# US 10,368,929 B2 · Bone implants for the treatment of infection

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- Number: US 10,368,929 B2
- Document ID: US10368929B2
- Status: Granted
- Kind: B2
- Application number: 16/015,085
- Filed: 2018-06-21
- Published: 2018-10-18
- Granted: 2019-08-06
- Earliest claimed: 2009-08-27
- Assignees: Silver Bullet Therapeutics, Inc.
- Applicants: Silver Bullet Therapeutics, Inc.
- Inventors: Houdin Dehnad; Bohdan Wolodymyr Chopko; Paul E. Chirico
- Web page: https://patentgrep.com/patent/US10368929B2

## CPC

- A61B 17/866: {Material or manufacture}
- A61B 17/56: Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61L 31/022: {Metals or alloys}
- A61L 31/088: {Other specific inorganic materials not covered by A61L31/084 or A61L31/086}
- A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)}
- A61M 25/0084: {being one or more injection needles}
- A61B 2017/00893: {pharmaceutically effective}
- A61B 2017/561: {Implants with special means for releasing a drug}
- A61F 2002/30677: {Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body}
- A61F 2310/00113: Silver or Ag-based alloys
- A61L 2300/102: Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
- A61L 2300/104: Silver, e.g. silver sulfadiazine
- A61L 2300/404: Biocides, antimicrobial agents, antiseptic agents
- A61L 2300/602: Type of release, e.g. controlled, sustained, slow
- A61L 2400/16: Materials with shape-memory or superelastic properties
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- 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)

## Abstract

Described herein are devices, systems and methods for treating disease and/or infection by the release of silver from an implant over an extended period of time. In particular, the devices described herein may be used to treat infections such as osteomyelitis by the controlled release of silver ions from multiple sites of an extended-use implant. This implant typically includes a plurality of arms that both anchor and help distribute the released ions within the tissue. Power may be applied to release the silver ions into the tissue.

## Claims

### Claim 1

An implantable screw for insertion into bone to treat or prevent infection, the implant having a deployed configuration in which at least one antimicrobial ion releasing arm extends from the implantable screw and an undeployed configuration in which the arm is not extended from the implantable screw, the implantable screw further comprising:
an elongate body having a threaded screw region configured for securing into bone;
a channel extending proximally to distally through the implantable screw, wherein the arm is configured to extend through the channel and out of the implantable screw in the deployed configuration, further wherein the arm comprises an antimicrobial ion reservoir; and
a galvanic reactor metal on the implantable screw configured to be in electrical communication with the reservoir when the implantable screw is in the deployed configuration to galvanically drive release of antimicrobial ions.

### Claim 2 (depends on 1)

The implantable screw of claim 1, wherein the antimicrobial ion comprises silver and/or zinc.

### Claim 3 (depends on 1)

The implantable screw of claim 1, wherein the elongate body comprises a hollow elongate member.

### Claim 4 (depends on 1)

The implantable screw of claim 1, further comprising a deflection pathway within the channel configured to deflect the arm away from the elongate body as it is extended out of the implantable screw.

### Claim 5 (depends on 1)

The implantable screw of claim 1, wherein the arm comprises a shape-memory material.

### Claim 6 (depends on 1)

The implantable screw of claim 1, wherein the arm comprises a nickel titanium alloy covered by an adhesion layer and a silver coating, wherein the adhesion layer is formed after removal of a titanium oxide layer from the outer surface of the nickel titanium alloy and before the silver coating.

### Claim 7 (depends on 1)

The implantable screw of claim 1, wherein the arm is curved when extended in the deployed configuration and configured to increase the resistance to pull-out from the bone.

### Claim 8 (depends on 1)

The implantable screw of claim 1, wherein the arm comprises a sharpened wire.

### Claim 9 (depends on 1)

The implantable screw of claim 1, wherein the at least one arm comprises two arms configured to extend from the implantable screw in the deployed configuration.

### Claim 10 (depends on 1)

The implantable screw of claim 1, wherein the arm is configured to release silver along its entire length in the deployed configuration.

### Claim 11 (depends on 1)

The implantable screw of claim 1, wherein the antimicrobial ion reservoir comprises a silver coating.

### Claim 12 (depends on 1)

The implantable screw of claim 1, wherein the elongate body comprises titanium.

### Claim 13 (depends on 1)

The implantable screw of claim 1, wherein the elongate body comprises a plating from the platinum group on the periodic table.

### Claim 14

An implantable screw for insertion into bone to treat or prevent infection, the implant having a deployed configuration in which at least one silver-releasing arm extends from the implantable screw and an undeployed configuration in which the arm is not extended from the implantable screw, the implantable screw further comprising:
an elongate body having a threaded screw region configured for securing into bone;
a channel extending through the implantable screw, wherein the arm is configured to extend through the channel and out of the implantable screw in the deployed configuration, further wherein the arm comprises a silver reservoir; and
a galvanic reactor metal configured to be in electrical communication with the silver reservoir when the implantable screw is in the deployed configuration to galvanically drive release of silver, but not in electrical communication with the silver reservoir when the implantable screw is in the undeployed configuration.
