# US 8,465,537 B2 · Encapsulated or coated stent systems

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- Number: US 8,465,537 B2
- Document ID: US8465537B2
- Status: Granted
- Kind: B2
- Application number: 10/871,946
- Filed: 2004-06-17
- Published: 2006-07-27
- Granted: 2013-06-18
- Earliest claimed: 2003-06-17
- Assignees: Gel-Del Technologies, Inc.
- Applicants: David B. Masters; Eric P. Berg
- Inventors: David B. Masters; Eric P. Berg
- Web page: https://patentgrep.com/patent/US8465537B2

## CPC

- A61L 31/10: Macromolecular materials
- A61F 2/90: characterised by a net-like or mesh-like structure
- A61F 2/91: made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
- A61K 31/337: having four-membered rings, e.g. taxol
- A61K 31/436: the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
- A61K 31/565: not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
- A61L 31/043: {Proteins; Polypeptides; Degradation products thereof}
- A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)}
- A61F 2/0077: {Special surfaces of prostheses, e.g. for improving ingrowth (A61F2/30767 takes precedence)}
- A61F 2/064: {with special features to facilitate anastomotic coupling (anastomosis of natural blood vessels A61B17/11)}
- A61F 2/852: Two or more distinct overlapping stents
- A61F 2002/826: {more than one stent being applied sequentially}
- A61F 2250/0063: Nested prosthetic parts
- A61F 2250/0067: Means for introducing or releasing pharmaceutical products into the body
- 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)
- 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)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

A stent system having zero or more inner stents inserted into an outer stent. The inner stents and outer stent are separated and/or encapsulated by a protein-based material of a protein matrix and/or a set biocoacervate, each one or more biocompatible proteins and one or more biocompatible solvents. The protein-based material may also include one or more carbohydrates and one or more pharmacologically active agents.

## Claims

### Claim 1

A single strand stent system comprising;
one or more single strand stent(s), each stent having at least one single strand twisted to form one or more open loops, the one or more open loops configured to be positioned around the lumen or passageway of a vessel, the at least one single strand including blunt distal and proximal ends, the at least one single strand further coated or encapsulated with a protein based material, the protein based material formed by a process including crosslinking a thermoplastic biocoacervate material that is administered to the one or more single strand stent(s); the thermoplastic biocoacervate material formed by a process including:
adding one or more glycosaminoglycan(s) to a solution of one or more soluble or solubilized primary protein(s), wherein at least one of the one or more primary protein(s) is dissolved in one or more solvent(s) and includes collagen;
minimally mixing the one or more glycosaminoglycan(s) with the one or more primary protein(s) and one or more solvent(s) to precipitate an amorphous coacervate that falls out of the solution as a protein body;
extracting the protein body from the solution and forming the protein body into the thermoplastic biocoacervate material.

### Claim 2 (depends on 1)

The single strand stent system of claim 1 further comprising a tube including the protein-based material and wherein the at least one single strand comprises at least two single strands twisted to form two separate loops, each loop coated or encapsulated with the protein-based material, wherein one loop is positioned on an end of the tube and another loop is positioned on the opposite end of the tube.

### Claim 3 (depends on 2)

The single strand stent system of claim 2 wherein the tube includes a mesh or cloth coated or encapsulated with the protein based material.

### Claim 4 (depends on 1)

The single strand stent system of claim 1 wherein the thermoplastic biocoacervate material includes the one or more primary proteins, the one or more glycosaminoglycans, the one or more solvents and further includes one or more secondary proteins.

### Claim 5 (depends on 1)

The single strand stent system of claim 1 wherein the protein based material comprises one or more additional proteins selected from the group consisting of elastin, albumin, keratin, fibronectin, silk, silk fibroin, actin, myosin, fibrinogen, thrombin, aprotinin, antithrombin III, elastinlike blocks, silklike blocks, collagenlike blocks, lamininlike blocks, fibronectinlike blocks, combinations of silklike blocks and elastinlike blocks, collagen-heparin and collagen-chondroitin.

### Claim 6 (depends on 1)

The single strand stent system of claim 1 wherein the one or more solvents is water.

### Claim 7 (depends on 1)

The single strand stent system of claim 1 further comprising one or more pharmacologically active agents.

### Claim 8 (depends on 7)

The single strand stent system of claim 7 wherein the one or more pharmacologically active agents is paclitaxel, rapamycin or estradiol.

### Claim 9 (depends on 1)

The single strand stent system of claim 1 wherein the one or more open loops have a shape or configuration selected from the group consisting of a single helix, “o”, “c”, “e”, oval, figure eight and loop strut stent.

### Claim 10

A vessel graft fastener comprising;
one or more clamping devices adjoined by a linking member including a cloth or mesh material; the one or more clamping devices and linking member coated or encapsulated with a protein-based material formed by administering a thermoplastic biocoacervate material to the one or more clamping devices and the liking member and crosslinking the thermoplastic biocoacervate material to set the thermoplastic biocoacervate material, the biocoacervate is formed by a process including:
adding one or more glycosaminoglycan(s) to a solution of one or more soluble or solubilized primary protein(s) that are dissolved in one or more solvent(s), wherein at least one of the primary protein(s) includes collagen;
minimally mixing the glycosaminoglycan(s) with the primary protein(s) and one or more solvent(s) to precipitate an amorphous coacervate that falls out of the solution as a protein body;
extracting the protein body from the solution, and;
forming the protein body into the thermoplastic biocoacervate.

### Claim 11 (depends on 10)

The graft fastener of claim 10 wherein the biocoacervate material includes the one or more primary proteins, the one or more glycosaminoglycans, the one or more solvents and further, one or more secondary proteins.

### Claim 12 (depends on 10)

The graft fastener of claim 10 wherein the protein based material comprises one or more additional proteins selected from the group consisting of elastin, albumin, keratin, fibronectin, silk, silk fibroin, actin, myosin, fibrinogen, thrombin, aprotinin, antithrombin III, elastinlike blocks, silklike blocks, collagenlike blocks, lamininlike blocks, fibronectinlike blocks, combinations of silklike blocks and elastinlike blocks, collagen-heparin and collagen-chondroitin.

### Claim 13 (depends on 10)

The graft fastener of claim 10 wherein the one or more solvents is water.

### Claim 14 (depends on 10)

The graft fastener of claim 10 further comprising one or more pharmacologically active agents.

### Claim 15 (depends on 14)

The graft fastener of claim 14 wherein the one or more pharmacologically active agents is paclitaxel, rapamycin or estradiol.

### Claim 16 (depends on 10)

The graft fastener of claim 10 wherein the clamping devices are selected from the group consisting of o-rings, c-rings and oval-rings.

### Claim 17

A stent system comprising:
two or more metallic or polymeric stents that are capable of being integrated one stent within another stent; and a biomaterial coating coated or encapsulated on one or more of the stents and formed by applying a thermoplastic amorphous biocoacervate to the one or more stents, the biocoacervate including one or more soluble or solubilized primary proteins, one or more secondary proteins, one or more glycosaminoglycans(s), and one or more biocompatible solvents, the biomaterial is formed by a process including:
adding the one or more glycosaminoglycan(s) to a solution of one or more of the primary protein(s) that are dissolved in the one or more biocompatible solvents, wherein at least one of the primary protein(s) includes collagen;
minimally mixing the glycosaminoglycan(s) with the one or more primary and secondary protein(s) and one or more solvent(s) to precipitate an amorphous coacervate that falls out of the solution as a protein body;
forming the protein body into the thermoplastic amorphous biocoacervate, and;
crosslinking the biocoacervate with one or more crosslinking agents to form the biomaterial.

### Claim 18 (depends on 17)

The stent system of claim 17 wherein the biomaterial coating comprises one or more additional proteins selected from the group consisting of elastin, albumin, keratin, fibronectin, silk, silk fibroin, actin, myosin, fibrinogen, thrombin, aprotinin, antithrombin III, elastinlike blocks, silklike blocks, collagenlike blocks, lamininlike blocks, fibronectinlike blocks, combinations of silklike blocks and elastinlike blocks, collagen-heparin and collagen-chondroitin.

### Claim 19 (depends on 17)

The stent system of claim 17 wherein the biocompatible solvent is water.

### Claim 20 (depends on 17)

The stent system of claim 17 further comprising one or more pharmacologically active agents.

### Claim 21 (depends on 20)

The stent system of claim 20 wherein the one or more pharmacologically active agents is paclitaxel, rapamycin or estradiol.

### Claim 22

A stent system comprising:
two or more metallic or polymeric stents including an inner stent fitted within one or more outer stents; and first and second protein based materials coating or encapsulating two or more of the two or more stents, the first and/or second protein based materials including a crosslinked biomaterial that is formed by a process including:
adding one or more glycosaminoglycan(s) to a solution of one or more soluble or solubilized primary protein(s) that are dissolved in one or more solvent(s), wherein at least one of the one or more primary protein(s) includes collagen;
minimally mixing the one or more glycosaminoglycan(s) with the one or more primary protein(s) and the one or more solvent(s) to precipitate an amorphous coacervate that falls out of the solution as a protein body;
extracting and forming the protein body into a thermoplastic amorphous biocoacervate, and;
crosslinking the thermoplastic amorphous biocoacervate,
wherein the first protein based material is encapsulated or coated on the inner stent and is biocompatible with host material present in a host lumen, wherein the second protein based material is encapsulated or coated on one or more of the outer stents and is different from the first protein-based material, and wherein the second protein based material is configured to be biocompatible when in contact with host tissue positioned adjacent to the one or more outer stents.

### Claim 23 (depends on 22)

The stent system of claim 22 wherein the first protein-based material and second protein-based material are different biomaterials, both protein based materials comprising the one or more primary proteins, the one or more secondary proteins, the one or more glycosaminoglycans and the one or more solvents.

### Claim 24 (depends on 22)

The stent system of claim 22 wherein one or both of the first or second protein based materials include one or more proteins selected from the group consisting of elastin, albumin, keratin, fibronectin, silk, silk fibroin, actin, myosin, fibrinogen, thrombin, aprotinin, antithrombin III, elastinlike blocks, silklike blocks, collagenlike blocks, lamininlike blocks, fibronectinlike blocks, combinations of silklike blocks and elastinlike blocks, collagen-heparin and collagen-chondroitin.

### Claim 25 (depends on 22)

The stent system of claim 22 wherein the one or more solvents is water.

### Claim 26 (depends on 22)

The stent system of claim 22 further comprising one or more pharmacologically active agents.

### Claim 27 (depends on 26)

The stent system of claim 26 wherein the one or more pharmacologically active agents is paclitaxel, rapamycin or estradiol.