INFLATABLE MEDICAL DEVICES

• US 20100241178A1
• Filed: 06/02/2009
• Published: 09/23/2010
• Est. Priority Date: 06/02/2008
• Status: Abandoned Application

• 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
• Application Number:
  US12/477,048
• Publication Number:
  US 20100241178A1
• Time in Patent Office: Days
• US Class Current: 606/86.R
• 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. A method for using an inflatable device for use at a target site in a biological body comprising:

inserting a working channel through the biological body, wherein the working channel has an inner diameter less than about 5 mm, and wherein the working channel has a distal port, and wherein the distal port is positioned adjacent to, or at, the target site;

delivering a first balloon through the working channel and positioning the first balloon at the target site;

after the delivering of the first balloon, delivering a second balloon through the working channel and positioning the second balloon at the target site while the first balloon is at the target site; and

delivering an unsupported pressure in free air of greater than or equal to about 150 psi to the first balloon.

2. The method of claim 1, wherein the first balloon has a balloon wall and wherein the balloon wall has a balloon wall area, and wherein the working channel has a working channel area, and wherein the balloon wall area is greater than or equal to about 55% of the working channel area.

3. The method of claim 1, further comprising delivering an unsupported pressure of greater than 200 psi to the second balloon.

4. The method of claim 1, further comprising inflating the first balloon

5. The method of claim 4, further comprising inflating the second balloon while the first balloon is inflated.

6. The method of claim 4, further comprising inflating the second balloon concurrent with inflating the first balloon.

7. The method of claim 1, further comprising deflating the first balloon.

9. The method of claim 1, wherein the first balloon is in fluid communication with a first fluid channel.

10. The method of claim 9, wherein the second balloon is in fluid communication with a second fluid channel.

11. The method of claim 1, wherein the target site is located in a bone.

13. The method of claim 1, further comprising delivering MMA to the target site.

8. The method of Claim I, further comprising removing the first balloon through the working channel.

12. The method of Claim II, wherein the target site is located in a vertebra.

14. A method for using an inflatable device for use at a target site in a biological body comprising:

inserting a working channel through the biological body, wherein the working channel has an inner diameter less than about 5 mm, and wherein the working channel has a distal port, and wherein the distal port is positioned adjacent to, or at, the target site;

delivering a first balloon through the working channel and positioning the first balloon at the target site; and

delivering a second balloon through the working channel and positioning the second balloon at the target site, and

wherein the first balloon is attached to a first deployment system and the second balloon is attached to a second deployment system, and wherein the position and orientation of the first deployment system is manipulatable separate from the position and orientation of the second deployment system; and

delivering an unsupported pressure of greater than about 150 psi to the first balloon.

15. The method of claim 14, wherein delivering the second balloon comprises delivering the second balloon while the first balloon is at the target site.

16. The method of claim 14, further comprising inflating the first balloon

17. The method of claim 16, further comprising inflating the second balloon while the first balloon is inflated.

18. The method of claim 16, further comprising inflating the second balloon concurrent with inflating the first balloon.

19. The method of claim 14, wherein the first balloon is in fluid communication with a first fluid channel.

20. The method of claim 19, wherein the second balloon is in fluid communication with a second fluid channel.

21. The method of claim 14, wherein the target site is located in a vertebra.

22. The method of claim 14, further comprising delivering MMA to the target site.

23. A method for using an inflatable device for use at a target site in a biological body comprising:

inserting a working channel through the biological body, wherein the working channel has an inner diameter less than about 5 mm, and wherein the working channel has a distal port, and wherein the distal port is positioned adjacent to or at the target site;

delivering a first balloon through the working channel and positioning the first balloon at the target site;

delivering a second balloon through the working channel and positioning the second balloon at the target site concurrent with delivering a first balloon through the working channel; and

delivering an unsupported pressure of greater than about 150 psi to the first balloon.

24. The method of claim 23, further comprising delivering MMA to the target site.

25. A method for using an inflatable device for use at a target site having a target site first segment and a target site second segment in a biological body comprising:

inserting a first working channel through the biological body, and wherein the first working channel has a first distal port, and wherein the first distal port is positioned adjacent to or at the target site first segment;

inserting a second working channel through the biological body, and wherein the second working channel has a second distal port, and wherein the second distal port is positioned adjacent to or at the target site second segment;

26. The method of claim 25, further comprising:

delivering a first balloon through the first working channel and positioning the first balloon at the target site first segment;

delivering a second balloon through the second working channel and positioning the second balloon at the target site second segment; and

delivering an unsupported pressure of greater than about 150 psi to the first balloon.

27. The method of claim 25, wherein the first working channel has an inner diameter less than about 5 mm.

28. The method of claim 25, wherein delivering the second balloon comprises delivering the second balloon concurrent with delivering a first balloon through the working channel.