WO2012164129A1

WO2012164129A1 - Intrastromal segment manipulator

Info

Publication number: WO2012164129A1
Application number: PCT/ES2012/070382
Authority: WO
Inventors: Salvador Gabriel DELHOM MUÑOZ; Pere Manel DEL CAMPO GARCÍA; Rafael Ignacio BARRAQUER COPTE
Original assignee: Imexclinic, S.L.
Priority date: 2011-05-27
Filing date: 2012-05-25
Publication date: 2012-12-06
Also published as: ES2397420A1; WO2012164129A9; ES2397420B1

Abstract

A description is given of a device designed for the manipulation of an intrastromal segment inserted in a patient's corneal tunnel for positional correction or extraction of a previously inserted segment. The device comprises a main cylindrical body, a rotary wheel, with a graduated scale on the base thereof, coupled to a first end of the main body and capable of transferring movement to clamp means positioned inside the opposite end of the main body, a transmitter bolt extended longitudinally inside a hole made inside the wall of the main body, a clamp holder that provides a lower clamp element with a carriage portion for supporting and moving the segment, and a Delhom carriage component carrying a retaining tip. A cap closes and protects the end of the body linked with the position of the clamps.

Description

INTRAESTROMAL SEGMENT MANIPULATOR DEVICE

DESCRIPTION

Object of the Invention

The present invention relates to an intrastromal segment manipulator device, which provides essential novelty characteristics and notable advantages over known means and used for the same purposes in the current state of the art.

More particularly, the invention proposes the development of a device specially designed to manipulate an intrastromal segment previously housed in the corneal tunnel of a patient, with a view to a possible positional adjustment of the segment once implanted or to an eventual extraction thereof from its position. operative, all with minimal stress for the cornea of the patient. The device is capable of adopting different arc lengths, for adaptation to the dimensional characteristics of the segment, and is structured on the basis of a cylindrical body, of circular section, and also of circular development clamp elements that follow a path equivalent to that of the segment, through which the segment is trapped and manipulated, the control being facilitated by means of a first wheel coupled to a first end of the body, by means of which an upper caliper element is actuated during the opening and closing operations, and a clamp holder means coupled to the opposite end of the body and carrier of a lower clamp element, configured as a rail, which in collaboration with the upper clamp element allows the segment to be controlled during its handling operations. A Delhom car coupled to this Second end of the body, provides a positional retention tip of the segment during repositioning.

The field of application of the invention is mainly comprised within the industrial sector dedicated in particular to the manufacture, implantation and manipulation of prostheses for the treatment of corneal keratoconus.

Background and Summary of the Invention

Those skilled in the art are aware of the existence of a multiplicity of people who are affected by a corneal pathology known as keratoconus. The term "keratoconus" derives from the union of the Greek terms "kerato" (cornea) and "konos" (cone). That is, it is a condition in which the usual shape of the cornea is distorted and develops a cone-shaped deformation that progressively alters and alters the patient's vision, making it increasingly blurred. The process depends on the age of the patient and the onset of symptoms. Normally, the younger the patient is and the earlier the onset of keratoconus is, the faster its progress; It always presents bilateral and asymmetric, and may be due to congenital alterations, or be caused by weakening in the corneal tissue (corneal surgery or previous trauma).

Currently, various treatment modalities are known, depending on the degree and process of corneal deformation, as listed below:

• Glasses in a first stage;

• Contact lenses when the glasses are no longer effective; Intracorneal rings when intolerance to the use of contact lenses is manifest and there are obvious signs of progression in the process;

Crosslinking, or ultraviolet light treatment to slow the progression of keratoconus, and

Corneal transplantation in the most advanced stages and in which other options can no longer offer improvement (for example, corneal scars, very advanced keratoconus, etc.).

As indicated, in the early stages the patient can wear glasses. However, when the disease progresses, the thinning and deformation of the cornea causes a high irregular astigmatism that cannot be corrected with glasses. In these cases it is necessary to wear rigid contact lenses that, although they improve vision, do not stop the progression of keratoconus, being necessary the surgical intervention as the only way to stop the progressive deformation of the cornea. The "crosslinking" treatment can be used as long as a good corneal thickness is available and its usefulness is the brake on the evolution of keratoconus.

In view of the above, certain implantable prostheses used in those situations in which the disease has reached a level in which the previous solutions are no longer effective for the patient, whose prostheses allow for much more effective practical results to be achieved, have been developed . These prostheses consist of longitudinal segments, of arched development, whose implantation requires that intra-stromal tunnels be made through which the segments must pass, move to their proper position, and then be housed in them. These tunnels vary both in width and in internal and external diameter, logically depending on the characteristics of the patient and the prosthesis itself.

Currently, known implants mainly respond to four types of design:

Segments of triangular section: isosceles triangle shaped section, with different arc lengths and thicknesses. ;

Segments of trapezoidal scalene section: section in the form of a truncated triangle in its upper portion; Hexagonal section segments: section with six edges, and

Oval section segments: cross section with oval configuration.

In all cases of mentioned segments of the current technique, the longitudinally arched bodies thereof have holes provided to facilitate the insertion of the segment into the corneal tunnel with the use of a Sinskey hook. However, it is a natural fact that the cornea, being an elastic tissue, is prone to generate difficulties for the implantation of the segment. In addition, the manufacturing of the segments is done by turning, and the material used is PMMA (polymethylmethacrylate), without subsequent polishing, so the quality of the finish is determined by the state of wear of the diamond tool used in its machining.

All this, together with the limitations of the software used in manufacturing, makes the mechanization of the segment find a multitude of difficulties, some of which are mentioned below: Making holes in the segment:

- Breakage in handling;

- Deposits of materials inside the hole and risks of infection;

- Need to use Sinskey hooks: risk of intrastromally scratching the tunnel bed and causing infections;

- Bad angulation for easy segment implantation.

PPMA turning:

- Excessive use of the diamond results in poor finishes with the risk of breakage or deposits and with consequences of infection.

Software limitations:

- Impossibility of using free software that allows any type of desired segment.

For the realization of intrastromal tunnels, there are currently two known techniques: manual technique and femtosecond technique. In the manual technique, different tunneling instruments made of titanium and a diamond knife are used. Such tuneller instruments do not cut but delaminate intrastromally creating a tunnel, which entails a high risk of perforation and in certain cases entails the need to use a suction console to keep the eye fixed while the tunnel is being made. Complications that may accompany this manual technique are, among others, unwanted perforations, superficial tunnels, wide incisions, infections, tunnel asymmetry, tunnel deposits or post-operative trauma, to name a few. In the case of the femtosecond technique, a femtosecond laser is used for the provision of intrastromal energy pulses that cause a separation of the lamellae and create a tunnel and an entry incision for the prosthesis. Compared to the manual technique, it has many advantages, such as being more sterile, less traumatic, exact depth, without limitation of diameters and less post-operative trauma, to name a few.

For the implantation of the segments, a clamp is usually used, which usually includes notches that facilitate the fact that the segment does not "dance" or jump and get lost. In practice, the implantation of the segments with the known means normally presents difficulties and disadvantages such as the fact that the segments often jump and get lost, the segments are broken with the use of the clamps, and they are also difficult of manipulating, with the added difficulty that the segments can be manufactured with different sections and parameters, which results in the clamps not being able to hold all the segment models in an appropriate manner.

In order to solve the implantation problems mentioned briefly in the foregoing, an implant device designed to position the prosthesis in the patient's corneal tunnel, whose implant device has a support for the segment, has already been developed by the same authors of the present work. or ring, configured as a rail, with an arched profile as well as the segment itself, from which the segment is pushed towards the location provided for it in the corneal tunnel, the movement of the segment being guided at all times during the operation of implementation by the form of the support rail itself from which the transfer is made. In addition, the implanting device adopts a cylindrical body shape, with a circular and internally hollow section, which allows the development of the entire process to be controlled precisely through it and without any obstacles.

However, although the prostheses and the implantation device conceived in the manner explained briefly in the foregoing, have allowed to solve the problems associated in practice both with the characteristics of the implant and with the process of its placement in the corneal tunnel. of the patient, in a substantially less traumatic way for the latter, there is, however, an additional problem that arises and that is that, with a certain assiduity, a segment or ring already positioned in its respective intrastromal tunnel, can be revealed as ineffective in to a greater or lesser extent, because it has been able to migrate, move undesirably, or it has not been exactly positioned at the time of implantation. This requires that such a segment be manipulated for its corresponding relocation, or even its extraction in cases where, for one reason or another, it must be removed and / or replaced.

Until now, post-implantation manipulation of a corneal segment or ring has been carried out with the help of an instrument consisting of a Sinskey hook. This device, which has been a fundamental tool both for insertion operations and for the resolution of a multitude of problems of the type discussed above, is therefore not exempt from certain drawbacks inherent in its own construction characteristics. As an example we can cite the fact that, due to the pressure itself that the cornea exerts on the segment, the removal of the hook with respect to the hole of the segment with which it is associated for operational purposes, presents a certain difficulty that frequently results in breaks and migrations of the segment, so that the surgeon must use the Sinskey hook again to find the hole of the segment to be able to exert on it the effect of thrust or traction that corresponds to move it and take it to its final location. This carries risks of instraestromal scratches and therefore of associated infections.

Taking into account the foregoing, in order that the manipulation of an intra-stromal segment or ring is as traumatic as possible, the present invention has as its main objective the development of an intrastromal segment manipulator device with which the inconveniences are solved. of the devices of the current state of the art, and allow the manipulation operations of a segment after its implantation in an intrastromal tunnel, can be carried out by an expert person in an easy, comfortable and practically exempt manner of risks. This objective has been fully achieved by means of the device to be described in the following, whose essential characteristics are included in the characterizing portion of the attached claim 1.

In essence, the manipulator device proposed by the present invention is reusable in nature, prior to sterilization thereof, made entirely of titanium or technical plastic, and is structured based on a main body that adopts cylindrical configuration, of circular section , internally hollow, equipped at one of its ends with clip-holder element to which it is associated with a lower circular caliper, capable of configuration with different arc amplitudes, equipped with a rail for collecting and supporting the segment or ring, and a wheel coupled to the opposite end of the body, also manually in rotation movement in both directions with respect to the longitudinal axis of the body, bearing an upper clamp which, in collaboration with the lower one, is intended to locate the position of engagement of the segment to be manipulated or explanted, in particular a notch or groove made in the vicinity of the corresponding end of said segment, to engage in said groove with a complementary rib made for this purpose, and thereby allow to exert a traction on said segment that causes its displacement towards the support rail. This last wheel mentioned is designed in such a way that it constitutes a grader for opening and closing the calipers, with micrometric precision in steps of 10 in 10 microns, thus facilitating that the opening is carried out with exact control of its amplitude, only to the extent necessary to carry out the required action with the minimum possible stress of the cornea. At the first mentioned end, the body includes an element of the Delhom car type, equipped with an anti-return tip to prevent the retraction of the segment once repositioned.

Brief Description of the Drawings

These and other features and advantages of the invention will become more clearly apparent from the following detailed description of a preferred embodiment thereof, given only by way of illustration and not limitation, with reference to the accompanying drawings , in which:

Figure 1 is a schematic, perspective view, of an exploded view made in a manipulator device of the present invention;

Figure 2 illustrates a schematic perspective view of the body of the manipulator with a rod or bolt of transmission of rotation movement coupled to a longitudinal hole made in the side wall of the body;

Figure 3 shows a schematic perspective view of a manipulator device according to the invention in the assembled condition, sectioned in longitudinal direction thereof through a diametral plane;

4 is a detail, in perspective and on a larger scale, of the clamp portion and retainer tip of the manipulator, and

Figure 5 represents a schematic top plan view of the manipulator of the invention.

Description of a Preferred Embodiment

As mentioned above, the detailed description of the preferred embodiment of the object of the invention will be carried out in the following with the help of the attached drawings, through which they use the same numerical references to designate the same or equivalent parts. Thus, in the first place according to the representation of Figure 1, a schematic perspective view of an exploded view made in a preferred embodiment of a manipulator device conceived in accordance with the present invention can be seen. Based on this representation, it is observed that the device is structured on the basis of a main body indicated in general with reference numeral 1, materialized as a hollow cylinder, provided with multiple annular grooves on its external surface for the purpose of a better grip during the use of the device. The body has in relation to one of its ends an externally threaded portion of relatively short length, indicated with the reference Ib and visible more clearly in Figure 2, intended to receive by means of a threaded wheel 2, capable of being manually rotated during use of the device, for which purpose it includes in its outer perimeter surface the formation of striae 2a made according to the longitudinal direction of the body. This wheel is generally cylindrical, internally hollow, and has a wide opening 2b at its base, through which the entire interior of the assembly can be appreciated.

The body 1 has an internal cavity in relation to this same coupling end of the wheel 2, indicated with the numerical reference 3, made as an internal recess in its side wall, and sized to house inside a marker or arrow 4 constituted by two right-angled portions, of which one portion is sized in accordance with the cavity 3 in which it is housed, and the other portion or arrow itself, is positioned on the outer face of the base of said wheel 2 , in order to indicate the arrowhead the graduations printed or engraved in any other way, carry said wheel on the surface of its base. This provision may be better appreciated in relation to the description in Figure 3.

Along the cylindrical wall of the body 1, in a position diametrically opposite to the cavity 3, a longitudinal hole 4 has been made that extends through the inside said wall to the second end of the body 1, intended to house a bolt 5 transmitter of rotation movement in cooperation with the operation of the wheel 2. This bolt 5 is operated from the adjacent end of the wheel 2, and by the opposite end is configured to allow the coupling of an upper clamp element 6, which is susceptible to fixing to said end with the help of a retaining element, for example a nut 7 or any other equivalent element. A clamp holder 8 is also cylindrically shaped, sized for insertion into this second end of the body 1 opposite the wheel 2, and is provided with a perimeter skirt 8a in relation to its outermost edge, which acts as stopper in the insertion of the piece 8 clamp holder inside the main body 1, and which also includes a hole 9 in a corresponding position for the passage of the bolt 5. The diametral dimension of this hole 9 is such that the bolt 5 can rotate freely inside. Additionally, the clip holder 8 has a protruding formation 8b protruding from the outer surface of its cylindrical portion, intended to engage in a corresponding recess in the wall of the body 1, in order to ensure a relative immobilization of said clip holder. 8 with respect to the base body 1.

The clamp-holder piece 8 has the fundamental mission of serving as a support means for a lower clamp element 10, configured as a rail, and which together with the clamp element 6 linked to the end of the bolt 5, will form the device necessary for the intended manipulation of the intrastromal segment.

Additionally, the device of the invention incorporates a piece of Delhom 11 car type prepared for coupling to said second end of the main body 1, above the clamp holder 8 itself, and bearing a retaining tip 12 integral with the piece and projected outwardly through one of its open bases, to its positioning in coincidence with the clamp element 10, inside the guide rail of the intrastromal segment (not visible in the Figure), to serve as a stop element during the repositioning operation of said segment inside the corneal tunnel of the patient. A cover 13 is configured to be coupled to said second end of the main body 1, for the purpose of protecting the manipulator clamp and, where appropriate, preserving the sterility condition of the assembly.

Referring now to Figure 2, there is a schematic representation, in perspective, of the main or base body 1, in which some of the aspects discussed in relation to Figure 1 are visible in greater detail. Thus, in the first place , the relative extension of the threaded area Ib close to the first end of the body, the position of the cavity 3 for housing the arrow, and also the passage of the bolt 5 through the hole 4 made through the interior of the wall can be appreciated perimeter of body 1, coinciding with a longitudinal edge thereof. The Figure also shows the formation of a recess 14 for the purpose of passage and accommodation of an internal circumferential rib 2c, formed integrally with the wheel 2, through which rotational movement is communicated from said crown 2 for transfer to the element of upper clamp 6.

It should also be noted the existence of a perimeter groove 15 made on the outer surface of the body 1 in a position close to the second end of the body, with an entrance access 15a consisting of a surface recess of said wall, intended for the insertion of an internal thickening corresponding liaise formed in the Delhom car part 11, and capable of displacement inside said groove during rotation manual of mentioned piece 11.

Figure 3 is a schematic representation of the manipulator device assembly of Figure 1 in the assembled condition, with all the parts coupled together according to the operative condition thereof, and sectioned by a diametral plane in the longitudinal direction thereof. In the Figure, the cover 2 can be seen coupled by threading to the portion Ib of the main body 1, and also the insertion of the rib 2c in the recess 14 of the bolt 5.

But the most important feature of the graphic representation shown in this Figure 3, is to show the relative positioning of the operating means of the assembly, namely the clamp elements 6, 10, and retaining tip element 12, all they are necessary for the various manipulation operations of an intrastromal segment or ring 16.

Indeed, as shown in the Figure, the lower clamp elements 10 and upper 6, overlap so that together they constitute a gripper for the end of segment 16. The lower clamp portion 10a is constituted as a rail with a configuration such that it is capable of supporting a segment 16 and allowing it to move along its length. Thus, when the wheel 2 is operated, the turning movement is transferred through the bolt 5 to the upper caliper element 6, for the purpose of look for the end of the intrastromal segment 16, and once secured by its extreme groove, exert a traction on it to modify its location and perform its extraction guided by the rail 10a of the lower clamp element 10. On the contrary, with the repositioning of the segment 16 in the corneal tunnel, it is the tip 12 that located on the rail 10a, allows the assembly to be removed while maintaining the segment in its position by exerting a clamping action through the Delhom car part 11.

This situation can be seen more clearly in the larger scale schematic representation shown in Figure 4 of the drawings. In said Figure the upper clamp element 6 is shown positioned above the rail 10a provided by the lower clamp element 10, and also the retaining tip 12 located on said rail as it would correspond to the reinsertion position of a segment 16 supported by said lane 10a. The linkage for releasable coupling between the upper clamp element 6 and said segment or ring 16, is carried out by means of a rib 6a formed integrally with said upper clamp element 6, protruding from the face facing the rail 10a provided by the lower clamp element 10, directed transversely in a predefined intermediate position of the length of said upper clamp element 6, whose transverse rib 6a is shaped and sized to be housed inside a corresponding transverse groove formed at the end of said segment (visible in the Figure, although not referenced for not being the object of this invention).

As mentioned above, the manipulator device of the present invention allows the calibrated, exact action on the clamp means from the wheel 2 rotatably linked to the first end of the main body 1. For this purpose, said wheel has been provided in the crown portion of its base that surrounds the central hole 2b, of a scaling 17. The arrow 4, already housed and fixed in the cavity 3 of the main body 1, indicates a fixed position, so that the operator can have a constant indication that serves as a reference for the various operations.

Similarly, in relation to the aforementioned Figure 3, it can be seen that the arm that supports the upper clamp element 6 is extractable inside a housing indicated with the numerical reference 10b, made in the lower clamp element 10. This configuration ensures relative positional maintenance between both upper and lower clamp elements 6, regardless of any small longitudinal variation that could occur in the bolt 5 as a result of the operation of the wheel 2 on it.

Figure 5 is a schematic plan illustration of the manipulator device assembly seen from the coupling end of the wheel 2 in assembled condition. This representation allows us to appreciate how the different components that make up the manipulator device, allow us to see through the whole the movement of the tweezers and thereby exercise a better control over their activity in relation to different operations. This fact considerably facilitates the use of the manipulator device and provides added value from the point of view of its operational utility. It is not considered necessary to make the content of this description more extensive so that a person skilled in the art can understand its scope and the advantages derived therefrom, as well as carry out the practical realization of its object.

Notwithstanding the foregoing, and since the description made corresponds only to a preferred embodiment, it will be understood that within its essentiality multiple modifications and variations of detail may be introduced, also within the scope of the invention, and that in particular they may affect features such as shape, size or manufacturing materials, or any others that do not alter the invention as described and as defined in the following claims.

Claims

1. - Intrastromal segment manipulator device, in particular a device specially designed and designed for the manipulation of an instraestromal segment or ring (16) that has been previously located inside a patient's corneal tunnel, for the purpose of correction positional of the segment or esplanade and repositioning thereof, the manipulative device being reusable after proper sterilization, characterized in that it is structurally integrated by a set of components such as a main body (1), generally cylindrical and internally hole; a wheel (2) configured for coupling to a first end of said cylindrical main body (1), and made with a wide central opening (2b) at its base; a caliper holder (8), also cylindrical reconstitution, adapted for coupling to a second end of the main body (1) opposite the coupling end of said end wheel (2), and bearing a lower caliper element ( 10); and a Delhom carriage-type part (11), configured for coupling to said second end of the main body (1) above said clamp piece (8), with the possibility of axial rotation with respect to the main body (1) , and carrier of a retention tip (12).

2. - Device according to claim 1, characterized in that said main body (1) has a threaded portion (Ib) in the vicinity of the first end, constituting the coupling portion with said wheel piece (2), with the possibility of relative turn between them.

3. Device according to claims 1 and 2, characterized in that said cylindrical main body (1) includes a longitudinal hole made inside its wall, extended to the total length thereof, and sized to allow housing inside a stem (5) for transfer of rotation movement from said wheel (2) to an upper caliper element (6) intended to form, together with said lower caliper element (10), a releasable gripper means of an intrastromal segment (16) during handling of the same.

4. - Device according to claim 3, characterized in that said bolt (5) has a recess

(14) in the vicinity of one of its ends, for interaction with an inner circumferential rib (2c) of said wheel (2) coupled to the end of the main body

(1), and the opposite end configured to allow the assembly of said upper clamp element (6) and its fixation with the help of some retaining element such as a nut (7).

5. - Device according to one or more of the preceding claims, characterized in that the cylindrical main body (1) includes a cavity (3) made in the inner upper part of its wall in relation to the first end thereof, configured and sized to admit inside an arrow piece (4).

6. - Device according to claim 5, characterized in that said arrow piece (4) adopts a right angle configuration, so that a portion thereof is housed and fixed inside the cavity (3) of the main body ( 1), and another portion, configured as an arrow itself, is positioned above the base surface of said part. wheel (2) extreme.

7. - Device according to claim 1, characterized in that the clip-holder piece (8) includes a perimeter skirt (8a) extended from its outermost edge, above which a raised formation (8b) of the projecting is projected outwards. outer surface of its cylindrical wall, appropriately configured to be housed inside a corresponding recess formed in the inner wall of the body for the purpose of positional immobilization of the piece, and whose skirt (8a) also includes a through hole (9) through from which, with the possibility of rotation, the mentioned movement transfer bolt (5) passes.

8. - Device according to one or more of claims 1 to 7, characterized in that the lower clamp element (10) includes a portion (10a) configured as a rail adapted to move in a movable way to the segment or ring (16) that It is being manipulated.

9. - Device according to one or more of claims 1 to 8, characterized in that the retaining tip (12) integral with the Delhom carriage part (11) is projected outwards in a positionable manner on said rail portion (10a) ) provided by the lower clamp element (10), for the purpose of exerting a stop action on the end of the segment during the reinsertion thereof.

10. - Device according to one or more of claims 1 to 9, characterized in that said upper clamp element (6) is configured so as to have the formation of an integral rib (6a) directed transversely with respect to the longitudinal direction of the upper clamp element to which it belongs, projected from the face facing the rail portion (10a) of the lower clamp element (10), and sized to releasably engage with the end groove of an intrastromal segment or ring (16) during its handling operations.

11. - Device according to one or more of the preceding claims, characterized in that the constituent part of the end wheel (2) has on the surface of its base on which the arrow portion of the part (4) extends, a graduation for control of the operations carried out with the clamp means, serving the arrow portion of the piece (4) as a reference point.

12. - Device according to claims 1 to 11, characterized in that the assembly includes a piece (13) of protective cover, attachable to the second end of the main body (1), for the purpose of protecting the clamp means positionally associated thereto. body end (1).