Expandable stent delivery system with outer sheath

• US 10,278,838 B2
• Filed: 04/28/2014
• Issued: 05/07/2019
• Est. Priority Date: 01/15/2008
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Tan-Malecki, Francisca, Sahatjian, Ronald A., Liu, Clifford M.
• Primary Examiner(s): Rodjom, Katherine M
• Application Number:
  US14/263,537
• Publication Number:
  US 20140257458A1
• Time in Patent Office: 1,835 Days
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• 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 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• 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

Abstract

According to aspects described herein, there is disclosed an improved hot balloon catheter delivery system for shape memory tubular stents. An outer sheath is provided on the delivery system that facilitates stent placement on a balloon during delivery through an endoscope. In one embodiment, the stent may be positioned between radiopaque markers/electrodes and the balloon may be heated. The stent may be prevented from moving proximally relative to the catheter as the delivery system is tracked through the patient'"'"'s anatomical passageways. The outer sheath may be positioned to ride over the proximal cone of the hot balloon catheter and abut the proximal end of the stent to facilitate proper alignment of the balloon for deployment. Upon deployment of the stent in an appropriate position, the sheath may be pulled away from the stent to expose the proximal cone of the balloon and thereby allow balloon and stent expansion.

Claims

1. A stent delivery catheter having an outer surface, the stent delivery catheter comprising:

a tube having a proximal end, a distal end, and a length measured from the proximal end to the distal end;

a sheath extending along a majority of the length of the tube, the sheath defined by a continuous circumferential wall at a distal end thereof;

the tube extending through a lumen of the sheath and longitudinally moveable relative thereto;

an expansion member secured to the tube;

a stent positioned around and in direct contact with the expansion member in an unexpanded configuration; and

a control assembly for actuating expansion of the expansion member;

wherein;

the distal end of the sheath abuts a proximal end of the stent forming a continuous surface, the continuous surface forming a part of the outer surface of the stent delivery catheter, wherein the continuous surface is at a radially outermost extent of the stent delivery catheter during advancement of the stent delivery catheter through a body lumen, wherein an inner diameter of the distal end of the sheath is less than an outer diameter of the stent in the unexpanded configuration.

2. The stent delivery catheter of claim 1, wherein the expansion member is a balloon.

3. The stent delivery catheter of claim 2, wherein the sheath overlays a proximal end and a proximal cone of the balloon.

4. The stent delivery catheter of claim 1, wherein the sheath includes a handle.

5. The stent delivery catheter of claim 1, wherein the proximal end of the tube includes an opening in communication with a longitudinal passage of the tube.

6. The stent delivery catheter of claim 1, wherein the stent delivery catheter is positioned inside a lumen of an endoscope.

7. The stent delivery system of claim 1, further comprising an electrode positioned between opposite ends of the expansion member.

8. The stent delivery system of claim 1, wherein an outer diameter of the distal end of the sheath is the same as the outer diameter of the stent in the unexpanded configuration.

9. A stent delivery system having an outer surface, the stent delivery system comprising:

an endoscope defining a lumen; and

a stent delivery catheter positioned in the lumen of the endoscope;

the stent delivery catheter having a delivery configuration, and a deployment configuration for expansion of a stent, the stent delivery catheter being in the deployment configuration after the delivery configuration;

the stent delivery catheter comprising;

a sheath defined by a continuous circumferential wall at a distal end thereof;

a stent;

a balloon having two ends;

a tube; and

a control assembly for actuating expansion of the balloon;

the stent delivery catheter being in the delivery configuration wherein;

a proximal end region of the stent delivery catheter comprises a handle of the sheath and a proximal end of the tube, the tube having a greater longitudinal length than the sheath, the sheath extending along a majority of the longitudinal length of the tube;

the tube positioned in a lumen of the sheath and longitudinally moveable relative thereto;

the balloon secured to the tube;

the stent positioned around and in direct contact with the balloon; and

the distal end of the sheath abuts a proximal end of the stent to form a continuous surface, the continuous surface forming a part of the outer surface of the stent delivery catheter in the delivery configuration, wherein the continuous surface is at a radially outermost extent of the stent delivery catheter during advancement of the stent delivery catheter through a body lumen, wherein an inner diameter of the distal end of the sheath is less than an outer diameter of the stent in the delivery configuration and the sheath overlays a proximal cone of the balloon in the delivery configuration.

10. The stent delivery system of claim 9, wherein when the stent delivery catheter is in the deployment configuration the sheath is proximal to the proximal cone of the balloon and a proximal end of the stent for expansion of the balloon and deployment of the stent.

11. The stent delivery system of claim 10, further wherein in the deployment configuration, the balloon is expandable for deployment of the stent.

12. The stent delivery system of claim 9, wherein a proximal end of the tube includes an opening in communication with a longitudinal passage of the tube.

13. The stent delivery system of claim 9, the sheath having a continuous circular cross-section.

14. The stent delivery system of claim 9, further comprising an electrode positioned between the two ends of the balloon, wherein the electrode is configured to heat the balloon.

15. The stent delivery system of claim 9, wherein an outer diameter of the distal end of the sheath is the same as the outer diameter of the stent in the delivery configuration.

16. A stent delivery catheter comprising:

a tube having a proximal end, a distal end, and a length measured from the proximal end to the distal end;

a sheath extending along a majority of the length of the tube, the sheath defined by a continuous circumferential wall at a distal end thereof, the circumferential wall defining a portion of an outer surface of the stent delivery catheter;

the tube extending through a lumen of the sheath and longitudinally moveable relative thereto;

a balloon secured to the tube; and

a stent having a proximal end and a distal end, the stent being radially expandable from an unexpanded state in a delivery configuration of the stent delivery catheter to an expanded state in a deployment configuration of the stent delivery catheter, the stent positioned around and in direct contact with the balloon in the unexpanded state such that the distal end of the sheath abuts the proximal end of the stent forming a continuous surface, the continuous surface forming a part of the outer surface of the stent delivery catheter, wherein the continuous surface is at a radially outermost extent of the stent delivery catheter during advancement of the stent delivery catheter through a body lumen;

wherein an inner diameter of the distal end of the sheath is less than an outer diameter of the stent in the unexpanded state;

wherein in the delivery configuration, the balloon is in a deflated state; and

wherein in the deployment configuration the balloon is in an inflated state to radially expand the stent to the expanded state.

17. The stent delivery catheter of claim 16, wherein when the stent delivery catheter is in the deployment configuration the distal end of the sheath is proximal to a proximal cone of the balloon and proximal to the proximal end of the stent for expansion of the balloon and deployment of the stent.

18. The stent delivery catheter of claim 17, wherein the sheath overlays the proximal cone of the balloon in the delivery configuration.

19. The stent delivery catheter of claim 16, wherein the proximal and distal ends of the stent are positioned between proximal and distal ends of the balloon in both the delivery configuration and the deployment configuration.

20. The stent delivery catheter of claim 19, wherein in the inflated state, the proximal end and the distal end of the balloon are wider than a central portion of the balloon.