FR2707872A1 - Novel opthalmological surgical method and adapted surgical instrument - Google Patents

Abstract

Occular microsurgery instrument allowing a different approach in surgery of the anterior capsule during a cateract operation by the so-called manual extracapsular method. It is characterised by a handle with two different models, which is articulated by a curvilinear cutting part allowing either sectioning of the anterior capsule or hemicorcular resection thereof. When the surgeon actuates this instrument which he will previously have brought under the anterior capsule of the lens after a short incision therein on the noon meridian, the section or resection of the capsule may be carried out by simple pressure on the handle. The instrument is designed to be used with the right hand and with the left hand.

Description

The present invention relates to a new surgical method

  ophthalmic and surgical instrument suitable for cutting the anterior capsule during cataract surgery by the METHOD

MANUAL EXTRACAPSULAR.

  The current development of phacoemulsification of the cataract is explained by the particular elegance of a narrow incision, and by the faculty which is offered to us during the intervention to practice an anterior capsulotomy as small as possible, but in any case regular. The phacoemulsifier head then comes to carry out the work in situ, without forcing the surgeon to widen the capsular opening: the risk of

  capsular tear is minimized.

  However, you should know that not all cataracts can be operated by the phacoemulsification technique, first of all for anatomical reasons. Furthermore, the surgeon may not have access, even momentarily, to this technique, and extracapsular extraction then becomes a "technique.

replacement ".

  Apart from this privileged case, it is necessary to have recourse to a technique of extraction of the cataract known as manual, and this technique then frequently obliges to practice a wider capsular opening than during phacoemulsification: the risk of unexpected enlargement of the capsular opening is then readily more important, because of the presence of tearing lines susceptible of extension. The presence of irregularities in the cutting of the capsule is indeed an indisputable favoring factor, not to mention that the volume of the nucleus to be expelled always involves a part of the unexpected, and the "exit" of the nucleus can prove to be dystocic, in case of capsulorrhexis too limited: it is then necessary to make one or two incisions on the sides of the capsulorrhexis, and ... we find ourselves in great danger of seeing these splitting lines occur to which the "envelope technique" exposes us. chance had a mishap during a cataract procedure using the envelope technique of seeing a capsulotomy incision

  achieve a "cookie cutter" and become impossible to.

  complete, (it was then necessary to make a new incision downwards, hoping that the same incident will not happen again), the idea of finding an instrument

  able to plan such a gesture came to us.

  The present invention aims to eliminate the risk of unexpected capsular tearing during cataract surgery. This then avoids "drawing" this anterior capsulotomy by an ultrasonic process (requiring expensive equipment), or creating it by using standard scissors (micro-scissors type

  Vannas), or to create it using a needle 28-

  G (with certainly less risk of irregular cutting of the capsule, but in exchange a dystocic risk for the

lens nucleus).

  DESCRIPTION: The method according to the invention consists in

  make an incision whose ends cannot constitute a primer for capsular tearing. The method therefore aims to obtain an incision whose ends are curved so as to reduce the risk of capsular tearing in a non-dangerous zone; FIGURE 1 shows an incision according to the invention comprising an arcuate part (1) made with a scalpel and at each end of the incisions (2) extending the previous one, and at the ends of these terminal safety incisions (3 ), in arc of

  circle, with a radius between 3 and 3.5mm.

  The connection angle (5) between the initial incision (1) and the second incision (2) prevents radial propagation

from any tears.

  FIGURE 2 shows that the microsurgical instrument adapted to this concept of capsulotomy comprises a handle "I (6), about 10 cm long (12) and easy to handle by the surgeon, extended by a" surgical part "(7 ) intended to be introduced into the eye through a traditional corneal or limbic incision. The blade curved to a length equal to 3.2 mm (8), a curvature of 180, and a cutting width of 1.2-1.5 The length of the surgical part can easily be extended by adding an intermediate part beyond the handle, between the blade itself and the articulation of the instrument (9), this extension can reach 1 at 2 cm, and has a cutting edge on

  its entire length, giving it a cutting function.

  The instrument is shown in profile in FIGURE 3.

  The angle (11) formed by the handle and the surgical part

  is equal to 10, which can be increased from 0 to 30.

  The surgical end of the instrument is rounded FiGURE 4 (13), and forms an angle equal to 180 (less if desired: 150). It can be bevelled, as can be seen in FIGURE 5 (14) where the instrument presents itself in profile, and the upper jaw FIGURE 6 (15) is slightly different from the lower jaw, FIGURE 6 (16). The lower jaw (17) is slightly bevelled on its anterior portion to allow easy insertion under the anterior capsule while the upper jaw (15) is not necessarily bevelled if one wishes to keep the section function . Beveling requires the creation of an instrument for right and left hands. This is one of the variants of the instrument. The surgical part can at will be thinned over its entire length or, on the contrary, over its terminal portion, the purpose of this particular design being the best aspect.

  opposite the nearby corneal endothelium.

  S_1Qp_lmodels of production: The handle can be of several models adapted to the precise tastes of each operator, with first of all a "spring model" in flexible steel allowing the blade of the instrument to loosen its grip by simply loosening pressure, (with a flat or round, smooth or finely grooved handle, of length adapted to the microsurgical function of the instrument FIGURE 2 - (12). A second model of handle can affect the shape of a handle with side lever operated by the surgeon with a section-relaxation function, although this model is less easy to handle by a surgeon who is not used to operating indifferently sometimes with one hand

sometimes on the other. FIGURE 7 (18).

  -The blade can be produced in two precise configurations, allowing in the first case the SECTION of the

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  anterior capsule, FIGURE 2 (7), in a second case the

  RESECTION of the capsule. FIGURE 8 (19).

  Referring to FIGURE 2 (7), we can distinguish that the distal part of the blade in the first

  section function is equal to 3.2 mm intra-

  eyepieces but actually that the total length of the

  blade before its machining and bending is equal to 5 mm.

  Bending is done at an angle of 180, option on request. The two jaws of the blade have a cutting edge, allowing the surgeon to change hands to perform the same maneuver symmetrically on the anterior capsule, without having to have two instruments, a "right" and a "left", provided that do not desire beveling of the anterior end. The length of the surgical part can be extended to

will, about 15 mm.

  Referring to FIGURE 8, we can distinguish that the length of the blade (20) in its second version is equal to approximately 15 mm intraocular, is closed and has a cutting edge over the entire extent of the instrument,

  except at the point of connection (22) on the handle.

  As the resection is carried out from a first incision, the instrument does not necessarily need to have a sharp portion at its connection (22) with the handle of the instrument. The blade is curvilinear (22), allowing capsular resection

  to marry from afar the curve of the crystalline equator.

  The surgical part makes an angle of 10 to 30 on the

handle (2.?).

  The general shape of the instrument is curvilinear type curved scissors for cutting (SECTION) curvilinear of the capsule and is usable with right and left hand for the symmetry of the layout; in the second option the instrument is of curvilinear shape allowing the curvilinear RESECTION of the capsule and can be used in the same way on the right and left for the symmetry of the layout The overall opening of the instrument in its two configurations reaches 1.0 mm . FIGURE 2 and

FIGURE 8.

  The instrument is calculated for a stainless material

  reduced thickness with tapered end. Sterilization

  choice. The width of the instrument is a function of the ntraintes of material and allows a wide section from 1.0 mm to 1.2 mm. The instrument is actually calculated for a stainless material of reduced thickness with rounded and spatulated end, of width equal to 1.2 mm - 1.5 mm. Width according to material constraint allowing a capsular resection not exceeding 1.0 mm in width over a variable length depending on the penetration of

  the instrument in the anterior chamber.

  The thickness of the instrument, once closed reduces to that of the two interpenetrating jaws, this oscillates according to material constraints

  the anterior end between 1.0 mm and 0.5 mm thick.

  In other words, its thickness will be calculated according to the material constraints, with a global directive of a thickness of 0.5 mm. The anterior end will be made flat like a spatula with additional optional beveling FIGURE 8 (24) to be easily introduced under the anterior capsule in front of the cortex separated by prior hydrodissection and under

  protection of viscoelastic previously injected.

  The end oriented towards the central pole of the lens will also be bevelled to allow its possible slippage

  towards the central pale of the lens FIGURE 8 (25).

  The final result as well as the procedure for the intervention with SECTION of the anterior capsule can be shown diagrammatically in FIGURES 9 10 and 11 for the instrument used. It is always possible to "resume" the initial layout to open laterally, thus avoiding annoying cutting irregularities

  sources of cross lines FIGURE 12.

  The ultimate goal is to implant in the bag.

  The final result as well as the procedure for the intervention with RESECTION can be schematized

  in FIGURES 13 and 14 for the instrument used.

  A resumption of the incision is in the same way possible

  FIGURE 15. The ultimate goal is to plant the bag.

  The compared traces of the capsular incisions are thus represented in FIGURES 16 (SECTION) and 17 (RESECTION): from an initial curvilinear incision (26) the trace follows a cut or a resection

  curvilinear (27) and non-rectilinear (28).

  THE ANGLE OF CONNECTION FIGURE 18 (29) will not cause splitting lines in the case of the SECTION of the capsule FIGURE 19 (30) if care is taken to prolong the initial incision with the instrument. During the RESECTION FIGURE 19 process (31), a splitting line initiation (32) may occur due to an orientation of the axis of the non-conforming instrument (33). It will then be necessary to orient the FIGURE 20 instrument (34) differently on the initial curved incision (1) so as to take it into the cut: the connection angle will be

creates FIGURE 20 (35).

  NB: The calculations give for an opening of diameter: 6.0 mmn a length to open equal to 9.40 mm 6.5 mm a length to open equal to 10.20 mmn 7.0 mm a length to open equal at 11.00 mm

  7.5 mm a length to open equal to 11.80 mm.

  The initial capsular incision made with a scalpel measuring approximately 3 mm to allow the introduction of the instrument, -there is no difficulty in achieving that two lateral incisions each measuring 3.5 mm will be enough to create a capsular cutout

  corresponding to an opening of 6.5 / 7.0 mm in diameter.

  These lines will always be REGULAR, adding as an advantage over the needle capsulorrhexis technique (regular cutting), that of keeping the "envelope" (implantation security, security for the endothelium), and being able to have of an opening

modular, but not tearable.

  VARIANTS OF THE INSTRUMENT: These can relate * either to the manufacture of the handle (scissors type or handle type with lateral lever) * or to different options relating to the end of the model comprising a capsular section:

  the end may have an angle of 150 to 1800.

  * either on the dimensions of the resection:

2707872

  width of l, Omm or 1.2mm depending on the manufacturing requirements * either on the shaping of the anterior end (beveling), its cutting length, the angle of the blade (about 30), the angle of the handle by compared to the blade itself (0 to 30 approximately), the material and the possible creation of an instrument specially adapted to the "right hand" or "left hand" version, in case beveling proves essential to the introduction of the instrument under the anterior capsule. It nevertheless appears possible FIGURE 21 to shape the upper jaw with a smaller thickness at the front (36) than at the rear (37) so as to create a false bevel. Similarly, the bevelled side faces of the instrument can be shaped in the same way: this avoids creating an instrument with a right hand and a

left hand instrument.

  * either on anti-reflective polishing or not, on the surface coating of the instrument, or even its

composition.

  The invention is capable of immediate application during a cataract intervention, a demonstration by common audio-visual means being possible by the sales department of the approved seller, with a first curvilinear incision FIGURE 19 (1) made with a scalpel then SECTION / RESECTION on demand at its ends FIGURE 19 (30) and FIGURE 20 (34), or started as a capsulorrhexis FIGURE 21 (38) and completed in the same way (3g) (40). The opening is flexible and

regular.

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Claims (3)

CLAIMS: 1) PROCESS for practicing extraction   of the lens nucleus during a cataract operation by the so-called MANUAL EXTRACAPSULAR method of making an incision in the anterior capsule, characterized in that the incision has curvatures at its ends intended to prevent the occurrence of anterior capsular tears unexpected, which can be complicated by posterior capsular tearing and therefore by vitreous outcome. This complication then considerably obscures the patient's visual prognosis and weighs down on the operating suites, which may even cause the implantation initially planned to be rejected. This incident is directly correlated with the quality of the initial capsular incision and the volume of the lens nucleus to be expelled. It was therefore necessary to find a process capable of bringing this additional security to the surgeon without increasing the surgical risks, thus creating an ophthalmological microsurgical instrument capable by its use not only of creating a simple and satisfactory anterior capsular opening, but also , by the form that this instrument will have given it, to prevent its unexpected enlargement. It is therefore a new form of "scissors   capsule ", with controlled capsular opening," blocked "-   The surgical instrument is characterized by a handle to which is articulated a cutting part intended to be introduced into the eye during eye surgery. The handle can be of different shapes as described in the chapter   DESCRIPTION, while the surgical part of   the instrument can have various characteristics while respecting a well-defined function: the Section or the   Resection of the anterior capsule.   2) diSPOSITIF for the implementation of the method according to claim 1, characterized in that it consists of a pair of scissors curved at their end at an angle of 180 and sufficiently thin, profiled in some way (tapered, of dimensions reduced) to be introduced into the anterior chamber of the eye. This device is suitable for the SECTION of the anterior lens capsule. The instrument must be introduced into the capsular bag until its first curvilinear part, after a curvilinear puncture with a scalpel 2mm long on the midday meridian then hydrodissection of the crystalline nucleus and injection of viscoelastic product. It is directed at 10 am and 2 pm towards the crystalline equator without reaching it and thus initiates a curvilinear cut. Its end then prints on the capsular cutout a circular stop, eliminating the beginnings of tearing lines formed by a linear incision. The stops are directed towards the central pole of the lens. The capsule is not intended to be removed because this technique is more particularly integrated in the so-called envelope technique, the utility of which is to preserve the corneal endothelium during MANUAL EXTRACAPSULAR surgery. is recognized.   The capsular cut thus left in no way impairs visibility during maneuvers subsequent surgical procedures.   The elasticity of the instrument makes it possible to release the grip effortlessly and the rounded end is kept immobile during the release in order to avoid lifting the central capsule, which in any case would notice immediately.   The instrument therefore makes it possible to cut the anterior capsule completely, with rounded ends, and in a modular manner depending on the size of the crystalline nucleus to be expelled. It is indeed possible to "resume" the original layout by extending it downwards when the core rotation maneuvers show that it is large. A capsulorrhexis is then initiated, without however entailing the risk of lengthening the incision then tearing of the anterior capsule, and this simply by pushing the instrument further under the anterior capsule previously separated from the crystalline cortex by l '' hydrodissection. If necessary, it is possible thanks to this instrument and visco-surgery to tangentially widen the capsular opening in order to create a wider opening of the capsule: the capsular remnants are then removed either in one time or during washing maneuvers   discourse aspiration of the masses that will follow.   3) DEVICE for implementing the method according to claim 1, characterized in that it consists of a "THREE-TONG PLIER" SHAPE, kidney-shaped, closed at its end, sharp on both jaws and sufficiently thin, profiled in a way (tapered, of reduced dimensions) to be introduced into the anterior chamber of the eye. This device is suitable for the RESECTION of the anterior lens capsule. The instrument must be introduced into the capsular bag until its origin, therefore in its first curvilinear part, after a curvilinear puncture with a scalpel 2mm long on the midday meridian then hydrodissection of the crystalline nucleus and injection of viscoelastic product. It is directed at 10H and 14H towards the crystalline equator without reaching it and thus initiates a curvilinear resection, "with the punch". Its end then prints on the capsular cutout a circular stop, eliminating the beginnings of tearing lines formed by a linear incision. The stops are directed towards the central pole of the lens. The rest of the capsule is not intended to be removed because this technique is more particularly integrated into the so-called envelope technique, the utility of which for preserving the corneal endothelium during MANUAL EXTRACAPSULAR surgery is recognized.   The capsular resection thus carried out in no way impairs visibility during subsequent surgical maneuvers and does not create a "lack" for   guiding the implant towards the posterior chamber.   The elasticity of the instrument makes it possible to release the grip effortlessly and the rounded end is kept immobile during the release in order to avoid lifting the central capsule, which in any case would notice immediately.   The instrument therefore makes it possible to cut the anterior capsule completely, with rounded ends, and in a modular manner depending on the size of the crystalline nucleus to be expelled. It is indeed possible to "resume" the original layout by extending it downwards when the maneuvers of rotation of the core show that it is of great   cut. A hemi- capsulectomy is then initiated   circular, without however carrying the risk of lengthening the incision and then tearing of the anterior capsule, and this quite simply by pushing the instrument further under the anterior capsule previously separated from the crystalline cortex by hydrodissection. If necessary, it is possible thanks to this instrument and visco-surgery to tangentially widen the capsular opening in order to create a wider opening of the capsule: the capsular remnants are then removed either in one time or during washing maneuvers discission suction of the masses which will follow. The instrument therefore has no fundamental difference except that it works on the principle of "cookie cutter" and therefore allows both to progress towards 10H and 14H during the establishment of capsulectomy as to widen the opening towards the equatorial periphery of the capsular bag with then elimination of the capsular debris by successive partial resections. The forceps are inserted in the desired orientation (34) to avoid the situation (31) and the capsular resection is carried out. The capsular remnants are removable and constitute pieces of   1, Omm to 1.2mm wide by 3.2mm long on average.   ABSTRACT OF THE TECHNICAL CONTENT OF THE INVENTION:   Eye microsurgery instrument allowing a different approach to anterior capsule surgery during cataract surgery by   the so-called manual extracapsular method.   The invention relates to an instrument capable of cutting or resecting in a regular manner and without the risk of a line splitting the anterior capsule of the cataract lens during the cataract operation, by providing a trace with rounded ends at the capsular incisions, in order to to allow the "exit" of the nucleus. It is characterized by a handle of two different models articulated with a cutting part of curvilinear shape, allowing either the cutting of the anterior capsule, or its hemicoruscular resection. When the surgeon actuates this instrument which he will have previously driven under the anterior lens capsule after a short incision thereof on the midday meridian, the section or resection of the capsule   can be achieved by simple pressure on the handle.   The instrument is designed to be used by hand right and left hand.   The instrument according to the invention is particularly intended for surgery of the anterior capsule of the lens during the cataract operation, (which represents the operation most frequently performed in ophthalmology), giving this surgery the qualifier of Safety Capsulotomy, or Blocked Capsulotomy, qualifying according to an Anglo-Saxon image of "Safe Locked Capsulotomy"   Diagram for the abstract: diagram N 2 and N 8.