Delivery systems and methods of implantation for prosthetic heart valves

• US 8,685,077 B2
• Filed: 03/14/2012
• Issued: 04/01/2014
• Est. Priority Date: 01/24/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Laske, Timothy G., Ryan, Timothy R., Majkrzak, Carolyn C., Bloom, Eliot, Tabor, Charles
• Primary Examiner(s): Erezo, Darwin
• Assistant Examiner(s): COLELLO, ERIN L
• Application Number:
  US13/420,101
• Publication Number:
  US 20120197379A1
• Time in Patent Office: 748 Days
• Field of Search: 623/1.11, 623/1.23, 623/1.24, 623 126- 128, 623/2.11, 606/200
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• 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 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• 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 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0054 : V-shaped
• CPC Class Codes: A61F 2230/008 : paraboloidal
• CPC Class Codes: A61F 2250/0018 : differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/003 : differing in adsorbability or resorbability, i.e. in adsorption or resorption time
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers

Abstract

A delivery system with sequential release mechanism and method of delivering and deploying an implantable stented device into a body lumen including a tabular body, a plurality of activation members extending from the distal end of the tubular body, and a plurality of disks. Each disk includes a proximal and distal surface, at least one stent engagement element attached to the distal surface of the disk and at least one aperture. At least one activation member attaches to the proximal surface of a first disk and at least one activation member passes through an aperture of the first disk and attaches to the proximal surface of a second disk. At least one stent engagement element attached to the distal surface of the first disk passes through an aperture of the second disk. Axially movement of the activation members causes sequential release of the stent engagement elements from a stented device.

Claims

1. A delivery system for delivering an implantable stented device into a body lumen, the delivery system comprising:

a tubular body having a proximal end and a distal end;

a plurality of activation members extending from the distal end of the tubular body; and

a first disk comprising;

a proximal surface;

a distal surface;

at least one stent engagement element attached to the distal surface of the first disk; and

an aperture; and

a second disk comprising;

a proximal surface;

a distal surface;

at least one stent engagement element attached to the distal surface of the second disk; and

an aperture,

wherein at least one activation member attaches to the proximal surface of the first disk,

wherein at least one activation member passes through the aperture of the first disk and attaches to the proximal surface of the second disk, and

wherein at least one stent engagement element attached to the distal surface of the first disk passes through the aperture of the second disk.

2. The delivery system of claim 1, wherein the first and second disks are generally along the same longitudinal axis.

3. The delivery system of claim 1, wherein a distal end each stent engagement element comprises a coiled portion.

4. The delivery system of claim 3, wherein each of the coiled portions has the same number of coils.

5. The delivery system of claim 3, wherein the coiled portion of at least one of the stent engagement elements has a different number of coils than the other stent engagement elements.

6. The delivery system of claim 3, wherein an outer diameter of the coiled portion of each stent engagement element passing through the aperture of the second disk is larger than the diameter of the aperture through which the stent engagement element passes, such that the stent engagement element cannot be moved axially through its respective aperture when in its coiled configuration.

7. The delivery system of claim 6, wherein the stent engagement element of each stent engagement element passing through the aperture of the second disk can be moved axially through its respective aperture when in its uncoiled configuration.

8. The delivery system of claim 3, wherein each stent engagement element can be at least temporarily deformed for engagement and disengagement with a stent crown of an implantable stented device.

9. The delivery system of claim 1, wherein each of the stent engagement elements has the same length.

10. The delivery system of claim 1, wherein at least one of the stent engagement elements has a different length than the other stent engagement elements.

11. The delivery system of claim 1, wherein the stent engagement elements are wires.

12. The delivery system of claim 1, wherein the activation members are wires.

13. The delivery system of claim 1, wherein the aperture of the first disk is centered about a longitudinal axis of the first disk.

14. The delivery system of claim 1, wherein the activation members are independently activated to axially move the first and second disks relative to each other.

15. The delivery system of claim 1, further comprising a sheath positioned at least partially around the activation members and the disks.

16. A sequential release mechanism for deploying an implantable stented device into a body lumen, the sequential release mechanism comprising:

a plurality of activation members;

a first disk comprising;

a proximal surface;

a distal surface;

at least one stent engagement element attached to the distal surface of the first disk; and

an aperture; and

a second disk comprising;

a proximal surface;

a distal surface;

at least one stent engagement element attached to the distal surface of the second disk; and

an aperture,

wherein at least one activation member attaches to the proximal surface of the first disk,

wherein at least one activation member passes through the aperture of the first disk and attaches to the proximal surface of the second disk, and

wherein at least one stent engagement element attached to the distal surface of the first disk passes through the aperture of the second disk.

17. The sequential release mechanism of claim 16, wherein a distal end of each stent engagement element comprises a coiled portion.

18. The sequential release mechanism of claim 16, wherein the activation members are independently activated to axially move the first and second disks relative to each other.

19. The sequential release mechanism of claim 16, wherein each stent engagement element can be at least temporarily deformed for engagement and disengagement with a stent crown of an implantable stented device.

20. A method of deploying an implantable stented device with a delivery system that comprises:

a tubular body having a proximal end and a distal end;

a plurality of activation members extending from the distal end of the tubular body; and

a first disk comprising;

a proximal surface;

a distal surface;

at least one stent engagement element attached to the distal surface of the first disk; and

an aperture; and

a second disk comprising;

a proximal surface;

a distal surface;

at least one stent engagement element attached to the distal surface of the second disk; and

an aperture,

wherein at least one activation member attaches to the proximal surface of the first disk,

wherein at least one activation member passes through the aperture of the first disk and attaches to the proximal surface of the second disk, and

wherein at least one stent engagement element attached to the distal surface of the first disk passes through the aperture of the second disk,

the method comprising;

engaging the stent engagement elements with a proximal end of the implantable stented device,

positioning the implantable stented device at an implantation location within a body lumen,

proximally moving at least one activation member, thereby proximally moving at least one disk, such that at least one stent engagement element disengages from the implantable stented device.

21. The method of claim 20, wherein proximally moving at least one activation member comprises:

proximally moving a first activation member or a first set of activation members, thereby moving the first disk, such that the at least one stent engagement elements attached to the first disk disengage from the implantable stented device; and

proximally moving a second activation member or a second set of activation members, thereby moving the second disk, such that the at least one stent engagement elements attached to the second disk disengage from the implantable stented device.

22. The method of claim of 21, wherein by proximally moving the first disk, the at least one stent engagement elements attached to the distal surface of the first disk contact the second disk and are at least temporarily deformed, allowing the at least one stent engagement elements to disengage from the implantable stented device and pass through the respective aperture of the second disk.

23. The method of claim 21, wherein the second disk is sequentially moved first, and the first disk is sequentially moved second.