# US 12,005,212 B2 · Medical balloon with coextruded radiopaque portion

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- Number: US 12,005,212 B2
- Document ID: US12005212B2
- Status: Granted
- Kind: B2
- Application number: 17/225,193
- Filed: 2021-04-08
- Published: 2021-07-22
- Granted: 2024-06-11
- Earliest claimed: 2012-03-09
- Assignees: Clearstream Technologies Limited
- Applicants: Clearstream Technologies Limited
- Inventors: Pat Byrne; Paul Fillmore; Justin Hall; Margo Shannon Underwood
- Web page: https://patentgrep.com/patent/US12005212B2

## CPC

- A61M 25/104: {used for angioplasty}
- 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 48/022: {characterised by the choice of material}
- B29C 48/09: Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
- B29C 48/18: the components being layers
- A61M 2025/1031: {Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface}
- A61M 2025/105: {having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes}
- A61M 2025/1079: {having radio-opaque markers in the region of the balloon}
- 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)

## Abstract

A balloon catheter includes an elongated, tubular shaft having a proximal end and a distal end, and a balloon positioned along the distal end of the shaft. A portion of a wall of the balloon partially comprises a coextruded radiopaque material. Related aspects and methods are also disclosed.

## Claims

### Claim 1

A method of forming a parison for forming a balloon for a balloon catheter, comprising:
forming a tube as the parison by coextruding a radiopaque-enhanced material and a non-radiopaque-enhanced material in an intermittent fashion.

### Claim 2 (depends on 1)

The method of claim 1, further including the step of creating a balloon from the tube, the balloon having generally conical sections and a generally cylindrical section between the generally conical sections.

### Claim 3 (depends on 2)

The method of claim 2, further including the step of creating a balloon from the tube, the balloon having generally conical sections and a generally cylindrical section between the generally conical sections.

### Claim 4 (depends on 1)

The method of claim 1, wherein the forming step comprises providing a radiopaque strip along portions of the tube.

### Claim 5 (depends on 1)

The method of claim 1, wherein the coextruding comprises coextruding the radiopaque material with the non-radiopaque material in an overlapping manner to provide the tube with multiple layers.

### Claim 6 (depends on 1)

The method of claim 1, wherein the coextruding comprises using a first die with one or more ports for the radiopaque-enhanced material corresponding to a desired number of radiopaque portions of the tube, and a second, adjacent die with ports for providing the non-radiopaque material of the tube.

### Claim 7

A method of forming a parison for forming a balloon for a balloon catheter, comprising:
forming a tube as the parison by coextruding a radiopaque-enhanced material and a non-radiopaque-enhanced material together at different time intervals.

### Claim 8 (depends on 7)

The method of claim 7, further including the step of creating a balloon with the tube, the balloon having generally conical sections and a generally cylindrical section between the generally conical sections.

### Claim 9 (depends on 7)

The method of claim 7, wherein the forming step comprises providing a radiopaque strip along portions of the tube.

### Claim 10 (depends on 9)

The method of claim 9, further including the step of creating a balloon from the tube, the balloon having generally conical sections and a generally cylindrical section between the generally conical sections.

### Claim 11 (depends on 7)

The method of claim 7, wherein the coextruding step comprises coextruding the radiopaque material with the non-radiopaque material in an overlapping manner to provide the partially radiopaque tube with multiple layers.

### Claim 12 (depends on 7)

The method of claim 7, wherein the coextruding step comprises using a first die with one or more ports for the radiopaque-enhanced material corresponding to a desired number of radiopaque portions of the tube, and a second, adjacent die with ports for providing the non-radiopaque material of the tube.

### Claim 13

A method of forming a parison for forming a balloon for a balloon catheter, comprising:
forming a tube as the parison by coextruding a first material having a radiopacifier with a second material; and
adjusting an amount of radiopacity provided by the first material during the coextruding, wherein the adjusting step is performed by controlling an amount of radiopacifier in the first material.

### Claim 14 (depends on 13)

The method of claim 13, further including the step of creating a balloon with the tube, the balloon having generally conical sections and a generally cylindrical section between the conical sections.

### Claim 15 (depends on 13)

The method of claim 13, wherein the coextruding step comprises coextruding the first material and the second material in an overlapping manner to provide the tube with multiple layers.

### Claim 16 (depends on 13)

The method of claim 13, wherein the forming step comprises providing the first material so as to form strips only along a portion of the tube.

### Claim 17 (depends on 13)

The method of claim 13, wherein the coextruding step comprises using a first die with one or more ports for the first material corresponding to a desired number of radiopaque portions of the tube, and a second, adjacent die with ports for providing the second material of the tube.
