WO2011021225A4

WO2011021225A4 - Scleral incision template and a special blade-knife for eye surgery

Info

Publication number: WO2011021225A4
Application number: PCT/IN2010/000547
Authority: WO
Inventors: Narayan Fakkadrao Avhad
Original assignee: Narayan Fakkadrao Avhad
Priority date: 2009-08-20
Filing date: 2010-08-18
Publication date: 2011-05-12
Also published as: EP2467111A4; AP2012006172A0; EA029263B1; EA201270294A1; EP2467111A1; WO2011021225A1

Abstract

A scleral incision template (SIT) and blade-knife is provided that facilitates adequate, efficient and smooth sclera-corneal tunnel dissection by achieving high quality scleral incision that may be close to ideal. The completed scleral incision has a correct predetermined size, shape, length, site and even depth throughout the length of the incisional groove. The synergetic action of the SIT with blade unit makes the sclero-corneal flaps uniform in thickness and tunnel uniform in depth. This facilitates the passage for the extraction of the cataract nucleus, as well as to implant the IOL inside the eyeball and also reduces complications more efficiently than when an incision is taken with help of blade-knife available.

Claims

AMENDED CLAIMS received by the International Bureau on 16 March 2011 (16.03.2011 )

1. A template made from a sheet in toric or ellipsoidal shape (Fig 6T) for eye surgery; the said template comprising at least one shape/groove cut in it.

2. A surgical blade complementary to template of claim 1 , the said surgical blade having dimensions complimentary to the dimensions of the said shape/groove in the said template for the purpose of inserting the said blade through the said cut shape/groove for piercing of the tip of the said surgical blade at one end of the said shape/groove by stabbing into the sclera only up to a depth that is required for the surgery and moving the said blade along the length of the shape/groove without rotating around itself to take an incision useful for a further operation.

3. A process or method of an eye surgery comprising use of: a. a template made from a sheet in toric or ellipsoidal shape (Fig 6T) comprising at least one shape/groove cut in it, for positioning in an eye surgery over the globe of an eye, and b. a surgical blade or a cutting device having dimensions complimentary to the dimensions of the said shape/groove in the said template for the purpose of inserting the said blade through the said cut shape/groove, piercing of the tip of the said surgical blade into the sclera only up to a depth that is required for the surgery and moving the said blade or said cutting device along the length of the shape/groove to take an incision useful for a further operation.

4. A template of claim 1 or 3 comprising at least one of the following features: (a) at least one groove or slit on the flat of the surface, (b) an extension and/or a mark that helps alignment, (c) structure/s that help stabilization, (d) structure/s that help anchorage over the globe of the eye preventing accidental slide, skidding or tumbling of the template over the globe and in keeping eye-ball immobile during the incision, (e) comprising a handle (32), (f) the shape of the template such that it can help to achieve juxtaposition with sclera enough to achieve immobilization of the globe.

5. A template of claim 4 further comprising at least one of the following features:

a. the said groove or a slit is in a shape of a straight line (26)or a frown (29) or a Chevron's V shape, b. the said extensions are two antennae (27), and said mark is a triangular or an arrow apex mark (28),

c. the said structure that helps stabilization includes two backward projections "tail" (31), d. structures that help anchorage comprise "teeth" (30) on the under-surface which is intended to be placed on the surface of the globe of the eye, the said teeth may preferably be in two rows and are positioned to penetrate the sclera when the template is placed with its undersurface in juxtaposition with the globe of the eye, e. the said handle is angulated (32), f. the said template is made in a metal sheet or disposable material including plastic, g. the said template handle can be attached to a blade- holder (38).

6. A blade of claim 2 comprising at least one of the following features: (a) a tip of the blade (37), (b) the middle portion called as Body (36), (c) the third portion called as Cross-Bar (35) (d) stopper (34) and (e) the handle (33).

7. A blade of claim 6. further comprising at least one of the following features: (a) the said tip is a semi-circular cutting edge of the blade having a height that is equal to the depth of the incision desired, (b) the said (body) middle portion has a shape and a thickness that precisely fits into the groove of the template such that whenever a proper pressure is applied and pulled in the same direction in which the incision is intended to proceed, it slides into the groove snuggly and smoothly, and because of its unique quadrilateral or oval shape (36 in Figure 7-R) it prevents self rotation into the slit or groove of the template, (c) the said cross bar has a diameter greater than the width of the groove or the slit in the template, to stop over penetration or perforation of the globe, (d) the said stopper stops further progression of the blade when inserted in the holder and provides a surface area on which the tip of the blade holder rests and enables stable operation of the blade and prevents unintended slight movements of the blade when it is used to take a cut, (e) blade handle can be attached to a blade-holder (38).

8. A process or method of taking an incision of claim 3, comprising steps of : a. using a template of toric or ellipsoidal shape to help to achieve with sclera a juxtaposition enough to achieve immobilization of the globe, the said template further comprising following features: (a) at least one groove or slit in a shape of a straight line (26)or a frown (29) or a Chevron's V shape on the flat

29 of the surface, (b) an extension of two antennae (27), and a triangular or an arrow apex mark (28) that helps alignment, (c) two backward projections "tail" that help stabilization and act as retractor, (d) "teeth" (30) in two rows on a surface intended to be placed on the surface of the globe of the eye, that help anchorage over the globe of the eye preventing accidental slide, skidding or tumbling of the template over the globe and in keeping eye-ball immobile during the incision, (e) comprising a handle (32) that is angulated and attached to a holder (38), b. using a blade comprising (a) tip of the blade (37) that is a semi-circular cutting edge of the blade having a height that is equal to the depth of the incision desired, (b) a middle portion called as body (36) that has a thickness that precisely fits into the groove of the template such that whenever a proper pressure is applied and pulled in the same direction in which the incision is intended to proceed, it slides into the groove snuggly and smoothly, (c) a third portion called as Cross-Bar (35) that has a diameter greater than the width of the groove or the slit in the template, to prevent any over penetration or accidental perforation of the globe,(d) a stopper (34) that limits and stops further progression of the blade when inserted in the holder and provides a surface area on which the tip of the blade holder rests and enables stable operation of the blade and prevents unintended slight movements of the blade when it is used to take a cut, and (e) a handle (33) that can be attached to a blade-holder (39),

30 c. dissecting and retracting the dissected conjunctiva and tenon capsule by inserting the tails of the template in between, placing both antennae parallel to the limbus and touching the gray- line, bringing the apex mark on the template in alignment with the steeper 'K' or otherwise at 12 O'clock over the scleral incision site, verifying that the distance of the incision groove from the limbus is about 2 mm, d. burying the teeth smoothly into the sclera by applying firm pressure over the base of the template handle, anchoring the template to the globe and immobilizing the same firmly making the same ready for the incision, e. inserting the blade into the selected template incision groove by holding the blade vertical to the template, keeping length of the semicircular blade tip parallel to the groove, and then inserting deep into the groove downwards over the sclera, firmly pressing the handle through the groove, stabbing the blade into the sclera till further insertion of the blade is stopped securely by the cross bar (35), pulling the blade handle slowly and steadily along the shape of the groove keeping the applied pressure constant over the blade holder, enjoining the other end of the groove, completing and ending the incision, pulling the knife slowly out of the template groove, f. inspecting depth of the incision, g. repeat step (e), before removing the template, if any doubts exist about the depth.

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9. A cutting device of claims 1 or 3 when the same is a laser ray capable of taking a cut useful for eye surgery.

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STATEMENT UNDER ARTICLE 19 (1 )

The applicant humbly presents his response to Re Item Box no. v in the Written Opinion of the Honorable ISR Authority.

Without any prejudice to restore the original claims, if desired, or without implying agreement with conclusions of the ISR Authority, following amendments are made in the claims to facilitate clarification:

Claims 1 and 3 are amended to add limitation to the Template being "made in a sheet in toric or ellipsoidal shape (Fig 6T)". This limitation has been taken from "as filed" claim 5, and is deleted from claim 5 to avoid repetition. The wording "made from sheet" is based on description in "as filed" specification on page 3 line 21 and "as filed" claims on page 23 line 5. Portions corresponding to surgical blade have been deleted from claim 1 , a part of the deleted portion incorporated in claim 2 and portions relating to limitations of template of claim 1 are deleted form claim 2. Claim 6 has been amended to depend on claim 2. No other amendments are done. With these amendments, none of the cited documents disclose a template made in sheet and in toric or ellipsoidal shape and a surgical blade complementary to the same.

Since amended claims 1 and 2 would be compliant to requirements of PCT Article 33 (2) and (3), all claims dependent on them shall be compliant to PCT Article 33 (2) and (3).

The amendments are based on re-arrangement of "as filed" claims or are made consistent to the scope of the "as filed" description and no new matter is added.

With these amendments, the applicant believes that objections of the Hon. ISR Authority mentioned in Box. v are overcome.

There may be a need to amend the description.

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