SPIRAL PERFUSION DILATATION BALLOON FOR USE IN VALVULOPLASTY PROCEDURE

• US 20120245520A1
• Filed: 03/26/2011
• Published: 09/27/2012
• Est. Priority Date: 03/26/2011
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Kelly, John, Kelly, Brian, Rabarimanantsoa-Jamous, Herinaina
• Granted Patent: US 8,486,014 B2
• Time in Patent Office: Days
• US Class Current: 604/103.09
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61M 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• 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 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• 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 25/104 used for angioplasty

Abstract

A balloon dilatation catheter for use in a valvuloplasty procedure includes a catheter shaft and a spiral perfusion balloon mounted thereon. The perfusion balloon is formed from an inflatable tube that is in fluid communication with a catheter shaft inflation lumen. The inflatable tube is coiled into a series of windings that in an inflated configuration form a cylindrical or hourglass profile. In the inflated configuration, inner surfaces of the coiled windings of the inflatable tube define a perfusion lumen to allow blood flow through the perfusion balloon. Adjacent windings may be secured together with a flexible adhesive and/or a support weave formed from one or more filaments of material that criss-crosses between the adjacent windings along substantially the entire length of the spiral perfusion balloon.

Claims

1. A perfusion dilatation balloon having deflated and inflated configurations, the balloon comprising:

an inflatable tube having an inflation lumen extending therethrough, wherein in the inflated configuration the inflatable tube is coiled into a series of windings that form an hourglass profile having an intermediate section with at least one winding that has a reduced outer diameter relative to an outer diameter of at least one winding in each of a proximal section and a distal section and wherein inner surfaces of the coiled windings of the inflatable tube define a lumen of the perfusion balloon to allow blood flow therethrough;

wherein in the deflated configuration, the windings of the inflatable tube are radially collapsed to a reduced profile smaller than the hourglass profile and wherein the lumen of the perfusion balloon is closed to prevent blood flow therethrough.

2. The perfusion dilatation balloon of claim 1, wherein adjacent windings are maintained in substantial contact with each other in both the inflated and deflated configurations.

3. The perfusion dilatation balloon of claim 1, wherein in the inflated configuration the reduced outer diameter of the at least one winding of the intermediate section is between 75% and 95% of the outer diameter of the at least one winding in each of the proximal and distal sections.

4. The perfusion dilatation balloon of claim 1, wherein in the inflated configuration adjacent windings of the proximal and distal sections gradually decrease in a tapered manner to the intermediate section.

5. The perfusion dilatation balloon of claim 4, wherein in the inflated configuration the proximal and distal sections of windings are mirror images of each other.

6. The perfusion dilatation balloon of claim 1, wherein adjacent windings are bonded together with a flexible adhesive.

7. The perfusion dilatation balloon of claim 1, wherein adjacent windings are secured to each other by a support weave extending along substantially the entire length of the balloon and being formed from one or more filaments woven over and under and criss-crossing between all adjacent windings.

8. The perfusion dilatation balloon of claim 7, wherein a plurality of support weaves are equally spaced around a circumference of the perfusion balloon.

9. A balloon catheter comprising:

a catheter shaft having an inflation lumen; and

a perfusion dilatation balloon mounted on a distal portion of the catheter shaft and being formed from an inflatable tube having a balloon inflation lumen extending therethrough and being in fluid communication with the catheter shaft , wherein in the inflated configuration the tube is coiled into a series of contacting windings that together form an hourglass profile wherein inner surfaces of the coiled windings of the inflatable tube define a lumen of the perfusion dilatation balloon to allow blood flow therethrough;

wherein in a deflated configuration, the windings of the inflatable tube are radially collapsed to a reduced profile smaller than the hourglass profile and wherein the lumen of the perfusion dilatation balloon is closed to prevent blood flow therethrough.

10. The balloon catheter of claim 9, wherein at least a portion of the catheter shaft extends through the perfusion lumen and distally of the perfusion dilatation balloon.

11. The balloon catheter of claim 10, wherein the catheter shaft is positioned off-center within the perfusion lumen and contacts at least a portion of the inner surface of the coiled windings of the inflatable tube.

12. The balloon catheter of claim 9, further comprising:

one or more guide struts that connect a proximal loop of the perfusion dilatation balloon and the catheter shaft and are operable in the deflated configuration to guide the perfusion balloon into a guide catheter.

13. The balloon catheter of claim 9, further comprising:

an elastic sheath that surrounds the perfusion dilatation balloon and elastically expands upon inflation of the perfusion balloon and returns to its original shape during deflation of the perfusion balloon to aid in reducing a profile of the perfusion balloon for removal.

14. The balloon catheter of claim 9, wherein adjacent windings are bonded together with a flexible adhesive.

15. The balloon catheter of claim 9, wherein adjacent windings are secured to each other by a support weave formed from one or more filaments of material that are woven over and under and criss-crossing between all adjacent windings along substantially the entire length of the balloon.

16. A perfusion dilatation balloon comprising:

an inflatable tube having an inflation lumen extending therethrough, wherein the inflatable tube is wrapped into a series of windings the inner surfaces of which define a perfusion lumen to allow blood flow through the perfusion balloon when in an expanded configuration, and wherein adjacent windings of the inflatable tube are secured to each other with a support weave formed from one or more filaments that are woven between all adjacent windings along substantially the entire length of the inflatable tube.

17. The perfusion balloon of claim 16, wherein outer diameters of the windings of the inflatable tube are varied to form a perfusion dilatation balloon with an hourglass profile.

18. The perfusion balloon of claim 16, wherein all the windings of the inflatable tube have substantially the same outer diameter to form a perfusion balloon with a cylindrical profile.

19. The perfusion balloon of claim 16, wherein adjacent windings are also bonded together with a flexible adhesive.

20. The perfusion balloon of claim 16, wherein a plurality of support weaves are equally spaced around the circumference of the perfusion dilatation balloon.