Patent Description:
Cystotomes are known in the prior art for incising the lens capsule of a patient's eye in performing a capsulotomy, e.g., during capsulorhexis. , as shown in <FIG>. Examples of commercially-available cystotomes are irrigating cystotomes sold by Beaver-Visitec International, Inc. of Waltham, MA. A cystotome is typically provided with a plastic hub from which the cystotome extends distally. The distal end of the cystotome defines an opening with a radially-protruding sharpened edge for incising the patient's eye, e.g., incising the anterior capsule of the patient's eye in performing a capsulotomy, and, the hub includes a female luer fitting for mounting onto a standard syringe. In use, the syringe allows for introduction of irrigation fluid through the cystotome during a capsulotomy.

Typically, a practitioner grips the syringe to manipulate, e.g., rotate, the cystotome during a capsulotomy, often adjusting their grip especially for a continuous curvilinear capsulorhexis (CCC). Standard syringe barrels typically have smooth outer surfaces and a constant-diameter barrel, providing no grip enhancement or ergonomic optimization, since grip enhancement is not a factor in administering injections.

<CIT> describes a luer connector pertaining to the features of the preamble of claim <NUM>.

<CIT> describes a syringe including a slide member, wherein force exerted on the slide member causes movement of a syringe plunger within a hollow or partially hollow syringe barrel, for withdrawing fluid from a source into the syringe, and also includes a reusable adaptor for use with existing conventional syringes, which has a ring that wholly or partially encircles the barrel and indirectly attaches to a plunger flange.

<CIT> describes an injector for delivering medicament including a first sleeve defining a longitudinal axis, a medicament container, and a locking tab. The medicament container is disposed within the first sleeve and configured for axial translation with respect to the first sleeve along the longitudinal axis. The medicament container includes a barrel, a needle mounted to a distal end of the barrel, a seal slidably mounted in the barrel, and a plunger rod. The locking tab extends through an aperture in the first sleeve and is in contact with or adjacent to a portion of the medicament container such that the locking tab restricts translation of the barrel with respect to the first sleeve along the longitudinal axis. The locking tab is configured to be movable to a second position in which the locking tab does not restrict translation of the barrel.

<CIT> describes an instrument and method for creating an intraocular incision.

The dependent claims recite selected optional features.

In one aspect of the subject invention, a syringe assembly for performing a capsulotomy on a patient's eye with a cystotome is provided, the assembly comprising: a syringe having a luer tip with a liquid outlet at a distal end thereof; and, a grip including an elongated body extending along a longitudinal axis (LA) between first and second ends, the first end defining a female luer fitting configured for mounting onto the luer tip of the syringe, an inlet opening being defined in the female luer fitting, the second end defining a male luer fitting defining an outlet opening at a distal end thereof, and, a liquid passageway defined through the body between the inlet opening and the outlet opening to allow liquid flow therebetween, wherein, the body defines an outer surface encircling the longitudinal axis (LA), the outer surface being at least partially textured, wherein the grip is mounted to the syringe with the female luer fitting mounted to the luer tip, wherein the inlet opening being aligned with the liquid outlet of the luer tip, and a cystotome, distally extending from a hub, the cystotome configured for incising the lens capsule of a patient's eye, the hub having a secondary female luer fitting mounted to the male luer fitting.

In a further example, a method is provided for performing a capsulotomy on a patient's eye, the method including: providing a grip having an elongated body extending along a longitudinal axis between first and second ends, the first end defining a female luer fitting with an inlet opening defined therein, the second end defining a male luer fitting defining an outlet opening at a distal end thereof, and, a liquid passageway defined through the body between the inlet opening and the outlet opening to allow liquid flow therebetween, wherein, the body defines an outer surface encircling the longitudinal axis, the outer surface being at least partially textured; mounting the female luer fitting of the grip onto a luer tip of a syringe containing irrigation fluid; and, mounting a hub, from which distally extends a cystotome, onto the male luer fitting of the grip.

As used herein, the term "distal," and derivatives thereof (e.g., distally) refers to a direction towards or closer to a patient. As used herein, the term "proximal," and derivates thereof (e.g., proximally) refers to a direction away or farther from a patient.

These and other features of the subject invention will be better understood through a study of the following detailed description.

With reference to the Figures, a grip <NUM> is shown in accordance with the subject invention. The grip <NUM> is mountable to a syringe <NUM> and is configured to mountingly receive a cystotome <NUM>.

As shown in <FIG>, the syringe <NUM> may be any standard syringe, including being pre-fillable (e.g., glass barrel) or disposable (e.g., plastic barrel). The syringe <NUM> may include a barrel <NUM>, formed of glass and/or plastic, for accommodating a liquid, which has an open proximal end <NUM>, through which plunger <NUM> may extend. A piston <NUM>, which may be elastomeric, may be provided at a distal end <NUM> of the plunger <NUM>, the piston <NUM> formed for sliding, liquid-tight engagement with inner surface <NUM> of the barrel <NUM>. A thumb pad <NUM> may be provided at a proximal end <NUM> of the plunger <NUM>. A wall <NUM> may extend across a distal end <NUM> of the barrel <NUM>. The wall <NUM> may be tapered to direct flow to a liquid outlet <NUM>. The wall <NUM> may be configured to define a luer tip <NUM>, as is known in the art. The luer tip <NUM> may be a slip tip or provided with a surrounding internally-threaded collar to provide a "luer lock" arrangement. The liquid outlet <NUM> extends through a distal end <NUM> of the luer tip <NUM>. For ease of handling, one or more finger flanges <NUM> may protrude radially outwardly from the barrel <NUM> about the open proximal end <NUM>.

The barrel <NUM> defines a reservoir <NUM> distally of the plunger <NUM>. Distal movement of the plunger <NUM>, results in distal movement of the piston <NUM> and, thus, liquid contained in the reservoir <NUM> being urged through the liquid outlet <NUM>.

The cystotome <NUM> may be of any known type. By way of non-limiting example, the cystotome <NUM> may include a hub <NUM>, which may be plastic, having a secondary female luer fitting <NUM> defined therein. The cystotome <NUM> may be in the form of a cannula <NUM>, which may be bent, and secured to the hub <NUM> to extend distally therefrom. The cystotome <NUM> may be configured for incising a lens capsule of a patient's eye, e.g., by including one or more radially protruding cutting edge(s) <NUM> at or proximate to a distal end <NUM> of the cannula <NUM>. The cystotome <NUM> may include a distal opening <NUM> formed at the distal end <NUM>, through which irrigation fluid may flow.

The grip <NUM> includes a body <NUM>, which may be a unitary piece, prepared by various techniques e.g., by molding or forming (e.g., three-dimensional printing). The grip <NUM> may be formed of thermoplastic and/or elastomeric material. Material must be selected to allow the grip <NUM> to be sterilized (e.g., by UV exposure, gas exposure, steam exposure, and so forth).

The body <NUM> is elongated to extend along a longitudinal axis LA between first and second ends <NUM>, <NUM> thereof. The first end <NUM> defines a female luer fitting <NUM> configured for mounting onto the luer tip <NUM> of the syringe <NUM>. The female luer fitting <NUM> defines an inlet opening <NUM>, which is formed to align with the liquid outlet <NUM> of the luer tip <NUM> with the female luer fitting <NUM> being mounted to the luer tip <NUM>. The second end <NUM> defines a male luer fitting <NUM> which defines an outlet opening <NUM> at a distal end <NUM> thereof. A liquid passageway <NUM> may be defined through the body <NUM> between the inlet opening <NUM> and the outlet opening <NUM> to allow liquid flow therebetween. The liquid passageway <NUM> preferably is straight, to run along the longitudinal axis LA. Changes in direction are not desired since such may cause resistance to flow through the liquid passageway <NUM>. It is also preferred that the liquid passageway <NUM> generally have a constant cross-section. The liquid passageway <NUM> may taper in a direction from the inlet opening <NUM> to the outlet opening <NUM>, preferably, the taper being gradual.

The body <NUM> defines an outer surface <NUM> which encircles the longitudinal axis LA. The outer surface <NUM> is at least partially textured, to enhance grip therewith. A full circumference of the body <NUM> may be textured, e.g., to define an annular band of texturing, to provide a practitioner with a radially uninterrupted textured surface for rotational adjustment of the cystotome <NUM>. The texturing may be provided by any known arrangement, including, but not limited to, raised elements <NUM> (such as beads and/or ribs) and/or hollows <NUM> (such as channels or dimples). <FIG> show exemplary forms of the raised elements <NUM>, particularly as raised beads. The raised elements <NUM> may include regular or irregular patterns of protruding or embossed elements. Likewise, the hollows 77may include regular or irregular patterns of recesses or indentations. For example, as shown in <FIG>, the hollows <NUM> may include spaced-apart discontinuities <NUM> defined in the outer surface <NUM> where open pockets are defined between solid portions of the outer surface <NUM>. The discontinuities <NUM> may be defined by a plurality of intersecting ribs <NUM>. In addition, or alternatively, the outer surface <NUM> may be defined by an anti-slip material which provides enhanced gripping. Examples of suitable anti-slip materials include one or more of a polymeric foam, a polymeric mesh, an elastomer, and a coated or treated polymer. The body <NUM> may be provided as a two-part piece with a core of one material encased by the outer surface <NUM> of a different material. In this configuration, the core may be formed as a unitary piece with the outer surface <NUM> being applied thereto as a secondary operation. The core may contain the female luer fitting <NUM>, the male luer fitting <NUM>, and the liquid passageway <NUM>.

In addition, or alternatively, the body <NUM> may be configured to enhance handling. For example, as shown in <FIG>, the diameter of the body <NUM> may vary along the longitudinal axis LA. This allows for the body <NUM> to have a concave shape, with indentations in which portions of a practitioner's fingers may nest. Other shapes are possible such as one or more undulations, convexities, and so forth. In addition, as shown in <FIG>, portions of the body <NUM> may be flattened or otherwise configured to define one or more panels or truncations <NUM>.

The grip <NUM> may be mounted to the syringe <NUM> with the female luer fitting <NUM> being mounted to the luer tip <NUM>. One or more thread elements <NUM> may be provided at the first end <NUM>, e.g., about the female luer fitting <NUM>, configured to engage, e.g., threadedly engage, a threaded collar <NUM> if provided about the luer tip <NUM> to form a "luer lock. " Slip mounting alone may be utilized. In addition, the cystotome <NUM> may be mounted to the grip <NUM> with the secondary female luer fitting <NUM> being mounted to the male luer fitting <NUM>. An internally-threaded collar <NUM> may be provided about the male luer fitting <NUM>, as shown in <FIG>, with one or more cooperating thread elements provided on the hub <NUM>, about the secondary female luer fitting <NUM>, to allow a "luer lock" to form therebetween. Slip mounting alone may be also utilized at this interface.

The grip <NUM>, the syringe <NUM>, and the cystotome <NUM> collectively form a syringe assembly useable for performing a capsulotomy on a patient's eye. The grip <NUM> provides a practitioner with an enhanced grip surface distally of the syringe <NUM>, to allow for good handling. Many practitioners use a rolling motion of a cystotome in performing a capsulotomy. With the outer surface <NUM> being textured, the practitioner is provided with an improved grip surface. With the outer surface <NUM> being textured about its entire circumference, an improved grip surface may be provided agnostic to rotational orientation of the grip <NUM>.

Claim 1:
A syringe assembly for performing a capsulotomy on a patient's eye with a cystotome, the assembly comprising:
a syringe (<NUM>) having a luer tip (<NUM>) with a liquid outlet (<NUM>) at a distal end (<NUM>) thereof; and,
a grip (<NUM>) including an elongated body (<NUM>) extending along a longitudinal axis (LA) between first and second ends (<NUM>, <NUM>), the first end (<NUM>) defining a female luer fitting (<NUM>) configured for mounting onto the luer tip (<NUM>) of the syringe (<NUM>), an inlet opening (<NUM>) being defined in the female luer fitting (<NUM>), the second end (<NUM>) defining a male luer fitting (<NUM>) defining an outlet opening (<NUM>) at a distal end (<NUM>) thereof, and, a liquid passageway (<NUM>) defined through the body (<NUM>) between the inlet opening (<NUM>) and the outlet opening (<NUM>) to allow liquid flow therebetween, wherein, the body (<NUM>) defines an outer surface (<NUM>) encircling the longitudinal axis (LA), the outer surface (<NUM>) being at least partially textured,
wherein the grip (<NUM>) is mounted to the syringe (<NUM>) with the female luer fitting (<NUM>) mounted to the luer tip (<NUM>),
and
the inlet opening (<NUM>) being aligned with the liquid outlet (<NUM>) of the luer tip (<NUM>),
characterized by
a cystotome (<NUM>), distally extending from a hub (<NUM>), the cystotome (<NUM>) configured for incising the lens capsule of a patient's eye, the hub (<NUM>) having a secondary female luer fitting (<NUM>) mounted to the male luer fitting (<NUM>).