KR20130008556A - Multi-fiber flexible surgical probe - Google Patents

Abstract

The present invention relates to a probe having a flexible small diameter optical fiber wrapped with a small diameter flexible tube, including the distal tip of the probe. Small diameter optical fibers and tubes have a low tube bending force during insertion, which bends the optical fiber to a tight radius that includes the length of most of the exposed portion of the optical fiber, thereby reducing the need for a straight distal portion of the flexible tube extending from the cannula or Remove Small diameter tubes also increase the rigidity of the instrument by making the wall thickness of the outer cannula used larger. One embodiment includes a larger flexible tube with a corresponding larger bending radius that encloses the plurality of optical fibers to provide optimized laser and light transmission paths individually. Anti-friction coating materials can be used to further reduce the insertion force.

Description

MULTI-FIBER FLEXIBLE SURGICAL PROBE}

The present invention relates to ophthalmic surgical equipment, and more particularly to posterior segment ophthalmic surgical equipment. More specifically, the present invention relates to multi-fiber ophthalmic probes.

Microsurgical instruments are typically used to remove tissue from delicate and confined spaces in the human body, especially during ocular surgery, more particularly to remove vitreous bodies, blood, scar tissue or crystalline lenses. Used by the surgeon during the procedure. Such instruments include a surgical handpiece and a control console through which the surgeon incise and remove tissue. In the context of posterior ocular surgery, the handpiece includes a vitreous cutter probe, a laser probe, an illumination probe, or an ultrasonic fragmenter for cutting or fragmenting tissue and supplying injection fluid to the surgical site. And a long pneumatic (pneumatic) line and / or power cable, optical cable, or flexible tube to drain or withdraw fluid from the surgical site. The ablation, infusion, and aspiration functions of the handpiece not only provide power to the surgical handpiece (s) (eg, reciprocating or rotary ablation blades or ultrasonically vibrated needles), It is controlled by a remote control console that controls the flow rate and provides a vacuum source (relative to atmosphere) to the aspiration and ablation / fragmentation of the fluid. The console's function is usually controlled by the surgeon manually, either by foot-operated switch or proportional control.

During posterior back surgery, the surgeon typically uses several handpieces or instruments during the procedure. This surgical procedure requires these instruments to be inserted into and removed from the incision. This repeated removal and insertion can cause trauma to the eye at the incision site. To solve this problem, hubbed cannulae have been developed at least in the mid-1980s. This mechanism consists of a narrow tube with an attached hub. The tube is inserted into the guide incision and into the hub acting as a stop so that the tube does not completely enter the eye. The surgical instrument may be inserted into the eye through the tube and the tube protects the incision side wall from repeated contact by the instrument. The surgeon may also use the instrument by manipulating the instrument as it is inserted into the eye through a tube to assist in positioning the eye during surgery.

Many surgical procedures require access to the side or anterior of the retina. To reach this area, the surgical probe must be pre-bent or intra-operatively capable of bending. Articulating laser / lighting probes are known (see, eg, US Pat. No. 5,281,214 (Wilkins, et al.)). However, the articulation mechanism adds additional complexity and cost. Flexible laser probes are commercially available unless they require segmentation mechanisms, but such instruments use a relatively large diameter optical fiber wrapped in a flexible tube that includes a distal tip to provide a large amount of bending stiffness. Resulting in distal tip diameter and large bend radius. These features require the distal tip to contain a non-bent straight portion for easy insertion of the bent portion, the straight portion being flexible as it passes through the hubized cannula. You should. The straight portion of the distal tip allows bending of the distal cannula of the handpiece through the hubized cannula before allowing it to enter the hubized cannula, allowing for maximum bending clearance of the flexible portion, thereby providing bending stress and corresponding friction. Minimize insertion force. Such large bending radii, large diameter flexible tubes, and straight distal tips extend the usable portion of the optical fiber relatively long from the distal end of the probe and limit the laser therapeutic access of the probe.

A further disadvantage in the known art is the flexibility of the distal cannula, which is determined by the gauge size of the inner diameter of the cannula for receiving the flexible tube and the outer diameter of the cannula for fixing inside the hub formed cannula. In this case, it is a function of the material properties and the cross sectional moment of inertia. For any given material, the outer and inner diameters of the cannula determine the flexibility of the cannula. This flexibility excludes the physician's ability to use the instrument to manipulate the eye's position during surgery.

A further disadvantage in the known art is that it does not provide a non-articulating flexible-tip probe that delivers both laser and illumination through separate paths optimized for each delivery function. Recent surgical procedures require specific delivery patterns for lasers and illumination, that is, narrow beam patterns for laser delivery, and wide angle patterns for illumination. The optical parameters required to deliver these two specific patterns differ depending on whether a single delivery path requires separate instrumentation or compromised performance for the laser delivery pattern and / or illumination pattern.

Thus, a non-segmental type that does not require a straight portion of the flexible tube at the distal tip, thus providing a smaller available tip length, thereby allowing greater laser therapeutic access to the inner posterior structure without compromising insertion force. Flexible tip probes are still needed. In addition, there is still a need for a flexible-tip probe that provides increased stiffness of the distal cannula to facilitate steering of the eye position during surgery. There is also a need for a flexible-tip prop that delivers both laser and illumination through separate paths optimized for each delivery function.

Summary of the Invention

The present invention improves upon the prior art by providing a probe with a flexible small diameter fiber that is flexible in flexible tubes, including the non-segmented distal tip of the probe. The combination of small diameter fibers and tubes bends to a tight radius that includes most of the length of the exposed portion of the fiber, thereby minimizing the need for straight portions and reducing insertion force. This tight radius and short length give the fiber more access to the posterior structures inside the eye; This increases the laser treatment area of the probe without lowering the insertion force.

It is therefore an object of the present invention to provide a laser probe with a flexible, small diameter, non-segmented fiber / tube comprising a distal tip of the probe.

It is yet another object of the present invention to provide a laser probe with a flexible small diameter fiber / tube comprising a distal end of the probe that bends to a tight radius that includes most of the exposed portion of the fiber.

It is a further object of the present invention to provide a laser probe that gives greater access to the posterior structures inside the eye.

Another object of the present invention is to provide increased stiffness of the distal cannula to facilitate steering of the eye position during surgery.

It is a further object of the present invention to provide a flexible-tip laser probe capable of delivering both laser and illumination through individual optimized optical fibers.

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

1 is a perspective view of a probe of the present invention.
2 is an elevation view of a probe of the present invention.
3 is a cross-sectional view of the probe of the present invention.
4 is a cross-sectional view of another embodiment of the present invention with separate laser and illumination fiber optic transmission paths.
5 is an enlarged cross-sectional view of the distal end of the embodiment of the invention shown in FIG.

Embodiments of the probes of the present invention are for minimally invasive Trocar-introduced surgical systems, unlike in the prior art, which can be used in minimally invasive Trocar-introduced surgical systems without providing separate fibers for delivering laser and illumination light. A single instrument designed to provide a flexible illuminated laser probe with individual optimized fibers for laser and illumination. Accordingly, embodiments of the present invention may provide probes with optimal illumination intensity, easy insertion into the surgical site, and small tips for a wide range of therapeutic approaches. Some of the advantages that can be provided by embodiments of the present invention are as follows: minimally invasive retinal photocoagulation with induced, optimized illumination for the treatment area; Laser and illumination in a single instrument, allowing the surgeon to perform self-scleral depression; Curved small tip and short active length provide broad access to the peripheral retina; Reducing or eliminating the likelihood of elliptical burn associated with a laser probe with a straight tip; Help to avoid lens contact when treating a surgical site opposite to the entry port; And facilitating posterior treatment of sclera buckle.

As best shown in FIGS. 1-5, the probe 10 of the present invention is generally a handle or body 12, flexible, containing or surrounding a laser fiber 16 and / or an illumination fiber 22. It consists of a tube 21, a distal cannula 18, and an optical fiber coating 14. Body 12 is generally hollow and may be made from any suitable material, such as stainless steel, titanium or thermoplastics. Cannula 18 may be made from any suitable material, such as titanium or stainless steel, and may be retained in body 12 by any conventional method such as adhesive or crimping. The optical fiber coating 14 may be any suitable tubing, such as thermoplastic or silicon. In some embodiments, the probe may comprise a plurality of optical fiber cables, each having one or more optical fibers (eg, optical fibers such as laser fiber 16 and illumination fiber 22). The plurality of optical fiber cables and optical fibers may have the same or similar optical properties or each may have unique optical properties suitable for their use (eg, illumination or laser light).

The laser fiber 16 and illumination fiber 22 may be connected to any suitable laser or illumination source on a proximal end (not shown) via a connector of the type well known in the art, and the exposed portion 19 Enclosed by a flexible tube 21 with The flexible tube 21 is made from a shape memory alloy such as Nitinol, is held in the cannula 18 by any conventional method such as adhesive or crimping, and the laser fiber 16 and / or illumination fiber Wrap 22 and they are held in the inner diameter of the flexible tube 21 by any conventional method such as adhesive or crimping. The exposed portion 19 of the laser optical fiber 16, the illumination optical fiber 22, and the flexible tube 21 is approximately 3 mm to 14 mm, respectively, for a single optical fiber or a plurality of optical fibers wrapped with the flexible tube 21, Very preferably it extends beyond the distal end 20 of the cannula 18 to a length of approximately 4 mm to 6 mm, or 11 mm to 13 mm.

The laser fiber 16 and the illumination fiber 22 may be made of any fiber material suitable for directing laser or illumination light, respectively. As the single laser transmission optical fiber, silica (or glass) having an outer diameter of 100 to 125 μm is preferable, and at least the exposed portion 19 of the flexible tube 21 is approximately 4.5 mm to 6 mm along the exposed portion 19. It is a 33 gauge (approximately 0.008 inch OD) flexible nitinol tube, curved at an angle of approximately 30 to 45 degrees relative to the radius. Importantly, the portion of the laser optical fiber 16 in the exposed portion 19 is bent at or near the distal end 20, with or without a straight portion proximate to the distal end 20 of the cannula 18. You can wheel. This configuration enhances peripheral laser treatment access adjacent the entry point of the cannula 18. With a small diameter flexible tube with a greatly reduced cross section moment of inertia, the simultaneous insertion force of the exposed portion 19 by the cannula 18 into the hubized surgical cannula is in an optimal range to facilitate manual insertion and ejection. Maintained within.

Preferred materials for the laser optical fiber, or for the plurality of optical fibers with additional illuminating optical fiber, are silica or plastic or combinations thereof having an outer diameter of 100 to 250 μm, and at least the exposed portion 19 of the flexible tube 21. ) Is a 31 to 28 gauge (approximately 0.010 to 0.015 inch OD) flexible nitinol tube that bends at an angle of approximately 30 to 45 ° for a radius of approximately 7 to 15 mm along the exposed portion 19. Importantly, the portion of the laser optical fiber 16 and / or the illumination optical fiber 22 in the exposed portion 19 may or may not have a straight portion proximate the distal end 20 of the cannula 18. 20) can be bent or bent at or close to it. This configuration provides both laser and illumination functions, as well as improves the peripheral laser treatment approach adjacent the entry point of the cannula 18. By using minimized flexible tube diameters, bend radii, and straight portions, the insertion force of the exposed portion 19 into the hub formed surgical cannula is optimized to facilitate manual insertion and removal while providing additional illumination. Keep it within range. Further reduction of the insertion force can be realized by using an antifriction coating 23 on the exposed portion 19 of the flexible tube 21.

In use, the exposed portion 19 surrounding the laser fiber 16 and / or the illumination fiber 22 may be straightened so that the exposed portion 19 can be inserted into the eye through a 23 gauge or 25 gauge hubed cannula. . When inserted into the eye, the shape memory feature of the nitinol tube causes the exposed portion 19 to recover the curved shape.

While certain embodiments of the invention have been described above, these descriptions are presented for purposes of illustration and description. Variations, changes, modifications, and variations of the above described systems and methods may be employed without departing from the scope or spirit of the invention.

Claims (8)

a) generally hollow body;
b) a cannula attached to the distal end of the hollow body;
c) a plurality of fiber optic cables extending through the hollow body, each of which has a fiber and extends through the cannula;
d) A probe comprising an exposed portion of an optical fiber extending beyond the distal end of the cannula and wrapped in a nitinol tube bent along a radius of approximately 4.5 mm to 15.0 mm. The probe of claim 1 wherein the nitinol tube bends at an angle of approximately 30 to 45 degrees. The probe of claim 1 wherein the outer diameter of the one or more plurality of optical fibers is approximately 100 μm to 250 μm. The probe of claim 1, wherein the exposed portion extends beyond the distal end of the cannula to a length of approximately 3.0 mm to 8.0 mm. The probe of claim 4 wherein the exposed portion extends beyond the distal end of the cannula to a length of approximately 4.0 mm to 6.0 mm. The probe of claim 1 wherein the exposed portion extends beyond the distal end of the cannula to a length of approximately 8.0 mm to 14.0 mm. The probe of claim 6, wherein the exposed portion extends beyond the distal end of the cannula to a length of approximately 11.0 mm to 13.0 mm. The probe of claim 1 wherein the outer diameter of the exposed portion is coated with an antifriction material.

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