Meniscal repair device and related kit

Abstract

A meniscal repair device comprises a main gripping body provided with a distal end and a proximal end, an actuating element movable on the main body, adapted to move a surgical needle, insertable in the main body, between an initial position of first engagement to a final position of complete release. The device further comprises a cannula, within which the needle slides, comprising a respective proximal end connected to the distal end of the main body and a respective distal end through which the needle exits. The main body is longitudinally passed through by a central passage from the proximal end, at which an inlet hole is provided, to the distal end at which an interconnection hole is provided with the cannula, so that the inlet hole, the interconnection hole and the cannula are in fluid communication. The device further comprises a fastening mechanism actuatable independently of the movement of the actuating element and selectively positionable in an unlocked position, at which the needle is released from the actuating element, and a locked position, at which the needle is constrained to the actuating element.

Description

[0001] “MENISCAL REPAIR DEVICE AND RELATED KIT”

[0002] DESCRIPTION

[0003] TECHNICAL FIELD

[0004] The present invention relates to a meniscal repair device.

[0005] The present invention further relates to a meniscal repair kit.

[0006] 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.

[0007] 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.

[0008] 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.

[0009] In addition to conservative therapies, surgical intervention is necessary in the most severe cases. Among the different surgical therapies, there is suturing the meniscus along the fracture zone, to stitch and bring the injured flaps together, which are then kept in contact by means of anchors and suture threads to promote healing and spontaneous regeneration.

[0010] There are basically three arthroscopic meniscal suturing techniques: - the Inside-Out technique in which the suture needle penetrates into the joint in the meniscus and exits outside; the sutures are then knotted on the capsule externally.

[0011] - the Outside-In technique in which the needle penetrates the meniscus from the outside and exits inside the joint;

[0012] - the All-Inside technique, which allows the surgeon to perform the entire suturing from inside the joint using at least one (anchor) component anchoring to the meniscal wall with a sliding, self-locking knot, which allows compression of the injured meniscal fragments.

[0013] In the remainder of this description, the inside-out technique will be examined in detail.

[0014] Inside-out meniscal repair is considered the gold standard for repairable injuries of the medial and lateral menisci, despite the recent popularity of all-inside devices. A careful passage of the suture is necessary to perform a stable repair and to prevent involuntary neurovascular injury caused by the suture needles. Through a cautious approach, efficient recovery and repair of the suture can be performed while protecting critical neurovascular structures.

[0015] PRIOR ART

[0016] Several needle devices provided with a pushing element that promotes the sequential exit of two surgical needles, constrained together by a suture thread, are known to the state of the art. Both needles must be introduced into the joint to pass through the meniscus astride of the lesion, in two distinct and adjacent places, so as to overlap the lesion with the suture, which, once pulled and knotted, brings the flaps closer to keep them in contact.

[0017] During meniscus repair procedures using the inside-out technique, the meniscal structures offer resistance to puncture forces, resulting in possible failure in the sutured needle passage.

[0018] The basic devices available on the market involve a set of cannulae, designed with different curvatures adapted to facilitate the insertion of the needle according to the correct spatial orientation. As the user has to insert the needle manually, the device may be inadequate if tissues oppose excessive resistance to perforation.

[0019] Alternatively, there are also devices that allow the needle to be advanced with discrete increments of 1 cm at a time, by simply pressing a trigger or button on the handle which, interacting with a spring system, make the needle advance; although this type of devices allow to introduce the needle more easily through the meniscal structure, what happens is, however, time consuming as it limits the user to the advancement of only a predetermined portion of needle at a time. In order to complete the needle insertion, it is necessary to press the advance button several times in sequence.

[0020] Furthermore, these devices provide for the needle to be grasped by the gripping device (a sort of gripper or jaw) only during the actual incremental advancement step that is made as a result of the thrust exerted by spring elements on the gripper element: once the needle has been moved by that predetermined step, the gripping device releases the needle and moves backwards, in order to be rearmed and repositioned towards the proximal end, by a distance equal to the predetermined incremental step (1 cm) and grasp the needle again in the corresponding position. The incremental advancement of the needle and the consequent necessary repetitive backward movement of the gripping device in order to grasp again the needle in a new position each time the device is pressed, is timeconsuming.

[0021] In addition, the advancement of the needle is triggered by means of spring elements: this makes the advancement, which cannot be guided in any way, completely automatic.

[0022] In fact, if during the incremental advancement the needle encounters a rigid structure such as a bone, the surgeon does not have immediate feedback because if the needle impacts against a bone, the needle remains still while the gripping device advances sliding in relation to the needle. This does not provide any tactile feedback to the surgeon who only notices the obstacle because, after pressing the trigger or button repeatedly, he / she does not see the needle come out.

[0023] Currently known devices, therefore, provide the possibility of making the meniscal needle slide and advance in increments of 1 cm at a time. These devices therefore do not allow instantaneous control of the armed needle in contact with the surrounding tissue, i.e. they do not allow the surgeon to be instantly aware of the interaction of the needle with bone cartilage or vascularised areas of the meniscus.

[0024] In addition, known devices do not give the surgeon the possibility of moving the advance button or the needle gripping device backwards, thus not allowing needle retraction.

[0025] An object of the present invention is to overcome the drawbacks of the prior art. In particular, the object of the present invention is to propose a meniscal repair device that is easy to use, reliable, precise and allows a rapid surgical procedure avoiding technical pauses to rearm the device.

[0026] A further object of the present invention is to realise a meniscal repair device that gives a tactile feedback to the surgeon, so that the movement of the needle is continuously controlled.

[0027] Finally, the object of the present invention is to propose a meniscal repair device that also allows the controlled backward movement of the needle to meet any surgical need.

[0028] These and further objects and benefits are achieved by a meniscal repair device as shown in the attached claims.

[0029] SUMMARY

[0030] In a first aspect, the present invention relates to a meniscal repair device comprising a main gripping body adapted to be grasped and comprising a distal end and a proximal end, an actuating element movable on the main body along a sliding path, adapted to move a surgical needle, insertable in the main body, between an initial position of first engagement and a final position of complete release; the final position of complete release being linearly displaced with respect to the initial position towards the distal end. The device further comprises a cannula, within which the surgical needle slides, comprising a respective proximal end connected to the distal end of the main body and a respective distal end through which the surgical needle can exit. The main body comprises a central passage running entirely through it along a longitudinal axis, from the proximal end, at which an inlet hole is provided, to the distal end at which an interconnection hole is provided with the cannula, so that the inlet hole, the interconnection hole and the cannula are in fluid communication. The device further comprises a fastening mechanism activatable independently of the movement of the actuating element and selectively positionable in an unlocked position, at which said central passage is completely free to allow the surgical needle to be freely inserted within the central passage, and a locked position, at which the central passage is at least partially obstructed to stably restrain the actuating element to the surgical needle.

[0031] The fastening mechanism is connected to the actuating element and is movable therewith along the sliding path; the fastening mechanism and the actuating element are both activatable independently of each other.

[0032] The actuating element is configured to freely and continuously slide in both directions along the sliding path, between the initial position of first engagement and the final position of complete release of the needle and vice versa.

[0033] The actuating element is configured to stably maintain engagement with the needle as long as the fastening mechanism is in the locked position.

[0034] The fastening mechanism comprises a lever that makes a pin having a cam profile rotate about an axis orthogonal to the longitudinal axis of the central passage.

[0035] The pin with cam profile is completely outside the cross section of the central passage when the fastening mechanism is in the unlocked position, while it partially obstructs the cross section of the central passage when the fastening mechanism is in the locked position, so as to reduce the cross section of the central passage and constrain the surgical needle to the actuating element passed through by the central passage.

[0036] The main gripping body has a graduated scale, along the extension of the sliding path, so as to provide a real and instantaneous visual reference of the advancement measure of the actuating element and surgical needle with respect to the initial position of first engagement.

[0037] The cannula is removable from the main body.

[0038] The cannula has a predominantly rectilinear development with a curved distal portion.

[0039] The cannula is rotatable about the longitudinal axis to properly orientate the exit direction of the surgical needle.

[0040] The main body comprises a system for locking and releasing the cannula with respect to the main body.

[0041] The locking and releasing system comprises a spring button with a shaped profile to obstruct or release the central passage at the distal end of the main body, to respectively constrain or release the proximal end of the cannula.

[0042] The main body comprises a second inlet hole positioned at its proximal end to access a secondary conduit parallel to the central passage.

[0043] The secondary conduit is blind and serves as a support conduit for a second surgical needle.

[0044] The secondary conduit comprises at least one magnet for holding a second surgical needle in a stable position.

[0045] In a second aspect, the present invention proposes a meniscal repair kit comprising a meniscal repair device according to the present invention and a range of interchangeable cannulae having different geometries and curvatures.

[0046] BRIEF DESCRIPTION OF THE DRAWINGS

[0047] 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:

[0048] - Figure 1 is a perspective view of a meniscal repair device according to the present invention, in an initial operating position;

[0049] - Figure 1 a is an enlargement of Figure 1 , with the rear needles partially visible; - Figure 2 is a side view of the device of Figure 1 and 1 a;

[0050] - Figure 2a is a side section of the view of Figure 2;

[0051] - Figure 3a is a top view of the device subject of the present invention in a final operating position;

[0052] - Figure 3a is a sectioned side view of the device subject of the present invention shown in Figure 3;

[0053] - Figure 4 is a top view of the device subject of the present invention according to an unlocked configuration in which a surgical needle can freely slide without being constrained;

[0054] - Figure 5 is a top view of the device subject of the present invention according to a locked configuration in which a surgical needle is constrained and cannot slide freely inside;

[0055] - Figure 4a is a sectioned top view of the device shown in Figure 4;

[0056] - Figure 5a is a sectioned top view of the device shown in Figure 5;

[0057] - Figure 4b is an enlargement of a detail of Figure 4a;

[0058] - Figure 5b is an enlargement of a detail of Figure 5a;

[0059] - Figure 6 is a rear view of the device subject of the present invention according to the configuration shown in Figure 4;

[0060] - Figures 7a and 7b are two section views along the plane A-A of the device in Figure 2, according to two different positions of a cannula locking and unlocking system;

[0061] - Figure 8 shows a perspective view of the cannula present in the device of the present invention;

[0062] - Figure 9 shows a partially sectioned perspective view of the device subject of the present invention.

[0063] DESCRIPTION

[0064] With reference to the accompanying figures, 1 denotes a meniscal repair device in accordance with the present invention.

[0065] 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.

[0066] The meniscal repair device 1 comprises a main gripping body 2 adapted to be grasped by a user.

[0067] This gripping body 2 therefore has a proximal end 2p and a distal end 2d, positioned on opposite sides of a longitudinal axis 1 a of the device 1. In the proximal position, the device 1 comprises an inlet hole 3 communicating with a central passage 2c present within the main body 2, and extending along the entire longitudinal development, along the axis 1a. A surgical needle 10 runs through the inlet hole 3 and throughout the central passage 2c.

[0068] At the opposite end, i.e. at the distal end 2d of the main body 2, a cannula 5 is provided, within which the aforementioned surgical needle 10 slides. This cannula 5 protrudes extending from the main body 2 following the extension of the longitudinal axis 1 a.

[0069] Advantageously, the centrally holed cannula 5 in turn comprises a proximal end 5p and a distal end 5d. Advantageously, both ends 5p and 5d of the cannula are open and communicating with the inner conduit 5c of the cannula 5.

[0070] The distal end 5d of the cannula 5 preferably has a blunt, non-cutting edge so that it can be inserted inside the patient without perforating anatomical tissue. The proximal end 5p of the cannula has a plurality of recesses 23, angularly equally-spaced around the circumferential development of the cannula itself. As will be described later, these recesses 23 serve to constrain the cannula to the main body 2.

[0071] The proximal end 5p is connectable to the distal end 2d of the main body, while the distal end 5d is the end part of the device 1 , from which a surgical needle 10 or 11 , connected to a suture thread 100, exits.

[0072] The device 1 is adapted to introduce two surgical needles 10 and 11 , both connected by a suture thread 100 (Figure 1 ).

[0073] The main body 2 therefore comprises, at the distal end 2d, an interconnection hole 4 with the cannula 5, so that the central passage 2c is in fluid communication with the inner conduit 5c to the cannula 5.

[0074] Specifically, the inlet hole 3, the central passage 2c, the interconnection hole 4, the inlet hole 5a of the cannula, the central conduit 5c of the cannula and finally the outlet hole 5b of the cannula 5 are in fluid communication with each other, to create a single channel, from the proximal end 2p to the distal end 5d, to allow the passage of the surgical needle 10, 11.

[0075] The device concerned further comprises an actuating element 6 slidably positioned above the main body 2; in particular, the actuating element 6 is movable on the main body 2 along a sliding path P, between an initial position and a final position. The position of the sliding element 6 allows to actuate it with only one finger of the surgeon while holding the device with the same hand.

[0076] The sliding path P is preferably rectilinear and has a predefined length D, along the longitudinal axis 1 a, preferably corresponding to the total advancement that the meniscal repair device 1 can impart to the surgical needle 10 or 11 .

[0077] A fastening mechanism 8, capable of stably constraining the surgical needle 10 (or 11 ) to the advancement element 6, is further provided to promote bidirectional displacement B of the needle.

[0078] Advantageously, the fastening mechanism 8 is directly connected to the actuating element 6. In particular, the fastening mechanism 8 is integrated directly inside the actuating element 6, as visible from the sectioned side view of the device shown in Figures 2a and 3a.

[0079] The advancement element 6 preferably comprises a slider 6a movable by an operator grasping the main body 2. Preferably, the advancement element 6 may comprise a sliding body 6b, connected below the slider 6a. The sliding body 6b is passed through by the central passage 2c present inside the main body 2.

[0080] The slider 6a protrudes partially above the sliding path P, while the sliding body 6b is inserted within this sliding path P.

[0081] The actuating element 6 is configured to move the surgical needle 10 once the latter is inserted into the main body 2 through the inlet hole 3. The needle is moved by the actuating element 6 between an initial position of first engagement P1 (Figure 2a) to a final position of complete release P2 (Figure 3a).

[0082] Specifically, the needle 10 is inserted into the inlet hole 3 within the main body 2 and constrained to the actuating element 6 by the fastening mechanism 8, as will be described below.

[0083] Once the needle is firmly constrained to the actuating element 6, it is moved, by means of a single one-way sliding movement of the actuating element 6, from the initial position P1 (i.e. from the initial position of first engagement) to the final position P2 (i.e. the final position of complete release) at which the disengagement of the needle from the actuating element 6 will take place. In the latter position, the needle is properly positioned in and through the meniscus, ready to be grasped from the outside to pull the suture thread 100.

[0084] Then, with a single sliding movement in a single direction, in particular towards the distal end 2d, the actuating element 6 makes the needle advance from the initial position to the final position, where it is released and pulled out of the meniscal repair device 1. There are no return, push or braking spring elements along the direction of the sliding path P. The movement of the actuating element 6 is smooth and continuous, with no jerks or incremental advances. Similarly, the return of the actuating element 6 from position P2 to position P1 occurs smoothly, continuously and is constantly and instantaneously controlled by the operator.

[0085] The actuating element 6 is therefore slidably movable between the above- mentioned two positions, as visible in the attached figures (Figures 2, 2a initial position of first engagement R1 and Figures 3, 3a final position of complete release P2). The final position of complete release (Figure 3) is linearly displaced from the initial position of first engagement (Figure 2) towards the distal end 2d by a predefined distance D which, as mentioned above, is equal to the total advancement that the needle must travel.

[0086] In other words, the initial position of the advancement element 6 is the initial position of first engagement of the needle, which is precisely engaged by the fastening mechanism 8 and stably connected to the actuating element 6.

[0087] The final position of the advancement element 6 is the final position of complete release of the needle 10 which is disengaged from the advancement element 6 by unlocking the fastening mechanism 8.

[0088] The initial position of the actuating element 6 is therefore closer to the proximal end 2p, as visible in Figure 1 .

[0089] The final position of the actuating element 6 is close to the distal end 2d of the main body 2 as visible in Figure 3.

[0090] Purely by way of example, the displacement made by the actuating element and thus the surgical needle is preferably of 70 mm. Other lengths are also possible depending on the surgical requirement and the size of the patient.

[0091] As mentioned above, this displacement corresponds to the maximum run that the actuating element 6 can perform between two extreme positions, i.e. between the initial position and the final position along the sliding path P. This displacement is also the maximum advancement made by the needle as it is inserted.

[0092] The sliding path P is, preferably, a grooved guide 9 formed within the main body 2, longitudinally along the axis 1 a. The grooved guide 9 has an opening in the upper part of the main body to allow the passage of the actuating element 6. Purely by way of example, this grooved guide 9 can be a through guide. Preferably, the main gripping body 2 has, along the extension of the sliding path P, in particular in a position adjacent and parallel to the opening of the grooved guide 9, a graduated scale 15 so as to provide a real and instantaneous visual reference of the advancement measure of the actuating element 6 and, therefore, of the surgical needle 10 or 11 with respect to the initial position of first engagement.

[0093] Preferably, the central passage 2c may comprise a secondary cannula 12, extending within the main body 2, from the proximal end 2p to the distal end 2d.

[0094] This secondary cannula 12 is coaxial with both the inlet hole 3 and the interconnection hole 4. The cannula is, advantageously, integral with the actuating element 6. As visible from the attached figures, the secondary cannula 12 is, preferably, integral with the sliding body 6b of the actuating element 6 and is movable therewith. When advancing the actuating element 6 from the initial position to the final position, the secondary cannula 12 is housed inside the cannula 5, thus being concentric and coaxial with it.

[0095] The movement of the actuating element 6 along the sliding path P can also take place in the opposite direction, i.e. from the final position to the initial position. The movement in the opposite direction serves to reposition the actuating element 6 to its initial position.

[0096] The actuating element 6 can thus slide actively and only under the force impressed by the surgeon (thus without any further elastic pushing elements) either advancing towards the final position, thus towards the distal end of the main body 2, and retracting towards the initial position, thus towards the proximal end of the main body 2.

[0097] Once the first needle 10 has been released, it is necessary to reposition the actuating element 6 in the initial position in order to proceed with the insertion of a second surgical needle 11 . The second surgical needle 11 must be inserted in a position different and spaced along the lesion, in order to allow the suture to overlap the lesion and embrace it, and then close it, bringing the flaps into contact, when the two suture threads are pulled from the outside, once both needles 10 and 1 1 have been inserted and passed through the meniscus to be repaired.

[0098] The actuating element 6 is configured to slide freely and continuously in both directions along the sliding path P, between the initial position of first engagement and the final position of complete release of the needle and vice versa.

[0099] The bi-directional movement B of the actuating element 6 allows to move the needle backwards if, during insertion, the surgeon realises he has encountered a bone structure and it is therefore necessary, for example, to change trajectory. In general, by having active control over the actuating element 6, which slides continuously, without discrete increments or jerks, it is possible to actively control the movement of the needle in both advancing and retreating steps.

[0100] The surgical needle can be brought from the initial position of first engagement P1 to the final position of complete release P2 with a single continuous one-way movement.

[0101] The fastening mechanism 8 is activatable to constrain the needle to the actuating element 6 or is deactivatable to release the connection between the two bodies. In particular, the fastening mechanism 8 is activatable independently of the movement of the actuating element 6: the fastening mechanism 8 is activatable so as to stably constrain the needle to the actuating element 6, even if the user does not act on the latter, just as the actuating element 6 can slide along the sliding path P even if the fastening mechanism 8 is not activated. In the latter case, the actuating element 6 but not the needle will move. Thus, the actuating element 6 and fastening mechanism 8 can both be activatable independently of each other.

[0102] The fastening mechanism 8 is also selectively positionable in an unlocked position (Figures 4, 4a and 4b), at which the central passage 2c is completely free, to allow the surgical needle to be freely inserted within the central passage 2c, and a locked position (Figures 5, 5a and 5b), at which the central passage 2c is at least partially obstructed to stably constrain the actuating element 6 to the surgical needle.

[0103] The fastening mechanism 8 is directly connected to the actuating element 6 and integrated therewith: thus the fastening mechanism 8 is movable with the actuating element 6 along the sliding path P relative to the main body 2.

[0104] The actuating element 6 is configured to stably maintain the engagement with the needle, as long as the fastening mechanism 8 is in the locked position (figure 5, 5a, 5b).

[0105] Preferably, the fastening mechanism 8 comprises a lever 13 and a pin 14, the latter having a cam profile. The pin 14 is constrained to the lever 13. The lever 13 is hinged to the actuating element 6.

[0106] In particular, the pin 14 is inserted inside the actuating element 6. More specifically, the pin 14 is inserted inside the sliding body 6b of the actuating element 6.

[0107] The lever 13, hinged to the actuating element 6, is capable of rotating about an axis 8a orthogonal to the longitudinal axis 1 a of the main body 2. In particular, the rotation axis 8a of the lever 13 is orthogonal to a plane X containing the plan projection of the opening of the grooved guide 9.

[0108] The rotation of the lever 13 preferably takes place about an arc, having an amplitude a of approximately 90°, contained on the aforementioned plane X containing the plan projection of the opening of the grooved guide 9.

[0109] The lever 13 makes the pin 14, having a lateral cam profile, rotate about the aforementioned axis 8a. The pin 14 is adjacent to the cross section of the central passage 2c, along which the surgical needle passes. Therefore, depending on its position, the pin 14 obstructs or does not obstruct the central passage 2c. In particular, depending on the angular position of the lever 13, about the rotation axis 8a, the pin 14 is placed in different positions in which it can partially obstruct the central passage 2c (Figures 5a and 5b), blocking the needle, or leave the central passage 2c completely free (Figures 4a and 4b), thus allowing the needle to be pulled out or inserted into the central passage.

[0110] In detail, when the locking mechanism 8 is in the unlocked position (Figures 4, 4a and 4b), the pin 14 with cam profile is completely outside the cross section of the central passage 2c. In fact, in this position, the most protruding part of the profile faces the opposite side of the central passage 2c, so that the least protruding part faces the central passage 2c, without thus encroaching on its section.

[0111] Alternatively, when the fastening mechanism 8 is in the locked position (Figures 5, 5a and 5b), the pin 14 at least partially obstructs the cross section of the central passage 2c. When the fastening mechanism 8 is in the locked position, the most protruding portion of the cam profile of the pin 14 partially obstructs the central passage 2c, thereby reducing its cross section: the surgical needle is thereby stably constrained by interference to the actuating element 6, in particular to the sliding body 6b of the actuating element 6.

[0112] The needle passes through the cannula 5 to be released in the proper position. The cannula 5 preferably has a predominantly rectilinear development with a curved distal portion 5e. The distal end 5d has different degrees of curvature depending on surgical requirements.

[0113] The cannula 5 is, therefore, removable from the main body 2c; it is thereby possible to select the cannula with the most suitable geometry and profile. Furthermore, the cannula 5 is, advantageously, rotatable about the longitudinal axis 1 a, as indicated by the arrow R in Figure 1 a, so as to properly orientate the exit direction of the surgical needle.

[0114] The connection between cannula 5 and main body 2 occurs by means of a locking and unlocking system 16, visible in section in Figures 7a and 7b.

[0115] This locking and unlocking system 16 comprises a spring button 160 provided with a head 17, a spring 26 and an stem 18 that is elongated and having a shaped profile 19.

[0116] The stem 18 extends orthogonal to the longitudinal axis 1 a, within a hole 20, which meets and at least partially interferes with the central passage 2c, at the distal end 2d of the main body 2.

[0117] The shaped profile 19 preferably has a groove 21 .

[0118] The cannula 5, at its proximal end 5p, has, as noted above, a plurality of recesses 23, angularly equally-spaced around the circumferential development of the cannula itself.

[0119] As shown in Figure 7a, when the locking and unlocking system 16 is in the rest position, the spring pushes the head 17 of the button 160 outwards. In this position, the groove 21 of the shaped profile 19 is misaligned from the section of the central passage 2c. This implies that a more protruding part 18' of the shaped profile 18 is at the section of the central passage 2c, fitting into one of the recesses 23 located on the outer surface of the cannula 5. In this configuration, the cannula 5 remains locked in the desired position, duly oriented.

[0120] As visible in Figure 7b, however, when the locking and unlocking system 16 is pressed, the groove 21 of the stem 18 having a shaped profile 19 is brought at the central passage 2c, completely releasing the cross section of the central passage 2c; the cannula 5 is thereby no longer locked because the protruding part of the shaped profile 19 disengages one of the recesses 23 of the cannula 5, releasing it.

[0121] At the proximal end 2p of the main body 2, in particular on the face of the main body 2 facing the user, there is a second inlet hole 24 (visible in Figure 6), to access a secondary conduit 22 (visible in Figure 9) parallel to the central passage 2c.

[0122] Preferably, the secondary conduit 22 is blind and serves as a support channel for a second surgical needle 11 .

[0123] The secondary conduit 22 comprises inner magnets 25 along its longitudinal development to secure the second needle 11 in a stable position and prevent it from accidentally falling or slipping out of the secondary conduit 22.

[0124] In fact, during the meniscal repair operation, two needles are needed, one for each end of the suture thread; the needles must be passed through different and spaced-apart positions, one for each flap of the lesion; this is necessary to bring the suture thread astride of the lesion and thus bring the flaps closer together by pulling the needles and the ends of the suture thread.

[0125] After inserting the first needle, the surgeon must grasp the second needle, which must already be connected to the first one by the suture. Therefore, having the second needle available and close to the surgical site is very convenient for the surgeon. This prevents the second needle from accidentally dropping, an event that would imply having to pull out also the first needle (which is tied to the second one by the suture thread) and start again.

[0126] The surgical site must always remain absolutely sterile, so dropping the second needle would compromise asepticity. Furthermore, as the surgical site also has body fluids, when grasping the second needle from a tray, the surgeon's grip could fail, causing the second needle to fall.

[0127] In use, after verifying that the fastening mechanism 8 is in the unlocked position, then that the lever 13 is oriented in such a way that the pin with a cam-profile does not obstruct the central passage 2c, which is thus completely free, the surgeon positions the first surgical needle 10 inside the central passage 2c of the main body 2, inserting it through the inlet hole 3, positioned on the proximal end 2p of the main body.

[0128] The surgeon then proceeds to move the fastening mechanism 8 to the locked position by rotating the lever 13 about the axis 8a from the unlocked position (Figure 4) to the locked position (Figure 5). Thus, the pin having a cam profile rotates, making the most protruding portion encroach at least partially the central passage 2c: the needle inserted within the central passage 2c is thus locked by mechanical interference from the cam profile of the pin 14, which pushes it against an inner wall of the sliding body 6b of the actuating element 6.

[0129] Once the first surgical needle 10 is constrained to the actuating element 6, the surgeon can activate the slider 6a and move it linearly along the sliding path P, for a predefined distance D. The movement of the slider 6a occurs continuously and without continuous rearming of the slider or without having to make interactive movements to move the needle forward in discrete small steps. The slider, in fact, has no spring push elements or push reloading elements, it is completely controlled by the hand of the user who, thereby, has the exact tactile perception of the path that the needle is following. The advancement of the needle is an active advancement that allows for a continuous, immediate and instantaneous control by the surgeon: by actuating the slider with his / her thumb, for example, the surgeon makes the needle advance and, if it impacts against an obstacle (tissues with different consistencies such as a bone), he / she immediately realises it (tactile feeling).

[0130] The device object of the present invention allows the needle to be advanced in a single one-way sliding movement, making it possible to save time because the transition from the initial position to the final position can be made in a single forward movement.

[0131] If there is a need to temporarily move the needle backwards, it is also possible to move the slider back by the required size, without having to completely pull the needle or the entire device out again.

[0132] This active control provides a great deal of tactile feedback: the surgeon is immediately aware if the needle encounters any obstructions, thus being able to act promptly on the position of the needle, making the needle move back just a little by retracting the slider 6a.

[0133] Once arrived at the end position, i.e. at the end of the stroke along the sliding path P (or along the grooved guide 9), the surgeon rotates the lever again, bringing it to the unlocked position: in doing so, the needle is released from the actuating element.

[0134] At this point, the surgeon can return the actuating element, disengaged from the needle, to the initial position and proceed to insert the second surgical needle. The surgeon repeats the same operations already performed with the first needle, now using the second needle 11 , which, until now, has remained housed inside the secondary conduit, parallel to the central passage.

[0135] The second surgical needle is temporarily positioned in the secondary conduit waiting to be implanted: this is extremely useful for the surgeon who thus has the second needle immediately available as soon as the first is in place; the magnets, arranged along the secondary conduit, holding the needle in place, prevent it from accidentally falling out.

[0136] The second surgical needle is then inserted in a different position by acting on the fastening mechanism to constrain the second needle to the actuating element, then actuating the sliding of the actuating element to insert the needle into the meniscus in the desired position, the fastening mechanism is then released, moving the actuating element backward again, and then completely pulling out the meniscal repair device from the operation site. The operation is then ended by pulling both needles from the outside, so that the suture thread is also pulled, literally stitching up the meniscal lesion.

[0137] Depending on the type of patient, there may be a need to be able to select a different needle insertion trajectory: the device which is the subject of the present invention makes it possible to rotate the cannula or to replace it with another one having a different geometry. The cannula is replaced or rotated by pressing on the locking and unlocking button, thus disengaging the proximal end of the cannula 5 from the shaped profile 19 of the stem 18; as long as the locking and unlocking button remains pressed, the cannula 5 is free to rotate or be pulled out from the main body. In this configuration, the surgeon can then proceed to rotate or pull out the cannula and replace it with another one with a more appropriate geometry. The cannula is re-engaged to the main body by releasing the locking and unlocking button.

[0138] The process for repairing a meniscal lesion involves the steps of providing a meniscal repair device comprising a main body provided with a cannula that protrudes extending from said main body.

[0139] Said main body comprises an actuating element slidable thereon, capable of traversing along a sliding path P. The actuating element, along the sliding path P, is capable of running a predetermined distance D corresponding to the total distance that the surgical needle must travel from an initial position of first engagement to a final position of complete release.

[0140] A first surgical needle is then inserted into a central passage within the main gripping body.

[0141] Constraining, by means of a fastening mechanism, said surgical needle to said actuating element, so that the translation of said actuating element produces the simultaneous and instantaneous translation of said surgical needle. The step of constraining said surgical needle to said actuating element is carried out by rotating a lever arranged in said fastening mechanism, so as to rotate a pin provided with a cam profile which, as a result of rotation, occludes at least partially the central passage wherein the needle is housed. A mechanical interference is therefore created by compression of said needle between the pin and an inner wall of the actuating element.

[0142] Actuating the slider of the actuating element and translating it along a defined grooved guide along the movement path. Bringing said slider from an initial position of first engagement of the needle to a final position of complete release. At the final position of complete release, positioned towards the distal end of the main body and distant from the initial position by exactly the total distance D that the needle must travel to be fitted in the meniscus, unlocking the fastening mechanism by rotating the lever in the opposite direction. Releasing the needle by removing the mechanical interference between the pin with a cam profile and the needle that is pressed against the inner wall of the actuating element.

[0143] Returning the actuating element to its initial position, thereby making it retract. Picking a second needle temporarily housed in a secondary conduit inside the main body.

[0144] Repeating the same operations as with the first needle: actuating the fastening mechanism to constrain the second needle to the actuating element, activating the actuating element by moving the slider along the sliding path through the grooved guide until it reaches the final position of complete release. Then disengaging the fastening mechanism by returning the lever in the opposite direction, repositioning the slider to the initial position by making it slide in the opposite direction along the grooved guide and then pulling the entire meniscal repair device out of the operation site.

[0145] At this point, surgical needles inserted from the inside of the meniscus can be pulled from the outside, allowing the suture thread to wrap around the lesion and bring the flaps into contact, to promote healing.

[0146] The device which is the subject of the present invention achieves the proposed objects because the particular structure of the entire needle advance mechanism allows for an active control over the movement of the needle itself, so that the surgeon constantly monitors, also by a tactile feedback, the path performed by the needle. The ability to insert the needle into the surgical site in a single movement reduces the operation time. In addition, the ability to also actively and continuously move the needle backwards allows for targeted adjustments during insertion. The secondary conduit also makes it possible to have the second needle already available and ready for use, avoiding the risk of fall or loss of the second needle, which is, from the beginning, already constrained to the first needle by the suture thread. The device, in its entirety, is easy to use and reduces intervention costs and time, while also ensuring greater safety than known devices.

[0147] Last but not least, the device subject of the present invention is also reusable, an advantage that allows to reduce costs.

Claims

CLAIMS1 . A meniscal repair device comprising a main gripping body (2) adapted to be grabbed and comprising a distal end (2d) and a proximal end (2p), an actuating element (6) slidably positioned above said main body (2) and movable along a sliding path (P), adapted to move a surgical needle (10, 11 ), insertable in said main body (2), between an initial position of first engagement (P1) to a final position of complete release (P2); said final position of complete release being linearly displaced with respect to said initial position towards said distal end (2d), a cannula (5), within which said surgical needle (10, 11 ) slides, comprising a respective proximal end (5p) connected to the distal end (2d) of said main body (2) and a respective distal end (5d) through which said surgical needle (10, 11) is able to exit; said main body (2) comprising a central passage (2c) running entirely through it along a longitudinal axis (1 a), from said proximal end (2p), at which an inlet hole (3) is provided, to said distal end (2d), at which an interconnection hole (4) with said cannula (5) is provided, so that said inlet hole (3), said interconnection hole (4) and said cannula (5) are in fluid communication, characterised in that it comprises a fastening mechanism (8) directly inserted within said actuating element (6), actuatable independently of the movement of the actuating element (6) and selectively positionable in an unlocked position, at which said central passage (2c) is completely free to allow said surgical needle to be freely inserted within said central passage (2c), and a locked position, at which said central passage (2c) is at least partially obstructed to stably restrain said actuating element (6) to said surgical needle (10, 11).

2. The meniscal repair device according to the preceding claim, characterised in that said fastening mechanism (8) is connected to saidactuating element (6) and is movable with it along the sliding path (P); said fastening mechanism (8) and said actuating element (6) being both actuatable independently of each other.

3. The meniscal repair device according to any one of the preceding claims, characterised in that said actuating element (6) is configured to slide freely and continuously in both directions along said sliding path (P), between said initial position of first engagement (P1) and said final position of complete release (P2) of said needle and vice versa.

4. The meniscal repair device according to the preceding claim, characterised in that said actuating element (6) is configured to keep stably engaged with said needle as long as the fastening mechanism (8) is in the locked position.

5. The meniscal repair device according to any one of the preceding claims, characterised in that said fastening mechanism (8) comprises a lever (13) which makes a pin (14) having a cam profile rotate about an axis orthogonal (8a) to the longitudinal axis (1 a) of said central passage (2c).

6. The meniscal repair device according to the preceding claim, characterised in that said cam-profiled pin (14) is completely external to the cross-sectional area of said central passage (2c) when the fastening mechanism (8) is in the unlocked position, while it partially obstructs said cross-sectional area of said central passage (2c) when the fastening mechanism (8) is in the locked position, so as to reduce the cross- sectional area of said central passage (2c) and restrain said surgical needle to said actuating element (6) passed through by said central passage (2c).

7. The meniscal repair device according to any one of the precedingclaims, characterised in that said main grip body (2) has a graduated scale (15) along the extension of the sliding path (P) so as to provide a real and instantaneous visual reference of the measure of advancement of said actuating element (6) and of said surgical needle (10, 11 ) with respect to the initial position of first engagement (P1).

8. The device according to any one of the preceding claims, characterised in that said cannula (5) is removable from the main gripping body (2).

9. The device according to any one of the preceding claims, characterised in that said cannula (5) has a predominantly rectilinear development with a curved distal portion (5e).

10. The device according to any one of the preceding claims, characterised in that said cannula (5) is rotatable about said longitudinal axis (1 a), in order to properly orientate the exit direction of said surgical needle (10, 11 ).11 . The device according to the preceding claim, characterised in that said main gripping body (2) comprises a system (16) for locking and unlocking said cannula (5) with respect to said main body (2).

12. The device according to the preceding claim, characterised in that said locking and unlocking system (16) comprises a spring button (160) having a shaped profile (19) for obstructing or releasing the central passage (2c) at said distal end (2d) of said main gripping body (2), respectively for restraining or releasing said proximal end (5p) of said cannula (5).

13. The device according to any one of the preceding claims, characterised in that said main gripping body (2) comprises a second inlet opening (24) positioned at its proximal end (2p) to access a secondaryconduit (22) parallel to the central passage (2c).

14. The device according to the preceding claim, characterised in that said secondary conduit (22) is blind and serves as a support conduit for a second surgical needle (11 ).

15. The device according to claim 13 or 14, characterised in that said secondary conduit (22) comprises at least one magnet (25) for holding a second surgical needle (11 ) in a stable position.

16. A meniscal repair kit comprising a meniscal repair device (1 ) according to one or more of claims 1 to 15 and a range of interchangeable cannulae (5) having different geometries and curvatures.

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