# US 2019/0167325 A1 · Drug eluting surgical screw

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- Number: US 2019/0167325 A1
- Document ID: US20190167325A1
- Status: Published application
- Kind: A1
- Application number: 16/266,302
- Filed: 2019-02-04
- Published: 2019-06-06
- Earliest claimed: 2012-08-15
- Assignees: DePuy Synthes Products, Inc.
- Applicants: DePuy Synthes Products, Inc.
- Inventors: David Armbruster; Anurag Pandey
- Web page: https://patentgrep.com/patent/US20190167325A1

## CPC

- A61B 17/864: {hollow, e.g. with socket or cannulated}
- A61B 17/86: Pins or screws {or threaded wires; nuts therefor (A61B17/72 take precedence)}
- A61B 17/8605: {Heads, i.e. proximal ends projecting from bone}
- A61B 17/8615: {at the central region of the screw head}
- A61B 17/866: {Material or manufacture}
- A61M 31/002: {Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time (artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50)}
- A61M 37/0069: {Devices for implanting pellets, e.g. markers or solid medicaments (for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027)}
- A61B 17/8685: {comprising multiple separate parts}
- A61B 2017/00004: {(bio)absorbable, (bio)resorbable or resorptive}
- A61B 2017/00889: {antimicrobial, disinfectant}
- A61B 2017/00893: {pharmaceutically effective}
- A61B 2017/561: {Implants with special means for releasing a drug}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)}

## Abstract

The present invention is directed to a method of reducing the risk of infection following surgery utilizing the drug eluting surgical screw disclosed herein to secure an implant in an animal following surgery. The drug eluting screw includes a drug eluting component that can elute a therapeutic agent locally at the surface of the implant reducing the risk of infection.

## Claims

### Claim 1

(canceled)

### Claim 2

A method of reducing risk of infection at a fracture fixation site comprising:
implanting a fracture fixation implant at a site of a bone fracture, the fracture fixation implant defining a surface and including at least one aperture extending from the surface through the implant;
applying a drug eluting screw through the at least one aperture and into the bone at the fracture site so as to secure the fracture fixation implant to the bone, wherein the drug eluting screw includes a drug eluting component comprising a carrier matrix including at least one antibiotic; and,
eluting the at least one antibiotic from the carrier matrix, wherein the at least one antibiotic elutes locally along the surface of the fracture fixation implant.

### Claim 3 (depends on 2)

The method of claim 2, wherein eluting the at least one antibiotic is at an elution rate of at least 50% by weight of the at least one antibiotic within a period of less than 7 days.

### Claim 4 (depends on 2)

The method of claim 2, wherein the at least one antibiotic comprises at least two antibiotics such that there is at least a first antibiotic and a second antibiotic, and wherein the step of eluting comprises eluting the first antibiotic at a first elution rate and eluting the second antibiotic at a second elution rate.

### Claim 5 (depends on 4)

The method of claim 4, wherein the first elution rate and the second elution rate are each at least 50% by weight of the first antibiotic and the second antibiotic respectively within a period of 7 days, and the first elution rate is different from the second elution rate.

### Claim 6 (depends on 4)

The method of claim 4, wherein the drug eluting component comprises at least one layer, and wherein the first antibiotic and the second antibiotic are both contained in a same layer of the at least one layer.

### Claim 7 (depends on 4)

The method of claim 4, wherein the drug eluting component comprises multiple layers, and wherein the first antibiotic is contained in a first layer of the multiple layers and the second antibiotic is contained in a second layer of the multiple layers.

### Claim 8 (depends on 4)

The method of claim 4, wherein the drug eluting component comprises multiple layers, and wherein a first layer of the multiple layers is a barrier layer that contains no antibiotic, and a second layer of the multiple layers contains the first antibiotic and the second antibiotic, and further wherein the step of eluting comprises inhibited diffusion of the first and second antibiotics from the second layer through the first layer.

### Claim 9 (depends on 2)

The method of claim 2, wherein the drug eluting component comprises multiple layers, and wherein a first layer of the multiple layers is a barrier layer that contains no antibiotic, and a second layer of the multiple layers contains the at least one antibiotic, and further wherein the step of eluting comprises inhibited diffusion of the at least one antibiotic from the second layer through the first layer.

### Claim 10 (depends on 2)

The method of claim 2, wherein the carrier matrix defines a concentration gradient of the at least one antibiotic within the drug eluting component from a direction at a surface of the drug eluting component through a depth of the drug eluting component.

### Claim 11 (depends on 2)

The method of claim 2, wherein the carrier matrix comprises a bioabsorbable polymer compounded with the at least one antibiotic such that the step of eluting comprises absorbing the bioabsorbable polymer.

### Claim 12 (depends on 11)

The method of claim 11, wherein the carrier matrix further comprises a nonabsorbable polymer.

### Claim 13 (depends on 2)

The method of claim 2, wherein the carrier matrix comprises a water swellable additive such that the step of eluting comprises swelling the drug eluting component with water.

### Claim 14 (depends on 2)

The method of claim 2, wherein the carrier matrix comprises a soluble additive such that the step of eluting comprises dissolving the soluble additive.

### Claim 15 (depends on 2)

The method of claim 2, wherein the carrier matrix comprises a soluble additive such that the step of eluting comprises generating pores in the carrier matrix.

### Claim 16 (depends on 15)

The method of claim 15, wherein the carrier matrix further comprises a nonabsorbable polymer.

### Claim 17 (depends on 2)

The method of claim 2, wherein the carrier matrix comprises an erodible ceramic material such the step of eluting comprises eroding the ceramic material.

### Claim 18 (depends on 2)

The method of claim 2, wherein the drug eluting component is a film, and wherein the at least one antibiotic is compounded in the carrier matrix.

### Claim 19 (depends on 2)

The method of claim 2, wherein the at least one antibiotic is dissolved within the carrier matrix.

### Claim 20 (depends on 2)

The method of claim 2, wherein the at least one antibiotic is present as discrete particles in the carrier matrix.