# US 8,771,354 B2 · Hard-tissue implant

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- Number: US 8,771,354 B2
- Document ID: US8771354B2
- Status: Granted
- Kind: B2
- Application number: 13/317,719
- Filed: 2011-10-26
- Published: 2013-05-02
- Granted: 2014-07-08
- Earliest claimed: 2011-10-26
- Assignees: George J. Picha
- Applicants: George J. Picha; Dawn Thompson
- Inventors: George J. Picha; Dawn Thompson
- Web page: https://patentgrep.com/patent/US8771354B2

## CPC

- A61F 2/30771: {applied in original prostheses, e.g. holes or grooves}
- A61B 17/68: Internal fixation devices {, including fasteners and spinal fixators, even if a part thereof projects from the skin (bone staples A61B17/0642)}
- A61C 8/0018: {characterised by the shape}
- A61C 8/0037: {Details of the shape}
- A61F 2/0077: {Special surfaces of prostheses, e.g. for improving ingrowth (A61F2/30767 takes precedence)}
- A61F 2/28: Bones
- A61F 2/2803: {for mandibular reconstruction (temporo-mandibular joints A61F2/3099; bone plates for the jaw A61B17/8071)}
- A61F 2/30756: {Cartilage endoprostheses (A61F2/3603 takes precedence)}
- A61F 2/3094: {Designing or manufacturing processes}
- A61L 27/04: Metals or alloys
- A61L 27/06: Titanium or titanium alloys
- A61L 27/18: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
- A61L 27/3608: {Bone, e.g. demineralised bone matrix [DBM], bone powder}
- A61L 27/3612: {Cartilage, synovial fluid}
- A61L 27/365: {Bones}
- A61L 27/50: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials}
- A61C 2008/0046: {Textured surface, e.g. roughness, microstructure (A61C8/0013 takes precedence)}
- A61F 2002/0081: {directly machined on the prosthetic surface, e.g. holes, grooves (A61F2/30771 takes precedence)}
- A61F 2002/30224: {cylindrical}
- A61F 2002/30252: {quadric-shaped}
- A61F 2002/30261: {parallelepipedal}
- A61F 2002/30273: {pyramidal}
- A61F 2002/30838: {Microstructures}
- A61F 2002/30878: {with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts}
- A61F 2002/3093: {for promoting ingrowth of bone tissue}
- A61F 2210/0076: multilayered, e.g. laminated structures
- A61F 2240/001: Designing or manufacturing processes
- A61F 2310/00359: Bone or bony tissue
- A61L 2400/18: Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61C: DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE (non-driven toothbrushes A46B; {tongue scrapers A61B17/24;} preparations for dentistry A61K6/00; preparations for cleaning the teeth or mouth A61K8/00, A61Q11/00)
- 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

Hard-tissue implants are provided that include a bulk implant, a face, pillars, and slots. The pillars are for implantation into a hard tissue. The slots are to be occupied by the hard tissue. The hard-tissue implant has a Young's modulus of elasticity of at least 10 GPa, has a ratio of the sum of (i) the volumes of the slots to (ii) the sum of the volumes of the pillars and the volumes of the slots of 0.40:1 to 0.90:1, does not comprise any part that is hollow, and does not comprise any non-pillar part extending to or beyond the distal ends of any of the pillars. Methods of making and using hard-tissue implants are also provided.

## Claims

### Claim 1

A hard-tissue implant comprising:
(a) a bulk implant;
(b) a face being an exterior surface of the bulk implant;
(c) pillars for implantation into a hard tissue, the pillars being distributed on the face, across an area of at least 80 mm2, and extending distally therefrom, and each pillar being integral to the bulk implant, having a distal end, having a transverse area of (200×200) to (10,000×10,000) μm2, and having a height of 100 to 10,000 μm; and
(d) slots to be occupied by the hard tissue, the slots being defined by the pillars and each slot having a width of 100 to 10,000 μm as measured along the shortest distance between adjacent pillars; wherein:
the hard-tissue implant can provide immediate load transfer upon implantation and prevent stress shielding over time, has a Young's modulus of elasticity of at least 10 GPa, has a ratio of (i) the sum of the volumes of the slots to (ii) the sum of the volumes of the pillars and the volumes of the slots of 0.40:1 to 0.90:1, does not comprise any part that is hollow, and does not comprise any non-pillar part extending to or beyond the distal ends of any of the pillars;
the bulk implant is non-porous; and
the pillars are non-porous.

### Claim 2 (depends on 1)

The hard-tissue implant of claim 1, wherein the hard-tissue implant is made of a material selected from the group consisting of implantable-grade polyetheretherketone, titanium, stainless steel, cobalt-chromium alloy, and titanium alloy.

### Claim 3 (depends on 1)

The hard-tissue implant of claim 1, wherein the face is flat.

### Claim 4 (depends on 1)

The hard-tissue implant of claim 1, wherein the face has a cylindrical contour.

### Claim 5 (depends on 1)

The hard-tissue implant of claim 1, wherein the pillars extend in a uniform direction.

### Claim 6 (depends on 1)

The hard-tissue implant of claim 1, wherein the pillars are perpendicular to the face.

### Claim 7 (depends on 1)

The hard-tissue implant of claim 1, wherein the transverse area of each pillar is (250×250) μm2 to (1,000×1,000) μm2.

### Claim 8 (depends on 1)

The hard-tissue implant of claim 1, wherein the height of each pillar is 200 to 2,500 μm.

### Claim 9 (depends on 1)

The hard-tissue implant of claim 1, wherein the width of each slot is 200 to 2,500 μm.

### Claim 10 (depends on 1)

The hard-tissue implant of claim 1, wherein the Young's modulus of the hard-tissue implant is 18 to 25 GPa and the ratio of (i) the sum of the volumes of the slots to (ii) the sum of the volumes of the pillars and the volumes of the slots is 0.51:1 to 0.60:1.

### Claim 11 (depends on 1)

The hard-tissue implant of claim 1, wherein the Young's modulus of the hard-tissue implant is 100 to 110 GPa and the ratio of (i) the sum of the volumes of the slots to (ii) the sum of the volumes of the pillars and the volumes of the slots is 0.72:1 to 0.76:1.

### Claim 12 (depends on 1)

The hard-tissue implant of claim 1, wherein the hard-tissue implant is made of implantable-grade polyetheretherketone, the transverse area of each pillar is (350×350) to (450×450) μm2, the height of each pillar is 400 to 600 μm, the width of each slot is 190 to 210 μm, and the ratio of the sum of (i) the volumes of the slots to (ii) the sum of the volumes of the pillars and the volumes of the slots is 0.51:1 to 0.60:1.

### Claim 13 (depends on 1)

The hard-tissue implant of claim 1, wherein the hard-tissue implant is made of titanium, the transverse area of each pillar is (350×350) to (450×450) μm2, the height of each pillar is 400 to 600 μm, the width of each slot is 390 to 410 μm, and the ratio of (i) the sum of the volumes of the slots to (ii) the sum of the volumes of the pillars and the volumes of the slots is 0.72:1 to 0.76:1.