Stent-graft delivery system having a rotatable single shaft tip capture mechanism

• US 8,920,485 B2
• Filed: 04/13/2012
• Issued: 12/30/2014
• Est. Priority Date: 04/13/2012
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Argentine, Jeff
• Primary Examiner(s): Woo, Julian W
• Assistant Examiner(s): PAEZ, LUCAS M
• Application Number:
  US13/447,107
• Publication Number:
  US 20130274860A1
• Time in Patent Office: 991 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.13, 623/1.23, 623/2.11, 606/108, 606/200
• US Class Current: 623/1.12
• 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 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9665 with additional retaining means

Abstract

A stent-graft delivery system includes an elongate shaft, a tip capture spindle disposed over the shaft, and a distal tip assembly coupled to the distal end of the shaft. At least one component of the delivery system constrains a stent of the stent-graft engaged with the tip capture spindle during delivery and partial-deployment of the stent-graft, and the at least one component is in a threaded relationship with the distal tip assembly. To fully deploy the stent-graft, the elongate shaft, having the distal tip assembly coupled thereto, is rotated to result in longitudinal movement of the at least one component and thereby release the stent from the tip capture spindle. The at least one component that longitudinally moves to fully deploy the stent-graft may be the tip capture spindle and/or a relatively short sleeve that extends over the tip capture spindle to the distal tip assembly.

Claims

1. A stent-graft delivery system comprising:

an elongate shaft;

a tip capture spindle disposed over the shaft, proximate to a distal end of the shaft, wherein a proximal portion of the tip capture spindle includes a plurality of retainer elements configured to engage a stent of a stent-graft prosthesis and a distal portion of the tip capture spindle includes a continuous helical groove on an outer surface thereof;

a distal tip assembly coupled to the distal end of the shaft, wherein a proximally-extending portion of the distal tip assembly proximally extends over the outer surface of the distal portion of the tip capture spindle;

a sleeve having a proximal end extending over the retainer elements of the tip capture spindle and a distal end extending over the proximally-extending portion of the distal tip assembly, wherein an inner surface of the sleeve includes a continuous helical groove that aligns with the continuous helical groove on the outer surface of the tip capture spindle to create a continuous helical passageway;

a spherical ball extending through an opening formed within the proximally-extending portion of the distal tip assembly, wherein a first half of the ball is housed within the helical groove of the sleeve and a second half of the ball is housed within the helical groove of the tip capture spindle;

wherein rotation of the elongate shaft rotates the distal tip assembly, thereby spinning the ball within the continuous helical passageway and resulting in longitudinal movement of the tip capture spindle and the sleeve.

2. The stent-graft delivery system of claim 1, further comprising:

a retractable outer sheath defining a lumen, wherein the elongate shaft is slidingly received within the lumen of the outer sheath.

3. The stent-graft delivery system of claim 1, further comprising:

a stent graft prosthesis mounted over the shaft, proximate to the tip capture spindle, wherein the stent graft prosthesis includes a radially-compressible stent coupled to a tubular graft.

4. The stent-graft delivery system of claim 3, wherein endmost crowns of the stent engage the plurality of retainer elements of the tip capture spindle.

5. The stent-graft delivery system of claim 4, wherein at least one endmost crown includes a radially extending barb that anchors the stent-graft in place within the vasculature after deployment.

6. The stent-graft delivery system of claim 3, wherein the sleeve has a stepped outer diameter in which a distal portion of the sleeve has a smaller outer diameter than a proximal portion of the sleeve, and the proximal portion of the sleeve covers and restrains the endmost crowns of the stent when the stent-graft prosthesis is in a delivery configuration or a partially-deployed configuration.

7. The stent-graft delivery system of claim 1, wherein a pitch of the continuous helical groove of the sleeve and a pitch of the continuous helical groove of the tip capture spindle are in opposing longitudinal directions.

8. The stent-graft delivery system of claim 7, wherein rotation of the elongate shaft moves the tip capture spindle in a proximal direction and the sleeve in a distal direction.

9. The stent-graft delivery system of claim 1, wherein the tip capture spindle includes a radially-extending pin that extends through a slot formed in the sleeve.

10. The stent-graft delivery system of claim 1, further comprising:

a hypotube which extends over an outer surface of a distal portion of the elongate shaft from at least a proximal end of the tip capture spindle to the distal end of the elongate shaft.

11. The stent-graft delivery system of claim 10, wherein the hypotube is formed from stainless steel and the elongate shaft is formed from Nitinol.

12. A method of deploying a stent-graft prosthesis, wherein the method comprises the steps of:

percutaneously advancing a delivery system having a stent-graft prosthesis mounted on an elongate shaft, wherein a tip capture spindle is disposed over the shaft, a proximal portion of the tip capture spindle including a plurality of retainer elements engaged with a stent of the stent-graft prosthesis and a distal portion of the tip capture spindle including a continuous helical groove on an outer surface thereof, wherein a distal tip assembly is coupled to a distal end of the shaft, a proximally-extending portion of the distal tip assembly proximally extends over the outer surface of the distal portion of the tip capture spindle, and wherein a sleeve having a proximal end extends over the retainer elements of the tip capture spindle and a distal end extends over the proximally-extending portion of the distal tip assembly, an inner surface of the sleeve including a continuous helical groove that aligns with the continuous helical groove on the outer surface of the tip capture spindle to create a continuous helical passageway, and wherein a spherical ball extends through an opening formed within the proximally-extending portion of the distal tip assembly and a first half of the ball is housed within the continuous helical groove of the sleeve and a second half of the ball is housed within the continuous helical groove of the tip capture spindle;

positioning the stent-graft prosthesis;

partially deploying the stent-graft prosthesis by retracting an outer sheath of the delivery system to expose the stent-graft prosthesis, wherein the stent-graft prosthesis self-expands and the stent remains engaged with the plurality of retainer elements of the tip capture spindle;

rotating the elongate shaft to fully deploy the stent-graft prosthesis, wherein rotation of the elongate shaft rotates the distal tip assembly, thereby spinning the ball within the continuous helical passageway and resulting in longitudinal movement of the tip capture spindle and the sleeve.

13. The method of claim 12, further comprising the step of:

repositioning the partially deployed stent-graft prosthesis, wherein the repositioning step is performed prior to the step of rotating the elongate shaft to fully deploy the stent-graft prosthesis.

14. The method of claim 12, wherein the sleeve has a stepped outer diameter in which a distal portion of the sleeve has a smaller outer diameter than a proximal portion of the sleeve, and the proximal portion of the sleeve covers and restrains endmost crowns of the stent when the stent-graft prosthesis is in a delivery configuration or a partially-deployed configuration.

15. The method of claim 12, wherein a pitch of the continuous helical groove of the sleeve and a pitch of the continuous helical groove of the tip capture spindle are in opposing longitudinal directions.

16. The method of claim 12, wherein rotation of the elongate shaft moves the tip capture spindle in a proximal direction and the sleeve in a distal direction.

17. The method of claim 12, wherein the tip capture spindle includes a radially-extending pin that extends through a slot formed in the sleeve.

18. The method of claim 12, wherein the delivery system further includes a hypotube which extends over an outer surface of a distal portion of the elongate shaft from at least a proximal end of the tip capture spindle to the distal end of the elongate shaft.

19. The method of claim 18, wherein the hypotube is formed from stainless steel and the elongate shaft is formed from Nitinol.

20. The method of claim 12, wherein endmost crowns of the stent engage the plurality of retainer elements of the tip capture spindle.