PERFUSION BALLOON WITH EXTERNAL VALVE

• US 20170252544A1
• Filed: 03/04/2016
• Published: 09/07/2017
• 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
• Granted Patent: US 10,625,058 B2
• Time in Patent Office: 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 fluid, comprising:

an inflatable perfusion balloon including an internal passage having a plurality of entrances for permitting the fluid flow in the vessel while the perfusion balloon is in an inflated condition; and

a valve associated with the balloon for controlling the fluid flow within the passage, the valve for selectively covering the entrances to the passage to control the flow of fluid therein.

2. The apparatus of claim 1, wherein the valve comprises a tube having a generally circular, continuous cross-section.

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

4. The apparatus of claim 2, wherein the balloon comprises a generally tapered portion, and the tube extends along the generally tapered portion.

5. The apparatus of claim 2, wherein the balloon comprises a plurality of cells in a single cross-section and a covering for covering the cells, wherein the tube is an extension of the covering.

6. The apparatus of claim 5, wherein each cell includes a neck in communication with an inflation lumen of a shaft supporting the balloon, and wherein the tube overlies the necks.

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

7. 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; and

a valve associated with the balloon for controlling the fluid flow within the passage, the valve comprising a plurality of elongated flaps, each for selectively covering an entrance to the passage to control the flow of fluid therein, wherein each flap includes a fixed proximal end.

8. The apparatus of claim 7, wherein the flaps each include a distal end that is not connected to the balloon.

9. The apparatus of claim 7, wherein the balloon comprises a generally tapered portion, and the flaps extend along the generally tapered portion.

10. The apparatus of claim 7, wherein the flaps each include a distal end connected to the balloon by a tether.

11. The apparatus of claim 7, wherein the flaps are narrower at the fixed proximal end than at a distal end.

12. The apparatus of claim 7, further including a sheath for covering the plurality of flaps.

13. 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; and

a valve associated with the balloon for controlling the fluid flow within the passage, the valve comprising a spiral covering adapted for compressing to restrict fluid flow to or from the passage and for expanding to permit fluid flow to or from the passage.

14. The apparatus of claim 13, wherein the spiral covering comprises an elongated piece of material wound spirally over the balloon.

15. The apparatus of claim 13, wherein the spiral covering comprises a material having a frusto-conical shape with a spiral cut formed therein.

16. The apparatus of claim 13, wherein the balloon comprises a generally tapered portion, and the spiral covering extends along the generally tapered portion.

17. The apparatus of claim 13, wherein the balloon comprises a plurality of cells in a single cross-section, and a covering for covering the cells, and wherein the spiral covering is an extension of the covering.

18. The apparatus of claim 17, wherein each cell includes a neck in communication with an inflation lumen of a shaft supporting the balloon, and wherein the spiral covering overlies the necks.

19. The apparatus of claim 17, wherein the spiral covering is located at a proximal end portion of the balloon.

27. The apparatus of claim 13, further including a sheath for at least partially covering the valve.

28. The apparatus of claim 17, further including a sheath for at least partially covering the valve.

20. 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 and separate from the covering.

21. The apparatus of claim 20, wherein the valve comprises a material having a generally frusto-conical shape and extending along a tapered portion of the balloon, the material including a plurality of openings for selectively opening to allow fluid flow to or from the passage.

22. The apparatus of claim 21, wherein the openings are covered by flaps.

23. The apparatus of claim 20, wherein the valve comprises a spiral covering extending along a tapered portion of the balloon.

24. The apparatus of claim 20, wherein the valve comprises a plurality of elongated flaps for selectively covering an entrance to the passage to control the flow of fluid therein, the flaps having a fixed proximal end.

25. The apparatus of claim 20, wherein the covering comprises a non-compliant covering.

29. The apparatus of claim 20, further including a sheath for at least partially covering the valve.

30. The apparatus of claim 21, further including a sheath for at least partially covering the valve.

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

an inflatable perfusion balloon including a passage for permitting the fluid flow in the vessel while the perfusion balloon is in an inflated condition; and

a valve associated with the balloon for controlling the fluid flow within the passage, the valve being arranged external to the passage; and

a sheath for at least partially covering the valve.