CRUCIATE REPLACING ARTIFICIAL KNEE
20170252173 · 2017-09-07
Inventors
Cpc classification
A61F2002/30462
HUMAN NECESSITIES
International classification
Abstract
A prosthetic knee with an artificial ACL/PCL. The prosthetic knee includes a femoral component and a tibial component. The artificial ACL/PCL connects the femoral component and the tibial component and includes an anterior cruciate ligament portion connecting an anterior anchor point on the tibial component to a posterior anchor point on the femoral component, and a posterior cruciate ligament portion connecting a posterior anchor point on the tibial component to an anterior anchor point on the femoral component. The artificial ligament may be provided as single length of material and may be pre-assembled into an ACL/PCL module having portions that may be inserted into at least one of the femoral component or the tibial component. A system is also provided for total knee replacement that includes a selection of femoral components, tibial components, and one or more ACL/PCL modules of varying sizes,
Claims
1. An ACL/PCL module attachable to a prosthetic knee having a femoral component, an articular insert, and a tibial component, said module comprising: at least one of a femoral portion configured to be coupled to the femoral component and a tibial portion configured to be coupled to at least one of the articular insert and the tibial component; and at least one artificial ligament connecting the femoral component and the tibial component, the at least one artificial ligament comprising an anterior cruciate ligament portion connecting an anterior anchor point on the tibial portion or tibial component to a posterior anchor point on the femoral portion or femoral component, and a posterior cruciate ligament portion connecting a posterior anchor point on the tibial portion or tibial component to an anterior anchor point on the femoral portion or femoral component.
2. The ACL/PCL module of claim 1, wherein the anterior cruciate is ligament portion and the posterior cruciate ligament portion are discrete components that are not connected to one another.
3. The ACL/PCL module of claim 1 comprising the tibial portion, the tibial portion comprising an insert configured to be releasably coupled to the articular insert.
4. The ACL/PCL module of claim 1 comprising the tibial portion, the tibial portion comprising an insert configured to be releasably coupled to the tibial component.
5. The ACL/PCL module of claim 1 comprising the femoral portion,the femoral portion comprising an insert configured to be releasably coupled to the femoral component.
6. The ACL/PCL module of claim 1, wherein the at least one artificial ligament comprises a single length of material in which the anterior cruciate ligament portion and the posterior cruciate ligament are connected to one another.
7. The ACL/PCL module of claim 6 comprising the tibial portion, wherein each end of he single length of material is fastened to the tibial portion.
8. The ACL/PCL module of claim 6 comprising the femoral portion, wherein each end of the single length of material is fastened to the femoral portion.
9. The ACL/PCL module of claim 6, wherein the ends of the single length of material are attached to one another to form a continuous loop.
10. The ACL/PCL module of claim 1, wherein the femoral portion of the module is configured to slidably engage the femoral component or the tibial portion of the module is configured to slidably engage the tibial component.
11. The ACL/PCL module of claim 10, wherein the module is configured to be retained in engagement with the femoral component via a locking taper or retained in engagement with the tibial component via a locking taper.
12. A modular prosthetic knee comprising: a femoral component configured for fixation to the distal portion of a femur; a tibial component configured for fixation to the proximal portion of a tibia; and the ACL/PCL module according to claim 1.
13. A prosthetic knee comprising: a femoral component configured for fixation to the distal portion of a femur; a tibial component configured for fixation to the proximal portion of a tibia, the tibial component comprising an articular insert configured to be coupled to the tibial component and at least one artificial ligament connecting the femoral component and the tibial component, the at least one artificial ligament comprising an anterior cruciate ligament portion connecting an anterior anchor point on the tibial component to a posterior anchor point on the femoral component, and a posterior cruciate ligament portion connecting a posterior anchor point on the tibial component to an anterior anchor point on the femoral component, wherein the at least one artificial ligament comprises a single length of material in which the anterior cruciate ligament portion and the posterior cruciate ligament are connected to one another.
14. The prosthetic knee of claim 13, wherein each end of the single length of material is fastened to the tibial component.
15. The prosthetic knee of claim 13, wherein each end of the single length of material is fastened to the femoral component.
16. The prosthetic knee of claim 13, wherein the artificial ligament comprises at least one of polyethylene, carbon fiber, and PTFE.
17. The ACL/PCL module of claim 1, wherein the artificial ligament comprises at least one of polyethylene, carbon fiber, and PTFE.
18. A system for providing total knee replacement on a plurality of patients of different sizes, the system comprising: a plurality of femoral components, each femoral component configured for fixation to the distal portion of a femur, the plurality of femoral components comprising a plurality of differently sized femoral components each configured to accommodate a range of patient femoral anatomies; a plurality of tibial components, each tibial component configured for fixation to the proximal portion of a tibia, the plurality of tibial components comprising a plurality of differently sized tibial components each configured to accommodate a range of patient tibial anatomies; a plurality of articular inserts, each articular insert configured for installation between the distal portion of the femur on which one of the plurality of femoral components is fixed and the proximal portion of the tibia on which one of the plurality of tibial components is fixed; and at least one ACL/PCL module comprising at least one of a femoral portion configured to be coupled to one or more of the femoral components and a tibial portion configured to be coupled to one or more of the tibial components or one or more of the articular inserts, and at least one artificial ligament connecting the femoral component and the tibial component, the at least one artificial ligament comprising an anterior cruciate ligament portion connecting an anterior anchor point on the tibial portion or the tibial component to a posterior anchor point on the femoral portion or the femoral component, and a posterior cruciate ligament portion connecting a posterior anchor point on the tibial portion or tibial component to an anterior anchor point on the femoral portion or the femoral component.
19. The system of claim 18, wherein each of the articular inserts have a different size.
20. The system of claim 18, wherein the plurality of articular inserts are differently sized, and the at least one ACL/PCL module comprises a single ACL/PCL module in which the tibial portion of the module comprises an insert configured to be releasably coupled to each of the plurality of differently sized articular inserts.
21. The system of claim 18, wherein the at least one ACL/PCL module comprises a single ACL/PCL module in which the tibial portion of the module comprises an insert configured to be releasably coupled to each of the plurality of differently sized tibial components.
22. The system of claim 18, wherein the at least one ACL/PCL module comprises a single ACL/PCL module in which the femoral portion of the module comprises an insert configured to be releasably coupled to each of the plurality of differently sized femoral components.
23. The system of claim 18, wherein the femoral portion of the ACL/PCL module is configured to be slidably engaged by the femoral component or the tibial portion of the module is configured to be slidably engaged by the tibial component.
24. The system of claim 19, where the ACL/PCL module is configured to be retained in engagement with the femoral component via a locking taper or retained in engagement with the tibial component via a locking taper.
25. The system of claim 18, wherein the at least one artificial ligament comprises a single length of material in which the anterior cruciate ligament portion and the posterior cruciate ligament are connected to one another.
26. The system of claim 18, wherein the artificial ligament comprises at least one of polyethylene, carbon fiber, and PTFE.
Description
BRIEF DESCRIPTION OF THE FIGURES
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DETAILED DESCRIPTION
[0031] In order to provide a more anatomically correct TKR, prosthesis embodiments that replicate the function provided by both the ACL and PCL are desirable. Referring to
[0032] Generally, the present invention provides various methods of utilizing an artificial material, preferably a synthetic fiber or cord, to replace an ACL and PCL, such that the artificial material is configured similarly to the respective orientation and location of the ACL and PCL in a normal knee. It should be understood, however, that the term “artificial” means only that it is not the original anatomical ACL or PCL ligament in its original form prior to the TKR, and should not be interpreted as a limitation to the use of only synthetic materials. Accordingly, the artificial ligament, may comprise “natural” materials, such as materials fashioned from biologically created materials and/or may comprise a hybrid of synthetic and natural materials. Specifically, the configuration is such that the origin and insertion points of the artificial material in a TKR is similar to the origin and insertion points of the ACL and PCL in a normal knee.
[0033] For example, according to various embodiments of the present invention, the artificial material in the form, for example, of artificial ligament may be incorporated into the TKR either at the time of surgery or the TKR may be pre-assembled with the artificial material in advance of surgery. At the time of the surgical procedure, the surgeon may use either a single strand of artificial ligament that is woven between the femoral component and articular insert with attachment points on either the femoral component or the articular insert of the TKR, or the surgeon may use two lengths of artificial material, one for the ACL and the other for the PCL. Alternatively, the TKR may be preassembled in a similar fashion in advance of surgery.
[0034] Once the artificial material is in place, metallic pieces may be used to crimp and permanently grip the ends. These metal pieces, however then preferably lock into the appropriate anatomical end points of an ACL and PCL in a manner such that the ends of the artificial material do not move or fret. Alternatively the ends of the artificial material may be brought in proximity of one another and tied or sewn together into a continuous loop. In another embodiment, smooth round metal balls may be used to crimp the artificial material and anchor the ends of the artificial material into the articular insert. The round shape of the balls allows the artificial material to move very slightly, reducing stress at the attachment point. Using a spherical anchor that has a diameter larger than the diameter of the artificial material and the diameter of the exit hole in the articular insert may also reduce impingement and stress at these points. It is preferable to include a smooth tunnel in the articular insert, tibial component, and/or femoral component through which the artificial material may be inserted, with the ends of the tunnel located in the approximately correct anatomical location of the endpoints of the ACL and PCL in the knee. Preferably, the opening of each side of the tunnel is also smooth. A smooth tunnel may protect the artificial material from the bone and prevent other potential problems, such as impingement and fretting of the artificial material during movement of the TKR.
[0035] In one method according to the present invention, the artificial material, such as an artificial ligament, may be provided separately from the TKR. During the replacement procedure, the surgeon may weave the ligament through the femoral component and articular insert and fasten the ends. Care should be taken when using this method in order to limit the potential error that may result, for example, from inadequate fastening or leaving an inappropriate length of artificial ligament when fastening is completed.
[0036] In another embodiment of the present invention, a single strand of artificial ligament may be weaved through a channel in the femoral component of a TKR and the ends of the artificial ligament may be attached to a tibial insert that locks into the tibial baseplate. The articular insert may then be provided with cut-outs to allow passage of the artificial ligament to the femoral component from the tibial insert. The femoral component of the TKR of this embodiment may be pre-assembled with the artificial ligament and the tibial insert. The tibial insert may be standardized to fit into any size tibial component of a TKR. However, the length of the artificial ligament may be variable to accommodate different size femoral components and articular inserts.
[0037] Alternatively, the artificial material may be attached to the articular insert, such that the articular insert, artificial material, and the femoral component are pre-assembled together. During the TKR after the femoral component and the tibial component are in place, the articular insert may be snapped onto the tibial component in typical fashion. However, because articular inserts and femoral components are provided in different sizes, multiple combinations of the femoral components and articular inserts may result in a large inventory of different pre-assemblies.
[0038] In yet another embodiment, one or more artificial ligaments may be woven through and/or the ends anchored to one or more modular inserts. The modular inserts may be inserted into one or more of the femoral component, tibial component, and articular insert of the TKR.
[0039] Referring now to
[0040] In a preferred embodiment, the artificial ligaments comprise a cord-like material. Preferred ligament materials are non-elastic or minimally elastic, similar to a natural ligament. Exemplary materials may comprise a variant of a woven polyethylene similar to material previously marketed as SecureStrand® cable, a braided, ultra high molecular weight polyethylene (UHMWPE) cable used for surgical fixation in posterior spinal reconstruction, material currently marketed as Super Cables® (Kinamed, Inc., Camarillo, Calif.) made from UHMWPE and Nylon 6/6,6, Gore-tex® (PTFE fiber manufactured by W. L. Gore and Associates, Inc. Newark, Del.), carbon fiber, or other similar woven materials.
[0041] In one embodiment, the artificial ligament 44 comprises a single length of material that weaves between the femoral component 34 and articular insert 32. For example referring to
[0042] The location of the ends and the order in which artificial ligament 44 weaves among points 26a, 26b, 28a, and 28b is not limited to any particular configuration, as long as the ACL/PCL structure creates at least one connection between openings 26a and 26b and at least one connection between openings 28a and 28b, as illustrated in
[0043] Referring again to
[0044] Knee replacement surgery requires the use of anesthetics. In order to ensure patient safety, doctors strive to perform the TKR procedure as quickly and efficiently as possible. During the procedure, the position of the various components of the prosthetic knee joint may be manipulated on the femur and tibia until the final position is set. Accordingly, it may be preferable to avoid connecting the femoral component and articular insert with an artificial ligament until close to the end of the procedure, when the components are in place on the patient. Because it may be difficult to weave the artificial ligament between the femoral component and the articular insert after the components have been installed, another embodiment of the present invention provides a removable ACL/PCL module that is separate from the femoral component and articular insert. The ACL/PCL module may be pre-assembled and may house the artificial ligaments, such that when the femoral component and tibial component of a TKR are in place, the ACL/PCL module may then be easily inserted and fastened between the two components.
[0045] An ACL/PCL module according to various embodiments of the present invention are illustrated in
[0046] The locking mechanism for the ends of the artificial ligaments are not limited to any particular construction. For example, in the embodiment illustrated in
[0047] The upper and lower portions of the ACL/PCL module may be made of the same or similar material as the femoral component, tibial component, and/or articular insert, or a different material. In general, however, all materials are preferably inert, not prone to cause infection, and otherwise safe and approved for use as a surgical implant. Exemplary materials include polyethylene, surgically approved metal alloys, surgically approved ceramic materials, or a combination thereof. Any well-known materials in the field of surgical implants may be used to fabricate any of the various embodiments or portions thereof according to the present invention.
[0048] One aspect of the exemplary embodiment comprising both an artificial ACL and PCL in a modular construction, is that the module may be easily and removably secured to the is femoral component of a TKR. As illustrated in
[0049] In another aspect of this exemplary embodiment, lower tibial portion 42 may be easily and removably inserted into an articular insert 60. The top surface 62 of the articular insert 60 may include a groove 61. The sides 64A, 646 of the groove 61 may optionally converge to provide a taper. The bottom tibial portion 42 of the ACL/PCL module may have side walls 45A, 456 with optional recesses 46a, 46b that mate with sides 64a, 64b of groove 61. Side walls 45a, 45b of the bottom tibial portion 42 may be parallel or converge to a lesser degree than the sides 64a, 64b of the groove 61 to secure the bottom tibial portion 42 to the articular insert 60 in a self-locking taper configuration, such as what is commonly referred to as a Morse taper. Instead of providing the groove 61 in the articular insert 60, the groove 61 may alternatively be provided in the top surface of an tibial component of a TKR, such as the tibial component 16 in
[0050] A particularly preferred embodiment of the present invention is illustrated in
[0051] In order to insert an articular insert between the tibial portion 76 illustrated in
[0052] The shape, size, and orientation of the upper and lower portions of the ACL/PCL module is not limited. For example both the upper and lower portion may be shaped like the lower portion 42 illustrated in
[0053] The use of an ACL/PCL module in various embodiments of the present invention is preferable because not only does the module allow the individualized selection of a femoral component, tibial component, and articular insert for a patient who will undergo a TKR procedure, but it also provides a standard ACL/PCL module that may be used with any combination of components. For example, all of the femoral components made and sold by a manufacturer may include the same size gap 54 illustrated in
[0054] While preferred embodiments of the invention have been shown and described herein, it will be understood that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions may occur to those skilled in the art without departing from the spirit of the invention. Accordingly, it is intended that the appended claims cover all such variations that fail within the spirit and scope of the invention.