Catheter including a compliant balloon

• US 7,632,242 B2
• Filed: 12/09/2004
• Issued: 12/15/2009
• Est. Priority Date: 12/09/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Chan, Huey Quoc, Griffin, Stephen, Lim, Elaine, To, Nhan Hue
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): VU, QUYNH-NHU HOANG
• Application Number:
  US11/008,452
• Publication Number:
  US 20060129175A1
• Time in Patent Office: 1,832 Days
• Field of Search: 604/93.01, 604/95.03, 604/96.01, 604/97.01, 604/101.02, 604/102.01, 604/102.02, 604/102.03, 604/103.03, 604/103.08, 604/103.09, 604/915, 606/108, 606/192
• US Class Current: 604/96.01
• CPC Class Codes: A61B 17/22032 having inflatable gripping elements balloon catheters A61M25/10
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B
• CPC Class Codes: A61M 25/10 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 Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

A catheter having an elongate shaft including a plurality of apertures disposed along at least a length of the shaft to facilitate bending. The catheter includes an inflatable balloon, wherein a subset of the plurality of apertures provides fluid communication from an inflation lumen to the inflatable balloon.

Claims

1. A medical device comprising:

an elongate shaft including a metallic tube having a proximal end, a distal end, a length and a lumen extending therethrough, the metallic tube having an outer surface and an inner surface defining a wall therebetween, wherein the metallic tube includes a plurality of apertures extending through the wall along at least a portion of the length to facilitate bending;

a polymer layer disposed about at least a portion of the metallic tube, wherein at least a portion of the plurality of apertures are fluidly sealed, a distal portion of the metallic tube having a subset of the plurality of apertures being free of the polymer coating; and

an inflatable balloon disposed about at least the distal portion of the metallic tube having a plurality of the apertures free of the polymer coating;

wherein the inflatable balloon is in fluid communication with the lumen of the metallic tube.

2. The medical device of claim 1, further comprising:

an inner tubular member disposed in at least a portion of the metallic tube, the inner tubular member having an outer surface spaced away from the inner surface of the metallic tube, defining an annular inflation lumen therebetween in fluid communication with the inflatable balloon.

3. The medical device of claim 2, further comprising:

a proximal portion of the metallic tube having a subset of the plurality of apertures being free of the polymer layer; and

a hub assembly having an inflation port disposed about at least the proximal portion of the metallic tube having a subset of the plurality of apertures being free of the polymer layer, wherein the inflation port is in fluid communication with the annular inflation lumen.

4. The medical device of claim 1, further comprising:

a proximal portion of the metallic tube having a subset of the plurality of apertures being free of the polymer layer; and

a hub assembly having an inflation port disposed about at least the proximal portion of the metallic tube having a subset of the plurality of apertures being free of the polymer layer, wherein the inflation port is in fluid communication with the inflatable balloon.

5. The medical device of claim 1, wherein the plurality of apertures are micromachined.

6. The medical device of claim 1, wherein the plurality of apertures extend substantially the length of the metallic tube.

7. The medical device of claim 2, further comprising a distal tip.

8. The medical device of claim 7, wherein the inner tubular member extends distal of the distal end of the metallic tube, wherein the distal tip includes the inner tubular member.

9. The medical device of claim 7, wherein the distal tip includes a coil.

10. The medical device of claim 7, wherein the distal tip occludes the lumen of the metallic tube at the distal end.

11. The medical device of claim 1, wherein the metallic tube is a nickel-titanium alloy.

12. The medical device of claim 1, wherein the metallic tube is a stainless steel.

13. The medical device of claim 1, wherein the polymer layer is PEBAX.

14. The medical device of claim 1, further comprising a hydrophilic coating disposed over at least a portion of the polymer layer.

15. A medical device comprising:

an elongate shaft having a proximal end, a distal end, a length and a lumen extending therethrough, the elongate shaft including a plurality of micromachined apertures along at least a portion of the length to facilitate bending;

a polymer layer disposed on at least a portion of the elongate shaft, the polymer layer fluidly sealing at least a portion of the plurality of micromachined apertures, a distal portion of the elongate shaft including at least one of the plurality of micromachined apertures being free of the polymer layer;

an inner tubular member disposed in the lumen of the elongate shaft, the inner tubular member having an outer surface and the elongate shaft having an inner surface;

an inflation lumen defined by a space between the outer surface of the inner tubular member and the inner surface of the elongate shaft;

an inflatable balloon disposed about at least the distal portion of the elongate shaft being free of the polymer layer, the inflatable balloon in fluid communication with the inflation lumen.

16. The medical device of claim 15, further comprising:

a proximal portion of the elongate shaft including at least one of the plurality of micromachined apertures being free of the polymer layer; and

a hub assembly having an inflation port disposed about at least the proximal portion of the elongate shaft being free of the polymer layer, wherein the inflation port is in fluid communication with the inflatable balloon.

17. The medical device of claim 15, wherein the micromachined apertures extend substantially the length of the elongate shaft.

18. The medical device of claim 15, further comprising a distal tip.

19. The medical device of claim 18, wherein the distal tip includes a coil.

20. The medical device of claim 18, wherein the distal tip occludes the inflation lumen at the distal end of the elongate shaft.

21. The medical device of claim 15, wherein the elongate shaft is a nickel-titanium alloy.

22. The medical device of claim 15, wherein the elongate shaft is a stainless steel.

23. The medical device of claim 15, wherein the polymer layer is PEBAX.

24. The medical device of claim 15, further comprising a hydrophilic coating disposed over at least a portion of the polymer layer.

25. A medical device comprising:

an elongate shaft including a metallic tube having a proximal end, a distal end and a lumen extending therethrough, the metallic tube having an inner surface and an outer surface defining a wall therebetween, wherein the metallic tube includes a plurality of micromachined apertures to facilitate bending extending through the wall of at least a portion of a proximal section, an intermediate section, and a distal section of the tubular member,

a polymer layer disposed about at least the intermediate section of the metallic tube, wherein a subset of the plurality of micromachined apertures are fluidly sealed, the proximal section and the distal section being free of the polymer layer,

an inner tubular member disposed in the lumen of the metallic tube, the inner tubular member having an outer surface,

an annular inflation lumen defined by a space between the outer surface of the inner tubular member and the inner surface of the metallic tube,

a hub assembly including an inflation port disposed about at least the proximal section of the metallic tube,

an inflatable balloon disposed about at least the distal section of the metallic tube, and

an inflation passageway defined by the inflation port, the plurality of micromachined apertures of the proximal section of the metallic tube, the annular inflation lumen, the plurality of micromachined apertures of the distal section of the metallic tube, and the inflatable balloon.

26. The medical device of claim 25, wherein the metallic tube is a nickel-titanium alloy.

27. The medical device of claim 25, wherein the metallic tube is a stainless steel.

28. The medical device of claim 25, wherein the polymer layer is PEBAX.

29. The medical device of claim 25, further comprising a hydrophilic coating disposed over at least a portion of the polymer layer.