Device for the resection of bones, method for producing such a device, endoprosthesis suited for this purpose and method for producing such an endoprosthesis

• US 10,052,110 B2
• Filed: 10/27/2017
• Issued: 08/21/2018
• Est. Priority Date: 08/13/2009
• Status: Active Grant

• Current Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Schuster, Luis
• Primary Examiner(s): Sevilla, Christian
• Application Number:
  US15/796,480
• Publication Number:
  US 20180049751A1
• Time in Patent Office: 298 Days
• CPC Class Codes: A61B 17/154 for preparing bone for knee prosthesis
• CPC Class Codes: A61B 17/155 Cutting femur
• CPC Class Codes: A61B 17/157 Cutting tibia
• CPC Class Codes: A61F 2/3859 Femoral components
• CPC Class Codes: A61F 2/389 Tibial components A61F2/3868 takes precedence
• CPC Class Codes: A61F 2002/30948 using computerized tomography, i.e. CT scans
• CPC Class Codes: A61F 2002/30962 using stereolithography
• CPC Class Codes: Y10T 29/49 Method of mechanical manufacture

Abstract

The present invention refers to a device for the resection of bones (1) for preparing the attachment of an endoprosthesis to the joints which consists of at least two joint elements cooperating with each other, comprising at least one tool guide (3, 4, 5, 7, 14) and at least one support (6, 9, 10, 15, 21) suitable for orienting the at least one tool guide (3, 4, 5, 7, 14), wherein, either in the immediate vicinity of the joint and/or across joints, the at least one support (15, 21) enables the at least one tool guide (3, 4, 5, 7, 14) to be oriented and positioned on a further joint element, or enables the at least one tool guide (3, 4, 5, 7, 14) to be oriented and positioned at the same joint element distally to the area to be treated and/or outside the surgical area. The at least one tool guide (3, 4, 5, 7, 14) and the at least one support are preferably immovably connected to each other so as to manufacture an individual single-use template. The invention also relates to a method for manufacturing such a device or template, an endoprosthesis suited for this purpose, a method for manufacturing such an endoprosthesis, and a surgical set consisting of said parts.

Claims

1. A method for manufacturing a device for resecting of bones with at least one tool guide and at least one support suitable for orienting the at least one tool guide, with the following steps:

a) Preparation of images of the bone, wherein the bone needs to be prepared,

b) Determination of linear contours of the bone at the images,

c) Determination of areas on the bone that need to be prepared and selection of areas on the bone for positioning of the at least one tool guide at a joint element, and

d) Manufacture of a template with the at least one support which enables the at least one tool guide to be oriented and positioned at the joint element or enables orientation or positioning of the at least one tool guide distally to the areas to be prepared and/or outside a surgical area at the joint element; and

to the at least one tool guide positioned and located relatively to the support;

wherein the at least one support includes a surface conforming to the linear contours of the bone in the areas on the bone for positioning of the at least one tool guide.

2. The method according to claim 1, wherein several, grid-shaped linear supports and several tool guides angular to each other are determined with help of the images of the bone that needs to be prepared and are saved in a three-dimensional data record in order to manufacture the template whereas, in accordance with the three-dimensional data record, the supports and tool guides are molded from one form or made from a material in such a way that the template is molded seamlessly from one piece.

5. The method of claim 1, wherein manufacture of the template further comprises constructing the at least one support by scanning a surface of the bone and making a mold of the surface of the bone along contours derived from the images.

6. The method of claim 1, wherein manufacture of the template with the at least one support further comprises manufacturing the template with rib structures having bone-facing surfaces corresponding to a portion of a bone surface extracted from the images along the linear contours.

7. The method of claim 6, wherein manufacturing the template with rib structures includes manufacturing the rib structures to form a grid structure.

8. The method of claim 7, wherein manufacturing the template with rib structures includes manufacturing the grid structure to include rib structures forming bone-facing cavities disposed between adjacent rib structures.

9. The method of claim 7, wherein the grid structure comprises:

a plurality of sagittal rib structures; and

a plurality of coronal rib structures intersecting the plurality of sagittal rib structures.

10. The method of claim 7, wherein at least one of the rib structures extends in a sagittal direction across a tibial or femoral hump of the bone.

11. The method of claim 6, wherein preparation of images of the bone comprises preparation of two-dimensional sectional images of the bone in sagittal or coronal planes of the bone.

12. The method of claim 11, wherein locations of the rib structures correspond to locations of the two-dimensional sectional images of the bone in the sagittal or coronal planes of the bone.

13. The method of claim 12, wherein the rib structures are positioned to avoid soft tissue.

14. The method of claim 6, wherein manufacture of the template comprises fabricating the template from an elastic material using a rapid manufacturing process.

3. A method for manufacturing an endoprosthesis or for manufacturing a support for locating and positioning at least one tool guide to a joint element for attachment to a bone, with the following procedures:

a) Preparation of images including linear contours of the bone, wherein the bone needs to be prepared,

b) Determination of areas on the bone that need to be prepared and selection and positioning of at least one area on the bone that needs to be removed from the bone,

c) Virtual correction of the images for an adjustment of contours of the bone to contours of a healthy bone, and

d) Manufacture of an endoprosthesis or support including a surface conforming to the linear contours based at least in part on the areas on the bone that need to be prepared and the virtual correction of the images.

4. The method according to claim 3, wherein the virtual correction of the images of the damaged bone is carried out by a comparison with images of healthy bones.

15. The method of claim 4, wherein the virtual correction of the images further comprises interpolating corrected contours of the bone from the contours of the healthy bone.

16. The method of claim 3, wherein manufacture of the endoprosthesis or support includes manufacturing the endoprosthesis or support to include a grid structure of support ribs comprising:

a plurality of sagittal support ribs; and

a plurality of coronal support ribs intersecting the plurality of sagittal support ribs perpendicularly;

wherein the support ribs have bone-facing surfaces that correspond to contours of the bone determined from the images.

17. A method for manufacturing a surgical guide for locating and positioning relative to a bone of a specific patient, the method comprising:

obtaining images of the bone of the specific patient in sagittal or coronal planes of the bone;

determining contours of the bone in the sagittal or coronal planes of the bone;

designing shapes of a plurality of elongate supports to mate with the contours of the bone in each sagittal or coronal plane; and

manufacturing the surgical guide to include the plurality of elongate supports having the shapes.

18. The method of claim 17, further comprising:

determining areas of the bone that need to be prepared or removed from the bone;

determining an immersion depth of a tool required to prepare or remove the bone; and

manufacturing the surgical guide to include a tool guide having the immersion depth.

19. The method of claim 17, wherein designing shapes of the plurality of elongate supports further comprises including tibial or femoral humps of the bone in the shapes.

20. The method of claim 17, further comprising:

determining areas of the guide that will include cavities between adjacent elongate supports; and

manufacturing the surgical guide to include cavities between adjacent elongate supports to permit soft tissue unrecognized in the images to be displaced.

21. The method of claim 20, wherein the cavities extend through the guide to form apertures for viewing the bone.

22. The method of claim 17, further comprising virtually correcting the images for an adjustment of the contours of the bone to contours of a healthy bone by a comparison with images of healthy bones.

23. The method of claim 17, wherein designing shapes of the plurality of elongate supports further comprises saving the shapes in a three-dimensional data record.