# US 2022/0133376 A1 · Bone implants for the treatment of infection

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- Number: US 2022/0133376 A1
- Document ID: US20220133376A1
- Status: Published application
- Kind: A1
- Application number: 17/578,289
- Filed: 2022-01-18
- Published: 2022-05-05
- 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/US20220133376A1

## 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

A method of treating or preventing infection in a bone, the method comprising:
inserting a silver-releasing implant into a bone in a collapsed configuration;
expanding the implant into the bone from the collapsed configuration into an expanded configuration having multiple pathways through the bone;
releasing silver ions from one or more silver reservoirs on the implant into the bone over an extended period of time at a sustained level; and
removing the implant after a predetermined period of time that is longer than a week.

### Claim 2 (depends on 1)

The method of claim 1, wherein inserting comprises pre-forming passageways for the implant.

### Claim 3 (depends on 1)

The method of claim 1, wherein inserting comprises inserting a passage forming implant having a plurality of expandable members to pre-form the multiple pathways.

### Claim 4 (depends on 1)

The method of claim 1, wherein expanding the implant comprises driving a plurality of arms of the implant through the bone by extending the arms from the implant, wherein the arms are sufficiently stiff and/or sharp to penetrate bone.

### Claim 5 (depends on 4)

The method of claim 4, wherein inserting comprises inserting the implant with a delivery device configured to hold one region of the implant while longitudinally moving another region of the implant to extend the arms.

### Claim 6 (depends on 4)

The method of claim 4, wherein removing comprises removing the implant with a delivery device configured to secure a proximal region of the implant while longitudinally moving another region of the implant to contract the arms.

### Claim 7 (depends on 1)

The method of claim 1, further comprising anchoring the implant in the bone.

### Claim 8 (depends on 1)

The method of claim 1, wherein releasing silver ions comprises applying energy to drive the release of ions.

### Claim 9 (depends on 1)

The method of claim 1, wherein releasing silver ions comprises applying less than 50 microAmps of power to release ions.

### Claim 10 (depends on 1)

The method of claim 1, wherein releasing silver ions comprises applying pulsatile energy to release ions.

### Claim 11 (depends on 1)

The method of claim 1, wherein releasing silver ions comprises applying energy in pulses to maintain a silver ion concentration above a minimum inhibitory concentration.

### Claim 12 (depends on 1)

The method of claim 1, wherein releasing silver ions comprises releasing silver ions to maintain a silver ion concentration above a minimum inhibitor concentration in a region of the bone surrounding the implant for a period of at least one week.

### Claim 13 (depends on 1)

The method of claim 1, wherein releasing silver ions comprises releasing silver ions to maintain a silver ion concentration above a minimum inhibitor concentration in a region of the bone surrounding the implant for a period of at least one month.

### Claim 14 (depends on 1)

The method of claim 1, wherein releasing silver ions comprises releasing silver ions to maintain a silver ion concentration above a minimum inhibitor concentration in a region of the bone surrounding the implant for a period of between about one day and six months.

### Claim 15 (depends on 1)

The method of claim 1, further comprising sampling a patient tissue when removing the implant.

### Claim 16 (depends on 1)

The method of claim 1, further comprising sampling a patient tissue using a sampling member on the implant when removing the implant.

### Claim 17 (depends on 1)

The method of claim 1, wherein the method is a method of treating osteomyelitis.

### Claim 18

A method of treating or preventing infection in a bone, the method comprising:
inserting a silver-releasing implant into a bone in a collapsed configuration;
expanding a plurality of arms from the implant into the bone from the collapsed configuration into an expanded configuration wherein the expanded arms extend in a pattern having multiple pathways through the bone;
galvanically releasing silver ions from one or more silver reservoirs on the arms into the bone over an extended period of time at a sustained level; and
removing the implant after a predetermined period of time that is longer than a week.
