Dilation balloon having multiple diameters

• US 6,488,653 B1
• Filed: 08/11/2000
• Issued: 12/03/2002
• Est. Priority Date: 08/12/1999
• Status: Expired due to Fees

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Wilson-Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Lombardo, Giuseppe
• Primary Examiner(s): Capossela, Ronald
• Application Number:
  US09/636,442
• Time in Patent Office: 844 Days
• Field of Search: 604/96.01, 604/101.01, 604/101.05, 604/103.06, 604/103.07, 606/192, 606/194
• US Class Current: 604/103.06
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/1047 having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61M 2025/1059 having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties with different compartments A61M2025/1072
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A dilation balloon catheter is disclosed comprising a non-compliant balloon attached to a catheter, the balloon portion includes a plurality of sections having different outer diameters, as measured at the central portion or midpoint of the section, when the balloon is inflated. In one embodiment that is deployable from an endoscope to treat esophageal, pyloric, or colonic strictures, a series of progressively larger balloon sections are used to safely dilate the stricture in stages. Each section includes a central portion having a waist for centering the balloon over the stricture, with the distal section having the smallest diameter and the intermediate and proximal sections being about 2 and 4 mm larger, respectively. A wire guide extends throughout the length of the catheter and balloon and forms a distal portion of the dilation balloon catheter for assisting in cannulation of the stricture. Optionally, the dilation balloon catheter can include a series of bands or other markings to indicate the location of the different balloon sections. These indicia can be located on the wire guide or the balloon material and may be radiopaque.

Claims

1. A dilation balloon catheter comprising:

a catheter having a distal end, the catheter having at least one lumen extending therethrough; and

a balloon affixed to the catheter, the balloon including a plurality of distinct balloon sections, each balloon section having a central portion and adjacent portions located on either side of the central portion, the central portion having a diameter that is smaller than a diameter of the adjacent portions, wherein the diameter of the central portion of each of the balloon sections, when the balloon is inflated, has a diameter that is different than the diameter of the central portions of the other balloon sections.

2. The balloon catheter of claim 1 wherein the balloon comprises a non-compliant material.

3. The balloon catheter of claim 2 wherein the non-compliant material includes polyethylene terephthalate.

4. The balloon catheter of claim 1 wherein the balloon catheter includes a system of indicia, wherein at least one indicium of the system of indicia corresponds with the central portion of at least one of the plurality of balloon sections.

5. The balloon catheter of claim 1 wherein the plurality of balloon sections comprises a distal section having a central portion and adjacent portions located on either side of the central portion, an intermediate section having a central portion and adjacent portions located on either side of the central portion, and a proximal section having a central portion and adjacent portions located on either side of the central portion.

6. The balloon catheter of claim 5 further comprising:

a first indicium corresponding to the central portion of the proximal section;

a second indicium corresponding to the central portion of the intermediate section; and

a third indicium corresponding to the central portion of the distal section.

7. The balloon catheter of claim 6 wherein at least one of the first indicium, second indicium, and third indicium is located about the wire guide.

8. The balloon catheter of claim 6 wherein at least one of the first indicium, second indicium, and third indicium is located about the balloon.

9. The balloon catheter of claim 6 wherein the proximal section has a first diameter, the intermediate section has a second diameter that is different from the first diameter, and the proximal section has a third diameter that is different from the first and the second diameters.

10. The balloon catheter of claim 5 wherein the first diameter is smaller than the second and the third diameters.

11. The balloon catheter of claim 1 further including a wire guide situated within one of the at least one lumen of the catheter and extending through the catheter and the balloon.

12. The balloon catheter of claim 11 wherein the wire guide comprises a superelastic alloy.

13. The balloon catheter of claim 1 wherein, when the balloon is inflated, the central portion of each balloon section has a concave outer surface with respect to a central axis of the catheter, and the adjacent portions of each balloon section has a convex outer surface with respect to the central axis of the catheter.

14. A dilation balloon catheter comprising:

a catheter having a distal end, the catheter having a lumen extending therethrough;

a balloon made of a non-compliant material, the balloon being affixed about the distal end of the catheter, the balloon comprising at least a distal section, an intermediate section and a proximal section, each of said distal, intermediate and proximal sections having a central portion and adjacent portions located on either side of the central portion, the central portion having a diameter that is smaller than a diameter of the adjacent portions, wherein the diameter of the respective central portions of each of the distal, intermediate and proximal sections, when the balloon is inflated, is different from the diameters of the central portions of the other sections; and

a wire guide situated within the at least one lumen of the catheter and extending through the catheter and the balloon.

15. The balloon catheter of claim 14 further comprising:

a first indicium corresponding to the central portion of the proximal section;

a second indicium corresponding to the central portion of the intermediate section; and

a third indicium corresponding to the central portion of the distal section.

16. The balloon catheter of claim 15 wherein at least one of the first indicium, second indicium, and third indicium is located about the wire guide.

17. The balloon catheter of claim 15 wherein at least one of the first indicium, second indicium, and third indicium is located about the balloon.

18. The balloon catheter of claim 16 wherein the proximal section has a first diameter, the intermediate section has a second diameter that is different from the first diameter, and the proximal section has a third diameter that is different from the first and the second diameters.

19. The balloon catheter of claim 18 wherein the first diameter is smaller than the second and the third diameters.

20. The balloon catheter of claim 14 wherein, when the balloon is inflated, the central portion of each said distal, intermediate and proximal sections of the balloon has a concave outer surface with respect to a central axis of the catheter, and the adjacent portions of each of said distal, intermediate and proximal sections has a convex outer surface with respect to the central axis of the catheter.

22. The balloon catheter of claim 20 wherein, when the balloon is inflated, the central portion of each said distal, intermediate and proximal sections of the balloon has a concave outer surface with respect to a central axis of the catheter, and the adjacent portions of each of said distal, intermediate and proximal sections has a convex outer surface with respect to the central axis of the catheter.

21. A dilation balloon catheter comprising:

a catheter having a distal end, the catheter including at least one lumen extending therethrough;

a balloon affixed about the distal end of the catheter, the balloon including a plurality of sections comprising a distal section, an intermediate section and a proximal section, said distal section, said intermediate section, and said proximal section each including a central portion having a waist located thereabout, wherein, when the balloon is inflated, the distal section has a maximum diameter smaller than a maximum diameter of the intermediate section, and the maximum diameter of the intermediate section is smaller than the maximum diameter of the proximal section;

a wire guide comprising a superelastic alloy, the wire guide situated within the at least one lumen of the catheter and extending through the catheter and the balloon; and

a system of indicia comprising a first indicium, a second indicium, and a third indicium, the system of indicia located on at least one of the wire guide and the balloon, the first indicium corresponding to the central portion of the proximal section, the second indicium corresponding to the central portion of the intermediate section, and the third indicium corresponding to the central portion of the distal section.