# US 2010/0185299 A1 · Bone Implant, and Set for the Production of Bone Implants

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- Number: US 2010/0185299 A1
- Document ID: US20100185299A1
- Status: Published application
- Kind: A1
- Application number: 12/516,354
- Filed: 2007-11-27
- Published: 2010-07-22
- Earliest claimed: 2006-11-27
- Inventors: Berthold Nies
- Web page: https://patentgrep.com/patent/US20100185299A1

## CPC

- A61F 2/28: Bones
- A61L 27/04: Metals or alloys
- A61L 27/12: Phosphorus-containing materials, e.g. apatite
- A61L 27/30: Inorganic materials
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61L 27/56: Porous materials, {e.g. foams or sponges}
- A61F 2/0095: {Packages or dispensers for prostheses or other implants (for intraocular lenses A61F2/1691; for dental surgery A61C19/02)}
- A61F 2/30767: {Special external or bone-contacting surface, e.g. coating for improving bone ingrowth}
- A61F 2/3094: {Designing or manufacturing processes}
- A61F 2002/2817: {Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]}
- A61F 2002/30011: {differing in porosity}
- A61F 2002/30062: {(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive}
- A61F 2002/30092: {using shape memory or superelastic materials, e.g. nitinol}
- A61F 2002/30677: {Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body}
- A61F 2002/3092: {having an open-celled or open-pored structure}
- A61F 2210/0004: bioabsorbable
- A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol
- A61F 2250/0023: differing in porosity
- A61F 2310/00011: Metals or alloys
- A61F 2310/00017: Iron- or Fe-based alloys, e.g. stainless steel
- A61F 2310/00023: Titanium or titanium-based alloys, e.g. Ti-Ni alloys
- A61F 2310/00029: Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
- A61F 2310/00041: Magnesium or Mg-based alloys
- A61F 2310/00095: Niobium or Nb-based alloys
- A61F 2310/00113: Silver or Ag-based alloys
- A61F 2310/00125: Hafnium or Hf-based alloys
- A61F 2310/00131: Tantalum or Ta-based alloys
- A61F 2310/00155: Gold or Au-based alloys
- A61F 2310/00293: containing a phosphorus-containing compound, e.g. apatite
- A61F 2310/00365: Proteins; Polypeptides; Degradation products thereof
- A61F 2310/00383: Gelatin
- A61F 2310/00395: Coating or prosthesis-covering structure made of metals or of alloys
- A61L 2300/404: Biocides, antimicrobial agents, antiseptic agents
- A61L 2300/41: Anti-inflammatory agents, e.g. NSAIDs
- A61L 2300/412: Tissue-regenerating or healing or proliferative agents
- A61L 2300/602: Type of release, e.g. controlled, sustained, slow
- A61L 2430/02: for reconstruction of bones; weight-bearing implants
- A61F: FILTERS 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 (dental prosthetics A61C)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

The invention relates to bone implants and sets for producing bone implants. Said bone implants are made from pasty or cementitious preparations which are introduced into open-cell metal structures comprising an interconnected pore system as solid or porous materials and are optionally allowed to set, the metal structure per se being biocompatible in biological conditions and being stable or corrodible. The bone implant according to the invention contains at least one open-cell metal structure that has an interconnected pore system which is at least partially filled with a preparation made of at least one bone replacement material. The open-cell metal structure is significantly less rigid than the solid material made of the same metal.

## Claims

### Claim at position 1

-23. (canceled)

### Claim 24

A bone implant comprising:
an open-cell metal structure with an interconnected pore system;
wherein a stiffness of the open-cell metal structure is significantly lower than that of a solid material consisting of the same metal as the open-cell metal structure;
wherein the stiffness of the open-cell metal structure surpass the stiffness of healthy cortical human bone by not more than a factor 2;
a preparation comprising at least one bone replacement material, wherein the pore system is filled at least partially with the preparation, wherein at least one bone replacement material is present in cells of the open-cell metal structure as a powder, a pasty suspension, a lyophilisate, or a cement-like cured material.

### Claim 25 (depends on 24)

The bone implant according to claim 24, wherein the open-cell metal structure is comprised of stainless steel, cobalt-based alloys, pure titanium, titanium alloys, tantalum, tantalum alloys, niobium, Nitinol, gold or silver.

### Claim 26 (depends on 24)

The bone implant according to claim 24, wherein the open-cell metal structure is comprised of a metal or an alloy of said metal that is corrodible (bio-corrodible) under biological conditions and wherein corrosion of said metal or a main component of sad alloy taking place under biological conditions produces compounds that occur naturally in a body of a vertebrate.

### Claim 27 (depends on 24)

The bone implant according to claim 24, wherein the pore system of the open-cell metal structure is a graduated pore system in which at least one of a pore diameter, a pore shape, and a pore volume is changed in at least one section plane of the open-cell metal structure.

### Claim 28 (depends on 24)

The bone implant according to claim 24, wherein the at least one bone replacement material comprises nano-crystalline calcium phosphate or forms nano-crystalline calcium phosphate after implantation.

### Claim 29 (depends on 24)

The bone implant according to claim 24, wherein the preparation comprises composite materials that contain collagen, gelatin and/or other proteins of the organic extracellular matrix of the bone and further contain as mineral components phosphates, silicates, carbonates or sulfates of alkali and earth alkali elements or ammonium compounds or combinations thereof.

### Claim 30 (depends on 24)

The bone implant according to claim 24, wherein the preparation contains biologically and/or pharmacologically active ingredients.

### Claim 31 (depends on 24)

The bone implant according to claim 24, wherein the preparation is porous and wherein the preparation fills an accessible pore volume of the pore system of the open-cell metal structure, relative to the theoretical/calculated possible degree of filling and calculated based on dry matter, to 5 to 80 weight percent

### Claim 32 (depends on 24)

The bone implant according to claim 24, wherein the open-cell metal structure has a compression strength of >1 MPa and <50 MPa, wherein the preparation alone has a compression strength of >2 MPa, and wherein a combination of the open-cell metal structure and the preparation has a compression strength that is greater than the sum of the compression strengths of components of the open-cell metal structure and the preparation.

### Claim 33 (depends on 24)

The bone implant according to claim 24, wherein the pore system of the open-cell metal structure is macroscopically homogenous or graduated, wherein only a portion of the pore system is filled with the preparation and wherein the remaining portion of the pore system is either unfilled or the remaining portion of the pore system is filled with a metal-based, ceramic-based, or polymer-based material either completely or partially.

### Claim 34 (depends on 24)

The bone implant according to claim 24, comprising additional structures that are fixedly attached, wherein the additional structures are substantially dense or have a porosity that is by a factor of >10 smaller than that of the open-cell metal structure and are comprised of a metal-based, ceramic-based, or polymer-based material.

### Claim 35 (depends on 24)

A set comprising;
at least one open-cell metal structure;
a pasty or cement-like preparation of at least one bone replacement material or a composition from which the pasty or cement-like preparation of at least one bone replacement material is producible,
wherein, before or during operation, a bone implant according to claims 24 is produced with the set.

### Claim 36

A bone implant comprising at least one open-cell metal structure that has fill openings and/or devices for filling with a preparation of at least one bone replacement material.

### Claim 37

A method for producing a bone implant, comprising the steps of:
providing an open-cell metal structure with an interconnected pore system, wherein a stiffness of the open-cell metal structure is significantly lower than that of a solid material consisting of the same metal as the open-cell metal structure;
filling the pore system of the metal structure with at least one preparation comprising at least one bone replacement material.