INFLATABLE MEDICAL DEVICES

• US 20090299327A1
• Filed: 06/02/2009
• Published: 12/03/2009
• Est. Priority Date: 06/02/2008
• Status: Abandoned Application

• Current Assignee: Loma Vista Medical, Inc. (Becton, Dickinson & Co)
• Original Assignee: Lorna Vista Medical Incorporated
• Inventors: SCHEEFF, Mark Christopher, TILSON, Alexander Quillin
• Application Number:
  US12/476,848
• Publication Number:
  US 20090299327A1
• Time in Patent Office: Days
• US Class Current: 604/500
• 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 system for use in a biological body comprising:

a balloon;

a reservoir;

a fluid in the reservoir; and

a sealed sterile package, wherein the balloon, the reservoir and the fluid are in the sealed sterile package.

2. The system of claim 1, wherein the reservoir is in fluid communication with the balloon

3. The system of claim 1, further comprising a fluid channel in the sterile package.

4. The system of claim 3, wherein the fluid channel in fluid communication with the balloon.

5. The system of claim 4, wherein the reservoir is in fluid communication with the fluid channel.

6. The system of claim 3, wherein the reservoir is in fluid communication with the fluid channel.

7. The system of claim 1, wherein the fluid comprises a saline solution fluid.

8. The system of claim 1, wherein the fluid comprises a radiopaque fluid.

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

a balloon having a fully inflated state having an inflated volume;

a fluid channel having a fluid channel volume;

a sealed reservoir;

a fluid in the reservoir, wherein the fluid in the reservoir has a fluid volume; and

wherein the fluid volume is within 10% of the sum of the inflated volume and the fluid channel volume.

10. The kit of claim 9, wherein the fluid volume is within 2% of the inflated volume.

11. The kit of claim 9, wherein the sealed reservoir is in fluid communication with the balloon.

12. The kit of claim 9, wherein the fluid channel is in fluid communication with the balloon.

13. The kit of claim 9, wherein the fluid channel is in fluid communication with the reservoir

14. The kit of claim 9, a sealed sterile package, wherein the balloon, the reservoir and the fluid are in the sealed sterile package.

15. A method for using an inflatable device for use at a target site in a biological body, wherein the inflatable device comprises a balloon, the method comprising:

a fluid first channel having an incoming port, the fluid first channel comprising a luer connector at the incoming port; and

the fluid first channel further comprising a check valve and a swabbable valve.

16. The method of claim 15, wherein the swabbable valve is adjacent to the luer connector, and wherein the check valve is downstream from the luer connector.

17. The method of claim 15, further comprising a second channel having a first, second and third port, wherein the first port is in fluid communication with the first channel.

18. The method of claim 17, wherein the second port is covered by a removable cap.

19. The method of claim 17, wherein the third port is in fluid communication with a syringe having a plunger.

20. A method for using an inflatable device for use at a target site in a biological body, wherein the inflatable device comprises a fluid channel, a delivery syringe in fluid communication with the fluid channel, a plunger in the syringe, and a self-sealing valve;

the method comprising;

filling the balloon with a fluid; and

wherein filling comprises inserting a proboscis into a valve, wherein the proboscis is in fluid communication with a fluid source.

21. The method of claim 20, further comprising positioning the balloon at the target site, wherein the balloon is in fluid communication with a fluid channel.