Patent ID: 12208035

DETAILED DESCRIPTION

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 toFIG.1A, an eye treatment system10for treating an eye E of a patient P generally includes an eye treatment probe handpiece110coupled with a console115by a cassette170. Handpiece110generally 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 console115and/or cassette170into the eye. Aspiration fluid may also be withdrawn through a lumen of the probe tip, with console115and cassette170generally including a vacuum aspiration source, a positive displacement aspiration pump, or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, cassette170will often comprise a sterilizable (or alternatively, disposable) structure, with the surgical fluids being transmitted through flexible conduits120of cassette170that avoid direct contact in between those fluids and the components of console115.

When a distal end of the probe tip of handpiece110is 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 console115to an ultrasound transmitter of handpiece110, a cutter mechanism, or the like. Alternatively, handpiece110may 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 handpiece110helps 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 handpiece110(or a separate probe structure) may also be provided, with both the aspiration and irrigation flows being controlled by console115.

To avoid cross-contamination between patients without incurring excessive expenditures for each procedure, cassette170and its flexible conduits120may be disposable. However, the flexible conduit or tubing may be disposable, with the cassette body and/or other structures of the cassette being sterilizable. Cassette170may be configured to interface with reusable components of console115, including, but not limited to, peristaltic pump rollers, a Venturi or other vacuum source, a controller125, and/or the like.

Console115may include controller125, 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 interface130(e.g. touch screen, graphical user interface (GUI), etc.), and the like. Controller125will 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. Controller125may have (or be coupled with) a recording media reader, or the code may be transmitted to controller125by a network connection such as an internet, an intranet, an ethernet, a wireless network, or the like. Along with programming code, controller125may 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 toFIG.1B, a simplified surgical console is illustrated, where a fluid path may be demonstrated under an exemplary embodiment. In this example, an irrigation source151may be configured as a bottle or bag hanging from an IV pole hanger150. 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 cassette154coupled with cassette tubing interface153, which receives fluid from irrigation source151via drip chamber152. Irrigation line156A and aspiration line157are coupled to handpiece158. Irrigation fluid may flow from drip chamber152through the irrigation tubing156into tubing cassette154. Irrigation fluid may then flow from the tubing cassette through handpiece irrigation line156A which may be coupled to an irrigation port on handpiece158. Aspirated fluid may flow from the eye through the handpiece aspiration line157back to tubing cassette154and into a waste collection bag155. A touch screen display159may 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 controller125ofFIG.1A) for entering data and/or instructions to the system ofFIG.1B.

FIG.2is a side view of handpiece110for use in the eye treatment system10ofFIG.1Aand an exemplary wrench assembly200attached thereto.FIG.3is a cross-sectional view of handpiece110and wrench assembly200. Handpiece110generally includes a handle112for manually manipulating and supporting an insertable probe tip114. Probe tip114has a distal end which is insertable into the eye, with one or more lumens in the probe tip allowing irrigation fluid to flow from console115and/or cassette170into the eye. Handle112includes a distal end116that defines a threaded handle bore118into which wrench assembly200is configured to rotate tip114. As described in further detail herein, wrench assembly200includes a shell202and a core204configured to be at least partially inserted into shell202. Tip114extends into wrench assembly200and is rotated by wrench assembly200to both attach and remove tip114from handle112. Tip114may be any tip known in the prior used in conjunction with a handpiece, e.g. phacoemulsification handpiece, irrigation/aspiration handpiece, or the like.

FIG.4is a perspective view of the wrench assembly200.FIG.5is a cross-sectional perspective view of shell202of wrench assembly200.FIG.6is a side view of core204of wrench assembly200.FIG.7is a cross-sectional perspective view of shell202illustrating core204positioned therein, andFIG.8is a cross-sectional bottom view of wrench assembly200taken along line8-8shown inFIG.4.

In the exemplary embodiment, wrench assembly200includes shell202having a base portion206and an extension portion208that extends away from base portion206. Base portion206includes an annular central portion210and a pair of wings212that extend from opposing sides of central portion210. In one embodiment, extension portion includes knurling to facilitate rotation of wrench assembly200by the technician. Similarly, wings212extend out from a central axis to provide additional leverage for a technician to facilitate rotation of wrench assembly200.

As illustrated inFIG.5, central portion210of shell202includes an interior annular wall214having an inner surface216that defines a central bore218of shell202. In one embodiment, as described herein, central bore218receives at least a portion of core204. Central portion210also includes a second annular wall220that defines a counterbore222with central bore218. Similarly, extension portion208includes an extension bore224that is aligned with counterbore222and central bore218such that tip114extends through bores218,222, and224when positioned within shell202.

Referring now toFIG.6with a view toFIG.7, core204includes an outer portion226coupled to shell202and an inner portion228configured for insertion into central bore218. In the exemplary embodiment, inner portion228is removably coupled to outer portion by a separation mechanism230. In one embodiment, separation mechanism230includes at least one of a plurality of perforations and circumferential groove in core204. Separation mechanism230facilitates separation of inner portion228from outer portion226at a predetermined torque, as described in detail herein. Outer portion226includes a core end surface232that is configured to be bonded (e.g. in an embodiment, permanently) to a shell end surface234(shown inFIG.5). In one embodiment, end surfaces232and234are ultrasonically welded together. In another embodiment, end surfaces232and234are adhesively bonded. Generally, end surfaces232and234are coupled together in any manner that restricts or prevent relative movement between outer portion226and shell202.

Inner portion228includes a flange236, an intermediate portion238extending away from flange236, and an extension portion240extending from intermediate portion238. In the exemplary embodiment, flange236includes a first bearing surface242configured to engage inner surface216of annular wall214. Similarly, extension portion240includes a second bearing surface244configured to engage second annular wall220. Bearing surfaces242and244are spaced apart on inner portion228to facilitate alignment of inner portion228with shell202.

As shown inFIGS.5-8, shell202includes a first rotation mechanism246and core204includes a second rotation mechanism248configured to selectively engage first rotation mechanism246. Specifically, first rotation mechanism246extends inwards into central bore218from inner surface216of annular wall214. Similarly, second rotation mechanism248extends outwards from extension portion240of core204such that second rotation mechanism248engages first rotation mechanism246when inner portion228of core204is positioned within central bore218of shell202. In one embodiment, first rotation mechanism246includes a plurality of ratchet members247, and second rotation mechanism248includes at least one pawl249. In other embodiments, first rotation mechanism246includes at least one pawl249, and second rotation mechanism includes a plurality of ratchet members247. As described in further detail herein, pawls249are flexible such that when shell202rotates in a first direction around inner portion228, pawls249are biased inward and do not engage ratchet members247. In such a configuration, inner portion228remains stationary within central bore218as shell202rotates around it. However, when shell202is rotated in the opposite direction, ratchet members247engage pawls249and rotate inner portion228of core204therewith.

FIG.9is an enlarged cross-sectional view of the handpiece and wrench assembly shown inFIG.3. In the exemplary embodiment, wrench assembly200is made from a plastic material such that wrench assembly can be produced at less expense to allow for disposal of wrench assembly200after a single use. In other embodiments, wrench assembly200is made from other materials, such as, but not limited to metal.

In operation of wrench assembly200in eye treatment system10, core204is inserted into shell202such that inner portion228of core204is positioned within central bore218of shell202. In such a configuration, a core bore250of inner portion228is aligned with bores218,222, and224of shell202. In various embodiments, outer portion226of core204is attached to shell202by affixing core end surface232to shell end surface234. As described herein, in one embodiment, surfaces232and234are attached using ultrasonic welding, press fitting, an adhesive, or a combination thereof. In other embodiments, surfaces232and234are attached by any means that facilitates operation of wrench assembly200as described herein. Tip114may then be inserted into core bore250such that a mating surface252of tip114engages a receiving surface254of inner portion228. Surfaces252and254are configured such that receiving surface254prevents rotation of tip114relative to inner portion228. More specifically, surfaces252and254allow tip114to couple to inner portion228such that wrench assembly200rotates tip114into distal end of handle112. In one embodiment, mating surface252and receiving surface254are correspondingly rectangular in shape. In various embodiments, surfaces252and254are correspondingly pentagon-shaped, hexagon-shaped, star-shaped, or Torx-shaped. Generally, surfaces252and254have any corresponding shape that enables operation as described herein.

In various embodiments, once tip114is coupled with wrench assembly200, wrench assembly200is attached to handpiece110by inserting distal end116of handle112into wrench assembly200to align tip114with handle bore118. Tip114is attached to handpiece110by rotating shell202and core204together in a first direction to a predetermined torque. As described herein, at the predetermined torque, separation mechanism230facilitates separation of inner portion228from outer portion226. Specifically, separation mechanism230includes lines of weakness, such as, but not limited to, a plurality of perforations and/or a circumferential groove around core204that are design to break at a predetermined torque. Torque is applied by rotating shell202and threading tip114into handle bore118. The further tip114is threaded into handle bore118, the more torque required for further insertion of tip114. To prevent over-torquing, which may damage tip114and/or handpiece110or cause stripping of wrench assembly200, inner portion228is designed to separate from outer portion226once the predetermined torque is reached that indicates tip114is fully inserted into handle112. In various embodiments, the predetermined torque is less than 10 inch-pounds (in-lb). Specifically, in some embodiments, the predetermined torque is within a range of between 2 in-lb and 5 in-lb. Generally, the predetermined torque is any torque that enables operation of wrench assembly200as described herein.

When the predetermined torque is reached and separation of inner portion228from outer portion226has occurred, further rotation of shell202in the tightening direction causes core rotation mechanism248, such as pawls249, to be biased against shell rotation mechanism246, such as ratchet members247, such that tip114and inner portion228remain stationary within central bore218of shell202.

Wrench assembly200may then be removed from tip114and handpiece110and surgery may be performed. To remove tip114from handle112after surgery, wrench assembly200is replaced over tip114such that receiving surface254engages with mating surface252. Shell202and core204are then rotated together in the opposite direction to remove tip114from handpiece110. Specifically, rotating shell202in the opposite, loosening direction causes pawls249to engage ratchet members247such that inner portion228rotates with shell202. Rotation of inner portion228causes rotation of tip114to facilitate removal. Wrench assembly200and tip114can 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. In various embodiments, the wrench assembly includes a core and a shell including a central portion that defines a central bore. In various embodiments, 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 of perforations and/or a circumferential groove around the core that is designed to break at the predetermined torque to prevent over-torquing to prevents 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, alternative constructions, and equivalents falling within the scope and spirit of the disclosure, any appended claims and any equivalents thereto.

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.

Further, the descriptions of the disclosure are provided to enable any person skilled in the art to make or use the disclosed embodiments. Various modifications to the disclosure will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other variations without departing from the spirit or scope of the disclosure. Thus, the disclosure is not intended to be limited to the examples and designs described herein, but rather are to be accorded the widest scope consistent with the principles and novel features disclosed herein.