# US 5,344,494 A · Method for cleaning porous and roughened surfaces on medical implants

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 5,344,494 A
- Document ID: US5344494A
- Status: Granted
- Kind: A
- Application number: 08/007,338
- Filed: 1993-01-21
- Granted: 1994-09-06
- Earliest claimed: 1993-01-21
- Assignees: Smith & Nephew Richards Inc.
- Inventors: James A. Davidson; Ajit K. Mishra
- Web page: https://patentgrep.com/patent/US5344494A

## CPC

- B24C 1/086: {Descaling; Removing coating films}
- A61B 90/70: Cleaning devices specially adapted for surgical instruments
- A61F 2/30767: {Special external or bone-contacting surface, e.g. coating for improving bone ingrowth}
- B08B 3/12: by sonic or ultrasonic vibrations
- B08B 7/00: Cleaning by methods not provided for in a single other subclass or a single group in this subclass
- B24C 1/003: {using material which dissolves or changes phase after the treatment, e.g. ice, CO2}
- B24C 11/00: Selection of abrasive materials {or additives} for abrasive blasts (polishing compositions C09G)
- A61F 2002/30719: {Means for cleaning prostheses}
- A61F 2002/30906: {shot- sand- or grit-blasted}
- A61F 2002/30968: {Sintering}
- A61F 2250/0092: Means for cleaning prostheses
- A61F 2310/00389: The prosthesis being coated or covered with a particular material
- A61N 7/00: Ultrasound therapy (lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 {; using ultrasound for introducing media into the body A61M37/0092})
- B24C: ABRASIVE OR RELATED BLASTING WITH PARTICULATE MATERIAL
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)
- B08B: CLEANING IN GENERAL; PREVENTION OF FOULING IN GENERAL
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

A method for the cleaning of roughened surface or porous-coated medical implants of all kinds. In the cleaning method, the roughened surface or porous-coated implant is subjected to blasting with particulate solids selected from the solids that are soluble in a biocompatible non-toxic solvent and solids that deliquesce, sublimate or vaporize. The particulate solids must be sufficiently hard to provide effective impact for dislodging debris and loosely attached particles from implant surfaces. After blasting, the surface is optionally treated with ultrasonic vibration to further remove debris particulates. The impacted surfaces may also be rinsed with a biocompatible liquid. After cleaning, the surfaces may be passivated by immersion in conventional passivation solutions or a solution of non-aggressive oxyanions.

## Claims

### Claim 1

A method of cleaning a medical implant having a porous-coated or roughened surface, the surface containing loose debris particles and loosely-adherent debris particles, the method comprising:
(a) impacting the porous-coated or roughened surface with particles of soluble solids selected from alkaline metal salts having anions selected from the group consisting of sulfate, phosphate, di-hydrogen phosphate, mono-hydrogen phosphate,borate, nitrate, nitrite, chloride, sulfite, and bisulfite, said soluble solids be of sufficient hardness and density to effectively dislodge and remove debris from the surface said particles propelled by a carrier fluid; and
(b) subjecting the impacted surface to ultrasonic cleaning in the presence of a solvent for the soluble solid to dissolve residual soluble solids left behind on the impacted surface and remove debris particles;
whereby the number and size of residual debris particles on the implant surface is reduced.

### Claim 2 (depends on 1)

The method of claim 1, further comprising passivating the impacted, treated implant surface by immersing the surface in a solution containing anions selected from the group consisting of sulfate, phosphate, di-hydrogen phosphate, mono-hydrogen phosphate and borate.

### Claim 3 (depends on 1)

The method of claim 1, further comprising passivating surfaces of the medical implant by immersing in a passivating acid solution.

### Claim 4

A method of cleaning a medical implant having a porous-coated or roughened surface, the surface containing loose debris particles and loosely-adherent debris particles, the method comprising:
(a) impacting the porous-coated or toughened surface with particles propelled by a carrier fluid, said particles selected from the group consisting of frozen gases and frozen liquids to remove debris and loosely-adherent coating particles from the surfaces, whereby the number and size of residual debris particles and loosely-adherent coating particles on the roughened or porous-coated surface is reduced;
(b) optionally, treating the impacted surface with a liquid solvent for further removal of debris from the surface; and
(c) passivating impacted surfaces of the medical implant by immersing the surfaces in a passivating solution.

### Claim 5 (depends on 4)

The method of claim 4, wherein the treating comprises:
subjecting the impacted surface to ultrasonic treatment in a liquid medium to remove residual loosely-adherent debris from the surface.

### Claim 6 (depends on 4)

The method of claim 4, wherein the treating comprises:
rinsing the impacted surface in a stream of biocompatible solvent to wash residual loosely-adherent debris from the surface.

### Claim 7 (depends on 4)

The method of claim 4, wherein the passivating comprises:
immersing surfaces of the medical implant in a solution of non-aggressive oxyanions.

### Claim 8 (depends on 4)

The method of claim 4, wherein the passivating comprises:
immersing surfaces of the medical implant in a passivating acid solution.

### Claim 9

A method of cleaning a medical implant having a roughened or porous-coated surface, the surface containing loose debris and loosely-adherent debris particles, the method comprising:
impacting the porous-coated or toughened surface with particles propelled by a carrier fluid, said particles selected from the group consisting of solids that sublimate, solids that dissolve and solids that deliquesce, said particles having sufficient density and hardness to effectively dislodge and remove debris from the surface, whereby the number and size of residual debris particles on the implant surface is reduced; and
passivating impacted surfaces of the medical implant with a passivating solution.

### Claim 10 (depends on 9)

The method of claim 9, further comprising rinsing the impacted surfaces with a non-toxic solvent to remove loosely-adherent and loose debris.

### Claim 11 (depends on 9)

The method of claim 9, wherein the particles of solid are selected from the group consisting of frozen carbon dioxide, frozen salt solutions and ice.

### Claim 12 (depends on 9)

The method of claim 9, wherein the:
passivating comprises immersing the impacted surfaces in a solution containing anions selected from the group consisting of sulfate, phosphate, di-hydrogen phosphate, monohydrogen phosphate and borate.

### Claim 13 (depends on 9)

The method of claim 9, wherein the passivating comprises immersing surfaces of the medical implant in a passivating acid solution.

### Claim 14 (depends on 9)

The method of claim 9, further comprising subjecting the impacted surfaces to ultrasonic treatment.

### Claim 15 (depends on 9)

The method of claim 9, further comprising rinsing the impacted surface with a biocompatible solvent to remove debris from the surface.
