# US 11,433,161 B2 · Autonomously growing implantable device

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- Number: US 11,433,161 B2
- Document ID: US11433161B2
- Status: Granted
- Kind: B2
- Application number: 17/146,464
- Filed: 2021-01-11
- Published: 2021-07-08
- Granted: 2022-09-06
- Earliest claimed: 2016-02-16
- Assignees: Children's Medical Center Corporation; The Brigham and Women's Hospital, Inc.
- Applicants: Children's Medical Center Corporation; The Brigham and Women's Hospital, Inc.
- Inventors: Eric N. Feins; Pedro J. del Nido; Nikolay V. Vasilyev; Haruo Yamauchi; Douglas P. Perrin; Peter E. Hammer; Veaceslav Arabagi; Jeffrey M. Karp; Yuhan Lee; Eoin D. O'Cearbhaill
- Web page: https://patentgrep.com/patent/US11433161B2

## CPC

- A61L 27/16: obtained by reactions only involving carbon-to-carbon unsaturated bonds
- A61B 17/04: for suturing wounds; Holders or packages for needles or suture materials
- A61B 17/7002: {Longitudinal elements, e.g. rods}
- A61F 2/2445: {Annuloplasty rings in direct contact with the valve annulus}
- A61F 2/28: Bones
- A61F 2/2846: {Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects (nets or sleeves applied to surface of endoprostheses A61F2/30907; bone plates A61B17/80; bone regeneration in dental surgery A61C8/0006)}
- A61L 27/04: Metals or alloys
- A61L 27/14: Macromolecular materials
- A61L 27/18: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
- A61L 27/34: Macromolecular materials
- A61L 27/50: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials}
- A61L 27/58: Materials at least partially resorbable by the body
- B29C 67/24: characterised by the choice of material
- C08G 63/16: Dicarboxylic acids and dihydroxy compounds
- C08G 63/916: {Dicarboxylic acids and dihydroxy compounds}
- A61B 2017/00862: {elastic or resilient}
- A61F 2002/2892: {Tibia}
- A61F 2002/30062: {(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive}
- A61F 2002/30069: {elastomeric}
- A61F 2002/30224: {cylindrical}
- A61F 2002/30706: {specially designed for children, e.g. having means for adjusting to their growth}
- A61F 2230/0069: cylindrical
- A61F 2250/0007: for adjusting length
- A61F 2250/0082: specially designed for children, e.g. having means for adjusting to their growth
- B29K 2995/006: Bio-degradable, e.g. bioabsorbable, bioresorbable or bioerodible
- 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)
- 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)
- B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00)
- C08G: MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
- B29K: INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR {MOULDS, } REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS

## Abstract

An implantable, autonomously growing medical device is disclosed. The device may have an outer, braided outer element that holds an inner core. Degradation and/or softening of the inner core permits the outer element to elongate, allowing the device to grow with surrounding tissue. The growth profile of the medical device can be controlled by altering the shape/material/cure conditions of the inner core, as well as the geometry of the out element.

## Claims

### Claim 1

A method of forming a biodegradable polymer, comprising:
polycondensation of an equimolar ratio of glycerol and sebacic acid at 120 degrees Celsius (°C) for 8 hours under dry nitrogen and for 16 hours in vacuum to form a pre-polymer; and
curing the pre-polymer in a vacuum at a temperature of 140° C. to 160° C. for 40 to 100 hours.

### Claim 2 (depends on 1)

The method of claim 1, further comprising:
putting the pre-polymer in a mold.

### Claim 3 (depends on 2)

The method of claim 2, wherein the mold is curved.

### Claim 4

A polymer comprising:
a Young's Modulus of greater than 5 megapascals (MPa); and
a crosslinking density of 600 to 12,000 moles per cubic meter,
wherein the polymer is formed from curing a poly(glycerol sebacate) pre-polymer in vacuum at a temperature of 140° C. to 160° C. for 40 to 100 hours.