Patent Description:
Cataracts affect more than <NUM> million Americans age <NUM> and older, and as the U. population ages, more than <NUM> million Americans are expected to have cataracts by the year <NUM>. Cataract surgery entails the removal of a lens of an eye that has developed clouding of the eye's natural lens, or opacification. As a result of opacification, light is unable to travel to the retina, thereby causing vision loss. Once vision becomes seriously impaired, cataract surgery is a viable option with a high level of success. During cataract surgery, a surgeon replaces the clouded lens with an intraocular lens (IOL).

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.

Currently during cataract surgery, the tip for phacoemulsification must be screwed on to the handpiece before the start of every surgery and then unscrewed after the surgery is concluded. This task is currently performed with a tip wrench. There are generally two types of tip wrenches that are used: disposable and reusable. Reusable tip wrenches are made from metal and require sterilization in an autoclave after each use. Disposable tip wrenches are made from plastic but are easily stripped during tightening of the tip onto the handpiece, so much so that a second tip wrench may be required to remove the tip from the handpiece post-surgery.

A problem common to both reusable and disposable tip wrenches is over-torquing. Applying too much torque with a plastic disposable tip wrench may cause the threads of the tip wrench to strip, rendering it unusable. Similarly, over-torquing a reusable tip wrench can over-tighten the tip and thus make removal difficult after the surgery is completed, or possibly damage the handpiece.

Similarly, if the tip is not secured to the handpiece tightly enough, it can affect ultrasound performance. Specifically, variations in tightness can impact tuning of the handpiece during surgery. A tip wrench that applies consistent torque to the tip during attachment would allow for consistent tuning and performance of the handpiece and also reduce the risks of stripping the tip wrench.

<CIT> discloses a surgical bone anchoring device and spinal column fixation system. <CIT> pertains to a wrench for the installation and removal of a tip onto and from a tool, and in particular, with respect to a tool for use in cataract surgery.

The present invention provides a wrench assembly for attachment and removal of a tip to a handpiece of a surgical system as recited in claim <NUM>. Optional features are recited in the dependent claims.

The present invention also provides a method of assembling and operating a wrench assembly for use in a surgical system that includes a tip and a handpiece as recited in claim <NUM>.

The accompanying drawings are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification. 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.

This disclosure is illustrated by way of example and not by way of limitation in the accompanying figure(s). The figure(s) may, alone or in combination, illustrate one or more embodiments of the disclosure. Elements illustrated in the figure(s) are not necessarily drawn to scale. Reference labels may be repeated among the figures to indicate corresponding or analogous elements.

It is to be understood that the figures and descriptions of the present disclosure 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.

Embodiments are provided throughout so that this disclosure is sufficiently thorough and fully conveys the scope of the disclosed embodiments to those who are skilled in the art. Numerous specific details are set forth, such as examples of specific components, devices, and methods, to provide a thorough understanding of embodiments of the present disclosure. Nevertheless, it will be apparent to those skilled in the art that certain specific disclosed details need not be employed, and that exemplary embodiments may be embodied in different forms. As such, the exemplary embodiments should not be construed to limit the scope of the disclosure. As referenced above, in some exemplary embodiments, well-known processes, well-known device structures, and well-known technologies may not be described in detail.

Referring now to <FIG>, an eye treatment system <NUM> for treating an eye E of a patient P generally includes an eye treatment probe handpiece <NUM> coupled with a console <NUM> by a cassette <NUM>. Handpiece <NUM> generally includes a handle for manually manipulating and supporting an insertable probe tip. The probe tip has a distal end which is insertable into the eye, with one or more lumens in the probe tip allowing irrigation fluid to flow from console <NUM> and/or cassette <NUM> into the eye. Aspiration fluid may also be withdrawn through a lumen of the probe tip, with console <NUM> and cassette <NUM> generally including a vacuum aspiration source, a positive displacement aspiration pump, or both to help withdraw and control a flow of surgical fluids into and out of eye E. As the surgical fluids may include biological materials that should not be transferred between patients, cassette <NUM> will often comprise a sterilizable (or alternatively, disposable) structure, with the surgical fluids being transmitted through flexible conduits <NUM> of cassette <NUM> that avoid direct contact in between those fluids and the components of console <NUM>.

When a distal end of the probe tip of handpiece <NUM> is inserted into an eye E, for example, for removal of a lens of a patient P with cataracts, an electrical conductor and/or pneumatic line (not shown) may supply energy from console <NUM> to an ultrasound transmitter of handpiece <NUM>, a cutter mechanism, or the like. Alternatively, handpiece <NUM> may be configured as an irrigation/aspiration (I/A) and/or vitrectomy handpiece. Also, the ultrasonic transmitter may be replaced by other means for emulsifying a lens, such as a high energy laser beam. The ultrasound energy from handpiece <NUM> helps to fragment the tissue of the lens, which can then be drawn into a port of the tip by aspiration flow. So as to balance the volume of material removed by the aspiration flow, an irrigation flow through handpiece <NUM> (or a separate probe structure) may also be provided, with both the aspiration and irrigation flows being controlled by console <NUM>.

To avoid cross-contamination between patients without incurring excessive expenditures for each procedure, cassette <NUM> and its flexible conduits <NUM> may be disposable. However, the flexible conduit or tubing may be disposable, with the cassette body and/or other structures of the cassette being sterilizable. Cassette <NUM> may be configured to interface with reusable components of console <NUM>, including, but not limited to, peristaltic pump rollers, a Venturi or other vacuum source, a controller <NUM>, and/or the like.

Console <NUM> may include controller <NUM>, which may include an embedded microcontroller and/or many of the components common to a personal computer, such as a processor, data bus, a memory, input and/or output devices (including a user interface <NUM> (e.g. touch screen, graphical user interface (GUI), etc.), and the like. Controller <NUM> will often include both hardware and software, with the software typically comprising machine readable code or programming instructions for implementing one, some, or all of the methods described herein. The code may be embodied by a tangible media such as a memory, a magnetic recording media, an optical recording media, or the like. Controller <NUM> may have (or be coupled with) a recording media reader, or the code may be transmitted to controller <NUM> by a network connection such as an internet, an intranet, an ethernet, a wireless network, or the like. Along with programming code, controller <NUM> may include stored data for implementing the methods described herein and may generate and/or store data that records parameters corresponding to the treatment of one or more patients.

Referring now to <FIG>, a simplified surgical console is illustrated, where a fluid path may be demonstrated under an exemplary embodiment. In this example, an irrigation source <NUM> may be configured as a bottle or bag hanging from an IV pole hanger <NUM>. It is understood by those skilled in the art that, while an integrated IV pole is illustrated, other configurations, utilizing standalone/static IV poles, pressurized infusion sources, and/or other suitable configurations, are contemplated by the present disclosure.

An exemplary irrigation path for fluid may be realized via tubing cassette <NUM> coupled with cassette tubing interface <NUM>, which receives fluid from irrigation source <NUM> via drip chamber <NUM>. Irrigation line 156A and aspiration line <NUM> are coupled to handpiece <NUM>. Irrigation fluid may flow from drip chamber <NUM> through the irrigation tubing <NUM> into tubing cassette <NUM>. Irrigation fluid may then flow from the tubing cassette through handpiece irrigation line 156A which may be coupled to an irrigation port on handpiece <NUM>. Aspirated fluid may flow from the eye through the handpiece aspiration line <NUM> back to tubing cassette <NUM> and into a waste collection bag <NUM>. A touch screen display <NUM> may be provided to display system operation conditions and parameters, and may include a user interface (e.g., touch screen, keyboard, track ball, mouse, etc. - see controller <NUM> of <FIG>) for entering data and/or instructions to the system of <FIG>.

<FIG> is a side view of handpiece <NUM> for use in the eye treatment system <NUM> of <FIG> and an exemplary wrench assembly <NUM> attached thereto. <FIG> is a cross-sectional view of handpiece <NUM> and wrench assembly <NUM>. Handpiece <NUM> generally includes a handle <NUM> for manually manipulating and supporting an insertable probe tip <NUM>. Probe tip <NUM> has a distal end which is insertable into the eye, with one or more lumens in the probe tip allowing irrigation fluid to flow from console <NUM> and/or cassette <NUM> into the eye. Handle <NUM> includes a distal end <NUM> that defines a threaded handle bore <NUM> into which wrench assembly <NUM> is configured to rotate tip <NUM>. As described in further detail herein, wrench assembly <NUM> includes a shell <NUM> and a core <NUM> configured to be at least partially inserted into shell <NUM>. Tip <NUM> extends into wrench assembly <NUM> and is rotated by wrench assembly <NUM> to both attach and remove tip <NUM> from handle <NUM>. Tip <NUM> may be any tip known in the prior art used in conjunction with a handpiece, e.g. phacoemulsification handpiece, irrigation/aspiration handpiece, or the like.

<FIG> is a perspective view of the wrench assembly <NUM>. <FIG> is a cross-sectional perspective view of shell <NUM> of wrench assembly <NUM>. <FIG> is a side view of core <NUM> of wrench assembly <NUM>. <FIG> is a cross-sectional perspective view of shell <NUM> illustrating core <NUM> positioned therein, and <FIG> is a cross-sectional bottom view of wrench assembly <NUM> taken along line <NUM>-<NUM> shown in <FIG>.

In the exemplary embodiment, wrench assembly <NUM> includes shell <NUM> having a base portion <NUM> and an extension portion <NUM> that extends away from base portion <NUM>. Base portion <NUM> includes an annular central portion <NUM> and a pair of wings <NUM> that extend from opposing sides of central portion <NUM>. In one embodiment, extension portion includes knurling to facilitate rotation of wrench assembly <NUM> by the technician. Similarly, wings <NUM> extend out from a central axis to provide additional leverage for a technician to facilitate rotation of wrench assembly <NUM>.

As illustrated in <FIG>, central portion <NUM> of shell <NUM> includes an interior annular wall <NUM> having an inner surface <NUM> that defines a central bore <NUM> of shell <NUM>. In one embodiment, as described herein, central bore <NUM> receives at least a portion of core <NUM>. Central portion <NUM> also includes a second annular wall <NUM> that defines a counterbore <NUM> with central bore <NUM>. Similarly, extension portion <NUM> includes an extension bore <NUM> that is aligned with counterbore <NUM> and central bore <NUM> such that tip <NUM> extends through bores <NUM>, <NUM>, and <NUM> when positioned within shell <NUM>.

Referring now to <FIG> with a view to <FIG>, core <NUM> includes an outer portion <NUM> coupled to shell <NUM> and an inner portion <NUM> configured for insertion into central bore <NUM>. In the exemplary embodiment, inner portion <NUM> is removably coupled to outer portion by a separation mechanism <NUM>. In one embodiment, separation mechanism <NUM> includes at least one of a plurality or perforations and circumferential groove in core <NUM>. Separation mechanism <NUM> facilitates separation of inner portion <NUM> from outer portion <NUM> at a predetermined torque, as described in detail herein. Outer portion <NUM> includes a core end surface <NUM> that is configured to be bonded (e.g. in an embodiment, permanently) to a shell end surface <NUM> (shown in <FIG>). In one embodiment, end surfaces <NUM> and <NUM> are ultrasonically welded together. In another embodiment, end surfaces <NUM> and <NUM> are adhesively bonded. Generally, end surfaces <NUM> and <NUM> are coupled together in any manner that restricts or prevent relative movement between outer portion <NUM> and shell <NUM>.

Inner portion <NUM> includes a flange <NUM>, an intermediate portion <NUM> extending away from flange <NUM>, and an extension portion <NUM> extending from intermediate portion <NUM>. In the exemplary embodiment, flange <NUM> includes a first bearing surface <NUM> configured to engage inner surface <NUM> of annular wall <NUM>. Similarly, extension portion <NUM> includes a second bearing surface <NUM> configured to engage second annular wall <NUM>. Bearing surfaces <NUM> and <NUM> are spaced apart on inner portion <NUM> to facilitate alignment of inner portion <NUM> with shell <NUM>.

As shown in <FIG>, shell <NUM> includes a first rotation mechanism <NUM> and core <NUM> includes a second rotation mechanism <NUM> configured to selectively engage first rotation mechanism <NUM>. Specifically, first rotation mechanism <NUM> extends inwards into central bore <NUM> from inner surface <NUM> of annular wall <NUM>. Similarly, second rotation mechanism <NUM> extends outwards from extension portion <NUM> of core <NUM> such that second rotation mechanism <NUM> engages first rotation mechanism <NUM> when inner portion <NUM> of core <NUM> is positioned within central bore <NUM> of shell <NUM>. In one embodiment, first rotation mechanism <NUM> includes a plurality of ratchet members <NUM>, and second rotation mechanism <NUM> includes at least one pawl <NUM>. In other embodiments, first rotation mechanism <NUM> includes at least one pawl <NUM>, and second rotation mechanism includes a plurality of ratchet members <NUM>. As described in further detail herein, pawls <NUM> are flexible such that when shell <NUM> rotates in a first direction around inner portion <NUM>, pawls <NUM> are biased inward and do not engage ratchet members <NUM>. In such a configuration, inner portion <NUM> remains stationary within central bore <NUM> as shell <NUM> rotates around it. However, when shell <NUM> is rotated in the opposite direction, ratchet members <NUM> engage pawls <NUM> and rotate inner portion <NUM> of core <NUM> therewith.

<FIG> is an enlarged cross-sectional view of the handpiece and wrench assembly shown in <FIG>. In the exemplary embodiment, wrench assembly <NUM> is made from a plastic material such that wrench assembly can be produced at less expense to allow for disposal of wrench assembly <NUM> after a single use. In other embodiments, wrench assembly <NUM> is made from other materials, such as, but not limited to metal.

In operation of wrench assembly <NUM> in eye treatment system <NUM>, core <NUM> is inserted into shell <NUM> such that inner portion <NUM> of core <NUM> is positioned within central bore <NUM> of shell <NUM>. In such a configuration, a core bore <NUM> of inner portion <NUM> is aligned with bores <NUM>, <NUM>, and <NUM> of shell <NUM>. In various embodiments, outer portion <NUM> of core <NUM> is attached to shell <NUM> by affixing core end surface <NUM> to shell end surface <NUM>. As described herein, in one embodiment, surfaces <NUM> and <NUM> are attached using ultrasonic welding, press fitting, an adhesive, or a combination thereof. In other embodiments, surfaces <NUM> and <NUM> are attached by any means that facilitates operation of wrench assembly <NUM> as described herein. Tip <NUM> may then be inserted into core bore <NUM> such that a mating surface <NUM> of tip <NUM> engages a receiving surface <NUM> of inner portion <NUM>. Surfaces <NUM> and <NUM> are configured such that receiving surface <NUM> prevents rotation of tip <NUM> relative to inner portion <NUM>. More specifically, surfaces <NUM> and <NUM> allow tip <NUM> to couple to inner portion <NUM> such that wrench assembly <NUM> rotates tip <NUM> into distal end of handle <NUM>. In one embodiment, mating surface <NUM> and receiving surface <NUM> are correspondingly rectangular in shape. In various embodiments, surfaces <NUM> and <NUM> are correspondingly pentagon-shaped, hexagon-shaped, star-shaped, or Torx-shaped. Generally, surfaces <NUM> and <NUM> have any corresponding shape that enables operation as described herein.

In various embodiments, once tip <NUM> is coupled with wrench assembly <NUM>, wrench assembly <NUM> is attached to handpiece <NUM> by inserting distal end <NUM> of handle <NUM> into wrench assembly <NUM> to align tip <NUM> with handle bore <NUM>. Tip <NUM> is attached to handpiece <NUM> by rotating shell <NUM> and core <NUM> together in a first direction to a predetermined torque. As described herein, at the predetermined torque, separation mechanism <NUM> facilitates separation of inner portion <NUM> from outer portion <NUM>. Specifically, separation mechanism <NUM> includes lines of weakness, such as, but not limited to, a plurality or perforations and/or a circumferential groove around core <NUM> that are design to break at a predetermined torque. Torque is applied by rotating shell <NUM> and threading tip <NUM> into handle bore <NUM>. The further tip <NUM> is threaded into handle bore <NUM>, the more torque required for further insertion of tip <NUM>. To prevent over-torquing, which may damage tip <NUM> and/or handpiece <NUM> or cause stripping of wrench assembly <NUM>, inner portion <NUM> is designed to separate from outer portion <NUM> once the predetermined torque is reached that indicates tip <NUM> is fully inserted into handle <NUM>. In various embodiments, the predetermined torque is less than <NUM> inch-pounds (in-lb) (<NUM>. Specifically, in some embodiments, the predetermined torque is within a range of between <NUM> in-lb (<NUM>. 23N-m) and <NUM> in-lb (<NUM>. Generally, the predetermined torque is any torque that enables operation of wrench assembly <NUM> as described herein.

When the predetermined torque is reached and separation of inner portion <NUM> from outer portion <NUM> has occurred, further rotation of shell <NUM> in the tightening direction causes core rotation mechanism <NUM>, such as pawls <NUM>, to be biased against shell rotation mechanism <NUM>, such as ratchet members <NUM>, such that tip <NUM> and inner portion <NUM> remain stationary within central bore <NUM> of shell <NUM>.

Wrench assembly <NUM> may then be removed from tip <NUM> and handpiece <NUM> and surgery may be performed. To remove tip <NUM> from handle <NUM> after surgery, wrench assembly <NUM> is replaced over tip <NUM> such that receiving surface <NUM> engages with mating surface <NUM>. Shell <NUM> and core <NUM> are then rotated together in the opposite direction to remove tip <NUM> from handpiece <NUM>. Specifically, rotating shell <NUM> in the opposite, loosening direction causes pawls <NUM> to engage ratchet members <NUM> such that inner portion <NUM> rotates with shell <NUM>. Rotation of inner portion <NUM> causes rotation of tip <NUM> to facilitate removal. Wrench assembly <NUM> and tip <NUM> can then be disposed of.

The implementations described herein relate a wrench assembly for attachment and removal of a tip to a handpiece of a surgical system. The wrench assembly includes a core and a shell including a central portion that defines a central bore. The core includes an outer portion fixedly coupled to the shell and an inner portion configured for insertion into the central bore. The inner portion of the core is removably coupled to the outer portion of the core by a separation mechanism configured to facilitate separation of the inner portion from the outer portion at a predetermined torque.

The separation mechanism includes lines of weakness, such as, but not limited to, a plurality or perforations and/or a circumferential groove around the core that is designed to break at the predetermined torque to prevent over-torquing to prevent damage to the tip and/or handpiece. Additionally, the predetermined torque is designed to be less than the torque required to strip the wrench-tip interface, which reduces the risk of stripping the wrench assembly. Furthermore, the predetermined torque means that a consistent amount of torque is applied each time the handpiece is used, which reduces variations in the tightness of the tip and improves the consistency of ultrasonic tuning.

In various embodiments, further rotation of the shell in the tightening direction after separation of the core causes the pawls of the core to be biased against the ratchet members of the shell such that the tip and the inner portion remain stationary within the central bore of the shell. To remove the tip from the handle after surgery, the shell and the core are rotated together in the opposite direction to cause the pawls to engage the ratchet members such that the inner portion rotates with the shell. Rotation of the inner portion causes rotation of the tip to facilitate removal.

Those of skill in the art will appreciate that the herein described apparatuses, devices, systems and methods are susceptible to various modifications and alternative constructions. There is no intention to limit the scope of the invention to the specific constructions described herein. Rather, the herein described systems and methods are intended to cover all modifications and alternative constructions falling within the scope of the claims.

In the foregoing detailed description, it may be that various features are grouped together in individual embodiments for the purpose of brevity in the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that any subsequently claimed embodiments require more features than are expressly recited.

Claim 1:
A wrench assembly (<NUM>) for attachment and removal of a tip (<NUM>) to a handpiece (<NUM>) of a surgical system, the wrench assembly (<NUM>) comprising:
a shell (<NUM>) comprising a central portion (<NUM>) that defines a central bore (<NUM>); and
a core (<NUM>) comprising:
an outer portion (<NUM>) fixedly coupled to an end surface of the shell (<NUM>); and
an inner portion (<NUM>) configured for insertion into the central bore (<NUM>), wherein the inner portion (<NUM>) comprises an inner bore for receiving the tip therein, the inner portion having a receiving surface (<NUM>) for engaging a mating surface (<NUM>) of the tip (<NUM>) to prevent rotation of the tip (<NUM>) relative to the inner portion (<NUM>), wherein the inner portion (<NUM>) is removably coupled to the outer portion (<NUM>) by a separation mechanism (<NUM>) configured to facilitate separation of the inner portion (<NUM>) from the outer portion (<NUM>) at a predetermined torque.