Perfusion balloon with external valve

• US 10,625,058 B2
• Filed: 03/04/2016
• Issued: 04/21/2020
• Est. Priority Date: 03/04/2016
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Gomes, Garrett, Hegde, Anant, Kurniawan, Jonathan, Moll, Andrew, Moore, Cameron, Radochonski, Samuel
• Primary Examiner(s): Orkin, Alexander J
• Application Number:
  US15/061,802
• Publication Number:
  US 20170252544A1
• Time in Patent Office: 1,509 Days
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• 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 2210/125 Heart
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/10185 Valves
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

An apparatus for performing a medical procedure and, in particular, an aortic valvuloplasty, in a vessel for transmitting a flow of fluid. The apparatus includes an inflatable perfusion balloon including an internal passage for permitting the fluid flow in the vessel while the perfusion balloon is in an inflated condition, the balloon including a plurality of cells in a single cross section and a covering for at least partially covering the cells. A valve associated with the balloon controls the fluid flow within the passage, the valve being arranged external to the passage. The valve may form a tubular extension of the covering, or may be separate from the covering, and may comprise flaps. A spiral covering may also form the valve.

Claims

1. An apparatus for performing a medical procedure in a vessel for transmitting a flow of blood, comprising:

a catheter including a guidewire lumen, the catheter having a distal end supporting an inflatable perfusion balloon including an internal passage having a plurality of entrances for permitting the blood flow in the vessel while the perfusion balloon is in an inflated condition; and

a valve associated with the balloon for controlling the blood flow within the passage, the valve comprising an extension for selectively covering the plurality of entrances to the passage to control the blood flow therein;

wherein the extension comprises a tube having a generally circular, continuous cross section; and

wherein the balloon comprises a generally tapered portion and a barrel portion, and the tube extends from the barrel portion to the generally tapered portion.

2. The apparatus of claim 1, wherein the tube is located at a proximal end portion of the balloon.

3. The apparatus of claim 1, wherein the balloon comprises a plurality of cells in a single cross-section and a covering for covering the cells, wherein the extension is attached to the covering.

4. The apparatus of claim 3, wherein each cell includes a neck in communication with an inflation lumen of a shaft supporting the balloon, and wherein the extension contacts the necks of at least three cells in a closed position of the valve.

5. The apparatus of claim 1, further including a sheath for at least partially covering the valve.

6. The apparatus of claim 1, wherein the plurality of entrances are at a proximal end of the inflatable perfusion balloon, and further including a plurality of exits at a distal end thereof.

7. The apparatus of claim 1, wherein the extension is attached to the balloon distal of the plurality of entrances.

8. An apparatus for performing a medical procedure in a vessel for transmitting a flow of fluid, comprising:

an inflatable perfusion balloon including an internal passage for permitting the fluid flow in the vessel while the perfusion balloon is in an inflated condition, the balloon including a plurality of cells in a single cross section and a covering for at least partially covering the cells; and

a valve associated with the balloon for controlling the fluid flow within the passage, the valve being arranged external to the passage, the valve having at least one piece of material extending therefrom adapted for covering a plurality of entrances to the internal passage in a closed position of the valve, the at least one piece of material moving to expose the plurality of entrances in an open position of the valve;

wherein the at least one piece of material is attached to the balloon distal of the plurality of entrances; and

wherein the at least one piece of material has a dimension in a circumferential direction that is greater than a distances between two adjacent entrances.

9. The apparatus of claim 8, wherein the covering comprises a non-compliant covering.

10. The apparatus of claim 8, further including a sheath for at least partially covering the valve.

11. An apparatus for performing a medical procedure in a vessel for transmitting a flow of blood, comprising:

a catheter including a guidewire lumen, the catheter having a shaft with a distal end supporting an inflatable perfusion balloon having a barrel portion and tapered end portions, the inflatable perfusion balloon including an internal passage for permitting the blood flow in the vessel while the perfusion balloon is in an inflated condition; and

a valve associated with the balloon for controlling the blood flow within the passage, the valve extending from the barrel portion of the inflatable balloon to the distal end of the shaft;

wherein the inflatable perfusion balloon comprises a plurality of necks extending to the distal end of the shaft, the internal passage having an entrance between each pair of adjacent necks of the plurality of necks, the valve comprises an extension adapted for covering a plurality of entrances to the internal passage; and

wherein the at extension has a dimension in a circumferential direction that is greater than a distance between two adjacent entrances.

12. The apparatus of claim 11, wherein the extension is attached to the balloon distal of the plurality of entrances.