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

• US 9,220,616 B2
• Filed: 04/13/2012
• Issued: 12/29/2015
• 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): Holwerda, Kathleen
• Assistant Examiner(s): DANG, ANH TIEU
• Application Number:
  US13/447,101
• Publication Number:
  US 20130274859A1
• Time in Patent Office: 1,355 Days
• Field of Search: 606/200, 606/108, 623/1.11, 623/1.12
• US Class Current: 1/1
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• 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 with a distal end for insertion into a vasculature of a patient;

a tip capture spindle disposed over the elongate shaft, proximate to the distal end of the elongate 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 threads on an outer surface thereof; and

a distal tip assembly coupled to the distal end of the elongate shaft, wherein a portion of the distal tip assembly proximally extends over the outer surface of the distal portion of the tip capture spindle and an inner surface of the distal tip assembly includes threads that mate with the threads on the tip capture spindle, and

wherein rotation of the elongate shaft rotates the distal tip assembly and results in longitudinal movement of the tip capture spindle.

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 retractable outer sheath; and

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

3. The stent-graft delivery system of claim 2, wherein the radially-compressible stent further comprises endmost crowns engaging the plurality of retainer elements of the tip capture spindle.

4. The stent-graft delivery system of claim 3, wherein the endmost crowns of the stent do not extend beyond a first end of the tubular graft and a plurality of suture loops couple the graft to the plurality of retainer elements of tip capture spindle when the stent-graft prosthesis is in a delivery configuration or a partially-deployed configuration.

5. The stent-graft delivery system of claim 4, wherein rotation of the elongate shaft moves the tip capture spindle in a distal direction.

6. The stent-graft delivery system of claim 4, wherein each retainer element includes a recess formed on an inner surface thereof for receiving a suture loop and the suture loop is disposed within the recess of the retainer element and captured between the retainer element and an outer surface of the elongate shaft when the stent-graft prosthesis is in a delivery configuration or a partially-deployed configuration.

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

a sleeve having a proximal end extending over the retainer elements of the tip capture spindle and a distal end extending into the distal tip assembly, wherein an inner surface of the sleeve includes threads that mates with threads on an outer surface of the distal tip assembly and wherein rotation of the elongate shaft rotates the distal tip assembly and results in longitudinal movement of the tip capture spindle and the sleeve.

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 7, 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 3, wherein the endmost crowns of the radially-compressible stent extend beyond a first end of the tubular graft and the plurality of retainer elements of the tip capture spindle cover and constrain the endmost crowns when the self-expanding stent-graft prosthesis is in a delivery configuration or a partially-deployed configuration.

11. The stent-graft delivery system of claim 10, wherein rotation of the elongate shaft moves the tip capture spindle in a proximal direction.

12. The stent-graft delivery system of claim 10, wherein the plurality of retainer elements are disposed around a circumference of the tip capture spindle and each retainer element includes a radially-extending base segment and an arm segment that distally extends from the radially-extending base segment such that the arm segment is spaced apart from an outer surface of the elongate shaft to define recesses that receive the endmost crowns.

13. 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 with a distal end for insertion into a vasculature of a patient, wherein a tip capture spindle is disposed over the elongate shaft, proximate to the distal end of the elongate 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 tip assembly is coupled to the distal end of the elongate shaft, a portion of the distal tip assembly proximally extending over an outer surface of a distal portion of the tip capture spindle, wherein an inner surface of the distal tip assembly includes threads that mate with threads formed on the outer surface of the distal portion of the tip capture spindle, and

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 and results in longitudinal movement of the tip capture spindle.

14. The method of claim 13, 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.

15. The method of claim 13, wherein the endmost crowns of the stent extend beyond a first end of the tubular graft and the plurality of retainer elements of the tip capture spindle cover and constrain the endmost crowns when the stent-graft prosthesis is in a delivery configuration or a partially-deployed configuration, and wherein rotating the elongate shaft to fully deploy the stent-graft prosthesis moves the tip capture spindle in a proximal direction until the retainer elements of the tip capture spindle do not cover the endmost crowns.

16. The method of claim 13, wherein the endmost crowns of the stent do not extend beyond a first end of the tubular graft and a plurality of suture loops couple the graft to the plurality of retainer elements of the tip capture spindle when the stent-graft prosthesis is in a delivery configuration or a partially-deployed configuration, and wherein a plurality of suture loops couple the tubular graft to the plurality of retainer elements and rotating the elongate shaft to fully deploy the stent-graft prosthesis moves the tip capture spindle in a distal direction until the suture loops do not couple the tubular graft to the retainer elements of the tip capture spindle.

17. The method of claim 13, wherein the delivery system further includes a sleeve having a proximal end extending over the retainer elements of the tip capture spindle and a distal end extending into the distal tip assembly, wherein an inner surface of the sleeve includes threads that mates with threads on an outer surface of the distal tip assembly, and rotating the elongate shaft to fully deploy the stent-graft prosthesis moves the tip capture spindle in a proximal direction and moves the sleeve in a distal direction.