WO2015185219A1 - Fabrication d'un composant de culture d'un implant de surface articulaire - Google Patents

Fabrication d'un composant de culture d'un implant de surface articulaire Download PDF

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Publication number
WO2015185219A1
WO2015185219A1 PCT/EP2015/001146 EP2015001146W WO2015185219A1 WO 2015185219 A1 WO2015185219 A1 WO 2015185219A1 EP 2015001146 W EP2015001146 W EP 2015001146W WO 2015185219 A1 WO2015185219 A1 WO 2015185219A1
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WO
WIPO (PCT)
Prior art keywords
breeding
implant
defect
area
component
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Application number
PCT/EP2015/001146
Other languages
German (de)
English (en)
Inventor
Michael Jagodzinski
Original Assignee
Michael Jagodzinski
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Michael Jagodzinski filed Critical Michael Jagodzinski
Publication of WO2015185219A1 publication Critical patent/WO2015185219A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4644Preparation of bone graft, bone plugs or bone dowels, e.g. grinding or milling bone material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17Guides or aligning means for drills, mills, pins or wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30756Cartilage endoprostheses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2/30942Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4684Trial or dummy prostheses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2/30942Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A61F2002/30948Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using computerized tomography, i.e. CT scans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4644Preparation of bone graft, bone plugs or bone dowels, e.g. grinding or milling bone material
    • A61F2002/4648Means for culturing bone graft

Definitions

  • the invention relates to a manufacturing method for custom-made components, which are used in the cultivation of a joint surface implant. Furthermore, the invention relates to a method of cultivating a joint surface implant and a method for implanting a joint surface implant.
  • the body's own tissue is available as a substitute material, but at the time of removal, defects at the donor site and, in some cases, other tissue properties (eg tendon as ligament replacement) must be accepted.
  • tissue properties eg tendon as ligament replacement
  • the reconstruction of tissues with a multi-layered structure eg cartilage bone or tendon bone
  • a foreign body transplantation is available. This alternative has the disadvantages of a stronger rejection and foreign body reaction and the potential transmission of infectious diseases.
  • tissue engineering Most of the previously known methods of tissue engineering (so-called tissue engineering) have the disadvantage that the cultivation of new tissue takes place in technically demanding and cost-intensive laboratories, which results in high costs with insufficiently secured superiority over less expensive therapy methods.
  • Bioreactors are known from US Pat. No. 6,228,117 B1, which are intended to ensure an organism-like supply of a tissue construct with nutrients, oxygen and electrolytes in order to support cell proliferation and cell differentiation. Disadvantages of these devices include the need to remove cells from the donor or recipient organism and vorzuhalten for these methods in a complex and costly manner clean room laboratories.
  • An object of the invention is to provide a method of cultivating articular surface implants in vivo, which enables targeted mechanical stimulation of the implants.
  • Another object of the invention is to provide a suitable method for implanting a so-cultivated articular implant.
  • the invention relates to a method for producing a customized component for use in the cultivation of a joint surface implant, comprising the following steps:
  • step (f) realizing the implantable component by presenting the virtual component model obtained from step (e).
  • the method can be used to grow a human articular surface implant or to grow an articular surface implant.
  • the defect-related and the defect-distant bone tissue may be human or animal tissue.
  • defects in the first bone tissue below the defective joint surface are imaged, so that a defect region can be defined so that the area of the defective joint surface as well as the area of any underlying bone damage can be completely detected. without selecting a too large area and thus sacrificing healthy tissue.
  • the depicted defect near bone tissue typically includes involved and uninvolved bone tissue.
  • discrete bone tissue also includes bone tissue that is facing the defect site on the opposite side of the joint, i. lies on the bone opposite the defect. The detection of unrelated bone tissue on the opposite bone during modeling can serve to define the defect area so that the surface of the scaffold or of the implant to be cultivated is precisely modeled.
  • the real generation of the component by presenting the virtual model can be done, for example, by milling or cutting from a non-individually manufactured product.
  • the defect articular surface may be at all joints with hyaline cartilage or fibrocartilage.
  • the defective articular surface is located in the knee joint, hip joint or shoulder joint.
  • the defective joint surface lies in the intervertebral region or on the intervertebral disc. Join these joints Defects often occur and can be treated with a suitable articular implant.
  • the involved bone tissue is the femur and the uninvolved bone tissue is the patella.
  • the defect-distant bone tissue is part of a pelvic bone or a bone of the pelvic girdle.
  • the iliac crest is particularly suitable for the contemplated breeding of articular implants in vivo in addition to mechanical stimulation.
  • the tomographic imaging technique is computed tomography (CT) or
  • Magnetic Resonance Imaging A combination of both image data records can also be used.
  • the component is a scaffold for the articular surface implant, a trial implant, a template, a surgical tool for bone processing, or a component of an implantable breeding hood.
  • several or all of said components can be prepared, steps (a) to (d) being performed only once, and steps (e) and (f) separately for each of the produced components.
  • steps (a) to (d) being performed only once, and steps (e) and (f) separately for each of the produced components.
  • two imaging methods (a) and (b) in a single appointment and a bundled modeling operation (c) and (d) to model a plurality of tailored components is sufficient.
  • the custom component is a three-dimensional scaffold for the articular surface implant. This should be identical in shape to the defect area and is therefore and under submission of the defect area modeled. Thus, a scaffold custom-made with regard to the shape and size of the defect area is modeled and created real.
  • the scaffold may consist of a molded hydrogel or a protein-based scaffold. It is conceivable that the scaffold is divided into at least two sections which differ with respect to the structure of the scaffold, for example the type of hydrogel. Suitable materials include collagen, fibrin, poly sugars, e.g. Chitosan or glycosaminoglycans (GAGs), e.g. Hyaluronic acid-based materials, polyesters, polylactic acid (PLA), polyglycolic acid (PGA) and polycaprolactone (PCL).
  • Suitable materials include collagen, fibrin, poly sugars, e.g. Chitosan or glycosaminoglycans (GAGs), e.g. Hyaluronic acid-based materials, polyesters, polylactic acid (PLA), polyglycolic acid (PGA) and polycaprolactone (PCL).
  • Suitable methods for real production of the scaffold include nanofiber self-assembly, textile methods, SCPL (Solvent Casting & Particulate Leaching), foaming, emulsification or freeze-drying, TIPS (Thermally Induced Phase Separation), electrospinning.
  • SCPL Solvent Casting & Particulate Leaching
  • TIPS Thermally Induced Phase Separation
  • electrospinning 3D printing of polymer particles, FDM (Fused Deposition Modeling) or LaBP (Laser Assisted BioPrinting) may be suitable in the context of the present method.
  • tissue cells such as autogenous bone cells or progenitor cells are introduced into the scaffold, which later promote tissue formation at the scaffold.
  • growth factors are immobilized on the scaffold, which also later promote tissue formation at the scaffold.
  • suitable growth factors include: Fibroblast Growth Factors (FGF), Transforming Growth Factors (TGF), Platelet Derived Growth Factors (PDGF), Epidermal Growth Factors (EGF) or Insuline Like Growth Factors (IGF).
  • FGF Fibroblast Growth Factors
  • TGF Transforming Growth Factors
  • PDGF Platelet Derived Growth Factors
  • EGF Epidermal Growth Factors
  • IGF Insuline Like Growth Factors
  • thread is not to be understood strictly in the sense of a braided fiber strand, but rather comprises thread-like or wire-shaped structures in general.
  • Suitable threads may for example consist of resorbable or non-absorbable plastic.
  • the tailored component is a trial implant.
  • the trial implant has a head section which is at least partially identical in shape to the defect region. At least in sections means that at least a substantial part of the lateral surface should be identical in shape, while for example the portion of the defect region which images the articular surface need not be imaged on the trial implant.
  • the head section is used in the application to fit the breeding site or destination before the scaffold or implant are used.
  • the trial implant can have a handle section, which is used for easier handling.
  • the head section is modeled prior to real production of the trial implant as part of the procedure presenting the defect area or breeding area.
  • the trial implant is made of a plastic, preferably polyamide. The production can be done for example by milling or by sintering. One possible manufacturing variant involves laser sintering, in particular in the context of a rapid prototyping method. The use of a 3D printer is conceivable.
  • the custom component is a template.
  • This template can promote targeted removal of bone material at the breeding site or target site.
  • the template is coming up their actual production modeled by presenting a virtual model. Depending on whether the template is to be used at the breeding site or at the destination, the modeling will be based on the first model and the defect area, or on the second model and the breeding area.
  • the template preferably has a support area that represents a negative mold to the surface of the bone tissue in the adjacent to the breeding site or destination area of each existing bone tissue there.
  • the template is designed so that the physician can orient himself at the insertion of striking bony reference points, which are easily recognizable during surgery and allow reliable placement of the template. Accordingly, the virtual definition of the breeding place and destination can be selected. It has means for guiding one or more tools for bone processing, such as holes for a drill or slots for cutting tool.
  • the custom component is a bone contouring surgical tool, such as a cutting tool.
  • the tailor-made tool also serves for purposeful removal of bone material at the breeding or destination site. It is modeled prior to its actual production by presenting the corresponding virtual model.
  • the tailored component is a component of an implantable breeding hood.
  • the component is modeled by presenting the second model and / or the breeding area.
  • the implantable breeding hood has a framework on which a screen is held.
  • the custom-made component may in particular be the framework.
  • the terms scaffolding and umbrella are not necessarily to be understood in the sense of a single component.
  • the framework can be composed of several discrete parts.
  • the screen can be made up of several - in
  • the respective discrete parts may differ in their properties.
  • the screen can be movably held on the scaffold.
  • the framework and screen can be combined to form a single integral component.
  • the screen can be made of a rigid or elastic plastic material.
  • a preferred choice of material is PEEK, PET or a bioinert porous material such as a ceramic.
  • the framework may consist of a preferably rigid plastic material.
  • a preferred choice of material is also PEEK, PET or a bioinert porous material such as a ceramic.
  • means may be provided on the scaffold for attachment to the defect-removed bone tissue.
  • Plastic materials used are preferably non-absorbable and biocompatible.
  • the scaffold and / or screen may either be impermeable to water or may be porous (especially open-pored) and water-permeable.
  • the latter allows a targeted supply of the tissue construct with tissue fluid and nutrients, while no cells or the like can happen.
  • Suitable average pore sizes are, for example, in the range of between 1 and 100 nm, preferably in the range of between 5 and 50 nm.
  • Tissue fluid and nutrients passing through the pores promote growth and differentiation of the cells present in the scaffold or expectant implant.
  • growth factors can be immobilized on deformable and / or rigid components. Suitable growth factors have been described above in connection with the scaffold.
  • the possibly deformable character of the breeding hood or the movable storage of the breeding hood or of sections thereof causes that in the implanted state Covered area reversibly deformed by the action of external force and therefore the implant maturing therein can be mechanically stimulated.
  • the framework causes the covered area to always have a certain volume and not implode. This way you can protect the maturing implant.
  • the framework may take the form of a bridge which has individually adapted bearing surfaces in the end regions, which forms a negative mold to the surface of the defect-distant bone tissue in the region adjacent to the breeding region and which is bent up between the two end regions.
  • the means for attachment may be arranged at the end regions. It may, for example, be one or more openings for screws.
  • the invention further relates to a method for cultivating a joint surface implant in the patient's own body, comprising the following steps:
  • step (D) performing a second surgical procedure on the patient, wherein the articular implant is removed from the breeding pit.
  • the first step (A) is optional.
  • the process according to steps (B) to (C) can also be carried out independently of the preparation process according to the invention using components which are not individually adapted. Nevertheless, the previous implementation of a production process according to the invention or the use of individual components prepared according to the invention is preferred.
  • the method can be used to grow a human articular surface implant or to grow an articular surface implant.
  • the defect-related and the defect-distant bone tissue may be human or animal tissue.
  • the patient may be a human or animal patient.
  • the articular surface implant may generally be one of joints with hyaline cartilage or fibrocartilage. In one embodiment, it is an implant for the knee joint, hip joint or shoulder joint. In another embodiment, it is an implant for the intervertebral area or an intervertebral disc implant.
  • the breeding pit can be worked into the iliac crest of the patient.
  • the properties of the scaffold are preferably as described in connection with the production method according to the invention, regardless of whether the scaffold was actually produced individually within the scope of a production method according to the invention or not.
  • the scaffold is manufactured by a manufacturing method according to the invention.
  • the breeding pit and the scaffold received therein are covered with a breeding hood during the first surgical procedure.
  • the breeding hood preferably has a framework on which a screen is held.
  • the properties of the framework and / or screen are preferably as described in connection with the production method according to the invention, regardless of whether the framework and / or screen were produced individually within the scope of a production method according to the invention manufactured a manufacturing process according to the invention.
  • step (A) it is expedient that the shape of the breeding pit corresponds to the shape of the virtually defined breeding area.
  • incorporation of the breeding pit is done using a custom template.
  • incorporation of the breeding pit is done using a custom bone processing tool.
  • the properties of stencil and / or tool are preferably as described in connection with the production method according to the invention.
  • the insertion of the scaffold is preceded by a fitting of the breeding pit with the trial implant.
  • the fitting includes inserting the head portion of the trial implant into the breeding pit to determine fit accuracy. If the accuracy of the fit is insufficient, a fine machining of the breeding pit can be carried out. This process can be repeated several times if necessary.
  • the maturity period is 6 to 12 weeks. There is typically no further intervention between the first and second surgical procedures.
  • the hood continuously covers the breeding pit and the scaffold or the forming implant.
  • the method according to the invention makes it possible to grow a joint surface implant with a multilayer structure (cartilage on bone) under conditions similar to those encountered at the implantation site (nutrient supply, mechanical stress). This allows tissue to ripen with a functional structure. Breeding takes place at a site that differs from the site of implantation and can be chosen independently.
  • the invention further relates to a method for implanting a joint surface implant, the method comprising the following steps:
  • step (ii) is preceded by a production process according to the invention or a cultivation process according to the invention.
  • the use of custom-made components made according to the invention is preferred.
  • bone tissue involved in the third surgical procedure is removed within the scope of the virtually defined defect area.
  • the removal of the involved bone tissue is accomplished using a custom template or a custom bone processing tool.
  • inserting the implant is preceded by a fitting of the target site with the trial implant.
  • the fitting includes inserting the head portion of the trial implant into the recess at the target site to determine fit accuracy. If the accuracy of fit is insufficient, the recess can be fine-machined at the destination. This process can be repeated several times if necessary.
  • FIG. 1 shows a flow chart showing the working sequence of an embodiment of a production method according to the invention
  • FIG. 3 shows a schematic representation of processes during the maturation time of an embodiment of a breeding method according to the invention
  • FIG. 4 shows a further schematic representation of processes during the
  • FIG. 5 shows a further schematic representation of processes during the
  • FIG. 6 schematic representations of the scaffold implanted in the body together with the breeding hood according to one embodiment of a breeding method according to the invention
  • FIG. 7 shows the difference between an implant grown in the context of a method according to the invention and a comparison implant
  • Intervention of an embodiment of an implantation method according to the invention are performed.
  • FIG. 1 shows a flow chart in which a possible sequence of method steps for a production method of individually adapted components for use in the cultivation of a joint surface implant, as provided according to the invention, is described.
  • a computed tomography (CT) method for thin slice imaging ( ⁇ 0.5 mm isotropic voxel size) of bone tissue is performed.
  • This imaging is done on the one hand for the hemipelvis and on the other hand for both adjacent to the damaged joint bone, the bone with the joint surface to be replaced and the opposite bone.
  • the visualized bone sections may be parts of the femur and patella on the one hand and a portion of the iliac crest on the other hand.
  • a virtual, three-dimensional model of the imaged bone parts is created on the basis of the sectional image. It can for example, the I-Plan and Freeform programs will be used. Smoothing of the model can be done with Meshlab ® .
  • step 3 based on the previously created model, a virtual definition of a defect area on the bone with the articular surface to be replaced takes place.
  • the defect area should include damaged or located below a damaged articular bone tissue. This area delineation can be made, for example, with l-PLAN ® .
  • the result is a first definition of the shape of the desired implant (corresponds to the negative of the defect area).
  • the joint-side surface of the implant or defect region is modeled in step 4.
  • This surface should correspond to the desired surface after treatment, ie a healthy and with the opposite bone / cartilage of the joint ideally cooperating joint surface mimic.
  • the definition is based on the virtual model of the uninvolved tissue on the opposite bone / cartilage of the joint.
  • a Buhl operation may be used in this modeling.
  • step 5 an estimate is made as to what strength cartilage tissue should have on the articular surface of an implant to be manufactured. Furthermore, a virtual smoothing of the virtual model takes place.
  • step 6 this now finished, virtual model of the implant or defect area is used in order to select a suitable site for breeding the implant on the basis of the virtual model of the iliac crest.
  • the breeding area is the virtual counterpart of an artificially recessed pit in the iliac crest, which is intended to breed an implant.
  • the dimensions of the breeding area are chosen so that the modeled implant can be inserted into the breeding area.
  • step 7 the virtual modeling of an implantable breeding hood, which is intended to cover the breeding pit during breeding of the implant and to ensure optimal conditions for growing.
  • the harvesting hood advantageously comprises a rigid framework and a rigid or flexible umbrella.
  • the screen may be rigidly or movably supported on the scaffold, or may form a single integral part with the scaffold.
  • Their modeling in step 7 takes place, in particular, in that properties of the framework and / or umbrella are adapted to the individual circumstances of the breeding area, for example with regard to the size and shape, the locations for attachment means to bone or the shape of bearing surfaces.
  • step 7 the virtual exemption of the implant takes place.
  • a virtual modeling of various tools, templates and trial implants takes place.
  • a set of such tools, templates and trial implants are designed for the treatment of the defect site in the joint and for the cultivation of the breeding site.
  • These tools, templates and trial implants serve to make it easier for the surgeon during surgery to make a recess shaped according to the created model at the correct location of the bone.
  • the template may be a surgical template that allows for the placement of a drill in the correct direction at the correct location. Oscillating saws, hollow drills or chisels or milling can be used here.
  • Trial implants advantageously have a head portion that has the same shape as the modeled defect area or breeding area. This is how it is done Surgeons during surgery will be able to fine-tune the shape of the area during surgery.
  • the implant is produced from a suitable material, such as a porous biomaterial or autologous material, such as bone tissue.
  • a suitable porous biomaterial is a three-dimensionally shaped hydrogel.
  • the plastic modeled implant is fabricated using LaBP (Laser-assisted BioPrinting), maintaining the model created in Section 7.
  • Steps 1-10 correspond to a production method according to the invention.
  • Steps 11 and 12 symbolize a possibly subsequently occurring first surgical intervention within the scope of a breeding method according to the invention and a third surgical procedure which may subsequently be performed as part of an implantation method according to the invention.
  • FIG. 1 The processes which take place during the first surgical procedure within the scope of a breeding method according to the invention are illustrated in FIG.
  • FIG. 2 a schematically illustrates the iliac crest 20 of a patient who has a previously virtually defined breeding area.
  • a drilling template 21 produced as part of a manufacturing method according to the invention is placed.
  • a recess called a breeding pit is incorporated in the breeding area.
  • the template is then removed and the shape and dimensions of the breeding pit are fine-tuned by the surgeon using a trial implant if necessary.
  • a scaffold is sunk in the breeding pit, as shown in Figure 2b.
  • the dimensions of the breeding pit correspond approximately to the dimensions of the scaffold 22 for the implant.
  • FIG. 2c shows how the breeding pit with inserted scaffold 22 was covered by a screen 23 belonging to a custom-made breeding hood.
  • the shield 23 has previously been custom-made in the context of a manufacturing process according to the invention, and fits exactly on the corresponding point of the pelvis.
  • This screen 23 may be, for example, a plastic layer, such as a PEEK layer.
  • the screen may for example consist of porous material to allow nutrients and tissue fluid to pass. However, the screen 23 can also be made impermeable to water at least in sections.
  • cells or growth factors can be immobilized on the screen.
  • certain cells or growth factors may also be applied to the implant.
  • FIG. 2d shows how a frame 24 belonging to the breeding hood is subsequently placed on the screen 23.
  • It is preferably made of a rigid plastic material, such as PEEK. It can be solid or porous.
  • the framework 24 has previously been custom-made in the context of a manufacturing process according to the invention, and fits exactly on the corresponding location of the pelvis. It has dimensions that are chosen to be the desired one Area at the desired height is exactly covered.
  • the scaffold has holes 25 at appropriate locations for anchoring to the patient's iliac crest.
  • Figures 3 to 6 are schematic representations of operations during the maturation period of an embodiment of a breeding method according to the invention.
  • a hood 100 for covering the breeding pit and the scaffold or expectant implant has a contour 101, which is composed in sections of a flexible, water-impermeable plastic film 102 and sections of a dimensionally stable, liquid-permeable membrane 103. On the basis of the dimensionally stable membrane 103, the hood 100 may be fixed to the bone tissue of the patient.
  • a scaffold 105 of a three-dimensionally shaped hydrogel is arranged.
  • growth factors may be immobilized.
  • the scaffold 105 has in the exemplary embodiment shown two discrete zones 106 and 107, which differ with regard to the structure and / or composition of the hydrogel. Zone 106 is for culturing bone cells, while zone 107 is for culturing cartilage cells. Depending on the type of tissue structure desired, the same or different growth factors may be immobilized in the respective zones 106 and 107, respectively.
  • By the reference numeral 108 cells are shown schematically, with which the device according to the invention is loaded in the context of a method according to the invention, before the loaded device is temporarily implanted in the human or animal body.
  • the scaffold may be a scaffold 105 which has already been matched with regard to the desired shape of the implant to be cultivated and which has been obtained as part of a production method according to the invention.
  • it is conceivable that it is an unshaped Scaffold 105a.
  • Reference numerals 106a, 107a and 108a denote different zones and cells of the unshaped scaffold 105a.
  • reference symbol 109 schematically represents tissue fluid which penetrates through the liquid-permeable porous membrane 103 into the interior of the chamber 104 and rinses the scaffold 105 in addition to the loaded autogenous cells 108.
  • the tissue fluid 109 contains nutrients that are supplied to the cells 108 in the scaffold 105.
  • growth factors can be immobilized, which also come into contact with the scaffold 105 or the autogenous cells 108 seated thereon. Growth factors can also be immobilized on scaffold 105 itself.
  • cuttings of blood vessels 110 into the tissue construct forming in the scaffold 105 can be recognized.
  • the tissue construct can be supplied with nutrients and oxygen from these lumps 110.
  • the seeding of blood vessels takes place from the side of the bone tissue 112 of the patient.
  • FIG. 5 shows a cross section through an implanted hood and scaffold 105 according to FIGS. 3 and 4, wherein the upper illustration shows the arrangement before or immediately after the implantation, and the lower illustration shows the device a certain time after implantation.
  • the contour 101 of the hood comprises porous sections, on the inside of which growth factors 113 are immobilized.
  • tissue fluid 109 penetrates through the at least partially porous hood and flows through and around the scaffold 105 or the implant that is forming.
  • FIG. 6 shows how the arrangement of breeding pit, scaffold and hood 100 sits below a muscle 111 on the iliac crest bone 112. Of the Muscle may exert a force F on the assembly, this force being communicated to the scaffold 105 by the flexible components 102 of the contour 101 of the hood. Thus, the forming tissue is exposed to mechanical stimuli that simulate mechanical stimuli at the later site.
  • FIG. 7 compares the histology of implants after six weeks of breeding.
  • the comparison implant shown in Figure 7a was grown without mechanical influence.
  • the implant shown in FIG. 7b was inventively bred under the influence of mechanical compression forces.
  • the mechanical compression forces arise on the iliac crest of the patient during the normal, everyday movement and are passed on to the implant by the partially flexible construction of the breeding hood.
  • the histological result shown shows that the regenerated tissue 30 is much thinner and more compact under mechanical influence (FIG. 7b) than without such a stimulus (FIG. 7a).
  • the cartilage tissue 30 according to FIG. 7b is optimally adapted in its nature to the requirements at the implantation site.
  • FIG. 1 The processes which take place during the third surgical procedure in the context of an implantation method according to the invention are illustrated in FIG.
  • FIG. 8 a schematically illustrates a femoral roll 40 of a patient, which has a previously virtually defined defect region.
  • the illustrated femoral roll belongs to a human patient, but of course it is of course also encompassed by the invention that the methods according to the invention are performed with regard to an animal thigh roll.
  • a drilling template 41 produced as part of a manufacturing method according to the invention is placed. Under use This drilling template 41 as well as possibly using custom-made tools removes defective bone tissue at the defect area.
  • the template is then removed and the shape and dimensions of the recess are fine-tuned by the surgeon using a trial implant 42, if desired. This is shown in FIG. 8b.
  • the finished recess 43 can be seen in FIG. 8c.
  • the implant 44 is sunk with the cartilaginous joint surface in the prepared recess at the destination with a plunger.
  • the recessed implant is shown in FIG. 8d.
  • the methods according to the invention enable a cultivation of articular surface implants in the body of the patient.
  • the target tissue similar properties at smaller sampling defects.
  • transplantation of the implant may occur at a later time to give the injured breeding site time to heal (e.g., after infection).
  • the costs for the implant are reduced compared to previous methods and the effort is reduced.
  • the implants are mechanically stronger after cultivation and more similar to the target tissue in terms of functional structure. It is also the formation of a multi-phase tissue structure possible.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Transplantation (AREA)
  • Animal Behavior & Ethology (AREA)
  • Surgery (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Molecular Biology (AREA)
  • Dentistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Geometry (AREA)
  • Manufacturing & Machinery (AREA)
  • Physics & Mathematics (AREA)
  • Rheumatology (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention concerne un procédé de fabrication d'un composant adapté individuellement en vue d'être utilisé dans la culture d'un implant de surface articulaire. Ce procédé comprend les étapes suivantes : (a) exécution d'un procédé d'imagerie tomographique sur un tissu osseux proche d'un défaut dans la zone d'une surface articulaire défectueuse et création d'un premier modèle virtuel en trois dimensions du premier tissu osseux ; (b) exécution d'un procédé d'imagerie tomographique sur un tissu osseux éloigné du défaut, situé en dehors de la surface articulaire défectueuse, et création d'un deuxième modèle virtuel en trois dimensions ; (c) définition virtuelle d'une zone défectueuse à remplacer dans le tissu osseux proche du défaut au moyen du premier modèle ; (d) le cas échéant, définition virtuelle d'une zone de culture dans le tissu osseux éloigné du défaut au moyen du deuxième modèle, la forme de la zone de culture correspondant au moins par segments à la forme de la zone défectueuse ; (e) modélisation virtuelle d'un composant adapté individuellement sur la base du premier et/ou du deuxième modèle et/ou de la zone défectueuse et/ou de la zone de culture ; et (f) fabrication réelle du composant implantable sur la base du modèle de composant virtuel obtenu à l'étape (e). L'invention concerne en outre un procédé de culture d'un implant de surface articulaire à l'intérieur même de l'organisme du patient. Elle concerne également un procédé d'implantation d'un implant de surface articulaire.
PCT/EP2015/001146 2014-06-05 2015-06-05 Fabrication d'un composant de culture d'un implant de surface articulaire WO2015185219A1 (fr)

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DE102014008476.0A DE102014008476A1 (de) 2014-06-05 2014-06-05 Herstellung einer Komponente zur Züchtung eines Gelenkflächenimplantats, Züchtung und Implantation eines Gelenkflächenimplantats

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US10292770B2 (en) 2017-04-21 2019-05-21 Medicrea International Systems, methods, and devices for developing patient-specific spinal treatments, operations, and procedures
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US10456211B2 (en) 2015-11-04 2019-10-29 Medicrea International Methods and apparatus for spinal reconstructive surgery and measuring spinal length and intervertebral spacing, tension and rotation
WO2019233641A1 (fr) * 2018-06-07 2019-12-12 Christoph Karl Procédé et dispositif de fabrication d'un implant
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US11065016B2 (en) 2015-12-16 2021-07-20 Howmedica Osteonics Corp. Patient specific instruments and methods for joint prosthesis
US11166733B2 (en) 2017-07-11 2021-11-09 Howmedica Osteonics Corp. Guides and instruments for improving accuracy of glenoid implant placement
US11612436B2 (en) 2016-12-12 2023-03-28 Medicrea International Systems, methods, and devices for developing patient-specific medical treatments, operations, and procedures
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US11432930B2 (en) 2008-06-20 2022-09-06 Tornier Sas Method for modeling a glenoid surface of a scapula, apparatus for implanting a glenoid component of a shoulder prosthesis, and method for producing such a component
US10970426B2 (en) 2013-09-18 2021-04-06 Medicrea International SA Methods, systems, and devices for designing and manufacturing a spinal rod
US10318655B2 (en) 2013-09-18 2019-06-11 Medicrea International Method making it possible to produce the ideal curvature of a rod of vertebral osteosynthesis material designed to support a patient's vertebral column
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US10045824B2 (en) 2013-10-18 2018-08-14 Medicrea International Methods, systems, and devices for designing and manufacturing a rod to support a vertebral column of a patient
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US11197718B2 (en) 2013-10-18 2021-12-14 Medicrea Iniernational Methods, systems, and devices for designing and manufacturing a spinal rod
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US11918295B2 (en) 2013-10-18 2024-03-05 Medicrea International Methods, systems, and devices for designing and manufacturing a spinal rod
US11179249B2 (en) 2013-11-13 2021-11-23 Tornier Sas Shoulder patient specific instrument
US10405993B2 (en) 2013-11-13 2019-09-10 Tornier Sas Shoulder patient specific instrument
US10456211B2 (en) 2015-11-04 2019-10-29 Medicrea International Methods and apparatus for spinal reconstructive surgery and measuring spinal length and intervertebral spacing, tension and rotation
US11980377B2 (en) 2015-12-16 2024-05-14 Howmedica Osteonics Corp. Patient specific instruments and methods for joint prosthesis
US11065016B2 (en) 2015-12-16 2021-07-20 Howmedica Osteonics Corp. Patient specific instruments and methods for joint prosthesis
US11612436B2 (en) 2016-12-12 2023-03-28 Medicrea International Systems, methods, and devices for developing patient-specific medical treatments, operations, and procedures
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US11185369B2 (en) 2017-04-21 2021-11-30 Medicrea Nternational Systems, methods, and devices for developing patient-specific spinal treatments, operations, and procedures
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US10959742B2 (en) 2017-07-11 2021-03-30 Tornier, Inc. Patient specific humeral cutting guides
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US11458020B2 (en) 2018-06-07 2022-10-04 Christoph Karl Method and device for producing an implant
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