Catheter system for introducing an expandable stent into the body of a patient

• US 10,307,251 B2
• Filed: 01/17/2017
• Issued: 06/04/2019
• Est. Priority Date: 05/20/2010
• Status: Active Grant

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology, Inc.
• Inventors: Straubinger, Helmut, Mayer, Arnulf, Jung, Johannes
• Primary Examiner(s): Lynch, Robert A
• Assistant Examiner(s): Gabr, Mohamed G
• Application Number:
  US15/407,560
• Publication Number:
  US 20170156858A1
• Time in Patent Office: 868 Days
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• 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 2002/9505 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
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61M 2025/09141 made of shape memory alloys which take a particular shape at a certain temperature

Abstract

This disclosure relates to a catheter system for introducing a heart valve stent into the body of a patient. The catheter system includes a catheter tip having a seat portion for accommodating the stent in its collapsed state and a stent holder for releasably fixing the stent, wherein the seat portion is constituted by a first sleeve and a second sleeve, said sleeves being moveable relative to each other and relative to the stent holder, and a catheter shaft for connecting the catheter tip to a handle.

Claims

1. A method of implanting an endoprosthesis including three positioning arches, three retaining arches, a valve prosthesis directly attached to the three retaining arches, and a plurality of retaining elements, the method comprising:

positioning the endoprosthesis relative a native heart 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 positioning arches while covering the plurality of retaining elements within the first sleeve, wherein manipulating the handle moves a first tubular member coupled to the first sleeve in the first direction;

positioning the positioning arches within pockets of the native valve;

manipulating the handle to move a second sleeve with respect to the stent holder in a second direction opposite the first direction and away from the handle to uncover the retaining arches, wherein manipulating the handle moves a second tubular member coupled to the second sleeve in the second direction; and

securing a plurality of native leaflets of the native valve within the positioning arches and outside of the retaining arches;

wherein the stent holder is fixed relative to the handle via a holder tube extending proximally from the stent holder, the holder tube having a distal end connected to the holder and a proximal end connected to the handle, and wherein the holder tube is within the first tubular member, and

wherein the holder includes a holder support section distal to the holder, and an extension portion has a proximal end connected to the holder and a distal end connected to the holder support section.

2. The method of claim 1, wherein the step of manipulating the handle to move the second sleeve relative the stent holder to uncover the retaining arches allows the retaining arches and the valve prosthesis to expand, wherein each of the three retaining arches includes an apex axially aligned along a longitudinal direction of the endoprosthesis with a respective apex of one of the three positioning arches.

3. The method of claim 1, wherein the second tubular member is disposed within the first tubular member.

4. The method of claim 3, wherein the holder tube and the extension portion each has an outer cross-section diameter less than an outer cross-section of the first tubular member and greater than an outer cross-section diameter of the second tubular member, wherein the holder tube is disposed within the first and second tubular members.

5. The method of claim 1, wherein the endoprosthesis overlies the holder, the extension portion, and the holder support section when the endoprosthesis is in a collapsed configuration, and wherein the three positioning arches includes exactly three positioning arches, and the three retaining arches includes exactly three retaining arches.

6. The method claim 1, wherein the holder support section includes a tapered portion completely accommodated in the second sleeve when manipulating the handle to move the second tubular member in the second direction.

7. The method of claim 1, further comprising moving the first sleeve in the first direction to uncover the plurality of retaining elements.

8. A method of implanting an endoprosthesis including a plurality of positioning arches, a plurality of retaining arches, a valve prosthesis directly attached to each of the retaining arches, and a plurality of retaining elements, the method comprising:

positioning the endoprosthesis relative a native valve;

manipulating a handle of a catheter to move a first sleeve relative to a stent holder in a first direction to uncover the positioning arches while covering the plurality of retaining elements, wherein the first sleeve at least partially surrounds the stent holder;

positioning the positioning arches within pockets of the native valve;

manipulating the handle to move a second sleeve in a second direction opposite the first direction to uncover the retaining arches to allow the retaining arches and the valve prosthesis to expand, wherein each of the retaining arches includes an apex axially aligned with an apex of a corresponding positioning arch;

securing a plurality of leaflets of the native valve within the positioning arches and outside of the retaining arches; and

manipulating the handle to further move the first sleeve to uncover the plurality of retaining elements;

wherein the stent holder is fixed relative to the handle via a holder tube extending proximally from the stent holder, the holder tube having a distal end connected to the holder and a proximal end connected to the handle, and wherein the holder tube is within the first tubular member, and

wherein the holder includes a holder support section distal to the holder, and an extension portion has a proximal end connected to the holder and a distal end connected to the holder support section.

9. The method of claim 8, wherein the plurality of positioning arches includes exactly three positioning arches, and the plurality of retaining arches includes exactly three retaining arches.

10. The method of claim 8, wherein manipulating the handle to move the first sleeve includes rotation of a portion of the handle to move a first tubular member coupled to the first sleeve in the first direction;

and wherein manipulating the handle to move the second sleeve includes moving a second tubular member coupled to the second sleeve in the second direction.

11. The method of claim 10, wherein the second tubular member is disposed within the first tubular member.

12. The method of claim 11, wherein the holder tube and the extension portion each has an outer cross-section diameter less than an outer cross-section of the first tubular member and greater than an outer cross-section diameter of the second tubular member, wherein the holder tube is disposed within the first and second tubular members.

13. The method of claim 8, wherein the endoprosthesis overlies the holder, the extension portion, and the holder support section when the endoprosthesis is in a collapsed configuration.

14. The method claim 8, wherein the holder support section includes a tapered portion completely seated in the second sleeve when manipulating the handle of the catheter to uncover the positioning arches while covering the plurality of retaining elements.

15. A method of implanting an endoprosthesis including exactly three positioning arches, exactly three retaining arches, a valve prosthesis directly attached to each of the exactly three retaining arches, and a plurality of retaining elements, the method comprising:

positioning the endoprosthesis relative a native heart valve;

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

positioning the positioning arches within pockets of the native valve;

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

securing a plurality of native leaflets of the native valve within the positioning arches and outside of the retaining arches;

wherein the stent holder is fixed relative to the handle via a holder tube extending proximally from the stent holder, the holder tube having a distal end connected to the holder and a proximal end connected to the handle, and wherein the holder tube is within the first tubular member, and

wherein the holder includes a holder support section distal to the holder, and an extension portion has a proximal end connected to the holder and a distal end connected to the holder support section.

16. The method of claim 15, further comprising moving the endoprosthesis through an aortic arch before positioning the endoprosthesis relative to the native valve.

17. The method of claim 15, wherein the step of actuating the handle to move the second sleeve relative the stent holder to uncover the retaining arches allows the retaining arches and the valve prosthesis to expand, wherein each of the three retaining arches includes an apex axially aligned along a longitudinal direction of the endoprosthesis with a respective apex of one of the three positioning arches.

18. The method of claim 15, wherein the holder tube and the extension portion each has an outer cross-section diameter less than an outer cross-section of the first tubular member and greater than an outer cross-section diameter of the second tubular member, wherein the holder tube is disposed within the first and second tubular members.

19. The method claim 15, wherein the holder support section is tapered.

20. The method of claim 15, wherein the positioning arches, the retaining arches, the valve prosthesis, and the plurality of retaining elements are held in a collapsed state within a tip of the catheter by the first and second sleeves.