WO2011135592A2

WO2011135592A2 - Surgical apparatus

Info

Publication number: WO2011135592A2
Application number: PCT/IN2011/000298
Authority: WO
Inventors: Amol Kadu
Original assignee: Amol Kadu
Priority date: 2010-04-30
Filing date: 2011-04-29
Publication date: 2011-11-03
Also published as: WO2011135592A3

Abstract

An apparatus for performing ophthalmic surgery including an insertion means(2) having art optimal width such as herein described, said insertion means being adapted to incorporate within it a shaping means(3), said shaping means being operatively connected to a cutting means and said shaping means being adapted to contract and expand within said insertion means, such that subsequent to the event of causing of an incision by said insertion means, said shaping means is adapted to be actuated to expand to a shape having a regular geometrical outline within the incision so formed, in the event of which, said cutting means adapted to be actuated to form an opening along said regular geometrical outline.

Description

Title Of Invention-SURGICAL APPARATUS

FIELD OF INVENTION

The present invention in general relates to the field of ophthalmic surgery, and in particular to an apparatus for performing capsulorrhexis/capsulotomy, which is a very important step in cataract surgery.

BACKGROUND OF THE INVENTION

Cataract is opacification of crystalline lens of human eye. The lens has a transparent capsule inside which lies the opaque matter. Cataract surgery is nothing but opening the front portion of the capsule (anterior or posterior capsule) and taking out the opaque matter followed by placing an artificial lens (called Intra-Ocular Lens or IOL) of the required power. Thus incising the capsule to make an opening for removal of cataract, becomes a very important step of the surgery. This step is called

capsulotomy or capsulorrhexis. Currently, can-opener capsulotomy and Continuous Curvilinear Capsulorrhexis (CCC) are the most frequently used techniques for capsule management. Whether it is ECCE or SICS or Phaco or micro surgery, CCC is preferred in all techniques

The standard method of Continuous Curvilinear Capsulorrhexis (CCC) begins by making a small nick in the anterior capsule at the center of the lens. The capsule tissue is pulled and a , flap of tissue is thus created which is tearing in a circular fashion so that the tear force vector is tangential to the circumference of the tear circle. This procedure is generally done by a bent needle or capsule holding forceps. It is important to keep the grasping point of the flap close to the tear point. Sometimes, if the grasping point of the flap is too far, the tear may run towards the periphery and it may be extremely hard to redirect the tear back to the desired circular pattern and may result in irreversible damage t the zonules. From time to time there have been so many revolutions in the field of cataract surgery. However the technique for continuous curvilinear capsulorrhexis (GGG) remains the same.

Phaco, the most popular surgical technique for cataract needs a perfect CCC for the best results. In immature cataracts a perfect CCC can be achieved with reasonable practice, but some cataracts like mature intumescent, hypermature morgagnian, subluxated, pediatric cataract it is difficult to achieve a perfect CCC. So, over the years research is on, in the area of capsulorrhexis for deciphering an

apparatus/device, which is applicable in surgery of all types of cataracts, such as immature cataract, mature cataract, mature intumescent cataract, hypermature catarct, hypermature cataract, hypermature morgagrian cataract, subluxated cataract and pediatric cataract. Several devices were disclosed in various patents/patent applications, but such patents/patent applications did not teach about any

device/apparatus which unequivocally performs capsulorrhexis/capsulotomy in respect of all types of cataracts, efficiently and effectively.

For example granted US Patent 6551326 (WO/2004/071312) discloses a

Capsulorrhexis device in which a cutting edge is affixed to the distal tip of a super- elastic rod with its distal end formed into a circular loop. The circular loop is first retracted inside of an outer tube member, and then the tube is inserted into the eye. The loop is then expelled from the tube, allowing the loop to reform inside of the eye. As the loop is retracted back into the tube, the cutting edge follows the circular path of the loop, cutting a circular opening (a capsulorrhexis), into the lens capsule. It was found that the device taught by the above patent is not effective in performing capsulorrhexis/capsulotomy in respect of all types of cataracts.

Granted US Patent 57281 17 discloses a retractable capsulorrhexis instrument, which comprises a flexible band having a razor sharp cutting edge which is fixed to a plunger and located within an inserter tube. While in its retracted position within the inserter tube, the flexible band assumes an oblong shape. When the flexible band is in its extended position outside of the inserter tube such as inside the eye, it expands into a circular shape whose cutting edge is sufficiently sharp to cut lens capsular tissue in response to pressure being applied to the lens capsular tissue by the cutting edge. In this invention, the band mechanically presses against the anterior capsule so that the sharp cutting edge of the band cuts the capsule in circular shape. So, mechanical force is used so that there are chances of stress on zonules and due to the involvement of force factor difficulty is encountered while applying the instrument.

United States Patent Application 20090048619 discloses a device including a motorized cutting element and a handle. The motorized cutting element has mechanical means to create a cut in the anterior capsule tissue along a planned capsulorrhexis line, creating a relatively smooth cut without the risk of undesired capsular tear. The device taught by the above patent application is however, not effective in performing capsulorrhexis/capsulotomy in respect of all types of cataracts. Accordingly there was a long felt need to decipher an apparatus which unequivocally performs capsulorrhexis/capsulotomy in respect of all types of cataracts, efficiently and effectively.

The present invention meets the aforesaid long felt need.

All through out the specification including the claims, the words "capsulotomy", "capsulorrhexis", "can-opener capsulotomy", "Continuous Curvilinear Capsulorrhexis (CCC)", "spring", "inserter tube", "ring", "plunger", "handle", "ophthalmic surgery", "apparatus" are to be interpreted in the broadest sense of the respective terms and includes all similar items in the field known by other terms, as may be clear to persons skilled in the art. Restriction/limitation, if any, referred to in the specification, is solely by way of example and understanding the present invention. OBJECTS OF THE INVENTION

It is the principal object of the present invention to provide an apparatus for performing ophthalmic surgery which is unequivocally applicable in respect of all types cataracts.

It is a further object of the present invention to provide an apparatus for performing continuous curvilinear capsulorrhexis (CCC) which is unequivocally applicable in respect of all types of cataracts such as but not limited to immature cataract, mature cataract, mature intumescent cataract, hypermature catarct, hypermature cataract, hypermature morgagrian cataract, subluxated cataract and pediatric cataract.

It is a further object of the present invention to provide an apparatus for performing can-opener capsulotomy which is unequivocally applicable in respect of all types of cataracts such as but not limited to immature cataract, mature cataract, mature intumescent cataract, hypermature catarct, hypermature cataract, hypermature morgagrian cataract, subluxated cataract and pediatric cataract. It is yet another object of the present invention to provide an apparatus for performing ophthalmic surgery which is safe and substantially avoids risk of irreversible damage.

It is a further object of the present, invention to provide an apparatus for performing continuous curvilinear capsulprrhexis (CCG)) which substantially avoids the chances of extension of CCC, radial tear or irregular CCC.

It is a further object of the present invention to provide an apparatus for performing continuous curvilinear capsulorrhexis(CCC), which substantially avoids stress or zonules and is time saving, thus being economically significant. It is yet another object of the present invention to provide an apparatus for performing continuous curvilinear capsulorrhexis(CCC), which involves achieving a preferred size of CCC as per type of cataract and type of surgery . It is a further object of the present invention to provide, an apparatus for performing ophthalmic surgery which is applicable on adults as well as on infants and does not involve learning curve.

It is another object of the present invention to provide an apparatus for performing posterior continuous curvilinear capsulorrhexis(CCC) in respect of infants and adults. It is a further object of the present invention to provide method for manufacturing an apparatus for performing ophthalmic surgery, which is unequivocally applicable in respect of all types cataracts.

How the foregoing objects are achieved and the other aspects of the present invention, will be clear from the following description which is purely by way of understanding and not by way of any sort of limitation.

SUMMARY OF THE INVENTION

Accordingly the present invention provides an apparatus for performing ophthalmic surgery including an insertion means having an optimal width such as herein described, said insertion means being adapted to incorporate within it a shaping means, said shaping means being operatively connected to a cutting means and said shaping means being adapted to contract and expand within said insertion means, such that subsequent to the event of causing of an incision by said insertion means, said shaping means is adapted to be actuated to expand to a shape having a regular > geometrical outline within the incision so formed, in the event of which, said cutting means is adapted to be actuated to form an opening along said regular geometrical outline.

In accordance with preferred embodiments pf the apparatus of the present invention:

-said insertion means includes an inserter tube, said shaping means includes a flexible metallic ring adapted to take an ellipticaliShape. within said insertion tube in retracted position and to take a circular shape in expanded position and said cutting means includes a cautery machine or a LASER actuated device.

-the inserter tube is attached to a handle at an angle between 1 10° to 140° for easy insertion into said incision.

-said metallic ring is attached to a metallic plunger, said plunger being adapted to move said ring to and fro in said inserter. tube, said ring being 5.5mm in diameter and 0.5mm wide and said plunger being 2cm long.

-said handle is provided with an aperture foTr said plunger to pass through and said plunger is provided with a spring to cause easy movement of said ring, -said plunger is connected to said cautery machine by means of an wire, -said inserter tube has a width so as to cause an incision in the vicinity of 2.5 mm. -said handle is a

rectangular pipe of 3mmx3mm and length 12cm and said inserter tube has dimension 1.8mmx0.7mx9mm.

-said handle is smooth or serrated or round cylinder shaped and said inserter tube has a larger opening to allow easy and uninterrupted traveling of said metallic ring.

The present invention also includes a method of making an apparatus for performing ophthalmic surgery including designing an insertion means of optimal width such as herein described, designing and incorporating a shaping means within said insertion means and operatively connecting said shaping means to a cutting means, such that subsequent to the event of causing of an incision by said insertion means, said shaping means is adapted to be actuated to expand to a shape having a regular geometrical outline within the incision so formed, in the event of which said cutting means is adapted to be actuated to form an opening along said regular geometrical outline.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS

The nature and scope of the present invention, will be better understood from the accompanying drawings, which are by way of illustration of some preferred embodiments and not by way of any sort of limitation, In the accompanying drawings, Figure 1 illustrates the handle arid inserter tube in accordance with a preferred embodiment of the apparatus of the present invention.

Figure 2 illustrates the flexible metallic ring , in accordance with a preferred embodiment of the present invention.

Figure 3 illustrates the inserter tube having within it the ring in folded position, according to a preferred embodiment of the present invention.

Figure 4 illustrates the position of the ring in fully expanded version according to a preferred embodiment of the present invention.

Figure 5 illustrates the position and function of the apparatus of the present invention , inside the eye.

Figure 6 illustrates the different alternative Versions of the handle of the apparatus in accordance with a preferred embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The following describes some preferred embodiments of the present invention, which are purely for the sake of understanding the performance of the invention, and not by way of any sort of limitation.

As stated under the portion "Background of the Invention" the present invention aims at providing an apparatus, which is applicable on al| types cataracts. This was hitherto not achieved. Furthermore, the apparatus in accordance with the present invention is economically significant as it saves time. That apart, the apparatus is safe and substantially avoids risk of irreversible damage, avoids the chances of extension of CCC, radial tear or irregular CCC and avoids stress or zonules. Additionally, it facilitates, achieving a preferred size of C;cc as per type of cataract and type of surgery . It is also worth mentionable, that the apparatus in accordance with the present invention is also adapted to carry out posterior continuous curvilinear capsulorrhexis(CCC) in respect of infants and adults. In the above context it is hereby clarified, that simply by way of example and for understanding the present-invention and not by way of any limitation, the apparatus in accordance with the present invention, has been referred to as applicable to continuous curvilinear capsulorrhexis(CCC). It should be understood to persons skilled in the art that the apparatus in accordance with the present invention is equally applicable to all other ophthalmic surgeries and will be equally effective, in achieving the objects of the present invention

As illustrated in the accompanying figure 1 the apparatus of the present invention comprises a handle part(l) and an inserter tube part(2). The inserter tube is attached to the handle at an angle (9) which is convenient for easy insertion into the incision made on the eye (the angle is usually between 1 10° to 140°). As illustrated in the accompanying figure 2 the inserter tube(2) contains a flexible metallic ring(3) which is fixed to a plunger(4) which can hiove the ring to and fro. While in its retracted position within the inserter tube, the flexible metallic ring(3) gets folded and assumes an elliptical shape. However, when the plunger pushes the flexible metallic ring outside of the inserter tube, it expands into a Circular shape(3')- When the ring is fully expanded to circular shape(3') it is rested onto the anterior capsule of the crystalline lens maintaining the centration. Cautery is then applied through the wire connected to the plunger so that the circular opening is made at the centre of the anterior capsule. The desired diameter of the capsulorrhexis is 5 to 6mm, but the incision to enter the eye needs to be as small as possible (preferably 2 to 3mm), hence the instrument being used for the capsulorrhexis has to be folded to be inserted through a smaller incision. In the present invention the flexible metallic ring assumes an elliptical shape to accommodate in an inserter tube of smaller cross sectional area while in fully extended position it assumes a circular shape of larger diameter to produce an ideal capsulorrhexis.

As illustrated in the accompanying figure 1 , the handle ( 1 ) is preferably a rectangular pipe of 3mmx3mm, and the length 12cm (can be variable). It has an aperture (Γ) for the plunger (4) to pass through. As stated before, the inserter tube (2) of 1.8mmx0.7mmx9mm is attached to handle (1) at an angle (9) which is convenient for easy insertion into the incision made on the eye (the angle is usually between 1 10° to 140°).The accompanying figure 2 shows a flexible metallic ring (3) which is preferably 5.5mm in diameter and 0.5mm wide and is attached to a metallic plunger (4), preferably 2cm long and it moves the ring to and fro in the inserter tube (2). A spring (5) is incorporated with the plunger to allow easy and uninterrupted traveling of metallic ring. The metallic ring (3) when folded inside the inserter tube (2) assumes an elliptical shape and in fully extended position, it regains its circular shape (3'). The plunger (4) is connected to a Cautery device (7) by means of wire. Now at the time of making the incision on the capsule, the ring(3) remains within the inserter tube(2) assuming an elliptical shape. Once, inside the incision the ring is caused to expand out and assume a circular shape on the capsule. Thereafter, cautery is applied on the capsule to obtain the desired regular circular opening.

The accompanying figure 3 shows that in the folded position the ring is inside the inserter tube, as stated hereinbefore. The anterior chamber of eye is filled with the visco-elastic substance. The inserter tube is inserted in the anterior chamber through a small incision (as made in phaco). Once the tube is inside the anterior chamber the plunger is pushed to expand the ring to circular shape.

As illustrated in the accompanying figure 4 when the ring is fully expanded to circular shape it is rested onto the anterior capsule of the crystalline lens maintaining the centration. Cautery (7) is then applied through the wire connected to the plunger so that a circular opening is made at the centre of the anterior capsule. Once the CCC is complete the plunger is pushed in a bit and the spring action will withdraw the ring to get folded inside the. inserter tube. The tube is then withdrawn from the eye. The accompanying figure 5 illustrates the position and function of the apparatus inside the eye.

The accompanying figure' 6 illustrates preferred embodiments of the handle of the apparatus of the present invention. It may be smooth (la) or serrated(lb,lc) to have better grip and control. Alternatiely, it may be a round cylinder shaped (Id) The angle (9) between handle and inserter tube may vary according to surgeon's choice and experience. The inserter tube may have its opening a little larger (2b) to allow easy and uninterrupted traveling of metallic ring. The inserter tube may have a smaller dimension to encompass every future attempt to keep the corneal incision as small as possible. The metallic ring can be of variable metal according to the best suitable metal available. The last step of creating a circular cut, namely capsulorrhexis can be made by LASER instead of cautery as described above.

The technical advantages and economic significance as described hereinbefore were hitherto not known or conceived by persons skilled in the art.

The method of manufacturing the apparatus in accordance with the present invention includes designing an insertion means such as inserter tube of optimal width such as herein described, designing and incp/porating a shaping means such as metallic ring within said insertion means and operativety connecting said shaping means to a cutting means such as a cautery machine,

The inserter tube(2) may have a width which easily fits within incisions as small as 2.5 mm. In the past, incisions were typically in the order of 4 mm, which gave extra room to accommodate capsulorrhexis instruments of larger dimensions. However, with incisions as small as 2.5 mm, the need for smaller dimensioned capsulorrhexis instruments is apparent, particular when one considers that incisions in the future will be still smaller in size.

In a nutshell following^'are some of the salient non-limiting advantages achieved by the apparatus in accordance with the present invention :

1) A perfect Continuous Curvilinear Capsulorrhexis (CCC) can be achieved in all types of cataracts (immature, mature, hypermature, pediatric, sub/uxated), in all types of capsules (thin, thick, fibrosed, elastic) and in all types of cataract surgeries (Phaco, SICS, ECCE)

2) No chances of extension of CCC, radial tear or irregular CCC 3) No stress on zonules as no force is applied to the anterior capsule.

4) Posterior CCC can be done in pediatric as well as in adult cataract.

5) A preferred size of CCC can be achieved. (5,6,7,8 mm) as per type of cataract and type of surgery.

6) Involves no mechanical force, so that there is no stress on zonules and as the force factor is eliminated from the mechanism of action the apparatus can be used with minimal difficulty.

7) The apparatus facilitates placing of total circumference of the metallic ring on the capsule and application of the cautery thereafter, so that whole circle is cut at the same moment. This eliminates the chances of shearing or tearing forces to act on a single tear point, thus minimizing the chances of extension or radial tear of a CCC.

8) Cauterized CCC margins being more stronger than the normally torn ones, this allows more manipulation while doing Phaco without causing any tear.

9) Enables application of Cautery power just sufficient to cut the capsule, thereby ensuring no damage to other intra ocular structures.

10) Facilitates saving of time and is therefore economically significant and does not involve learning curves.

1 1 ) Facilitates to carry out ophthalmic surgery which is safe , substantially avoiding risk of irreversible damage.

The present invention has been described with reference to some drawings and preferred embodiments, purely for the sake of understanding and not by way of any limitation and the present invention includes all legitimate developments within the scope of what has been described hereinbefore and claimed in the appended claims.

Claims

WE CLAIM:

1. An apparatus for performing ophthalmic surgery including an insertion means having an optimal width such as herein described, said insertion means being adapted to incorporate within it a shaping means, said shaping means being operatively connected to a cutting means and said shaping means being adapted to contract and expand within said insertion means, such that subsequent to the event of causing of an incision by said insertion means, said shaping means is adapted to be actuated to expand to a shape having a regular geometrical outline within the incision so formed, in the event of which, said cutting means is adapted to be actuated to form an opening along said regular geometrical outline.

2. The apparatus as claimed in claim 1 , wherein said insertion means includes an inserter tube, said shaping means includes a flexible metallic ring adapted to take an elliptical shape within said insertion, tube ir retracted position and to take a circular shape in expanded position and said cutting means includes a cautery machine or a LASER actuated device,

3. The apparatus as claimed in claims 1 to 2, wherein the inserter tube is attached to a handle at an angle between 1 10° to 140° for easy insertion into said incision.

4. The apparatus as claimed in claim 2, wherein said metallic ring is attached to a metallic plunger, said plunger being adapted to move said ring to and fro in said inserter tube, said ring being 5.5mm in diameter and 0.5mm wide and said plunger being 2cm long.

5. The apparatus as claimed in claims 3 and.4, wherein said handle is provided with an aperture for said plunger to pass through and said plunger is provided with a spring to cause easy movement of said ring.

6. The apparatus as claimed in claims 2 to 5, wherein said plunger is connected to said cautery machine by means of an wire. ^'

7. The apparatus as claimed in claims 2 to 6, wherein said inserter tube has a width so as to cause an incision in the vicinity of 2.5 mm.

8. The apparatus as claimed in claims 2 to 7, wherein said handle is a rectangular pipe of 3mmx3mm and length 12cm and said inserter tube has dimension

1.8mmx0.7mx9mm.

9. The apparatus as claimed in claims 2 to 6, wherein said handle is smooth or serrated or round cylinder shaped and said inserter tube has a larger opening to allow easy and uninterrupted traveling of said metallic ring.

10. A method of making an apparatus for performing ophthalmic surgery including designing an insertion means of optimal width such as herein described, designing and incorporating a shaping means within said insertion means and operatively connecting said shaping means to a cutting means, such that subsequent to the event of causing of an incision by said insertion means, said shaping means is adapted to be actuated to expand to a shape having a regular geometrical outline within the incision so formed, in the event of which said cutting means is adapted to be actuated to form an opening along said regular geometrical outline.