LIGAMENT FIXING AND A METHOD OF ATTACHING A LIGAMENT

Abstract

An artificial ligament is provided having an elongate body and two ends, with a loop being provided at least one of the ends and a loop liner being provided within the loop. A kit of artificial ligaments is also provided with each ligament in the kit having a different fixed length. Also provided are methods for determining a length of artificial ligament to be used within a prosthetic knee joint, selecting a ligament from a range or kit of ligaments, and implanting a prosthetic knee joint assembly comprising an artificial ligament.

Claims

1-20. (canceled)

21. An instrument for measuring between first and second ligament fixings of prosthetic components comprising: an elongate body; an arcuate portion provided at or towards one end of the elongate body; and a slideable jaw, configured to slide along the elongate body.

22. The instrument of claim 21, wherein the elongate body further comprises a measurement scale.

23. The instrument of claim 22, wherein the measurement scale indicates the size of artificial ligament required to link the first and second fixings.

24. The instrument of claim 21, wherein the arcuate portion is configured to closely engage the first fixing.

25. The instrument of claim 21, wherein the slideable jaw is configured to engage the second fixing.

26. The instrument of claim 21, wherein the position of the slideable jaw can be selectively fixed relative to the elongate body.

27. The instrument of claim 26, wherein the jaw and the elongate body are provided with cooperating formations and the jaw is fixed by rotating a portion of the jaw to engage the cooperating formations.

28. A ligament measuring device comprising: an elongate shaft portion; a hook portion extending from an end of the elongate shaft portion; and a slider member axially movable along the elongate shaft portion, the slider member including a slider body, a jaw, and a locking component.

29. The ligament measuring device of claim 28, wherein the locking component is rotatable relative to the slider body and the elongate shaft portion for locking the slider member axially with respect to the elongate shaft portion.

30. The ligament measuring device of claim 29, wherein the locking component comprises one or more tabs provided on an inner surface of the slider member, the one or more tabs configured for engagement with one or more grooves in the elongate shaft portion.

31. The ligament measuring device of claim 30, wherein the one or more tabs do not engage the elongate shaft portion in an unlocked position.

32. The ligament measuring device of claim 31, further comprising measurement markings on the elongate shaft portion for determining a required length of a ligament.

33. The ligament measuring device of claim 28, wherein the hook portion extends from the elongate shaft portion in a first direction, and the jaw of the slider member extends from the elongate shaft portion in a second direction.

34. The ligament measuring device of claim 33, wherein the first and second directions are the same.

35. The ligament measuring device of claim 34, wherein a distalmost end of the hook portion faces the jaw of the slider member.

36. The ligament measuring device of claim 35, wherein an axial distance between the distalmost end of the hook portion and the jaw is adjustable by moving the slider member along the elongate shaft portion.

37. An instrument for measuring between first and second ligament fixings of prosthetic components comprising: an elongate shaft portion including a proximal end and a distal end; an arcuate portion extending from the distal end of the elongate shaft portion; a slideable jaw operably coupled to the elongate shaft portion, wherein the slideable jaw is configured to slide along the elongate shaft portion to adjust an axial distance between the arcuate portion and the slideable jaw; and a locking element operable to fix an axial position of the slideable jaw relative to the arcuate portion.

38. The instrument of claim 37, wherein the arcuate portion is configured to engage the first ligament fixing and the slideable jaw is configured to engage the second ligament fixing.

39. The instrument of claim 38, further comprising a measurement scale disposed on the elongate shaft portion for determining a required length of a ligament.

40. The instrument of claim 39, wherein the first ligament fixing comprises a femoral bollard and the second ligament fixing comprises a tibial bollard.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0040] For a better understanding of the present invention, and to show more clearly how it may be carried into effect, reference will now be made by way of example, to the accompanying drawings, in which:

[0041] FIG. 1 shows a full knee replacement prosthetic knee joint comprising an artificial ligament according to an example of the present invention.

[0042] FIG. 2 is a sectional view of a full knee replacement prosthetic knee joint comprising an artificial ligament according to an example of the present invention.

[0043] FIG. 3 shows an artificial knee ligament according to one example of the present invention.

[0044] FIG. 4 shows an artificial knee ligament according to a second example of the present invention.

[0045] FIG. 5 is a sectional view showing an example implementation of a biasing element and tension element used to provide the desired stiffness to an artificial ligament according to the present invention.

[0046] FIG. 6 shows an implanted trial prosthetic knee joint assembly according to an example of the present invention, including a trial tibial component and a trial artificial ligament.

[0047] FIG. 7 shows instrumentation for measuring the required length of a ligament.

DETAILED DESCRIPTION

[0048] Referring to FIG. 1, a knee prosthesis 2 comprises a tibial component 4 having a tibial tray 6 integrally formed with a stem 8, a femoral component 10 and a pair of bearing components 12, 13. The bearing components 12, 13 separate the tibial component 4 and the femoral component 10 and are formed with proximal and distal bearing surfaces which engage corresponding bearing surfaces 14, 15, 16 on the tibial tray 6 and on the femoral component 10. These various bearing surfaces enable the tibial component 4 to rotate and translate relative to the femoral component 10. The bearing components 12, 13 may be meniscal bearing components, rotational platform bearing components, or may be fixed bearing components. The combination of the bearing surfaces 14, 15, 16 and the bearing components 12, 13 allows the knee prosthesis to achieve a similar range of movements to an anatomical knee joint.

[0049] An artificial knee ligament 20 is provided within the knee prosthesis 2 to restrict undesirable movements of the knee prosthesis, improving the stability of the joint in use, as well as reducing the risk of dislocation of the bearing components 12, 13. The ligament 20 is elongate in form and constructed substantially of a first biocompatible material which has high tensile strength and stiffness.

[0050] With reference to FIG. 2, the ligament 20 is terminated at the proximal end by a proximal loop 22 and at the distal end by a distal loop 24, both loops having a fixed size. In the embodiment shown, the loops are formed by looping back the material at each end of the ligament to form the loops, and gluing the free ends of the ligament back to itself to secure the loop. Alternatively, another method for securing the loop could be used, for example the individual fibres of the ligament could be separated, then woven back in to the ligament to secure the loop or the ligament could be passed through a washer looped on one side of the washer then the individual fibres of the ligament could be fed back though holes in the washer to secure the loop.

[0051] The distal loop 24 is connected to a fixing provided on the tibial component 4 which may comprise a tibial bollard 26 and the proximal loop 22 is connected to a fixing provided on the femoral component 10 which may comprise a femoral bollard 28. The bollards 26, 28 comprise a neck portion and a head portion, with the neck portion being narrower in form than the head portion. When the ligament 20 is fitted to the knee prosthesis 2, the loops 22, 24 rest on the neck portions of the bollards and are prevented from sliding or working themselves off the bollard by the wider head portion.

[0052] With reference to FIG. 3, a wear portion 30, is provided on the inside of the proximal and distal loops 22, 24. In the embodiment shown in FIG. 3, the wear portion 30 is moulded into the loop to form a single component. The wear portion 30 is located in the area of each loop 22, 24 where the loop contacts the neck of the tibial or femoral bollard when the ligament is fitted. The wear portion may be shaped or dipped to rest against the fixing in use. The wear portion 30 may be formed in a second biocompatible material, such as polyethylene, which has a greater resistance to abrasive wear than the first biocompatible material which forms the ligament. The wear portion 30 may comprise a resilient ring of material and may be configured to pull the loop towards a closed or partially closed configuration. The wear portion 30 may thus be configured to grip the bollard 26, 28 when fitted, further reducing the possibility of the ligament becoming disconnected. The wear portion 30 may be elastically deformable allowing the loops 22, 24 to become substantially circular in an open configuration. In the open configuration, as shown in FIG. 3, the loops can be fitted over the head portion of the bollards 26, 28.

[0053] With reference to FIG. 4, the loops 22, 24 of the artificial ligament 20 may be further secured by the use of ferrules 32. In the embodiment shown in FIG. 4 the wear portions 30 comprise thimbles which are formed as separate loops which are trapped within the eyes of the ligament loops 22, 24. The thimbles are resilient and may be configured hold the loops in the closed condition when not fitted to the bollards, as shown in FIG. 4.

[0054] With reference to FIG. 5, a biasing element 538 may be provided between the tibial bollard 26 and the tibial component 4. The biasing element 538 is provided within a bore 508 of the stem 8 of the tibial component 4. The tibial bollard 26 may also be received within the bore 508. The bore 508 opens onto the bearing surface 14 of the tibial tray 6. The artificial ligament 20 extends into the bore 508 through a space 516 between the bearing components 12, 13, so that the artificial ligament 20 substantially does not interfere with the bearing components 12, 13 during normal articulation of the prosthesis.

[0055] The biasing element 538 comprises a resilient element 40. In the illustrated embodiment, the resilient element 40 is a coiled compression spring 42 and the bearing element 44 is a plate 46. However, the resilient element 40 may consist of or comprise any appropriate spring or springs, for example a Belleville washer or an elastomeric member. An appropriate bearing element may be selected according to the choice of resilient element or may be omitted if not required.

[0056] With continued reference to FIG. 5, the knee prosthesis also comprises a tensioning element 518. The tensioning element 518 is mounted in the stem 8 of the tibial component 4. The tensioning element 518 is cylindrical and formed with an external thread 520 which engages with an internal thread 522 formed in the bore 508. The tensioning element 518 acts between the biasing element 538 and the tibial component 4. The tensioning element 518 is adjustable, to allow the tension in the ligament 20 to be set to appropriately.

[0057] In the embodiment shown, the resilient element 538 and the tensioning element 518 are both provided on the tibial component 4 of the knee prosthesis 2. It is equally envisaged that both could be provided on the femoral component 10, or one could be provided on each of the prosthetic components. Alternatively one or both could be omitted.

[0058] With reference to FIG. 6, in order to determine a suitable length of artificial ligament 20 to be fitted to the knee prosthesis 2, a trial ligament 620 may be created. When the trial ligament is created, the tibial component 4 of the knee prosthesis 2 may not have been implanted and hence a trial tibial component 604 may be used temporarily within the knee joint assembly. The trial tibial component 604 also comprises a tibial tray 606, a stem 608 and a tibial bollard 626. The connection between the trial tibial component 604 and the trial ligament 620 is substantially the same as the connection between the tibial component 4 and the ligament 20 as shown in FIG. 1. Similarly, the final bearing components 12, 13 may not be fitted, and trial bearing components 612, 613 may be temporarily used in the assembly when creating the trial ligament 620. The trial ligament 620 can be formed by tying a length of surgical string around the femoral bollard 28 and the trial tibial bollard 626. Alternatively the trial ligament could be formed from a zip tie or any other suitable elongate element which is selectively connectable to form a continuous band. In some cases, the trial tibial component 604 may be the final tibial component 4 which has been fitted in a temporary manner.

[0059] In order to address the shortcomings recognised in a method for implanting a prosthetic knee joint, as presented in the background section above, improved methods of implanting the prosthesis 2 are herein described.

[0060] In one method of implanting the prosthesis 2, the femoral component 10 is implanted into the distal end of a femur 650; the trial tibial component 604 is fitted temporarily to the proximal end of a tibia 652 such that the tibial tray 606 rests of the resected proximal end of the tibia 652. Trial bearing components 612, 613 are placed between the femoral component 10 and the trial tibial component 604. The trial ligament 620 is then created by tying off a length of surgical string after it has been tightened around the femoral bollard 28 and the trial tibial bollard 626. The trial ligament 620 is then cut away and removed from the operative site. The trial ligament 620 can then be reassembled into a closed loop and the length of the loop measured to determine the length of artificial ligament 20 required to be fitted into the knee prosthesis 2.

[0061] In an alternative method (not shown), the trial ligament 620 could comprises a tie which is colour coded, such that the length of ligament required can be determined by the colour of the trial ligament 620 at the position it has been tied. Alternatively, the trial ligament 620 could comprise a zip tie with a ratchet head and rather than being tied, the zip tie could be tightened around the bollards using the ratchet head, the colour of the tie at the position of the head could be noted and the tie could then be undone and removed from the operative site. Alternatively, rather than being colour coded, the tie could be marked with numbers or letters, denoting the length of tie used.

[0062] Once the length of trial ligament 620 has been determined, an artificial ligament 20 of a suitable length may be selected from a range or kit of artificial ligaments available.

[0063] With reference to FIG. 7, a ligament gauge 700 can alternatively be used to determine the length of ligament required. The ligament gauge 700 comprises a hook 702, which is configured to couple with a femoral bollard 28, and an elongate shaft portion 704. A slider 706 is configured to be axially movable along the shaft 704. The slider comprises a body 708, a jaw 710 and a locking component 712. The locking component 712 can be rotated relative to the slider body 708 and shaft 704 to lock the slider axially with respect to the shaft 704. Measurement markings 714 are provided on the shaft for the required length of ligament to be read off. In use, the hook 702 is coupled to the femoral bollard 28 of a prosthetic component implanted on to the femur of a patient. The slider is moved along the shaft until the jaw 710 engages with the tibial bollard 26. The locking component is then rotated to lock the position of the slider. The locking action may be achieved through the use of tabs (not shown) provided on the inside of the locking component 712 which engage with grooves in the shaft 704. The shaft may be configured such that the tabs on the locking component 712 do not engage the shaft 704 in the unlocked position. The ligament gauge 700 can be rotated about the femoral bollard 28 to disengage the jaw 710 from the tibial bollard 26. The hook 702 can then be unhooked from the femoral bollard 28 and the gauge can be removed. In this way, the measurement recorded on the ligament gauge 700 can be read after the gauge has been removed from the operative site.

[0064] Once a suitable artificial ligament 20 has been selected, the trial tibial component 604 is removed from the joint. The distal loop 24 of the artificial ligament 20 is attached to the tibial bollard 26 of the final tibial component 4. The proximal loop 22 of the artificial ligament 20 is then attached to the femoral bollard 28 of the femoral component 10. By attaching the artificial ligament to both the tibial component 4 and the femoral component 10 before the tibial component 4 is finally implanted, the problem highlighted in the current methods is avoided.

[0065] At this stage the trial bearing components 612, 613 may be removed, and the final bearing components 12, 13 may be inserted between the tibial tray 6 and the bearing surfaces 15, 16 of the femoral component 10. Alternatively, if desirable, a meniscal spacer (not shown) which is slightly thinner than the final bearing components 12,13 can be fitted to the prosthetic joint 2 to reduce loading of the ligament 20 during the final stages of the implantation. The tibial component 4 is then implanted into the proximal end of the tibia 652.

[0066] If the meniscal spacer or the trial bearing components 612, 613 are still present within the joint, they are now removed and the final bearing components 12, 13 are fitted to the knee prosthesis 2.

[0067] Although in the example shown, the final femoral component 10 is implanted first, and the tibial component 4 of the knee prosthesis is then fitted loosely or a suitable trial tibial component 604 is fitted to allow the required length of the artificial ligament 20 to be determined, it is equally envisaged that the final tibial component 4 could be implanted first, and the femoral component 10 or a suitable trial femoral component (not shown) could be fitted thereafter to allow the required artificial ligament length to be determined. It is also considered, that both the femoral and tibial components could be trial components and could be fitted temporarily whilst the trial ligament 620 is formed.