INFLATABLE MEDICAL DEVICES

• US 20100241153A1
• Filed: 06/02/2009
• Published: 09/23/2010
• 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, ADAMS, Christopher Michael, DOWNS, Roland J., HOLWEGER, Jon Michael
• Granted Patent: US 9,504,811 B2
• Time in Patent Office: Days
• US Class Current: 606/191
• 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 defining a longitudinal axis having a longitudinal axis length, the balloon comprising a fiber having a fiber length, wherein the fiber length is from about 175% to about 300% of the longitudinal axis length.

2. The device of claim 1, wherein the fiber is parallel with the longitudinal axis.

3. The device of claim 1, wherein the fiber is unspiraled.

4. The device of claim 1, wherein the balloon comprises a wall comprising a layer, and wherein the fiber is in the layer, and wherein the layer comprises a resin contacting the fiber.

5. The device of claim 1, wherein the balloon comprises a wall comprising a first layer and a second layer, and wherein the fiber is in a second layer, and wherein the first layer is radially inside of the fiber, and wherein the first layer is leak-proof.

6. The device of claim 1, wherein the balloon comprises a wall comprising a first layer and a second layer, and wherein the fiber is in a second layer, and wherein the first layer is radially outside of the fiber, and wherein the first layer is MMA-resistant.

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

a balloon comprising a wall comprising a reinforcement fiber, wherein the balloon has a proximal terminal end and a distal terminal end, and wherein the balloon has no longitudinal through-lumen extending through the proximal terminal end and through the distal terminal end, and wherein the reinforcement fiber is in a matrix.

8. The device of claim 7, wherein the reinforcement fiber is oriented parallel with a balloon longitudinal axis, and wherein the reinforcement fiber extends around the distal terminal end of the balloon.

9. The device of claim 7, wherein the balloon has a balloon area and wherein the fiber is congruent with about 50% or more of the balloon area.

10. The device of claim 7, wherein the matrix comprises a thermoplastic material.

11. The device of claim 7, wherein the matrix comprises a urethane.

12. The device of claim 7, wherein the matrix comprises a polyether block amide.

13. The device of claim 7, wherein the matrix comprises a polyamide.

14. The device of claim 7, wherein the matrix comprises an epoxy.

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

a balloon comprising a wall comprising a first strip and a second strip, wherein the first strip comprises a fiber, and wherein the second strip comprises a fiber;

wherein the balloon has a closed distal end, and wherein the second strip overlays the first strip at the distal end.

16. The device of claim 15, wherein the first strip has a first strip longitudinal axis, and wherein the second strip has a second strip longitudinal axis, and wherein the first strip longitudinal axis intersects the second strip longitudinal axis forming a first strip-second strip angle at the distal end, and wherein the first strip-second strip angle is greater than or equal to about 30 degrees.

17. The device of claim 15, wherein the first strip and the second strip each comprise a fiber.

18. The device of claim 15, wherein the first strip and the second strip comprise no fiber.

19. The device of claim 15, wherein the first strip-second strip angle is greater than or equal to about 45 degrees.

20. The device of claim 15, wherein the first strip-second strip angle is about 90 degrees.

21. The device of claim 15, wherein the first strip-second strip angle is about 60 degrees.

22. The device of claim 15, further comprising a third strip, and wherein the third strip overlays the distal end and wherein the third strip has a third strip longitudinal axis

23. The device of claim 22, wherein the third strip longitudinal axis intersects the second strip longitudinal axis forming a second strip-third strip angle at the distal end, and wherein the second strip-third strip angle is greater than or equal to about 30 degrees..

24. The device of claim 23, wherein the first strip-second strip angle is about 60 degrees and wherein the second strip-third strip angle is about 60 degrees.

25. The device of claim 15, wherein the first strip has a first length, and wherein the first strip along the first length has a first width, and wherein the first strip has a second length adjacent to the first length, and wherein the first strip along the second length has a second width larger than the first width, and wherein the first strip along the second length tapers to the first strip along the first length, and wherein the first strip has a third length adjacent to the second length, and wherein the first strip along the third length has a substantially round shape.

26. The device of claim 15, wherein the first strip has a fourth length adjacent to the third length, and wherein the first strip along the fourth length has a fourth width, and wherein the first strip has a fifth length adjacent to the fourth length, and wherein the first strip along the fifth length has a fifth width smaller than the fourth width, and wherein the first strip along the fourth length tapers to the first strip along the fifth length.

27. The device of claim 15, wherein the first strip has a first strip longitudinal axis, and wherein the second strip has a second strip longitudinal axis, and wherein the first strip longitudinal axis intersects the second strip longitudinal axis forming a first strip-second strip angle at the distal end, and wherein the first strip-second strip angle is greater than about 30 degrees

28. The device of claim 15, wherein the second strip has a first length, and wherein the second strip along the first length has a first width, and wherein the second strip has a second length adjacent to the first length, and wherein the second strip along the second length has a second width larger than the first width, and wherein the second strip along the second length tapers to the second strip along the first length, and wherein the second strip has a third length adjacent to the second length, and wherein the second strip along the third length has a substantially round shape.

29. The device of claim 28, wherein the first strip has a first strip longitudinal axis, and wherein the second strip has a second strip longitudinal axis, and wherein the first strip longitudinal axis intersects the second strip longitudinal axis forming a first strip-second strip angle at the distal end, and wherein the first strip-second strip angle is greater than about 30 degrees

30. The device of claim 28, wherein the second strip has a fourth length adjacent to the third length, and wherein the second strip along the fourth length has a fourth width, and wherein the second strip has a fifth length adjacent to the fourth length, and wherein the second strip along the fifth length has a fifth width smaller than the fourth width, and wherein the second strip along the fourth length tapers to the second strip along the fifth length.

31. The device of claim 15, wherein the first strip has a substantially constant thickness along the second length, third length, and fourth length.