Controllable inflation profile balloon cover apparatus

Patent metadata

Field	Value
Publication number	US-10016579-B2
Application number	US-201213619806-A
Country	US
Kind code	B2
Filing date	Sep 14, 2012
Priority date	Jun 23, 2011
Publication date	Jul 10, 2018
Grant date	Jul 10, 2018

Abstract

Embodiments are presented of a balloon assembly operable to provide a balloon diameter vs. balloon pressure profile generally depicting a balloon inflation sequence providing at least one intermediate inflated diameter and a final inflated diameter of a balloon such that the balloon attains the at least one intermediate diameter at a predetermined pressure, and attains the final diameter at a final predetermined pressure that is lower than a predetermined pressure of a last intermediate pressure.

First claim

What is claimed is:

1. A catheter balloon assembly comprising:
an inflatable balloon comprising a balloon body portion defining a balloon working length and an un-inflated diameter and a working diameter; and
a frangible cover covering at least a portion of an outer surface of the balloon body portion and extending beyond the balloon working length, the frangible cover being operable to rupture under an internal pressure before a rupture of the balloon wherein, prior to rupture, the frangible cover is operable to control the balloon to open to an intermediate diameter that is substantially uniform along the working length that is less than the working diameter, the frangible cover having a diameter that is the same as the intermediate diameter; and
an outer cover covering at least a substantial portion of the frangible cover operable to contain the frangible cover once the frangible cover ruptures during use within a passageway of a patient's body,
wherein an inner surface of the frangible cover is in contact with the outer surface of the balloon body along at least a portion of the balloon working length.

2. The catheter balloon assembly of claim 1 further comprising a plurality of frangible covers each being operable to control the balloon to open sequentially to a different larger intermediate diameter that is smaller than the working diameter.

3. The catheter balloon assembly of claim 1 wherein the balloon increases in diameter substantially uniformly along the working length of the balloon after the rupture of the frangible cover.

4. The catheter balloon assembly of claim 1 , wherein the balloon is a compliant balloon.

5. The catheter balloon assembly of claim 1 , wherein the balloon is a non-compliant balloon.

6. The catheter balloon assembly of claim 1 , the balloon comprising two opposed balloon leg portions that are each integrally connected to a balloon taper portion, with each of the balloon taper portions connected to a balloon body portion therebetween, the balloon working length defined as the length of the balloon body portion of the balloon that comprises an approximate length between opposed balloon taper portions;
further comprising a balloon cover comprising:
a first legged cover portion including a first cover body portion integrally connected to a first cover taper portion, further including a cover leg portion located at an apex of the first cover taper portion, the first cover body portion being operable to overlay a portion of the balloon body portion, the first cover taper portion being operable to overlay a portion of the balloon taper portion, the cover leg portion being operable to allow the leg portion of the balloon to pass through; and
a second legged cover portion including a second cover body portion integrally connected to a second cover taper portion, further including a cover leg portion located at an apex of the second cover taper portion the second cover body portion being operable to overlay a portion of the balloon body portion, the second cover taper portion being operable to overlay a portion of the balloon taper portion, the cover leg portion being operable to allow the leg portion of the balloon to pass through, the first cover taper portion and the second cover taper portion are located at opposite ends of the balloon cover, the first cover portion and the second cover portion are coaxially aligned along axis X and overlay the balloon such that at least a portion of the first cover body portion overlays at least a portion of the second cover body portion,
the frangible cover overlaying the first cover body portion, the second cover body portion, and at least a portion of each of the first cover taper portion and the second cover taper portion,
the outer cover covers the frangible cover and is coupled to the first cover leg portion and the second cover leg portion.

7. The catheter balloon assembly of claim 6 , wherein the balloon cover comprises a fibrillated material.

8. The catheter balloon assembly of claim 7 , wherein the fibrillated material is ePTFE.

9. The catheter balloon assembly of claim 8 , wherein fibrils in said ePTFE are oriented in a radial direction.

10. The catheter balloon assembly of claim 8 , wherein the balloon cover is made from strips of ePTFE that are adhered to each other.

11. The catheter balloon of claim 10 , wherein the strips are laid in multiple angular orientations on the working length and the cover taper portions.

12. The catheter balloon of claim 6 , wherein the balloon cover is adhered to the balloon.

13. The catheter balloon of claim 6 , wherein the cover body portions that overlap for at least a substantial portion of the balloon body portion also cover a portion of balloon taper portion.

14. The catheter balloon of claim 6 , wherein the working diameter of the balloon cover is smaller than the working diameter of the balloon.

15. The catheter balloon of claim 1 , wherein the inflation of the balloon is provided by a single inflation lumen.

16. The catheter balloon of claim 1 , wherein the intermediate diameter is greater than 20% of the working diameter.

17. The catheter balloon of claim 1 , wherein the intermediate diameter is greater than 30% of the working diameter.

18. The catheter balloon of claim 1 , wherein the intermediate diameter is greater than 50% of the working diameter.

19. A frangible balloon assembly comprising:
a catheter shaft including an inflation lumen in fluid communication with an inflation port;
a balloon coupled to the catheter shaft and in fluid communication with the inflation port, the balloon including a balloon body portion and a balloon working length, the balloon having a working diameter; and
a frangible cover covering at least a portion of an outer surface of the balloon body portion and extending beyond the balloon working length, the frangible cover being operable to restrain the balloon to an intermediate diameter that is smaller than the working diameter up to a predetermined pressure, the frangible cover operable to rupture at the predetermined pressure to allow the balloon to expand to the working diameter; and
an outer cover covering at least a substantial portion of the frangible cover operable to contain the frangible cover once the frangible cover ruptures during use within a passageway of a patient's body,
wherein, prior to rupture, the frangible cover is operable to control the balloon to open to an intermediate diameter that is substantially uniform along the working length that is less than the working diameter, the frangible cover having a diameter that is the same as the intermediate diameter,
wherein the frangible cover has a smooth outer surface at the intermediate diameter.

20. The frangible balloon assembly of claim 19 , further comprising a plurality of frangible covers each being operable to control the balloon to open sequentially to a different larger intermediate diameter that is smaller than the working diameter.

21. The frangible balloon assembly of claim 19 , wherein the balloon increases in diameter substantially uniformly along the working length of the balloon after the rupture of the frangible cover.

22. The frangible balloon assembly of claim 19 , wherein the balloon is a compliant balloon.

23. The frangible balloon assembly of claim 19 , wherein the balloon is a non-compliant balloon.

24. The frangible balloon assembly of claim 19 , the balloon comprising two opposed balloon leg p

Assignees

• Campbell Carey V
• Goepfrich James L
• Hedberg Brandon C
• Trapp Benjamin M
• Gore & Ass

Inventors

• Campbell Carey V
• Goepfrich James L
• Hedberg Brandon C
• Trapp Benjamin M

Classifications

• A61M25/1029 Primary

  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 title

• F04C2270/041

  Controlled or regulated · CPC title

• A61M2025/1031

  Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface · CPC title

• A61M25/10 Primary

  Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00}) · CPC title

• A61F2/958

  Inflatable balloons for placing stents or stent-grafts · CPC title