Perfusion catheters and related methods

• US 10,159,821 B2
• Filed: 09/10/2015
• Issued: 12/25/2018
• 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
• Application Number:
  US14/850,095
• Publication Number:
  US 20160066932A1
• Time in Patent Office: 1,202 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 perfusion catheter, comprising:

an inflatable balloon including concentric inner and outer tubes, a polymer of the inner tube is cross-linked, a polymer of the outer tube is non-cross-linked, and the polymer of the inner tube has sufficient radial stiffness to resist bursting when exposed to inflation pressure;

the inner and outer tubes are coiled in a helical manner around a central axis into a series of windings with adjacent windings stacked against and bonded to each other through adhesive properties of the polymer of the outer tube when heated, an inner surface of the series of windings, when inflated, defines a passage through the balloon; and

an elongate shaft extending from a proximal portion to a distal portion, having an inner surface that defines a lumen for providing inflation fluid to, or withdrawing inflation fluid from, the balloon, and having an outer surface, the balloon is welded to the outer surface of the shaft at a location of affixing such that the polymers of the inner and outer tubes are radially closer to the shaft'"'"'s outer surface than the shaft'"'"'s inner surface at the location of affixing, the elongate shaft is eccentrically positioned relative to the helically coiled inner and outer tubes and its lumen is in fluid communication with the interior of the balloon, wherein the balloon is affixed to an outer surface portion of the elongate shaft that is covered with nylon.

2. The perfusion catheter of claim 1, wherein the polymer of the inner tube has a higher melting temperature than the polymer of the outer tube.

3. The perfusion catheter of claim 1, wherein the inner and outer tubes are coextruded.

4. The perfusion catheter of claim 1, further comprising a guidewire support tube including a lumen, separate from the lumen of the elongate shaft and the passage through the balloon, for receiving a guidewire.

5. The perfusion catheter of claim 1, wherein the elongate shaft includes a proximal hypotube, a distal support member immovably secured to the hypotube, and means for affixing an outer surface portion of the elongate shaft and the inflatable balloon.

6. The perfusion catheter of claim 5, wherein the means for affixing includes nylon surrounding the outer surface portion of the elongate shaft.

7. A perfusion catheter, comprising:

a balloon including an inflatable tube coiled in a helical manner around a central axis into a series of windings with adjacent windings stacked against and bonded to each other, an inner surface of the series of windings, when inflated, defines a passage through the balloon, the inflatable tube includes two different polymer tubes, a cross-linked inner tube and a non-cross-linked outer tube, that are coextruded; and

an elongate shaft extending from a proximal portion to a distal portion and including a lumen, defined by the shaft'"'"'s inner surface, for providing inflation fluid to, or withdrawing inflation fluid from, the balloon, an outer surface of the elongate shaft and a proximal portion of the inflatable tube are affixed by a heat treatment process such that the shaft'"'"'s lumen is in fluid communication with the interior of the balloon and the cross-linked inner tube and the non-cross-linked outer tube of the balloon are radially closer to the shaft'"'"'s outer surface than the shaft'"'"'s inner surface at the location of affixing wherein the balloon is affixed to an outer surface portion of the elongate shaft that is covered with nylon.

8. The perfusion catheter of claim 7, wherein the inflatable tube has a length ranging from 40 cm-120 cm before being coiled in the helical manner.

9. The perfusion catheter of claim 7, wherein the passage has a diameter ranging from 2 mm-6 mm and a length ranging from 10 mm-50 mm.

10. The perfusion catheter of claim 7, wherein the proximal portion and an intermediate portion of the elongate shaft include a hypotube.

11. The perfusion catheter of claim 10, wherein the distal portion of the elongate shaft includes a support wire that is coupled to the intermediate portion.

12. The perfusion catheter of claim 11, wherein the support wire is laser welded to the hypotube.

13. The perfusion catheter of claim 7, further comprising a guidewire lumen, separate from the lumen of the elongate shaft and the passage through the balloon, for receiving a guidewire.

14. The perfusion catheter of claim 13, wherein the guidewire lumen is positioned within the passage and is inset into the inner surface of the series of windings.

15. The perfusion catheter of claim 13, wherein the guidewire lumen is equal to, or slightly longer than, a length of the passage.

16. The perfusion catheter of claim 7, further comprising a first radiopaque marker positioned proximal to the balloon and a second radiopaque marker positioned distal to the balloon.

17. The perfusion catheter of claim 7, wherein the cross-linked inner tube has a higher melting temperature than the non-cross-linked outer tube.

18. A perfusion catheter, comprising:

a balloon including a cross-linked inner tube and a non-cross-linked outer tube coiled in a helical manner around a central axis into a series of windings with adjacent windings stacked against and bonded to each other, an inner surface of the series of windings, when inflated, defines a passage through the balloon;

an elongate shaft having an inner surface that defines a lumen extending from a proximal portion to a distal portion and including a proximal hypotube, a distal support member immovably secured to the hypotube, and nylon covering an outer surface portion of the elongate shaft for affixing the elongate shaft and the balloon, the lumen for providing inflation fluid to, or withdrawing inflation fluid from, the interior of the balloon, and having an outer surface,

the elongate shaft is eccentrically positioned relative to the helically coiled inner and outer tubes and a proximal end of the balloon is affixed through a heat treatment process to the nylon covering the outer surface portion of the elongate shaft such that the inner and outer tubes are radially closer to the shaft'"'"'s outer surface than the shaft'"'"'s inner surface at the location of affixing; and

a guidewire support tube including a lumen, separate from the lumen of the elongate shaft and the passage of the helically coiled inner and outer tubes, for receiving a guidewire.

19. The perfusion catheter of claim 18, wherein the balloon is affixed to the nylon covering the outer surface portion of the elongate shaft for a minimum of 5 mm.

20. The perfusion catheter of claim 18, wherein the inner tube, through its cross-linking, has a radial stiffness within each winding to resist bursting when exposed to inflation pressure.

21. The perfusion catheter of claim 18, wherein the inner tube, through its cross-linking, has a radial stiffness within each winding to resist bursting when exposed to inflation pressure.