TECHNICAL FIELD

The present disclosure is directed to systems, instruments, and methods for use in medical procedures, and, more particularly, to systems, instruments, and methods for vitrectomy and related procedures.

BACKGROUND

Vitreoretinal procedures are commonly performed within the posterior segment of the human eye to treat many serious conditions of the posterior segment of the eye. In particular, vitreoretinal procedures may treat conditions such as age-related macular degeneration (AMD), diabetic retinopathy and diabetic vitreous hemorrhage, macular hole, retinal detachment, epiretinal membrane, cytomegalovirus (CMV) retinitis, and many other ophthalmic conditions.

Such procedures frequently involve the cutting and removal of portions of the vitreous humor from the posterior segment of the eye. The vitreous humor is formed of microscopic fibers or strands within the posterior segment. A surgeon may perform vitreoretinal procedures with a microscope and special lenses designed to provide a clear image of the posterior segment. Several tiny incisions just a millimeter or so in size are typically made on the sclera at the pars plana. In a vitrectomy procedure, the surgeon inserts microsurgical instruments through the incisions, including a vitrectomy probe or tip to cut and remove the strands of the vitreous body.

Examples of vitrectomy instruments are disclosed, for example, in U.S. Pat. Nos. 5,176,628, 8,038,692, U.S. Patent Application No. 2008/0172077, U.S. Patent Application No. 2014/0171997, U.S. Patent Application No. 2014/0364886, and U.S. Patent Application No. 2015/0173948. Mechanisms for driving a reciprocating cutter of a vitrectomy instrument and other common features and functions of vitrectomy instruments are known, for example from U.S. Pat. No. 8,038,692 and the ULTRAVIT® vitrectomy instrument produced by Alcon Laboratories, Inc., located at 6201 South Freeway, Fort Worth, Tex. 76134, and therefore the details of such mechanisms are not repeated herein.

The removal of vitreous fibers is a sensitive procedure that should be performed efficiently and without damage to the retina or other parts of the eye.

SUMMARY

The present disclosure provides for improvements in vitrectomy instruments and associated systems and methods.

An aspect of the present disclosure encompasses a vitrectomy instrument that may include a housing, a reciprocating cutter, and a motor. The housing may include a proximal end and a distal end. The reciprocating cutter may include a needle projecting from the distal end of the housing. The needle may include a proximal end, a distal end, a first lumen, and a port disposed at the distal end of the needle. The port may provide fluid communication between the exterior of the needle and the first lumen. The reciprocating cutter may also include an inner tube that extends within the first lumen of the needle. The inner tube may include a second lumen and a cutting edge adapted to cut tissue drawn into the port. The reciprocating cutter may also include a needle stop coupled to the proximal end of the needle and comprising a first contact surface and a cutter stop coupled to the inner tube and. The first contact surface may be configured to contact the second contact surface limiting distal movement of the inner tube and defining a fully extended position of the inner tube. The motor may be operable to reciprocate the inner tube.

A second aspect, the disclosure describes a method of assembling a vitrectomy instrument. The method may include forming a first assembly that may include coupling an inner tube of a cutter to a diaphragm and coupling a needle stop proximal component of a needle stop to the housing; forming a second assembly that may include assembling a needle of the cutter and needle stop distal component of the needle stop together; positioning the inner tube at a desired position within the first assembly; combining the second assembly to the first assembly that may include positioning the needle stop distal component over the needle stop proximal component; and affixing the second assembly to the first assembly that may include fixing the needle stop distal component to the needle stop proximal component.

The various aspects may include one or more of the following features. The motor may include a diaphragm disposed in the housing and movable in response to pneumatic pressure. The diaphragm may be connected to the inner tube of the reciprocating cutter such that the inner tube is movable with the diaphragm. The diaphragm may include a rigid diaphragm part connected to the inner tube and a flexible membrane connected to the rigid diaphragm part and to the housing. The cutter stop and the needle stop may be formed from a metal. The cutter stop and the inner tube may be formed from a metal, and the cutter stop may be welded to the inner tube. The cutter stop may include a stop ring that is welded to the inner tube. The cutter stop may include a stop ring. The cutter stop may also include a stop pad, and the second contact surface may be a surface of the stop pad. The needle stop may also include a needle stop proximal component and a needle stop distal component coupled to the needle stop proximal component. The needle stop proximal component may be received into a cavity defined by the needle stop distal component. The needle stop proximal component may include a proximal portion having a first cross-sectional size, a distal portion having a second cross-sectional size smaller than the first cross-sectional size, and a shoulder joining the proximal portion and the distal portion. The proximal portion of the needle stop proximal component may be received into a cavity defined by the needle stop distal component. The needle stop proximal component may be welded to the needle stop distal component. The shoulder may define the first contact surface.

The various aspects may also include one or more of the following features. Combining the second assembly to the first assembly may also include adjusting a position of the second assembly relative to the first assembly until a desired position of the second assembly is reached. Affixing the second assembly to the first assembly may include fixing the needle stop distal component to the needle stop proximal component. Fixing the needle stop distal component to the needle stop proximal component may include welding the needle stop distal component to the needle stop proximal component.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory in nature and are intended to provide an understanding of the present disclosure without limiting the scope of the present disclosure. In that regard, additional aspects, features, and advantages of the present disclosure will be apparent to one skilled in the art from the accompanying drawings and the following detailed description.

