Meniscal repair device

Abstract

A meniscal repair device comprises a needle having a distal end, a proximal end both open and communicating with a cavity axially extending along the entire extension of the needle; a gripping sleeve arranged at the proximal end of the needle and from which the needle extends; a first pusher element placed inside the needle, coaxial with it and axially hollow; a second pusher element positioned within the first pusher element and coaxial with the needle. Both the first pusher element and the second pusher element each have a respective and separate drive unit. The device further comprises a first anchor internal to the needle and external to the first pusher element; a second anchor arranged inside the first pusher element; a slider arranged on the gripping sleeve, comprising a movement mechanism integral with the slider, to move, separately and in sequence, the first pusher element and then the second pusher element by the interaction of the movement mechanism with the respective drive unit of the first pusher element first and then with the respective drive unit of the second pusher element; the first pusher element is configured to axially slide within the needle and act exclusively on the first anchor, the second pusher element is configured to axially slide within the first pusher element and act exclusively on the second anchor.

Description

[0001] “MENISCAL REPAIR DEVICE” DESCRIPTION

[0002] TECHNICAL FIELD

[0003] The present invention relates to a meniscal repair device.

[0004] The knee is the largest joint in the human body and also one of the most complex. Since it is stressed by even the simplest movement such as walking, it wears out. The most common injuries affecting the knee are related to the menisci.

[0005] The (medial and lateral) menisci are two wedge-shaped fibro-cartilaginous structures that act as shock absorbers between the femur and tibia, helping to cushion and reduce longitudinal and transverse loads on the knee, keep it stable and protect the cartilage.

[0006] Diseases that may affect the menisci include injuries caused by a sports injury, an involuntary or abrupt movement, uncontrolled overloading of the knee usually due to hyperflexion or hyperextension, or degeneration mainly due to ageing.

[0007] In addition to conservative therapies, surgical intervention is necessary in the most severe cases. Among the different surgical treatments, there is meniscus suturing at the fracture points, to stitch and bring together the injured flaps, which are then kept in contact by means of anchors and suture threads. Anchors are also sutures and serve to hold the thread and prevent it from slipping out.

[0008] In order to position the anchors in the correct place, cannulated needle devices are used to insert and release the anchors beyond the lesion, with respect to the insertion point, in at least two separate places that act as anchoring points for the suture thread, which is then pulled and tightened around the injury to “stitch” the flaps.

[0009] PRIOR ART

[0010] Several needle devices provided with a pushing element that promotes the release of two anchoring implants (called anchors) near the laceration edges are known in the prior art.

[0011] Generally, the fixation implants are released in sequence at two separate points along the laceration. The needle is then pulled out of the wound and the suture thread, connected to the two anchors so as to create a loop structure, is pulled to bring the flaps together, then knotted and cut.

[0012] It has been found that known devices often fail to position the anchors due to the incorrect interaction between the pushing system releasing the anchors and the anchors themselves.

[0013] In fact, it can happen that the anchors or the suture thread get caught inside the needle, thus preventing the correct release of the anchoring implants, or the pushing system gets blocked in its movement, thus failing to advance to push the anchors out, or it can happen that both anchoring implants come out simultaneously and, once inserted, can no longer be removed or repositioned, or it can happen that, in order to bend the needle in the most appropriate way, the insertion and release system can no longer work correctly.

[0014] Known meniscal repair devices are shown, for example, in documents US 2012 / 004669, US 2020 / 383679, US 104 999 902, US2018 / 0360441 , US 8828054, US2023 / 134233 or US8128640.

[0015] An object of the present invention is to overcome the drawbacks of the prior art. In particular, an object of the present invention is to propose a meniscal repair device that is reliable, accurate and always working properly, without failing in use. A further object of the present invention is to create a meniscal repair device that can assume different angled configurations, depending on the curvature and inclination that the surgeon deems most suitable for the patient he has to operate.

[0016] Furthermore, an object of the present invention is to provide a meniscal repair device that is easy and immediate to use for the surgeon, reduces the commands on which the surgeon has to act or, in any case, has the commands in a convenient position on the device so that they can be activated quickly and simply by the surgeon, using even just one hand.

[0017] These and further objects and benefits are achieved by a meniscal repair device as shown in the attached claims.

[0018] SUMMARY

[0019] A first aspect of the present invention provides a meniscal repair device comprising a needle having a distal end and a proximal end, both open and communicating with a cavity axially extending along the entire extension of the needle. The device further comprises a gripping sleeve, which is arranged at the proximal end of the needle and from which the needle extends. The device also comprises a first pusher element placed inside the needle, coaxial with it and axially hollow, a second pusher element, placed inside the first pusher element and coaxial with the needle; the first pusher element and the second pusher element each have a respective and separate drive unit. The device further comprises a first anchor inside the needle and outside the first pusher element and a second anchor arranged inside the first pusher element. A slider arranged on the gripping sleeve and comprising a movement mechanism, integral with the slider itself, is also provided to move, separately and in sequence, the first pusher element and, subsequently, the second pusher element, through the interaction of the movement mechanism with the respective drive unit of the first pusher element first and then with the respective drive unit of the second pusher element. The first pusher element is configured to axially slide within the needle and act exclusively on the first anchor, as well as the second pusher element is configured to slide axially inside the first pusher element and act exclusively on the second anchor.

[0020] Preferably, the first anchor is placed between the distal end of the needle and a distal end of the first pusher element. The first anchor is advantageously folded in a U-shape.

[0021] Preferably, the second anchor is axially arranged inside the first pusher element, between a distal end of the first pusher element and a distal end of the second pusher element.

[0022] Advantageously, the first pusher element is a cylindrical tube coaxially sliding inside the needle.

[0023] Advantageously, the second pusher element is a rod positioned inside the first pusher element, coaxial with it and axially sliding therein.

[0024] The drive unit of the first pusher element comprises a pushing and engagement unit positioned at a proximal end of the first pusher element. The drive unit of the second pusher element comprises an engagement and movement unit positioned at a proximal end of the second pusher element.

[0025] Preferably, the movement mechanism is interposed between the pushing and engagement unit of the first pusher element and the engagement and movement unit of the second pusher element.

[0026] The first pusher element is configured to be movable between a first rest position wherein it is inside the needle and retracted towards the gripping sleeve, and a second pushing position of the first anchor, wherein it is in an advanced position, with its own distal end at the distal end of the needle, to push the first anchor out of the needle.

[0027] The pushing and engagement unit is configured to interact with the movement mechanism of the slider to move from the first rest position to the second pushing position, and to be stably constrained with the gripping sleeve at the second pushing position.

[0028] The pushing and engagement unit comprises a pushing surface facing the movement mechanism of the slider against which the movement mechanism impacts to move the first pushing element between the first rest position and the second pushing position; the pushing and engagement unit further comprises an engagement head, opposite the pushing surface, configured to be stably constrained with respective undercuts within the gripping sleeve, so as to lock the first pusher element at the second pushing position.

[0029] The second pusher element is configured to be movable between a first rest position wherein it is inside the needle and retracted towards a proximal end of the gripping sleeve, and a second pushing position of the second anchor, wherein it is in an advanced position, with its distal end at the distal end of the needle, to push the second anchor out of the needle.

[0030] The engagement and movement unit is configured to lock the second pusher element in the first rest position until it interacts with the movement mechanism of the slider, which then promotes its movement from the first rest position to the second pushing position.

[0031] The engagement and movement unit comprises an engagement head facing the movement mechanism of the slider and configured to be constrained with the movement mechanism in order to be dragged and promote the sliding of the second pushing element between the first rest position and the second pushing position.

[0032] The movement mechanism of the slider comprises at least one undercut, facing the engagement head of the engagement and movement unit of the second pusher element, to irrevocably engage and constrain the engagement head.

[0033] The engagement and movement unit of the second pusher element comprises a constraint system configured to lock the second pusher element in the first rest position prior to the engagement with the movement mechanism of the slider.

[0034] The constraint system comprises at least one elastic element interacting with appropriate abutment elements in the gripping sleeve.

[0035] The gripping sleeve comprises shoulders adapted to interact with the elastic element of the constraint system to prevent the second pusher element from returning to its first rest position.

[0036] There is also a locking device to prevent the slider from sliding completely towards a proximal end of the gripping sleeve before engaging the first pusher element.

[0037] In addition, the locking device is preferably a toggle hinged within the gripping sleeve, protruding externally from the outer surface of the gripping sleeve to interfere with a cavity in the body of the slider; the toggle is preferably housed in a compartment of the gripping sleeve, delimited towards the proximal end of the gripping sleeve by an abutment wall to prevent the toggle from rotating towards the proximal end.

[0038] The device advantageously comprises a sheath placed outside the needle, axially sliding around it to cover it completely or to expose it at least partially to an extent proportionate to the thickness of the meniscus to be operated.

[0039] A sliding device is also provided adapted to promote the axial sliding of the sheath according to discrete steps.

[0040] The sliding device comprises a rack, integral with the gripping sleeve and provided with protrusions and grooves, a button, slidingly positioned on the gripping sleeve, and a pin, protruding below the button, adapted to interact with the grooves of the rack to promote the advancement, according to discrete steps, of the sheath.

[0041] BRIEF DESCRIPTION OF THE DRAWINGS

[0042] A meniscal repair device according to what described and claimed is shown in the following figures, which are intended for illustrative and non- exhaustive purposes, wherein:

[0043] - Figure 1 is a perspective view of a meniscal repair device in accordance with the present invention;

[0044] - Figure 2 is a perspective view of the device in Figure 1 , with an outer part removed for a better understanding of the inner structure;

[0045] - Figure 3 is an enlargement of a detail of Figure 2;

[0046] - Figure 4 is a sectional view of the device object of the present invention according to a first non-operating configuration;

[0047] - Figure 4a is a view from above of the device according to the configuration shown in Figure 4;

[0048] - Figure 4b is an enlargement of a detail of Figure 4; - Figure 5 is a sectional view of the device object of the present invention according to a first operating configuration of insertion through the incision made by the surgeon, wherein an outer sheath protects the needle therein;

[0049] - Figure 6 is a sectional view of the device object of the present invention according to an operating engagement configuration of a first pusher element;

[0050] - Figure 6a is a perspective view of the configuration shown in Figure 6;

[0051] - Figure 6b is an enlargement of a detail of Figure 6a;

[0052] - Figure 6c is an enlargement of a detail of Figure 6;

[0053] - Figure 7 is a sectional view of the device object of the present invention according to an operating pushing configuration of the first anchoring implant;

[0054] - Figure 7a is a perspective view of the configuration shown in Figure 7;

[0055] - Figure 7b is an enlargement of a detail of Figure 7a;

[0056] - Figure 7c is an enlargement of a detail of Figure 7;

[0057] - Figure 8 is a sectional view of the device object of the present invention according to an operating configuration of the transition between the insertion of the first anchoring implant and engagement with the second implant system;

[0058] - Figure 8a is a perspective view of the configuration shown in Figure 8;

[0059] - Figure 8b is an enlargement of a detail of Figure 8a;

[0060] - Figure 8c is an enlargement of a detail of Figure 8;

[0061] - Figure 9 is a sectional view of the device object of the present invention according to an operating pushing configuration of the second anchoring implant;

[0062] - Figure 9a is a perspective view of the configuration shown in Figure 9; - Figure 9b is an enlargement of a detail of Figure 9a;

[0063] - Figure 9c is an enlargement of a detail of Figure 9;

[0064] - Figure 10 is a schematic view of a meniscus sutured at an injury with the aid of the device object of the present invention.

[0065] DESCRIPTION

[0066] With reference to the accompanying figures, 1 denotes a meniscal repair device in accordance with the present invention.

[0067] In the remainder of this description, reference will be made to the terms proximal and distal, explicitly referring to the surgeon's hand: "proximal" therefore means the portion, end or part of the device or component closest to, and therefore nearest to, the surgeon or user holding the device, while "distal" means the portion, end or part of the device or component most distant and therefore furthest from the body, from the hand of the surgeon or user holding the device.

[0068] The meniscal repair device 1 therefore has a proximal end 1 p and a distal end 1d, positioned on opposite sides of a longitudinal axis 1 a of the device

[0069] 1 itself. In the proximal position, the device 1 comprises a gripping sleeve

[0070] 2 from which a cannulated structure 3 protrudes extending to the distal end 1d.

[0071] In detail, the cannulated structure 3 comprises a needle 4 having in turn a distal end 4d and a proximal end 4p, both open and communicating with a central cavity 5 axially extending along the entire longitudinal extension of the needle 4. In addition, the cannulated structure 3 comprises pusher elements 6 and 7, adapted to push respective anchoring systems or anchors 8 and 9 out of the needle 4, as will be described in detail below.

[0072] The distal end 4d of the needle is pointed, shaped preferably like a slice of salami, to penetrate a patient's tissue. The proximal end 4p, inside said gripping sleeve 2, is open to allow for the sliding of the aforementioned pusher elements.

[0073] These pusher elements comprise a first pusher element 6 and a second pusher element 7.

[0074] The first pusher element 6 is placed inside the needle 4, coaxial with it.

[0075] The second pusher element 7 is positioned inside the first pusher element 6, in a coaxial position with both the first pusher element 7 and the needle 4.

[0076] The device further comprises a first anchoring implant or first anchor 8 and a second anchoring implant or second anchor 9, better visible in Figure 4b. Both the anchors are internal to the needle 4, but positioned in different places: the first anchor 8 is internal to the needle 4 and external to the first pusher element 6, the second anchor 9 instead is not only arranged inside the needle 4, but contained completely within the first pusher element 6 (Figure 4b).

[0077] In particular, the first anchor 8 is placed between the distal end 4d of the needle 4 and a distal end 6d of the first pusher element 6. Advantageously, the first anchor 8 is folded in a U-shape, preferably with the convex portion of the curvature facing outwards, then towards the distal end 4d of the needle 4.

[0078] The second anchor 9, on the other hand, is arranged inside the first pusher element 6, between a distal end 6d of the first pusher element 6 and a distal end 7d of the second pusher element 7.

[0079] Advantageously, the first pusher element 6 is a cylindrical tube configured to be coaxially sliding inside the needle 4. The first pusher element 6 always remains inside the needle 4, regardless of the position assumed. The second pusher element 7, on the other hand, is a rod positioned inside the first pusher element 6, coaxial with it and axially sliding therein along the axis 1 a. The second pusher element 7 always remains inside both the needle 4 and the first pusher element 6, regardless of the position assumed.

[0080] The sliding of the first pusher element 6 takes place between a first rest position (Figures 6, 6a) wherein it is inside the needle 4 and retracted towards the inside of the gripping sleeve 2, and a second pushing position (Figures 7, 7a) of the first anchor 8, wherein it is in an advanced position, with its own distal end 6d positioned at the distal end 4d of the needle 4, to push the first anchor 8 out of the needle 4.

[0081] Even at the second pushing position, the first pusher element 6 always remains contained inside the needle 4, in the most extreme position towards the distal end 4d of the needle 4, in order to push the first anchor

[0082] 8 completely out, while still remaining contained inside the needle 4.

[0083] The second pusher element 7 is also configured to axially slide along the axis 1 a, inside the needle 4. In particular, the second pusher element 7 is slidingly movable along the axis 1a of the device 1 , between a first rest position (Figures 5, 6, 7, 8) wherein it is retracted towards the proximal end 2p of the gripping sleeve 2, and a second pushing position (Figures 9 and 9a) of the second anchor 9, wherein it is in a advanced position towards the distal end 4d of the needle 4, with its own distal end 7d positioned at the distal end 4d of the needle 4, to push the second anchor

[0084] 9 out of the needle 4, into the correct position next to the meniscus M.

[0085] The cannulated structure 3 further comprises a stiffness cannula 10 placed at least partially around the needle 4 and, consequently, around the pusher elements 6 and 7, extending from the gripping sleeve 2 to an intermediate portion of the needle 4.

[0086] For further protection, a sheath 11 is also present, placed radially further out than the rest of the cannulated structure 3, mainly protecting the needle 4.

[0087] The cannulated structure 3 thus comprises, listing them in order from innermost to outermost, the second pusher element 7, the first pusher element 6, the needle 4, the stiffness cannula 10 and the sheath 11 , all coaxial with each other and with the axis 1 a of the device 1 .

[0088] The sheath 11 is movable axially and externally along the needle 4, placed therein, to cover its tip (the distal end 4d) in order to avoid accidental and involuntary perforation of soft tissues, other than the meniscus, during the step of inserting the device 1 inside the incision made by the surgeon. Alternatively, the sheath 11 is axially slidable externally and along the needle 4 to expose it, at least partially, to an extent proportionate to the thickness of the meniscus to be operated.

[0089] The movement of the sheath 11 is implemented by means of a sliding device 14, adapted to promote the axial sliding of the sheath 11 according to steps at discrete intervals. The sliding device 14 is placed on the gripping sleeve 2, near the distal end 2d of the gripping sleeve 2. The sliding device 14 comprises a graduated scale 14a on which it is possible to read how much the needle 4 is exposed, thus, how much the needle protrudes from the sheath 11 . The measurement read on the graduated scale 14a corresponds to the thickness of the meniscus to be penetrated. Discrete steps are preferably established by a rack 15 with which a pin 16, protruding from a button 17 positioned on the gripping sleeve 2, which is operated by the surgeon, interacts.

[0090] The sheath 11 is constrained to the sliding device 14, in particular to the button 17. The button 17 slides axially relative to the gripping sleeve 2, moving the sheath 11 forward.

[0091] The rack 15, on the other hand, is arranged below the button 17, in a housing formed in the body of the gripping sleeve 2; the rack 15 and button 17 are not constrained to each other. The rack 15 has protrusions and grooves 15a facing the axis 1a of the gripping sleeve 2, i.e. facing the side opposite the position of the button 17. The pin 16, on the other hand, protrudes from the button 17 towards the gripping sleeve 2, then protrudes below the button 17 towards the rack 15, engaging it from below; each time the button 17 is pressed, the pin 16 is pushed downwards, exits one of the grooves 15a of the rack 15 and re-enters a groove following the release of the button 17, which rises upwards. The rack 15, button 17 and pin 16 are part of the sliding device 14 of the sheath 11 .

[0092] When the pin is engaged in the last groove of the rack, that is the one placed closest to the proximal end 1 p of the device 1 , the sheath 11 is in the most extracted position (Figure 5), completely encasing the needle 4 therein.

[0093] The first pusher element 6 and the second pusher element 7 are actuated by a slider 12, located on the gripping sleeve 2.

[0094] In particular, the slider 12 is able to move the first 6 and the second 7 pusher elements separately and in sequence by means of a movement mechanism 13 integral with the slider 12. This movement mechanism 13 acts as a shuttle and is configured so as to interact separately, and in a predetermined order, with the first pusher element 6 (Figures 6, 7) first and then, once the first pusher element has been released (Figure 8), with the second pusher element 7 (Figure 9).

[0095] The slider 12, moved by the surgeon, causes the first pusher element 6 to move axially from the first rest position (Figure 6) to the second pushing position (Figure 7), thus bringing the distal end 6d of the first pusher element 6 towards the distal end 4d of the needle 4; in this way, the first pusher element 6 acts exclusively on the first anchor 8, pushing it away from the needle 4 (as visible in Figure 7a).

[0096] Similarly, after disengaging with the first pusher element 6 (Figure 8), as will be described in detail with reference to the operation of the device 1 , the slider 12, still by means of the movement mechanism 13, engages the second pusher element 7 by making it axially slide within the first pusher element 6; in this way, the second pusher element 7 is moved from the first rest position (Figure 8) to the second pushing position (Figure 9). As a result of this movement, the distal end 7d of the second pusher element 7 is brought at both the distal end 4d of the needle 4 and the distal end 6d of the first pusher element 6. The second pusher element 7 thus acts exclusively on the second anchor 9, pushing it out of the device 1 (Figure 9a), positioning it next to the meniscus M in the desired position, appropriately spaced from the release position of the first anchor 8.

[0097] At their respective proximal ends, both the first pusher element 6 and the second pusher element 7 each have a respective drive unit 18, by means of which both of them interact, individually, in sequence and at distinct and different times in the operation of the device 1 , with the movement mechanism 13 of the slider 12. The drive unit 18 relating to the first pusher element 6 is separated from drive unit 18 relating to the second pusher element 7. It is precisely the interaction of the movement mechanism 13 with the respective drive unit 18 of each pusher element 6 or 7 that causes the first pusher element 6 and then the second pusher element 7 to move individually and in sequence. In other words, this interaction between the movement mechanism 13 with the respective drive unit 18 causes the axial movement, then the translation, of the first pusher element 6 first and, subsequently, of the second pusher element 7 to push the respective anchor out of the needle. In other words, the movement mechanism 13 of the slider 12 interacts individually and sequentially with the drive unit 18 of the respective pusher element (with the first pusher element 6 first, then with the second pusher element 7) with which it interacts. Therefore, the interaction between the movement mechanism 13 and the drive unit 18 of one of the pusher elements (of the first 6 or of the second 7) occurs separately, with one interaction at a time and never simultaneously. Both each of the drive units 18 of the first pusher element 6 and of the second pusher element 7 as well as the movement mechanism 13 of the slider are contained and movable within a housing 19 inside the gripping sleeve 2.

[0098] Going into more detail, as visible in Figures 6c, 7c, 8c and 9c, the drive unit 18 of the first pusher element 6 is located, as mentioned above, at the proximal end 6p of the first pusher element 6; this drive unit 18 of the first pusher element 6 comprises a pushing and engagement unit 186.

[0099] The drive unit 18 of the second pusher element 7 is located, as mentioned above, at the proximal end 7p of the second pusher element 7. This drive unit 18 of the second pusher element 7 comprises an engagement and movement unit 187.

[0100] The pushing and engagement unit 186 of the first pusher element 6 and the engagement and movement unit 187 of the second pusher element 7 are located on opposite sides of the movement mechanism 13 of the slider 12. In other words, the movement mechanism 13 is interposed between the drive unit 18 of the first pusher element 6 and the drive unit 18 of the second pusher element 7. Specifically, therefore, the movement mechanism 13 is interposed between the pushing and engagement unit

[0101] 186 of the first pusher element 6 and the engagement and movement unit

[0102] 187 of the second pusher element 7.

[0103] The interaction of each drive unit 18 with the movement mechanism 13 causes, as a result of the movement of the slider 12 and the particular configuration of each drive unit 18, the movement of the first pusher element 6 and, subsequently, the second pusher element 7, respectively.

[0104] Each drive unit 18 is then configured to interact with the movement mechanism 13 to move the respective pusher element from a rest to a pushing configuration.

[0105] Specifically (Figure 6c), the pushing and engagement unit 186 of the first pusher element 6 comprises a pushing surface 1861 , facing the movement mechanism 13 of the slider 12 and against which the movement mechanism 13 impacts to push the first pusher element 6 from the first rest position to the second pushing position.

[0106] The pushing and engagement unit 186 further comprises an engagement head 1862, opposite to the pushing surface 1861 , configured to stably constrain with respective constraint elements 21 , such as undercuts, inside the gripping sleeve 2.

[0107] Then, as shown in Figures 6, 6a, 6b and 6c, by making the slider 12 advance from the initial position towards the distal end 2d of the gripping sleeve 2, the movement mechanism 13 impacts and pushes against the pushing surface 1861 of the pushing and engagement unit 186, thus causing the first pusher element 6 to move from its first rest position (Figures 6, 6a, 6b, 6c) to the second pushing position (Figure 7, 7a, 7b).

[0108] In detail, as visible in Figures 6c, 7c, 8c and 9c, the engagement head 1862 has at least one arm 61 , preferably two arms 61 , which protrudes elongating towards the proximal end 6p of the first pusher element 6 to form an arrowhead, thereby defining an acute angle a with the longitudinal axis 1 a coinciding with the axis of the first pusher element 6. A cavity 20 is present between the housing 19 and the distal end 2d of the gripping sleeve 2 within which the aforementioned constraint elements 21 , preferably undercuts, are formed, with which the arm or arms 61 interfere so as to lock the first pusher element 6 at the second pushing position.

[0109] The cavity 20 communicates with, and opens into, the housing 19. The inlet section of the cavity 20 is smaller than the transversal section of the housing 19.

[0110] The inlet of this cavity 20 has, in cross-section, a small dimension compared to the cross-sectional width of the arms 61 which, being flexible, can close elastically by flexing temporarily to allow the passage of the engagement head 1862 of the pushing and engagement unit 186 through the inlet of the cavity 20. Once the engagement head 1862 enters the cavity 20 (Figure 7, 7a), the arms 61 , finding more space, elastically reopen: the free ends of the arms 61 , in the open rest configuration, have a transversal extension (with respect to the longitudinal direction of the axis 1a) greater than that of the constraint elements 21 or undercuts 21 present in the cavity 20 and, therefore, interfere with these, preventing the engagement head 1862 from being able to slip out of the cavity 20. The first pusher element 6, once pushed to the second pushing position, can no longer move back to its first rest position. The second pusher element 7, at the end of its single translation, then remains locked in the second pushing position.

[0111] The movement mechanism 13, which interacts with the pushing and engagement unit 186 of the first pusher element 6 only by simply resting to push on the pushing surface 1861 , abandons the pushing and engagement unit 186 (now constrained in the cavity 20) and moves back to couple with the engagement and movement unit 187 of the second pusher element 7.

[0112] The movement of the first pusher element 6 from the first rest position to the second pushing position therefore ends with the pushing head 1862 entering the cavity 20 and the engagement of the arms 61 with the constraint elements 21 (Figure 7, 7a).

[0113] At this configuration, the first anchor 8 protrudes from the needle 4, as visible in Figure 7b. The second anchor 9, on the other hand, remains in its initial position inside the first pusher element 6, near its distal end 6d.

[0114] Moving on to describe the movement unit 18 of the second pusher element 7 (Figures 6c and 9c), it results that the engagement and movement unit 187 is configured to lock the second pusher element 7 in the first rest position until the movement mechanism 13 arrives, which promotes its movement (Figures 8 and 9), unlocking it from the first rest position (Figure 8) to move it to the second pushing position (Figure 9).

[0115] The engagement and movement unit 187 comprises an engagement head 1871 facing the movement mechanism 13 and configured to be constrained with the latter to be dragged; thus the sliding of the second pusher element 7 between the first rest position and the second pushing position is promoted.

[0116] This engagement head 1871 preferably has at least one arm 71 that extends elongating like an arrowhead towards the proximal end 7p of the second pusher element 7, thereby defining an acute angle [3 with the longitudinal axis 1 a coinciding with the axis of the second pusher element 7.

[0117] The movement mechanism 13 has, therein, a compartment 131 provided with appropriate constraint elements 22, such as at least one undercut; said compartment 131 has an access opening on the side facing the engagement head 1871 of the engagement and movement unit 187. When the engagement head 1871 of the engagement and movement unit 187 of the second pusher element 7 is inserted inside the compartment 131 , the constraint element 22, preferably an undercut, irrevocably engages the arm 71 of that engagement head. In particular, when the slider 12 has released the first pusher element 6 in the second pushing position, it moves back towards the proximal end 2p of the gripping sleeve 2 to engage the engagement head 1871 of the engagement and movement unit 187 (Figure 8, 8a) and set the second pusher element 7 in motion (Figure 8c).

[0118] As shown in Figures 8 and 8a, the engagement occurs by introducing the engagement head 1871 of the second pusher element 7 into the compartment 131 of the movement mechanism 13. The inlet section of this compartment 131 is smaller than the transversal extension of the engagement head 1871 , which, however, since the arm 71 is flexible, is able to enter the compartment 131 by elastically compressing the arm 71 during the passage step: once the head is inside the compartment 131 , the arm 71 reopens, elastically returning to its rest configuration and thus interfering with the undercut 22 or with a generic constraint element 22 present in the compartment 131. The interference between the arm and the undercut occurs because the arm 71 , once extended and returned to its rest configuration, has a transverse extension greater than the inlet / outlet of the compartment 131 : therefore, the free end of the arm 71 is caught against the undercut, preventing the engagement head 1871 of the second pusher element 7 from exiting the compartment 131 .

[0119] In this configuration, the slider 12, moved towards the distal end 2d of the gripping sleeve 2, drags the second pusher element 7 which, as mentioned above, is a rod axially sliding within the first pusher element 6; the latter is, as mentioned above, a cylindrical tube internally hollow and coaxial with both the needle 4 and the rod defining the second pusher element 7. The second anchor 9 is positioned inside the hollow cylindrical tube defining the first pusher element 6, arranged in an elongated configuration along the longitudinal axis 1 a. The rod head of the second pusher element 7 (i.e. the distal end 7d of the second pusher element 7) impacts against a proximal end 9p of the second anchor 9 and pushes it, by translating, towards the distal end 4d of the needle, outside the device 1 , to release it in the desired position (visible in Figures 9, 9a and 9b). As shown in Figures 6c, 7c, 8c and 9c, the engagement and movement unit 187 of the second pusher element 7 comprises a constraint system 1872, configured to lock the second pusher element 7 in the first rest position, prior to engagement with the movement mechanism 13 of the slider 12.

[0120] This constraint system also ensures that the second pusher element 7 cannot move freely during the transport of the device, causing an accidental and unwanted release of the second anchor.

[0121] This constraint system 1872 is located at the proximal end 7p of the second pusher element 7, on the opposite side of the engagement and movement unit 187 with respect to the engagement head 1871 .

[0122] As visible in Figure 6c or 7c, when the second pusher element 7 is in the first rest position, the constraint system 1872 is initially housed inside a chamber 23 of the gripping sleeve 2, formed inside the gripping sleeve 2 and proximal to its proximal end 2p; in particular, said chamber 23 is positioned between the housing 19, within which the movement mechanism 13 moves, and the proximal end 2p of the gripping sleeve 2. The chamber 23 communicates with, and opens into, the compartment 19. The inlet section of the chamber 23 is smaller than the cross-section of the housing 19.

[0123] The constraint system 1872 comprises an elastic element 72, e.g. a tab, configured to interact by friction or interference with surfaces or appropriate abutment elements 24 of the chamber 23. For merely exemplary purposes, the tab 72 is connected to the constraint system, for example, by means of an elastic or bending hinge 73 which allows it to be bent to an appropriate extent to allow the engagement and movement unit 187 to be inserted into the chamber 23. In this chamber 23, appropriate abutment elements 24 are present, such as additional undercuts or surfaces inclined in an appropriate manner to hinder the disengagement of the engagement and movement unit 187 from the chamber 23. In Figure 6c, for example, the tab 72 can be seen to be inclined with respect to the longitudinal axis 1 a, passing through the second pusher element 7, so as to define an acute angle y therewith.

[0124] The engagement and movement unit 187 is at least partially inserted within the chamber 23 (as illustrated in Figure 8c) by slightly bending the tab 72 to make it close by means of the elastic bending hinge 73 and bring it closer to the body of the engagement and movement unit 187 itself, so as to reduce its transverse size and allow it to be inserted into the chamber 23.

[0125] The chamber 23 has an abutment element 24 consisting, for example, of an inclined surface against which the tab 72 abuts, tending to open due to the elastic bending hinge 73.

[0126] This frictional interaction is sufficient to hold the engagement and movement unit 187, and in particular the constraint system 1872, stationary in position within the chamber 23; consequently, the second pusher element 7 also remains stationary in its first rest position until the movement mechanism 13 engages the engagement head 1871 of the engagement and movement unit 187, thereby successfully disengaging the latter from the chamber 23.

[0127] As visible in Figure 6c, 7c or 8c, in fact, the constraint system 1872 is contained within the chamber 23, while the engagement head 1871 protrudes within the housing 19, in order to interact with the movement mechanism 13.

[0128] When the movement mechanism 13 engages the engagement head 1871 to drag the second pusher element 7 from the first rest position (Figures 8, 8a) to the second pushing position (Figures 9, 9a), the inclined surface 24 acts as a chute for the tab 72, facilitating its bending around the elastic hinge 73: the tab 72 thus closes and allows the engagement and movement unit 187 to slide and disengage from the chamber 23. Once the constraint system 1872 of the engagement and movement unit 187 completely exits the chamber 23, the tab 72, under the thrust of the elastic hinge 73, tends to open inside the housing 19. As mentioned above, the inlet section of the chamber 23 is smaller than the cross-section of the housing 19, considered in a direction transverse to the extension longitudinal direction of the axis 1 a: this defines shoulders 191 against which the elastic element or tab 72 abuts, having modified its shape and its transversal size (in the direction orthogonal to that of extension of the axis 1 a) opening, by means of the elastic hinge 73, after entering the housing 19. The interference between tab 72 and shoulders 191 prevents the second pusher element 7 from returning to its first rest position even after pushing the second anchor out of the device.

[0129] Advantageously, the device 1 further comprises a locking device 30 (better visible in Figures 6c, 7c, 8c and 9c) to prevent the slider 12 from sliding completely towards the proximal end 2p of the gripping sleeve 2, before engaging the first pusher element 6.

[0130] Preferably, the locking device 30 comprises a toggle 31 hinged inside the gripping sleeve 2 and protruding externally from the outer surface of the gripping sleeve 2, to interfere with a cavity 121 in the body of the slider 12. This toggle 31 being housed in a compartment 26 of the gripping sleeve 2 is delimited towards the proximal end 2p of the gripping sleeve 2 by an abutment wall 27, to prevent the rotation of the toggle 31 towards the proximal end 2p of the gripping sleeve 2.

[0131] Therefore, as long as the toggle 31 is inserted into the cavity 121 of the body of the slider 12, the slider cannot slide further towards the proximal end 2p of the gripping sleeve 2 because the abutment wall 27 locks the toggle 31 and prevents it from rotating backwards, towards the proximal end 2p.

[0132] By contrast, the toggle 31 has no lock, in front of it, towards the distal end 2d of the gripping sleeve 2, as the compartment 26 where it is housed communicates with the housing 19.

[0133] Therefore, when the slider 12 is advanced towards the distal end 2d of the gripping sleeve 2, the toggle 31 is pushed forward and falls back into its housing compartment 26, releasing the body of the slider 12 which is thus free to slide both forward and backward, beyond its initial position A, towards the proximal end 2p of the gripping sleeve 2.

[0134] The slider 12 then performs two forward slidings towards the distal end 2d of the gripping sleeve 2 and one backward sliding towards the proximal end 2p of the gripping sleeve 2: the two journeys towards the distal end 2d are to separately advance the two pusher elements towards the respective anchors and push them out of the device, the backward journey, towards the proximal end 2p, is to re-engage the slider which will engage the second pusher element.

[0135] The two journeys performed by the slider 12 during the movement of the pusher elements have different lengths: the first journey (A-B) relating to the sliding of the first pusher element 6 is shorter than the second journey (OB'), run by the second pusher element 7, since in the first case the slider 12 starts from an intermediate distance (A) to the two extremes (B and C) reached and at which it must reverse direction. Initially, the slider 12 is locked in position A (Figure 6) and its sliding towards the proximal end 2p is prevented by the locking device 30.

[0136] Thus, the slider 12 starts from an initial starting position A (Figure 6) wherein it is held stationary by means of the locking device 30, and can only advance towards the distal end 2d. In this journey it engages, by means of the movement mechanism 13 acting as a shuttle, the pushing and engagement unit 186 of the first pusher element 6. Continuing to slide, the slider 12 reaches an arrival position B (Figure 7), wherein the pushing and engagement unit 186 is received and constrained within the cavity 20 and, at the same time, the first pusher element 6 reaches the second pushing position: at this position, the first anchor 8 is pushed out of the device.

[0137] During the first advancement, the slider 12 has caused the toggle 31 of the locking device 30 to fall forward and, therefore, there is now no longer any lock at the first starting position A. Therefore, once the first pusher element 6 has been released, the slider 12 is moved backwards from the arrival position B until it crosses the first starting position A and arrives at a second starting position C (Figure 8). In this second starting position C, the slider 12 engages and irrevocably constraints the engagement and movement unit 187 of the second pusher element 7. The slider is then advanced again to the arrival position B' (Figure 9), which is basically the same as the arrival position B.

[0138] The first starting position A is therefore intermediate to the arrival position B and second starting position C.

[0139] Once the second sliding has also been completed, the two anchoring implants 8 and 9 are located in the desired position inside the patient's knee, close to meniscus M, and the device 1 can be removed. Subsequently, the suture thread F, which connects the two anchors and forms a loop around the injury L, is carefully pulled by the surgeon, causing the flaps of the meniscal lesion to come together: the thread F, finding anchoring elements in the form of the anchors, is stretched between them, stitching up the injury L (figure 10).

[0140] In use, once the device has been positioned inside the injury and the thickness of the meniscus has been measured and the position of the sheath has been adjusted to expose the needle to the correct size, one proceeds as follows.

[0141] Operating the slider 12 by sliding it towards the distal end 2d of the sleeve 2, from the initial rest position A to the distal or (front) end-stop limit position B, in order to activate the movement mechanism 13. Making the movement mechanism 13 interact with the pushing and engagement unit 186 connected to the first pushing element 6.

[0142] Advancing, towards the proximal end 2p of the gripping sleeve 2, the pushing and engagement unit 186 connected to the first pusher element 6, by means of the thrust exerted by the movement mechanism 13 on the pushing surface 1861 of the pushing and engagement unit 186.

[0143] Sliding the first pusher element 6 from the first rest position to the second pushing position, until the distal end 6d of the first pusher element 6 is positioned at the distal end 4d of the needle 4.

[0144] Releasing the first anchor 8 out of the needle 4 as a result of the thrust exerted by the distal end 6d of the first pusher element 6 on said anchor 8. At the second pushing position of the first pusher element 6, thus when the slider is in the distal (or front) end-stop limit position B, forcing the thrust of the slider 12 to introduce the engagement head 1862 of the pushing and engagement unit 186 within a cavity 20 of the gripping sleeve 2, to promote stable and permanent engagement of the engagement head 1862 in the cavity 20, with suitable constraint elements 21 adapted to prevent disengagement of the engagement head 1862 from said cavity 20: the first pusher element 6 thus remains stably locked in the second pushing configuration.

[0145] Once the first anchor 8 is out and the first pusher element 6 is stable in the second pushing position, the second pusher element 7 can be operated.

[0146] Moving the slider 12 by moving it from the distal (or front) end-stop limit position B to the proximal (or rear) end-stop limit position C by sliding it towards the proximal end 2p of the gripping sleeve 2.

[0147] Making the movement mechanism 13 interact with the engagement and movement unit 187 of the second pusher element 7.

[0148] At the first rest position of the second pusher element 7, i.e. when the slider is in the proximal (or rear) end-stop limit position C, forcing the retraction of the slider 12 to introduce the engagement head 1871 of the engagement and movement unit 187 into the compartment 131 of the movement mechanism 13 and to promote stable and permanent engagement between the engagement head 1871 and the movement mechanism 131 , by means of suitable constraint elements 22 adapted to prevent disengagement of the engagement head 1871 : the second pusher element 7 thus remains stably constrained with the movement mechanism 13.

[0149] Operating the slider 12 by sliding it towards the distal end 2d of the sleeve 2, from the proximal (or rear) end-stop limit position C to the distal or (front) end-stop limit position B' (coinciding with the aforementioned position B), so as to activate the movement mechanism 13.

[0150] Making the engagement and movement unit 187 connected to the second pusher element 7 advance towards the proximal end 2p of the gripping sleeve 2, by means of the stable constraint with the movement mechanism 13 which drags the engagement head 1871 of the engagement and movement unit 187.

[0151] Making the second pusher element 7 slide from the first rest position to the second pushing position, until the distal end 7d of the second pusher element 7 is positioned at the distal end 4d of the needle 4 and of the distal end 6d of the first pusher element 6.

[0152] Releasing the second anchor 9 out of the needle 4 as a result of the thrust exerted by the distal end 7d of the second pusher element 7 on said anchor 9. The device of the present invention achieves the intended purposes.

[0153] The presence of two separate pusher elements, each moved separately and adapted to position a dedicated anchor, avoids problems of accidental failure in positioning one or the other anchor as a result of simultaneous jamming or escape of the two anchoring implants.

[0154] The movement system of each pusher element is linear and does not require any overriding of other components in order to be correctly positioned with respect to the second anchoring implant after the first one has been released and positioned.

[0155] The particular conformation of the entire cannulated structure comprising the needle, first and second pusher elements, their relative positioning and the particular mechanism by which the various parts interact by simple relative sliding, allows the device to be folded and curved according to the inclination with which the device is to be inserted inside the patient, with extreme ease and without the risk of deformation of the individual components or system malfunction. This is possible mainly due to the relative positioning between the various components. A simple, extremely reliable, disposable device that allows the correct positioning of the anchoring implants in the desired positions in order to quickly and safely stitch and repair the meniscal injury is thus obtained.

Claims

CLAIMS1 . A meniscal repair device comprising a needle (4) having a distal end (4d), a proximal end (4p) both open and communicating with a cavity (5) axially extending along the entire extension of said needle (4); a gripping sleeve (2) arranged at the proximal end of said needle (4) and from which said needle (4) extends; a first pusher element (6) placed inside said needle (4), coaxial with it and axially hollow; a second pusher element (7) positioned inside said first pusher element (6) and coaxial with said needle (4); said first pusher element (6) and said second pusher element (7) each having a respective and separate drive unit (18); a first anchor (8) internal to said needle (4) and external to said first pusher element (6); a second anchor (9) arranged inside said first pusher element (6); a slider (12), arranged on said gripping sleeve (2), comprising a movement mechanism (13) integral with said slider (12), to move, separately and in sequence, said first pusher element (6) and subsequently said second pusher element (7) by the interaction of said movement mechanism (13) with the respective drive unit (18) of said first pusher element (6) first and then with the respective drive unit (18) of said second pusher element (7); said first pusher element (6) being configured to axially slide within said needle (4) and act exclusively on said first anchor (8), said second pusher element (7) being configured to axially slide within said first pusher element (6) and act exclusively on said second anchor (9).

2. The meniscal repair device according to claim 1 , wherein said firstanchor (8) is placed between the distal end (4d) of said needle (4) and a distal end (6d) of said first pusher element (6); said first anchor (8) being U-folded.

3. The meniscal repair device according to claim 1 or 2, wherein said second anchor (9) is arranged axially within said first pusher element (6), between a distal end (6d) of said first pusher element (6) and a distal end (7d) of said second pusher element (7).

4. The meniscal repair device according to any one of the preceding claims, wherein said first pusher element (6) is a cylindrical tube coaxially sliding within the needle (4).

5. The meniscal repair device according to any one of the preceding claims, wherein said second pusher element (7) is a rod positioned within said first pusher element (6), coaxial therewith and axially sliding therein.

6. Meniscal repair device according to claim 1 , wherein said drive unit (18) of the first pusher element (6) comprises a pushing and engagement unit (186) positioned at a proximal end (6p) of said first pusher element (6).

7. Meniscal repair device according to claim 1 , wherein said drive unit (18) of the second pusher element (7) comprises an engagement and movement unit (187) positioned at a proximal end (7p) of said second pusher element (7).

8. The device according to claims 6 and 7, wherein said movement mechanism (13) is interposed between said pushing and engagement unit (186) of said first pusher element (6) and said engagement and movement unit (187) of said second pusher element (7).

9. The meniscal repair device according to claim 1 , wherein said first pusher element (6) is configured to be movable between a first rest position wherein it is inside the needle (4) and retracted towards the gripping sleeve (2), and a second pushing position of said first anchor (8), wherein it is in an advanced position, with its own distal end (6d) at the distal end (4d) of the needle (4), to push said first anchor (8) out of said needle (4).

10. The meniscal repair device according to claims 8 and 9, wherein said pushing and engagement unit (186) is configured to interact with said movement mechanism (13) of said slider (12) to move from the first rest position to the second pushing position, and to be stably constrained with said gripping sleeve (2) at the second pushing position.

11. The meniscal repair device according to the preceding claim, wherein said pushing and engagement unit (186) comprises a pushing surface (1861 ) facing said movement mechanism (13) of said slider (12) against which said movement mechanism (13) impacts to move said first pusher element (6) between said first rest position and said second pushing position; said pushing and engagement unit (186) further comprising an engagement head (1862), opposite to the pushing surface (1861 ), configured to be stably constrained with respective constraint elements (21 ) internal to said gripping sleeve (2), so as to lock said first pusher element (6) at the second pushing position.

12. The meniscal repair device according to claim 1 , wherein said second pusher element (7) is configured to be movable between a first rest position wherein it is within said needle (4) and retracted towards a proximal end (2p) of said gripping sleeve (2) and a second pushing position of said second anchor (9), wherein it is in an advanced position, with its distal end (7d) at the distal end (4d) of the needle (4), to push saidsecond anchor (9) out of said needle (4).

13. The meniscal repair device according to claims 7 and 12, wherein said engagement and movement unit (187) is configured to lock said second pusher element (7) in the first rest position until it interacts with said movement mechanism (13) of said slider (12) which promotes movement thereof from the first rest position to the second pushing position.

14. The meniscal repair device according to the preceding claim, wherein said engagement and movement unit (187) comprises an engagement head (1871 ) facing said movement mechanism (13) of said slider (12) and configured to be constrained with said movement mechanism (13) to be dragged and to promote sliding of said second pusher element (7) between said first rest position and said second pushing position.

15. The meniscal repair device according to the preceding claim, wherein said movement mechanism (13) of said slider (12) comprises, facing said engagement head (1871 ) of said engagement and movement unit (187) of said second pusher element (7), at least one constraint element (22) for permanently engaging and constraining said engagement head (1871 ).

16. The meniscal repair device according to claims 7 and 12, wherein said engagement and movement unit (187) of said second pusher element (7) comprises a constraint system (1872) configured to lock said second pusher element (7) in the first rest position prior to engagement with the movement mechanism (13) of said slider (12).

17. The meniscal repair device according to the preceding claim, wherein said constraint system (1872) comprises at least one elastic element (72) interacting with appropriate abutment elements (24) present in saidgripping sleeve (2), to maintain said second pusher element (6).

18. The meniscal repair device according to the preceding claim, wherein said gripping sleeve (2) has shoulders (191) adapted to interact with said at least one elastic element (72) of said constraint system (1872) to prevent said second pusher element (7) from returning to its first rest position.

19. The meniscal repair device according to any one of the preceding claims, comprising a locking device (30) to prevent the slider (12) from sliding completely towards a proximal end (2p) of the gripping sleeve (2) before engaging the first pusher element (6).

20. The meniscal repair device according to the preceding claim, wherein said locking device (30) is a toggle (31 ) hinged within said gripping sleeve (2), protruding externally from the outer surface of said gripping sleeve to interfere with a cavity (121 ) present in the slider (12); said toggle (31 ) being housed in a compartment (26) of said gripping sleeve (2) delimited towards the proximal end of the gripping sleeve (2) by an abutment wall (27) to prevent said toggle from rotating towards said proximal end (2p).

21. The meniscal repair device according to any one of the preceding claims, comprising a sheath (11 ) placed outside said needle (4), sliding axially around said needle (4) to cover it completely or to expose the needle at least partially by a measure proportionate to the thickness of the meniscus to be operated.

22. The meniscal repair device according to the preceding claim, comprising a sliding device (14) adapted to promote the axial sliding of said sheath (11 ) according to discrete steps.

23. Meniscal repair device according to the preceding claim, wherein the sliding device (14) comprises a rack (15), integral with the gripping sleeve (2) and provided with protrusions and grooves (15a), a button (17) slidingly positioned on the gripping sleeve (2), and a pin (16), protruding below the button (17), adapted to interact with the grooves (15a) of said rack (15) to promote the advancement, according to discrete steps, of the sheath (11 ).

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