Focalized stent implantation

• US 20030028211A1
• Filed: 06/24/2002
• Published: 02/06/2003
• Est. Priority Date: 02/24/1994
• Status: Active Grant

• Current Assignee: Lynn M. Shimada, Michael Crocker
• Original Assignee: Lynn M. Shimada, Michael Crocker
• Inventors: Crocker, Michael, Shimada, Lynn M.
• Granted Patent: US 6,872,215 B2
• Time in Patent Office: Days
• US Class Current: 606/192
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• 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
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• 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
• CPC Class Codes: A61M 25/10184 Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• 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
• CPC Class Codes: A61M 25/1034 Joining of shaft and balloon
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Disclosed is a focal balloon having at least one reference zone and a focal zone. In one embodiment, the reference zone and focal zone are inflatable to a first generally cylindrical profile at a first pressure. At a second, greater pressure, the focal section expands to a second, greater diameter, while the reference zone remains substantially at the first diameter. In an alternate embodiment, the focal zone and the reference zone are inflatable to their respective predetermined diameters at the inflation pressure, in the absence of constricting lesions or anatomical structures. Multiple lobed and drug delivery embodiments are also disclosed.

Claims

1. A balloon catheter, comprising:

an elongate, flexible tubular body having proximal and distal ends;

a first inflatable balloon on the distal end of the tubular body;

a first inflation lumen extending through the tubular body and communicating with the first inflatable balloon;

a second inflatable balloon surrounding at least a portion of the first inflatable balloon;

a second inflation lumen extending through the tubular body and communicating with the second inflatable balloon;

wherein the second inflatable balloon is inflated to a first inflation profile by inflation of the first balloon, and the second balloon is inflatable to a second profile by inflation of the second balloon.

2. A balloon catheter as in claim 1, wherein the first profile comprises a generally cylindrical configuration.

3. A balloon catheter as in claim 2, wherein the second profile comprises at least a first zone of a first diameter and a second zone of a second, larger diameter.

4. A balloon catheter as in claim 3, wherein the second balloon is provided with a plurality of delivery ports.

5. A balloon catheter, comprising:

an elongate, flexible tubular body having proximal and distal ends;

an inflatable balloon on the distal end of the tubular body;

an inflation lumen extending through the tubular body and communicating with the inflatable balloon;

said balloon having a proximal zone, an intermediate zone and a distal zone;

wherein the inflated diameter of each of the proximal and distal zones is greater than the inflated diameter of the intermediate zone.

6. A balloon catheter as in claim 5, wherein the inflated diameter of the proximal zone is approximately equal to the inflated diameter of the distal zone.

7. A balloon catheter as in claim 5, wherein the inflated diameter of the intermediate zone is at least about 90% of the inflated diameter of the proximal zone.

8. A balloon catheter as in claim 5, further comprising at least one expansion limiting band in the intermediate zone of the balloon.

9. A balloon catheter as in claim 5, wherein at least one of the proximal and distal zones is inflatable to a first diameter at a first pressure and to a second, greater diameter at a second, greater pressure.

10. A balloon catheter as in claim 5, further comprising an outer balloon, surrounding the intermediate zone to form a potential space between the inner and outer balloons and between the proximal and distal zones.

11. A balloon catheter as in claim 10, wherein the potential space is in fluid communication with a delivery lumen extending through the tubular body.

12. A balloon catheter as in claim 10, further comprising a plurality of apertures in the outer balloon.

13. A balloon catheter, comprising:

an elongate, flexible tubular body having proximal and distal ends;

an inflatable balloon on the distal end of the tubular body, said balloon comprising an inner layer and an outer layer;

an inflation lumen extending through the tubular body and communicating with the inflatable balloon; and

a plurality of apertures through the inner layer of the balloon, so that when the balloon is inflated with inflation media, the inflation media rapidly fills the inner layer of the balloon, and then expresses through the apertures to fill at least a portion of the outer layer of the balloon.

14. A balloon catheter, comprising:

an elongate, flexible, tubular body; and

an inflatable balloon on the tubular body, wherein a proximal segment, a central segment, and a distal segment of said balloon are inflatable to a first inflated diameter at a first inflation pressure, and where the material of the proximal and distal segments expands to a second, greater inflated diameter at a second, greater inflation pressure, and the central segment remains at a diameter which is less than the second diameter at the second inflation pressure.

15. A balloon catheter as in claim 14, additionally comprising at least one expansion limiting band on said central segment to limit inflation of said central segment of the inflation balloon.

16. A balloon catheter as in claim 15, wherein the expansion limiting band limits expansion of the central segment to no more than about the first inflated diameter.

17. A method of treating a site in a body lumen, comprising the steps of:

providing a catheter of the type having an elongate, flexible, tubular body and a dilatation balloon on the body, wherein a proximal segment, a central segment, and a distal segment of said balloon are inflatable to a first diameter at a first inflation pressure, and where the proximal and distal segments of said balloon are inflatable to a second greater diameter at a second, greater inflation pressure, and the central segment remains substantially at the first diameter at said second inflation pressure;

positioning the catheter within a body lumen so that the balloon is adjacent to a treatment site;

inflating the balloon to said first inflation pressure, wherein said proximal segment, said distal segment, and said central segment are inflated to no more than about the first inflation diameter, to treat the site; and

inflating the balloon to a second inflation pressure while simultaneously restraining the central segment against further radial expansion, thereby substantially preventing the central segment from expanding materially beyond said first inflation diameter and expanding the proximal and distal segments to said second inflation diameter, to further treat the site.

18. A method of implanting a tubular graft within a body lumen, comprising the steps of:

providing an elongate flexible tubular body having an inflatable balloon thereon, said balloon inflatable to a first diameter at a first inflation pressure to produce a generally cylindrical balloon profile and proximal and distal portions of said balloon additionally inflatable to a second, larger diameter at a second, greater inflation pressure;

positioning an expandable tubular graft on the balloon;

positioning the balloon within a body lumen adjacent a treatment site;

inflating the balloon to the first inflation diameter to expand the tubular graft; and

thereafter

increasing the inflation pressure to said second inflation pressure such that the proximal and distal portions of the balloon inflate to the second larger diameter to further expand proximal and distal portions of the tubular graft.

19. A method of sizing two axially adjacent tubular stents within a body lumen, comprising the steps of:

locating two axially adjacent stents positioned within a body lumen;

providing a stent sizing catheter of the type having an elongate tubular body with a stent sizing balloon on the distal end thereof, said balloon comprising a proximal zone inflatable to a first diameter and a distal zone inflatable to a second, smaller diameter;

positioning the catheter such that the proximal zone is within the proximal of the two stents and the distal zone of the balloon is within the distal of the two stents;

inflating the balloon such that the proximal zone inflates to a greater diameter than the distal zone;

deflating the balloon; and

withdrawing the catheter from the patient.

20. A method as in claim 19, wherein said inflation step comprises inflating the balloon such that the proximal zone is at least about 0.2mm in diameter greater than the distal zone.

21. A method as in claim 19, wherein each of the proximal and distal zones are inflated to a generally cylindrical configuration.

22. A balloon catheter, comprising:

an elongate flexible tubular body having proximal and distal ends and at least one inflation lumen extending axially therethrough;

an inflatable balloon on the distal end of the tubular body, said balloon in communication with the inflation lumen;

a proximal zone on the balloon inflatable to a first diameter at a predetermined inflation pressure; and

a distal zone on the balloon inflatable to a second diameter at the predetermined pressure.

23. A method of sizing a tubular stent within a body lumen, comprising the steps of:

locating a tubular stent positioned within a body lumen;

providing a stent sizing catheter of the type having an elongate tubular body with a stent sizing balloon on the distal end thereof, said balloon comprising a proximal zone inflatable to a first diameter and a distal zone inflatable to a second, smaller diameter;

positioning the catheter such that the proximal zone is within a proximal portion of the stent and the distal zone of the balloon is within a distal portion of the stent;

inflating the balloon such that the proximal zone inflates to a greater diameter than the distal zone, thereby expanding the proximal portion of the stent to a greater inside diameter than the inside diameter of the distal portion of the stent;

deflating the balloon; and

withdrawing the catheter from the patient.