# US 12,178,205 B2 · Systems and methods for storing and preserving implantable devices

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- Number: US 12,178,205 B2
- Document ID: US12178205B2
- Status: Granted
- Kind: B2
- Application number: 17/307,493
- Filed: 2021-05-04
- Published: 2021-08-19
- Granted: 2024-12-31
- Earliest claimed: 2016-02-09
- Assignees: Rutgers, The State University of New Jersey
- Applicants: Rutgers, The State University of New Jersey
- Inventors: Joseph Benevenia; Sheldon S. Lin; Michael J. Vives
- Web page: https://patentgrep.com/patent/US12178205B2

## CPC

- A01N 1/124: Disinfecting agents, e.g. antimicrobials
- A01N 1/142: Apparatus
- A01N 1/12: Chemical aspects of preservation
- A01N 1/146: Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving
- A01N 59/16: Heavy metals; Compounds thereof
- A61F 2/0095: {Packages or dispensers for prostheses or other implants (for intraocular lenses A61F2/1691; for dental surgery A61C19/02)}
- A61F 2/08: Muscles; Tendons; Ligaments
- A01N: PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF (preservation of food or foodstuff A23); BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES (preparations for medical, dental or toiletry purposes which kill or prevent the growth or proliferation of unwanted organisms A61K); PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- 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

This disclosure provides systems and methods for storing and preserving an implantable device. The system comprises a first sealable container; a second sealable container housed within the first sealable container; and a storage solution comprising a zinc compound contained in the second sealable container. The storage solution exhibits antimicrobial activity of inhibiting or controlling growth of microbial organisms and is capable of maintaining the implantable device in a hydrated state.

## Claims

### Claim 1

A system for storing and preserving a hydrated implantable device, comprising:
a first sealable container;
a second sealable container housed within the first sealable container, wherein the second sealable container comprises an implantable device; and
a storage solution comprising a zinc compound contained in the second sealable container, wherein the storage solution exhibits antimicrobial activity of inhibiting or controlling growth of microbial organisms and is capable of maintaining the implantable device in a hydrated state.

### Claim 2 (depends on 1)

The system of claim 1, wherein the first sealable container or the second sealable container is a bag, a box, a jar or a tube.

### Claim 3 (depends on 1)

The system of claim 1, wherein the second sealable container is sterilized.

### Claim 4 (depends on 1)

The system of claim 1, wherein the second sealable container is removably housed within the first sealable container.

### Claim 5 (depends on 1)

The system of claim 1, further comprising an insulation layer disposed between the first sealable container and the second sealable container, wherein the insulation layer separates a least a portion of the first sealable container from the second sealable container.

### Claim 6 (depends on 1)

The system of claim 1, wherein the insulation layer is configured to reduce heat transmission between the first sealable container and the second sealable container.

### Claim 7 (depends on 1)

The system of claim 1, wherein the first sealable container or the second sealable container is formed of steel, aluminum, glass, plastic, paper composite, or ceramic material.

### Claim 8 (depends on 7)

The system of claim 7, wherein the plastic material comprises a polymer selected from the group consisting of polyolefins, polyesters, polyamide, polyvinylchloride, acrylic, polycarbonates, polyethylene naphthalate (PEN), polyethylene terephthalate (PET), polystyrene, polyurethane, and mixtures thereof.

### Claim 9 (depends on 1)

The system of claim 1, wherein the zinc compound comprises an inorganic zinc compound.

### Claim 10 (depends on 9)

The system of claim 9, wherein the inorganic zinc compound is selected from the group consisting of zinc chloride, zinc sulfate, zinc phosphate, zinc carbonate, and zinc nitrate, zinc chlorate, zinc chromate, and combinations thereof.

### Claim 11 (depends on 1)

The system of claim 1, wherein the zinc compound comprises an organic zinc salt.

### Claim 12 (depends on 11)

The system of claim 11, wherein the organic zinc salt is selected from the group consisting of zinc acetate, zinc formate, zinc propionate, zinc gluconate, bis(maltolato)zinc, zinc acexamate, zinc aspartate, bis(maltolato)zinc(II) [Zn(ma)2], bis(2-hydroxypyridine-N-oxido)zinc(II) [Zn(hpo)2], bis(allixinato) Zn(II) [Zn(alx)2], bis(6-methylpicolinato) Zn(II) [Zn(6mpa)2], bis(aspir-inato)zinc(II), bis(pyrrole-2-carboxylato)zinc [Zn(pc)2], bis(alpha-furonic acidato)zinc [Zn(fa)2], bis(thiophene-2-carboxylato)zinc [Zn(tc)2], bis(thiophene-2-acetato)zinc [Zn(ta)2], (N-acetyl-L-cysteinato) Zn(II) [Zn(nac)], zinc(II)/poly(γ-glutamic acid) [Zn(γ-pga)], bis(pyrrolidine-N-dithio-carbamate)zinc(II) [Zn(pdc)2], zinc(II) L-lactate [Zn(lac)2], zinc(II) D-(2)-quinic acid [Zn(qui)2], bis(1,6-dimethyl-3-hydroxy-5-methoxy-2-pentyl-1,4-dihydropyridine-4-thionato)zinc(II) [Zn(tanm)2], β-alanyl-L-histidinato zinc(II) (AHZ), or the like, or combinations thereof.

### Claim 13 (depends on 1)

The system of claim 1, wherein the storage solution comprises between about 1 mM and about 1 M zinc chloride.

### Claim 14 (depends on 1)

The system of claim 1, wherein the storage solution comprises between about 0.1 wt % and about 20 wt % zinc chloride.

### Claim 15 (depends on 1)

The system of claim 1, wherein the implantable device is tissue.

### Claim 16 (depends on 1)

The system of claim 1, wherein the implantable device is a tissue graft.

### Claim 17 (depends on 16)

The system of claim 16, wherein the tissue graft is selected from the group consisting of allograft bone, autograft bone, xenograft bone, allograft cartilage, amniotic tissue, ligament tissue, tendon tissue, porous tissue, and soft tissue.

### Claim 18 (depends on 16)

The system of claim 16, wherein the implantable device is an allograft tissue.

### Claim 19 (depends on 17)

The system of claim 17, wherein the soft tissue is a ligament or a tendon.