Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
  • A61F9/007—Methods or devices for eye surgery
  • A61F9/00736—Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments
  • A61F9/00754—Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments for cutting or perforating the anterior lens capsule, e.g. capsulotomes

Definitions

• the present invention is primarily intended for a CIRCULAR SCALPEL FOR ANTERIOR CAPSULOTOMY OF THE LENS IN CATARACT SURGERY, which responds to a very special constructive and functional concept specially designed to simplify and make more precise the continuous circular capsulotomy which requires the surgical technique called phacoemulsification to remove the cloudy lens, and then including a transparent lens .
• the present invention relates to a novel scalpel specifically created for running a continuous circular capsulotomy (CCC) in microincision cataract surgery, which is able to enter the eye through the same incision that uses such surgery and support itself, properly focused on the capsular surface of the lens so that with a slight pressure a perfect circular cut is carried out, most appropriately sized and with the required depth .
• CCC continuous circular capsulotomy
• phacoemulsification is one of the most modern techniques in the treatment of cataract, which is practiced worldwide, highlighted because it allows the removal of the opaque lens and replaces it with a transparent lens through a minimal incision (approximately 3 mm), which generally does not require suturing.
• the continuous circular capsulotomy capsulorhexis
• it is one of the most difficult stages of the indicated process, because it requires a great skill by the intervening surgeon, who must make a circumferential cut of very small size, on living tissue, and has to execute it freehand.
• CCC continuous circular capsulorhexis
• this invention relates to, the need for performing the rhexis freehand is eliminated and the circular shifts that produce the cut by tearing, being possible to execute a perfect circular cut without any circumferential displacement, through a slight pressure action on the capsular surface.
• the circular scalpel of the present invention basically comprises a flexible hollow cylindrical body of circular section and open bases, which transversely crushed, can enter into the eye through the same channel of the incision approach, while it is expanded, it keeps some structural rigidity so that, resting on the capsular surface, it is possible to produce a well defined and most suitably sized circumferential cut through a manually controlled pressure perpendicular to said receiving surface .
• cataract is a progressive disease which comprises a clouding or opacification of the lens (normally transparent) that prevents the efficient passage of light rays into the eye. It is frequently experienced by individuals over 50 years. The most common symptoms are: blurred vision, opaque color vision, and discomfort with the brightness of sunlight, poor night vision etc. and especially a clear decrease in vision, that in many cases it is not noticeable due to its slow and gradual nature.
• extra capsular which involves opening the eye with an enlarged incision, lifting the cornea and extracting the cataract.' Then an intraocular lens is introduced, placing it appropriately in the capsular bag or groove ( irido-capsular ) when it is retained, or by stitches.
• phacoemulsification allows removal of the entire lens through an incision of 3 mm. It involves the use of an ultrasound probe to mechanically split lens while being aspirated. Then, it is proceeded to implant an intraocular lens that replaces the lens. In most cases no suturing is required because they are very small and self sealing.
• the incision is made using blades, a pincer ("utrata") is entered, through which the initial tear of the capsule (such as an eyelet) is produced. From this eyelet, the surgeon freehand leads the pincer in a circumferential offset action causing a 360° tear.
• an apparatus designed to make a circumferential incision.
• said apparatus is constituted of a carrier handle (110) which, by its distal end section retains a circular cutting ring (120) which carries a pair of diametrically opposite holes (122), practiced in the wall thereof, where it crosses said carrier handle that contains it.
• This circular cutting ring (120) can be deformed by stretching, taking a minimum thickness, to be driven through the incision approach, for which the same handle has two separate abutments (130a) and (130b) of slightly greater dimension than the diameter of said holes (122) .
• the same buffers unlock it to resume its circular conformation and can be properly centered, with its sharp edge in contact with the tissue to be cut.
• Another important aspect relates to the entry and exit of the assembly through the incision. It is emphasized that the instrument has an edge on the lower edge of the ring, so that when entering and exiting the incisional tunnel, the . crossing structures will be undoubtedly damaged.
• the anterior chambers of ' the eye have different depths, if a deep chamber is faced, how can the ring be positioned on the capsular surface? The angle between the plane and the instrument would make the incisional tunnel damage, or even worse, that there is no contact with the lens surface.
• the invented scalpel can be removed with ease, after running the "CCC", through the same incision through which it was entered.
• the scalpel to which this invention relates to will create a new principle of operation since, to perform said perfect circular cutting it only scrolls by a slight pressure in the perpendicular direction and sense to the capsular surface on which it rests, which eliminates all types of circular motion . It also stands out because the cutting height is determined accurately and independently of the scalpel's own body, given its conformation it stops scrolling when it arrives to the necessary depth.
• the scalpel basically comprises a flexible, hollow and cylindrical body with a circular section and open bases, which, in a preferred embodiment, may show a sectional diameter between 5 mm and 6 mm, keeping a circular edge of serrated edge intended to rest on the capsular surface, while the opposite edge is defined as "blunt".
• Said flexible condition allows it to be crushed with pincers or the injector/extractor instrument driving it, until a minimum thickness is achieved, with their internal faces in mutual contact, in which case a width greater than 2 mm is established, a condition in which it can be led to enter the interior of the eye by the microinsicional tunnel, which is usually practiced in the cornea, whose dimensions are typically 2.2 mm to 3.2 mm as appropriate, without requiring the scalpel body to make contact with the walls of said tunnel.
• invented scalpel can be entered using an injector-ejector, of conventional type, as usual for the "IOL Implant” (intraocular lens) which, for this application, will be duly amended to take the ring and submit and remove it in one operation.
• injector-ejector of conventional type, as usual for the "IOL Implant” (intraocular lens) which, for this application, will be duly amended to take the ring and submit and remove it in one operation.
• the instrument of this invention expands to recover its cylindrical structural format, with sharp cutting teeth resting on the capsular surface, in which case, driven by a suitable tool ("chopper” and/or “utrata”), it is positioned properly focused and aligned.
• a suitable tool chopper" and/or “utrata”
• the thickness of the capsule is approximately 25 microns, so that in preferred embodiments the height of the cylindrical wall of the invented scalpel may be 0.75 mm, in which case its sharp cutting teeth are of 0.25 mm, enough to ensure that with said slight manual pressure a complete circle is obtained, homogeneous on the whole 360°, without any need for a circular displacement.
• the aforementioned cutting nails are flat and tapered, which may include one sharp edge or two sharp edges for easy cutting action to be executed.
• these cutting teeth adopt various shapes, defining curved edges converging towards the same point of free end or by combining a curved and sharp edge and another straight one, or even edges which form different angular values with each other.
• the constituent material it is a constructive condition that while presenting some structural rigidity, it keeps the referred flexible condition, in which case it is possible to manufacture it with polypropylene, or grillon, with a proper density, it should even considered the possibility of using an alloy of nickel and titanium (NiTi) .
• the inventive scalpel can be entered using a similar injector/extractor which applies to the "IOL implant".
• the injector must include a special carrier cartridge, through which it is possible for the scalpel body to be provided properly crushed forming a minimum thickness, with its cutting teeth facing downwards, and in these conditions be moved until dispose it over capsular surface, in which case, while the injector is removed, it returns to its cylindrical shape, with its serrated section supported on said surface, while maintaining a minimum structural rigidity to prevent deformation when pressed perpendicularly by the upper blunt edge.
• the nozzle of the carrier cartridge which will contact incisional tunnel wall, keeping the scalpel cultured and crushed over the scalpel which looks and expands only when it is arranged facing the capsular surface.
• Figure 1 is a perspective view in elevation showing the overall conformation that presents the circular scalpel for capsulotomy of the present patent invention.
• Figure 2 is a side view of the same scalpel shown in the previous figure, where the cutting teeth are triangular in shape, whose equal sides converging to the open vertex, form the cutting edges.
• Figure 3 is a side view of the same scalpel shown in the previous figures, in this case where the cutting teeth have edges of different lengths.
• Figure 4 is a schematic side view similar to the previous figures, depicting the case where the edges of each cutting tooth are curved.
• Figure 5 is a cross-sectional view of the same scalpel shown in figure 1, including an enlarged detail which highlights how the cutting edge presented by each sharp tooth is composed.
• Figure 6 is a perspective view depicting the carrier cartridge of the injector/extractor especially designed to hold the scalpel, shown in the arrangement that adopts for receiving the same.
• Figure 7 is a perspective view showing the carrier cartridge of the injector/extractor able to enter through the incisional micro channel.
• Figure 8 depicts a portion of the human eye, duly enlarged showing the entry of the invented scalpel hovering crushed from the in ector/extractor.
• Figure 9 represents the same section of the preceding figure, in this case showing the scalpel properly positioned on the capsular surface of the lens.
• Figure 10 shows the same section of the preceding figure, showing in this case the invented instrument as it is positioned when the circumferential cut is produced by penetrating the capsular surface.
• Figure 11 shows the same cutting of the preceding figure showing the presence of the intraocular lens disposed on the capsular bag of the lens once the torn portion has been extracted by suction.
• the circular scalpel for anterior capsulotomy of the lens referred to in the present invention comprises a hollow cylindrical body (1) of open bases, defining a blunt upper edge (2) and a lower serrated edge (3) .
• the invented scalpel is known for being flexible and of variable height, defining a cylindrical wall whose lower edge portion comprises a circumferential alignment of cutting teeth (4) also flat and of sharp shape, whose height may be slightly less than half the total height of the scalpel.
• the total height of the wall of the scalpel may be between 0.75 mm and 1 mm, in which case the height of each cutting tooth (4) will be between 0.25 mm and 0.40 mm, in which case the diameter of the circular section thereof may be 4 mm and about 7 mm.
• the present invention defines as basic and main condition that the lower cutting edge (3) having the scalpel is serrated, but is not subject to the conformation and orientation that can present each of those cutting teeth (4) that give shape to said serrated edge.
• figures 2 to 4 show different options for the cutting teeth, each of which have been specifically designed to produce the cut on the capsular surface of the lens, from a slight perpendicular pressure.
• the teeth (4) are triangular, where the sides converging toward the free vertex are equal to each other.
• the teeth (4') are also triangular but the sides converging to the free corner are uneven, which can result, when said perpendicular pressure to the support surface is carried out, the scalpel tends to make a small circular movement which favors the penetration of the tissue without tearing.
• figure 4 shows the case where the cutting teeth (4") are curved sides.
• a preferred embodiment for the entry and exit of the scalpel of this invention into the eye is exemplified, which comprises arranging the same in a carrier cartridge (C) specially designed for this purpose .
• Said cartridge (C) comprises a receiving cavity which is defined between the hinged flaps (25) and (26), which enclose a longitudinal central channel (24).
• said longitudinal central channel (24) allows that said flaps can be arranged depressed or open for incorporating the scalpel.
• the scalpel (1) can be positioned between the longitudinal straight ribs (27) and (28), so that, when the flaps are closed, as shown in figure 7, the body of the scalpel crushes until its side wall remains overlies, giving shape to a more elongated and flattened body which is accommodated with some fairness in said longitudinal channel (24).
• said channel (24) is in communication with the dispensing nozzle (29) , specially designed to pass through the tunnel incisional and dispose its distal end facing the capsular surface of the lens (see figure 8) .
• the outer surface of the nozzle can be curved and flat, since it makes contact with the walls of the incisional tunnel, however it is desirable that the inner channel keeps the quadrangular section conformation and thereby ensure that the scalpel is maintained properly positioned during its transportation of entry and exit into the eye.
• FIG. 7 shows that the referred carrier cartridge (C) , is suitable for engaging the distal end of the actuating syringe (J) that integrates the extractor designed for the application.
• FIG 16 Sclera Looking now to figure 8, it is seen that for cataract surgery by phacoemulsification it is proceeded with a micro corneal incision (17) which does not require sutures, through which slender instruments are introduced which act on the cataract, removed by absorption and then an intraocular lens (19) (shown schematically in figure 11) is implanted that is foldable to pass through said insicional channel (17) which then expands to stay in perfect shape over the lens, taking the place of the extracted capsular surface portion.
• a micro corneal incision (17) which does not require sutures, through which slender instruments are introduced which act on the cataract, removed by absorption and then an intraocular lens (19) (shown schematically in figure 11) is implanted that is foldable to pass through said insicional channel (17) which then expands to stay in perfect shape over the lens, taking the place of the extracted capsular surface portion.
• the lens is enclosed and covered by a capsule (10) highly refractile to the electron microscope, which is seen as thick and homogeneous (11 to 18 microns thick) .
• the internal surface of the capsule is maintained in direct contact with the base of the epithelial cells.
• the invented scalpel (1) is also designed to enter into the eye, more precisely into the anterior chamber of the eye between the lens (15) and cornea (6), passing through the aforementioned micro corneal incision (17), for which is disposed properly crushed inside the channel of the dispensing nozzle (29) of the carrier cartridge (C) which integrates the extracting medium injector.
• the scalpel As depicted in figure 9 as the scalpel is moved out of the dispensing nozzle (29) , it is disposed directly on the anterior capsular surface (10) which, once released, it tends to expand to adopt the cylindrical form shown in the figures, with cutting teeth supported on said surface.
• figure 11 shows that the forming invented device was removed as well as the torn capsular portion, in which case, there having been a perfect capsulorhexis , as taught by the aforementioned method phacoemulsification proceeds to incorporate the lens (19) .

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Citations (11)

• 2014
  • 2014-05-05 AR ARP140101817A patent/AR096171A1/es unknown
• 2015
  • 2015-04-30 WO PCT/EP2015/000891 patent/WO2015169426A1/en active Application Filing

Patent Citations (11)

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