# US 10,765,538 B2 · Biodegradable supporting device

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 10,765,538 B2
- Document ID: US10765538B2
- Status: Granted
- Kind: B2
- Application number: 15/206,242
- Filed: 2016-07-09
- Published: 2016-11-03
- Granted: 2020-09-08
- Earliest claimed: 2012-03-09
- Assignees: Q3 Medical Devices Limited
- Applicants: Q3 Medical Devices Limited
- Inventors: Eric K. Mangiardi
- Web page: https://patentgrep.com/patent/US10765538B2

## CPC

- A61F 2/844: folded prior to deployment
- A61B 17/0057: {Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect (sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009)}
- A61B 17/12113: {within an aneurysm}
- A61F 2/07: Stent-grafts
- 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)
- A61F 2/86: Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F 2/90: characterised by a net-like or mesh-like structure
- A61F 2/915: with bands having a meander structure, adjacent bands being connected to each other
- 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
- A61L 31/005: {Ingredients of undetermined constitution or reaction products thereof}
- A61L 31/022: {Metals or alloys}
- A61L 31/088: {Other specific inorganic materials not covered by A61L31/084 or A61L31/086}
- A61L 31/10: Macromolecular materials
- A61L 31/14: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials}
- A61L 31/148: {Materials at least partially resorbable by the body}
- A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)}
- A61P 9/04: Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
- A61P 35/00: Antineoplastic agents
- A61B 17/12109: {in a blood vessel}
- A61B 2017/00588: {Rigid or stiff implements, e.g. made of several rigid parts linked by hinges}
- A61B 2017/00592: {Elastic or resilient implements}
- A61B 2017/00632: {Occluding a cavity, i.e. closing a blind opening}
- A61F 2002/91575: {connected peak to trough}
- A61F 2002/91583: {by a bridge, whereby at least one of its ends is connected along the length of a strut between two consecutive apices within a band}
- A61F 2210/0004: bioabsorbable
- A61F 2210/0009: using materials or accessories for preventing galvanic or electrolytic corrosion
- A61F 2210/0076: multilayered, e.g. laminated structures
- A61F 2230/0069: cylindrical
- A61F 2250/003: differing in adsorbability or resorbability, i.e. in adsorption or resorption time
- A61F 2250/0067: Means for introducing or releasing pharmaceutical products into the body
- A61F 2310/00041: Magnesium or Mg-based alloys
- A61F 2310/00065: Manganese or Mn-based alloys
- A61L 2300/416: Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
- A61L 2300/64: Animal cells
- A61L 2400/12: Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
- A61L 2420/02: Methods for coating medical devices
- A61L 2420/04: Coatings containing a composite material such as inorganic/organic, i.e. material comprising different phases
- A61L 2420/08: Coatings comprising two or more layers
- B82Y 5/00: Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- B82Y: SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES

## Abstract

A biodegradable in vivo supporting device is disclosed. The in vivo supporting device comprises a biodegradable metal scaffold and a biodegradable polymer coating covering at least a portion of the biodegradable metal scaffold, wherein the biodegradable polymer coating has a degradation rate that is faster than the degradation rate of the biodegradable metal scaffold.

## Claims

### Claim 1

An in vivo supporting device, comprising:
a biodegradable metal scaffold; and
a biodegradable polymer coating covering at least a portion of said biodegradable metal scaffold,
wherein said biodegradable polymer coating has a thickness of 10-200 μm and a degradation rate that is different than the degradation rate of said biodegradable metal scaffold,
wherein said biodegradable metal scaffold comprises an alloy,
wherein the alloy comprises magnesium, manganese, and at least one rare earth metal,
wherein the biodegradable metal scaffold comprises metal struts,
wherein the biodegradable polymer coating partially covers the metal struts, but does not cover openings between the struts, and
wherein the struts from the biodegradable metal scaffold are fully encapsulated by the biodegradable polymer coating and the coated struts and openings therebetween are fully covered by the biodegradable polymer covering.

### Claim 2 (depends on 1)

The in vivo supporting device of claim 1, wherein said alloy has a magnesium content of 96-97.9 wt. %, a manganese content of 1.6-2 wt. %, and at least one rare earth metal in the amount of 0.5-2 wt. %.

### Claim 3 (depends on 1)

The in vivo supporting device of claim 1, wherein said biodegradable metal scaffold comprises metal struts, wherein said metal struts are covered by said biodegradable polymer coating, wherein said coating has one or more holes that allow direct contact of the metal strut with a body fluid when said supporting device is placed inside a body lumen.

### Claim 4 (depends on 1)

The in vivo supporting device of claim 1, further comprising a biodegradable polymer covering that covers the exterior surface of said metal scaffold, including openings between said metal struts.

### Claim 5 (depends on 4)

The in vivo supporting device of claim 4, wherein said covering comprises an agent that prevents or reduces the post-implantation hyperplastic response.

### Claim 6 (depends on 1)

The in vivo supporting device of claim 1, wherein the in vivo supporting device is a heart failure closure device for atrial septal defect (ASD), patent foramen ovale (PFO) or ventricular septal defect (VSD) or a device for fistula and aneurysm closures.

### Claim 7 (depends on 1)

The in vivo supporting device of claim 1, wherein said outer layer comprises a first agent that prevents or reduces the post-implantation hyperplastic response.

### Claim 8 (depends on 7)

The in vivo supporting device of claim 7, wherein said inner layer comprises a second agent that prevents or reduces the post-implantation hyperplastic response.

### Claim 9 (depends on 1)

The in vivo supporting device of claim 1, wherein said biodegradable metal scaffold is a self-expandable scaffold that expands after implantation and wherein said biodegradable polymer coating is an elastic coating that expands with said biodegradable metal scaffold.

### Claim 10 (depends on 1)

The in vivo supporting device of claim 1, wherein said biodegradable polymer coating comprises an agent that prevents or reduces the post-implantation hyperplastic response.

### Claim 11 (depends on 1)

The in vivo supporting device of claim 1, wherein said biodegradable metal scaffold is a self-expandable scaffold that expands after implantation and wherein said biodegradable polymer coating is a coating that forms fissures when said biodegradable metal scaffold is expands in vivo.

### Claim 12 (depends on 11)

The in vivo supporting device of claim 11, wherein said biodegradable polymer coating is permeable to body fluid.

### Claim 13 (depends on 1)

The in vivo supporting device of claim 1, wherein said biodegradable metal scaffold constitutes less than 50 wt % of said supporting device.

### Claim 14 (depends on 1)

The in vivo supporting device of claim 1, wherein said supporting device comprises magnesium as a minor component.

### Claim 15 (depends on 1)

The in vivo supporting device of claim 1, wherein said biodegradable metal scaffold has a magnesium content that is less than 50 wt % of said supporting device.

### Claim 16 (depends on 1)

The in vivo supporting device of claim 1, wherein said biodegradable polymer coating comprises a biodegradable polymer and metal particles.

### Claim 17 (depends on 16)

The in vivo supporting device of claim 16, wherein said metal particles are nanoparticles.

### Claim 18 (depends on 1)

The in vivo supporting device of claim 1, wherein said biodegradable polymer is an elastic coating that allows the device to be used in non-conforming lesions.