Breaking tool and breaking system with bilaterally articulated breaking elements - Patent Application 20070122997

Abstract

The present invention relates to a breaking instrument for surgical interventions and a breaking system comprising a breaking instrument and a breaking motion generator, which is intended for the field of traumatology, in particular for the creation of bone tunnels suitable for the proper anatomical reconstruction of tendons and ligaments, for example in interventions for the reconstruction of the anterior cruciate ligament (ACL) of the knee joint and for the repair of the supraspinatus tendon of the shoulder joint.

Description

[Technical Field]

[0001] The present invention relates to a breaking instrument for surgical interventions and a breaking system comprising a breaking instrument and a breaking motion generator, which is intended for the field of traumatology, in particular for the creation of bone tunnels suitable for the proper anatomical reconstruction of tendons and ligaments, for example in interventions for the reconstruction of the anterior cruciate ligament (ACL) of the knee joint and for the repair of the supraspinatus tendon of the shoulder joint. [Background technology]

[0002] One of the most common injuries in the field of traumatology is the rupture of joint tendons and ligaments.

[0003] The most common tendon rupture is that of the rotator cuff of the shoulder, primarily the supraspinatus tendon. This injury is the leading cause of shoulder instability and is present in 20.7% of the general population, with prevalence increasing with age (Yamamoto A et al., J Shoulder Elbow Surg. 2010 Jan;19(1):116-20).

[0004] Screws threaded into the humeral head are often used during supraspinatus tendon reconstruction surgery. These screws carry sutures or suture bands that are passed through the damaged end of the tendon to tension, reduce, and secure the tendon to its original insertion site.

[0005] A problem that often hinders successful reconstruction is that the screws carrying the sutures only provide superficial compression to the ends of the tendon, an area that is further reduced by the screws themselves at the tendon's original insertion site, thereby hindering the healing process. If the tendon does not heal, surgery becomes inappropriate, as the surgery is intended not only to reposition the tendon within the bone, but also to promote the tendon-bone healing process for proper reconstruction of the injured tendon (Castagna et al. 2018, Arthroscopic Transosseous Rotator Cuff Repair).

[0006] With regard to ligaments, rupture of the knee cruciate ligaments, primarily the anterior cruciate ligament (ACL), occurs in patients of all ages and stands out as the most common rupture.

[0007] In most cases, patients suffering from an ACL tear must undergo a surgical procedure that consists of removing the damaged ACL and replacing it with an implant, the ends of which are placed and secured into the respective tibial and femoral bone tunnels.

[0008] Similar to tendons, achieving an anatomical ACL reconstruction requires a system that can restore the original insertion area. Unfortunately, with current technology, 70% of patients develop osteoarthritis within 15-20 years after surgery.

[0009] Solutions are currently known in the art that describe arthroscopic guides capable of forming two or more consecutive bone tunnels that are subsequently attached by dilators to successfully restore the original anatomical bony insertion of the ACL. For example, U.S. Patent Application Publication No. 2019 / 0192278 describes an arthroscopic guide capable of forming three consecutive bone tunnels that are subsequently attached by dilators.

[0010] However, the first problem associated with this type of multi-tunnel fracture system is that the tibia cannot be accessed "inside-out," making it impossible to perform an "all-in" cruciate ligament reconstruction technique. The second problem is that accessing the lateral femoral condyle through the medial portal makes it impossible to create a femoral tunnel that is sufficiently transverse, resulting in the loss of torsional integrity of the original ACL. The consequences of failing to fully restore the torsional biomechanics of the original ACL are widely documented in the literature: rotational instability of the knee and mid-term osteoarthritis.

[0011] The solution to these problems requires minimally invasive surgery to create bone tunnels for the passage of sutures and carve bone receiving areas along the original anatomical insertion area intended for the insertion of the damaged ends of the tendons and / or implants used in repair or reconstruction, which is not possible with the articulating breaking instruments currently present in the state of the art, such as those described in documents US WO219US22632 and US 9254138.

[0012] These state-of-the-art articulating breaking instruments are intended to break tissue during minimally invasive discectomy procedures. Both breaking instruments comprise a rotary motion transmission shaft and a breaking element articulated to the rotary motion transmission shaft. However, both of the solutions described in the literature result in one-sided instruments with multiple components, which increases manufacturing and assembly costs and does not provide the breaking instruments with the rigidity required to carve bone tissue.

[0013] Furthermore, both state-of-the-art breaking instruments allow sweeping of only one of the sagittal sides of the breaking instrument: the breaking element starts from a straight position where it is coaxial with the rotary motion transmitting shaft, and goes to an inclined position where it is inclined to said shaft, but only to one of the sides and not to the opposite side.

[0014] In intervertebral dissection, a small and lightweight motion generating device, i.e., a microdrill, is used because the tissue being broken is soft tissue, and therefore, once introduced into the intervertebral space, a simple unilateral articulation of the breaking instrument is sufficient, as the system comprising the breaking instrument and microdrill can be easily manipulated and rotated due to its light weight.

[0015] However, in minimally invasive surgery for anatomical enlargement of bone tunnels in large bones such as the tibia, femur, and humerus, heavier drills are used, and in this application, a bilateral articulating breaking instrument prevents the complication of having to rotate the entire system to chisel the bone bilaterally.

[0016] Therefore, taking these issues into consideration, there is a need to provide bilateral articulating breaking instruments and systems that are rigid enough to carve bone tissue into larger bones, allowing them to create a straight bone tunnel and then widen its intra-articular exit opening bilaterally in a simple, reliable, reproducible, and precise manner, providing a bone receptacle suitable for anatomical reinsertion and regeneration of the end of a damaged tendon or ligament. Summary of the Invention

[0017] The present invention proposes a solution to the aforementioned problems by means of a breaking instrument for surgical intervention according to claim 1 and a breaking system for surgical intervention according to claims 15 and 16. The dependent claims define preferred embodiments of the invention.

[0018] In a first inventive aspect, the present invention provides a bilateral breaking instrument for minimally invasive surgical intervention, comprising: longitudinal elements oriented according to a main longitudinal axis, a first longitudinal body configured to perform linear movement along a primary longitudinal axis and having a first distal end; a second longitudinal body arranged parallel to the first longitudinal body, configured to perform a linear movement along the main longitudinal axis, and having a second distal end, A break assembly, a breaking element including a breaking axis and configured to undergo and perform a breaking movement about the breaking axis and to perform an angular movement in a major plane forming a plurality of angles α with respect to a major longitudinal axis contained in the major plane, the major plane including the major longitudinal axis and the breaking axis; and A motion transmission element comprising a distal portion, The motion transmission element is disposed inside the longitudinal element between the first longitudinal body and the second longitudinal body; attached to the breaking element by a distal portion; a breaking assembly comprising, in sequence, a motion transfer element configured to receive and perform the breaking motion and transfer the breaking motion to the breaking element; Articulated attachment means, a first portion attached to a first distal end of the first longitudinal body; a second portion attached to the second distal end of the second longitudinal body; and a central portion including a through hole through which the break assembly passes, the break assembly being secured inside the through hole; the articulating mounting means being configured for angular movement in a major plane of the breaking tool; - when the first longitudinal body undergoes a linear movement in a proximal-distal direction, the second longitudinal body undergoes a linear movement in a distal-proximal direction and the breaking element undergoes an angular movement in a first direction in the main plane; - a double-sided breaking instrument comprising articulated mounting means, wherein when the first longitudinal body undergoes a linear movement in a distal-proximal direction, the second longitudinal body undergoes a linear movement in a proximal-distal direction and the breaking element undergoes an angular movement in a direction opposite to the first direction in the main plane.

[0019] The bilateral rupture instrument of the present invention can create bone tunnels suitable for anatomical reconstruction of damaged tendons and / or ligaments. In particular, the instrument can create elongated, e.g., straight, curved, or angled, bone tunnels with intra-articular exit openings resembling the original anatomical insertion area, allowing the tendon or ligament being reconstructed to be accommodated at a bone depth sufficient to ensure its regeneration. This achieves restoration favorable for osseointegration.

[0020] Throughout this specification, tendon shall be understood to mean a band of connective tissue configured to attach muscle to bone, and ligament shall be understood to mean a band of connective tissue configured to attach bones to one another.

[0021] Throughout this specification, the proximal end of an element of an instrument (or system) shall be understood to mean the end closer to the subject who will be using the instrument. In contrast, the distal end of an element of an instrument (or system) shall be understood to mean the end further away from the subject who will be using the instrument. Preferably, the subject or user is a physician, veterinarian, or medical or veterinary professional.

[0022] First, the device comprises a longitudinal element. "Longitudinal" shall be understood to mean that the body is made or arranged oriented along its length, in particular along its main longitudinal axis.

[0023] The longitudinal elements in turn comprise a first longitudinal body and a second longitudinal body, both of which are arranged in parallel and each of which undergoes a linear movement along a main longitudinal axis. Preferably, the first longitudinal body and the second longitudinal body are in the form of a channel, a conduit or a semi-cylindrical tube, the hollow portions of each of the bodies facing each other.

[0024] Second, the instrument comprises a break assembly, which in turn comprises a break element and a motion transfer element attached to one another. This attachment may be a fixed attachment, so that the assembly is a one-piece assembly, or may be by an intermediate attachment element, for example, by a bearing. Furthermore, this attachment is established between a distal portion of the motion transfer element and a proximal-most end of the break element.

[0025] Throughout this specification, "breaking element" shall be understood to mean any type of element capable of breaking, crushing, cutting, reaming, abrading, compressing or perforating biological tissue, in particular bone tissue.

[0026] In particular examples, the breaking element is a mill, a breaking mill, a bit, a blade, a scraper, a file, a vibratory breaking element, or a reciprocating breaking and / or compression element.

[0027] In another particular example, the fracture element is a compression mill that induces bone compaction, which is important for early loading, and can shorten the rehabilitation time required to return to pre-injury activity levels.

[0028] In another more specific example, the breaking element is: have a frustoconical shape with a proximal diameter greater than the distal diameter; -Has a cylindrical shape A mixed element, the proximal segment is a compression segment and the distal segment is a fracture segment; · Having a distal cross section that corresponds to a circular, elliptical, trilobal, polygonal, or any other geometric shape.

[0029] In certain embodiments, the diameter of the breaking element is user adjustable.

[0030] The breaking element comprises a breaking axis, for example a rotation axis about which the element rotates or a vibration axis about which the element performs a vibration movement. The element is configured to receive and perform a breaking movement, which is understood to be a movement that can be performed by the breaking element so that the element can break human tissue, preferably bone. Examples of breaking movements include rotational and / or reciprocating and / or vibration movements performed about the breaking axis.

[0031] Throughout this specification, rotation or rotational movement shall be understood to mean a movement in which the breaking element makes a rotation (constant or not) of 360 degrees, and oscillation or oscillatory movement shall be understood to mean a movement in which the breaking element oscillates about a stable equilibrium position, preferably in a cyclical movement, moving between two extreme positions.

[0032] Furthermore, the breaking element is configured to undergo and perform angular movements in a major plane, whereby said breaking element gradually forms a plurality of angles α (denoted as α1, α2, etc.) with respect to the major longitudinal axis, whereby a major plane shall be understood to mean a plane containing the major longitudinal axis and the breaking axis at any position of said breaking axis.

[0033] To enable the breaking element to perform the breaking movement, the breaking assembly further comprises a motion transmission element disposed inside the longitudinal element, i.e., between the first and second longitudinal bodies. Preferably, the first and second longitudinal bodies are semi-cylindrical tubes, and the motion transmission element is housed inside the hollow portions of both semi-cylindrical tubes.

[0034] Preferably, the motion transfer element is flexible. In one example, the flexibility of the motion transfer element is due to the braided tubular configuration of the element. In another example, the flexibility of the motion transfer element is due to the tubular configuration with cuts and / or openings in the element. In another example, the flexibility of the motion transfer element is due to the element comprising a superelastic nitinol braided core and an outer polymer layer.

[0035] The motion transmission element is attached to the breaking element either directly or by an intermediate attachment means, so that the breaking motion received and performed by the motion transmission element relative to its breaking axis is transmitted to the breaking element which performs said breaking motion relative to its own breaking axis.

[0036] Preferably, the motion transmitting element is in the form of a rod or an elongated cylinder.

[0037] Finally, the device comprises articulating attachment means. Throughout this specification, the term "articulating" shall be understood as a means or element that is attached to one or more elements so that they maintain a certain degree of freedom of movement relative to one another, as well as an element that folds on itself, constituting a part that maintains a certain degree of freedom of movement relative to one another.

[0038] Thus, the articulated attachment means comprises three parts attached to each other to form a single part, a first part which is in turn attached at its distal end to a first longitudinal body; a second portion which is in turn attached at its distal end to a second longitudinal body, and - a central part arranged between the first part and the second part, the central part having a through hole through which the breaking assembly passes, the breaking assembly being fixed inside the through hole.

[0039] Preferably, the attachment between the first part and the first longitudinal body, as well as the attachment between the second part and the second longitudinal body, is a mechanical attachment, for example by a hinge. Alternatively, this or these attachments may be flexible, i.e. all elements form an integral assembly, but their attachments maintain a degree of freedom.

[0040] The articulating mounting means is configured to perform angular movement about the through hole in a major plane of the instrument, this angular movement being the result of linear movement of the first longitudinal body and the second longitudinal body. On the one hand, when the first longitudinal body undergoes a linear movement in the proximal-distal direction, the first part of the articulating attachment means also describes a proximal-distal movement. At the same time, the second longitudinal body undergoes a linear movement in the distal-proximal direction, and the second part of the articulating attachment means also describes a distal-proximal movement. In this way, both parts move in opposite directions around the through-hole of the central part.

[0041] On the other hand, when the first longitudinal body performs a distal-proximal linear movement, the first part describes the distal-proximal movement, and at the same time the second longitudinal body and the second part of the articulated attachment means perform a corresponding proximal-distal linear movement.

[0042] The purpose of this angular movement is to cause the breaking element to perform an angular movement relative to the main longitudinal axis in a main plane. Since the breaking assembly passes through and is fixed inside the through-hole of the attachment means, angular movement of said attachment means causes angular movement of the breaking element. In particular, when the first part performs a proximal-distal movement, the breaking element moves angularly on its front face in a first direction, for example, to the left. On the other hand, when the second part is the part that performs said proximal-distal movement, the breaking element moves angularly on its front face in a direction opposite to the first direction, for example, to the right.

[0043] Throughout this specification, movement left or right, or up or down, shall be understood to mean movement from the perspective of the user handling the breaking instrument.

[0044] First, the bilateral breaking instrument of the present invention allows a user to carve a straight bone tunnel when the breaking element is in a first position with its breaking axis coaxial with the major longitudinal axis of the breaking instrument, and then, after describing an angular movement, allows a user to widen the intra-articular exit opening of said bone tunnel when the breaking element is in a second position so that it is oriented according to a second longitudinal axis that forms an angle α with respect to the major longitudinal axis.

[0045] The intra-articular outlet opening has a geometry similar to that of the original anatomical region of insertion of the ligament or tendon being repaired. For example, to repair an ACL in a knee joint, an elongated intra-articular outlet opening having a funnel shape and / or a rectangular shape can be carved into the respective tibial and femoral bone tunnels, and to repair a damaged supraspinatus tendon in a shoulder joint, a similarly elongated intra-articular outlet opening having a funnel shape and / or a rectangular shape can be carved into a transosseous bone tunnel.

[0046] In a first specific example of the use of the device to repair a damaged supraspinatus tendon of the rotator cuff, the dimensions of the intra-articular exit opening of the bone tunnel formed must be such as to allow for the insertion of the end of the damaged tendon, measuring between 4 mm and 5 mm in thickness and between 20 mm and 25 mm in width at the level of the rotator cuff.

[0047] In a second specific example of the use of the instrument to reconstruct the anterior cruciate ligament, the intra-articular exit opening of the bone tunnel formed must be such as to allow the insertion of a fibrous material having a thickness measuring between 2 mm and 4 mm and a width measuring between 12 mm and 18 mm.

[0048] However, these specific measurement ranges provided in the two specific use cases must be adapted based on the anatomy of each patient and on the end use for which the breaking instrument will be used, which in general use is suitable for breaking any connective tissue and / or cartilage tissue and / or bone tissue in medicine or veterinary medicine.

[0049] Advantageously, such anatomic expansion created with the instrumentation is highly favorable for tissue healing, meaning that the surgery is effective and the results are long-lasting.

[0050] In another particular use, the disruption instrument is suitable for efficiently disrupting and removing tissue from an intervertebral disc to create a space of a selected shape and size during a minimally invasive vertebral discectomy.

[0051] In a particular example of use, the disruption device is suitable for disrupting any connective tissue and / or cartilage and / or bone tissue in human or veterinary medicine.

[0052] In a particular example of use, the breaking instrument is suitable for forming and / or carving out any kind of tunnel in surgical interventions for the reconstruction of any connective and / or cartilage and / or bone tissue in medicine or veterinary medicine.

[0053] In one embodiment, the breaking device is disposable.

[0054] In certain embodiments, the break assembly is passed through the interior of the through hole, by a breaking element, or by a motion-transmitting element, or Partly by a breaking element and partly by a motion-transmitting element, or by bearings fitted in through-holes, or -Fixed by a combination of two or more of the above.

[0055] In certain embodiments, the breaker assembly penetrates and is secured inside the through hole by a bushing or bearing fitted into the through hole.

[0056] The attachment between the motion transmission element and the breaking element may be proximal to the through conduit, or distal to the through conduit, or the attachment may be located on the through conduit.

[0057] In this particular embodiment, different possible configurations between the break assembly and the articulating attachment means are contemplated, although there may be other configurations that are viable in the context of the present invention. As mentioned above, the articulating attachment means comprises a central portion having a through hole through which the break assembly passes and to which the break assembly is fixed inside the through hole.

[0058] In one embodiment, the element secured through the through hole is a breakaway element rigidly attached to the motion transfer element outside the through hole.

[0059] In one embodiment, the element secured through the through hole is a motion transmission element that is rigidly attached to the breaking element outside the through hole.

[0060] In one embodiment, the breaking element and the motion transmission element each pass partially through the through hole and are fixed inside the through hole, in which case the attachment between said elements is established inside the through hole.

[0061] In this embodiment, different possible configurations between the break assembly and the articulating attachment means are contemplated, although there may be other configurations that are feasible in the context of the present invention. As mentioned above, the articulating attachment means comprises a central portion with a through hole through which the break assembly passes and which is fixed inside the through hole.

[0062] In one embodiment, the element fixed through the through hole is a break-away element that is attached rigidly or by a fixing means to the motion-transmitting element outside the through hole.

[0063] In one embodiment, the element fixed through the through hole is a motion transmission element that is attached, rigidly or by a fixing means, to the breaking element outside the through hole.

[0064] In one embodiment, both the breaking element and the motion transfer element each pass partially through the through hole and are fixed inside the through hole, in which case the attachment between said elements is established inside the through hole.

[0065] In one embodiment, the element fixed through the through hole is a bearing that acts as a fixing means between the motion transmission element and the breaking element.

[0066] In certain embodiments, the motion transmission element and / or the breaking element are cannulated.

[0067] Throughout this specification, the adjective "cannulated" when referring to an element shall be understood to mean including a longitudinal conduit through which the element extends.

[0068] In certain embodiments, the double-sided breaking tool further comprises at least a first attachment and / or coupling means configured to attach and / or couple the motion transmission element to the breaking motion generating device.

[0069] The double-sided breaking tool can be coupled to a breaking motion generating device, e.g., a drilling device, which generates a rotational motion, from which the tool, in particular the motion transmission element, receives the breaking motion and in turn transmits it to the breaking element.

[0070] In anticipation of the possibility that there may be many different types of breaking motion generating devices, the present embodiment contemplates an option for the tool to include one or more attachment and / or coupling means configured to attach or couple a motion transmission element to one or more such devices.

[0071] Advantageously, the device also has great versatility and can be coupled to any commercially available breaking motion generating device.

[0072] In certain embodiments, the bilateral breaking device further comprises a support at least partially surrounding the longitudinal element and a second attachment and / or coupling means configured to attach and / or couple the support to the breaking motion generating device.

[0073] In this embodiment, the instrument comprises a support, understood to be a body that partially surrounds the longitudinal element and facilitates gripping the instrument. Optionally, this body may be further attached or coupled to the breaking motion generating device by one or more second attachment and / or coupling means.

[0074] In anticipation of the possibility that there may be many different types of breaking motion generating devices, the present embodiment contemplates the option of an apparatus comprising one or more secondary attachment and / or coupling means configured to attach or couple the support to one or more such devices.

[0075] Advantageously, the device also has great versatility and can be coupled to any commercially available breaking motion generating device.

[0076] In certain embodiments, the bilateral breaking instrument further comprises a breaking guide configured to guide the longitudinal element from the original position to at least one target position, the breaking guide comprising: a tubular guide, a longitudinal conduit having a proximal end and a third distal end, the longitudinal conduit including a distal appendage at the third distal end; a striking edge, an extension of the longitudinal conduit at the proximal end, Equipped with the longitudinal conduit is configured to receive the longitudinal element therein; the tubular guide is oriented according to a first longitudinal guide axis; a tubular guide, the striking edge being configured to receive a striking force in the direction of the first longitudinal guide axis; and a guide arch, a proximal arch portion comprising first coupling means configured to securely couple and uncouple the proximal arch portion to the tubular guide at a plurality of different locations along the tubular guide; a distal arch portion, the distal arch portion in turn comprising a distal tip and a distal point through which the first longitudinal guide axis passes; a second coupling means configured to couple and decouple the distal arch portion to the proximal arch portion at a plurality of different positions, the second coupling means being oriented according to a first longitudinal guide axis starting from a first position according to the tubular guide, and wherein the second coupling means forms an angle β with the first longitudinal axis when the second coupling means is in a position other than the first position according to the second longitudinal guide axis; and a guide arch.

[0077] In this embodiment, the instrument contemplates a break guide configured to guide the breaking element and the longitudinal element from a first original position where the breaking element is coaxial with the primary longitudinal axis (to initiate engraving of the straight bone tunnel) to at least a first target position, particularly a position where the breaking element has been moved forward to linearly engrave the straight bone tunnel. Further, the break guide is configured to guide the breaking element and the longitudinal element from a second original position where the breaking element is angled relative to the primary longitudinal axis (to widen the intra-articular exit opening of the straight bone tunnel) to at least a second target position, particularly a position where the user has moved the breaking instrument rearward with the breaking element angled relative to the longitudinal axis (to thereby reverse engrave the intra-articular exit opening of the initially engraved straight bone tunnel).

[0078] Advantageously, the use of a fracture guide allows for increased precision in the placement of the fracture instrument to carve a bone tunnel at a targeted anatomical location as well as to improve the actual utility of the instrument.

[0079] Firstly, the breaking guide comprises at least one tubular guide, which comprises, in order, the following elements:

[0080] A longitudinal conduit, preferably tubular, having a proximal end and a distal end. The conduit is dimensioned so that the longitudinal element can be accommodated therein. Furthermore, the distal end comprises a distal appendage (e.g., a peripheral recess), understood to be a distal end portion, an extension of the longitudinal conduit, the cross section of which has a smaller diameter than the diameter of the remainder of the longitudinal conduit. In certain embodiments, this distal appendage comprises a polyhedral surface.

[0081] - striking edge, an extension of the longitudinal conduit at its proximal end. In the context of the present invention, "striking edge" shall be understood to mean a protrusion of the longitudinal conduit at its proximal end. For example, the striking edge may be a part glued to the longitudinal assembly or integrated into said longitudinal assembly as a single part.

[0082] The guide is oriented according to the first longitudinal guide axis mentioned above, which coincides with the main longitudinal axis along which the longitudinal element is oriented when it is inserted into the break guide.

[0083] The method for introducing the breaking device is as follows: - Carving out the entire bone tunnel with the fracture instrument and fracture guide; removing the guide arch by maintaining a breaking instrument inside the bone tunnel and inside the tubular guide; and - introducing the distal appendage into the first segment of the bone tunnel by striking the striking edge.

[0084] The distal appendage, once chiseled, is sized and configured to be inserted into the first segment of the bone tunnel, with a diameter that allows for the introduction of the appendage in the first segment of the bone tunnel with a specific clamping force, while preventing the introduction of the remainder of the longitudinal conduit in the bone tunnel. Preferably, the outer diameter of the appendage is substantially equal to or slightly larger than the diameter of the first segment of the bone tunnel.

[0085] To introduce the appendage into the first segment of the bone tunnel, the user must exert a certain striking force on the proximal end of the striking edge in the direction of the first longitudinal guide axis, which force can be applied, for example, by means of a hammer.

[0086] Preferably, the proximal end of the striking edge is substantially flat.

[0087] Advantageously, the force applied to the striking edge ensures play-free penetration of the distal appendage in the first segment of the bone tunnel, which allows the guide to remain in a stable position, thereby increasing the accuracy of placement of the longitudinal element for engraving the second segment of the bone tunnel at the anatomical target location as well as improving the actual usability of the instrument.

[0088] Second, the break guide comprises a guide arch. Thus, the curved element comprises a proximal arch portion, which in turn should be understood to comprise a first coupling means capable of securely coupling said proximal arch portion to the tubular guide at a plurality of different locations along the tubular guide. The guide arch further comprises a distal arch portion terminating at a distal tip and comprising a distal point through which the first longitudinal guide axis passes. Finally, the guide arch comprises a second coupling means capable of coupling said distal arch portion to the proximal arch portion at a plurality of different locations.

[0089] The first longitudinal guide axis about which the tubular guide is oriented when the second coupling means is in one position forms a different angle α2 with the first longitudinal guide axis about which the tubular guide is oriented when the second coupling means is in any of the other positions.

[0090] The distal tip of the distal portion is preferably configured to be introduced into a patient's body, thereby securing the fracture guide. In one example, the distal portion has an elliptical, cylindrical, or annular configuration, and optionally, the distal tip is sharp.

[0091] By fixing the distal tip within the patient, a more stable guide position can be achieved, which allows for greater accuracy in the placement of the longitudinal elements to carve bone tunnels into anatomical target locations as well as to improve the actual utility of the instrument.

[0092] Additionally, the first coupling means is configured to securely couple and uncouple the proximal arch portion to the tubular guide at a plurality of different locations along the guide. Advantageously, this first coupling means allows the tubular guide to be positioned at different locations, making the fracture guide highly versatile and adaptable to specific applications (medical or veterinary), specific surgeries, and / or specific patient anatomy. Another additional advantage is that the guide arch can be easily uncoupled from the tubular guide, allowing the guide arch to be easily removed once the longitudinal element has been inserted into the tubular guide and the bone tunnel has been carved.

[0093] The second coupling means between the proximal and distal arch portions allows the user to adapt the guide to the direction in which they wish to carve the first segment of the bone tunnel based on the user's preference and each patient's anatomy.

[0094] Enlarging the intra-articular exit opening of the bone tunnel requires tilting the breaking element on either side of the first longitudinal guide axis with the breaking movement activated.

[0095] In certain embodiments, the tubular guide further comprises a first longitudinal hole and a second longitudinal hole; the first longitudinal body further comprising a first protrusion; the second longitudinal body further comprises a second protrusion; the first longitudinal bore is sized and configured to receive and guide the first protrusion from the proximal position to the distal position and vice versa; The second longitudinal bore is sized and configured to receive and guide the second projection from a proximal position to a distal position and vice versa.

[0096] In this embodiment, the invention contemplates two holes in the guide and two protrusions of the longitudinal element disposed on the first and second longitudinal bodies, each hole-protrusion pair intended to guide the breaking element both to form a linear bone tunnel and to carve the intra-articular exit opening.

[0097] Both holes are sized and configured to receive and guide both protrusions of the longitudinal bodies from a proximal position, i.e., the point at which one of the longitudinal holes receives its corresponding protrusion, to a distal position where the protrusion extends all the way through the corresponding longitudinal hole. The longitudinal bodies move in opposite directions so that when the protrusion of the first longitudinal body is in a proximal position, the protrusion of the second longitudinal body is in a distal position, and vice versa.

[0098] Furthermore, the hole-protrusion pair also allows for guiding the breaking element during the reverse engraving procedure. Thus, once the straight bone tunnel is created, the user can move the breaking instrument posteriorly inside the tubular guide in a distal-proximal direction to widen the intra-articular exit opening. This widening requires a continuous actuation of the breaking motion.

[0099] Advantageously, the break guide increases the usefulness and accuracy of the break instrument when forming a reamed intra-articular exit opening in the bone tunnel.

[0100] In certain embodiments, the distal appendage comprises: Trilobed tip, or Two tips, or chamfered recesses, or ·Polyhedral surface Equipped with.

[0101] In this embodiment, different types of distal appendages are provided, although there may be other types that fall within the context of the present invention.

[0102] In certain embodiments, the bilateral breaking instrument further comprises an actuator configured to generate and transmit linear motion to the first longitudinal body and the second longitudinal body such that both longitudinal bodies move linearly in opposite directions.

[0103] Thus, the movement of the two longitudinal bodies is coordinated by an actuator, so that when one of the longitudinal bodies moves in one direction, the other longitudinal body moves linearly in the opposite direction. Both linear movements are simultaneous movements in opposite directions and are driven by actuators.

[0104] Advantageously, the actuator allows the user of the breaking tool to tilt the breaking element at will. Furthermore, in order for the breaking element to perform an angular movement, the longitudinal bodies of the longitudinal elements must move linearly in opposite directions.

[0105] In this embodiment, enlarging the bone tunnel using the bilateral breaking instrument is performed by an actuator that allows a user to tilt the breaking element to one side of the first longitudinal guide axis to back-cut a first enlarged segment of the bone tunnel, and then, again by the actuator, allows the user to tilt the breaking element in the opposite direction to back-cut a second enlarged segment of the bone tunnel.

[0106] In particular, in different specific embodiments of the breaking device of the present invention, the breaking element comprises: a) coaxial with the first longitudinal axis (used in this position to carve a straight bone tunnel); b) inclined to a first side of the first longitudinal axis; and c) can be arranged in a different position, inclined to a second side of the first longitudinal axis, the second side being opposite the first side;

[0107] In one embodiment, the first longitudinal body comprises a first longitudinal notch configured to cooperate with an actuator; the second longitudinal body comprises a second longitudinal notch configured to cooperate with an actuator; The actuator a first rod configured to extend through and cooperate with the first longitudinal notch; a second rod configured to extend through and cooperate with the second longitudinal notch; and an actuation trigger attached to the first rod; the first rod and the second rod are arranged in parallel and attached to each other at their ends by two longitudinal portions; when the actuation trigger performs a rotational movement in a proximal-distal direction about a rotation axis located between the first rod and the second rod; the first rod undergoes a proximal-distal rotational movement and causes the first longitudinal body to undergo a proximal-distal linear movement; the second rod has a distal-proximal rotational movement and a distal-proximal linear movement of the second longitudinal body; When the actuation trigger performs a rotational movement in the distal-proximal direction relative to the rotation axis, the first rod undergoes a distal-proximal rotational movement and causes the first longitudinal body to undergo a distal-proximal linear movement; The second rod provides proximal-distal rotational movement and imparts proximal-distal linear movement to the second longitudinal body.

[0108] This embodiment describes a first embodiment of an actuator configured to generate and transmit a linear motion to a longitudinal element, which cooperates mechanically with this element.

[0109] On the one hand, the first longitudinal body and the second longitudinal body of the longitudinal element each include a longitudinal notch, both longitudinal notches being configured to cooperate with an actuator.

[0110] The actuator comprises, in sequence, a first rod and a second rod, each sized and configured to pass through and cooperate with a notch in the longitudinal element. The rods are arranged parallel and attached to each other by two longitudinal portions, the two rods and two longitudinal portions forming a quadrilateral. The actuator further comprises a manual trigger attached to the first rod that can be operated by a user.

[0111] When the user manipulates the actuation trigger, it represents a proximal-distal or distal-proximal movement, and by attaching the trigger to the first rod, the quadrilateral formed by the rod and the longitudinal portion describes a rotation about its own axis of rotation located between the first rod and the second rod in turn.

[0112] When the motion described by the trigger is in the proximal-distal direction, the first rod performs a rotational motion in the proximal-distal direction about the rotation axis of the quadrilateral, causing the first longitudinal body to perform a proximal-distal linear motion. In turn, the second rod performs a rotational motion in the opposite direction, i.e., in the distal-proximal direction, causing the second longitudinal body to perform a distal-proximal linear motion.

[0113] In contrast, when the motion described by the trigger is in the distal-proximal direction, the first rod performs a rotational motion about the quadrilateral's axis of rotation in the distal-proximal direction, causing the first longitudinal body to perform a distal-proximal linear motion. In turn, the second rod performs a rotational motion in the opposite direction, i.e., in the proximal-distal direction, causing the second longitudinal body to perform a proximal-distal linear motion.

[0114] Advantageously, this mechanism allows the longitudinal body of the longitudinal element to move synchronously in the opposite direction to the actuation trigger, which in turn causes the breaking element to describe angular motion in both directions. In other words, the actuator of this embodiment successfully converts the rotational motion of the trigger into linear motion of the longitudinal element by means of this "slot" or groove shape.

[0115] In one embodiment, the double-sided breaking instrument further comprises positioning and fixing means for the actuator, the positioning and fixing means for the actuator being configured to position and fix the actuator in a plurality of different positions such that for each of said positions the distance between the first distal end and the second distal end of both longitudinal bodies is different.

[0116] In this embodiment, it is contemplated that the instrument comprises positioning and fixing means for the actuator configured to position the actuator in different positions and fix the actuator in selected positions.

[0117] Preferably, the actuator positioning and fixing means are adapted to position the actuator in three positions: 1. A position of the first end where the first longitudinal body achieves its maximum proximal-distal movement and the second longitudinal body achieves its maximum distal-proximal movement; 2. A position of the second end where the first longitudinal body achieves its maximum distal-proximal movement and the second longitudinal body achieves its maximum proximal-distal movement; and 3. Fixing in a neutral position where both longitudinal bodies are aligned such that the relative distance between their distal ends is substantially zero.

[0118] Alternatively, the actuator positioning and fixing means may allow the actuator to be positioned and fixed in other intermediate positions in addition to both end positions and the neutral position.

[0119] In a more particular embodiment, the actuator positioning and fixing means comprises a hole in the support sized and configured to receive a ball and a spring, the spring being disposed at the bottom of the hole in the support such that the spring urges the ball outward from the hole, and the trigger further comprises two or more holes sized and configured to partially receive the balls.

[0120] When the hole in the support is positioned facing one of the holes in the trigger, the ball, pressed by the spring, is partially positioned in the hole in the trigger and fixes the position, which can be overcome by rotating the trigger so that the ball is again fully housed inside the hole in the support until it reaches a new position in which the hole in the support is positioned facing the new hole in the trigger, thereby allowing the positioning means to fix different positions of the trigger in which the hole in the support is positioned facing one of the holes in the trigger.

[0121] In one embodiment, the actuator further comprises a return spring configured to apply a returning force to the first longitudinal body and the second longitudinal body such that relative motion between said bodies is substantially zero.

[0122] In this embodiment, it is contemplated that all of the actuators of the preceding embodiments include a return spring configured to position the longitudinal bodies in a neutral position, i.e., a position where there is zero relative movement between the longitudinal bodies.

[0123] In another embodiment, the first longitudinal body includes a first external thread configured to cooperate with an actuator, and the second longitudinal body includes a second external thread configured to cooperate with the actuator, the first external thread and the second external thread having opposite thread directions; The actuator is Nuts, in turn, a first female thread portion that mates with the first male thread; and A second female thread portion that is compatible with the second male thread, and the first female thread portion and the second female thread portion have opposite threading directions. a nut configured to cooperate with the first longitudinal body and the second longitudinal body such that the assembly functions like a dual spindle mechanism; -with an actuation control device attached to the nut, When the actuation control device executes a rotational movement in the thread direction of the first female threaded portion, the first longitudinal body executes a proximal-distal linear movement, and the second longitudinal body executes a distal-proximal linear movement; When the actuation control device performs a rotational movement in the thread direction of the second female threaded portion, the first longitudinal body performs a distal-proximal linear movement, and the second longitudinal body performs a proximal-distal linear movement.

[0124] Throughout this document, "spindle mechanism" shall be understood to mean the assembly formed by the spindle screw and the nut, wherein rotational movement of the screw while the nut remains fixed causes linear movement of the screw relative to the nut, and vice versa. Thus, rotational movement of the screw is successfully converted by this system into linear movement of the nut, and vice versa.

[0125] In this embodiment, a "double spindle mechanism" is used. On the one hand, the first longitudinal body and the second longitudinal body each have an external thread, which allows them to function as spindle screws. The threads of both longitudinal bodies have opposite or opposite thread directions.

[0126] The actuator, on the other hand, comprises a nut with two different internal threads. The first internal thread is adapted to fit the external thread of the first longitudinal body, and the second internal thread is adapted to fit the external thread of the second longitudinal body. "Adaptable" shall be understood to mean that the longitudinal body can be screwed onto the threads. Furthermore, the first and second threads have opposite thread directions.

[0127] The actuator further includes a control device attached to the nut. Operation of the control device, i.e., its rotation to one side or the other, causes the attached nut to rotate. Thus, when the control device rotates, the double spindle mechanism is activated, causing the longitudinal body, acting like a spindle screw, to move linearly in different directions relative to the nut.

[0128] Thus, when the actuation control device effects a threaded rotation of the first internally threaded portion, the first longitudinal body performs a proximal-distal linear motion and the second longitudinal body performs a distal-proximal linear motion, whereas when the actuation control device effects a threaded rotation of the second internally threaded portion, the first longitudinal body performs a distal-proximal linear motion and the second longitudinal body performs a proximal-distal linear motion.

[0129] In one embodiment, the double-sided disruption tool further comprises a suction line connectable to an external suction device for removing tissue.

[0130] In certain embodiments, the breaking instrument comprises a suction line connectable to an external suction device for removing the broken tissue. Preferably, the breaking element and the breaking motion transmission element are cannulated, each comprising a distal suction window for aspirating bone powder simultaneously with cutting bone and / or for aspirating soft tissue simultaneously with breaking or reaming tissue. In even more particular embodiments, the external suction device comprises a vacuum system.

[0131] In one embodiment, the first longitudinal body and / or the second longitudinal body are rigid and / or straight.

[0132] In an embodiment, the first longitudinal body and the second longitudinal body are structural elements, i.e. they form part of the external structure of the breaking instrument in order to provide the breaking instrument with a certain resistance and stiffness. Preferably, the elements are straight and stiff to provide the breaking instrument with an appropriate stiffness for efficiently carving bone tissue.

[0133] Additionally, a second inventive aspect of the present invention provides a breakage system for minimally invasive surgical intervention, the bilateral breakage system comprising: a breaking movement generating device configured to generate and execute a breaking movement; - at least one breaking tool according to any of the preceding embodiments, which is connectable to the breaking motion generator by at least one motion transmission element; and Equipped with.

[0134] In this embodiment of the double-sided breaking system, the actuator is preferably included in the breaking instrument itself, and the motion transmission element acts like a mechanical linkage to transmit the breaking motion generated by the breaking motion generating device to the breaking instrument.

[0135] In this case, the invention contemplates not only a double-sided breaking instrument, but also such an instrument in combination with a breaking motion generating device.

[0136] In one embodiment, the breaking instrument of the system is disposable. In another alternative or additional embodiment, at least a portion of the breaking motion generating device is disposable.

[0137] The advantages mentioned above for the instrument also apply to this system.

[0138] A third inventive aspect of the present invention is alternatively a bilateral break system for minimally invasive surgical intervention, comprising: a breaking movement generating device configured to generate and execute a breaking movement; at least one breaking tool as described above in the first inventive aspect, which can be coupled to the breaking motion generator by means of a motion transmission element and by means of a support, The breaking motion generating device provides a double-sided breaking system, further including an actuator configured to generate and transmit linear motion to the first longitudinal body and the second longitudinal body such that both longitudinal bodies linearly move in opposite directions upon receiving linear motion from the actuator.

[0139] In this embodiment, the present invention contemplates not only a double-sided breaking instrument, but also such an instrument in combination with a breaking motion generating device.

[0140] In the context of the present invention where it is not explicitly stated that the actuator is included in the breaking movement generating device, the actuator refers to an element belonging to the breaking instrument itself.

[0141] For the breaking element to undergo angular motion, the longitudinal body of the longitudinal element must move linearly in the opposite direction. Thus, this embodiment contemplates that the breaking motion generator provides a breaking motion to the motion transfer element, which in turn transfers the motion to the breaking element, providing a linear motion to the longitudinal body, causing the longitudinal body to move linearly in the opposite direction.

[0142] In one embodiment, the breaking instrument of the system is disposable. In another alternative or additional embodiment, at least a portion of the breaking motion and linear motion generating device is disposable.

[0143] In one embodiment, the fracture system of the present invention is an all-in-one system.

[0144] All the advantages obtained from the breaking device of the first aspect of the invention are applicable to any breaking system equipped with said breaking device.

[0145] All features and / or steps of the methods described herein (including the claims, description, and drawings) may be combined in any combination, except for such mutually exclusive feature combinations.

[0146] These and other features and advantages of the present invention will be more clearly shown on the basis of the following detailed description of preferred embodiments, given by way of illustrative and non-limiting example only, with reference to the accompanying drawings, in which: [Brief explanation of the drawings]

[0147] [Figures 1a-1e] 1 shows different views of a double-sided breaking tool according to an embodiment of the present invention, in particular, Fig. 1d shows an exploded view of the double-sided breaking tool when equipped with a first exemplary actuator, and Fig. 1e corresponds to a different configuration for attaching the flexible transmission element to the breaking element. [Figure 2] 10A-10C illustrate exemplary configurations of breaking elements according to different embodiments of the present invention. [Figures 3a-3d]10A-10C show a double-sided breaking instrument according to an embodiment of the present invention, wherein the instrument includes a breaking guide. [Figures 4a-4c] 1A-1C show side cross-sectional views of the instrument for different states of a first exemplary actuator. [Figures 5a-5c] 10 details the movement of the breaking element as a result of operation of the first exemplary actuator. [Figure 5d-5e] 1A-1C are a general three-dimensional perspective and side cross-sectional views of a double-sided breaking instrument according to an embodiment of the present invention. [Figure 6] 1 shows in detail the positioning and fixing means of a first exemplary actuator. [Figure 7a-7b] Figure 7a shows an exploded view of the breaking device including a second exemplary actuator, and Figure 7b shows a side cross-sectional view of the second exemplary actuator. [Figures 8a-8c] 10A-10C show side cross-sectional views of a breaking tool for different states of a second exemplary actuator. [Figures 9a-9f] 1 shows a two-part break-off system for surgical intervention in which a bilateral break-off instrument can be coupled to an orthopedic drill. [Figures 10a-10c] Figure 10a shows the cylindrical shape of a tunnel carved by a conventional unilateral breaking instrument, while Figures 10b and 10c show the funnel-shaped geometry of the respective bone tunnels carved by a bilateral breaking instrument of the present invention. [Figures 11a-11f] Figure 11a shows steps of a method for carving a bone tunnel with an enlarged intra-articular exit opening using the system of the present invention, and Figures 11b-11f show a first example of use of the system for repairing the supraspinatus tendon in the shoulder joint. [Figures 12a-12f] 1 illustrates steps in an example of using the system to repair the anterior cruciate ligament of the knee. [Figures 13a-13c] 1 illustrates different configurations of implants for anatomical repair of the anterior cruciate ligament of the knee. DETAILED DESCRIPTION OF THE INVENTION

[0148] Figures 1a-1c show perspective views of the exterior of the double-sided breaking device (100) with the breaking element (130) in a neutral position (Figure 1a), tilted in one direction (Figure 1b), and tilted in the opposite direction (Figure 1c). Figure 1d shows an exploded view of the double-sided breaking device (100). Figure 1e shows different configurations for attaching the motion transfer element (140) (flexible transfer element) to the breaking element (130).

[0149] 1a shows a preferred embodiment of a bilateral breaking instrument (100) for minimally invasive surgical interventions, comprising a longitudinal element (120) oriented according to a main longitudinal axis (101) which in turn comprises a first longitudinal body (121) and a second longitudinal body (122). Preferably, the first and second longitudinal bodies (121, 122) are in the form of channels, conduits or semi-cylindrical tubes, the hollow portions of each of said bodies facing each other.

[0150] This figure further shows that the instrument comprises an actuator (180) configured to generate and transmit linear motion to the first longitudinal body (121) and the second longitudinal body (122) such that both longitudinal bodies (121, 122) move linearly in opposite directions. This actuator (180) is merely an illustrative example, and there may be other types of similar actuators or elements that perform the same function as this actuator in the context of the present invention.

[0151] The figure further shows, although optional, a support (110) partially surrounding the longitudinal element (120) and accommodating therein the actuator (180). Furthermore, the double-sided breaking tool (100) may also optionally comprise second attachment and / or coupling means (170) configured to attach and / or couple the support (110) to a breaking motion generating device (200, 200'), for example a drilling device.

[0152] Second, the instrument comprises a breakaway assembly, which, not visible in this Figure 1a, comprises a breakaway element (130) and a motion transfer element (140) attached to one another in sequence. This attachment may be a fixed attachment, so that the assembly is a one-piece assembly, or may be provided by an intermediate attachment element, for example, by a bearing. Furthermore, this attachment is established between the distal portion (140.1) of the motion transfer element (140) and the proximal-most end of the breakaway element (130), as shown in Figure 1e.

[0153] The motion transmission element (140) is arranged inside the longitudinal element (120) between the first longitudinal body (121) and the second longitudinal body (122) and is configured to receive and execute the breaking motion and to transmit the breaking motion to the breaking element (130). Preferably, the motion transmission element (140) receives the breaking motion from a breaking motion generating device (200, 200'), for example a drilling device.

[0154] In turn, the breaking element (130) is configured to receive a breaking motion from the motion transfer element (140) and to perform said motion around its breaking axis (131).

[0155] Furthermore, the breaking element (130) is configured to undergo and perform angular movements at its front surface, whereby said breaking element (130) gradually forms a plurality of angles α with respect to the main longitudinal axis (101). To enable said breaking element (130) to perform the above-mentioned breaking movements, a motion transmission element (140) is arranged inside the longitudinal element (120), i.e., between the first longitudinal body (121) and the second longitudinal body (122). Preferably, the first longitudinal body (121, 122) and the second longitudinal body (121, 122) are semi-cylindrical tubes, and the motion transmission element (140) is housed inside the hollow portions of both semi-cylindrical tubes.

[0156] Optionally, the motion transmission element (140) and / or the breaking element (130) are cannulated as shown in detail in Figures 5d and 5e, which correspond to a three-dimensional view and a side cross-sectional view, respectively, of an embodiment of the breaking instrument (100) in which both the motion transmission element (140) and the breaking element (130) have respective longitudinal conduits (130.2, 140.2) passing therethrough.

[0157] Optionally, the bilateral breaking tool (100) also comprises at least a first attachment and / or coupling means (160) configured to attach and / or couple the motion transfer element (140) to a breaking motion generating device (200) without a second actuator (180'), e.g., a drilling device. Alternatively, the motion transfer element (140) can be coupled to a breaking motion generating device (200') that comprises a second actuator (180'), the latter case not being included in FIG.

[0158] In a preferred embodiment, the double-sided breaking instrument (100) comprises an actuator (180, 190) and at least a first attachment and / or coupling means (160) configured to attach and / or couple the motion transmission element (140) to a breaking motion generating device (200), e.g., a drilling device, without an actuator.

[0159] In another particular embodiment, the double-sided breaking instrument (100) does not comprise actuators (180, 190), but instead comprises mounting and / or coupling means (160, 170) for mounting and / or coupling to a breaking motion generating device (200) which in turn comprises actuators (180', 190').

[0160] 1b and 1c show by arrows the movements described by the elements of the instrument (100) during use. On the one hand, both parallel-arranged longitudinal bodies (121, 122) each perform a linear movement along the main longitudinal axis (101). The direction of movement depends on the rotation performed by the user on the trigger (180.1) of the actuator (180), respectively. The operation of this actuator (180) is explained in detail in the following figures.

[0161] Similarly, the direction of rotation of the breaking element (130) depends on the direction of linear motion of the longitudinal bodies (121, 122).

[0162] Preferably, the motion transfer element (140) is in the form of a rod or elongated cylinder.

[0163] Finally, the device (100) is made up of three parts attached together to form a single piece: a first part (150.1) which is in turn attached to the first longitudinal body (121) at its distal end (121.1); a second portion (150.2) which is in turn attached to the second longitudinal body (122) at its distal end (122.1), and - comprising articulated mounting means (150), partially visible in Figures 1a to 1c, formed by a central part (151) arranged between the first part (150.1) and the second part (150.2), the central part (151) including a through hole (151.1) through which the breaking assembly passes and which is fixed inside the through hole (151.1).

[0164] Preferably, the attachment between the first part (150.1) and the first longitudinal body (121) as well as the attachment between the second part (150.2) and the second longitudinal body (122) is a mechanical attachment, for example by means of a hinge. Alternatively, this or these attachments may be flexible, i.e. all elements form an integral assembly, but their attachments maintain a degree of freedom.

[0165] The articulating attachment means (150) is configured to perform angular movement about the through-hole (151.1) in the main plane of the instrument (100), this angular movement being the result of the linear movement of the first longitudinal body and the second longitudinal body (121, 122). On the one hand, when the first longitudinal body (121) performs a linear movement in the proximal-distal direction, the first part (150.1) of the articulating attachment means (150) also describes a proximal-distal movement. At the same time, the second longitudinal body (122) performs a linear movement in the distal-proximal direction, and the second part (150.2) of the articulating attachment means (150) also describes a distal-proximal movement. In this way, both parts (150.1, 150.2) move in opposite directions around the through-hole (151.1) of the central part (151). On the other hand, when the first longitudinal body (121) performs a linear distal-proximal movement, the first part (150.1) describes a distal-proximal movement, and at the same time the second longitudinal body (122) and the second part (150.2) of the articulated attachment means (150) perform a corresponding linear proximal-distal movement.

[0166] The purpose of this angular movement is to cause the breaking element (130) to perform an angular movement to the left or right (upward or downward, depending on how the instrument is positioned) relative to the main longitudinal axis (101) within the main plane. Since the breaking assembly passes through and is secured inside the through-hole (151.1) of the attachment means (150), angular movement of said attachment means (150) causes angular movement of the breaking element (130). In particular, when the first part (150.1) performs a proximal-distal movement, the breaking element (130) moves angularly at its front surface in a first direction, e.g., to the left (or downward). On the other hand, when the second part (150.2) is the part performing said proximal-distal movement, the breaking element (130) moves angularly at its front surface in a direction opposite to the first direction, e.g., to the right (or upward).

[0167] Figure 1d shows an exploded view of all elements of the breaking instrument (100) according to the embodiment shown in Figures 1a-1c. It should be noted that the actuator (180) is one of several possible actuators in the context of the present invention and is shown merely as an illustrative example.

[0168] The reference ring (102) surrounding the longitudinal element (120), along which the ring may move, can be further seen in Figures 1a-1d. This ring (102) is entirely optional, but is used as a reference for the user using the breaking tool (100), and in particular to inform the user of the depth of the counter-engraving.

[0169] Figure 1e shows in detail different alternatives of the configuration that exists between the articulating attachment means (150) and the breaking assembly, which passes through the through hole (151.1) and has inside it: by a breaking element (130) attached to the motion transmission element (140) outside the through-hole (151.1), or by a motion transmission element (140) attached to the breaking element (130) outside the through-hole (151.1), or The attachment between said elements (130, 140) is fixed partly by the breaking element (130) and partly by the movement transmission element (140), in this case so as to be established inside the through-hole (151.1).

[0170] In all these examples, the breaker assembly penetrates and is secured inside the through hole (151.1) by a bushing or bearing fitted into the through hole (151.1).

[0171] In one embodiment, the bilateral breaking instrument (100) further comprises a suction line connectable to an external suction device for removing tissue. Preferably, the breaking element (130) is cannulated and comprises a distal suction window for aspirating bone powder simultaneously with cutting bone and / or for aspirating soft tissue simultaneously with breaking or reaming tissue. In an even more particular embodiment, the external suction device comprises a vacuum system.

[0172] FIG. 2 shows an exemplary configuration of a breaking element (130) according to different embodiments of the present invention.

[0173] 3a-3d show a bilateral breaking instrument (100) according to an embodiment of the present invention, the instrument (100) comprising a breaking guide (300) configured to guide a longitudinal element (120) from an original position to at least one target position.

[0174] First, the breaking guide (300) comprises at least one tubular guide (310), which comprises, in order, the following elements: a third, preferably tubular longitudinal conduit (311) having a proximal end (311.1) and a distal end (311.2), the conduit (311) being sized to allow the longitudinal element (120) to be accommodated therein, the distal end (311.2) further comprising a distal appendage (311.3), e.g. a peripheral recess which is an extension of the longitudinal conduit (311), the cross-section of which has a diameter smaller than that of the remainder of the longitudinal conduit (311). - a striking edge (312), an extension of the longitudinal conduit (311) at its third proximal end (311.1).

[0175] The tubular guide (310) is oriented according to a first longitudinal guide axis (301), which coincides with the main longitudinal axis (101), according to which the longitudinal element (120) is oriented when it is inserted into the break guide (300).

[0176] The distal appendage (311.2) is sized and configured to be inserted into the first segment of the bone tunnel once carved. Some examples of the distal appendage (311.3) include a trilobed tip, or two tips, or a chamfered recess, or a polyhedral face.

[0177] In order to introduce the attachment (311.2) into the first segment of the bone tunnel, the user must apply a certain striking force to the proximal end of the striking edge (312) in the direction of the first longitudinal guide axis (301).

[0178] Preferably, as can be seen in these figures, the proximal end of the striking edge (312) is substantially flat.

[0179] Second, the break guide (300) comprises a guide arch (320) having a proximal arch portion (321) which in turn comprises a first coupling means (330) that allows said proximal arch portion (321) to be securely coupled to the tubular guide (310) at a plurality of different positions therealong. The guide arch (320) further comprises a distal arch portion (322) that terminates at a distal tip (322.1) and has a distal point (322.2) through which the first longitudinal guide axis (301) passes. Finally, the guide arch comprises a second coupling means (340) that allows said distal arch portion (322) to be coupled and uncoupled to the proximal arch portion (321) at a plurality of different positions.

[0180] Starting from a first position in which the tubular guide (320) is oriented according to the first longitudinal guide axis (301), when the second coupling means (340) is in a position other than the first position according to the second longitudinal guide axis (301.1), it forms an angle β with the first longitudinal axis (301).

[0181] The distal tip (322.1) is configured to be introduced into the patient's body, thereby securing the fracture guide, and is sharp in these particular illustrations.

[0182] The first coupling means (330) is configured to securely couple and decouple the proximal arch portion (321) to the tubular guide (310) at a plurality of different locations along the guide, these elements being uncoupled in Figure 3a but coupled in Figure 3b.

[0183] Furthermore, Figure 3c shows the break guide (300) into which the longitudinal element (120) of the instrument (100) is introduced, and Figure 3d shows the instrument (100) when the longitudinal element (120) is introduced to the bottom of the break guide (300).

[0184] 3a-3d show that, optionally, the tubular guide (310) further comprises a first longitudinal hole (313) and a second longitudinal hole (313′) sized and configured to receive the first protrusion (121.3) disposed on the first longitudinal body (121) and the second protrusion (122.3) disposed on the second longitudinal body (122), respectively. In this manner, the longitudinal holes (313, 313′) allow the first protrusion (121.3) and the second protrusion (122.3) to be guided from a proximal position to a distal position and vice versa.

[0185] Returning to Figure 1d, this figure shows an exploded view of the breaking instrument (100) when including a first exemplary actuator (180). Figures 4a-4c show side cross-sectional views of the instrument (100) for different states of the actuator (180). This actuator (180) is configured to generate and transfer linear motion to the first longitudinal body (121) and the second longitudinal body (122) such that both longitudinal bodies (121, 122) move linearly in opposite directions.

[0186] To that end, the first longitudinal body (121) comprises a first longitudinal notch (121.4) configured to cooperate with the actuator (180), and the second longitudinal body (122) comprises a second longitudinal notch (122.4) configured to cooperate with the actuator (180), which can be seen in detail in Figure 1d, which shows an exploded view of the device with this actuator (180).

[0187] In turn, the actuator (180) a first rod (181) adapted to pass through and cooperate with the first longitudinal notch (121.4); a second rod (182) adapted to pass through and cooperate with the second longitudinal notch (122.4), and - includes an actuation trigger (180.1) attached to a first rod (181).

[0188] The first rod (181) and the second rod (182) are arranged in parallel and are attached to each other at their ends by two longitudinal sections (183, 184), so that together they form a quadrilateral. In turn, the actuation trigger (180.1) is a manual trigger and can be operated by the user.

[0189] When the user manipulates the actuation trigger (180.1), it can perform a rotational movement in the proximal-distal or distal-proximal direction, and by attaching said trigger (180.1) to the first rod (181), the quadrilateral formed by the rods (181, 182) and the longitudinal portions (183, 184) describes a rotation about its own axis of rotation (185), which is located between the first rod (181) and the second rod (182).

[0190] 4a shows an example in which the movement described by the trigger (180.1) is in the proximal-distal direction. This movement causes the first rod (181) to perform a proximal-distal rotational movement relative to the quadrilateral's rotation axis (185), which in turn causes the first longitudinal body (121) to perform a proximal-distal linear movement. In turn, the second rod (182) performs a rotational movement in the opposite direction, i.e., distal-proximal, which causes the second longitudinal body (122) to perform a distal-proximal linear movement. As can be seen, these movements of the longitudinal bodies (121, 122) cause the breaking element (130) to perform an angular movement in a first direction, in this case downward or to the left (depending on how the breaking instrument is positioned).

[0191] 4b shows an example in which the movement described by the trigger (180.1) is in the distal-proximal direction. This movement causes the first rod (181) to perform a rotational movement in the distal-proximal direction relative to the quadrilateral's rotation axis (185), which in turn causes the first longitudinal body (121) to perform a distal-proximal linear movement. In turn, the second rod (182) performs a rotational movement in the opposite direction, i.e., in the proximal-distal direction, which causes the second longitudinal body (122) to perform a proximal-distal linear movement. As can be seen, these movements of the longitudinal bodies (121, 122) cause the breaking element (130) to perform an angular movement in a direction opposite to the first direction, in this case upward or to the right (depending on how the breaking instrument is positioned).

[0192] 4c shows an example where the trigger (180.1) has not been moved in either direction, i.e., is in an intermediate or neutral position. In such a case, no linear movement of the longitudinal bodies (121, 122) occurs, and therefore the breaking element (130) remains in a neutral position, remaining coaxial with the longitudinal element (120).

[0193] Finally, it should be noted that Figures 4a-4c simultaneously show the breaking motion, in this case a rotational motion, being received by the motion transmission element (140), which in turn transmits it to the breaking element (130).

[0194] Figures 5a to 5c show in detail the movement of the breaking element (130) as a result of the action of the actuator (180) according to the three states described in Figures 4a to 4c respectively.

[0195] 5a-5c show in detail certain exemplary positioning and fixation means for the first exemplary actuator (180). In both this example and other possible examples, these positioning and fixation means for the actuator (180) are configured to position and fix the actuator (180) in a number of different positions, such that for each of the positions, the distance between the first distal end (121.1) and the second distal end (122.1) of both longitudinal bodies (121, 122) is different.

[0196] Preferably, the actuator positioning and fixing means allows the actuator (180) to be positioned in at least three positions: 1. The position of the first end where the first longitudinal body (121) achieves its maximum proximal-distal movement and the second longitudinal body (122) achieves its maximum distal-proximal movement; 2. The position of the second end where the first longitudinal body (121) achieves its maximum distal-proximal movement and the second longitudinal body (122) achieves its maximum proximal-distal movement; and 3. Fixing in a neutral position where both longitudinal bodies (121, 122) are aligned such that the relative distance between their distal ends (121.1, 122.1) is substantially zero.

[0197] Alternatively, the actuator positioning and fixing means may allow the actuator (180) to be positioned and fixed in other intermediate positions in addition to both end positions and a neutral position.

[0198] In the particular example of Figure 6, the positioning and securing means of the actuator (180) comprises a hole (195.3) in the support (110) sized and configured to receive a ball (195.1) and a spring (195.2). The spring (195.2) is disposed at the bottom of the hole (195.3) in the support (110) such that the spring (195.2) pushes the ball (195.3) outward from the hole (195.3). The trigger (180.1) further comprises two or more holes (195.4) sized and configured to partially receive the balls (195.1).

[0199] When the hole 195.3 of the support 110 is positioned facing one of the holes 195.4 of the trigger 180.1, the ball 195.3, pressed by the spring 195.2, is partially positioned in the hole of the trigger 180.1, fixing the position. This position can be overcome by rotating the trigger 180.1 so that the ball 195.1 is again fully housed inside the hole 195.3 of the support 110, until a new position is reached in which the hole 195.3 of the support 110 is positioned facing the new hole 195.4 of the trigger 180.1, whereby the positioning means makes it possible to fix different positions of the trigger 180.1 in which the hole 195.4 of the support 110 is positioned facing one of the holes 195.4 of the trigger 180.1.

[0200] In one embodiment, the actuator (180) further comprises a return spring configured to apply a returning force to the first and second longitudinal bodies (121, 122) such that the relative motion between said bodies (121, 122) is substantially zero. The return spring is thus configured to position the longitudinal bodies (121, 122) in a neutral position, i.e., a position where neither of the longitudinal bodies (121, 122) is located in a forward or rearward position relative to the other.

[0201] Figure 7a shows an exploded view of the breaking device (100) including a second exemplary actuator (190), and Figure 7b shows a side cross-sectional view of the second exemplary actuator (190).

[0202] The actuator (190) is configured to generate and transmit linear motion to the first longitudinal body (121) and the second longitudinal body (122) such that both longitudinal bodies (121, 122) move linearly in opposite directions.

[0203] To that end, the first longitudinal body (121) comprises a first external thread (191) configured to cooperate with the actuator (190), and the second longitudinal body (122) comprises a second external thread (192) configured to cooperate with the actuator (190). The first external thread (191) and the second external thread (192) have opposite thread directions and can be seen in detail in Figure 7a, which shows an exploded view of the instrument (100) with this actuator (190).

[0204] The actuator (190) comprises a nut (193) having therein a first internal thread (193.1) that mates with the first external thread (191) and a second internal thread (193.2) that mates with the second external thread (192). The first internal thread (193.1) and the second internal thread (193.2) have opposite thread directions, and the nut (193) is configured to cooperate with the first longitudinal body (121) and the second longitudinal body (122) such that the assembly functions like a double spindle mechanism.

[0205] On the one hand, the external threads (191, 192) of the first and second longitudinal bodies (121, 122) make these bodies act like spindle threads, while the internal threads (193.1, 193.2) of the nut (193) interact with said spindle threads in such a way that one and the same nut (193) performs a dual function: as a result of the opposite threading directions of both internal threads (193.1, 193.2), when the nut (193) is rotated, one of the spindle threads moves linearly in one direction and the other in the opposite direction, as will be explained in more detail below.

[0206] The actuator (190) further comprises an actuation control (194) attached to the nut (193). Movement of this control (194), i.e., its rotation to one side or the other, causes the nut (193) attached to it to rotate itself. In this way, when the actuation control (194) performs a rotation, the double spindle mechanism is activated, causing the longitudinal bodies (121, 122), acting like spindle screws, to move linearly in opposite directions.

[0207] 8a-8c show side cross-sectional views of the breaking device (100) for different states of the second exemplary actuator (190).

[0208] Figure 8a shows an example in which the actuation control device (194) executes a threaded rotation of the first internally threaded portion (193.1), which causes the first longitudinal body (121) to perform a proximal-distal linear movement and the second longitudinal body (122) to perform a distal-proximal linear movement. As can be seen in Figure 8a, these movements of the longitudinal bodies (121, 122) cause the breaking element (130) to describe an angular movement in a first direction, in this case downward or to the left (depending on how the breaking tool is positioned).

[0209] In contrast, as shown in Figure 8b, when the actuation control device (194) executes a threaded rotation of the second internally threaded portion (193.2), the first longitudinal body (121) executes a distal-to-proximal linear movement, and the second longitudinal body (122) executes a proximal-to-distal linear movement. As can be seen in Figure 8b, these movements of the longitudinal bodies (121, 122) cause the breaking element (130) to describe an angular movement in a direction opposite to the first direction, in this case upward or to the right (depending on how the breaking tool is positioned).

[0210] 8c shows an example where the control device (194) is not moved in either direction, i.e., in an intermediate or neutral position. In such a case, no linear movement of the longitudinal bodies (121, 122) occurs, and therefore the breaking element (130) remains in a neutral position, remaining coaxial with the longitudinal element (120).

[0211] Advantageously, the actuator (190) fixes different angular positions by means of an inverted spindle mechanism without the need for additional positioning means.

[0212] Finally, it should be noted that Figures 8a-8c simultaneously show the breaking motion, in this case a rotational motion, being received by the motion transfer element (140), which in turn transfers it to the breaking element (130).

[0213] Figures 9a-9f show two embodiments of a breaking system (400, 500) for surgical intervention. In particular, Figures 9a-9d refer to a first breaking system (400), and Figures 9e-9f refer to a second breaking system (500). The breaking system (400) comprises a breaking motion generator (200) and a double-sided breaking instrument (100) with actuators according to any of the previous embodiments. In this breaking system (400), the breaking instrument (100) comprises actuators (180, 190).

[0214] Furthermore, the breaking system (500) comprises a breaking motion generator (200') which comprises sequential actuators (180', 190'), and therefore in this particular embodiment the breaking instrument does not comprise an actuator. The linear movements in opposite linear directions performed by the first longitudinal body (121) and the second longitudinal body (122) are generated and transmitted by said actuators (180', 190') of said breaking motion generator (200').

[0215] The breaking motion generating devices (200, 200') in these figures are drilling devices (200, 200') configured to generate and execute a breaking motion, in this particular example a rotational motion, and in addition, they are configured to transmit the breaking motion to the motion transmission element (140).

[0216] In particular, Figure 9a shows a side view of the system (400) with the bilateral instrument (100) decoupled from the break motion generator (200).

[0217] Figure 9b shows a side view of the system (400) with the bilateral instrument (100) coupled to the breaking motion generator (200) in an inactivated state. This coupling is established between the breaking motion generator (200) and the motion transmission element (140) via the first attachment and / or coupling means (160).

[0218] 9c shows a side view of a system (400) with a bilateral instrument (100) coupled to a breaking motion generator (200), inactive as in the previous figure. In this case, coupling is established between the breaking motion generator (200) and the motion transmission element (140) via a first attachment and / or coupling means (160) and between the breaking motion generator (200) and the support (110) via a second attachment and / or coupling means (170).

[0219] Figure 9d shows in detail the second attachment and / or coupling means (170) mentioned above.

[0220] Figure 9e shows a side view of a second breaking system (500) comprising a breaking motion generator (200') and a breaking tool (100), in which the breaking motion generator (200') is shown decoupled from the breaking tool (100).

[0221] FIG. 9f shows a second disruption system (500) for surgical intervention, which system a breaking movement generator (200') configured to generate and execute a breaking movement, said breaking movement generator (200') being an actuator (190'); - at least one double-sided breaking tool (100) without an actuator, which can be coupled to a breaking motion generator (200') by means of a motion transmission element (140) and by means of a support (110), The breaking motion generator (200') is further configured to transmit a breaking motion to the motion transmission element (140) and a linear motion to the first longitudinal body (121) and the second longitudinal body (122) by means of the actuator (190'). The linear motion of the first longitudinal body (121) is in a direction opposite to that of the second longitudinal body (122).

[0222] In this example, shown in Figure 9f, the coupling position of the breaking system (500) of Figure 9e is shown, where the breaking tool (100) is coupled to the breaking motion generator (200'). The coupling is established between the breaking motion generator (200') and the motion transmission element (140) via a first attachment and / or coupling means (160), and between the breaking motion generator (200') and the support (110) via a second attachment and / or coupling means (160). In the example of Figure 9f, the arrow indicates that the breaking motion generator is activated (arrow pointing to the drill trigger), causing rotation of the breaking assembly.

[0223] In a particular example, the breaking motion generating device (200') comprises mechanical and / or electronic means that are freely adjustable by the user.

[0224] In certain embodiments, the rupture system (400, 500) comprises a disposable double-sided rupture instrument (100).

[0225] In another specific embodiment, the breaking system (400, 500) comprises a bilateral breaking instrument (100) and a breaking motion and linear motion generating device (200) or a breaking motion generating device (200') that is disposable, excluding the motor and battery of the breaking motion generating device (200, 200').

[0226] Figure 10a shows the state of the art known for retro-reverse engraving of bone tunnels using previously known fracture instruments with a single axis of rotation coinciding with the fracture axis: the reverse engraving only results in a cylindrical enlargement of the first bone tunnel.

[0227] Figure 10b shows a bone tunnel that has been formed and reamed with the bilateral breaking instrument (100) of the present invention.

[0228] The particular embodiment of the double-sided breaking tool (100) demonstrates the advantages of the present invention over breaking tools available in the state of the art, these advantages being as follows: - Lower manufacturing and assembly costs due to fewer parts; and It should be pointed out that the greater rigidity of the assembly allows for engraving bone tissue.

[0229] A surgical method performed by the disruption system of the present invention.

[0230] In a fourth aspect, which is complementary to the first aspect, the present invention provides a method for carving an angled bone tunnel with an enlarged intra-articular exit opening into the human or animal body during connective tissue repair, the method being shown in the flow chart of Figure 11a.

[0231] The method comprises the following steps: a) providing a breaking system (400, 500) comprising a bilateral articulated breaking device (100) of the present invention; b) with the breaking element (130) in a neutral or non-angled position relative to the primary longitudinal axis (101), the primary longitudinal axis (101) and the breaking axis (131) being coaxial, actuating the breaking system (400, 500) to form a linear bone tunnel having an entrance opening in the outer cortex of the bone to be carved and an exit opening in the inner cortex of said bone; c) carving a first enlarged segment of the bone tunnel by using the instrument (100) to angle the breaking element (130) in a first direction relative to the primary longitudinal axis (101); d) (optionally) moving the breaking instrument (100) rearward to back-cut the bone, thereby continuing the first enlarged segment of the straight bone tunnel; e) carving a second enlarged segment of the bone tunnel by using the instrument (100) to tilt the breaking element (130) in a direction opposite to the first direction relative to the primary longitudinal axis (101); f) (optionally) moving the breaking instrument (100) rearward to back-cut the bone, thereby continuing the second enlarged segment of the straight bone tunnel; g) repositioning the breaking element (130) to a neutral or non-angular position relative to the main longitudinal axis (101), where the main longitudinal axis (101) and the breaking axis (131) are coaxial; and h) removing the breaking instrument (100) from the anatomically reamed bone tunnel.

[0232] Throughout this specification, "reverse carving" shall be understood to mean the action of returning the breaking element (130) from a first distal position within the bone tunnel to a second proximal position within the bone tunnel, which action widens the bone tunnel segment through which the breaking element (130) has been moved.

[0233] In this example, in step c), the angle defined between the main longitudinal axis (101) and the fracture axis (131) is called α1, which is the angle that defines the first enlargement segment of the bone tunnel. Furthermore, in step e), the angle defined between the main longitudinal axis (101) and the fracture axis (131) is called α2.

[0234] To perform the method of this example, the user may further provide a breaking motion generating device (200, 200').

[0235] In certain other embodiments, the above method can be performed without either optional step d) or f), or without either step.

[0236] In an alternative specific method, a unilateral articulated breaking instrument having sufficient rigidity to carve bone tissue can be used in step a), in which step e) of changing the angular orientation of the breaking element (130) relative to the primary longitudinal axis (101) is replaced by a joint rotation of the unilateral articulated breaking instrument and breaking motion generator (200, 200′). Because this joint rotation is technically demanding for the user, requires less practice and precision in the bone tunnel carving method, and may even cause complications, this method is preferably performed by a bilateral breaking system (400, 500) of the present invention specifically designed for this task.

[0237] First use of the rupture system: Repair of the supraspinatus tendon in the shoulder joint In a first use case, the connective tissue to be repaired (i.e., the method described above) is the supraspinatus tendon of the shoulder joint.

[0238] Figure 11b shows in detail the different segments of the bone tunnel carved into the greater tuberosity of the humerus. 1) Side and front views of a straight bone tunnel (1). 2) Side, front and perspective views of a complete bone tunnel (1-3) with an intra-articular exit opening (2, 3) anatomically widened with the system (400, 500) of the present invention.

[0239] FIG. 11c shows a preferred and more specific embodiment, in which the breaking system (400, 500) used in the method comprises a breaking tool (100) which in turn comprises a breaking guide (300).

[0240] In an embodiment of this method, step b) comprises the following sub-steps: b1) inserting the distal tip (322.1) of the distal portion (322) of the guide arch (320) of the fracture guide (300) into the patient's body and positioning said distal tip (322.1) approximately in the center of the original insertion footprint; b2) placing the distal end of the tubular guide (310) of the fracture guide (300) on the outer cortex of the bone to be carved, with the guide arch (320) parallel to the coronal plane, at an approximate distance of about 15 mm to 25 mm from the greater tuberosity; b3) Carving a linear tunnel in the bone using a bit with laser depth markings; b4) removing the bit and applying a striking force to the striking edge (312) of the tubular guide (310) so that the distal appendage (311.3) of the tubular guide (310) penetrates the linear tunnel.

[0241] In other words, in this embodiment, the bone tunnel is completely carved (step b3), the guide arch (320) is removed, leaving the breaking instrument (100) inside the bone tunnel and inside the tubular guide (310), and force is applied to the striking edge (312) to insert the distal tip (322.1) of the tubular guide (310) into the bone tunnel.

[0242] FIG. 11d shows a musculoskeletal view of a bone tunnel (1-3) carved with one of the systems (400, 500) of the present invention and the insertion of a graft to repair the supraspinatus tendon in the shoulder joint.

[0243] In the specific example of repairing a torn supraspinatus tendon of the rotator cuff, the dimensions of the intra-articular exit opening of the created bone tunnel must be such as to allow for the insertion of the end of the torn tendon, measuring between 4 mm and 5 mm in thickness and between 20 mm and 25 mm in width at the level of the rotator chord. However, these specific measurement ranges provided in the foregoing example must be adapted based on the respective anatomical structure and the end use for which the breaking instrument will be used, which, in general, is suitable for breaking any connective tissue and / or cartilage and / or bone tissue in human or veterinary medicine.

[0244] Once the angled bone tunnel has been created by one of the inventive fracture systems (400, 500) and the intra-articular exit opening widened into a fan- or funnel-like shape (2-3), the end of the supraspinatus tendon to be repaired is sutured and a suture band is passed through the widened angled bone tunnel (1-3), e.g., with a curved suture threader. The lower left portion of Fig. 11d shows the tendon end already passing through the anatomically widened bone tunnel opening and the suture band emerging from the bone tunnel. Fig. 11d also shows the suture band held by a cortical fixation device, such as that described in European Patent Application No. 3897455, in the lower right portion.

[0245] Figure 11e shows the repair of a partial supraspinatus tendon rupture through a bone tunnel using a suture band (20) threading the end of the tendon through an anatomically reamed bone tunnel opening created with either of the fracture systems (400, 500) of the present invention. The bottom right portion of the figure shows the suture band (20) held by a cortical fixation device such as that described in European Patent Application No. 3897455.

[0246] Figure 11f shows an overview of the steps of a method for repairing a complete rupture of the supraspinatus tendon. The method involves forming an anatomically reamed bone tunnel created by one of the rupture systems (400, 500) of the present invention, and using reinforcement tissue (30) and a suture band (20) that threads the end of the reinforcement tissue through the opening of the anatomically reamed bone tunnel. In a specific embodiment, the reinforcement tissue (30) is decellularized skin tissue. In another specific embodiment, the reinforcement tissue (30) comprises biodegradable biopolymer fibers. In another specific embodiment, the reinforcement tissue (30) comprises a bioabsorbable poly(lactic-co-glycolic acid) (PLGA) aligned microfiber scaffold.

[0247] Considering that failure rates of up to 68% have been reported in complete ruptures of the supraspinatus tendon (Jost B, Pfirrmann CWA, Gerber C. Clinical outcomes after structural failure of rotator cuff repair. J Bone Joint Surg Am 2000;82:304-14.), the goal in all cases is to achieve revascularization of the tendon ends with osseointegration of the reinforcing tissue (30).

[0248] A second example of use of the rupture system: repair of the anterior cruciate ligament of the knee joint.

[0249] In a second use case, the connective tissue to be repaired is the cruciate ligaments of the knee joint. Figure 12a shows the steps of the method described in Figure 11a but performed on the tibia.

[0250] 1. Point 1 indicates a straight bone tunnel (4) formed in the tibia by the breaking system (400, 500) of the present invention, with an entrance opening in the outer cortex of the bone and an exit opening in the inner cortex of the bone. During this step, the breaking axis (131) of the breaking element (130) remains coaxial with the main longitudinal axis (101) of the breaking instrument (100).

[0251] 2. Point 2 shows how the breaking element (130) is inclined in a first direction relative to the main longitudinal axis (101) of the breaking instrument (100), thereby carving out a first enlarged segment (5) of the intra-articular exit opening of the straight bone tunnel (4).

[0252] 3. Point 3 shows how the breaking element (130) is inclined in a direction opposite to the first direction relative to the main longitudinal axis (101) of the breaking instrument (100), thereby carving out a second enlarged segment (6) of the intra-articular exit opening of the straight bone tunnel (1).

[0253] After these operations, the breaking axis (131) of the breaking element (130) moves to a position where the breaking axis (131) is coaxial with the main longitudinal axis (101) of the breaking instrument (100), i.e., a neutral position. Finally, the breaking instrument (100) is removed from the straight bone tunnel (4) by the first and second enlargement segments (5, 6).

[0254] FIG. 12b shows in detail a straight bone tunnel (4) with first and second enlarged segments (5, 6) carved into the tibia. A perspective view of the valve (4). 2) Perspective view of a straight bone tunnel (4) with a first enlarged segment (5) carved by a breaking instrument (100) of the present invention. 3) Perspective view of a straight bone tunnel (4) with first and second enlarged segments (5, 6) carved by the breaking instrument (100) of the present invention.

[0255] FIG. 12c shows the steps of the above method performed on the femur.

[0256] 1. Point 1 indicates a straight bone tunnel (4) formed in the femur by the breaking system (400, 500) of the present invention, with an entrance opening in the outer cortex of the bone and an exit opening in the inner cortex of the bone. During this step, the breaking axis (131) of the breaking element (130) remains coaxial with the main longitudinal axis (101) of the breaking instrument (100).

[0257] 2. Point 2 shows how the breaking element (130) is inclined in a first direction relative to the main longitudinal axis (101) of the breaking instrument (100), thereby engraving a first enlarged segment (5) of the intra-articular exit opening of the straight bone tunnel (4), defined by angle α1.

[0258] 3. Point 3 shows how the breaking element (130) is inclined in a direction opposite to the first direction relative to the main longitudinal axis (101) of the breaking instrument (100), thereby engraving a second enlarged segment (6) of the intra-articular exit opening of the straight bone tunnel (1), defined by angle α2.

[0259] 4. Point 4 shows a lateral view of a straight bone tunnel (4) carved into the femur, with a first enlarged segment and a second enlarged segment (5, 6).

[0260] Figure 12d shows the expansion process in detail. 1) Perspective view of a straight bone tunnel (4); 2) A perspective view of a straight bone tunnel (4) having a first enlarged segment (5) carved with the system (400, 500) of the present invention; and 3) Perspective view of a straight bone tunnel (4) with first and second enlarged segments (5, 6) carved with one of the systems (400, 500) of the present invention.

[0261] In the specific example of reconstructing the anterior cruciate ligament, the intra-articular exit opening of the created bone tunnel must be such as to allow for the insertion of fibrous material, which in the Caucasian population generally measures between 2 mm and 4 mm in thickness and between 12 mm and 18 mm in width. However, these specific measurement ranges provided in the preceding example must be adapted in human and veterinary medicine based on the specific anatomy of other populations, the specific anatomy of a particular patient, and the type of implant and / or technique used and / or the end use for which the disruption device will be used.

[0262] Figure 12e shows an overview of the steps of a method for reconstructing the anterior cruciate ligament (ACL) of a right knee. In particular, step 1) shows an overview of the joint with the bone tunnel anatomically reamed by the breaking instrument (100) of the present invention. Step 2) shows the introduction of sutures into the tibial tunnel, drawing both branches of the quartered semitendinosus graft (500) into the tibial tunnel. Step 3) shows the sutures at the femoral end of the implant being introduced into the femoral tunnel. Step 4) shows the anatomical twisting of both branches of the implant.

[0263] In certain embodiments, fixation of the femoral end of the quadruple implant (40) is performed by a fixation loop cortical button, and fixation of the sutures hanging from both tibial ends of the graft is performed by holding the sutures corresponding to each branch of the graft on either side of a cortical fixation device (10) such as that described in European Patent Application No. 3897455.

[0264] Figure 13a shows the construction of a quadruple implant (40) from semitendinosus grafts (ST) for ACL restoration.

[0265] In a specific embodiment not shown in the figures, a small rigid cannula is used through which the suture is threaded, thereby evenly distributing the pulling force that the suture exerts on the folded ends of the implant, thereby facilitating the introduction of these folded ends in the enlarged segments of each bone tunnel created by the system (400, 500) of the present invention.

[0266] Figure 13b shows the configuration of an implant with two branches from an Achilles tendon allograft (41) for restoring the ACL.

[0267] Figure 13c shows the configuration of an implant with two branches from a quadriceps tendon graft (42) with a bone plug to restore the ACL.

Claims

1. A bilateral breaking instrument (100) for minimally invasive surgical intervention, comprising: - longitudinal elements (120) oriented according to a main longitudinal axis (101), a first longitudinal body (121) configured to perform a linear movement along said main longitudinal axis (101) and comprising a first distal end (121.2); a second longitudinal body (122) arranged parallel to said first longitudinal body (121) and adapted to perform a linear movement along said main longitudinal axis (101), said second longitudinal body (122.2) having a second distal end (122.2); A break assembly, a breaking element (130) comprising a breaking axis (131) and configured to receive and perform breaking movements about said breaking axis (131) and to perform angular movements, forming a number of angles α with said main longitudinal axis (101) contained in a main plane (101′), said main plane (101′) comprising said main longitudinal axis (101) and said breaking axis (131); and a motion transmission element (140) comprising a distal portion (140.1), The motion transmission element (140) located inside the longitudinal element (120) between the first longitudinal body (121) and the second longitudinal body (122); attached to the breaking element (130) by the distal portion (140.1); a breaking assembly comprising, in turn, a movement transfer element (140) configured to receive and perform a breaking movement and to transfer said breaking movement to said breaking element (130); - articulated attachment means (150), a first portion (150.1) attached to the first distal end (121.2) of the first longitudinal body (121); a second portion (150.2) attached to the second distal end (122.2) of the second longitudinal body (122); a central portion (151) including a through hole (151.1) through which the breaking assembly passes, the breaking assembly being fixed inside the through hole (151.1); said articulated mounting means (150) being adapted for angular movement in said main plane (101') of said breaking tool (100); - when said first longitudinal body (121) undergoes a linear movement in the proximal-distal direction, said second longitudinal body (122) undergoes a linear movement in said distal-proximal direction and said breaking element (130) undergoes an angular movement in a first direction in said main plane (101'), - articulated mounting means (150) such that when said first longitudinal body (121) undergoes a linear movement in said distal-proximal direction, said second longitudinal body (122) undergoes a linear movement in said proximal-distal direction and said breaking element (130) undergoes an angular movement in said main plane (101') in a direction opposite to said first direction; A double-sided breaking tool (100) comprising:

2. The breaking assembly passes through the inside of the through hole (151.1) and by said breaking element (130), or by said motion transfer element (140), or Partially by said breaking element (130) and partially by said motion transfer element (140), or by a bearing fitted in said through-hole (151.1), or - fixed by a combination of two or more of the above, A double-sided breaking tool (100) according to the preceding claims.

3. 10. A double-sided breaking instrument (100) according to any of the preceding claims, wherein said motion transfer element (140) and / or said breaking element (130) are cannulated.

4. A double-sided breaking tool (100) according to any of the preceding claims, further comprising at least a first attachment and / or coupling means (160) configured to attach and / or couple said motion transmission element (140) to a breaking motion generating device (200, 200').

5. a support (110) at least partially surrounding said longitudinal elements (120); - second attachment and / or coupling means (170) adapted to attach and / or couple said support (110) to a breaking movement generating device (200, 200'); A double-sided breaking tool (100) according to any of the preceding claims, further comprising:

6. The device further comprises a break guide (300) configured to guide the longitudinal element (120) from an original position to at least one target position, the break guide (300) comprising: a tubular guide (310), a longitudinal conduit (311) having a third proximal end (311.1) and a third distal end (311.2), said longitudinal conduit (311) comprising a distal appendage (311.3) at said third distal end (311.2); a striking edge (312), an extension of said longitudinal conduit (311) at said third proximal end (311.1); Equipped with said longitudinal conduit (311) is configured to accommodate said longitudinal element (120) therein; said tubular guide (310) is oriented according to a first longitudinal guide axis (301); a tubular guide (310), wherein the striking edge (323) is configured to receive a striking force in the direction of the first longitudinal guide axis (301); and - a guide arch (320), a proximal arch portion (321) comprising first coupling means (330) configured to securely couple and decouple said proximal arch portion (321) to said tubular guide (310) at a plurality of different positions along said tubular guide (310); a distal arch portion (322) having in turn a distal tip (322.1) and a distal point (322.2) through which said first longitudinal guide axis (301) passes; a second coupling means (340) configured to couple and decouple said distal arch portion (322) to said proximal arch portion (321) in a plurality of different positions, said second coupling means (340) being oriented according to a first longitudinal guide axis (301) starting from a first position according to said tubular guide (320), said second coupling means (340) forming an angle β with said first longitudinal axis (301) when said second coupling means (340) is in a position other than said first position according to said second longitudinal guide axis (301.1); a guide arch (320) comprising: A double-sided breaking tool (100) according to any of the preceding claims, comprising:

7. said tubular guide (310) further comprising a first longitudinal hole (313) and a second longitudinal hole (313'); said first longitudinal body (121) further comprising a first protrusion (121.3); said second longitudinal body (122) further comprises a second protrusion (122.3); the first longitudinal hole (313) is sized and configured to receive and guide the first protrusion (121.3) from a proximal position to a distal position and vice versa; said second longitudinal hole (313') is sized and configured to receive and guide said second protrusion (122.3) from a proximal position to a distal position and vice versa; A double-sided breaking tool (100) according to the preceding claims.

8. The distal appendage (311.3) comprises: - a trilobed tip, or two tips, or - chamfered recesses, or ・Polyhedral surface A double-sided breaking tool (100) according to any of claims 6 or 7, comprising:

9. A double-sided breaking instrument (100) according to any of the preceding claims, further comprising actuators (180, 190) configured to generate and transmit linear motion to the first longitudinal body (121) and the second longitudinal body (122) so that both longitudinal bodies (121, 122) move linearly in opposite directions.

10. - said first longitudinal body (121) comprises a first longitudinal notch (121.4) adapted to cooperate with said actuator (180); - said second longitudinal body (122) comprises a second longitudinal notch (122.4) adapted to cooperate with said actuator (180); The actuator (180) a first rod (181) adapted to pass through and cooperate with said first longitudinal notch (121.4); a second rod (182) adapted to pass through and cooperate with said second longitudinal notch (122.4), and - an actuation trigger (180.1) attached to said first rod (181), the first rod (181) and the second rod (182) are arranged in parallel and attached to each other at their ends by two longitudinal portions (183, 184); - when said actuation trigger (180.1) performs a rotational movement in said proximal-distal direction about a rotation axis (185) located between said first rod (181) and said second rod (182), said first rod (181) undergoing a rotational movement in said proximal-distal direction and causing said first longitudinal body (121) to undergo a linear proximal-distal movement; said second rod (182) undergoing rotational movement in said distal-proximal direction and causing said second longitudinal body (122) to undergo distal-proximal linear movement; - when said actuation trigger (180.1) performs a rotational movement in said distal-proximal direction relative to said axis of rotation (185), said first rod (181) undergoing a rotational movement in said distal-proximal direction and causing said first longitudinal body (121) to undergo a distal-proximal linear movement; said second rod (182) undergoing rotational movement in said proximal-distal direction and causing said second longitudinal body (122) to undergo proximal-distal linear movement; A double-sided breaking tool (100) according to claim 9.

11. Further comprising positioning and fixing means for said actuator (180), the positioning and fixing means for the actuator (180) are configured to position and fix the actuator (180) in a plurality of different positions, such that for each of said positions the distance between the first distal end (121.1) and the second distal end (122.1) of both longitudinal bodies (121, 122) is different; A double-sided breaking tool (100) according to claim 10.

12. 12. A double-sided breaking tool (100) according to any one of claims 9 to 11, wherein the actuator (180, 190) further comprises a return spring configured to exert a returning force on the first longitudinal body and the second longitudinal body (121, 122) such that the relative motion between the bodies (121, 122) is substantially zero.

13. - said first longitudinal body (121) comprises a first external thread (191) adapted to cooperate with said actuator (190); - said second longitudinal body (122) comprises a second external thread (192) adapted to cooperate with said actuator (190), said first external thread (191) and said second external thread (192) having opposite thread directions; The actuator (190) - a nut (193) in which, in turn, a first internal thread (193.1) that matches the first external thread (191), and a second internal thread (193.2) that matches the second external thread (192), the first internal thread (193.1) and the second internal thread (193.1) having opposite threading directions; a nut (193) configured to cooperate with the first longitudinal body (121) and the second longitudinal body (122) such that the assembly functions like a double spindle mechanism; - an actuation control device (194) attached to said nut (193), - when said actuation control device (194) performs a rotational movement in the screw direction of said first internal threaded portion (193.1), said first longitudinal body (121) performs a proximal-distal linear movement and said second longitudinal body (122) performs a distal-proximal linear movement; and - when the actuation control device (194) performs a rotational movement in the screw direction of the second internally threaded portion (193.1), the first longitudinal body (121) performs a distal-proximal linear movement and the second longitudinal body (122) performs a proximal-distal linear movement; A double-sided breaking tool (100) according to claim 9.

14. 10. A double-sided breaking instrument (100) according to any of the preceding claims, further comprising a suction line connectable to an external suction device for removing tissue.

15. 10. A double-sided breaking instrument (100) according to any of the preceding claims, wherein said first longitudinal body (121) and / or said second longitudinal body (122) are rigid and / or straight.

16. A bilateral break-down system (400) for minimally invasive surgical intervention, comprising: a breaking movement generator (200) configured to generate and execute a breaking movement; - at least one breaking tool (100) according to any of the preceding claims, which can be coupled to said breaking motion generator (200) by at least said motion transmission element (140); Equipped with The breaking motion generating device (200) is further configured to transmit the breaking motion to the motion transmission element (140). A double-sided break system (400).

17. A bilateral breakage system (500) for minimally invasive surgical intervention, comprising: a breaking movement generator (200') adapted to generate and execute a breaking movement; - at least one breaking tool (100) according to any one of claims 5 to 15, which can be coupled to the breaking motion generator (200') by means of the motion transmission element (140) and by means of the support (110), the breaking motion generator (200') is configured to transmit the breaking motion to the motion transmission element (140); the breaking motion generating device (200') further comprises actuators (180', 190') configured to generate and transmit linear motion to the first longitudinal body (121) and the second longitudinal body (122) such that both longitudinal bodies (121, 122) linearly move in opposite directions upon receiving the linear motion from the actuators (180', 190'), A double-sided break system (500).

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