# US 9,005,508 B2 · Air disengagement assembly and method for manufacturing dip-molded articles out of RTV silicone by fully automated process

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- Number: US 9,005,508 B2
- Document ID: US9005508B2
- Status: Granted
- Kind: B2
- Application number: 14/095,841
- Filed: 2013-12-03
- Published: 2014-04-24
- Granted: 2015-04-14
- Earliest claimed: 2010-05-11
- Assignees: Polyzen Inc.
- Applicants: Polyzen Inc.
- Inventors: Tilak M. Shah; Medhadakshina Murty Peri
- Web page: https://patentgrep.com/patent/US9005508B2

## CPC

- B05C 11/00: Component parts, details or accessories not specifically provided for in groups B05C1/00 - B05C9/00 (means for manipulating or holding work B05C13/00; enclosures for apparatus, booths B05C15/00; spray booths B05B16/00)
- B05C 3/09: for treating separate articles
- B29C 41/14: Dipping a core {(B29C41/10 takes precedence)}
- A61F 2/12: Mammary prostheses
- A61F 2240/001: Designing or manufacturing processes
- A61M 25/1029: {Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril}
- B29K 2019/00: Use of rubber not provided for in a single one of main groups {B29K2007/00 - B29K2011/00,} as moulding material
- B05C: APPARATUS FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL (spraying apparatus, atomising apparatus, nozzles B05B; plant for applying liquids or other fluent materials to objects by electrostatic spraying B05B5/08)
- 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)
- 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)
- 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)}
- 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 automated mandrel dip coating process assembly for RTV silicone dispersions is described, including an enclosure adapted to hold a moisture-cure ambient temperature curable medium for mandrel dip molding and at least one mandrel having a surface for contacting the moisture-cure ambient temperature curable medium. An automated motive drive assembly is arranged to removably translate one or more of the mandrel(s) into contact with the moisture-cure ambient temperature curable medium in the enclosure, and to subsequently translate at least one mandrel contacted with the moisture-cure ambient temperature curable medium into at least one of (A) contact with a bubble crusher in the enclosure, and (B) disengagement from the moisture-cure ambient temperature curable medium in the enclosure and rotation of the mandrel at a vertical displacement angle of from 70° to 110°. By such arrangement, air bubble entrapment on the dip molded film on the mandrel is avoided, and controlled film thickness is achieved at desired location(s) so that the product molded film article is free of pinholes and air bubble inclusions in the film, and complies with desired thickness specifications.

## Claims

### Claim 1

A mandrel coating method, comprising:
providing an enclosure adapted to hold a moisture-cure ambient temperature curable medium for mandrel dip molding;
actuating a motive drive assembly to translate at least one mandrel into contact with a moisture-cure ambient temperature curable medium in said enclosure for coating of said mandrel with such curable medium; and
thereafter, by continued action of said motive drive assembly, translating the at least one mandrel contacted with the moisture-cure ambient temperature curable medium into at least one of (A) contact with a bubble crusher in the enclosure, and (B) disengagement from the moisture-cure ambient temperature curable medium in the enclosure and rotation of the at least one mandrel at a vertical displacement angle of from 70° to 110°.

### Claim 2 (depends on 1)

The method of claim 1, wherein the at least one mandrel is contacted with a bubble crusher in the enclosure.

### Claim 3 (depends on 2)

The method of claim 2, wherein the bubble crusher includes a resiliently deformable material arranged for contact with the mandrel surface to crush air bubbles entrapped in said moisture-cure ambient temperature curable medium thereon.

### Claim 4 (depends on 3)

The method of claim 3, wherein said resiliently deformable material comprises sponge material.

### Claim 5 (depends on 4)

The method of claim 4, wherein said sponge material is arranged as a layer on a floor of the enclosure.

### Claim 6 (depends on 1)

The method of claim 1, including a solvent-resistant liner in said enclosure to hold the moisture-cure ambient temperature curable medium therein.

### Claim 7 (depends on 1)

The method of claim 1, wherein said motive drive assembly is programmably arranged to translate said at least one mandrel for curing of said moisture-cure ambient temperature curable medium on the mandrel in exposure to an ambient air environment of the mandrel coating assembly.

### Claim 8 (depends on 7)

The method of claim 7, wherein said motive drive assembly is programmably arranged for translation of said mandrel for said exposure to said ambient air environment of the mandrel coating assembly according to a temperature/humidity/time relationship.

### Claim 9 (depends on 1)

The method of claim 1, wherein said motive drive assembly is arranged to rotate one or more of said at least one mandrel.

### Claim 10 (depends on 1)

The method of claim 1, wherein said motive drive assembly is arranged to rotate said at least one mandrel during curing of the moisture-cure ambient temperature curable medium thereon.

### Claim 11 (depends on 1)

The method of claim 1, as carried out to manufacture an implantable medical device.

### Claim 12 (depends on 11)

The method of claim 11, wherein the implantable medical device comprises a device selected from the group consisting of breast implants, saline solution-filled breast implants, space-occupying balloon devices, and non-silicone gel filled devices.

### Claim 13 (depends on 11)

The method of claim 11, wherein the implantable medical device comprises a thin-wall device having wall thickness of less than 0.30 inch (0.76 cm).
