Perfusion catheters and related methods

• US 9,968,763 B2
• Filed: 10/18/2016
• Issued: 05/15/2018
• Est. Priority Date: 09/10/2014
• Status: Active Grant

• Current Assignee: Teleflex Life Sciences LLC (Teleflex Incorporated)
• Original Assignee: Teleflex Innovations S.a.r.l. (Teleflex Incorporated)
• Inventors: Root, Howard, Kugler, Chad, Peterson, Dean, Brenizer, Joshua
• Primary Examiner(s): LOUIS, RICHARD G
• Application Number:
  US15/296,183
• Publication Number:
  US 20170050003A1
• Time in Patent Office: 574 Days
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• 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 25/104 used for angioplasty

Abstract

This patent document discloses perfusion catheters and related methods for treating complications related to CTO interventions or dilating a vessel occlusion while maintaining a passage through the treated vessel segment. A perfusion catheter can include a balloon formed of an inflatable tube and an elongate shaft having a lumen for providing inflation fluid to, or withdrawing inflation fluid from, the balloon. The inflatable tube can be coiled in a helical manner around a central axis into a series of windings. Adjacent windings can be stacked against and bonded to each other, and an inner surface of the series of windings, when inflated, can define the passage. The elongate shaft can be eccentrically attached to a proximal portion of the balloon and the shaft'"'"'s lumen can be in fluid communication with the interior of the balloon, specifically the inflatable tube. The inflatable tube can include two different polymer tubes, one slightly smaller than the other.

Claims

1. A method, comprising:

passing a perfusion catheter, including a balloon, formed of a cross-linked inner tube and a non-cross-linked outer tube, and an elongate shaft that is attached to the balloon, into a blood vessel until the balloon is positioned adjacent a perforation or dissection in a wall of the blood vessel;

inflating the balloon to seal the perforation or dissection in the wall of the blood vessel, including urging fluid through a lumen of the elongate shaft and into the inner tube to inflate a series of helical windings of the balloon held together via adhesive properties of the outer tube;

the balloon, upon inflation, moving from a deflated configuration to an inflated configuration at which an outer surface of the balloon engages the wall of the blood vessel and an inner surface of the balloon'"'"'s series of helical windings defines a passage; and

after inflating the balloon, passing a treatment device at least partially through the passage, including receiving, in a distal-to-proximal direction, or delivering, in a proximal-to-distal direction, the treatment device.

2. The method of claim 1, wherein passing the perfusion catheter into the blood vessel includes advancing a guidewire through a guidewire support tube, which is separate from the lumen of the elongate shaft and the passage defined by the balloon'"'"'s series of helical windings.

3. The method of claim 2, further comprising deflating the balloon by withdrawing fluid through the lumen of the elongate shaft, and retracting the perfusion catheter from the blood vessel along the guidewire.

4. The method of claim 1, wherein passing the perfusion catheter into the blood vessel includes advancing a guidewire through a guidewire support tube, which is inset into the inner surface of the balloon'"'"'s series of helical windings.

5. The method of claim 1, wherein inflating the balloon by urging fluid through the lumen of the elongate shaft includes urging fluid through a hypotube, which is plugged on its distal end by a balloon support wire.

6. The method of claim 1, wherein inflating the balloon to seal the perforation or dissection in the wall of the blood vessel includes allowing flow of bodily fluid through the passage.

7. The method of claim 1, wherein inflating the balloon includes dilating occlusive material accumulation within the wall of the blood vessel.

8. The method of claim 1, wherein inflating the balloon includes inflating the balloon to a pressure between 2 atm-20 atm, inclusive.

9. The method of claim 1, wherein receiving, in the distal-to-proximal direction, the treatment device includes funneling the treatment device into the passage as a result of the engagement between the outer surface of the inflated balloon and the wall of the blood vessel.

10. The method of claim 1, wherein delivering, in the proximal-to-distal direction, the treatment device includes delivering the treatment device to a treatment site distal to the perforation or dissection in the wall of the blood vessel.

11. The method of claim 10, wherein delivering the treatment device to the treatment site or distal to the perforation or dissection includes guiding the treatment device along a path offset from an axis of the elongate shaft.

12. The method of claim 1, wherein passing the treatment device at least partially through the passage includes receiving, in the distal-to-proximal direction, or delivering, in the proximal-to-distal direction, a guidewire or a guidewire support catheter.

13. The method of claim 1, wherein pas sing the treatment device at least partially through the passage includes receiving, in the distal-to-proximal direction, or delivering, in the proximal-to-distal direction, the treatment device through the passage, wherein the treatment device is in the form of a balloon catheter or a stent.

14. The method of claim 1, wherein passing the treatment device at least partially through the passage includes passing the treatment device at least partially through a passage having a length between 10 mm-50 mm, inclusive, and a diameter between 2 mm-6 mm, inclusive.

15. The method of claim 1, further comprising inserting a placement catheter into the passage defined by the balloon'"'"'s series of helical windings, and expanding a portion of the placement catheter into engagement with the inner surface of the balloon.

16. The method of claim 15, further comprising deflating the balloon by withdrawing fluid through the lumen of the elongate shaft, and simultaneously retracting the placement catheter and the perfusion catheter from the blood vessel.

17. A method, comprising:

passing a perfusion catheter, including a balloon formed of a cross-linked inner tube and a non-cross-linked outer tube having a collective thickness between 0.1 mm-0.5 mm, inclusive, and an elongate shaft attached to the balloon, into a blood vessel until the balloon is positioned near or within a treatment site;

inflating the balloon by urging fluid through a lumen of the elongate shaft and into the inner tube, including inflating a series of helical windings of the inner and outer tubes;

the balloon, upon inflation, moving from a deflated configuration to an inflated configuration at which an outer surface of the balloon engages a wall of the blood vessel or occlusive material accumulation within the wall and seals a perforation or dissection, and an inner surface of the series of helical windings defines a passage having a central axis offset from an axis of the elongate shaft; and

after inflating the balloon, passing a treatment device at least partially through the passage.

18. The method of claim 17, wherein passing the treatment device at least partially through the passage includes receiving, in a distal-to-proximal direction, a treatment device that is funneled into the passage as a result of the engagement between the outer surface of the inflated balloon and the wall of the blood vessel or occlusive material accumulation within the wall at the treatment site.

19. The method of claim 17, wherein passing the treatment device at least partially through the passage includes delivering, in a proximal-to-distal direction, a treatment device to the treatment site or distal to the treatment site.