Guide tool for cartilage repair

Abstract

A method of designing a guide tool for cartilage repair in an articulating surface of a joint, comprising the steps of: I. determining physical parameters for cartilage damage in a joint and generating design parameters for cartilage repair objects and their relative placement in a predetermined pattern. comprising: II. selecting repair objects to fit the individual cartilage damage site wherein the repair objects have: cross sectional areas adapted to fit the surface area of the cartilage damage site, lengths adapted to fit the selected joint and/or type of cartilage damage, and surfaces intended to align with the articular cartilage surface in the joint, based on the healthy surface contour curvature, III. determining, based on obtained image data, positions and angles of the selected cartilage repair objects, wherein the positions and angles are adapted so that the selected repair objects fit the individual cartilage damage site, IV. generating design parameters of the guide tool, for placement of the cartilage repair objects comprising the following steps of: generating the design for an upper part and a lower part of a guide channel in a guide body extending from the positioning body, said guide channel passing through said positioning body and said guide body wherein the angles and positions are generated dependent on and substantially corresponding to the determined angles and positions of the selected cartilage repair objects. and wherein the design for the lower part of all the guide channel is generated dependent on and substantially corresponding to the determined cross sectional areas, of the selected cartilage repair objects.

The invention claimed is: 
     
       1. A method of designing a guide tool for cartilage repair in an articulating surface of a joint wherein the guide tool is provided with guide channels intended for insertion of cartilage and bone plugs and also for enabling of guiding insert tools, comprising the steps of:
 I. determiningidentifying physical parameters forof cartilage damage in a joint in a patient's limb by:
 obtaining image data comprising a three dimensional image that comprises a representation of cartilage in the joint and an underlying subchondral bone in an area of cartilage damage,   scanning at least a part of the image data for one or more predetermined characteristics of the cartilage damage,   determining, based on the image data, the physical parameters of the cartilage damage, and   storing the determined physical parameters of the determined cartilage damage in association with the three dimensional image in the image data; and generating design parameters for cartilage and bone plugs and their relative placement in a predetermined pattern, comprising:   
 II. selecting repair objects to fit the individual cartilage damage site wherein the cartilage and bone plugs have surfaces intended to align with the articular cartilage surface in the joint, based on the healthy surface contour curvature; 
 III. determining, based on obtained image data, positions and angles of the selected cartilage and bone plugs, wherein the positions and angles are adapted so that the selected cartilage and bone plugs fit the individual cartilage damage site, wherein said angle of said cartilage and bone plug is selected between 0-40 degrees in relation to the normal of a tangential plane drawn at a point at the articulate surface of the cartilage or of the bone where the axis of the guide channels intersect the articulate surface; 
 IV. generating design parameters for at least a portion of the guide tool based on the stored determined physical parameters of the determined cartilage damage in association with the three dimensional image in the image data; 
 generating design parameters for at least one cartilage repair object for repair of the determined cartilage damage based on the physical parameters of the determined cartilage damage; and 
 selecting cartilage repair objects from a set of cartilage repair objects based on the generated design parameters, for placement of the cartilage and bone plugs comprising the following steps; 
 V. generating the design for an upper part and a lower part of a guide channel in a guide body extending from the positioning body, said guide channel passing through said positioning body and said guide body wherein the angles and positions are generated dependent on and substantially corresponding to the determined angles and positions of the selected cartilage and bone plugs and are selected between 0-40 degrees in relation to the normal of a tangential plane drawn at a point at the articulate surface of the cartilage or of the bone where the axis of the channels intersect the articulate surface, and 
 wherein the design of each guide channel is provided with a stop function to delimit penetration by a cartilage and bone harvesting and insertion tool and to delimit bone drilling penetration by a drill bit at a site of cartilage damage, and is generated dependent on and substantially corresponding to the determined cross sectional areas, of the selected cartilage and bone plugs. 
 
     
     
       2. The method for designing a guide tool according to  claim 1 , wherein design parameters are generated for the guide channel to have a height of 0.3-20 cm. 
     
     
       3. The method for designing a guide tool of  claim 1  wherein the cartilage and bone plugs are selected to fit the individual cartilage wherein the cartilage and bone plugs have:
 cross sectional areas adapted to fit the surface area of the cartilage damage site; and 
 lengths adapted to fit the selected joint and/or type of cartilage damage or longer. 
 
     
     
       4. The method for designing a guide tool according to  claim 1 , wherein the cartilage and bone plug is a healthy cartilage and bone plug. 
     
     
       5. The method for designing a guide tool according to  claim 1 , wherein the cartilage contact surface may be 10-90% larger than the area of muzzles of the guide channels  200 . 
     
     
       6. The method for designing a guide tool according to  claim 1 , wherein each cartilage and bone plug has a size of between 0.1 cm 2  and 5 cm 2 . 
     
     
       7. The method for designing a guide tool according to  claim 1 , wherein the guide tool is intended to repair cartilage damage of areas between 0.1-10 cm 2  which is between 0.1-50% of the total cartilage area in a joint. 
     
     
       8. The method for designing a guide tool according to  claim 1 , wherein the guide tool is designed to repair cartilage damage of a size that is 1-70% of the total cartilage in the joint with high precision. 
     
     
       9. The method for designing a guide tool according to  claim 1  wherein guide channels are designed to be oriented such that the longitudinal axis of the guide channel is inclined at a selected angle between 0-40 degrees in relation to the normal of a tangential plane drawn at a point at the articulate surface of the cartilage or of the bone where the axis of the channels intersect the articulate surface and in this way providing a desired and exact repair of the cartilage damage site. 
     
     
       10. The method for designing a guide tool according to  claim 1  wherein said guide further is designed to comprise a hollow space which enables output of waste such as cartilage tissue and bone chips from boring or reaming in the preparation of the recess for the implant in the joint and/or also designed so that the surgeon easier can see the cartilage damage site. 
     
     
       11. The method for designing a guide tool according to  claim 1  wherein the guide tool comprises a positioning body which extends laterally outside the periphery of the guide channel. 
     
     
       12. The method for designing a guide tool of  claim 1 , wherein image data representing an image of the joint is obtained using magnetic resonance imaging (MRI), computerized tomography (CT) imaging or a combination of both, or other suitable techniques such as delayed Gadolinium-enhanced MRI of cartilage (dGEMRIC) techniques or combinations of CT or MR and radio contrast agents. 
     
     
       13. A surgical method comprising the steps of:
 a) using the data and the guide tool designed according to the design method described in  claim 1 ;   b) mounting the individually shaped guide tool from step a) on the cartilage damage site and optionally fastening the guide tool to the cartilage;   c) using selected guide channels in the guide tool for guidance when drilling out recesses in the bone and cartilage within the cartilage damage site of the patient;   d) placing selected cartilage repair objects into recesses created in step c) using the guide tool for guidance.   
     
     
       14. A manufacturing method of the guide tool designed according to  claim 1 , wherein the manufacturing steps are dependent on the following factors:
 the size of the cartilage and bone plugs needed;   the localization of the injury;   the appearance of the cartilage surface and/or bone intended to be replaced;   the placement of the cartilage and bone plugs in relation to the injury site and also in relation to each other and in a certain angle and depth; and   the harvesting site such as non bearing cartilage in a joint wherefrom the healthy cartilage and bone plugs are harvested,   wherein the insert tools are manufactured depending on the selected choices for the guide tool and also depending on the selected sizes for the healthy cartilage and bone plugs,   wherein the designs may be based on the MR images/CT-scanning images from the joint of the person having the cartilage damage, using surgical planning software, and   wherein the surgical planning software is connected to manufacturing devices, for example a laser printer, a lathe and/or a reamer, and the parts of the kit are manufactured using for example additive manufacturing, laser sintering techniques, turnery or reaming.   
     
     
       15. A method for designing a guide tool according to  claim 1 , wherein the relative shortest distances between the designed guide channels are 1-3 mm. 
     
     
       16. The method according to claim 1, further comprising visualizing said at least one cartilage repair object in the three dimensional image, using an image based tool.  
     
     
       17. The method according to claim 1, further comprising creating a representation of a healthy surface contour curvature in the determined area of cartilage damage; and
 generating the design parameters for said at least one cartilage repair object so that said at least one cartilage repair object has a surface intended to be aligned with the created healthy surface contour curvature in the area of the determined cartilage damage.    
     
     
       18. The method according to claim 1, wherein said at least one cartilage repair object is an implant.  
     
     
       19. The method according to claim 1, wherein said at least one cartilage repair object is a set of cartilage and bone plugs, and
 wherein the method further comprises determining positions and angles of said set of cartilage and bone plugs so that they fit the physical parameters of the determined cartilage damage.    
     
     
       20. The method according to claim 19, wherein the guide tool is designed to comprise guide channels corresponding to the determined positions and angles of said set of cartilage and bone plugs.  
     
     
       21. The method according to claim 20, wherein the guide tool is designed to comprise a positioning body that extends laterally outside the periphery of the guide channels and is designed to fit the contour of the cartilage in a predetermined area surrounding the determined area of cartilage damage.  
     
     
       22. The method according to claim 1, wherein the physical parameters of the cartilage damage comprise a location, a size, and a shape of the cartilage damage.  
     
     
       23. The method according to claim 1, wherein the physical parameters of the cartilage damage are determined by determining a boundary line for healthy cartilage surrounding cartilage damage.  
     
     
       24. The method according to claim 1, determining, based on the image data, the physical parameters of the cartilage damage includes:
 determining presence, location, size, and shape of the cartilage damage;   determining curvature of a surface contour of the cartilage or the subchondral bone in the area of the cartilage damage; and   determining a cartilage site based on the determined physical parameters of the cartilage damage.    
     
     
       25. The method according to claim 1, wherein the physical parameters of the determined cartilage damage is stored as a set of defined coordinates in the image data in association with the three dimensional image.  
     
     
       26. The method according to claim 1, wherein the image data is received from one or more of i) magnetic resonance imaging (MRI); ii) computerized tomography (CT) imaging; iii) a combination of MRI and CT imaging; or iv) delayed Gadolinium-enhanced MRI of cartilage (dGEMRIC) techniques.  
     
     
       27. The method according to claim 1, further comprising obtaining said at least one cartilage repair object using the generated design parameters.