BR202016020982U2 - CATARACT SURGERY INSTRUMENT AND PROCEDURE FOR CIRCULAR CUTTING - Google Patents

Abstract

It is a device that allows to make the cut in the eye capsule to be operated from the cataract with the correct size and shape.

Description

(54) Title: INSTRUMENT FOR CATARACT SURGERY AND PROCESS TO MAKE A CIRCULAR CUT IN THE CAPSULE (51) Int. Cl .: A61F 9/007 (52) CPC: A61F 9/00763 (73) Holder (s): ANDRÉ RAPOSO MONSANTO (72) Inventor (s): ANDRÉ RAPOSO MONSANTO (74) Attorney (s): MÁRCIO LOBO PETINATI (57) Abstract: This is a device that allows cutting the capsule of the eye to be operated on the cataract with the size and shape

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INSTRUMENT FOR CATARACT SURGERY AND PROCESS TO MAKE A CIRCULAR CUT IN THE CAPSULE [001] This report refers to a utility model for an Instrument for Cataract Surgery, an eye problem in the population, especially in the elderly, and which belongs to the field of human needs, particularly in the health care segment, was developed to provide technical and economic advantages, enabling doctors to proceed with surgery with better working conditions, technical perfection and patient safety.

[002] Cataracts can, without proper treatment, lead to blindness, surgery being the only form of treatment possible.

[003] In the surgical procedure, the opaque lens is removed and an intraocular lens is replaced, because if this is not done, the only option would be to use glasses with a high degree to be able to supply the absence of the lens.

[004] However, it has to be said that the lens is wrapped in the so-called capsule and to have access to it, it is necessary to make an opening in the anterior part of this capsule in order to allow the removal of opaque material and the placement of the intraocular lens. . This opening is called capsulorhexis.

[005] Currently, the best way to make this opening in the capsule is to build it in a circular shape, with approximately 5 to 5.5 mm in diameter, and centralized with the visual axis of the eye.

Petition 870160050828, of 9/12/2016, p. 5/29 / 12 [006] This diameter is the most used because the intraocular lenses are, in general, 6mm in diameter, in which case what is done is the insertion of the lens in the opening made in the capsule so that the its edges are covered by the edges of the capsule, a procedure that makes the positioning of the lens in the capsular bag more stable over time, especially in the case of toric tests (which corrects astigmatism). or multifocal (which allows you to focus far and near).

[007] The problem, however, is that the cuts that are made today in the capsule are, in general, created manually using tweezers or needles, and in this case they are subject to imperfections in their construction since they depend on the skill of the surgeon and create a perfect circular cut, which doesn’t follow the cut is made by the surgeon and each of the two eyes of the patient, a condition that complicates even more when it comes to different circuits and different skills .

[008] In this case, even with very experienced surgeons, it is not uncommon that these cuts do not meet the necessary standard, which can compromise the surgical result in terms of visual quality or even lead to surgical complications such as the pi pi there, what can be pro ected between the surgical result.

[009] Another option would be to perform the cut using a femtosecond laser, which allows it to be performed perfectly, but unfortunately, few patients have access to this technology, either due to the high cost that does not allow the acquisition of the

Petition 870160050828, of 9/12/2016, p. 6/29 / 12 equipment by the medical service, either by the high cost built into the use of the equipment.

[010] And here there is still a third element that makes it difficult to use this system, which is the fact that it is not unanimous in the scientific community, which states that the use of the laser would make a cut less resistant to tension (which can occur during surgery) than the cut performed manually. Other complications have also been attributed to the cuts made by this type of laser.

[011] Therefore, the shape of the precision of the circular cut of the capsule is a problem that has been known to the medical community for years, because of the various instruments that have been created in search of the ideal mechanism to proceed with the best surgical system. quality, being some of the most prescribed known those proposed in the North American patent applications filed under numbers US 8137344, US

8702698, US 20130197548, US 5569280, WO 2014193702 and US 20100185222, processes that resemble what is being protected here, but do not have the same characteristic and functionality.

[012] In order to correct the problems described, and what the cited patents do not accomplish, the present INSTRUMENT FOR CATARACT SURGERY AND PROCESS FOR PERFORMING A CIRCULAR CUT IN, which, in addition to being a disposable structure and low cost, the purpose is to effect circular cutting with better quality and obtain a satisfactory result in almost all cases where it is used, without the

Petition 870160050828, of 9/12/2016, p. 7/29 / 12 need for the surgeon to have specialization in its use because it is a simple and easy to use instrument.

[013] The Instrument has a standard constructive structure with three possibilities for handling, an important condition since it allows each doctor to use the one that best fits his way of acting and professional dexterity.

[014] In order to facilitate the understanding of what the Cataract Surgery Instrument looks like and how it works, it will be the basic instrument described with the eric references and the annexes that illustrate the constructive and exemplary arrangement. restrictive, in which:

[015] Fig. 1 shows a lower external view of the instrument [016] Fig. 2 shows a side sectional view of the instrument! [017] Fig. 3 shows a side view of the A-A section of the instrument!

[018] Fig. 4a shows the instrument being inserted into the capsule using the auxiliary instrument!

[019] Fig. 4b shows the instrument being inserted into the capsule using the fuel to be used!

[020] fig. 5 show the upper view of the str i nt within the eye being positioned for use!

[021] Fig. 6 shows a side view of the instrument inside the eye and the light is activated!

[022] fig. 7 show the side view of the eye after the vacuum is activated and shows the contact with the caps!

[023] Fig. 8 shows a side view of section A-A of the

Petition 870160050828, of 9/12/2016, p. 8/29 / 12 instrument and shows the position of the file inside during operation!

[024] Fig. 9 shows the main instrument and the auxiliary in the position of use, when the latter magnetizes the Blade, before cutting begins, and detail “B” shows the end of the auxiliary instrument in increase!

[025] Fig. 10 shows a top view of the instrument's cutting blade movement, as guided by the surgeon using the auxiliary instrument!

[026] Fig. 11 shows the instrument being removed from the eye through the main incision.

[027] Thus, and with the aforementioned figures, the instrument for cataract surgery (1) is presented in malleable material (today the most common being silicone) and in the form of a ring, the latter having 6.1 mm in diameter on the outside and 3.9 mm in diameter on the inside, and at least 0.5 mm in height.

[028] This ring (1) is connected to a cable (2) in the form of a rigid tube that the surgeon will hold and within which circulates a liquid called Balanced Saline Solution, commonly used in this surgery.

[029] To use the instrument the surgeon through an incision (3) in the cornea (9) that varies from 2.0mm to 2.75mm. This is the main incision of the surgery, through which the material of the lens will be removed later and the surgery and the trocular lute will be implanted. or to be co stituted by flexible material the structure can be served by this division and return to its circular composition and be used

Petition 870160050828, of 9/12/2016, p. 9/29 / 12 in surgery.

[030] The insertion in the eye can be done in two ways, the first with the help of an auxiliary instrument (10) to serve it as a guide, as shown in Fig. 4a.

[031] This auxiliary instrument (10) can be the same secondary instrument with a magnet (12) that will be described below, or any other instrument of a similar shape that the surgeon wishes to use, such as a Sinskey hook or an opper, instruction and with this surgery.

[032] As an alternative way, the insertion can be carried out with the help of a plastic piece (13) in the form of a flat funnel, which directs the instrument (1) through its passage through the main incision (3) as shown in Fig. 4b. This plastic part (13) can be used remaining in position during the activation of the instrument (1) or be removed after passing the instrument (1) through the incision (3).

[033] Internally the instrument (1) has in its ring a cavity (5) through which the balanced saline solution circulates, and this cavity (5) has lower openings (6) that are used to fix the instrument (1) in the capsule anterior (4) during the procedure, fixation that occurs by suction, which creates a vacuum between the instrument (1) and the anterior capsule (4) of the lens and permits the fixation of the intruent in place.

[034] This fixation is important due to the fact that inside this cavity of the instrument ring (1), there is a thin blade (7) and very sharp that will be used to make the desired cut in the anterior capsule (4). If there was no fixation, the surgeon would lose control over the position of the cut and its

Petition 870160050828, of 9/12/2016, p. 10/29 / 12 accuracy.

[035] In the main model of this instrument, there is a Blade (7) that rests inside a circular groove (8) with a diameter of 5mm, which is the desired size to perform the capsulorhexis. Thus, when the suction is triggered to create a vacuum between the instrument (1) and the anterior capsule (4) of the lens, there is a retraction in the circular part of the instrument (1) which, as it is made of flexible material, squeezes and reduces its thickness, a condition that causes the blade (7) inserted in it to be exposed, and penetrates the capsule (4), starting the cut.

[036] Once the penetration has been completed, the surgeon must guide this blade (7) through the circular groove (8) of the instrument (1) to make the desired circular cut, and for this he uses a second instrument (10) that is inserted into the eye by a second incision, this 1mm, which is the usual accessory incision in this type of surgery.

[037] This instrument consists of a thin metal rod (11) which has a magnet (12) 1mm in diameter at its end, and which attracts the upper part of the blade (7), which is an etched piece of metal if it is and if inserted against the instrument (1) in the upper part of the internal circular groove (8). [038] As the instrument wall (1) at the blade location (7) is 0.1 mm thick, the surgeon simply needs to make the magnet (12) contact the upper part of the blade (7) and drag it in circular motion by panning the internal groove (8) of the instrument (1), causing the blade (7) to make the circular movement and make the desired cut in the cornea (9).

Petition 870160050828, of 9/12/2016, p. 11/29 / 12 [039] Once the cut is made, that following the circular groove (8) of the instrument (1) becomes a perfect circular cut, the instrument (1) and the portion center of the capsule, and the surgical process is continued according to the standard adopted by the surgeon and within what is already known to the technique.

[040] The instrument will always have the same way of acting on the eye, however, allowing the other to use it, if the second option of handling the medical intervention is given, instead of using the conduction of the lony ( 7) cutting by a magnet on a metal rod (11), this occurs by means of a metal rod (14) internal to the instrument and which moves through a mechanism (15) on the handle (2) that pulls the blade (7 ) through the circular groove (8).

[041] To better illustrate this variation, it will be the instrument (1) described with numerical references in the accompanying drawings that illustrate its exemplary and non-restrictive constructive disposition, in which:

[042] Fig. 12 shows a top view of the movement of the cutting blade of the instrument coupled to the cutting blade and the movement mechanism existing in the handle;

[043] Fig. 13 shows the side and sectional view of the instrument;

[044] Fig. 14 shows a side view of the A-A section of the instrument and shows the position of the blade and above.

[045] In this variation of the instrument (1), everything occurs as described above, except that the blade (7) does not perform its circular movement to effect capsulorhexis due to the stem (11)

Petition 870160050828, of 9/12/2016, p. 12/29 / 12 with magnetic tip (12), but by an internal rod (14) to the instrument (1) which is attached to the blade (7) at one end and is attached to a mechanism (15) on the cable (2) which pulls the blade (7) into the circular groove (8).

[046] This mechanism (15) on the handle (2) consists of pi which is coupled at the end of the ase eqe effect a circular movement, a movement that causes the rod (14) to move the blade (7) at the other end and proceed with the circular cut (Kig.12).

[047] the trigger of this ovi and the pi o can take place an al and up to the electric otor triggered by the surgeon, in order to automate the procedure.

[048] The rod consists of two articulated parts, one connected to the blade (7) and the other connected to the pin of the pulling mechanism (15).

[048] In this variation of the instrument (1) the differential occurs in its thickness, which needs to be 0.7 mm in order to accommodate the internal stem (14).

[049] The upper part of the blade (7) consists of a circular circular piece connected to the blade and the opposite circular portion of this diameter with the opposite polarity at the end of the shaft (14), so that there can be an independent circular movement between the two magnets that remain attracted so that the movement of the rod (14) on the blade (7) is transmitted in the desired way (Fig. 14).

[050] A third variation of this instruction can also be used, where it does the same as described above and in the first model, except that instead of the blade

Petition 870160050828, of 9/12/2016, p. 13/29 / 12 (7) what is inside the circular silicone structure is a clamp (16) with asymmetrical tips.

[051] To better illustrate this variation, it will be the instrument (1) described with numerical references in the accompanying drawings that illustrate its exemplary and non-restrictive constructive disposition, in which:

[052] Fig. 15 shows a side sectional view of the instrument!

[053] Fig. 16 shows a side view of the A-A section of the instrument and shows the position of the clamp inside it!

[054] Fig. 17 shows a side view of the A-A section of the instrument and shows the position of the plug and its interior during operation!

[055] Fig. 18 shows a side view of the clamp in its initial position!

[056] Fig. 19 shows a side view of the forceps in position of use, when the two parts touch, and the view shows the fragment of the capsule between the parts when they touch!

[057] Fig. 20 shows a top view of the clamp in its initial position!

[058] Fig. 21 shows a top view of the forceps in position of use, when the two parts touch, and shows the fragment of capsule between the parts.

[059] The clamp (16) rests inside the instrument (1) instead, and in place, of the blade (7) present in the two variations, in which it lies within a groove (8) with a diameter of 5 mm . [060] Thus, when the suction is activated to create a vacuum between the instrument (1) and the anterior capsule

Petition 870160050828, of 9/12/2016, p. 14/29 / 12 (4) of the lens, there is a retraction in the circular part of the instrument (1) which causes the clamp (16) to penetrate the capsule (4) allowing the beginning of the circular cut.

[061] This is because the clamp (16) has two teeth of different lengths (16a and 16b) the longest is also pointed, which allows it to pierce the capsule (4) to start cutting.

[062] In order for the capsule (4) to be cut by the forceps (16), it is necessary that a fragment of tissue (19) be grasped by the forceps between its teeth (16a and 16b), so that afterwards the forceps (16) pull the rest of the fabric (19) following the circular shape, completing the desired cut.

[063] For this to happen, after the long clamp tooth (16) has pierced the capsule (4), it is necessary that the two teeth (16a and 16b) meet, keeping the tissue (19) between them, so that it is possible to pull and tear the capsule (4) in a controlled manner as desired.

[064] In order for the two teeth (16 a and 16b) to touch and firmly grasp the tissue fragment (19) of the capsule (4) between them, the forceps (16) have a closing mechanism in the upper part. This ec o is the ulti ction (18) in a circular shape with two possible positions, open (Fig 16) and closed (Fig 17).

[065] The natural position of the clamp (16) is opened and its closing is activated by the magnet (12) on the secondary instrument (10), the same as described in the later models.

[066] When the rnaã (12) comes into contact with the instrument (1), its action causes the clamp (16) to be drawn upwards. When

Petition 870160050828, of 9/12/2016, p. 15/29 / 12 this happens, the circular joint (18) is dragged through a structure (17) in the form of a cone, with the upper portion narrower. Thus, the smaller diameter of this structure (17) requires a reduction in the diameter of the circular joint of the clamp (16), which makes the teeth (16a and 16b) unite, seizing the desired capsular tissue (19) (Figs. 18 to 21).

[067] Once the tissue is seized (19), it will continue to be torn in a controlled manner following the movement controlled by the surgeon.

[068] Therefore, after drilling, the surgeon must guide this clamp (16) through the circular groove of the instrument (1) to make the desired circular cut, in this case using the rod (11) with the magnetized tip (12).

[069] At the end of the cut, when the instrument (10) with a magnet (11 and 12) is removed, the forceps (16) will return to their natural state, releasing the fragment of capsular tissue (19) that has been cut and it will be removed do the instruction with the instruction (1) and with the capsule disk normally removed in the capsulorhexis.

Petition 870160050828, of 9/12/2016, p. 16/29 / 1

Claims (4)

Claims 1. CATARACT SURGERY INSTRUMENT characterized by essentially comprising a ring-shaped cataract surgery instrument (1), containing a cavity (5), lower openings (6), and a groove (8) containing a blade (7), all connected to a cable (2). 2. INSTRUMENT FOR CATARACT SURGERY as characterized in 1, which presents a variation that comprises, in essence, the existence of a clamp (16) for cutting. 3. PROCESS TO MAKE A CIRCULAR CUT IN THE CAPSULE which is characterized by essentially, by cutting and inserting the instrument (1) in the anterior capsule (4) of the eye, together with an auxiliary instrument (10) containing a stem ( 11) metallic and with a magnet at the end (12) that adheres and drags the blade (7) through the circular groove (8), making the circular cut to caps la. 4. PROCESS TO MAKE A CIRCULAR CUT IN THE CAPSULE as characterized in 3, which presents a variation that is characterized by understanding, in essence, the existence of an internal rod (14) that is fixed at one end to a mechanism ( 15) that when carrying out a traction ovari to the extreme extreme the wool (7) within the circular furrow (8). Petition 870160050828, of 12/09/2016, p. 17/29 1/10 Petition 870160050828, of 12/09/2016, p. 19/29 2/10