EP2015708A1

EP2015708A1 - Improved cartridge for an intraocular implant

Info

Publication number: EP2015708A1
Application number: EP06743766A
Authority: EP
Inventors: David Enfrun; Gilles Bos; Stéphane MENDRAS
Original assignee: Xcelens SA
Current assignee: Xcelens SA
Priority date: 2006-05-05
Filing date: 2006-05-05
Publication date: 2009-01-21
Also published as: WO2007128886A1; US20100087833A1

Abstract

A cartridge (4) for an intraocular implant (48) consists of a loading chamber (32) and an injection chamber (30) communicating in a proximal portion of the cartridge (4). The cartridge (4) further includes a piston chamber (50) which has a zone (54) for communication with the loading chamber (32) in a distal portion of the cartridge (4). The piston chamber (50) contains a piston provided with an actuation end (56) arranged to penetrate the loading chamber (32) and to urge an intraocular implant (48) located in the loading chamber (32) through the injection chamber (30). An intraocular implant injector including such a cartridge is also described.

Description

Improved cartridge for intraocular implant.

The present invention relates to an intraocular implant cartridge.

In the context of cataract surgery, it is known to destroy a patient's lens with ultrasound and then remove it with an incision made in the patient's eye. The lens is then replaced by a lens also called "intraocular implant".

The intraocular implants used generally have an optical portion provided with two loops forming a haptic portion for centering the intraocular lens in the capsular bag which contained the lens before it is destroyed.

In order to introduce the intraocular implant into the capsular bag, it is known to place the implant in a so-called "folding" cartridge and to connect it to an injector made in the form of a syringe.

Such operations require extreme precision and the very nature of the eye necessitates extensive asepsis.

The known solutions are complex to implement by their nature and for the satisfaction of the requirements related to this type of operations. The work of the surgeon is complicated, and the sterility chain has some weak points, especially in terms of sterile separation between the elements intended to be in contact with the patient and those having a mechanical role only.

The invention aims to improve the situation.

For this purpose, the application proposes an intraocular implant cartridge, of the type comprising a loading chamber and an injection chamber communicating in a proximal part of the cartridge. This cartridge also has a piston chamber which has a communication zone with the loading chamber in a distal portion of the cartridge, and which receives a piston provided with an actuating end. This actuating end is arranged to penetrate the loading chamber and push an intraocular implant received in the loading chamber through the injection chamber.

Such a cartridge is particularly interesting because it reduces the number of manipulations during the surgical operation. Indeed, as the piston is already received in the cartridge, it is no longer necessary to introduce it at the same time as the implant, which reduces possible handling errors.

Moreover, such a cartridge also improves the sterile insulation because the pre-loaded piston allows to separate the parts that are in contact with the implant on the one hand and the parts that are only intended to allow to inject it on the other hand.

Thus, the only operation that may jeopardize sterility is that of introduction of the implant, and this operation is generally well controlled. In addition, since the surgeon no longer has to deal with the loading of the plunger and the sterility problems that accompany this loading, it can better focus on the rest of the operation.

In various embodiments, the cartridge may have the following characteristics:

the loading chamber and the piston chamber are substantially cylindrical (in the broad sense of cylindrical surface, of any directrix, for example a circle or ellipse) and of substantially identical inner radius (s);

the loading chamber has a frustoconical shape that converges towards the proximal part of the cartridge; at the level of the injection chamber, the loading chamber has a first diameter substantially equal to the diameter of the injection chamber, and, at the level of the piston chamber, a second diameter substantially equal to the diameter of the chamber of piston;

the piston is prepositioned so as to fill the piston chamber substantially completely and to sterilize the cartridge;

the injection chamber has a frustoconical shape diverging towards the loading chamber;

the injection chamber, the loading chamber and the piston chamber are made of polypropylene;

the piston is made of elastomer material;

- The loading chamber has clean wings to cooperate to close the cartridge.

Other features and advantages of the invention will appear better on reading the following description of examples given for illustrative and non-limiting purposes, and from the drawings in which:

Figure 1 shows a perspective view of an intraocular implant injector comprising a cartridge according to the invention;

Figure 2 shows a perspective view of the cartridge of Figure 1 prior to loading the intraocular implant;

- Figure 3 shows a sectional view along the longitudinal axis of the cartridge of Figure 2, after loading an intraocular implant; Figure 4 shows a perspective view of an alternative cartridge; and

FIG. 5 shows a sectional view along the longitudinal axis of the cartridge of FIG. 4.

The drawings and the description below contain, for the most part, elements of a certain character. They can therefore not only serve to better understand the present invention, but also contribute to its definition, if any.

By loading an intraocular implant, its further meaning is its disposition in a folding cartridge and its folding in it. Moreover, an intraocular implant is not arranged alone in the cartridge: it is loaded with its medium, which may be a solution facilitating sliding in the cartridge, for example of the viscoelastic type.

As can be seen in FIG. 1, an intraocular implant injector comprises a folding cartridge 4 housed in an injector body 6. The injector 2 has the general shape of a syringe, that is to say that the body 6 has a generally cylindrical hollow shape which receives a pusher 8, and a pointed end.

The body 6 has at its proximal end a housing 10 which is sized to fixably receive the cartridge 4. The cartridge 4 comprises an injection head 12 which is preceded by a cannula 14.

The cartridge 4 is held in place in the housing 10 by a closing mechanism 16. The closing mechanism 16 may be formed for example by a notch of the housing 10 in which two wings 18 and 20 of the cartridge 4 are housed.

The closing mechanism 16 ensures a locking in translation and rotation of the wings 18 and 20. The wings 18 and 20 are held against each other, and the cartridge 4 can not leave the housing 10. The wings 18 and 20 will be described in more detail using FIGS. 2 and 3.

The body 6 is separated between its proximal portion and its distal portion by a ring 22. The ring 22 extends substantially radially and serves as a finger rest for the forefinger and middle finger of a hand.

The pusher 8 is in the general form of a rod 24 which penetrates the body 6 and whose proximal end is adapted to penetrate a distal end of the cartridge 4. The rod 24 has at its distal end a generally circular head 26 on which the thumb of a hand can press to slide the rod 24 into the body 6.

To inject the intraocular implant into the patient's eye, the surgeon begins by folding the intraocular implant into the cartridge 4 as will be described hereinafter. He then fixes the cartridge 4 in the housing 10 of the body 6.

Finally, the surgeon presses the head 26 with his thumb while holding the finger support 22 with his middle finger and his index finger, and slides the rod 24 until the proximal end of the rod 24 penetrates the cartridge 4 to inject the intraocular implant.

In the example described here, the body 6 and the pusher 8 are made by molding any plastic material, and the cartridge 4 is made by molding polypropylene. Preferably, the polypropylene used to mold the cartridge 4 is without additive element and is of medical grade, but other types of polypropylene may be suitable.

The skilled person will appreciate that there is a wide variety of injectors. It will be understood in particular that the only requirements with regard to the injector concern the compatibility in terms of reception and maintenance of the cartridge, and the presence of a pusher having an end for pushing the prepositioned piston into the cartridge.

Cartridge 4 can take two extreme positions:

- An extended position, out of the body 6, shown in Figure 2, wherein the cartridge 4 is adapted to receive an intraocular implant for loading (folding) thereof;

- A closed position, shown in longitudinal section in Figure 3, wherein the cartridge 4 contains an intraocular implant and is adapted to be mounted on the injector 2 to inject the implant.

As can be seen in Figure 2, the cartridge 4 has an injection chamber 30 in its proximal portion. The injection chamber 30 is formed by the injection head 12 and the cannula 14. The injection head 12 has a generally frustoconical shape converging towards the proximal end of the cartridge 4, cut by a plane thus forming an end beveled at about 45 °.

The end of the cartridge 4 thus has a profile particularly suitable for injection of the implant, in the manner of the head of a syringe. Depending on the application, the angle of the bevel formed by this end may vary.

The cannula 14 has a generally frustoconical external shape that converges towards the proximal end of the cartridge 4. Along its longitudinal axis, the cannula 14 is pierced with a frustoconical bore that guides the intraocular implant during its injection. In addition, this bore allows a progressive winding of the implant which reduces its size at the injection head 16, and therefore the size of the incision required to perform the injection.

In its distal portion, the injection chamber 30 is connected to a loading chamber 32 which is shown deployed in FIG. a communication end 34 and two open channels 36 and 38. The channels 36 and 38 have complementary shapes, so as to form a closed loading channel 40 (see Figure 3) when the cartridge 4 is closed.

The channels 36 and 38 are extended respectively by the wing 18 and the wing 20, which allow the deployment and closure of the cartridge 4 by bringing them together or spacing them. In the embodiment described, the channel 38 and its flange 20 are pivotally mounted relative to the channel 36 and its flange 18 by means of a hinge 42. The maintenance of the cartridge 4 in its closed position is provided by the mechanism closure 16 of the body 6.

In order to avoid jamming of the intraocular implant between the wings 18 and 20 during the closure of the cartridge 4, the wing 18 has a projecting portion 44 and the wing 20 has a housing 46 homologous to the projecting portion 44 .

The cooperation of the projecting portion 44 and the housing 46 further allows the wings 18 and 20 to be centered relative to each other when the cartridge 4 is closed. The centering thus produced makes it possible to ensure better folding. intraocular implant, and good symmetry for channel 40.

The folding of the implant is performed by positioning it in the chamber 42 when it is in the extended position, and closing the chamber 32 by bringing the wings 18 and 20 closer together until the protruding portion 44 is housed in the housing 46.

Numerous variants will be apparent to those skilled in the art to make the channels 36 and 38 pivotally relative to each other using the wings 18 and 20.

The inner shape of the channels 36 and 38 determines how the intraocular implant will bend upon closure of the cartridge 4, as well as the subsequent injection of the intraocular implant through the injection chamber. The intraocular implant is folded by winding around itself because of the shape that is given to the channels 36 and 38. It then has the general shape of the implant 48 shown in FIG.

The outer casing of the channel 40 formed by the joining of the channels 36 and 38 is generally cylindrical, and the wings 18 and 20 have a generally rectangular shape, the wing 18 being smaller than the wing 20 to facilitate the opening of the cartridge 4. Here again, many variants will appear to those skilled in the art for the opening and closing of the cartridge 4.

In the distal portion of the cartridge 4, the loading chamber 32 is connected to a piston chamber 50 which receives a piston 52. As can be seen in FIG. 3, the piston chamber 50 has a communication zone 54 which communicates with the loading chamber 42.

As mentioned above, the closed channel 40 has a shape determined by that of the channels 36 and 38. This shape is rather close to that of a cylinder, without necessarily being exactly cylindrical, and the internal diameter d1 of the channel 40 is equal to about 3 mm. The piston chamber 50 is generally cylindrical in shape with a bore of diameter equal to that of the channel 40.

The piston 52 is made of elastomer and can be made generally in any elastomeric material which has adequate deformability. The piston 52 is generally cylindrical in shape, with a diameter slightly greater than the internal diameter of the piston chamber 50, so that the piston 52 fills the latter in a sealed manner.

When the surgeon presses the pusher 8 of the injector 2, the end thereof pushes the piston 52 from the rear through the piston chamber 50. The piston 52 progressively passes a communication zone 54, and then enters the loading chamber 32, until an actuating end 56 of the piston 52 The intraocular implant 48 and the surrounding medium are pushed through the injection chamber 30 and into the capsular bag of the patient's eye.

The piston chamber 50 and the piston 52 of the invention thus allow a sterile isolation of the cartridge 4 with the rest of the injector 2. Thus, the surgeon no longer has to worry about this aspect, and he can devote to the operation itself.

In addition, the integration of the piston chamber 50 with the piston 52 ensures that the intraocular implant 48 can not lock between the channel 40 and the piston 52 during its loading. The embodiment of the piston 52 also ensures an optimal and facilitated thrust of the intraocular implant 48 and its medium.

Finally, the cartridge 4 being made of polypropylene, the thickness of the piston chamber 50 protects the piston 52 against ambient light radiation which could alter its deformation properties. The cartridge 4 can therefore be stored relatively long without the piston 52 is so deteriorated as to become unusable.

Figure 4 shows an alternative cartridge which has other advantages. As seen in this figure, the loading chamber 32 is made differently.

Thus, the channels 36 and 38 have been modified so that, once the cartridge 4 is closed, the channel 40 is no longer substantially cylindrical but frustoconical converging towards the proximal part of the cartridge 4. The frustoconical shape of the channel 40 makes it possible to guide and wrap the intraocular implant as described above.

As can be seen in FIG. 5, the channel 40 thus has a diameter d1 equal to that of the piston chamber 50 at the level of the latter, and a diameter d2 substantially equal to 2.5 mm at the level of the chamber Injection 30

In the example shown, the diameter d2 is slightly smaller than the diameter d3 of the injection chamber 30 in the region in which the loading chamber 32 communicates with the injection chamber 30. The diameter d2 may be equal to the diameter d3.

In addition, the wings 18 and 20 are made differently in this variant. The wings 18 and 20 are always of generally rectangular shape, but they are identical in this embodiment, and arranged in mirror with respect to each other.

The wings 18 and 20 each comprise, in their most eccentric region with respect to the channel 40, an engagement portion 64 which extends between one of the edges of the rectangle and the middle thereof.

At its end in the middle of the rectangle, each engagement portion 64 is provided with a lug 62 which extends towards the wing opposite it. Thus, when the wings 18 and 20 are folded against each other, the lugs 62 of each wing cooperate resiliently to form a closure "portfolio", and maintain the cartridge 4 in its closed position.

The description of the above embodiment is given to allow a better understanding of the invention. The scope of the latter should not however be limited to this embodiment, but it encompasses all the variants that the skilled person will consider, and is defined by the appended claims.

Claims

claims

1. Cartridge (4) for intraocular implant (48), of the type comprising a loading chamber (32) and an injection chamber (30) communicating in a proximal portion of the cartridge (4), characterized in that it further comprises a piston chamber (50) having a communication zone (54) with the loading chamber (32) in a distal portion of the cartridge (4), said piston chamber (50) receiving a piston (52) provided with an actuating end (56), which actuating end (56) is arranged to penetrate the loading chamber (32) and urging an intraocular implant (48) received in the loading chamber (32) through the chamber injection molding (30).

2. Cartridge according to claim 1, characterized in that the loading chamber (32) and the piston chamber (50) are substantially cylindrical, and of substantially identical inner radius (d1).

3. Cartridge according to claim 1, characterized in that characterized in that the loading chamber (32) has a frustoconical shape converging towards the proximal portion of the cartridge (4).

Cartridge according to claim 3, characterized in that, at the injection chamber (30), the loading chamber (32) has a first diameter (d2) substantially equal to the diameter of the injection chamber ( 30), and at the piston chamber (50) a second diameter (d1) substantially equal to the diameter of the piston chamber (50).

5. Cartridge according to one of the preceding claims, characterized in that the piston (52) is prepositioned so as to fill the piston chamber (50) substantially completely and sterilely isolate the cartridge (4).

6. Cartridge according to one of the preceding claims, characterized in that the injection chamber (30) has a frustoconical shape diverging towards the chamber of loading (32).

7. Cartridge according to one of the preceding claims, characterized in that the injection chamber (30), the loading chamber (32) and the piston chamber (50) are made of polypropylene.

8. Cartridge according to one of the preceding claims, characterized in that the piston (52) is elastomeric material.

9. Cartridge according to one of the preceding claims, characterized in that the loading chamber (32) comprises wings (18, 20) adapted to cooperate to close the cartridge (4).

Injector (2) intraocular implant (48), of the type comprising a body (6) receiving a hollow pusher (8), and receiving at a proximal end a cartridge

(4) according to one of the preceding claims, characterized in that the pusher (8) has a thrust end, arranged to push the piston

(52) received the piston chamber (50) through the loading chamber (32).