Inflatable medical devices

• US 8,708,955 B2
• Filed: 06/02/2009
• Issued: 04/29/2014
• Est. Priority Date: 06/02/2008
• Status: Active Grant

• Current Assignee: Loma Vista Medical, Inc. (Becton, Dickinson & Co)
• Original Assignee: Loma Vista Medical, Inc. (Becton, Dickinson & Co)
• Inventors: Tilson, Alexander Quillin, Scheeff, Mark Christopher
• Primary Examiner(s): FLICK, JASON E
• Application Number:
  US12/477,084
• Publication Number:
  US 20090306589A1
• Time in Patent Office: 1,792 Days
• Field of Search: 604/103.1
• US Class Current: 604/103.1
• CPC Class Codes: A61B 17/8816 characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections
• CPC Class Codes: A61B 17/8827 with filtering, degassing, venting or pressure relief means
• CPC Class Codes: A61B 17/8833 Osteosynthesis tools specially adapted for handling bone cement or fluid fillers; Means for supplying bone cement or fluid fillers to introducing tools, e.g. cartridge handling means
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61M 2025/1031 Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2025/1088 having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 2025/1097 with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
• CPC Class Codes: A61M 2210/02 Bones
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: 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
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: B29C 41/04 : Rotational or centrifugal casting, i.e. coating the inside of a mould by rotating the mould
• CPC Class Codes: B29C 41/14 : Dipping a core B29C41/10 takes precedence
• CPC Class Codes: Y10T 156/1028 : by bending, drawing or stretch forming sheet to assume shape of configured lamina while in contact therewith
• CPC Class Codes: Y10T 156/108 : Flash, trim or excess removal

Abstract

Inflatable medical devices and methods for making and using the same are disclosed. The inflatable medical devices can be medical balloons. The balloons can be configured to have a through-lumen or no through-lumen and a wide variety of geometries. The device can have a high-strength, non-compliant, fiber-reinforced, multi-layered wall. The inflatable medical device can be used for angioplasty, kyphoplasty, percutaneous aortic valve replacement, or other procedures described herein.

Claims

1. An inflatable device for use in a biological body comprising

a balloon comprising a wall comprising an inner layer, a first middle layer, a second middle layer, and an outer layer, the first middle layer and the second middle layer between the inner layer and the outer layer,

wherein the first middle layer comprises at least one radiopaque element,

wherein the second middle layer comprises at least one reinforcement fiber, and

wherein the at least one radiopaque element and the at least one reinforcement fiber are oriented within the balloon such that the balloon has a compression ratio of at least 3:

1.

2. The device of claim 1, wherein the compression ratio is at least 4:

1.

3. The device of claim 1, wherein the compression ratio is 5:

1.

4. The device of claim 1, wherein the compression ratio is 6:

1.

5. The device of claim 1, wherein the balloon has a packing density of greater than about 40%.

6. The device of claim 5, wherein the packing density is greater than about 55%.

7. The device of claim 5, wherein the packing density is greater than about 70%.

8. The device of claim 1, wherein the radiopaque element is a foil or a wire.

9. An inflatable device for use in a biological body comprising:

a balloon comprising a wall comprising an inner layer, a first middle layer, a second middle layer, and an outer layer, the first middle layer and the second middle layer between the inner layer and the outer layer,

wherein the first middle layer comprises at least one radiopaque element,

wherein the second middle layer comprises at least one reinforcement fiber, and

wherein the at least one radiopaque element and the at least one reinforcement fiber are provided within the balloon wall such that the balloon has a compression ratio of at least 3;

1.

10. The device of claim 9, wherein the compression ratio is at least 4:

1.

11. The device of claim 9, wherein the compression ratio is 5:

1.

12. The device of claim 9, wherein the compression ratio is 6:

1.

13. An inflatable device for use in a biological body comprising:

a balloon comprising a wall comprising an inner layer, a first middle layer, a second middle layer, and an outer layer, the first middle layer and the second middle layer between the inner layer and the outer layer,

wherein the first middle layer comprises at least one radiopaque element,

wherein the second middle layer comprises at least one reinforcement fiber, and

wherein the at least one radiopaque element and the at least one reinforcement fiber are provided within the balloon wall and the balloon wall is arranged such that the balloon has a compression ratio of at least 3;

1.

14. The device of claim 13, wherein the compression ratio is at least 4:

1.

15. The device of claim 13, wherein the compression ratio is 5:

1.

16. The device of claim 13, wherein the compression ratio is 6:

1.