WO2010028873A1

WO2010028873A1 - Intraocular lens injection system comprising an injector with a cartridge and a loading device

Info

Publication number: WO2010028873A1
Application number: PCT/EP2009/058222
Authority: WO
Inventors: Patrick Meunier; Jean-Marc Le Pair
Original assignee: Patrick Meunier; Jean-Marc Le Pair
Priority date: 2008-09-11
Filing date: 2009-06-30
Publication date: 2010-03-18
Also published as: EP2344073A1; FR2935606A1; FR2935606B1

Abstract

The present invention relates to an injection system for injecting a flexible intraocular lens into the eye, comprising an injection device (1) including a tubular injection body (10) equipped with an injection cartridge (20) and a plunger (11), and a loading device (3) to load a lens in said injection cartridge that comprises a tubular rolling body (4) with a section (43) for receiving a lens (9) in a non-folded state and a truncated rolling section (44), said rolling body being capable to be removeably engaged, obliquely, in a longitudinal slot (103) of the injection body, such that the truncated rolling section opens onto the receiving chamber (21) of the cartridge, and a plunger (6) to push a lens, positioned in the receiving section, through the truncated rolling section, in order to progressively roll it up, then into the receiving chamber.

Description

INTRAOCULAR LENS INJECTION SYSTEM COMPRISING AN INJECTOR WITH A CARTRIDGE AND A LOADING DEVICE

The present invention relates to an injection system for injecting a flexible intraocular lens into the eye of a patient, said system comprising an injection device or injector with an injection cartridge, and a loading device for loading a lens in said injection cartridge, said loading device serving as a support for the packaging of a flexible intraocular lens before use. Intraocular lenses (IOL) are used for replacing the natural crystalline lens of a cataract-affected eye. The extraction of the natural crystalline lens and its replacement by an intraocular lens are done surgically. With the emergence of the surgical method using phacoemulsification of the natural crystalline lens, it has been proposed to use intraocular lenses made of flexible and foldable material so that they can be inserted in folded form into the eye by means of a small incision. This insertion of the intraocular lens into the eye is generally done by means of a syringe-type injection system also called injector, comprising a tubular body equipped with a piston whereon a disposable injection cartridge is removeably mounted. The injection cartridge comprises a lens-receiving chamber extended by a cannula, the receiving chamber being formed by two half-tubes connected by a hinge, each tube being provided with a flap for closing the receiving chamber. After placing a lens from a sterile packaging into the open chamber by means of an instrument such as a set of forceps, it is then pre-folded by the closing of the chamber, the cartridge is placed in the tubular body of the injector. The injection of the folded intraocular lens in the cartridge is then done mechanically or hydraulically by actuating the piston after the distal end of the cannula has been inserted into the eye. To facilitate the transfer of the intraocular lens to the lens- injection cartridge, document EP 1 173 115 has proposed a device for loading a lens into the open receiving chamber of an injection cartridge, the device being formed by a first support system capable of receiving an injection cartridge and of keeping its receiving chamber in an open position and a second support system capable of holding an intraocular lens. The two systems work together to enable the transfer of the cartridge in an open and flat position on the second support system, the second support system being then folded to transfer the intraocular lens into the receiving chamber and enable the cartridge to be removed from the second support by hand. Then the receiving chamber is closed by hand. The two support systems are designed to be disposable and also serve as systems for packaging the cartridge and the lens before use.

The aim of the present invention is to propose a novel injection system comprising a loading device of a flexible intraocular lens into an injection cartridge that is simple in its design and use. To this end, an object of the present invention is an injection system for injecting a flexible intraocular lens into the eye of a patient, comprising

- an injection device including

- a tubular injection body provided with a longitudinal opening or slot,

- an injection cartridge comprising an intraocular lens-receiving chamber, provided with an open proximal end, extended by a cannula fitted with an open distal end, said injection cartridge being capable of being mounted on said injection body, - a plunger comprising a rod moveably mounted in said injection body, capable of being moved from a retracted position towards an injection position to push the lens at a pre-folded state and positioned in the receiving chamber into the cannula and inject it into the eye, and

- a loading device capable of loading a flexible intraocular lens in said injection cartridge in a pre-folded state, characterized in that said loading device comprises

- a tubular rolling body or system having an open distal end, an open proximal aperture, and an inner passage, said inner passage comprising a receiving section capable of receiving a lens in a non- folded state, and a rolling or folding truncated section, said rolling body being capable of being, partially, obliquely, and removeably engaged in said longitudinal slot of the injection body, in a so-called mounted position, when the plunger of the injection device is in retracted position, such that the rolling truncated section opens onto the receiving chamber of the injection cartridge mounted on the injection body, its distal end portion abutting against the open proximal end of the receiving chamber of the cartridge, the main longitudinal axis of the rolling body being inclined with respect to the main longitudinal axis of the injection body, and

- a plunger comprising a rod moveably mounted in said inner passage of the rolling body, capable of pushing a lens positioned in the receiving section through the truncated rolling section to progressively roll-up or fold said lens, then in the receiving chamber of an injection cartridge.

According to the invention, the injection system comprises a loading device directly adaptable on the injection body of an injection device already equipped with an injection cartridge, the loading device allowing, by a simple mechanical pushing operation, to progressively fold the flexible intraocular lens initially in a non-folded state and to introduce it directly in its pre-folded state into an injection cartridge. After loading the lens into the cartridge, the loading device is withdrawn from the injection device, the latter thus being usable classically for injecting the lens into the eye of a patient.

The folding of the lens in the cartridge, then the insertion thereof into the eye do not require any particular manual manipulation, contrary to the use of a standard cartridge, the loading device according to the invention advantageously serves as a support for the packaging of the lens. According to an embodiment, the injection system comprises a loading device including a flexible intraocular lens pre-loaded in the receiving section of the rolling body. According to an embo diment, said inj ection device advantageously comprises an injection cartridge capable of being moveably mounted on said injection body.

According to an embodiment, said injection cartridge comprises on its outer wall at least one longitudinal flap extending radially outwards, said longitudinal slot of the injection body comprising a first part allowing for the insertion of the cartridge into the inner passage of the injection body and extending by a second part for receiving said longitudinal flap in order to rotationally block said cartridge, said rolling body being capable of getting partially inserted in said injection body by said first opening. The loading device using a simple pushing operation for folding and loading the lens, make it possible to use easy to produce injection cartridges with no moveable part.

According to another embodiment, the cartridge is fixedly mounted on the injection body, the injection body and the cartridge being formed from a unique, single-piece.

According to a feature, the loading device is equipped with holding means capable of holding, preferably by clip-fastening, said rolling body in the mounted position on the injection body of the injection device. According to an embodiment, said holding means comprise a rib formed on the outer wall of the rolling body getting inserted in said longitudinal slot and coming at least against the upstream edge of said longitudinal slot in the mounted position, advantageously, said rib has a general U shape, its base coming against said front edge, the two arms of the U-shape coming against the longitudinal edges of said slot. According to an embodiment, said holding means comprise at least two lateral elastic legs capable of being clip-fastened elastically on either side of the injection body.

Advantageously, to ensure the alignment of the loading device with the injection device, and thus ensure a correct loading of the lens, the distal end portion of the rolling body is capable to be partially inserted in the receiving chamber of the injection cartridge in the mounted position of the loading device. According to an embodiment, the receiving chamber comprises a truncated section delimited on one side by the open proximal end of the receiving chamber and extending on the other side by a cylindrical section.

According to a feature, the rod of the plunger of the loading device comprises a deformable endpiece in elastomeric material, said endpiece being capable of deforming so as to partially penetrate into at least the receiving chamber of the cartridge in the loading position of the plunger.

According to another feature, the rod of the plunger of the loading device comprises an endpiece exhibiting at its distal end a horizontal tab intended to support the trailing haptic of a lens in the retracted position of the plunger, said distal end of the endpiece exhibiting an upper convex wall for the folding of said trailing haptic and a lower concave wall for pushing the lens during the handling of the plunger towards its loading position.

Advantageously, the loading device further comprises a removable blocking system capable of longitudinally blocking the plunger in retracted position and/or a lens in the receiving section of the inner passage of the rolling body.

According to another feature, the inner passage of the rolling body exhibits two lower longitudinal shoulders whereon a pre-loaded lens may rest, combined with two upper longitudinal shoulders extending along the rolling section, against which the lens abuts when pushed, said upper shoulders serving to guide the pre-folding or pre- rolling of the lens.

An object of the present invention is also a loading device such as described previously, being adaptable on an injection device, comprising an endpiece fitted with said folding upper convex wall of the trailing haptic and/or made of an elastomeric material.

The invention will be better understood, and other objects, details, characteristics and advantages will become more apparent in the following detailed explanatory description of two currently-preferred particular embodiments of the invention, with reference to the accompanying schematic drawings, wherein:

- Fig. l is a perspective view of an injection system according tothe invention comprising an injection device and a loading device, the loading device being in mounted position on the injection device, and equipped with its blocking system or blocker for blocking its plunger in retracted position and blocking the lens, the loading device comprising a tubular rolling body according to a first embodiment;

- Fig.2 is a perspective view of the device of fig. l, after withdrawal of the blocker; - Fig. 3 is a perspective view of the device of fig.1 , the plunger of the loading system in loading position;

- Fig.4 is a longitudinal cross-sectional view of the injection device, without the loading device, said injection device comprising the injection body equipped with the plunger and an injection cartridge; - Fig.5 is a longitudinal cross-sectional view of the injection system of fig. 1, the injection device being equipped with the loading device with its plunger in retracted position;

- Fig.6 is an analogous view to that of fig.5, the plunger of the loading device in the loading position;

- Figs. 7 A, 7B, and 7C are perspective views of the tubular rolling body of the loading device of the injection system of fig. 1;

- Figs. 8A and 8B are perspective views of the two pieces constituting the plunger of the loading device of fig. 1; - Figs. 9A, 9B and 9C are respectively a side view and two perspective views of the rod endpiece of the loading device plunger of

% i;

- Fig.10 is a perspective view of the blocking system of the loading device of fig.1 ; - Figs.1 1 and 12 are respectively transversal cross-sectional views according to cutting planes XI-XI and XII-XII of fig.5;

- Fig. 13 is a partial view according to cutting plane XIII-XIII of fig.5;

- Fig. 14A is a schematic top view illustrating the positioning of the intraocular lens with respect to the endpiece of the plunger rod with the plunger in retracted position;

- Fig. 14B is an analogous view to that of fig. l4A illustrating the folding operation of the intraocular lens haptic at the start of the moving of plunger towards its loading position; - Figs. 15 and 16 are perspective views of a rolling body of a loading device according to a second embodiment of the invention, said rolling body being formed by a first tubular piece and a second tubular piece assembled together;

- Figs. 17 and 18 are perspective views of the first tubular piece and the second tubular piece constituting the rolling body of figs. 15 and

16;

- Fig 19 is a perspective view of the first tubular piece of fig 17 mounted on a injection device equipped with a cartridge;

- Fig. 20 is a perspective view of the second tubular piece of fig. 18 equipped with a plunger; - Fig. 21 is a perspective view of a blocker of the loading system according to the second embodiment; and,

- Fig. 22 is a perspective view of the second tubular piece equipped with the plunger and the blocker of fig. 18. With reference to fig.1 , the injection system according to the invention comprises an injection device 1, also called injector, comprising a tubular injection body 10, called injection body, a plunger 11, and an injection cartridge 20, which, in this embodiment, may be removeably mounted on said injection body, as well as a loading device 3 able to be removeably mounted on the injection device to load a lens in the injection cartridge mounted on said injection body.

With particular reference to figs. 1 and 4, the injection device is in the form of a syringe-type device. It includes an injection body 10, with an open proximal end 101 , an open distal end 102, and an inner passage 105 with a longitudinal axis A. A rod 1 1 1 of plunger 1 1 is slidingly mounted in the inner passage of the injection body, by its open proximal end 101. The rod is equipped at its distal end with an endpiece 112 and at its proximal end with an operating knob 113. The injection body 10 is fitted with a slot or longitudinal opening 103 for moveably mounting an injection cartridge 20, as well as, according to the invention, for moveably mounting the loading device 3, such as described hereafter.

The injection cartridge 20 is of a single-piece type, with no moveable flaps. The cartridge comprises a chamber 21 for receiving the pre-folded or pre -rolled lens, extended by a cannula 23 for injecting the folded lens. The receiving chamber and cannula are formed of a unique single -piece tube 22. The receiving chamber comprises a truncated section 211 delimited on one side by the inlet hole 21a of the receiving chamber, also called open proximal end, and extending on the other side by a cylindrical section 212. The injection cannula 23 comprises an inner channel 231 positioned in the extension of the cylindrical section 212 and exhibiting an inner diameter that gradually decreases in the direction of the open distal end 22a of the cannula for the additional folding or stretching of the lens prior to injection into the eye. The distal end is advantageously beveled to facilitate the insertion of the cannula into the eye. On its outer wall, the tube comprises a rectangular longitudinal flap 24 extending radially outwards.

The longitudinal slot 103 of the tubular injection body extends from an upstream edge 131 to a downstream edge 132 and comprises one first portion 103a, of great width, that begins from said upstream edge and extends by a second portion 103b called of small width that extends on an angular section lower than the first portion. The first portion extends on an angular sector sufficient to allow the insertion of tube 22 of the cartridge in the inner passage 105, the second portion allowing the passage of the cartridge flap. The mounting of the cartridge on said injection body is carried out by inserting the cartridge in the inner passage 105 by the first portion 103a of the slot, by holding it by its flap, then by moving it towards the distal end 102, the flap coming to be inserted in the second portion of the slot. In mounted position, the flap is in abutment against the downstream edge 132, and the cartridge cannula is positioned beyond the distal end 102 of the injection body.

Two diametrically opposed legs 106, extending radially outwards, are provided on the outer wall of the body, on the side of its proximal end 101, to form supporting surfaces for actuating the plunger between a retracted position, illustrated in fig.4, towards a so-called injection position, to push, via its endpiece 112, a lens at its pre-folded state positioned in the receiving chamber in the cannula, then injecting it into the eye of a patient.

The loading device 3 according to the invention associated to the injection device 1 allows to load a lens, initially in a non- folded state in the receiving chamber of the cartridge, in a pre-folded state, when said cartridge is in mounted position on the injection body.

With reference to figs. 1, 5, 7A-7C, the loading device 3 comprises a tubular body or system 4, so-called rolling body, comprising an inner passage 40 with a longitudinal axis B, wherein is slidingly mounted, by the open proximal end 41, the rod 61 of a plunger 6. According to fig. 5, the inner passage 40 comprises, from its open proximal end 41 to its open distal end 42, a first so-called receiving section 43, of substantially constant transversal section, of mainly elliptical form, to receive a lens 9 at the deployed or unfolded state, extending by a second truncated section 44, called a folding section, whereof the transversal section, also of mainly elliptical form, gets reduced in the direction of the open distal end.

As better shown on fig.11 , the inner wall of the inner passage exhibits at the receiving section 43 two longitudinal shoulders 45, called lower shoulders, whereon a pre-loaded intraocular lens 9 may rest. The inner wall of the inner passage further comprises two upper longitudinal shoulders 46 extending along the folding section, against which the lens abuts when pushed, said upper shoulders serving to guide the pre-folding or pre-rolling of the lens. The rolling body is capable of being partially engaged, obliquely in said first portion 103a of the longitudinal slot in a so-called mounted position, wherein the distal end portion 47 of said rolling body that is fitted with said open distal end is against the open proximal end 21a of the receiving chamber, such as illustrated in fig.5, such that the folding truncated section opens onto the receiving chamber of the injection cartridge.

In this mounted position, the rolling body is positioned obliquely with respect to the injection body, axis B of its inner passage 40 being inclined with respect to axis A of the inner passage 105 of the injection body, axes A and B forming for example an angle comprised between 10 and 35°, preferably between 15 and 20°, for example around 16°.

In the present embodiment, the distal end portion of the body is externally sized such that it may be inserted in the cartridge receiving chamber, the open distal end 42 of the rolling body thus being positioned in the receiving chamber. With reference to figs. 7A to 1C, the distal end portion externally exhibits a lower rib 49, as well as reduced thickness 48 forming an upper shoulder 48a. In the mounted position, the distal end portion 47 gets inserted in the truncated section 211, its shoulder 48a and its rib 49 coming against the cartridge 20 around the open proximal end 21 a of the receiving chamber. From the open distal end to the shoulder and rib, the distal end portion exhibits an external shape that is defined to match that of truncated section 211. Such as illustrated on fig.5, the folding section of the inner passage may be slightly curved upwards at this distal end portion. To ensure the holding of the loading device on the injection body in this mounted position, the rolling body is fitted with two lateral elastic legs 50 coming to get clipped on either side of the injection body. The legs are fitted with internal concave supporting surfaces 51. When the rolling body is inserted in the slot 103, the elastic legs get slightly deformed and its concave supporting surfaces come against the external wall of the tubular injection body. The rolling body further comprises a mainly U-shaped rib 52 whereof the base 53 penetrates into the slot 103 and comes in abutment with the upstream edge 131 of the slot, the arms 54 of the U shape also penetrating into the slot along the longitudinal edges 131a of the first portion 103a of the slot. In mounted position, the tube is in abutment by the shoulder 48a and rib 49 with the cartridge, and in abutment by the base 53 of the rib with the upstream edge 131 of the slot. Moreover, said longitudinal edges are found to be pinched between said arms 54 of the U-shaped rib and the elastic legs 50.

The rib 52 is advantageously fitted at its base with a pin 57 extending into the inner passage 105 of the injection body and serving as a stopper to the plunger rod of the injection device, in order to prevent said plunger from moving towards its injection position when the loading device is mounted on the injection device.

With reference to figs. 5, 8A and 8B, the plunger 6 comprises a rod 61 that can be actuated by an operating system from a retracted position towards a loading position. The rod 61 is formed by a rigid body 62 equipped at its proximal end with an operating system and at its distal end with an anti-rotation system 621 whereon a deformable endpiece 63 (figs. 5 and 9A to 9C), made of elastomeric material is mounted. The operating system is formed by two pieces assembled together, one first U-shaped piece 64 comprising two parallel arms 641 connected to each other by a base 642 whereto the rod is fixed by its proximal end, parallely to the arms. This first U-shaped piece is fixed inside a second U-shaped piece 65, the external faces of the arms 641 and of the base 642 of the first piece 64 against respectively the internal faces of the arms 651 and of the base 652 of the second piece. This second piece further comprises an upper stiffening wall 653 extending between the upper arms.

The plunger is slidingly mounted by the operating system on the rolling body. The internal faces of the arms 641 of the first piece comprise longitudinal ribs 643 of dovetail-shaped transversal section coming to engage themselves in the corresponding lateral longitudinal dovetail grooves 55 provided on the rolling body. The arms fitted with ribs extend beyond the endpiece 63 such as to guide the insertion of the endpiece into the inner passage during the mounting of the plunger on the rolling body in a so-called retracted position illustrated in fig. 5.

The rolling body exhibits two catches 56 behind which plunger catches 654, formed on the internal face of the stiffening wall 653 of the second piece, come to interlock, such as illustrated on fig. 13, to prevent the accidental withdrawal of the plunger after mounting it on the rolling body.

The loading device may be used for loading a lens 9 comprising an optical part 91 and a haptic part, constituted for example of two lateral haptics 92, 93 such as illustrated in fig 14A. The lens is positioned in the receiving section, in front of the plunger endpiece in retracted position, and rests on its optical part on the lower shoulders 45.

The plunger is moveable from the retracted position towards a loading position illustrated in fig.6 wherein the endpiece is capable of pushing the lens into the receiving chamber of the cartridge. In the present embodiment, the endpiece partially penetrates into the receiving chamber of the cartridge. In order to enable this movement, the upper wall of the plunger exhibits a central opening 655.

Advantageously, with reference to figs 9A to 9C, the endpiece 63 exhibits at its distal end a horizontal tab 631, positioned above the longitudinal axis C of the endpiece. Above said tab, the substantially vertical wall of the distal end exhibits a convex shape, called upper convex wall 632. Below said tab, the substantially vertical wall of the distal end exhibits a concave shape, called lower concave wall 633, the bottom of this lower concave wall being substantially positioned vertically from the end or top of the upper convex wall. The endpiece exhibits longitudinal grooves 634 corresponding to the upper shoulders 56.

In the retracted position of the plunger, one of the haptics of the lens 9, called trailing haptic 92, is placed on the tab such as illustrated in fig 14 A. At the beginning of the movement of the plunger towards its loading position, the upper convex wall 632, against which the trailing haptic abuts serves to guide the rolling of the trailing haptic above the optical part such as illustrated in fig. 14B. Then, the lens is pushed by the lower concave wall 633 in contact with its optical part.

The loading device further comprises a blocking system 8, called blocker, making it possible to block the plunger in retracted position and to lock the lens in position in the receiving section.

According to the fig.10, the blocker 8 comprises a central plate 80 fitted with two pins 81 capable of getting engaged in lateral recesses 656 (fig. 8A) provided on the longitudinal edges of the opening 655 of the wall 653, when the plunger is in retracted position. The plate further comprises two pins 82 able to engage in holes 58 of the rolling body opening onto the receiving section of the inner passage such that the pins come to position themselves on either side of the optical part of the lens positioned in the receiving section, each pin coming to be intercalated between the optical part and a haptic. The holding of the blocker on the rolling body is ensured by two lateral elastic legs 83 fitted in their lower part with a rib 84 coming to be clipped under the lower edge of the arms 651 of the second piece of the plunger. The legs exhibit upper parts 85 extending above the central plate and serving as supporting surfaces to facilitate the placing and withdrawal of the blocker. Presently, a description of the use of the system according to the invention will be carried out.

First, an intraocular lens 9, comprising for example an optical part 91 and two haptics 92, 93, is placed in the receiving section 43 of the inner passage 40 of the rolling body 4 by the open proximal end 41, then the plunger 6 is mounted on the rolling body in retracted position, by engaging and sliding the ribs 643 of the plunger in the corresponding grooves 55 of the rolling body. During the insertion of the rod 61 into the inner passage 40, the trailing haptic 92 of the lens is brought onto the tab 631 of the endpiece 63. The blocker 8 is then mounted on the rolling body in order to block the lens 9 and to block the plunger 6 in retracted position.

The injection cartridge is mounted on the injection body 10, and the rolling body is mounted on the injection body, such as shown particularly in fig. 1. The pre-charged lens loading device, equipped with its blocker, and mounted on the injection device, such as shown in fig.1, are sterilized together and placed in a sterile container for the storage, transportation and commercial distribution. The lens in the non-folded state is radially held between the upper 46 and lower 45 shoulders, and longitudinally by pins 82.

For the loading of the lens into the injection cartridge 20, the blocker is first withdrawn, such as shown in fig. 2. The practitioner can then inject a viscoelastic agent through holes 58 of the rolling body then mechanically introduce the lens into the injection cartridge by actuating the plunger 6 towards its loading position. During the forward movement of the plunger, the trailing haptic 92 is folded above the optical part 91 of the lens by the upper convex wall 632 of the endpiece, then the lens is pushed by the lower concave wall 633 into the receiving chamber. Once the cartridge loaded, the loading device is withdrawn from the injection device, the latter thus being classically used for the insertion of the lens into the eye of the patient by a small incision, by pushing the plunger 11 of the injection device.

According to another embodiment, the loading device is not mounted on the injection device for their storage and commercial distribution, the two devices may be accordingly placed in separate sterile containers after a sterilizing operation. According to an alternative embodiment, the injection device comprises a so-called classic cartridge, with moveable flaps, wherein the receiving chamber is formed by two semi-circular section half-tubes, connected by a hinge-forming linking line, each tube being fitted with a flap to allow the closing and opening of the chamber. Placing the cartridge on the body is carried out after having brought the two flaps towards each other to close the injection chamber.

In the embodiment described in reference with Fig. 1 to 14B, the tubular rolling body of the loading device is formed of a unique tubular single -piece. Advantageously, the cartridge and/or the rolling body comprise a gliding agent and/or a gliding coating so as to facilitate the folding of the lens. A gliding agent can be incorporated into the material constituting the rolling body and/or the cartridge, and/or a gliding agent can be applied onto the surfaces of the rolling body and/or the cartridge into which the lens comes into contact during the folding. Preferably, the rolling body and/or the injection cartridge are made of material, for example Polypropylene, including a gliding agent, for a example a Glycero Mono Stearate, or coated with a gliding coating, for example a Hyaluronate or Polyvinylpyrrolidone based polymer.

The hydrophobic intraocular lenses are usually stored in sterilized atmosphere, contrary to the hydrophilic intraocular lenses which are usually stored in a aqueous solution. In the case of a hydrophobic intraocular lens, the loading device pre-loaded with a hydrophobic lens fitted with its blocker, and mounted on the injection device, can be positioned in a container, with no risk of transfer of the gliding agent or gliding coating from the rolling body and the cartridge to the hydrophobic lens.

Fig. 15 to 22 illustrate a second embodiment of the invention in which the rolling body 104 of the loading device is formed of two distinct tubular pieces 104a, 104b. With reference to fig 15 to 18, the rolling body 104 comprises a first tubular piece 104a, whereof the internal passage 140a forms a truncated section 144, as previously described, and a second tubular piece 104b, whereof the internal passage forms a lens-receiving section 143, as previously described. The internal passage 104a of the first tubular piece extends from a first end 141a to a second end 142a which constitutes the open distal end of the rolling body. The internal passage 140b of the second tubular piece extends from a first end 141b, which constitutes the proximal end of the rolling body, to a second end 142a. With reference to fig. 17, the first tubular piece 104a has a support tongue 171 extending longitudinally rearwards from its first end 141a, onto which the second tubular piece 104b is capable to be positioned such that the longitudinal axis of the internal passages 140a, 140b are aligned, with the second end 142b of the second tubular piece substantially in contact with the first end 141a of the first tubular piece. The second tubular piece comprises holding means capable of cooperating with complementary holding means of the first tubular piece in order to ensure a correct longitudinal and transversal position of the second tubular piece on the first tubular piece. The second tubular piece is provided with two lateral legs 172 coming against the lateral edges 171a of the tongue, and a lower lug 173 getting inserted in an opening 174 of the tongue 171.

As illustrated in fig. 19, the first tubular piece is sized to be removably engaged in the longitudinal slot 103 of an injection device 1, with the truncated section 144 opening onto the receiving chamber of the injection cartridge 20 mounted on the injection body, as the rolling body 4 previously described. The first tubular piece is provided with two lateral elastic legs 150 coming to get clipped on either side of the injection body to ensure its holding on the injection body in this mounted position.

The legs 172 of the second tubular piece are provided with lateral longitudinal dovetail grooves 155b for the slidingly mounting of a plunger 6, as previously described.

The plunger can be mounted on the second tubular piece in its retracted position, as illustrated in fig. 20, the second tubular piece having two catches 156 to prevent accidental withdrawal of the plunger.

The first tubular piece also has longitudinal lateral longitudinal dovetail grooves 155a which are positioned in the extension of that of the second tubular piece when the two tubular pieces are assembled together, for the displacement of the plunger towards its loading position in order to push the lens into the receiving chamber of the cartridge.

With reference to fig. 21, a blocker 108 can be mounted on the second tubular piece to block the plunger in retracted position and the lens in the receiving section. The blocker comprises a central plate 180 provided with two lateral pins 181 capable of getting engaged in lateral recesses 656 of the plunger 6, and two lower pins 182 able to engage in holes 158 of the second tubular piece. The plate 180 is also provided with a front transversal wall 186 coming against the second end 142b so as to close the internal passage and to ensure the holding of the blocker on the second tubular piece. A leg 187 is also provided on the plate and/or the wall to facilitate the placing and withdrawal of the blocker.

This second embodiment is particularly adapted for the use of the injection system with hydrophilic intraocular lens which are usually stored in an aqueous solution. The first tubular piece 104a can be mounted on the injection device fitted with a cartridge. This set illustrated in Fig 19 can be placed in a same container. The first tubular piece which defines the truncated section is advantageously made of a material including a gliding agent and/or coated with a surface polymer gliding coating.

After placing the hydrophilic lens in the receiving section 143, the plunger 6 is mounted on the second tubular piece in its retracted position, as illustrated in fig 18. The blocker 108 is then mounted on the second tubular piece as illustrated in fig 22. This set can be placed in a container comprising a aqueous solution for the preserving of the hydrophilic lens. The second tubular piece is made of material including no gliding agent.

For the loading of the lens into the cartridge, the blocker is withdrawn, and the second tubular piece fitted with the plunger is mounted on the first tubular piece. The practitioner can then introduce the lens into the injection cartridge by actuating the plunger 6 towards its loading position.

Although the invention has been described with reference to two particular embodiments, it is to be understood that it is in no way restricted thereto and that it includes all the technical equivalents of the means described as well as their combinations, should these combinations fall within the scope of the invention.

Claims

1) An injection system for injecting a flexible intraocular lens into the eye of a patient, comprising - an injection device (1) including

- a tubular injection body (10) fitted with a longitudinal slot (103),

- an injection cartridge (20) comprising a receiving chamber (21) for receiving an intraocular lens extended by a cannula (23), mountable on said injection body, and

- a plunger (11) comprising a rod (111) moveably mounted in said injection body, able to be moved from a retracted position towards an injection position to push a lens in a pre-folded state positioned in the receiving chamber in the cannula and inject it into the eye, and - a loading device (3) capable of loading a flexible intraocular lens in said injection cartridge in a pre-folded state, characterized in that said loading device comprises

- a tubular rolling body (4, 104) having an open distal end (42, 142a), and an inner passage (40; 140a, 140b), said inner passage comprising a receiving section (43, 143) capable of receiving a lens (9) in a non- folded state and a truncated rolling section (44, 144), said rolling body being capable of being removeably engaged obliquely in said longitudinal slot (103) of the injection body, such that the truncated rolling section opens onto the receiving chamber (21) of the injection cartridge mounted on the injection body, and,

- a plunger (6) comprising a rod (61) moveably mounted in said inner passage of the rolling body, capable of pushing a lens (9) positioned in the receiving section through the truncated rolling section to progressively roll-up said lens, then in the receiving chamber of an injection cartridge.

2) An injection system according to claim 1, characterized in that said injection device (1) comprises an injection cartridge (20) capable of being removeably mounted on said injection body (10).

3) An injection system according to claim 2, characterized in that said injection cartridge (20) comprises on its outer wall at least one longitudinal flap (24) radially extending outwards, said longitudinal slot (103) of the injection body comprising a first portion (103a) allowing the insertion of the cartridge in the inner passage (40) of the injection body (10) and extending by a second portion (103b) to receive said longitudinal flap (24). 4) An injection system according to one of claims 1 to 3, characterized in that the loading device (3) is equipped with holding means (50, 52; 150) capable of maintaining, by clip-fastening, said rolling body (4, 140) in mounted position on the injection body (10) of the injection device (3). 5) An injection system according to claim 4, characterized in that said holding means comprise a rib (52), formed on the outer wall of the rolling body (4), getting inserted in said longitudinal slot (103) and coming at least against the upstream edge (131) of said longitudinal slot in the mounted position. 6) An injection system according to claim 4 or 5, characterized in that said holding means comprise at least two lateral elastic legs (50, 150) capable of being elastically clip-fastened on either side of the injection body (10).

7) An injection system according to one of claims 1 to 6, characterized in that the distal end portion (47) of the rolling body (4 ;

104) is capable to be partially inserted in the receiving chamber (21) of the cartridge with the loading device in the mounted position.

8) An injection system according to one of claims 1 to 7, characterized in that the rod (61) of the plunger (6) of loading device (3) comprises a deformable endpiece (63) made of elastomeric material.

9) An injection system according to one of claims 1 to 8, characterized in that the rod (61) of the plunger (6) of loading device (3) comprise an endpiece (63) exhibiting at its distal end a horizontal tab (631) intended to support the trailing haptic (92) of a lens (9) with the plunger (6) in retracted position, said distal end of the endpiece exhibiting an upper convex wall (632) for folding said trailing haptic and a lower concave wall (633) for pushing the lens during the handling of the plunger (6) towards its loading position.

10) An injection system according to one of claims 1 to 9, characterized in that the loading device (3) further comprises a removeable blocking system (8 ; 108) capable of longitudinally locking the plunger (6) in retracted position and/or a lens (9) in the receiving section (43, 143) of the inner passage (40, 140b) of the rolling body (4, 104).

1 1) An injection system according to one of claims 1 to 10, characterized in that the inner passage (40 ; 140a, 140b) of the rolling body (4, 104) exhibits two lower longitudinal shoulders (45) whereon a pre-charged lens (9) may rest, combined with two upper longitudinal shoulders (46) extending along the rolling section (44, 144) against which the lens presses when it is pushed, said upper shoulders serving to guide the pre-folding or pre-rolling of the lens.

12) An injection system according to one of claims 1 to 11, characterized in that the tubular rolling body (4) of the loading device comprising the receiving section (43) and the truncated rolling section (44) is formed of a tubular single-piece. 13) An injection system according to one of claims 1 to 1 1 , characterized in that the tubular rolling body (104) of the loading device is formed of two tubular pieces, a first tubular piece (104b) comprising said truncated rolling section (144), capable of being removeably engaged obliquely in said longitudinal slot (103) of the injection body, and a second tubular piece (104b) comprising said receiving section (143), capable of being mounted on the first tubular piece such that the said receiving section opens onto said truncated rolling section.

14) An injection system according to one of claims 1 to 13, characterized in that it comprises a loading device (3) including a flexible intraocular lens (9) pre-loaded in the receiving section (43, 143) of the rolling body (4, 104).

15) An injection system according to claim 14, characterized in that the loading device is preloaded with a hydrophobic intraocular lens.

16) An injection system according to claim 14, characterized in that the loading device is preloaded with a hydrophilic intraocular lens.