Methods of implanting an endoprosthesis

• US 9,295,551 B2
• Filed: 05/12/2008
• Issued: 03/29/2016
• Est. Priority Date: 04/13/2007
• Status: Active Grant

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology GmbH (JenaValve Technology, Inc.)
• Inventors: Straubinger, Helmut, Jung, Johannes
• Primary Examiner(s): Anderson, Gregory
• Assistant Examiner(s): LAUER, CHRISTINA C
• Application Number:
  US12/599,934
• Publication Number:
  US 20110015616A1
• Time in Patent Office: 2,878 Days
• Field of Search: 623/1.11, 623/1.12, 623/2.11, 606/108
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires

Abstract

A catheter insertion system for inserting an expandable valve stent into the body of a patient and a method of implanting a valve stent. The catheter insertion system includes a catheter having a handle for manipulating a catheter tip, and enables the implantation of a valve prosthesis attached to a valve stent. The handle is configured to enable a pre-set sequence of steps to manipulate the catheter tip and sequentially release the valve stent. The catheter tip is configured to sequentially release the valve stent from a first collapsed mode to a second expanded mode.

Claims

1. A method of implanting an endoprosthesis including a plurality of positioning arches, a plurality of retaining arches, and a plurality of retaining elements, the method comprising:

positioning the endoprosthesis relative to a native valve;

manipulating a handle of a catheter to move a first sleeve with respect to a stent holder in a first direction toward the handle to uncover the plurality of positioning arches while covering the plurality of retaining elements with the first sleeve, wherein manipulating the handle includes rotating a portion of the handle to move a first tubular member coupled to the first sleeve in the first direction;

positioning the positioning arches within pockets of the native valve; and

manipulating the handle to move a second sleeve with respect to the stent holder in a second direction away from the handle to uncover the plurality of retaining arches, wherein manipulating the handle includes moving a second tubular member coupled to the second sleeve in the second direction;

wherein the stent holder is fixed relative to the handle via a third tubular element extending from the stent holder to the handle, the third tubular element being radially inward of the first tubular element and radially outward of the second tubular element.

2. The method of claim 1, further including releasing a temporary securing mechanism after uncovering the plurality of positioning arches and before uncovering the plurality of retaining arches.

3. The method of claim 1, wherein manipulating the handle to move the second sleeve includes operating a slide mechanism.

4. The method of claim 3, wherein operating the slide mechanism includes displacing the slide mechanism between a first stop and a second stop to define a stroke length for moving the second sleeve.

5. The method of claim 1, further including manipulating the handle after uncovering the plurality of retaining arches to move the first sleeve farther in the first direction to uncover the plurality of retaining elements.

6. The method of claim 5, further including releasing a temporary securing mechanism after uncovering the plurality of retaining arches and before uncovering the plurality of retaining elements.

7. The method of claim 1, wherein the catheter includes a tip region that includes the first and second sleeves and a handle region that includes the handle, the method further including manipulating the handle to deflect the tip region relative to the handle region.

8. The method of claim 1, further including:

manipulating the handle to move the second sleeve in the first direction to cover the plurality of retaining arches; and

subsequently manipulating the handle to move the first sleeve in the second direction to cover the plurality of positioning arches.

9. The method of claim 1, wherein the plurality of positioning arches are disposed radially outward from the second sleeve and radially inward from the first sleeve before uncovering the plurality of positioning arches.

10. The method of claim 1, wherein the first and second sleeves are arranged telescopically.

11. The method of claim 1, further including maneuvering the endoprosthesis through a patient'"'"'s vasculature to the native valve.

12. The method of claim 1, further including maneuvering the endoprosthesis through a patient'"'"'s femoral artery.

13. The method of claim 1, wherein a prosthetic valve is attached to the plurality of retaining arches.

14. The method of claim 1, wherein an outermost surface of the stent holder includes three discrete recesses extending along a longitudinal axis of the catheter, each recess being open towards the handle of the catheter and closed towards the tip of the catheter.

15. A method of implanting an endoprosthesis including a plurality of positioning arches, a plurality of retaining arches, a plurality of retaining elements, and a prosthetic valve attached to the retaining arches, the method comprising:

positioning the endoprosthesis relative to a native valve;

manipulating a handle of a catheter to move a first tubular element and a first sleeve element coupled to the first tubular element with respect to a stent holder in a first direction toward a tip of the catheter to uncover the plurality of positioning arches and permit the plurality of positioning arches to radially expand;

while uncovering the plurality of positioning arches, maintaining the plurality of retaining elements within the first sleeve element, wherein the plurality of retaining elements engage a plurality of discrete recesses formed in an outermost surface of the stent holder, each recess extending in the first direction from a closed end to an open end facing the handle of the catheter;

positioning the positioning arches within pockets of the native valve;

after uncovering the plurality of positioning arches, manipulating the handle of the catheter to move a second tubular element and a second sleeve element coupled to the second tubular element with respect to the stent holder in a second direction away from the tip of the catheter to uncover the plurality of retaining arches and permit the plurality of retaining arches and the prosthetic valve to radially expand; and

after uncovering the plurality of retaining arches, manipulating the handle of the catheter to move the first sleeve element relative to the stent holder farther in the first direction to uncover the plurality of retaining elements;

wherein the stent holder is fixed relative to the handle via a third tubular element extending from the stent holder to the handle, wherein the third tubular element is radially inward of the first tubular element and radially outward of the second tubular element.

16. The method of claim 15, wherein manipulating the handle of the catheter to move the first sleeve includes operating a slide mechanism.

17. The method of claim 15, further including releasing a temporary securing mechanism of the handle after uncovering the plurality of positioning arches and before uncovering the plurality of retaining arches.

18. The method of claim 15, further including releasing a temporary securing mechanism of the handle after uncovering the plurality of retaining arches and before uncovering the plurality of retaining elements.

19. The method of claim 15, wherein the plurality of positioning arches are disposed radially outward from the second sleeve and radially inward from the first sleeve before uncovering the plurality of positioning arches.

20. The method of claim 15, wherein the first and second sleeves are arranged telescopically.

21. The method of claim 15, wherein each recess is substantially perpendicular to a longitudinal axis of the stent holder.

22. The method of claim 15, wherein

the catheter includes a platic filler material between the first tubular element and the second tubular element.

23. The method of claim 22, wherein the filler material is rigid.

24. A method of implanting an endoprosthesis including a plurality of positioning arches, a plurality of retaining arches, a plurality of retaining elements, and a prosthetic valve attached to the retaining arches, the method comprising:

maneuvering the endoprosthesis at least partially through a femoral artery and an aortic arch;

positioning the endoprosthesis relative to a native aortic valve;

manipulating a handle of a catheter by rotating a portion of the handle to move a first tubular element and a first sleeve element coupled to the first tubular element with respect to a stent holder a fixed longitudinal distance in a first direction toward the handle to uncover the plurality of positioning arches and permit the plurality of positioning arches to radially expand;

while permitting the positioning arches to radially expand, maintaining the plurality of retaining elements within the first sleeve element, the plurality of retaining elements engaged within respective recesses formed in the stent holder;

positioning the positioning arches within pockets of the native aortic valve;

rotating the positioning arches relative to the native aortic valve and relative to the first and second sleeves;

manipulating the handle to move a second tubular element and a second sleeve element coupled to the second tubular element with respect to the stent holder in a second direction away from the handle to uncover the plurality of retaining arches and permit the plurality of retaining arches and the prosthetic valve to radially expand; and

manipulating the handle by further rotating the portion of the handle to move the first sleeve element with respect to the stent holder in the first direction to uncover the plurality of retaining elements and release the plurality of retaining elements from the respective recesses of the stent holder;

wherein the stent holder is fixed relative to the handle via a third tubular element extending from the stent holder to the handle, the third tubular element being radially inward of the first tubular element and radially outward of the second tubular element.

25. The method of claim 24, further including operating a slide mechanism to move the second sleeve in the second direction between a first endpoint and a second endpoint.

26. The method of claim 24, wherein the respective recesses include three discrete recesses uniformly spaced about an outermost surface of the stent holder, each recess extending in the second direction from a rounded closed end to an open end facing the tip of the catheter.