# US 10,869,994 B2 · Apparatuses and methods for providing radiopaque medical balloons

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- Number: US 10,869,994 B2
- Document ID: US10869994B2
- Status: Granted
- Kind: B2
- Application number: 14/915,064
- Filed: 2014-08-28
- Published: 2016-07-21
- Granted: 2020-12-22
- Earliest claimed: 2013-08-28
- Assignees: Clearstream Technologies Limited
- Applicants: Clearstream Technologies Limited; Hiep Do; Andrew Schaffer
- Inventors: Hiep Do; Andrew Schaffer; Paul Fillmore
- Web page: https://patentgrep.com/patent/US10869994B2

## CPC

- A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00})
- 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}
- B29C 48/0017: {combined with blow-moulding or thermoforming}
- B29C 48/0022: {combined with cutting}
- B29C 48/09: Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
- B29C 49/04114: {for keeping constant thickness}
- B29C 51/008: {without using a mould, e.g. ballooning (as prestretching step B29C51/06)}
- A61M 2025/1031: {Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface}
- A61M 2025/1079: {having radio-opaque markers in the region of the balloon}
- B29K 2105/258: {Tubular}
- B29L 2031/7543: {Balloon catheters}
- 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)}
- 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)
- 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
- B29L: INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES

## Abstract

A medical balloon is provided for which the working surface may be identified during an interventional procedure with enhanced precision. Related methods of manufacturing such a balloon are also disclosed.

## Claims

### Claim 1

A method of providing a medical balloon or a parison for forming a medical balloon with a radiopaque portion, comprising:
inserting a mandrel and a radiopaque material into the medical balloon or the parison; and
expanding the mandrel.

### Claim 2 (depends on 1)

The method of claim 1, wherein the radiopaque material comprises a film inserted into the parison prior to the inserting of the mandrel.

### Claim 3 (depends on 1)

The method of claim 1, further including the step of removing the mandrel after the expanding step.

### Claim 4 (depends on 3)

The method of claim 3, wherein the mandrel is adapted to deposit the radiopaque material on an interior surface of the medical balloon or parison during the expanding step.

### Claim 5 (depends on 1)

The method of claim 1, wherein the mandrel is partially flexible.

### Claim 6 (depends on 1)

The method of claim 1, wherein the mandrel comprises expandable interwoven struts.

### Claim 7 (depends on 1)

The method of claim 1, wherein the mandrel comprises a compliant balloon.

### Claim 8 (depends on 1)

The method of claim 1, further including the step of blow molding the parison to form a medical balloon after the expanding step.

### Claim 9 (depends on 1)

The method of claim 1, further including the step of applying a solution including the radiopaque material to the mandrel prior to the inserting step.

### Claim 10 (depends on 1)

The method of claim 1, further including the step of expanding the parison to form the medical balloon prior to the inserting and expanding steps.

### Claim 11 (depends on 1)

The method of claim 1, wherein the radiopaque material comprises one or more radiopaque fibers associated with the mandrel, and the step of expanding the mandrel is completed to associate the radiopaque fibers with the parison or the medical balloon.

### Claim 12 (depends on 1)

The method of claim 1, wherein the radiopaque material comprises one or more radiopaque fibers, and the method comprises adhesively attaching the fibers to an interior surface of the parison or the medical balloon.

### Claim 13 (depends on 1)

The method of claim 1, wherein the radiopaque material comprises one or more radiopaque fibers, and the method comprises adhesively attaching the fibers to the parison or the medical balloon.

### Claim 14 (depends on 1)

The method of claim 1, wherein the radiopaque material comprises a lattice.

### Claim 15

A method of providing a medical balloon or a parison for forming a medical balloon with a radiopaque portion, comprising:
inserting an inflatable mandrel and a radiopaque material into the medical balloon or the parison; and
expanding the mandrel.

### Claim 16 (depends on 14)

The method of claim 14, further including the step of blow molding the parison to form a medical balloon after the expanding step.

### Claim 17 (depends on 14)

The method of claim 14, wherein the mandrel comprises expandable interwoven struts.

### Claim 18 (depends on 14)

The method of claim 14, wherein the mandrel comprises a compliant balloon.

### Claim 19

A method of providing a medical balloon, comprising:
inserting an inflatable mandrel and a radiopaque material into a parison;
expanding the mandrel; and
blow molding the parison into the medical balloon.

### Claim 20 (depends on 19)

The method of claim 19, wherein the mandrel is inflatable.
