Patent Description:
The phacoemulsification method includes emulsifying, or liquefying, the cataractic lens with an ultrasonically driven needle before the lens is aspirated. A phacoemulsification system <NUM> known in the art is shown in <FIG>. The system <NUM> generally includes a phacoemulsification handpiece <NUM> coupled to an irrigation source <NUM> an and more or more aspiration pumps, e.g. pump <NUM>. The handpiece <NUM> includes a distal tip (or needle) <NUM> (shown within the anterior chamber of the patient's eye <NUM> that emits ultrasonic energy to emulsify the cataractic lens within the patient's eye <NUM>. The handpiece <NUM> further includes a sleeve <NUM> that surrounds at least a portion of needle <NUM> and has one or more irrigation ports <NUM> proximal to the distal tip <NUM>, which is coupled to an irrigation source <NUM> via an irrigation line <NUM>, and an aspiration port <NUM> at the distal tip <NUM>, which is coupled to an aspiration pump <NUM> via an aspiration line <NUM>. Concomitantly with the emulsification, fluid from the irrigation source <NUM>, which is typically an elevated bottle of saline solution, is irrigated into the eye <NUM> via the irrigation line <NUM> and the irrigation port <NUM>, and the irrigation fluid and emulsified cataractic lens material are aspirated from the eye <NUM> by the aspiration pump <NUM> via the aspiration port <NUM> and the aspiration line <NUM>. [<NUM>] Turning to <FIG>, a functional block diagram of a phacoemulsification system <NUM> known in the art is shown. The system <NUM> includes a control unit <NUM> and a handpiece <NUM> operably coupled together. The control unit <NUM> generally controls the operating parameters of the handpiece <NUM>, e.g., the rate of aspiration A, rate of irrigation (or flow) F, and power P applied to the needle, and hence the eye E. The control unit <NUM> generally includes a microprocessor computer <NUM> which is operably connected to and controls the various other elements of the system <NUM>. The control unit <NUM> may include an aspiration pump, such as a Venturi (or vacuum-based pump) or a variable speed pump (or a flow based or peristaltic pump) <NUM> for providing a vacuum/aspiration source, which, in the case of a variable speed pump <NUM>, can be controlled by a pump speed controller <NUM>. The unit <NUM> further includes an ultrasonic power source <NUM> and an ultrasonic power level controller <NUM> for controlling the power P applied to the needle of the handpiece <NUM>. A vacuum sensor <NUM> provides an input to the computer <NUM> representing the vacuum level on the output side of the pump <NUM>. Venting may be provided by a vent <NUM>. The system <NUM> may also include a phase detector <NUM> for providing an input to the computer <NUM> that represents the phase between a sine wave representation of the voltage applied to the handpiece <NUM> and the resultant current into the handpiece <NUM>. Further disclosure about the phase detector <NUM> can be found in <CIT>et al. , The functional representation of the system <NUM> also includes a system bus <NUM> to enable the various elements to be operably in communication with each other.

Turning to <FIG>, the cross-section along the longitudinal axis of a portion of a phacoemulsification handpiece <NUM> known in the art is shown. Generally, the handpiece <NUM> includes a needle <NUM>, defining a lumen that is operatively coupled to an aspiration pump (e.g. aspiration pump <NUM> (<FIG>)), forming an aspiration line <NUM>. At least a portion of the distal end of needle <NUM> is surrounded by sleeve <NUM> and proximal end of the needle <NUM> is coupled to a horn <NUM>, which has its proximal end coupled to a set of piezoelectric crystals <NUM>, shown as three rings. The horn <NUM>, crystals <NUM>, and a proximal portion of the needle <NUM> are enclosed within a handpiece casing <NUM> having an irrigation port coupled to an irrigation line <NUM> defining an irrigation pathway <NUM>. Irrigation pathway <NUM> extends between the wall of sleeve <NUM> and the wall of needle <NUM> allowing fluid to flow around needle <NUM> and exit one or more ports <NUM> in sleeve <NUM>. The irrigation line <NUM> is coupled to the irrigation source <NUM> (<FIG>). The horn <NUM> is typically an integrated metal, such as titanium, structure and often includes a rubber O ring <NUM> around the mid-section, just before the horn <NUM> tapers to fit with the needle <NUM> at the horn's <NUM> distal end. The O-ring <NUM> snugly fits between the horn <NUM> and the casing <NUM>. The O ring <NUM> seals the proximal portion of the horn <NUM> from the irrigation pathway <NUM>. Thus, there is a channel of air defined between the horn <NUM> and the casing <NUM>. Descriptions of handpieces known in the art are provided in <CIT>) and <CIT>).

In preparation for operation, a sleeve <NUM> is typically added to the distal end of the handpiece <NUM>, covering the proximal portion of the needle <NUM> (thus, exposing the distal tip of the needle), and the distal end of the irrigation pathway <NUM>, thereby extending the pathway <NUM> and defining an irrigation port <NUM> just before the distal tip of the needle <NUM>. The needle <NUM> and a portion of the sleeve <NUM> are then inserted through the cornea of the eye to reach the cataractic lens.

During operation, the irrigation path <NUM>, the eye's chamber and the aspiration line <NUM> form a fluidic circuit, where irrigation fluid enters the eye's chamber via the irrigation path <NUM>, and is then aspirated through the aspiration line <NUM> along with other materials that the surgeon desires to aspirate out, such as the cataractic lens. If, however, the materials, such as the cataractic lens, are too hard and massive to be aspirated through the aspiration line <NUM>, then the distal end of the needle <NUM> is ultrasonically vibrated and applied to the material to be emulsified into a size and state that can be successfully aspirated.

The needle <NUM> is ultrasonically vibrated by applying electric power to the piezoelectric crystals <NUM>, which in turn, cause the horn <NUM> to ultrasonically vibrate, which in turn, ultrasonically vibrates the needle <NUM>. The electric power is defined by a number of parameters, such as signal frequency and amplitude, and if the power is applied in pulses, then the parameters can further include pulse width, shape, size, duty cycle, amplitude, and so on. These parameters are controlled by the control unit <NUM> and example control of these parameters is described in <CIT>.

With respect to <FIG>, an exemplary handpiece known in the prior art is shown. As discussed above, the distal end <NUM> of the handpiece <NUM> is show with a tip/needle <NUM> and sleeve <NUM> having port <NUM>. The proximal end <NUM> of the of the handpiece <NUM> comprises multiple ports/connector points <NUM>, include a port 406a for connecting to the irrigation line, a port 406b for connecting to the aspiration line, and a connector port 406c for electrical power for the ultrasound. The location of the ports/connector points <NUM> at the proximal end <NUM> of the handpiece <NUM> are known to create fatigue on the surgeon's hand and wrist due to the orientation of the ports/connector points <NUM> and the weight of the proximal end <NUM> once the irrigation and aspiration lines and the power cord are connected to the handpiece (not shown). Also, as shown in <FIG>, the handpiece is typically one piece made of a metal type material and to adjust or rotate the distal end of the phacoemulsification (phaco) tip/needle requires the entire handpiece and connected lines to be moved/rotated to achieve the desired position. Such requirement of moving/rotating the entire handpiece is also known to create fatigue for the surgeon's hand and/or wrist during surgery. As such, a new ergonomic handpiece with features that address these drawbacks is needed.

<CIT> discloses an ocular implant delivery system comprising a rotation mechanism configured to rotate and orient a cannula of the system, and an advancement mechanism configured to advance and retract an ocular implant through the delivery system and into an eye of a patient. <CIT> discloses a lipoplasty device with a motor that when connected to a cannula, rotates the cannula while removing adipose tissue from a surgical site. <CIT> discloses a low frequency rotary oscillatory coupling for imparting rotary oscillatory movement to a shaft. <CIT> discloses an electrosurgical apparatus which includes a body having a longitudinal axis, the body comprising a hollow passageway extending through the longitudinal axis from an inlet at a distal end to a port at a proximal end. The apparatus further includes an electrode extending from the distal end of the body adjacent to the inlet, and a swivel portion moveably coupled to the port, the swivel portion having a second hollow passageway fluidly coupled to the hollow conduit extending from the port to an outlet, wherein the swivel portion comprises a first swivel element operable to rotate around the longitudinal axis relative to the body, and wherein the swivel portion comprises a second swivel element operable to rotate relative to the first swivel element and the body. <CIT> discloses a hand-held instrument which has a distal section and a proximal section joined by an attachment piece. The attachment piece enables the distal section to be swiveled/rotated independent of the proximal section. A tip, such as an electrode tip, is coupled to the distal end of the distal section and rotates with the distal section, enabling a user to adjust the rotational orientation of the tip during use.

The present invention provides a handpiece as recited in the independent claim. Optional features are recited in the dependent claims.

In order to better appreciate how the above-recited and other advantages and objects of the inventions are obtained, a more particular description of the embodiments briefly described above will be rendered by reference to specific embodiments thereof, which are illustrated in the accompanying drawings. It should be noted that the components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. However, like parts do not always have like reference numerals. Moreover, all illustrations are intended to convey concepts, where relative sizes, shapes and other detailed attributes may be illustrated schematically rather than literally or precisely.

The present invention relates to ergonomic handpieces and in particular a handpiece that has one or more moveable segments and/or cord and irrigation/aspiration line management.

In an embodiment, as shown in <FIG>, the handpiece <NUM> may have at least two segments, a proximal segment <NUM> and a distal segment <NUM>. Proximal segment <NUM> and distal segment <NUM> may be referred to as first segment <NUM> and second segment <NUM>, respectively. Proximal segment <NUM> and distal segment <NUM> may be coupled to each other. Proximal segment <NUM> may have a first end <NUM> and a second end <NUM>. Distal segment <NUM> may have a first end <NUM> and a second end <NUM>. Proximal segment <NUM> may be coupled to distal segment <NUM> via the first end <NUM> and second end <NUM>. First segment <NUM> and second segment <NUM> may be coupled together by coupler <NUM> by any means known in the art, including, but not limited to a snap fit feature having male and female connectors. The male or female connector may be located on the first end <NUM> and the opposite connector on the second end <NUM>. In addition, at least one coupler <NUM> may be a part of the proximal segment <NUM> or the distal segment <NUM> and have a swivel feature allowing proximal segment <NUM> and distal segment <NUM> to rotate along an axis A independently of each other. In an embodiment, the proximal and/or distal segments are capable of rotating <NUM> degrees. In another embodiment, the rotation may be limited to less than <NUM> degrees depending upon the freedom of movement and amount of control desired. In an embodiment, the material of the coupler may be the same as the segment it is connected to or may be of a different material.

In an embodiment, the distal segment <NUM> of handpiece <NUM> may have a needle <NUM> connected to a distal portion of distal segment <NUM>. A sleeve <NUM> may also be coupled with handpiece <NUM> and at least partial surround needle <NUM>. Needle <NUM> and sleeve <NUM> may be separate components attachable to the distal segment 510a or may be integrally coupled with the distal segment <NUM> of handpiece <NUM>. Proximal segment <NUM> of handpiece <NUM> includes tubing/cord management section <NUM> that includes one or more port/connector <NUM>.

The location and position of the one or more port/connector <NUM> helps manage the cords <NUM> and/or tubing <NUM> connected thereto. It allows the connected cords and/or tubing lay or rest against a user's hand to keep the same in a comfortable and convenient location. The one or more port/connector <NUM> exits the tubing/cord management section <NUM> at any angle to achieve an ergonomic handpiece. In an embodiment, the port/connector <NUM> are between <NUM> degrees and <NUM> degrees from the longitudinal Axis A.

According to an embodiment, a user's hand may grip the first segment <NUM> with her fingers and rest the second segment <NUM> on the hand between the thumb and pointer finger. This positioning coupled with a swivel connector allows the user to rotate first segment <NUM> independent of second segment <NUM>. Second segment <NUM> may remain stationary. The length of the proximal segment and distal segment may vary to achieve the desired balance of the handpiece. For example, as shown in <FIG>, a similar handpiece <NUM> is shown with similar features having the same corresponding reference numbers as in <FIG>, however the length of proximal segment <NUM> and distal segment <NUM> are different. Proximal segment <NUM> is shorter and distal segment <NUM> is longer. The coupler <NUM> is now located more proximally on the handpiece <NUM>.

In <FIG>, tubing/cord management section <NUM> is shown in three different geometries (6a, 6b, and 6c). The tubing/cord management section <NUM> may achieve the different rotational geometries relative to the rest of the handpiece via coupler <NUM>. In an embodiment the proximal segment <NUM> primarily includes the tubing/cord management section <NUM> and the distal segment <NUM> includes a majority of the length of the handpiece <NUM>.

In an embodiment shown in <FIG>, tubing/cord management section <NUM> is shown in three different geometries (7a, 7b, 7c), but also with a different orientation for one or more port/connector <NUM>. In the embodiment, the port/connector <NUM> a is in line with Axis C and port connector 730b and 730c are located at an angle from Axis C. Coupler <NUM> may be part of proximal segment <NUM> or distal segment <NUM>. Rotation of distal segment <NUM> around Axis C is possible without movement/rotation of proximal segment <NUM>.

As shown in <FIG>, <FIG>, the tubing/cord management section <NUM> of handpiece <NUM> may be placed in multiple orientations depending upon a user's preference. Since handpiece <NUM> has at least two independently movable segments, e.g. proximal segment <NUM> and distal segment <NUM> coupled together via coupler <NUM> (as shown in <FIG>, <FIG>), tubing/cord management section <NUM> may remain stationary in the user's desired position while the distal segment <NUM> may be rotated around the longitudinal axis of the handpiece.

In another embodiment, proximal segment <NUM> and distal segment <NUM> may be of any shape, e.g. straight, bent, curved, etc. to assist with the ergonomics of handpiece <NUM>. An example of such a handpiece <NUM> is shown in <FIG>, where proximal segment <NUM> may have a bend or curve <NUM>. In an embodiment, the bend or curve <NUM> has an angle between <NUM> degrees and <NUM> degrees, preferably between <NUM> degrees and <NUM> degrees. The bend or curve <NUM> may be located along any portion of segment <NUM> and in other embodiments may be located on the distal segment <NUM>. Having such a curve or bend <NUM> may help achieve an ergonomic feel of handpiece <NUM> and provide a more comfortable location for tubing/cord management section <NUM>. In addition, in an embodiment coupler <NUM> may be located on the proximal segment <NUM>, the distal segment <NUM>, or may be a separate component coupled with proximal segment <NUM> and distal segment <NUM> and allow each segment to move or rotate independently.

In an embodiment, the internal structures needed for activation of ultrasound for a phacoemulsification handpiece, e.g. piezoelectric crystals, may be located in either the first segment, the second segment, or both. In an embodiment, if there are more than two segments, the various internal structures may be located in any segment or in multiple segments.

In an embodiment, the needle <NUM> and sleeve <NUM> may be separate parts used for rotations and are independent of the internal components of the handpiece. In addition, one or more O-ring gaskets may be used on the proximal and distal segments to create a seal between the parts and assist with rotation. In an additional embodiment, bearings or tubing may be used alone or in combination with another similar feature, e.g. O-ring, bearing, tubing, etc., for creating a seal between the various parts of the handpiece to prevent fluids from entering or exiting the handpiece as these locations.

The distal segment and proximal segment, are separable to replace the distal segment with another distal segment that may have the same or different needle and/or sleeve. The proximal segment is designed to be sterilizable and is thus, reusable. The distal segment is designed to be disposable.

In an embodiment, the one or more segments may be of any material suitable for the handpiece application. The segments may be titanium, plastic, rubber, or any similar material. Each segment may have its own material type or the same material type as another segment.

Claim 1:
A handpiece (<NUM>) comprising:
a proximal segment (<NUM>) disposed along a longitudinal axis (A) of the handpiece (<NUM>) and comprising a first end (<NUM>), a second end (<NUM>), and a tubing and cord management section (<NUM>) located on the first end (<NUM>) of the proximal segment (<NUM>), wherein the tubing and cord management section (<NUM>) includes at least one port or connector (<NUM>); and
a distal segment (<NUM>) disposed along the longitudinal axis (A) of the handpiece (<NUM>) and comprising a first end (<NUM>) and a second end (<NUM>), wherein the second end (<NUM>) of the distal segment (<NUM>) comprises a needle (<NUM>),
wherein the second end (<NUM>) of the proximal segment (<NUM>) is coupled with the first end (<NUM>) of the distal segment (<NUM>) and the proximal segment (<NUM>) and the distal segment (<NUM>) are capable of rotating independently around the longitudinal axis (A) of the handpiece (<NUM>), wherein the at least one port or connector (<NUM>) exits the tubing and cord management section (<NUM>) at an angle relative to the longitudinal axis (A) such that the at least one port or connector (<NUM>) can be positioned in different rotational geometries relative to the distal segment (<NUM>),
characterized in that the proximal segment (<NUM>) is separable from the distal segment (<NUM>) to replace the distal segment (<NUM>), and the proximal segment (<NUM>) is reusable and the distal segment (<NUM>) is disposable.