The present disclosure sets forth a system and method for forming sheets of material, such as titanium mesh or plates, for surgical applications prior to surgery. The disclosed solutions provide this capability without incurring expense from use of PEEK or PEKK by manufacturing contoured plates based on a shape of an anatomical structure in a 3D image, such as a pre-defect MRI. The contoured plates are used to stamp the titanium mesh, plate, or other sheet of material into the shape of the bone prior to the defect. In some aspects, the mesh or other material layer can also be trimmed prior to surgery using, for example, a reproduction of the anatomical structure manufactured from a post-defect MRI of the same anatomical structure.

Various embodiments of craniofacial implants, surgical instruments, and techniques are described to provide improved surgical results.

A portable device, method and system are provided for automated, quantitative assessment of orbital compliance and soft tissue restriction with emphasis on applicability to orbital trauma and fracture management is provided.

Embodiments of the invention described herein thus provide systems and methods for providing improved surgical implants. Embodiments of the implants may include a thin porous sheet formed on a mandrel. The porous sheet that is formed has an interconnected pore structure that may be compressed by a heat compression mold without losing porosity. Additional membrane materials or other layer materials may be applied to one of the face surfaces of the porous sheet or to one of the edges of the porous sheet. For example, a solid membrane surface may be compressed, bonded, welded, or secured a surface face or an edge of the porous sheet. The solid membrane may be compressed or laminated to the upper surface, lower surface, or both. The solid membrane may be welded to at least one edge of the porous sheet (by, for example, being butt welded, thermally bonded, or heat compressed to the at least one edge).

A method of forming a patient-specific-bone-graft cage based on a patient-specific bone graft cage computer model that is based on a contour of a surface of the bone defining a void, and/or a patient-specific-bone-graft cage that includes a plurality of apertures, that terminate at a location between a front surface and a back surface of the patient-specific-bone-graft cage, for receipt of bone graft material. The patient-specific-bone-graft cage can construct an essential portion (including complex thin anatomical structures) of or substantially the entirety of the mid-face region (e.g., to fill a void in a damaged orbital region), which enables an improved structure reproduction and simplification for the surgeon. For example, the patient-specific-bone-graft cage may be formed based on the contour of the periphery defining the void in the damaged region, and require less modification by a surgeon compared to graft cages formed only by mirroring techniques or normalized models.

Described herein are systems and methods for controlling a design and manufacturing process of a user-specific device (e.g., a patient-specific medical device). A method involves receiving, from the requesting entity user-specific information related to a requested device. Based on the information, a list of devices matching user-specific information is determined and displayed for selection by the requesting entity. Based on the information and the selection, a sequence of tasks for design and manufacturing of the user-specific device is generated. Based on the received information and the tasks, a designing entity can generate an interactive digital model of the user-specific device. Based on the interactive model, feedback is received from the requesting entity. Based on the feedback, the interactive digital model and sequence of tasks may be updated. Depending on a location of the requesting entity, the sequence of tasks or devices can be configured to satisfy regulatory compliance.

In some aspects, the present disclosure provides an implant. In some embodiments, the implant comprises a porous body comprising a form that fills a defect of a bone of a head of a subject. In some embodiments, the implant comprises a recess in the porous body, wherein the recess comprises a dimension larger than an average pore dimension of the porous body. In some embodiments, the implant comprises a biologic disposed in the recess. In some embodiments, the implant comprises an extension.

Embodiments of the present disclosure relate generally to an orbital floor implant (10). One embodiment provides an implant with a first surface that is a fully porous, bone-side layer (16) and a second surface that is a non-porous, orbital content-side layer (18). The implant material itself may be polymeric material throughout, without the need for an embedded mesh or other support matrix. The implant is provided in a pre-shaped configuration and is of a material that allows it to be bent for shaping purposes. An extending tab (12) with eyelet portion/opening (14) can enhance securement options to a patient's bone.

A biocompatible polymer composition is disclosed comprised of high density polyethylene particles. The high density polyethylene particles when sintered into an article can promote vascular growth. For example, when molded into an article, the particles produce a porous structure particularly well suited for maxillofacial implants.

An implant (X) for replacing or filling a defect of a flat bone has a flat shape with a first side (X1) and an opposite second side (X2). The implant (X) includes a first layer (S1) formed of non-porous polyetheretherketone or polyethylene, which has such a layer thickness that the shape of the implant (X) is established by the shape of the first layer (S1). The implant (X) includes, in at least some portions on the first side (X1), a second layer (S2) formed of a porous polymer which is not polyaryletherketone or polyetheretherketone. A method for producing such an implant (X) is also provided.