Patent Description:
Certain surgical procedures, such as phacoemulsification surgery, have been successfully employed in the treatment of certain ocular problems, such as cataracts. Phacoemulsification surgery utilizes a small corneal incision to insert the tip of at least one phacoemulsification handheld surgical implement, or handpiece, through the corneal incision. The handpiece includes a needle which is ultrasonically driven once placed within the incision to emulsify the eye lens, or to break the cataract into small pieces. The broken cataract pieces or emulsified eye lens may subsequently be removed using the same handpiece, or another handpiece, in a controlled manner. The surgeon may then insert a lens implant into the eye through the incision. The incision is allowed to heal, and the result for the patient is typically significantly improved eyesight.

As may be appreciated, the flow of fluid to and from a patient through a fluid infusion or extraction system, and thus the control of fluids and fluid pressure through the phacoemulsification handpiece, is critical to the procedure performed. Different medically recognized techniques have been utilized to control the fluid flow during the lens removal portion of the surgery. Among these, one popular technique is a simultaneous combination of phacoemulsification, irrigation and aspiration using a single handpiece. This method includes making the incision, inserting the handheld surgical implement to emulsify the cataract or eye lens, and, simultaneously with this emulsification, having the handpiece provide a fluid for irrigation of the emulsified lens and a vacuum for aspiration of the emulsified lens and inserted fluids.

Currently available phacoemulsification systems, such as those mentioned above, typically include a variable speed peristaltic pump and/or vacuum pump, a vacuum sensor, an adjustable source of ultrasonic power, and a programmable microprocessor with operator-selected presets for controlling aspiration rate, vacuum and ultrasonic power levels. The phacoemulsification handpiece is interconnected with a control console by an electric cable for powering and controlling a piezoelectric transducer that drives the action of the handpiece. Tubing provides irrigation fluid to the eye through the handpiece and enables withdrawal of aspiration fluid from an eye through the handpiece.

Generally, irrigation and aspiration are employed by the surgeon using the device to remove unwanted tissue and maintain pressure within the eye. Moreover, the use of, and particularly the pressurization of, the irrigation fluid is critical and may, for example, prevent the collapse of the eye during the removal of the emulsified lens. Irrigation fluid pressure is also used to protect the eye from the heat generated by the ultrasonic cutting needle and may suspend fragments created during the surgery in fluid for more easy removal through aspiration.

Irrigation fluid pressure has been conventionally handled in two ways. The first method to increase irrigation fluid pressure has relied upon the height of the fluid source. Conventional IV poles may be adjusted in height to create the desired pressure head using gravity-feed principles. The second method includes the use of an infusion pump either directly pumping the fluid typically in the form of a peristaltic pump used in-line with an irrigation delivery line or by pressurizing the fluid container thus increasing higher atmosphere above the fluid resulting in higher infusion pressure and flow to the surgical site.

In the aforementioned configurations, combining phacoemulsification, irrigation and aspiration, the handpiece may be configured to provide a fluid for irrigation of an emulsified lens and a vacuum for aspiration of the emulsified lens and inserted fluids. In such configurations fluidics lines are typically switched from phacoemulsification to irrigation and aspiration. While the configuration provides advantages for the surgical procedure, the switching of fluidics lines unnecessarily slows down the procedure and creates the potential for fluid to drain accidentally. Furthermore, the switching of lines has the tendency to introduce fluctuations of intra-ocular pressure.

Thus, there is a need for a system and method that provides a surgical process that does not require a separate phacoemulsification and I/A hand piece, and therefore reduce insertions and withdrawals.

<CIT> discloses a solid needle-based phacoemulsification handpiece and phacoemulsification equipment.

The present invention provides a surgical instrument as recited in claim <NUM>. Optional features are recited in the dependent claims. A hub and sleeve encapsulates at least part of the surgical instrument. The hub and sleeve may be placed in alternative states. In at least one initial state the sleeve and hub are placed in position for normal phacoemulsification surgery and a subsequent state to place the sleeve in position for typical irrigation/aspiration mode. The hand piece allows for lateral movement of the sleeve and may be manually controlled and/or at least partially automated.

The surgical hand piece may be fitted with a bullet-nose cover as part of the convertible sleeve. The bullet-nose cover may be comprised of polyimide materials and allows for alternative modes of phacoemulsification and irrigation/aspiration.

The drawings illustrate disclosed embodiments and/or aspects and, together with the description, serve to explain the principles of the invention, the scope of which is determined by the claims.

It is to be understood that the figures and descriptions of the present invention have been simplified to illustrate elements that are relevant for a clear understanding of the present invention, while eliminating, for the purpose of clarity, many other elements found in typical surgical, and particularly optical surgical, apparatuses, systems, and methods. Those of ordinary skill in the art may recognize that other elements and/or steps are desirable and/or required in implementing the present invention. However, because such elements and steps are well known in the art, and because they do not facilitate a better understanding of the present invention, a discussion of such elements and steps is not provided herein. The disclosure herein is directed to all such variations and modifications to the disclosed elements and methods known to those skilled in the art.

A convertible sleeve of a surgical handpiece may be in a retracted, or initial, state, which may place the sleeve in a desired relationship with the exposed distal portion of the phacoemulsification tip to support normal phacoemulsification in the same manner as current practice. A convertible sleeve of a surgical handpiece may be in an extended state. The sleeve may include a distally placed aspiration hole located forward from the distal end of a phacoemulsification tip allowing for typical irrigation/aspiration ("I/A") activities to occur. The aspiration hole may be placed roughly perpendicular to the bevel surface at the end of the sleeve, for example. Surfaces adjacent to the aspiration hole may be used for capsule polishing and may be altered to best perform the intended purpose. Irrigation outflow holes on the sleeve may be located slightly further back proximally adjacent to a seal feature of the sleeve for the tip. The irrigation outflow holes may be angulated, for example, and both the irrigation and aspiration holes may be kerf, chamfered, beveled, rounded, or otherwise not substantially square to the face to the device.

In an embodiment of the present invention, an adaptor is installed, for example, screwed, onto existing threads on the distal end of a standard phacoemulsification hand piece, such as a standard AMO® hand piece, followed by a hub component, subsequently allowing mounting of a sleeve. The hub component comprises a sliding hub which may further comprise an actuator enabling the movement of the sleeve along the length of the phacoemulsification tip. The sliding hub may also control the amount of linear movement allowed. For example, the sliding hub may be keyed and may be regulated in that it may self-register (align) and latch, allowing for repositioning after, for example, the I/A portion of the procedure, should additional phacoemulsification be needed.

The lateral movement of the sleeve may be manually controlled and/or at least partially automated. For example, the user of the hand piece may be able to easily move the sleeve forwards and backwards along an axis of the adapter in concert with one or more grooves or reliefs correspondent to the sliding hub. The friction between the hub and adapter, for example, may prove sufficient to resist unwanted movement of the sleeve. A locking mechanism may also be used to retain the sleeve and hub in a desired position and may comprise a latch, a detent and corresponding relief, and other engagements which may prevent unwanted movement. Movement of the sleeve and hub may also be at least partially mechanical and may allow a user to use a remote device, such as a foot pedal, to control the movement of the sleeve. By way of example, the hub may be communicatively connected to a motor and/or electromagnetic assembly which may provide for hands-free lateral movement of the sleeve.

In yet another embodiment of the present invention, a more remote or proximally-oriented location on a surgical hand piece for an actuator to position the sleeve may be preferred. Alternate materials for consideration for the convertible sleeve may be higher shore diameter silicone (90A+) or TPE medias (for additional axial stiffness). In an embodiment of the present invention, at least a portion of the sleeve may be composed of two or more layers and may, for example, be composed of a two-layer system wherein the second layer provides rigidity to the first layer. For example, a soft silicone may be used for a top layer and a more rigid plastic used as the second layer to provide a desired amount of support and rigidity of the top layer.

Ribbed features inside the annular portion of the convertible sleeve cannula may also be used. For example, ABS, and other related plastics, may be considered for the convertible sleeve construction using a TPE or silicone over molded shaft and tip end, thereby providing other opportunities to provide connective means of actuation of the mechanism and retain the soft requirements desired of the distal tip end portion. Other means of achieving axial stiffness may also include an extruded PTFE tube used as a support liner inserted into the interior diameter of the sleeve shank after molding.

It is to be understood that the convertible sleeve may be molded into alternative shapes, such as a curved shape, or with specific distal angulations which may be achieved by molding into a desired shape. Even further, a sleeve may be straight-molded to conform to a curved or angulated phacoemulsification tip.

As illustrated in <FIG>, diagram <NUM> shows an exploded view of a surgical instrument in accordance with a typical embodiment of the present invention. Diagram <NUM> illustrates sleeve <NUM> encapsulating, at least partially, needle <NUM> and hub adaptor <NUM>, which is removeably attached to the hand piece <NUM>. As mentioned above, certain adaptors may be employed to aid in operation of the sleeve <NUM>. For example, the instrument includes a hub adaptor <NUM> and a hand piece adaptor <NUM>. Hand piece adaptor <NUM> may be secured to the instrument utilizing handpiece threads <NUM> and hub adaptor <NUM> is slidably resident on adaptor <NUM>. Sleeve <NUM> may slidably fit onto hub adaptor <NUM> and removably engages with attachment portion <NUM> mechanically and/or through a friction fit, for example. Mechanical means may take the form of threads and/or other mated and non-mated protrusions and recesses, either on adaptor <NUM> and/or within the body of sleeve <NUM>.

As illustrated in <FIG>, diagram 200A and 200B show the surgical instrument in an extended position and a retracted position, respectively. For example, in 200A, sleeve <NUM> is in an extended position and needle <NUM> (not shown) is in a retracted position, allowing for typical I/A activities to occur. Also shown is attachment portion <NUM> and handpiece <NUM>. In 200B, sleeve <NUM> is in a retracted position allowing for typical phacoemulsification surgical procedures. As shown, needle <NUM> is in the extended position. Also shown is attachment portion <NUM> and handpiece <NUM>. As illustrated in a cross-sectional view of <FIG>, diagram 300A shows sleeve <NUM> in an extended position and 300B shows sleeve <NUM> in a retracted position.

As illustrated in <FIG>, diagram <NUM> shows a side elevation close-up of the surgical instrument with sleeve <NUM> in an extended position and needle <NUM> (not shown) in a retracted position. Aspiration port <NUM> is shown being at an angle of <NUM>° and having a diameter of <NUM>, for exemplary purposes. Extended portion <NUM> of sleeve <NUM> may be used for polishing and/or removal of lens epithelial cells from the interior part of the capsular bag. Sleeve <NUM> may also include angle flow ports <NUM>. It is understood that ports, such as the aspiration port and irrigation ports, may be at different angles with varying diameters.

As illustrated in <FIG>, diagram <NUM> shows a top cross-section close-up of flow ports <NUM> and <NUM> of sleeve <NUM>. As shown by the arrows in <FIG>, fluid flow exits irrigation ports <NUM> and <NUM>. In one preferred embodiment, fluid may flow along a channel surrounding the needle <NUM>. Sleeve <NUM> may also include a sleeve tip seal <NUM>. The tip seal <NUM> may be a radial lip seal inside the sleeve <NUM> intended to choke off/prevent any fluid from discharging anywhere other than through the irrigation ports. Body of the sleeve <NUM> may engage with needle <NUM> to provide a seal after ports <NUM> and <NUM>. This seal may prevent back flow and restricts fluid discharge to ports <NUM> and <NUM>.

<FIG> illustrate the implementation of alternative materials that may be used for sleeve <NUM>. Diagram <NUM> of <FIG> shows an exemplary implementation of a Silicone or TPE sleeve <NUM> with an overmolded external stiffening jacket <NUM>. The external stiffening jacket <NUM> may prevent the lumen of the sleeve from buckling or sticking to the shaft of the surgical tip when translating between I/A or phacoemulsification modes. For example, when the needle switches between an extended or retracted position.

Diagram <NUM> of <FIG> shows another exemplary implementation of a silicone or TPE sleeve <NUM> with a PTFE inserted liner <NUM>. Diagram <NUM> of <FIG> shows an exemplary implementation an ABS sleeve <NUM> (shaded) with a silicone or TPE overmolded shank and a distal tip segment <NUM>. It is to be understood that different materials may be utilized alone or in combination within the scope of the present invention.

As illustrated in <FIG>, the surgical hand piece distal tip segment may comprise a bullet-nose shaped tip <NUM>, in which in an embodiment it may be overmolded to a portion of the surgical handpiece and may be comprised of polyimide materials. The implementation of a polyimide liner may reinforce the lumen of the sleeve described herein and above. <FIG> illustrates a side-view cross-section of the surgical hand piece described above and as shown in <FIG> and <FIG>. <FIG> illustrates different angled segments which are all deemed exemplary. Different angled segments allows for smooth operation of the surgical handpiece and proper fluid flow during aspiration/irrigation, or the like. <FIG> and <FIG> illustrate simplified side cross-sectional views of the surgical hand piece as shown and described above with respect to <FIG>.

<FIG> illustrates another exemplary embodiment. As shown in <FIG>, another side-view of the surgical instrument having a distal tip segment may be overmolded by a bullet-nose shaped tip <NUM> comprised of polyimide materials.

As illustrated in <FIG>, the distal tip segment overmolded by a bullet-nose tip <NUM> may include a split or slit feature at the distal end to facilitate egress of a surgical needle <NUM>, such as a phaco needle. As shown in diagram <NUM> of <FIG>, when extended, the needle <NUM> may push through a split/slit feature of the bullet-nose tip sleeve <NUM> (see <FIG>) to allow for phacoemulsification, or the like. As shown in diagram <NUM> of <FIG>, when needle <NUM> is retracted, the split/slit feature <NUM> of the tip may self-collapse to create a seal, thereby converting the surgical instrument and allowing for aspiration and/or irrigation only (see <FIG> and <FIG>, diagrams <NUM> and <NUM>). <FIG> shows, in diagram <NUM>, the phaco tip <NUM> in a retracted state.

Claim 1:
A surgical instrument (<NUM>), comprising:
a handpiece (<NUM>)
a hub (<NUM>, <NUM>) attached to the handpiece (<NUM>);
a sleeve (<NUM>) attached to the hub (<NUM>, <NUM>); and
a needle (<NUM>) at least partially resident within the hub (<NUM>, <NUM>) and the sleeve (<NUM>); characterized in that:
the hub comprises a first static portion (<NUM>) attached to the handpiece (<NUM>) and a second portion (<NUM>) slidable relative to the first static portion (<NUM>) and the handpiece (<NUM>), the first static portion (<NUM>) having a longitudinal axis;
the sleeve is removably attached to the second slidable portion (<NUM>) of the hub; and
wherein the second slidable portion (<NUM>) of the hub is capable of laterally moving along the longitudinal axis away from the handpiece (<NUM>).