# US 9,433,722 B2 · Vascular shield and delivery system

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- Number: US 9,433,722 B2
- Document ID: US9433722B2
- Status: Granted
- Kind: B2
- Application number: 13/205,921
- Filed: 2011-08-09
- Published: 2013-02-14
- Granted: 2016-09-06
- Earliest claimed: 2011-08-09
- Assignees: Abbott Cardiovascular Systems Inc.
- Applicants: Paul M. Consigny
- Inventors: Paul M. Consigny
- Web page: https://patentgrep.com/patent/US9433722B2

## CPC

- A61M 1/3655: {Arterio-venous shunts or fistulae}
- A61B 17/08: Wound clamps {or clips, i.e. not or only partly penetrating the tissue (suture bridges A61B17/0466); Devices for bringing together the edges of a wound}
- A61B 17/12: for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B 17/122: Clamps or clips, e.g. for the umbilical cord {(for the vas deferens A61F6/206)}
- A61B 2017/00778: {Operations on blood vessels (A61B2017/22097, A61B2017/320741 take precedence)}
- A61B 2017/1107: {for blood vessels}
- A61F 2/82: Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents (stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07)
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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

Devices for providing physical support to vascular regions including vascular regions that may contain an anastomosis region are disclosed. These devices may also deliver therapeutic agents to the vascular region. Methods for using these devices are disclosed, as well.

## Claims

### Claim 1

A vascular sheath for fortifying a section of vasculature, the sheath comprising:
a tubular body having a longitudinal axis, a length, and a lumen extending the length of the tubular body, wherein the tubular body includes a wall, and wherein the tubular body includes a stiffness adapted to fortify a section of animal vasculature having pulsatile blood flow, and wherein the stiffness limits expansion of the tubular body from a first configuration to a second configuration when the pulsatile blood flow pressurizes the section of animal vasculature;
a longitudinal slot through the wall and extending along the longitudinal axis, the longitudinal slot spacing apart a first lateral edge of the wall from a second lateral edge of the wall by a first width when the tubular body is in the first configuration and a second width greater than the first width when the tubular body is in the second configuration; and
a circular portal in the wall, wherein the longitudinal slot intersects the circular portal, wherein the circular portal includes a first circumference when the tubular body is in the first configuration and a second circumference greater than the first circumference when the tubular body is in the second configuration.

### Claim 2 (depends on 1)

The sheath of claim 1, wherein the section of animal vasculature contains an anastomosis.

### Claim 3 (depends on 2)

The sheath of claim 2, wherein the wall comprises a region that includes a lattice.

### Claim 4 (depends on 3)

The sheath of claim 3, wherein the wall comprises a polymeric material.

### Claim 5 (depends on 4)

The sheath of claim 4, wherein the polymeric material comprises a drug eluting material.

### Claim 6 (depends on 5)

The sheath of claim 5, wherein the drug eluting material comprises a drug that treats proliferation of vascular cells, neointimal thickening, thrombosis, or collagen degradation.

### Claim 7 (depends on 6)

The sheath of claim 6, wherein the drug is any one or any combination of everolimus, zotarolimus, paclitaxel, PDGF, bFGF, 1-arginine, nitric oxide donors, heparin, prostacyclin, tetracycline, antiproliferatives, antineoplastics, antimitotics, anti-inflammatories, antiplatelets, anticoagulants, antifibrins, antithrombins, antibiotics, antiallergics, antioxidants, or any pro-drugs, metabolites, analogs, homologues, congeners, functional derivatives, structural derivatives, or salts.

### Claim 8 (depends on 5)

The sheath of claim 5, wherein the drug eluting material comprises a pro-healing drug.

### Claim 9 (depends on 4)

The sheath of claim 4, wherein the wall includes a plurality of filaments of the polymeric material.

### Claim 10 (depends on 4)

The sheath of claim 4, wherein the polymeric material includes a biodegradable polymer.

### Claim 11 (depends on 10)

The sheath of claim 10, wherein the stiffness is based on the biodegradable polymer including one or more of a poly(caprolactone) or a poly(lactide), and wherein the stiffness is further based on the wall having a thickness in a range between 40 to 250 microns.

### Claim 12 (depends on 11)

The sheath of claim 11, wherein the poly(lactide) is selected from the group consisting of poly(D-lactic acids), poly(L-lactic acids), poly(D,L-lactic acids), poly(D-lactide), and poly(D,L-lactide).

### Claim 13 (depends on 3)

The sheath of claim 3, wherein the wall comprises a metallic material.

### Claim 14 (depends on 13)

The sheath of claim 13, wherein the metallic material comprises any one, any combination, or any alloy of stainless steel, nickel-free stainless steel, 316L stainless steel, high nitrogen stainless steel tantalum, tungsten, molybdenum, silicon, platinum-iridium alloy, molybdenum-rhenium alloy, gold, cobalt-chromium alloy, cobalt-chromium alloy L-605, cobalt-chromium-tungsten alloys, cobalt-nickel-chromium alloys, cobalt-nickel-chromium-molybdenum alloys, silver, titanium, MP35N, MP20N, nitinol nickel-titanium alloy, nickel-titanium-vanadium alloy, platinum-iridium alloy, or magnesium.

### Claim 15 (depends on 14)

The sheath of claim 14, wherein the metallic material is coated with a polymeric material.

### Claim 16 (depends on 15)

The sheath of claim 15, wherein the polymeric material comprises a drug eluting material.

### Claim 17 (depends on 16)

The sheath of claim 16, wherein the drug eluting material comprises a drug that is any one or any combination of everolimus, zotarolimus, paclitaxel, PDGF, bFGF, 1-arginine, nitric oxide donors, heparin, prostacyclin, tetracycline, antiproliferatives, antineoplastics, antimitotics, anti-inflammatories, antiplatelets, anticoagulants, anti fibrins, antithrombins, antibiotics, antiallergics, antioxidants, or any pro-drugs, metabolites, analogs, homologues, congeners, functional derivatives, structural derivatives, or salts.

### Claim 18 (depends on 16)

The sheath of claim 16, wherein the drug eluting material comprises a pro-healing drug.

### Claim 19 (depends on 1)

The sheath of claim 1, wherein the wall has a thickness that ranges from 25 to 1000 microns and the tubular body has an outer diameter that ranges from 4 to 8 mm.

### Claim 20 (depends on 1)

The sheath of claim 1, wherein the tubular body includes a first end separated from a second end by the length, and wherein the circular portal is disposed substantially nearer to the first end than to the second end.
