <CIT>, recently reached its <NUM>-year anniversary.

Phacoemulsification handpieces today are essentially the same as the ones developed in the <NUM>. They have a very complicated design, are expensive to manufacture, and require sterilization by autoclaving in order to reuse them. The main reason for these disadvantages is the fact that the irrigation and aspiration lines extend through the handpiece and interfere with the performance of the vibrating transducer in the handpiece.

Additionally, the housing that contains the vibrating transducer must be waterproof in order to withstand the high temperatures and pressures of the pressurized steam used during autoclaving. The power cord and the electrical connector must also be able to withstand these high temperatures and pressures of the pressurized steam and must be water proof because they also must be sterilized. This adds considerable expense to the materials and procedures used in the manufacture of the handpiece.

Due to the complexity of the handpieces and the expense of the manufacturing process, ultrasonic phacoemulsification handpieces are generally sold to ophthalmic surgeons with a price ranging from four thousand to seven thousand dollars each. For example, the Alcon® OZil® Torsional Handpiece (Alcon® Model <NUM>) currently retails for $<NUM>,<NUM> from Medex Supply.

<CIT> discloses a surgical hand piece that has a solid knife connected to and supported at its proximal end by a source of ultrasonic energy. A plastic sleeve has the knife located in it. A support is provided between the sleeve and the knife to support the sleeve while minimizing the effect of the vibration of the knife on the sleeve. The space between the knife and the sleeve form a first fluid channel. A plastic fluid tube can be located along the sleeve and can provide a second fluid channel. In order to use the handpiece for cleanup the sleeve can be moved forward to cover the knife and a small aspiration tube can be provided within the sleeve. <CIT> discloses a surgical hand piece that has a solid surgical knife connected to a source of ultrasonic energy. Two or more rigid plastic irrigation and aspiration tubes are provided alongside the knife and they may be supported with respect to the knife by tube holders fastened to the hand piece housing for the source of ultrasonic energy. The rigid plastic tubes may be connected toward their distal ends by a support in the form of bands about the tubes and knife, a sleeve about the tubes and knife or a sleeve about the knife with the tubes supported on the external surface thereof. <CIT> discloses a surgical handpiece that has a connecting body with a distal end and a work tip with a hub at a proximal end. The hub is detachably connected to the connecting body by a threaded connector. The work tip has an open operating end at a distal end. This opening leads an axial channel extending through the work tip from the operating end to the hub. A radial channel extends from the axial channel in the hub to the external surface of the hub. A sleeve surrounds and is spaced from the hub. This sleeve extends to the vicinity of the operating end of the work tip, and has a first external connector in the region of the radial channel of the hub. The sleeve also has a second external connector. A seal is provided for establishing a fluid connection between the radial channel of the hub and the second external connector of the sleeve. The first external connector of the sleeve is in fluid connection with an irrigation channel between the inner surface of the sleeve and the external surface of the work tip. This irrigation channel extends to the vicinity of the operating end of the work tip for delivery of irrigation fluid to that area. The irrigation channel is generally concentric with the axial channel in the hub. Aspiration fluid is withdrawn from the open operating end of the work tip, through the axial and radial channels of the hub, the seal and the second external connector of the sleeve to an aspiration pump. <FIG> shows a prior art handpiece <NUM> made by Surgical Design Company, the present applicant, with a magnetostrictive ultrasonic transducer <NUM> that works by expanding and contracting nickel laminations <NUM> in a magnetic field. The magnetic field is provided by a wire coil <NUM> that is wound within the handpiece. As the nickel laminations expand and contract, the ultrasonic vibration is amplified and transmitted through a connecting body <NUM> to the work tip <NUM> through the connecting body <NUM>. This version of the handpiece contains fluid lines <NUM>, <NUM> within the vibrating transducer. The center fluid line <NUM> is the aspiration line that starts with the vibrating hollow phacoemulsification needle work tip <NUM> and ends at the rear connector <NUM> of the handpiece. Similarly, the irrigation line <NUM> enters the rear connector <NUM> and goes through the nickel laminations <NUM>. From there, the irrigation line enters the irrigation sleeve <NUM>.

<FIG> illustrates the complexity of the handpiece <NUM>. This complexity is due to the design of the handpiece, the autoclaving requirements, and the dozens of specialized components that are required to construct the handpiece.

<FIG> shows an enlarged view of the prior art connecting body <NUM> for the same handpiece <NUM>. The aspiration line <NUM>, the irrigation line <NUM>, and a thread design <NUM> where the connecting part <NUM> attaches to the work tip <NUM> are shown. <FIG> illustrates the complexity and tolerances of the machining required to manufacture a titanium connecting body. This complexity is in part due to the existence of the fluid lines in the body of the handpiece. For example, the tolerances and the radii are specified to thousandths of an inch.

<FIG> shows a typical prior art design for the coil assembly <NUM> for the same handpiece <NUM>, including the wire coil <NUM>. This portion of the handpiece has center fluid line <NUM> and irrigation line <NUM> passing through it. Further, this portion can be seen in relation to the rear fluid connector <NUM>, an O-Ring <NUM> for confining fluid to the lines, a waterproof housing <NUM> that surrounds the structure, a coil nut <NUM> that holds the wire coil <NUM> in place and a centering pin <NUM>. Also, as shown in <FIG> there is a cable connector <NUM>, a power cord <NUM>, a power cord jacket <NUM>, a socket set screw <NUM> and soldering terminals <NUM> that allow the ultrasonic signal transmitted over cable <NUM> to be applied to the coil to create the magnetic field that vibrates the laminations <NUM>, the connecting body and the work tip.

Repeated autoclave cycles require extraordinary efforts to seal the handpiece so that it can withstand the moisture, high pressure, and high temperatures of the autoclaving cycle. For example, in the prior Surgical Design product and other prior products the coil wire <NUM> is wound onto the handpiece and sealed with an epoxy such as the Huntsman Araldite® CY <NUM> Resin Brominated Epoxy. The power cord jacket <NUM> and the soldering terminals <NUM> that connect the power cord <NUM> to the coil wire <NUM> are sealed with GE RTV133 silicone rubber adhesive sealant that can withstand autoclaving. The power cord <NUM> is prone to failures from repeated autoclaving because the high pressures and temperatures result in water vapor that gets inside the insulation and corrodes the wires. To minimize corrosion, custom-made power cords need to be used in the handpiece. For example, a nickel-plated wire with a gold coating can be used, which is available from New England Wire Technologies (Lisbon, NH <NUM>). A roll of this custom wire was offered for $<NUM>,<NUM> per 1000ft in <NUM>, but this product is no longer available because of the complexity and cost of manufacturing it.

Because of the expense involved in the manufacture of ultrasonic surgical handpieces, it has so far been impractical to offer them as disposable items. Manufacturers have only offered reusable, autoclavable handpieces.

One of the most common uses for ultrasonic handpieces in the field of ophthalmology is for removing cataracts. Phacoemulsification systems have typically been sold in combination with the console that contains the ultrasonic generator and controls the fluidics. The titanium phacoemulsification tips and external plastic tubing that transports fluid between the surgical system and the handpiece are marketed as disposable, with the rationale that because these components come into contact with the patient's bodily fluids, it is easier and safer to dispose of them after a single use rather than autoclave them. This approach has been very profitable for manufacturers. However, the present inventor has realized that logically this does not make sense since the handpiece itself is being reused after exposure to bodily fluids, even though the channels internal to the handpiece (especially the aspiration tube) are exposed to bodily fluids and are much harder to clean and sterilize.

Concerns about the spread of infection through contaminated body fluids have intensified significantly in recent years with the escalation of HIV/AIDS and other lethal viruses; antibiotic-resistant bacteria; Toxic Anterior Segment Syndrome (TASS); and Prion (Mad Cow) Disease, against which autoclaving may not be <NUM>% effective. For example, with Prion Disease, the proteins are very stable and normal autoclaving may not be enough to denature the structure of the infectious protein and render it harmless. Also, regarding TASS, the Association of periOperative Registered Nurses (Denver, CO <NUM>) reports that most cases. appear to result from inadequate instrument cleaning and sterilization. Other reported TASS cases were associated with glutaraldehyde and detergent residue on instruments, endotoxins from gram-negative bacteria in ultrasonic cleaners, impurities in steam from improperly maintained sterilizers, and degradation of brass surgical instruments sterilized by hydrogen peroxide gas plasma. Prevention of TASS requires thorough cleaning and rinsing of surgical instruments. ("Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment," Association of periOperative Registered Nurses, p. <NUM>) Thorough cleaning does not always occur.

Even when it is effective, the autoclaving process is time-consuming and expensive. The Association of Surgical Technologists (Littleton, CO <NUM>) details <NUM> practices over <NUM> pages regarding the complexity of dealing with the decontamination of surgical instruments ("Standards of Practice for the Decontamination of Surgical Instruments," Association of Surgical Technologists). These practices involve several different steps and techniques such as placing instruments in a sterile water bath directly after surgery; manually rinsing and flushing the instruments; using ultrasonic cleaning baths with or without enzymatic detergents; etc..

The "Guidelines for the Cleaning and Sterilization of Intraocular Surgical Instruments," compiled by the Ophthalmic Instrument Cleaning and Sterilization (OICS) Task Force (which includes representatives from the American Society of Cataract and Refractive Surgery (ASCRS), the American Academy of Ophthalmology (AAO), and the Outpatient Ophthalmic Surgery Society (OOSS)) gives an overview of the comprehensive training required of nursing and medical staff regarding sterilization procedures. The guidelines, recommend that "Personnel. should be properly trained in handling, cleaning, and sterilizing intraocular surgical instruments and subject to periodic oversight. In addition to the general principles of asepsis, this training should also include the cleaning, inspection, preparation, packaging, sterilization, storage, and distribution of intraocular surgical instruments. Appropriate staff should also be trained in related tasks, such as equipment operation and preventive maintenance. They should undergo competency validations by direct observation of performance. Staff education, training, and validation of competency should be updated and documented at least annually and be coincident with the introduction of new surgical equipment, medical devices, or packaging systems. "
In addition, each instrument comes with its own specifications for autoclaving from the manufacturer, but it is highly impractical to autoclave instruments individually. All of these procedures require strict quality control guidelines and specifications, as well as careful documentation, and this takes up a significant amount of time.

In accordance with the invention an ultrasonic surgical handpiece is provided with a solid ultrasonic knife or scalpel located in a sleeve with multiple fluid channels, while retaining a uniform cross section. Further, a cobra cone shape is incorporated into the distal end of the knife to improve it efficiency. The connecting body and the knife or scalpel are manufactured as one piece. Thus, there is no thread between the connecting body and the work tip. This cuts down on manufacturing expense, greatly improves the transmission of ultrasonic vibrational energy from the connecting body to the work tip and is easier to keep clean because there are no threads to provide spaces for bacteria. The increase in efficiency allows for smaller, less expensive parts to be used to achieve the same output energy for removing surgical tissue as a typical, more complex handpiece.

The ultrasonic surgical handpiece contains a housing that is not designed, manufactured, or extensively sealed to be waterproof in order to withstand numerous autoclaving cycles because, being disposable, there is no need to autoclave it. Further, the disposable aspect of the handpiece also allows the power cord and connector to be made of simpler, less expensive materials.

Ultrasonic surgical handpieces have always been complex and expensive to manufacture. For example, phacoemulsification handpieces used for removing cataracts have the irrigation and aspiration fluid lines built into the handpiece. This interferes with the core vibrating transducer within the handpiece, and results in unnecessary complexity. Furthermore, the autoclaving of these handpieces and materials management is a huge disadvantage to the operating room staff. This complexity and its cost are avoided with the present invention wherein the fluid lines do not pass through the handpiece and it can be made to be disposable.

The benefits of having an entirely disposable ultrasonic surgical handpiece are numerous. As the European Pharmaceutical Review (Kent, TN16 1NU, UK) explains in general: "The advantages of single-use technology can be summarized as: eliminating the need for cleaning; removing requirements for in-house sterilization (typically by autoclaving) for all components; reducing the use of cleaning chemicals; cutting storage requirements; lowering process downtime; and increasing process flexibility and reducing cross-contamination risks. Tim Sandle, "Strategy for the adoption of single-use technology," <NUM> March <NUM>.

A disposable phacoemulsification handpiece that is included in a disposable tray that contains all the equipment required for a surgeon to do a cataract procedure is an additional approach to the present invention with further benefits.

Further, typically the work tip is vibrated axially. However, it is known that the work tip can be made more efficient during phacoemulsification if the work tip additionally vibrates side-to-side. See for example the transverse vibration of the J. Shock Phaco Fragmentation Unit and the OZil® Torsional Handpiece, both made by Alcon®, in which a component of motion perpendicular to the axis is present in addition to longitudinal vibration due to eccentric masses in the vibrator in general and in the tip in particular. This is beneficial regardless of the type of work tip, i.e., blade, tube or rod. According to the present invention, simpler ways to establish the side-to-side vibration are provided. For example, a stationary or slidable pin can be located in an angled slot in the center of the blade to create the side-to-side movement as the work tip vibrates axially. This side-to-side movement will be at the axial frequency if the pin is stationary or a higher frequency based on the rate of movement of the pin. In a second embodiment, a pin with a driving force perpendicular to the axial direction of the rod can apply a periodic variable pressure to the rod at the rate of the driving force and independent of the axial frequency. A still further embodiment can have a stationary pin which engages an angled or curved portion of the rod or blade so that as it vibrated the portion rides along the pin and is bent out of the axial direction at the axial direction frequency.

The foregoing and other objects and advantages of the present invention will become more apparent when considered in connection with the following detailed description and appended drawings in which like designations denote like elements in the various views, and wherein:.

<FIG> shows a disposable ultrasonic surgical handpiece <NUM> according to the present invention. This handpiece is unique in its design simplicity. The housing <NUM> can be made of plastic or metal, but does not require waterproofing to withstand the moisture, high temperatures, and high pressures of autoclaving. The internal elements can be fixed to the housing <NUM> with simple plastic or elastic components <NUM>, e.g., O-rings. No epoxies or sealants are required between the housing <NUM> and the internal components. The power cord connector <NUM> also does not require epoxies or silicones to keep moisture from entering the rear of the handpiece. In addition, the power cord <NUM> can be made of simple, inexpensive electrically conducting wires covered with insulation, where the insulation is only required for the purpose of isolating the electrical conductivity of the wires. It is not necessary to insulate the wires against corrosion due to moisture, high temperatures, and detergents or other chemicals that are encountered during autoclaving.

The ultrasonic transducer <NUM> of this handpiece <NUM> can be either magnetostrictive or made of ceramic piezo crystals. The connecting body <NUM> extends from the transducer <NUM> into a long flat blade <NUM> with a chisel work tip <NUM>. This configuration has been described in a previous patent application, i.e., Surgical Design Corp <CIT>, to which priority is claimed. Having the connecting body and the work tip as a single piece has several significant advantages. Manufacturing a single-piece connecting body costs only a fraction of the cost of manufacturing a connecting body and work tip in two pieces with threads that screw them together. For example, creating the thread <NUM> in <FIG> requires precision machining with extremely tight tolerances (thousandths of an inch). In addition to the expense, unless the thread on the work tip exactly matches the thread on the connecting body, there is a loss of energy. In particular, there is never one-hundred percent efficiency in coupling the two parts, so there is a power loss especially during ultrasonic vibration when the connecting body transmits the vibration at a frequency of anywhere from <NUM>/s to <NUM>/s. An arrangement in which the connecting body and work tip are a single piece is thus much more efficient for transmitting ultrasonic vibration and offers cost-savings that are so significant that the handpiece can be disposable.

The distal work tip <NUM> can have several configurations, as described in a previous Surgical Design Corp. However, for the purposes of this invention, these work tips are now part of an ultrasonic surgical instrument that does not require that the housing, power cord, or electrical connector be waterproof. The various work tip configurations as shown in <FIG> are as follows:.

Power is provided to the handpiece from a connector <NUM> that is attached to a console (now shown) that contains an ultrasonic signal generator and also controls the fluidics. The ultrasonic signal is passed from connector <NUM> through cable <NUM> to plug <NUM> on the proximal end of the workpiece <NUM>. The power cord parts <NUM>, <NUM> and <NUM> differ from similar parts <NUM> and <NUM> of the prior art as shown in <FIG>, in that they are disposable, so the never have to withstand autoclaving. As a result, they need not be waterproof or corrosion resistant, and as a result can be less expensive than the prior art.

During a typical phacoemulsification procedure an incision is made in the eye, and the surgeon extends the work tip <NUM> through the incision and into the vicinity of a cataract that is to be removed. The console is then operated so that fluid is directed into the incision and also withdrawn from the incision. For example, irrigation fluid from the console may be passed through flexible plastic tube <NUM> attached to the console by connector <NUM>. Fluid may be aspirated from the incision through tube <NUM>' and delivered back to the console or a separate disposable container (not shown) through connector <NUM>'. Tube <NUM>' may extend to a rotary peristaltic pump on the exterior of the console, but not into the console itself. It should be noted that the fluid lines and the blade <NUM> are surrounded by a sheath <NUM> at the distal end of the handpiece that keeps these elements together as they pass into the incision. When the cataract is contacted with the work tip <NUM>, the console provides ultrasonic electrical signals through cable <NUM> to the transducer <NUM>, which causes the tip to vibrate at an ultrasonic frequency and to chop or emulsify the cataract. During this procedure the surgical site is bathed in irrigation fluid and the pieces of cataract are withdrawn with the aspiration fluid. In this operation bodily fluid is entrained with the aspiration fluid. Also, it is possible for bodily fluid to pass through sheath <NUM> along the knife <NUM> and the exteriors of the tubes <NUM>, <NUM>'. However, this fluid cannot pass along the handpiece because of the front section of the housing <NUM> of the handpiece, which may be augmented with a seal or O-ring (not shown).

After phacoemulsification a cleanup procedure may be used to remove epithelial cells while preventing the tearing of the capsular bag of the eye. This can be done with a separate irrigation/aspiration (I/A) tool. As an alternative there are dual mode handpieces that can be converted from use in phacoemulsification to cleanup. Such a handpiece is disclosed in <CIT>. When the phacoemulsification procedure or the phacoemulsification and cleanup procedures when accomplished with a single tool are over, the entire handpiece with its connected fluid tubes and electrical power lines can be disposed of. If the aspiration line <NUM>' is directed to a waste container through connector <NUM>', that container would also be discarded. Thus, there is nothing to sterilize before operating on the next patient. Instead a new handpiece with its connected fluid tubes and electrical power lines is connected to the console and the next procedure begun. The savings in time between procedures allows for more procedure to be performed in a single session, which can lower the overall cost of each procedure. The elimination of the need for autoclaving also provides an additional saving in time and expense that can lead to a further reduction in cost.

<FIG> discloses a handpiece <NUM> which is similar to handpiece <NUM> of <FIG>. However, instead of the ultrasonic signals being hard wired from plug <NUM> to piezo crystals <NUM>, a plug <NUM> passes the signals through a socket <NUM> to a plug <NUM> on the proximal end of the crystals <NUM>. The socket <NUM> provides wires <NUM> that are connected to sockets receptacles <NUM>. The transducer <NUM> has a plug or terminal <NUM> at its proximal end. The terminal has pins <NUM> that are designed to be removably inserted into receptacles <NUM> of socket <NUM> in order to provide ultrasonic electrical power to crystal transducer <NUM>. The terminal <NUM> and the socket <NUM> can be reversed so that the socket is on the transducer and the terminal is on the cable plug <NUM>. The pins and receptacles can be generically referred to as "connectors.

Handpiece <NUM> also differs from handpiece <NUM> in that the distal end of the housing <NUM> is generally open to allow the connecting body <NUM> to pass through. However, that opening is sealed with an O-ring <NUM>. Further, the design includes a surgical drape or sterile sheet <NUM> that is fastened to the distal end of the connecting body and can be draped over the handpiece housing. As a result, the sheet <NUM> protects housing and the power cable from bodily fluids. With the design of <FIG>, the knife <NUM>, connecting body <NUM>, transducer <NUM> and terminal <NUM> may be detached as a unit from socket <NUM>, so that the socket <NUM>, plug <NUM>, cord <NUM> and connector <NUM> need not be discarded and because of surgical sheet <NUM>, they also do not need to be sterilized between procedures on different patients. In effect the connecting body with the sheet <NUM> is pulled in the distal direction out of the opening in the housing so that it, the transducer <NUM> and terminal <NUM> slide out of the housing <NUM> beyond the O-ring <NUM>. By saving the housing <NUM>, socket <NUM> and powerline, and avoiding the need to sterilize them between procedures, the cost of the disposable parts is greatly reduced, making this a much more viable option.

<FIG> is a design for a handpiece <NUM> that is similar to handpiece <NUM> of <FIG>, but for use with a magnetostrictive transducer such as that shown in handpiece <NUM> of <FIG> instead of a piezoelectric crystal transducer. In fact, because piezoelectric crystals need direct connection to an electrical supply, while the nickel laminations <NUM> of a magnetostrictive transducer only need electromagnetic connection to the coils <NUM> of the handpiece, the connecting body <NUM> is easily separated from the rest of the handpiece without any special plug/socket arrangement, presenting a further reduction in cost.

As shown in <FIG>, the handpiece and power cord could be disposed of because the tubes <NUM>, <NUM>' do not run through the handpiece. However, by including a sheet <NUM> attached to the connecting body <NUM> as shown in <FIG>, the rest of the handpiece and the power cord are protected from bodily fluids. This includes any fluids that may travel along the blade to the distal end of the connecting body. With this arrangement, when the surgical procedures are completed, all that is necessary is to pull the connecting body <NUM> so that it and the laminations <NUM> are withdrawn from the portion of the housing <NUM> with the surrounding coils <NUM>. The blade <NUM>, connecting body <NUM>, tubing <NUM>,<NUM>' and sterile sheet <NUM> are then discarded. However, the handpiece, including the coils <NUM>, and the power cord <NUM>, <NUM> can be retained and reused without the need for sterilization.

Typically, the work tip <NUM> is vibrated axially. However, it is known that the work tip can be made more efficient during phacoemulsification if the work tip additionally vibrates side-to-side. This is beneficial regardless of the type of work tip, i.e., blade, tube or rod. According to the present invention, simpler ways to establish the side-to-side vibration are provided. For example, <FIG> shows a pin <NUM> located in an angled slot <NUM> in the center of the blade <NUM>. The pin may be stationary or movable in the axial direction. When the pin is stationary axial forward movement (to the right in <FIG>) of the blade causes the pin to contact the angled edge <NUM> of the slot, which forces the blade more and more to one side. During the rearward movement of the blade returns to its center position. The pin <NUM> can be fastened either to the housing <NUM> as shown in <FIG> or to the expanded proximal end of the sheath <NUM>, which may be made of a hard-plastic material or metal. As a result, the blade (rod or tube) will vibrate side-to-side at the same frequency as the axial motion. However, if the pin moves axially, the side-to-side frequency can be increased based on that movement, but it will be related to the axial movement of the blade.

The contact between the edge <NUM> and the pin <NUM> may create friction that generates some heat in the blade and wear on the pin. One way to reduce this is to make the pin of a low friction materials, e.g., Teflon®. Further, if the blade and pin are disposable after each use, they will be discarded before they loses their effectiveness. Movement of the pin <NUM> may be by means of a small transducer on the housing <NUM> or the sheath <NUM> that is provided with an electrical signal, e.g., from the console.

If the connecting body is designed to be disposable, the housing arrangement of <FIG> is required. In such a case, the pin should be mounted on the expanded distal end of the sheath <NUM> or their will need to be an extension of the housing <NUM> to the vicinity of the blade <NUM>.

In a second embodiment in <FIG>, there is a pin <NUM> moved by a driving force perpendicular to the axial direction of the rod. It applies a periodic variable pressure to one side of the rod to create the side-to-side motion. The driving force can come from a transducer (not shown but indicated by arrows at the pin) located in the wall of the housing <NUM> or the sheath <NUM>. The transducer may have a self-generator or be supplied with a variable electrical signal from the console. The main transducer <NUM> causes axial movement of the blade <NUM>, while the transducer attached to pin <NUM> causes perpendicular movement of the pin and hence the blade. The arrangement of <FIG> has a benefit over the embodiment of <FIG> in that the side-to-side motion can be at a different and independent frequency from that of the longitudinal vibration. However, this benefit comes at the expense of additional elements in the design. In order to reduce friction, the pin <NUM> may be made of a material such as Teflon.

A still further embodiment is shown in <FIG>. In that design a curved area <NUM> is created in the rod or blade <NUM> on one side. A stationary pin <NUM> extending from the housing or sheath engages the area <NUM> so that it bents the blade out of the axial direction creating side-to-side movement at the same frequency as the axial movement.

<FIG> shows another embodiment in which the side-to-side vibration is caused by a magnetic field. In particular, a magnetic coil <NUM> is set up on the housing or sheath <NUM>. It is fed with an electrical signal from the console or otherwise. A magnet <NUM> is placed on the blade <NUM>. When an alternating magnetic field is set up by the coil, it causes the blade to vibrate from side-to-side.

A disposable phacoemulsification handpiece that is included in a disposable tray that contains all the equipment required for a surgeon to do a cataract procedure is an ideal way of addressing the problems that traditional handpieces raise.

<FIG> illustrates the components of a disposable surgical tray <NUM> that includes a handpiece <NUM> described in this invention. The tray contains the following items:.

<FIG> illustrates the components of a second disposable surgical tray that does not include the surgical instruments. The tray contains the following:.

With the cost savings from (a) eliminating the threaded connection between the connecting body and blade, and perhaps between the blade and work tip; (b) eliminating the need to form fluid channels through the handpiece; and (c) eliminating the hollow tube work tip and replacing it with a blade, the cost of the hand piece can be sufficiently low that it can be a disposable single-use item. Making the handpiece disposable means there is no longer a need to sterilize the handpiece after use. The sterilization process typically involves moisture and high temperatures. As a result, the handpiece, particularly the ultrasonic transducer, must be made to withstand sterilization, e.g., making the coils of gold wire. Thus, by avoiding sterilization the transducer can be made of less extensive parts (e.g., copper wire) making it even more feasible to have it as a single-use disposable item.

Even more savings can be realized by making the work tip, blade, connecting body, transducer and at least part of an electrical terminal such that they can be plugged and unplugged from a socket, housing and electrical cord of the handpiece. Thus, only the former need to be disposed of and the later can be reused without sterilization because of a sheet <NUM> attached to the connecting body and draped over the housing during a phacoemulsification procedure. With a magnetoelectric transducer, there is no need for a plug/socket arrangement since the nickel laminations can simply be slid out of the coils in the hand piece.

While the invention has been shown and described in connection with the removal of a cataract from the eye of a patient and subsequent I/A clean up, the apparatus and method may also be used for other types of surgery in other parts of the body, e.g., the removal of neurological tissue.

Claim 1:
An ultrasonic surgical handpiece (<NUM>, <NUM>, <NUM>) comprising:
a transducer (<NUM>);
a single-piece connecting body (<NUM>) that tapers to a blade (<NUM>) and then to a sharp chisel shape to form a work tip (<NUM>) at its distal end, said transducer (<NUM>) directly attached to said connecting body (<NUM>);
a housing (<NUM>) for containing at least part of the connecting body (<NUM>) and the transducer (<NUM>), said housing (<NUM>) being formed without provisions for water proofing;
irrigation and aspiration fluid lines (<NUM>, <NUM>') that extend along the blade (<NUM>) to the chisel shape, but extend around the housing (<NUM>); and
a power cord (<NUM>) for providing an ultrasonic signal to said transducer (<NUM>), said power cord (<NUM>) being attached to said housing (<NUM>) and being formed without provisions for water proofing or corrosion resistance.