RU2803924C2 - Medical fastening device for fastening grafts in bone tunnel - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: group of inventions relates to a medical fastening device for fixing a graft in a bone tunnel and a system for inserting a medical fastening device into a bone tunnel. The following is proposed: a medical fastening device for fixing a graft in a bone tunnel, where the medical fastening device is designed to be inserted into the bone bone tunnel, the medical fastening device comprises the first and the second fastening elements. The second fastening element contains the first through channel and the second fastening channel. The system for introducing a medical fastening device into a bone tunnel comprises the above medical fastening device and an insertion device.

EFFECT: use of the inventions makes it possible to provide sufficient holding power of the graft while reducing the risk of its damage.

14 cl, 18 dwg

Description

Subject of the invention

The present invention relates to the field of traumatology. In particular, the present invention relates to a medical fastening device for securing at least one graft in at least one bone tunnel. This invention is intended for the restoration of connective tissue, such as tendons and ligaments, of the knee joint or other parts of the body.

BACKGROUND OF THE INVENTION

In the field of traumatology, one of the most common injuries is the rupture of joint ligaments. A ligament is a band of longitudinal connective tissue designed to connect bones to each other at a joint.

One of the most common injuries in sports medicine is a torn anterior cruciate ligament (ACL) of the knee. A person whose ACL has undergone a complete tear has both anteroposterior instability and rotational instability, which precludes re-entry into sports.

Today, the preferred option for repairing a torn or damaged ACL is the use of fibrous connective tissue obtained from the patient, primarily semitendinosus and gracilis tendon autografts.

In any case, to restore the damaged ACL, the graft is inserted into the tibial and femoral bone tunnels. In particular, a common practice is to suspend the curved end of the graft in the femoral bone tunnel or femoral bone tunnels by means of cortical buttons and use interference screws, with or without a plug/sleeve, to connect the free ends in the tibial bone tunnel.

This practice requires sufficient graft volume, so semitendinosus and gracilis tendon autografts are commonly used.

Semitendinosus-gracilis tendons have an average length of about 260 mm, so when two grafts are secured and folded once, the result is a graft length and thickness sufficient for repair.

There are various studies that show that there are fewer consequences for the patient when only the semitendinosus is used without removing the gracilis tendon. Below are examples of the studies mentioned:

Ardern CL, Webster KE, Taylor NF, Feller JA. (2010) “ Hamstring strength recovery after hamstring tendon harvest for anterior cruciate ligament reconstruction: a comparison between graft types” , and Segawa H, Omori G, Koga Y, Kameo T, Iida S, Tanaka M. (2002) “ Rotational muscle strength of the limb after anterior cruciate ligament reconstruction using semitendinosus and gracilis tendon .”

For this reason, a second practice has become common for this type of repair, and said practice consists of joining the free ends of one semitendinosus graft, which is rolled up to form a graft of three or four branches connected by sutures. This provides sufficient volume and allows the use of cortical buttons to suspend the semitendinous autograft in both the femoral bone tunnel and the tibial bone tunnel.

However, there are studies showing that the use of knots, sutures, and cortical buttons can cause repair failure due to loss of graft tension by slipping in the knots and sutures and by movement of the cortical buttons, which may even extend into the bone tunnel. Below are examples of the studies mentioned:

Barrow AE, Pilia M, Guda T et al. (2014) “ Femoral suspension devices for anterior cruciate ligament reconstruction: do adjustable loops lengthen? ” and Johnson JS, Smith SD, Laprade CM et al. (2014) “ A biomechanical comparison of femoral cortical suspension devices for soft tissue anterior cruciate ligament reconstruction under high loads .”

An interference screw is a connecting device that directly holds the graft relative to the inner wall of the bone tunnel, located in porous cancellous bone. Consequently, the screw is positioned longitudinally near the graft, holding it relative to the bone tunnel wall. A screw probe that passes through the interferent screw and a screwdriver are used for this connection.

Figure 1A shows an interference screw (600) which, like most interference screws, contains two adjacent longitudinal through channels (601, 602) of smaller diameter. In particular, the distal channel (601), which has the smallest diameter of the two, is designed for insertion of a screw probe. The proximal channel (602), which has the largest diameter of the two, is provided with internal polyhedral faces for screwdriver engagement, without consideration of other uses of these channels. Figure 1A shows, in a cross-section of the screw, both channels (601, 602). Interference screws (600) are fastening devices adapted to hold the graft relative to the inner wall of the bone tunnel. The internal channels are secondary elements for guiding and screwing the screw into the bone canal.

The danger associated with the use of an interference screw is that cancellous bone has porosity of up to 90%. Therefore, due to the incompatibility of the porous bone of the tibia, these interference screws may undergo migration and improperly retain the graft within the tunnel with subsequent failure of repair.

Another difficulty with interference screws is that they are screwed directly onto the graft with the risk of damaging it and that they do not allow precise adjustment of the tension with which the graft is attached. In addition, this device may cause widening of the bone tunnel, which slows and delays proper integration of the graft with the bone.

In this regard, in the current state of the art, there is a need, in the case of interference screws, to improve the performance of modern connecting devices in terms of final tensile strength, loss of graft tension, the possibility of migration of the device into the bone tunnel, the efficiency of securing a single semitendinosus graft without the need extraction of thin tendons, and resistance to graft sliding.

To address the described problems associated with the use of interference screws and cortical buttons, various patents have been developed that disclose ACL coupling devices. However, the challenges associated with these devices continue to determine the mechanical properties of the joint after repair, with the interference screw and cortical button still being the most used devices. A few of the patents mentioned are listed below.

In order to mitigate the risk of graft damage, US 6517579 B1 describes a technical solution consisting of securing the grafts by means of a screw that is inserted into a plug/sleeve with external longitudinal channels in which the grafts are located, so that when the screw is inserted into the longitudinal central channel existing in plug, the grafts are held between the outside of the plug and the wall of the bone tunnel.

This type of technical solution prevents the graft from coming into contact with the screw when screwed into it, which actually happens with interference screws without a plug/sleeve. However, this technical solution suffers from the main problem associated with interference screws: when grafts are confined between the outer surface of the plug and the actual wall of the bone canal, due to the incompatibility of the porous bone of the walls of the tibial bone canal, this device does not provide sufficient holding force and the graft may slide into the tibial bone canal. bone tunnel.

Patent document US20160100936 describes a screw that screws coaxially into the sleeve to enclose the graft. Figures 1C and 1D depict the device from the mentioned patent application. As can be seen, the screw is screwed directly onto the graft, which, as in the case of an interference screw, can damage it.

Patent document WO 2006/091278 A1 describes a screw that is inserted into a bone tunnel and limits the graft relative to the inner wall of the tunnel, while, at the same time, a second screw with a washer, which enters perpendicular to the cortical bone and is screwed into the angular side of the first screw, limits transplant for the second time.

In this configuration, the reinforcing screw must separate and necessarily pass between the graft ligaments, performing fastening, therefore:

- the area formed on the actual corner side of the screw is reduced due to the space occupied by the actual reinforcing screw, and accordingly the reinforcing surface is very small, and

- use of this device involves placing the graft between the washer and a limited and open tightening area, resulting in possible incomplete attachment and/or possible damage to the graft.

Patent document US 2006052787 A1 proposes a solution similar to that proposed in WO 2006/0912678 A1, but the screw is replaced by a non-threaded limiting element. Figures 1E and 1F depict the device from the mentioned patent application. As can be seen, the graft (10) necessarily passes between the outer side of the limiting element (801) and the wall of the bone tunnel of the bone, then bending towards the angular side of the limiting element, with a screw (802) and washer clamping the graft (10) against the said element.

Patent document WO 2015/169978 A1 describes an attachment for grafts with a longitudinal channel and a screw element and an attachment passage exclusively in the proximal upper edge of the coupling. Figures 2A-2E depict the device from the mentioned patent application. In practice, this device showed the following limitations:

- Although the proximal superior edge provides the graft with the claimed retaining curve, it provides a restricted retaining passage that leaves a portion of the graft unretained, reducing the sliding resistance of the retained graft, and for this reason the device must be resized to retain the entire graft.

- The use of directly mechanically holding devices located on the cortical bone, of the type described in the international patent application WO 2015/169978 A1, does not allow the ACL to be restored with a single semitendinosus graft, since in order to achieve sufficient thickness, it is folded into a 3-strand or 4-strand a configuration that is too short for a cortical connection.

Patent application US-A1 2013/304099 describes a fixation device for securing a graft in a bone tunnel.

Patent application US-A1 2008/051795 describes a tissue fixation device, preferably used to attach a ligament or graft within a prepared bone tunnel.

Therefore, there is a need to provide a solution that allows at least one graft to be secured within a bone tunnel, improving the performance of current devices, providing the required rigidity and strength, and solving the problems described.

Description of the invention

The present invention provides a solution to these problems by using a medical fastening device for securing a graft in a bone tunnel, according to claim 1, and a system for introducing a medical fastening device into a bone tunnel, according to claim 14. Preferred embodiments of the present invention are defined in the dependent claims.

In a first aspect of the invention , a medical fastening device is provided for securing a graft in a bone tunnel, wherein the medical fastening device is configured to be inserted into a bone tunnel of the bone, and wherein said medical fastening device comprises:

- the first fastening element,

- a second fastening element containing:

- a first through channel with a first end and a second end, wherein said first through channel extends along a first longitudinal axis, the first through channel is adapted to receive a graft at its first end and contain a graft within it and at its second end,

- a second fastening channel with a first end and a second end, wherein said second fastening channel extends along a second longitudinal axis,

where the first through channel and the second fastening channel are located inside the second fastening element so that the first longitudinal axis and the second longitudinal axis form an angle α with each other that is not equal to 0,

wherein the second end of the first through channel and the second end of the second fastening channel together form an annular proximal surface,

so that when the first fastening element is located and secured in the fastening channel, an annular fastening passage is formed between the first fastening element and the annular proximal surface.

In one embodiment, the first longitudinal axis coincides with the axial axis of symmetry of the first through channel. In another embodiment, consistent with any of the preceding embodiments, the second fastening channel is adapted to contain and secure the first fastening element. In another embodiment, consistent with any of the preceding embodiments, the second fastening channel extends along the second longitudinal axis.

In this document, a transplant is understood as:

- any type of autograft from an actual patient,

- any type of allograft or xenograft from a donor, or

- any type of manufactured graft, flexible material or synthetic graft.

In this document, the first end of each element of a given medical fastening device is understood to mean the distal end of said element, i.e. the end of the element furthest from the surgeon during insertion into the bone tunnel. On the other hand, the second end of each element of a given medical fastening device is understood to mean the proximal end of said element, i.e. the end of the element closest to the surgeon during insertion into the bone tunnel. On the other hand, it will also be understood that both the first through channel and the second fastening channel are hollow.

In this sense, the proximal element or the proximal end is, respectively, an element or area located in the nearest gripping position of the second fastening element for use by the surgeon. Therefore, when the second fastener is inserted into the bone tunnel, the proximal end is the area closest to the surgeon and farthest from the bone tunnel. The distal element or distal region, respectively, is the element or region located at the position that is the farthest in use by any surgeon, and therefore closest to the bone tunnel. Accordingly, when the second fastener is inserted into the bone tunnel, the distal region is the region farthest from the surgeon and closest to the bone tunnel.

The first through channel of the second fastening element is adapted to receive a graft through one of the ends of the through channel and guide said graft through it while at least one of the ends of the graft is in the inner part or side of the annular proximal surface.

An annular proximal surface is located at the second end of this medical fastening device. In particular, the annular proximal surface is a rim that connects the second end of the first through channel and the second end of the second fastening channel. Advantageously, the annular proximal surface guides the graft so that it emerges from the first longitudinal axis with a retaining bend. As a result of said rim, a retaining bend can be formed in any part of the perimeter of the rim, enhancing the fastening.

The inner side of the annular proximal surface is part of the annular anchoring passage and advantageously allows for the attachment of multiple grafts in the anchoring passage, which is more than one in the mentioned elements of the state of the art. Therefore, the device of the present invention is adapted to secure one or more grafts.

It should be understood that the annular fastening passage is annular because the position of the annular proximal surface continuously extends the perimeter defining the connection of the second end of the first through channel and the second end of the second fastening channel.

The inner side of the surface of the annular fastening passage represents the fastening surface. The bonding surface is a surface that attaches the graft such that the graft is contained in the annular bonding passage and is deposited on the surfaces constituting the bonding surface.

Therefore, the annular fastening passage is a space or volume that is formed between the first fastening element and the inner side of the annular proximal surface of the second end of the second fastening element when the first fastening element is contained in the second fastening channel, such that when the graft is in the annular fastening passage and , in turn, settles between the surfaces that make up the fastening passage, it allows the graft to be attached and fixed. The graft portion may be linear, curved, zigzag, curved, or any other shape specified in the medical literature. Advantageously, said annular fastening passage ensures that the fastening is complete and carried out in a simple and more reliable manner compared to devices of the state of the art.

In one embodiment, the annular proximal surface extends along the entire annular perimeter to form a proximal cavity.

The proximal cavity is located at the second end or proximal end of the medical fastening device, and, like any cavity, it contains a bottom and an external opening defining said volume. Consequently, the bottom and the opening of the cavity are separated from each other by a predetermined distance.

The bottom of the proximal cavity forms a connection between the second end of the first through channel and the second end of the second fastening channel. In a particular embodiment, the annular proximal surface and proximal cavity are located around a second longitudinal axis of a second fastening channel configured to contain a first fastening element.

The annular proximal surface contains two surfaces: an outer side for contact with bone material and an inner side for contact with the graft. The proximal cavity can be considered as a continuation of the first through channel and the second fastening channel, such that it arises from the second fastening element like a protrusion extending from the first and second longitudinal axes.

Therefore, in this embodiment, the annular fastening passage is a space or volume that is formed between the first fastening element and the annular proximal surface when the first fastening element is located in the second fastening channel so that it allows attachment of at least one graft.

Advantageously, this embodiment allows the proximal cavity to be part of an annular bonding passage, substantially and advantageously increasing the bonding surface. Accordingly, the fastening surface and annular fastening passage of the fastening device of the present invention enhance the anchorage and graft capabilities leading to successful recovery. This new configuration provides the graft with an annular bracing surface sufficient to accommodate it as it expands under constraint.

This allows increasing the anchorage force in at least one graft and obtaining optimal anchorage, thus solving the problems observed in the current state of the art. This is in contrast to what happens with fastening devices at the angled proximal end of an interference screw, in which, since there is very little or reduced fastening surface available due to the area occupied by the screw itself, the fastening achieved may be incomplete.

Advantageously, the annular fastening passage of the present invention provides complete anchorage of the graft, which prevents some of the graft material from escaping from the annular securing passage when the graft is retained, thereby solving the problem observed in the present state of the art. This is different from what happens with other fastening devices, in which fastening is sometimes incomplete because the fastening surface is very small or reduced.

In a particular embodiment, the second fastening element is a fastening sleeve.

In a particular embodiment , the second fastening element includes a distal tab with a first end and a second end .

In another particular embodiment , the second end of the distal ear is connected to the first end of the first through channel, the distal ear protruding from the first end of the first through channel . Preferably, the distal ear is connected to the first end of the first through channel.

In a particular embodiment , the second end of the distal ear is further located in the first through channel, dividing said first through channel into two sections, and the first end protrudes from the first end of the first through channel .

In another further embodiment, the first through channel has axial symmetry. On the other hand, the distal ear is located on a first plane perpendicular to the entrance section of the first end of the first through channel. This position will be considered in this document when the distal ear is in a vertical position.

In another embodiment, the distal ear is on a second plane perpendicular to the entrance section of the first end of the first through channel, which in turn is also perpendicular to the first plane perpendicular to the entrance section of the first end of the first through channel defined in the previous embodiment. This position will be considered in the paper when the distal eyelet is in a horizontal position.

The distal eyelet allows the branches of at least one graft to be kept separate. Advantageously, these embodiments make it possible, in an anatomical cruciate ligament repair using a single tibial bone tunnel, to provide the intra-articular segment of the graft branches with the exact torsional angles that the original ACL has in the particular flexion-extension position of the knee in which it is being repaired. It must be understood that the intra-articular segment refers to the graft segment between both inserts, tibial and femoral, in the intra-articular cavity. Therefore, it corresponds to the entire part of the graft connecting both bones, tibial and femoral, and is located outside the bone tunnels, i.e. where the ACL is originally located.

The ACL is reconstructed using a single tibial bone tunnel, the distal eyelet advantageously allowing the two main branches of the ACL, the anteromedial (AM) branch and the posterolateral (PL) branch, to be inserted into the tibial bone tunnel, in positions corresponding to both branches of the original inserts. Accordingly, the original anatomy of the ACL is predominantly restored.

Advantageously, in one or more specific embodiments, in which the distal eyelet keeps the graft branches separated by a certain distance, this allows for the reconstruction of a more anatomical ACL, in which this separation allows for the restoration of sufficient insertion areas of the original ACL in both the tibia and femur bones without the need to use dual tunnel technologies in the tibia and/or femur.

In one embodiment, the first end of the distal tab further includes an opening, wherein said opening is configured to suspend the curved end of the graft so that when the first fastening element is located and secured in the second fastening channel of the second fastening element, the medical fastening device allows attachment of at least one free end of the graft, and at the same time this hole allows the suspension of at least one curved end of the graft to be supported .

The distal eye with the hole is a suspension member adapted to receive the curved end of the graft, as this allows the graft to be suspended when it is inserted through this hole. This configuration allows the free ends of the graft to return in a circle so they can be anchored. If the cruciate ligament is repaired with a single graft of sufficient length, it advantageously allows the use of a 3-core or 4-core graft configuration without the use of sutures or knots. Avoiding the use of sutures or knots allows the free ends of the graft to be secured using this device in a direct mechanical manner.

Advantageously, this configuration reduces the size of the device because, even though the intra-articular segment of the graft is in a 3-strand or 4-strand configuration, the device only needs to secure its two free ends as they circle back through the intra-articular region from the tibia to the tibia. femur and back from the femur to the tibia.

Therefore, in a 3-wire configuration with one tibial bone tunnel, the graft has two loops, a tibial loop and a femoral loop, which are suspended from the respective holes of the respective tibial and femoral anchorage devices, with the free end of the graft coming from the tibial foramen secured by the femoral anchorage device, and the free end of the graft coming from the femoral opening is secured using a tibial fastening device.

In one embodiment, the distal eyelet is preferably a tape, cord or strip, wherein the first end of the distal eyelet is attached to a second fastening element, and where the second end of the distal eyelet is a free end, such that when the first fastening element is positioned and secured in the fastening channel, further the second end of the distal tab is located in the fastening passage, forming an adjustable loop, where the adjustable loop is designed to suspend the curved end of the graft .

Advantageously, unlike cortical buttons, this adjustable loop does not require knots and can be modified so that, when necessary, the first fastening element can be loosened to vary the tension of the graft, the curved end of which is suspended from the adjustable loop.

In particular, the distal eyelet in the form of a tape, cord or strip of the previous embodiment is woven or interwoven.

In a particular embodiment, the distal eyelet is preferably a tape, cord or strip, in which the first end and the second end of the distal eyelet are connected to a second fastening element, forming an opening, where the hole is configured to suspend the curved end of the graft, so that when the first fastening element is positioned and secured in the second fastening channel of the second fastening element, the medical fastening device allows at least one free end of the graft to be fastened, and at the same time the hole maintains suspension of at least one curved end of the graft. Since both ends of the distal ear are connected, the distal ear is reinforced and not adjustable.

In a special case, the distal eyelet in the form of a tape, cord or strip from the previous embodiment is woven or interwoven.

In a particular embodiment , the first fastening element is a screw with a shaft and a screw head and a washer, where

- the screw head contains a circular step concentric with the screw shaft, and

- the washer contains an internal circular step of an inverse shape relative to the circular step concentric to the screw shaft, where said internal circular step is located in the area of the washer for receiving the screw head .

The inner surface of the washer is the inner side or section that is designed to accommodate the screw and is where said circular step is located. On the other hand, the outer surface of the washer is the outer side of the washer designed to come into contact with the graft and/or the annular proximal surface.

Advantageously, this embodiment prevents the washer from being pulled into a position that is not coaxial with the screw shaft, which prevents the rotational motion of the screw from being transmitted to the washer, facilitating insertion and fastening in the medical fastening device of the present invention.

In a particular embodiment, the first fastening element comprises

- a round head screw with threads on its shaft, and

- a round washer designed to fit into the head of the screw, and

wherein the second fastening channel includes threads complementary to the screw threads adapted to secure the screw to the second channel.

The washer contains a hole and an inner surface extending from this hole to an outer edge where said surface ends. The hole is adapted to receive a screw shank, and the inner surface of the washer is adapted to receive the head of the screw. In embodiments containing a washer, the fastening surface is located between the outer surface of the washer and the inner side of the annular proximal surface.

In these embodiments, because the annular proximal surface is around the threaded screw shaft as it completely surrounds the entire opening of the proximal cavity, the fastening device of the present invention allows the use of greater compressive force without retracting the graft and without passing the fastening screw through the graft during fastening . Accordingly, the present invention prevents the screw from obligatory passage and deterioration of the graft, as occurs with current devices, by means of a screw and washer.

Advantageously, the graft is placed between the wide sector of the outer side of the washer and the inner side of the annular proximal surface. The device of the present invention provides higher fastening rigidity than the device that was provided by the screw and washer of the state of the art.

In a particular embodiment , the second fastening element comprises a movable connection region movable between the first through channel and the second fastening channel, and said movable connection region is capable of:

- move to a first position inside the second fastening channel and

- move to the second position inside the first through channel .

The connection region should be understood as the region where the edges of the second end of the first through channel and the second end of the second fastening channel are connected.

On the one hand, the first position leaves room for the graft to be contained. On the other hand, the second position protects the graft by preventing it from being compressed and/or penetrated by the first fastening element when inserted into the second fastening channel.

In a particular embodiment, the second end of the second fastening element further comprises at least one flange located on an axis perpendicular to the second longitudinal axis. Preferably, the at least one flange is in the form of an annular retaining tab.

The at least one flange is adapted to abut cortical bone that delimits the outer superior portion of the entrance opening to the bone tunnel. Advantageously, this embodiment prevents the medical fastening device of the present invention from moving in the bone tunnel.

In a particular embodiment, the angle (α) is from 30° to 60°.

In a preferred embodiment, the second end of the second fastening element includes two flanges located on an axis perpendicular to the second longitudinal axis.

In a particular adjustable hinge embodiment, the second fastening element comprises a tape or strip further comprising cutouts that correspond to the cutouts existing in the first fastening element, preferably a screw without a washer. Advantageously, this embodiment enhances the fastening of the adjustable loop formed in the device.

In one embodiment, the second fastening element is integral.

In one embodiment, the elements of the medical fastening device are made of a semi-crystalline and biocompatible thermoplastic polymer material.

In a particular embodiment, the first fastening element is made of titanium and the second fastening element is made of polyetheretherketone.

In a particular embodiment, the second fastening element consists of two parts, where the first part is made of polyetheretherketone, to which is attached by cutting and/or ultrasound a second part containing a braided or interlaced cord or tape.

In another particular embodiment, the second fastening element consists of two parts made of polyetheretherketone and a titanium ring or half-ring.

In a particular embodiment, the second fastening element comprises at least one longitudinal or helical rib on its outer surface.

Advantageously, in embodiments in which the second fastening element includes at least one longitudinal rib on its outer surface, the second fastening element is prevented from folding inside the bone tunnel when the fastening screw is screwed in.

In a particular embodiment, the annular proximal surface includes at least one slot or cutout on its inner side. In another embodiment, the annular proximal surface includes at least one ridge or protrusion on its inner side. In another embodiment, the annular proximal surface includes at least one cutout and at least one rib on its inner side.

Advantageously, in embodiments in which the inner side of the fastening surface includes at least one notch and/or rib, the attachment to the graft is enhanced.

In a second aspect, the present invention provides a system for introducing a medical fastening device into a bone tunnel, comprising

- a medical fastening device according to any of the embodiments of the first aspect,

- insertion device containing

- a first end mutually shaped with respect to the shape of the second fastening element and adapted to engage the second end of the second fastening element,

- a handle located at the second end of the insertion device, and

- connecting screw.

In particular, the insertion system of the present invention allows for a rapid and efficient system for implanting a medical fastening device into a patient.

In a further example , a medical fastening device is provided for securing a graft, wherein the medical fastening device is configured to be inserted into a bone tunnel of the bone, and wherein said medical fastening device comprises

- the first fastening element,

- a second fastening element containing:

- a fastening channel designed to contain a first fastening element, forming a fastening passage for fastening relative to the bone or relative to the device itself, and

- a distal eyelet forming a suspension element, preferably a hole or loop, intended for suspension of at least one curved end of the graft.

It should be understood that the definition of a graft specified in the first aspect of the invention is used mutatis mutandis in all embodiments of the third aspect of the invention.

This hole or loop is formed to receive and suspend the curved end of the graft. This configuration allows the free ends of the graft to return in a circle so that they can be anchored. This advantageously allows the use of a single graft of sufficient length, a 3-strand or 4-strand graft configuration, without the use of sutures or knots in cruciate ligament reconstruction. Avoiding the use of sutures and knots allows the free ends of the graft to be secured using this device in a direct mechanical manner.

In addition, this configuration advantageously reduces the size of the device, since when the intra-articular segment has a 3-strand graft configuration, the graft has two loops, a tibial loop and another, a femoral loop, which are suspended from the corresponding holes or loops of the respective tibial and femoral anchorage devices, wherein the free end of the graft emerging from the tibial hole or loop is secured by a femoral fastening device, and the free end of the graft emerging from the hole or loop located in the femoral bone tunnel is secured by a tibial fastening device.

Likewise, in a 4-strand configuration, the device only needs to secure its two free ends as they return from a path through the intra-articular region from the tibia to the femur and back from the femur to the tibia.

In a particular embodiment, the distal eyelet is preferably a tape, cord or strip and comprises a first end and a second end, wherein the first end of the distal eyelet is connected to a second fastening element, and wherein the second end of the distal eyelet is a free end such that when the first fastening element is positioned and secured in the fastening channel, further the second end of the distal ear is located in the fastening passage forming an adjustable loop, wherein the adjustable loop is designed to suspend the curved end of the graft.

In a particular embodiment, the distal eyelet in the form of a tape, cord or strip from the previous embodiment is woven or interwoven.

Advantageously, in one or more specific embodiments in which the hole or loop keeps the branches of the curved end of the suspended graft separated by a certain distance, a more anatomical ACL reconstruction is possible, in which this separation allows for the restoration of sufficient insertion areas of the original ACL in both the tibia and the tibia. in the femur without the need to use double tunnel technology in the tibia and femur.

In a particular embodiment, the distal eyelet is preferably a tape, cord or strip and comprises a first end and a second end, wherein the first end and the second end of the distal eyelet are connected to a second fastening member to form an opening or loop, wherein the opening or loop is for hanging the curved end graft such that when the first fastening element is positioned and secured in the fastening channel, the medical fastening device allows at least one free end of the graft to be secured in the fastening channel, and at the same time the hole or loop allows the suspension of at least one curved end of the graft.

In a particular embodiment, the distal eyelet in the form of a tape, cord or strip from the previous embodiment is woven or interwoven.

All features of the embodiments described for the first aspect of the invention apply to this third aspect of the invention, except for excluding or incompatible combinations.

Likewise, all features described in this application (including the claims, description and drawings) can generally be combined in any combination except combinations of mutually exclusive features.

Description of drawings

These and other features and advantages of the present invention will become more apparent from the following detailed description of preferred embodiments, given by way of non-limiting illustrative examples only, with reference to the accompanying drawings.

Figures 1A-1E show several graft retention systems of this state of the art.

Figures 2A-2E show the graft anchorage system of this state of the art, where retention is performed at the top of the inner region of the sleeve.

Figures 3A-3D show several exploded views of a medical fastening device of the first aspect of the invention.

Figures 4A-4C show several views of a medical fastening device of the first aspect of the invention when the first fastening element is located in the second fastening element.

Figures 5A and 5B show several views of a medical fastening device of the first aspect of the invention with a graft being secured.

Figures 6A - 6D show several views of a medical fastening device of the first aspect of the invention with a distal tab forming an adjustable loop.

Figures 7A - 7C show several views of a medical fastening device of the first aspect of the invention with a distal tab forming a secured loop.

Figures 8A - 8C show several views of a medical fastening device of the first aspect of the invention with a distal tab forming a half-ring.

Figures 9A - 9D show several views of a medical fastening device of the first aspect of the invention with a horizontal distal tab.

Figures 10A - 10D show several views of a medical fastening device of the first aspect of the invention with a vertical distal tab.

Figures 11A - 11E show several views of a system for introducing a medical fastening device according to the first and second aspects of the invention.

Figures 12A - 12D show the steps of using a medical fastening device of the first aspect of the invention with an adjustable femoral loop and a vertical eyelet without an opening during SIJ reconstruction of the right knee.

Figures 13A - 13D show a schematic representation of the device system of the first aspect of the invention as a whole, which allows a 3-strand configuration of a single graft.

Figures 14A - 14C show a schematic representation of the device system of the first aspect of the invention as a whole, which allows a 4-strand configuration of a single graft.

Figures 15A - 16D show several views of the device of the third aspect of the invention.

Figures 17A - 17D show several views of a medical fastening device of the first aspect of the invention with two flanges located at the second end of the second fastening element.

Figures 18A - 18D show several steps of a surgical method for repairing an injured anterior cruciate ligament (ACL) using the first and second fastening devices of the present invention.

Detailed Description of the Invention

The present invention describes two alternative graft anchorage devices. Preferably, in the embodiments described in this section, the second fastening element may be solid, made from a semi-crystalline and biocompatible thermoplastic polymer material; the first fastening element may comprise a screw made of a titanium alloy and a washer made of a semi-crystalline and biocompatible thermoplastic polymer material or any other material described in the present state of the art. Additionally, the outer surface of the second fastening element may include cutouts that promote osseous integration of the device by increasing the bone contact surface.

All possible geometries, all possible materials, all possible manufacturing methods, and all possible surface treatments found in the medical literature are contemplated in other embodiments for the second fastening element and for the first fastening element.

A first fastening element that is integral is also contemplated in other embodiments.

When reconstructing the anterior cruciate ligament (ACL) of the knee with grafts, a femoral bone tunnel is typically used in which the curved end of the graft is suspended by the anchoring devices described herein with a loop, adjustable loop, hole, or hanger. On the other hand, one or more fastening devices described herein are used in one or two tibial tunnels having a diameter of 6 mm to 12 mm to secure the other end of the graft. Therefore, this spacing is the preferred size provided for the second fastening elements of medical fastening devices for use in these embodiments.

This should not limit the application of the present invention, which works effectively in restoring any ligaments present in the joint, with suitable dimensions in each case.

First fastening device

Figures 3A-14D show embodiments of the first medical fastening device (1). In particular, the medical fastening device (1) contains a first fastening element (100) and a second fastening element (200). It can be seen that in any of the described examples, the second fastening element (200) may be a fastening sleeve.

First fastening device: first fastening element (100)

One embodiment of the first fastening element (100) according to the first invention can be seen in figures 3A-3D. In this example, the first fastening element is a fastening screw (110) with a head provided with a hex drive region and a thread (113) that matches the threads (223) of the second channel (220).

In addition, the first fastening element (100) includes a washer (120) surrounding the screw head in use.

Figures 3A-3D show an image of a screw (110) and a washer (120). In particular, the head of the screw matches the shape of the inner surface of the washer (120). In this embodiment, the screw (110) includes a circular step (111) in a plane perpendicular to the stub of the screw. In turn, the washer (120) is suitably provided with an inner circular step (121) opposite to the screw step. Advantageously, this example prevents the washer's engagement with the screw from seizing, thereby keeping the washer aligned with the screw and optimizing the transfer of force between them.

First fastening device: first embodiment of the second fastening element (200): figures 3A-5B

Figures 3A-5B show a first embodiment of the first medical fastening device (1). In particular, the second fastening element (200) includes a first through channel (210) that extends along the first longitudinal axis (215). As can be seen in the sectional views of Figures 3C and 3D, the second fastening element (200) further includes a first end (211) and a second end (212).

With respect to the first through channel (210) of the second fastening element (200), Figures 3A and 3B show that said through channel (210) further includes a first end (211) and a second end (212). In particular, the first through channel (210) is adapted to contain the graft (10), as will be shown below in the description of the method of application shown in figures 5A-5B, 14A-14D. In particular, the first end (211) is intended to receive the graft (10), the second end (212) is intended to be part of the fastening surface of the annular fastening passage (300) as shown in figures 5A and 5B.

The configuration of the distal end of the first channel (210) of the second fastening element (200) may be circular, elliptical, rectangular, trilobed, semi-circular, or any other geometric shape known in the art, without necessarily having a correspondence between the configuration of the distal end and the proximal end.

Additionally, as can be seen in Figures 3A-3D, the second fastening element (200) includes a second fastening channel (220) that extends along a second longitudinal axis (225). The second fastening channel (220) further includes a first end (221) and a second end (222).

The second fastening channel (220) is adapted to contain and secure the first fastening element (100), as can be seen in figures 3A-5B. In this case, the second fastening channel (220) may have several shapes on its inner side corresponding to the shape of the first fastening element (100). For example, in the sectional view of Figure 3C, the inner side of the second fastening channel (220) has a thread shape corresponding to the threads of a screw. In another embodiment, the inner side of the second channel (220) is in the form of a clamp or flat spring complementary to the outer surface of the first fastening element (100). In another embodiment, the inner side of the second fastening channel (220) has a smooth shape for the first self-tapping fastening element (100).

As can be seen in the example cross-sectional view of Figure 3C, the first through channel (210) and the second fastening channel (220) are located within the second fastening element (200) such that the first longitudinal axis (215) and the second longitudinal axis (225) form an angle (α) with each other that is not equal to 0, preferably an angle from 0° to 90°. Preferably, the angle (α) is from 30° to 60°. Even more preferably, in these embodiments, the angle (α) may be 45°.

In particular, Figure 3A shows that the second fastening element (200) includes an annular proximal surface (230) that defines a proximal cavity (235) at the second end (212) of the second fastening element (200). In addition, the second end (212) of the first through channel (210) and the second end (222) of the second fastening channel (220) are connected, defining a connection (290) at the bottom of the proximal cavity (235). The connection (290), the second end (212) of the first through channel (210) and the second end (222) of the second fastening channel (220) are part of the bottom of the proximal cavity (235) of the second end (212) of the second fastening element (200), extending to openings of said proximal cavity (235).

In addition, it can be seen in Figure 4B that the connection (290) is movable in this embodiment.

As can be seen in the embodiment of Figure 3D, there is a lower stop (236) on the annular proximal surface (230) of the second fastening element (200). Therefore, the annular proximal surface (230) includes a lower stop (236). The combination of the annular proximal surface (230) and the anvil (236) creates a position of maximum compression in which a sector of the contour of the first fastening element (100) rests on the lower anvil (236), which advantageously increases the rigidity of the fastening provided by the device.

The stop (236) allows the graft to be secured to a specified thickness, providing rigidity to the attachment. The annular configuration of the annular proximal surface (230) ensures sufficient space for expansion of the graft (10) from the initial thickness to that predetermined thickness, which corresponds to the position of maximum compression of the fastening device (1).

As can be seen in the embodiment of Figures 3A-5B, the second fastening element includes a flange (231) which advantageously prevents the device (1) from migrating into the bone tunnel.

Finally, Figures 4A-5B show an embodiment with the first fastening element (100) located and secured in the second fastening channel (220) of the first embodiment of the second fastening element (200). An annular fastening passage (300) can be seen formed between the inner side of the annular proximal surface (230) and the outer surface of the washer (120).

Figures 5A and 5B show views of the overall upper portion and lower sectional portion, respectively, of a medical fastening device with at least one graft (10) held therein. In particular, the annular fastening passage (300) created by the medical fastening device (1) of the present invention can be clearly seen in Figure 5B. Said annular fastening passage (300) is annular because the arrangement of the annular proximal surface (230) forms a continuous and annular surface of the proximal cavity (235). This allows the annular proximal surface (230) to be part of an annular fastening passage (300), which allows multiple grafts to be secured in a larger fastening passage than the elements mentioned in this state of the art. In addition, the shape of the annular fastening passage (300) imparts greater structural stability to the fastening.

If Figures 5A and 5B are compared with Figures 1A to 1F, one can clearly see the differences between the medical fastening device (1) of the present invention relative to other devices (600, 700, 800) of the present state of the art. The interference screw (600) in Figures 1A and 1B provides an attachment relative to the bone, where it is very weak due to the porosity of said bone (900). In addition, it can be seen that said interference screw (600) can damage the ligaments, further weakening the attachment.

The screw (700) in Figures 1C and 1D is screwed coaxially into the sleeve containing the graft directly onto the graft, which, like an interference screw, can damage said graft. In addition, when used in the tibia, the largest part of the screw head is located inside the tibia, which, due to the high porosity of this bone, weakens the resistance to movement of the device.

The retaining element (800) in figures 1E-1F is inserted into the bone tunnel and holds the graft relative to the inner wall of the tunnel, while the screw (802) with a washer, which enters perpendicular to the cortical bone and is screwed into the angular side of the retaining element, holds the graft a second time. This configuration creates a fastening area around the screw and washer, so the screw must necessarily separate and pass between the graft bundles to begin fastening them, which, as in the two previous examples of the technique, can damage the graft, further causing other problems associated with these devices , which have been described in the prior art section of this invention.

In contrast, the first medical fastening device (1) prevents damage to the ligaments by the screw (110) due to the fact that the first channel (210) and the second channel (220) are located inside the second fastening element (200) so that the first longitudinal axis (215) and the second longitudinal axis (225) form an angle (α) with each other that is not equal to 0. In addition, since in the first medical fastening device (1) the ligament is located inside it, with the help of the annular proximal surface (230) a larger fastening passage ( 300) and attachment to relatively porous bone (900) is prevented, providing a stronger and more secure attachment.

The configuration of the fastening passage exclusively in the upper proximal region of the coupling can be seen in Figure 2E. When Figure 2E is compared to Figures 5A and 5B, Figure 2E provides a limited anchorage passage that leaves a portion of the graft (10) unretained, which reduces both anchorage stability and the full tensile strength provided by the device unless the device is increased in size, which is an unacceptable solution.

First fastening device: second embodiment of the second fastening element (200): a distal eye (240) forming an adjustable loop (245); figures 6A-6D

Figures 6A-6D show a second embodiment of the first medical fastening device (1) of the present invention. As can be seen, the second embodiment is similar to the first embodiment with the exception that the second embodiment further includes a distal eye (24) forming an adjustable loop (245).

As can be seen in Figure 6A, the distal eyelet (240) includes a tape, cord or strip with a first end (241) attached to the first end of the second fastening element (200), and a second end (242) with a first position free from fastening. In the second position, the second end (242) may be positioned such that said end (242) extends back into the second fastening element (200), forming an adjustable loop (245), which is secured in the desired position by the first fastening element (100), as shown in Figures 6B, 6C and 6D.

In particular, as shown in Figures 6B-6D, when the first fastening element (100) is located and secured in the second fastening channel (220) of the second fastening element (200), the free end (242) is also secured in said fastening passage (300).

As can be seen in Figure 6C, the dotted line shows an example of different positions of the adjustable loop (245); therefore, the distal tab (240) can be considered to be flexible and can define more than one end position in this embodiment.

The length of the adjustable loop (245) is secured by the first fastening member (100), the adjustable loop (245) being designed to suspend the curved end of the graft (10) in the bone tunnel or bone canal. This attachment is adjustable from a first tension-free position to a final position with ideal tension on the suspended graft.

First fastening device: third embodiment of the second fastening element (200): a distal eye (250) forming a fixed loop; figures 7A-7C

Figures 7A-7C show a third embodiment of the first medical fastening device (1) of the present invention. As can be seen, the third embodiment is similar to the first embodiment with the exception that the third embodiment further includes a distal eye (250) with an opening (253) forming a non-adjustable loop. It can be called a fixed or non-adjustable loop, since both ends (251, 252) of the eye (250) are attached to the second fastening element (200), and therefore the hanging area, i.e. the hole size (253) is constant. In one embodiment, the distal ear (250) is flexible. In the examples in Figures 7A-7C, the distal ear (250) is in a vertical position.

As can be seen, in this particular embodiment, the distal eye (250) includes a tape, cord or strip, both ends of which (251, 252) are attached to the second fastening element (200) so as to form a closed or non-adjustable loop for hanging a curved end of the graft in the bone tunnel.

First fastening device: fourth embodiment of the second fastening element (200): a distal eye (260, 270) with a hanging hole; figures 8A-9D

Figures 8A-8C show a fourth embodiment of the first medical fastening device (1) of the present invention. As can be seen, the fourth embodiment is similar to the first embodiment except that the fourth embodiment further includes a distal ear (260). In these examples, the distal eyelet (260) is a half-ring defining an opening (263) for suspending the curved end of the graft in the bone tunnel.

In the particular embodiment of Figures 9A-9D, the second fastening element (200) does not include a flange (231) and instead has a frusto-conical outer contour that advantageously retains the device at the entrance of the bone tunnel (10), preventing it from penetrating the bone tunnel (10), said second fastening element (200) being similar to the element shown in the first embodiment of the first invention in other respects.

As can be seen in the examples of Figures 9C and 9D, the distal eye (270) includes a first end (271) and a second end (272) located at the first end of the second fastening element (200). In addition, the distal eye (270) includes an opening (273) for suspending the curved end of the graft in the bone tunnel. More specifically, an opening (273) is located at the first end (271) of the distal ear (270).

In other embodiments, the second fastening element (200) in Figures 9A-9D may include a flange (231) similar to the flange shown in the examples in Figures 8A-8D.

In the depiction of Figures 8A-9D, the distal ear (260, 270) can be considered to be in a horizontal position.

First fastening device: fifth embodiment of the second fastening element (200): a distal eye (280) with a hanging hole (281); figures 10A-10D

Figures 10A-10D show a fifth embodiment of the first medical device (1) of the present invention. As can be seen, the fifth embodiment is similar to the first embodiment with the exception that the fifth example further includes a distal eye (280) located at the first end of the second fastening element (200). In these examples, the distal eyelet (280) includes a first end (281), a second end (282), and an opening (283) for suspending the curved end of the graft in the bone tunnel. In addition, an opening (283) is located at the first end (281) of the distal ear (280).

In the depiction of Figures 10A-10D, the distal ear (280) can be considered to be in a vertical position.

Specifically, the second end (282) is located in the first through channel (210), dividing the first through channel (210) into two sections. In other words, the first through channel (210) is divided into a first section (213) and a second section (214) by the second end (282) of the distal ear (280).

On the other hand, figures 10A, 10B and 10D show that the second end (282) of the distal ear (280) is part of the bottom of the proximal cavity (235) and the connection between the second end (212) of the first through channel (210) and the second end (222 ) of the second fastening channel (220).

First fastening device: sixth embodiment of the second fastening element (200): a distal eye (290) with a hanging hole (293); figures 17A-17D

Figures 17A to 17D show a sixth embodiment of the first medical fastening device (1) of the present invention. As can be seen, the sixth embodiment is similar to the first embodiment with the exception that the second end (222) of the second fastening channel (220) in the sixth example further includes two flanges located opposite on an axis perpendicular to the second longitudinal axis (225). Another difference from the first embodiment is that the sixth example includes a distal eye (290) located at the first end of the second fastening element (200).

In this example, the two flanges (231) are in the form of annular retaining tabs adapted to abut the cortical bone that delimits the outer superior portion of the bone tunnel entrance.

Advantageously, the flanges (231) hold the device at the entrance of the bone tunnel (10), preventing it from penetrating the bone tunnel (10).

In this example, the distal eyelet (290) includes an opening (293) for suspending the curved end of the graft in the bone tunnel.

First fastening device: system (400) for introducing a medical fastening device (1): figures 11A-11E

Figures 11A-11E show one embodiment of a system (400) for introducing a medical fastening device (1) according to any of the embodiments shown above. The system (400) includes a medical fastening device (1) of the present invention, connecting a screw (440), an insertion device (450) to a first end (410) adapted to engage a second end of a second fastening element (200), and a handle (430), located at the second end (420) of the input device (450).

Advantageously, the use of an insertion device (450) with a connecting screw (440) allows the device to be controlled using a handle (430) and the necessary force to be applied to insert the device (1) into the bone tunnel (11). This prevents the device (1) from becoming detached from the input device (450), as can be seen in more detail in Figures 11A- and 11E.

First fastening device: example of using a medical fastening device with an adjustable loop in the femur and a rigid vertical distal tab in the tibia: figures 12A-12D

Figures 12A-12D show reconstruction of the anterior cruciate ligament (ACL) of the right knee (15) using the first two medical fastening devices (1) of the present invention. The first medical fastening device (1) is similar to the device described in the example of Figures 6A-6C, and the second medical fastening device (1) includes a distal ear in a vertical position without an opening.

Advantageously, this distal eyelet without an opening allows for the maintenance of torsion of the intra-articular segment of the graft branches without achieving said torsion to the intra-tunnel segment, which is important for restoring the anatomy and biomechanics of torsion of the original ACL, as can be seen in the embodiment of Figures 12A-12D.

Figure 12A shows the free ends of the grafts (10) protruding from a bone tunnel (12) made in the tibia. The curved ends of the grafts (10) are suspended from the adjustable loop (245) of the first medical fastening device (1).

Advantageously, the adjustable loop (245) allows the femoral bone tunnel (11), or femoral bone canal, to be made and the curved end of the graft to be pulled and adjusted, which also allows the tension at which the graft is secured to be checked and adjusted (10).

Figure 12B shows the curved ends of the grafts when they are adjusted using the adjustable loop held by the femoral anchorage device. The free ends of the grafts (10) still protrude from the bone tunnel (12) made in the tibia.

Figure 12C shows the torsion of the intra-articular segment of the graft (10), which mimics the anatomical torsion (16) characteristic of the original ACL, i.e. counterclockwise into the ACL of the right knee, which is shown. Advantageously, the second medical device (1) with a distal eyelet and without an opening, shown in Figure 12C, allows the branches of the graft (10) to be kept separated so that the anatomical twist imparted to the intra-articular segment of the graft does not propagate in an uncontrolled manner into the bone tunnel. As can be seen, an insertion system (400) is used to handle the device.

Figure 12D shows the fastening device (1) with the first threaded fastening element (100) when the graft (10) has been tensioned at the tension required to restore stability to the knee joint.

First fastening device: example of use of the first medical fastening device (1) of the present invention: 3-strand graft configuration: figures 13A-13D

Figure 13A shows an image of the combined use of the first two medical devices (1) of the present invention in the reconstruction of the ACL of the right knee, where said use comprises:

- providing a graft (10) that is organized into three branches with two curved ends and two free ends.

- providing two medical fastening devices (1) with a distal eye (250, 260, 270, 280) with a hole, intended for insertion into the corresponding first and second bone tunnels (11, 12). The assembly of the first fastening element (100) and the second fastening element (200) is depicted as a rectangle in Figure 13A. The hole (253, 263, 273, 283) is depicted as a circle in Figure 13A.

- arrangement, as shown in figures 13B-13D, of two medical fastening devices (1) so that it allows fastening of the first free end and suspension of the first curved end of the graft (10) by means of the first medical device (1) inserted into the first bone tunnel (eleven). On the other hand, securing the second free end and suspending the second curved end of the graft (10) by means of a second medical device (1) inserted into the second bone tunnel.

Figures 13B-13D show the use of two medical fastening devices (1), such as those shown in Figures 9A-9D, for a 3-wire single graft configuration as depicted in Figure 13A.

First fastening device: example of use of the medical fastening device (1) of the first invention: 4-strand graft configuration: figures 14A-14C

Figure 14A shows an image of the use of the first two medical devices (1) of the present invention in ACL reconstruction of the right knee, where said use comprises:

- providing a graft (10) in a 4-strand configuration with four branches with three curved ends and two free ends.

- providing two medical devices (1), a first device with a vertical distal eye with an opening (280) in figures 10A-10D, intended for insertion into the first bone tunnel (11), and a second device with an adjustable loop, intended for insertion into the second bone tunnel tunnel (12). The assembly of the first fastening element (100) and the second fastening element (200) is depicted as a rectangle in Figure 14A. Suspension element, i.e. hole or adjustable loop, shown as a circle in figure 14A.

- arrangement, as shown in figures 14B and 14C, of two medical fastening devices (1) so that they allow the fastening of both free ends and the simultaneous suspension of the first curved end of the graft (10) by means of the first medical device (1) inserted into the first bone tunnel (11). On the other hand, by means of a second medical device (1) inserted into the second bone tunnel (12), the second and third curved ends of the graft (10) are suspended in an adjustable manner.

Second fastening device

Figures 15A-15D show embodiments of the second medical fastening device (500) of the present invention. Specifically, the medical fastening device (500) includes a first fastening element (510) and a second fastening element (520) comprising a fastening channel (523) and a suspension element. In this second fastening device (500), when the first fastening element (510) is secured in the fastening channel (523) of the second fastening element (520) and inserted into the bone tunnel, a fastening passage between the second fastening element (520) and the bone tunnel is obtained, which secures the graft in said bone tunnel, or between the first fastening element (510) and the second fastening element (520), which secures the graft to the device itself.

Second fastening device: first fastening element (510)

One embodiment of the first fastening element (510) according to the second fastening device can be seen in figures 15A-16D. In the examples of Figures 15A, 15C and 15D, the first fastening element (510) is a screw whose head has the same diameter as its shank (514). In the example of Figure 15B, the diameter of the screw head is greater than the diameter of its shank (514). The head of the screw (511) is provided with a drive area with an internal hexagon (512), and its shaft contains threads.

Second fastening device: first embodiment of the second fastening element (520): figures 15A-15C and 16A-16D

Figures 15A-15C and 16A-16D show a first embodiment of a second medical fastening device (500) of the present invention. For clarity, in the example of Figures 15A-15C and 16A-16D, the second fastening element (520) has a first end (521) and a second end (522); in addition, the second fastening element (520) includes a fastening channel (523), located at its second end (522), designed to contain the first fastening element (510).

As can be seen, the second fastening element (520) includes a distal tab (530) organizing the suspension element, the first end (531) and the second end (532) being attached to the first end (521) of the second fastening element (520) so that a a non-adjustable hole or closed loop (533) designed to suspend the curved end of the graft in a bone tunnel.

Advantageously, the devices in Figures 15A-15C and 16A-16D allow the images of Figure 13A, 3-strand graft configuration, and Figure 14A, 4-strand graft configuration, to be reproduced using methods similar to those described in the first invention.

Second fastening device: a second embodiment of a second fastening element (520) forming an adjustable loop; figure 15D

Figure 15D shows a second embodiment of a second medical fastening device (500) of the present invention. As can be seen, the second embodiment is similar to the first embodiment except that the distal ear (530) is formed as an adjustable loop (533).

As can be seen in Figure 15D, in this particular embodiment, the distal eye (530) includes a tape, cord or strip with a first end (531) connected to the first end (521) of the second fastening element (520), and a second free from the attachment end (532). The second end (532) may be arranged to extend back into the second fastener (520) to form an adjustable loop (533), as shown in Figure 15D.

The length of the adjustable loop is secured by the first fastening member (510), the adjustable loop (533) being designed to suspend the curved end of the graft (10) in the bone tunnel or bone canal. Said anchorage is adjustable from a first tension-free position to a final position with ideal tension on the suspended graft.

Surgical method: repair of the damaged anterior cruciate ligament (ACL) using the first and second fastening devices (1); figures 18A-18D.

Figures 18A-18D show an example of a surgical method for repairing an injured anterior cruciate ligament (ACL). In this surgical method, ACL repair is performed using first and second fastening devices (1) with hanging holes (273).

Advantageously, equipping the device (1) with a suspension hole (273) for each bone tunnel - tibial and femoral bone tunnels - allows the first graft (10) to be suspended in one of the bone tunnels and the second graft (10) to be suspended in the other bone tunnel, securing, in both cases, the free ends of each graft (10) by a device (1) located on the opposite side where the graft (10) is suspended, as shown in Figures 18B, 18C and 18D.

The surgical method contains the following steps:

1) making a femoral bone tunnel with an intra-articular entrance of the femoral bone tunnel at the insertion site of the original ACL,

2) making a tibial bone tunnel with an intra-articular entrance of the tibial bone tunnel at the site of entry of the original ACL,

3) hanging, from the hanging hole (273) of the first fastening device (1), the curved end of the first graft (10),

4) insertion of the free ends of the first graft (10) through the extra-articular entrance of the femoral bone tunnel until reaching, through the intra-articular cavity of the knee joint, the intra-articular entrance of the tibial bone tunnel until the free ends of the first graft (10) protrude from the extra-articular entrance of the tibial bone tunnel,

5) hanging, from the hanging hole (273) of the second fastening device (1), the curved end of the second graft (10),

6) insertion of the free ends of the second graft (10) through the extra-articular entrance of the tibial bone tunnel until reaching, through the intra-articular cavity of the knee joint, the intra-articular entrance of the femoral bone tunnel until the free ends of the second graft (10) protrude from the extra-articular entrance of the femoral bone tunnel,

wherein the free ends of the first and second grafts (1) are located in the extra-articular tibial and femoral portals so that each of the free ends can be secured by a device (1) located on the opposite side from where the graft (10) is suspended, as shown in Figure 18C and 18D.

This configuration further allows both grafts to be weaved such that the intra-articular segment of the grafts has an anatomical weave that is characteristic of the biomechanics of the original ACL, as shown in Figures 18C and 18D.

Claims (35)

1. A medical fastening device (1) for securing a graft (10) in a bone tunnel, where the medical fastening device (1) is configured to be inserted into a bone tunnel (11, 12) of the bone, and said medical fastening device contains - first fastening element (100), - a second fastening element (200), containing: - a first through channel (210) with a first end (211) and a second end (212), wherein said first through channel (210) runs along the first longitudinal axis (215), said first through channel (210) is configured to receive a graft ( 10) at its first end (211) and the graft accommodation (10) inside it and at its second end (212), - a second fastening channel (220) with a first end (221) and a second end (222), where said second fastening channel (220) extends along the second longitudinal axis (225), wherein the first through channel (210) and the second fastening channel (220) are located inside the second fastening element (200) so that the first longitudinal axis (215) and the second longitudinal axis (225) form an angle α with each other different from 0, wherein the second end (212) of the first through channel (210) and the second end (222) of the second fastening channel (220) are connected to form an annular proximal surface (230), so that when the first fastening element (100) is placed and secured in the fastening channel (220), an annular fastening passage (300) is formed between the first fastening element (100) and the annular proximal surface (230). 2. The device according to claim 1, characterized in that the annular proximal surface (230) extends along the entire annular perimeter, defining a proximal cavity (235). 3. Device (1) according to any of the previous paragraphs, in which the second fastening element (200) includes a distal eye (250, 260, 270, 280) with a first end (251, 261, 271, 281) and a second end (252, 262, 272, 282). 4. Device (1) according to claim 3, in which the second end (252, 262, 272, 282) of the distal ear (250, 260, 270, 280) is connected to the first end (211) of the first through channel (210), and a distal ear (250, 260, 270, 280) projects from the first end (211) of the first through channel (210). 5. Device (1) according to claim 3 or 4, in which - the second end (282) of the distal ear (280) is further located in the first through channel (210), dividing said first through channel (210) into two sections, and - the first end (281) protrudes from the first end (211) of the first through channel (210). 6. Device (1) according to any one of paragraphs. 4 or 5, wherein the first end (271, 281) of the distal ear (270, 280) further comprises an opening (273, 283), wherein said opening (273, 283) is for hanging the curved end of the graft (10) so that, when the first fastening element (100) is located and secured in the second fastening channel (220) of the second fastening element (200), the medical fastening device (1) allows fastening of at least one free end of the graft (10), and at the same time an opening (263 ) allows the suspension of at least one curved end of the graft (10) to be maintained. 7. Device (1) according to claim 3, wherein the distal eye (240) is preferably a tape, cord or strip, wherein the first end (241) of the distal ear (240) is attached to the second fastening element (200), and wherein the second end (242) of the distal ear (240) is a free end such that when the first fastening element (100) is located and secured in the fastening channel (220), further the second end (242) of the distal ear (240) is located in the fastening passage (300), forming an adjustable loop (245), where the adjustable loop (245) is designed to suspend the curved end of the graft (10). 8. Device (1) according to claim 3, wherein the distal eye (250, 260) is preferably a tape, cord or strip, wherein the first end (251, 261) and the second end (252, 262) of the distal ear (250, 260) are connected to the second fastening element (200), forming an opening (253, 263), where the opening (253, 263) is provided for suspending the curved end of the graft (10), so that when the first fastening element (100) is located and secured in the second fastening channel (220) of the second fastening element (200), the medical fastening device (1) allows fastening at least one free the end of the graft (10), and at the same time the hole (253, 263) maintains the suspension of at least one curved end of the graft (10). 9. Device (1) according to any of the previous paragraphs, in which the first fastening element is a screw (110) with a rod and a screw head and a washer (120), where - the screw head contains a circular step (111) concentric with the screw shaft (110), and - the washer (120) contains an internal circular step (121) of reverse shape relative to the circular step (111), concentric to the screw shaft (110), where said internal circular step (121) is located in the area of the washer (120) for receiving the screw head. 10. Device (1) according to any one of the previous paragraphs, in which the second fastening element (200) includes a movable connection area (290) moving between the first through channel (210) and the second fastening channel (220), wherein said movable connection area is adapted For: - movement to a first position inside the second fastening channel (220) and - movement to a second position inside the first through channel (210). 11. Device (1) according to any of the previous paragraphs. 1-10, in which the angle (α) is from 30° to 60°. 12. Device (1) according to any of the previous paragraphs, in which the second end (222) of the second fastening element (200) contains at least one flange (231) located on an axis perpendicular to the second longitudinal axis (225). 13. Device (1) according to claim 12, wherein the second end (222) of the second fastening element (200) comprises two flanges located on an axis perpendicular to the second longitudinal axis (225). 14. System (400) for introducing a medical fastening device into a bone tunnel, containing - medical fastening device (1) according to any of the previous paragraphs, - insertion device (450) containing - a first end (410) mutually shaped relative to the shape of the second fastening element (200) and configured to engage the second end (212) of the second fastening element (200), - a handle (430) located at the second end (420) of the insertion device (450), and - connecting screw (440).