# US 2024/0366384 A1 · An implant having an implant surface of layered coatings and a method thereof

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- Number: US 2024/0366384 A1
- Document ID: US20240366384A1
- Status: Published application
- Kind: A1
- Application number: 18/683,187
- Filed: 2022-07-28
- Published: 2024-11-07
- Earliest claimed: 2021-08-13
- Assignees: Wissenkraft Labs Pvt. Ltd.
- Applicants: Wissenkraft Labs Pvt. Ltd.
- Inventors: Chinmay Chandrashekhar Khare
- Web page: https://patentgrep.com/patent/US20240366384A1

## CPC

- A61F 2/28: Bones
- A61L 27/06: Titanium or titanium alloys
- A61F 2/0077: {Special surfaces of prostheses, e.g. for improving ingrowth (A61F2/30767 takes precedence)}
- A61F 2/30767: {Special external or bone-contacting surface, e.g. coating for improving bone ingrowth}
- A61F 2/3094: {Designing or manufacturing processes}
- A61L 27/306: {Other specific inorganic materials not covered by A61L27/303 - A61L27/32}
- A61L 27/50: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials}
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61F 2002/0081: {directly machined on the prosthetic surface, e.g. holes, grooves (A61F2/30771 takes precedence)}
- A61F 2002/30838: {Microstructures}
- A61F 2002/3092: {having an open-celled or open-pored structure}
- A61F 2002/30925: {etched}
- A61F 2002/30929: {having at least two superposed coatings}
- A61F 2002/3097: {using laser}
- A61F 2002/30985: {using three dimensional printing [3DP]}
- A61F 2240/001: Designing or manufacturing processes
- A61F 2310/00407: Coating made of titanium or of Ti-based alloys
- A61F 2310/00425: Coating made of magnesium or of Mg-based alloys
- A61F 2310/00796: Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
- A61L 2300/104: Silver, e.g. silver sulfadiazine
- A61L 2300/404: Biocides, antimicrobial agents, antiseptic agents
- A61L 2420/02: Methods for coating medical devices
- 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

An implant has an implant surface of layered coatings. A method of manufacturing is for an implant having an implant surface. The implant having an implant surface has a micro-pattern layer on the implant surface made by micro-machining, and a primary component layer deposited over the micro-pattern layer that promotes bio-integration of the implant. The micro-pattern layer has micro-trenches in predefined dimensions and arranged in a periodic array.

## Claims

### Claim 1

An implant having an implant surface comprising:
a micro-pattern layer on the implant surface by micro-machining, wherein the micro-pattern layer comprises micro-trenches in predefined dimensions and arranged in a periodic array; and
a primary component layer deposited over the micro-pattern layer; wherein the implant surface promotes bio-integration of the implant.

### Claim 2 (depends on 1)

The implant as claimed in claim 1, wherein the primary component layer comprises at least one of titanium and titanium alloy, Titanium-Tantalum alloy, Magnesium alloy, Titanium-Zirconium alloy and/or combinations thereof as a primary component, and wherein the primary component layer is deposited by using a high-pressure cold-spray deposition technique, wherein the cold spray deposition technique allows synthesizing of the primary component layer with porosity while retaining original phase of sprayed species of the primary component, wherein the primary component, after being deposited, forms a thickness of layer from 70 μm to 800 μm.

### Claim 3 (depends on 1)

The implant as claimed in claim 1, wherein the micro-trenches are in a shape comprising of at least one of hemi-circular, quasi-triangle, cross, isotoxal-star, oval, circular and square in an arrangement comprising at least one of honeycomb-like or planar-hexagonal closed-packed arrangement, wherein the micro-trenches are in a dimension range comprising of one or more of width 10 μm to 50 μm, depth 50 μm to 500 μm and inter-pattern distance 400 μm to 2000 μm.

### Claim 4 (depends on 1)

The implant as claimed in claim 1, further comprising an anti-microbial component layer deposited over the primary component layer using physical vapor deposition technique, wherein the anti-microbial component layer is configured for continuous release of anti-microbial component, from the anti-microbial component layer, to inhibit microbial growth and prevent colonization on the implant surface;
wherein the anti-microbial component comprises at least one of Silver, Gold, Zinc, Platinum, Palladium, Iridium and Copper, Nickel or a combinations thereof.

### Claim 5 (depends on 4)

The implant as claimed in claim 4, wherein the anti-microbial component layer is having a thickness of deposition in the range of 1 nm-500 nm, wherein the thickness of deposition is regulated by tuning a duration of the deposition based on a rate of the deposition of the anti-microbial component on the implant surface, and wherein the thickness of deposition is determined based on the surface area of the implant in such a manner to prevent cytotoxicity caused due to the anti-microbial component.

### Claim 6

A method of manufacturing an implant having an implant surface, the method comprising the steps of:
micro-machining to create a micro-pattern layer on the implant surface, wherein the micro-pattern layer comprises of micro-trenches in predefined dimensions and arranged in a periodic array: and
depositing a primary component layer over the micro-pattern layer;
wherein the implant surface promotes bio-integration of the implant.

### Claim 7 (depends on 6)

The method as claimed in claim 6, wherein the method further comprises one or more intermittent steps of ultrasonic cleaning, surface cleaning and drying to remove organic/inorganic and other surface impurities, a further step of surface blasting with a blasting media to increase the surface roughness and a step of post-processing with nitrogen/compressed air blow, sterilization and packaging/storage.

### Claim 8 (depends on 6)

The method as claimed in claim 6, wherein the primary component layer comprises at least one of titanium and titanium alloy, Titanium-Tantalum alloy, Magnesium alloy, Titanium-Zirconium alloy and/or combinations thereof as a primary component, and wherein depositing the primary component layer is performed by using a high-pressure cold-spray deposition technique, wherein the cold spray deposition technique allows synthesizing of the primary component layer with porosity, while retaining original phase of sprayed species of the primary component,
wherein depositing the primary component forms a thickness of layer from 70 μm to 800 μm.

### Claim 9 (depends on 6)

The method as claimed in claim 6, wherein the micro-trenches are in a shape comprising of at least one of hemi-circular, quasi-triangle, cross, isotoxal-star, oval, circular and square in a honeycomb-like or planar-hexagonal closed-packed-like arrangement,
wherein the micro-machining comprises creating micro-trenches in a dimension ranges comprising one or more of width 10 μm to 50 μm, depth 50 μm to 500 μm and inter-pattern distance 400 μm to 2000 μm.

### Claim 10 (depends on 6)

The method as claimed in claim 6, further comprising depositing an anti-microbial component layer over the primary component layer using physical vapor deposition technique, wherein the anti-microbial component layer is configured for continuous release of the anti-microbial component from the anti-microbial component layer, to inhibit microbial growth and prevent colonization on the implant surface,
wherein the anti-microbial component comprises at least one of Silver, Gold, Zinc, Platinum, Palladium, Iridium, Copper and Nickel or a combination thereof.

### Claim 11 (depends on 10)

The method as claimed in claim 10, wherein the anti-microbial component layer is having a thickness of deposition in the range of 1 nm-500 nm, wherein the thickness of deposition is regulated by tuning a duration of deposition based on a rate of deposition of the anti-microbial component on the implant surface, wherein the thickness of deposition is determined based on the surface area of the implant in such a manner to prevent cytotoxicity caused due to anti-microbial component.