Patient-specific instrumentation for patellar resurfacing surgery and method

Abstract

A system for creating a patient-specific jig model for patellar resurfacing surgery comprises a patellar implant positioning module for obtaining a planned position of a patellar implant on a model of the patella, the model being anatomically patient-specific. A patella resurfacing calculator module calculates a position and/or orientation of a resurfacing plane and attachment bore in the patella as a function of the planned position of the patellar implant. A jig model generator module for generates and outputs a virtual jig model using the resurfacing plane and attachment bore of the patella and the model of the patella, the jig model comprising at least one patient-specific contact surface corresponding to a surface of the patella for complementary contact, at least one drill guide positioned relative to the at least one patient-specific contact surface to be configured to guide a tool defining the attachment bore for the patellar implant, and at least one cut guide positioned relative to the at least one patient-specific contact surface to be configured to guide a tool in resurfacing the patella to form the planned resurfacing plane.

Claims

1. A patient-specific jig for patellar resurfacing surgery comprising: a first jig portion defining at least one patient-specific contact surface negatively corresponding to a posterior surface of an anatomically patient-specific patella for complementary contact, and at least one drill guide in the first jig portion positioned relative to the at least one patient-specific contact surface to be configured to guide a tool defining an attachment bore in the posterior surface for a single-peg patellar implant, and another drill guide configured to secure a pin for securing the jig during resurfacing, the another drill guide being offset relative to the at least one drill guide and configured for a pin to be offset relative to the attachment bore in the patella; and a second jig portion having a part projecting from only a portion of a periphery of the first jig portion, the part defining at least one cut guide positioned relative to the at least one patient-specific contact surface to be configured to guide a tool in resurfacing the patella to form a planned resurfacing plane for supporting the patellar implant.

2. The patient-specific jig according to claim 1, further comprising the first jig portion and the second jig portion concurrently define a male-female mating engagement, the second jig portion having a hole aligned with the another drill guide in the first jig portion for the pin to pass through the hole and the another drill guide.

3. The patient-specific jig according to claim 2, further comprising indicia on the first jig portion, the indicia being anatomically patient-specific so as to be configured to be aligned with at least one of a proximal-distal axis and a medio-lateral axis.

4. The patient-specific jig according to claim 2, wherein the first jig portion and the second jig portion have complementary circular shapes for said mating engagement.

5. The patient-specific jig according to claim 4, wherein the second jig portion has a receiving cavity for said mating engagement of the first jig portion therein.

6. The patient-specific jig according to claim 5, wherein the first jig portion and the second jig portion are substantially cylindrical.

7. The patient-specific jig according to claim 2, wherein the at least one drill guide includes a central drill guide.

8. The patient-specific jig according to claim 7, wherein the hole in the second jig portion is aligned with the central drill guide.

9. The patient-specific jig according to claim 2, further comprising a clamp configured for pressing said mating engagement of the first jig portion and of the second jig portion against the posterior surface of the patella by contacting an anterior surface of the patella.

10. An assembly comprising the patient-specific jig according to claim 1, and a verification jig having a periphery representative of the patellar implant, the verification jig configured to be laid flat against the resurfacing plane of the patella and aligned with the attachment bore.

11. An assembly comprising the patient-specific jig according to claim 1, and the single-peg patellar implant.

12. The assembly according to claim 11, further comprising the pin.

Description

BRIEF DESCRIPTION OF THE FIGURES

(1) FIG. 1 is a flowchart showing a method for creating a PSI jig for patellar resurfacing surgery in accordance with an embodiment of the present disclosure;

(2) FIG. 2 is a perspective view showing a contour-matching surface of a first portion of the PSI jig;

(3) FIG. 3 is a side view showing the first portion of the PSI jig on a patella;

(4) FIG. 4 is a face view of the first portion of the PSI jig on the patella;

(5) FIG. 5A is a perspective view of a second portion of the PSI jig on the patella;

(6) FIG. 5B is a side view of the second portion of the PSI jig on the patella;

(7) FIG. 6 is a perspective view of the PSI jig secured to the patella for resurfacing the patella;

(8) FIG. 7 is a face view of the resurfaced patella;

(9) FIG. 8 is a face view of the resurfaced patella of FIG. 7, with a verification jig;

(10) FIG. 9 is a face view of the resurfaced patella with patellar implant; and

(11) FIG. 10 is a system for creating a PSI jig for patellar resurfacing surgery in accordance with another embodiment of the present disclosure.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

(12) Referring to the drawings, and more particularly to FIG. 1, there is illustrated a method 10 for creating a patient specific instrumentation (hereinafter PSI) jig for patellar resurfacing surgery using one or more processors within a computing system, in which the patella is resurfaced and an implant (prosthesis) is secured to the resurfaced patella. For clarity, reference to patient specific in the present application may pertain to the creation of negative corresponding surfaces, i.e., a surface that is the negative opposite of a patient bone/cartilage surface, such that the patient specific surface conforms to the patient bone/cartilage surface, by complementary confirming contact, enabling a unique positioning of the instrument on the bone. An instrument may also be patient specific in that it is used to plant guide references in a patient's bone, at a specific pre-planned location based on the patient's specific anatomythe geometry of the instrument is anatomically specific to the patient. The method is particularly suited to be used in conjunction with or subsequent to knee revision in which the femoral knee implant needs to be replaced.

(13) According to 12, the patella is modeled. The model may be obtained and/or generated using imaging, and may be a virtual model, for example in 3D. The imaging may be done by any appropriate technology such as CT scanning (computerized tomography), fluoroscopy, or like radiography methods, providing suitable resolution of images. The model of the patella includes a surface geometry of its posterior surface and other parts of the bone that are exposed. The modeling may include a surface geometry of the adjacent femur with or without implant. In particular, if applicable, a combination of radiography and magnetic resonance imagery (MRI) may provide a suitable resolution between implant, femur and cartilage, useful to recognize the boundaries of the implant relative to the bone. The images of the implant may be confirmed, or the model improved using the manufacturer's model of the existing implant. The bone modeling may comprise generating a 3D surface of the patella if the bone modeling is not directly performed by the imaging equipment, or if not complete. The imaging may also include information relating to surrounding soft tissue. The model of the patella and, if modeled, of the femur with or without implant provides data that may be used by an operator, such as a surgeon, to plan patellar resurfacing surgery.

(14) According to 13, a positioning of the patellar implant model is planned. The patellar implant may be a stock implant, as shown at B on resurfaced patella A in FIG. 9. The planning may also include selecting an implant size from a selection of available patellar implants, the selecting being based on the dimensions of the patella, as obtained from the patellar implant model. The operator may select the position and orientation of a 3D model of a patellar implant (i.e., a new implant) that will be used in surgery, by looking at the model and/or determining locations for cut planes on the patella to support the patellar implant. As the patellar implant may be round as in FIG. 9, the planning may involve determining the location of the center of the patellar implant relative to the patella.

(15) A factor that may come into consideration include native positioning between patella and femur (native meaning the current preoperative state). The positioning of the patellar implant model may include calculating the native positioning between the patella and the femur to assist in reproducing or to provide a corrective value based on the native positioning. Another factor that may affect the positioning of the patellar implant model is the soft tissue tension, such as the tension in the quadriceps tendon and/or in the patellar ligament. The positioning may aim to reduce or increase the tension, during extension and/or flexion. Therefore, an assessment of the soft tissue tension may be done preoperatively, and the information is available in 13 to determine the positioning of the patellar implant model to adjust the soft tissue tension for example by calculating the corrective value to the native positioning. Also, as the patellar resurfacing surgery may occur simultaneously with knee joint replacement, the implant planning for the femur and of the tibia may be taken into consideration in 13. For example, the implanting of a femoral knee implant will cause a change in the contact surface for the patella implant. Therefore, the positioning of the patellar implant model may be based on the planned femoral knee implant position and orientation on the femur, along with the geometry of the femoral knee implant.

(16) As part of the planning of 13, the cut planes of the patella may be determined or selected by the processor, based on a selected patellar implant position and orientation. The cut plane may be based on the thickness of the selected implant, and a desired thickness of the resurfaced patella with implant, for example along the antero-posterior axis.

(17) According to 14, using the patellar model of 12, and the planning of 13, a PSI jig model is generated. The jig model will have a contact surface(s) defined to abut against the posterior surface(s) of the patella obtained in 12, in a predictable and precise manner, although it is considered to position the jig model against other parts of the patella as well, such as the anterior face. Moreover, the PSI reference jig model may have guiding features to guide an operator in positioning landmarks and/or guides in the patella, such that the guiding features are at the planned position and orientation. For example, the PSI jig model may have a cut slot or guide to guide a saw in making a cut plane upon which the patellar implant will be anchored, as well as drill guides for securing the PSI jig to the bone, and/or for positioning an attachment bore in the patella for securing the patellar implant to the resurfaced patella in a planned manner. The drill guide may be used to create an attachment bore for receiving a pin or peg of the patellar implant.

(18) According to 15, once the PSI jig model has been generated, the PSI jig may be output and/or produced, using any appropriate technique, prototyping, 3D printing, casting, etc. The PSI jig model may be a set of executable instructions for 3D printing, machining numerically, etc. The computer system may include an output (screen, monitor, port, transmitter) for the output.

(19) Now that a method for creating a PSI jig for patellar implant surgery has been defined, a method for positioning a patellar implant during surgery is set forth, using the PSI jig as created in the method 10 described above.

(20) Referring to FIGS. 2-4, a first portion of the PSI jig is generally shown as 20. The first portion 20 of the PSI jig has a contour-matching surface 21 (FIG. 2) adapted to contact in complementary engagement the posterior surface of patella A, as in FIGS. 3 and 4, and could also contact other parts of the patella, such as circumferential surfaces and/or the anterior surface of the patella A, in its native state. The first portion 20 may have a pair of drill guides, namely a central drill guide 22 and an offset reference drill guide 23. Moreover, indicia such as ML (medial and lateral) and PD (proximal and distal) axes may be provided on the face of the first portion 20, as guidance or confirmation for the operator. When installing the first portion 20 of the PSI jig on the patella A, the contact surface 21 on the PSI jig is applied against the native posterior surface of the patella A, with a unique complementary match that will ensure that the planned positioning is reached.

(21) At that point, the first portion 20 may be anchored to the patella A via the central drill guide 22 and with a pin 24 or like fastener, as in FIG. 5A. Moreover, the attachment bore is drilled using the reference drill guide 23, the attachment bore being deeper than that of the pin 24, as it is intended that the attachment bore resulting from the reference drill guide 23 be present in the resurfaced patella for reception of a peg of the patellar implant, as detailed hereinafter. The attachment bore may indeed serve as reference position for the patellar implant. Alternatively, a single one of the drill guides 22 and 23 may be present. Moreover, due to the PSI nature of the PSI jig, it may not be necessary to use the pin 24. The unique complementary engagement may provide enough stability such that PSI jig may remain in position when manually held. Clamps and other like tools may also be used as alternatives or additionally to the pin 24.

(22) Referring to FIGS. 5A and 5B, once the first portion 20 of the PSI jig is secured to the patella, a second portion 30 of the PSI jig is connected to the first portion 20, by mating engagement. The second portion 30 has a hole 31 to allow passage of the pin 24, for alignment, and a cut guide 32 with a cut slot 32A (FIG. 5B). The cut slot 32A is distanced so as to ensure that the resulting cut plane of the patella is based on the planning (including the thickness of the patellar implant). It is pointed out the first portion 20 and the second portion 30 may be a single PSI jig instead of two interconnected pieces. Moreover, it is contemplated to have integrated metallic components in the cut slot 32A for a body of polymer, etc. According to an embodiment, the second portion 30 is a stock piece while the first portion 20 is a PSI piece. Stated differently, the first portion 20 is manufactured to be anatomically patent specific, in terms of its contact surface 21, of the position of the drill guides 22 and 23 and of its thickness. The second portion 30 may be a stock piece of a more rigid material, such as metal, and hence configured to be reused. The thickness of the first portion 20 is therefore selected as a function of the geometry of the stock second portion 30, to ensure that the cut is located as planned. Therefore, the connection arrangement between the first portion 20 and the second portion 30 may be a male-female tapered engagement with quasi-cylindrical geometries for the first portion 20 and a receiving cavity in the second portion 30.

(23) Referring to FIG. 6, a clamp 40 may then be used to ensure that the PSI jig 20/30 remain anchored in the planned position on the patella A, during the resurfacing of the patella A. The clamp 40 may be any appropriate set of pliers, etc, by which a pressure is applied on the PSI jig 20/30 and on the anterior surface of the patella A. The resecting of the patella may also be done without the clamp 40.

(24) Once the cut is completed, the patella A is resurfaced, and may have a trace of the bore drilled using the reference drill guide 23. Referring to FIG. 8, a verification jig 50 may be used to ensure that the patellar implant B will not overlap the periphery of the resurfaced patella A, when centered relative to the trace bore. Referring to FIG. 9, the patellar implant B may then be secured to the resurfaced patella A, in the planned position. Although not shown, other machining steps may be performed to anchor the patellar implant B to the resurfaced patella A.

(25) Now that the methods for creating a PSI jig for patellar implant surgery and for positioning a patellar implant during surgery have been defined, a system for creating a PSI jig for patellar implant surgery is described and generally shown at 60, in FIG. 10. The system 60 may comprise an imaging unit 70, such as a CT scan or an X-ray machine, so as to obtain images of the patella and surrounding bones and soft tissue. As an alternative, images may be obtained from an image source 71. As an example, a CT scan may be operated remotely from the system 70, whereby the system 70 may simply obtain images and/or processed bone and implant models from the image 71.

(26) The system 70 comprises one or more processors, shown for simplicity as processor 80 (e.g., computer, laptop, etc.) that comprises different modules so as to ultimately produce the jig model(s). The processing unit 80 of the system 60 may therefore comprise a bone model generator module 81 receiving images from sources 70 or 71 to generate a 3D model of the patella. In accordance with the method 10 of FIG. 1, the 3D model of the bone may comprise data pertaining to the surface geometry of a relevant portion of the patella, with or without surrounding bones and soft tissue.

(27) The bone model generator module 81 will create the 3D model of the patella that is then used by a patellar implant positioning module 82 and a patella resurfacing calculator module 83 of the processing unit 80. Alternatively, the modules 82 and 83 may use a 3D model provided by the image source 71, provided the model obtained from the image source 71 comprises sufficient data.

(28) The patellar implant positioning module 82 is used for the virtual planning of the positioning of the patellar implant model. The implant database 82A may provide virtual models of stock patellar implant, as shown at B on resurfaced patella A in FIG. 9. The selection of the implant size may be based on the dimensions of the patella, as obtained from the patellar implant model. The patellar implant positioning module 82 may assist the operator in selecting the position and orientation of the 3D model of the patellar implant that will be used in surgery, by proposing a position and orientation based on the native patella and/or by enabling a relative movement between the models of the patella and of the implant for the operator to virtually select a position and orientation. The patellar implant positioning module 82 may provide data related to the current position to assist the operator, such as the position of the femoral contact surface of the virtual model relative to that of the native patella, for example.

(29) The patellar implant positioning module 82 may factor in soft tissue tension, such as the tension in the quadriceps tendon and/or in the patellar ligament. The positioning of the implant may aim to reduce or increase the tension, during extension and/or flexion. Therefore, the patellar implant positioning module 82 may provide an assessment of the soft tissue tension to allow an adjustment the soft tissue tension for example by calculating the corrective value to the native positioning. Also, as the patellar resurfacing surgery may occur simultaneously with knee joint replacement, the patellar implant positioning module 82 may take into consideration implant planning for the femur and of the tibia. For example, the implanting of a femoral knee implant will cause a change in the contact surface for the patella implant. Therefore, the patellar implant positioning module 82 may base the positioning of the patellar implant model on the planned femoral knee implant position and orientation on the femur, along with the geometry of the femoral knee implant.

(30) The patella resurfacing calculator module 83 of the processing unit 80 calculates the cut planes of the patella based on the selected patellar implant position and orientation output by the patellar implant positioning module 82. The cut plane may be based on the thickness of the selected implant, and a desired thickness of the resurfaced patella with implant, for example along the antero-posterior axis. The patella resurfacing calculator module 83 may factor in the native positioning between patella and femur (native meaning the current preoperative state) in the calculating. The patella resurfacing calculator module 83 of the processing unit 80 may also calculate the location of the center of the patellar implant relative to the patella.

(31) Once the position and orientation of the patellar implant is selected and the cut planes are defined, a PSI jig model generator module 84 may generate a jig model or jig models 90, for instance similar to 20 and 30 shown in FIGS. 2-9. As in 14 of the method 10, the jig model will have a contact surface(s) defined to abut against the patella, in a predictable and precise manner. As the PSI jig will support a tool to perform alterations on the patella, the jig model 90 comprises cutting planes, guides, slots, or any other tooling interface or tool, trackers, oriented and/or positioned to allow bone alterations to be formed in a desired location of the patella, relative to the contact surface(s). Thus, jig model generator module 84 may also take into consideration any planning done by the operator (e.g., surgeon). Accordingly, the system 60 outputs PSI jig model(s) 90 that will be used to create the PSI jig 20/30.

(32) It is considered to use the reference guides as guides for a robotic arm to cut the planes on the bone. In such a case, no jig model would be required. Instead, a navigation file could be provided for a robotic system to perform surgery based on the position and orientation of the patella.

(33) While the methods and systems described above have been described and shown with reference to particular steps performed in a particular order, these steps may be combined, subdivided or reordered to form an equivalent method without departing from the teachings of the present disclosure. Accordingly, the order and grouping of the steps is not a limitation of the present disclosure.