ARRANGEMENTS AND METHODS IN THE PREPARATION OF THE PROXIMAL SURFACE OF THE TIBIA AND/OR FEMUR AND POSTERIOR FEMORAL CONDYLE PROXIMAL SURFACES FOR THE COMPONENTS OF A PROSTHETIC KNEE JOINT

Abstract

An arrangement for the preparation of the proximal surface of the tibia and/or the proximal surface of the distal end of the femur and the posterior femoral condyle for a tibia component and/or a femoral component of a prosthetic knee joint. The arrangement includes an electronic system arrangement that receives or measures data information to which the electronic system can utilise this information to communicate control of a blade and/or cutting implement to resect the proximal surface of the tibia and/or distal end of the femur and/or the posterior femoral condyle to required reference plane cuts that provide for balanced angular movement between the femoral component and the tibia component of the prosthetic knee joint throughout an arc of motion from extension, mid-flexion and flexion.

Claims

1. An arrangement adapted to provide final bone resections of a proximal surface of a distal end of the femur and a posterior femoral condyle of the femur for a femoral component of a prosthetic knee joint, said arrangement including: a generally L shaped femoral tibia stability gap alignment clamp mountable to the femur such that a vertical arm of the generally L shaped femoral tibia gap alignment clamp is adapted to be contiguous and/or aligned with the distal end of the femur and a horizontal arm of the generally L shaped femoral tibia gap alignment clamp is adapted to be contiguous and/or aligned with a posterior femoral condyle of the femur; said vertical arm of the generally L shaped femoral tibia stability gap alignment clamp including user-operable lateral adjustable extension tabs, wherein each user-operable lateral adjustable extension tab is adapted to engage a front plate, such that lateral adjustment of the front plate by said plurality of user-operable lateral adjustable extension tabs defines a measurement taken by a user in each of extension, mid-flexion and flexion, wherein the measurement is commensurable with a distal end of the femur reference plane defined by a front surface of the front plate, said horizontal arm of the generally L shaped femoral tibia stability gap alignment clamp includes user-operable height adjustable extension tabs adapted to adjust the vertical height of a base plate relative to the horizontal arm of the generally L shaped femoral tibia stability gap alignment clamp, such that vertical height adjustment of said plurality of user-operable height adjustable extension tabs upon the base plate defines a measurement taken by a user in each of extension, mid-flexion and flexion, wherein the measurement is commensurable with a posterior femoral condyle reference plane defined by an underside surface of the base plate; and an electronic system arrangement adapted to receive input signals, wherein the input signals are derived from the measurements taken by the user in each of extension, mid-flexion and flexion, and provide distal end of the femur reference plane measured data information and posterior femoral condyle reference plane measured data information; said electronic system arrangement further configured to respond to the distal end of the femur reference plane measured data information and the posterior femoral condyle reference plane measured data information provided by the input signals to communicate electrical energy in the form of an output action to align and move a blade and/or cutting implement in a cutting action that replicates the distal end of the femur reference plane and the posterior femoral condyle reference plane when the fine bone resections to the distal end of the femur and the posterior femoral condyle of the femur are completed by the blade and/or cutting implement.

2. The arrangement of claim 1, further including a sensor arrangement wherein the sensor arrangement includes an accelerometer, gyroscope, a position sensor, an inductor sensor, a capacitive displacement sensor, laser sensor, optical sensor, pressure sensor, magnetic and magneto-inductor sensors, confocal sensors and/or draw-wire sensors wherein the sensor arrangement assists in providing measurements to be taken by the user in each of extension, mid-flexion and flexion.

3. The arrangement of claim 2 wherein the arrangement further includes a robotic arm, and to which the blade and/or cutting implement is attached to said robotic arm.

4. The arrangement of claim 1 wherein the arrangement further includes a robotic arm, and to which the blade and/or cutting implement is attached to said robotic arm.

5. The arrangement of claim 4 wherein the robotic arm is under the control of the electronic system arrangement.

6. The arrangement of claim 1 wherein the electronic system arrangement includes and/or communicates with a display screen, wherein the display screen is adapted to display the distal end of the femur reference plane measured data information and the posterior femoral condyle reference plane measured data information.

7. An arrangement adapted to provide final bone resections of a proximal surface of a distal end of the femur and a posterior femoral condyle of the femur for a femoral component of a prosthetic knee joint, said arrangement including: a generally L shaped femoral tibia stability gap alignment device positionable to the femur such that a vertical arm of the generally L shaped femoral tibia gap alignment clamp is adapted to be aligned with the distal end of the femur and a horizontal arm of the generally L shaped femoral tibia gap alignment device is adapted to be aligned with a posterior femoral condyle of the femur; said vertical arm of the generally L shaped femoral tibia stability gap alignment device including user-operable lateral adjustable extension tabs, wherein each user-operable lateral adjustable extension tab is adapted to engage a distal end of the femur or a device mounted to the distal end of the femur front plate, such that lateral adjustment by said plurality of user-operable lateral adjustable extension tabs defines a measurement taken by a user in each of extension, mid-flexion and flexion, wherein the measurement is commensurable with a distal end of the femur reference plane defined by a front surface of the L shaped femoral tibia stability gap alignment device; said horizontal arm of the generally L shaped femoral tibia stability gap alignment device includes a plurality of user-operable height adjustable extension tabs such that vertical height adjustment of the plurality of user-operable height adjustable extension tabs upon the posterior femoral condyle or a device positioned on the posterior femoral condyle defines a measurement taken by a user in each of extension, mid-flexion and flexion, wherein the measurement is commensurable with a posterior femoral condyle reference plane defined by an underside surface of the horizontal arm of the L shaped femoral tibia stability gap alignment device; an electronic system arrangement adapted to received input signals, wherein the receive input signals are derived from the measurements taken by the user in each of extension, mid-flexion and flexion, and provide distal end of the femur reference plane measured data information and posterior femoral condyle reference plane measured data information; said electronic system arrangement further configured to respond to the distal end of the femur reference plane measured data information and the posterior femoral condyle reference plane measured data information provided by the input signals to communicate electrical energy in the form of an output action to align and move a blade and/or cutting implement in a cutting action that replicates the distal end of the femur reference plane and the posterior femoral condyle reference plane when the fine bone resections to the distal end of the femur and the posterior femoral condyle of the femur are completed by the blade and/or cutting implement.

8. The arrangement of claim 7 further including a sensor arrangement wherein the sensor arrangement includes an accelerometer, gyroscope, a position sensor, an inductor sensor, a capacitive displacement sensor, laser sensor, optical sensor, pressure sensor, magnetic and magneto-inductor sensors, confocal sensors and/or draw-wire sensors wherein the sensor arrangement assists in providing measurements to be taken by the user in each of extension, mid-flexion and flexion.

9. The arrangement of claim 8 wherein the arrangement further includes a robotic arm, and to which the blade and/or cutting implement is attached to said robotic arm.

10. The arrangement of claim 7 wherein the arrangement further includes a robotic arm, and to which the blade and/or cutting implement is attached to said robotic arm.

11. The arrangement of claim 10 wherein the robotic arm is under the control of the electronic system arrangement.

12. The arrangement of claim 7 wherein the electronic system arrangement includes and/or communicates with a display screen, wherein the display screen is adapted to display the distal end of the femur reference plane measured data information and the posterior femoral condyle reference plane measured data information.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0045] FIG. 1 is a rear perspective view of the generally L shaped femoral tibia stability gap alignment clamp and the front plate arrangement in a preferred embodiment of the invention.

[0046] FIG. 2 is a front perspective view of the generally L shaped femoral tibia stability gap alignment clamp and the front plate arrangement in a preferred embodiment of the invention.

[0047] FIGS. 3a to 3h are schematic representations of a method by which the arrangement can be utilized in order to prepare and cut the final bone resections to the distal end of the femur and the posterior femoral condyle in a preferred embodiment of the invention.

[0048] FIGS. 4a and 4b show perspective views of the tibia and femoral stability gap preparation plate in a preferred embodiment of the invention wherein FIG. 4a shows the user operable extension tabs in a lowered position wherein FIG. 4b shows the user operable extension tabs in adjusted raised positions.

[0049] FIGS. 5a to 5f are schematic representations of a method by which the arrangement can be utilized in order to prepare and cut the final bone resection to the proximal surface of the tibia in a preferred embodiment of the invention.

[0050] The illustrations need to be placed in the context of the intended outcome achieved through the use of arrangement and methods provided for in this invention.

DETAILED DESCRIPTION OF THE DRAWINGS

[0051] Orthopaedic surgeons during surgery aim to provide balance, unobstructed movement of the knee components for the complete arc of motion from extension, mid-flexion and flexion and then back again.

[0052] Accordingly, the final bone resection of the proximal surface of the tibia and that of the distal end of the femur and the posterior femoral condyle is required to be cut correctly in order to present the appropriate profile to the tibia and femur prosthetic components positioning in the knee arthroplasty whether that be a total knee or uni-compartmental knee operation.

[0053] The establishment of the reference planes to be describe below help to achieve this outcome.

[0054] FIGS. 1 to 3h show the arrangement (10) that is responsible for the preparation of the distal end of the femur reference plane 70 shown as the broken lines in FIG. 3e, and the preparation of the posterior condyle reference plane 74 shown as broken lines in FIG. 3f of which information which will be discussed in greater detail below is inputted into the Electronic System Arrangement shown as 72, purely for a pictorial reference only, wherein this Electronic System Arrangement 72 is responsible in the preferred embodiment to control the robotic arm 78 and cutting blade 79 responsible for the final bone resections of the distal end of the femur 39 and the posterior femoral condyle 80.

[0055] The arrangement (10) includes the generally L shaped femoral tibia stability gap alignment clamp (11).

[0056] In the preferred embodiment the front plate (12) is a separate piece to the generally L shaped femoral tibia stability gap alignment clamp (11). The exterior surface of the front plate (12) is referenced as (28).

[0057] The front plate (12) is commensurate in dimensions with dimensions and shape of the distal end of the femur as best seen in FIG. 3a.

[0058] The base of the front plate (12) in the preferred embodiment includes separate sections (7a) and (7b), wherein each section (7a) and (7b) of the base of the front plate (12) is engaging below a corresponding user-operable height adjustable tab (17a) and (17b) on the respective sections (43a) and (43b) of the horizontal arm (16) of the generally L shaped femoral tibia stability gap alignment clamp (11).

[0059] In other embodiments not shown the front plate (12) and the base plate (7a) and (7b) can be integral as a single assembly with the generally L shaped femoral tibia stability gap alignment clamp (11).

[0060] As best seen in FIGS. 1 and 2 the front plate (12) and the base plate sections (7a) and (7b) are all a single piece wherein the single piece forms a generally L shaped configuration replicating shape of femoral component commensurate with the configuration of the generally L shaped femoral tibia stability gap alignment clamp (11).

[0061] The horizontal arm (16) of the generally L shaped femoral tibia stability gap alignment clamp (11) as introduced above is in fact two sections (43a) and (43b) so that the horizontal arm (16) is configured generally consistent with the posterior femoral condyle (80) at the distal end of the femur 32.

[0062] The vertical arm (14) of the generally L shaped femoral tibia stability gap alignment clamp (11) includes the user-operable lateral adjustable tabs (15a) and (15) which are adapted to engage the internal side (30) of the front plate (12) when the front plate (12) is mounted or connected to the generally L shaped femoral tibia stability gap alignment clamp (11).

[0063] In the preferred embodiment shown in FIGS. 1 and 2 there are two of the user-operable height adjustment tabs (17a) and (17b) and two user-operable laterally adjustable tabs (15a) and (15b).

[0064] Nonetheless there is no limit to the amount and/or orientation of the user-operable height and lateral adjustable extension tabs for this invention.

[0065] As will be discussed in greater detail shortly hereafter, the scope of the invention simply provides for incorporating a plurality of user-operable lateral extension tabs on the vertical arm (14) and a plurality of height adjustable extension tabs on the underside of the horizontal arm (16) of the generally L shaped femoral tibia stability gap alignment clamp (11).

[0066] The height adjustability shown by way of arrows (21a) and (21b) for the height adjustable extension tabs (17a) and (17b) along with the lateral adjustability of the user-operable lateral extension tabs (15a) and (15b) shown by way of arrows (19a) and (19b) will establish the requisite distal end of the femur reference plane 70 shown in FIG. 3e, and the preparation of the posterior condylar reference plane 74 shown in FIG. 3f.

[0067] The preferred embodiment shows a series of slots (18) to which requisite tooling can engage in order to laterally and vertically adjust the lateral extension tabs (15a), (15b) and/or height adjustable extension tabs (17a) and (17b), again in the arrowed directions shown as (19a), (19b) or (21a) and (21b).

[0068] The positioning and operation of the slots (18) is not essential to the invention and can be achieved through a variety of design choices and tool operation to drive the lateral extension tabs (15a), (15b) and/or height adjustable extension tabs (17a) and (17b) including mechanically, hydraulically, electrically, electronically and/or through computer navigation, robotics or a pneumatic drive action arrangement.

[0069] The slots (18) simply signify that the relevant laterally adjustable extension tabs (15a) and (15b) and the height adjustable extension tabs (17a) and (17b) can be manipulated accordingly in order to orientate the front plate 12 and the sections (7a) and (7b) of the base plate relative to the generally L shaped femoral tibia stability gap alignment clamp (11) so that requisite distal end of the femur reference plane 70 shown in FIG. 3e and posterior condyle reference plane 74 shown in FIG. 3f can be established and to which, again as referenced above and to be explained shortly hereafter, that information is inputted into the Electronic System Arrangement 72 to control the robotic arm 78 and cutting blade 79 responsible for the final bone resections of the distal end of the femur and the posterior femoral condyle.

[0070] Firstly referring to the distal end of the femur reference plane (70) shown in FIG. 3(e).

[0071] As discussed above, surgeon adjustment of lateral extension tabs (15a) and (15b) have orientated the front plate (12) to present the distal end of the femur reference plane (70).

[0072] Importantly for this invention however it is how this established distal end of the femur reference plane (70) and the way in which it is replicated upon the surface of the distal end of the femur when the final bone resection has been completed.

[0073] In the preferred embodiment of the invention the electronic system arrangement (72) is adapted to respond to an inputted signal wherein that inputted signal into the electronic system arrangement (72) has identified, measured and/or allows the recording of the information of the distal end of the femur reference plane (70) so that the electronic system arrangement (72) is able to use that information in the control of the robotic arm (78) and the cutting blade (79) attached to the robotic arm (78).

[0074] In the illustrations the electronic system arrangement (72) is not intended to represent where it would be relative to the knee joint being operated.

[0075] The electronic system arrangement (72) is shown only for pictorial purposes to understand its use in the invention, in that in certain preferred embodiments the electronic system arrangement (72) could be incorporate into, at least in part, the components being used by the surgeon or the electronic system arrangement (72) could remain a separate entity utilised within a computer or other electronic operable devices.

[0076] The essence of this invention however is that once the end of the femur reference plane (70) and/or posterior condyle reference plane (74) has been established by the surgeon, the electronic system arrangement (72) is inherently adapted to be able to receive a signal which provides information of the established distal end of the femur reference plane (70) shown in FIG. 3 with the inputted signal shown as (71) and in the case of the posterior condyle reference plane (74) in FIG. 3(f) being inputted as the signal (75).

[0077] Again for pictorial reasons, in FIGS. 3(e) and 3 (g) the electronic system arrangement (72) receives the inputted signal (71) which provides information of the distal end of the femur reference plane (70) wherein the electronic system arrangement (72), again shown pictorially as (73) sends out a control signal to the robotic arm (78) for the robotic arm (78) to be able to be positioned and to have the cutting blade (79) orientated such that resecting of the bone at or below the distal end of the femur once complete will replicate that same established distal end of the femur reference plane (70) shown in FIG. 3(e).

[0078] In the case of FIGS. 3(f) and 3(h) the established posterior condyle reference plane (74) is inputted as an appropriate signal (75) into the electronic system arrangement (72) wherein the electronic system arrangement (72) sends out a control signal (77) to the robotic arm (78) and the corresponding cutting blade (79) so that as seen in FIG. 3(h) the cutting blade (79) for the final resection cut provides for the same profiled surface as the poster condyle reference plane (74) referenced in FIG. 3(f).

[0079] Although not shown in the illustrations the electronic system arrangement (72) could include a sensor arrangement such as pressure sensors that would be incorporated into the generally L femoral tibia stability gap alignment clamp (11), the front plate (12) and/or the base of the front plate (12). The information derived from the pressure sensors can then be sent as a signal to which the electronic system arrangement (72) for the electronic system arrangement (72) to action accordingly.

[0080] FIGS. 4a, 4b and 5a to 5f are schematic representations of a method by which the arrangement can be utilized in order to prepare and cut the final bone resection to the proximal surface of the tibia in a preferred embodiment of the invention.

[0081] Referring FIGS. 4 and 5a to 5f, the tibia and femoral stability gap preparation plate which forms part of the overall arrangement of the preparation of the proximal surface of the tibia for the tibia component of a prosthetic knee joint for this invention is referenced generally as 110.

[0082] The tibia and femoral stability gap preparation plate 110 in the preferred embodiment includes a base plate 112. The base plate 112 is configured to rest appropriately upon the initial cut 135 of the proximal surface of the tibia 127.

[0083] In the preferred embodiment there is also included the top plate or platform 122. However, the user operable height adjustable extension tabs 113, 114 and 115 and the associated tip 119, 120 and 121 can also directly engage the underside 143 of the joint liner 137, again as to be discussed in greater detail when referencing FIGS. 5a to 5f, in the preferred embodiments the top plate 122 will engage the underside 143 of the joint liner 137.

[0084] The user operable height adjustable extension tabs 113, 114 and 115 are in operable engagement with the rotatable knobs 116, 117 and 118. As referenced by arrows 145, 146 and 147 rotations of rotatable knobs 116, 117 and 118 translates to the vertical height adjustment of the tips 119, 120 and 121 of the corresponding user operable height adjustment extension tabs 113, 114 and 115.

[0085] FIG. 4a shows tips 119, 120 and 121 of the user operable extension tabs 113, 114 and 115 in a lowered position and in FIG. 4b rotational movement of the user engagable knobs 116, 117 and 118 has seen the elevated height of the tips 119, 120 and 121 of the corresponding height adjustable extension tabs 113, 114 and 115 raised which is representative of their adjustability in order to establish the tibia reference plane 160 shown as broken lines in FIG. 5e.

[0086] By having three tips 119, 120 and 121 this provides for a triangulation which is establishing the appropriate tibia reference plane upon the plate 122 which will then be translated to the orientation of the underside 143 of the joint liner 137, to which plate 122 of the tibia and femoral stability gap preparation plate 110 engages.

[0087] The knee joint is shown generally as 129.

[0088] A cutter 131, prepares for the initial resection of the proximal surface 135 of the tibia 127. The general distal end of the femur 130 is also shown. The tibia and femoral stability gap preparation plate 110 shown by way of arrow 134 is being inserted onto the initially resected proximal surface 135 of the tibia 127.

[0089] In other preferred embodiments although not shown in the illustrations the cutter (131) can be included as part of a robotic arm arrangement to complete the initial resection, or in still other preferred embodiments the cutter (131) would include and/or work in combination with a hand saw, robotics, navigation, Patient specific cutting guides and the like.

[0090] It can realise that the general shape of the tibia and femoral stability gap preparation plate 110 is of a comparative dimension of the proximal surface 135 of the tibia 127.

[0091] FIG. 5c shows the actual positioning of tibia and femoral stability gap preparation plate 110 on the proximal surface 135 of the tibia 127 and to be sandwiched therein between the femoral component 136 and the tibia and femoral stability gap preparation plate 110 is the joint liner 137.

[0092] Arrow 138 is representative as to the location the joint liner 137 will be positioned in the knee joint 129.

[0093] The joint liner 137 has an articulated upper surface 139 to engage the femoral component 136 of the femur 130. 143 is representative of the under side of the joint liner 137.

[0094] FIG. 5d shows the knee joint at mid-flexion. Operable knobs 116, 117 and 118 when rotated by way of arrows 145, 146 and 147 though the height adjustable extension tabs, 113, 114 and 115 will adjust the orientation of the underside 143 of the joint liner 137.

[0095] This height adjustability although not shown in the illustrations would also have been completed at extension and then ultimately at flexion or 90 degrees.

[0096] Accordingly, the user operable height adjustable extension tabs 113, 114 and 115 create a triangular support of the top plate 122, which then aligns and/or orientates the underside 143 of the joint liner 137 accordingly. As shown in FIG. 5e the tibia references plane 160 that has now been established on the underside 143 of the joint liner 137 through the height adjustability of the height adjustable extension tabs 113, 114 and 115 from extension, mid-flexion and flexion.

[0097] With the tibia referenced plane 160 now established on the underside 143 of the joint liner 137, the final bone resection of the proximal surface of the tibia will require the same profiling as this tibia reference plane 160.