INFLATABLE MEDICAL DEVICES

• US 20090306589A1
• Filed: 06/02/2009
• Published: 12/10/2009
• 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: SCHEEFF, Mark Christopher, TILSON, Alexander Quillin
• Granted Patent: US 8,708,955 B2
• Time in Patent Office: Days
• US Class Current: 604/103.100
• 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, and an outer layer, wherein the first middle layer is substantially contiguous throughout the wall, and wherein the first middle layer comprises a radiopaque material.

2. The device of claim 1, wherein the balloon is substantially inelastic.

3. The device of claim 1, wherein the first middle layer comprises a metal foil.

4. The device of claim 1, wherein the first middle layer comprises a metal wire.

5. The device of claim 1, wherein the first middle layer can support a substantial tensile load.

6. The device of claim 1, wherein the radiopaque material comprises a radiopaque metal from the group consisting of:

tantalum, platinum, palladium, tungsten, and gold.

7. The device of claim 1, further comprising a second middle layer comprising a fiber, and wherein the second middle layer is between the inner layer and the first middle layer.

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

a non-compliant balloon comprising a wall comprising an inner layer, a first middle layer, and an outer layer, wherein the first middle layer comprises a first elongated strip, and wherein the first elongated strip comprises a first radiopaque material.

9. The device of claim 8, wherein the first elongated strip extends around the distal end of the balloon.

10. The device of claim 8, further comprising a second elongated strip comprising a second radiopaque material.

11. The device of claim 10, wherein the first radiopaque material is the same material as the second radiopaque material.

12. The device of claim 8, wherein the first elongated strip has a first strip longitudinal axis, and wherein the second elongated strip has a second strip longitudinal axis, and wherein the first strip longitudinal axis forms a strip angle with the second strip longitudinal axis at the distal end, and wherein the strip angle is equal to or greater than about 30 degrees.

13. The device of claim 8, wherein the first elongated strip comprises a metal foil.

14. The device of claim 8, wherein the radiopaque material comprises a radiopaque metal from the group consisting of:

tantalum, platinum, palladium, tungsten, and gold.

15. The device of claim 8, further comprising a second middle layer comprising a fiber, and wherein the second middle layer is between the inner layer and the first elongated strip.

16. The device of claim 8, wherein the radiopaque material comprises a radiopaque wire.

17. The device of claim 8, wherein the radiopaque wire is hoop wound around the balloon.

18. The device of claim 8, wherein the first middle layer comprises a fiber.

19. The device of claim 8, wherein the first middle layer comprises a metal foil.

20. The device of claim 8, wherein an axial load is applied to the balloon, the first middle layer at least partially substantially supports the axial load of the balloon.

21. The device of claim 8, wherein when an axial load is applied to the balloon, the second middle layer supports the hoop load of the balloon.

22. The device of claim 8, wherein the radiopaque material comprises tantalum.

23. The device of claim 8, wherein the radiopaque material comprises a radiopaque metal from the group consisting of:

tantalum, platinum, palladium, tungsten, and gold.

24. A non-compliant balloon comprising an outer layer, an inner layer and a radiopaque foil between the outer layer and the inner layer.

25. The device of claim 24, wherein the radiopaque foil comprises metal.

26. The device of claim 25, wherein the metal foil is greater than 8 μ

m thick.

27. The device of claim 25, wherein the metal foil is less than 40 μ

m thick.