SYSTEM AND METHOD FOR SIDE INSERTION OF A BICONDYLAR MINI KNEE IMPLANT

20170290669 · 2017-10-12

    Inventors

    Cpc classification

    International classification

    Abstract

    A bicondylar knee implants with improved fixation means for resurfacing only the weight-bearing surface of the femoral medial and lateral condyles, while preserving the cruciate ligaments and avoids displacing the patella. The inventive device includes metallic convex articular surfaces for resurfacing the medial and lateral femoral condyles, and concave multifacial non-articular surfaces to be affixed to the resected distal surfaces of the femur. The prosthesis provides claws situated at the anterior and posterior ends of the medial and lateral metallic condyles, which will firmly attach the implant against the resected femoral condyle. The prosthesis is designed to be implanted through a direct lateral approach and does not resurface the femoropatellar joint. Furthermore, a minirobot or electromechanical actuator is used to perform the femoral and tibial bone cuts using electromagnetic bone chipper.

    Claims

    1. An implantable bicondylar femoro-tibial prosthetic device adapted to be implanted by lateral insertion through a direct lateral approach to a retropatellar region of a knee joint and for forming a joint between a femur and a tibia, the prosthetic device comprising: a biconylar femoral component having a thin shell convexly curved outer articular surface having a medial condyle having two ends, a lateral condyle having two ends, and an intercondylar anterior connection connecting the medial condyle to the lateral condyle and a concave non articular inner surface having retaining claws situated at each anterior ends and each posterior ends of the medial condyle and the lateral condyle, wherein, when the prosthesis is implanted on the weight bearing portion of the femur, the outer surface of the convexly curved articular surface is sized to substantially cover only the weight bearing portion and to substantially cover no portion of the patello-femoral joint of the knee, and wherein the concave non-articular inner surface consists of two or more substantially planar surfaces, and wherein during the implantation of the fermoral component onto a resected portion of the femur by lateral insertion, the retaining claws are embeddable within a laterally resected surface of the femur; and wherein only the weight bearing portion of the femur is resurfaced by the lateral resection, which weight bearing portion is substantially defined by the articular surface of the femur which contacts the tibia of the knee joint during flexion from full extension through flexion.

    2. The prosthetic device of claim 1, wherein the retaining claws each include two planar sides extending from the non-articulating inner surface, and wherein the two planar sides converge to form a sharp edge.

    3. The prosthetic device of claim 1, wherein the retaining claws each include two planar sides extending from the non-articulating inner surface, and wherein the two planar sides are substantially parallel to each other and form a blunt edge.

    4. An implantable prosthetic device adapted to be implanted by lateral insertion through a direct lateral approach to a retropatellar region of a knee joint, and for forming a knee joint between a femur and a tibia, the prosthetic device comprising: a bicondylar femoral component having a concave non-articular inner surface and a curved articular portion including a medial condyle having two ends, a lateral condyle having two ends, and an intercondylar bridge connecting the medial condyle to the lateral condyle, and an inner surface including four retaining claws, one of each claws at said ends of the medial condyle and lateral condyle, and wherein the concave non-articular inner surface consists of two or more substantially planar surfaces; a tibial component having a tibial metallic platform which has a bottom surface which includes an anterior and posterior retaining claws, and, a top surface which includes at least two restraining lips, and a polyethylene insert having a top surface, having two circular depressions, and a bottom surface having includes transverse retaining ridges configured to be fitted between the at least two restraining lips; wherein, during the implantation of the femoral component onto a resected portion of the femur by lateral insertion, substantially no portion of the outer surface of the prosthesis resurfaces any area of the patello-femoral joint, and, during which insertion the four retaining claws are embeddable into the femur; wherein during the implantation of the tibial metallic platform onto a laterally resected portion of the tibia by lateral insertion. during which insertion the anterior and posterior transverse retaining claws are adapted to both guide the tibial platform along a laterally resected surface of the tibia and to hold onto the tibia; and wherein the polyethylene insert is adapted to be affixed to the tibial metallic platform by lateral insertion wherein the during which insertion the transverse retaining ridges the restraining lips of the tibial platform and is ultimately restrained upon of the top surface of the tibial metallic platform.

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    21. An implantable bicondylar femoro-tibial prosthetic device adapted to be implanted by lateral insertion through a direct lateral approach to a retropatellar region of a knee joint and for forming a joint between a femur and a tibia, the prosthetic device comprising: a biconylar femoral component having a convexly curved outer articular surface having a medial condyle, a lateral condyle, and an intercondylar anterior connection therebetween, and a concave non articular flat inner having extending outwardly therefrom a first mini post extending from the medial condyle and a second mini post extending from the lateral condyle, wherein, when the prosthesis is implanted on the weight bearing portion of the femur, the outer surface of the convexly curved articular surface is sized to substantially cover only the weight bearing portion and to substantially cover no portion of the patello-femoral joint of the knee, and wherein during the implantation of the fermoral component onto a resected portion of the femur by lateral insertion, each of the mini posts are embeddable within a laterally resected surface of the femur; and wherein only the weight bearing portion of the femur is resurfaced by the lateral resection, which weight bearing portion is substantially defined by the articular surface of the femur which contacts the tibia of the knee joint during flexion from full extension through flexion.

    22. The prosthetic device of claim 21, wherein one or both of the miniposts have flat ends adapted to be penetrated into cancellous bone.

    23. The prosthetic device of claim 21, wherein one or both of the miniposts have curved ends adapted to be penetrated into cancellous bone.

    24. The prosthetic device of claim 21, wherein one or both of the miniposts have pointed ends adapted to be penetrated into cancellous bone.

    Description

    SUMMARY DESCRIPTION OF THE DRAWINGS

    [0046] Various objects, features and attendant advantages of the present invention will become fully appreciated as the same becomes better understood when considered in conjunction with the accompanying drawings, in which like references characters designate the same or similar parts throughout the several views, and wherein:

    [0047] FIG. 1 is a perspective view of the femoral component showing the retaining claws.

    [0048] FIG. 2 is a perspective view of the femoral component in a different embodiment showing central miniposts.

    [0049] FIG. 3 is a schematic illustration of the patient positioned in lateral decubitus on the operating table with split platform between legs. Lower leg been secured to the platform with stockinet and Velcro.

    [0050] FIG. 4 is a perspective view of the hand held femoral template.

    [0051] FIG. 5 is a perspective view of the hand held femoral template secured over the lateral condyle with two fixation pins.

    [0052] FIG. 6 is a perspective view of the polygonal cutting blocks secured over the lateral condyle with two fixation pins.

    [0053] FIG. 7 is a sectional view of the femoral component inserted onto the distal femur and the tibial component inserted onto the proximal tibia.

    [0054] FIG. 8 is a sectional view of different embodiment of the femoral and tibial component with dull and sharp posts.

    [0055] FIG. 9 is a perspective view of the metallic tibial component inserted onto the proximal tibia.

    [0056] FIG. 10 is a perspective view of the polyethylene tray inserted in position onto the metallic tibial tray.

    [0057] FIG. 11 is a perspective view of the operated femur secured to the operating table with two pins attached to the outrigger.

    [0058] FIG. 12 is a perspective view of the electromechanical bone cutter, showing the T slotted cutting blocks with electromagnetic bone chipper device gliding into T slots.

    [0059] FIG. 13 Is a perspective view of the electromechanical bone cutter, showing the T shaped rail and locking knob attached to the bottom of the device.

    [0060] FIG. 14 Is a perspective view of the proximal tibia being attached to the outrigger with two fixation pins after distal femur articular surfaces been already resected.

    [0061] FIG. 15 is a schematic illustration of the robotic electromechanical bone cutter and attachment to the operating table.

    DETAILED DESCRIPTION OF THE INVENTION

    [0062] Turning now descriptively to the drawings, in which similar references characters denote similar element throughout the several views, the attached figures illustrate a concise bicondylar knee resurfacing prosthesis, which comprises a thin metallic femoral arcuate component, a metallic tibial tray and a polyethylene tibial insert. Furthermore, the present invention provides a detailed description of the method to insert the mini bicondylar implant through a small surgical incision made over the lateral aspect of the operated knee away from the patella and without any disruption or damage to the quadriceps muscle or the patellar tendon.

    [0063] As opposed to conventional surgical total knee replacement surgery, where the patient lies supine on his back, the surgical technique utilized in the present invention is performed with patient lying on his side on the operative table. The operated knee placed onto a surgical platform 15 firmly attached to the side rails of the operative table 40 with at least four adjustable brackets 30. The operated lower extremity is then secured to the platform using strong commercial grade wide VELCRO 19 that will firmly stick to the stockinet wrapped around the lower leg and hold the leg firmly attached to the platform.

    [0064] To attain this objective, the present invention describes a method where an electromagnetic bone chipper device 47 is used to precisely perform the bone resection through the lateral approach. Such device is described in details in U.S. Pat. No. 8,167,883 of Zafer Termanini.

    [0065] The femoral component (FIG. 1) of the bicondylar implant comprises two highly polished convex articular surfaces medial and lateral 1, that are connected anteriorly with an intercondylar connection 8, leaving a space or intercondylar interval 7, which will allow the cruciate ligaments to be preserved and retained.

    [0066] The concave surface of the medial and lateral condyles have a metallic claws on either end of each condyle 2, 3, 4, 5 (FIG. 1). Said metallic claws have the shape of a recurve flange in its cross section and extend transversely along the entire width of each condyle, as depicted. Said metallic claws 2, 3, 4, 5 form an angle of 70 to 95 degrees with the posterior non-articulating adjacent surface 6 of the implant.

    [0067] The length of the claws varies between 10 to 20 millimeters and measures approximately 7-12 millimeters thick at its base where it contacts the body of the femoral component. The tip of each claw is sharp, however, the side edges are rounded so they do not fond any stress risers, which may cause bone damage and lead to osteolysis.

    [0068] In another embodiment of the present invention, the metallic claws can have a parallel front and back surfaces and have a rounded blunt tip.

    [0069] The concave surface of the present implant provides fine asperities and voids to allow bone ingrowth, which will solidly affix the femoral metallic component to bone. Said femoral metallic component can also, if need arise, be cemented to the femur 20 using conventional methyl methacrylate bone cement.

    [0070] The metallic tibial tray 21 (FIG. 7) has a flat top and bottom surface. As shown in FIG. 7 and in FIG. 8, the bottom surface provides metallic downward extensions 23 and 24 in the form of claws for the purpose of securely retaining the metallic tibial tray to the tibia. Said metallic claws run transversely across the lower surface of the metallic tibial tray in the front 23 and the back 24 thereof. Once slid in place from the side, the claws will provide a strong mean of fixation of said tibial tray to the bony tibial plateau 18.

    [0071] In a different embodiment of the present invention (FIG. 8), the aforementioned tibial claws can be replaced with at least two short miniposts 57, which may have sharp pointed tip to facilitate penetration into soft cancellous bone.

    [0072] The top surface of the metallic tray, has an anterior 22 and posterior 43 metallic ridges having the shape of lips, each of which runs transversely across the entire width of the top surface of the metallic tibial tray 21, as shown in FIG. 7 and in FIG. 9.

    [0073] The bottom surface of the tibial implant provides fine asperities and voids to allow bone ingrowth, which will solidly affix the tibial metallic component to tibial bone. Said tibial metallic component can also, if the need arises, be cemented to the tibia using conventional methyl methacrylate bone cement.

    [0074] The tibial insert 42 is made of polyethylene and has the same shape and size of the tibial metallic tray as shown in FIG. 10. The top surface, which articulates with the femoral component, provides two cupules 33 or shallow condylar grooves that conformably match the condylar convex articular surfaces of the metallic femoral medial and lateral condyles.

    [0075] The bottom of said polyethylene tibial insert has a groove configuration 41 that run transversely at the front of the polyethylene tibial insert and a similar transverse groove 41 runs at the back of the insert allowing said insert to slide conformably and easily between the two corresponding lips 22 and 43 of the metallic tibial tray 21 as shown in FIG. 7.

    [0076] In addition, the polyethylene tibial tray 42 is locked in place using a small locking tab extending from the inferior surface of the polyethylene insert into a recess 44 situated at the lateral edge of the metallic tibial tray 21. Said tab when locked in place after lateral insertion will prevent it from moving out as shown in FIG. 9.

    [0077] The metallic tibial tray 21 further provides two holes 45 at the side of said metallic tibial tray 21 which are used for insertion of a guiding tool and an impactor for seating said tibial tray in the proper position over the bony tibial plateau.

    [0078] In a different embodiment of the present invention seen in FIG. 2, the retaining claws 2, 3, 4 and 5 (of FIG. 1) are replaced with central short mini posts 9 and 10 having a length between five and ten millimeters. Said mini posts 9, 10 being very short will not interfere with the insertion of the implant directly through the direct lateral approach but permit the operating surgeon to use conventional methylmetacrylate bone cement and insert and seat the bicondylar prosthesis anteriorly. The miniposts will prevent side migration of the implant. Furthermore, this method eliminates the need for displacement of the patella sideways and does not damage any adjacent soft tissue including the quadriceps tendon. In a different embodiment, the miniposts have a sharp pointed tip 57 to facilitate penetration into bone.

    [0079] In order to perform the bone resection, the operating surgeon must delineate the three resection planes, which will remove the weight bearing articular surface of the medial 32 and lateral 31 femoral condyles. A hand held femoral template 37 (FIG. 4) is used, which will allow the operating surgeon to precisely insert two template pins 28 over the lateral aspect of the distal femur at the proximal end of the incision, without the need to do a new skin incision. The hand held femoral template comprises two articular arcuate pads 25, connected together by adjustable connecting rod 34. Said pads are placed over the corresponding articular surfaces and manually held in place by handle 29 then firmly secured in place with two small pins introduced through holes 27.

    [0080] Subsequent to the precise placement of the hand held femoral template 37 and insertion of the two fixation pins 28, through bracket 26, the operating surgeon will withdraw the hand held femoral template 37 and then position the T slotted polygonal cutting blocks 39 over the two fixation pins and against the lateral surface of the distal femur (FIG. 6). Said T slotted cutting block 39 comprises flat surfaces 35 that correspond to the three flat surfaces of the concave non-articular surfaces 6 of the metallic femoral component.

    [0081] As mentioned above, the resection of the femoral bone is advantageously performed by using the electromagnetic bone cutter unit 47, (FIG. 13) which is fully described in U.S. Pat. No. 8,167,883, of Zafer Termanini. Said electromagnetic driver 55 comprises an oscillating circular cutter 50 and has an inverted T shaped railing 48 at the bottom of the device in a form of an inverted T to guide its movement when said railing 48 slides into a T groove 36 located on the femoral and tibial cutting templates 39.

    [0082] The accidental sliding of the oscillating circular cutter 50 beyond its intended bony target may cause soft tissue damage and disrupt major anatomical structures. In order to prevent such undesirable event, a conventional caliper or depth gage is used to measure the travel distance, which is equal to the width of the medial and lateral condyles Subsequently, a mechanical stop 46 in the form of a slidably movable bolt is applied on the rail 48 in order to restrict its travel beyond the desired resection point.

    [0083] In a different embodiment of the present invention, the resection of the articular surfaces from the distal femur and the proximal tibia is performed using a robotic actuator 56 having at least four axis of freedom.

    [0084] Said robotic actuator is situated on top of a rotating circular platform 54 situated on top of the outrigger 11 (FIG. 14). It is to be noted that the outrigger 11 is constructed of metal or durable plastic material, which withstands autoclave sterilization. Said outrigger is attached, over the drapes, to the side rails of the operating table after the appropriate sterile draping of the patient. Sterile clear plastic will cover the entire robotic actuator unit to preserve the surgical field sterility. The connection to a control module can be established with sterilizable cable connection or remotely without a cable connection using Wi-Fi or other wireless transmission well known in the art. A Power supply will then be provided using rechargeable battery pack unit 53 contained in the robotic actuator itself.

    [0085] The robotic actuator is connected to a computer and monitor where DICOM from the pre-operative CT scan of the patient is retrieved allowing the registration of the registration of the actuator.

    [0086] As in CNC machining, where the work piece is solidly fixed with a vise prior to milling, the distal femur is solidly fixed to the operating platform—using outrigger 11, attached via bracket to the side rails 14 of platform 15. After the resection of the articular surface of the distal femur is done, and the three flat surfaces are prepared 51 (FIG. 14), attention is then turned to preparation of the proximal tibia, which is then secured in similar fashion to the outrigger with two large fixation pins 12 as was for the femoral side. Subsequently, the proximal tibial surface is prepared by resecting the articular surface of the proximal tibia 18 using the electromagnetic bone cutter 50.

    [0087] As opposed to prior art methods, using such as haptic technology or navigation, where the target objects such as bone is movable, in the present invention, the bone is firmly fixed and does not move. Furthermore, prior art navigation is basically used to align cutting guides. In the present invention, the actuator 56 will guide the electromagnetic bone cutter 50 to perform the bone cutting directly without the use of templates or cutting slotted guides (such as in FIG. 6).

    [0088] With respect to the above description, it is to be realized that the optimum dimensional relationships for the parts of the invention, to include variations in size, materials, shape, form, function and manner of operation, assembly and use, are deemed readily apparent and obvious to one skilled in the art, and all equivalent relationships to those illustrated in the drawings and described in the specification are intended to be encompassed by the present invention.

    [0089] Therefore, the forgoing is considered as illustrative only of the principles of the invention. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.