Apparatus for deliver and deployment of a stent

• US 6,136,006 A
• Filed: 07/27/1998
• Issued: 10/24/2000
• Est. Priority Date: 05/08/1992
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Corporation
• Inventors: Johnson, Liann M., Thompson, Richard J., Scholl, John A.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US09/123,389
• Time in Patent Office: 820 Days
• Field of Search: 606/108, 606/191, 606/198, 623/1.11, 623/1.12, 623/1.23, 604/220
• US Class Current: 606/108
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/962 having an outer sleeve
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/821 Ostial stents
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia
• 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

Abstract

A radially self-expanding stent particularly suited for treating esophageal strictures, includes a medial region and proximal and distal cuffs having diameters greater than the medial region diameter when the stent is in the relaxed state. A silicone coating circumscribes the medial region, but the cuffs are not coated and retain their open weave construction. As a result, the cuffs remain particularly well suited to immediately contact esophageal wall tissue and resist stent migration, while the silicone coated medial region provides a barrier to tumor ingrowth, and has an enhanced radial restoring force to maintain an open passageway in the esophagus. A deployment device for the stent includes an interior catheter surrounded by the stent and having an esophageal dilation feature, along with an exterior catheter that radially compresses the stent. A low durometer sleeve, fixed to the interior tube and in surface engagement with the compressed stent, tends to fix the axial position of the stent relative to the interior catheter whenever the exterior catheter is moved axially relative to the inner catheter. Consequently, precision in stent placement and the ability to recapture a partially deployed stent are enhanced.

Claims

1. An apparatus for deploying a radially expandable stent within a body lumen, including:

a stent confining device adapted to maintain a radially expandable stent in a delivery configuration in which the radially expandable stent has a reduced radius;

an elongate and flexible stent delivery device having a proximal end, a distal end, and a distal region near the distal end for use in delivering the radially expandable stent into a body lumen and in positioning the stent at a treatment site within the body lumen with the stent surrounding the delivery device along the distal region, while the proximal device along the distal region, while the proximal end of the stent delivery device remains outside of the body;

an axial stent restraining apparatus disposed along the distal region of the delivery device, wherein friction between said restraining apparatus and said stent is greater than friction between said stent confining device and said stent; and

a position control apparatus operably associated with the delivery device and the confining device for moving the confining device axially relative to the delivery device toward and away from a confinement position in which the confining device maintains the radially expandable stent in the delivery configuration and urges the stent into a surface engagement with the axial stent restraining apparatus;

wherein the axial stent restraining apparatus, during said surface engagement, tends to maintain the radially expandable stent axially aligned with the deployment device as the confining device is moved axially away from the confinement position to release the stent for radial expansion; and

a cylindrically shaped detent device, cut axially for removable mounting to the stent delivery device portion near the proximal end, for preventing any substantial axial movement of the stent delivery device relative to the stent confining device, to maintain the stent confining device in the confinement position.

2. The apparatus of claim 1 wherein:

the stent delivery device comprises a first elongate and flexible length of tubing.

3. The apparatus of claim 2 further including:

a central lumen running the axial length of the first tubing, for accommodating a guidewire.

4. The apparatus of claim 2 further including:

a distal tip at the distal end of the first tubing, for dilating a malignant stricture at the treatment site.

5. The apparatus of claim 2 wherein:

the stent confining device comprises a second elongate and flexible length of tubing having a lumen running the length thereof, and wherein the first length of tubing is contained within the lumen with a proximal portion of the first tubing extended proximally of the second tubing when the second tubing is in the confinement position.

6. The apparatus of claim 5 wherein:

the position control apparatus comprises a first hub at the proximal end of the first tubing and a second hub at the proximal end of the second tubing.

7. The apparatus of claim 5 wherein:

the axial restraining apparatus comprises a sleeve surrounding the first tubing along the distal region.

8. The apparatus of claim 7 further including:

an adhesive applied to an exterior surface of the sleeve.

9. The apparatus of claim 5 wherein:

the axial stent restraining apparatus comprises a plurality of elongate strips disposed along the distal region.

10. The apparatus of claim 9 wherein:

the strips are oriented axially and spaced apart angularly from one another to form a set of the strips surrounding the first tubing.

11. The apparatus of claim 10 further including:

an adhesive layer along a radially outward surface of each of the strips.

12. The apparatus of claim 5 further including:

visible indicia along the proximal portion of the first tubing for indicating the position of a distal end of the second tubing with respect to the distal region of the first tubing.

13. The apparatus of claim 12 wherein:

said indicia further measure the extent to which the radially self-expanding stent is deployed.

14. The apparatus of claim 5 further including:

visible markings along at least a proximal region of the second tubing for indicating the extent of insertion of the second tubing into the body lumen.

15. The apparatus of claim 5 further including:

an enlargement feature near the distal end of the stent delivery device, said enlargement feature having a diameter substantially equal to an interior diameter of the second tubing, a distal transition region diverging proximally from the tip to a mid-portion of the enlargement feature, and a proximal transition region converging in the proximal direction from the enlargement feature mid-portion.

16. The apparatus of claim 2 further including:

radiopaque markings on the first tubing along the distal end region.