WO2021170891A1

WO2021170891A1 - Vitrectomy probe

Info

Publication number: WO2021170891A1
Application number: PCT/ES2021/070127
Authority: WO
Inventors: Carlos RÍOS MESAS; Anatole Tkatchenko; Carlos MATEO GARCÍA; Jeroni Nadal Reus
Original assignee: Rios Mesas Carlos; Anatole Tkatchenko
Priority date: 2020-02-25
Filing date: 2021-02-23
Publication date: 2021-09-02
Also published as: ES2777881A1; ES2777881A8

Abstract

Vitrectomy probe that comprises: a tube (8), suitable for penetrating the eye as far as the vitreous humor, having a closed end and a port (7) located to the side of the distal end (8a) thereof, a cutting element (3) located within the tube (8) suitable for cutting the vitreous humor that enters through the port (7) of the tube (8), means for absorbing/sucking the vitreous humor already cut by the cutting means or by the tube, wherein the port (7) of the tube (8), in the same area where conventionally there is a single hole, comprises at least two holes (6), so that the detached retina is hindered from entering through the port (7); at the same time the vitreous humor that has access to the cutting means is cut in more than one piece, thus faciltating suction thereof by the vitrectomy probe. Preferably, at least one of the holes of which the port (7) of the tube (8) consists is groove-shaped (6'), maximizing suction.

Description

VITRECTOMY PROBE

DESCRIPTIVE MEMORY

OBJECT OF THE INVENTION

The invention, as expressed in the wording of the present specification, refers to a vitrectomy probe that provides, for its intended function, advantages and characteristics, which are described in detail below and which entail an improvement in the condition. current state of the art.

The object of the present invention lies, specifically, in a vitrectomy probe consisting of a high-speed cutting surgical instrument of the type that is used, in ophthalmic surgery, specifically in vitreoretinal surgery, to eliminate different types of ocular tissues, such as vitreous humor and the membranes that cover the retina, which is distinguished, essentially, by having a port at the end of the tube that includes its cutting element, where tissue is cut and suctioned through a hole, and that unlike what is known up to now, instead of a single large hole, it includes two or more micro-holes that, in addition, have different design patterns specially adapted for different types of action on said tissues.

FIELD OF APPLICATION OF THE INVENTION

The field of application of the present invention is framed within the sector of the industry dedicated to the manufacture of surgical instruments, focusing particularly on the field of ophthalmic microsurgical instruments, and more particularly instruments for the removal of intraocular material or intraocular injection, e.g. vitrectomy instruments with cutting elements.

BACKGROUND OF THE INVENTION

Vitrectomy cutters in ophthalmic surgery are well known. Document US2007185514 describes such a probe and would be the closest example of the current state of the art.

These probes have a cutting element in the shape of a needle or similar with a piece at its end, which has a single hole called a port, which is used to extract and dissect tissues.

This port, in currently known probes, is integrated into a fixed part of the end of the probe's cutting element and has a single standard design made up of a single entrance hole, large in relation to the diameter of the tubular body that constitutes the mentioned needle, through which the tissue is introduced, for example by aspiration, then the port is closed, the tissue is cut and the tissue is aspirated. This action can be repeated to remove the desired tissues.

These prior art vitrectomy probes include a single standardized aspiration window or hole at the distal end of the cutting element, to remove and cut vitreous or other tissues, so that optimized cutters cannot be used for different needs and pathologies that require a surgical solution. At most, as described in document EP 2648630, the hole can be adjustable in size through a mechanism of various kinds that moves an internal element of the cutter. The most critical example for the patient is the surgical "shaving" step, where the most peripheral vitreous attached to the retina must be peeled off and removed through the distal end of the probe. This is especially dangerous when the retina is detached or has great mobility, as well as for patients where the vitreous humor is especially dense and generates traction on the different retinal layers. In such cases, due to the tendency of neighboring tissues to be drawn towards the tip of the cutter, there is a high risk of inadvertently performing a retinotomy. Therefore, maintaining distance from the retina turns out to be the only option to maintain safety and avoid iatrogenic retinotomy.

Therefore, it would be desirable to have a vitrectomy cutter optimized for the different surgical steps of vitrectomy and / or the multiple techniques that resolve multiple pathologies and risk situations in vitrectomy surgery, the objective of the invention being the development of a new type of probe in which said cutter has a tip that presents different port designs, according to each need.

On the other hand, and as a reference to the current state of the art, it should be noted that, although, as has been indicated, other vitrectomy probes are known, at least by the applicant, the existence of any that present technical characteristics is unknown, structural and constitutive elements equal or similar to those presented by the one claimed here.

EXPLANATION OF THE INVENTION The vitrectomy probe proposed by the invention is configured as the an ideal solution to the aforementioned objective, the characterizing details that make it possible and that distinguish it conveniently included in the final claims that accompany the present description.

More specifically, what the invention proposes, as noted above, is a vitrectomy probe consisting of a high-speed cutting surgical instrument of the type used, in ophthalmic surgery, specifically in vitreoretinal surgery, to eliminate different types of ocular tissues, such as the vitreous humor and the membranes that cover the retina, which probe is distinguished by having a structural configuration that includes, replacing the port formed by a single hole at the end of the tubular body that constitutes the needle that includes the cutting element, a port with at least two holes.

More specifically, said port has two or more holes that have been made in the surface of the tube in the form of circular microholes and / or in the form of more or less elongated slots, and whose arrangement, number and combination respond to different design patterns. specifically studied to provide a type of cutting and aspiration that is as suitable as possible for specific needs that are required in different surgical circumstances.

The choice between different designs is made based on the desired control, which is a function of the mobility room of the patient's retina, and the need to get closer to it.

Preferably, the probe port comprises holes with diameters ranging between 150 and 50 microns, although the preferred size is 100 microns in diameter or width in the case of being slot-shaped, with This size, on the one hand, prevents the retina from accidentally entering and imprisoning itself in the mouth of the vitreotome and, in turn, it is possible to absorb the vitreous freely by the vitreotome.

In addition, since the main objective of the probe of the invention is to bring it as close to the retina as possible to eliminate the vitreous without causing any damage to the retina, the small holes of the size specified above allow them to be placed remarkably close to the distal end of the cutter. . Specifically, the desired distance from the distal end of the probe tube to them should be between 100 and 200 microns, preferably less than 200, and preferably 100 microns. Such proximity cannot be achieved with the conventional device provided with a single hole, as shown in Figure 11-A.

The use of a vitrectomy probe such as the one described avoids, not only being able to erroneously cut the retina, but also damaging the structure of the retina due to the traction generated in it when the vitreous humor is aspirated with a vitrectomy probe with a port. standard. The traction force is a consequence of the vacuum that is generated when a volume of vitreous humor enters as aspirated by the vitrectomy probe.

The use of multiple ports with diameters much smaller than the diameter of the port of a standard vitrectomy probe, as proposed by the invention, very considerably reduces the traction generated on the retina when the vitreous humor is aspirated since said traction is directly related to the volume aspirated in each slice. The greater the traction, the greater the volume of vitreous humor aspirated in each cut. The volume aspirated in each slice is drastically reduced with the probe vitreciomy object of the invention. By way of example, the volume of vitreous humor that is aspirated in each cut through a standard 500 micron diameter port is 125 times greater than the volume of vitreous that is aspirated per port as described in this invention of 100 microns. The use of several ports with smaller diameters generates a lower vacuum compared to the vacuum generated by a standard port and consequently the traction generated by each port is also lower. The traction generated globally by the set of ports of the vitrectomy probe object of the invention also improves compared to a standard vitrectomy probe since small pulses are generated in vacuum and the traction generated in the retina is stable. and of a lower value.

Finally, it should be noted that the preferred layout of the probe holes is such that they are aligned in the visible area so that the surgeon can observe which tissue is being absorbed by the cutter (Figure 10).

On the other hand, the cutter is preferably longitudinal cut as shown in Figures 11-B and 11-C.

DESCRIPTION OF THE DRAWINGS

To complement the description that is being made and in order to help a better understanding of the characteristics of the invention, the present specification is attached, as an integral part thereof, to a plan in which, with an illustrative and non-limiting character, has represented the following:

Figure number 1 - Shows a schematic sectional view of a example of the vitrectomy probe object of the invention, with a rough appreciation of the main parts and elements that it comprises as well as their configuration and arrangement; Figures 2-A and 2-B show an enlarged view of detail A indicated in figure 1, in section and side elevation respectively, of the end of the tube with the cutting port and the end of the cutting element inside it; Figures 3, 4, 5, 6, 7, 8 and 9.- They show respective schematic views in front elevation, of various examples of the arrangement and shape that the probe port holes may present, in different embodiment options according to each surgical need; Figure number 10.- Shows a schematic perspective view of another example of the arrangement and shape that the holes in the probe port may have, in a preferred embodiment; and Figures 11 -A, 11-B and 11 -C show respective views, in perspective, in longitudinal section and in side elevation, of an example of a probe port, according to the state of the art, showing the single large hole size it has.

PREFERRED EMBODIMENT OF THE INVENTION

In view of the aforementioned figures, and in accordance with the numbering adopted, various examples of non-limiting embodiment of the recommended vitrectomy probe can be observed, which comprises what is described in detail below. Thus, as can be seen in figures 1, 2A and 2B, the probe (1) in question is of the type that comprises: a tube (8), suitable for needle-like penetration of the eye into the vitreous humor, with the distal end (8a) closed and with a port (7) located on the side near said distal end (8a); a cutting element (3) located inside the tube (8) capable of cutting the vitreous humor that enters inside the port (7) of the tube (8); and means for suctioning the vitreous humor already cut through the cutting means (3) or through the tube (8). And it is distinguished in that the port (7) of the tube (8), in the same area where traditionally there is a single large hole (6), as shown in Figures 10-A and 10-B where the state is shown of the prior art or technique, it comprises at least two holes (6), in such a way that an eventual entry of the detached retina through the port (7) is hindered at the same time that the vitreous humor that accesses is cut by the cutting element (3) in more than one piece, thus facilitating its aspiration through the vitrectomy probe (1).

In an embodiment, such as the one shown in figure 3, the holes (6) that make up the port (7) of the tube (8) form a symmetrical figure and occupy a large part of the lateral half of the cylinder that defines said tube ( 8). This port is designed to maximize suction / aspiration and is useful when working in a safe area away from the retina.

In another embodiment, such as that shown in figure 4, the holes (6) that make up the port (7) of the tube (8) form a longitudinal figure and occupy only a small part of the lateral half of the cylinder that defines the tube (8). This port is designed to allow the probe (1) to rotate without losing sight of the entire port (7), through a camera provided for this purpose, thus increasing the safety of the tool. In a preferred embodiment, as shown in figure 10, the holes (6) that make up the port (7) are 10 and are aligned in two rows of 5 holes (6) so that they are all in the visible area of the chamber mentioned above, so that the surgeon can observe which tissue is being absorbed by the cutter.

On the other hand, the holes (6) that make up the port (7) of the tube (8) can be circular (referenced as 6 in the figures) or slot-shaped (referenced as 6 'in the figures). When the holes of the port (7) are slot-shaped (6 '), and therefore, being elongated, have a larger size than those of circular configuration (6), the port (7) maximizes the aspiration. Optionally, the port (7) is made up of at least one larger hole in the shape of the slot (6 ') that is partially surrounded by circular holes (6) or in the shape of a slot (6') of smaller size, such as as shown in the examples of figures 5 to 8. Surrounding the larger slot (6 ') by smaller holes (6, 6') reduces the possibility of the retina entering through said slot hole (6 ') therefore, this type of port is suitable when working closer to the retina.

Preferably, when the hole has a circular shape (6) its size is between 150 and 50 microns in diameter, preferably approximately 100 microns in diameter. And when the hole is in the shape of a groove (6 '), its width is also between 150 and 50 microns, preferably approximately 100 microns, in which case its length varies. Furthermore, preferably, the distance (d) between the distal end (8a) of the tube (8) and the holes (6) and / or slots (6 ') of the port (7) is between 100 and 200 microns, to be able to bring the probe as close to the retina as possible without damaging the retina . Preferably said distance (d) is less than 200 microns and, preferably, it is 100 microns.

Also, in one embodiment, the slot-shaped hole (6 ') is arranged diagonally with respect to at least one cutting surface (31, 31') of the cutter element (3), as shown by the examples of the Figures 5 and 6. This configuration makes it easy to cut the vitreous humor when cutting is started on a smaller surface (guillotine effect / diagonal cut).

And, in another embodiment, the slot-shaped hole (6 ') is arranged perpendicular to at least one cutting surface (31, 31') of the cutter element (3), as shown by the examples of the Figures 7 and 8. This configuration causes a shear / perpendicular shear effect.

In the preferred embodiment, the tube (8) of the probe (1) of the invention, as seen in Figure 2, is a kind of needle consisting of an internally hollow cylindrical body with the distal end (8a) closed and the port (7) of holes (6, 6 ') located on its lateral surface near said distal end (8a), and the cutting element (3) is an internal body, also cylindrical, that fits internally to the body of the tube (8) presenting longitudinal sliding movement within said tube (8), in such a way that the cutting surfaces (31, 31 ') of the cutting element (3) located at its end move in front of the holes ( 6) from the port (7) of the tube (8) to cut and allow the aspiration of the vitreous humor. Furthermore, in the preferred embodiment, as shown in the representation of figure 1, the probe (1) comprises a housing (2) in which the tube (8) is coupled, with the cutting element (3) in its interior, so that it extends longitudinally from a first end of the housing (2) along a longitudinal axis, an oscillator (4) operable to slide the internal cutting element (3), and a travel limiter (5 ) operable to adjust the position of the cutting surfaces (31, 31 ') of the cutting element (3) in the port (7) of the end of the tube (8), eventually including at the opposite end of said casing (2) the wiring connecting to a suction means (not shown).

Looking at Figures 11 -A, 11-B and 11-C, it can be seen how, according to the prior art, the port (7) at the end of the tube (8) of the probes existing up to now, is defined by a single large hole (6).

Having sufficiently described the nature of the present invention, as well as the way of putting it into practice, it is not considered necessary to make its explanation more extensive so that any expert in the field understands its scope and the advantages derived from it.

Claims

1 Vitrectomy probe comprising

• a tube (8), suitable to penetrate the eye to the vitreous humor, with the end closed and with a port (7) located on the side of its distal end (8a)

• a cutting element (3) located inside the tube (8) suitable to cut the vitreous humor that enters inside the port (7) of the tube (8)

• means for suction of the vitreous humor already cut through the cutting means or through the tube, characterized in that the port (7) of the tube (8), in the same area where there is traditionally a single hole, comprises at least two holes (6), in such a way that the entry of the detached retina through the port (7) is hindered while the vitreous humor that accesses it is cut into more than one piece, thus facilitating its aspiration through the vitrectomy probe.

2. Vitrectomy probe, according to claim 1, characterized in that the holes (6) that make up the port (7) of the tube (8) form a symmetrical figure that maximizes aspiration.

3.- Vitrectomy probe, according to claim 1, characterized in that the holes (6) that make up the port (7) of the tube (8) form a longitudinal figure of holes, allowing the rotation of the probe without losing sight of the entire of the port.

4 Vitrectomy probe, according to claim 1, characterized in that at least one of the holes that make up the port (7) of the tube (8) has the shape of a slot (6 '), maximizing aspiration.

5. Vitrectomy probe, according to claim 1, characterized in that the port (7) of the tube (8) comprises a slot-shaped hole (6 ') partially surrounded by holes (6) of smaller size, reducing the possibility of that the retina enters through said slot-shaped hole (6 ').

6. Vitrectomy probe, according to claim 1, characterized in that the port (7) of the tube (8) comprises a slot-shaped hole (6 ') arranged diagonally with respect to at least one cutting surface (31, 31 ') of the cutting element (3).

7 Vitrectomy probe, according to claim 1, characterized in that the port (7) of the tube (8) comprises a slot-shaped hole (6 ') arranged perpendicular to at least one cutting surface (31, 31' ) of the cutter element (3).

8. Vitrectomy probe, according to claim 1, characterized in that the holes (6) have a diameter of between 150 and 50 microns.

9. Vitrectomy probe, according to claim 1, characterized in that the distance (d) existing between the distal end (8a) of the tube (8) and the holes (6) of the port (7) is between 100 and 200 microns .

10. Vitrectomy probe, according to claim 1, characterized in that the holes (6) that make up the port (7) are 10 and are aligned in two rows of 5 holes (6).