Imaging balloon catheter and methods for use and manufacture

• US 5,316,016 A
• Filed: 07/07/1992
• Issued: 05/31/1994
• Est. Priority Date: 07/07/1992
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Wang, Lixiao, Sogard, David J., Adams, Daniel O., Hendrickson, Gary L.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US07/909,772
• Time in Patent Office: 693 Days
• Field of Search: 128/774, 604/96-101
• US Class Current: 600/587
• CPC Class Codes: A61B 5/1078 by moulding
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61M 2025/0098 having a strain relief at the proximal end, e.g. sleeve
• CPC Class Codes: A61M 25/1029 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

Abstract

The present invention includes an imaging catheter for providing a three-dimensional representation of a body vessel wall. The imaging catheter includes an expandable deformable balloon which is inserted into a lumen of the body vessel at a position of interest on the vessel wall. After the balloon has been inflated, the balloon is then deflated and withdrawn from the body vessel to provide a three-dimensional image of the position of interest on the vessel wall.

Claims

1. A catheter comprising:

a shaft adapted for insertion into a vascular system, said shaft having a distal portion and a fluid passageway that communicates with said distal portion; and

an expandable tubular element mounted on the distal end of said shaft and in fluid communication with said fluid passageway to conform to the shape of the vessel when said expandable tubular element is inflated at a first pressure,

said expandable tubular element constructed of a material that conforms to the shape of the vessel when said balloon is inflated at a first pressure and maintains the shape of the vessel after said balloon has been deflated and removed from the vascular system and reinflated at a second pressure.

2. A catheter according to claim 1 wherein said first pressure is greater than said second pressure.

3. A catheter according to claim 1 wherein said first pressure is less than a lesion deforming pressure.

4. A catheter according to claim 3 wherein the ratio of glycol-modified polyethylene terephthalate to polybutylene terephthalate is 3:

7 by weight.

5. A catheter according to claim 1 wherein said first pressure ranges between 40 and 100 psig.

6. A catheter according to claim 1 wherein said first pressure ranges between 40 and 80 psig.

7. A catheter according to claim 1 wherein said first pressure ranges between 40 and 60 psig.

8. A catheter according to claim 1 wherein said second pressure ranges between 5 and 25 psig.

9. A catheter according to claim 1 wherein said second pressure ranges between 5 and 10 psig.

10. A catheter according to claim 1 wherein said expandable tubular element is constructed of a blend of polybutylene terephthalate (PBT) and glycol-modified polyethylene terephthalate (PETG).

11. A catheter according to claim 10 wherein the ratio of glycol-modified polyethylene terephthalate to polybutylene terephthalate ranges from 1:

1 to 1;

9 by weight.

12. A catheter according to claim 1 wherein said expandable tubular element material is a polymeric material that has been biaxially oriented.

13. A method for imaging a body vessel lumen, the method comprising:

providing an imaging catheter having an expandable balloon mounted at a distal end, the balloon being characterized by an ability to conform to the shape of the vessel wall upon inflation, and return to the conformed shape after deflation and reinflation;

advancing the imaging catheter into the body lumen to an imaging position;

inflating the balloon so that the balloon is forced against the vessel wall and conforms to the shape of the vessel wall;

deflating the balloon and withdrawing the balloon from the lumen; and

reinflating the balloon to expand the balloon to assume the balloon'"'"'s previous shape that corresponds to the shape of the vessel wall thereby providing an image of the lumen.

14. A method according to claim 13 wherein said balloon is expanded at a first pressure within the lumen and then reinflated at a second pressure after being withdrawn from the lumen wherein said first pressure is greater than said second pressure.

15. A method according to claim 14 wherein the body lumen has a lesion or obstruction and a balloon is positioned adjacent the lesion or obstruction such that when the balloon is inflated, the balloon deforms to the shape of the lesion or obstruction.

16. A method according to claim 15 wherein the balloon is inflated to a pressure that will not deform the lesion or obstruction.

17. A method according to claim 14 wherein the balloon is constructed of a blend of polybutylene terephthalate and polyethylene terephthalate glycol.

18. A method according to claim 17 wherein the ratio of glycol-modified polyethylene terephthalate to polybutylene terephthalate ranges from 1:

1 to 1;

9 by weight.

19. A catheter comprising:

a shaft adapted for insertion into a vascular system, said shaft having a distal portion and a fluid passageway that communicates with said distal portion; and

an expandable tubular element mounted on the distal end of said shaft and in fluid communication with said fluid passageway to conform to the shape of the vessel when said expandable tubular element is inflated at a first pressure,

said expandable tubular element constructed of a blend of polybutylene terephthalate (PBT) and glycol-modified polyethylene terephthalate (PETG).

20. A catheter to claim 19 wherein the ratio of glycol-modified polyethylene terephthalate to polybutylene terephthalate ranges from 1:

1 to 1;

9 by weight.