MX2012009035A

MX2012009035A - Multi-fiber flexible surgical probe.

Info

Publication number: MX2012009035A
Application number: MX2012009035A
Authority: MX
Inventors: Jack R Auld; Mark H Farley
Original assignee: Alcon Res Ltd
Priority date: 2010-02-17
Filing date: 2010-12-15
Publication date: 2012-09-07
Also published as: CA2787024A1; CN102762162A; EP2509526A4; JP2013519492A; EP2509526A1; BR112012020778A2; KR20130008556A; AU2010346509A1; RU2012139445A; WO2011102870A1

Abstract

A probe having a flexible, small diameter fiber optic sheathed in a small diameter flexible tube comprising the distal tip of the probe. The small diameters of the fiber and tube allow the fiber to be bent in a tight radius comprising the major portion of the length of the exposed portion of the fiber, with low tube bending forces during insertion, providing a compact design which reduces or eliminates the need for a straight distal portion of flexible tube extending from the cannula. The small diameter tube also allows a greater wall thickness outer cannula to be used, thereby increasing instrument rigidity. One embodiment encompasses a larger flexible tube with corresponding larger bend radius, to encase a plurality of fiber optics, providing separately optimized laser and illumination delivery paths. Anti-friction coating material may be used to further reduce insertion forces.

Description

FLEXIBLE SURGICAL PROBE OF MULTIPLE FIBERS BACKGROUND OF THE INVENTION The present invention relates to ophthalmic surgical equipment and more particularly to posterior segment ophthalmic surgical equipment. Even more particularly, the present invention relates to multi-fiber ophthalmic probes.

BACKGROUND OF THE INVENTION Microsurgery instruments are generally used by surgeons for the removal of tissue from delicate and restricted spaces in the human body, especially in surgery in the eye and more particularly in procedures for the removal of the vitreous body, blood, tissue scar, or the lens. Such instruments include a control console and a surgical hand piece with which the surgeon dissects and removes the tissue. With respect to posterior segment surgery, the handpiece may be a probe to cut the vitreous, a laser probe, a lighting probe, or an ultrasonic fragmentor to cut or fragment tissue and connect to the control console by a line of high pressure air (pneumatic) and / or power cable, optical cable, or flexible tubes for the supply of a perfusion liquid to the surgical area and for the withdrawal or aspiration of the liquid and the cut / tissue fragmented in the place. The cut, infusion, and suction functions of the handpiece are controlled by the remote control console that not only provides the energy for the surgical handpiece (for example, an alternate or rotary cutting blade or an ultrasonically vibrating needle) ), but also controls the flow of infusion fluid and provides a vacuum source (relative to the atmosphere) for liquid aspiration and fragmented tissue / cutting. The functions of the console are controlled manually by the surgeon, usually by means of a foot operated or proportional control switch.

During posterior segment surgery, the surgeon normally uses several hand pieces of or instruments during the procedure. This procedure requires that these instruments be inserted into, and removed from, the incision. This removal and repeated insertion may cause trauma to the eye at the site of the incision. To solve this problem, mazase cannulas have been developed at least by the mid-1980s. These devices consist of a narrow tube with an attached bucket. The tube is inserted into an incision in the eye to the center, which acts as a stop, preventing the tube from entering the eye completely. Surgical instruments can be inserted into the eye through the tube and the tube protects the lateral incision wall from repeated contact by the instruments. In addition, the surgeon can use the instrument, by manipulating the instrument when the instrument is inserted into the eye through the tube, to assist the position of the eye during surgery.

Many surgical procedures require access to the sides or front of the retina. To reach these areas, the surgical probes must be pre-bent or have to be flexible within the surgery. Articulation / illumination of laser probes is known. See, for example, USPN 5,281, 214 (Wilkins et al.). The articulation mechanism, however, adds additional complexity and expense. A flexible laser probe that does not need articulation mechanism is commercially available, but this device uses a fiber of relatively large optical diameter encased in a flexible tube comprising the distal tip, resulting in a large radius of curvature and distal tip diameter large with the rigidity of significant curvature. These features require that the distal tip contains a straight, unfolded portion for ease of insertion of the bent part, which must be flexibly straightened as it passes through the hub cannula. The straight part of the distal tip allows the bent portion to pass flexibly through the hub cannula before the distal cannula of the handpiece enters the hub cannula, to allow the maximum flexion spacing of the flexible part, thus minimizing bending deformation and the corresponding friction insertion forces. Such a large radius of curvature, the large diameter flexible tube, and the straight distal tip cause the usable portion of the fiber to extend a relatively long distance from the distal tip of the probe and the laser limits access to the treatment of the probe.

A further disadvantage in the known art is the flexibility of the distal cannula, which is a function of the properties of the material and the moment of inertia of the cross section, as determined by the gauge size of the outer diameter of the cannula to fit inside the cannula of the hub and the inner diameter of the cannula to accept the flexible tube. For any given material, the outer and inner diameters of the cannula determine the flexibility of the cannula. This flexibility limits the ability of the surgeon to use the instrument to manipulate the position of the eye during surgery.

A further disadvantage in the known art is that it does not offer a flexible tip probe without articulation providing both laser and illumination delivery through separate paths optimized for each delivery function. Current surgical procedures require unique patterns of laser delivery and illumination: a narrow beam pattern for laser delivery and a wide-angle pattern for illumination. The optical parameters needed to supply these two unique patterns differ in that a single delivery path requires either separate instruments, or the compromised modality of the laser delivery pattern and / or the illumination pattern.

Accordingly, a continuing need exists for a flexible tip probe without articulation that does not require a straight portion of flexible tubing at the distal end and thus provides a more compact tip of usable length, which allows greater access to treatment with internal laser of posterior structures of the eye, without compromising the forces of insertion. The need also continues to exist for a flexible tip probe that provides greater rigidity of the distal cannula to facilitate manipulation of the position of the eye during surgery. In addition, there is a need for a flexible tip probe that provides laser delivery and illumination through separate paths optimized for each delivery function.

BRIEF SUMMARY OF THE INVENTION The present invention improves upon the prior art by providing a probe having a flexible, small diameter fiber within a flexible tube, comprising the distal non-articular tip of the probe. The small diameter fiber and tube combination allows the fiber to be bent into a small radius comprising most of the length of the exposed portion of the fiber, minimizing the need for a straight portion to reduce the insertion forces. So that a small radius and compact length allows access of the greater fiber to the posterior internal structures of the eye; thus increasing the laser treatment area of the probe, without compromising the insertion forces.

Accordingly, an object of the present invention is to provide a laser probe having a fiber / tube of small non-articulated flexible diameter comprising the distal tip of the probe.

Another object of the present invention is to provide a laser probe having a flexible, fiber tube / small diameter tubing comprising the distal tip of the probe that is bent into a small radius comprising most of the length of the exposed portion of fiber.

A further objective of the present invention is to provide a laser probe that allows greater access to the posterior internal structures of the eye.

A further objective of the present invention is to provide greater rigidity of the distal cannula to facilitate manipulation of the position of the eye during surgery.

A further objective of the present invention is to provide a flexible probe with a laser tip capable of supplying both laser and illumination through optimized, separate optical fiber paths.

Other objects, features and advantages of the present invention will become apparent with reference to the drawings and the following description of the drawings and the claims.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a perspective view of the probe of the present invention.

Figure 2 is a top view of the probe of the present invention.

Figure 3 is a cross-sectional view of the probe of the present invention.

Figure 4 is a cross-sectional view of an alternative embodiment of the present invention, having separate laser and delivery fiber optic lighting paths.

Figure 5 is an enlarged cross-sectional view of the distal end of an embodiment of the present invention shown in the Figure.

DETAILED DESCRIPTION OF THE INVENTION The modalities of the probe of the present invention provide a flexible laser light probe system with separate fibers, optimized for laser and illumination in a single instrument designed for Trocar entry minimally invasive surgical systems, unlike the prior art which does not provides separate fibers for laser delivery and illumination and can be used in Trocar entry minimally invasive surgical systems. The embodiments of this invention can thus provide a probe having optimum illumination intensity, ease of insertion into a surgical site and a compact tip for access to broad treatment. Some of the advantages that can be provided by the modalities of this invention are: minimally invasive photo-coagulation of the retina with the instructions, optimal illumination of a treatment area; laser and illumination in a single instrument, allowing a surgeon to perform self-scleral depression; the compact curved tip and short active length provides ample access to the peripheral retina, reduces or eliminates the possibility of burning elliptical associated with straight laser probes tip; help avoid contact with the contact lens is a surgical site opposite the port of entry and facilitate treatment after the sclera band.

As best seen in Figures 1-5, the probe 10 of the present invention generally consists of the handle or body 12, which contains or encloses a laser optical fiber 16 and / or a lighting optical fiber 22, flexible tube 21, distal cannula 18 and fiber optic sheath 14. Body 12 is generally hollow and can be made of any suitable material such as stainless steel, titanium or thermoplastic. The cannula 18 can be made of any suitable material, such as titanium or stainless steel and held within the body 12 by any conventional method, such as adhesive or press. The fiber optic cover 14 can be any suitable tube, such as thermoplastic or silicone. In some embodiments, the probe may comprise a plurality of optical fiber cables, each having one or more optical fibers (eg, optical fiber, such as fiber optic laser 16 and illumination optical fiber 22). The plurality of fiber optic cables and the optical fiber may have the same or similar optical properties or may each have unique optical properties suitable for their purpose (e.g., illumination or laser light).

The laser optical fiber 16 and the optical fiber optic 22 can be connected at a proximal end (not shown) to any suitable laser or light source through a connector of a type well known in the art and are surrounded by a flexible tube 21 with the exposed portion 19. The flexible tube 21 is made of a shape memory alloy, such as nitinol and is held within the cannula 18 by any conventional method, such as adhesive or crimping and containing fiber laser optic 16 and / or optical fiber optic 22, which are carried out for inner diameter of flexible tube 21 by any conventional method, such as adhesive or pressing. Fiber optic laser 16, illuminating fiber optic 22, and exposed part 19 of flexible tube 21 extend beyond distal end 20 of cannula 18 a distance of about 3 millimeters to 14 millimeters, with about 4 millimeters to 6 millimeters or 1 millimeters of 1 to 13 millimeters being the most preferred, respectively, for a single optical fiber or a plurality of optical fibers enclosed in the flexible tube 21.

The laser optical fiber 16 and the optical fiber optic 22 can be made of any fiber optic material for laser or illumination conduction, respectively. Silica (or glass) with an outside diameter of ??? μ is preferred for a single laser fiber optic supply. and 125 μ ?? with at least exposed part 19 of flexible tube 21 is a flexible elbow of 33-gauge nitinol tube (approximately 0.002 cm OD) at an angle of approximately 30-45 ° over a radius of approximately between 4.5 mm and 6 mm throughout of the exposed section 19. It is important to note that the fiber optic laser section 16 within the exposed section 19 can be curved or flexed at the start at or near the distal end 20 of the cannula 18, with minimal or no cross section of the distal end 20 of the cannula 18. Such construction improves the peripheral access of laser treatment near the entry point of the cannula 18. Under the tube of smaller flexible diameter with significantly reduced moment of inertia in cross-section, the force of simultaneous insertion of the exposed section 19 with the cannula 18 into a surgical mallet cannula is maintained within an optimum range to facilitate insertion and ext manual rationing.

The preferable material for an optical fiber with additional optical fiber laser, or for a plurality of optical fibers, is silica or plastic or a combination thereof, with an outer diameter between 100 μp? and 250 μp? with at least exposed part 19 of flexible tube 21 being a 31 to 28 gauge (approximately 0.025 to 0.3 cm OD) nitinol flexible tube bent at an angle of approximately 30-45 ° over a radius of approximately between 7 mm and 15 mm a along the exposed portion 19. It is important to note that the fiber optic section of laser 16 and / or optical illumination fiber 22 within the exposed section 19 may be curved or bent at the beginning at or near the distal end 20 of the cannula 18, with minimal or no straight section near the distal end 20 of the cannula 18. Said construction provides both the laser and the lighting functions, as well as improving the peripheral laser treatment access near the cannula entry point 18 By using a flexible tube of minimum diameter, radius of curvature and straight section, the insertion force of the exposed section 19 in a surgical mallet cannula is maintained within an optimal range to facilitate manual insertion and removal, while providing the additional lighting function. A further reduction of insertion force can be realized by the use of anti-friction coating 23, on the exposed section 19 of flexible tube 21.

In use, the exposed section 19 enclosing the laser optical fiber 16 and / or optical illumination fiber 22 can be straightened so that the exposed section 19 can be inserted into an eye through a 23 gauge or 25 gauge of a cannula of mallet. Once in the eye, the shape memory features of the nitinol tube cause the exposed section 19 to resume its curved configuration.

While certain embodiments of the present invention have been described above, these descriptions are given for purposes of illustration and explanation. The variations, changes, modifications and deviations of the systems and methods described above can be adopted without departing from the scope or spirit of the present invention.

Claims

1. - A probe, comprising: a) a generally hollow body; b) a cannula attached to the distal end of the body; c) a plurality of fiber optic cables extending through the hollow body, each of the plurality of fiber optic cables having an optical fiber and extending through the cannula, and d) an exposed portion of optical fibers, the exposed portion of the optical fibers extending beyond a distal end of the cannula, the exposed portion of the optical fibers provided with a nitinol tube that is bent along a length of radius between approximately 4.5 mm and 15.0 mm.

2. - The probe of claim 1, wherein the nitinol tube is bent at an angle of about 30-45 degrees.

3. - The probe of claim 1, wherein one or more of the plurality of optical fiber has an outer diameter of between approximately? Μp? and 250 m.

4. - The probe of claim 1, wherein the exposed part extends beyond the distal end of the cannula a distance of about 3.0 millimeters to 8.0 millimeters.

5. - The probe of claim 4, wherein the exposed portion extends beyond the distal end of the cannula a distance of about 4.0 millimeters to 6.0 millimeters.

6. - The probe of claim 1, wherein the exposed part extends beyond the distal end of the cannula a distance of about 8.0 millimeters to 14.0 millimeters.

7. - The probe of claim 6, wherein the exposed part extends beyond the distal end of the cannula a distance of about 10.0 millimeters to 13.0 millimeters.

8. - The probe of claim 1, wherein the outer diameter of the exposed portion is coated with an anti-friction material. SUMMARY A probe having a flexible small diameter optical fiber covered with a small diameter flexible tube comprising the distal tip of the probe. The small diameters of the fiber and tube allow the fiber to be flexed in a narrow radius comprising the main portion of the length of the exposed portion of the fiber, with low tube bending forces during insertion, providing a compact design that reduces or eliminates the need for a straight distal portion of flexible tube extending from the cannula. The small diameter tube also allows an external cannula of greater wall thickness to be used, thereby increasing instrumental rigidity. One embodiment encompasses a larger flexible tube with corresponding bending radius, for enclosing a plurality of optical fiber, providing optimized laser delivery and lighting paths separately. The antifriction coating material can be used to further reduce the insertion forces.