HK40000894B - Design method of a rig - Google Patents

Description

Device design methods

This application is a divisional application of the invention patent application with application date of July 9, 2015, application number 201580048028.5 and invention name “Method for designing an instrument”.

Technical Field

Embodiments herein generally relate to the fields of orthopedic surgery and cartilage and/or bone resurfacing. Embodiments herein relate to instruments intended to guide the replacement of a portion of a bone and/or cartilage portion and methods for designing such instruments. Other embodiments herein also relate to implants, surgical kits, methods for designing tool kits, and methods for replacing a portion of an articular surface of a joint.

Background Art

In surgical procedures involving the implantation of small implants, it is crucial to position the implant in a precise manner. If the implant deviates from its intended position, it may cause increased wear or load on the joint. For example, if the implant is tilted, this may result in an edge protruding above the cartilage surface and cause wear on the relative cartilage in the joint. Another example is that the implant is placed in a position where the surface of the implant protrudes above the cartilage surface, causing the joint to articulate in an uneven manner and increasing the load on the relative points of the joint. For the patient, a small positional offset or deviation from the ideal position may also result in pain, longer recovery time, or even ineffective surgery, and make it more difficult to repair the damage in the joint. Therefore, a large burden is placed on the surgeon to avoid misplacement or mismatching the implant. A guide or instrument that can guide the surgeon to place the implant in a precise manner and can also guide the removal of damaged tissue is needed. In addition, an instrument that is designed to be suitable for various injuries and that can still provide reproducible and precise placement even if the position of the injury changes each time is needed.

Existing technology

An example of prior art disclosing an implant and a tool for replacing damaged cartilage is: EP2389905 shows a design method for designing an implant and a tool kit.

WO2008098061 and US20120271417 disclose implants for replacing a portion of an articular surface, wherein the implant comprises first, second, and third segments, wherein the first and second segments partially overlap, and the third and second segments partially overlap. The implant is inserted using a guidance system, wherein the reaming of the articular surface is guided by the use of a guide pin. A drill guide can be used to establish the axis of the guide pin relative to the articular surface.

US8062302 discloses a guide comprising a block having a patient-specific surface and first and second bores.

US20110152869 discloses a pulley repair system having two mutually offset working axes, wherein the two working axes are used to produce two partially overlapping sockets.

WO2010099357 discloses a system for repairing defects in a joint surface, comprising a guide block which may include an opening configured to allow a cutter to pass through the guide block.

The purpose of this embodiment

A general object of embodiments herein is to solve the problem of providing a method for designing a rig capable of accurately inserting and positioning an implant at the articular surface of a joint.An object of embodiments herein is also to provide a rig and an implant and a method for designing an implant.

There is a need for a tool or instrument designed to provide the surgeon with precise guidance and support during the implantation of a small implant. In addition, there is a need for a flexible design method for such an instrument.

The embodiments herein also seek to address some of the following issues:

- To provide a method for cartilage replacement in which the implant is securely attached in the joint and well integrated into the surface structure of the joint so as to produce optimal repair of damaged tissue with minimal damage to surrounding tissue.

- Provide a method for designing instruments for positioning an implant to be implanted in a joint, improve the positioning of the implant so as to produce optimal repair of damaged tissue and cause minimal damage to surrounding tissue, and assist the surgeon in achieving this positioning.

- Provide individual design of the device.

By using the design method according to embodiments herein, a surgeon can obtain a precise way of placing an implant in a joint using the design method of an instrument and using an instrument according to embodiments herein, a system according to embodiments herein, wherein the instrument channel shape is individually constructed according to the cartilage damage and the location of the damage in the joint and by selecting from circular shapes or substantially circular shapes of different sizes,

The combinations that can be selected individually for a patient partially overlap with each other, allowing the surgeon to select an implant of a size and shape appropriate for the bone and/or cartilage injury or defect, and making it easy for the surgeon to use the designed method and tool set for making the desired resection.

The design method according to the embodiment herein allows production to be easy to be applicable to instrument and the implant of individual injury and individual patient.The design of making up in this method comprises and selects size and at least two circular shapes and selects thickness, surface shape, articular surface etc. for each implant, makes this solution unique and be easy to individualization, but still is suitable for large-scale industrial manufacturing.The circular shape of instrument channel makes instrument also easy to use, and provides the accurate cooperation of each implant in each patient.

Advantages of the embodiments herein

If the damaged area is elongated or irregular or large in shape, the area of joint damage may not be easily covered by a single circular implant. Instead of using multiple separate implants or implants that require complex bone removal techniques, using several different drills and tools, the design methods of surgical implants and instruments according to embodiments of the present invention provide a solution for the entire pre-drilling and drilling operation that also utilizes a single instrument that is anchored in place.

In one embodiment, the same double drill, the same pre-drilled guide socket, and the same depth adjustment socket are used for all drillings. This is achieved by an instrument that allows the guide socket or adjustment socket to be offset from one side of the hollow housing to the other, or to multiple sides, between drillings. In one embodiment, a removable internal arcuate wall insert can also be inserted in each position to provide a complete cylinder for holding the pre-drilled guide socket for each drilling. The socket can also be adjustable. In another embodiment, the removable insert is not arcuate, but cylindrical. In yet another embodiment, no insert is used at all. Other similar embodiments are of course possible.

According to one embodiment, this creates two identical nail holes and precisely excavated cavities to accommodate implants in the form of two intersecting circles of the same diameter. Simply removing the insert wall within the cylindrical interior creates a securely mounted housing for the instrument for the elongated implant 1 having two nails 23 and 23'. After drilling, an implant-shaped processing gauge is inserted to verify that the proper drilling depth has been achieved. After all drilling and depth checks are complete, the instrument is removed.

Summary of the Invention

Presented herein are design methods for designing an instrument and a tool model system including the instrument.The instrument includes a hollow tubular housing, and the interior of the housing defines at least first and second intersecting cylinders.

An embodiment of the design method includes identifying an injury area, presenting a 3D view of the identified injury area, and generating a 3D model of a virtual instrument. The generation includes virtually placing a shape in the 3D view that covers or partially covers the injury area, and creating a position of a hollow tubular instrument shell of the virtual instrument based on the position of the virtually placed shape. The method also includes selecting at least a first and a second intersecting cylinder of the virtual instrument based on the size and form of the virtually placed shape, and creating a positioning surface for the virtual instrument, which is a bone and/or cartilage engaging end of the hollow tubular shell. When the virtual instrument is placed in the virtual model of the joint, the positioning surface is adapted to follow a surface surrounding the virtually placed shape. The method includes producing an instrument based on the virtually created instrument.

In one embodiment, a method for designing an instrument (600) for guided surgery in a joint, wherein the instrument (600) includes a guide body in the form of a hollow tubular housing (510), the guide body being configured to define at least first and second intersecting cylinders,

The design method includes:

- identifying the damaged area in the joint (4);

- presenting a 3D view (9) of said identified damaged area (4) in a virtual model of the joint;

- generating a 3D model of a virtual instrument, wherein said generating comprises virtually placing a shape (303) in said 3D view (9) which at least partially covers said injury area (4) in said virtual model of the joint;

- creating a position of said hollow tubular shell (510) of a virtual instrument based on the position of the virtually placed shape (303);

- selecting at least first and second intersecting cylinders of the virtual instrument based on the size and form of the virtually placed shape (303);

- A positioning surface (560) of the virtual instrument is created as the bone and/or cartilage engaging end of the hollow tubular shell (510), and the positioning surface (560) is adapted to follow the surface of the joint around the shape of the virtual placement when the virtual instrument is placed in the virtual model of the joint.

- Producing an instrument based on the virtual instrument (600).

In other embodiments herein, the hollow tubular housing of the guide body of the virtual instrument is configured to define the at least first and second intersecting cylinders with a hole for each respective cylinder.

In other embodiments herein, the hollow tubular housing of the guide body of the dummy instrument is configured to define the at least first and second intersecting cylinders by an inserter guide having at least one hole for at least one of the cylinders.

In other embodiments herein, the hollow tubular housing of the guide body of the virtual instrument and the insert are configured such that the insert can be inserted into the hollow tubular housing in at least two different positions to define one of the at least two intersecting cylinders in each position.

In other embodiments herein, each of the first and second intersecting cylinders is provided with a circular cross-sectional profile.

In other embodiments herein, the circular cross-sectional profile of the first intersecting cylinders has a diameter that is different than a diameter of the circular cross-sectional profile of the second intersecting cylinders.

In other embodiments herein, the circular cross-sectional profile of the first intersecting cylinders may have a diameter equal to a diameter of the circular cross-sectional profile of the second intersecting cylinders.

In other embodiments herein, the interior of the housing can define first, second, and third intersecting cylinders.

In other embodiments herein, each of the first, second, and third intersecting cylinders can have a circular cross-sectional profile, and the diameter of each cylinder can be equal to one another.

In other embodiments herein, the design method may further include designing a removable insert including an arcuate wall adapted to be selectively inserted into the interior of the housing to complete the entire circumference as desired.

In other embodiments herein, the removable insert may have a cylindrical shape.

In other embodiments herein, the hollow tubular housing and insert of the guide body of the virtual instrument are configured such that the insert can be inserted into the hollow tubular housing, and the interior cross-section of the housing and the exterior cross-section of the insert have one of: a circular cross-section;

oval cross section;

rectangular cross section;

triangular cross section;

and/or other symmetrical, partially symmetrical or asymmetrical cross-sections.

In other embodiments herein, the positioning surface of the instrument may be provided with a plurality of holes for pins to firmly anchor the instrument in place on the surface to be repaired.

In other embodiments of the present invention, the shape may include at least two circular shapes, and the method may further include placing at least two points, each of which the axis will start from. The point can be placed on the bone surface in the 3D view of the joint in the area of bone and/or cartilage damage or the point can be placed on the simulated bone surface, which is a virtually created surface in the area of bone and/or cartilage damage or near the area of cartilage damage. The method may further include selecting an axis distance and selecting the diameter of the at least two circular shapes. The diameter of the circular shape can be selected between 10-30mm or, for example, between 15-25mm. The method may further include selecting the coverage of the implant area on the cartilage and/or bone damage. The coverage can be between 50-100%. The method may further include selecting the angle of the axis of the point originating from the simulated bone surface. The axis can have an angle of 0-40 degrees relative to the bone axis, and the bone axis is orthogonal to the tangent plane of the simulated bone surface in the point.

In other embodiments herein, each of at least two circular shapes may include an axis, and wherein the overlap of the circular shapes depends on a selection of the diameters of the circular shapes, in combination with a selection of the proximity of the axis of one circular shape relative to another axis of another circular shape, and in combination with a selection of the desired coverage of the implant over the cartilage and/or bone damage.

In other embodiments herein, each of the at least two circular shapes can include an axis, and the overlap of the circular shapes can depend on the selection of a diameter between 1-3cm of the circular shape, the selection of an axial distance of 6mm to 32mm between the axis of one circular shape relative to another axis of another circular shape, and the selection of 50-100% coverage of the implant body on cartilage and/or bone damage.

In other embodiments herein, identifying cartilage and/or bone areas in a patient can be achieved by taking CT, CBCT, MRI images, etc. of the patient's joints and using these images, for example, using a software program for virtual 3D animation to create 3D views of the bone and/or cartilage areas 4 and bone and/or cartilage lesions 5.

In other embodiments herein, at least three circular shapes may be positioned to partially overlap, cover, or partially cover a cartilage and/or bone lesion.

In other embodiments herein, the circular shape may have a size between 0.5-4 cm in diameter.

In other embodiments herein, 2-5 circular shapes may be placed to partially overlap, covering bone and/or cartilage lesions.

In other embodiments herein, virtually placing at least two circular shapes may include virtually placing at least two points, with an axis starting from each of them. The points may be placed on a bone surface of a joint in an area or near bone and/or cartilage damage, or the points may be placed on a simulated bone surface, which is a virtually created surface in or near the area of bone and/or cartilage damage. The simulated bone surface may be a surface that preferably corresponds to a three-dimensional (3D) image of a bone surface in a healthy joint, and wherein the point is at the center of the circular shape. The circular shapes may partially overlap each other, and the axis may be placed so that the combined area expansion of the circular shapes covers or partially covers the identified bone and/or cartilage damage.

In other embodiments herein, virtually placing at least two circular shapes may be performed by placing virtual circles including axes at predetermined angles relative to each other.

In other embodiments herein, each circular shape may have an axis that is 90° relative to the surface of the circular shape.

In other embodiments herein, the circular shaped area positioned may include a surrounding area to allow for insertion of the adjustment socket, which would include the hollow space created in the instrument.

In other embodiments herein, at least three circular shapes may be virtually placed in a row or other symmetrical manner, wherein at least one circular shape overlaps with at least two other circular shapes.

In other embodiments herein, each circular shape has an axis at a point, and the axis can be 90° relative to a normal to a tangent line in the point on the simulated bone surface.

In other embodiments herein, creating the virtual model of the instrument may further include creating a simulated bone surface in the 3D view that mimics an undamaged bone surface in a healthy patient, and using the simulated bone surface as a basis when creating the virtual model.

In other embodiments herein, there is provided a device designed according to any of the design methods herein.

In other embodiments herein, methods are provided for placing an implant in a bone and/or cartilage area in a joint using an instrument designed according to any of the methods herein.

In other embodiments herein, a tool module system for replacing a portion of an articular surface of a joint is provided. The tool module system includes an instrument having at least first and second guide channels and an inserter guide stop, wherein the inserter guide stop is adapted to support an implement for use in one of the guide channels of the guide tool and is configured to fit within a portion of a volume within at least one guide channel.

Other embodiments herein relate to a design method for designing an individually customized instrument 600 having a hollow tubular housing 510 open at both ends, wherein the interior of the housing defines at least first and second intersecting cylinders, and wherein the design method of the instrument 600 comprises:

- A first lesion identification step 101 comprising identifying a bone and/or cartilage area 4 in a patient comprising a bone and/or cartilage lesion and rendering a 3D view 9 of the identified area using a software program.

- A second virtual model making step 14, comprising making a 3D model of a virtual instrument, comprising the step of virtually placing at least two circular shapes 303 in the 3D view 9, wherein each circular shape 303 partially overlaps at least one other circular shape 303', and wherein the combined area 20 of the circular shapes covers or partially covers the identified bone and/or cartilage lesion 5, and wherein positioning data is used to create the position and interior of a hollow tubular instrument shell 510 of the virtual instrument, which is open at both ends, and wherein the selection of at least a first and a second intersecting cylindrical instrument is based on the size of the selected circular shape 303 or slightly larger, and wherein a positioning surface 560 of the virtual instrument is created, which is the bone and/or cartilage engaging end of the hollow tubular shell 510, and wherein the positioning surface 560 is adapted to face and align with the surface structure of the hollow circular shape surrounding the instrument when the instrument is placed in the virtual model of the joint.

A third production step 34 consists in producing a device 600 from the virtually created device, adapted to follow the volumes and shapes of the virtual model of the created device.

Other embodiments herein include a design method for designing an individually customized instrument 600 wherein the interior of the housing defines first and second intersecting cylinders having equal diameters.

Other embodiments herein include a design method for designing an individually customized instrument 600 wherein the interior of the housing defines first, second, and third intersecting cylinders having equal diameters.

Other embodiments herein include design methods for designing an individually customized instrument 600 wherein a design step is added to design an arcuate wall adapted to be selectively inserted into the interior of the housing to complete the entire circumference as desired.

Other embodiments herein include design approaches where the removable insert is not arcuate, but rather cylindrical.

Other embodiments herein include a design method for designing an individually customized instrument 600, wherein the positioning surface 560 of the instrument 600 is provided with a plurality of holes 61, 161 for pins to firmly anchor the instrument to the surface to be repaired.

Other embodiments herein include a design method for designing an individually customized device 600, wherein the first selection step further comprises:

- placing at least two points 19, from each of which the axis 15 will originate, the points 19 being placed on the bone surface 50 in the 3D view 9 of the joint in the area of or near the bone and/or cartilage lesion 5, or on a simulated bone surface, which is a virtually created surface in or near the area of the bone and/or cartilage lesion 5,

-Select axis distance 53,

- selecting a diameter of the circular shape, the diameter 302 of the circular shape 303 is selected to be between 10-30 mm or for example between 15-25 mm,

- selecting the coverage of the implant region 20 on the cartilage and/or bone lesion 5, wherein the coverage may be between 50-100%, and wherein the second selection step comprises:

- selecting the angle 25 of the axis 15 originating from the point 19 of the simulated bone surface 51 and wherein the axes 15 and 15 ′ have an angle of 25-40° relative to the bone axis 60 which is orthogonal to the tangential plane 28 of the simulated bone surface in this point 19,

Other embodiments herein include a design method for designing an individually customized instrument 600, wherein each circular shape 303 includes an axis 15, and wherein the overlap 301 of the circular shapes 303 depends on a selection of the diameter 302 of the circular shapes 303, in combination with a selection of the proximity of the axis 15 of one circular shape 303 relative to another axis 15' of another circular shape 303, and in combination with a selection of a desired coverage of the cartilage and/or bone lesion 5 by the implant,

Other embodiments herein include a design method for designing an individually customized instrument 600, wherein each circular shape 303 includes an axis 15 and wherein the overlap 301 of the circular shapes 303 depends on the selection of a diameter 302 of the circular shapes 303 between 1-3 cm, in combination with the selection of an axial distance 53 of between 6 mm and 32 mm between one axis 15 of one circular shape 303 and another axis 15' of another circular shape 303, and in combination with the selection of a coverage of the implant body on the cartilage implantation and/or bone lesion 5 between 50-100%.

Other embodiments herein include a design method for designing an individually customized instrument 600, wherein identifying cartilage and/or bone areas 4 in a patient is accomplished by taking CT, CBCT, MRI images, etc. of the patient's joints and using these images to create 3D views of the bone and/or cartilage areas 4 and bone and/or cartilage lesions 5, for example using a software program for virtual 3D animation.

Other embodiments herein include design methods for designing an individually customized instrument 600 , wherein at least three circular shapes 303 are positioned to partially overlap, cover, or partially cover a cartilage and/or bone lesion 5 .

Other embodiments herein include design methods for designing an individually customized instrument 600, wherein the circular shape 303 has a size of between 0.5-4 cm in diameter.

Other embodiments herein include a design method for designing an individually customized instrument 600 wherein 2-5 circular shapes 303 are placed to partially overlap, covering a bone and/or cartilage lesion 5,

Other embodiments herein include a design method for designing an individually customized instrument 600, wherein creating a virtual model of the instrument further comprises creating a simulated bone surface 53 in the 3D view 9 that mimics an undamaged bone surface in a healthy patient, and using the simulated bone surface 51 as a basis when creating the virtual model.

Other embodiments herein include a design method for designing an individually customized instrument 600, wherein in the second step 14 of the method according to embodiments herein, the virtually placing of at least two circular shapes 303 includes virtually placing at least two points 19, from each of which an axis 15 will originate, the points 19 being placed on a bone surface 50 of a joint in the area of or near the bone and/or cartilage lesion 5, or on a simulated bone surface, the simulated bone surface being a virtually created surface in or near the area of the bone and/or cartilage lesion 5, and wherein the simulated bone surface 51 is a surface that preferably corresponds to a three-dimensional 3D image of a bone surface in a healthy joint, and wherein the point 19 is in the center of the circular shapes 303, and wherein the circular shapes 303 partially overlap each other, and wherein the axis 15 is placed such that a combined area expansion 20 of the circular shapes 303 covers or partially covers the identified bone and/or cartilage lesion 5,

Other embodiments herein include a design method for designing an individually customized instrument 600 , wherein the virtual placement of at least two circular shapes 303 is achieved by placing the virtual circular shapes 303 including the axis 15 in a predetermined angle relative to each other.

Other embodiments herein include a design method for designing an individually customized instrument 600 , wherein each circular shape has an axis that is 90° relative to a surface 451 of the circular shape 303 .

Other embodiments herein include a design method for designing an individually customized instrument 600, wherein the area of the placed circular shape 303 including the surrounding area for inserting the adjustment socket will include the resulting hollow space in the instrument 600,

Other embodiments herein include design methods for designing an individually customized instrument 600 , including virtually placing at least three circular shapes 303 in a row or other symmetrical arrangement, wherein at least one circular shape overlaps at least two other circular shapes 303 .

Other embodiments herein include a design method for designing an individually customized instrument 600 comprising virtually placing two circular shapes 303 , wherein the two circular shapes overlap one another.

Other embodiments herein include a design method for designing an individually customized instrument 600, wherein each circular shape 303 has an axis 15 at point 19, and wherein the normal of the axis 15 is 90° relative to a tangent in point 19 on the simulated bone surface 51,

Other embodiments herein include an apparatus 600 designed according to the design method described above.

Other embodiments herein include methods for placing an implant in a bone and/or cartilage area in a joint using the instruments described herein.

Other embodiments herein include a tool module system for placing a portion of an articular surface 6 of a joint, wherein the tool module system includes an instrument 600 having at least first and second guide channels and an insert guide stop, wherein the insert guide stop is adapted to support the instrument for use in one of the guide channels of the guide tool and is configured to fit within a portion of a volume within at least one guide channel.

The guide tool of the guide system according to embodiments herein comprises at least two guide holes or guide channels or openings to allow insertion of a tool (eg a cutter or a drill or a rotary cutter) therethrough.

Other embodiments herein include a tool module system for guiding surgery in a joint, comprising:

- an instrument (600) having a guide body in the form of a hollow tubular shell (510) configured to define at least first and second intersecting cylinders;

- A positioning surface (560) of the virtual instrument, which is the bone and/or cartilage engaging end of the hollow tubular shell (510), and the positioning surface (560) is adapted to follow the surface of the joint surrounding the identified injury area in the joint.

Other embodiments herein include tool module systems wherein the hollow tubular housing of the guide body of the instrument is configured to define the at least first and second intersecting cylinders with a bore for each respective cylinder.

Other embodiments herein include tool module systems wherein the hollow tubular housing of the guide body of the instrument is configured to define the at least first and second intersecting cylinders via an insert guide having at least one hole for at least one of the cylinders.

Other embodiments herein include a tool module system wherein the hollow tubular housing of the guide body of the instrument and the insert are configured such that the insert can be inserted into the hollow tubular housing at at least two different positions to define one of the at least two intersecting cylinders at each position.

Other embodiments herein include a tool module system wherein each of the first and second intersecting cylinders is provided with a circular cross-sectional profile.

Other embodiments herein include a tool module system wherein the circular cross-sectional profile of the first intersecting cylinders has a diameter that is different than a diameter of the circular cross-sectional profile of the second intersecting cylinders.

Other embodiments herein include a tool module system wherein the circular cross-sectional profile of the first intersecting cylinders has a diameter equal to a diameter of the circular cross-sectional profile of the second intersecting cylinders.

Other embodiments herein include a tool module system wherein the housing is configured to define first, second, and third intersecting cylinders.

Other embodiments herein include a tool module system wherein each of the first, second, and third intersecting cylinders has a circular cross-sectional profile, and wherein the diameter of each cylinder is equal.

Other embodiments herein include a tool module system further comprising an inserter guide configured and adapted to be selectively inserted into the interior of the housing such that the guide is configured to define the intersecting cylinders.

Other embodiments herein include a tool module system wherein:

The hollow tubular housing and the insert of the guide body of the virtual instrument are configured such that the insert can be inserted into the hollow tubular housing, and an inner cross-section of the housing and an outer cross-section of the insert have one of the following:

circular cross section;

oval cross section;

rectangular cross section;

triangular cross section;

and/or other symmetrical, partially symmetrical or asymmetrical cross-sections.

Other embodiments herein include a tool module system wherein the positioning surface (560) of the instrument (600) is provided with a plurality of holes (61, 161) for pins to firmly anchor the instrument to the surface to be repaired.

Other embodiments herein include a tool module system wherein:

- the diameter (302) of the cylinder is selected between 10-30 mm or for example between 15-25 mm; and/or

- the cross section of the intersecting cylinders of the implant region (20) covers the cartilage and/or bone lesion (5) by between 50% and 100%, and/or

- The axes (15) and (15') of the cylinders have an angle (25) of 0-40 degrees relative to the bone axis (60), which is orthogonal to the tangential plane (28) of the bone surface.

Other embodiments herein include tool module systems wherein the cross-sections of at least three circular shapes (303) are configured to partially overlap, cover, or partially cover the cartilage and/or bone lesion (5).

Other embodiments herein include a tool module system wherein the cross-section of the cylinder has a diameter between 0.5-4 cm.

Other embodiments herein include a tool module system wherein 2-5 cylindrical cross-sections are positioned to partially overlap, cover, or partially cover the bone and/or cartilage lesion (5).

Other embodiments herein include tool module systems configured to define at least three cylinders in a row or other symmetrical manner, wherein a cross-section of at least one cylinder overlaps a cross-section of at least two other cylinders.

BRIEF DESCRIPTION OF THE DRAWINGS

The embodiments herein will now be described in more detail with reference to the accompanying drawings. Please note that the exemplary embodiments of the embodiments disclosed in the accompanying drawings should not be interpreted as limiting the scope of the embodiments herein.

FIG. 1 is an exemplary embodiment according to an embodiment herein, without limiting the scope of the embodiments herein, disclosing a 3D view of a patient's knee joint including cartilage damage, the 3D view being created from MR data images or the like.

FIG. 2 is an exemplary embodiment according to embodiments herein, without limiting the scope of the embodiments herein, and shows different examples of placement of circular shapes relative to each other in a first step of the design method.

3 is an exemplary embodiment according to embodiments herein, without limiting the scope of the embodiments herein, and shows a virtual implant placed in a knee.

Figure 4a shows a pre-drilling guide socket. Figure 4b shows a drilling depth adjustment socket.

FIG. 5 is an exemplary embodiment according to embodiments herein, without limiting the scope of the embodiments herein, and illustrates an example where a circular shape has a varying diameter.

6 is an exemplary embodiment according to embodiments herein, without limiting the scope of the embodiments herein, and shows a view after placement of a circular shape and a design of a circular shape with non-parallel axes.

7 is an exemplary embodiment according to embodiments herein, without limiting the scope of the embodiments herein, and illustrates two circular shapes covering bone and/or cartilage lesions.

Figures 8a and 8b are exemplary embodiments according to an embodiment of the present invention, which do not limit the scope of the embodiment of the present invention, and show a virtual model of an implant placed at an implantation site and including a simulated cartilage surface 6 of the implant 1 that simulates the cartilage surface before cartilage damage. Figure 8a is a view from one side, and Figure 8b is a virtual implant from above.

9 is an exemplary embodiment according to an embodiment herein, without limiting the scope of the embodiments herein, and illustrates a bone and cartilage injury wherein a simulated repair surface 16 is created, which is a surface that preferably corresponds to a three-dimensional 3D image of a simulated healthy cartilage surface.

FIG. 10 is an example flow chart of a method according to embodiments herein.

11a is an exemplary embodiment according to embodiments herein, without limiting the scope of the embodiments herein, and shows two circular shaped axes placed in a joint with cartilage and bone damage.

FIG11 b is an exemplary embodiment according to an embodiment herein, without limiting the scope, showing the placement of axes relative to each other with a center distance and relative to a simulated bone surface, wherein the axes originate from a point on the simulated bone surface. Alternatively, a simulated cartilage surface may also be used for axis placement.

Figure 12 shows a double nail implant.

Figure 13 shows an instrument for a double nail implant according to one embodiment of the present invention. The instrument is installed in place.

FIG. 14 a shows an embodiment of a three-pin implant having the form of three identical intersecting circles.

FIG. 14 b shows an embodiment of an instrument with a wall insert for a three-pin implant, viewed from above.

FIG. 15 shows an example of a double drill for use with an instrument according to embodiments herein.

16A-16C illustrate examples of cross-sections of instruments having inserts according to embodiments herein.

FIG. 16D shows an example of a profile of a cross section defined by the instrument and insert of FIG. 16B .

DETAILED DESCRIPTION

introduce

The embodiments herein relate to a design method for designing an individually customized instrument 600. The instrument 600 designed by the method according to the embodiments herein is used for cartilage repair in a joint of a human or animal. The design method for designing an individually customized instrument according to the embodiments herein is described below.

The instrument includes a hollow tubular shell, and the interior of the shell defines at least first and second intersecting cylinders. The design method includes identifying an injury area, presenting a 3D view of the identified injury area, and generating a 3D model of a virtual instrument. The generation includes virtually placing a shape covering or partially covering the injury area in the 3D view, and creating a position of the hollow tubular instrument shell of the virtual instrument based on the position of the virtually placed shape. The method also includes selecting at least the first and second intersecting cylinders of the virtual instrument based on the size and form of the virtually placed shape, and creating a positioning surface for the virtual instrument, which is the bone and/or cartilage engaging end of the hollow tubular shell. When the virtual instrument is placed in the virtual model of the joint, the positioning surface is adapted to follow the surface surrounding the virtually placed shape. The method includes producing an instrument based on the virtually created instrument.

A method for designing an individually customized device 600 having a hollow tubular housing 510 open at both ends, wherein the interior of the housing defines at least first and second intersecting cylinders, and wherein the method comprises the steps of:

- a first lesion identification step 101 comprising identifying a bone and/or cartilage area in the patient comprising a bone and/or cartilage lesion 4 and rendering a 3D view 9 of the identified area using a software program

- A second virtual model making step 14, comprising making a 3D model of a virtual instrument, comprising the step of virtually placing at least two circular shapes 303 in the 3D view 9, wherein each circular shape 303 partially overlaps at least one other circular shape 303', and wherein the combined area 20 of the circular shapes covers or partially covers the identified bone and/or cartilage lesion 5, and wherein these positioning data are used to create the position and interior of a hollow tubular instrument shell 510 of the virtual instrument, which is open at both ends, and wherein the selection of at least a first and a second intersecting cylindrical instrument is based on the size of the selected circular shape 303 or slightly larger, and wherein a positioning surface 560 of the virtual instrument is created, which is the bone and/or cartilage engaging end of the hollow tubular shell 510, and wherein the positioning surface 560 is adapted to face and align with the surface structure of the hollow circular shape surrounding the instrument when the instrument is placed in the virtual model of the joint.

A third production step 34 consists in producing a device 600 according to the virtually created device, adapted to simulate the volume and shape according to the virtual model of the created device.

The figure shows a design method according to an embodiment of the present invention, comprising three general steps: a first damage identification step 101, a second virtual model making step 14, a third production step 34,

Design methods according to embodiments herein allow for the production of devices that are easily tailored to repair individual injuries in patients.

The design and construction of this method includes selecting a size and at least two circular shapes for each device as well as selecting overlap, thickness, articulating surface, etc., making the solution unique and easy to individualize, but still suitable for large-scale industrial manufacturing.

The rounded shape of the implant makes it easy to place instruments by drilling and/or reaming, giving each implant a precise fit in each patient.

Damage Identification

A first lesion identification step 101 comprises identifying a bone and/or cartilage region 4 in a joint of a patient comprising a bone and/or cartilage lesion 5, and presenting a 3D view 9 of the identified region using a software program. The first lesion identification step 101 in the design method according to an embodiment of the present invention is used to identify a bone and/or cartilage region 4 in a joint of a specific patient in need of bone and/or cartilage repair. This is done by a 2D image such as an MR image. The 3D view 9 of the joint comprising the bone and/or cartilage region 4 and/or comprising the bone and/or cartilage lesion 5 is created by taking 2D images of the joint and converting them into a 3D view 9. The bone and/or cartilage lesion 5 can, for example, be identified in a 2D image and then converted into a 3D view 9,

Useful imaging techniques are, for example, computed tomography (CT), cone-beam computed tomography (CT), magnetic resonance imaging (MRI) or other suitable techniques, such as delayed gadolinium-enhanced MRI of cartilage (dGEMRIC). The captured 2D images of the joint are used to create a 3D model or view 9 of the patient's bone and/or cartilage, and 3D animation is useful using, for example, a software program, such as a CAD animation program, such as a radiography software program, or the like.

Create a joint representation - a CAD animated model that is based on a 3D view 9 of the joint including bone and/or cartilage areas 4. The model also includes bone and/or cartilage lesions 5,

The lesion representation animated CAD model showing bone and/or cartilage lesions 5 may be manually created from the 2D images by manually labeling the lesion area pixels in each 2D image, from which the 3D view 9 is created or the lesion representation animated CAD model may be a combination of labeled 2D images.

In an automated process, a computer program (e.g. a radiography software program) can be adapted to scan the image for predetermined features of an area in the image data and/or the development, curvature and/or location of the bone and/or cartilage lesion 2 and combine the automatically labeled 2D images into a 3D view 9, also referred to as a lesion representation CAD animated model. The size of the area of interest for mapping or creating the 3D view 9 does not typically depend on the size of the cartilage lesion and the type of joint or bone part to be repaired, and typically the surgeon does not know where the lesion is located in the joint before taking an image of the patient's joint, so typically an image of the entire bone and/or cartilage area 4 of the joint is used to create a virtual 3D view 9, which is a joint representation CAD animated model that can be selected to show the bone and/or cartilage area 4, the bone and/or cartilage lesion 5, the placement of virtual instruments or virtual implants, etc.

In one embodiment according to the embodiments of the present invention, the first injury identification step 101 of the design method according to the embodiments of the present invention includes identifying the patient's bone and/or cartilage areas 4 by taking images of the damage or injury in the patient's joint, and then using these images of the individual patient's bone and/or cartilage areas 4 to create a joint representation CAD animation model.

1 , which does not limit the scope of the embodiments herein, a view of a 3D view 9 of a patient's knee joint and a cartilage and/or bone region 4 including a bone and/or cartilage lesion 5, as created from an MR image or the like. FIG1 shows a 3D view 9 of a patient's knee joint including a bone and/or cartilage lesion 5, with a boundary 18 surrounding the bone and/or cartilage lesion marked.

A joint in a human or animal that can be repaired by using a device designed using a design method according to embodiments herein can be selected from any one of, for example, a knee, hip, shoulder, toe, or finger joint.

Figure 9 shows a 3D view 9 in which the bone and/or cartilage damage is marked as 5, and in which the simulated cartilage repair surface 16 is marked, and in which the simulated bone surface 51 is marked, and in which the view also includes the surrounding cartilage surface 36 and the surrounding bone 35.

Virtual model making

The second step 14 in the method according to an embodiment herein comprises a first step of selecting a surface comprising at least two circular shapes 301 that determines how much of the identified bone and/or cartilage lesion 5 is covered or partially covered by the combined area 20 of the circular shapes 301. Such positioning data of the circular shapes 301 is used to generate the position and interior of a hollow tubular instrument shell 510 of a virtual instrument that is open at both ends, and wherein the selection of at least a first and a second intersecting cylindrical instrument is based on the size of the selected circular shapes 303 or slightly larger, and wherein a positioning surface 560 of the virtual instrument is created that is the bone and/or cartilage engaging end of the hollow tubular shell 510, and wherein the positioning surface 560 is adapted to face and align with the surface structure of the hollow circular shape surrounding the instrument when the instrument is placed in the virtual model of the joint.

In one embodiment, the second step 14 of the method according to embodiments herein includes virtually placing at least two points 19, with an axis 15 originating from each point. Points 19 are placed on a bone surface 50 of a joint in or near the region of the bone and/or cartilage lesion 5, or on a simulated bone surface 51, which is a virtually created surface that covers the region of the bone and/or cartilage lesion 5. The simulated bone surface 51 is preferably a surface corresponding to a three-dimensional 3D image of a bone surface in a healthy joint. Points 19 are enclosed by a selected circular shape 303. Points 19 are centered about the partially overlapping circular shapes 301 and 303, and the points 19, along with the axis 15, are placed such that a combined area extension 20 of the circular shapes 303 covers or partially covers the identified bone and/or cartilage lesion 5. The axes 15 are spaced a selected axial distance 53 from each other. In one embodiment of the embodiments herein, the second step 14 of the method according to the embodiments herein includes a first selection of the diameter 302 of the circular shape 303, a selection of how much of the circular shape 303 should cover the bone and/or cartilage lesion 5, and a selection of the placement of the axis 15 by selecting the intersection point 19 of the axis 15 on the simulated bone surface 51 or directly on the bone surface 50 in the 3D view of the joint. In another embodiment, the diameter 302 of the circular shape is selected simultaneously with the placement of the point 19.

Different types of selections may be included in the second virtual model making step 14 and are selected in the following order in one embodiment of the design method according to the embodiments herein. In other embodiments, the first, second and third selections may be made in any order or may be made simultaneously;

First choice;

The first selection made in the second virtual model making step 14 according to an embodiment of the present invention can be made in any order or can be made simultaneously: and includes - placing at least two points 19 (the axis 15 will start from each of its points), the points 19 are placed on the bone surface 50 of the joint in or near the area of the bone and/or cartilage damage 5, or the points 19 are placed on the simulated bone surface 51, which is a virtually created surface and covers the area of the bone and/or cartilage damage 5.

- selecting a diameter of the circular shape, the diameter 302 of the circular shape 303 is selected to be between 10-30 mm or for example between 15-25 mm;

- wherein the axial distance 53 between the points 19 is, for example, between 6 and 32 mm or 7 and 20 mm or 7 and 12 mm;

- Selecting the coverage of the implant area 7 on the cartilage and/or bone lesion 5. The coverage is preferably 100%, but can be between 50-100%.

Second choice;

- Selecting the angle 25 of the axis 15. The angle 25 is relative to the simulated bone surface 51 or 50 and relative to the other axis.

FIG11 a shows an exemplary embodiment according to embodiments herein, which does not limit the scope of the embodiments herein, showing the placement of two circularly shaped axes in a joint with cartilage and bone damage, the placement of axes 15 and 15 ′ is shown with an axis distance 53 relative to each other and relative to a simulated bone surface 51, see FIG11 b, wherein axes 15 and 15 ′ originate from point 19 of the simulated bone surface 51, and wherein axes 15 and 15 ′ have angles 25, 25 ′ relative to a bone axis 60, which is orthogonal to tangential planes 28, 28 ′ of the simulated bone surface in point 19, FIG11 a and FIG11 b also include cartilage 36, bone 35, bone surface 50,

Third choice;

In the third selection step of the second step 14, the height 710 of the hollow tubular instrument housing 510 of the virtual instrument is determined. The height of the hollow tubular instrument housing 510 is selected based on the location of the surrounding tissue and cartilage damage, so as to facilitate placement of the instrument 600 during surgery and minimize surgical intervention. The height can be determined based on the location of the implant placement. The height can vary depending on whether the implant is placed on a condyle or trochlea of the knee, for example, ranging from at least 20-30 mm in the first case and at least 25-45 mm in the second case. However, a total variation in height 710 of 10-90 mm is foreseeable.

In the third selection step of the second step 14, an extension of the individually customized positioning surface 560 is also selected. A positioning surface 560 of the virtual instrument is created, which is the bone and/or cartilage engaging end of the hollow tubular shell 510, and wherein the positioning surface 560 is adapted to face and align with the hollow circular surface structure surrounding the instrument when the instrument is placed in the virtual model of the joint. The extension of the positioning surface 560 is selected based on the location of the surrounding tissue and cartilage damage to facilitate placement of the instrument 600 during surgery and to minimize surgical intervention. In one embodiment, the extension is selected to cover an area with curvature in the joint to guide the surgeon so that the instrument 600 can only be placed in the joint in one way, thereby minimizing incorrect placement. The positioning surface 560 protrudes around the hollow tubular shell 510 so that the positioning surface provides support for the instrument during use.

The hollow tubular instrument housing 510 of the virtually generated instrument preferably has a height 710 of between 10-90 mm, in particular between 20-30 mm for the condyles and between 25-45 mm for the pulley of the knee.

In one embodiment, the height of the hollow tubular instrument housing 510 is determined by using the surface of the circular shape 303 placed on the simulated bone surface 51 to create an elongated cylinder that presents a virtual view of the sidewalls of the circular shape.

Different types of first and/or second and/or third options in the second virtual model making step 14 can be combined according to the method

In one embodiment according to embodiments herein, the center-to-center distance 53 is between 6-32 mm or such as 7-20 mm or such as 7-12 mm.

In one embodiment according to the embodiments herein, the axis distance 53 is greater than 8 mm. In one embodiment according to the embodiments herein, the axis distance 53 is 8 mm. The operator manually or automatically completes the placement of the points 19 and/or axes 15 and/or the selection of the diameter 302 of the circular shape 303 using a software program. In one embodiment, at least two axes 15 are parallel to each other. However, even if the two axes are parallel, due to the curvature of the cartilage, the angle between the surface of the cartilage and the axis in this embodiment is not 90 degrees. In other embodiments, the axes 15 have different angles relative to each other and to the simulated bone surface 51.

See, for example, FIG6 , an example according to embodiments herein, wherein two circular shapes 303 are placed on a bone surface with overlap 301 and non-parallel axes 15 and 15 ′, and surfaces 301 of the circular shapes 303 and 303 ′ are also shown.

In one embodiment, the design method for designing an individually customized instrument 600 according to any of the preceding claims comprises virtually placing at least two circular shapes 303, performed by placing the two circular shapes 303 such that the diameters of the circular shapes 303 have an overlap 301 of 20-90% or 40-70% relative to the diameter of each circle.

The second virtual modeling step 14 in the method according to one embodiment of the embodiments herein comprises virtually placing at least two circular shapes 303 that partially overlap, cover or partially cover the identified bone and/or cartilage lesion 5 .

7 shows an example according to embodiments herein of the second virtual modeling step 14 and comprises two virtually placed circular shapes 303 unfolded over the implantation area 20 covering the identified cartilage and/or bone lesion 5 in the 3D view 9 .

In one embodiment, the second virtual model making step 14 in the design method according to the embodiments of this document includes:

- virtually placing at least two circular shapes 303 that partially overlap, cover or partially cover the identified cartilage and/or bone lesions 5, and

Virtually creating two orientations of at least two circular shapes 303 relative to the identified cartilage and/or bone area 4 .

In one embodiment, different orientations of the axes are described for the angles of axes 15 and 15'. Axis 15 has an angle 25 of 0-40 degrees relative to bone axis 60, which is orthogonal to a tangential plane 28 of the simulated bone surface 51 or to the bone surface 51 at point 19, and axis 15' has an angle 25' of 0-40 degrees relative to bone axis 60', which is orthogonal to a tangential plane 28 of the simulated bone surface 51 at point 19' in the 3D view 9 of the virtual repaired articular cartilage surface.

In one embodiment, the different axes 15 and 15' of the circular shape 303 have directions parallel to each other. In one embodiment, the different axes 15 of the circular shape 303 have different directions relative to each other.

In one embodiment, the second step 14 in the method according to embodiments herein comprises virtually placing at least two circular shapes 303 , which partially overlap, covering the identified bone and/or cartilage lesions 5 ,

In one embodiment, the second step 14 in the method according to embodiments herein comprises virtually placing at least two circular shapes 303 , which partially overlap, covering the identified bone and/or cartilage lesion 5 , and wherein all circular shapes 303 have the same or approximately the same diameter.

In one embodiment, the second virtual modeling step 14 of the method according to embodiments herein includes virtually placing at least two circular shapes 303 that partially overlap, covering the identified bone and/or cartilage lesion 5, and wherein the different circular shapes 303 have diameters of varying sizes, e.g., one having a smaller diameter than the other. See, for example, FIG. 5 , wherein one circular shape 303 has a diameter 302 and another circular shape 303′ has a smaller diameter 302′, and wherein the two circular shapes have an overlap 301.

In one embodiment, the second virtual modeling step 14 in the method according to the embodiments of the present invention includes virtually placing at least two circular shapes 303, which partially overlap, covering a partial or complete bone and/or cartilage lesion 5 identified in the image and presented in the 3D model of the bone and/or cartilage area 4 in the joint identified in the first step 101 of the design method according to the embodiments of the present invention.

The combined area 20 of the overlapping circular shapes 303 and the surrounding area providing space for the drill socket together define the area 20 of the implant body 30 to be produced. In other words, the area or cross section of the interior of the hollow tubular shell 510 represents the sum of the developed parts of the shapes of the circular shapes 303.

The placement of the circular shapes 303 relative to each other may be in a row or in symmetrical groups or, for example, in an asymmetrical sequence. For different examples of placement patterns of the circular shapes 303, see FIG.

The placement pattern is selected based on, for example, the placement of the bone and/or cartilage lesions 5, and/or the size of the bone and/or cartilage lesions 5, and/or the spread of the bone and/or cartilage lesions 5, and/or the depth of the bone and/or cartilage lesions 5. The overlapping 301 of the circular shapes 303 is performed in one embodiment of the embodiments herein such that the diameters of the circular shapes 303 have an overlap 301 of 20-90%, or such as 30-80%, or such as 40-70%, relative to the diameter 302 of each overlapping circle.

The overlapping 301 of the circular shapes 303 is performed in one embodiment of the embodiments herein such that the diameter of the circular shapes 303 has an overlap 301 of at least 40% relative to the diameter of each overlapping circle.

The diameter of the circular shape 303 according to embodiments herein is between 5-30 mm or between 10-25 mm or such as between 15-25 mm.

FIG3 shows an exemplary embodiment of an embodiment of the present invention, FIG3 shows a virtual implant 42 placed in a knee, wherein the virtual implant 42 comprises two circular shapes 303 such that they have an overlap and the axes 15, 15' of the circular shapes 303, 303' of the implant are parallel in this example. The implant is placed with the help of an instrument designed by a design method according to an embodiment of the present invention,

Fig. 8a and 8b illustrate exemplary embodiments according to the present invention, without limiting the scope of the present invention, showing a virtual model of an implant 42, which is placed at the implantation site and includes a simulated cartilage surface 41 of a virtual model of the implant 42 that simulates the cartilage surface before cartilage damage. In addition, the virtual implant model 42 in the example of Fig. 8a includes a virtual implant body 30 and two extension posts 23, see Fig. 8a.

FIG. 8 a is a view of the virtual model of the implant 42 from one side, FIG. 8 b is a view of the virtual model of the implant 42 from above and shows a region 20 of the implant to be produced.

The apparatus according to embodiments herein may further include a wall insert 610. The guide tool of the guide system according to embodiments herein includes at least two guide holes or guide channels or openings to allow an insertion tool (e.g., a cutter or drill or rotary cutter) to pass therethrough. In one embodiment, the design of the wall insert 610 is part of a design method according to embodiments herein. The wall insert 610 is used to support the insertion tool so that during use of the apparatus, the channel inside the hollow tubular housing 510 of the apparatus 600 supports the insertion tool.

In one embodiment, the insertion tool is supported by a portion of the wall of the guide channel within the hollow tubular housing 510 and a portion of the sidewall of the wall insert 610. The wall insert 610 is a module that fits within the guide channel by mimicking the pattern of the interior area of the instrument's guide channel. The combination of the portion of the interior guide channel wall and the portion of the sidewall of the wall insert 610 forms a circular or cylindrical guide hole, referred to herein as an active guide hole or guide channel. The active guide channel is a guide channel that can be used to insert the insertion tool.

The active guide channel is changed by moving the wall insert 610 around the inner area of the guide channel. By moving the wall insert 610 around to guide or support another guide channel in the guide tool, a new active guide channel is formed. It is also possible to use multiple inserts of different sizes in parallel instead of adjusting the inserts during operation.

In another embodiment, the movable insert is not arcuate but cylindrical.

In another embodiment, no insert is used at all. Other similar embodiments are of course possible.

When the wall insert 610 is placed in the instrument channel, the wall insert 610 effectively blocks the guide channel that is not in use and, together with the inner wall of the active guide channel, forms a cylindrical wall surrounding the active guide channel of the instrument 600 .

Embodiments herein can include the design method for instrument and wall insert 610, which together makes the surgeon drill or cutter used in the guide inside form the excision site corresponding to the implant structure.The guide channel in the guide is suitable for making the excision site formed partially overlap each other.By using the guiding tool according to the embodiment of this paper, the surgeon can obtain accurate mode to carry out the excision that implant is placed on the joint.According to the system of the embodiment of this paper (wherein, implant shape can be selected from the circular shape 303 of different sizes, partially overlap each other and combine to create) allow the surgeon to select the implant of the size and shape that is suitable for cartilage damage or defect, and make the surgeon easy to use tool group to carry out required cutting.

Production steps

The design method according to embodiments herein involves a third production step 34 of producing the device 600 .

The third production step 34 according to the embodiment herein comprises producing an instrument 600 having the same shape and volume as the virtual instrument planned and created in the first lesion identification step 101 and the second virtual model making step 14,

Polyamide devices produced using selective laser sintering (SLS) are particularly useful. Other production techniques and other materials are also possible. Other similar polymers can be used, such as polypropylene, polyethylene, polystyrene, polymethyl methacrylate (PMMA), acrylonitrile butadiene styrene (ABS), and similar compounds. Devices can also include any metal or metal alloy used for structural applications in the human or animal body, such as stainless steel, cobalt-based alloys, chromium-based alloys, titanium-based alloys, pure titanium, zirconium-based alloys, tantalum, niobium, and precious metals and their alloys. If a ceramic is used, it can be a biocompatible ceramic, such as aluminum oxide, silicon nitride, or yttria-stabilized zirconium oxide. Devices can also contain components made of other materials.

Method of using the device 600 according to the embodiments herein

Figure 13 shows an example of an embodiment of an instrument according to an embodiment of this paper, which is used for all hole preparations. Instrument comprises an elongated hollow shell 510 with the form of two intersecting overlapping cylinders 52 of equal diameter, and hollow tubular instrument housing 510 has a height 710 between 10-90mm. Instrument 600 can be formed as the shape that meets the bone and cartilage area of patient to be repaired, or can be a standard instrument. In this case, instrument is firmly maintained in the appropriate position on the condyle surface by individually customizing positioning surface 560 and the not shown pin that is screwed into through hole 61, so that instrument is firmly maintained in place in whole drilling process.

After the pin has been screwed in, the cutting and drilling process can begin with the wall insert 610 being inserted into one end of the hollow shell, leaving the entire first cylinder 52 at one end of the hollow tubular shell. At this point, the surgeon can insert the depth adjustment socket 505 ( FIG. 4 b ) into the first cylinder, and then a sharp cylindrical hand blade precisely positioned inside the adjustment socket 505 forms a preliminary circular sharp-edged incision through the cartilage down to the bone. A circular bare bone area is left after this cartilage removal.

In one embodiment, the surgeon uses a 17/4 mm double drill as schematically shown in Figure 15. It has a central narrow 4 mm diameter drill bit 401 and a wider 17 mm diameter cutting drill bit 402. The outer surface 403 of the double drill conforms to the cylinder, which firmly holds the double drill in the same operation to drill the central 4 mm hole for the first nail 23 and the much shallower surrounding holes of 17 mm in diameter. According to one embodiment, a guide socket 501 (Figure 4a) can be used to make the pre-drilled initial part of the nail hole in the bone, which improves the precise location of the nail hole and the circular bare bone area drilled simultaneously with the double drill (Figure 15). After removing the drill and flushing out the organic matter, the surgeon then slides the wall insert 610 out and inserts it into the other side of the hollow shell, thereby producing a complete cylindrical guide hole on the opposite side of the hollow shell.

The surgeon then inserts the adjustment socket and uses the same cylindrical knife in the newly created guide hole to make a circular excision of the cartilage that is not a complete circle because the intersecting portion was removed in the previous step.

In this embodiment, the 17/4mm double drill is then used again first with the guide socket 501 to pre-drill the nail hole and then with the adjustment socket 505 to double drill the nail hole to its full depth and create a bare bone circle, i.e. a 4mm hole for the second nail and a second surrounding shallow hole of course also 17mm diameter.

The two drilling operations have produced a 4mm nail hole and space in the bone to accurately accommodate the 17+17 implants of the embodiments of this paper in this case, and then the wall insert 610 is completely removed. Use a gauge equipped with the processing corresponding to the intersecting circles that form the implant to ensure that the hole has been drilled to the appropriate depth in the bone. Then remove the instrument and insert the implant nail or extension column 23 into its hole. In this case, for the cap of the implant to be accurately placed in the 17+17 shallow cavity removed from the bone surface, it is usually necessary to carefully tap the cap with a hammer through a special mandrel on the top of the first nail to achieve an interference fit. The first slightly thick nail is knocked into its hole, and the second slightly narrow nail easily slides into its hole. In this example, the larger diameter portion of the 17/4mm drill has an edge to dig a peripheral groove slightly deeper than the 17mm shallow cavity to accommodate the peripheral ridge 47 of the implant, which helps to firmly hold the implant in place during healing and subsequent use loads.

Thus, the instrument, which in this example can be shaped to match the cartilage surface of the individual patient, can be placed over the damaged area of the condyle and, in this particular non-limiting example, securely anchored in place by screwing four pins (not shown) into holes 61 in the condyle-shaped lower end of the instrument 600, which is now securely in place for the entire drilling operation, which is greatly simplified and more precise and less dependent on the surgeon's skill, which can vary from day to day.

After the hole is drilled, the pin is pulled out and the instrument is removed from the site for placement of the implant and reconstruction of the joint with the new implant.

A person skilled in the art will appreciate that the claimed instrument can be supplemented with an insert sleeve to produce one of the cylinders with a small diameter, for example 17 mm in diameter, to accommodate an implant in the form of two intersecting circles of slightly different diameters (for example +17 mm). Of course, an instrument with a specific predetermined fixed diameter can also be prepared.

It is of course also possible within the scope of the embodiments herein to create implants in the form of three or more intersecting circles to cover more irregular shapes.

One such three-circle implant is shown from below in FIG. 14 a , showing three pegs 148 , 149 and 150 , in which example peg 148 has an interference fit diameter relative to a common nominal diameter of all three pegs, while the other two pegs 149 and 150 have clearance fit diameters relative to the common nominal diameter.

The instrument for this three-circular implant is shown from above in Figure 14b. The instrument is held in place on the bone by a pin (not shown) inserted through hole 161. A wall insert 610 completes the first cylinder 152, covering the remainder of the other two cylinders. When the first circular hole has been drilled, the wall insert 610 is pulled out, rotated 120 degrees, and reinserted to provide a drill guide for the next circular hole using the same double drill, which in one embodiment can be the same 17/4 drill used with the double-circle instrument. After another rotation of 120 degrees and drilling, the three nailed implants are inserted. As described above, the insert has one nail with an interference fit relative to its nominal diameter (in this case, 4 mm), while the other two nails have a clearance fit.

Figure 15 shows an exemplary 4/17 double drill used with the above-mentioned multi-circle instrument or a previously known single-circle instrument. The double drill has a 4mm center drill bit 401 for producing the hole of the nail and a wider cutting surface 402 for producing a 17mm shallow hole. One of the advantages of the embodiments herein is that the same double drill can be used for single, double or three or more intersecting circular implants, used twice or three times, as in the case of the two embodiments shown here. According to the example in Figure 15, the hole is shallower than the nail. According to other examples, it can also be deeper than the nail.

Figures 16A-16C illustrate examples of cross-sections of instruments with inserts according to embodiments described herein. Figures 16A-16C illustrate examples of cross-sections of an embodiment of a hollow tubular housing 510 of an instrument with an insert 610 configured to define a cylinder having a cross-section 152. In the first position shown, insert 610 defines a first cylinder. When insert 610 is removed, rotated 180 degrees, and reinserted into housing 510, it defines a second cylinder. In the embodiment shown in Figures 16A and 16B, the interior cross-section of the housing and the cross-section of the insert are elliptical. In Figure 16A, the cross-section of the cylinder is defined by the hole in insert 610. In Figure 16B, the section of the cross-section of the cylinder defining the hole is part of the housing 510, while another section is part of the insert 610. In Figure 16C, the interior cross-section of the housing 510 and the cross-section of the insert are rectangular. In other embodiments, other cross-sections are preferably provided or are conceivable, such as symmetrical, partially symmetrical or asymmetrical cross-sections.

FIG. 16D shows an example of a profile of a cross section defined by the instrument and insert of FIG. 16B .

Fig. 12 shows an exemplary embodiment of an implant 1 according to embodiments herein having two circular shapes with two extended posts 23, 23' or spikes and a protruding edge 47 around the implant body 30. This example relates to an example in which the two circles have the same diameter.

The foregoing disclosure is not intended to limit the invention to the precise forms disclosed or to the specific applications. It is contemplated that various alternative embodiments and/or modifications to the embodiments herein, whether explicitly described or implied herein, are possible in light of this disclosure. Accordingly, the scope of protection is limited solely by the claims.

Claims (19)

1. A method for designing an instrument (600) for guiding surgery in a joint, wherein the apparatus (600) comprises a guide body in the form of a hollow tubular housing (510) configured to define at least first and second guide channels in the form of intersecting cylinders, and a movable wall insert (610) configured to fit within the hollow tubular housing (510) such that a hole in the wall insert (610) defines an active guide channel in the form of a first cylinder, wherein a further active guide channel in the form of a second cylinder can be formed by moving the movable wall insert (610) to another position within the hollow tubular housing (510), The design method includes: - identifying (101) the damaged area (4) in the joint; - presenting a 3D view (9) of said identified damaged area (4) in a virtual model of the joint; - generating a 3D model of a virtual instrument, wherein said generating comprises virtually placing a shape (303) in said 3D view (9) which at least partially covers said injury area (4) in said virtual model of the joint; - creating a position of said hollow tubular shell (510) of a virtual instrument based on the position of the virtually placed shape (303); - selecting at least first and second intersecting cylinders of the virtual instrument based on the size and form of the virtually placed shape (303); - designing the movable wall insert (610) to mimic the pattern of a portion of the guide channel in the area of the instrument (600); - creating a positioning surface (560) of the virtual instrument as a bone and/or cartilage engaging end of the hollow tubular shell (510), and the positioning surface (560) is adapted to follow the shape of the joint around the virtual placement when the virtual instrument is placed in the virtual model of the joint; - Producing an instrument based on the virtual instrument (600). 2. The design method of claim 1 , wherein the hollow tubular housing of the guide body of the virtual instrument is configured to define the at least first and second intersecting cylinders by a hole for each corresponding cylinder, or, wherein the hollow tubular housing of the guide body of the virtual instrument is configured to define the at least first and second intersecting cylinders by an inserter guide having at least one hole for at least one cylinder, and wherein the hollow tubular housing of the guide body of the virtual instrument and the wall insert are configured such that the wall insert can be inserted into the hollow tubular housing in at least two different positions to define one of the at least first and second intersecting cylinders in each position, or, wherein each of said first and second intersecting cylinders is provided with a circular cross-sectional profile, wherein the circular cross-sectional profile of the first intersecting cylinders has a diameter that is different from the diameter of the circular cross-sectional profile of the second intersecting cylinders, Alternatively, wherein the circular cross-sectional profile of the first intersecting cylinders has a diameter equal to a diameter of the circular cross-sectional profile of the second intersecting cylinders. 3. The design method of claim 1 , wherein the hollow tubular shell is configured to define first, second, and third intersecting cylinders, wherein each of the first, second and third intersecting cylinders has a circular cross-sectional profile, and wherein the diameter of each cylinder is equal. 4. The design method of claim 1, further comprising designing an inserter guide adapted to be selectively inserted into the interior of the hollow tubular housing, such that the guide is configured to define the intersecting cylinders. 5. The design method according to any one of the preceding claims 1 to 4, wherein: The hollow tubular housing and the wall insert of the guide body of the virtual instrument are configured such that the wall insert can be inserted into the hollow tubular housing, and an inner cross-section of the hollow tubular housing and an outer cross-section of the wall insert have one of the following: circular cross section; oval cross section; rectangular cross section; triangular cross section; and/or other symmetrical, partially symmetrical or asymmetrical cross-sections. 6. Design method according to any of the preceding claims 1-4, wherein the positioning surface (560) of the instrument (600) is provided with a plurality of holes (61, 161) for pins for firmly anchoring the instrument to the surface to be repaired. 7. The design method according to any one of the preceding claims 1 to 4, wherein the virtually placed shapes include at least two circular shapes, the method further comprising: - placing at least two points (19), from each of which the axis (15) will originate, said points (19) being placed on the bone surface (50) in the 3D view (9) of the joint in or near the area of the bone and/or cartilage lesion (5), or said points (19) being placed on a simulated bone surface, said simulated bone surface being a virtually created surface in or near the area of the bone and/or cartilage lesion (5); - Select the axis distance (53); - selecting diameters of the at least two circular shapes, wherein the diameter (302) of the circular shape (303) is selected to be between 10 and 30 mm; - selecting a coverage of the implant area (20) on the cartilage and/or bone lesion (5), wherein said coverage is between 50-100%, and; - Selecting an angle (25) of the axis (15) originating from a point (19) of the simulated bone surface (51), and wherein the axis (15) has an angle (25) of 0-40 degrees relative to a bone axis (60), the bone axis (60) being orthogonal to a tangential plane (28) of the simulated bone surface in the point (19). 8. Design method according to claim 7, wherein each of the at least two circular shapes (303) comprises an axis (15), and wherein the overlap (301) of the circular shapes (303) depends on the choice of the diameter (302) of the circular shapes (303), in combination with the choice of the proximity of the axis (15) of one circular shape (303) relative to the other axis (15') of the other circular shape (303), in combination with the choice of the desired coverage of the cartilage and/or bone lesion (5) by the implant; Alternatively, wherein each of the at least two circular shapes (303) comprises an axis (15), and wherein the overlap (301) of the circular shapes (303) depends on the selection of a diameter (302) of the circular shapes (303) between 1 and 3 cm, the selection of an axial distance (53) between 6 mm and 32 mm between one axis (15) of one circular shape (303) and another axis (15') of the other circular shape (303), and the selection of a coverage of the implant body on the cartilage and/or bone lesion (5) between 50 and 100%. 9. The design method according to any of the preceding claims 1 to 4, wherein at least three circular shapes (303) are placed to partially overlap, covering the cartilage and/or bone lesion (5), and/or wherein said shape (303) is a circle having a diameter between 0.5-4 cm, And/or wherein 2-5 circular shapes (303) are placed to partially overlap, covering the bone and/or cartilage lesion (5). 10. A design method according to claim 7, wherein the virtually placing of at least two circular shapes (303) comprises virtually placing at least two points (19), each of which the axis (15) will originate from, the points (19) being placed on the bone surface (50) of the joint in the area of or near the bone and/or cartilage lesions (5), or the points (19) being placed on a simulated bone surface, the simulated bone surface being a virtually created surface in the area of or near the bone and/or cartilage lesions (5), and wherein the simulated bone surface (51) is a surface corresponding to a three-dimensional (3D) image of a bone surface in a healthy joint, and wherein the points (19) are at the centers of the circular shapes (303), and wherein the circular shapes (303) partially overlap each other, and wherein the axis (15) is placed so that the combined area expansion of the circular shapes (303) covers the identified bone and/or cartilage lesions (5). 11. The design method according to any of the preceding claims 1-4, wherein the virtual placement of the at least two circular shapes (303) is achieved by placing the virtual circular shapes (303) comprising the axis (15) in a predetermined angle relative to each other. 12. The design method according to any of the preceding claims 1-4, wherein each circular shape has an axis that is 90° relative to the surface (451) of the circular shape (303). 13. The design method according to any one of the preceding claims 1-4, wherein the area of the placed circular shape (303) includes a surrounding area for inserting the adjustment socket, which should include a hollow space created in the instrument (600). 14. The design method according to any one of the preceding claims 1-4, comprising virtually placing at least three circular shapes (303) in a row or other symmetrical manner, wherein at least one circular shape overlaps with at least two other circular shapes (303). 15. A design method according to any one of the preceding claims 1-4, wherein each circular shape (303) has an axis (15) at a point (19), and wherein the axis (15) is 90° relative to the normal of the tangent in the point (19) on the simulated bone surface (51). 16. A design method according to any one of the preceding claims 1-4, wherein creating a virtual model of the instrument further comprises creating a simulated bone surface (51) in the 3D view (9) that mimics an undamaged bone surface in a healthy patient, and using the simulated bone surface (51) as a basis when creating the virtual model of the instrument. 17. A device (600) designed according to the design method (2) of any one of the preceding claims 1-16. 18. A tool module system for guiding surgery in a joint, comprising: - an instrument (600) having a guide body in the form of a hollow tubular housing (510), the guide body being configured to define a guide channel in the form of at least first and second intersecting cylinders; - a positioning surface (560) of the instrument, which is the bone and/or cartilage engaging end of the hollow tubular shell (510), characterized in that the positioning surface (560) is adapted to follow the surface of the joint surrounding the identified lesion area in the joint; and The device also includes a removable wall insert (610) configured to be mounted within the hollow tubular housing (510) such that the hole in the wall insert (610) defines an active guide channel in the form of a first cylinder, wherein another active guide channel in the form of a second cylinder can be formed by moving the removable wall insert (610) to another position within the hollow tubular housing (510). 19. The tool module system of claim 18, wherein the hollow tubular housing of the guide body of the instrument is configured to define the at least first and second intersecting cylinders with a hole for each corresponding cylinder, or wherein the hollow tubular housing of the guide body of the instrument is configured to define the at least first and second intersecting cylinders by an insert guide having at least one hole for at least one cylinder, or wherein the hollow tubular housing of the guide body of the instrument and the wall insert are configured such that the wall insert can be inserted into the hollow tubular housing in at least two different positions to define one of the at least first and second intersecting cylinders in each position, or, wherein each of said first and second intersecting cylinders is provided with a circular cross-sectional profile, wherein the circular cross-sectional profile of the first intersecting cylinders has a diameter that is different from the diameter of the circular cross-sectional profile of the second intersecting cylinders, or, wherein the circular cross-sectional profile of the first intersecting cylinders has a diameter equal to the diameter of the circular cross-sectional profile of the second intersecting cylinders, and/or wherein the hollow tubular housing is configured to define first, second and third intersecting cylinders, wherein each of said first, second and third intersecting cylinders has a circular cross-sectional profile, and wherein the diameter of each cylinder is equal, wherein the tool module system further comprises an inserter guide configured and adapted to be selectively inserted into the interior of the hollow tubular housing to configure the guide to define the intersecting cylinders, and/or wherein the hollow tubular housing and the wall insert of the guide body of the instrument are configured such that the wall insert can be inserted into the hollow tubular housing, and the inner cross-section of the hollow tubular housing and the outer cross-section of the insert have one of the following: circular cross section; oval cross section; rectangular cross section; triangular cross section; and/or other symmetrical, partially symmetrical or asymmetrical cross-sections, and/or wherein the positioning surface (560) of the instrument (600) is provided with a plurality of holes (61, 161) for pins to firmly anchor the instrument to the surface to be repaired, and/or wherein, - the diameter of the cylinder (302) is selected between 10 and 30 mm; and/or - the cross section of the intersecting cylinders of the implant region (20) covers the cartilage and/or bone lesion (5) by between 50% and 100%, and/or - the axis of the cylinder (15) has an angle (25) of 0-40 degrees relative to the bone axis (60), said bone axis (60) being orthogonal to a tangential plane (28) of the bone surface, and/or wherein the cross-sections of at least three circular shapes (303) are configured to partially overlap, covering said cartilage and/or bone lesion (5), and/or wherein the cross-section of the cylinder has a diameter between 0.5-4 cm, and/or wherein 2-5 cylinder cross-sections are positioned to partially overlap, covering said bone and/or cartilage lesion (5), And/or the tool module system is further configured to define at least three cylinders in a row or other symmetrical manner, wherein a cross-section of at least one cylinder overlaps a cross-section of at least two other cylinders.