Abstract
The present invention relates to a medical fastening device for the fastening of grafts, wherein the medical fastening device is suitable for being inserted in a bone tunnel of a bone, and wherein said medical fastening device comprises a first fastening element and a second fastening element. The invention also describes a system for inserting the medical fastening device of the present invention and a second alternative medical fastening device for the fastening of a graft.
Claims
1. A method comprising: forming a bone tunnel extending from a distal end to a proximal end through a bone of a patient; inserting a second fastening element into the proximal end of the bone tunnel, wherein the second fastening element comprises a first through conduit and a second through conduit extending at an angle relative to the first through conduit, wherein inserting the second fastening element into the proximal end of the bone tunnel comprises positioning the first through conduit coaxially with the bone tunnel; advancing a manufactured longitudinal element through the bone tunnel and through the first through conduit of the second fastening element; attaching the manufactured longitudinal element at the distal end of the bone tunnel; and inserting a first fastening element into the second through conduit of the second fastening element to secure the manufactured longitudinal element between the first fastening element and the second fastening element.
2. The method of claim 1, wherein advancing the manufactured longitudinal element through the bone tunnel and through the first through conduit of the second fastening element comprises advancing the manufactured longitudinal element in a linear path through the bone tunnel and through the first through conduit of the second fastening element and then bending the manufactured longitudinal element about a proximal end of the second fastening element.
3. The method of claim 1, wherein the bone comprises cortical bone, the second fastening element comprises at least one flange, and inserting the second fastening element into the proximal end of the bone tunnel comprises inserting the second fastening element until the at least one flange abuts the cortical bone.
4. The method of claim 1, wherein the second fastening element comprises a stop and inserting the first fastening element into the second through conduit of the second fastening element comprises inserting the first fastening element into the second through conduit of the second fastening element until the first fastening element contacts the stop.
5. The method of claim 1, wherein the first fastening element comprises a screw.
6. The method of claim 1, wherein the second fastening element comprises an annular passageway.
7. The method of claim 1, wherein: the first fastening element further comprises a washer; and inserting the first fastening element into the second through conduit of the second fastening element to secure the manufactured longitudinal element between the first fastening element and the second fastening element comprises securing the manufactured longitudinal element between the washer and the second fastening element.
8. The method of claim 1, wherein the first fastening element comprises metal and the second fastening element comprises a polymeric material.
9. The method of claim 1, wherein forming the bone tunnel extending from the distal end to the proximal end through the bone of the patient comprises forming the bone tunnel having a diameter within a range from 6 mm to 12 mm.
10. The method of claim 1, wherein the first through conduit of the second fastening element defines a first longitudinal axis, the second through conduit of the second fastening element defines a second longitudinal axis, and the second longitudinal axis is angled at a non-zero degree angle within a range from 30 degrees to 60 degrees relative to the first longitudinal axis.
11. The method of claim 1, wherein inserting the second fastening element into the proximal end of the bone tunnel comprises manipulating an inserter attached to the second fastening element to insert the second fastening element into the proximal end of the bone tunnel.
12. The method of claim 11, further comprising attaching the inserter to the second fastening element by inserting a first end of the inserter into a proximal end of the second fastening element and coupling the first end of the inserter to the proximal end of the second fastening element with a coupling screw.
13. The method of claim 1, wherein the bone is a first bone, the bone tunnel is a first bone tunnel, and further comprising forming a second bone tunnel through a second bone, wherein: attaching the manufactured longitudinal element at the distal end of the bone tunnel comprises attaching the manufactured longitudinal element at a distal end of the second bone tunnel; and advancing the manufactured longitudinal element through the bone tunnel and through the first through conduit of the second fastening element advancing comprise the manufactured longitudinal element through the first bone tunnel and through the second bone tunnel.
14. The method of claim 1, wherein the bone is a tibia or a femur.
15. The method of claim 1, wherein advancing the manufactured longitudinal element through the bone tunnel and inserting the first fastening element into the second through conduit of the second fastening element to secure the manufactured longitudinal element between the first fastening element and the second fastening element comprises reconstructing and/or repairing a connective tissue.
16. The method of claim 15, wherein the connective tissue is a tendon or a ligament.
17. The method of claim 1, wherein the manufactured longitudinal element is a flexible, synthetic strand.
18. A method comprising: forming a bone tunnel extending from a distal end to a proximal end through a bone of a patient; inserting into the proximal end of the bone tunnel a device that comprises an annular fastening passage and a through conduit intersecting the annular fastening passage; advancing a manufactured longitudinal element through the bone tunnel and through the annular fastening passage of the device; attaching the manufactured longitudinal element at the distal end of the bone tunnel; and inserting a screw into the through conduit of the device to secure the manufactured longitudinal element between the screw and a wall of the annular fastening passage.
19. The method of claim 18, wherein advancing the manufactured longitudinal element through the bone tunnel and through the annular fastening passage of the device comprises advancing the manufactured longitudinal element in a linear path through the bone tunnel and through the annular fastening passage of the device and then bending the manufactured longitudinal element about a proximal end of the device.
20. The method of claim 18, wherein the manufactured longitudinal element is a flexible, synthetic strand.
Description
DESCRIPTION OF DRAWINGS
[0134] These and other features and advantages of the invention will become more apparent from the following detailed description of preferred embodiments given solely by way of non-limiting illustrative examples in reference to the attached drawings.
[0135] FIGS. 1A to 1F show several graft retaining systems of the state of the art.
[0136] FIGS. 2A to 2E show a graft fastening system of the state of the art where the retention is performed in the upper part of the inside of the ferrule.
[0137] FIGS. 3A to 3D show several exploded views of the medical fastening device of the first inventive aspect.
[0138] FIGS. 4A to 4C show several views of the medical fastening device of the first inventive aspect, when the first fastening element is housed in the second fastening element.
[0139] FIGS. 5A and 5B show several views of the medical fastening device of the first inventive aspect with the graft being fastened.
[0140] FIGS. 6A to 6D show several views of the medical fastening device of the first inventive aspect with a distal appendage configuring an adjustable loop.
[0141] FIGS. 7A to 7C show several views of the medical fastening device of the first inventive aspect with a distal appendage configuring a fastened loop.
[0142] FIGS. 8A to 8C show several views of the medical fastening device of the first inventive aspect with a distal appendage configuring a half-ring.
[0143] FIGS. 9A to 9D show several views of the medical fastening device of the first inventive aspect with a horizontal distal appendage.
[0144] FIGS. 10A to 10D show several views of the medical fastening device of the first inventive aspect with a vertical distal appendage.
[0145] FIGS. 11A to 11E show several views of the system for inserting a medical fastening device according to the first and second inventive aspects.
[0146] FIGS. 12A to 12D show the steps for using a medical fastening device according to the first inventive aspect, with an adjustable loop in the femur, and a vertical appendage without a hole, during right knee ACL repair.
[0147] FIGS. 13A to 13D show a schematic view of a system of devices of the first inventive aspect as a whole, which allow the 3-strand configuration of a single graft.
[0148] FIGS. 14A to 14C show a schematic view of a system of devices of the first inventive aspect as a whole, which allow the 4-strand configuration of a single graft.
[0149] FIGS. 15A to 16D show several views of the device of the third inventive aspect.
[0150] FIGS. 17A to 17D show several views of the medical fastening device of the first inventive aspect with two flanges located at the second end of the second fastening element.
[0151] FIGS. 18A to 18D show some steps of a surgical method for restoring a damaged anterior cruciate ligament (ACL) by means of a first and a second fastening devices of the invention.
DETAILED DESCRIPTION OF THE INVENTION
[0152] The present invention describes two alternative graft fastening devices. Preferably, in the embodiments described in this section the second fastening element can be one-piece, manufactured from a semicrystalline and biocompatible thermoplastic polymer material; the first fastening element may comprise a screw made of a titanium alloy and a washer made of a semicrystalline and biocompatible thermoplastic polymer material, or of any other material described in the state of the art. Additionally, the outer surface of the second fastening element may comprise grooves which favor osseointegration of the device by increasing the contact surface with the bone.
[0153] All possible geometries, all possible materials, all possible methods of manufacture, and all possible surface treatments to be found in the medical literature are contemplated in other embodiments for the second fastening element and for the first fastening element.
[0154] The first fastening element being one-piece is likewise contemplated in other embodiments.
[0155] In the repair of the anterior cruciate ligament (ACL) of the knee by means of grafts, a femoral bone tunnel is normally used in which the bent end of the graft is suspended by means of fastening devices described herein, with loop, adjustable loop, hole, or suspension element. On the other hand, one or more fastening devices described herein are used in one or two tibial tunnels having a diameter of between 6 mm and 12 mm for fastening the other end of the graft. Therefore, this range is the preferred size envisaged for the second fastening elements of the medical fastening devices intended for being used in the embodiments shown.
[0156] This must not limit the applications of the present invention, which works efficiently in the repair of any ligament present in a joint, with suitable dimensions in each case.
First Fastening Device
[0157] FIGS. 3A to 14D show embodiments of the first medical fastening device (1). In particular, the medical fastening device (1) comprises a first fastening element (100) and a second fastening element (200). It must be observed that in any of the described examples, the second fastening element (200) can be a fastening ferrule.
First Fastening Device: First Fastening Element (100)
[0158] An embodiment of a first fastening element (100) according to the first invention can be observed in FIGS. 3A to 3D. In this example, the first fastening element is a fastening screw (110) with a head provided with an Allen-type actuation area and a threading (113) that is reciprocal with respect to the threading (223) of the second conduit (220).
[0159] Furthermore, the first fastening element (100) comprises a washer (120) surrounding the head of the screw when in use.
[0160] FIGS. 3A to 3D show a view of the screw (110) and the washer (120). In particular, the head of the screw is reciprocal with respect to the shape of the inner surface of the washer (120). In this embodiment, the screw (110) comprises a circular step (111), in a plane perpendicular to the shaft of the screw. In turn, there is provided in a reciprocal manner in the washer (120) an inner circular step (121) opposite that of the screw. Advantageously, this example prevents the engagement of the washer with the screw from seizing up, which allows keeping the washer aligned with the screw and optimizes the transmission of force between both.
First Fastening Device: First Embodiment of the Second Fastening Element (200): FIGS. 3A to 5B
[0161] FIGS. 3A to 5B show a first embodiment of the first medical fastening device (1). In particular, the second fastening element (200) comprises a first through conduit (210) which is extended along a first longitudinal axis (215). As can be seen in the section view of FIGS. 3C and 3D, the second fastening element (200) further comprises a first end (211) and a second end (212).
[0162] In relation to the first through conduit (210) of the second fastening element (200), FIGS. 3A and 3B show that said through conduit (210) further comprises a first end (211) and a second end (212). In particular, the first through conduit (210) is configured for housing a graft (10) as will be shown below in the description of the method of use indicated in FIGS. 5A to 5B, 14A to 14D. In particular, the first end (211) is intended for receiving the graft (10), the second end (212) is intended for being part of the fastening surface of the annular fastening passage (300) as shown in FIGS. 5A and 5B.
[0163] The configuration of the distal end of the first conduit (210) of the second fastening element (200) can be circular, elliptical, rectangular, trilobular, half-annular, or correspond to any other geometric shape known in the state of the art, without there necessarily having to be a correspondence between the configuration of the distal end and of the proximal end.
[0164] Furthermore, as can be seen in FIGS. 3A to 3D, the second fastening element (200) comprises a second fastening conduit (220) which is extended along a second longitudinal axis (225). The second fastening conduit (220) further comprises a first end (221) and a second end (222). The second fastening conduit (220) is configured for housing and fastening the first fastening element (100) as can be seen in FIGS. 3A to 5B. To that end, the second fastening conduit (220) can have several forms on its inner face according to the form of the type of the first fastening element (100). For example, in the section view of FIG. 3C, the inner face of the second fastening conduit (220) has the form of threading complementary to the threads of a screw. In another embodiment, the inner face of the second conduit (220) is in the form of a clip or leaf spring complementary to the outer surface of the first fastening element (100). In another embodiment, the inner face of the second fastening conduit (220) has a smooth form for a first self-tapping fastening element (100).
[0165] As can be seen in the example of the section view of FIG. 3C, the first through conduit (210) and the second fastening conduit (220) are arranged inside the second fastening element (200) such that the first longitudinal axis (215) and the second longitudinal axis (225) define an angle () with one another other than 0, preferably an angle between 0 and 90. Preferably, the angle () is comprised between 30 and 60. Even more preferably, in these embodiments the angle () can be 45.
[0166] In particular, FIG. 3A shows that the second fastening element (200) comprises an annular proximal surface (230) which defines a proximal cavity (235) at the second end (212) of the second fastening element (200). Furthermore, the second end (212) of the first through conduit (210) and the second end (222) of the second fastening conduit (220) are joined defining a junction (290) at the bottom of the proximal cavity (235). The junction (290), the second end (212) of the first through conduit (210), and the second end (222) of the second fastening conduit (220) are part of the bottom of the proximal cavity (235) of the second end (212) of the second fastening element (200) extending to the opening of said proximal cavity (235).
[0167] Furthermore, it can be seen in FIG. 4B that the junction (290) is movable in this embodiment.
[0168] As can be seen in the embodiment of FIG. 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) comprises a lower stop (236). The combination of the annular proximal surface (230) and stop (236) allows there to be a position of maximum tightness, in which a sector of the contour of the first fastening element (100) is supported on the lower stop (236), which advantageously increases the rigidity of the fastening provided by the device.
[0169] The stop (236) allows the fastening of the graft to a predetermined thickness, providing rigidity to the fastening. The annular configuration of the annular proximal surface (230) guarantees enough space for expansion of the graft (10) from the starting thickness to this predetermined thickness which corresponds with the position of maximum tightness of the fastening device (1).
[0170] As can be seen in the embodiment of FIGS. 3A to 5B, the second fastening element comprises a flange (231) which advantageously prevents migration of the device (1) into the bone tunnel.
[0171] Finally, FIGS. 4A to 5B show an embodiment with the first fastening element (100) housed and fastened in the second fastening conduit (220) of the first embodiment of the second fastening element (200). It can be seen how the annular fastening passage (300) is formed between the inner face of the annular proximal surface (230) and the outer surface of the washer (120).
[0172] FIGS. 5A and 5B show views of the upper part as a whole and the lower part in section, respectively, of the medical fastening device with at least one graft (10) restrained therein. In particular, the annular fastening passage (300) created by the medical fastening device (1) of the present invention can clearly be seen in FIG. 5B. Said annular fastening passage (300) is annular because the arrangement of the annular proximal surface (230) generates the continuous and annular surface of the proximal cavity (235). This allows the annular proximal surface (230) to be part of the annular fastening passage (300), which allows fastening several grafts with a larger fastening passage than in the elements mentioned of the state of the art. Furthermore, the shape of the annular fastening passage (300) provides greater structural consistency to the fastening.
[0173] If FIGS. 5A and 5B are compared with FIGS. 1A to 1F, the differences of the medical fastening device (1) of the present invention with respect to other devices (600, 700, 800) of the state of the art can clearly be seen. The interference screw (600) of FIGS. 1A and 1B performs fastening against the bone, where it is a very weak fastening due to the porosity of said bone (900). Furthermore, it can be seen that said interference screw (600) can damage the ligament, even further weakening the fastening.
[0174] The screw (700) of FIGS. 1C and 1D is coaxially screwed into the ferrule housing the graft, directly onto the graft, which, like the interference screw, may damage said graft. Furthermore, in the case of use in the tibia, the largest part of the head of the screw is housed inside the tibia bone which, due to the high porosity of this bone, weakens the resistance to movement of the device.
[0175] The restraining element (800) of FIGS. 1E to 1F is introduced into the bone tunnel and restrains the graft against the internal wall of the tunnel, while at the same time the screw (802), with the washer, which enters perpendicular to the cortical bone and is screwed into the angled face of the restraining element, restrains the graft a second time. This configuration locates the fastening area around the screw with the washer, so the screw must necessarily separate and pass between the bundles of the graft to proceed to the fastening thereof, which, like in the two prior art examples, may damage the graft, in addition to causing other problems associated with these devices that have been described in the background of the invention.
[0176] In contrast, the first medical fastening device (1) prevents damaging the ligament with the screw (110) due to the fact that the first conduit (210) and the second conduit (220) are arranged inside the second fastening element (200) such that the first longitudinal axis (215) and the second longitudinal axis (225) define an angle (x) with one another other than 0. Furthermore, like in the first medical fastening device (1) the ligament is housed inside same, with the aid of the annular proximal surface (230), a larger fastening passage (300) is obtained and fastening against porous bone (900) is prevented, providing a stronger and more durable fastening.
[0177] The configuration of the fastening passage exclusively in the upper proximal area of the ferrule can be seen in FIG. 2E. If FIG. 2E is compared with FIGS. 5A and 5B, FIG. 2E provides a limited fastening passage which leaves part of the graft (10) unrestrained, which reduces both the stability of the fastening and the ultimate tensile strength offered by the device, unless the device is oversized, which is not an acceptable solution.
First Fastening Device: Second Embodiment of the Second Fastening Element (200): Distal Appendage (240) Configuring an Adjustable Loop (245); FIGS. 6A to 6D
[0178] FIGS. 6A to 6D show a second embodiment of the first medical fastening device (1) of the invention. As can be seen, the second embodiment is similar to the first embodiment, with the exception that the second embodiment further comprises a distal appendage (240) configuring an adjustable loop (245).
[0179] As can be seen in FIG. 6A, the distal appendage (240) comprises a strip, cord, or band, with a first end (241) joined to the first end of the second fastening element (200) and a second end (242) with a first fastening-free position. In a second position, the second end (242) can be configured such that said end (242) goes back to the second fastening element (200) configuring an adjustable loop (245) which is fastened in the desired position by means of the first fastening element (100), as shown in FIGS. 6B, 6C, and 6D.
[0180] In particular, as shown in FIGS. 6B to 6D, once the first fastening element (100) is housed and fastened in the second fastening conduit (220) of the second fastening element (200), the free end (242) is also fastened in said fastening passage (300).
[0181] As can be seen in FIG. 6C, the dotted line shows an example of the different positions the adjustable loop (245) can take; therefore, it can be considered that the distal appendage (240) is flexible and can define more than one final position in this embodiment.
[0182] The length of the adjustable loop (245) is fastened by means of the first fastening element (100), the adjustable loop (245) being intended for the suspension of a bent end of the graft (10) in the bone tunnel or bone canal. Said fastening is adjustable from a first position without tension, to a final position with ideal tension of the suspended graft.
First Fastening Device: Third Embodiment of the Second Fastening Element (200): Distal Appendage (250) Configuring a Fastened Loop; FIGS. 7A to 7C
[0183] FIGS. 7A to 7C show a third embodiment of the first medical fastening device (1) of the invention. As can be seen, the third embodiment is similar to the first embodiment, with the exception that the third embodiment further comprises a distal appendage (250) with hole (253) configuring a non-adjustable loop. It can be called a fastened or non-adjustable loop because both ends (251, 252) of the appendage (250) are fastened to the second fastening element (200), and therefore the area of suspension, i.e., the size of the hole (253), is constant. In one embodiment, the distal appendage (250) is flexible. In the examples of FIGS. 7A to 7C, the distal appendage (250) is in the vertical position.
[0184] As can be seen in this particular embodiment, the distal appendage (250) comprises a strip, cord, or band, with both ends (251, 252) joined to the second fastening element (200), such that a closed or non-adjustable loop intended for the suspension of a bent end of the graft in the bone tunnel is configured.
First Fastening Device: Fourth Embodiment of the Second Fastening Element (200): Distal Appendage (260, 270) with a Hole for Suspension; FIGS. 8A to 9D
[0185] FIGS. 8A to 80, show a fourth embodiment of the first medical fastening device (1) of the invention. As can be seen, the fourth embodiment is similar to the first embodiment, except that the fourth embodiment further comprises a distal appendage (260). In these examples, the distal appendage (260) is a half-ring defining a hole (263), intended for the suspension of a bent end of the graft in the bone tunnel.
[0186] In the particular embodiment of FIGS. 9A to 9D, the second fastening element (200) does not comprise a flange (231), and instead it has a frustoconical external contour, which advantageously retains the device at the inlet of the bone tunnel (10), preventing it from penetrating the bone tunnel (10), with said second fastening element (200) being similar to that shown in the first embodiment of the first invention in terms of the remaining aspects.
[0187] As can be seen in the examples of FIGS. 9C and 9D, the distal appendage (270) comprises a first end (271) and a second end (272) located at the first end of the second fastening element (200). Furthermore, the distal appendage (270) comprises a hole (273) intended for the suspension of a bent end of the graft in the bone tunnel. More particularly, the hole (273) is located at the first the end (271) of the distal appendage (270).
[0188] In other embodiments, the second fastening element (200) of FIGS. 9A to 9D may comprise a flange (231) like the one shown in the examples of FIGS. 8A to 8D.
[0189] In view of FIGS. 8A to 9D, it can be considered that the distal appendage (260, 270) is in the horizontal position.
First Fastening Device: Fifth Embodiment of the Second Fastening Element (200): Distal Appendage (280) with a Hole (281) for Suspension; FIGS. 10A to 10D
[0190] FIGS. 10A to 10D show a fifth embodiment of the first medical fastening device (1) of the invention. As can be seen, the fifth embodiment is similar to the first embodiment, with the exception that the fifth example further comprises a distal appendage (280) located at the first end of the second fastening element (200). In these examples, the distal appendage (280) comprises a first end (281), a second end (282), and a hole (283) intended for the suspension of a bent end of the graft in the bone tunnel. Furthermore, the hole (283) is located at the first the end (281) of the distal appendage (280).
[0191] In view of FIGS. 10A to 10D, it can be considered that the distal appendage (280) is in vertical position.
[0192] In a particular manner, the second end (282) is housed in the first through conduit (210) dividing the first through conduit (210) into two sections. In other words, the first through conduit (210) is divided into a first section (213) and a second section (214) by the second end (282) of the distal appendage (280).
[0193] On the other hand, FIGS. 10A, 10B, and 10D show that the second end (282) of the distal appendage (280) is part of the bottom of the proximal cavity (235) and of the junction between the second end (212) of the first through conduit (210) and the second end (222) of the second fastening conduit (220).
First Fastening Device: Sixth Embodiment of the Second Fastening Element (200): Distal Appendage (290) with a Hole (293) for Suspension; FIGS. 17A to 17D
[0194] FIGS. 17A to 17D show a sixth embodiment of the first medical fastening device (1) of the invention. As it can be seen, the sixth embodiment is similar to the first embodiment, with the exception that the second end (222) of the second fastening conduit (220) in the sixth example further comprises two flanges located opposite on an axis perpendicular to the second longitudinal axis (225). Another difference with the first embodiment is that the sixth example comprises a distal appendage (290) located at the first end of the second fastening element (200).
[0195] In the example, the two flanges (231) are in the form of an annular retaining lobe configured for abutting with the cortical bone which demarcates the external upper part of the inlet opening into the bone tunnel.
[0196] Advantageously, the flanges (231) retains the device at the inlet of the bone tunnel (10), preventing it from penetrating the bone tunnel (10).
[0197] In the example, the distal appendage (290) comprises a hole (293) intended for the suspension of a bent end of the graft in the bone tunnel.
First Fastening Device: System (400) for Inserting a Medical Fastening Device (1): FIGS. 11A to 11E
[0198] FIGS. 11A to 11E show an embodiment of a system (400) for inserting a medical fastening device (1) according to any of the embodiments shown above. The system (400) comprises the medical fastening device (1) of the present invention, a coupling screw (440), and an inserter (450) with a first end (410) configured for engaging the second end of the second fastening element (200) and a handle (430) located at a second end (420) of the inserter (450).
[0199] Advantageously, the use of an inserter (450) with coupling screw (440) allows handling the device through the handle (430) and applying the necessary force for the insertion of the device (1) in the bone tunnel (11). This prevents the device (1) from uncoupling from the inserter (450), as can be seen in greater detail in FIGS. 11A and 11E.
First Fastening Device: Example of Use of a Medical Fastening Device, with an Adjustable Loop in the Femur and Rigid Vertical Distal Appendage in the Tibia: FIGS. 12A to 12D
[0200] FIGS. 12A to 12D show the repair of an anterior cruciate ligament (ACL) of a right knee (15) using two of the first medical fastening devices (1) of the invention. The first medical fastening device (1) is similar to that described in the example of FIGS. 6A to 6C and the second medical device (1) comprises a distal appendage in the vertical position, without a hole.
[0201] Advantageously, this distal appendage without a hole allows maintaining the twisting of the intra-articular segment of the graft branches without said twisting reaching the intra-tunnel segment, which is important for restoring the anatomy and biomechanics of twisting of the original ACL, as can be seen in the embodiment of FIGS. 12A to 12D.
[0202] FIG. 12A shows the free ends of the grafts (10) projecting from the bone tunnel (12) made in the tibia. The bent ends of the grafts (10) are suspended from the adjustable loop (245) of the first medical fastening device (1).
[0203] Advantageously, the adjustable loop (245) allows making a femoral bone tunnel (11), or a femoral bone canal, and pulling on the bent end of the graft to fit it in, which further allows checking and adjusting the tension at which the graft (10) is fastened.
[0204] FIG. 12B shows the bents ends of the grafts once they are fitted in, with the adjustable loop being restrained by the femoral fastening device. The free ends of the grafts (10) still project from the bone tunnel (12) made in the tibia.
[0205] FIG. 12C shows the twisting of the intra-articular segment of the graft (10) which mimics the anatomical twisting (16) characteristic of the original ACL, i.e., counter-clockwise direction, in the ACL of the right knee which is shown. Advantageously, the second medical device (1) with a distal appendage and without a hole shown in FIG. 12C allows keeping the branches of the graft (10) separated, such that the anatomical twisting imparted to the intra-articular segment of the graft does not uncontrollably propagate into the bone tunnel. As can be seen, an inserter system (400) is used for handling the device.
[0206] FIG. 12D shows the fastening device (1) with the first threaded fastening element (100) once the graft (10) has been tensed at the tension necessary for recovering the stability in the knee joint.
First Fastening Device: Example of Use of the First Medical Fastening Device (1) of the Invention: 3-Strand Configuration of a Graft: FIGS. 13A to 13D
[0207] FIG. 13A shows a diagram of the joint use of two first medical devices (1) of the invention, in the repair of the ACL of the right knee, in which said use comprises: [0208] providing a graft (10) which is configured in three branches, with two bent ends and two free ends. [0209] providing two medical fastening devices (1) with a distal appendage (250, 260, 270, 280) with a hole, intended for being introduced in respective first and second bone tunnels (11, 12). The first fastening element (100) and second fastening element (200) assembly is depicted as a rectangle in FIG. 13A. The hole (253, 263, 273, 283) is depicted as a circle in FIG. 13A. [0210] configuring, as shown in FIGS. 13B to 13D, the two medical fastening devices (1) such that it allows fastening a first free end and suspending a first bent end of the graft (10) by means of the first medical device (1) inserted in the first bone tunnel (11). On the other hand, fastening a second free end and suspending a second bent end of the graft (10) by means of the second medical device (1) inserted in the second bone tunnel.
[0211] FIGS. 13B to 13D show the use of two medical fastening devices (1) such as those shown in FIGS. 9A to 9D for the 3-strand configuration of a single graft, according to the diagram of FIG. 13A.
First Fastening Device: Example of Use of the Medical Fastening Device (1) of the First Invention: 4-Strand Configuration of a Graft: FIGS. 14A to 14C
[0212] FIG. 14A shows the use diagram of two first medical devices (1) of the invention in the repair of the ACL of the right knee, in which said use comprises: [0213] providing a graft (10) with a 4-strand configuration in four branches, with three bent ends and two free ends. [0214] providing two medical fastening devices (1), a first device with a vertical distal appendage with a hole (280), of FIGS. 10A to 10D, intended for being introduced in a first bone tunnel (11), and a second device with an adjustable loop, intended for being introduced in a second bone tunnel (12). The first fastening element (100) and second fastening element (200) assembly is depicted as a rectangle in FIG. 14A. The suspension element, i.e., hole or adjustable loop, is depicted as a circle in FIG. 14A. [0215] configuring, as shown in FIGS. 14B and 14C, the two medical fastening devices (1) such that they allow fastening both free ends and simultaneously suspending a first bent end of the graft (10), by means of the first medical device (1) inserted in the first bone tunnel (11). On the other hand, by means of the second medical device (1) inserted in the second bone tunnel (12), suspending, in an adjustable manner, a second and a third bent end of the graft (10).
Second Fastening Device
[0216] FIGS. 15A to 16D show embodiments of the second medical fastening device (500) of the invention. In particular, the medical fastening device (500) comprises a first fastening element (510) and a second fastening element (520) comprising a fastening conduit (523) and a suspension element. In this second fastening device (500), once the first fastening element (510) is fastened in the fastening conduit (523) of the second fastening element (520) and introduced in the bone tunnel, a fastening passage is produced between the second fastening element (520) and the bone tunnel which fastens the graft in said bone tunnel, or between the first fastening element (510) and the second fastening element (520) which fastens the graft to the device itself.
Second Fastening Device: First Fastening Element (510)
[0217] An embodiment of a first fastening element (510) according to the second fastening device can be observed in FIGS. 15A to 16D. In the examples of FIGS. 15A, 15C, and 15D, the first fastening element (510) is a screw the head of which has the same diameter as its shank (514). In the example of FIG. 15B, the diameter of the head of the screw is greater than the diameter of its shank (514). The head of the screw (511) is provided with an Allen-type actuation area (512) and its shank (514) comprises a threading.
Second Fastening Device: First Embodiment of the Second Fastening Element (520): FIGS. 15A to 15C and 16A to 16D
[0218] FIGS. 15A to 15C and 16A to 16D show a first embodiment of the second medical fastening device (500) of the invention. To clarify in the example of FIGS. 15A to 15C and 16A to 16D, it has been indicated that the second fastening element (520) has a first end (521) and a second end (522); furthermore, the second fastening element (520) comprises a fastening conduit (523) located at its second end (522) intended for housing the first fastening element (510).
[0219] As can be seen, the second fastening element (520) comprises a distal appendage (530) configuring a suspension element, with a first end (531) and a second end (532) connected to the first end (521) of the second fastening element (520), such that a non-adjustable hole or closed loop (533) intended for the suspension of a bent end of the graft in the bone tunnel is configured.
[0220] Advantageously, the devices of FIGS. 15A to 15C and 16A to 16D allow reproducing the diagrams of FIG. 13A, 3-strand configuration of the graft, and FIG. 14A, 4-strand configuration of the graft, by means of methods of use similar to those described in the first invention.
Second Fastening Device: Second Embodiment of the Second Fastening Element (520) Configuring an Adjustable Loop; FIG. 15D
[0221] FIG. 15D shows a second embodiment of the second medical fastening device (500) of the invention. As can be seen, the second embodiment is similar to the first embodiment, with the exception that the distal appendage (530) is configured as an adjustable loop (533).
[0222] As can be seen in FIG. 15D, in this particular embodiment the distal appendage (530) comprises a strip, cord, or band, with a first end (531) connected to the first end (521) of the second fastening element (520) and a second fastening-free end (532). The second end (532) can be configured such that it goes back to the second fastening element (520) configuring an adjustable loop (533) as shown in FIG. 15D.
[0223] The length of the adjustable loop is fastened by means of the first fastening element (510), with the adjustable loop (533) being intended for the suspension of a bent end of the graft (10) in the bone tunnel or bone canal. Said fastening is adjustable from a first position without tension, to a final position with ideal tension of the suspended graft.
Surgical Method: Restauration of a Damaged Anterior Cruciate Ligament (ACL) by Means of a First and a Second Fastening Devices (1); FIGS. 18A-18D.
[0224] In FIGS. 18A-18D an example of a surgical method for restoring a damaged anterior cruciate ligament (ACL) is shown. With this surgical method, the restauration of the ACL is carried out by means of a first and a second fastening devices (1) with suspension holes (273).
[0225] Advantageously, providing a device (1) with a suspension hole (273) for each of the bone tunnels-tibial and femoral bone tunnels-allows suspending a first graft (10) in one of the bone tunnels and suspending a second graft (10) in the opposite bone tunnel to fasten, in both cases, the free ends of each graft (10) with the device (1) placed in the opposite side where the graft (10) is suspended, as shown in FIGS. 18B, 18C and 18D.
[0226] The surgical method comprises the following steps: [0227] 1) performing a femoral bone tunnel, with intra-articular entrance of the femoral bone tunnel in the insertion site of the original ACL, [0228] 2) performing a tibial bone tunnel, with intra-articular entrance of the tibial bone tunnel in the insertion site of the original ACL, [0229] 3) suspending, from the suspension hole (273) of the first fastening device (1), the bent end of a first graft (10), [0230] 4) introducing the free ends of the first graft (10) through the extra-articular entrance of the femoral bone tunnel until reaching, throughout 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, [0231] 5) suspending, from the suspension hole (273) of the second fastening device (1), the bent end of a second graft (10), [0232] 6) introducing the free ends of the second graft (10) through the extra-articular entrance of the tibial bone tunnel until reaching, throughout 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, being the free ends of the first and second grafts (1) placed in the extra-articular tibial and femoral entrances, so that each of the free ends can be fastened by the device (1) placed in the opposite side where the graft (10) is suspended, as shown in FIGS. 18C and 18D.
[0233] This configuration, additionally, allows twisting both grafts so that the intra-articular segment of the grafts is configured with the anatomical twist that is characteristic of the biomechanics of the original ACL, as it is shown in FIGS. 18C and 18D.
